| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2802669 | 66 | F | AL | 10/27/2024 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
Y011819 Y011819 |
Erythema, Peripheral swelling; Erythema, Peripheral swelling
Erythema, Peripheral swelling; Erythema, Peripheral swelling
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Very red and swollen arm. Redness got bigger across the entire arm
Very red and swollen arm. Redness got bigger across the entire arm
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| 2801462 | 49 | F | IL | 10/22/2024 |
COVID19 FLU3 PNC21 COVID19 FLU3 PNC21 |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. UNKNOWN MANUFACTURER GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
LM2216 KM5GK YO11819 LM2216 KM5GK Y011819 |
Injection site rash; Injection site rash; Injection site rash; Injection site ra...
Injection site rash; Injection site rash; Injection site rash; Injection site rash, Investigation; Injection site rash, Investigation; Injection site rash, Investigation
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Patient had rash on her left arm near vaccine injection site. Patient stopped at our pharmacy and re...
Patient had rash on her left arm near vaccine injection site. Patient stopped at our pharmacy and reported rash on 10/22/2024.
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| 2799230 | 78 | F | AZ | 10/15/2024 |
COVID19 FLU3 PNC21 VARZOS COVID19 FLU3 PNC21 VARZOS |
PFIZER\BIONTECH SANOFI PASTEUR MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS PFIZER\BIONTECH SANOFI PASTEUR MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
lm2211 ut8473aa y011819 e7335 Y011819 |
Infection, Pain in extremity, Peripheral swelling, Rash, Skin warm; Infection, P...
Infection, Pain in extremity, Peripheral swelling, Rash, Skin warm; Infection, Pain in extremity, Peripheral swelling, Rash, Skin warm; Infection, Pain in extremity, Peripheral swelling, Rash, Skin warm; Infection, Pain in extremity, Peripheral swelling, Rash, Skin warm; Infection, Pain in extremity, Peripheral swelling, Rash, Skin warm; Infection, Pain in extremity, Peripheral swelling, Rash, Skin warm; Infection, Pain in extremity, Peripheral swelling, Rash, Skin warm; Infection, Pain in extremity, Peripheral swelling, Rash, Skin warm
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The patient's right arm had swollen up, sore, hot, rash, and painful. Started up on Friday 10/1...
The patient's right arm had swollen up, sore, hot, rash, and painful. Started up on Friday 10/11/2024 She went to urgent care and they gave her Keflex on Sunday 10/13/2024. She was admitted to the hospital on 10/14/2024. As of 10/15/2025 the doctors were still not sure what the infection was and were starting steroids.
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| 2832945 | M | 03/24/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
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Arthralgia, Blood test, Brain fog, Cough, Fatigue; Haematochezia, Haemoptysis, I...
Arthralgia, Blood test, Brain fog, Cough, Fatigue; Haematochezia, Haemoptysis, Inflammation, Myalgia, Rash; Sleep disorder, Sluggishness
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Got blood in his stools and his cough; Fatigue; Muscle pain; Joint pain; Cough; Brain fog; Sleep dis...
Got blood in his stools and his cough; Fatigue; Muscle pain; Joint pain; Cough; Brain fog; Sleep disturbance; sluggish; skin rashes, rashes on his face; Got Inflammation in his body; Got blood in his stools and his cough; This is a spontaneous report received from a Consumer or other non HCP. A 44-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: HAEMATOCHEZIA (medically significant), HAEMOPTYSIS (non-serious), outcome "unknown" and all described as "Got blood in his stools and his cough"; FATIGUE (non-serious), outcome "unknown"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; COUGH (non-serious), outcome "unknown"; BRAIN FOG (non-serious), outcome "unknown"; SLEEP DISORDER (non-serious), outcome "unknown", described as "Sleep disturbance"; SLUGGISHNESS (non-serious), outcome "unknown", described as "sluggish"; RASH (non-serious), outcome "unknown", described as "skin rashes, rashes on his face"; INFLAMMATION (non-serious), outcome "unknown", described as "Got Inflammation in his body". The events "got blood in his stools and his cough", "fatigue", "muscle pain", "joint pain", "cough", "brain fog", "sleep disturbance", "sluggish", "skin rashes, rashes on his face" and "got inflammation in his body" required physician office visit. Clinical course: the patient took the Pfizer Covid Vaccine and he got crazy side effects: It is fatigue, muscle and joint pain, cough, brain fog, sleep disturbance, he can't get worked out, he is feeling rest of the time, he is very sluggish, he has got blood in his stools and his cough, he has got skin rashes, rashes on his face, 'when he eats' he has got inflammation in his body. Regarding the treatment for side effects, it was reported as yes, he has been to several doctors. Do not know which one per say exactly, but he has been to psychologist, he is going to blood specialist, he is seeing so many doctors, he is waiting for people being reviewed for almost over 3 years. It has been over 3 years and he is terrible. For the patient age, it was reported probably 44 or 45. Maybe 44, event start: probably around 44 years of age, so maybe 4 years before 20Mar2025. Concomitant medications or other medical conditions reported as several medications on daily basis, but do not know which ones. Treatment: He is taking medication now but he never used to have to take medication, like the way he is doing it now. The patient underwent the following laboratory tests and procedures: Blood test: Unknown results. Therapeutic measures were taken as a result of haematochezia, fatigue, myalgia, arthralgia, cough, brain fog, sleep disorder, sluggishness, rash, inflammation, haemoptysis. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2832946 | M | TX | 03/24/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
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Covid/had it again; COVID; COVID; This is a spontaneous report received from a Consumer or other non...
Covid/had it again; COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An 83-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "COVID"; DISEASE RECURRENCE (medically significant) with onset 21Feb2024, outcome "not recovered", described as "Covid/had it again". The event "covid/had it again" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Feb2024) positive. Clinical course: During an inbound call the caller stated "Last night (21Feb2024) I went to the doctor, I had got COVID I tested positive yesterday went to the doctor last night told them I had used the Paxlovid about 2 years ago when I had umm, and I had gotten the shots the COVID shots first, second and the booster but that was prior that's going back to 2019 and 2020 whenever they did the shots but then I still got the COVID and I had the used the Paxlovid it helped me get out of the symptoms" So just yesterday I found out I had it again" Later during the call, the caller was asked if they had previously taken Paxlovid and the caller replied "Yes it was about 2 year I want to say it was 2 years ago last fall I was up in (Withheld) I know it wasn't this past fall probably the October prior to that. "2022" "It could've been 22, 21 or 22". The information on the batch/lot number for BNT162B2 will be requested and submitted if and when received.
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| 2832947 | 1.25 | F | CA | 03/24/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK040AA |
No adverse event, Product preparation issue
No adverse event, Product preparation issue
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administered pentacel to a patient yesterday but only the dtap-ipv component was given. the hib comp...
administered pentacel to a patient yesterday but only the dtap-ipv component was given. the hib component was not reconstituted with no reported ae; Initial information received on 11-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old female patient who was administered Diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] but only the DTAP-IPV component was given the HIB component was not reconstituted with no reported AE (adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided Concomitant medications included Pneumococcal vaccine for Immunisation. On 10-Mar-2025, the patient received a 0.5ml dose which was of suspect Diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection standard strength (frequency-once) (lot UK040AA) (expiry date-31-Jul-2025) intramuscular route in the left thigh for immunization and only the dtap-ipv component was given. the hib component was not reconstituted with no reported AE (single component of a two-component product administered) (latency-same day). Reportedly- It was supposed to be a final series 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.
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| 2832956 | 77 | F | NC | 03/24/2025 |
PNC21 |
MERCK & CO. INC. |
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Injection site bruising, Injection site pain
Injection site bruising, Injection site pain
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02/27/2025 at her pharmacy. The caller stated that she noticed a bruise forming underneath the banda...
02/27/2025 at her pharmacy. The caller stated that she noticed a bruise forming underneath the bandage. The next day on 02/28/2025, she removed the bandage and there was a large bruise at the injection site.; On 03/04/2025, the caller took a photo of her arm and stated that the bruise was still "huge" and tender.; This spontaneous report was received from a patient reporting on herself as a 77-year-old female patient. Her medical history, concurrent conditions and drug reactions/allergies were not reported. Concomitant medications included Xarelto (Rivaroxaban.) On 27-Feb-2025, at her pharmacy, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine solution for injection (CAPVAXIVE) 1 dosage form (dosage regimen, anatomical location, route of administration, lot # and expiration date were not reported) administered as prophylaxis. On the same date, the patient noticed a bruise forming underneath the bandage (vaccination site bruising). The next day on 28-FEB-2025, she removed the bandage and there was a large bruise at the injection site. On unspecified date in 2025, she experienced vaccination site pain. On 04-MAR-2025, she took a photo of her arm and stated that the bruise was still "huge" and tender. On 11-MAR-2025, (also reported as "yesterday"), she stated that she went back to the pharmacy to show the pharmacist. It was also stated that she read that this was only supposed to last for a few days, but it had been 2 weeks at that point. She had not spoken to her health care professional (HCP) about this. No further details provided. She had not recovered from the events, as at the reporting time (reported as "today"), her arm was still very bruised and tender at the injection site. The reporter considered vaccination site bruising and vaccination site pain to be related to Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), considering that she had had many vaccines before including a flu shot about a month ago, and she had never had this reaction before and believed that she was having a reaction to Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) vaccine itself. Lot # is being requested and will be submitted if received.
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| 2832957 | F | AR | 03/24/2025 |
PNC21 |
MERCK & CO. INC. |
Y013009 |
Pyrexia, Rash pruritic, Urticaria
Pyrexia, Rash pruritic, Urticaria
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fever; itchy rash; welts; This spontaneous report was received from a health professional referring ...
fever; itchy rash; welts; This spontaneous report was received from a health professional referring to a 56-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 14-Mar-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) for prophylaxis, lot number Y013009, which has been verified to be valid, expiration date reported and validated as 17-NOV-2025. (formulation, strength, dose, scheme, route of administration and anatomical location not provided). On the same date the patient developed itchy rash that was hot to touch, welts and fever. The reporter stated that the fever was currently resolved, but the patient was still experiencing the rash and itchiness. The causal relationship between the events and the suspect vaccine was unknown.
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| 2832958 | 03/24/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Therapeutic response unexpected
Therapeutic response unexpected
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this was above 90 percent accuracy /they have not had a recurrence of shingles; This non-serious cas...
this was above 90 percent accuracy /they have not had a recurrence of shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of unexpected therapeutic effect in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included pain (the pain was still just as bad). Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (got shingles 7 months after getting the first Shingles shot). On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced unexpected therapeutic effect (Verbatim: this was above 90 percent accuracy /they have not had a recurrence of shingles). The outcome of the unexpected therapeutic effect was not applicable. Additional Information: GSK Receipt Date: 16-MAR-2025 This case was reported by a patient via interactive digital media. The got shingles 7 months after getting the first Shingles shot, it was not as bad as far as breaking out, but the pain was still just as bad. In 2017, the patient received a second set of the new shingles vaccine. The pharmacist informed the patient that this vaccine had over 90 percent accuracy. The patient confirmed that the pharmacist was right, and 8 years later, they have not had a recurrence of shingles.
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| 2832959 | 48 | F | WA | 03/24/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA MODERNA |
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Anti-aquaporin-4 antibody, Anti-ganglioside antibody, Antinuclear antibody, C-re...
Anti-aquaporin-4 antibody, Anti-ganglioside antibody, Antinuclear antibody, C-reactive protein, COVID-19; CSF cell count, CSF glucose, CSF immunoglobulin, CSF protein, CSF red blood cell count; CSF test, HIV antibody, Magnetic resonance imaging, Neuro-ophthalmological test, Neurological examination; Oligoclonal band assay, Ophthalmoplegia, Polymerase chain reaction, Red blood cell sedimentation rate, SARS-CoV-2 antibody test; SARS-CoV-2 test, Syphilis test, Viral test
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Recurrent acute ophthalmoparesis syndrome; Recurrent COVID-19; This literature-non-study case was re...
Recurrent acute ophthalmoparesis syndrome; Recurrent COVID-19; This literature-non-study case was reported in a literature article and describes the occurrence of OPHTHALMOPLEGIA (Recurrent acute ophthalmoparesis syndrome) in a 48-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. LITERATURE REFERENCE: 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, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OPHTHALMOPLEGIA (Recurrent acute ophthalmoparesis syndrome) (seriousness criterion medically significant) and COVID-19 (Recurrent COVID-19). The patient was treated with Immunoglobulins nos (Immunoglobulin i.v) at a dose of 2 gram per kilogram. At the time of the report, OPHTHALMOPLEGIA (Recurrent acute ophthalmoparesis syndrome) and COVID-19 (Recurrent COVID-19) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Anti-aquaporin-4 antibody: (Negative) at Initial presentation. On an unknown date, Anti-ganglioside antibody: (Negative) anti-GQ1b IgG at Initial presentation and (Negative) anti-GQ1b IgG at Recurrence. On an unknown date, Antinuclear antibody: (Negative) Anti-MOG IgG at Initial presentation and (Negative) Initial presentation. On an unknown date, C-reactive protein (0-5): less than 3 at Initial presentation. On an unknown date, CSF cell count (0-5): Cerebrospinal fluid Nucleated cells 0. On an unknown date, CSF glucose (40-70): 57. On an unknown date, CSF immunoglobulin (0-0.7): 0.4. On an unknown date, CSF protein (0-44): 36. On an unknown date, CSF red blood cell count: 0. On an unknown date, CSF test: normal. On an unknown date, HIV antibody: (Negative) at Initial presentation. On an unknown date, Magnetic resonance imaging: revealed T2 hyperintensity, enlargement, and enhancement of left CN III extending from the cavernous sinus into the posterior orbit., after vaccination showed similar T2 signal abnormality and enhancement of left CN III and Repeated approximately 7 months after hospitalization showed persistent enlargement and T2 hyperintensity of the left CN III with resolution of prior abnormal enhancement. On an unknown date, Neuro-ophthalmological test: At the time of the initial presentation, pupils were equally round and reactive to light. There was trace ptosis of the left upper eyelid. Horizontal ductions were full. There was a -2 supraduction deficit in both eyes that was partially overcome with head thrusts downward. There was a -1 infraduction deficit in the left eye. There was no nystagmus. There was no fatiguability of ductions. The findings were felt to suggest a partial supranuclear upgaze palsy and partial left third cranial nerve palsy. and At the time of recurrence, pupils were equally round and reactive to light. There was no ptosis. There was a trace adduction deficit of the left eye, with horizontal ductions otherwise full. There was a -1 supraduction deficit in the right eye and -2 supraduction deficit in the left eye, both of which were partially overcome with head thrusts downward. There was a -1 infraduction deficit in the left eye. There was no nystagmus. There was no fatiguability of ductions. The findings were felt to suggest a partial supranuclear upgaze palsy and partial left third cranial nerve palsy.. On an unknown date, Neurological examination: normal, a partial supranuclear vertical gaze palsy and a partial left cranial nerve (CN) III palsy and after vaccinations showed partial supranuclear vertical gaze palsy and partial left CN III palsy. On an unknown date, Oligoclonal band assay (0-3): 0. On an unknown date, Polymerase chain reaction: (Negative) Cerebrospinal fluid Meningitis/encephalitis PCR panel. On an unknown date, Red blood cell sedimentation rate (0-32): 5 at Initial presentation. On an unknown date, SARS-CoV-2 antibody test: (Negative) at Initial presentation and (Negative) at Initial presentation. On an unknown date, SARS-CoV-2 test: Negative and (Positive) by nasopharyngeal swab. On an unknown date, Treponema test: (Negative) at Initial presentation. On an unknown date, Viral test: (Negative) severe acute respiratory distress syndrome coronavirus 2 (SARS-CoV-2) PCR in the CSF. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. Patient with no significant medical history presented with vertical diplopia and 3 days of upper respiratory symptoms. She tested positive for SARS-CoV-2 by nasopharyngeal swab. Examination revealed a partial supranuclear vertical gaze palsy and a partial left cranial nerve (CN) III palsy. The remainder of her neurologic examination was normal. Laboratory results included normal CSF profile, negative severe acute respiratory distress syndrome coronavirus 2 (SARS-CoV-2) PCR in the CSF, and negative serum anti-GQ1b IgG. MRI revealed T2 hyperintensity, enlargement, and enhancement of left CN III (Fig. 1). She was treated with intravenous immune globulin and her diplopia rapidly improved. Six weeks later, her neuro-ophthalmologic examination was normal, and her symptoms had resolved. She subsequently received 2 doses of the Moderna mRNA COVID-19 vaccine without complication. She subsequently received 2 doses of the Moderna mRNA COVID-19 vaccine without complication. Twenty-six months later, she presented with 4 days of nasal congestion and 2 days of diplopia. She tested positive for SARS-CoV-2 by nasal swab. Her neurologic examination again showed partial supranuclear vertical gaze palsy and partial left CN III palsy. Serum anti-GQ1b IgG was negative. She was treated with IVIG and her diplopia rapidly improved. At follow-up 6 weeks later, her examination was normal, and she was asymptomatic. Author stated that to their knowledge, this may be the 1st reported case of recurrent AO associated with recurrent COVID-19. Although patient did not have the typical clinical triad of MFS, author classified her as having AO variant MFS based on the para-infectious onset, combined central and peripheral oculomotor dysfunction, imaging findings, and response to immunotherapy.; Reporter's Comments: Company comment: Event of ophthalmoplegia is assessed as not related to Spikevax NOS considering that COVID 19 reinfection could provide more likely etiology. The benefit-risk relationship of product is not affected by this report.
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| 2832960 | UT | 03/24/2025 |
PNC20 |
PFIZER\WYETH |
LC5484 |
Device connection issue
Device connection issue
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the whole top section of the luer lock broke off the syringe; This is a spontaneous report received ...
the whole top section of the luer lock broke off the syringe; This is a spontaneous report received from an Other HCP from product quality group. A patient (age and gender not provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: LC5484, Expiration Date: 31Jan2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "the whole top section of the luer lock broke off the syringe". Additional information: The reporter said that while opening a box, a medical assistant grabbed a dose, and the whole top section of the luer lock has broken off the syringe. The reporter mentioned that this is not her first rodeo with this issue. The luer lock breaking off the syringe has occurred with other pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20) vaccines. No patients were involved with any of the PREVNAR 20 vaccines that had this issue. Causality for "the whole top section of the luer lock broke off the syringe" was determined associated to device constituent of pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (malfunction).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400237868 same reporter/product/PC, different lots;US-PFIZER INC-202400266262 same reporter/product/PC, different lots;US-PFIZER INC-202400272234 same reporter/product/PC, different lots;
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| 2832961 | F | 03/24/2025 |
RSV |
PFIZER\WYETH |
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Foetal exposure during pregnancy, Respiratory syncytial virus infection
Foetal exposure during pregnancy, Respiratory syncytial virus infection
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the baby was diagnosed with RSV when she was 9 months old; the baby was diagnosed with RSV when she ...
the baby was diagnosed with RSV when she was 9 months old; the baby was diagnosed with RSV when she was 9 months old; This is a spontaneous report received from a Pharmacist. A 9-month-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), in 2023 as dose number unknown, single (Batch/Lot number: unknown) other for maternal immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RESPIRATORY SYNCYTIAL VIRUS INFECTION (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovered" and all described as "the baby was diagnosed with RSV when she was 9 months old". It was unknown if therapeutic measures were taken as a result of respiratory syncytial virus infection, drug ineffective. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: The 9-month-old infant received one dose of ABRYSVO for maternal immunization then was diagnosed with RSV; a lack of efficacy with the vaccine ABRYSVO therefore cannot be completely excluded. The patient's predispositions such as young age and underlying conditions may also contribute to suboptimal response after vaccination.
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| 2832963 | MS | 03/24/2025 |
COVID19 |
PFIZER\BIONTECH |
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Chills, Headache, Insomnia
Chills, Headache, Insomnia
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headaches; chills; insomnia; This is a spontaneous report received from a Consumer or other non HCP,...
headaches; chills; insomnia; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2), in Apr2021 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: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), administration date: Apr2021, for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches"; CHILLS (non-serious), outcome "unknown"; INSOMNIA (non-serious), outcome "unknown". Additional information: The patient took 2 Covid vaccine shots in Apr2021 and it's been an absolute nightmare experience. The patient had side effects like headaches, chills, insomnia & many other side effects. The patient wanted a settlement of some kind and $100,000 would be perfect.
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| 2832964 | 85 | F | AL | 03/24/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Vaccination failure
COVID-19, Vaccination failure
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I have Covid; I have Covid; This is a spontaneous report received from a Consumer or other non HCP, ...
I have Covid; I have Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An 85-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 85 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization completed.), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunization; Comirnaty (2023-2024 formula) (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I have Covid". Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient has got all the patient has had all of the Pfizer COVID Vaccines. The last one got was in October of this previous year. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2832965 | F | NJ | 03/24/2025 |
COVID19 |
PFIZER\BIONTECH |
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Body temperature, COVID-19, Drug ineffective
Body temperature, COVID-19, Drug ineffective
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Covid after Vaccine/3rd time with Covid; Covid after Vaccine/3rd time with Covid; This is a spontane...
Covid after Vaccine/3rd time with Covid; Covid after Vaccine/3rd time with Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 65-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "pre-diabetic" (unspecified if ongoing); "COVID" (unspecified if ongoing), notes: previous 2 times. The patient's concomitant medications were not reported. Vaccination history included: Fully vaccinated (Primary immunization completed, MANUFACTURER UNKNOWN), for COVID-19 immunization; Boostered (BOOSTER, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid after Vaccine/3rd time with Covid". The patient underwent the following laboratory tests and procedures: Body temperature: 103. Clinical course: During this inbound call for financial assistance, the caller stated she did have Covid, her temperature is 103, and her primary care doctor ordered it but it did not go through". The caller was then asked to confirm the reason for the call and that they were prescribed the medication and what the name was, and the caller stated "Paxlovid, and it was denied this is my 3rd time with Covid, and I think this time I'm the worst and I am fully vaccinated and boostered." The caller stated she didn't understand with Covid right now, even the test, they're telling her its not covered by the insurance any longer. Near the end of the call, the caller stated they denied the entire prescription. If she can't get it she won't get it, she'll just bear with it you know? The caller then stated her doctors approved her for Wegovy and, and with all the things she have medically they didn't cover it. She's not diabetic, she's pre-diabetic. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2832967 | 11 | M | KS | 03/24/2025 |
MNQ MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
9m2r7 9m2r7 |
Burning sensation, Erythema, Immediate post-injection reaction, Mobility decreas...
Burning sensation, Erythema, Immediate post-injection reaction, Mobility decreased, Pain; Skin warm, Swelling
More
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He had pain and burning right away. Red and hot to the touch skin plus swelling started soon after t...
He had pain and burning right away. Red and hot to the touch skin plus swelling started soon after the vaccine and got so bad the next day he could not move his arm. We went to the doctor on day 2 (Saturday, March 15th) and Dr. said it was a histamine reaction.
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| 2832968 | 1.17 | M | NJ | 03/24/2025 |
VARCEL |
MERCK & CO. INC. |
Y004554 |
Herpes zoster, Varicella virus test positive
Herpes zoster, Varicella virus test positive
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Patient developed shingles on 3/20/2025. He has required prolong hospitalization and IV acyclovir. ...
Patient developed shingles on 3/20/2025. He has required prolong hospitalization and IV acyclovir. Pediatric ID consulted as well as Dermatology
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✓ | |||||
| 2832969 | 3 | F | WA | 03/24/2025 |
DTPPVHBHPB MMRV |
MSP VACCINE COMPANY MERCK & CO. INC. |
U7392AA Y009589 |
Gait disturbance, Injection site erythema, Injection site swelling; Gait disturb...
Gait disturbance, Injection site erythema, Injection site swelling; Gait disturbance, Injection site erythema, Injection site swelling
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Vaccinated on 3/17/2025 with Vaxelis and MMRV. Began feeling symptomatic on 3/18/2025 with redness, ...
Vaccinated on 3/17/2025 with Vaxelis and MMRV. Began feeling symptomatic on 3/18/2025 with redness, swelling, "bumpiness" at site and limping on left leg. Symptomatic with fever on same day that broke on Wednesday 3/19/2025, but fever came back worse on Friday 3/21/2025. Went to Medical Center Walk-In Clinic and was prescribed antibiotics. Still symptomatic.
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| 2832982 | 50 | F | GA | 03/24/2025 |
HEP VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
4BX39 93KK4 |
Axillary pain, Erythema, Pruritus; Axillary pain, Erythema, Pruritus
Axillary pain, Erythema, Pruritus; Axillary pain, Erythema, Pruritus
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Redness, itchiness, and pain under armpit
Redness, itchiness, and pain under armpit
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| 2832983 | 78 | F | MT | 03/24/2025 |
PNC21 |
MERCK & CO. INC. |
Y019157 |
Injection site erythema, Injection site swelling
Injection site erythema, Injection site swelling
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Patient reports local reaction including redness, swelling, and pain that started about 3 days afte...
Patient reports local reaction including redness, swelling, and pain that started about 3 days after vaccination. She said injection site became painful shortly after injection, but redness and swelling was delayed. The redness and swelling did spread down from the injection site to the elbow. She started applying ice to the area and hydrocortisone cream. Condition is improving, but still present 6 days post vaccination.
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| 2832984 | 19 | F | 03/24/2025 |
FLU3 HEPAB IPV MMR VARCEL |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. |
TFAA2448 324BY Y1A201M Y014094 Y017063 |
Dizziness, Pallor; Dizziness, Pallor; Dizziness, Pallor; Dizziness, Pallor; Dizz...
Dizziness, Pallor; Dizziness, Pallor; Dizziness, Pallor; Dizziness, Pallor; Dizziness, Pallor
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Patient became very dizzy after administration and almost passed out. Patient looked paled. We had p...
Patient became very dizzy after administration and almost passed out. Patient looked paled. We had patient elevate legs and had patient smelled isopropyl alcohol pads. She came to and felt better after about 15 to 20 minuets.
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| 2832985 | 56 | F | CA | 03/24/2025 |
FLU3 |
SANOFI PASTEUR |
UT8434KA |
Extra dose administered
Extra dose administered
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no symptoms or signs. Vaccine administration error only. Previous dose 10/02/2024
no symptoms or signs. Vaccine administration error only. Previous dose 10/02/2024
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| 2832986 | 60 | M | GA | 03/24/2025 |
MMR |
MERCK & CO. INC. |
|
Measles
Measles
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Breakthrough Measles for 10 days
Breakthrough Measles for 10 days
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| 2832987 | 41 | F | TX | 03/24/2025 |
COVID19 |
PFIZER\BIONTECH |
NDC: 00069-2432 |
Mobility decreased, Periarthritis
Mobility decreased, Periarthritis
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Frozen shoulder, could not lift arm for over a day past a few inches; within a week could raise arm ...
Frozen shoulder, could not lift arm for over a day past a few inches; within a week could raise arm overhead. Al?s most a month later cannot fully extend or rotate without pain. Cannot bear weight when pulling overhead.
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| 2832988 | 1 | F | MN | 03/24/2025 |
UNK UNK UNK UNK UNK UNK VARCEL VARCEL VARCEL |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
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Blood test, Body temperature decreased, Chest X-ray abnormal, Crying, Influenza ...
Blood test, Body temperature decreased, Chest X-ray abnormal, Crying, Influenza virus test negative; Irritability, Oxygen saturation decreased, Pneumonia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative; Urine analysis; Blood test, Body temperature decreased, Chest X-ray abnormal, Crying, Influenza virus test negative; Irritability, Oxygen saturation decreased, Pneumonia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative; Urine analysis; Blood test, Body temperature decreased, Chest X-ray abnormal, Crying, Influenza virus test negative; Irritability, Oxygen saturation decreased, Pneumonia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative; Urine analysis
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Patient had a runny nose and watery eyes with no cough. Runny nose seemed to be improving at the tim...
Patient had a runny nose and watery eyes with no cough. Runny nose seemed to be improving at the time of the vaccune on the 18th. Late night of the 19th and early morning hours of the 20th she began to cry and inconsolable for 3 hours. We took her to the clinic on thr 20th where her oxygen and temperature were both very low. She was taken to the ER and staying in the pediatric unit until the 23nd. She was found to have what they believed to be pneumonia. She was but on antibiotics and oxygen for several says in the hospital. She was completely normal the night of 18th and all say on the 19th until she began to get fussy.
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✓ | ✓ | ||||
| 2832989 | 40 | F | NC | 03/24/2025 |
COVID19 |
PFIZER\BIONTECH |
6028774 |
Fatigue, Gait disturbance, Headache, Hypoaesthesia, Muscular weakness
Fatigue, Gait disturbance, Headache, Hypoaesthesia, Muscular weakness
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Headaches, numbness on one side, fatigue, weak limbs, off balance gait
Headaches, numbness on one side, fatigue, weak limbs, off balance gait
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✓ | |||||
| 2832990 | 32 | M | AZ | 03/24/2025 |
TDAP |
SANOFI PASTEUR |
U8339BA |
Discomfort, Electrocardiogram abnormal, Palpitations, Sleep disorder, Ventricula...
Discomfort, Electrocardiogram abnormal, Palpitations, Sleep disorder, Ventricular extrasystoles
More
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Approximately 90-120 minutes after receiving the vaccine, I began feeling heart palpitations - clust...
Approximately 90-120 minutes after receiving the vaccine, I began feeling heart palpitations - clusters of them. I had an idea about what they were, but never had them before so I wasn't completely sure. Beginning the day I received the vaccine, and still to this day, I get clusters of palpitations every day. Often multiple times throughout the day for anywhere between 5 mins to an hour. They are almost always guaranteed to occur during, and especially after, a stress response. As such, it seems catecholamine release induces them most often, but I still seem to get them even when at rest and not stressed and more commonly at night. They are HARD, I feel them in my chest and in the back of my throat. They are extremely uncomfortable and have prevented me from falling asleep some nights. While at work one evening, I was finally able to capture these events on an EKG and my suspicions were correct - they were Premature Ventricular Contractions. My EKG is otherwise unchanged compared to tracings before the palpitations started other than the PVCs. I've never had PVCs (at least that I've felt) before the vaccine, and now have had them every single day since getting it. Obviously I can't say with 100% certainty the Tdap vaccine caused them, but there's an extremely strong correlation because of the suspicious timing.
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| 2832994 | 62 | M | MO | 03/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
N77J2 |
Chills, Migraine, Pain, Pyrexia
Chills, Migraine, Pain, Pyrexia
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103.6 Fever from 1:00 AM to 5:30 AM along with chills terrible body aches worst migrane ever. felt t...
103.6 Fever from 1:00 AM to 5:30 AM along with chills terrible body aches worst migrane ever. felt terrible next day that evening 101.3 Fever, migrane and body aches continued Thru day 3.
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| 2832995 | 82 | F | MI | 03/24/2025 |
PNC20 |
PFIZER\WYETH |
LG5579 |
Injection site erythema, Injection site induration, Injection site inflammation
Injection site erythema, Injection site induration, Injection site inflammation
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I had a red inflammation from the site down to my elbow + halfway around my arm. It began to get har...
I had a red inflammation from the site down to my elbow + halfway around my arm. It began to get hard in areas so I went to ER. They diagnosed possible cellulitis + put me on an antibiotic + prednisone. It continued to continue being red + inflamed until I finished antibiotic + prednisone
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| 2833007 | 11 | M | AZ | 03/24/2025 |
MNQ TDAP |
NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS |
LN75D 5YB5G |
Injection site pruritus, Injection site swelling, Injection site warmth; Injecti...
Injection site pruritus, Injection site swelling, Injection site warmth; Injection site pruritus, Injection site swelling, Injection site warmth
More
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1 day post injection with erythema, swelling, pruritis to injection site. Treated with benadryl and...
1 day post injection with erythema, swelling, pruritis to injection site. Treated with benadryl and symptoms resolved within 2 days. No difficulty breathing or swallowing.
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✓ | |||||
| 2832711 | 70 | M | SC | 03/23/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
|
Atrial fibrillation, Bell's palsy, Coronary arterial stent insertion, Endot...
Atrial fibrillation, Bell's palsy, Coronary arterial stent insertion, Endotracheal intubation, Hypoxia; Implantable defibrillator insertion, Myocardial infarction, Pneumonia, Pyrexia
More
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Bell?s Palsy, High Fever, Oxygen Deprivation, Double Pneumonia, Cardiac Attack, Afib, Intubation, Re...
Bell?s Palsy, High Fever, Oxygen Deprivation, Double Pneumonia, Cardiac Attack, Afib, Intubation, Rehabilitation Therapy, Stent Surgery, Defibrillator Implant
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✓ | ✓ | ||||
| 2832712 | 72 | F | FL | 03/23/2025 |
PNC20 |
PFIZER\WYETH |
Lk6651 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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No adverse event
No adverse event
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| 2832713 | 51 | M | NJ | 03/23/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Herpes ophthalmic
Herpes ophthalmic
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Herpes eye infection
Herpes eye infection
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| 2832714 | 22 | F | VA | 03/23/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
010M20A 010M20A |
Coeliac artery compression syndrome, Condition aggravated, Ehlers-Danlos syndrom...
Coeliac artery compression syndrome, Condition aggravated, Ehlers-Danlos syndrome, Herpes zoster, Ileus; Impaired gastric emptying, Intestinal obstruction, May-Thurner syndrome, Postural orthostatic tachycardia syndrome, Renal vein compression
More
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Intestin Obstruction, Intestion Shut down, Mals, EPS, Pots, Gastropresis, Shingles, Knutcracket, Mal...
Intestin Obstruction, Intestion Shut down, Mals, EPS, Pots, Gastropresis, Shingles, Knutcracket, MalTherna,
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✓ | |||||
| 2832715 | 48 | F | GA | 03/23/2025 |
PNC20 |
PFIZER\WYETH |
LX4482 |
Extra dose administered, Fatigue, Pain in extremity
Extra dose administered, Fatigue, Pain in extremity
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duplicate administration -- pt received dose of vaccine 4/3/2023. Pt informed, not experiencing ADR ...
duplicate administration -- pt received dose of vaccine 4/3/2023. Pt informed, not experiencing ADR other than sore arm and fatigue (another vaccine administered simultaneously)
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| 2832716 | 45 | M | 03/23/2025 |
FLU3 |
SEQIRUS, INC. |
946614 |
Extra dose administered
Extra dose administered
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Patient received a second flu shot this season.
Patient received a second flu shot this season.
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| 2832717 | 85 | F | PA | 03/23/2025 |
PNC20 |
PFIZER\WYETH |
LI5284 |
Erythema
Erythema
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Pt reported arm redness around whole area of upper arm. There were no other symptoms reported.
Pt reported arm redness around whole area of upper arm. There were no other symptoms reported.
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| 2832718 | 65 | F | FL | 03/23/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
n77j2 |
Hypoaesthesia, Laboratory test, Paraesthesia
Hypoaesthesia, Laboratory test, Paraesthesia
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about a minute after getting the vaccine her left cheek and jaw starting feeling a little numb and t...
about a minute after getting the vaccine her left cheek and jaw starting feeling a little numb and tingly. By the time the patient got home about 5 minutes later the numbness had worsened. After about 10 more minutes, her left arm started feeling numb. After another 5 minutes the numbness spread to left leg and food. the symptoms lasted about 30 hours and gradually improved before disappearing.
More
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✓ | |||||
| 2832719 | 78 | F | CT | 03/23/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
KB2YT KB2YT |
Chills, Eye pain, Feeling abnormal, Headache, Influenza; Lacrimation increased, ...
Chills, Eye pain, Feeling abnormal, Headache, Influenza; Lacrimation increased, Nausea, Ocular hyperaemia, Pyrexia
More
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PATIENT REPORTS FEELING VERY "UNDER THE WEATHER" FOR 7 DAYS, AS THEY WERE VACCINATED ON A ...
PATIENT REPORTS FEELING VERY "UNDER THE WEATHER" FOR 7 DAYS, AS THEY WERE VACCINATED ON A FRIDAY AND REPORTS NOT LEAVING THEIR HOUSE UNTIL THE FOLLOWING FRIDAY, 2/21/25. PATIENT EXPERIENCED THE FOLLOWING (REPORTED BY PATIENT AS SEVERE) EVENTS: 102 DEGREE FEVER, SEVERE CHILLS, NAUSEA, HEADACHE, FLU SYMPTOMS, AND EYE PAIN. PATIENT REPORTS THEIR EYE TISSUES BEING UNUSUALLY RED (NOT THE ACTUAL EYEBALL, BUT THE TISSUES WITHIN EYE ORBIT) AND WERE LEAKING/RUNNING SO BAD AND WERE SO PAINFUL, PATIENT REPORTS THINKING THEIR EYES WERE BLEEDING. PATIENT DOES NOT RECALL HOW LONG THE EYE PAIN & WATERING LASTED BUT DID CONSULT WITH HER OPTOMETRIST.
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| 2832720 | 76 | F | NY | 03/23/2025 |
PNC21 |
MERCK & CO. INC. |
Y019157 |
Injection site rash, Rash
Injection site rash, Rash
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Patient developed large painful rash on arm several inches below injection site (not at injection si...
Patient developed large painful rash on arm several inches below injection site (not at injection site).
More
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| 2832721 | 81 | F | FL | 03/23/2025 |
PNC20 |
PFIZER\WYETH |
LX4482 |
Injection site erythema, Injection site swelling, Nausea, Tenderness
Injection site erythema, Injection site swelling, Nausea, Tenderness
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Patient's arm at and around injection site is very, very red and swollen. She states she feels ...
Patient's arm at and around injection site is very, very red and swollen. She states she feels constantly nauseous since receiving the vaccine, and her chest and left trunk area are extremely tender to the touch.
More
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| 2832722 | 70 | F | FL | 03/23/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7zm55 |
Chills, Dry mouth, Eye swelling, Skin warm, Swelling of eyelid
Chills, Dry mouth, Eye swelling, Skin warm, Swelling of eyelid
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Same day, patient got dry mouth and severe chills. She skin felt hot to the touch and she was in bed...
Same day, patient got dry mouth and severe chills. She skin felt hot to the touch and she was in bed almost all day. on 3/6/25, she had a swollen eye/eyelid that lasted 2 days. She took zyrtec and used cold compresses.
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| 2832723 | 75 | F | IL | 03/23/2025 |
PNC21 RSV TDAP |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
Y013009 AE435 AK334 |
Pain in extremity, Rash, Skin warm; Pain in extremity, Rash, Skin warm; Pain in ...
Pain in extremity, Rash, Skin warm; Pain in extremity, Rash, Skin warm; Pain in extremity, Rash, Skin warm
More
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Patient received three vaccines on 3/17/2025, with Boostrix and Capvaxive on her right arm and Arexv...
Patient received three vaccines on 3/17/2025, with Boostrix and Capvaxive on her right arm and Arexvy on her left arm. Patient said her left arm was sore for a few days, but just noticed the rash today on 3/23/2025 and reported to the pharmacy. Rash is warm to touch, but doesn't itch. The rash is about the size of 3 quarter coins. I recommended for her to draw a circle around the rash and monitor if the rash improve or spread outside the circle, and reach out to her primary care provider for follow up. Patient also picked up a tube of hydrocortisone cream over the counter to help with her rash.
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| 2832769 | 60 | F | VA | 03/23/2025 |
PNC20 |
PFIZER\WYETH |
LC5482 |
Extra dose administered, Pain in extremity
Extra dose administered, Pain in extremity
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Pt potentially received a second dose of Prevnar20. Pt did not recollect ever receiving the vaccine,...
Pt potentially received a second dose of Prevnar20. Pt did not recollect ever receiving the vaccine, however may have received 3/6/2024 and on 3/12/2025 according to system. Pt reported no adverse effects other than a "sore arm for a couple of days"
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| 2832770 | 62 | F | TX | 03/23/2025 |
PNC20 |
PFIZER\WYETH |
HH9323 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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NO ADVERSE REACTION WAS REPORTED, WHILE GOING OVER PATIENT PROFILE FOR VACCINATION PHARMACIST NOTICE...
NO ADVERSE REACTION WAS REPORTED, WHILE GOING OVER PATIENT PROFILE FOR VACCINATION PHARMACIST NOTICED THAT PATIENT HAD RECEIVED TWO DOSES, RECOMMENDED DOSE BY MANUFACTURER IS ONE.
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| 2832771 | 68 | F | CO | 03/23/2025 |
PNC21 |
MERCK & CO. INC. |
Y013009 |
Chills, Injection site erythema, Malaise, Skin warm
Chills, Injection site erythema, Malaise, Skin warm
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Patient's arm is red around the site of the injection. She stated her arm feels warm to the tou...
Patient's arm is red around the site of the injection. She stated her arm feels warm to the touch. Patient further explained she felt sick with chills for 3 days and went to urgent care today. Patient also stated provider was not certain if she had an allergic reaction or adverse event from the vaccine or cellulitis. The provider prescribed Augmentin for cellulitis.
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| 2832772 | 76 | F | IL | 03/23/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
00069-2432-10 00069-2432-10 00069-2432-10 |
Amnesia, Angiocardiogram, Arthralgia, Atrial fibrillation, Carditis; Chest disco...
Amnesia, Angiocardiogram, Arthralgia, Atrial fibrillation, Carditis; Chest discomfort, Dyspnoea, Echocardiogram, Electrocardiogram, Hypopnoea; Laboratory test, Loss of personal independence in daily activities, Myalgia
More
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Started as preasure in chest, breathing shallow, as week went on, muscles ache. Joint ache started ...
Started as preasure in chest, breathing shallow, as week went on, muscles ache. Joint ache started and by week end, Friday, shortness of breath, preasure in chest and by Friday decided I needed to go to emergency room. 5 days later, after many tests and no knowledge of the last 5 days, I woke up in hospital. Was told there was inflamation in my heart and was told all the test I had undergone. During many heart tests they also detected Afib. which I had never had before. I am now on blood thinner and causing me heave bruising . limited ablility to lift or activity
More
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✓ | ✓ | ||||
| 2832783 | 0.25 | M | NY | 03/23/2025 |
DTPPVHBHPB PNC15 RV5 |
MSP VACCINE COMPANY MERCK & CO. INC. MERCK & CO. INC. |
U7921AA X027947 Y0058T |
Culture stool, Diarrhoea; Culture stool, Diarrhoea; Culture stool, Diarrhoea
Culture stool, Diarrhoea; Culture stool, Diarrhoea; Culture stool, Diarrhoea
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Began with watery diarrhea that day and has persisted 2 weeks
Began with watery diarrhea that day and has persisted 2 weeks
|
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| 2832682 | OH | 03/22/2025 |
RVX |
UNKNOWN MANUFACTURER |
|
Dehydration, Rotavirus infection
Dehydration, Rotavirus infection
|
patient developed rotavirus, became dehydrated and required hospitalization.; This spontaneous repor...
patient developed rotavirus, became dehydrated and required hospitalization.; This spontaneous report was received from a Physician via company representative and refers to a child patient of unknown gender and age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent, (lot # and expiration date were not reported), for prophylaxis. On an unknown date, the patient developed rotavirus, became dehydrated and required hospitalization. At the reporting time, the outcome of the event was unknown. The causal relationship between the event and Rotavirus Vaccine, Live, Oral, Pentavalent was not provided. Lot # is being requested and will be submitted if received.
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✓ | |||||||
| 2832683 | F | AZ | 03/22/2025 |
HPV9 HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
W011264 W026150 W011264 |
Inappropriate schedule of product administration, No adverse event; Inappropriat...
Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event
More
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No symptoms reported; Customer called to report that 2 years ago a female patient in her 20s receive...
No symptoms reported; Customer called to report that 2 years ago a female patient in her 20s received her 2nd and 3rd dose of GARDASIL 9 within 10 weeks of each other. No symptoms reported. See related request case 02772685. Patient's first dose received on 20DEC2022; Information has been received from Business Partner/CRO on 18-Mar-2025. This spontaneous report was received from a/an Pharmacist and refers to a(n) Adult female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 30-Jun-2023, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (lot #W026150, expiration date: 20-Oct-2024), dose number 3, 0.5 mL. On 20-Dec-2022, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (lot #W011264, expiration date: 05-Sep-2024), dose number 1, 0.5 mL. On 13-Apr-2023, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (lot #W011264, expiration date: 05-Sep-2024), dose number 2, 0.5 mL. On an unknown date, the patient started therapy with unknown dosage. On an unknown date, the patient started therapy with unknown dosage. On an unknown date, the patient started therapy with unknown dosage. The patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant for the treatment of prophylaxis. The patient started therapy with for the treatment of prophylaxis. The patient started therapy with for the treatment of prophylaxis. The patient started therapy with for the treatment of prophylaxis. The patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant for the treatment of prophylaxis. The patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant for the treatment of prophylaxis. On 30-Jun-2023, the patient experienced Customer called to report that 2 years ago a female patient in her 20s received her 2nd and 3rd dose of GARDASIL 9 within 10 weeks of each other. No symptoms reported. See related request case 02772685. Patient's first dose received on 20DEC2022. On an unknown date, the patient experienced No symptoms reported. At the reporting time, the outcome of Customer called to report that 2 years ago a female patient in her 20s received her 2nd and 3rd dose of GARDASIL 9 within 10 weeks of each other. No symptoms reported. See related request case 02772685. Patient's first dose received on 20DEC2022 and No symptoms reported was unknown. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant. nHuman Papillomavirus 9-valent Vaccine, Recombinant and Human Papillomavirus 9-valent Vaccine, Recombinant was reported as not applicable.
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