chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash, Rash pruritic, Vaccination failure
Clinical narrative: Susoected vaccination failure; confirmed I had shingles; had a burning; had a, itchy, rash; had, painful rash; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received original shot when it was available).   On an unknown date, the patient received Shingles vaccine. On 30th May 2021, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, burning sensation, itchy rash and painful rash. The patient was treated with medication unknown (Cream (Medication Unknown)). On an unknown date, the outcome of the vaccination failure, shingles, burning sensation, itchy rash and painful rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation, itchy rash and painful rash to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received the original shot when it was available. The patient received the new shots in last fall (2020). On this past Sunday, 30th May 2021, the patient had a burning, itchy, painful rash on the lower left quadrant of back. A trip to clinic confirmed shingles. The patient stated shingles were miserable and she was taking the script and using the cream from the doctor. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first Shingrix vaccine September 2019. It has been more than six months; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix in September 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details provided were as follows: The patient was the reporter. The age at vaccination was not applicable for this report. Till the time of reproting, patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter mentioned that it had been more than 6 months apart since patient received the 1st dose and it was almost 21 months. The reporter asked if I just get my 2nd vaccine now, or do I have to start over again and get two doses of Shingrix within a six month period.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Eye haemorrhage, Eye swelling, Ocular hyperaemia, Urticaria
Clinical narrative: bleeding in the left eye, described by the reporter as capillaries bursting; swelling of both eyes; leaving red in the eye; left cheek bone pain; Hives about the face; This case was reported by a consumer via call center representative and described the occurrence of eye hemorrhage in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th May 2021, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced eye hemorrhage (serious criteria GSK medically significant), eye swelling, eye red, bone pain and hives. On an unknown date, the outcome of the eye hemorrhage, eye swelling, bone pain and hives were not recovered/not resolved and the outcome of the eye red was unknown.   It was unknown if the reporter considered the eye hemorrhage, eye swelling, eye red, bone pain and hives to be related to Shingrix.  Additional detail were reported as follows: The case was reported by the patient's daughter. The patient received the 1st dose of Shingrix 15 days prior to the report in a pharmacy. After several unspecified hours, the patient began to experience hives about the face. The patient experienced bleeding in the left eye, described by the reporter as capillaries bursting and leaving red in the eye. The patient also experienced left cheek bone pain and swelling of both eyes. It was not known how soon other events began relative to receiving the dose. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient was late for the second dose / first dose was administrated on 2018; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose was received in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. No patient's identifiers was provided. There were no lot number or expiration date provided for the 1st dose and no vaccination date was provided. The patient was late for the 2nd dose of Shingrix and did not receive the second dose till the time of reporting, which led to incomplete course of vaccination. No adverse event was reported.  The reporter consented to follow -up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix 10 months ago / didn´t get the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose of Shingrix, 10 months prior to the reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that, patient had not received the 2nd dose at the moment of call. The patient was called and was given information about right protocol to follow. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: reported on 04Jun2021 /first dose / administered on 16Sep2019 / second dose on /day as reported it; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 92C34, expiry date 4th June 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 16th September 2019).   On 4th June 2021, the patient received the 2nd dose of Shingrix. On 4th June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received the second dose of Shingrix later than the recommended schedule which led to lengthening of vaccination schedule. The second dose was given on the same day of reporting. The reporter consented to follow up.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: BODY ACHES; CHILLS; FEVER; HEADACHE; FATIGUE; SORENESS AT INJECTION SITE; NO SENSE OF SMELL; This spontaneous report received from a patient concerned a male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included osteoarthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced no sense of smell. On 02-JUN-2021, the subject experienced body aches. On 02-JUN-2021, the subject experienced chills. On 02-JUN-2021, the subject experienced fever. On 02-JUN-2021, the subject experienced headache. On 02-JUN-2021, the subject experienced fatigue. On 02-JUN-2021, the subject experienced soreness at injection site. Laboratory data included: Body temperature (NR: not provided) 99, 100.9. Treatment medications included: naproxen sodium. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness at injection site, fever, body aches, headache, and chills, and the outcome of fatigue and no sense of smell was not reported. This report was non-serious. This case, from the same reporter is linked to 20210604773.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case is assessed as non serious.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: BODY ACHES; CHILLS; FEVER; HEADACHE; FATIGUE; SORENESS AT INJECTION SITE; NO SENSE OF SMELL; This spontaneous report received from a patient concerned a male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included osteoarthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced no sense of smell. On 02-JUN-2021, the subject experienced body aches. On 02-JUN-2021, the subject experienced chills. On 02-JUN-2021, the subject experienced fever. On 02-JUN-2021, the subject experienced headache. On 02-JUN-2021, the subject experienced fatigue. On 02-JUN-2021, the subject experienced soreness at injection site. Laboratory data included: Body temperature (NR: not provided) 99, 100.9. Treatment medications included: naproxen sodium. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness at injection site, fever, body aches, headache, and chills, and the outcome of fatigue and no sense of smell was not reported. This report was non-serious. This case, from the same reporter is linked to 20210604773.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case is assessed as non serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED PRODUCT; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 21-JUN-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced administered expired product. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired product was not reported. This report was non-serious.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hyperhidrosis, Nausea, Pallor, Seizure
Clinical narrative: SEIZURE; DIAPHORESIS; PALE; NAUSEOUS; This spontaneous report received from a patient concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies and patient had no drug abuse or illicit drug usage. Patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 31-OCT-2021) frequency 1 total, dose was not reported, administered to left arm on 03-JUN-2021 at 14:37 p.m. for prophylactic vaccination.  No concomitant medications were reported.  On 03-JUN-2021, events occurred within 3 minutes post-vaccination- seizure, diaphoresis. After seizure-like activity, patient was nauseated and pale. The reporter began cool compress, BP monitoring (Blood pressure measurement) result not reported, called EMS (emergency medical services), and gave water and snacks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure, diaphoresis, pale, and nauseous on 03-JUN-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210607494-Covid-19 vaccine ad26.cov2.s-Seizure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Off label use, Wrong technique in product usage process
Clinical narrative: WRONG TECHNIQUE IN DRUG USAGE PROCESS; INAPPROPRIATE DOSE OF VACCINE ADMINISTERED; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 61 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204a21a,  expiry: 23-JUN-2021) .3 ml, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced wrong technique in drug usage process. On 02-JUN-2021, the subject experienced inappropriate dose of vaccine administered. On 02-JUN-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the wrong technique in drug usage process, inappropriate dose of vaccine administered and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210607539 and 20210607725.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Influenza like illness
Clinical narrative: This spontaneous report received from a patient concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non-alcohol user, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug use. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, expiry: UNKNOWN) dose was not reported, administered on 02-JUNE-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUNE-2021, the subject experienced pain in eyes. On 02-JUNE-2021, the subject experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in eyes, and flu like symptoms. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Musculoskeletal stiffness
Clinical narrative: NUMBNESS OF HANDS AND FINGERS; HANDS STIFFNESS; This spontaneous report received from a patient concerned an 85 year old female. The patient's weight was 142 pounds, and height was 66 inches. The patient's past medical history included valve replacement, and concurrent conditions included diabetes, non alcohol user, non-smoker, and stent user, and other pre-existing medical conditions included the patient had no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced hands stiffness. On 03-APR-2021, the subject experienced numbness of hands and fingers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness of hands and fingers, and hands stiffness. This report was non-serious.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer concerned a 39 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. Patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Reporter stated that the patient took the vaccine and then died 3 days later (date unspecified). Reporter did not have any further information to provide. On an unspecified date, the patient died from unknown cause of death. It was unknown whether autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210611846-COVID-19 VACCINE AD26.COV2.S-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: GRAND MAL SEIZURE; This spontaneous report received from a parent concerned a patient of 19-year-old female. The patient's weight was 210 pounds, and height was 170 centimeters. The patient's past medical history included seizures, drop blood pressure, and pulse drop, and concurrent conditions included borderline personality, bipolar disorder, cigarette smoker, non-alcohol user, marijuana user, and memory loss, and other pre-existing medical conditions included patient had no known allergies. The patient had no drug abuse/illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 03-JUN-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported.  On 03-JUN-2021, at 7 pm the patient complained of being very tired, she felt that she was passing out and nauseated. At 3 am in morning (04-JUN-2021), patient started to have a grand mal seizure, lied on the floor, totally confused, her eyes went all over the place, she did not remember all the people around her. Based on description patient had memory loss, she could not remember the last 3 years of her life and she was on year between 2017 and 2018. Patient had a history of seizure last 2017 when she was on a psychotropic medication (Topamax) which she was taking because of her bipolar disorder. Medication which was taken for bipolar disorder causes her to drop her blood pressure and pulse which resulted to seizure. Patient was planning to visit doctor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from grand mal seizure. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210611850-COVID-19 VACCINE AD26.COV2.S-Grandmal seizure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage
Clinical narrative: EXCESSIVE BLEEDING; This spontaneous report received from a patient concerned a other, Hispanic or Latino male of unspecified age. The patient's height, and weight were not reported.  The patient's concurrent conditions included no alcohol, non-smoker, penicillin allergy. The patient experienced drug allergy when treated with clarithromycin for drug used for unknown indication.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: unknown) dose was not reported, 1 total dose was administered on 04-JUN-2021 to right arm for prophylactic vaccination. Concomitant medications included Sertraline (100 mg once daily) used for unknown indication. On 04-JUN-2021, the patient experienced excessive bleeding when he tried to cut his nails and scratch his beard but the bleeding did not stop. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from excessive bleeding. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210612348-Covid-19 vaccine ad26.cov2.s -excessive bleeding . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: HURT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hurt was not reported. This report was non-serious. This case, from the same reporter is linked to 20210611888.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Eye pain, Fatigue
Clinical narrative: CONSTANT TO BAD DIZZINESS (TO THE POINT WITH FEELS LIKE ROOM IS SPINNING); PAIN BEHIND EYES; MODERATE CONSTANT HEADACHE; NAUSEA; VOMITED 10 MINS AFTER FEELING NAUSEOUS; FEVER OF 102 CONSISTENTLY; FATIGUE; MUSCLE PAIN; LEFT ARM SORENESS; CHILLS BADLY; BODY ACHES EVERYWHERE; This spontaneous report received from a patient concerned a 23 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine, non alcohol user, cigarette smoker, bees allergy, and insect allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 28-MAY-2021, the subject experienced body aches everywhere. On 28-MAY-2021, the subject experienced left arm soreness. On 28-MAY-2021, the subject experienced chills badly. On 28-MAY-2021, the subject experienced fatigue. On 28-MAY-2021, the subject experienced muscle pain. On 28-MAY-2021, the subject experienced fever of 102 consistently. Laboratory data included: Body temperature (NR: not provided) 102 (units unspecified). On 29-MAY-2021, the subject experienced vomited 10 mins after feeling nauseous. On 29-MAY-2021, the subject experienced nausea. On 04-JUN-2021, the subject experienced constant to bad dizziness (to the point with feels like room is spinning). On 04-JUN-2021, the subject experienced pain behind eyes. On 04-JUN-2021, the subject experienced moderate constant headache. On 07-JUN-2021, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches everywhere, chills badly, fatigue, muscle pain, and fever of 102 consistently on 31-MAY-2021, vomited 10 mins after feeling nauseous, and nausea on 29-MAY-2021, and left arm soreness on 02-JUN-2021, and had not recovered from constant to bad dizziness (to the point with feels like room is spinning), moderate constant headache, and pain behind eyes. This report was non-serious.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pain, Pain in extremity
Clinical narrative: CONSTANT TO BAD DIZZINESS (TO THE POINT WITH FEELS LIKE ROOM IS SPINNING); PAIN BEHIND EYES; MODERATE CONSTANT HEADACHE; NAUSEA; VOMITED 10 MINS AFTER FEELING NAUSEOUS; FEVER OF 102 CONSISTENTLY; FATIGUE; MUSCLE PAIN; LEFT ARM SORENESS; CHILLS BADLY; BODY ACHES EVERYWHERE; This spontaneous report received from a patient concerned a 23 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine, non alcohol user, cigarette smoker, bees allergy, and insect allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 28-MAY-2021, the subject experienced body aches everywhere. On 28-MAY-2021, the subject experienced left arm soreness. On 28-MAY-2021, the subject experienced chills badly. On 28-MAY-2021, the subject experienced fatigue. On 28-MAY-2021, the subject experienced muscle pain. On 28-MAY-2021, the subject experienced fever of 102 consistently. Laboratory data included: Body temperature (NR: not provided) 102 (units unspecified). On 29-MAY-2021, the subject experienced vomited 10 mins after feeling nauseous. On 29-MAY-2021, the subject experienced nausea. On 04-JUN-2021, the subject experienced constant to bad dizziness (to the point with feels like room is spinning). On 04-JUN-2021, the subject experienced pain behind eyes. On 04-JUN-2021, the subject experienced moderate constant headache. On 07-JUN-2021, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches everywhere, chills badly, fatigue, muscle pain, and fever of 102 consistently on 31-MAY-2021, vomited 10 mins after feeling nauseous, and nausea on 29-MAY-2021, and left arm soreness on 02-JUN-2021, and had not recovered from constant to bad dizziness (to the point with feels like room is spinning), moderate constant headache, and pain behind eyes. This report was non-serious.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: CONSTANT TO BAD DIZZINESS (TO THE POINT WITH FEELS LIKE ROOM IS SPINNING); PAIN BEHIND EYES; MODERATE CONSTANT HEADACHE; NAUSEA; VOMITED 10 MINS AFTER FEELING NAUSEOUS; FEVER OF 102 CONSISTENTLY; FATIGUE; MUSCLE PAIN; LEFT ARM SORENESS; CHILLS BADLY; BODY ACHES EVERYWHERE; This spontaneous report received from a patient concerned a 23 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine, non alcohol user, cigarette smoker, bees allergy, and insect allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 28-MAY-2021, the subject experienced body aches everywhere. On 28-MAY-2021, the subject experienced left arm soreness. On 28-MAY-2021, the subject experienced chills badly. On 28-MAY-2021, the subject experienced fatigue. On 28-MAY-2021, the subject experienced muscle pain. On 28-MAY-2021, the subject experienced fever of 102 consistently. Laboratory data included: Body temperature (NR: not provided) 102 (units unspecified). On 29-MAY-2021, the subject experienced vomited 10 mins after feeling nauseous. On 29-MAY-2021, the subject experienced nausea. On 04-JUN-2021, the subject experienced constant to bad dizziness (to the point with feels like room is spinning). On 04-JUN-2021, the subject experienced pain behind eyes. On 04-JUN-2021, the subject experienced moderate constant headache. On 07-JUN-2021, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches everywhere, chills badly, fatigue, muscle pain, and fever of 102 consistently on 31-MAY-2021, vomited 10 mins after feeling nauseous, and nausea on 29-MAY-2021, and left arm soreness on 02-JUN-2021, and had not recovered from constant to bad dizziness (to the point with feels like room is spinning), moderate constant headache, and pain behind eyes. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and chills was not reported. This report was non-serious.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: left arm (where vaccine was administered) was swollen; left arm (where vaccine was administered) was red; left arm (where vaccine was administered) was itching, it was bigger and more itchy; left arm (where vaccine was administered) was itching with a small rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (left arm (where vaccine was administered) was swollen) and VACCINATION SITE ERYTHEMA (left arm (where vaccine was administered) was red) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE SWELLING (left arm (where vaccine was administered) was swollen) (seriousness criterion intervention required), VACCINATION SITE ERYTHEMA (left arm (where vaccine was administered) was red) (seriousness criterion intervention required), VACCINATION SITE PRURITUS (left arm (where vaccine was administered) was itching, it was bigger and more itchy) and VACCINATION SITE RASH (left arm (where vaccine was administered) was itching with a small rash). The patient was treated with Physical therapy (ice) for Vaccination site swelling; Physical therapy (ice) for Vaccination site erythema; Physical therapy (ice) for Vaccination site pruritus and Physical therapy (ice) for Vaccination site rash. At the time of the report, VACCINATION SITE SWELLING (left arm (where vaccine was administered) was swollen), VACCINATION SITE ERYTHEMA (left arm (where vaccine was administered) was red), VACCINATION SITE PRURITUS (left arm (where vaccine was administered) was itching, it was bigger and more itchy) and VACCINATION SITE RASH (left arm (where vaccine was administered) was itching with a small rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment reported was antibiotics (for one week) for adverse events.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: 45 minutes after first vaccination, her heart was raising; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (45 minutes after first vaccination, her heart was raising) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-May-2021, the patient experienced HEART RATE INCREASED (45 minutes after first vaccination, her heart was raising) (seriousness criterion medically significant). At the time of the report, HEART RATE INCREASED (45 minutes after first vaccination, her heart was raising) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not 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. Further information has been requested.; 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. Further information has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Oxygen saturation decreased, SARS-CoV-2 antibody test, SARS-CoV-2 test positive, Somnolence
Clinical narrative: Oxygen level was dropping; Slight cough; He was very sleepy.; COVID-19 virus test positive; could not finish his sentences; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OXYGEN SATURATION DECREASED (Oxygen level was dropping), COUGH (Slight cough) and SOMNOLENCE (He was very sleepy.) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Immunodeficiency (Common variable immune deficiency - Some doctors says he has it, some doctors says he does not have it.), Prostate cancer and COPD.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced OXYGEN SATURATION DECREASED (Oxygen level was dropping) (seriousness criterion hospitalization), COUGH (Slight cough) (seriousness criterion hospitalization), SOMNOLENCE (He was very sleepy.) (seriousness criterion hospitalization), SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) and SPEECH DISORDER (could not finish his sentences). The patient was hospitalized on 15-Apr-2021 due to COUGH, OXYGEN SATURATION DECREASED and SOMNOLENCE. At the time of the report, OXYGEN SATURATION DECREASED (Oxygen level was dropping), COUGH (Slight cough), SOMNOLENCE (He was very sleepy.), SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) and SPEECH DISORDER (could not finish his sentences) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, SARS-CoV-2 antibody test: positive (Positive) Positive and. On 15-Apr-2021, SARS-CoV-2 antibody test positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment was reported.  On 15 Apr 2021, the patient developed a slight cough, had difficulty finishing his sentences, the patient's oxygen levels had dropped and was sleepy. The patient was admitted to the hospital and tested twice for COVID-19, both times were positive.  Company comment:Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for the event of SARS-CoV-2 test positive which is unlikely.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for the event of SARS-CoV-2 test positive which is unlikely.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: Oxygen level was dropping; Slight cough; He was very sleepy.; COVID-19 virus test positive; could not finish his sentences; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OXYGEN SATURATION DECREASED (Oxygen level was dropping), COUGH (Slight cough) and SOMNOLENCE (He was very sleepy.) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Immunodeficiency (Common variable immune deficiency - Some doctors says he has it, some doctors says he does not have it.), Prostate cancer and COPD.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced OXYGEN SATURATION DECREASED (Oxygen level was dropping) (seriousness criterion hospitalization), COUGH (Slight cough) (seriousness criterion hospitalization), SOMNOLENCE (He was very sleepy.) (seriousness criterion hospitalization), SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) and SPEECH DISORDER (could not finish his sentences). The patient was hospitalized on 15-Apr-2021 due to COUGH, OXYGEN SATURATION DECREASED and SOMNOLENCE. At the time of the report, OXYGEN SATURATION DECREASED (Oxygen level was dropping), COUGH (Slight cough), SOMNOLENCE (He was very sleepy.), SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) and SPEECH DISORDER (could not finish his sentences) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, SARS-CoV-2 antibody test: positive (Positive) Positive and. On 15-Apr-2021, SARS-CoV-2 antibody test positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment was reported.  On 15 Apr 2021, the patient developed a slight cough, had difficulty finishing his sentences, the patient's oxygen levels had dropped and was sleepy. The patient was admitted to the hospital and tested twice for COVID-19, both times were positive.  Company comment:Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for the event of SARS-CoV-2 test positive which is unlikely.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for the event of SARS-CoV-2 test positive which is unlikely.
Sex: F
Vaccine: COVID19
Symptoms: Amnesia
Clinical narrative: Caller stated she received the first Pfizer covid vaccine and had a "bad reaction" and blocked memory; This is a spontaneous report from a non-contactable consumer (Patient).  A female patient of unknown age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiration date unknown), via an unknown route of administration on unknown date, 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated that she received the first Pfizer COVID vaccine and had a bad reaction and blocked memory. Patient did not further elaborate and unable to clarify and was abruptly disconnected due to telephone issue. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: sore arm; Discomfort in arm after first shot; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 64-years-old male patient received first dose of bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 06Apr2021, the patient experienced sore arm and discomfort in arm after first shot. After 6 hours of the first shot, arm discomfort started and lasted for 3 days. Regarding treatment of events, the patient stated that he did not do anything. The outcome of the events was recovered on an unspecified date of Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Migraine
Clinical narrative: Experienced a migraine starting about 2 hours after the vaccine /severe migraines daily lasting 3-12 hours each.; This is a spontaneous report from a contactable consumer (Patient). A 25-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer COVID-19 Vaccine, Solution for injection, Lot Number: FP7534), via an unspecified route of administration, administered in left arm on 29Mar2021 at 10:00 (at the age of 25-years-old) as single dose for COVID-19 immunisation. Medical history included Hashimoto's thyroiditis, PCOS, Asthma, Bipolar 2, ASD, ADHD, MDD, GAD. Patient had no known allergies. Patient was not diagnosed with Covid prior vaccination. The patient did not receive any other vaccine four weeks prior vaccination. Concomitant medications included propranolol (PROPRANOLOL), venlafaxine hydrochloride (EFFEXOR).On 29Mar2021 at 12:00 (within 2-hours after vaccination), patient experienced a migraine/severe migraines daily lasting 3-12 hours each. Patient have been getting them almost every single day since the first dose on 29Mar2021. It has now been just over 2 months. They commonly start in the morning then go away and come back later in the day, but they've also started later in the day on quite a few occasions. Patient tried Motrin, Tylenol, Excedrin Migraine, Midol, and Ubrelvy and they do not help much if at all. The only thing that helped significantly is medical Marijuana with CBD. Patient visited 2 different doctors multiple times and no other cause has been found. The patient underwent lab tests and procedures which included extensive blood work and CT, however, nothing has been found to explain the migraines from the investigations on an unspecified date. It was reported that patient had not received any specific treatment for event. Patient was not diagnosed with Covid prior vaccination and not tested for Covid post vaccination. The outcome of the events was unknown.   No follow up attempts possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Menstruation delayed, Menstruation irregular, Pregnancy test
Clinical narrative: cough; fatigue; irregular menstrual cycle; callers cycle is late by 10-12 days.; This is a spontaneous report from a contactable consumer or other non health care professional. A 22-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 for Covid-19 immunisation. On an unspecified date, the patient had experienced cough, fatigue irregular menstrual cycle and caller cycle is late by 10-12 days. It was reported that she received both doses of vaccine. Patient states that she took a few pregnancy test and they were negative. She would like to know if any of these side effects have been reported. The patient underwent lab tests and procedures which included pregnancy test: negative. The outcome of the events was unknown.   Information about lot/batch number has been requested.