chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oesophageal disorder, Red blood cell sedimentation rate normal, SARS-CoV-2 antibody test positive, Spinal X-ray
Clinical narrative: Day of Shot - Loss of balance, dizziness. Continued for several days and worsened. Day 3-4 started with PVCs and nausea. BP elevated 200+/100+.   Admitted to hospital on 2/25 with chest pain, PVCs, very high blood pressure. It has been almost 1 year of doctor appointments and tests since that shot. I still am not well and have not been able to work or manage my home.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound chest, Ultrasound scan abnormal, Ventricular extrasystoles
Clinical narrative: Day of Shot - Loss of balance, dizziness. Continued for several days and worsened. Day 3-4 started with PVCs and nausea. BP elevated 200+/100+.   Admitted to hospital on 2/25 with chest pain, PVCs, very high blood pressure. It has been almost 1 year of doctor appointments and tests since that shot. I still am not well and have not been able to work or manage my home.
Sex: U
Vaccine: COVID19
Symptoms: Arterial thrombosis, Embolism, Thrombosis
Clinical narrative: COVID19  Pfizer BioNTech. Around 3 months after taking the vaccine, I was diagnosed with Blood Clots / Embolism without any injury or symptoms. Seveir artery thrombosis caused with almost certainty by the vaccine, and now I'm sentenced for life to take anticoagulants every day, which cost 550 per month.
Age: 31.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Eye swelling, Injection site erythema, Injection site pain, Injection site reaction, Sensitive skin
Clinical narrative: On 2/12 woke up with L eye swelling, used ice pack for 20 minutes and swelling mostly resolved. at 7pm she noticed site redness with burning/stinging pain, no treatment was applied or taken but traced with blue pen to observe.    On 2/13 woke with increased L eye swelling used ice pack to resolve swelling.   At 8:50am this nurse  met with patient, a new employee, the site in question was the site where her varicella immunization was administered by this nurse. Advised pain relief of acetaminophen or ibuprofen and Benedryl at bedtime, and continue to monitor and report adverse changes as directed by CCO, Dr. At 205pm employee reported increased sensation and irritation extending into L axilla.  Redness exceeded pen-drawn boarder slightly.  After speaking to Dr. employee was advised to take 400mg up to 800mg of ibuprofen for pain relief.  She was also advised to take Benedryl when at home and at bedtime, as she reports drowsiness with Benedryl use.  On 2/13 at 807am Employee reports site redness and sensitivity improved.  One Benedryl was taken at bedtime, no eye swelling was observed.  Employee encouraged to continue pain relief and Benedryl as needed.
Age: 31.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Skin irritation
Clinical narrative: On 2/12 woke up with L eye swelling, used ice pack for 20 minutes and swelling mostly resolved. at 7pm she noticed site redness with burning/stinging pain, no treatment was applied or taken but traced with blue pen to observe.    On 2/13 woke with increased L eye swelling used ice pack to resolve swelling.   At 8:50am this nurse  met with patient, a new employee, the site in question was the site where her varicella immunization was administered by this nurse. Advised pain relief of acetaminophen or ibuprofen and Benedryl at bedtime, and continue to monitor and report adverse changes as directed by CCO, Dr. At 205pm employee reported increased sensation and irritation extending into L axilla.  Redness exceeded pen-drawn boarder slightly.  After speaking to Dr. employee was advised to take 400mg up to 800mg of ibuprofen for pain relief.  She was also advised to take Benedryl when at home and at bedtime, as she reports drowsiness with Benedryl use.  On 2/13 at 807am Employee reports site redness and sensitivity improved.  One Benedryl was taken at bedtime, no eye swelling was observed.  Employee encouraged to continue pain relief and Benedryl as needed.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Echocardiogram abnormal, Illness, Pericarditis, SARS-CoV-2 test positive
Clinical narrative: Illness after each covid-19 vaccination and booster. Covid-19 was a positive diagnosis but the effects were several times worse than normal. My physician advised me not to take any further vaccines after the first booster because of the intensity of my illness resulting from the vaccination.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Colonoscopy, Endoscopy upper gastrointestinal tract, Gastrointestinal disorder, Helicobacter infection
Clinical narrative: Sever stomach issues....hpylori
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cardiac ablation, Cardiac operation, Epstein-Barr virus infection, Imaging procedure
Clinical narrative: Chronic EBV, heart surgery, heavy metal poisoning with Lead and Mercury.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Metal poisoning, Post-acute COVID-19 syndrome, Scan, Supraventricular tachycardia
Clinical narrative: Chronic EBV, heart surgery, heavy metal poisoning with Lead and Mercury.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Condition aggravated, Death, Dementia Alzheimer's type, Malaise, Mobility decreased
Clinical narrative: Covid 19 shot and Flu shot sames time. Got deathly sick. Got down in bed and never got up again. She kept getting worse and worse. She died 4.5 weeks later.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Nausea, Peripheral swelling
Clinical narrative: swollen arm, severe headache, nausea, diarrhea
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: PATIENT RECEIVED DUPLICATE VACCINE- PATIENT RECEIVED HER RSV VACCINE ( AREXVY) ON 12/23/23 WHICH WAS NOT REPORTED TO REGISTRY. PATIENT RECEIVED ABRYSVO ON 2/12/25.
Age: 50.0
Sex: F
Vaccine: COVID19, FLU3, HEP, MMR, PNC21, COVID19, FLU3, MMR, PNC20, VARZOS
Symptoms: Arthralgia, Laboratory test, Loss of personal independence in daily activities, Product administered at inappropriate site, X-ray
Clinical narrative: The pharmacist gave me two shots on each shoulder, and one in my left forearm, on my right shoulder he did one too high and I still have pain in that shoulder, he did two in my left shoulder and the pain is unbearable. I had to go to the er a couple days after because they pain was too much. I have been to the er three times since Dec and Feb 5th.  This has completely affected every area of my life. The pain has not gotten better and I don?t know where to go from here.
Age: 50.0
Sex: F
Vaccine: COVID19, FLU3, HEP, MMR, PNC21, COVID19, FLU3, MMR, PNC20, VARZOS
Symptoms: Arthralgia, Asthenia, Joint swelling, Mobility decreased, Skin warm
Clinical narrative: The pharmacist gave me two shots on each shoulder, and one in my left forearm, on my right shoulder he did one too high and I still have pain in that shoulder, he did two in my left shoulder and the pain is unbearable. I had to go to the er a couple days after because they pain was too much. I have been to the er three times since Dec and Feb 5th.  This has completely affected every area of my life. The pain has not gotten better and I don?t know where to go from here.
Age: 47.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Induration, Pain in extremity, Skin swelling, Skin warm
Clinical narrative: Patient called at 7pm and reported issues with pain in arm,red hot and hard and puff spots. Requested pt take benadryl and ice the area. Patient will follow up with me 2/13/25 and if still irritated or unwell call dr for RX treatment
Age: 86.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient did not need this vaccine as received 11/17/23
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Diarrhoea, Stool analysis normal, Urticaria
Clinical narrative: Diarrhea and hives
Age: 3.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: fever; gave COMIRNATY COVID vaccine to a 1 and 3 year old; gave COMIRNATY COVID vaccine to a 1 and 3 year old; This is a spontaneous report and received from Other HCPs from medical information team, Program ID:.  A 3-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 13Jan2025 as dose 1, single (Lot number: LP1776, Expiration Date: 25Feb2025) at the age of 3 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Autism", start date: 19Nov2024 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OVERDOSE (non-serious), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) all with onset 13Jan2025, outcome "unknown" and all described as "gave COMIRNATY COVID vaccine to a 1 and 3 year old"; PYREXIA (non-serious) with onset 15Jan2025, outcome "recovered", described as "fever". The event "fever" required physician office visit. Therapeutic measures were not taken as a result of pyrexia, overdose, product administered to patient of inappropriate age.  Additional information: The patient did not receive any other vaccines on the same date as the Pfizer vaccine. The patient was not taking any other medications within 2 weeks prior to the event onset. The patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. It was reported that the medication error occurred when the product was prepared, dispensed and administered to the patient. Misunderstanding of instructions by the individual administering the medication was a factor considered to be responsible for the medication error.  Follow-up (13Jan2025): This is a spontaneous follow-up report received from an Other HCP from medical information team, Program ID:. Updated information: reporter details updated.  Follow-up (10Feb2025): This is a spontaneous follow-up report received from an Other HCP. Updated information: relevant medical history, historical vaccine details, suspect vaccine details (lot number, expiration date, vaccination date, route of vaccination, anatomical location), vaccine facility information, new event (fever).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500007655 Same reporter/drug/event, different patient;
Age: 3.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Overdose, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: fever; gave COMIRNATY COVID vaccine to a 1 and 3 year old; gave COMIRNATY COVID vaccine to a 1 and 3 year old; This is a spontaneous report and received from Other HCPs from medical information team, Program ID:.  A 3-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 13Jan2025 as dose 1, single (Lot number: LP1776, Expiration Date: 25Feb2025) at the age of 3 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Autism", start date: 19Nov2024 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OVERDOSE (non-serious), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) all with onset 13Jan2025, outcome "unknown" and all described as "gave COMIRNATY COVID vaccine to a 1 and 3 year old"; PYREXIA (non-serious) with onset 15Jan2025, outcome "recovered", described as "fever". The event "fever" required physician office visit. Therapeutic measures were not taken as a result of pyrexia, overdose, product administered to patient of inappropriate age.  Additional information: The patient did not receive any other vaccines on the same date as the Pfizer vaccine. The patient was not taking any other medications within 2 weeks prior to the event onset. The patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. It was reported that the medication error occurred when the product was prepared, dispensed and administered to the patient. Misunderstanding of instructions by the individual administering the medication was a factor considered to be responsible for the medication error.  Follow-up (13Jan2025): This is a spontaneous follow-up report received from an Other HCP from medical information team, Program ID:. Updated information: reporter details updated.  Follow-up (10Feb2025): This is a spontaneous follow-up report received from an Other HCP. Updated information: relevant medical history, historical vaccine details, suspect vaccine details (lot number, expiration date, vaccination date, route of vaccination, anatomical location), vaccine facility information, new event (fever).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500007655 Same reporter/drug/event, different patient;
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes virus infection
Clinical narrative: it was an HSV outbreak; This non-serious case was reported by a consumer via call center representative and described the occurrence of herpes simplex in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 09-OCT-2024, the patient received the 1st dose of Shingrix (intramuscular, unknown arm). In OCT-2024, 2 days after receiving Shingrix, the patient experienced herpes simplex (Verbatim: it was an HSV outbreak). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the herpes simplex was not resolved.   It was unknown if the reporter considered the herpes simplex to be related to Shingrix.     It was unknown if the company considered the herpes simplex to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-FEB-2025 The patient self-reported this case for himself. The patient received Shingrix vaccine and had a herpes virus outbreak.  The patient reported that he received the 1st and only Shingrix vaccine at a local pharmacy.  The patient did not have the lot number or expiry information and did not recall in which arm the vaccine was administered.  The patient reported two days later he had a herpes virus reaction outbreak and he continue having it since.  At the end of the call the patient clarified the virus information and stated it was a HSV (herpes simplex virus) outbreak.  The patient reported he was prescribed Valtrex and wanted to know have GSK heard this before. This was a major problem and wanted to know has anyone else report this. The patient wanted to talk about filing a claim against GlaxoSmithKline guys due to a reaction to Shingrix vaccine. No additional information was reported. It was a potential legal case.  Patient wanted to be contacted by GlaxoSmithKline.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes simplex
Clinical narrative: it was an HSV outbreak; This non-serious case was reported by a consumer via call center representative and described the occurrence of herpes simplex in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 09-OCT-2024, the patient received the 1st dose of Shingrix (intramuscular, unknown arm). In OCT-2024, 2 days after receiving Shingrix, the patient experienced herpes simplex (Verbatim: it was an HSV outbreak). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the herpes simplex was not resolved.   It was unknown if the reporter considered the herpes simplex to be related to Shingrix.     It was unknown if the company considered the herpes simplex to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-FEB-2025 The patient self-reported this case for himself. The patient received Shingrix vaccine and had a herpes virus outbreak.  The patient reported that he received the 1st and only Shingrix vaccine at a local pharmacy.  The patient did not have the lot number or expiry information and did not recall in which arm the vaccine was administered.  The patient reported two days later he had a herpes virus reaction outbreak and he continue having it since.  At the end of the call the patient clarified the virus information and stated it was a HSV (herpes simplex virus) outbreak.  The patient reported he was prescribed Valtrex and wanted to know have GSK heard this before. This was a major problem and wanted to know has anyone else report this. The patient wanted to talk about filing a claim against GlaxoSmithKline guys due to a reaction to Shingrix vaccine. No additional information was reported. It was a potential legal case.  Patient wanted to be contacted by GlaxoSmithKline.
Age: 29.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Discomfort, Erythema, Pruritus, Swelling
Clinical narrative: 29 yo M presents for skin irritation at injection site. Received varicella vaccine on 2/11. Noticed lump forming 2/12 AM and said he thought it got better throughout the day, but this morning noticed redness and itching. No h/o previous vaccine reaction. No h/o allergies. No tongue or lip swelling, difficulty breathing. No f/c.  Well-developed well-nourished, in no acute distress Skin: Large raised erythematous area located on back of forearm. Photo is uploaded in chart and is demarcated on patient arm. Firm to touch. No blistering.
Age: 29.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Erythema, Induration, Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: 29 yo M presents for skin irritation at injection site. Received varicella vaccine on 2/11. Noticed lump forming 2/12 AM and said he thought it got better throughout the day, but this morning noticed redness and itching. No h/o previous vaccine reaction. No h/o allergies. No tongue or lip swelling, difficulty breathing. No f/c.  Well-developed well-nourished, in no acute distress Skin: Large raised erythematous area located on back of forearm. Photo is uploaded in chart and is demarcated on patient arm. Firm to touch. No blistering.
Age: 29.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Injection site reaction, Skin irritation
Clinical narrative: 29 yo M presents for skin irritation at injection site. Received varicella vaccine on 2/11. Noticed lump forming 2/12 AM and said he thought it got better throughout the day, but this morning noticed redness and itching. No h/o previous vaccine reaction. No h/o allergies. No tongue or lip swelling, difficulty breathing. No f/c.  Well-developed well-nourished, in no acute distress Skin: Large raised erythematous area located on back of forearm. Photo is uploaded in chart and is demarcated on patient arm. Firm to touch. No blistering.
Age: 27.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 27 yo M presents with skin irritation at injection site. Received vaccine on 2/11 at clinic. Noticed redness and lump this morning at back of L upper arm with itching and redness. Says the itching is similar to a mosquito bite. Is uncertain if he has received a varicella in the past. Denies previous shot reaction. No tongue or lip swelling, no difficulty breathing.  Well-developed well-nourished, in no acute distress Skin: Approx 3 x 3 circular erythematous raised area noted on posterior aspect of L forearm, firm to touch.
Age: 27.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Erythema, Induration, Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: 27 yo M presents with skin irritation at injection site. Received vaccine on 2/11 at clinic. Noticed redness and lump this morning at back of L upper arm with itching and redness. Says the itching is similar to a mosquito bite. Is uncertain if he has received a varicella in the past. Denies previous shot reaction. No tongue or lip swelling, no difficulty breathing.  Well-developed well-nourished, in no acute distress Skin: Approx 3 x 3 circular erythematous raised area noted on posterior aspect of L forearm, firm to touch.
Age: 27.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Injection site reaction, Skin irritation
Clinical narrative: 27 yo M presents with skin irritation at injection site. Received vaccine on 2/11 at clinic. Noticed redness and lump this morning at back of L upper arm with itching and redness. Says the itching is similar to a mosquito bite. Is uncertain if he has received a varicella in the past. Denies previous shot reaction. No tongue or lip swelling, no difficulty breathing.  Well-developed well-nourished, in no acute distress Skin: Approx 3 x 3 circular erythematous raised area noted on posterior aspect of L forearm, firm to touch.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 62-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 31-JAN-2025 The patient self-reported this case for himself. No other products given to the patient. The patient received Shingles vaccine (2 doses) and had shingles for which intervention required. The patient had shingles four times a year. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description,  time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.  Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Peripheral swelling, Pyrexia
Clinical narrative: fever; The first Shingrix vax made me really sick; my arm swelled like a football; ache in my shoulder; This non-serious case was reported by a consumer and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included autoimmune disorder.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: fever), sickness (Verbatim: The first Shingrix vax made me really sick), swelling arm (Verbatim: my arm swelled like a football) and shoulder pain (Verbatim: ache in my shoulder). The outcome of the fever, sickness, swelling arm and shoulder pain were resolved (duration 10 days).   It was unknown if the reporter considered the fever, sickness, swelling arm and shoulder pain to be related to Shingrix.     It was unknown if the company considered the fever, sickness, swelling arm and shoulder pain to be related to Shingrix.   Additional Information: GSK receipt date: 14-JAN-2025 The patient indicated that he/she do not get regular flu vaccinations because they tend to harm more than help. The patient had the Shingrix vaccine because patient was concerned about getting shingles in optical nerve.  The first Shingrix vaccine made him/her really sick and had ran a fever, his/her arm swelled like a football, and had full virus like symptoms for 10 days.  The patient had a lesser reaction for the booster, but it lasted 7 days. The patient was required to be vaccinated for job. The patient had an ache in shoulder a few days later, had totally forgotten that he/she had the vax. The patient have had a couple of boosters.  No reaction were reported. The patient stated that his/her body hates everything and if a medication of any kind can be taken by 99 percent of the world, he/she was the 1 percent and the patient could not even take baby aspirin.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received his first Shingrix dose in his doctor's office over 2 years ago; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose over 2 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received his first Shingrix dose in his doctor's office over 2 years ago). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 06-FEB-2025 The pharmacist reported that a patient had received his first Shingrix dose in his doctor office might had been before covid and wants to know that the patient still get the second dose or he start over. Till the time of reporting, the patient did not receive second dose of Shingrix which led to incomplete course of vaccination. This was 1 of the 4 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020239730:same reporter US-GSK-US2020209374:same reporter US-GSK-US2020209373:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix over year ago and has not received second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose over a year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: first dose of Shingrix over year ago and has not received second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 06-FEB-2025 The pharmacist stated that a patient had not received his second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case is linked with US2025015910 reported by the same reporter.; Sender's Comments:  US-GSK-US2025015910:Same reporter
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Electrocardiogram, X-ray
Clinical narrative: Chest pain in the lower right breast.  Persistent soreness with occasional shotting pain
Sex: U
Vaccine: VARZOS
Symptoms: COVID-19
Clinical narrative: that they received the shingles vaccine in 2020 and thought they were coming down with COVID-19 until they read the side effects from Shingrix and realized they ticked all the boxes.; This non-serious case was reported by a consumer and described the occurrence of covid-19 in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced covid-19 (Verbatim: that they received the shingles vaccine in 2020 and thought they were coming down with COVID-19 until they read the side effects from Shingrix and realized they ticked all the boxes.). The outcome of the covid-19 was resolved.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.     It was unknown if the company considered the covid-19 to be related to Shingrix.   Additional Information: GSK Receipt Date:16-JAN-2025 The patient got the shingles shot in 2020.  The reporter thought for sure I was coming down with Covid, and then he/she read all of the side effects from the Shingrix , ticked all the boxes.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Potential late second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: Potential late second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 17-JAN-2025 The reporter contacted via web chat anonymous started conversation mentioning was it acceptable to administer 2 dose of shingles greater than 6 months after 1st. The healthcare provider abandoned the chat right after agent asked for consent to store contact details into the database, without any additional data about the case. It was not clarified if a patient was involved or if it was just a hypothetical question, and if the vaccine was Shingrix. The agent did not have a chance to ask for consent to follow up with safety team. Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine which led to incomplete course of vaccination.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is really strange, I always took the vaccines, the Pfizer vaccines, and thought I was up to date. I still got Covid on 05Oct; This is really strange, I always took the vaccines, the Pfizer vaccines, and thought I was up to date. I still got Covid on 05Oct; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 73-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Paxlovid, start date: 07Oct2023, for COVID-19 treatment. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Oct2024, outcome "unknown" and all described as "This is really strange, I always took the vaccines, the Pfizer vaccines, and thought I was up to date. I still got Covid on 05Oct". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient found it really strange, he always took the vaccines, the Pfizer vaccines, and thought he was up to date. He still got Covid on 05Oct. The doctor got him on our product (Paxlovid) and so in the 5 days he was fine.  The information on the batch/lot number for BNT162B2 will be requested and submitted if and when received.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Allergy test, Food allergy, Hypertension, Vomiting
Clinical narrative: I now have high blood pressure and have developed a severe allergic reaction to eating eggs. I wasn't allergic to anything food related prior to covid vaccine. I grew up eating eggs. Now if I eat even one egg I throw up.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination error
Clinical narrative: patient did not request this vaccine
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: PATIENT REPORTED THAT HE STARTED FEELING ITCHY IN THE EVENING ON THE VACCINE ON 02/11/2025 AND OVERNIGHT HE DEVELOPED RASHES ALL OVER HIS BODY.  HE DID NOT DEVELOP ANY OTHER SYMPTOMS
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Intense shivering and fevers the evening of the vaccination. The next morning, headaches
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Chills, Decreased appetite, Headache, Pain, Pyrexia
Clinical narrative: Fever >103 x 4 days, still febrile on day 4, 103.8, headache, body aches, chills, vomiting, loss of appetite
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Respiratory pathogen panel, Vomiting
Clinical narrative: Fever >103 x 4 days, still febrile on day 4, 103.8, headache, body aches, chills, vomiting, loss of appetite
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Aphasia, Decreased eye contact
Clinical narrative: Decreased vocalization/babbling (slowly improving with time), Decreased eye contact (slowly improving with time)
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy lymph gland, Lymphadenopathy
Clinical narrative: Lymph nodes were enlarged for months.  Ultra Sound done on 7/13/21
Age: 1.33
Sex: F
Vaccine: TYP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: SHE RECEIVED THEY TYPHOID VACCINE AFTER WE WERE TOLD SHE COULDN'T HAVE IT BECAUSE OF HER AGE
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia, Rash
Clinical narrative: Per the parents patient experienced fever and rash after administration of MCV4 vaccine.  Rash on torso, face and extremities.  No lethargy, wheeze, resp distress or sore throat.  Resolved with OTC Benadryl.
Age: 1.42
Sex: M
Vaccine: DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: Patient was given an extra dose of IPV at 15 month visit. Patient should have only received DTaP and received DTaP-IPV
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation issue
Clinical narrative: The Lot # is for the Diluent that came with the vaccine. The medical assistant did not mix the vaccine and the diluent and only gave the patient the diluent. No adverse reactions were reported . Vaccine count was done same day and we found the mistake. Dr contacted the patient and informed her of the mistake and told the patient to make an appointment to come back in to receive the actual vaccine.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: patient had already had vaccine on Jan 4, 2024
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Fatigue, Pain, Pruritus, Rash macular
Clinical narrative: Splotchy after shot, became warm to touch, swollen, sore, itching, redness fatigue, body aches
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Skin warm, Swelling
Clinical narrative: Splotchy after shot, became warm to touch, swollen, sore, itching, redness fatigue, body aches
Age: 5.0
Sex: M
Vaccine: IPV, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given a dose of Polio and MMR when he was not due for them.  The series were previously completed 02/15/2024.  Patient has not had any adverse reactions or outcomes reported.
Age: 4.0
Sex: M
Vaccine: COVID19, DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Red raised warm area around injection sites to left upper thigh. Itchy. Started small and increased in size within 24 hours. Examined today X4 days after vaccines, X3 days post site reaction-site is visible, flat, hyperpigmented with irregular borders. Mom reports improvement overall.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: given less than 28 days since MMR dose given 11/21/2024
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given past Beyond Use Date of 02/04/2025.  No adverse events or complications reported.  Parents were informed and advised to have patient re-vaccinated for adequate coverage against COVID-19 infection.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: vaccine given when MMR live virus given less than 28 days apart 11/21/24
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient reported today she has had arm aching, pain even. Gets better throughout the day, but is bad in the morning. Reportedly started with her Fluzone shot and has continued
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Seasonal allergy, Sneezing
Clinical narrative: Seasonal allergies which I never had before. I got the 3rd booster, and was out of the country. When I came back I instantly started sneezing, and first assumed I was catching a cold from my flight. Then I had the AC checked twice because I thought something was wrong. Eventually I realized my symptoms were of allergies, and I got tested. Now I have allergies each year at the end of the summer
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Injection site reaction, Papule, Rash, Rash erythematous, Rash macular
Clinical narrative: Approximately 20 minutes after injections and oral immunization administration, the patient developed a red rash all over the right cheek and a red macular rash on the forehead, top of head, and around mouth. There were some red papular lesions on the legs around the injections sites
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Blood creatinine increased
Clinical narrative: Acute Kidney Injury (AKI) unknown cause per nephrology consultation atnephrology on Feb 14, 2025.  I am a physician and strongly suspect AKI as a vaccine adverse reaction because there were no other interventions, medication changes, changes in health or activity, NSAID use, recreational drug use or other precipitant.  Nephro also diagnosed Chronic Renal Insufficiency as a result of AKI based on duration of renal injury.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction, Cholecystectomy, Cholecystitis, Coronary artery bypass, Endocarditis
Clinical narrative: 29-Dec-21, Inflammatory Heart attack Hospitalized (Medical Center) from 12/29/2021 to 12/31/2021 Note: transferred to Medical Center for surgery. 04-Jan-22, CABG Triple Bypass surgery, Hospitalized (Medical Center) from 01/01/22 to 01/11/22, Cardiologist: Dr., Surgeon: Dr. Internal Medicine - Cardiovascular Disease 25-Jan-22, Emergency Room Visit, Diagnosis: Tachycardia, 01-Mar-22, Emergency Room Visit, Hospitalized (MC) from 03/01/22 to 03/14/22, Diagnosis:  Cholecystitis, Physician:  Dr. Internal Medicine 06-May-22, Day surgery  Cholecystectomy, Hospitalized (MC) from 05/06/22 to 05/28/22  Physician: Dr. General Surgeon  06-May-22, Post-day surgery Cholecystectomy, Hospitalized (MC) from 05/06/22 to 05/28/22  Surgeon: Dr., Physician: Dr., Physician: Dr.  Diagnosis: Numerous problems were encountered after the day-surgery procedure. (Sepsis, pneumonia, and a collapsed lung)  18-Jul-22, Endocarditis, Hospitalized (MC) from 7/18/22 to 07/28/22  Cardiologist: Dr., Infectious Disease: Dr.   15-Sep-22, Pneumonia, Hospitalized from 09/15/22 to 09/18/22  Physician: Dr., Physician: Dr.  08-Nov-22, Pneumonia and Residual Endocarditis, Hospitalized from 11/08/22 to 11/19/22, Physician: Dr., Physician: Dr., Infectious Disease: Dr.   10-Apr-23, Acute Myocardial Infarction, Hospitalized (MC) from 04/10/23 to 04/12/23  Physician Dr., Cardiologist Dr.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pneumonia, Pneumothorax, Sepsis
Clinical narrative: 29-Dec-21, Inflammatory Heart attack Hospitalized (Medical Center) from 12/29/2021 to 12/31/2021 Note: transferred to Medical Center for surgery. 04-Jan-22, CABG Triple Bypass surgery, Hospitalized (Medical Center) from 01/01/22 to 01/11/22, Cardiologist: Dr., Surgeon: Dr. Internal Medicine - Cardiovascular Disease 25-Jan-22, Emergency Room Visit, Diagnosis: Tachycardia, 01-Mar-22, Emergency Room Visit, Hospitalized (MC) from 03/01/22 to 03/14/22, Diagnosis:  Cholecystitis, Physician:  Dr. Internal Medicine 06-May-22, Day surgery  Cholecystectomy, Hospitalized (MC) from 05/06/22 to 05/28/22  Physician: Dr. General Surgeon  06-May-22, Post-day surgery Cholecystectomy, Hospitalized (MC) from 05/06/22 to 05/28/22  Surgeon: Dr., Physician: Dr., Physician: Dr.  Diagnosis: Numerous problems were encountered after the day-surgery procedure. (Sepsis, pneumonia, and a collapsed lung)  18-Jul-22, Endocarditis, Hospitalized (MC) from 7/18/22 to 07/28/22  Cardiologist: Dr., Infectious Disease: Dr.   15-Sep-22, Pneumonia, Hospitalized from 09/15/22 to 09/18/22  Physician: Dr., Physician: Dr.  08-Nov-22, Pneumonia and Residual Endocarditis, Hospitalized from 11/08/22 to 11/19/22, Physician: Dr., Physician: Dr., Infectious Disease: Dr.   10-Apr-23, Acute Myocardial Infarction, Hospitalized (MC) from 04/10/23 to 04/12/23  Physician Dr., Cardiologist Dr.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Medication was never mixed with the powder - unaware medication needed to be reconstituted. Pt was only given Saline only into Right deltoid on 02/11/2025 at 1425. No harm done to the pt.  Mother notified that vaccine was not actually given (only saline) and patient will need to have this completed at a later date. Verbalized understanding.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: Mild fevers, chills, headache, fatigue
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine was given out of the CDC recommended guidelines of once every 6 months. Patient received vaccine at approximately 3 months from previous covid vaccine
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Extra dose administered
Clinical narrative: Patient presented with siblings for catch up vaccinations. Patient was accidentally given two doses of IPV, one in combo vaccine Vaxelis and one individual IPV vaccine. Two medical assistants were working together to inoculate all three siblings during the same appointment. MAs both reviewed vaccines that were drawn and prepared for patients, however both MAs missed the IPV dose within the Vaxelis combination.  MD was consulted and CDC/manufacturer website  were also viewed. Mother of patient and patient were explained the accidental double dose and possible side effects to look for. Mother and patient were understanding of incident and what to look for for possible side effects. Patient left clinic with mother and siblings feeling good and able to ambulate on her own.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Patient hospitalized. Was going to transfer to another hospital for higher level of care but no beds available. Other hospital requested COVID test. Patient had no definitive symptoms pointing to COVID.
Age: 69.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Reaction to previous exposure to any vaccine
Clinical narrative: noticed the day after getting the shots.  has been taking benadryl at bedtime only.
Age: 57.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: patient presented to pharmacy with injection site reaction; area was red slightly swollen warm to touch with slight itch
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Cartilage injury, Gait disturbance, Hip arthroplasty
Clinical narrative: I had 2 Pfizer vaccines in 2021. One in March and then another in April. I almost immediately started having pain in my hip. Within a month of the 2nd dose I had to go to the dr. I was having trouble walking. I was scheduled with an orthopedic surgeon and they began to run tests thinking I had an autoimmune disease because my inflammatory levels were so high. I was tested by a rheumatologist and they ruled out autoimmune diseases. I had an MRI which showed that I had a lot of inflammation around my hip joint that had caused the cartilage to breakdown. It was an unexplained issue that had caused me to be on a walker. The surgeon did not specify vaccine injury but said that it was an unexplainable very aggressive arthritis he guessed. He told me I had no other choice but to have a hip replacement. I had not had any hip pain or hip problems before that vaccine so it was very confusing to all of us to have this happen to me so fast out of nowhere. I had the hip replacement by September 2021 (which was just a few months after my 2nd vaccine dose). I unfortunately developed sepsis from a staph infection from that hip replacement and almost died. I was hospitalized for weeks and had to be treated by infectious disease dr for the next year. I still have a lot of health issues today. I have researched and talked with many people and have come to realize that all of that happened immediately after the 2 covid vaccines that I had. I had one in March 2021 and 2nd in April 2021. I was at drs office in may and having hip replacement surgery by September. My surgeon never implied that it was caused by the vaccines. I had a dr in the hospital that suggested it might be a covid vaccine injury but nothing documented. I am convinced that it was caused by the 2 vaccines within a month of each other. Thank you for your time
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammatory marker increased, Magnetic resonance imaging abnormal, Post procedural infection, Sepsis, Staphylococcal infection
Clinical narrative: I had 2 Pfizer vaccines in 2021. One in March and then another in April. I almost immediately started having pain in my hip. Within a month of the 2nd dose I had to go to the dr. I was having trouble walking. I was scheduled with an orthopedic surgeon and they began to run tests thinking I had an autoimmune disease because my inflammatory levels were so high. I was tested by a rheumatologist and they ruled out autoimmune diseases. I had an MRI which showed that I had a lot of inflammation around my hip joint that had caused the cartilage to breakdown. It was an unexplained issue that had caused me to be on a walker. The surgeon did not specify vaccine injury but said that it was an unexplainable very aggressive arthritis he guessed. He told me I had no other choice but to have a hip replacement. I had not had any hip pain or hip problems before that vaccine so it was very confusing to all of us to have this happen to me so fast out of nowhere. I had the hip replacement by September 2021 (which was just a few months after my 2nd vaccine dose). I unfortunately developed sepsis from a staph infection from that hip replacement and almost died. I was hospitalized for weeks and had to be treated by infectious disease dr for the next year. I still have a lot of health issues today. I have researched and talked with many people and have come to realize that all of that happened immediately after the 2 covid vaccines that I had. I had one in March 2021 and 2nd in April 2021. I was at drs office in may and having hip replacement surgery by September. My surgeon never implied that it was caused by the vaccines. I had a dr in the hospital that suggested it might be a covid vaccine injury but nothing documented. I am convinced that it was caused by the 2 vaccines within a month of each other. Thank you for your time