chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID; COVID; MODERNA COVID-19 VACCINE, on 06Dec2021 as dose 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: EP7534), in left arm and on 17Apr2021 as dose 2, single (Lot number: ER8729) at the age of 25 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Dec2021 as dose 3, (booster), single (Lot number: 06OH21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE. Past drug history included: Diflucan, reaction(s): "Drug Allergy"; Miconazole, reaction(s): "Drug Allergy".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset Jul2022, outcome "not recovered", described as "MODERNA COVID-19 VACCINE, on 06Dec2021 as dose 3". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Aug2022) Positive, notes: I took a test on 3Aug prior to symptoms returning and it was very faintly positive; (05Aug2022) Positive, notes: On 5Aug I felt sick again and took another test which was very bright and clearly positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, interchange of vaccine products.  Clinical course: COVID rebound after finishing a course of paxlovid from 28Jul2022 to 01Aug2022 for the treatment of covid. She took a test on 03Aug prior to symptoms returning and it was very faintly positive. On 05Aug she felt sick again and took another test which was very bright and clearly positive. Symptoms aren't as severe as the first infection so far.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). A 59-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "DM2" (unspecified if ongoing); "HLD" (unspecified if ongoing); "HTN" (unspecified if ongoing); "RAD" (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19, included PAXLOVID. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Considering a plausible drug-event temporal association and the consistency of the events with the known safety profile of the suspect product, a reasonable possibility that the events are related to the vaccine administration cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: en5318), in right arm, on 18Feb2021 as dose 2, single (Lot number: en6203), in left arm and on 27Aug2021 as dose 3 (booster), single (Lot number: ew0217) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Known allergies: strawberries" (unspecified if ongoing), notes: Known allergies: strawberries. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  Clinical Course: Patient was sicker with rebound covid than ever was with first time around. Anti-viral details: product: COVID 19 Treatment, Treatment start date: 27Jul2022 ,Treatment stop date: 01Aug2022, Indication: Treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jun2021 as dose 1, single (Lot number: Ex2405019), in left arm and on 05Jul2021 as dose 2, single (Lot number: Fe3064001) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 17Dec2021 as dose 3 (booster), single (Lot number: 041j21a), in left arm and on 07May2022 as dose 4 (booster), single (Lot number: 001MZ1a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer maintenance Tamoxifen" (unspecified if ongoing), notes: Breast cancer maintenance Tamoxifen. Concomitant medication(s) included: TAMOXIFEN, start date: 31May2019; WEGOVY, start date: 01Mar2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 25Jul2022 to 29Jul2022.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 23 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: "Chronic pain" (unspecified if ongoing); "depression" (unspecified if ongoing); "endometriosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Aug2022) positive, notes: Rebound- developed COVID-19 symptoms again and tested positive today (05Aug); only took paxlovid for 2 days due to severe vomiting. 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, 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 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Feb2021 as dose 1, single (Lot number: EL9267), in right arm, on 02Mar2021 as dose 2, single (Lot number: EN6202), in right arm and on 18Sep2021 as dose 3 (booster), single (Lot number: EWO172) at the age of 71 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Apr2022 as dose 4 (booster), single (Lot number: 002M21A), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex", notes: Known allergies: Keflex. 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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive; (2022) Negative. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. Reported Event was rebound mild symptoms positive home antigen test 6 days after stopping Paxlovid and 4 days after second day of negative home antigen test.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 78-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had taken Paxlovid from 23Jul2022 to 28Jul2022 for Indication of Treatment of COVID-19. Paxlovid alleviated COVID symptoms but upon completion of 5 day regimen, though milder, symptoms returned. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Lot number: EL3247) and on 12Feb2021 as dose 2, single (Lot number: EL9266) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history was not reported. Patient had no Known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I have Covid again after testing negative twice". Therapeutic measures were taken as a result of drug ineffective, Covid-19.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: vaccinated with the 3 doses of the Pfizer COVID-19 vaccine, tested positive for Covid/sore throat; vaccinated with the 3 doses of the Pfizer COVID-19 vaccine, tested positive for Covid/sore throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EN6199), in arm, on 25Mar2021 as dose 2, single (Lot number: EN6207), in arm and on 17Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 62 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: A long time ago, maybe 10-year- ago. Concomitant medication(s) included: SYNTHROID oral taken for hypothyroidism. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Jul2022, outcome "not recovered" and all described as "vaccinated with the 3 doses of the Pfizer COVID-19 vaccine, tested positive for Covid/sore throat". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative; (25Jul2022) Positive; (30Jul2022) a weak positive; (01Aug2022) Negative; (05Aug2022) slightly positive; (05Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Vaccinated with the 3 doses of the Pfizer COVID-19 vaccine, tested positive for COVID. 1st dose: NDC number, lot number, expiration date: Says EN6199 on the vaccination card. Unknown what that number is; 2nd dose: NDC number, lot number, expiration date: Says EN6207 on the vaccination card. Unknown what that number is; 3rd dose: NDC number, lot number, expiration date: Says FH8030 on the vaccination card.  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: his is a spontaneous report received from a non-contactable reporter(s) (Physician). A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (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 "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Unknown if patient received other medication in 2 weeks. She had no Known allergies. The patient received Paxlovid orally as COVID 19 treatment on 03Aug2022 to 06Aug2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 18Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 70 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 and concomitant medications were not reported. Past drug history included: Visteral, reaction(s): "Drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Off label use
Clinical narrative: rebound covid 4 days following the last dose; rebound covid 4 days following the last dose; Moderna/ Pfizer / BioNTech; Moderna/ Pfizer / BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Lot number: FG3527) and on 07Jul2022 as dose 4 (booster), single (Lot number: FD7150), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 16Jan2021 as dose 1, single (Lot number: 011J20A) and on 13Feb2021 as dose 2, single (Lot number: 024M20A), 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), COVID-19 (medically significant), outcome "unknown" and all described as "rebound covid 4 days following the last dose"; OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown" and all described as "Moderna/ Pfizer / BioNTech". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 53.0
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 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 18Jan2021 as dose 1, single (Lot number: 042L20A), in left arm, on 17Feb2021 as dose 2, single (Lot number: 030M20A), in left arm and on 09Dec2021 as dose 3 (booster), single (Lot number: 029H21B) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ESOMEPRAZOLE, start date: 07Nov2012, stop date: 06Aug2022; ZYRTEC ALLERGY, start date: 04Jul2016, stop date: 06Aug2022. The following information was reported: VACCINATION FAILURE (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: positive, notes: tested positive for COVID; Negative, notes: tested negative within 8 days of first positive test; positive, notes: tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had no known allergies. Patient started Paxlovid the evening she tested positive for COVID. She did very well and tested negative within 8 days of first positive test. She began having symptoms again, after 8 days of finishing full 5-day course of Paxlovid. She tested positive again on the 9th day after finishing full 5-day course of Paxlovid. Patient anti-viral medication included Paxlovid for COVID 19 Treatment. Treatment started on 22Jul2022 and stopped on 26Jul2022.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 09Apr2021 as dose 2, single (Lot number: EW0153), in left arm, on 15Aug2021 as dose 3 (booster), single (Lot number: FA7485), in left arm and on 31Jan2022 as dose 4 (booster), single (Lot number: 33036BD) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Common Variable Immune Deficiency (CVID)" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "migraines" (unspecified if ongoing); "trigeminal neuralgia" (unspecified if ongoing); "B-12 deficiency" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing), notes: high blood pressure (well-controlled with medication). The patient took concomitant medications. Past drug history included: Fioricet, reaction(s): "Known allergies: Fioricet"; Keflex, reaction(s): "Known allergies: Keflex". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: antigen tests (her mom has ALS so patient didn't want to take chance of her getting it) for 6 days and had negative results and no symptoms; Positive, notes: daily antigen test it came back positive; Positive, notes: at-home "PCR-like" test and it was also positive; Positive; Negative, notes: Patient completed the entire regimen and tested negative and had no symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: On 26Jul2022 (the day symptoms started), started a 5-day Rx of Paxlovid, taking the first dose in and evening. Completed the entire regimen and tested negative and had no symptoms. After symptoms resolved, continued to use antigen tests (her mom has ALS so patient didn't want to take chance of her getting it) for 6 days and had negative results and no symptoms. On 06Aug2022, she woke up with an asthma attack, a cough and scratchy throat, and when she did the daily antigen test it came back positive. To be sure, she used the more sensitive, at-home "PCR-like" test and it was also positive. So, despite 5-day Paxlovid treatment, she tested positive again 6 days later and have worse symptoms than she originally had. Other medication in 2weeks was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Lot number: FF2588) at the age of 71 years, in right arm for covid-19 immunisation; Covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 02Feb2021 as dose 1, single (Lot number: 012M20A), in right arm, on 03Mar2021 as dose 2, single (Lot number: 011A21A), in left arm and on 24Jul2022 at 15:00 as dose 4 (booster), single (Lot number: 060A22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma; "bronchiectatis" (unspecified if ongoing), notes: Other medical history: bronchiectatis; "microscopic colitis" (unspecified if ongoing), notes: Other medical history: microscopic colitis. Concomitant medication(s) included: FLUTICASONE PROPIONATE; SALMETEROL; CHOLESTYRAMINE; VITAMIN C [ASCORBIC ACID]; CALCIUM CITRATE + D3; D3; FISH OIL. Past drug history included: Cholestryamine, reaction(s): "Have experienced hives", notes: Known allergies: Have experienced hives with a particular brand of Cholestryamine but not the one I am on currently. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, 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 drug ineffective, covid-19.The patient received vaccine. Other medication in 2weeks product Multivitamin women 50, lot number: 21FGF0120. Fluticasone propionate/salmeterol discus Inhalation Powder 250mcg/50mc, Cholestryamine for oral suspension brand: Vitamin C 500 mg and D3 brand: Nature Made. Anti-viral details: Product: COVID 19 Treatment, Brand: Pfizer, Treatment start date: 05Aug2022, Lot number: G05280, Indication: Treatment of COVID-19. Adverse event: Hives on both arms and legs, Adverse event start date: 05Aug2022, AE resulted in: None of the above, the patient was recovered. Adverse events stop date: 06Aug2022, if treatment AE was no.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, 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 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 01Apr2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 01Nov2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 22Jul2022 at 14:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CLARITIN D 12 HOUR, start date: 28Jul2022, stop date: 07Aug2022; XANAX, start date: 28Jul2022, stop date: 07Aug2022; MIRALAX, start date: 28Jul2022, stop date: 07Aug2022. Past drug history included: Thimersol, reaction(s): "Known allergies Thimersol". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "Covid-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: after positive covid test at home; (07Aug2022) Positive; Body temperature: (unspecified date) 99.8 Centigrade, notes: Slight temp. @ 99.8. Therapeutic measures were taken as a result of covid-19. Started Paxlovid on Day 2 of symptoms (after positive covid test at home). My symptoms were Extemely Dry Mouth, post nasal drip, extremely RAW feeling in upper chest when coughed, seems unlike any cough I have ever had. Slight temp. @ 99.8 Felt much better already after 1 day on Paxlovid and almost completely fine 2 days later, seemed like a miracle pill except for the horrible taste alaays at back of mouth, like a pill dissloving back there. Then 5 days after finishing Paxlovid, woke up with Sore Throat, completely stuffed up nose and achy. Took Claritin D to decongest. Now Day 2 of recurrence, I feel slightly better but still extremely runny nose, sinus pressure, tired, only very slight sore throat, no cough. Tested today positive for Covid. Never tested after feeling better on Paxlovid till now after recurrence of symptoms Feel free to contact me with any questions. I can provide vaccine batch #'s if needed. I am surprised that I got any symptoms at all since got all vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 37.0
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 38-year-old male patient received BNT162b2 (BNT162B2), on 18Feb2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 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. Concomitant medication(s) included: TRUVADA, start date: Jan2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jul2022) Negative; (01Aug2022) Negative; (05Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies. Patient received other medication in two weeks. Paxlovid (anti-viral) treatment started on 24Jul2022 and stopped on 29Jul2022.  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, 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 70-year-old male patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: EM9810), in right arm, on 26Feb2021 as dose 2, single (Lot number: EN6200), in right arm and on 25Sep2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 69 years, in right arm for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 18Apr2022 as dose 4 (booster), single (Lot number: 00SM21A), in right arm for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jul2022) Positive, notes: COVID rebound - positive test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had no known allergies.  No follow-up attempts are possible. 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 non-contactable reporter(s) (Physician). The reporter is the patient.  A 28-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 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: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course include rebound symptoms with sore throat, headache, but no fevers, as of 01Aug COVID 19 treatment of paxlovid and treatment start date was 24Jul2022 and treatment stop date was 04Aug2022.  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 available information and possible temporal association the causal relationship between the reported event and suspect cannot be excluded.The case will be reviewed further with FU information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Apr2022 as dose 4 (booster), single (Lot number: FMO), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 19Jan2021 as dose 1, single (Lot number: 011620A), in left arm, on 19Feb2021 as dose 2, single (Lot number: 024M20A), in left arm and on 27Oct2021 as dose 3 (booster), single (Lot number: 032FF21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast Ca Spleenectomy" (unspecified if ongoing), notes: Other medical history: Breast Ca Spleenectomy; "R knee replacement" (unspecified if ongoing), notes: Other medical history: R knee replacement; "laryngeal stenosis" (unspecified if ongoing), notes: Other medical history: laryngeal stenosis; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Vaccine brand: Pfizer/BioNTech, vaccine dose number: 4/vaccine brand other: Moderna, vaccine dose number: 3" (unspecified if ongoing), notes: Pfizer/BioNTech, vaccine dose number: 4/vaccine brand other: Moderna, vaccine dose number: 3. 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 "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 26Jul2022 to 29Jul2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Product administered at inappropriate site, Wheezing
Clinical narrative: Shortness of breathe; wheezing; 2-year-old male patient received BNT162B2 in the right leg; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 2-year-old male patient received BNT162b2 (BNT162B2), on 05Aug2022 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 2 years, in right leg for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 05Aug2022 at 15:00, outcome "unknown", described as "2-year-old male patient received BNT162B2 in the right leg"; DYSPNOEA (medically significant) with onset 05Aug2022 at 20:15, outcome "recovering", described as "Shortness of breathe"; WHEEZING (medically significant) with onset 05Aug2022 at 20:15, outcome "recovering". The events "shortness of breathe" and "wheezing" required physician office visit.   Therapeutic measures were taken as a result of dyspnoea, wheezing that included Steroids.  Additional information: The patient had no covid prior to vaccination and no covid tested post vaccination. No known allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 27Jul2021 as dose 1, single (Lot number: fa7485), on 17Aug2021 as dose 2, single (Lot number: fc3183), on 19Jan2022 as dose 3 (booster), single (Lot number: fk5618) and on 13Jul2022 as dose 4 (booster), single (Lot number: fm0173) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Esophageal Cancer" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: CETIRIZINE; FAMOTIDINE; LOSARTAN POTASSIUM; OPDIVO; PANTOPRAZOLE; MULTIVITAMINS. Known allergies: nka. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Jul2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Jul2022) Positive; (02Aug2022) Negative; (06Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.   No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid-19 returned, two days after two negative at-home tests; Covid-19 returned, two days after two negative at-home tests; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL8982), in right arm, on 10Feb2021 as dose 2, single (Lot number: EU5318), in right arm, on 01Sep2021 as dose 3 (booster), single (Lot number: FC3184), in right arm and on 06Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Essential Thrombocythemia" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: Jan2019, stop date: 26Jul2022; HYDROXYUREA, start date: Feb2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid-19 returned, two days after two negative at-home tests". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative, notes: two days after two negative at-home tests; Negative, notes: two days after two negative at-home tests; Positive, notes: Covid-19 returned. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: If vaccine received: Yes. Other medication in 2 weeks: Yes. Anti viral details: Product: COVID 19 Treatment. Brand: Paxlovid. Treatment start date: 26Jul2022, Treatment stop date: 31Jul2022. Indication: Treatment of COVID-19. Other medication details: Other medication in 2weeks product: Prednisone. Other medication in 2weeks Brand: generic. Other medication in 2weeks Start Date: 15Jul2022. Other medication in 2weeks Stop Date: 22Jul2022. Other medication in 2weeks Brad: Rosuvastatin. Other medication in 2weeks Brand: generic. Other medication in 2weeks Start Date: Jan2019. Other medication in 2weeks Stop Date: 26Jul2022. Other medication in 2weeks Brad: Hydroxyurea. Other medication in 2weeks Brand: generic. Other medication in 2weeks Start Date: Feb2021. Adverse event: Covid-19 returned, two days after two negative at-home tests. Adverse event start date: 04Aug2022. Adverse event start time: 09:00 AM. Ae resulted in: [None of the above]. If patient recovered: Not Recovered. If treatment ae: No. Known allergies no. Other medical history: Essential Thrombocythemia, high cholesterol.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chest pain, Chills, Dizziness
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient. A 50-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, on 31Jul2022 at 13:15 as dose 4 (booster), single (Lot number: fmo137) at the age of 50 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: PRILOSEC [OMEPRAZOLE MAGNESIUM]; HYDROCHLOROTHIAZIDE. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 3; MANUFACTURER UNKNOWN; Lot number unknown), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 31Jul2022 at 23:00, outcome "recovering"; FATIGUE (non-serious) with onset 31Jul2022 at 23:00, outcome "recovering"; PYREXIA (non-serious) with onset 31Jul2022 at 23:00, outcome "recovering", described as "High fever then a persistent fever/ low grade fever"; ARTHRALGIA (non-serious), CHEST PAIN (non-serious) all with onset 31Jul2022 at 23:00, outcome "recovering" and all described as "Severe pain in joints, shoulders, chest"; ABDOMINAL DISCOMFORT (non-serious) with onset 31Jul2022 at 23:00, outcome "recovering", described as "Stomach discomfort"; DIZZINESS (non-serious) with onset 31Jul2022 at 23:00, outcome "recovering"; DYSPNEA (non-serious) with onset 31Jul2022 at 23:00, outcome "recovering", described as "shortness of breath". Therapeutic measures were taken as a result of pyrexia, arthralgia, chest pain, chills, fatigue, abdominal discomfort, dizziness, dyspnea. Additional information: Adverse events were high fever then a persistent fever, and now 7 days later, she still had a low-grade fever. Chills, severe pain in joints, shoulders and chest. Fatigue, stomach discomfort, dizziness and shortness of breath. Ae treatment was Tylenol.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient. A 50-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, on 31Jul2022 at 13:15 as dose 4 (booster), single (Lot number: fmo137) at the age of 50 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: PRILOSEC [OMEPRAZOLE MAGNESIUM]; HYDROCHLOROTHIAZIDE. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 3; MANUFACTURER UNKNOWN; Lot number unknown), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 31Jul2022 at 23:00, outcome "recovering"; FATIGUE (non-serious) with onset 31Jul2022 at 23:00, outcome "recovering"; PYREXIA (non-serious) with onset 31Jul2022 at 23:00, outcome "recovering", described as "High fever then a persistent fever/ low grade fever"; ARTHRALGIA (non-serious), CHEST PAIN (non-serious) all with onset 31Jul2022 at 23:00, outcome "recovering" and all described as "Severe pain in joints, shoulders, chest"; ABDOMINAL DISCOMFORT (non-serious) with onset 31Jul2022 at 23:00, outcome "recovering", described as "Stomach discomfort"; DIZZINESS (non-serious) with onset 31Jul2022 at 23:00, outcome "recovering"; DYSPNEA (non-serious) with onset 31Jul2022 at 23:00, outcome "recovering", described as "shortness of breath". Therapeutic measures were taken as a result of pyrexia, arthralgia, chest pain, chills, fatigue, abdominal discomfort, dizziness, dyspnea. Additional information: Adverse events were high fever then a persistent fever, and now 7 days later, she still had a low-grade fever. Chills, severe pain in joints, shoulders and chest. Fatigue, stomach discomfort, dizziness and shortness of breath. Ae treatment was Tylenol.
Age: 35.0
Sex: F
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 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's relevant medical history included: "Hashimotos" (unspecified if ongoing). 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: experience rebound affects after testing negative for two days; (unspecified date) Positive; (02Aug2022) Positive, notes: Rebound started the following Tuesday 2Aug with a positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:The patient experienced rebound affects after testing negative for two days with no symptoms. Rebound started the following Tuesday 2Aug with a positive test. A day later fever and congestion set in and loss of taste and smell. The patient had no known allergies. No other medication within 2weeks of vaccination.  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, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Dec2020 at 07:00 as dose 1, single (Lot number: eh9899), as dose 2, single (Lot number: EL8982), in right arm, on 14Oct2021 at 20:00 as dose 3 (booster), single (Lot number: FF2590), in right arm and on 24Mar2022 at 20:00 as dose 4 (booster), single (Lot number: FM9992), in right arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism migraines" (unspecified if ongoing); "hypothyroidism migraines" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: 01Jun2022, stop date: 05Aug2022. Past drug history included: Cefuroxime, reaction(s): "Known allergies: cefuroxime". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19; COVID 19 Treatment included Paxlovid from 06Jul2022 to 10Jul2022.; Sender's Comments: The contribution of the suspect drug to the onset of events cannot be ruled out since drug efficacy varies from one patient to another and affected by different factors.