chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Lot number: EL9264), in left arm and in 2021 as dose 2, single (Lot number: EL 9266), in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20Dec2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Allergic to bee stings" (unspecified if ongoing); "Allergic to poison ivy" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing); "Cough" (unspecified if ongoing); "Pain" (unspecified if ongoing). Concomitant medication(s) included: DAYQUIL taken for cough, start date: 18May2022, stop date: 21May2022; ADVIL [IBUPROFEN] taken for pain, start date: 24May2022, stop date: 30May2022. Past drug history included: Tylenol, reaction(s): "known allergies: Tylenol"; Codeine, reaction(s): "known allergies: Codeine"; Erythromycin, reaction(s): "known allergies: Erythromycin". 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 results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course of the events: Other medication in 2weeks product: Vitamins. other medication in 2 weeks brand: Vitafusion. Other medication in 2 weeks start date: 01May2022. Patient had a persistent terrible taste in my mouth, especially the roof of my mouth. More importantly, patient started coughing again (enough to wake me up), joint pain, and having nasal congestion on day 4 out of 5 on Paxlovid. I had no coughing for two days and my nose was fine. Patient allso had only a little joint pain, which was normal since she have rheumatoid arthritis. Essentially she felt really good and now I'm sick again. Adverse event start date: 31May2022. Vaccine administration date of dose 2: 02Feb2021. Vaccine administration time: 03:00PM. Vaccine administration date of dose 1: 04Feb2021. Vaccine administration time: 03:00PM.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: contracting covid for third time/I've had two Pfizer covid vaccines and one booster; contracting covid for third time/I've had two Pfizer covid vaccines and one booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) 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: "small wart" (unspecified if ongoing), notes: I had a small wart on my hand that I've had for almost 30 years. 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 "contracting covid for third time/I've had two Pfizer covid vaccines and one booster". Therapeutic measures were taken as a result of covid-19. Patient recently went through a 5 day course of Paxlovid after contracting covid for third time and I noticed an interesting side effect. I had a small wart on my hand that I've had for almost 30 years. I've had it frozen off four or five times over the years but it always came back. It disappeared after Paxlovid and I just have a small scar there now. I'm amazed and I thought you might want to know. I've had two Pfizer covid vaccines and one booster. I guess I don't develop good immunity to covid.  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Brain injury, Seizure
Clinical narrative: permanent brain damage; recurrent seizures; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (NA).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BRAIN INJURY (medically significant, life threatening), outcome "unknown", described as "permanent brain damage"; SEIZURE (medically significant, life threatening), outcome "unknown", described as "recurrent seizures". Therapeutic measures were taken as a result of brain injury.  Clinical information: It was reported that as many feared when these jabs were rushed to the market largely untested, it was only as time passes that some of the effects become more obvious. One example was the case of a 12-year-old girl who participated in Pfizer's pre-release safety study. In a presentation of families who had been injured by Covid vaccines (Name withheld), (Name withheld) mother said she was now confined to a wheelchair as a result of getting the jab. In addition to suffering from permanent brain damage and requiring tube feeding, she had been experiencing recurrent seizures.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: My other three shots - no problem except a little bit of soreness from my shot.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:  The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 06May2021 as dose 1, single (Lot number: EW0186), on 12Jun2021 as dose 2, single (Lot number: EW0186) and on 14Jan2022 as dose 3 (booster), single (Lot number: FL320PN) at the age of 71 years for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "My other three shots - no problem except a little bit of soreness from my shot." Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: There was no other conditions, Other Products. Patient stated her other three Pfizer Covid shots she had no problem with and the sores she had with she thinks probably all three of her prior vaccine doses and it was very little soreness. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. No Emergency Room and Physician Office visit. Prior Vaccinations (within 4 weeks) was None. Family Medical History Relevant was None. Relevant Tests was None. Caller states she was thinking from the fact that there were two separate lot numbers of her Pfizer Covid vaccine and it was sort of like the 1st had one lot number and the 2nd had one lot number and maybe it was a different lot and somehow that lot was something different; states her question for the previous agent was what are the percentages of people that come out of trial that have had these symptoms and she was also wondering if they do trials on each lot of the vaccine or how does that work; caller was offered transfer regarding her question.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Rebound of Covid symptoms after seemingly resolved.; Rebound of Covid symptoms after seemingly resolved.; This is a spontaneous report received from 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 29Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 22Feb2021 as dose 2, single (Lot number: EN5318), in left arm and on 12Nov2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing); "hemolytic anemia" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LIALDA also received as other medication in 2weeks product. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset May2022, outcome "not recovered", DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown" and all described as "Rebound of Covid symptoms after seemingly resolved.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result. Therapeutic measures were taken as a result of suspected covid-19, drug ineffective included Paxlovid, treatment start date-18May2022, treatment stop date-23May2022.  Clinical course: Rebound of Covid symptoms after seemingly resolved. Felt completely better day 7. Slightly elevated temperature and cold symptoms resumed day 10. Cough, sore throat, runny nose.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Nov2021 as dose 3 (booster), single (Lot number: FH8028), in left arm and on 12Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), first regimen (Batch/Lot number: unknown) at single (dose 2, single) and second regimen (Batch/Lot number: unknown) at single (dose 1, single) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient did not receive other medication in 2weeks.  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: positive; positive, notes: continued to have symptoms and test positive for 12+ days. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti viral details: product: COVID 19 treatment, Brand: Pfizer, treatment start date: 15May2022, treatment stop date: 19May2022, indication: Treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 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 43-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: 33130BA) 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. The patient took 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: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. This report was about COVID-19 treatment. Patient did receive the vaccine. Patient received other medication in 2 weeks. Patient received paxlovid as a treatment for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200781668 Same patient, different product and event
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 27Sep2021 at 09:30 as dose 3 (booster), single (Lot number: 301308A) at the age of 38 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing); "Type 1 diabetes with gastroparesis" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "low HDL" (unspecified if ongoing); "major depression" (unspecified if ongoing); "restless leg syndrome" (unspecified if ongoing). Concomitant medication(s) included: HUMALOG, start date: 20Aug1998, stop date: 20Aug1998; LAMICTAL; LISINOPRIL; BUPROPION HCL XL; ROPINIROLE; ATORVASTATIN, start date: 01May2016, stop date: 27May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Anti-viral details: product-COVID 19 Treatment, brand-Paxlovid. Treatment start date-27May2022, Lot number=GA3588, Indication is used for treatment of COVID-19. Adverse event: I have type 1 diabetes and my blood sugars have been regularly jumping to over 400 mg/dL since taking the antiviral medications. This is especially true in the evening (when I believe the amount is probably maximal in my system). These highs have been very resistant to insulin treatment and large fluid intake. I normally don't see numbers this high basically ever. The patient had Known allergies to NKA. Other medical history: Type 1 diabetes with gastroparesis, high blood pressure, low HDL, major depression, and restless leg syndrome. Adverse event experienced on 27May2022 at 11:00 PM, The outcome of event was Recovering with treatment Increased insulin regiment (self-administered).  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: prescribed paxlovid after vaccination; prescribed paxlovid after vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 21Jul2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 19Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient did not have any Known allergies. Concomitant medication(s) included: ROSUVASTATIN, start date: 20Nov2012, stop date: 16May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "prescribed paxlovid after vaccination". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.. Antiviral details product: COVID 19 Treatment, brand: Paxlovid, Treatment start date: 16May2022, Treatment stop date: 20May2022 Lot number: N/A, Indication: Treatment of COVID-19. Adverse event: 5days following completion of Paxlovid I started experiencing extreme dry and sore throat, cough, chest and nasal congestion, exhaustion, loss of taste, inability to speak without "tired" throat, very low voice, inability to speak loudly enough to be heard properly. Adverse events start date: 25May2022, Adverse event start time: 04:00 AM, If patient recovered: Not recovered, If treatment ae: Yes, Ae treatment: (1) Tylenol PM at night to sleep  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
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Contracted symptomatic covid after vaccination; Contracted symptomatic covid after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (COMIRNATY), on 24Feb2021 as dose 1, single (Lot number: EL3247); on 17May2021 as dose 2, single (Lot number: EL3247); and on 03Nov2021 as dose 3 (booster), single (Lot number: EL00217) at the age of 37 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30May2022, outcome "recovering" and all described as "Contracted symptomatic covid after vaccination". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2021) Negative, notes: Nasal Swab; (Jan2022) Negative, notes: Nasal Swab; (Mar2022) Negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: There was no other vaccine in four weeks. There was no covid prior vaccination. However the patient tested positive post vaccination.  No follow-up attempts are possible. No further information is expected.
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 (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 20Feb2021 as dose 1, single (Lot number: EL9266), on 13Mar2021 as dose 2, single (Lot number: EN6206) and on 05May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 27Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: REMICADE, start date: 20May2022, stop date: 20May2022. The patient had no known allergies. 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: (unspecified date) Unknown results, notes: Treatment of COVID-19; (May2022) negative. 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. The patient received "paxlovid" to treat vaccination failure, covid-19. Treatment start date: 26May2022, treatment stop date: 31May2022.
Age: 47.0
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 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 03May2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 27Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Positive, notes: Test type: Antigen Test. Therapeutic measures were taken as a result of covid-19, drug ineffective.Brand: Paxlovid.treatment start date:14May2022. treatment stop date:18May2022.Recurrence of Covid symptoms (stuffy nose only), positive antigen test after 3 days of negative testing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200781722 Same patient, different product and event
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Tested positive for covid; Tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 16Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 27Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in right arm 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), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "Tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (29May2022) Negative, notes: Tested positive for covid again with Symptoms of fever/chills/muscle aches 4 days after completing the full course of paxlovid. I had previously tested Negative on the 3rd day following Completion of treatment; (31May2022) Positive, notes: Tested positive for covid again with Symptoms of fever/chills/muscle aches 4 days after completing the full course of paxlovid. 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.
Sex: M
Vaccine: COVID19
Symptoms: Nodule
Clinical narrative: there was a nodule in his neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: NODULE (non-serious), outcome "unknown", described as "there was a nodule in his neck".  Additional information: Reporter was called on behalf her husband who received the Pfizer biotech covid-19 vaccine and after that they realized that there was a nodule in his neck and it was not there before the vaccination and wants to know if this side effect has been reported before. Reaction / Event as Reported  was Nodule in neck, Caller just wanted to see if that's an event and then how to get it resolved because it doesn't seem to be dissipating. Clarifies patient is a Psychologist.  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, SARS-CoV-2 test
Clinical narrative: COVID-19; 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 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. 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: Unknown results, notes: Treatment of COVID-19. 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.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngitis, Pain, Pyrexia
Clinical narrative: I tested positive for COVID 19 via a home testing kit on 22May2022; I tested positive for COVID 19 via a home testing kit on 22May2022; Fever; Ache; cold symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient of unspecified age/gender received COVID-19 immunisation with the first dose of BNT162B2 (COMIRNATY, solution for injection; batch/lot and expiry information not provided) as a single dose via unspecified route on an unspecified date; a second dose of BNT162B2 (COMIRNATY solution for injection; batch/lot and expiry information not provided) as a single dose via unspecified route on an unspecified date; and a third (booster) dose of BNT162B2 (COMIRNATY, solution for injection; batch/lot and expiry information not provided) as a single dose via unspecified route on 21Dec2021. There was no medical history or concomitant medications reported. The patient reported that he/she tested positive for COVID-19 via a home testing kit on 22May2022. The patient mentioned that he/she was certain that the caught in on an airline flight on 15May2022. The patient reported that the symptoms were minor and included fever and aches lasting approximately 12 hours, followed by cold symptoms that lasted three days. The patient reported that he maintained CDC guidelines on quarantining and masking. Treatment details, if any, were not reported. The outcome of the events Fever and Aches was recovered on an unspecified date in May2022 after approximately twelve hours. The outcome of the event cold symptoms was recovered on an unspecified date in May2022 after three days. The outcome of the events I tested positive for COVID 19 via a home testing kit on 22May2022 was unknown.   The information on the batch/lot number for [BNT162B2], has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: I tested positive for COVID 19 via a home testing kit on 22May2022; I tested positive for COVID 19 via a home testing kit on 22May2022; Fever; Ache; cold symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient of unspecified age/gender received COVID-19 immunisation with the first dose of BNT162B2 (COMIRNATY, solution for injection; batch/lot and expiry information not provided) as a single dose via unspecified route on an unspecified date; a second dose of BNT162B2 (COMIRNATY solution for injection; batch/lot and expiry information not provided) as a single dose via unspecified route on an unspecified date; and a third (booster) dose of BNT162B2 (COMIRNATY, solution for injection; batch/lot and expiry information not provided) as a single dose via unspecified route on 21Dec2021. There was no medical history or concomitant medications reported. The patient reported that he/she tested positive for COVID-19 via a home testing kit on 22May2022. The patient mentioned that he/she was certain that the caught in on an airline flight on 15May2022. The patient reported that the symptoms were minor and included fever and aches lasting approximately 12 hours, followed by cold symptoms that lasted three days. The patient reported that he maintained CDC guidelines on quarantining and masking. Treatment details, if any, were not reported. The outcome of the events Fever and Aches was recovered on an unspecified date in May2022 after approximately twelve hours. The outcome of the event cold symptoms was recovered on an unspecified date in May2022 after three days. The outcome of the events I tested positive for COVID 19 via a home testing kit on 22May2022 was unknown.   The information on the batch/lot number for [BNT162B2], has been requested and will be submitted if and when received.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Subarachnoid haemorrhage
Clinical narrative: Spontaneous severe bilateral subarachnoid bleed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), on 18Oct2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 50 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EL0142, Location of injection: Arm Right), administration date: 10Jan2021, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EK5730, Location of injection: Arm Right), administration date: 20Dec2020, for COVID-19 immunization. The following information was reported: SUBARACHNOID HAEMORRHAGE (hospitalization, medically significant, life threatning) with onset 11Apr2022, outcome "unknown", described as "Spontaneous severe bilateral subarachnoid bleed". The patient was hospitalized for subarachnoid haemorrhage (hospitalization duration: 16 day(s)). The event "spontaneous severe bilateral subarachnoid bleed" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Apr2022) Negative. Therapeutic measures were taken as a result of subarachnoid haemorrhage.  Case Narrative: Spontaneous severe bilateral subarachnoid bleed, etiology unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Device Date: 31May2022.
Sex: F
Vaccine: PNC20
Symptoms: Vaccination site mass
Clinical narrative: A patient received Prevnar 20 in 17May and since then she developed a lump in her arm; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 17May2022 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE MASS (non-serious) with onset 17May2022, outcome "unknown", described as "A patient received Prevnar 20 in 17May and since then she developed a lump in her arm". The action taken for pneumococcal 20-val conj vac (dipht CRM197 protein) was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Patient reported getting Covid on 31May2022; Patient reported getting Covid on 31May2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 52-year-old male patient received BNT162b2 (BNT162B2), on 24Jan2021 as dose 1, single (Lot number: el3302), on 04Feb2021 as dose 2, single (Lot number: EL9264) and on 01Dec2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 52 years 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), SUSPECTED COVID-19 (medically significant) all with onset 31May2022, outcome "recovering" and all described as "Patient reported getting Covid on 31May2022". It was unknown if therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Follow-up (02Jun2022): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Hypoacusis, Illness, Nausea
Clinical narrative: having a hard time hearing the agent cause she is on a hearing aid; dizziness; no appetite; nausea; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 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: HYPOACUSIS (non-serious), outcome "unknown", described as "having a hard time hearing the agent cause she is on a hearing aid"; DIZZINESS (non-serious), outcome "unknown"; DECREASED APPETITE (non-serious), outcome "unknown", described as "no appetite"; NAUSEA (non-serious), outcome "unknown"; ILLNESS (non-serious), outcome "unknown", described as "sick".  Additional information: Reaction, Event as Reported: Horrible side effects.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Diffuse pain throughout the body; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29May2022 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN oral. Vaccination history included: Covid-19 vaccine (DOSE: 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE: 2, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE: 1, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: PAIN (non-serious) with onset 30May2022, outcome "recovered", described as "Diffuse pain throughout the body". Therapeutic measures were not taken as a result of pain.  Additional information: Facility type vaccine was Pharmacy or Drug Store. The patient had no other vaccine in four weeks. Other medications in two weeks included Gabapentin. The patient had no Covid prior vaccination. The patient was not Covid tested post vaccination. Known allergies are Unknown.   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: 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 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Batch/Lot number: unknown), on 09Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 12Nov2021 as dose 3 (booster), 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 patient did not receive any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.  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". The patient had a return of symptoms and infected my husband on day 12 after testing positive. The patient had previously tested negative then removed her mask and infected him. The patient had a return of symptoms that lasted quite a while. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: previously tested negative; (2022) positive. Therapeutic measures were taken as a result of covid-19. The patient took Paxlovid for COVID 19 Treatment. The start date of the treatment was 18Apr2022 and stop date was 23Apr2022.  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, 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) (Nurse).  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 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: "Type 2 Diabetes" (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 May2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22May2022) Negative; (May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Did you/the patient previously receive a COVID-19 Vaccine: Yes. Reported Event: 24May2022 Had head cold symptoms after completing Paxlovid treatment and testing negative on 22May2022. Tested positive on rapid test as well.  known allergies: None  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Husband only experienced headaches as a side effect of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:   A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "leukemia" (unspecified if ongoing), notes: She also mentioned that her husband has leukemia. The patient's concomitant medications were not reported.  The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Husband only experienced headaches as a side effect of the vaccine".  Clinical course: Reporter also mentioned that her husband only experienced headaches as a side effect of the vaccine, and he has leukemia.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 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: "High Blood Pressure" (unspecified if ongoing); "Penicillian allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. 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, COVID19
Symptoms: COVID-19, Drug ineffective
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 69-year-old male patient received BNT162b2 (BNT162B2), on 06Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years 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 included: "Diabetes II" (unspecified if ongoing), notes: Other medical history: Diabetes II (For 25 years). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 18May2022 to 22May2022 for the treatment of COVID-19. after 5 days from the date of last Paxlovid pills Virus reappeared.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: En6201), in left arm, on 14Mar2021 as dose 2, single (Lot number: En6206), in left arm and on 04Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood sugar" (unspecified if ongoing); "Melanoma" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN, start date: 24Jan2022; LIPITOR, start date: 01Jan2017, stop date: 18May2022. Past drug history included: Bacitracin, reaction(s): "Known allergies: Bacitracin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Still testing positive using at home antigen test 5 days after onset of second set of symptoms; Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received other medication in 2 weeks. COVID 19 Treatment: Paxlovid, treatment start date: 18May2022 and stop date: 22May2022. On 26May2022, reoccurrence of nasal congestion and fatigue 4 days after completing 5 day course of Paxlovid. Still testing positive using at home antigen test 5 days after onset of second set of symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jan2021 as dose 1, single (Lot number: EL3248), in left arm, on 03Feb2021 as dose 2, single (Lot number: EL3247), in left arm and on 13Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), 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: Unknown Results; Positive, notes: I had a serious rebound of COVID Required ER visit for vomiting, diarrhea, nausea, consistent fever of 102-103 for 4 days. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medication in 2 weeks was reported as yes.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Developed Covid symptoms 19May2022, positive home test 20May2022; Developed Covid symptoms 19May2022, positive home test 20May2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Feb2021 at 12:45 as dose 1, single (Lot number: EN5318), on 08Mar2021 at 10:00 as dose 2, single (Lot number: EL9269) and on 30Sep2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 67 years for covid-19 immunization. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: May2019; CETIRIZINE HYDROCHLORIDE, start date: Mar2012; NASACORT, start date: May2018; HCTZ, start date: 15Nov2021; AMLODIPINE, start date: 08Feb2022; LUTEIN ZEAXANTHIN; VITAMIN D3; CALCIUM WITH VITAMIN D [CALCIUM CARBONATE; COLECALCIFEROL]; MAGNESIUM; MELATONIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20May2022, outcome "unknown" and all described as "Developed Covid symptoms 19May2022, positive home test 20May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) Positive; (26May2022) Positive, notes: very light positive line; (27May2022) Positive, notes: very light positive line; (31May2022) very dark line, notes: very dark line. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course Developed Covid symptoms 19May2022, positive home test 20May2022, ill on 19May2022, 20May2022, 21May2022. Took Paxlovid on 20May2022 - 25May2022. Home test on 26May2022 or 27May2022, very light positive line.Cold /allergy symptoms on 29 May2022, 30 May2022 and 31 May2022. Home test on 31May2022 very dark line. No Known allergies were reported. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.