| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2859766 | 09/18/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
|
got my first injection in January. I forgot to get my second; This non-serious case was reported by ...
got my first injection in January. I forgot to get my second; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (received 1st dose in January 2025). On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. The patient had incomplete course of vaccination (Verbatim: got my first injection in January. I forgot to get my second). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 12-SEP-2025 The reporter reported that he/she got first dose in January and totally forgot to go back and got second in March. The reporter asked did the reporter need to start over, or was it okay to just go get the second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination.
More
|
|||||||||
| 2859767 | 68 | F | FL | 09/18/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Pruritus, Rash papular, Urticaria
Pruritus, Rash papular, Urticaria
|
she began itching in several places on her body; she scratched and noted raised bumps coming up in t...
she began itching in several places on her body; she scratched and noted raised bumps coming up in the places where she scratches; Urticaria; Rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included levothyroxine sodium (Levothyroxine). On 21-JUL-2025, the patient received the 2nd dose of Shingrix (intramuscular). On 21-JUL-2025, less than a day after receiving Shingrix, the patient experienced generalized pruritus (Verbatim: she began itching in several places on her body), papular rash (Verbatim: she scratched and noted raised bumps coming up in the places where she scratches), urticaria (Verbatim: Urticaria) and rash (Verbatim: Rash). The patient was treated with levocabastine hydrochloride (Zyrtec). The action taken with Shingrix was unknown. The outcome of the generalized pruritus and papular rash were not reported and the outcome of the urticaria and rash were not resolved. It was unknown if the reporter considered the generalized pruritus, papular rash, urticaria and rash to be related to Shingrix. It was unknown if the company considered the generalized pruritus, papular rash, urticaria and rash to be related to Shingrix. Linked case(s) involving the same patient: US2025107407 Additional Information: GSK receipt date: 20-AUG-2025 Beginning about an hour after the injection, patient began itching in several places on her body. Thinking it was a bug bite, she scratched and noted raised bumps coming up in the places where she scratches. This was continued to happen all over her body. The bumps did not raise until the area was rubbed or scratched in response to the intense itching. She stated that the bumps went away after about an hour. The itching was worst in the evenings. She reported having treated the itching with Zyrtec for about two weeks, but it did not help. Patient was on Levothyroxine since 2000. For tolerance of 1st dose, please refer US2025107407.; Sender's Comments: US-GSK-US2025107407:Same patient
More
|
||||||
| 2859768 | M | MI | 09/18/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
37R35 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
|
Boostrix accidental dose; This non-serious case was reported by a other health professional via call...
Boostrix accidental dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 62-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 37R35, expiry date 21-OCT-2027) for prophylaxis. Previously administered products included Boostrix (received 1st dose on 30-APR-2013) and Boostrix (received 2nd dose on 17-AUG-2023). On 21-AUG-2025, the patient received the 3rd dose of Boostrix. On 21-AUG-2025, an unknown time after receiving Boostrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: Boostrix accidental dose). The outcome of the inappropriate schedule of vaccine administered was not applicable. It was unknown if the reporter considered the inappropriate schedule of vaccine administered to be related to Boostrix. It was unknown if the company considered the inappropriate schedule of vaccine administered to be related to Boostrix. Additional Information: GSK Receipt Date: 21-AUG-2025 The medical assistant called to report a dose of Boostrix was given on 21st August 2025 accidentally to a patient. Patient had previously received Boostrix on 17th August 2023 and on 30th April 2013. On the day of reporting the patient also received a pneumonia vaccine. The healthcare professional confirmed accidental dose would be the third dose of Tdap in total for the patient which led to inappropriate schedule of vaccine administration.
More
|
|||||||
| 2859769 | 5 | F | OH | 09/18/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
A32BB |
Expired product administered
Expired product administered
|
expired drug used; This non-serious case was reported by a other health professional via call center...
expired drug used; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number A32BB, expiry date 10-AUG-2025) for prophylaxis. On 19-AUG-2025, the patient received Pediarix. On 19-AUG-2025, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: expired drug used). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 22-Aug-2025 Clinical Supervisor reported that a dose of expired Pediarix was administered to patient.
More
|
||||||
| 2859770 | 2 | M | AZ | 09/18/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
324BY |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
Twinrix administration under 18 years of age; This non-serious case was reported by a other health p...
Twinrix administration under 18 years of age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received HAB (Twinrix) (batch number 324BY, expiry date 28-SEP-2026) for prophylaxis. On 03-SEP-2025, the patient received Twinrix. On 03-SEP-2025, an unknown time after receiving Twinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Twinrix administration under 18 years of age). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 10-SEP-2025 The reporter wanted to get safety information on the administration of Twinrix in five patients below 18 years of age which led to inappropriate age at vaccine administration. This is one of five cases reported by same reporter.; Sender's Comments: US-GSK-US2025116669:same reporter US-GSK-US2025116668:same reporter US-GSK-US2025116676:same reporter US-GSK-US2025116674:same reporter
More
|
||||||
| 2859771 | 1 | F | AZ | 09/18/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
324BY |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
Twinrix under 18 years of age administration; This non-serious case was reported by a other health p...
Twinrix under 18 years of age administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-month-old female patient who received HAB (Twinrix) (batch number 324BY, expiry date 28-SEP-2026) for prophylaxis. On 08-SEP-2025, the patient received Twinrix. On 08-SEP-2025, an unknown time after receiving Twinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Twinrix under 18 years of age administration). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 10-SEP-2025 The reporter wanted to get safety information on the administration of Twinrix in five patients below 18 years of age which led to inappropriate age at vaccine administration. This was one of the five cases reported by same reporter.; Sender's Comments: US-GSK-US2025116676:same reporter US-GSK-US2025116673:same reporter US-GSK-US2025116669:SAME REPORTER US-GSK-US2025116674:same reporter
More
|
||||||
| 2859772 | 1 | M | AZ | 09/18/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
324BY |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
Twinrix under 18 years of age administration; This non-serious case was reported by a other health p...
Twinrix under 18 years of age administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-month-old male patient who received HAB (Twinrix) (batch number 324BY, expiry date 28-SEP-2026) for prophylaxis. On 05-SEP-2025, the patient received Twinrix. On 05-SEP-2025, an unknown time after receiving Twinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Twinrix under 18 years of age administration). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 10-SEP-2025 The reporter wanted to get safety information on the administration of Twinrix in five patients below 18 years of age which led to inappropriate age at vaccine administration. This was one of the five cases reported by same reporter.; Sender's Comments: US-GSK-US2025116674:same reporter US-GSK-US2025116669:same reporter US-GSK-US2025116673:same reporter US-GSK-US2025116668:same reporter
More
|
||||||
| 2859773 | F | WA | 09/18/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
7745R |
Expired product administered
Expired product administered
|
Expired dose given; This non-serious case was reported by a other health professional via call cente...
Expired dose given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 7745R, expiry date 22-AUG-2025) for prophylaxis. On 28-AUG-2025, the patient received Kinrix. On 28-AUG-2025, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Expired dose given). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 15-SEP-2025 The healthcare professional called in to request data about the validity of an expired dose of Kinrix which was given in 28th August 2022, but the dose expired on 22nd August 2025 which led to expired vaccine used. The patient was a 4 year old. The vaccine administration facility was the same as primary reporter.
More
|
|||||||
| 2859774 | F | 09/18/2025 |
COVID19 |
MODERNA |
|
Bronchiectasis, Chronic obstructive pulmonary disease, Lung neoplasm malignant, ...
Bronchiectasis, Chronic obstructive pulmonary disease, Lung neoplasm malignant, Pneumonia
More
|
Bronchiectasis/Bronchitis; Pneumonia; COPD; Lung cancer; This spontaneous case was reported by a con...
Bronchiectasis/Bronchitis; Pneumonia; COPD; Lung cancer; This spontaneous case was reported by a consumer and describes the occurrence of LUNG NEOPLASM MALIGNANT (Lung cancer), BRONCHIECTASIS (Bronchiectasis/Bronchitis), PNEUMONIA (Pneumonia) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Spikevax. Past adverse reactions to the above products included No adverse effect with Spikevax. Concomitant products included Estrogens conjugated (Premarin) for an unknown indication. In November 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In November 2024, the patient experienced LUNG NEOPLASM MALIGNANT (Lung cancer) (seriousness criteria hospitalization and medically significant), PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) (seriousness criterion hospitalization). On an unknown date, the patient experienced BRONCHIECTASIS (Bronchiectasis/Bronchitis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 14 days due to BRONCHIECTASIS, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, LUNG NEOPLASM MALIGNANT and PNEUMONIA. At the time of the report, LUNG NEOPLASM MALIGNANT (Lung cancer), BRONCHIECTASIS (Bronchiectasis/Bronchitis), PNEUMONIA (Pneumonia) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) outcome was unknown. It was reported that patient had never received a Pfizer COVID-19 vaccine. Caller mentioned that from the beginning to the last one, patient had received the MODERNA vaccine. Caller also mentioned that patient received the MODERNA COVID-19 vaccine just before she ended up in the hospital with pneumonia and bronchitis. Caller explained that she didn't even know she had pneumonia when she went to the emergency room at that time, she wasn't on oxygen at that point, but she was on oxygen after that. Additionally, caller stated that she had been in the hospital the previous number and that on that particular day in November, patient woke up and didn't feel right. Caller explained that she was uncomfortable with the fact that Pfizer was aware that she had been hospitalized for 14 days when, to her knowledge, she did not receive a Pfizer product. During call, caller explained that patient had taken PREMARIN for a decade or more, but that patient had never experienced an adverse reaction. When asked whether PREMARIN was mentioned within letter sent by, patient stated that it did not. Patient got 4 breathing treatments a day which was a bit much.; Reporter's Comments: Company comment: Events have been assessed as not related due to lack of biological plausibility. The benefit-risk relationship of product is not affected by this report.
More
|
✓ | |||||||
| 2859775 | 09/18/2025 |
UNK |
UNKNOWN MANUFACTURER |
|
Influenza like illness
Influenza like illness
|
full flu-like effects; This spontaneous case was reported by a consumer and describes the occurrence...
full flu-like effects; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (full flu-like effects) in a patient of an unknown age and gender who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS (Patient had all the previous covid vaccines). Past adverse reactions to the above products included No adverse effect with Spikevax NOS. In 2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (unknown route) .5 milliliter. In 2025, the patient experienced INFLUENZA LIKE ILLNESS (full flu-like effects). At the time of the report, INFLUENZA LIKE ILLNESS (full flu-like effects) outcome was unknown. No concomitant medications were reported. The condition resulted in 1.5 days of bed rest. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-789274 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789274:Master case (Reporter's case)
More
|
|||||||||
| 2859776 | 41 | F | 09/18/2025 |
COVID19 COVID19 |
MODERNA PFIZER\BIONTECH |
|
COVID-19; COVID-19
COVID-19; COVID-19
|
COVID; This spontaneous case was reported by an other health care professional and describes the occ...
COVID; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID) in a 41-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Co-suspect products included non-company products Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication and Nirmatrelvir, Ritonavir (Paxlovid) for an unknown indication. The patient's past medical history included COVID-19 in February 2025. Concurrent medical conditions included Postural orthostatic tachycardia syndrome, Hypotension and Marfan's syndrome. On 18-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On an unknown date, the patient received dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form and Nirmatrelvir, Ritonavir (Paxlovid) (unknown route) 1 dosage form. In February 2025, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) outcome was unknown. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. The patient had suspicion by having all of those boosters and vaccines and prevented contracting COVID before. The patient had COVID one time and suspected that the combination of that and Paxlovid had kept it at bay. No treatment medications were reported. This case was linked to MOD-2025-789303 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2025: Live Non-significant follow-up received: Reference added.
More
|
|||||||
| 2859777 | 78 | F | 09/18/2025 |
COVID19 |
MODERNA |
|
Decreased appetite, Fatigue, Headache, Illness, Urticaria
Decreased appetite, Fatigue, Headache, Illness, Urticaria
|
loss of appetite; desperately sick from the March vaccine; hives/ the ones patient had before, patie...
loss of appetite; desperately sick from the March vaccine; hives/ the ones patient had before, patient thinks, had all been on the right; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), ILLNESS (desperately sick from the March vaccine), URTICARIA (hives/ the ones patient had before, patient thinks, had all been on the right), FATIGUE (fatigue) and HEADACHE (headache) in a 78-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer (side effects were usually pretty much the same, dose 1) in January 2021, Pfizer (side effects were usually pretty much the same and dose 2) in February 2021. Past adverse reactions to the above products included Vaccination adverse reaction with Pfizer and Pfizer. In March 2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In March 2025, the patient experienced DECREASED APPETITE (loss of appetite), ILLNESS (desperately sick from the March vaccine), URTICARIA (hives/ the ones patient had before, patient thinks, had all been on the right), FATIGUE (fatigue) and HEADACHE (headache). In 2025, DECREASED APPETITE (loss of appetite), ILLNESS (desperately sick from the March vaccine), URTICARIA (hives/ the ones patient had before, patient thinks, had all been on the right), FATIGUE (fatigue) and HEADACHE (headache) had resolved. No concomitant medication was reported. The patient's side effects were usually pretty much the same. The patient always had side effects that start around 3 in the afternoon because she always gets the vaccines early in the morning. They subside by nighttime the next day. At the time of current vaccination (Spikevax LP.8.1 PFS), her usual side effects - headache, fatigue, loss of appetite - were milder time in comparison to the vaccine she had in March. The patient was desperately sick from the March vaccine but did not have itchy rash at the injection site plus the hives that come and go on different parts of her body. The patient always plans it when she did not have important things to do the day after the COVID vaccine because she knows that she was going to be real sick. The current hives she had right now were on her right leg but the ones before, she thinks, had all been on the right. The patient did not remember but her feeling was that it was on her right hand and right arm. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to MOD-2024-773529 (Patient Link).
More
|
|||||||
| 2859778 | M | 09/18/2025 |
COVID19 |
MODERNA |
|
COVID-19, SARS-CoV-2 test
COVID-19, SARS-CoV-2 test
|
He had a positive test on Sept 9; This spontaneous case was reported by a consumer and describes the...
He had a positive test on Sept 9; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (He had a positive test on Sept 9) in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 07-Jun-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 09-Sep-2025, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced COVID-19 (He had a positive test on Sept 9). At the time of the report, COVID-19 (He had a positive test on Sept 9) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2025, SARS-CoV-2 test: Positive. No concomitant medication was reported. The patient had vaccine on 7-Jun-2025 and tested positive on 9-Sep-2025. It was unknown if the patient experienced any additional symptoms or events. Reporter causality was not reported. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789359 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789359:wife's case
More
|
||||||||
| 2859779 | M | 09/18/2025 |
COVID19 |
MODERNA |
|
COVID-19, Fatigue
COVID-19, Fatigue
|
covid infection; felt tired; This spontaneous case was reported by a consumer and describes the occu...
covid infection; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid infection) and FATIGUE (felt tired) in an elderly male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. In 2024, the patient received eighth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. In 2024, the patient experienced COVID-19 (covid infection) and FATIGUE (felt tired). In 2024, FATIGUE (felt tired) had resolved. At the time of the report, COVID-19 (covid infection) outcome was unknown. Relevant Medical History (vaccines within the past 4 weeks, medical conditions) was given as none. No concomitant medication was reported. The patient had covid infection 2 times after taking covid vaccines, one time in 2022 or 2023 and another time around Mar or Apr-2024. His last vaccine around Mar or Apr-2024, he felt tired for 3 days. He also stated that he took a total of 8 covid vaccines so far. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported. This case was linked to MOD-2025-789405 (Patient Link).
More
|
||||||||
| 2859780 | F | 09/18/2025 |
COVID19 |
MODERNA |
|
Autoimmune disorder
Autoimmune disorder
|
autoimmune disease; This spontaneous case was reported by a consumer and describes the occurrence of...
autoimmune disease; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (autoimmune disease) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (autoimmune disease) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE DISORDER (autoimmune disease) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications were provided. The patient wanted to receive the COVID booster. But the vaccine was not available. She had always received the Moderna vaccine and had managed to stay safe from COVID. Patient had an autoimmune disease. Patient was feeling frustrated about not being able to get the vaccine. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was provided.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.
More
|
||||||||
| 2859781 | F | 09/18/2025 |
UNK UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
|
Asthenia, Balance disorder, Brain fog, Confusional state, Decreased appetite; Di...
Asthenia, Balance disorder, Brain fog, Confusional state, Decreased appetite; Disorientation, Headache, Lethargy, Malaise, Mobility decreased; Nausea, Pain in extremity, Poor quality sleep, Syncope
More
|
loss of syncope; had the sore arm/arm hurts a lot for several days; not feeling well; had loss of ap...
loss of syncope; had the sore arm/arm hurts a lot for several days; not feeling well; had loss of appetite; lack of energy; lethargic; had some disorientation; didn't sleep well Friday night/couldn't sleep all night; could not get out of bed or get up off the couch without her husband helping her; balance issues when getting up; sort of mixed up, mean she was just not herself; currently a little foggy; experienced nausea; felt like was gonna throw up; headache; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (loss of syncope) in an elderly female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (loss of syncope) (seriousness criterion medically significant), PAIN IN EXTREMITY (had the sore arm/arm hurts a lot for several days), MALAISE (not feeling well), DECREASED APPETITE (had loss of appetite), ASTHENIA (lack of energy), LETHARGY (lethargic), DISORIENTATION (had some disorientation), INSOMNIA (didn't sleep well Friday night/couldn't sleep all night), MOBILITY DECREASED (could not get out of bed or get up off the couch without her husband helping her), BALANCE DISORDER (balance issues when getting up), CONFUSIONAL STATE (sort of mixed up, mean she was just not herself), BRAIN FOG (currently a little foggy), NAUSEA (experienced nausea), VOMITING (felt like was gonna throw up) and HEADACHE (headache). At the time of the report, SYNCOPE (loss of syncope), PAIN IN EXTREMITY (had the sore arm/arm hurts a lot for several days), MALAISE (not feeling well), DECREASED APPETITE (had loss of appetite), ASTHENIA (lack of energy), LETHARGY (lethargic), DISORIENTATION (had some disorientation), INSOMNIA (didn't sleep well Friday night/couldn't sleep all night), MOBILITY DECREASED (could not get out of bed or get up off the couch without her husband helping her), BALANCE DISORDER (balance issues when getting up), CONFUSIONAL STATE (sort of mixed up, mean she was just not herself), NAUSEA (experienced nausea), VOMITING (felt like was gonna throw up) and HEADACHE (headache) outcome was unknown and BRAIN FOG (currently a little foggy) had not resolved. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. Concomitant medication was not reported. It was reported that, patient was currently a little foggy. After the shot, she had a sore arm. Patient had got this shot on Friday, and as the day progressed, she started not feeling well. She didn't sleep well on Friday night. The patient fell asleep early but couldn't sleep all night and woke up at 12 and thought that it was the next day and then went back to sleep. On the next day, which was Saturday, she had lack of energy. She stated that she could not get out of bed or get up off the couch without help. She had a loss of syncope, lethargic, and had balance issues when getting up. It was added that her arm hurt a lot for several days and had some disorientation and was not sure what day it was and when it was sort of mixed up, she was just not herself. Patient had a COVID-19 shot every year and noted that her worst symptom was a sore arm. The last booster she had was a month before her trip in March. She did not know the lot number of the vaccine given to her but verified it was the latest vaccine which the pharmacy received on Monday. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789244, US-MODERNATX, INC.-MOD-2025-789242, US-MODERNATX, INC.-MOD-2025-789243 (E2B Linked Report). This case was linked to MOD-2025-789239, MOD-2025-789240 (Patient Link).; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789243:Patient son case (R-D) US-MODERNATX, INC.-MOD-2025-789244:Patient son case (D-D) US-MODERNATX, INC.-MOD-2025-789242:Patient daughter case (A-D)
More
|
||||||||
| 2859782 | 72 | F | 09/18/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
|
Abdominal discomfort, Chills, Injection site pain, Malaise, Nausea; Retching, Sl...
Abdominal discomfort, Chills, Injection site pain, Malaise, Nausea; Retching, Sleep disorder
More
|
stomach feels wonky; Patient was not feeling great at all; Patient woke up in the middle of the nigh...
stomach feels wonky; Patient was not feeling great at all; Patient woke up in the middle of the night with arm hurts at the site of the injection; Patient had chills; Patient feel a bit nauseous/dry-heaving; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach feels wonky), MALAISE (Patient was not feeling great at all), VACCINATION SITE PAIN (Patient woke up in the middle of the night with arm hurts at the site of the injection), CHILLS (Patient had chills) and NAUSEA (Patient feel a bit nauseous/dry-heaving) in a 72-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS (Patient had four vaccines from Moderna in the past with no adverse reaction.). Past adverse reactions to the above products included No adverse effect with Spikevax NOS. Concurrent medical conditions included AFib (diagnosed with A-fib 2 years ago). On 08-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 09-Sep-2025, the patient experienced ABDOMINAL DISCOMFORT (stomach feels wonky), MALAISE (Patient was not feeling great at all), VACCINATION SITE PAIN (Patient woke up in the middle of the night with arm hurts at the site of the injection), CHILLS (Patient had chills) and NAUSEA (Patient feel a bit nauseous/dry-heaving). At the time of the report, ABDOMINAL DISCOMFORT (stomach feels wonky), MALAISE (Patient was not feeling great at all), VACCINATION SITE PAIN (Patient woke up in the middle of the night with arm hurts at the site of the injection), CHILLS (Patient had chills) and NAUSEA (Patient feel a bit nauseous/dry-heaving) had not resolved. No concomitant medications were provided. Patient did not know which vaccine and report was received, no paperwork with a product name nor lot number. Patient got a Moderna COVID shot late yesterday afternoon. It seemed to be okay after that shot, but the patient woke up in the middle of the night with arm hurts at the site of the injection. And now this morning, the patient was not feeling great at all. The patient had chills and felt a bit nauseous. The patient had not vomited or anything yet. The patient had dry-heaving and even though stomach felt wonky, it was like nothing came up. The patient never had symptoms like that before after a Covid shot. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was provided. Reporter did not allow further contact
More
|
|||||||
| 2859783 | 78 | M | GA | 09/18/2025 |
UNK |
UNKNOWN MANUFACTURER |
3052549 |
No adverse event, Syringe issue, Underdose
No adverse event, Syringe issue, Underdose
|
No adverse effect; a quarter of the way through the injection, it got stuck, and HCP was not able to...
No adverse effect; a quarter of the way through the injection, it got stuck, and HCP was not able to administer the rest of it/patient only received maybe a quarter or so of the dose; a quarter of the way through the injection, it got stuck, and HCP was not able to administer the rest of it/HCP was administering a vaccine and had a malfunction with it; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (a quarter of the way through the injection, it got stuck, and HCP was not able to administer the rest of it/patient only received maybe a quarter or so of the dose), DEVICE MALFUNCTION (a quarter of the way through the injection, it got stuck, and HCP was not able to administer the rest of it/HCP was administering a vaccine and had a malfunction with it) and NO ADVERSE EVENT (No adverse effect) in a 78-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052549) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection (batch no. 3052549) for COVID-19 prophylaxis. No Medical History information was reported. On 09-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 09-Sep-2025, the patient experienced UNDERDOSE (a quarter of the way through the injection, it got stuck, and HCP was not able to administer the rest of it/patient only received maybe a quarter or so of the dose) and DEVICE MALFUNCTION (a quarter of the way through the injection, it got stuck, and HCP was not able to administer the rest of it/HCP was administering a vaccine and had a malfunction with it). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse effect). At the time of the report, UNDERDOSE (a quarter of the way through the injection, it got stuck, and HCP was not able to administer the rest of it/patient only received maybe a quarter or so of the dose), DEVICE MALFUNCTION (a quarter of the way through the injection, it got stuck, and HCP was not able to administer the rest of it/HCP was administering a vaccine and had a malfunction with it) and NO ADVERSE EVENT (No adverse effect) outcome was unknown. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. No concomitant medications were provided. The patient did not receive full dose of vaccine. HCP administering a vaccine and had a malfunction with it. The quarter of the way through the injection, it got stuck, and HCP was not able to administer the rest of it. Patient only received maybe a quarter or so of the dose. The Device problem code for pre-filled syringe include FDA code 1670, IMDRF code A23 which included Use of Device Problem. No treatment medication was provided. It was unknown if the patient experienced any additional symptoms/events.
More
|
||||||
| 2859784 | 78 | F | AZ | 09/18/2025 |
UNK |
UNKNOWN MANUFACTURER |
|
Decreased appetite, Feeling abnormal, Gait disturbance, Incoherent, Presyncope
Decreased appetite, Feeling abnormal, Gait disturbance, Incoherent, Presyncope
|
Never when she's completely fainted/Stood up and walked about 10 feet and began collapsing/had ...
Never when she's completely fainted/Stood up and walked about 10 feet and began collapsing/had trouble talking for a very short period of time/Was a little incoherent for a very short time; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Never when she's completely fainted/Stood up and walked about 10 feet and began collapsing/had trouble talking for a very short period of time/Was a little incoherent for a very short time) in a 78-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. Concurrent medical conditions included Allergy and Low blood pressure. On 08-Sep-2025 at 2:00 PM, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Never when she's completely fainted/Stood up and walked about 10 feet and began collapsing/had trouble talking for a very short period of time/Was a little incoherent for a very short time) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Never when she's completely fainted/Stood up and walked about 10 feet and began collapsing/had trouble talking for a very short period of time/Was a little incoherent for a very short time) had resolved. The action taken with mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) was unknown. Concomitant medication was not provided. The patient had not received any other vaccines 4 weeks prior to the vaccine. Patient had allergy shots within 4 weeks. Patient had no other medical conditions and heart related problems. It was reported that the patient had received the vaccine at pharmacy. On that morning, the patient felt fine when she got up. About one hour later when she had been sitting and starting to have breakfast, she had not been able eat at first then she felt bad. Afterwards, she had stood up, and walked about 10 feet, and had begun collapsing. The reporter had held her up as she became a dead weight. She had been a little incoherent for a very short time. Then the reporter lowered her to the floor where she had sat for a few minutes. Then she had been able to get up with assistance and had laid down on a couch. And after a few minutes, she recovered. It was reported that the patient had low blood pressure and that she had experienced a couple of similar episodes of feeling the same with low blood pressure, but never when she had completely fainted. It was clarified that the patient had not lost consciousness, but she had trouble talking for a very short period of time and she broke out in sweat and felt clammy. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported. Reporter causality was not provided.; Reporter's Comments: Concurrent medical condition Low blood pressure is a contributor for the event. The benefit -risk relationship of product is not affected by this report.
More
|
||||||
| 2859785 | F | 09/18/2025 |
UNK |
UNKNOWN MANUFACTURER |
|
Fatigue, Injection site pain
Fatigue, Injection site pain
|
fatigue; Patient had some soreness at the injection site; This spontaneous case was reported by a co...
fatigue; Patient had some soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and VACCINATION SITE PAIN (Patient had some soreness at the injection site) in an adult female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 08-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue) and VACCINATION SITE PAIN (Patient had some soreness at the injection site). At the time of the report, FATIGUE (fatigue) and VACCINATION SITE PAIN (Patient had some soreness at the injection site) outcome was unknown. No concomitant medications were reported. Patient had some soreness at the injection site and fatigue, but nothing horrible. Patient's husband had no side effects after receiving suspect vaccine. No treatment medications were reported. It was unknown if the patient experienced any additional symptoms/events.
More
|
||||||||
| 2859786 | F | 09/18/2025 |
UNK |
UNKNOWN MANUFACTURER |
|
Pain
Pain
|
She is requesting advice on which pain relief she can use without affecting the effectiveness of the...
She is requesting advice on which pain relief she can use without affecting the effectiveness of the vaccine; she is currently experiencing the usual side effects; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (She is requesting advice on which pain relief she can use without affecting the effectiveness of the vaccine) and IMMUNISATION REACTION (she is currently experiencing the usual side effects) in a female patient of an unknown age who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 10-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. In September 2025, the patient experienced PAIN (She is requesting advice on which pain relief she can use without affecting the effectiveness of the vaccine) and IMMUNISATION REACTION (she is currently experiencing the usual side effects). At the time of the report, PAIN (She is requesting advice on which pain relief she can use without affecting the effectiveness of the vaccine) and IMMUNISATION REACTION (she is currently experiencing the usual side effects) outcome was unknown. No concomitant medication was reported. The patient had received the Spikevax vaccine on 10-Sep-2025 and shared that she experienced the usual side effects. She requested advice on which pain relief she could use without affecting the effectiveness of the vaccine. It was unknown if the patient experienced any additional symptoms/events. Reporter causality was not reported. No treatment medication was reported. Reporter did not allow further contact
More
|
||||||||
| 2859787 | 70 | F | 09/18/2025 |
UNK |
UNKNOWN MANUFACTURER |
|
Peripheral swelling
Peripheral swelling
|
swelling of the arm; This spontaneous case was reported by a consumer and describes the occurrence o...
swelling of the arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling of the arm) in a 70-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 13-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling of the arm). At the time of the report, PERIPHERAL SWELLING (swelling of the arm) outcome was unknown. The action taken with mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) was unknown. No concomitant medications were reported. The patient did not experience any side effects from mNEXSPIKE vaccine except for swelling of the arm. She wanted to know if it was advisable to take another booster since the vaccine she received was a lower dose. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided.
More
|
|||||||
| 2859788 | M | 09/18/2025 |
COVID19 |
MODERNA |
|
COVID-19
COVID-19
|
covid infection; This spontaneous case was reported by a consumer and describes the occurrence of CO...
covid infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid infection) in an elderly male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid infection). At the time of the report, COVID-19 (covid infection) outcome was unknown. Relevant Medical History (vaccines within the past 4 weeks, medical conditions) were reported as none. No concomitant medication was reported. Patient had covid infection 2 times after taking covid vaccines, one time in 2022 or 2023 and another time around Mar or Apr-2024. Patient also had his last vaccine around Mar or Apr-2024, he felt tired for 3 days. Patient took a total of 8 covid vaccines so far. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to MOD-2025-789408 (Patient Link).
More
|
||||||||
| 2859789 | 67 | F | 09/18/2025 |
COVID19 |
MODERNA |
|
Chills, Immunisation reaction, Pyrexia
Chills, Immunisation reaction, Pyrexia
|
a pretty strong reaction; fever; chills; This spontaneous case was reported by a consumer and descri...
a pretty strong reaction; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (a pretty strong reaction), PYREXIA (fever) and CHILLS (chills) in a 67-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Concurrent medical conditions included Immunocompromised. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (a pretty strong reaction), PYREXIA (fever) and CHILLS (chills). At the time of the report, IMMUNISATION REACTION (a pretty strong reaction), PYREXIA (fever) and CHILLS (chills) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. The patient was immunocompromised and that she normally got the Moderna COVID19 vaccine. No details were provided as to why she was immunocompromised. She did mention that with previous Moderna COVID19 vaccines she had a pretty strong reaction and got a fever and chills. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported.
More
|
|||||||
| 2859790 | 76 | M | 09/18/2025 |
COVID19 |
MODERNA |
|
Immunisation reaction, Pruritus
Immunisation reaction, Pruritus
|
itching on the arm; experiencing mild symptoms; This spontaneous case was reported by a consumer and...
itching on the arm; experiencing mild symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching on the arm) and IMMUNISATION REACTION (experiencing mild symptoms) in a 76-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching on the arm) and IMMUNISATION REACTION (experiencing mild symptoms). At the time of the report, PRURITUS (itching on the arm) and IMMUNISATION REACTION (experiencing mild symptoms) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. Relevant Medical History (vaccines within the past 4 weeks, medical conditions) was given as unknown. No concomitant medication was reported. The patient received every available Spikevax COVID-19 vaccine. He had mild symptoms, including itching on the arm. No treatment medication was reported. Reporter did not allow further contact
More
|
|||||||
| 2859791 | F | 09/18/2025 |
COVID19 |
MODERNA |
|
COVID-19
COVID-19
|
Patient caught COVID; This spontaneous case was reported by a consumer and describes the occurrence ...
Patient caught COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient caught COVID) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In 2024, the patient experienced COVID-19 (Patient caught COVID). At the time of the report, COVID-19 (Patient caught COVID) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. It was reported that the spike backed. Patient had that last year. It worked pretty well, the last time patient had it, had COVID. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not reported.
More
|
||||||||
| 2859792 | F | 09/18/2025 |
COVID19 |
MODERNA |
|
Body temperature, Pyrexia
Body temperature, Pyrexia
|
Report severe side effects from your vaccine/patient had 101 fever for three days; This spontaneous ...
Report severe side effects from your vaccine/patient had 101 fever for three days; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Report severe side effects from your vaccine/patient had 101 fever for three days) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Report severe side effects from your vaccine/patient had 101 fever for three days). At the time of the report, PYREXIA (Report severe side effects from your vaccine/patient had 101 fever for three days) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. Reporter thought there was something wrong with the vaccine. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not reported. Reporter did not allow further contact
More
|
||||||||
| 2859793 | 72 | F | 09/18/2025 |
COVID19 COVID19 |
MODERNA PFIZER\BIONTECH |
|
Feeling abnormal; Feeling abnormal
Feeling abnormal; Feeling abnormal
|
feeling sort of bad for a week or two; This spontaneous case was reported by a consumer and describe...
feeling sort of bad for a week or two; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling sort of bad for a week or two) in a 72-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. Previously administered products included for Product used for unknown indication: Pfizer BioNTech COVID-19 vaccine (previously received multiple Pfizer doses). Past adverse reactions to the above products included No adverse effect with Pfizer BioNTech COVID-19 vaccine. Concurrent medical conditions included Selective IgG immunodeficiency. In 2024, the patient received dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feeling sort of bad for a week or two). At the time of the report, FEELING ABNORMAL (feeling sort of bad for a week or two) had resolved. No concomitant medication was reported. Patient had previously received multiple Pfizer doses, a Moderna booster, and another Pfizer booster last year. Patient had felt sort of bad for a week or two after previous COVID-19 vaccinations but clarified it was nothing unusual. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not reported.
More
|
|||||||
| 2859795 | M | 09/18/2025 |
UNK |
UNKNOWN MANUFACTURER |
|
Vaccine interaction
Vaccine interaction
|
potential interaction between the Pfizer COVID-19 vaccine and an antibiotic, levofloxacin.; This is ...
potential interaction between the Pfizer COVID-19 vaccine and an antibiotic, levofloxacin.; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; levofloxacin (LEVOFLOXACIN), for infection. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INTERACTION (non-serious), outcome "unknown", described as "potential interaction between the Pfizer COVID-19 vaccine and an antibiotic, levofloxacin.". The action taken for levofloxacin was unknown. Additional information: Caller questioned that he have another question and that always has been fine in the past, but he have Alpha-gal, which is allergy to mammalian and previously when he contacted Pfizer, they said that there were not animal or mammalian products in the product and that was fine. he assuming since it was fine last year, He took is that still good. Levels are much lower and there is less risk this year. He wanted to double check. After he provided available information to address her question caller stated that what it said last year and he took it and he was fine. Responded that animal-derived raw materials are used during the manufacturing process of Comirnaty (2025-2026 Formula)|(COVID-19 Vaccine, mRNA) but are not expected to be in the final product presentation. The final product does not contain any animal-derived ingredients. The caller inquired about the potential interaction between the Pfizer COVID-19 vaccine and an antibiotic, levofloxacin. Would it affect the efficacy of the vaccine or antibiotic itself. Caller stated that he has taken it for 10 days and has 20 more days to go, when attempted to clarify who the caller was referring to, in terms of taking medication, caller stated that "he is right here though" unclear who the caller was referring to later on caller stated "this is just a mild infection".
More
|
||||||||
| 2859796 | 77 | F | MO | 09/18/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
|
Got Vaccines in the past the Pfizer Vaccines (Pfizer COVID-19 Vaccine); Prescribed the medication (P...
Got Vaccines in the past the Pfizer Vaccines (Pfizer COVID-19 Vaccine); Prescribed the medication (Paxlovid) today; I have taken Paxlovid once before; Got Vaccines in the past the Pfizer Vaccines (Pfizer COVID-19 Vaccine); Prescribed the medication (Paxlovid) today; I have taken Paxlovid once before; sick; This is a spontaneous report received from a Consumer or other non HCP. A 77-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) at the age of 77 years for covid-19 treatment. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Paxlovid, notes: I have taken Paxlovid once before. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Got Vaccines in the past the Pfizer Vaccines (Pfizer COVID-19 Vaccine); Prescribed the medication (Paxlovid) today; I have taken Paxlovid once before"; ILLNESS (non-serious), outcome "not recovered", described as "sick". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: The call was transferred from the Patient Support Program regarding a patient who reported an adverse event related to Paxlovid. The agent stated that the patient had previously received Pfizer COVID-19 vaccines and had been prescribed Paxlovid that day, which the patient confirmed as correct after the concern was paraphrased. The patient was informed about the role of Pfizer Drug Safety. The patient mentioned a height of approximately five feet three and a quarter inches, though it was not clarified further. Regarding the prescribing healthcare professional, the patient stated that she was an intern with their doctor, possibly an internist or primary care physician, but this was not certain. When asked about follow-up consent, the patient questioned why contact would be needed and declined, preferring not to have the healthcare provider bothered. The patient described details on the Paxlovid packaging, including numbers under the expiration date and above the lot number, as well as a UPC number on the barcode. The patient reported testing positive for COVID and explained that they had not yet started Paxlovid, as they had just picked it up from the pharmacy and would take the first dose once at home. When asked about COVID-19 vaccination history, the patient stated that they had not received the most recent dose but were up to date on vaccines and had previously taken Paxlovid. The patient confirmed that they had received Pfizer COVID-19 vaccines and Paxlovid in the past and had now been prescribed Paxlovid again. Further probing was not possible as the patient ended the call abruptly, resulting in limited information being available. A product complaint was also reported, and the information on the batch and lot number for BNT162B2 was to be requested and submitted if and when received. On follow-up, additional information was provided, including confirmation of the patient's gender and the addition of a new event, sick. During the call, the patient explained that they had signed up for the card to get a discount on Paxlovid, that they were sick, and that they needed to take the medication. While waiting for payment to process, the patient commented positively about Pfizer and their COVID vaccines, expressing appreciation for the work done to keep people healthy and help them recover. The call was then transferred to a DSU pharmacist, though the safety information provided was incomplete, and the source document was sent to include that the patient was sick. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
More
|
||||||
| 2859797 | F | PA | 09/18/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Injection site erythema, Injection site pain, Myalgia, Pyrexia
Injection site erythema, Injection site pain, Myalgia, Pyrexia
|
redness and pain at the site; redness and pain at the site; stayed in bed with generalized muscle ac...
redness and pain at the site; redness and pain at the site; stayed in bed with generalized muscle aches and fever for at least one full day.; stayed in bed with generalized muscle aches and fever for at least one full day.; This is a spontaneous report received from a Nurse. An elderly female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose 7, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "sulfa allergy" (unspecified if ongoing); "GI cramping" (unspecified if ongoing), notes: with cantaloupe and avocado. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 immunisation, reaction(s): "Generalized muscle aches", "fever", "Vaccination site erythema", "Vaccination site pain"; Bnt162b2 (dose 2, single), for COVID-19 immunisation, reaction(s): "Generalized muscle aches", "fever", "Vaccination site erythema", "Vaccination site pain"; Bnt162b2 (dose 3, single), for COVID-19 immunisation, reaction(s): "Generalized muscle aches", "fever", "Vaccination site erythema", "Vaccination site pain"; Bnt162b2 (dose 4, single), for COVID-19 immunisation, reaction(s): "Generalized muscle aches", "fever", "Vaccination site erythema", "Vaccination site pain"; Bnt162b2 (dose 5, single), for COVID-19 immunisation, reaction(s): "Generalized muscle aches", "fever", "Vaccination site erythema", "Vaccination site pain"; Bnt162b2 (dose 6, single), for COVID-19 immunisation, reaction(s): "Generalized muscle aches", "fever", "Vaccination site erythema", "Vaccination site pain". The following information was reported: INJECTION SITE ERYTHEMA (non-serious), INJECTION SITE PAIN (non-serious), outcome "unknown" and all described as "redness and pain at the site"; MYALGIA (non-serious), PYREXIA (non-serious), outcome "unknown" and all described as "stayed in bed with generalized muscle aches and fever for at least one full day.". Additional information: The pharmacist struggled to inject the contents of the syringe, and the reporter suspected that the vaccine never entered her body. After feeling the needle in her arm, she said, 'It's not going in.' The pharmacist proceeded to push against the patient's arm, to the extent that she had to rigidly tighten her upper body to stay upright in the chair during her odd "pushing" attempts. She never said that the contents of the syringe had gone in. She withdrew the syringe, wrote on some papers, and quickly dismissed her. After all seven previous Pfizer Covid-19 vaccinations, the reporter experienced redness and pain at the injection site and had to stay in bed with generalized muscle aches and a fever for at least one full day. However, after yesterday's vaccination, she has not experienced any pain at the injection site. She wonders why the practitioner had so much trouble after the needle was in. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500182329 same patient, different vaccine/event;
More
|
|||||||
| 2859798 | 56 | F | MI | 09/18/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Fatigue, Vaccination site pain
Fatigue, Vaccination site pain
|
extremely tired 24 hours after receiving the shot; arm where she received the injection was still ve...
extremely tired 24 hours after receiving the shot; arm where she received the injection was still very sore; This is a spontaneous report received from a Consumer or other non HCP from a sales representative. A 56-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 15Sep2025 at 15:30 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing); "drug allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 16Sep2025, outcome "not recovered", described as "arm where she received the injection was still very sore"; FATIGUE (non-serious) with onset 16Sep2025 at 15:30, outcome "unknown", described as "extremely tired 24 hours after receiving the shot". Therapeutic measures were not taken as a result of vaccination site pain, fatigue. Additional information: The patient did not receive any other vaccines on the same date as the vaccine. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
More
|
||||||
| 2859799 | 09/18/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Illness
Illness
|
Still feel sick three days after the new Covid shot; This is a spontaneous report received from a Co...
Still feel sick three days after the new Covid shot; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Still feel sick three days after the new Covid shot". Additional information: Reported Event: Unique Identification number: NA, Chat question Verbatim: Still feel sick three days after the new Covid shot. Is this normal? The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
More
|
|||||||||
| 2859800 | NJ | 09/18/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Parosmia, Taste disorder
Parosmia, Taste disorder
|
Just received latest vaccine shot. I believe my senses of smell and taste have been enhanced; Just r...
Just received latest vaccine shot. I believe my senses of smell and taste have been enhanced; Just received latest vaccine shot. I believe my senses of smell and taste have been enhanced; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1; MANUFACTURER UNKNOWN), administration date: Mar2020, for Covid-19 immunization, reaction(s): "fever". The following information was reported: PAROSMIA (non-serious), TASTE DISORDER (non-serious), outcome "unknown" and all described as "Just received latest vaccine shot. I believe my senses of smell and taste have been enhanced". Batch/lot number is not provided, and it cannot be obtained.
More
|
||||||||
| 2859801 | 09/18/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective
COVID-19, Drug ineffective
|
have COVID/my eyes are burning/can hardly breathe; have COVID/my eyes are burning/can hardly breathe...
have COVID/my eyes are burning/can hardly breathe; have COVID/my eyes are burning/can hardly breathe; This is a spontaneous report received from a Consumer or other non HCP. An elderly patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Pfizer vaccines (I've had seven to date), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "have COVID/my eyes are burning/can hardly breathe". During an inbound call for financial assistance for Paxlovid and during explanation of Program eligibility requirements, the patient stated as follows, "If I don't take it - I have COPD-I'm risking dying, here." The patient then went on to state, "I've got all my daggone Pfizer vaccines, I've had seven to date - and yet here I am with COVID, and this is the Pfizer medication, I just happen to be over 65 and have insurance. The patient later stated, "Does this stuff really work? I don't know, I have no experience with COVID, I've been really really careful for five years, but suddenly, here I am. I mean really, does this stuff work?" Later in the call, the patient stated, "I did everything possible to avoid this for five years." When advised that they can reach out to Pfizer, the patient stated, that they had COVID and don't have time to dig around, eyes are burning and can hardly breathe". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
More
|
|||||||||
| 2859805 | M | PA | 09/18/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Meniere's disease
Meniere's disease
|
flare up in my husband's meniere's; This is a spontaneous report received from a Consumer ...
flare up in my husband's meniere's; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), in Sep2025 as dose 1,single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Meniere's disease" (ongoing). The patient's concomitant medications were not reported. The following information was reported: MENIERE'S DISEASE (medically significant) with onset Sep2025, outcome "unknown", described as "flare up in my husband's meniere's". The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. Clinical course: It was reported that covid vaccine they had a week ago caused a flare up in her husband's meniere's. She saw the had noticed this in patients so wanted to let you guys know. Maybe learning why that flared can lead to an understanding of menieres that can lead to medications that help. It was debilitating condition. It's report it to vaers, but just wanted to give a heads up. Thanks, she had strong RA flare side effects to Moderna previously and did great with yours. The information on the batch/lot number yuygfor BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
More
|
|||||||
| 2859806 | 33 | F | PA | 09/18/2025 |
FLU3 |
SANOFI PASTEUR |
UT8792LA |
Exposure during pregnancy, No adverse event
Exposure during pregnancy, No adverse event
|
patient is pregnant with no reported adverse event; Initial information received on 11-Sep-2025 rega...
patient is pregnant with no reported adverse event; Initial information received on 11-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 33 years old pregnant female patient who was exposed to Influenza Usp Trival A-B Subvirion Vaccine [Fluzone] in context of patient is pregnant with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported patient is pregnant with no reported adverse event occurred at 7 weeks of pregnancy and the patient was exposed to Influenza Usp Trival A-B Subvirion Vaccine at 7 weeks of pregnancy, during first pregnancy trimester for Influenza Usp Trival A-B Subvirion Vaccine. The date of last menstrual period was reported as 25-Jul-2025. The estimated due date is 01-May-2026. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies. On 11-Sep-2025, the pregnant patient received an unknown dose (dose 1) of suspect Influenza Usp Trival A-B Subvirion Vaccine, Suspension for injection (Lot UT8792LA, expiry date and strength not reported) via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation) and with no reported adverse event (maternal exposure during pregnancy). Action taken was not applicable. Additionally, at time of reporting, the pregnancy is still ongoing.
More
|
||||||
| 2859807 | IL | 09/18/2025 |
DTAPIPVHIB HIBV |
SANOFI PASTEUR SANOFI PASTEUR |
|
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
More
|
patient received pentacel and acthib the same day at the same time with no reported ae; Initial info...
patient received pentacel and acthib the same day at the same time with no reported ae; Initial information received on 12-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Mrc5)/Hib(Prp/T) Vaccine [Pentacel] And Hib (Prp/T) Vaccine [Act-Hib], on same day at the same time with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Mrc5)/Hib(Prp/T) Vaccine, Suspension for injection, and received an unknown dose of suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection both with (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for immunisation, on same day at the same time with no reported adverse event (Extra dose administered) (Same day). Reportedly, duplicate dose of Hib administered to a patient. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA277652:
More
|
||||||||
| 2859808 | 78 | F | NY | 09/18/2025 |
FLU3 |
SANOFI PASTEUR |
U8764BB |
Asthenia, Clumsiness, Hypoaesthesia, Tremor
Asthenia, Clumsiness, Hypoaesthesia, Tremor
|
clumsiness; after a few days since, they developed severe shaking in their hands; added that also fe...
clumsiness; after a few days since, they developed severe shaking in their hands; added that also feel weakness; numbness; Initial information received on 12-Sep-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional). This case involves a 78 years old female patient who had clumsiness, after a few days since, they developed severe shaking in their hands, added that also feel weakness and numbness after receiving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 25-Aug-2025, the patient received an unknown dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8764BB, expiry date 30-Jun-2026, strength not reported) via unknown route in unknown administration site for Immunization. On an unknown date in 2025, the patient developed clumsiness, after a few days since, they developed severe shaking in their hands (tremor), added that also feel weakness (asthenia) and numbness (hypoaesthesia) (latency unknown) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine. Action taken was not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Not Recovered / Not Resolved for the event (Tremor), was Unknown for the event (numbness), (Asthenia) and (Hypoaesthesia).
More
|
||||||
| 2859809 | IL | 09/18/2025 |
DTAPIPVHIB HIBV |
SANOFI PASTEUR SANOFI PASTEUR |
|
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
More
|
stated that a patient received pentacel and acthib the same day at the same time with no reported ad...
stated that a patient received pentacel and acthib the same day at the same time with no reported adverse event; Initial information received on 12-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case was linked to US-SA-2025SA276269 This case involves an unknown age and unknown gender patient who received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Mrc5)/Hib(Prp/T) Vaccine [Pentacel] and Hib (Prp/T) Vaccine [Act-Hib], on same day at the same time with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Mrc5)/Hib(Prp/T) Vaccine, Suspension for injection, and received an unknown dose of suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection both with (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for immunisation, on same day at the same time with no reported adverse event (Extra dose administered) (Same day). Information regarding batch number corresponding to the one at time of event occurrence is requested. Reportedly, duplicate dose of Hib administered to a patient. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA276269:
More
|
||||||||
| 2859810 | 20 | M | FL | 09/18/2025 |
COVID19 |
JANSSEN |
|
Illness, Tension headache
Illness, Tension headache
|
Sickness following the vaccine, tension headaches since receiving
Sickness following the vaccine, tension headaches since receiving
|
||||||
| 2859811 | 31 | M | NC | 09/18/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
|
Drug eruption, Echocardiogram, Ejection fraction decreased, Fibrin D dimer, Haem...
Drug eruption, Echocardiogram, Ejection fraction decreased, Fibrin D dimer, Haematochezia; Multisystem inflammatory syndrome in adults, Myocarditis, Rash maculo-papular, Tachycardia, Ultrasound Doppler
More
|
Myocarditis, hematochezzia, drug induced exanthem, macular papilar rash, tachycardia, reduced EF and...
Myocarditis, hematochezzia, drug induced exanthem, macular papilar rash, tachycardia, reduced EF and MIS-A
More
|
✓ | |||||
| 2859812 | 36 | M | VA | 09/18/2025 |
COVID19 COVID19 |
JANSSEN JANSSEN |
unknown unknown |
Feeling cold, Hepatic steatosis, Hypertension, Immediate post-injection reaction...
Feeling cold, Hepatic steatosis, Hypertension, Immediate post-injection reaction, Magnetic resonance imaging; Multiple sclerosis, Pyrexia
More
|
Immediately following the event I developed a horrible fever and had heavy blankets and a coat on in...
Immediately following the event I developed a horrible fever and had heavy blankets and a coat on in the middle of the desert in the summer. This lasted for days. Months later I developed symptoms which would eventually lead to me being diagnosed with multiple sclerosis.
More
|
✓ | ✓ | ||||
| 2859813 | 47 | M | CT | 09/18/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
En6206 En6206 |
Arthralgia, Fatigue, Lymphadenopathy, Magnetic resonance imaging, Pain in extrem...
Arthralgia, Fatigue, Lymphadenopathy, Magnetic resonance imaging, Pain in extremity; Taste disorder, X-ray
More
|
Fatigue, joint pain, swollen lympnodes, suddenly can?t stand mint and certain tastes, lower leg pain...
Fatigue, joint pain, swollen lympnodes, suddenly can?t stand mint and certain tastes, lower leg pain/fatigue
More
|
||||||
| 2859814 | 26 | F | WA | 09/18/2025 |
COVID19 |
JANSSEN |
1822809 |
Headache, Impaired work ability, Malaise, Mobility decreased, Tremor
Headache, Impaired work ability, Malaise, Mobility decreased, Tremor
|
I became extremely ill after receiving the J&J Covid-19 Vaccine- I needed an inhaler, an oxidize...
I became extremely ill after receiving the J&J Covid-19 Vaccine- I needed an inhaler, an oxidizer, and was bed-ridden for 4 days. This put me out of my work place, and behind in my pilot training. I was extremely healthy before this, too. I have since had random spurts of hand shakes and headaches.
More
|
||||||
| 2859815 | 84 | F | FL | 09/18/2025 |
FLU3 |
SEQIRUS, INC. |
|
Erythema, Pain
Erythema, Pain
|
Explained to patient that to put ice and patient is already taking pain medication with tylenol, and...
Explained to patient that to put ice and patient is already taking pain medication with tylenol, and also indicated the redness could be an immune response reaction., and contact her provider if the condition gets worse
More
|
||||||
| 2859816 | 52 | F | GA | 09/18/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
NR4T5 |
Blister, Oral mucosal blistering
Blister, Oral mucosal blistering
|
Blisters on face and mouth
Blisters on face and mouth
|
||||||
| 2859817 | 32 | M | CA | 09/18/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Unevaluable event
Unevaluable event
|
IM/intramuscular second dose not administered
IM/intramuscular second dose not administered
|
||||||
| 2859818 | 35 | F | 09/18/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
|
Angina pectoris, Arteriospasm coronary, Cardiac perfusion defect, Dyspnoea, Dysp...
Angina pectoris, Arteriospasm coronary, Cardiac perfusion defect, Dyspnoea, Dyspnoea exertional; Exercise electrocardiogram abnormal, Fatigue, Ischaemia, Pulmonary embolism, Ventilation/perfusion scan abnormal
More
|
Began to have new, shortness of breath and fatigue consistently with even minimal exertion
Began to have new, shortness of breath and fatigue consistently with even minimal exertion
|
✓ | ✓ | |||||
| 2859819 | 35 | M | FL | 09/18/2025 |
FLU3 HEPAB HPV9 PNC20 |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. PFIZER\WYETH |
u8832da az2a3 y012921 lc1281 |
Fall, Presyncope, Syncope; Fall, Presyncope, Syncope; Fall, Presyncope, Syncope;...
Fall, Presyncope, Syncope; Fall, Presyncope, Syncope; Fall, Presyncope, Syncope; Fall, Presyncope, Syncope
More
|
Vasovagal Fainted and fell down
Vasovagal Fainted and fell down
|