chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Adnexa uteri pain, Burning sensation, Dizziness, Feeling hot, Injection site pain
Clinical narrative: 1st dose: got vaccine in left arm, got lightheaded and dizzy with a migraine and felt warm 30 minutes after my vaccine. Got sore arm at injection site 1 hour after vaccine. Got pain on my two fingers on my right hand, felt like I burned myself and it hurt more when you touched it and had to take my ring off. Next day burning pain went up to my arm?feels like nerve pain or inflammation. Cramping in chest and ovaries randomly and still feel dizzy with migraine. Day 3: still have burning pain on right arm but it?s going away, still have migraine and feel dizzy, still getting random chest and ovary cramps. At night got really bad back muscle pain and ovary pain, feels like contractions and hurts when I walk or bend?it is extremely painful.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Muscle spasms, Myalgia, Pain in extremity
Clinical narrative: 1st dose: got vaccine in left arm, got lightheaded and dizzy with a migraine and felt warm 30 minutes after my vaccine. Got sore arm at injection site 1 hour after vaccine. Got pain on my two fingers on my right hand, felt like I burned myself and it hurt more when you touched it and had to take my ring off. Next day burning pain went up to my arm?feels like nerve pain or inflammation. Cramping in chest and ovaries randomly and still feel dizzy with migraine. Day 3: still have burning pain on right arm but it?s going away, still have migraine and feel dizzy, still getting random chest and ovary cramps. At night got really bad back muscle pain and ovary pain, feels like contractions and hurts when I walk or bend?it is extremely painful.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Pt reports chest discomfort with associated feelings of shortness of breath about 45 minutes after receiving vaccine. Symptoms have now lasted for over 12 hours .
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Precancerous cells present, Smear cervix
Clinical narrative: I'm 62 ad for the first time in my life, I got an abnormal pap smear with PRE-cancerous cells on my cervix!; This spontaneous case was reported by a consumer and describes the occurrence of PRECANCEROUS CELLS PRESENT (I'm 62 ad for the first time in my life, I got an abnormal pap smear with PRE-cancerous cells on my cervix!) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 086B21A and O37A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 10-Jun-2021, the patient experienced PRECANCEROUS CELLS PRESENT (I'm 62 ad for the first time in my life, I got an abnormal pap smear with PRE-cancerous cells on my cervix!). At the time of the report, PRECANCEROUS CELLS PRESENT (I'm 62 ad for the first time in my life, I got an abnormal pap smear with PRE-cancerous cells on my cervix!) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jun-2021, Smear cervix: abnormal (abnormal) Abnormal, PRE-CANCEROUS pap smear.         No Concomitant medication information was reported. No treatment medications were provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chromaturia, Dyspepsia, Renal pain, Thrombosis
Clinical narrative: Discomfort in chest area; Rusty colored urine for 3 days; Mild heartburn for 8 days; 3 small red dots on lower left arm; Possible blood clots on lower arm; Soreness in the kidney area; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Possible blood clots on lower arm), RENAL PAIN (Soreness in the kidney area), CHEST DISCOMFORT (Discomfort in chest area), CHROMATURIA (Rusty colored urine for 3 days) and DYSPEPSIA (Mild heartburn for 8 days) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced THROMBOSIS (Possible blood clots on lower arm) and RENAL PAIN (Soreness in the kidney area). On 18-Aug-2021, the patient experienced CHEST DISCOMFORT (Discomfort in chest area), CHROMATURIA (Rusty colored urine for 3 days), DYSPEPSIA (Mild heartburn for 8 days) and VACCINATION SITE RASH (3 small red dots on lower left arm). On 28-Aug-2021, CHROMATURIA (Rusty colored urine for 3 days), DYSPEPSIA (Mild heartburn for 8 days) and VACCINATION SITE RASH (3 small red dots on lower left arm) had resolved. At the time of the report, THROMBOSIS (Possible blood clots on lower arm), RENAL PAIN (Soreness in the kidney area) and CHEST DISCOMFORT (Discomfort in chest area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.; Sender's Comments: This case concerns a 61-year-old male patient with no details on previous medical history, who experienced the unexpected events of Thrombosis (reported as possible blood clots on lower arm) after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred after the first dose of Spikevax, temporal relationship is unknown. The rechallenge was not applicable since only information about one dose was disclosed. The benefit-risk relationship of Spikevax vaccine is not affected by this report. Thrombosis was automatically upgraded as serious as per Regulatory authority list. However,  based on information available and due to the lack of evidence of seriousness from a regulatory or clinical standpoint, it was assessed as non-serious. Medical confirmation has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Discomfort in chest area; Rusty colored urine for 3 days; Mild heartburn for 8 days; 3 small red dots on lower left arm; Possible blood clots on lower arm; Soreness in the kidney area; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Possible blood clots on lower arm), RENAL PAIN (Soreness in the kidney area), CHEST DISCOMFORT (Discomfort in chest area), CHROMATURIA (Rusty colored urine for 3 days) and DYSPEPSIA (Mild heartburn for 8 days) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced THROMBOSIS (Possible blood clots on lower arm) and RENAL PAIN (Soreness in the kidney area). On 18-Aug-2021, the patient experienced CHEST DISCOMFORT (Discomfort in chest area), CHROMATURIA (Rusty colored urine for 3 days), DYSPEPSIA (Mild heartburn for 8 days) and VACCINATION SITE RASH (3 small red dots on lower left arm). On 28-Aug-2021, CHROMATURIA (Rusty colored urine for 3 days), DYSPEPSIA (Mild heartburn for 8 days) and VACCINATION SITE RASH (3 small red dots on lower left arm) had resolved. At the time of the report, THROMBOSIS (Possible blood clots on lower arm), RENAL PAIN (Soreness in the kidney area) and CHEST DISCOMFORT (Discomfort in chest area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.; Sender's Comments: This case concerns a 61-year-old male patient with no details on previous medical history, who experienced the unexpected events of Thrombosis (reported as possible blood clots on lower arm) after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred after the first dose of Spikevax, temporal relationship is unknown. The rechallenge was not applicable since only information about one dose was disclosed. The benefit-risk relationship of Spikevax vaccine is not affected by this report. Thrombosis was automatically upgraded as serious as per Regulatory authority list. However,  based on information available and due to the lack of evidence of seriousness from a regulatory or clinical standpoint, it was assessed as non-serious. Medical confirmation has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood Clots / Left Leg BKA Amputation; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood Clots / Left Leg BKA Amputation) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic, Drug allergy (Relafin), Allergy to antibiotic (Vancomycin), Penicillin allergy, Drug allergy (Phenagryn), Iodine allergy (Iodine) and Allergy to antibiotic (Zosyn).   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced THROMBOSIS (Blood Clots / Left Leg BKA Amputation) (seriousness criteria hospitalization prolonged and medically significant). The patient was treated with Surgery (Left leg amputation) for Thrombosis. At the time of the report, THROMBOSIS (Blood Clots / Left Leg BKA Amputation) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had blood clots from groin to toes, five surgeries were done to remove clots but it was unsuccessful. Patient was underwent 6th surgery to amputate left leg below the knee.  No concomitant medications reported. No treatment medications provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Medical history of diabetes could be a predisposing factor for the event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Medical history of diabetes could be a predisposing factor for the event.
Age: 0.33
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no additional AE has been reported; a 4 month old patient was administered MMR II and VARIVAX; This spontaneous report was received from a medical assistant and refers to a 4- month-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.   On 26-AUG-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # T041687, expiration date: 10-DEC-2022; 0.5 milliliter (strength, dosing schedule and route of administration were not provided) for prophylaxis. On the same day, the patient received 0.5 ml dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA))(M-M-R II) lot# T012806, expiration date: 14-APR-2022 (strength, dosing schedule and route of administration were not provided) for prophylaxis. Both vaccines were administered to a patient prior to recommended age indicated in prescribing information. No additional adverse event (AE) had been reported at time of call.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered, No adverse event
Clinical narrative: On unknown dates, the pt received 2 doses of HepB vaccine but missed the third dose. On 01 Sep2021, the Recombivax Adult Hep B Vaccine was administered as her third dose./Pharmacisthad not received his third dose back then as recommended; the patient had not experienced any issues and she was doing fine when she left the clinic/No additional information/o additional adverse events reported; Recombivax Adult Hep B Vaccine, 10mcg, was administered as her third dose. After the dose was give, the physician realized that, due to her age, she should have received 5mcgs./ The pt came into the clinic and received a dose of 1.0 ml; This spontaneous report has been received from a physician and a pharmacist, concerning a 18-year-old female patient. No information was provided regarding the patients' pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.   On an unspecified date (reported as when she was younger, and as an infant), the patient was vaccinated with the first and second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (also reported as HepB vaccine) at a dose of 0.5 milliliters (ml) or 5 micrograms (mcg); then on 01-SEP-2021 (inappropriate schedule of product administration), she was vaccinated with the third dose (and final dose of a series) of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) at a dose of 10mcg or 1.0 ml (also reported as 0.1ml, conflicting information), instead of 5mcg or 0.5ml (incorrect dose administered); all the vaccines as prophylaxis (product formulations, route of administrations, anatomical locations of vaccination, lot numbers and expirations dates were not reported). The physician stated that she was fine when she left the clinic; no additional information or adverse events reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: Underdose
Clinical narrative: No additional AE reported; During administration when they pulled the needle out, some of the vaccine leaked out of the patient; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided.   On 02-SEP-2021, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliters (route of administration not provided) lot number T041503 expiration date 09-DEC-2022 as prophylaxis.  During administration when they pulled the needle out, some of the vaccine leaked out of the patient (vaccine underdose). It's unknown how much the patient received since the product leaked out. The reporter confirmed that there was no product quality complaints.  No adverse symptoms were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event
Clinical narrative: no additional AE; overdose; This spontaneous report was received from a practice supervisor concerning a patient of unknown age. No information about the patient's current condition, medical history or concomitant therapy was reported.    On 07-SEP-2021, the patient was vaccinated with two doses of varicella virus vaccine live (oka/merck)(VARIVAX) (at the dose of 1 ml, route was not reported) at the same time for prophylaxis (overdose). No additional adverse event was reported.
Age: 0.5
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; the vaccine was administered at the six month checkup instead of the twelve month check up.; Information has been received from a healthcare business professional(HBP), referring to a 6 months old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 11-JUN-2021 (at the six month checkup instead of the twelve month checkup), the patient was administered the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (0.5 milliliter, strength, frequency, therapy type, route, lot# and expiration date were unknown) for prophylaxis (Inappropriate age at vaccine administration). No other adverse event was reported.
Sex: U
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 28 week old patient received the first dose of Rotateq; Information has been received from the nurse concerning a 28-week-old patient. The patient's gender, concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not provided.  On 10-SEP-2021, the patient received the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 2 milliliter, (lot # reported as 1077487, expiration date on 23-MAR-2022), for prophylaxis purposes (product administered to patient of inappropriate age).  Lot # 1077487 is not valid for Rotavirus Vaccine, Live, Oral, Pentavalent.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Circumstance or information capable of leading to medication error, Incorrect route of product administration
Clinical narrative: they were going to administer to the patient via G-tube today; they were going to administer to the patient via G-tube today; This spontaneous report was received from a nurse referring to a 4 months old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 10-SEP-2021, the reporter was going to administer to the patient via G-tube with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) for prophylaxis (circumstance or information capable of leading to medication error and incorrect route of product administration).
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Varivax vaccine was administered following a supported temperature excursion; This spontaneous report was received from a other health professional referring to a 4-year-old male patient. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.     On 26-AUG-2021, the patient was inadvertently administered with varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (strength, dose, route of administration, and anatomical location were not reported; lot number T038830 had been verified to be a valid number; expiration date 17-NOV-2022); following a supported temperature excursion on 28-JUN-2021 (product storage error). It was reported the temperature excursion was at 8.4 degrees Fahrenheit (F) for a time frame of 1 hour 30 minutes and 0 seconds. No had previous temperature excursion.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; underwent a temperature excursion that took place on 8/13/2021 were administered; This spontaneous report has been received from a reporter specified as other, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 16-AUG-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product storage error) (dose and vaccine scheme was not reported; lot number 1707590 has been verified to be valid, expiration date reported and established as 23-MAR-2022) taken orally for prophylaxis.   The vaccine was exposed to a temperature excursion of below 36 degrees Fahrenheit (32.9°F) during a time frame of 90 hours. There was no previous temperature excursion. No additional adverse event (no adverse event) was reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA003185:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE/PQC was reported; improperly stored VARlVAX was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.  On 24-AUG-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T006347, expiration date 20-FEB-2022) for prophylaxis (product storage error).Temperature excursion was 18.1 Fahrenheit degree for 408 hours 0 minutes and 0 seconds. Previous temperature excursions were - 7.0 Fahrenheit degree for 0 hours 20 minutes and 0 seconds; 7.7 Fahrenheit degree for 0 hours 15 minutes and 0 seconds; 5.4 Fahrenheit degree for 0 hours 5 minutes and 0 seconds. No additional AE/PQC was reported.  This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA003761: US-009507513-2109USA003760: US-009507513-2109USA003762:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No symptoms reported no other AE; received dose of VARIVAX on 7/30/2021 and again on 9/14/2021; received dose of VARIVAX on 7/30/2021 and again on 9/14/2021; This spontaneous report was received from a nurse referring to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.   On 30-JUL-2021, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot# T029533 with an expiration date on 01-SEP-2022) at a dose of 0.5 milliliters subcutaneously for prophylaxis and on 14-SEP-2021, the patient received the second dose of the vaccine at a dose of 0.5  milliliters subcutaneously (schedule of product administration and product administered to patient of inappropriate age). Strength and anatomical location were not reported for the doses.   No symptoms were reported and no adverse event as well.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE/PQC was reported; improperly stored VARlVAX was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.  On 01-SEP-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # T006347, expiration date 20-FEB-2022) for prophylaxis (product storage error).Temperature excursion was 18.1 Fahrenheit degree for 408 hours 0 minutes and 0 seconds. Previous temperature excursions were - 7.0 Fahrenheit degree for 0 hours 20 minutes and 0 seconds; 7.7 Fahrenheit degree for 0 hours 15 minutes and 0 seconds; 5.4 Fahrenheit degree for 0 hours 5 minutes and 0 seconds. No additional AE/PQC was reported.  This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA003330: US-009507513-2109USA003761: US-009507513-2109USA003762:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC was reported; improperly stored VARlVAX was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.  On 30-AUG-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # T006347, expiration date 20-FEB-2022) for prophylaxis (product storage error).Temperature excursion was 18.1 Fahrenheit degree for 408 hours 0 minutes and 0 seconds. Previous temperature excursions were - 7.0 Fahrenheit degree for 0 hours 20 minutes and 0 seconds; 7.7 Fahrenheit degree for 0 hours 15 minutes and 0 seconds; 5.4 Fahrenheit degree for 0 hours 5 minutes and 0 seconds. No additional AE/PQC was reported.  This is one of four reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE/PQC was reported; improperly stored VARlVAX was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.  On 31-AUG-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T006347, expiration date 20-FEB-2022) for prophylaxis (product storage error).Temperature excursion was 18.1 Fahrenheit degree for 408 hours 0 minutes and 0 seconds. Previous temperature excursions were - 7.0 Fahrenheit degree for 0 hours 20 minutes and 0 seconds; 7.7 Fahrenheit degree for 0 hours 15 minutes and 0 seconds; 5.4 Fahrenheit degree for 0 hours 5 minutes and 0 seconds. No additional AE was reported.  This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA003330: US-009507513-2109USA003760: US-009507513-2109USA003761:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE.; the product was administered to a patient on 9/14/2021 after a temperature excursion.; This spontaneous report has been received from a reporter specified as other, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 14-SEP-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, route of administration, anatomical site of vaccination and vaccine scheme were not reported; lot number u008183 has been verified to be valid, expiration date reported and established as 07-FEB-2023) as prophylaxis.   The vaccine was exposed to the following temperature excursions (product storage error): 12.9 degrees Fahrenheit during a time frame of 3 hours and 45 minutes, 11 degrees Fahrenheit during a time frame of 5 hours and 5 minutes, 13.2 degrees Fahrenheit during a time frame of 7 hours, and 14.9 degrees Fahrenheit during a time frame of 15 minutes. There was a previous temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (7.5°F) for 1 hour and 10 minutes.  The reporter confirmed that no other adverse event (AE) occurred.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: no adverse event; product was administered in the right glute; This spontaneous report was received from an office manager referring to a 40 year old patient of unspecified gender.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.    On 14-SEP-2021, the patient was vaccinated with 1 dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # T030746, expiring on 16-MAR-2023, in the right gluteus for prophylaxis (product administered at inappropriate site).  The patient did not experienced any adverse event. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck; devicelotnumber: T030746; expirationdate: 16-MAR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Peripheral swelling, Vaccine positive rechallenge
Clinical narrative: red swollen area on her arm; red swollen area on her arm; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 58-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced erythema of extremities and swelling arm. On an unknown date, the outcome of the erythema of extremities and swelling arm were recovered/resolved.   It was unknown if the reporter considered the erythema of extremities and swelling arm to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at the vaccination was not reported. The case was reported by patient herself. The patient had red swollen area on her arm after each flu shot. The red swollen area on arm after flu shot were resolved. The patient had the same reaction every year to the flu shot. The patient had both doses of COVID19 vaccines in 2021 and she had a strong reaction (no details provided) to the second dose of COVID19 vaccine. The reporter consented to follow up. This case is linked to case US2021193298 reported by the same reporter for the same patient (Shingrix vaccine).; Sender's Comments:  US-GLAXOSMITHKLINE-US2021193298:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain
Clinical narrative: horrible reaction for two solid days, so painful, awful, were down for the count; was so awful; This case was reported by a consumer via interactive digital media and described the occurrence of pain 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, unknown after receiving Shingles vaccine, the patient experienced pain and feels awful. On an unknown date, the outcome of the pain and feels awful were unknown.   It was unknown if the reporter considered the pain and feels awful to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had absolutely horrible reaction from the Shingle shot for 2 solid days and it was so painful and awful. The patient was down for the count and suggested GlaxoSmithKline need to do something about this shot. This case has been linked with case US2021AMR194183, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR194183:Same reporter - Husband
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain
Clinical narrative: horrible reaction for two solid days, so painful, awful, were down for the count; Was so awful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain and feels awful. On an unknown date, the outcome of the pain and feels awful were unknown.   It was unknown if the reporter considered the pain and feels awful to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's spouse. The age at vaccination was not reported. The patient had absolutely horrible reaction from the Shingle shot for 2 solid days and it was so painful and awful. The patient was down for the count and they need to do something about this shot. This case has been linked with case US2021AMR194173, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR194173:Same reporter, different patient (wife)
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: gotten 3 doses of Shingrix; This case was reported by a other health professional via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter thought that, the patient might have received 3rd dose of Shingrix, which led to extra dose administered.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles vaccine and 2 days later and had the shingles and never had it before and not since.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: 2nd shot got really sick; This case was reported by a consumer via media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had it when, he/she was 12) and pain (would never forget the pain).   On 8th September 2021, the patient received the 2nd dose of Shingles vaccine. In September 2021, less than a week after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient took the 2nd Shingles shot prior day of reporting and got really sick. But the patient would still advise everyone to take the vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: Swollen glands in my neck; This case was reported by a consumer via interactive digital media and described the occurrence of lymphadenopathy cervical in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In September 2021, the patient received the 1st dose of Shingles vaccine. In September 2021, 2 days after receiving Shingles vaccine, the patient experienced lymphadenopathy cervical. On an unknown date, the outcome of the lymphadenopathy cervical was not recovered/not resolved.   It was unknown if the reporter considered the lymphadenopathy cervical to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient had swollen glands in neck since the second day after shingles vaccine. The patient asked it was day 4 at the time of reporting, was that normal. The contact details were not reported hence follow up not possible.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: broke out with the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient got shingles shot and within a couple of weeks broke out with the shingles and could not even hug his/her 3 great grandkids. The contact details were not reported hence follow up not possible.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Pyrexia
Clinical narrative: fever of 101; Sick; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Covid vaccine (had covid vaccine in March 2021).   In September 2021, the patient received the 1st dose of Shingles vaccine. In September 2021, less than a week after receiving Shingles vaccine, the patient experienced fever and sickness. On an unknown date, the outcome of the fever and sickness were recovered/resolved.   It was unknown if the reporter considered the fever and sickness to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient got shingles shot and felt sick for a couple days with a fever of 101 degree F. The patient stated that well worth it. The patient also took covid vaccine in March 2021. The patient stated that one more shingles shot in December. The contact details was not reported hence follow up not possible.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness where shot was given; This case was reported by a consumer via media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 8th September 2021, the patient received Shingles vaccine. In September 2021, less than a week after receiving Shingles vaccine, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient received shingles shot on Wednesday and now there was redness where shot was given. The patient enquired if he or she should worry about this. No contact details were reported hence follow-up not possible.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: Arm pain; Feeling crappy; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and feeling unwell. On an unknown date, the outcome of the pain in arm and feeling unwell were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and feeling unwell to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age vaccination was not reported. The patient just took second shot of Shingles vaccine and the patient's arm was hurting so bad and the patient was feeling crappy. The contact details were not reported hence follow-up not possible.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Vaccine positive rechallenge
Clinical narrative: Sick; This case was reported by a consumer and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got shingles 2 years ago it was so painful). Previously administered products included Shingles vaccine with an associated reaction of illness (1st dose received on unknown date, refer case US2021AMR195152).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had shingles 2 years ago and it was so painful, and stated nothing works it had to run it was course. The patient got the shingles vaccine and got a little sick but still worth getting it. The patient mentioned that took vaccine and did not regret it. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR195152:same reporter,same patient
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia, Somnolence
Clinical narrative: slept two nights and one whole day; had a 101 fever for a day; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles on face and back and was very painful).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever and sleepiness. On an unknown date, the outcome of the fever and sleepiness were recovered/resolved.   It was unknown if the reporter considered the fever and sleepiness to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient got the shingles vaccine and had a 101 degree F fever for a day and slept two nights and one whole day.  The patient was still glad that he/she got the shot. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain
Clinical narrative: Abdominal pain; This case was reported by a consumer via interactive digital media and described the occurrence of abdominal pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced abdominal pain. On an unknown date, the outcome of the abdominal pain was not recovered/not resolved.   It was unknown if the reporter considered the abdominal pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient had shingles vaccine and the second day after suffered from extreme abdominal pain and still had them. The patient enquired about was this normal. The contact details were not reported hence follow-up not possible.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Insomnia, Mobility decreased
Clinical narrative: painful shoulder; couldn't sleep; nor reach out 4 anything; This case was reported by a consumer via interactive digital media and described the occurrence of shoulder pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 10th September 2021, the patient received Shingles vaccine. In September 2021, less than a week after receiving Shingles vaccine, the patient experienced shoulder pain, sleeplessness and mobility decreased. On an unknown date, the outcome of the shoulder pain, sleeplessness and mobility decreased were unknown.   It was unknown if the reporter considered the shoulder pain, sleeplessness and mobility decreased to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. The patient received a dose of Shingles vaccine a day ago of the reporting day and could not sleep nor reach out for any thing due to painful shoulder. The patient was hoping that the shot was worth the pain. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (patient had it twice).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details provided were as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received Shingles vaccine and was sore for 3 days and stated never again. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: chills; FEVER; This case was reported by a consumer via (Shingrix) interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2021, the patient received Shingrix. On 11th September 2021, 1 days after receiving Shingrix, the patient experienced chills and fever. On an unknown date, the outcome of the chills and fever were recovered/resolved.   It was unknown if the reporter considered the chills and fever to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received shot Shingrix a day ago of reporting day and next day experienced chills and fever. The patient reported that the adverse events were gone at the time of reporting. The patient enquired about how long did these side effects last. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Had a mild case; They hurt; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient for himself/ herself. The age at vaccination was not reported. The patient had a mild case of Shingles as per the physician and stated that it hurt. The patient was asked to get the 2nd shot also.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Sickness; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had very mild case of shingles ten years ago ). Previously administered products included Shingles shot (received Shingles shot after having shingles ten years ago) and Shingles shot (received 1st Shingles shot an an unknown day).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingles shot which made him/her sick.