| ID | Age | Sex | State | Date βΌ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | π | π₯ | π | βΏ | β οΈ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2860854 | 09/23/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Chills, Fatigue, Headache, Illness, Myalgia
Chills, Fatigue, Headache, Illness, Myalgia
|
sick; fatigue; muscle aches; headaches; chills / teeth chattering; This is a spontaneous report rece...
sick; fatigue; muscle aches; headaches; chills / teeth chattering; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-773535 (Moderna Clinical Safety and Pharmacovigilance). This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), FATIGUE (fatigue), MYALGIA (muscle aches), HEADACHE (headaches) and CHILLS (chills / teeth chattering) in a patient who received mRNA-1273 (Moderna COVID-19 Vaccine). In January 2021, the patient received first dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced FATIGUE (fatigue), MYALGIA (muscle aches), HEADACHE (headaches) and CHILLS (chills / teeth chattering). On an unknown date, the patient experienced ILLNESS (sick) and EXTRA DOSE ADMINISTERED ((redacted) said that is why (redacted) has stuck with Moderna and has gotten everything (every vaccine) plus (redacted) 'unauthorized one'). At the time of the report, ILLNESS (sick) had resolved and FATIGUE (fatigue), MYALGIA (muscle aches), HEADACHE (headaches), CHILLS (chills / teeth chattering) and EXTRA DOSE ADMINISTERED ((redacted) said that is why (redacted) has stuck with Moderna and has gotten everything (every vaccine) plus (redacted) 'unauthorized one') outcome was unknown. No concomitant medications were reported. No vaccines were administered within the past 4 weeks. It was reported that, other than the first 2 doses in January/February 2021, when (redacted) got Pfizer, (redacted) always gets Moderna. It was reported that, (redacted) would get the vaccine in the morning and by 3 in the afternoon, (redacted) started to get the fatigue, muscle aches, headaches and chills. Sometimes (redacted) got teeth chattering and was sick the day after the vaccine but by that evening, (redacted) was fine. (redacted) tried to plan (redacted) activities accordingly. (redacted) got Moderna vaccine every 6 months because (redacted) was old and it was what (redacted) physician recommended. Somewhere in the beginning, (redacted) snuck in an extra dose because (redacted) was so petrified. (redacted) believed it was when there was a 2nd dose, where the first dose was a higher amount and the second dose was less. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500188016 same patient, different dose/event;
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| 2860855 | 1.75 | F | OH | 09/23/2025 |
HIBV |
SANOFI PASTEUR |
UK208AA |
No adverse event, Product preparation error
No adverse event, Product preparation error
|
act-hib was mixed with sterile water with no reported adverse event; Initial information received on...
act-hib was mixed with sterile water with no reported adverse event; Initial information received on 17-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 21 months old female patient who received HIB (PRP/T) Vaccine [Act-Hib], which was mixed with sterile water with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Dtap) for Immunization. On 04-Sep-2025, the patient received 0.5ml dose of suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection, Strength Standard, frequency Once, lot UK208AA and expiry date 30-Apr-2026 via unknown route in right leg for immunisation, which was mixed with sterile water with no reported adverse event (product preparation error). 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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| 2860856 | 11 | F | PA | 09/23/2025 |
FLU3 |
SANOFI PASTEUR |
UT8802MA |
No adverse event, Product storage error
No adverse event, Product storage error
|
patient received FLUZONE NP which was exposed to temperature excursion due to Storage in cooler with...
patient received FLUZONE NP which was exposed to temperature excursion due to Storage in cooler with ice packs where Max/low temperature reached was unknown for 4 hours with no reported adverse event; Initial information received on 17-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 years old female patient who received Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] which was exposed to temperature excursion due to storage in cooler with ice packs where maximum/lowest temperature reached was unknown for 4 hours with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other immunizations On 13-Sep-2025, the patient received 0.5ml (Dose 1) of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine (once), Suspension for injection, Strength Standard, lot UT8802MA and expiry date 30-Jun-2026 via intramuscular route in the right deltoid for immunisation which was exposed to temperature excursion due to storage in cooler with ice packs where max/low temperature reached was unknown for 4 hours with no reported adverse event (product storage error) (Latency Same day). Reportedly, this excursion occurred due to a human error, extended stability data did not cover the excursion, Previous excursion none. 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-2025SA281965:
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| 2860857 | 1.42 | F | FL | 09/23/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK226AA |
No adverse event, Product preparation issue
No adverse event, Product preparation issue
|
gave PENTACEL, but they only gave the diluent and not the vaccine with no reported AE; Initial infor...
gave PENTACEL, but they only gave the diluent and not the vaccine with no reported AE; Initial information received on 18-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 17 months old female patient who was administered with Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel] but they only gave the diluent and not the vaccine with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), Hib Vaccine Conj (Menigococcal Protein), Pertussis Vaccine Acellular 5-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid (Vaxelis) for Immunisation; and Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation. On 11-Sep-2025, the patient received 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Powder and suspension for suspension for injection, lot UK226AA,, expiry date:31-Aug-2026, strength: standard, frequency: once, via intramuscular route in the left thigh for immunisation, but they only gave the diluent and not the vaccine with no reported adverse event (single component of a two-component product administered) (latency: same day). 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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| 2860858 | 69 | M | KY | 09/23/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
UT8409CA |
Rash, Urticaria; Rash, Urticaria
Rash, Urticaria; Rash, Urticaria
|
developed a severe case or rash; developed a severe case or hives which lasted for more than 4 month...
developed a severe case or rash; developed a severe case or hives which lasted for more than 4 month; Initial information received on 18-Sep-2025 regarding an unsolicited valid non-serious case received from a patient. This case involves 69 years old male patient who developed a severe case or rash and hives which lasted for more than 4 month after receiving Elasomeran (Moderna COVID-19 vaccine) and Influenza USP TRIVAL A-B High Dose Subvirion Vaccine [Fluzone HD]. The patient's past vaccination(s) included Fluzone HD for prophylactic vaccination (immunization) in 2020, 2021, 2023 with no adverse reaction and Moderna Covid Vaccine for COVID-19 immunization. The patient's past medical history, medical treatment(s) and family history were not provided. On an unknown date in 2024, the patient received a dose of suspect Influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (lot UT8409CA) for Influenza (Influenza immunization) and received a dose of suspect Moderna COVID-19 vaccine not produced by Sanofi Pasteur (unknown formulation and lot number) for COVID-19 immunization, both (strength, expiry date -not reported) via unknown route in unknown administration site. On an unknown date in 2024 the patient developed a severe case or rash (rash) and hives which lasted for more than 4 month (urticaria) (unknown latency) following the administration of Influenza USP trival A-B high dose subvirion vaccine and Moderna COVID-19 vaccine. Reportedly, Patient stated that last year, they got FLUZONE HD (high dose) and Moderna Covid Vaccines, but they developed a severe case or rash and hives which lasted for more than 4 month. Patient wanted to know if they can still get FLUZONE HD this year. Patient was not sure if it was really caused by FLUZONE HD because they also got the Moderna Covid Vaccine which they were also able to use before. Patient wanted to know if the ingredients of FLUZONE HD this year changed from last year. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was Recovered / Resolved on an unknown date for both the events.
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| 2860859 | 1.25 | F | WV | 09/23/2025 |
TDAP |
SANOFI PASTEUR |
3CA07C1 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
|
15-month-old patient was administered with ADACEL instead of DTaP with no reported Adverse event; In...
15-month-old patient was administered with ADACEL instead of DTaP with no reported Adverse event; Initial information received on 19-Sep-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 with Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] instead of Diphtheria, Tetanus And Acellular Pertussis Vaccine with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis A Vaccine Inact (Vaqta) for Immunisation. On 17-Sep-2025, the patient received 0.5mL (dose 4) of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (lot 3CA07C1, expiry date 31-Dec-2025, strength standard and frequency once) via intramuscular route in the right thigh for Immunisation and it was administered instead of Diphtheria, Tetanus And Acellular Pertussis Vaccine (lot, expiry date and strength not reported) with no reported adverse event (wrong product administered) (latency same day). 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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| 2860880 | 68 | F | NC | 09/23/2025 |
FLUX UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
|
Headache, Influenza like illness, Pain; Headache, Influenza like illness, Pain
Headache, Influenza like illness, Pain; Headache, Influenza like illness, Pain
|
flu like symptoms/flu like symptoms, aches, headache A little better but still achy; This spontaneou...
flu like symptoms/flu like symptoms, aches, headache A little better but still achy; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms/flu like symptoms, aches, headache A little better but still achy) in a 68-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. The patient's past medical history included COVID-19 (Patient was diagnosed with Covid 19.) on 28-Oct-2024. Concomitant products included Etodolac (Lodine) for an unknown indication. On 12-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On 12-Sep-2025, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms/flu like symptoms, aches, headache A little better but still achy). On 14-Sep-2025, INFLUENZA LIKE ILLNESS (flu like symptoms/flu like symptoms, aches, headache A little better but still achy) had resolved. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. The patient had no medical history, concomitant disease or risk factor. There were no lab data or results available. It was reported that within the first 24 hours after vaccination the patient had experienced flu-like symptoms, aches, headache. These symptoms were a little better but still achy until 48 hours. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported.
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| 2860882 | 24 | F | FL | 09/23/2025 |
UNK UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
Ink Ink Ink |
Bell's palsy, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therap...
Bell's palsy, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture; Magnetic resonance imaging, Malaise, Migraine, Muscular weakness, Nerve conduction studies; Paraesthesia, Wheelchair user
More
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Received 3 consecutive doses. Fell ill 30 days later, numbness and tingling of extremities, muscle w...
Received 3 consecutive doses. Fell ill 30 days later, numbness and tingling of extremities, muscle weakness became reliant on wheelchair, Bell?s palsy, and eventually diagnosed with Guillien Barre Syndrome
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| 2860883 | 82 | F | NC | 09/23/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52Z52 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient was given second dose of Arexvy on 9/22 at off-site clinic. Followed up with patient on 9/23...
Patient was given second dose of Arexvy on 9/22 at off-site clinic. Followed up with patient on 9/23. Patient stated to be doing well without any adverse events.
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| 2860884 | 60 | F | NC | 09/23/2025 |
COVID19 |
MODERNA |
3052663 |
Intertrigo, Rash, Rash erythematous, Rash pruritic
Intertrigo, Rash, Rash erythematous, Rash pruritic
|
A rash started on my chest and continued to break out on shoulders, stomach and abdomen for 5-7 days...
A rash started on my chest and continued to break out on shoulders, stomach and abdomen for 5-7 days. Urgent care diagnosed Intertrigo, on Wednesday 17Sep25 and Dermatologist diagnosed contact dermatitis possibly poison ivy on 19Sep25. Prescribe anti-viral, antibiotics and cream on 17Sep25 and told to stop and take Prednisone on 19Sep25. Rash is itchy but is not blistering. 23Sep25 still continues to be itchy and the redness is spreading at most of the spots. I have received 6 previous Moderna vaccines with no reactions. I received a Flu and RSV shot on 28Aug25. I think this rash may be related to the vaccine. I have no rash on hands, arms or legs.
More
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| 2860885 | 63 | M | CA | 09/23/2025 |
FLU3 |
SEQIRUS, INC. |
407247 |
No adverse event
No adverse event
|
No Adverse event - Patient confirmed no symptoms - was okay
No Adverse event - Patient confirmed no symptoms - was okay
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| 2860886 | 42 | M | CA | 09/23/2025 |
FLU3 |
SEQIRUS, INC. |
407247 |
Unevaluable event
Unevaluable event
|
None-
None-
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| 2860887 | 85 | M | TX | 09/23/2025 |
COVID19 |
MODERNA |
3052586 |
Arthralgia, Mobility decreased, Pain in extremity, Sleep disorder
Arthralgia, Mobility decreased, Pain in extremity, Sleep disorder
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Patient stated that after receiving the vaccine, he had pain in his arm/shoulder. He stated he coul...
Patient stated that after receiving the vaccine, he had pain in his arm/shoulder. He stated he could not sleep for 4 to 5 days. He also stated it is still painful to the point that he can not raise his arm to screw in a light bulb. This was communicated to us today, 09/23/25. He has not gone in to see a physician.
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| 2860888 | 84 | F | NJ | 09/23/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SEQIRUS, INC. |
my9548 407245 |
Dizziness, Loss of consciousness, Nausea; Dizziness, Loss of consciousness, Naus...
Dizziness, Loss of consciousness, Nausea; Dizziness, Loss of consciousness, Nausea
More
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Patient was waiting after her vaccine administration in a chair and was feeling lightheaded. She s...
Patient was waiting after her vaccine administration in a chair and was feeling lightheaded. She subsequently lost consciousness while sitting in the chair. With the help of her daughter, we lowered her to the ground and laid her flat and she regained consciousness but was very nauseous. 911 was called immediately and they took her to the hospital for evaluation.
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| 2860889 | 59 | F | CA | 09/23/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SEQIRUS, INC. |
NA0739 948406 |
Peripheral swelling, Rash; Peripheral swelling, Rash
Peripheral swelling, Rash; Peripheral swelling, Rash
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Patient got vaccinated on 9/19/25 and reported left upper arm was really swollen on Saturday 9/20 an...
Patient got vaccinated on 9/19/25 and reported left upper arm was really swollen on Saturday 9/20 and Sunday 9/21. Patient has taken advil and benadryl for past few days. She still noticed some swelling on left upper arm and rash spreading down her arm.
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| 2860890 | 74 | M | MI | 09/23/2025 |
FLU3 |
SEQIRUS, INC. |
406985 |
Extra dose administered, Wrong product administered
Extra dose administered, Wrong product administered
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Flu shot was accidentally administered by a technician instead of the requested COVID vaccine. Pati...
Flu shot was accidentally administered by a technician instead of the requested COVID vaccine. Patient had already had FLUAD at a doctor's office last week. Patient is aware of side effects that could occur and the higher chance of experiencing them with the second flu shot administered on 9/23/25.
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| 2860900 | 70 | F | OH | 09/23/2025 |
FLU3 |
SANOFI PASTEUR |
U8855AA |
Cough, Dry throat, Sputum increased
Cough, Dry throat, Sputum increased
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Four hours after patient received immunization patient experienced increased sputum production and c...
Four hours after patient received immunization patient experienced increased sputum production and cough along with dry throat. Patient also stated potentially seeing blood in sputum.
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| 2860901 | 56 | F | KY | 09/23/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EL 1284 EL 1284 EL 1284 EL 1284 EL 1284 |
Angina pectoris, Anxiety, Blood pressure increased, Brain fog, Chest discomfort;...
Angina pectoris, Anxiety, Blood pressure increased, Brain fog, Chest discomfort; Confusional state, Depression, Dyspnoea, Head discomfort, Headache; Herpes simplex test positive, Herpes zoster, Immune system disorder, Insomnia, Laboratory test; Myocarditis, Neck pain, Neuralgia, Oesophageal disorder, Optic neuritis; Palpitations, Pyrexia, Tinnitus, Varicella virus test positive
More
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Right away I had tightness in chest with myocarditis and hard to breath in my lungs. Fever, Brain fo...
Right away I had tightness in chest with myocarditis and hard to breath in my lungs. Fever, Brain fog and mild confustion and for the first 6 months shingles or herpes 2 nerve pain in left leg taking valtrex 1000 mg twice a day. The next 12 months from june2021 had issues with my immune systme attacking my esophagus. In spring of 2022 optic neuritis started in my vision and ear buzzing in left ear at the same time. The chicken pox viris and herpes 2 virus begain to spike high in my blood work and I have lived on up to 3000 mg of valtrex a day since then. I am on gabapenton for nerve pain in my crainial regeion of my entire head. from feb 2023 until summer of 2024 I was in ER 5 times thru that whole time frame with severe pain and pressure at the base of my skull and in my neck. In the winter of 2025 my blood pressure went way high and I went to ER. My had chest pain in my heart and had 2 more visits to the ER in that month. For the past 3 years I have had pounding heart rate from 3am to 6 am in the morning. The ear buzzing is continual in my left ear. The doctors fianlly gave me blood presure meds to stop the heart from pounding in the middle of the night. I have permanent insomnia now. There isn't any over the counter meds or melatonin that helps me sleep. I have struggled with depression and anxiety for the past 4 years not knowing when episodes of symptoms will send me to the ER.
More
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| 2860902 | 91 | F | NY | 09/23/2025 |
FLU3 |
SEQIRUS, INC. |
407981 |
Chest pain, Dyspnoea, Malaise
Chest pain, Dyspnoea, Malaise
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About 5 minutes after I gave her her flu shot, she came back to pharmacy. Her daughters said she was...
About 5 minutes after I gave her her flu shot, she came back to pharmacy. Her daughters said she wasn't feeling well. She had pain in her chest and her breathing was a little labored. She could still talk. I called EMS and they sent the EMS. She started feeling better as she was sitting in the counseling room. They checked everything and took her blood pressure and the daughter said everything was fine and she was feeling better, and they continued their shopping. I called her at 7:12 PM at night to see how she was doing, and she said she was doing fine.
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| 2860903 | 0.58 | F | UT | 09/23/2025 |
DTAPHEPBIP FLU3 MMRV |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR MERCK & CO. INC. |
TF499 UT8779LA 2008864 |
No adverse event, Wrong product administered; No adverse event, Wrong product ad...
No adverse event, Wrong product administered; No adverse event, Wrong product administered; No adverse event, Wrong product administered
More
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Patient received an incorrect vaccine (Proquad). This was given in error. No notable symptoms
Patient received an incorrect vaccine (Proquad). This was given in error. No notable symptoms
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| 2860904 | 81 | F | PA | 09/23/2025 |
FLU3 |
SANOFI PASTEUR |
u8823ca |
Injection site rash, Injection site swelling, Injection site warmth, Rash erythe...
Injection site rash, Injection site swelling, Injection site warmth, Rash erythematous
More
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left arm further down below injection got red bumpy, warm and swollen but went away after 4 days
left arm further down below injection got red bumpy, warm and swollen but went away after 4 days
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| 2860905 | 16 | M | GA | 09/23/2025 |
HPV9 TDAP |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
Y015179 9YB4G |
Unevaluable event; Unevaluable event
Unevaluable event; Unevaluable event
|
N/A
N/A
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| 2860906 | 60 | F | WI | 09/23/2025 |
PNC20 RSV UNK |
PFIZER\WYETH PFIZER\WYETH UNKNOWN MANUFACTURER |
ndc:00005-2000- ndc:00069-2465- ndc:0069-2528-1 |
Pruritus; Pruritus; Pruritus
Pruritus; Pruritus; Pruritus
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itchy on upper arm but not really a noticeable rash, self treated with hydrocortisone cream. the ri...
itchy on upper arm but not really a noticeable rash, self treated with hydrocortisone cream. the right arm got the Comirnaty 12 + Covid 2025-26
More
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| 2860907 | 33 | F | KS | 09/23/2025 |
COVID19 |
MODERNA |
|
Fatigue, Injection site pain, Myalgia, Pyrexia
Fatigue, Injection site pain, Myalgia, Pyrexia
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Fever of 100.8-101.4 for two days, extreme fatigue, and muscle pain around the injection site and th...
Fever of 100.8-101.4 for two days, extreme fatigue, and muscle pain around the injection site and throughout body, all lasting two days
More
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| 2860908 | 13 | F | CA | 09/23/2025 |
COVID19 |
MODERNA |
3052741 |
Syncope
Syncope
|
Patient fainted after. Possibly due to anxiety and low blood pressure/sugar
Patient fainted after. Possibly due to anxiety and low blood pressure/sugar
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| 2860909 | 10 | F | CA | 09/23/2025 |
FLU3 |
SEQIRUS, INC. |
948401 |
Blood test abnormal, Immune thrombocytopenia, Immunoglobulin therapy, Petechiae
Blood test abnormal, Immune thrombocytopenia, Immunoglobulin therapy, Petechiae
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DEVLEOPED PETECHIAL RASH THAT CONTINUED TO SPREAD - SEEN AT ER AND DIAGNOSED W/ ITP - IVIG GIVEN AND...
DEVLEOPED PETECHIAL RASH THAT CONTINUED TO SPREAD - SEEN AT ER AND DIAGNOSED W/ ITP - IVIG GIVEN AND CONTINUED FOLLOW UP
More
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| 2860910 | 90 | F | MO | 09/23/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
3052296 407252 |
Acute myocardial infarction, Death, Wheezing; Acute myocardial infarction, Death...
Acute myocardial infarction, Death, Wheezing; Acute myocardial infarction, Death, Wheezing
More
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Resident received both flu and Covid vaccine around 9am without any adverse reactions. Daughter pre...
Resident received both flu and Covid vaccine around 9am without any adverse reactions. Daughter present for vaccinations, then took her mom outside to visit. After returning to the room, the daughter noticed that the resident had begun wheezing and went to notify the nurse (resident has a hx of asthma and was receiving breathing txs). When the nurse and daughter returned to the room, the resident had already passed away. The coroner is calling the cause of death acute MI.
More
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β | |||||
| 2860911 | 7 | M | AL | 09/23/2025 |
FLU3 |
SANOFI PASTEUR |
u8823aa |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
Patient was at an immunization clinic, Pharmacist was the supervisor and staff member was also an im...
Patient was at an immunization clinic, Pharmacist was the supervisor and staff member was also an immunizer, staff member gave the shot to the patient, but she did not realize that there was an age restriction (9 and over ) for the Flublok, it is the fault of the supervisor for not realizing the child was under 9 and stopping the shot
More
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| 2860912 | 18 | M | MI | 09/23/2025 |
COVID19 |
PFIZER\BIONTECH |
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Condition aggravated, Fatigue, Headache, Insomnia, Migraine
Condition aggravated, Fatigue, Headache, Insomnia, Migraine
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Chronic migraines fatigue, and insomnia started about a week or two after receiving the second shot....
Chronic migraines fatigue, and insomnia started about a week or two after receiving the second shot. It has gotten much worse since then. A few days after I ended up in the ER with a blinding headache.
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| 2860913 | 33 | F | MI | 09/23/2025 |
FLU3 |
SEQIRUS, INC. |
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Cellulitis, Erythema, Nasal congestion, Periorbital oedema, Swelling face
Cellulitis, Erythema, Nasal congestion, Periorbital oedema, Swelling face
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Periorbital edema/cellulitis/erythema, facial swelling, nasal congestion
Periorbital edema/cellulitis/erythema, facial swelling, nasal congestion
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| 2860914 | 11 | M | NY | 09/23/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
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Injection site erythema, Injection site pain, Injection site pruritus, Injection...
Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
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On 9/12/25, 3:15pm after shot given, left upper arm pain at injection site. Applied ice pack. On 9/1...
On 9/12/25, 3:15pm after shot given, left upper arm pain at injection site. Applied ice pack. On 9/12/25 at 9:16 pm, left upper arm pain, itchy. Applied ice pack. On 9/13/25 at 9:57am, left upper arm still sore, itchy, and red. Applied ice pack. On 9/13/25 at 6:34 pm, left upper arm is red, sore, itchy, swollen and warm to the touch. I took my son to Urgent Care and he was given Motrin. Urgent Care also drew a circle on my son's arm with a black sharpie marker and advised if the redness spreads outside of the black circle over the next 24 hours to have him seen again. Discharge instructions indicated to give ibuprofen 20ml every 6 hours as needed for pain and swelling, may use Benadryl 10ml by mouth for itchiness of reaction site. On 9/14/25 at 8:44am, the redness spread outside the black marker circle on his arm. I left a message for answering service. On 9/14/25 at 12:10pm, redness spread even more and we made a return trip to Urgent Care where they prescribed Cephalexin 250mg/5ml susp 200ml 10ml by mouth twice daily for 10 days. By 9/20/25, symptoms disappeared.
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| 2860915 | 60 | F | TN | 09/23/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
793pt |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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pt received two doses of tdap(boostrix) in one year. First dose was on 02/0 1/2025, and second dose ...
pt received two doses of tdap(boostrix) in one year. First dose was on 02/0 1/2025, and second dose was on 09/15/2025.Patient doing well with no side effects
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| 2860916 | 37 | M | NC | 09/23/2025 |
COVID19 |
PFIZER\BIONTECH |
30155BA |
Chest pain, Electrocardiogram, Immunisation reaction, Sleep disorder, X-ray
Chest pain, Electrocardiogram, Immunisation reaction, Sleep disorder, X-ray
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Woke up next morning with slight chest pain above left lung. Felt like an arrow was stuck in my left...
Woke up next morning with slight chest pain above left lung. Felt like an arrow was stuck in my left shoulder. The pain progressed through the weekend waking me up several times through the night. Monday morning driving in to school I began to hunch over in severe continuous pain. I called my instructor informing him I was going to sick.
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| 2860917 | 13 | M | WI | 09/23/2025 |
HPV9 |
MERCK & CO. INC. |
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Loss of consciousness, Mydriasis, Seizure
Loss of consciousness, Mydriasis, Seizure
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10 seconds aftee injection, my son leaned forward unconscious and pupils dialated. After lying him d...
10 seconds aftee injection, my son leaned forward unconscious and pupils dialated. After lying him down on his left he convulsed. I continued to encourage him to come back while Doctor was called back in.
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| 2860918 | 84 | M | 09/23/2025 |
PNC20 |
PFIZER\WYETH |
LN4927 |
Extra dose administered
Extra dose administered
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PATIENT REQUEST A PREVNAR 20 VACCINE 09/04/25. THERE WAS NO RECORD OF THE PATIENT PREVIOUSLY RECEIVI...
PATIENT REQUEST A PREVNAR 20 VACCINE 09/04/25. THERE WAS NO RECORD OF THE PATIENT PREVIOUSLY RECEIVING THE SHOT IN JULY OF 2023 IN THE AL IMMPRINT SYSTEM OR ON THE PATIENT'S TWO-YEAR PROFILE. THIS RESULTED IN THE PATIENT RECEIVING TWO PREVNAR 20 VACCINES IN A TWO-YEAR TIME FRAME.
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| 2860919 | 41 | M | CA | 09/23/2025 |
COVID19 FLU3 HEP |
PFIZER\BIONTECH SEQIRUS, INC. MERCK & CO. INC. |
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Pruritus, Rash, Skin mass; Pruritus, Rash, Skin mass; Pruritus, Rash, Skin mass
Pruritus, Rash, Skin mass; Pruritus, Rash, Skin mass; Pruritus, Rash, Skin mass
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Nodule about 1 inch in diameter, rash and itchiness on right arm. Appeared next day after vaccine. P...
Nodule about 1 inch in diameter, rash and itchiness on right arm. Appeared next day after vaccine. Persisted and slowly dissipated over 3 days.
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| 2860920 | 58 | M | CA | 09/23/2025 |
FLU3 |
SANOFI PASTEUR |
UT8763FA |
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
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Patient is 58 years old and received fluzone high dose instead of the regular dose. No side effects...
Patient is 58 years old and received fluzone high dose instead of the regular dose. No side effects.
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| 2860921 | 7 | F | CA | 09/23/2025 |
FLU3 |
SEQIRUS, INC. |
406982 |
Erythema, Induration, Pruritus, Skin mass, Swelling
Erythema, Induration, Pruritus, Skin mass, Swelling
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Large 2 inch diameter nodule, half the circumference of the arm, raised, hard red and itchy Sunday n...
Large 2 inch diameter nodule, half the circumference of the arm, raised, hard red and itchy Sunday night. By day 3 nodule had gone away but still itchy.
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| 2860922 | 26 | F | TX | 09/23/2025 |
COVID19 |
MODERNA |
012M20A |
Abortion spontaneous, Exposure during pregnancy, Malaise, Pyrexia, Ultrasound an...
Abortion spontaneous, Exposure during pregnancy, Malaise, Pyrexia, Ultrasound antenatal screen abnormal
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Lost baby, was extremely ill with uncontrolled fever
Lost baby, was extremely ill with uncontrolled fever
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| 2860934 | 0.33 | F | OH | 09/23/2025 |
FLU3 HEPA MMR VARCEL |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
Y0255 J4KYX Y010046 Y017914 |
No adverse event, Product administered to patient of inappropriate age; No adver...
No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age
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Vaccines were given by mistake patient received vaccines too early. No swelling or redness at the si...
Vaccines were given by mistake patient received vaccines too early. No swelling or redness at the sight. No immediate symptoms or sign of adverse reaction
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| 2860938 | 82 | F | AZ | 09/23/2025 |
FLU3 |
SANOFI PASTEUR |
U8830AA |
Unevaluable event
Unevaluable event
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None stated.
None stated.
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| 2860226 | FL | 09/22/2025 |
HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
W001494 W001494 |
Incomplete course of vaccination, No adverse event; Incomplete course of vaccina...
Incomplete course of vaccination, No adverse event; Incomplete course of vaccination, No adverse event
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The patient did not receive the third dose yet.; No additional AEs; This spontaneous report was rece...
The patient did not receive the third dose yet.; No additional AEs; This spontaneous report was received from a Pharmacist and referred to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 25-Oct-2022, the patient was vaccinated with the 1st dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #W001494, expiration date: 15-Sep-2024), 1 dosage form total for prophylaxis. On 04-Dec-2022, the patient was vaccinated with the 2nd dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #W001494, expiration date: 15-Sep-2024), 1 dosage form, total for prophylaxis. The patient did not receive the third dose yet (Inappropriate schedule of vaccine administered). No additional adverse event (no adverse event).
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| 2860227 | M | 09/22/2025 |
HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
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Chest pain, Chills, Electrocardiogram T wave inversion, Myopericarditis, Pain in...
Chest pain, Chills, Electrocardiogram T wave inversion, Myopericarditis, Pain in jaw; Paraesthesia, Pyrexia, Troponin increased
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Myopericarditis; Arm Tingling and Jaw Pain; Arm Tingling and Jaw Pain; Chills and Fever; Chills and ...
Myopericarditis; Arm Tingling and Jaw Pain; Arm Tingling and Jaw Pain; Chills and Fever; Chills and Fever; Crushing Chest Pain; This spontaneous, social-media report was received from a pharmacist via Business Partner and refers to an 18-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASILοΏ½9) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prohpylaxis. On an unknown date (within 24 hours), the patient experienced chills and phyrexia. The patient recovered without sequelae within 48 hours. On an unknown date (three days later), the patient experienced chest pain (reported as: crushing chest pain), pain in jaw, paraesthesia (reported as: arm tingling and jaw pain). The patient was triaged directly to the emergency room where he had troponins of greater that 11000 and T wave inversions on his EKG. Other diagnostic tests and labs showed normal heart anatomy and no early coronary artery disease. He was diagnosed with myopericarditis by cardiology. He was treated and recovered fully within 3 months. The reporter considered the event of myopericarditis to be related to Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (reported as: this case has a consistent causal relationship with vaccination). The causal relationship between the rest reported events and Human Papillomavirus 9-valent Vaccine, Recombinant was unknown/not reported/not provided. Upon internal review, the event(s) of Myopericarditis was/were determined to be medically significant.
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| 2860228 | M | TX | 09/22/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
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Injection site pain
Injection site pain
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First Dose of HEPLISAV-B In May of 2025, Told to Wait 6 Months for Second; Injection Site Pain; Init...
First Dose of HEPLISAV-B In May of 2025, Told to Wait 6 Months for Second; Injection Site Pain; Initial report received on 14-Aug-2025. A consumer in the US (TX) reported that her husband, an 80-year-old male (race and ethnicity not reported), received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and did not receive the second dose yet and experienced injection site pain. Medical history included allergies to amiodarone, propranolol, flecainide, MULTAQ (dronedarone), metoprolol, and sotalol. All medications caused throat swelling. No concomitant medications were reported. In May-2025, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot #; expiration date and NDC #, route not available) in the left arm. In May-2025, after receiving HEPLISAV-B, the patient experienced injection site pain for two days. At the time of reporting, the patient had not received the second dose of HEPLISAV-B yet. The pharmacy instructed the patient to wait six months before receiving the second dose. No other information was available. Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
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| 2860229 | F | IL | 09/22/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
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Exposure during pregnancy, No adverse event
Exposure during pregnancy, No adverse event
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I am Pregnant, Gave Me HEPLISAV-B; Initial report received on 15-Aug-2025. Additional information r...
I am Pregnant, Gave Me HEPLISAV-B; Initial report received on 15-Aug-2025. Additional information received on 29-Aug-2025 from the reporter that included the patient's last menstrual period date, estimated date of delivery, and concomitant medications. A physician reported that she, a 37-year-old female, received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while 12 weeks pregnant. No medical history was reported. Concomitant medications included prenatal vitamins, aspirin, rizatriptan, and TYLENOL (acetaminophen). On 11-Jul-2025, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, and NDC number not available) intramuscularly in the left deltoid. The patient presented to the pharmacy, filled out her paperwork, and notified staff that she was pregnant. The patient later found out she was given HEPLISAV-B. The patient was 12 weeks gestation at the time of injection. Her last menstrual period (LMP) was 18-Apr-2025. Her due date is 23-Jan-2026. No side effects were reported. She has had an uncomplicated pregnancy so far. No additional information was reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2860230 | F | VA | 09/22/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
943186 |
Incomplete course of vaccination
Incomplete course of vaccination
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Patient Received First Dose of HEPLISAV-B One Year Ago, Has Not Received The Second Dose; Initial re...
Patient Received First Dose of HEPLISAV-B One Year Ago, Has Not Received The Second Dose; Initial report received on 27-Aug-2025. A pharmacy technician reported that a 26-year-old female received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization one year ago but never received the second dose. No medical history or concomitant medications were reported. The patient had no known drug allergies. On 22-Aug-2024, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot number 943186, expiration date 30-Nov-2025, and NDC number 43528-0003-05; site not available) intramuscularly. At the time of reporting, the patient had not received the second dose of HEPLISAV-B yet. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2860231 | M | 09/22/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
55TH4 |
Bell's palsy
Bell's palsy
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Bell's palsy; This serious case was reported by a consumer and described the occurrence of bel...
Bell's palsy; This serious case was reported by a consumer and described the occurrence of bell's palsy in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 55TH4) for prophylaxis. Previously administered products included Shingrix (patient had 1st dose on 09-NOV-2024, with batch number GA99K). Concurrent medical conditions included diabetes. Concomitant products included metformin, levothyroxine, atorvastatin and lisinopril. On 26-APR-2025, the patient received the 2nd dose of Shingrix. On 29-AUG-2025, 125 days after receiving Shingrix, the patient experienced bell's palsy (Verbatim: Bell's palsy) (serious criteria hospitalization and GSK medically significant). The outcome of the bell's palsy was not resolved. It was unknown if the reporter considered the bell's palsy to be related to Shingrix. The company considered the bell's palsy to be unrelated to Shingrix. Additional Information: GSK receipt date: 10-SEP-2025 The reporter reported seriousness for bell's palsy as intervention required.; Sender's Comments: A case of Bell's palsy, 125 days after receiving Shingrix, in a 58-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative risk factor (Concurrent medical conditions included diabetes).
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| 2860232 | M | TN | 09/22/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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second dose of vaccine is late; This non-serious case was reported by a consumer via call center rep...
second dose of vaccine is late; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received HAB (Twinrix) for prophylaxis. Concomitant products included HEPATITIS A VACCINE INACT;HEPATITIS B VACCINE RHBSAG (YEAST) (TWINRIX). On 03-SEP-2025, the patient received the 2nd dose of Twinrix (intramuscular) 1 ml. On 03-SEP-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: second dose of vaccine is late). The outcome of the drug dose administration interval too long 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: 04-SEP-2025 A patient who was transferred from the response center and had a question concerning Twinrix dose scheduling. The standard dosing schedule consists of 3 doses (1-ml each), given intramuscularly at 0, 1, and 6 months so the second dose of vaccine was late. The patient disconnected the call when asked details for filing a safety report.
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| 2860233 | F | 09/22/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
GJ952 |
Neuralgia, Pain in extremity
Neuralgia, Pain in extremity
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Neuralgia; left arm pain; This non-serious case was reported by a other health professional and desc...
Neuralgia; left arm pain; This non-serious case was reported by a other health professional and described the occurrence of neuralgia in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number GJ952, expiry date 25-APR-2027) for prophylaxis. On 08-AUG-2025, the patient received Shingrix (intramuscular) .5 ml. On 09-AUG-2025, 1 days after receiving Shingrix, the patient experienced neuralgia (Verbatim: Neuralgia) and pain in arm (Verbatim: left arm pain). The outcome of the neuralgia and pain in arm were not resolved. It was unknown if the reporter considered the neuralgia and pain in arm to be related to Shingrix. It was unknown if the company considered the neuralgia and pain in arm to be related to Shingrix. Additional Information: GSK Receipt Date: 05-SEP-2025 Reporter reported that the left arm pain appears to be neuralgia, dermatomal in location got affected. Pain became worse in the last two. The patient had two primary care visits related to that and had required medication management for pain. No rashes were observed.
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| 2860234 | 09/22/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Malaise
Malaise
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Sick for 5 days; This non-serious case was reported by a consumer via interactive digital media and ...
Sick for 5 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included gastritis. Previously administered products included Flu vaccine (received a flu shot for least 30 years and had never got the flu once). On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Sick for 5 days). The outcome of the sickness was resolved (duration 5 days). It was unknown if the reporter considered the sickness to be related to Shingles vaccine. It was unknown if the company considered the sickness to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 27-AUG-2025 This case was reported by a patient via interactive digital media. The reporter love pharmaceuticals because reporter very rarely get sick. The reporter had a funny stomach and get gastritis which would put reporter down for a day. The only reaction the reporter had to any of the preventive shots. The reporter reported that was the Shingles shot. The reporter was sick for 5 days and never got the second shot. The reporter had got a flu shot for least 30 years and reporter have never got the flu once. When before the reporter got the shot would get it every year. The reporter believed they work. They could believe what you want, but reporter living proof they did work. And Covid reporter had a case of Covid in own household and being in his/her 70. The reporter would be prime candidate to get it which the reporter did not. The reporter granddaughter lived with reporter and she was the one that had it. She tested positive twice. The home tests that everyone got for free and also at a emergency clinic.
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