chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Flank pain, Herpes zoster, Nausea, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; Shingles Rash; Pain; This serious case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 01-SEP-2024, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). In SEP-2024, the patient experienced rash (Verbatim: Shingles Rash) and pain (Verbatim: Pain). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown and the outcome of the rash was not resolved and the outcome of the pain was resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash and pain to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles, rash and pain to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 10-SEP-2024 The nurse reported and mentioned that she already received 2 doses of Shingrix a couple years ago (she did not had specific dates, lot numbers or expiration dates) and on 1st September 2024 she got shingles and shingles rash which never erupted but pain was gone.  She started taking Valtrex on 2nd September 2024. This case was considered as suspected vaccination failure since the details regarding the  time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix (Dose 1 and Dose 2).
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; Shingles Rash; Pain; This serious case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 01-SEP-2024, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). In SEP-2024, the patient experienced rash (Verbatim: Shingles Rash) and pain (Verbatim: Pain). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown and the outcome of the rash was not resolved and the outcome of the pain was resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash and pain to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles, rash and pain to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 10-SEP-2024 The nurse reported and mentioned that she already received 2 doses of Shingrix a couple years ago (she did not had specific dates, lot numbers or expiration dates) and on 1st September 2024 she got shingles and shingles rash which never erupted but pain was gone.  She started taking Valtrex on 2nd September 2024. This case was considered as suspected vaccination failure since the details regarding the  time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix (Dose 1 and Dose 2).
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Fell 11 times after receiving the Pfizer and BioNTech Covid vaccine on 8/30/24, Entered hospital on 9/06/24. Diagnosed with Guillain Barre syndrome on 9/08/24.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Fall, Guillain-Barre syndrome, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: Fell 11 times after receiving the Pfizer and BioNTech Covid vaccine on 8/30/24, Entered hospital on 9/06/24. Diagnosed with Guillain Barre syndrome on 9/08/24.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paralysis
Clinical narrative: Fell 11 times after receiving the Pfizer and BioNTech Covid vaccine on 8/30/24, Entered hospital on 9/06/24. Diagnosed with Guillain Barre syndrome on 9/08/24.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Nurse calling to report an adverse event regarding an improperly stored and administered dose of PROQUAD.  Nurse stated that the PROQUAD was involved in a Temperature Excursion that occurred on 9/12/2024, and that a dose of PROQUAD was administered o; This spontaneous report was received from registered nurse, concerning a patient of unknown age and gender.   The patient's pertinent medical history, past drug reactions or allergies, concurrent conditions and concomitant therapies were not provided.  The nurse stated that the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was involved in a temperature excursion that occurred on 12-SEP-2024. However on 16-SEP-2024, the patient was vaccinated with an improperly dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, two dose series, lot #Y009107, expiration date: 06-NOV-2025 (albumin status: recombinant human albumin (rHa)) administered for prophylaxis (strength, and route of administration were not provided). The operator of device was a health professional. The nurse confirmed that there have been no reports of the patient involved reporting any medical concern or symptoms after the dose administered. No adverse event  This is one of the several cases created from the same source.
Age: 0.17
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Hepatitis B vaccine administered on 19Apr2001 and 13Mar2002; Hepatitis B vaccine administered on 01Feb2001 and 19Apr2001; This spontaneous report has been received from a physician, via medical record from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (MARRS # 2407USA003649), concerning a currently 15-year-old female patient.  The patient's medical history, her concurrent conditions and concomitant therapies were not reported.  On 01-FEB-2001 at the age of 2-month-old, the patient was vaccinated with the first dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection. Subsequently, on 19-APR-2001, she received the second dose of the vaccine (inappropriate schedule of product administration). Then, on 13-MAR-2002, the patient was vaccinated with the third dose of the vaccine (inappropriate schedule of product administration). All the doses were administered as prophylaxis (strengths, doses, lot #s, expiry dates, anatomical locations and routes of administration were not provided).  This is one of the 2 cases received from the same reporter.; Sender's Comments:  US-009507513-2407USA003649:
Age: 17.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms reported. No additional AE reported; a patient that was administered an expired dose of MMR-II; This spontaneous report was received from a nurse regarding a 17-year-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-SEP-2024, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin [rha]) (M-M-R II) injection, 0.5 milliliter/dose, lot #W026512, with an expiration date on 22-AUG-2024, administered for prophylaxis (strength, vaccination scheme, route of administration, and anatomical site of vaccination were not provided) (Expired product administered). No symptoms and no additional adverse event (AE) reported. (No adverse event).  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2409USA007749:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth ulceration
Clinical narrative: Mouth ulcers developed on roof of mouth approximately 5 days after vaccination.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Rash
Clinical narrative: Pain in left wrist. Pea-sized bumps on inside of left wrist
Age: 45.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site pain, Mobility decreased, Musculoskeletal stiffness, Pain
Clinical narrative: severe pain at injection site, severe arm stiffness, unable to really move arm as usual  without severe pain
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site pain, Nasal congestion, Rash, Rash erythematous
Clinical narrative: Red rash started on left wrist. (Same arm vaccine received in). Rash moved to left hand and fingers a couple days after initially noticing it on wrist. Injection site had pain on day one. Bruising in injection site since. Also noticed stuffy nose on 9/24.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Hyperhidrosis, Influenza virus test negative
Clinical narrative: Mild body aches and lethargy days 2-4 after vaccination. evening of day 4 dry ineffective cough develops. Fever, chills, body aches set in heavily.  Rested negative for Covid via antibody test on day 4 abd 5. Day 6, cough is persistent, body aches, particularly joints around extremities and spine. Overnight day 6-7 fever spikes 102.2 and persists. Treated with ibuprofen and acetaminophen at recommended doses. Limited affect on fever.  Shivering and sweating through sheets and bedding wake and allow no sleep/poor sleep. Went to urgent care the next day (day 7). Tested negative for Covid and flu. Given aside of prednisone for heavy ineffective cough. Overnight day 8-9 cough still heavy interrupting sleep, fever again reaches 102.5. End of day 9 fever broke, temperature returned to normal. Cough still persists. Seeking further treatment.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Lethargy, Pain, Poor quality sleep, Pyrexia
Clinical narrative: Mild body aches and lethargy days 2-4 after vaccination. evening of day 4 dry ineffective cough develops. Fever, chills, body aches set in heavily.  Rested negative for Covid via antibody test on day 4 abd 5. Day 6, cough is persistent, body aches, particularly joints around extremities and spine. Overnight day 6-7 fever spikes 102.2 and persists. Treated with ibuprofen and acetaminophen at recommended doses. Limited affect on fever.  Shivering and sweating through sheets and bedding wake and allow no sleep/poor sleep. Went to urgent care the next day (day 7). Tested negative for Covid and flu. Given aside of prednisone for heavy ineffective cough. Overnight day 8-9 cough still heavy interrupting sleep, fever again reaches 102.5. End of day 9 fever broke, temperature returned to normal. Cough still persists. Seeking further treatment.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test negative
Clinical narrative: Mild body aches and lethargy days 2-4 after vaccination. evening of day 4 dry ineffective cough develops. Fever, chills, body aches set in heavily.  Rested negative for Covid via antibody test on day 4 abd 5. Day 6, cough is persistent, body aches, particularly joints around extremities and spine. Overnight day 6-7 fever spikes 102.2 and persists. Treated with ibuprofen and acetaminophen at recommended doses. Limited affect on fever.  Shivering and sweating through sheets and bedding wake and allow no sleep/poor sleep. Went to urgent care the next day (day 7). Tested negative for Covid and flu. Given aside of prednisone for heavy ineffective cough. Overnight day 8-9 cough still heavy interrupting sleep, fever again reaches 102.5. End of day 9 fever broke, temperature returned to normal. Cough still persists. Seeking further treatment.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dementia, Dysphonia, Hallucination, Mental status changes
Clinical narrative: Paxlovid use for COVID-19 under Emergency Use Authorization (EUA): Elderly father under my care tested positive for Covid-19. Had most recent Covid booster shot ~3-4 weeks prior. Was experiencing undue hoarseness while recovering so requested prescribing of Paxlovid. Twice during morning 3 days into Paxlovid treatment he awoke, went to the bathroom, and on return to bed (assisted by myself) started speaking of nonsensical, near-hallucinatory subjects as if in walking dream state. 1st was references to deceased friend as if still alive and his need to help father pack items in room to "ship out". 2 hours later, now daylight outside, he spoke extensively of need to return outdoors to help a (non-existent) paving/maintenance crew to direct them in how ot put tar down to complete a (non-existent) paving job. In sensing the gravity and unprecedentedness of this turn of events, I went to get my phone to record rest of conversation with voice recorder. I did my best to convience him of errors of his perceptions and concerns and get him calmed down and back to bed while wondering if a "switch had been turned" to take a nominally normal person irreversibly down road into instant' onset dementia. He has had history of waking me with his talking in his sleep on a semi-regular basis, upon which I have gone to his room to ask him who he was talking to. Replies have been of non-serious dream situations; non inducing major concerns. He was mostly back to normal after these potential Paxlovid-augmented events hours later on waking for the day. I then did basic online research to look for reports of such phenomena. All I could findw as at online articles on "Neuropsychiatric Effects of Antiviral Drugs" in which was mentioned "subjective effects which may be similar to those of psychedelic hallucinogen lysergic acid diethylamide (LSD)." None of specific antivirals was either component of Paxlovid but I am not familiar with possibility if there are chemical similarities between those mentioned and Paxlovid's to the point for similar side effects to be expected or possible. As Paxlovid is now in common use and older people are taking it, I convey this concern and history to yourselves for consideration. The recording I made can be made available if needed for further s evaluation. I have been an experienced CDC field agent in the past and am used to having to having taken in much in the line of the public's individual medical histories, though never thought that any such reportable event would strike close to home years later.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Paxlovid use for COVID-19 under Emergency Use Authorization (EUA): Elderly father under my care tested positive for Covid-19. Had most recent Covid booster shot ~3-4 weeks prior. Was experiencing undue hoarseness while recovering so requested prescribing of Paxlovid. Twice during morning 3 days into Paxlovid treatment he awoke, went to the bathroom, and on return to bed (assisted by myself) started speaking of nonsensical, near-hallucinatory subjects as if in walking dream state. 1st was references to deceased friend as if still alive and his need to help father pack items in room to "ship out". 2 hours later, now daylight outside, he spoke extensively of need to return outdoors to help a (non-existent) paving/maintenance crew to direct them in how ot put tar down to complete a (non-existent) paving job. In sensing the gravity and unprecedentedness of this turn of events, I went to get my phone to record rest of conversation with voice recorder. I did my best to convience him of errors of his perceptions and concerns and get him calmed down and back to bed while wondering if a "switch had been turned" to take a nominally normal person irreversibly down road into instant' onset dementia. He has had history of waking me with his talking in his sleep on a semi-regular basis, upon which I have gone to his room to ask him who he was talking to. Replies have been of non-serious dream situations; non inducing major concerns. He was mostly back to normal after these potential Paxlovid-augmented events hours later on waking for the day. I then did basic online research to look for reports of such phenomena. All I could findw as at online articles on "Neuropsychiatric Effects of Antiviral Drugs" in which was mentioned "subjective effects which may be similar to those of psychedelic hallucinogen lysergic acid diethylamide (LSD)." None of specific antivirals was either component of Paxlovid but I am not familiar with possibility if there are chemical similarities between those mentioned and Paxlovid's to the point for similar side effects to be expected or possible. As Paxlovid is now in common use and older people are taking it, I convey this concern and history to yourselves for consideration. The recording I made can be made available if needed for further s evaluation. I have been an experienced CDC field agent in the past and am used to having to having taken in much in the line of the public's individual medical histories, though never thought that any such reportable event would strike close to home years later.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: After Covid 19 2024 booster vaccination, I began to vaginally bleed intermediately, but every single day. This was not expected because I would not be getting a menstrual cycle during that time and also was on birth control pill consecutively.
Age: 68.0
Sex: M
Vaccine: PPV, PNC20
Symptoms: Asthenia, Chills, Dehydration, Feeling abnormal, Fluid intake reduced
Clinical narrative: I had a Prevnar vaccine at pharmacy. I did not get any paperwork telling me which Prevnar type I got, it was either 13 or 20. Only the store can tell you. I'm 68, wear and ostomy appliance but I'm reasonably good health for my age. I'm on Crestor 5mg one per day. After I got home from the sore, I began feeling side effects. It was like a bad case of the flu. I was feverish, had headache, chills, body ache, and I stayed in bed for almost 2 full days. Dehydration became a problem the next day. I had to use Pedialyte to help out. I was not able to eat or drink much for 2 full days. On day three Wednesday, the symptoms began to decline. Today on Friday the 20, I still feel weak and run down. I noticed I have three places on my tongue where the skin has peeled away. What caused this I don't know. I've never ever had a bad reaction to any vaccine in my life. I've only been this ill one time in 1995 when I had the flu. This was the worst I've been for an illness. It was debilitating and hit very fast. I would not use this vaccine on anyone without telling them how risky the side effects are. Contact the company and vaccine maker. This is NOT a safe product. Thanks for your help.
Age: 68.0
Sex: M
Vaccine: PPV, PNC20
Symptoms: Headache, Hypophagia, Influenza like illness, Pain, Pyrexia
Clinical narrative: I had a Prevnar vaccine at pharmacy. I did not get any paperwork telling me which Prevnar type I got, it was either 13 or 20. Only the store can tell you. I'm 68, wear and ostomy appliance but I'm reasonably good health for my age. I'm on Crestor 5mg one per day. After I got home from the sore, I began feeling side effects. It was like a bad case of the flu. I was feverish, had headache, chills, body ache, and I stayed in bed for almost 2 full days. Dehydration became a problem the next day. I had to use Pedialyte to help out. I was not able to eat or drink much for 2 full days. On day three Wednesday, the symptoms began to decline. Today on Friday the 20, I still feel weak and run down. I noticed I have three places on my tongue where the skin has peeled away. What caused this I don't know. I've never ever had a bad reaction to any vaccine in my life. I've only been this ill one time in 1995 when I had the flu. This was the worst I've been for an illness. It was debilitating and hit very fast. I would not use this vaccine on anyone without telling them how risky the side effects are. Contact the company and vaccine maker. This is NOT a safe product. Thanks for your help.
Age: 68.0
Sex: M
Vaccine: PPV, PNC20
Symptoms: Tongue exfoliation
Clinical narrative: I had a Prevnar vaccine at pharmacy. I did not get any paperwork telling me which Prevnar type I got, it was either 13 or 20. Only the store can tell you. I'm 68, wear and ostomy appliance but I'm reasonably good health for my age. I'm on Crestor 5mg one per day. After I got home from the sore, I began feeling side effects. It was like a bad case of the flu. I was feverish, had headache, chills, body ache, and I stayed in bed for almost 2 full days. Dehydration became a problem the next day. I had to use Pedialyte to help out. I was not able to eat or drink much for 2 full days. On day three Wednesday, the symptoms began to decline. Today on Friday the 20, I still feel weak and run down. I noticed I have three places on my tongue where the skin has peeled away. What caused this I don't know. I've never ever had a bad reaction to any vaccine in my life. I've only been this ill one time in 1995 when I had the flu. This was the worst I've been for an illness. It was debilitating and hit very fast. I would not use this vaccine on anyone without telling them how risky the side effects are. Contact the company and vaccine maker. This is NOT a safe product. Thanks for your help.
Age: 68.0
Sex: M
Vaccine: PPV, PNC20
Symptoms: Hypersensitivity
Clinical narrative: I had a Prevnar vaccine at pharmacy. I did not get any paperwork telling me which Prevnar type I got, it was either 13 or 20. Only the store can tell you. I'm 68, wear and ostomy appliance but I'm reasonably good health for my age. I'm on Crestor 5mg one per day. After I got home from the sore, I began feeling side effects. It was like a bad case of the flu. I was feverish, had headache, chills, body ache, and I stayed in bed for almost 2 full days. Dehydration became a problem the next day. I had to use Pedialyte to help out. I was not able to eat or drink much for 2 full days. On day three Wednesday, the symptoms began to decline. Today on Friday the 20, I still feel weak and run down. I noticed I have three places on my tongue where the skin has peeled away. What caused this I don't know. I've never ever had a bad reaction to any vaccine in my life. I've only been this ill one time in 1995 when I had the flu. This was the worst I've been for an illness. It was debilitating and hit very fast. I would not use this vaccine on anyone without telling them how risky the side effects are. Contact the company and vaccine maker. This is NOT a safe product. Thanks for your help.
Sex: U
Vaccine: PPV, PNC20
Symptoms: Asthenia, Chills, Dehydration, Feeling abnormal, Fluid intake reduced
Clinical narrative: severe allergic reaction; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 16Sep2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "severe allergic reaction".  Additional information: the patient specified that he/she never had any problems with any vaccines in his/her life.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: U
Vaccine: PPV, PNC20
Symptoms: Headache, Hypophagia, Influenza like illness, Pain, Pyrexia
Clinical narrative: severe allergic reaction; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 16Sep2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "severe allergic reaction".  Additional information: the patient specified that he/she never had any problems with any vaccines in his/her life.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: U
Vaccine: PPV, PNC20
Symptoms: Tongue exfoliation
Clinical narrative: severe allergic reaction; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 16Sep2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "severe allergic reaction".  Additional information: the patient specified that he/she never had any problems with any vaccines in his/her life.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: U
Vaccine: PPV, PNC20
Symptoms: Hypersensitivity
Clinical narrative: severe allergic reaction; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 16Sep2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "severe allergic reaction".  Additional information: the patient specified that he/she never had any problems with any vaccines in his/her life.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Had a Pfizer COMIRNATY 2024-25(12Y UP) SYRG covid vaccine from lot LM2222. 24 hours later my upper lip swelled for over 24 hours. There was no pain and now that it is 48 hours after the injection the upper lip swelling is going down. I wanted to report this because when I called the pharmacist, where he administered it, he said it is a rare ( 1 in a million) side effect. I don't believe it is rare because no one is required to report side effects that are not bad. So I am reporting it here because I have never had a side effect for any medication or 3 previous Pfizer covid vaccine shots. This one may have a problem needing investigation.
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Chills, Pyrexia, Tremor
Clinical narrative: Uncontrolable shaking and chills due to Flu shot Fluzone High Dose TRIV 2024-25 Sanofi-Pasteur Lot # U8489DA Expires: 9/19/25. Twelve hours after receiving injection. Patient was unable to steady had to get a drink of of water or take medication. Chills and fever 101.8
Age: 76.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Blister, Herpes zoster
Clinical narrative: Received SPIKEVAX 50MCG/0.5ML SUSY NO.5 and FLUZONE HIGH-DOSE 0.5ML SUSY NO.5 on 9/9/24, and within days developed a small eruption of Shingles consisiting of 9 blisters over an area about half dollar size on my left outside thigh. I have photo.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Eye pruritus, Eye swelling
Clinical narrative: Diarrhea, itching and swelling around eyes
Age: 77.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Diarrhoea, Intensive care
Clinical narrative: Patient developed worsening diarrhea a day after the first oral typhoid vaccine dose (and hep A administration). This worsened to the point he was admitted to an outside hospital to their ICU for 4 days.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Pruritus
Clinical narrative: Intense itching red spots all over body starting about a week to ten days after each of seven injections  lasting for approximately 3 to 4 months. Corticosteroid ointment. Prednisone, 3 biopsies, all determinations inconclusive but probably drug related.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Hypersensitivity, Rash pruritic
Clinical narrative: Allergic reaction to varicella vaccine. Had vaccination 9/17/24.  Rash getting larger, itchy, nonpainful. No other prior vaccination reaction. Also had Tdap, PPD, and flu vaccination that had no reaction on other arm.  No prior chickenpox outbreak. No fever, fatigue.
Age: 69.0
Sex: F
Vaccine: PNC20, TDAP, VARZOS
Symptoms: Abdominal pain upper, Malaise, Vomiting
Clinical narrative: She reports "I got sick, on Friday, I started vomiting, watery green, tasted like medicine for two days, I thought maybe it was from all the things I had done that week.  I had two steroid injections for my knees, had teeth worked on and had numbing shot.  It was like an ulcer pain in my stomach. I got over it pretty good."
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Breath sounds abnormal, Chest discomfort, Cough, Erythema, Eye swelling
Clinical narrative: Within 5-8 minutes after TDAP admin pt was heard coughing. Went to check on patient. Pt was wheezing with coughing, chest tightness, facial redness, and eye swelling. Went to get FNP for evaluation. Pt had mildly diminished lung sounds with expiratory wheezes bilaterally. Pt initially used her own inhaler with spacer, but this did not improve her symptoms significantly. Pt was given an albuterol nebulizer treatment. She initially expressed the desire to see if her symptoms could be managed without going to the ED, but after several minutes, agreed to transportation by EMS. Prior to transport, she self-administered her personal epi pen. Pt was also given solumedrol 125mg IM left buttock by LP
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Wheezing
Clinical narrative: Within 5-8 minutes after TDAP admin pt was heard coughing. Went to check on patient. Pt was wheezing with coughing, chest tightness, facial redness, and eye swelling. Went to get FNP for evaluation. Pt had mildly diminished lung sounds with expiratory wheezes bilaterally. Pt initially used her own inhaler with spacer, but this did not improve her symptoms significantly. Pt was given an albuterol nebulizer treatment. She initially expressed the desire to see if her symptoms could be managed without going to the ED, but after several minutes, agreed to transportation by EMS. Prior to transport, she self-administered her personal epi pen. Pt was also given solumedrol 125mg IM left buttock by LP
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: Parents while still in office reported that pt developed a small rash , a few  mild pinkish  slightly raised bumps on face near forehead and eyes approx10- 20 min after the vaccine was administered . Denies  sob, diff breathing , or any other sx at all. Rash  subsided after a 30 min observation and parents and MD could not confirm if the rash was there prior . MD cleared pt to leave after the 30 min observation and advised to reach out if any subsequent sx occur.
Age: 38.0
Sex: M
Vaccine: FLU3, HEP, HEPA, TDAP
Symptoms: Extra dose administered
Clinical narrative: Patient inadvertently received another dose of influenza vaccine on 9/23/24. Patient had previously received influenza vaccine on 9/11/24.
Age: 77.0
Sex: M
Vaccine: CHIK, HEPA, TYP
Symptoms: Headache, Pyrexia
Clinical narrative: Low grade fevers and headache
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered
Clinical narrative: Duplicate influenza vaccination administered patient. Patient did not remember that he had already received an influenza vaccine previously when recommended to do so at pharmacy checkout counter. Pharmacist reviewed patient's immunization profile on Immunization Registry which did NOT indicate that patient received the vaccine previously. Therefore, the pharmacist proceeded to administer the vaccination. After further investigation, pharmacist discovered that patient had already received the same vaccination 1 month prior. Pharmacist notified patient and provided counseling.
Age: 28.0
Sex: F
Vaccine: RSV
Symptoms: Abdominal pain upper, Alanine aminotransferase normal, Aspartate aminotransferase normal, Dizziness, Exposure during pregnancy
Clinical narrative: Pt is G3P1 with EDC of 10/8/24. She developed a severe headache, dizziness, and "fuzzy" vision after receiving the vaccine. She had a period of 30 seconds where she saw bright white lights when bending down to wash her hands. She also experienced right upper quadrant pain. Pt still c/o headache when she saw physician 7 days after she received Abrysvo.
Age: 28.0
Sex: F
Vaccine: RSV
Symptoms: Full blood count normal, Headache, Ultrasound foetal, Urine albumin/creatinine ratio normal, Visual impairment
Clinical narrative: Pt is G3P1 with EDC of 10/8/24. She developed a severe headache, dizziness, and "fuzzy" vision after receiving the vaccine. She had a period of 30 seconds where she saw bright white lights when bending down to wash her hands. She also experienced right upper quadrant pain. Pt still c/o headache when she saw physician 7 days after she received Abrysvo.
Age: 52.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Chills, Dizziness, Headache, Heart rate increased
Clinical narrative: Weakness - onset 1:00am and still experiencing; Fast heartbeat >120bpm - onset 2:00am and lasted for 3 hours; Dizziness - onset 2:00am  and lasted for 5 hours. Took 1000mg extra strength Tylenol for milder symptoms including fever, chills, aches, headache; headache and aches still persisting.
Age: 52.0
Sex: M
Vaccine: UNK
Symptoms: Pain, Pyrexia
Clinical narrative: Weakness - onset 1:00am and still experiencing; Fast heartbeat >120bpm - onset 2:00am and lasted for 3 hours; Dizziness - onset 2:00am  and lasted for 5 hours. Took 1000mg extra strength Tylenol for milder symptoms including fever, chills, aches, headache; headache and aches still persisting.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: patient was given a second flu shot
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: No adverse event occurred. As per CDC vaccine was to be taken off formulary and not be administered however we were not made aware of this change until several weeks after.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: No adverse event occurred. As per CDC vaccine was to be taken off formulary and not be administered however we were not made aware of this change until several weeks after.
Age: 0.33
Sex: F
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: MMR and Varicella administered in error to 4 month old. No adverse effects noted at this time.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Optic nerve disorder, Vitreous floaters
Clinical narrative: I suddenly developed a large floating spot in my eye as well as other spots - checked with ophthalmologist and no retinal tear. reported a red spot of blood on optic nerve and a "floater" that separated from retina.  Said it would be permanent.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: Patient came in and requested to get the new COVID-19 Vaccine and was  given a Flu shot instead.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Cerumen removal, Cough, Paraesthesia, Paraesthesia ear
Clinical narrative: Mom reported pt with in 1-2 hours after receiving flu vaccine in office pt c/o 5 pm  and had a tingling feeling in bilat ear and side and hands all over body .States she had no sob ,diff breathing and sx subsided with in approx 1 hr. States the feeling in her hand was the last to go.  States it has subsided now and she feels fine a this time .  of note mom reports pt has a slight cough at time of visit and had col sx for a few days after that continued .Also of note pt did have earwax removed from ears at visit .
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Chest pain, Cough, Dizziness
Clinical narrative: Patient, a 75-year-old patient with obesity, hypertension, hyperlipidemia, asthma, and prediabetes, reports feeling unwell since receiving a COVID vaccine last Wednesday. She reports pain in the left arm where the vaccine was administered, weakness, dizziness, stomach and chest pain, increased wheezing and coughing at night, and a headache in the back of her neck. She also reports soreness in her throat, which she attributes to an inhaler she was prescribed for her asthma. The patient's arm pain is likely due to the vaccine, either from the vaccine itself or from the administration of the shot. The patient's other symptoms could be a reaction to the vaccine, as it is common to feel weak and dizzy and to have symptoms similar to a mild infection after receiving vaccines. However, it is also possible that the patient has an entirely different issue, as she reported having some of these symptoms before receiving the vaccine.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Oropharyngeal pain, Pain in extremity, Wheezing
Clinical narrative: Patient, a 75-year-old patient with obesity, hypertension, hyperlipidemia, asthma, and prediabetes, reports feeling unwell since receiving a COVID vaccine last Wednesday. She reports pain in the left arm where the vaccine was administered, weakness, dizziness, stomach and chest pain, increased wheezing and coughing at night, and a headache in the back of her neck. She also reports soreness in her throat, which she attributes to an inhaler she was prescribed for her asthma. The patient's arm pain is likely due to the vaccine, either from the vaccine itself or from the administration of the shot. The patient's other symptoms could be a reaction to the vaccine, as it is common to feel weak and dizzy and to have symptoms similar to a mild infection after receiving vaccines. However, it is also possible that the patient has an entirely different issue, as she reported having some of these symptoms before receiving the vaccine.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Patient is a 66 year old male, given Children's dosage from 5-12 years of age. Pfizer vaccine 2024-2025 formula.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: swollen face, no reported breathing problems
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Hyperhidrosis, Presyncope, Vision blurred, Visual impairment
Clinical narrative: Vagal Reaction, Pt became sweaty and felt blurred vision along with colorful spots in vision, Pt also expressed this happens with her Anxiety.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Pt was given adult dose of Havrix IM instead of pediatric dose. Pt mother was notified at time of incident. NP overseeing care of pt was notified. Pt suffered no adverse reactions due to administration of adult Havrix.
Age: 71.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects noted. Patient came in and asked for an RSV shot, but pharmacist didn't realize that the patient had already received one in October 2023 and gave a second dose by mistake.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: redness, swelling, fever
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Injection site urticaria, Urticaria
Clinical narrative: Redness and rash around injection site for few days following injection, then mosquito bite like hives around injection site and migrating to other random areas of the body over the course of a week after injection.
Age: 21.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: Nause and vomiting
Age: 65.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Nodule
Clinical narrative: knot in right arm for >7 days
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: pt was in office for well child exam on 9/23/24 and was given an expired hpv, the hpv expired on 8/10/2023
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Incorrect dose administered, Single component of a two-component product administered
Clinical narrative: Did not dilute the HIB powder. Gave only the Dtap/IPV portion
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: pt came into office for well child exam 9/23/24 and was given an expired hpv vaccine. the vaccine expired 8/10/24
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, PNC20
Symptoms: Asthenia, Lacrimation increased, Ocular hyperaemia, Periorbital swelling
Clinical narrative: mother called apx 30 minutes to an hour later after vaccines were given to report that the infant's left eye was red, watering, and slightly puffy. NOT both, just the left eye. Did state that it could be "pink eye" but could not be sure.  Mother stated she felt better reporting it. On 9/24/24, phone call was made to ask about child and mother stated eye is still red but the child is back to being energetic.
Age: 15.0
Sex: M
Vaccine: HEPA, IPV, MNQ, TDAP
Symptoms: Dyskinesia, Loss of consciousness, Pallor, Syncope
Clinical narrative: Pt fainted after giving last vaccine and had some abnormal movement, but quickly regained consciousness. After about one minute, patient was fully consciousness patient was able to lay down on the floor on his own, and his feet were elevated. Pt face/lips were pale in color. Patient was given lemonade and asked to lay down for a few minutes. Pt regained color after about 5 mins. Patient stated he felt better and was able to get up on his own and was ready to leave.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Asthenia, Myalgia, Pyrexia
Clinical narrative: Employee  recieved vaccine Thursday 09-19-2024  at  2:30 PM and stated early Friday  morning and into Saturday evening she had a 101.7 fever and muscle/joint  soreness/weakness everywhere.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient received 2 COVID vaccines. Supposed to be a flu shot and COVID shot for husband and wife and patient was accidentally given 2 COVID vaccines.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: patient reports that within an hour after Gardasil #2 administration that her right upper arm/extremity (RUE) started swelling, in and around the area where vaccine was given. Swelling has not receded any.  Area is painful to touch but no overlying erythema. No fevers or streaking. no limitation in movement of RUE.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: PATIENT IS A 15 YEAR OLD GIVEN A FLUBLOK VACCINE (>18 AGE). SPOKE TO PARENT/GAURDIAN. PATIENT IS FEELING OKAY AND NO PROBLEM WITH POST-VACCINATION SIDE EFFECT. PATIENT AND PARENT/GAURDIAN ARE AWARE OF VACCINE GIVEN WAS INCORRECT FOR PATIENT AGE GROUP
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Immediate post-injection reaction, Pruritus, Swelling face, Throat clearing
Clinical narrative: Immediate facial swelling and whole body itching, throat clearing. Symptoms were treated with IM epinephrine, antihistamines.
Age: 5.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Medication given to 5 year old, per cdc up to 4 years only
Age: 18.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: MMRV (Proquad) only to be given from ages 2-12.  Patient is 18 year old. No adverse reaction reported.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Chest, shoulder, arm and head worse when lying down
Age: 81.0
Sex: F
Vaccine: PNC20
Symptoms: Chest pain, Cough, Dyspnoea, SARS-CoV-2 test, SARS-CoV-2 test negative
Clinical narrative: severe chest pain and cough with shortness of breath which started three days later.   Today, Sept 24, the pain has gone away after 4 days however, I still have coughing and shortness of breath
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient complained of rash all over her chest starting the day after the flu shot was given. She is taking Benadryl and over the counter antihistamine Claritin. Improved but still present. Getting better slowly.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: HCP/employee received annual Flu Vaccine on 9/17/24-tol well, no issues. On 9/23 injection site became itchy, tender and warm to touch. Contacted Occupational Health dept, was seen/evaluated diagnosed with cellulitis, started on oral antibiotics with follow up plan
Age: 28.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administration error, Wrong product administered
Clinical narrative: Patient was given Arexy instead of Abrysvo due to error
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Patient developed hives along his left arm after the injection
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Pyrexia, Vomiting
Clinical narrative: Throwing up, fever, exhaustion
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Patient also received a bexsero lot #  G334J via IM injection.  This was his first Bexsero.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Arthroscopy, Back pain, Magnetic resonance imaging joint
Clinical narrative: Severe right knee inflammation ensued on 10/04/2021. It has spread to a rheumatic poly  arthritis. I have severe pain in my knees, hips especially the left hip, back and neck. I had been a heart surgical PA-C for 25 years. I can?t sit, stand, walk or do anything  without pain.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging pelvic, Neck pain, Pain, Rheumatoid arthritis
Clinical narrative: Severe right knee inflammation ensued on 10/04/2021. It has spread to a rheumatic poly  arthritis. I have severe pain in my knees, hips especially the left hip, back and neck. I had been a heart surgical PA-C for 25 years. I can?t sit, stand, walk or do anything  without pain.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric dose was given to this pt.
Age: 6.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain upper, Delirium, Nasal congestion, Nausea, Pyrexia
Clinical narrative: Fever100-102, stuffy nose, sore throat, stomach ache, delirious, nausea and vomiting since Sunday 9/22, worst symptoms Monday 9/23, fever 100-101, stuffy nose, sore throat, stomachache 9/24 as of present- symptoms appear to be less
Age: 6.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vomiting
Clinical narrative: Fever100-102, stuffy nose, sore throat, stomach ache, delirious, nausea and vomiting since Sunday 9/22, worst symptoms Monday 9/23, fever 100-101, stuffy nose, sore throat, stomachache 9/24 as of present- symptoms appear to be less