chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech: Dose Number: 4; paxlovid: COVID 19 Treatment; Pfizer / BioNTech: Dose Number: 4; paxlovid: 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 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2022 at 15:00 as dose 4 (booster), single (Lot number: FK9895), 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 had no relevant medical history. Concomitant medication(s) included: SIMVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Pfizer / BioNTech: Dose Number: 4; paxlovid: COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I took Paxlovid as directed after a positive test; Negative, notes: Seven days and10 days later received negative test results; Negative, notes: Seven days and10 days later received negative test results; Positive, notes: Fifteen days later received a positive test result. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:  Patient received treatment with anti-viral "paxlovid" from 28Jun2022 to 05Jul2022 for COVID 19 Treatment. Other medication in 2weeks: Simvastatin. The patient took Paxlovid as directed after a positive test. Seven days and 10 days later received negative test results. Fifteen days later received a positive test result. Patient did not have known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: on the Paxlovid/had a breakthrough infection; on the Paxlovid/had a breakthrough infection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "non-smoker" (unspecified if ongoing); "non-alcohol user" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "on the Paxlovid/had a breakthrough infection". 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: Patient stated, he took the Pfizer COVID vaccine first and second and 2 boosters and everything was fine. Unfortunately, despite all that, he had a breakthrough infection, because of his age, his doctor put him on the Paxlovid, the 5-day regimen, he had 2 pills a day 1 yellow and 1 white, he tolerated this fine. After day 3 he was instructed to do a nasal swab, but it was still showing positive, he wants to know how long it takes for it go away after taking Paxlovid. He states that he was feeling better, he just did not know, after 3 days he was still getting a positive result, he asks this agent how long he had to quarantine. He asks how widespread this is.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Product administered at inappropriate site
Clinical narrative: Location of injection: Leg Right; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right leg for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Crab, Lobster, sand fleas" (unspecified if ongoing), notes: Known allergies: Crab, Lobster, sand fleas. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious), outcome "unknown", described as "Location of injection: Leg Right". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid oral treatment from 30Jun2022 to 04Jul2022. The patient did not received any other medications the patient received within 2 weeks of vaccination.  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 information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective,Covid 19.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: 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 a contactable reporter(s) (Consumer or other non HCP).  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Feb2021 as dose 1, single (Lot number: EL9269), in left arm, on 02Mar2021 as dose 2, single (Lot number: EN6202), in right arm, on 07Oct2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 22Jun2022 as dose 4 (booster), single (Lot number: FK6534) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "RA" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; HYDROXYCHLOROQUINE; METOPROLOL SUCCINATE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (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: Unknown Results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech / Tested positive; Pfizer / BioNTech / Tested positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 11Nov2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart attack w defibulator implant" (unspecified if ongoing), notes: Other medical history: Heart attack w defibulator implant, ; "Heart attack w defibulator implant" (unspecified if ongoing); "loss of hearing" (unspecified if ongoing); "cold/lung disease" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Pfizer / BioNTech / Tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Unknown results, notes: Treatment of COVID-19; (14Jul2022) positive, notes: Tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: The patient received Paxlovid for COVID 19 Treatment from 05Jul2022 to 10Jul2022. The patient received other medication in 2 weeks. The patient had no known allergies.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech/ tested positive for COVID; Pfizer / BioNTech/ tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Apr2022 as dose 3 (boster), single (Lot number: FK9894) at the age of 52 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: "Hyperlipidemia" (unspecified if ongoing); "Chronic back pain" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "Kidney stones" (unspecified if ongoing); "Hemorrhoids" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing), notes: Known allergies: Yes. Concomitant medication(s) included: ESTRACE vaginal; BUSPAR oral; FIORICET oral; SPIRONOLACTONE oral. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Jul2022, outcome "not recovered" and all described as "Pfizer / BioNTech/ tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jul2022) Negative, notes: Testing negative on 05Jul2022; (13Jul2022) Positive, notes: tested positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Return of nasal congestion, cough and decreased taste/smell on 13Jul2022 and tested positive for COVID after previously testing negative on 05Jul2022.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of covid-19 and drug ineffective.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Weight
Clinical narrative: Test Name: COVID/Result: positive; Test Name: COVID/Result: positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-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's relevant medical history included: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Breo for Asthma, notes: History, Other medical conditions: No, she has asthma. She used Breo for years, but now is using Ventolin as needed.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Jul2022, outcome "unknown" and all described as "Test Name: COVID/Result: positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jul2022) Positive, notes: Test Name (free text): Covid   Result Unstructured Data (free text): Result: positive; Unit: Not Provided; Weight: (unspecified date) 152-153 lbs, notes: Patient weight: 152-153 pounds. Therapeutic measures were taken as a result of drug ineffective, COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 40.0
Sex: M
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) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), 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) Unknown results; (12Jul2022) Positive, notes: Return of symptoms on day 12 after starting Paxlovid and positive test result. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient had not received other medication in 2 weeks. Patient was received Paxlovid for COVID 19 Treatment. Return of symptoms on day 12 after starting Paxlovid and positive test result.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: still ended up testing positive; still ended up testing positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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 10Jul2022, outcome "unknown" and all described as "still ended up testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jul2022) Positive, notes: testing positive on Sunday; (13Jul2022) Positive, notes: yesterday and it was still positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient stated he has received the primary series of Pfizer Covid 19 vaccines followed by two booster doses, states he is a health individual who wears as mask and doesn't smoke. The last booster being 4-5 months ago. He states that he did not have any side effects with the vaccines at all. He takes precautions and still ended up testing positive on Sunday. He began Paxlovid on Tuesday. He relays that he tested again yesterday and it was still positive. He would like to know how long until he tests negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: M
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) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 05Aug2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in right 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), 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: covid rebound. symptoms and tested positive; (12Jul2022) Negative, notes: 4 days after completing treatment and testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: For the treatment of COVID-19 patient took Paxlovid with start date 04Jul2022 and end date was 08Jul2022, on 12Jul2022 03:00 PM adverse event Covid rebound symptoms and tested positive 4 days after completing treatment and testing negative, patient was not recovered, no treatment was received and no allergies and medical history.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Headache; Muscles aches; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 06Feb2021 as dose 2, single (Lot number: EN5318) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Viral cardiomyopathy" (unspecified if ongoing); "Congestive heart failure" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Asthma" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 01, Lot: EL1283, Time: morning, probably 11 AM), administration date: 17Jan2021, when the patient was 66-year-old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown"; MYALGIA (non-serious), outcome "unknown", described as "Muscles aches".  Clinical course: Asthma Medications: Spiriva 1.2mcg per spray. 1 spray in morning and 1 in evening. Alvesco:160 mcg per spray. 1 spray in morning and 1 in evening. Albuterol rescue inhaler, which she generally doesn't take, but did take during that time because of the breathing difficulties. No Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). AE(s) following prior vaccinations: Headache and muscles aches most with second COVID-19 Vaccine.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 positive after receiving three Pfizer COVID-19 Vaccines; COVID-19 positive after receiving three Pfizer COVID-19 Vaccines; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 17Jan2021 at 11:00 as dose 1, single (Lot number: EL1283), on 06Feb2021 at 11:00 as dose 2, single (Lot number: EN5318) and on 18Sep2021 at 15:00 as dose 3 (booster), single (Lot number: FE3592) at the age of 67 years for covid-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma Diagnosed in her twenties; "Obesity" (unspecified if ongoing), notes: takes Contraze for weight loss, prescribed by her HCP.; "Viral cardiomyopathy" (unspecified if ongoing); "congestive heart failure" (unspecified if ongoing). Concomitant medication(s) included: SPIRIVA taken for asthma; ALVESCO taken for asthma; CONTRAVE oral taken for obesity. Vaccination history included: Shingles (Worst would have been newest Shingles vaccine: , Date: 2 years ago , NDC/LOT/EXP: unknown), for Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jul2022, outcome "unknown" and all described as "COVID-19 positive after receiving three Pfizer COVID-19 Vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: She was a cardiac patient and has been taking half of her digoxin while taking Paxlovid and right now. Had completed 5 day Paxlovid, that ended on Monday. Started Paxlovid in morning of 07Jul2022. No other vaccination within four weeks prior to the first administration of the suspect vaccine. Flu vaccine one month after 3rd COVID-19 Vaccine on 21Oct2021. Headache and muscles aches most with second COVID-19 Vaccine. No antipyretic use.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the event COVID-19, Vaccination failure and the suspect drug BNT162B2 cannot be excluded.
Age: 42.0
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 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: en6202), in left arm, on 31Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Oct2021 as dose 3 (booster), single (Lot number: ew0191) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "ADHD" (unspecified if ongoing). The patient's 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 "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  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, SARS-CoV-2 test
Clinical narrative: COVID-19 treatment; 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 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete; unknown manufacturer), for covid-19 immunisation. The following information was reported: COVID-19 (medically significant) with onset 2022, outcome "not recovered"; DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative; (Jul2022) Positive; (Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical Course: Patient received treatment drug as Paxlovid from 01Jul2022 to 06Jul2022 for COVID-19. Tested negative finally on day ten of initial COVID infection. Major bitter taste in mouth for the five days of plaxovid. Started Plaxovid on day 2. 7 days after Plaxovid stop. retested positive. Extreme fatigue and congestion so far. Still positive.am on day 8 post Paxlovid. Patient did not received any other medications/products within 2 weeks of starting COVID-19 treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: she initially didnt feel anything and the pain wasnt even that bad; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 14Jul2022, this case now contains all required information to be considered valid.  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 69-year-old female patient received BNT162b2 (BNT162B2), on 27Jun2021 as dose 1, single (Lot number: EW0181) at the age of 68 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.The patient did not receive any other vaccines within four weeks prior to the vaccination. The following information was reported: PAIN (non-serious), outcome "unknown", described as "she initially didnt feel anything and the pain wasnt even that bad". Therapeutic measures were not taken as a result of pain.  Additional information: Caller was a 68 year-old female who was calling about the Pfizer Covid-19 vaccine and Paxlovid. Caller reports that she had a reaction last year to first two dose of the Pfizer Covid-19 vaccine. Caller reports that she was reading about the severe reactions people were having to the Pfizer Covid-19 vaccine and thinks it was the polyethylene glycol in the Pfizer Covid-19 vaccine that caused these reactions. Caller reports there were issues with the Pfizer Covid-19 vaccine and that Pfizer should learn from other peoples reactions in regards to Covid-19 vaccines. Caller was asking if the ingredients for the Omnicron-based vaccines were the same as for the Pfizer Covid-19 vaccine. Also, patient stated to be honest, when she had the shots, she initially didn't feel anything and the pain wasn't even that bad. She was actually one of those people who don't do medications. Does a lot of juice and exercises, was a very healthy person. The AE(s) did not require a visit to Emergency Room and Physician Office. The patient does not even get flu vaccine. Had not had flu vaccine since 70's when swine flu was out.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 73-year-old male patient received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Batch/Lot number: unknown), on 23Feb2021 as dose 2, single (Batch/Lot number: unknown), on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 19Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "asthma" (unspecified if ongoing); "DVT" (unspecified if ongoing); "Melanoma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (14Jul2022) Positive. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical course: The patient didn't received any other medications within two weeks prior to vaccination. The patient was not having any known allergies. On 14Jul2022 at 08:00, the patient experienced nasal congestion, fever, shortness of breath, positive Covid-19 antigen testing. Patient was given Paxlovid for COVID 19 treatment with therapy start date as 30Jun2022 and stop date as 05Jul2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2  to the reported events Vaccination failure and COVID-19 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: I was in pain in my arm; my hand closed up; it was my right hand they closed up I was in pain in my arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EW0175, Expiration Date: 31Aug2021), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "I was in pain in my arm"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "my hand closed up; it was my right hand they closed up I was in pain in my arm". Therapeutic measures were not taken as a result of pain in extremity, limb discomfort.  Additional information: Anatomical site of administration: Consumer stated, it was her right hand they closed up I was in pain in my arm. Consumer was informed about the role of Pfizer Drug Safety. Consumer stated, she just want to because she got the first Pfizer shot back in May (not clarified) and she had a reaction on that while she got the shot before and she was trying to get jab and her doctor told her to not take second one because her hand closed up and it was 3 days after it was back to normal and she want to know how she could go and get the no saying that she could not take the second shot. No other investigations and no other conditions reported.  No follow-up attempts are possible. No further information is expected.
Sex: F
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: The patient also received Other medication in 2weeks and patient had no known allergies. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: ER2613), in left arm, on 23Apr2021 as dose 2, single (Lot number: EW0172), in left arm and on 19Nov2021 as dose 3 (booster), single (Lot number: FF8879) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 04Jul2022, outcome "unknown", COVID-19 (medically significant) with onset 04Jul2022, outcome "recovered" (2022) and all described as "COVID 19". Therapeutic measures were taken as a result of covid-19.  Clinical information: No known allergies. No other medication in 2weeks. Paxlovid was received for COVID 19 Treatment on 04Jul2022.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events VACCINATION FAILURE and COVID-19 and BNT162B2.
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ADVIL [IBUPROFEN]; VITAMIN D NOS. The following information was reported: COVID-19 (medically significant), 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: Unknown results. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Additional information: Patient was taking medication for 5 days. Felt good but 3 days after stop taking symptoms return. Other medication in 2 weeks product was Advil and Vitamin d.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 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 included: "Psoriasis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Unknown results, notes: COVID 19 Treatment; Positive, notes: rebound infection return symptoms and positive test on day 19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Report about covid treatment reported as Yes. If vaccine received reported as Yes, Other medication in 2weeks reported as No. Antiviral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 22Jun2022, Treatment stop date: 26Jun2022, Indication: Treatment of COVID-19, Administrator route: Oral. Adverse event reported as rebound infection return symptoms and positive test on day 19. Known allergies reported as no.  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 available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of COVID-19 and Drug ineffective.
Sex: F
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 (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine, as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Known allergies: Penicilin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: tested negative for 4 days; Negative, notes: Tested at midnight and was negative; Positive, notes: Tested the next afternoon and was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid. Clinical course: Rebounded-tested negative for 4 days, started to get itchy throat and runny nose. Tested at midnight and was negative. Tested the next afternoon and was positive. Patient had not left the house in 11 days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) 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: "Type 2 diabetes" (unspecified if ongoing); "Graves Disease" (unspecified if ongoing); "Major Depressive Disorder" (unspecified if ongoing). Concomitant medication(s) included: PROZAC; METHIMAZOLE; PROPRANOLOL; METFORMIN; GLIMEPIRIDE; LANTUS. Past drug history included: Intolerant to erythromycin, reaction(s): "Intolerant". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, 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: Experienced Covid rebound. Sxs started Saturday 02Jul2022. Tested positive and continued to test positive along with sxs until Jul162022; (02Jul2022) Positive, notes: Experienced Covid rebound. Sxs started Saturday 02Jul2022. Tested positive and continued to test positive along with sxs until Jul162022. Therapeutic measures were taken as a result of drug ineffective, covid-19 included COVID 19 Treatment with Paxlovid from 19Jun2022 to 23Jun2022.  Clinical course: The patient experienced Covid rebound. Sxs started Saturday, 02Jul2022. Tested positive and continued to test positive along with sxs until 16Jul2022.  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: COVID-19, SARS-CoV-2 test, Vaccination failure
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 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 29Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 17May2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Atrial Fibrillation" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: Report about Covid treatment: Yes. If vaccine received: Yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: M
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 69-year-old male patient received BNT162b2 (BNT162B2), in Mar2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LIPITOR, start date: Mar2008, stop date: 03Jul2022. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Rebound 5 days after completion of last dose. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient was treated with Paxlovid from 04Jul2022 to 08Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; sars covid-2 infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 26Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 07Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: BACLOFEN; LEVOTHYROXINE; MELOXICAM; ATORVASTATIN; LOSARTAN; FAMOTIDINE. The following information was reported: VACCINATION FAILURE (medically significant) with onset 14Jul2022, outcome "recovering", described as "COVID 19"; COVID-19 (medically significant) with onset 14Jul2022, outcome "recovering", described as "sars covid-2 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jul2022) Positive, notes: When I got up in the morning of 14Jul I took a COVID test and the results were positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: The patient experienced rebound effect on the 10th day or 4th day after completing the treatment. First day of symptoms July 5th started treatment the evening of July 5th. Finished the treatment on July 10th. Starting in early morning Of July 14th, The patient experienced chest congestion and constant coughing. When the patient got up in the morning of July 14th she took a COVID test and the results were positive. Chest congestion continued through the day the late afternoon it moved to nasal congestion. That is where the patient was then.  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, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Mar2021 at 14:30 as dose 2, single (Batch/Lot number: unknown), in left arm and on 08Oct2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's hypothyroidism" (unspecified if ongoing); "PCOS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jun2022) Positive, notes: Initial Covid positive test 28Jun; (05Jul2022) Negative, notes: testing negative Tuesday 05Jul; (11Jul2022) Positive, notes: tested positive for Covid 11Jul. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Initial Covid positive test 28Jun. Prescribed and began Paxlovid 29Jun. Paxlovid rebound occurred after testing negative Tuesday 05Jul (completed medication on Sunday 03Jul). Developed symptoms again Sunday 10Jul and tested positive for Covid 11Jul. Other medication in 2weeks product: Levoxyl, other medication in 2weeks start date: 20Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: rebound Covid; rebound Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570).  A patient (no qualifiers provided) 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 "rebound Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results.  Clinical information: Forwarded as an Adverse Event by the team on 14Jul2022. Reporter provided verification of contact address on 14Jul2022 you need to update your records on rebound Covid after taking your antiviral medication. In my small circle she know 7 people that have gotten Covid again. "If I do my husband has it again and I am still testing positive. I never would have taken it if I knew that percentage of peoples that get it again. It should only be given to very high risk people".   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-PV202200023743 same drug /event, different patient.;