chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Computerised tomogram head normal, Computerised tomogram spine, Cystitis, Diarrhoea, Dyspnoea
Clinical narrative: 5/15/2023 - 5/18/2023 (3 days)  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: UTI (urinary tract infection)  Weakness  Acute cystitis without hematuria  Pneumonia of right upper lobe due to infectious organism  COVID-19   HOSPITAL COURSE: Patient is a 71 y.o. female with PMH of GERD, GAD, HLA b27 spondyloarthropathy and ho presents today with cc of sob. She reports she has been having sob accompanied w chills since Saturday. Has also been feleing weak and fatigued.   In ED pts VS stable. Pertinent labs include: elevated wbc count, positive UA. Chest xray showing RUL pna. CT head, C-spine were unremarkable for any sign of acute traumatic process.  COVID was positive. CTA was obtained which does show a 7 mm pulmonary nodule which is recommended to have follow-up in 6 months.    The patient was on room air throughout her stay.  No steroids or remdesivir were initiated.  Patient was treated for urinary tract infection as well as pneumonia.  On discharge she was switched to levofloxacin to complete a 5 day course for the pneumonia.  During her hospital stay the patient did report having diarrhea after antibiotic administration, however that resolved prior to discharge.  The patient was feeling much better than when she 1st came in and she was instructed follow up with her primary care doctor for further monitoring.  The patient was discharged in stable condition.
Age: 70.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Fatigue, Pneumonia, Pulmonary mass, SARS-CoV-2 test positive, Urinary tract infection
Clinical narrative: 5/15/2023 - 5/18/2023 (3 days)  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: UTI (urinary tract infection)  Weakness  Acute cystitis without hematuria  Pneumonia of right upper lobe due to infectious organism  COVID-19   HOSPITAL COURSE: Patient is a 71 y.o. female with PMH of GERD, GAD, HLA b27 spondyloarthropathy and ho presents today with cc of sob. She reports she has been having sob accompanied w chills since Saturday. Has also been feleing weak and fatigued.   In ED pts VS stable. Pertinent labs include: elevated wbc count, positive UA. Chest xray showing RUL pna. CT head, C-spine were unremarkable for any sign of acute traumatic process.  COVID was positive. CTA was obtained which does show a 7 mm pulmonary nodule which is recommended to have follow-up in 6 months.    The patient was on room air throughout her stay.  No steroids or remdesivir were initiated.  Patient was treated for urinary tract infection as well as pneumonia.  On discharge she was switched to levofloxacin to complete a 5 day course for the pneumonia.  During her hospital stay the patient did report having diarrhea after antibiotic administration, however that resolved prior to discharge.  The patient was feeling much better than when she 1st came in and she was instructed follow up with her primary care doctor for further monitoring.  The patient was discharged in stable condition.
Age: 70.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Urine analysis abnormal, White blood cell count increased
Clinical narrative: 5/15/2023 - 5/18/2023 (3 days)  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: UTI (urinary tract infection)  Weakness  Acute cystitis without hematuria  Pneumonia of right upper lobe due to infectious organism  COVID-19   HOSPITAL COURSE: Patient is a 71 y.o. female with PMH of GERD, GAD, HLA b27 spondyloarthropathy and ho presents today with cc of sob. She reports she has been having sob accompanied w chills since Saturday. Has also been feleing weak and fatigued.   In ED pts VS stable. Pertinent labs include: elevated wbc count, positive UA. Chest xray showing RUL pna. CT head, C-spine were unremarkable for any sign of acute traumatic process.  COVID was positive. CTA was obtained which does show a 7 mm pulmonary nodule which is recommended to have follow-up in 6 months.    The patient was on room air throughout her stay.  No steroids or remdesivir were initiated.  Patient was treated for urinary tract infection as well as pneumonia.  On discharge she was switched to levofloxacin to complete a 5 day course for the pneumonia.  During her hospital stay the patient did report having diarrhea after antibiotic administration, however that resolved prior to discharge.  The patient was feeling much better than when she 1st came in and she was instructed follow up with her primary care doctor for further monitoring.  The patient was discharged in stable condition.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, COVID-19, Dizziness, SARS-CoV-2 test positive
Clinical narrative: The patient has a history of diabetes. He was brought to the ED by EMS on 3/14/23 for evaluation of weakness that began the night prior. He additionally reported lightheadedness . A COVID-19 PCR test performed in the ED resulted positive. Notably, his wife tested positive for COVID four days prior. The patient was admitted 3/14/23 - 3/18/23 with discharge diagnoses of COVID-19 and generalized weakness due to COVID-19. He did not require supplemental O2 during admission and was not on steroids. Paxlovid was started during his admission. Of note, the patient has received the primary COVID vaccine series and three booster doses.
Age: 0.83
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event, incorrect strength of Covid19 vaccine given, reported to, NP.  Directed to have parent bring back child to get vaccinated with correct strength of Covid19 vaccine.  I called parent over the phone, no answer; left voicemail message for parent to call me back.
Age: 64.0
Sex: F
Vaccine: COVID19-2, TDAP
Symptoms: Imaging procedure, Visual impairment, Vitreous floaters
Clinical narrative: In May of 2023, I woke up in the morning and I noticed I had a floater in my left eye. I looked at the wall and thought I saw a dark spot on the wall. I consulted my eye doctor and the did some imaging. At the time, he did not see any damage to my retina.
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered 6/2/23  expired on  5/30/23. I have a case number with Moderna, they are checking the data to check the viability of the vaccine. Case# MI-00030447
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test positive, Upper-airway cough syndrome
Clinical narrative: I was having some postnasal drip and I really thought I was having some allergy things from cleaning out this closet a few days beforehand. The people that I had been cleaning the closet with ended up doing a COVID-19 Home Test and it was positive. I got a COVID-19 PCR Test through my employer to confirm I was positive as well and then followed up with a telehealth appointment through my healthcare provider. They did give me paxlovid but other than the postnasal drip I did not have symptoms so i did not take it.
Age: 0.17
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Kinrix given to incorrect age. No adverse effects.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, COVID-19, Cough, Malaise, Nasopharyngitis
Clinical narrative: On the morning of 12/01/2022, I began to feel like I was coming down with a cold. I was on a trip, and I decided to stay in my room. I did go to dinner in the restaurant later that day, though. On the morning of 12/2/2022, we left at about 8:30 AM to go home. The vehicle left at about 4:00 PM. During this time, my cold-like symptoms had gotten continually worse. I had a terrible cough, runny nose, and malaise. By the time I got home, it was probably 9:00 PM, and I took a home antigen test. The result was positive. I called my healthcare provider's nurse helpline, and I was told to retest in 24 hours. I was also told that I had up to five days to start the antiviral. After the 24 hours passed, I tested again and got another positive result. I called the same nurse helpline as before and told them of the test results. I was told that they would review my medical history and later get back in touch with me if they thought I should take the antiviral. As it turns out, they never called back. I didn't press the issue, though, and I decided not to take the antiviral. I treated my symptoms with OTC medicines like Mucinex DM and Tessalon Perles for the cough. I was sick until about 12/11/2022, and the OTC medicines helped me get through. It took me a little while afterwards to get my energy back, but I considered myself okay.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: On the morning of 12/01/2022, I began to feel like I was coming down with a cold. I was on a trip, and I decided to stay in my room. I did go to dinner in the restaurant later that day, though. On the morning of 12/2/2022, we left at about 8:30 AM to go home. The vehicle left at about 4:00 PM. During this time, my cold-like symptoms had gotten continually worse. I had a terrible cough, runny nose, and malaise. By the time I got home, it was probably 9:00 PM, and I took a home antigen test. The result was positive. I called my healthcare provider's nurse helpline, and I was told to retest in 24 hours. I was also told that I had up to five days to start the antiviral. After the 24 hours passed, I tested again and got another positive result. I called the same nurse helpline as before and told them of the test results. I was told that they would review my medical history and later get back in touch with me if they thought I should take the antiviral. As it turns out, they never called back. I didn't press the issue, though, and I decided not to take the antiviral. I treated my symptoms with OTC medicines like Mucinex DM and Tessalon Perles for the cough. I was sick until about 12/11/2022, and the OTC medicines helped me get through. It took me a little while afterwards to get my energy back, but I considered myself okay.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Administered expired initial Shingrix immunization to patient on 6/5/2023.  Discovered immunization was expired upon completion of paperwork later on in the day.  Expiration date of 11/07/2022
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, Blood test normal, Chills, Colitis microscopic, Computerised tomogram abdomen normal
Clinical narrative: I had diarrhea for about 3 or 4 hours on May 17, 2023, chills and fatigue.  I had it again on May 25th and I went to the urgent care on the 27th for the diarrhea and ride side abdominal pain.  My doctor sent me to the emergency room on May 29th because he wanted imaging. I went to my gastroenterologist and was diagnosed with microscopic colitis and I am being treated with prescription medication, budesonide.  As of today, I am much better.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Diarrhoea, Fatigue, Symptom recurrence
Clinical narrative: I had diarrhea for about 3 or 4 hours on May 17, 2023, chills and fatigue.  I had it again on May 25th and I went to the urgent care on the 27th for the diarrhea and ride side abdominal pain.  My doctor sent me to the emergency room on May 29th because he wanted imaging. I went to my gastroenterologist and was diagnosed with microscopic colitis and I am being treated with prescription medication, budesonide.  As of today, I am much better.
Age: 0.5
Sex: M
Vaccine: MENB, PNC13, RV1
Symptoms: Unevaluable event
Clinical narrative: No outcome
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; TE with PROQUAD.; This spontaneous report as received from an other health professional and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.   On an unknown date the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status: rHA) (PROQUAD) lot # W012728 and expiration date 16-OCT-2023, 0.5 milliliter for prophylaxis (dose number and route of administration were not reported) (product storage error and no adverse event).; Sender's Comments:  US-009507513-2305USA003072:
Age: 47.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/ PQC.; 47 year old female who received GARDASIL 9 from her pharmacy, and knowing GARDASIL 9 is not used in patient over 45 years of age; This spontaneous report was received from a Medical Assistant and refers to a 47-year-old female patient. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  In May 2023, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis (Product administered to patient of inappropriate age).  No additional adverse events were reported.
Sex: F
Vaccine: VARCEL
Symptoms: Extra dose administered, Injection site pain
Clinical narrative: arm soreness at site of injection; patient inadvertently received VARIVAX vaccine; This spontaneous report was received from a licensed practical nurse referring to an 18-year-old non-pregnant female patient. Information of concurrent conditions, pertinent medical history, drug reactions/allergies, and concomitant medications was unknown.   In 2005, the patient was vaccinated with 1st dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection intramuscularly for prophylaxis, and in 2009, the patient received 2nd dose of varicella virus vaccine live (oka/merck) (VARIVAX) intramuscularly (both strength, dose, lot#, expiration date and anatomical location were unknown). On 21-APR-2023, the patient inadvertently received varicella virus vaccine live (oka/merck) (VARIVAX) intramuscularly (0.5 milliliter (mL), lot# W031811, expiration date 05-OCT-2024, strength and anatomical location were unknown) (extra dose administered).  At the reporting time, the patient complained of arm soreness at site of injection of most recent dose (vaccination site pain) (onset date reported as 21-APR-2023). It was unknown if any lab diagnostics or studies were performed. The patient did not seek for any medical attention or receive treatment. The outcome of the event vaccination site pain was reported as recovered.   The causality assessment between the suspect vaccine and event vaccination site pain was not provided.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Diarrhoea, Rash, Rash erythematous
Clinical narrative: Mom called in to report her son received VARIVAX and MMR II and 3 days after receiving vaccines her son has had diarrhea for over one month, broke out in rash, bright red, dry patchy skin open and raw on neck torso and arms and chin. Consumer staters; Mom called in to report her son received VARIVAX and MMR II and 3 days after receiving vaccines her son has had diarrhea for over one month, broke out in rash, bright red, dry patchy skin open and raw on neck torso and arms and chin. Consumer staters; Mom called in to report her son received VARIVAX and MMR II and 3 days after receiving vaccines her son has had diarrhea for over one month, broke out in rash, bright red, dry patchy skin open and raw on neck torso and arms and chin. Consumer staters; Mom called in to report her son received VARIVAX and MMR II and 3 days after receiving vaccines her son has had diarrhea for over one month, broke out in rash, bright red, dry patchy skin open and raw on neck torso and arms and chin. Consumer staters; This spontaneous report was received from Consumer and refers to an 1-year-old male patient. The patient's pertinent medical history and concomitant medications were not reported. His drug reactions/allergies included dairy.  On 06-MAY-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), injection (lot# W018836, expiration date was not reported, but upon internal validation established as 14-JUN-2024) (strength, dose, anatomical location, and route of administration were not provided); and with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) injection (lot# W023072, expiration date was not reported, but upon internal validation established as 05-APR-2024) (strength, dose, anatomical location, and route of administration were not provided); both were administered for prophylaxis.  On 09-MAY-2023, 3 days after received vaccines, the patient had diarrhea (conflicting information, also reported as had diarrhea for over one month), broke out in rash, bright red (rash erythematous), dry patchy skin (dry skin) open and raw on neck torso and arms and chin (skin erosion). The patient went to see pediatrician. No treatment was given for the events. Currently, the patient's diarrhea was not as severe, not gone, and rash was still present on neck, torso, arms, and under chin. At the time of report, outcome of all the events were considered as not recovered. The action taken with varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) were not applicable.  The causal relationship between the events and suspect vaccines was not provided. The patient's pediatrician advised the events were from the varicella virus vaccine live (oka/merck) (VARIVAX).
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; MMRII and VARIVAX administered to patient after TE occurred.; This spontaneous report was received from a medical assistant and referred to a 4-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 22-MAY-2023, the patient vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (lot# was reported as U39664, expiration date was reported as 15-DEC-2023, therapy type, strength, dose, frequency, and route were unknown) and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection(lot #W011625, expiration date: 06-APR-2024, strength, dose, frequency, and route were unknown) for prophylaxis(Product storage error). No adverse effect was reported.  The stored temperature was 73 Fahrenheit (F). The time frame was 51 hours and 30 minutes. There was no previous temperature excursion.  Lot Number U39664 was not valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and did not match any Company product.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2305USA008345: US-009507513-2305USA008288: US-009507513-2305USA008329:
Age: 0.17
Sex: U
Vaccine: PPV
Symptoms: Infant irritability, Product administered to patient of inappropriate age, Swelling face
Clinical narrative: Caller reported 11 week old infant received PNEUMOVAX 23 vaccine; Caller reported 11 week old infant received PNEUMOVAX 23 vaccine and developed swollen face and irritability.; Caller reported 11 week old infant received PNEUMOVAX 23 vaccine and developed swollen face and irritability.; This spontaneous report has been received from a physician, regarding an 11-weeks-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) injection, at a dose of 0.5 milliliters (ml) intramuscularly in a deltoid as prophylaxis (not specified) (lot number: FM7207, which was determined to be non-valid and did not match any Merck product according to lot validation team) (strength and scheme was not reported) (Product administered to patient of inappropriate age).   On an unspecified date, the patient developed swollen face and irritability. The patient sought medical attention, did not received treatment but the outcome of the events was reported as recovered.   The causal relationship between the aforementioned events and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Immune system disorder, Inappropriate schedule of product administration, Viral titre decreased
Clinical narrative: the patient had a titer done on 5/19/2023 and it showed low immunity to rubella; The caller said the patient received her second dose on 8/17/2000; This spontaneous report was received from an other reporter and referred to a 33-year-old non-pregnant female patient. The patients' concurrent condition, concomitant therapy and medical history were not reported. The drug reactions/allergies were not reported.  On 09-JAN-1991, the patient was administered with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route, lot #, expiration date and anatomical location were not provided) for prophylaxis. On 17-AUG-2020, the patient was administered with the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route, lot #, expiration date and anatomical location were not provided) for prophylaxis (inappropriate schedule of product administration).   On 19-MAY-2023, The patient had a titer done and it showed low immunity to rubella. The patient sought medical attention. The patient did not receive treatment. The outcome of low immunity to rubella was unknown. The causality between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and low immunity to rubella was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse calling to report VARIVAX was administered to patient while it had a temperature excursion. Exact date of administration not provided. Patient is asymptomatic. No additional AE. No PQC. Names of vaccines involved (including lot/exp) VARIVAX W03; no additional ae; This spontaneous report was received from Other Health Professional and refers to a patient of unknown gender and age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, lot #W032370, expiration date: 10-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided).  On an unknown date, nurse was calling to report that varicella virus vaccine live (oka/merck) (VARIVAX) was administered to patient while it had a temperature excursion. Exact date of administration not provided. Temperature excursion was 24.4 degree F for 5 hours and 51 minutes. Patient is asymptomatic. No additional AE. No PQC.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse calling to report VARIVAX was administered to patient while it had a temperature excursion. Exact date of administration not provided. Patient is asymptomatic. No additional AE. No PQC. Names of vaccines involved (including lot/exp) VARIVAX W03; No additional AE; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions, and concomitant medications.  On an unknown date the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # W031812 and expiration date 05-OCT-2024 for prophylaxis (exact dose, route of administration and dose number were not reported) (storage error and no adverse event).
Sex: M
Vaccine: HPV9
Symptoms: Chest pain, Dizziness, Immediate post-injection reaction, Pallor
Clinical narrative: Merck Vaccine Representative called on behalf of physician to report a patient who received GARDASIL 9 over a year ago began having chest pain and became lightheaded and pale immediately after receiving the injection. Physician reported they laid pat; Merck Vaccine Representative called on behalf of physician to report a patient who received GARDASIL 9 over a year ago began having chest pain and became lightheaded and pale immediately after receiving the injection. Physician reported they laid pat; Merck Vaccine Representative called on behalf of physician to report a patient who received GARDASIL 9 over a year ago began having chest pain and became lightheaded and pale immediately after receiving the injection. Physician reported they laid pat; This spontaneous report was received from Physician and refers to a 12-year-old male.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, administered intramuscularly for prophylaxis (strength, lot #, and expiry date were not provided).  On an unknown date, Merck Vaccine Representative called on behalf of physician to report a patient who received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) over a year ago began having chest pain and became lightheaded and pale immediately after receiving the injection. Physician reported they laid patient down and gave him oxygen and he had recovered after 45 minutes. Limited patient demographic information available. No further information provided. Merck Vaccine Representative stated she learned of this less than 24 hours ago. No additional AE/no PQC. Treatment for events were given. On an unknown date, the patient recovered from the events of chest pain, lightheaded and pale. The action taken with GARDASIL 9 regarding chest pain, lightheaded and was reported as Not Applicable.   The causal relationship between chest pain, lightheaded and and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
Age: 0.58
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse Event; inadvertent administration; This spontaneous report was received from an other health professional refers to a 7-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 30-MAY-2023, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # W029724, expiration date: W029724, 0.5 milliliter (route of administration and anatomical location were not reported) for prophylaxis instead of pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) (wrong product administered). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse calling to report VARIVAX was administered to patient while it had a temperature excursion. Exact date of administration not provided. Patient is asymptomatic. No additional AE. No PQC. Names of vaccines involved (including lot/exp) VARIVAX W03; No Adverse Event; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with one dose of improper storage varicella virus vaccine live (oka/merck)(VARIVAX) lot #W031812, expiration date: 05-OCT-2024, (exact dose, route of administration and anatomical location were not reported) for prophylaxis.  Administered dose of vaccine experienced the temperature excursion of 24.4 degrees Fahrenheit for 5 hours and 51 minutes (product storage error). No previous temperature excursion had occurred. There were no additional adverse events reported (no adverse event).
Age: 2.0
Sex: M
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptomatic adverse event were reported; Inbound call from office manager calling to report administration of ROTATEQ that was expired to two patients.; This spontaneous report has been received from an office manager, regarding a 2-years-old male patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 31-MAY-2023, the patient was vaccinated with an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, at a dose of 2 milliliters (ml) once as prophylaxis (lot number: U038863, which was determined to be valid, with an expiration date on 27-MAY-2023) (Expired product administered). The vaccine did not have any previous temperature excursion outside recommended range in the past.  No additional adverse event was reported.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2306USA000729:
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: chronic diahrrea; This serious case was reported by a consumer and described the occurrence of chronic diarrhea in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28-MAR-2023, the patient received the 1st dose of Shingrix. In MAR-2023, 2 days after receiving Shingrix, the patient experienced chronic diarrhea (Verbatim: chronic diahrrea) (serious criteria clinically significant/intervention required). The outcome of the chronic diarrhea was not resolved.   It was unknown if the reporter considered the chronic diarrhea to be related to Shingrix.     It was unknown if the company considered the chronic diarrhea to be related to Shingrix.   Additional Information: GSK Receipt date: 29-MAY-2023 This case was submitted by consumer via the online direct entry reporting system. The caregiver reported that the patient received a dose of Shingrix and within 2 days of receiving vaccine had chronic diarrhea. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Skin abrasion, Skin haemorrhage, Vaccination failure
Clinical narrative: received the vaccine and got shingles after/suspected vaccination failure; very very painful; rub my skin so hard; received the vaccine and got shingles after; 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.   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: received the vaccine and got shingles after/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: received the vaccine and got shingles after), pain (Verbatim: very very painful) and chafed skin (Verbatim: rub my skin so hard). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved (duration 2 years) and the outcome of the pain and chafed skin were resolving.   The reporter considered the vaccination failure, shingles, pain and chafed skin to be possibly related to Shingles vaccine.     The company considered the vaccination failure, shingles, pain and chafed skin to be possibly related to Shingles vaccine.   Additional Information: GSK receipt date: 31-May-2023 The case was received from the patient via interactive digital media. In the last 5 years as soon as she got the shingles shot and recently got shingles. The patient stated that they were very very painful and lasted almost 2 years. The patient rub her skin so hard that her body would bleed there was really nothing for shingles and she was in recovery so it would not take any painkillers. The patient believed that the medicine was not the alternative. The patient  prayed that you get better it was a tough road but eventually you did get better. 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: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Discomfort, Herpes zoster, Laboratory test normal, Vaccination failure
Clinical narrative: She describes her symptoms as feeling like she's having shingles flare-up /Suspected vaccination failure; Feeling like having shingles flare-up; This serious case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had two outbreaks prior to receiving Shingrix) and chickenpox (had as a child). Concurrent medical conditions included osteoarthritis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: She describes her symptoms as feeling like she's having shingles flare-up /Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Feeling like having shingles flare-up). The patient was treated with hydrocortisone + lidocaine (Hydrocortisone And Lidocaine). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-JUN-2023 The reporter reported that the patient received Shingrix vaccine and experienced symptoms as feeling like she had shingles flare up. The reporter stated that the symptoms are on and off and sporadic it was uncomfortable and unpredictable. It was came in fingers or upper extremities, legs and feet and it was rotates. The patient received cream include lidocaine 4percentage and Hydrocortisone OTC maximum strength as a treatment. The patient symptoms was last a week to 10 days after putting the cream on that area and patient never tried going without putting the cream on it.  The patient saw rheumatologist and all her tests with him had came back negative for any rheumatology disorders. 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. The reporter requested to consent the follow up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Hyperaesthesia, Pain, Pain in extremity
Clinical narrative: She describes her symptoms as feeling like she's having shingles flare-up /Suspected vaccination failure; Feeling like having shingles flare-up; This serious case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had two outbreaks prior to receiving Shingrix) and chickenpox (had as a child). Concurrent medical conditions included osteoarthritis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: She describes her symptoms as feeling like she's having shingles flare-up /Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Feeling like having shingles flare-up). The patient was treated with hydrocortisone + lidocaine (Hydrocortisone And Lidocaine). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-JUN-2023 The reporter reported that the patient received Shingrix vaccine and experienced symptoms as feeling like she had shingles flare up. The reporter stated that the symptoms are on and off and sporadic it was uncomfortable and unpredictable. It was came in fingers or upper extremities, legs and feet and it was rotates. The patient received cream include lidocaine 4percentage and Hydrocortisone OTC maximum strength as a treatment. The patient symptoms was last a week to 10 days after putting the cream on that area and patient never tried going without putting the cream on it.  The patient saw rheumatologist and all her tests with him had came back negative for any rheumatology disorders. 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. The reporter requested to consent the follow up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Tenderness, Vaccination failure
Clinical narrative: She describes her symptoms as feeling like she's having shingles flare-up /Suspected vaccination failure; Feeling like having shingles flare-up; This serious case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had two outbreaks prior to receiving Shingrix) and chickenpox (had as a child). Concurrent medical conditions included osteoarthritis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: She describes her symptoms as feeling like she's having shingles flare-up /Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Feeling like having shingles flare-up). The patient was treated with hydrocortisone + lidocaine (Hydrocortisone And Lidocaine). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-JUN-2023 The reporter reported that the patient received Shingrix vaccine and experienced symptoms as feeling like she had shingles flare up. The reporter stated that the symptoms are on and off and sporadic it was uncomfortable and unpredictable. It was came in fingers or upper extremities, legs and feet and it was rotates. The patient received cream include lidocaine 4percentage and Hydrocortisone OTC maximum strength as a treatment. The patient symptoms was last a week to 10 days after putting the cream on that area and patient never tried going without putting the cream on it.  The patient saw rheumatologist and all her tests with him had came back negative for any rheumatology disorders. 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. The reporter requested to consent the follow up.
Sex: M
Vaccine: RSV
Symptoms: Cough, Headache, SARS-CoV-2 test negative
Clinical narrative: Cough; Headache; This non-serious case was reported by a other health professional and described the occurrence of cough in a 70-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced cough (Verbatim: Cough) and headache (Verbatim: Headache). The outcome of the cough and headache were not reported.   It was unknown if the reporter considered the cough and headache to be related to Arexvy.     It was unknown if the company considered the cough and headache to be related to Arexvy.   Additional Information: GSK Receipt Date: 26-MAY-2023 The reporter reported that the patient experienced cough and headache after receiving Arexvy vaccine. The patient had been self-medicated. The reporter reported that the patient was tested negative for covid. The patient had been struggling to reach the clinic. The reporter gave the patient the clinic's number and told that they would escalate further. The reporter did consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Discharge, Headache, Herpes zoster, Lymphadenopathy
Clinical narrative: Breakout on face and scalp of shingles-like; blisters that ooze yellow discharge; ooze yellow discharge; Headache; Fever; Sore arm; swollen glands on right face and throat; This non-serious case was reported by a consumer and described the occurrence of shingles in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension, gastroesophageal reflux disease and hormone replacement therapy. Concomitant products included losartan, pantoprazole, estradiol (Estradiol Patch) and carvedilol.   On 23-MAY-2023, the patient received the 1st dose of Shingrix. In MAY-2023, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: Headache), fever (Verbatim: Fever), pain in arm (Verbatim: Sore arm) and swollen glands (Verbatim: swollen glands on right face and throat). On 26-MAY-2023, the patient experienced shingles (Verbatim: Breakout on face and scalp of shingles-like), blister (Verbatim: blisters that ooze yellow discharge) and fluid discharge (Verbatim: ooze yellow discharge). The outcome of the shingles, blister, fluid discharge and fever were not resolved and the outcome of the headache, pain in arm and swollen glands were not reported.   It was unknown if the reporter considered the shingles, blister, fluid discharge, headache, fever, pain in arm and swollen glands to be related to Shingrix.     It was unknown if the company considered the shingles, blister, fluid discharge, headache, fever, pain in arm and swollen glands to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-MAY-2023. This report was submitted via the online direct entry reporting system. this report was submitted by site public reporting. The patient was not pregnant at the time of reporting The patient was the reporter. Dates for Breakout on face and scalp of shingles-like blisters that ooze yellow discharge from 26 May 2023 to ongoing. The patient received Losartan, Carvedilol, Pantoprazole and Estradiol patch start date was unknown stop date was ongoing. Patient had expected side effects of headache, fever, sore arm, then the breakout. Still had temperature of 100 and swollen glands on right face and throat that appeared when blisters did. The patient reported that the symptoms were not treated. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Breakout on face and scalp of shingles-like; blisters that ooze yellow discharge; ooze yellow discharge; Headache; Fever; Sore arm; swollen glands on right face and throat; This non-serious case was reported by a consumer and described the occurrence of shingles in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension, gastroesophageal reflux disease and hormone replacement therapy. Concomitant products included losartan, pantoprazole, estradiol (Estradiol Patch) and carvedilol.   On 23-MAY-2023, the patient received the 1st dose of Shingrix. In MAY-2023, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: Headache), fever (Verbatim: Fever), pain in arm (Verbatim: Sore arm) and swollen glands (Verbatim: swollen glands on right face and throat). On 26-MAY-2023, the patient experienced shingles (Verbatim: Breakout on face and scalp of shingles-like), blister (Verbatim: blisters that ooze yellow discharge) and fluid discharge (Verbatim: ooze yellow discharge). The outcome of the shingles, blister, fluid discharge and fever were not resolved and the outcome of the headache, pain in arm and swollen glands were not reported.   It was unknown if the reporter considered the shingles, blister, fluid discharge, headache, fever, pain in arm and swollen glands to be related to Shingrix.     It was unknown if the company considered the shingles, blister, fluid discharge, headache, fever, pain in arm and swollen glands to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-MAY-2023. This report was submitted via the online direct entry reporting system. this report was submitted by site public reporting. The patient was not pregnant at the time of reporting The patient was the reporter. Dates for Breakout on face and scalp of shingles-like blisters that ooze yellow discharge from 26 May 2023 to ongoing. The patient received Losartan, Carvedilol, Pantoprazole and Estradiol patch start date was unknown stop date was ongoing. Patient had expected side effects of headache, fever, sore arm, then the breakout. Still had temperature of 100 and swollen glands on right face and throat that appeared when blisters did. The patient reported that the symptoms were not treated. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Rash on right arm; Hives on right arm; This non-serious case was reported by a consumer and described the occurrence of rash in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number 44HD4) for prophylaxis.   Concurrent medical conditions included hypertension and blood cholesterol increased. Concomitant products included atorvastatin calcium.   On 28-MAY-2023, the patient received Shingrix (intramuscular, left deltoid) .5 ml. On 29-MAY-2023, 1 days after receiving Shingrix, the patient experienced rash (Verbatim: Rash on right arm) and hives (Verbatim: Hives on right arm). The outcome of the rash and hives were not resolved.   It was unknown if the reporter considered the rash and hives to be related to Shingrix.     It was unknown if the company considered the rash and hives to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-MAY-2023 Concomitant products included Hydroxycholorithiazide from 01-SEP-2021 and was ongoing for Hypertension. The patient self-reported this case. The reporter consented to follow up.