chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza B virus test, Middle ear effusion, Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test positive
Clinical narrative: I got home from work at 4:30 PM, and I started feeling bad. I had a terrible headache, a temperature of 102.5, and a dry, unproductive cough. I took Tylenol PM, but it didn't help. The following morning, I showed up for work, and I was sent to the workplace clinic at 7:30 AM. I underwent a PCR test and got a positive result for COVID-19. I was also tested for RSV, influenza A, and influenza B, and the results on those were negative. I was then sent home to isolate for ten days. I was given Tessalon Perles, Tylenol, Motrin, and Paxlovid. It took four days for the fever to break. During my fever, I sweated profusely. I often had to change my bedclothes and the clothes I was wearing. After the fourth and fifth day, I started having issues with my right ear. Whenever I went to bed, it was clogged, but it was clear whenever I woke up the following morning. My problem with my right ear persists to this day, and it has affected my hearing to the point that I can't really gauge the volume of my own voice, so I often sound like I'm yelling. I went to an audiologist on 2/27/2023. My hearing in the left ear was fine, but when the audiologist administered the audiograph to the right ear, it flatlined. I couldn't hear anything out of that ear. She then checked my right ear with the otoscope and noted that there was a lot of fluid buildup. I get my healthcare through the agency, and I have been waiting ever since to see an ENT specialist. I was told that it would probably take three months.
Age: 45.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: COVID-19, Discomfort, Feeling abnormal, Headache, Influenza virus test negative
Clinical narrative: I started feeling weird like not sick but something was wrong. By the evening I was feeling a headache. I woke up at midnight with a fever and a really bad sore throat. On Thursday I had 102.5 fever. The next day I had a 101.5 fever. Saturday I had fever, thick congestion, and a runny nose. I went to urgent care on Saturday and they said I was positive for COVID-19 and they prescribed PAXLOVID which I started taking that evening. I was very uncomfortable with overall discomfort and achiness.
Age: 45.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: I started feeling weird like not sick but something was wrong. By the evening I was feeling a headache. I woke up at midnight with a fever and a really bad sore throat. On Thursday I had 102.5 fever. The next day I had a 101.5 fever. Saturday I had fever, thick congestion, and a runny nose. I went to urgent care on Saturday and they said I was positive for COVID-19 and they prescribed PAXLOVID which I started taking that evening. I was very uncomfortable with overall discomfort and achiness.
Age: 45.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: SARS-CoV-2 test negative, SARS-CoV-2 test positive, Sleep disorder, Streptococcus test negative
Clinical narrative: I started feeling weird like not sick but something was wrong. By the evening I was feeling a headache. I woke up at midnight with a fever and a really bad sore throat. On Thursday I had 102.5 fever. The next day I had a 101.5 fever. Saturday I had fever, thick congestion, and a runny nose. I went to urgent care on Saturday and they said I was positive for COVID-19 and they prescribed PAXLOVID which I started taking that evening. I was very uncomfortable with overall discomfort and achiness.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Aphonia, Fatigue, Malaise, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: I had a sore throat, loss my voice, running nose, and fatigue. I saw my doctor and I tested negative for strep and COVID-19. He suggested over the counter medications. I was sick for a week. Then I got another cold 04/09/2023. I had a sore throat and sneezing. Now I believe it is turning into a mild sinus infection.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rhinorrhoea, SARS-CoV-2 test negative, Sinusitis, Sneezing, Streptococcus test negative
Clinical narrative: I had a sore throat, loss my voice, running nose, and fatigue. I saw my doctor and I tested negative for strep and COVID-19. He suggested over the counter medications. I was sick for a week. Then I got another cold 04/09/2023. I had a sore throat and sneezing. Now I believe it is turning into a mild sinus infection.
Age: 77.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Dysphonia
Clinical narrative: I had no real adverse event.  I was Rx'd Paxlovid because of my age.  My symptoms were extremely mild, mostly just hoarse, and I had rebound of the same mild symptom.
Age: 37.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Blood alkaline phosphatase increased, Fatigue, Laboratory test, Serum ferritin decreased
Clinical narrative: Extreme fatigue symptoms. Elevated alkaline phosphatase. Low ferritin levels.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: rash/itch all over patient's body, but resolved by taking benedryl
Age: 61.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: none. given expired covid 19 vaccine: expired. 11/22/2022 Given: 12/13/2022
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Amnesia, Aphasia
Clinical narrative: AFTER COMING HOME PATIENT STOPPED TALKING AND DEVELOPED AMNESIA THAT LASTED ABOUT 2 HOURS. WAS TAKEN TO ER BY SPOUSE AND RELEASED.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: NONE GAVE EXPIRED COVID-19 Vaccine: expired 11/22/2022 given: 12/13/2022
Age: 22.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Disorientation, Fall, Head injury, Heart rate increased, Immediate post-injection reaction
Clinical narrative: patient experience syncope episode approximately a minute after receiving the vaccine and fell out of the chair and hit his right temple. he came to disoriented and sprung upright. he was placed in a chair and moved to the floor where his feet were elevated on a chair. we gave him an ice pack for his head. he reported a rapid heart rate and feeling nauseous. once he felt better he sat up and we gave him some water and crackers. the patient stated he hadn?t ate anything today. after approximately 30 minutes in store he left on his own accord.
Age: 22.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Nausea, Syncope
Clinical narrative: patient experience syncope episode approximately a minute after receiving the vaccine and fell out of the chair and hit his right temple. he came to disoriented and sprung upright. he was placed in a chair and moved to the floor where his feet were elevated on a chair. we gave him an ice pack for his head. he reported a rapid heart rate and feeling nauseous. once he felt better he sat up and we gave him some water and crackers. the patient stated he hadn?t ate anything today. after approximately 30 minutes in store he left on his own accord.
Age: 22.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Asthenia, Blindness, Concussion, Dizziness
Clinical narrative: patient experience syncope episode approximately a minute after receiving the vaccine and fell out of the chair and hit his right temple. he came to disoriented and sprung upright. he was placed in a chair and moved to the floor where his feet were elevated on a chair. we gave him an ice pack for his head. he reported a rapid heart rate and feeling nauseous. once he felt better he sat up and we gave him some water and crackers. the patient stated he hadn?t ate anything today. after approximately 30 minutes in store he left on his own accord.
Age: 22.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Erythema, Head injury, Headache, Immediate post-injection reaction, Injection site pain
Clinical narrative: patient experience syncope episode approximately a minute after receiving the vaccine and fell out of the chair and hit his right temple. he came to disoriented and sprung upright. he was placed in a chair and moved to the floor where his feet were elevated on a chair. we gave him an ice pack for his head. he reported a rapid heart rate and feeling nauseous. once he felt better he sat up and we gave him some water and crackers. the patient stated he hadn?t ate anything today. after approximately 30 minutes in store he left on his own accord.
Age: 22.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Loss of consciousness, Lymphadenopathy, Myalgia, Rash, Syncope
Clinical narrative: patient experience syncope episode approximately a minute after receiving the vaccine and fell out of the chair and hit his right temple. he came to disoriented and sprung upright. he was placed in a chair and moved to the floor where his feet were elevated on a chair. we gave him an ice pack for his head. he reported a rapid heart rate and feeling nauseous. once he felt better he sat up and we gave him some water and crackers. the patient stated he hadn?t ate anything today. after approximately 30 minutes in store he left on his own accord.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: General physical health deterioration
Clinical narrative: I should have never got the shots because they ruined my life/My health has been deteriorating after I got the shots.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 at 11:00 as dose 1, single (Lot number: EN6198, Expiration Date: 20Jun2021) at the age of 69 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "I should have never got the shots because they ruined my life/My health has been deteriorating after I got the shots."  Additional Information: Caller would like to know what Pfizer is developing in order to help patients like him. "I should have never got the shots because they ruined my life. It destroyed my body and you folks are not developing anything new to help us".; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021605543 same patient, different events/vaccine doses;
Age: 67.0
Sex: M
Vaccine: PNC20
Symptoms: Bursitis, Injection site pain, Joint range of motion decreased, Product administered at inappropriate site
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: At injection, pt felt vaccine was given high and had pain upon injection which subsided after needle was removed. RPH checked him out, told him to f/u with us if pain persists. 3 wks later came back but an rph mistakenly gave him customer service number. Today, has sx of bursitis, loss of motion in left shoulder. Told him we would report 4/14/23 and follow up, to see MD
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia
Clinical narrative: long Covid; I developed severe covid-19 10Oct2021; I developed severe covid-19 10Oct2021; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 57-year-old female patient received BNT162b2 (COMIRNATY), on 30Dec2020 at 16:00 as dose 1, single (Lot number: EJ1686) intramuscular, in left deltoid and on 21Jan2021 as dose 2, single (Lot number: EL3246) at the age of 57 years, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Prior vaccinations were none. Family Medical History Relevant to Adverse Event was None. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Oct2021, outcome "unknown" and all described as "I developed severe covid-19 10Oct2021"; POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "long Covid". Clinical course: Patient developed severe Covid-19 10Oct2021, followed by long Covid. The patient received 3rd dose (booster dose) of Novavax on 29Dec2022. Reporter considered the Pfizer product had a casual effect to the adverse event.; Sender's Comments: Based on the information in the case report, a possible causal relationship between the events vaccination failure, covid-19, post-acute covid-19 syndrome and suspect drug cannot be excluded.,Linked Report(s) : US-PFIZER INC-PV202300022716 same reporter/ patient, different dose number / event;
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Post-acute COVID-19 syndrome, Vaccination failure
Clinical narrative: long Covid; I developed severe covid-19 10Oct2021; I developed severe covid-19 10Oct2021; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 57-year-old female patient received BNT162b2 (COMIRNATY), on 30Dec2020 at 16:00 as dose 1, single (Lot number: EJ1686) intramuscular, in left deltoid and on 21Jan2021 as dose 2, single (Lot number: EL3246) at the age of 57 years, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Prior vaccinations were none. Family Medical History Relevant to Adverse Event was None. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Oct2021, outcome "unknown" and all described as "I developed severe covid-19 10Oct2021"; POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "long Covid". Clinical course: Patient developed severe Covid-19 10Oct2021, followed by long Covid. The patient received 3rd dose (booster dose) of Novavax on 29Dec2022. Reporter considered the Pfizer product had a casual effect to the adverse event.; Sender's Comments: Based on the information in the case report, a possible causal relationship between the events vaccination failure, covid-19, post-acute covid-19 syndrome and suspect drug cannot be excluded.,Linked Report(s) : US-PFIZER INC-PV202300022716 same reporter/ patient, different dose number / event;
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19-2, FLU4
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I was traveling overseas. My symptoms started on 03/13/2023. That evening, I had a slight tickle in the throat. The next day, I did a 7 mile walk and I felt tired after that. I also had some nasal congestion. Wednesday morning, I took an at home COVID-19 test, and it was positive. For 2 years, I have had all vaccinations and have had most groceries pick up, and I always wear a mask. We finally decided to vacation. Before we left, friends of ours had just returned from overseas. They gave us their prescribed PAXLOVID, so I had it with me while I was overseas. I took the PAXLOVID the morning I tested positive. Within 2 days, I had no symptoms. Before we left, I was testing negative. I ended up having a slight rebound and tested lightly positive on 03/26/2023. That lasted 2 days and I tested negative after that. I took no further medications for the rebound. I checked in with my doctor who assured me that I was doing all the right things as far as isolating and treatment.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19-2, FLU4
Symptoms: COVID-19, Fatigue, Foreign travel, Nasal congestion, Patient isolation
Clinical narrative: I was traveling overseas. My symptoms started on 03/13/2023. That evening, I had a slight tickle in the throat. The next day, I did a 7 mile walk and I felt tired after that. I also had some nasal congestion. Wednesday morning, I took an at home COVID-19 test, and it was positive. For 2 years, I have had all vaccinations and have had most groceries pick up, and I always wear a mask. We finally decided to vacation. Before we left, friends of ours had just returned from overseas. They gave us their prescribed PAXLOVID, so I had it with me while I was overseas. I took the PAXLOVID the morning I tested positive. Within 2 days, I had no symptoms. Before we left, I was testing negative. I ended up having a slight rebound and tested lightly positive on 03/26/2023. That lasted 2 days and I tested negative after that. I took no further medications for the rebound. I checked in with my doctor who assured me that I was doing all the right things as far as isolating and treatment.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19-2, FLU4
Symptoms: SARS-CoV-2 test positive, Throat irritation
Clinical narrative: I was traveling overseas. My symptoms started on 03/13/2023. That evening, I had a slight tickle in the throat. The next day, I did a 7 mile walk and I felt tired after that. I also had some nasal congestion. Wednesday morning, I took an at home COVID-19 test, and it was positive. For 2 years, I have had all vaccinations and have had most groceries pick up, and I always wear a mask. We finally decided to vacation. Before we left, friends of ours had just returned from overseas. They gave us their prescribed PAXLOVID, so I had it with me while I was overseas. I took the PAXLOVID the morning I tested positive. Within 2 days, I had no symptoms. Before we left, I was testing negative. I ended up having a slight rebound and tested lightly positive on 03/26/2023. That lasted 2 days and I tested negative after that. I took no further medications for the rebound. I checked in with my doctor who assured me that I was doing all the right things as far as isolating and treatment.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Brain fog, Computerised tomogram normal, Dizziness, Electrocardiogram normal, Fibrin D dimer normal
Clinical narrative: FEEL WEIRD / BRAIN FEELS FOGGY / THOUGHTS EVERYTHING FEELS FOGGY; LIGHT HEADED; SMALL HEADACHE / HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient was not pregnant at the time of report. The patient was very healthy. The patient had no history of drug abuse or illicit drug usage. The patient had no known allergies. The patient gets a physical done twice a year and everything had always been fine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 216D21A expiry: UNKNOWN) dose, start therapy date were not reported for covid-19 prophylaxis. No concomitant medications were reported. On an unspecified date, the patient experienced feel weird / brain feels foggy / thoughts everything feels foggy, light headed, and small headache / headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from small headache / headache, and had not recovered from feel weird / brain feels foggy / thoughts everything feels foggy, and light headed. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Skin haemorrhage
Clinical narrative: FEEL WEIRD / BRAIN FEELS FOGGY / THOUGHTS EVERYTHING FEELS FOGGY; LIGHT HEADED; SMALL HEADACHE / HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient was not pregnant at the time of report. The patient was very healthy. The patient had no history of drug abuse or illicit drug usage. The patient had no known allergies. The patient gets a physical done twice a year and everything had always been fine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 216D21A expiry: UNKNOWN) dose, start therapy date were not reported for covid-19 prophylaxis. No concomitant medications were reported. On an unspecified date, the patient experienced feel weird / brain feels foggy / thoughts everything feels foggy, light headed, and small headache / headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from small headache / headache, and had not recovered from feel weird / brain feels foggy / thoughts everything feels foggy, and light headed. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling abnormal, Headache
Clinical narrative: FEEL WEIRD / BRAIN FEELS FOGGY / THOUGHTS EVERYTHING FEELS FOGGY; LIGHT HEADED; SMALL HEADACHE / HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient was not pregnant at the time of report. The patient was very healthy. The patient had no history of drug abuse or illicit drug usage. The patient had no known allergies. The patient gets a physical done twice a year and everything had always been fine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 216D21A expiry: UNKNOWN) dose, start therapy date were not reported for covid-19 prophylaxis. No concomitant medications were reported. On an unspecified date, the patient experienced feel weird / brain feels foggy / thoughts everything feels foggy, light headed, and small headache / headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from small headache / headache, and had not recovered from feel weird / brain feels foggy / thoughts everything feels foggy, and light headed. This report was non-serious.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no additional AE; HCP reports that VARIVAX was administered to patient  with temperature excursion; This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, or drug reactions or allergies was provided.  On 10-FEB-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter (lot # W008712, has been verified to be a valid lot number, expiration date reported and upon internal validation established as 14-MAR-2024), administered for prophylaxis (anatomical location, and route of administration were not reported) (Product storage error). Temperature excursion as following: 15.7 Fahrenheit (F) for 0 hours 20 minutes and 0 seconds. No additional adverse event was reported (no adverse event).  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-2304USA001247:
Age: 0.5
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No AE; 6 month old patient inadvertently received a dose of MMR II and VARIVAX.; This spontaneous report was received from registered nurse and refers to a 6-month-old patient of an unknown gender. The patient's medical history, and concurrent conditions were not reported. Concomitant medications included sterile diluent.   On 05-APR-2023, the patient was inadvertently vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) recombinant human albumin (rHA) subcutaneous injection, 0.5 milliliter, lot #W007182, expiration date: 01-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #W006413, expiration date: 23-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided) (product administered to patient of inappropriate age). There was no adverse event reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE/PQC; MMR-II was inadvertently administered after a supported temp excursion; This spontaneous report was received from the Medical Assistant, and refers to a patient of unknown age, and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On 22-MAR-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (recombinant Human albumin) subcutaneous injection, lot #U039906, verified to be valid (after internal review), expiration date: 16-DEC-2023, administered for prophylaxis (strength, and route of administration were not provided). The vaccine was inadvertently administered after a supported temp excursion: 9.1 C for 4 hours and 54 minutes. There was no previous temperature excursion (discrepancy, as HCP called back to report multiple excursions on different dates). No adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Patient was administered expired PNEUMOVAX 23 via Corresponding PNEUMOVAX 23 Prefilled Syringe on 04/03/2023; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, or drug reactions or allergies was provided.  On an unknown date, the patient was vaccinated with expired vaccine of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe injection, lot #U027357, has been verified to be a valid lot number, expiration date reported and upon internal validation established as 25-MAR-2023 (strength, route of administration, vaccination scheme frequency, anatomical location, and dose were not reported) (Expired product administered). No Temperature Excursion reported. No additional adverse event reported (No adverse event).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; HCP calling to report a TE for ROTATEQ, product administered after the excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, or drug reactions or allergies was provided.  On 05-APR-2023, the patient started therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1x dose, lot #W026136, has been verified to be a valid lot number, expiration date reported and upon internal validation established as 31-JAN-2024, administered orally for prophylaxis (strength, vaccination scheme frequency, and dose were not provided) after a temperature excursion (temperature: 61.7 Fahrenheit (F); time frame: 4 hours 39 minutes) (product storage error). There was no previous temperature excursion. No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Caller inadvertently administered STERILE DILUENT Reconstituted Expired MMRII to Patient on 04/10/2023; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, or drug reactions or allergies was provided.  On 10-APR-2023, the patient was inadvertently administered with expired vaccine of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, lot #U011149, expiration date: 08-APR-2023, administered for prophylaxis (strength, route of administration, vaccination scheme frequency, anatomical location, and dose were not reported) (expired product administered), which was reconstituted with sterile diluent (lot# W010864, expiry date 23-OCT-2024) (strength and dose were not reported). No Temperature Excursion reported. No additional adverse event reported (No adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were noted; A HCP called to report that an expired dose of VAQTA was inadvertently administered to a patient on 4/10/2023 with an expiration date of 3/6/2023. No adverse effects were noted. No additional AE reported. No PQC.; This spontaneous report was received from an unspecified health care professional and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On 10-APR-2023, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 mL (lot # W002894, expiration date: 06-MAR-2023) once (route of administration, anatomical location not provided) for prophylaxis.  No adverse effects were noted.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP reports that improperly stored vaccines were administered. Names of vaccines involved (including lot/exp) PROQUAD (lot: W028561 exp:03/06/2024); No Additional AEs.; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On an unknown date, the patient was vaccinated with an improper stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), 1 time dose, (lot # W028561, has been verified to be a valid lot number for measles, mumps, rubella and varicella [oka-merck] virus vaccine live [PROQUAD], expiration date reported and upon internal validation established as 06-MAR-2024) for prophylaxis (exact dose, anatomical location, and route of administration were not reported). The vaccine was stored at a temperature of 7.7 Fahrenheit (F) for 8 hours and 54 minutes. It has previously suffered a temperature excursion at a temperature of 7.7F for 2 hours 18 minutes (Product storage error).  No adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Shingles, after taking a Shingrix dose/ suspected vaccination failure; Shingles; Acute pain associated with shingles, transient; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure an unspecified number of patients 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 vaccination failure (Verbatim: Shingles, after taking a Shingrix dose/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and acute pain (Verbatim: Acute pain associated with shingles, transient). The outcome of the vaccination failure was unknown and the outcome of the shingles and acute pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and acute pain to be related to Shingrix.     It was unknown if the company considered the vaccination failure, shingles and acute pain to be related to Shingrix.   Additional Information: GSK receipt date:11-APR-2023 The doctor described that some of his Shingrix patients in the past had experienced the acute pain associated with the shingles, after taking a Shingrix dose. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow up. This case had been linked with US2023AMR052445 reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR052445:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Shingles / Suspected vaccination failure; Shingles; Acute pain associated with shingles, pain persists; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in an unspecified number of patients 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 vaccination failure (Verbatim: Shingles / Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and acute pain (Verbatim: Acute pain associated with shingles, pain persists). The outcome of the vaccination failure was unknown and the outcome of the shingles and acute pain were resolved.   It was unknown if the reporter considered the vaccination failure, shingles and acute pain to be related to Shingrix.     It was unknown if the company considered the vaccination failure, shingles and acute pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-APR-2023 The physician reported that in the past, some of his patients after receiving one dose of Shingrix experienced the acute pain associated with the shingles. He mentioned that with some of these patients the pain persists and was not transient and lasted as long as a patient with a Shingles experience. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case is linked with US2023AMR052430, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR052430:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Neuropathy peripheral, Pain, Paraesthesia
Clinical narrative: Have neuropathy symptoms; pain; patient has had tingling; This serious case was reported by a physician via sales rep and described the occurrence of neuropathy in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (left arm). In DEC-2022, an unknown time after receiving Shingrix, the patient experienced tingling sensation (Verbatim: patient has had tingling). On an unknown date, the patient experienced neuropathy (Verbatim: Have neuropathy symptoms) (serious criteria GSK medically significant) and pain (Verbatim: pain). The outcome of the neuropathy was not resolved and the outcome of the tingling sensation was not reported and the outcome of the pain was resolved.   It was unknown if the reporter considered the neuropathy, tingling sensation and pain to be related to Shingrix.     It was unknown if the company considered the neuropathy, tingling sensation and pain to be related to Shingrix.   Additional Information: GSK Receipt date- 11-APR-2023 The reporter reported that patient has had tingling sensation since 1st dose, pain had resolved but continues to had neuropathy symptoms. The reporter agreed to follow up from GSK.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had it and I had all the shots/suspected vaccination failure; had it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had it and I had all the shots/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had it). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 19-Mar-2023 The case was received from the patient via interactive digital media. The patient had all the shots and had them. The patient stated that they said there was a 10 percent chance of that happening. The patient stated it was a pain. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had both shots, got shingles/Suspected vaccination failure; shingles, going through it right now; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 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: Had both shots, got shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles, going through it right now). The outcome of the vaccination failure was unknown 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.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 11-APR-2023 The case  was received from the patient via interactive digital media. The patient had both shots and he/she got shingles anyway.  The patient was going through it right now. 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. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Got shot, got shingles/suspected vaccination failure; Since October gave me; Burning, still burning; Pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shot, got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Since October gave me), burning sensation (Verbatim: Burning, still burning) and pain (Verbatim: Pain). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the burning sensation and pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, burning sensation and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 12-APR-2023 The case  was received from the patient via interactive digital media. The patient stated that this disease was terrible nothing compared to the burning and pain, the vaccine was nothing since October gave me and still had that burning on the skin. No contact details were provided. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had the shots but still got them/Suspected vaccination failure; Got them; Terrible pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the shots but still got them/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Got them) and pain (Verbatim: Terrible pain). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved and the outcome of the pain was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 19-MAR-2023 The case  was received from the patient via interactive digital media. The patient had the Shingles shots but still got them but had a shorter time. The patient was dealing with terrible pain yet. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Surgery, Vaccination failure
Clinical narrative: Have them now, had vaccine too/had shingles/suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Have them now, had vaccine too/had shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 19-Mar-2023 The case was received from the patient via interactive digital media. The patient had them now and had vaccine too. The patient had surgery and few days later had the shingles. The patient stated that terrible. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: Had vaccine too and got shingles/ suspected vaccination failure; Shingles; Slightly itchy spots; Minor backache; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had vaccine too and got shingles/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), pruritus (Verbatim: Slightly itchy spots) and back pain (Verbatim: Minor backache). The outcome of the vaccination failure was unknown and the outcome of the shingles, pruritus and back pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and back pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pruritus and back pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and experienced shingles. The patient stated that the shingles were mild and they were no more than a minor problem. The patient had seven slightly itchy spots and minor backache. The patient reported that the vaccine lessened them considerably. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got 2 shots and still got them/suspected vaccination failure; got them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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: got 2 shots and still got them/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got them). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 13-APR-2023 The case was received from the patient via interactive digital media. The patient had Shingles vaccine and still got them. The patient's friend was diagnosed with shingles and she could not believed how painful it was. The patient was at chapter in his/her life where he/she should be enjoying it to the fullest. The patient did not want to be on the sidelines because of shingles. 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. The follow-up could not be possible as no contact details were available.