chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Test positive for Covid; Test positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: EW0153), in left arm, on 03May2021 as dose 2, single (Lot number: EW0167), in left arm, on 21Aug2021 as dose 3 (booster), single (Lot number: FC3180), in left arm and on 12Feb2022 as dose 4 (booster), single (Lot number: FJ6369) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "MS -taking ocervus immunosuppressant to manage" (unspecified if ongoing); "known allergies: peanuts" (unspecified if ongoing); "known allergies: gluten (celiac)" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Flu vaccine, for immunization, reaction(s): "allergic to flu vaccine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Apr2022, outcome "unknown" and all described as "Test positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Positive; (03May2022) Negative; (06May2022) Postive, notes: Test positive for Covid again,Symptoms continue and are getting worse, not better. Therapeutic measures were taken as a result of covid-19.
Sex: M
Vaccine: COVID19
Symptoms: Vascular pain
Clinical narrative: his leg veins were hurting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose number unknown, single (Lot number: ER8730) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VASCULAR PAIN (non-serious) with onset 2021, outcome "unknown", described as "his leg veins were hurting".  Additional information: Caller states that what was weird was that like two weeks after she got that shot, her and her husband ran into one of his friends that got the same shot at the same hour she did and his leg veins were hurting as well. Caller did not have any patient information for her husband's friend, thinks name was (Name withheld) but could be wrong about that. No other information known or provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Headache; Low grade fever; Upper body pain; Enlarged axillary lymph node-left; This is a spontaneous report received from a contactable reporter (nurse). The reporter is the patient.  A 35-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) on 06May2022 at 17:00 as dose 3 (booster), single (Lot number: FM9992), at the age of 35 years in left arm for COVID-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: Known allergies: yes. The patient had received unspecified concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: FC3184; Anatomical location: Left arm), administration date: 06Sep2021, when the patient was 35 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: FF2589; Anatomical location: Left arm), administration date: 27Sep2021, when the patient was 35 years old, for COVID-19 immunisation.  The following information was reported: HEADACHE (non-serious) with onset 07May2022 at 11:00, outcome "recovered" (an unknown date in May2022); PYREXIA (non-serious) with onset 07May2022 at 11:00, outcome "recovered" (an unknown date in May2022), described as "Low grade fever"; PAIN (non-serious) with onset 07May2022 at 11:00, outcome "recovered" (an unknown date in May2022), described as "Upper body pain"; LYMPHADENOPATHY (non-serious) with onset 07May2022 at 11:00, outcome "recovered" (an unknown date in May2022), described as "Enlarged axillary lymph node-left". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient did not receive other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events.   No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 27Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 03Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Slightly overweight" (unspecified if ongoing), notes: Slightly overweight: 6'2" 225 lbs; "Slight hypertension" (unspecified if ongoing), notes: Slight hypertension. BP: 125-130/ 85-92. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) 125-130/85-92; SARS-CoV-2 test: (unspecified date) Negative, notes: Testing negative for 2 days; (05May2022) positive; (10May2022) Positive, notes: Covid returned positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course included feeling better from Covid and testing negative for 2 days, rapid tests for Covid returned positive on 10May. (Initial positive test was on 01May, so 9 days later). Some minor symptoms have returned today 11May. Patient not received treatment and no known allergy reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2021 as dose 1, single (Lot number: EP7533), in left arm, on 25Apr2021 as dose 2, single (Lot number: EU 0170), in left arm, on 27Nov2021 as dose 3 (booster), single (Lot number: FH8030), in left arm and on 21Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 64 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, latency 2 days 30 min after the suspect product(s) administration, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course included: Treatment of COVID-19 included Paxlovid from 7May2022. On 9May2022 the patient experienced muscle cramps. No known drug allergies.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Jan2021 as dose 1, single (Lot number: EK4176), in right arm, on 30Jan2021 as dose 2, single (Lot number: EL9262), in right arm and on 29Sep2021 as dose 3 (booster), single (Lot number: 301308A) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Benadryl, reaction(s): "Known allergies: Benadryl". The following information was reported: SUSPECTED COVID-19 (medically significant) with onset 30Apr2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Apr2022) Postive, notes: I tested positive. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Rebound COVID symptoms after taking the full course of Paxlovid.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Illness, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Covid; Covid; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (177954). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid"; ILLNESS (non-serious), outcome "unknown", described as "sick". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical Course: Supplier / Reporter Information Accompanying a Product Safety Report:  Reporter was not a healthcare professional. It was reported that, after receiving the Covid vaccine from Pfizer and getting very sick and then on top of it getting Covid a month later, the patient didn't believe that he would ever try or recommend anything from them.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Knee arthroplasty
Clinical narrative: 2 knees replacements; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: EN5318), in arm and on 01Mar2021 as dose 2, single (Lot number: EN6202) at the age of 75 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "parathyroidectomy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: KNEE ARTHROPLASTY (medically significant), outcome "unknown", described as "2 knees replacements".  Clinical course: Only other thing different with caller's health was that in Jan2022, after getting all of these vaccines caller had a parathyroidectomy and during the previous year, after the first and second doses of the vaccine, caller had 2 knees replacements. No additional vaccines administered on same date of the Pfizer suspect. No events required a visit to emergency room and physician office. Prior vaccinations (within 4 weeks) no other vaccinations were done. Events following prior vaccinations were not provided. Family medical history relevant to events were not provided. No relevant tests done. There were no predisposing factors and culture was not performed. Information on culture positive, serotyping, culture source and antipyretic use were not provided.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Knee arthroplasty which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. 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: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, 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's relevant medical history was not reported. There were no concomitant medications. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of suspected covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Headache, Hyperhidrosis, Nasopharyngitis
Clinical narrative: Monday 9May got sick - cold, sore throat, headache. Chills. Sweats. Body aches. Since then I have a bad cold; Monday 9May got sick - cold, sore throat, headache. Chills. Sweats. Body aches. Since then I have a bad cold; Monday 9May got sick - cold, sore throat, headache. Chills. Sweats. Body aches. Since then I have a bad cold; Monday 9May got sick - cold, sore throat, headache. Chills. Sweats. Body aches. Since then I have a bad cold; Monday 9May got sick - cold, sore throat, headache. Chills. Sweats. Body aches. Since then I have a bad cold; Monday 9May got sick - cold, sore throat, headache. Chills. Sweats. Body aches. Since then I have a bad cold; I tested positive 29Apr; I tested positive 29Apr; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1 , single (Batch/Lot number: unknown), in left arm, on 24Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 10Dec2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seizure disorde" (unspecified if ongoing). Concomitant medication(s) included: PAXLOVID taken for covid-19 treatment, start date: 30Apr2022, stop date: 04May2022. The following information was reported: VACCINATION FAILURE (medically significant) with onset 29Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 29Apr2022, outcome "recovered with sequelae" (2022) and all described as "I tested positive 29Apr"; NASOPHARYNGITIS (non-serious), OROPHARYNGEAL PAIN (non-serious), HEADACHE (non-serious), CHILLS (non-serious), HYPERHIDROSIS (non-serious), PAIN (non-serious) all with onset 09May2022, outcome "recovered with sequelae" (2022) and all described as "Monday 9May got sick - cold, sore throat, headache. Chills. Sweats. Body aches. Since then I have a bad cold". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Apr2022) Positive, notes: tested positive April 29th. Therapeutic measures were not taken as a result of vaccination failure, covid-19, nasopharyngitis, oropharyngeal pain, headache, chills, hyperhidrosis, pain. Clinical course: The patient reported that I tested positive 29Apr took 5-day pill. Felt recovered. Monday 9May got sick - cold, sore throat, headache. Chills. Sweats. Body aches. Since then I have a bad cold. The patient recovered with lasting effects. There was no other medication in two weeks. The patient revived no treatment. The patient had no allergy. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Monday 9May got sick - cold, sore throat, headache. Chills. Sweats. Body aches. Since then I have a bad cold; Monday 9May got sick - cold, sore throat, headache. Chills. Sweats. Body aches. Since then I have a bad cold; Monday 9May got sick - cold, sore throat, headache. Chills. Sweats. Body aches. Since then I have a bad cold; Monday 9May got sick - cold, sore throat, headache. Chills. Sweats. Body aches. Since then I have a bad cold; Monday 9May got sick - cold, sore throat, headache. Chills. Sweats. Body aches. Since then I have a bad cold; Monday 9May got sick - cold, sore throat, headache. Chills. Sweats. Body aches. Since then I have a bad cold; I tested positive 29Apr; I tested positive 29Apr; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1 , single (Batch/Lot number: unknown), in left arm, on 24Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 10Dec2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seizure disorde" (unspecified if ongoing). Concomitant medication(s) included: PAXLOVID taken for covid-19 treatment, start date: 30Apr2022, stop date: 04May2022. The following information was reported: VACCINATION FAILURE (medically significant) with onset 29Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 29Apr2022, outcome "recovered with sequelae" (2022) and all described as "I tested positive 29Apr"; NASOPHARYNGITIS (non-serious), OROPHARYNGEAL PAIN (non-serious), HEADACHE (non-serious), CHILLS (non-serious), HYPERHIDROSIS (non-serious), PAIN (non-serious) all with onset 09May2022, outcome "recovered with sequelae" (2022) and all described as "Monday 9May got sick - cold, sore throat, headache. Chills. Sweats. Body aches. Since then I have a bad cold". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Apr2022) Positive, notes: tested positive April 29th. Therapeutic measures were not taken as a result of vaccination failure, covid-19, nasopharyngitis, oropharyngeal pain, headache, chills, hyperhidrosis, pain. Clinical course: The patient reported that I tested positive 29Apr took 5-day pill. Felt recovered. Monday 9May got sick - cold, sore throat, headache. Chills. Sweats. Body aches. Since then I have a bad cold. The patient recovered with lasting effects. There was no other medication in two weeks. The patient revived no treatment. The patient had no allergy. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 16Dec2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm, on 10Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 48 years, in left arm and on 01May2022 as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 18Mar2022, outcome "recovering", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: After a negative test on the day after completing the Paxlovid; Positive, notes: I had a positive athome Covid test a week after the final Paxlovid dose. Therapeutic measures were taken as a result of covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in right arm, as dose 2, single (Batch/Lot number: unknown) and on 04Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation. The patient had no relevant medical history. No known allergies. No other medical history. There were no concomitant medications. No other medication in 2 weeks.   The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Apr2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient was tested positive for Covid on 28Apr2022. Paxlovid was prescribed. She took it for 5 days as recommended (from Apr2022 to 02May2022). Tested negative on 05May2022. On 10May2022, she was tested positive again. Symptoms were mild but she has to quarantine again. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Apr2022) Positive; (05May2022) negative; (10May2022) Positive. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Chills, Pain in extremity, Pyrexia
Clinical narrative: Patient Mentioned that she got covid positive on 01Apr2022; fever; chills at night; little sore in the arm; Patient Mentioned that she got covid positive on 01Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): MOD22-013255 (Moderna).  A 73-year-old female patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Batch/Lot number: unknown), on 16Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06May2022 as dose 4 (booster), single (Lot number: 057M21A) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: Condition 1: patient mentioned that she has high blood pressure. The patient's concomitant medications were not reported. Past drug history included: Advil, reaction(s): "Allergy", notes: Patient mentioned that she has allergies with High doses of Advil 800mg. The following information was reported: COVID-19 (medically significant) with onset 01Apr2022, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Patient Mentioned that she got covid positive on 01Apr2022"; CHILLS (non-serious) with onset 06May2022, outcome "unknown", described as "chills at night"; PYREXIA (non-serious) with onset 06May2022, outcome "not recovered", described as "fever"; PAIN IN EXTREMITY (non-serious) with onset 06May2022, outcome "unknown", described as "little sore in the arm". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 99.8 to 101.2, notes: According to the patient, she still has a low-grade fever about 99.8 to 101.2; SARS-CoV-2 test: (01Apr2022) Positive.  Clinical course:The Caller called in behalf of her wife who experienced side-effects after getting the second booster dose of Moderna. Both him and his wife got the second Moderna booster day before day 06May2022. He mentioned that his wife had a fever and chills last night which he read are general side-effects of the vaccine. Patient also mentioned that she still has low-grade fever about 99.8 to 101.2 and a little sore in the arm. The caller wants to know if his wife is contagious and if is it ok to have a covid test even if they got the vaccine. Patient also mentioned that the pharmacist told her that she could get the vaccine after 2 weeks of having positive with Covid on 01Apr2022. The caller gave consent to be contacted by safety  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: Patient Mentioned that she got covid positive on 01Apr2022; fever; chills at night; little sore in the arm; Patient Mentioned that she got covid positive on 01Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): MOD22-013255 (Moderna).  A 73-year-old female patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Batch/Lot number: unknown), on 16Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06May2022 as dose 4 (booster), single (Lot number: 057M21A) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: Condition 1: patient mentioned that she has high blood pressure. The patient's concomitant medications were not reported. Past drug history included: Advil, reaction(s): "Allergy", notes: Patient mentioned that she has allergies with High doses of Advil 800mg. The following information was reported: COVID-19 (medically significant) with onset 01Apr2022, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Patient Mentioned that she got covid positive on 01Apr2022"; CHILLS (non-serious) with onset 06May2022, outcome "unknown", described as "chills at night"; PYREXIA (non-serious) with onset 06May2022, outcome "not recovered", described as "fever"; PAIN IN EXTREMITY (non-serious) with onset 06May2022, outcome "unknown", described as "little sore in the arm". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 99.8 to 101.2, notes: According to the patient, she still has a low-grade fever about 99.8 to 101.2; SARS-CoV-2 test: (01Apr2022) Positive.  Clinical course:The Caller called in behalf of her wife who experienced side-effects after getting the second booster dose of Moderna. Both him and his wife got the second Moderna booster day before day 06May2022. He mentioned that his wife had a fever and chills last night which he read are general side-effects of the vaccine. Patient also mentioned that she still has low-grade fever about 99.8 to 101.2 and a little sore in the arm. The caller wants to know if his wife is contagious and if is it ok to have a covid test even if they got the vaccine. Patient also mentioned that the pharmacist told her that she could get the vaccine after 2 weeks of having positive with Covid on 01Apr2022. The caller gave consent to be contacted by safety  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Physician). A 44-year-old female patient (not pregnant) 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) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "migraines" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN]; XELJANZ, start date: 07May2022. Past drug history included: Augmentin, reaction(s): "Known allergies:augmentin", notes: known allergies: yes - augmentin; Demerol, reaction(s): "Known allergies:demerol", notes: known allergies: yes - demerol; Imitrex, reaction(s): "known allergies:imitrex", notes: known allergies: yes -  imitrex. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 30Apr2022 to 04May2022 taken orally.   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 available reported information, the causal association between the events drug ineffective and covid-19 and the suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site rash, Vomiting
Clinical narrative: Rash on her arm where booster was injected; Vomiting; Feeling tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2022US108572_NS   A 22-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; secukinumab (COSENTYX), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed; manufacturer unknown), for Covid-19 immunization. The following information was reported: VACCINATION SITE RASH (non-serious), outcome "unknown", described as "Rash on her arm where booster was injected"; VOMITING (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "Feeling tired". The action taken for secukinumab was unknown.  Additional information: The patient was not sure if the events occurred due to booster or her Cosentyx.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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), 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 covid-19.  Clinical course: Patient had no other medication in 2 weeks. Patient had none known allergies and no other medical history. Patient was in good health.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Swelling
Clinical narrative: swelling; severe headaches; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A female patient received BNT162b2 (COMIRNATY), as dose number unknown, 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: SWELLING (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown", described as "severe headaches".  Additional information: It was reported that after taking Comirnaty that she experienced swelling and severe headaches. The dosing was over a year ago. 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.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I began testing positive; I began testing positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Nov2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 35 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "environmental allergies" (unspecified if ongoing); "environmental allergies (mold)" (unspecified if ongoing); "environmental allergies (dust)" (unspecified if ongoing); "environmental allergies (pollen)" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "tachycardia" (unspecified if ongoing); "allergies" (unspecified if ongoing). Concomitant medication(s) included: QVAR; ALBUTEROL [SALBUTAMOL]; EMERGEN-C; ZICAM [PIROXICAM]; FLONASE [FLUTICASONE PROPIONATE]; CETIRIZINE; ATENOLOL. Past drug history included: Pseudofed, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I began testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive; Negative. Therapeutic measures were taken as a result of covid-19.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Nurse). A 29-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 29 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), 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 12May2022, outcome "unknown" and all described as "had symptoms 09May and tested positive home AG on 12May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) Positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical information of the events: Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient receives any other vaccines within 4 weeks prior to the COVID vaccine: Unknown. Reported Event: COVID + husband 05May2022 and then she had symptoms 09May and tested positive home AG on 12May2022. Prior to vaccination, was the patient diagnosed with COVID-19: Unknown. Since the vaccination, the patient had been tested for COVID-19. No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Drug ineffective, Covid-19 cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Addison's disease
Clinical narrative: Addison's Disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, 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: ADDISON'S DISEASE (medically significant), outcome "unknown". Clinical course: Question: Customer Verbatim: My friend received the Pfizer COVID-19 vaccine and has recently been told that she has Addison's Disease. Is there a link between vaccination and the development of Addison's Disease. Proposed response: 1. Confirm if Non-HCP or HCP .2. Obtain information regarding her friend's development of Addison's disease after receiving the Pfizer COVID-19 vaccine and offer to transfer to agent. 3. If Non-HCP notify that we do not have any information regarding a causal relationship between the Pfizer COVID-19 vaccine and Addison's Disease. Refer to HCP for further guidance (friend's HCP).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; Tested positive for 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 67-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, 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), outcome "unknown" and all described as "Tested positive for 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.  Clinical course: The patient stated that he had the Pfizer COVID 19 vaccine and right after his last report with V-safe, he tested positive for COVID. His doctor has put him on Paxlovid. The patient asked do you have a similar reporting program for paxlovid, like V-safe.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperthyroidism
Clinical narrative: she started to feel sick so she went to see her doctor who diagnosed her with hyperthyroidism; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: EW0153) at the age of 46 years, in left arm and on 06May2021 as dose 2, single (Lot number: EW0169), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperthyroidism", start date: Oct2021 (ongoing), notes: Hyperthyroidism Caller states she is not taking any medications for this condition. There were no concomitant medications. The following information was reported: HYPERTHYROIDISM (medically significant), outcome "unknown", described as "she started to feel sick so she went to see her doctor who diagnosed her with hyperthyroidism". Clinical course: The caller mentioned that in October she started to feel sick so she went to see her doctor who diagnosed her with hyperthyroidism, for which she received treatment for a month and a half (6 weeks) and that she has and has returned to normal values. She presented that with no family history of hyperthyroidism  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), 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 included: "Overweight BMI" (unspecified if ongoing), notes: Overweight BMI. No other medication in 2 weeks. No known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Patient took Paxlovid for mild COVID symptoms for days 0-5 of illness from 27Apr2022 to 02May2022 and was asymptomatic and testing COVID antigen negative on day 7 of illness. Patient developed new nasal congestion on day 13 of illness and again tested positive for COVID antigen on day 15 of illness. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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 current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective and COVID-19 cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Flatulence, Nausea, Taste disorder
Clinical narrative: Developed very bad taste in mouth 45 minutes after taking first dose of medicine and continues throughout the course of taking the medicine; developed nausea within first hour of taking medicine.; Also developed foul smelling flatulence; This is a spontaneous report received from contactable reporter nurse. The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EP7534) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "hysterectomy" (unspecified if ongoing); "T&A" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "cholecystectomy" (unspecified if ongoing); "appendectomy" (unspecified if ongoing); "tubal ligation" (unspecified if ongoing). Concomitant medication(s) included: DULOXETINE; PREVACID; RESTASIS; METOPROLOL; VITAMIN D 2000; CLARITIN ALLERGIC; VITAMIN B COMPLEX. Past drug history included: Tavist-d, reaction(s): "Allergy". The following information was reported: FLATULENCE (non-serious) with onset 19Mar2021, outcome "unknown", described as "Also developed foul smelling flatulence"; TASTE DISORDER (non-serious) with onset 19Mar2021, outcome "unknown", described as "Developed very bad taste in mouth 45 minutes after taking first dose of medicine and continues throughout the course of taking the medicine"; NAUSEA (non-serious) with onset 19Mar2021, outcome "unknown", described as "developed nausea within first hour of taking medicine.". Therapeutic measures were taken as a result of taste disorder.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for covid; Tested positive for covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EP6955), in left arm and on 15Apr2021 as dose 2, single (Lot number: EW0162) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Nov2021 as dose 3 (booster), single (Lot number: 017F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Dose 1, 2: Pfizer/ Dose 3: Moderna" (unspecified if ongoing), notes: Dose 1, 2: Pfizer/ Dose 3: Moderna. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Apr2022, outcome "unknown" and all described as "Tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Apr2022) Positive; (07May2022) Negative; (08May2022) Negative; (12May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Tested positive for covid on 29Apr2022. Took Paxlovid 02May - 07May2022. Tested negative for covid on 07May2022, and tested negative for covid on 08May2022. Started coughing and sneezing, again on 09May2022 or 09May2022 or 10May2022. Also was very tired. Tested positive for covid on 12May2022.