chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 12Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 63 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 15Jun2021 as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing), notes: COPD; "HTN" (unspecified if ongoing), notes: HYN; "DB" (unspecified if ongoing), notes: DB. The patient's concomitant medications were not reported. Past drug history included: Pcm, reaction(s): "Known allergies: PCM". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Took prescribed dose of Paxlovid one week later started coughing wheezing horrible runny nose. Tested positive for COVID. Therapeutic measures were taken as a result of covid-19.  Additional information: Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No. Other medication in 2weeks Yes. Anti viral details: product=COVID 19 Treatment, brand=Paxlovid, treatment start date=25Jul2022, treatment stop date=30Jul2022. other medication details: other medication in 2weeks brand=Metoprolol. other medication in 2weeks brand=Losartan. other medication in 2weeks brand=Atorvastatin. other medication in 2weeks brand=Metformin. Adverse event: Took prescribed dose of Paxlovid one week later started coughing wheezing horrible runny nose. Tested positive for COVID. Adverse event start date: 05Aug2022. AE resulted in: [None of the above]. The patient was recovering. Treatment Ae: Yes. Ae treatment : Steroids Mucinex. Other medical history: COPD, HYN, DB. Device timestamp: 11Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 26Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 37 years, all intramuscular 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) all with onset May2022, outcome "recovered" (2022) and all described as "COVID".  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
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (other healthcare professional). The reporter is the patient. A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: Unknown), in left arm for Covid-19 immunisation, coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: Unknown), as dose 2, single (Batch/Lot number: Unknown) and as dose 3 (booster), single (Batch/Lot number: Unknown) for covid-19 immunisation. The patient relevant medical history included: "Breast cancer", start date: 2018 (unspecified if ongoing), notes: in remission/groundglass lesion in lung. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (01Aug2022) Negative; (10Aug2022) Positive, notes: with symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: No other medication in 2weeks. Patient received Paxlovid treatment, start date: 27Jul2022, treatment stop date: 01Aug2022, lot number: 2815213. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 at 16:30 as dose 1, single (Lot number: EL3247), in left arm, on 11Feb2021 at 16:00 as dose 2, single (Lot number: EM9809), in left arm, on 17Aug2021 at 09:00 as dose 3 (booster), single (Lot number: EW0187), in left arm and on 17Feb2022 at 14:00 as dose 4 (booster), single (Lot number: FK9729) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pulmonary Sarcoidosis" (unspecified if ongoing); "High BP" (unspecified if ongoing), notes: High BP; "High Cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Jul2022, outcome "not recovered", described as "Treatment of COVID-19"; VACCINATION FAILURE (medically significant) with onset Jul2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: tested antigen positive again on Day 9; (Jul2022) Negative, notes: antigen negative on day 6 and 7; (Jul2022) Negative, notes: antigen negative on day 6 and 7; (2022) Positive, notes: COV+ as of Day 13. Therapeutic measures were taken as a result of covid-19. Clinical course: Adverse event: Breakthrough recurrence of COVID - tested antigen negative on day 6 and 7 after starting PAXLOVID treatment, developed symptoms again on Day 8 and tested antigen positive again on Day 9. First course of PAXLOVID was taken as directed for full 5 days. Started treatment with a 2nd course of PAXLOVID on Day 10 and remain COV+ as of Day 13. Ae treatment: Primary Provider visit and second course. Other medical history: Pulmonary Sarcoidosis, High BP, High Cholesterol. Device timestamp: 11Aug2022. No Known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate increased, SARS-CoV-2 test
Clinical narrative: Vaccination failure; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 at 16:30 as dose 1, single (Lot number: EL3247), in left arm, on 11Feb2021 at 16:00 as dose 2, single (Lot number: EM9809), in left arm, on 17Aug2021 at 09:00 as dose 3 (booster), single (Lot number: EW0187), in left arm and on 17Feb2022 at 14:00 as dose 4 (booster), single (Lot number: FK9729) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pulmonary Sarcoidosis" (unspecified if ongoing); "High BP" (unspecified if ongoing), notes: High BP; "High Cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Jul2022, outcome "not recovered", described as "Treatment of COVID-19"; VACCINATION FAILURE (medically significant) with onset Jul2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: tested antigen positive again on Day 9; (Jul2022) Negative, notes: antigen negative on day 6 and 7; (Jul2022) Negative, notes: antigen negative on day 6 and 7; (2022) Positive, notes: COV+ as of Day 13. Therapeutic measures were taken as a result of covid-19. Clinical course: Adverse event: Breakthrough recurrence of COVID - tested antigen negative on day 6 and 7 after starting PAXLOVID treatment, developed symptoms again on Day 8 and tested antigen positive again on Day 9. First course of PAXLOVID was taken as directed for full 5 days. Started treatment with a 2nd course of PAXLOVID on Day 10 and remain COV+ as of Day 13. Ae treatment: Primary Provider visit and second course. Other medical history: Pulmonary Sarcoidosis, High BP, High Cholesterol. Device timestamp: 11Aug2022. No Known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Consumer is taking Paxlovid; Consumer is taking Paxlovid; 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. 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) all with onset 2022, outcome "unknown" and all described as "Consumer is taking Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: PQC not present. Consumer was taking Paxlovid and she's getting a foaming affect in her stomach and it's causing acid reflux. She developed a huge hematoma on her right arm after getting the Pfizer COVID vaccine. She got a rash on her thigh after the 2nd dose. Now, after starting Paxlovid she had a painful bump and bruising on her arm. The pain feels like it's in the bone. She states she did not feel well.  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: Rash
Clinical narrative: Consumer is taking Paxlovid; Consumer is taking Paxlovid; 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. 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) all with onset 2022, outcome "unknown" and all described as "Consumer is taking Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: PQC not present. Consumer was taking Paxlovid and she's getting a foaming affect in her stomach and it's causing acid reflux. She developed a huge hematoma on her right arm after getting the Pfizer COVID vaccine. She got a rash on her thigh after the 2nd dose. Now, after starting Paxlovid she had a painful bump and bruising on her arm. The pain feels like it's in the bone. She states she did not feel well.  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: Haematoma
Clinical narrative: Consumer is taking Paxlovid; Consumer is taking Paxlovid; 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. 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) all with onset 2022, outcome "unknown" and all described as "Consumer is taking Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: PQC not present. Consumer was taking Paxlovid and she's getting a foaming affect in her stomach and it's causing acid reflux. She developed a huge hematoma on her right arm after getting the Pfizer COVID vaccine. She got a rash on her thigh after the 2nd dose. Now, after starting Paxlovid she had a painful bump and bruising on her arm. The pain feels like it's in the bone. She states she did not feel well.  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
Clinical narrative: She got a rash on her thigh after the 2nd dose; 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 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (dose 1 single), for Covid-19 immunisation. The following information was reported: RASH (non-serious), outcome "unknown", described as "She got a rash on her thigh after the 2nd dose".  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: Rash
Clinical narrative: She got a rash on her thigh after the 2nd dose; 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 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (dose 1 single), for Covid-19 immunisation. The following information was reported: RASH (non-serious), outcome "unknown", described as "She got a rash on her thigh after the 2nd dose".  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: Haematoma
Clinical narrative: She got a rash on her thigh after the 2nd dose; 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 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (dose 1 single), for Covid-19 immunisation. The following information was reported: RASH (non-serious), outcome "unknown", described as "She got a rash on her thigh after the 2nd dose".  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
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (the patient). A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. The patient developed a hematoma (developed a huge hematoma on her right arm after getting the Pfizer COVID-19 vaccine), with outcome of unknown. Additional information: It was reported she was taking Paxlovid and getting a foaming effect in her stomach. It was causing acid reflux. Patient developed a huge hematoma on her right arm after getting the Pfizer COVID-19 vaccine. She got a rash on her thigh after the 2nd dose. The information on the batch/lot number for BNT162B2 requested and will be submitted if/when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (the patient). A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. The patient developed a hematoma (developed a huge hematoma on her right arm after getting the Pfizer COVID-19 vaccine), with outcome of unknown. Additional information: It was reported she was taking Paxlovid and getting a foaming effect in her stomach. It was causing acid reflux. Patient developed a huge hematoma on her right arm after getting the Pfizer COVID-19 vaccine. She got a rash on her thigh after the 2nd dose. The information on the batch/lot number for BNT162B2 requested and will be submitted if/when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Haematoma
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (the patient). A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. The patient developed a hematoma (developed a huge hematoma on her right arm after getting the Pfizer COVID-19 vaccine), with outcome of unknown. Additional information: It was reported she was taking Paxlovid and getting a foaming effect in her stomach. It was causing acid reflux. Patient developed a huge hematoma on her right arm after getting the Pfizer COVID-19 vaccine. She got a rash on her thigh after the 2nd dose. The information on the batch/lot number for BNT162B2 requested and will be submitted if/when received.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL8982), on 11Feb2021 as dose 2, single (Lot number: em9809) and on 23Sep2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19. The patient was provided with antiviral treatment of Paxlovid from 18Jul2022 to 23Jul2022. adverse event: From Paxlovid, horrible taste in mouth the entire time of taking it, nonstop. Still residual bad taste on 01Aug2022. There was no other medication within 2 weeks. No known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fall, Myocardial infarction
Clinical narrative: fell over and died of heart attack; fell over; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 27-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: MYOCARDIAL INFARCTION (death, medically significant), outcome "fatal", described as "fell over and died of heart attack"; FALL (non-serious), outcome "unknown", described as "fell over". The patient date of death was unknown. Reported cause of death: "fell over and died of heart attack". It was not reported if an autopsy was performed. Clinical course: the reporter reported that I just heard on the news today that the doctor (not clarified) who was 27 years old a doctor in the prime of her life running a Triathlon nothing wrong with her she just fell over and died of heart attack. She had two Pfizer shots and a booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: fell over and died of heart attack
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: had problems with their periods they started get them again after they had the Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant), outcome "unknown", described as "had problems with their periods they started get them again after they had the Pfizer".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Emotional distress, Fear, Postmenopausal haemorrhage
Clinical narrative: she started period again; highly upset; scared; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 60-year-old female patient received BNT162b2 (BNT162B2), as dose number unknow, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant), outcome "unknown", described as "she started period again"; EMOTIONAL DISTRESS (non-serious), outcome "unknown", described as "highly upset"; FEAR (non-serious), outcome "unknown", described as "scared".  Clinical course: Reporter stated, "For this case no because I called may be 6 months ago because one of my girlfriend gone through menopause got Pfizer shot and she was scared to call so I called for she started period again. She's 60 years old haven't had period like 7 years so she was highly upset and scared, and I called then you know before on that."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 80-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL9263) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mitral valve replacement" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "glaucoma" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN 81; VITAMIN D [VITAMIN D NOS]; WARFARIN. The following information was reported: FATIGUE (non-serious) with onset 28Jan2021, outcome "recovered" (29Jan2021), described as "A little tired the first shot". Therapeutic measures were not taken as a result of fatigue. Additional information: The patient had no drug allergy. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient felt a little tired after the first shot. No reaction after the other three. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202201049304 same patient, different event and different dose;
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jul2022 as dose 4 (booster), single (Lot number: FH2908) at the age of 51 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN; ZYRTEC ALLERGY; FLONASE [FLUTICASONE PROPIONATE]; MUCINEX; ROBITUSSIN DX. Past drug history included: Known allergies: cipro, reaction(s): "Drug allergy"; Known allergies: zithromax, reaction(s): "Drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown"; COVID-19 (medically significant) with onset 2022, outcome "unknown", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Paxlovid treatment start date was 01Aug2022 and stop date was 06Aug2022.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 62-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "DM" (unspecified if ongoing), notes: Other medical history: DM; "HTN" (unspecified if ongoing), notes: Other medical history: HTN; "hypercholesterolemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (10Aug2022) positive, notes: tested positive again on 10Aug2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient completed Paxlovid course prescribed on 29Jul2022, and had rebound of symptoms and tested positive again on 10Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Each one made me sick I missed five days of work each time I got the shot; it was nasty and it was horrible; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, I had the three shots from the Pfizer (Covid-19 vaccine). I had the first two and then I had the booster shot. Each one made me so sick I missed five days of work each time I got the shot.), for Covid-19 immunization, reaction(s): "Each one made me so sick I missed five days of work each time I got the shot."; Bnt162b2 (Dose: 1st), for Covid-19 immunization, reaction(s): "I have covid". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Each one made me sick I missed five days of work each time I got the shot; it was nasty and it was horrible". Therapeutic measures were not taken as a result of illness.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201056718 same patient, event and product, different dose;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Illness, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 61-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Each one made me so sick I missed five days of work each time I got the shot.), for COVID-19 Immunization, reaction(s): "Sick"; Bnt162b2 (DOSE 1, SINGLE, Each one made me so sick I missed five days of work each time I got the shot.), for COVID-19 Immunization, reaction(s): "Sick". The following information was reported: BLISTER (non-serious), outcome "unknown", described as "The last one (booster) put the huge blister on my arm"; ILLNESS (non-serious), outcome "unknown", described as "Each one made me so sick I missed five days of work each time I got the shot". Relevant laboratory tests and procedures are available in the appropriate section. The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s) : US-PFIZER INC-202201056719 same patient, different product and event; PFIZER INC-202201056718 same patient and product, different dose; PFIZER INC-202201056342 same patient, different product and event; PFIZER INC-202201056967 same patient, different doses and events;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 61-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Each one made me so sick I missed five days of work each time I got the shot.), for COVID-19 Immunization, reaction(s): "Sick"; Bnt162b2 (DOSE 1, SINGLE, Each one made me so sick I missed five days of work each time I got the shot.), for COVID-19 Immunization, reaction(s): "Sick". The following information was reported: BLISTER (non-serious), outcome "unknown", described as "The last one (booster) put the huge blister on my arm"; ILLNESS (non-serious), outcome "unknown", described as "Each one made me so sick I missed five days of work each time I got the shot". Relevant laboratory tests and procedures are available in the appropriate section. The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s) : US-PFIZER INC-202201056719 same patient, different product and event; PFIZER INC-202201056718 same patient and product, different dose; PFIZER INC-202201056342 same patient, different product and event; PFIZER INC-202201056967 same patient, different doses and events;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Illness, SARS-CoV-2 test
Clinical narrative: I have covid; I have covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I have covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I have covid they gave me Paxlovid to take. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Concern: Consumer stated, "I have covid they gave me Paxlovid to take and the first dose, horrible taste I cannot get out of my mouth and it made me not quite dizzy just it's like my equilibrium is off or something. I cannot walk straight. I run into things and then second dose today did make me dizzy and I finally had to sit down, I was so dizzy, I had to close my eyes. In the stomach, I feel like I am going to throw up, it's really bad and I still cannot get out the horrible taste in my mouth." When probed if consumer had any medical query: Consumer stated, "I mean it does not really proof that this stuff is helpful and I am making myself sick by taking it. I did not know that there this number existed where you complain about shot. My question is, do I continue to make myself even sicker or do I stop taking it?" Consumer was informed about the role of Pfizer Drug Safety and Pfizer Medical Information for the concern. Consumer was provided with the contact details of Pfizer Medical Information Department as (phone number-withheld), option 3 and timings as 8 am to 9 pm, Monday to Friday. Consumer stated, "I did not know that this number existed and I even not think that I can complain about this. I had the three shots from the Pfizer (Covid-19 vaccine). I had the first two and then I had the booster shot. Each one made me so sick I missed five days of work each time I got the shot. The last one (booster) put the huge blister on my arm. It was nasty and it was horrible." Email address: Consumer stated, "I do not use email." NDC#: Consumer stated, "No." LOT# (Covid-19 Vaccine): Consumer stated, "No. I do not have that." Treatment: Consumer stated, "No.". Dose: Consumer stated, "Take 3 tablet in the morning and 3 tablet in the evening twice in a day for five days."  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
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I have covid; I have covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I have covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I have covid they gave me Paxlovid to take. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Concern: Consumer stated, "I have covid they gave me Paxlovid to take and the first dose, horrible taste I cannot get out of my mouth and it made me not quite dizzy just it's like my equilibrium is off or something. I cannot walk straight. I run into things and then second dose today did make me dizzy and I finally had to sit down, I was so dizzy, I had to close my eyes. In the stomach, I feel like I am going to throw up, it's really bad and I still cannot get out the horrible taste in my mouth." When probed if consumer had any medical query: Consumer stated, "I mean it does not really proof that this stuff is helpful and I am making myself sick by taking it. I did not know that there this number existed where you complain about shot. My question is, do I continue to make myself even sicker or do I stop taking it?" Consumer was informed about the role of Pfizer Drug Safety and Pfizer Medical Information for the concern. Consumer was provided with the contact details of Pfizer Medical Information Department as (phone number-withheld), option 3 and timings as 8 am to 9 pm, Monday to Friday. Consumer stated, "I did not know that this number existed and I even not think that I can complain about this. I had the three shots from the Pfizer (Covid-19 vaccine). I had the first two and then I had the booster shot. Each one made me so sick I missed five days of work each time I got the shot. The last one (booster) put the huge blister on my arm. It was nasty and it was horrible." Email address: Consumer stated, "I do not use email." NDC#: Consumer stated, "No." LOT# (Covid-19 Vaccine): Consumer stated, "No. I do not have that." Treatment: Consumer stated, "No.". Dose: Consumer stated, "Take 3 tablet in the morning and 3 tablet in the evening twice in a day for five days."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Mar2021 as dose 1, single (Lot number: EN6207), on 02Apr2021 as dose 2, single (Lot number: ER8734), on 22Nov2021 as dose 3 (booster), single (Lot number: FH8027) and on 29Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM; DILTIAZEM; LOSARTAN; MONTELUKAST; ADVAIR; VITAMIN C [ASCORBIC ACID]; VITAMIN D [VITAMIN D NOS]; FLAX SEED OIL. Past drug history included: Sulfadrugs, reaction(s): "allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included treatment with Paxlovid started on 30Jul2022.  Clinical course: The patient Report about covid treatment and Vaccine received and Other medication used with in 2weeks. The Product COVID 19 Treatment Paxlovid was start date: 30Jul2022 and stop date 03Aug2022 The Other medication details were Escitalopram, Diltiazem, Losartan, Montelukast , Fluticasone, Advair, Vitamin C, Multivitamin, ascorbic, Vitamin D and Flax Seed Oil. The Adverse event Rebound after Paxlovid treatment from 30Jul2022 to 08Aug2022 .The Adverse event onset start date: 08Aug2022 patient Not recovered and no AE treatment. The Known has allergies with Sulfa drugs and Other medical history was Asthma .Device times tamp: 12Aug2022
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 at 16:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 20Apr2021 at 16:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 16Nov2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that, the patient did not received other medications in two weeks. The patient received Paxlovid on 19Jul2022 to 24Jul2022 for treatment of COVID-19. Known allergies oral Sulfa and other medical history none.  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
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Aug2022 at 12:00, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Paxlovid treatment start date=10Aug2022, lot number= GE1666. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Asplenia
Clinical narrative: asplenic; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 69-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in 2016 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pneumovax 23, administration date: 2011, for immunisation. The following information was reported: ASPLENIA (medically significant), outcome "unknown", described as "asplenic". The patient wanted to get the Prevnar 20 and they have questions about eligibility  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently provided, the reported event ASPLENIA is considered not related to PREVENAR 13 but represents the patient's underlying medical condition.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: U
Vaccine: PNC20
Symptoms: Arthralgia, Condition aggravated, Rheumatoid arthritis
Clinical narrative: RA flare; Joint pain; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "RA flare"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain". Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently provided, the reported serious event RHEUMATOID ARTHRITIS is considered not related to PREVENAR 13 but more likely due to worsening of the patient's underlying medical condition.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Magnetic resonance imaging, Muscle spasms, Urine analysis normal
Clinical narrative: some lower leg cramping; several severe morning charley horses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6203) at the age of 69 years, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: MUSCLE SPASMS (non-serious) with onset Mar2021, outcome "unknown", described as "several severe morning charley horses"; MUSCLE SPASMS (non-serious) with onset Apr2021, outcome "unknown", described as "some lower leg cramping". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of muscle spasms.  Additional information: The patient had occasional left arm cramping after small amount of activity. Leg cramping was worse at night but acetaminophen, and resting and applying heat helps.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Contusion
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient. A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 Immunization. The following information was reported: CONTUSION (non-serious), outcome "unknown", described as "Bruised up"; BLISTER (non-serious), outcome "unknown", described as "Blisters". Therapeutic measures were taken as a result of contusion, blister. Additional information: A caller had a reaction after getting the vaccine for booster, she had bruised up and blisters. She was prescribed antibiotics for the reactions she had. She would like to know if that was okay after getting the booster. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.