chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Blood test, Induration, Magnetic resonance imaging, Pain in extremity
Clinical narrative: NERVE PAIN; EXHAUSTION; FIBROIDS THAT GREW FAST AND CONJOINED; BILATERAL SWELLING AND EDEMA (BOTH LEFT AND RIGHT LEG WERE SWOLLEN); This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient had no known allergies, no medical history she was super healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 41 years old. No concomitant medications were reported. On an unspecified date, the patient experienced nerve pain, exhaustion. On 20-APR-2021, the patient experienced fibroids that grew fast and conjoined, and bilateral swelling and edema (both left and right leg were swollen). The patient had laparoscopic hysterectomy. On an unspecified date, For 1 year the patient had ultrasound test, MRI's (Magnetic resonance imaging), biopsies, multiple Laboratory test that showed liquid and swelling in both legs. Her surgeon told her that the leg swelling was continuing. She has seen multiple specialists, also mentioned that there was skin tightening and ripping in both legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bilateral swelling and edema (both left and right leg were swollen), and the outcome of nerve pain, exhaustion, fibroids that grew fast and conjoined and skin tightening in both legs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20220625469-covid-19 vaccine ad26.cov2.s-Fibroids that grew fast and conjoined. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Skin discolouration, Ultrasound scan
Clinical narrative: NERVE PAIN; EXHAUSTION; FIBROIDS THAT GREW FAST AND CONJOINED; BILATERAL SWELLING AND EDEMA (BOTH LEFT AND RIGHT LEG WERE SWOLLEN); This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient had no known allergies, no medical history she was super healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 41 years old. No concomitant medications were reported. On an unspecified date, the patient experienced nerve pain, exhaustion. On 20-APR-2021, the patient experienced fibroids that grew fast and conjoined, and bilateral swelling and edema (both left and right leg were swollen). The patient had laparoscopic hysterectomy. On an unspecified date, For 1 year the patient had ultrasound test, MRI's (Magnetic resonance imaging), biopsies, multiple Laboratory test that showed liquid and swelling in both legs. Her surgeon told her that the leg swelling was continuing. She has seen multiple specialists, also mentioned that there was skin tightening and ripping in both legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bilateral swelling and edema (both left and right leg were swollen), and the outcome of nerve pain, exhaustion, fibroids that grew fast and conjoined and skin tightening in both legs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20220625469-covid-19 vaccine ad26.cov2.s-Fibroids that grew fast and conjoined. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy, Fatigue, Magnetic resonance imaging, Neuralgia, Oedema peripheral
Clinical narrative: NERVE PAIN; EXHAUSTION; FIBROIDS THAT GREW FAST AND CONJOINED; BILATERAL SWELLING AND EDEMA (BOTH LEFT AND RIGHT LEG WERE SWOLLEN); This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient had no known allergies, no medical history she was super healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 41 years old. No concomitant medications were reported. On an unspecified date, the patient experienced nerve pain, exhaustion. On 20-APR-2021, the patient experienced fibroids that grew fast and conjoined, and bilateral swelling and edema (both left and right leg were swollen). The patient had laparoscopic hysterectomy. On an unspecified date, For 1 year the patient had ultrasound test, MRI's (Magnetic resonance imaging), biopsies, multiple Laboratory test that showed liquid and swelling in both legs. Her surgeon told her that the leg swelling was continuing. She has seen multiple specialists, also mentioned that there was skin tightening and ripping in both legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bilateral swelling and edema (both left and right leg were swollen), and the outcome of nerve pain, exhaustion, fibroids that grew fast and conjoined and skin tightening in both legs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20220625469-covid-19 vaccine ad26.cov2.s-Fibroids that grew fast and conjoined. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan, Uterine leiomyoma
Clinical narrative: NERVE PAIN; EXHAUSTION; FIBROIDS THAT GREW FAST AND CONJOINED; BILATERAL SWELLING AND EDEMA (BOTH LEFT AND RIGHT LEG WERE SWOLLEN); This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient had no known allergies, no medical history she was super healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 41 years old. No concomitant medications were reported. On an unspecified date, the patient experienced nerve pain, exhaustion. On 20-APR-2021, the patient experienced fibroids that grew fast and conjoined, and bilateral swelling and edema (both left and right leg were swollen). The patient had laparoscopic hysterectomy. On an unspecified date, For 1 year the patient had ultrasound test, MRI's (Magnetic resonance imaging), biopsies, multiple Laboratory test that showed liquid and swelling in both legs. Her surgeon told her that the leg swelling was continuing. She has seen multiple specialists, also mentioned that there was skin tightening and ripping in both legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bilateral swelling and edema (both left and right leg were swollen), and the outcome of nerve pain, exhaustion, fibroids that grew fast and conjoined and skin tightening in both legs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20220625469-covid-19 vaccine ad26.cov2.s-Fibroids that grew fast and conjoined. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyporeflexia, Laboratory test abnormal, Pain in extremity, Paraesthesia
Clinical narrative: a few hours after the vaccine, pt started to develop muscle pain in the hip, thigh, leg , fever. A few days later, started to experience patchy numbness in teh bilateral shins, but then in the bilateral LE and progressed up into the proximal LE.  Started to have L hand numbness on 5/29/2022.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Arthralgia, Blood albumin increased, Blood chloride decreased, Blood immunoglobulin G
Clinical narrative: a few hours after the vaccine, pt started to develop muscle pain in the hip, thigh, leg , fever. A few days later, started to experience patchy numbness in teh bilateral shins, but then in the bilateral LE and progressed up into the proximal LE.  Started to have L hand numbness on 5/29/2022.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood sodium decreased, CSF protein increased, Full blood count normal, Hypoaesthesia, Magnetic resonance imaging head normal
Clinical narrative: a few hours after the vaccine, pt started to develop muscle pain in the hip, thigh, leg , fever. A few days later, started to experience patchy numbness in teh bilateral shins, but then in the bilateral LE and progressed up into the proximal LE.  Started to have L hand numbness on 5/29/2022.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging spinal abnormal, Metabolic function test, Myalgia, Nucleated red cells, Osteoarthritis
Clinical narrative: a few hours after the vaccine, pt started to develop muscle pain in the hip, thigh, leg , fever. A few days later, started to experience patchy numbness in teh bilateral shins, but then in the bilateral LE and progressed up into the proximal LE.  Started to have L hand numbness on 5/29/2022.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pathology test, Protein total increased, Pyrexia, Red blood cell count increased
Clinical narrative: a few hours after the vaccine, pt started to develop muscle pain in the hip, thigh, leg , fever. A few days later, started to experience patchy numbness in teh bilateral shins, but then in the bilateral LE and progressed up into the proximal LE.  Started to have L hand numbness on 5/29/2022.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: a few hours after the vaccine, pt started to develop muscle pain in the hip, thigh, leg , fever. A few days later, started to experience patchy numbness in teh bilateral shins, but then in the bilateral LE and progressed up into the proximal LE.  Started to have L hand numbness on 5/29/2022.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Burning, itchy rash - chest area; Burning, itchy rash - chest area; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20May2022 at 12:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 52 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Mold" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Sulfa, reaction(s): "allergy". Vaccination history included: BNT162b2 (Dose 1 (Single), Batch/Lot: EM9809., Location of injection: Arm Left.), administration date: 04Feb2021, when the patient was 50-year-old, for COVID-19 immunization; BNT162b2 (Dose 2 (Single), Batch/Lot: EN6198., Location of injection: Arm Right.), administration date: 26Feb2021, when the patient was 51-year-old, for COVID-19 immunization; BNT162b2 (Dose 3 (Single), Batch/Lot: FF2589., Location of injection: Arm Left.), administration date: 21Oct2021, when the patient was 51-year-old, for COVID-19 immunization. The following information was reported: BURNING SENSATION (non-serious), RASH PRURITIC (non-serious) all with onset 31May2022 at 22:00, outcome "recovering" and all described as "Burning, itchy rash - chest area". Therapeutic measures were taken as a result of burning sensation, rash pruritic.  Additional information: Other medication in 2weeks: Yes. Anti viral details :Product: COVID 19. Treatment Brand : Paxlovid, Treatment start date: 31May2022, Treatment stop date: 01Jun2022, Lot number: GA6206, Indication: Treatment of COVID-19. Other medication details:  Other medication in 2weeks product: Women's Multivitamins, Other medication in 2weeks brand: Other medication in 2weeks start date: Sep2019, Other medication in 2weeks stop date: 01Jun2022. Other medication in 2weeks product: Probiotic Gummies, Other medication in 2weeks brand:  Other medication in 2weeks start date: Sep2019, Other medication in 2weeks stop date: 01Jun2022. If treatment ae:  Yes. Ae treatment pending: awaiting advice of primary physician.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Rash pruritic
Clinical narrative: Burning, itchy rash - chest area; Burning, itchy rash - chest area; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20May2022 at 12:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 52 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Mold" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Sulfa, reaction(s): "allergy". Vaccination history included: BNT162b2 (Dose 1 (Single), Batch/Lot: EM9809., Location of injection: Arm Left.), administration date: 04Feb2021, when the patient was 50-year-old, for COVID-19 immunization; BNT162b2 (Dose 2 (Single), Batch/Lot: EN6198., Location of injection: Arm Right.), administration date: 26Feb2021, when the patient was 51-year-old, for COVID-19 immunization; BNT162b2 (Dose 3 (Single), Batch/Lot: FF2589., Location of injection: Arm Left.), administration date: 21Oct2021, when the patient was 51-year-old, for COVID-19 immunization. The following information was reported: BURNING SENSATION (non-serious), RASH PRURITIC (non-serious) all with onset 31May2022 at 22:00, outcome "recovering" and all described as "Burning, itchy rash - chest area". Therapeutic measures were taken as a result of burning sensation, rash pruritic.  Additional information: Other medication in 2weeks: Yes. Anti viral details :Product: COVID 19. Treatment Brand : Paxlovid, Treatment start date: 31May2022, Treatment stop date: 01Jun2022, Lot number: GA6206, Indication: Treatment of COVID-19. Other medication details:  Other medication in 2weeks product: Women's Multivitamins, Other medication in 2weeks brand: Other medication in 2weeks start date: Sep2019, Other medication in 2weeks stop date: 01Jun2022. Other medication in 2weeks product: Probiotic Gummies, Other medication in 2weeks brand:  Other medication in 2weeks start date: Sep2019, Other medication in 2weeks stop date: 01Jun2022. If treatment ae:  Yes. Ae treatment pending: awaiting advice of primary physician.   No follow-up attempts are possible. No further information is expected.
Age: 9.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product preparation error
Clinical narrative: overall not feeling well; increased arm soreness; headache that is all over the head; The dose that was given was undiluted Both of her children got the vaccine doses; The dose that was given was undiluted Both of her children got the vaccine doses; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 9-year-old male patient received BNT162b2 (BNT162B2), on 08Jun2022 as dose 1, single (Lot number: FL8095) at the age of 9 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 08Jun2022, outcome "unknown" and all described as "The dose that was given was undiluted Both of her children got the vaccine doses"; HEADACHE (non-serious) with onset 08Jun2022 at 20:00, outcome "not recovered", described as "headache that is all over the head"; PAIN IN EXTREMITY (non-serious) with onset 08Jun2022 at 20:00, outcome "not recovered", described as "increased arm soreness"; MALAISE (non-serious) with onset 09Jun2022 at 09:30, outcome "not recovered", described as "overall not feeling well".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200825421 same reporter/drug, different patient, different AE;
Age: 9.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Malaise, Overdose, Pain in extremity, Product preparation error
Clinical narrative: overall not feeling well; increased arm soreness; headache that is all over the head; The dose that was given was undiluted Both of her children got the vaccine doses; The dose that was given was undiluted Both of her children got the vaccine doses; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 9-year-old male patient received BNT162b2 (BNT162B2), on 08Jun2022 as dose 1, single (Lot number: FL8095) at the age of 9 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 08Jun2022, outcome "unknown" and all described as "The dose that was given was undiluted Both of her children got the vaccine doses"; HEADACHE (non-serious) with onset 08Jun2022 at 20:00, outcome "not recovered", described as "headache that is all over the head"; PAIN IN EXTREMITY (non-serious) with onset 08Jun2022 at 20:00, outcome "not recovered", described as "increased arm soreness"; MALAISE (non-serious) with onset 09Jun2022 at 09:30, outcome "not recovered", described as "overall not feeling well".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200825421 same reporter/drug, different patient, different AE;
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure measurement, COVID-19, Heart rate, SARS-CoV-2 test
Clinical narrative: HEART RATE HIGH; HEART WAS RACING/HIGH BLOOD PRESSURE; COVID-19; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (Demerol, Sudafed, tramadol) and other pre-existing medical conditions included: nothing before this incident. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of administration, and batch number were not reported, expiry: unknown) dose and start therapy date were not reported, 1 total administered on right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. (Dose number in series 1). The patient received booster dose of non-company suspect vaccine Moderna (Spikevax) elasomeran (Dose number in series 2) (form of administration and route of administration were not reported, batch number: unknown, expiry: unknown) dose was not reported, administered on 13-FEB-2022 on right arm for prophylactic vaccination.  On an unspecified date in 2022, the patient experienced covid-19 (Dose number in series 2). The patient received non company suspect paxlovid (form of administration and route of administration were not reported, and batch number: Ndc 0069-1085-30, expiry: unknown) dose was not reported, administered on 18-MAY-2022 till 22-MAY-2022 for covid-19 treatment.  On 22-MAY-2022, patient tested negative. On 23-MAY-2022 patient went back to work and noticed heart was racing and high heart rate (Dose number in series 2). Patient went to the ER (Emergency Room). They said all tests look normal. On 29-MAY-2022 went to ER by ambulance, high heart rate and high BP again. All test looked normal nothing they could do. On 31-MAY-2022, same heart rate and BP sky rockets at work, taken to hospital again by ambulance. When patient got home patient took a covid test and patient was positive. Patient did not realize a covid rebound was a thing until it happened. As of 05-JUN-2022 patient still covid positive. Beta blocker taken to slow down heart and control high blood pressure (Dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s, elasomeran and paxlovid was not applicable. The patient recovered with sequelae from covid-19, and the outcome of heart rate high and heart was racing/high blood pressure was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure measurement, COVID-19, Heart rate, Heart rate increased, Hypertension
Clinical narrative: HEART RATE HIGH; HEART WAS RACING/HIGH BLOOD PRESSURE; COVID-19; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (Demerol, Sudafed, tramadol) and other pre-existing medical conditions included: nothing before this incident. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of administration, and batch number were not reported, expiry: unknown) dose and start therapy date were not reported, 1 total administered on right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. (Dose number in series 1). The patient received booster dose of non-company suspect vaccine Moderna (Spikevax) elasomeran (Dose number in series 2) (form of administration and route of administration were not reported, batch number: unknown, expiry: unknown) dose was not reported, administered on 13-FEB-2022 on right arm for prophylactic vaccination.  On an unspecified date in 2022, the patient experienced covid-19 (Dose number in series 2). The patient received non company suspect paxlovid (form of administration and route of administration were not reported, and batch number: Ndc 0069-1085-30, expiry: unknown) dose was not reported, administered on 18-MAY-2022 till 22-MAY-2022 for covid-19 treatment.  On 22-MAY-2022, patient tested negative. On 23-MAY-2022 patient went back to work and noticed heart was racing and high heart rate (Dose number in series 2). Patient went to the ER (Emergency Room). They said all tests look normal. On 29-MAY-2022 went to ER by ambulance, high heart rate and high BP again. All test looked normal nothing they could do. On 31-MAY-2022, same heart rate and BP sky rockets at work, taken to hospital again by ambulance. When patient got home patient took a covid test and patient was positive. Patient did not realize a covid rebound was a thing until it happened. As of 05-JUN-2022 patient still covid positive. Beta blocker taken to slow down heart and control high blood pressure (Dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s, elasomeran and paxlovid was not applicable. The patient recovered with sequelae from covid-19, and the outcome of heart rate high and heart was racing/high blood pressure was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, SARS-CoV-2 test
Clinical narrative: HEART RATE HIGH; HEART WAS RACING/HIGH BLOOD PRESSURE; COVID-19; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (Demerol, Sudafed, tramadol) and other pre-existing medical conditions included: nothing before this incident. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of administration, and batch number were not reported, expiry: unknown) dose and start therapy date were not reported, 1 total administered on right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. (Dose number in series 1). The patient received booster dose of non-company suspect vaccine Moderna (Spikevax) elasomeran (Dose number in series 2) (form of administration and route of administration were not reported, batch number: unknown, expiry: unknown) dose was not reported, administered on 13-FEB-2022 on right arm for prophylactic vaccination.  On an unspecified date in 2022, the patient experienced covid-19 (Dose number in series 2). The patient received non company suspect paxlovid (form of administration and route of administration were not reported, and batch number: Ndc 0069-1085-30, expiry: unknown) dose was not reported, administered on 18-MAY-2022 till 22-MAY-2022 for covid-19 treatment.  On 22-MAY-2022, patient tested negative. On 23-MAY-2022 patient went back to work and noticed heart was racing and high heart rate (Dose number in series 2). Patient went to the ER (Emergency Room). They said all tests look normal. On 29-MAY-2022 went to ER by ambulance, high heart rate and high BP again. All test looked normal nothing they could do. On 31-MAY-2022, same heart rate and BP sky rockets at work, taken to hospital again by ambulance. When patient got home patient took a covid test and patient was positive. Patient did not realize a covid rebound was a thing until it happened. As of 05-JUN-2022 patient still covid positive. Beta blocker taken to slow down heart and control high blood pressure (Dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s, elasomeran and paxlovid was not applicable. The patient recovered with sequelae from covid-19, and the outcome of heart rate high and heart was racing/high blood pressure was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Drug ineffective, Liver function test, Renal function test, SARS-CoV-2 test
Clinical narrative: breakthrough infection/Covid; breakthrough infection/Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown, Expiration Date: Mar2022) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "breakthrough infection/Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient was calling because of the manufacturer. Patient had two Pfizer vaccines, the booster Oct last year and it expired in Mar this year patient thought and had a breakthrough infection, patient was given the medicine, it was recently authorized, her doctor did not know much about it. If patient wanted a booster, she could not get the booster until 3 months later, is that true?  Patient want to get a second booster, then isolate herself, she did not want to go outside anymore was indoors, the nurse got infected and didn't notify on time and everybody on that environment. She did not have the full effect of Covid she thought she had the "only virus" she didn't have any of the ache, she didn't have fever, and she didn't have diarrhea, only have a cough, for 3 nights on and off and her nose was infected bad, she was sneezing constantly. Once she took Paxlovid and the doctor gave her, she asked for some antibiotics and he gave her Levofloxine (Levofloxacine?) which was very good, that stopped the nose from running. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Suspected COVID-19
Clinical narrative: breakthrough infection/Covid; breakthrough infection/Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown, Expiration Date: Mar2022) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "breakthrough infection/Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient was calling because of the manufacturer. Patient had two Pfizer vaccines, the booster Oct last year and it expired in Mar this year patient thought and had a breakthrough infection, patient was given the medicine, it was recently authorized, her doctor did not know much about it. If patient wanted a booster, she could not get the booster until 3 months later, is that true?  Patient want to get a second booster, then isolate herself, she did not want to go outside anymore was indoors, the nurse got infected and didn't notify on time and everybody on that environment. She did not have the full effect of Covid she thought she had the "only virus" she didn't have any of the ache, she didn't have fever, and she didn't have diarrhea, only have a cough, for 3 nights on and off and her nose was infected bad, she was sneezing constantly. Once she took Paxlovid and the doctor gave her, she asked for some antibiotics and he gave her Levofloxine (Levofloxacine?) which was very good, that stopped the nose from running. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: breakthrough infection/Covid; breakthrough infection/Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown, Expiration Date: Mar2022) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "breakthrough infection/Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient was calling because of the manufacturer. Patient had two Pfizer vaccines, the booster Oct last year and it expired in Mar this year patient thought and had a breakthrough infection, patient was given the medicine, it was recently authorized, her doctor did not know much about it. If patient wanted a booster, she could not get the booster until 3 months later, is that true?  Patient want to get a second booster, then isolate herself, she did not want to go outside anymore was indoors, the nurse got infected and didn't notify on time and everybody on that environment. She did not have the full effect of Covid she thought she had the "only virus" she didn't have any of the ache, she didn't have fever, and she didn't have diarrhea, only have a cough, for 3 nights on and off and her nose was infected bad, she was sneezing constantly. Once she took Paxlovid and the doctor gave her, she asked for some antibiotics and he gave her Levofloxine (Levofloxacine?) which was very good, that stopped the nose from running. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthritis, Cough, Nasal congestion, Rhinorrhoea, Staphylococcal infection
Clinical narrative: COVID positive; COVID positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 47-year-old male patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Batch/Lot number: unknown), in arm, on 08Apr2021 as dose 2, single (Batch/Lot number: unknown), in arm and on 08Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30May2022, outcome "recovering" and all described as "COVID positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (30May2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: (Name) had an injury to his leg that began to swell, darken and spraid. Took to urgent care 30May who recommended IV antibiotics in Emergency room. Went to ER for antibiotics. Covid test was conducted due to wash and it was positive. Sent home Tuesday 31May, leg injury spreed even further, went to ER where he was admitted for diagnosis and broad spectrum antibiotics. This is the same time he developed joint pain and inflammation. Discharged 04Jun. Injection seems to be healing, now COVID negative. Joints still inflamed and weak. Visit from home neath 08Jun. Primary care visit scheduled 10Jun.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if  and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Suspected COVID-19, Swelling
Clinical narrative: COVID positive; COVID positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 47-year-old male patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Batch/Lot number: unknown), in arm, on 08Apr2021 as dose 2, single (Batch/Lot number: unknown), in arm and on 08Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30May2022, outcome "recovering" and all described as "COVID positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (30May2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: (Name) had an injury to his leg that began to swell, darken and spraid. Took to urgent care 30May who recommended IV antibiotics in Emergency room. Went to ER for antibiotics. Covid test was conducted due to wash and it was positive. Sent home Tuesday 31May, leg injury spreed even further, went to ER where he was admitted for diagnosis and broad spectrum antibiotics. This is the same time he developed joint pain and inflammation. Discharged 04Jun. Injection seems to be healing, now COVID negative. Joints still inflamed and weak. Visit from home neath 08Jun. Primary care visit scheduled 10Jun.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if  and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: COVID positive; COVID positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 47-year-old male patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Batch/Lot number: unknown), in arm, on 08Apr2021 as dose 2, single (Batch/Lot number: unknown), in arm and on 08Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30May2022, outcome "recovering" and all described as "COVID positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (30May2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: (Name) had an injury to his leg that began to swell, darken and spraid. Took to urgent care 30May who recommended IV antibiotics in Emergency room. Went to ER for antibiotics. Covid test was conducted due to wash and it was positive. Sent home Tuesday 31May, leg injury spreed even further, went to ER where he was admitted for diagnosis and broad spectrum antibiotics. This is the same time he developed joint pain and inflammation. Discharged 04Jun. Injection seems to be healing, now COVID negative. Joints still inflamed and weak. Visit from home neath 08Jun. Primary care visit scheduled 10Jun.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if  and when received.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Lost hearing in my left ear and I have Rinne in my left ear I have never ever suffered from these, I do not want to lose my hearing.; Lost hearing in my left ear and I have Rinne in my left ear I have never ever suffered from these, I do not want to lose my hearing.; I was very uncomfortable, I had a headache, body ache and the fever.; I was very uncomfortable, I had a headache, body ache and the fever.; I was very uncomfortable, I had a headache, body ache and the fever.; I was very uncomfortable, I had a headache, body ache and the fever.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 10Jun2022 at 16:00 as dose number unknown, single (Lot number: FP7135) at the age of 59 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: DISCOMFORT (non-serious), HEADACHE (non-serious), PAIN (non-serious), PYREXIA (non-serious) all with onset 11Jun2022 at 03:00, outcome "unknown" and all described as "I was very uncomfortable, I had a headache, body ache and the fever."; DEAFNESS (medically significant), TINNITUS (non-serious) all with onset 11Jun2022 at 07:00, outcome "unknown" and all described as "Lost hearing in my left ear and I have Rinne in my left ear I have never ever suffered from these, I do not want to lose my hearing.". The patient underwent the following laboratory tests and procedures: Body temperature: (11Jun2022) Unknown results. Therapeutic measures were not taken as a result of deafness, tinnitus, discomfort, headache, pain, pyrexia.  Clinical course: NDC number and UPC number of COVID 19 vaccine was unknown. The vaccination facility type was the pharmacy. The patient had a Pfizer vaccine yesterday at about 4 'O'clock in the afternoon and by 3 'O'clock in the morning she was very uncomfortable. she had a headache, body ache and the fever at 7 'O'clock in the morning when she woke up she had lost hearing in her left ear and had Rinne in her left ear, she had never ever suffered from these 'items'. Patient stated, "It is really sad I cannot even understand what you are saying, you are supposed to be here to help and yes I cannot understand what you are saying, you cannot understand me and you are giving me no assistance meanwhile Pfizer continues to earn lot of money after causing problem and you cannot even tell me if there is any assistance that I can get right now on the Saturday. In response to further probing: Consumer stated, "I have no idea what you are saying, yes fine, questions yes." Prior vaccination before four weeks: Patient stated, "Are you kidding me? Yes, there was all the vaccination we have to have in United States. If I had any COVID Vaccination? What do you mean general health care vaccination like MMR, PCP (Further clarifications unknown) all of those was that, what you are talking about? I am fully vaccinated. No lab test the patient underwent.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Tinnitus
Clinical narrative: Lost hearing in my left ear and I have Rinne in my left ear I have never ever suffered from these, I do not want to lose my hearing.; Lost hearing in my left ear and I have Rinne in my left ear I have never ever suffered from these, I do not want to lose my hearing.; I was very uncomfortable, I had a headache, body ache and the fever.; I was very uncomfortable, I had a headache, body ache and the fever.; I was very uncomfortable, I had a headache, body ache and the fever.; I was very uncomfortable, I had a headache, body ache and the fever.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 10Jun2022 at 16:00 as dose number unknown, single (Lot number: FP7135) at the age of 59 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: DISCOMFORT (non-serious), HEADACHE (non-serious), PAIN (non-serious), PYREXIA (non-serious) all with onset 11Jun2022 at 03:00, outcome "unknown" and all described as "I was very uncomfortable, I had a headache, body ache and the fever."; DEAFNESS (medically significant), TINNITUS (non-serious) all with onset 11Jun2022 at 07:00, outcome "unknown" and all described as "Lost hearing in my left ear and I have Rinne in my left ear I have never ever suffered from these, I do not want to lose my hearing.". The patient underwent the following laboratory tests and procedures: Body temperature: (11Jun2022) Unknown results. Therapeutic measures were not taken as a result of deafness, tinnitus, discomfort, headache, pain, pyrexia.  Clinical course: NDC number and UPC number of COVID 19 vaccine was unknown. The vaccination facility type was the pharmacy. The patient had a Pfizer vaccine yesterday at about 4 'O'clock in the afternoon and by 3 'O'clock in the morning she was very uncomfortable. she had a headache, body ache and the fever at 7 'O'clock in the morning when she woke up she had lost hearing in her left ear and had Rinne in her left ear, she had never ever suffered from these 'items'. Patient stated, "It is really sad I cannot even understand what you are saying, you are supposed to be here to help and yes I cannot understand what you are saying, you cannot understand me and you are giving me no assistance meanwhile Pfizer continues to earn lot of money after causing problem and you cannot even tell me if there is any assistance that I can get right now on the Saturday. In response to further probing: Consumer stated, "I have no idea what you are saying, yes fine, questions yes." Prior vaccination before four weeks: Patient stated, "Are you kidding me? Yes, there was all the vaccination we have to have in United States. If I had any COVID Vaccination? What do you mean general health care vaccination like MMR, PCP (Further clarifications unknown) all of those was that, what you are talking about? I am fully vaccinated. No lab test the patient underwent.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: This spontaneous report received from a health care professional concerned a male of unspecified age. 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, and batch number were not reported) dose was not reported, administered on 14-JUN-2022 for prophylactic vaccination. The drug was associated with Medication error. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-JUN-2022, the patient experienced vaccine administered from a vial that was left at room temperature for 2 hours 30 minutes, and incorrect product storage. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered from a vial that was left at room temperature for 2 hours 30 minutes and incorrect product storage was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: This spontaneous report received from a health care professional concerned a male of unspecified age. 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, and batch number were not reported) dose was not reported, administered on 14-JUN-2022 for prophylactic vaccination. The drug was associated with Medication error. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-JUN-2022, the patient experienced vaccine administered from a vial that was left at room temperature for 2 hours 30 minutes, and incorrect product storage. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered from a vial that was left at room temperature for 2 hours 30 minutes and incorrect product storage was not reported. This report was non-serious.