chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19, 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) (Physician). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 03May2021 as dose 2, single (Lot number: EW0167), in left arm and on 03Dec2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 59 years, in left arm 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: "mildly raised cholesterol" (unspecified if ongoing); "hay fever" (unspecified if ongoing); "coeliac disease" (unspecified if ongoing), notes: Known allergies: coelic disease. Concomitant medication(s) included: LORATADINE, start date: Jan2007, stop date: 28May2022; ATORVASTATIN, start date: Jan2020. The following information was reported: VACCINATION FAILURE (medically significant) with onset 28May2022, outcome "unknown", COVID-19 (medically significant) with onset 28May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28May2022) Positive; (01Jun2022) Positive, notes: Antigen test weakly positive days 5 and 6; (02Jun2022) Positive, notes: Antigen test weakly positive days 5 and 6; (03Jun2022) Negative, notes: Antigen test weakly positive days 5 and 6, negative day 7 (03Jun2022); (04Jun2022) Positive, notes: On day 8 after treatment start (04Jun2022) test was positive again; (06Jun2022) Positive, notes: Antigen test strongly positive on day 10 (within 1 minute). Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Paxlovid rebound Symptoms started 27May2022. Paxlovid started on 28May2022 after positive test that day. Symptoms that day were of cough, runny nose, blocked sinuses and sore throat. Briefly had tachycardia of 105 on first day of treatment. Symptoms resolved on day 4. Antigen test weakly positive days 5 and 6, negative day 7 (03Jun2022) On day 8 after treatment start (04Jun2022) test was positive again. Symptoms except tachycardia returned on day 9 but less severe so far. Antigen test strongly positive on day 10 (within 1 minute) product COVID 19 Treatment, brand Paxlovid, treatment start date 28May2022, treatment stop date 01Jun2022, Lot number GA5120.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A female patient (age: 65 unit not reported, not pregnant) received BNT162b2 (BNT162B2), on 09May2022 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Patient had no 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 "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid treatment from 23May2022 to 27May2022 orally for covid-19. Patient did not received any other medication within 2 weeks.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 68.0
Sex: M
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) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Lot number: 939909) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 immunization. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29May2022) positive, notes: On Sunday 5/29 I had no symptoms, tested positive. On Wed. 6/1; (01Jun2022) negative, notes: tested negative. On Sunday, 6/5,; (05Jun2022) positive, notes: woke up with head cold and dry cough, tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient took Pfizer anti viral drug from 24May2022 to 29May2022 for treatment of COVID-19. Adverse event reported as On Sunday 29May patient had no symptoms, tested positive. On Wed. 01Jun, tested negative. On Sunday, 05Jun, woke up with head cold and dry cough, tested positive. Event occurred on 05Jun2022. Patient was recovering without treatment. Known allergies was reported. Patient did not take any other medication within 2 weeks. Vaccine administration time was reported as 02:00 PM.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Contracted COVID; Contracted COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 56-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "heart disease" (unspecified if ongoing); "obesity" (unspecified if ongoing). There were no known allergies. No other vaccine in four weeks. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 05Jun2022 at 14:30, outcome "recovering" and all described as "Contracted COVID". The event "contracted covid" required physician office visit. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The patient received treatment with monoclonal antibodies.  Clinical course: The patient did not have covid prior vaccination and did not tested post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Indication for use in the case: Treatment of COVID-19; Indication for use in the case: Treatment of COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) via a Pfizer sales representative.  A 71-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HLDL" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN oral. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Indication for use in the case: Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Patient was treated with oral Paxlovid from 21May2022 to 26May2022 for Covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
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) (Nurse) from product quality group. The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jan2021 as dose 1, single (Lot number: EL0140), in right arm, on 29Jan2021 as dose 2, single (Lot number: EL3249), in right arm and on 29Sep2021 as dose 3 (booster), single (Lot number: FB3592) at the age of 50 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "DM" (unspecified if ongoing); "NASH" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "HTN" (unspecified if ongoing); "cardiac arrhythmia with past ablations" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Cipro, reaction(s): "Allergy"; Dilauded, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jun2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (06Jun2022) Positive, notes: Tested positive with home antigen test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Took last doses of Paxlovid felt better symptoms resolved. Tested negative with home antigen testing 3 days later. Then on 06Jun2022 began feeling Ill sore throat, headache, nasal congestion , fatigue. Tested positive with home antigen test x's 2.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported event Covid-19, vaccination failure and the administration of the vaccine cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Indication for use in the case: Treatment of COVID-19; Indication for use in the case: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Lot number: EH9899), in right arm, on 11Jan2021 as dose 2, single (Lot number: EK4176), in right arm, on 18Aug2021 as dose 3 (booster), single (Lot number: FC3180), in right arm and on 01Feb2022 as dose 4 (booster), single (Lot number: FK9729) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Variable Immunodeficiency Disorder" (unspecified if ongoing), notes: On weekly immunoglobulin; "Known allergies" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS oral. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16May2022, outcome "not recovered" and all described as "Indication for use in the case: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30May2022) Negative, notes: had negative antigen test on 30May22; (06Jun2022) Positive, notes: Still positive on 06Jun22 and symptoms still present. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Eliquis orally as medication in 2weeks. Rebound infection. Initial symptoms on 16May2022. Started Paxlovid started afternoon of 17May2022 and completed on morning of 22May2022 as treatment for covid-19. Symptoms improved over the next week and had negative antigen test on 30May2022. Recurrent cough, diarrhea, fatigue on 02Jun2022 and antigen test again positive. Still positive on 06Jun2022 and symptoms still present.; Sender's Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162b2 to the development of events vaccination failure and COVID-19 cannot be excluded.  The case will be reassessed if additional information becomes available.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for Covid-19 the morning of 5/23/22; tested positive for Covid-19 the morning of 5/23/22; 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 04Feb2021 as dose 1, single (Lot number: EL9264), in right arm, on 25Feb2021 as dose 2, single (Lot number: EN6203), in right arm, on 27Sep2021 as dose 3 (booster), single (Lot number: 301308A), in right arm and on 05Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 68 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: BUPROPION HCL XL, start date: 01Jan2022; ROSUVASTATIN, start date: 01Jan2022, stop date: 23May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23May2022, outcome "recovering" and all described as "tested positive for Covid-19 the morning of 5/23/22". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23May2022) Positive; (29May2022) Negative; (02Jun2022) positive; (04Jun2022) Negative; (06Jun2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medication in 2weeks. Pfizer Paxlovid for COVID 19 Treatment; Treatment start date: 23May2022; Treatment stop date: 28May2022. Bupropion HCL XL 300mg, started on 01Jan2022. Rosuvastatin brand from torrent started on 01Jan2022 stopped on 23May2022. I tested positive for Covid-19 the morning of 23May2022. I called my doctor and he prescribed Paxlovid. I started taking that medication the evening of 23May and finished the morning of 28May. Tested negative for Covid on 29May. Continued to wear mask per CDC through 02Jun2022. But, tested positive for Covid on 02Jun2022 and again on 23Jun. Tested negative for Covid on 04Jun2022 and again on 06Jun2022.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Arthralgia, COVID-19, Drug ineffective, Gastric pH decreased
Clinical narrative: Indication for use in the case: Treatment of COVID-19; Indication for use in the case: Treatment of COVID-19; Headache; excess stomach acid and stomach ache; excess stomach acid and stomach ache; soreness at site of hip replacement; soreness at site of hip replacement; hot flashes; 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 27Sep2021 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 02Jun2022, outcome "not recovered"; ABDOMINAL PAIN UPPER (non-serious), GASTRIC PH DECREASED (non-serious) all with onset 02Jun2022, outcome "not recovered" and all described as "excess stomach acid and stomach ache"; HOT FLUSH (non-serious) with onset 02Jun2022, outcome "not recovered", described as "hot flashes"; HIP ARTHROPLASTY (non-serious), ARTHRALGIA (non-serious) all with onset 02Jun2022, outcome "not recovered" and all described as "soreness at site of hip replacement"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Indication for use in the case: Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, headache, abdominal pain upper, gastric ph decreased, hip arthroplasty, arthralgia, hot flush.  Clinical course: Anti viral details, Paxlovid, Treatment start date: 26May2022 and Treatment stop date: 31May2022. Indication: Treatment of COVID-19. Headache, excess stomach acid and stomach ache, soreness at site of hip replacement, hot flashes treatment included Zofran.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hip arthroplasty, Hot flush
Clinical narrative: Indication for use in the case: Treatment of COVID-19; Indication for use in the case: Treatment of COVID-19; Headache; excess stomach acid and stomach ache; excess stomach acid and stomach ache; soreness at site of hip replacement; soreness at site of hip replacement; hot flashes; 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 27Sep2021 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 02Jun2022, outcome "not recovered"; ABDOMINAL PAIN UPPER (non-serious), GASTRIC PH DECREASED (non-serious) all with onset 02Jun2022, outcome "not recovered" and all described as "excess stomach acid and stomach ache"; HOT FLUSH (non-serious) with onset 02Jun2022, outcome "not recovered", described as "hot flashes"; HIP ARTHROPLASTY (non-serious), ARTHRALGIA (non-serious) all with onset 02Jun2022, outcome "not recovered" and all described as "soreness at site of hip replacement"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Indication for use in the case: Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, headache, abdominal pain upper, gastric ph decreased, hip arthroplasty, arthralgia, hot flush.  Clinical course: Anti viral details, Paxlovid, Treatment start date: 26May2022 and Treatment stop date: 31May2022. Indication: Treatment of COVID-19. Headache, excess stomach acid and stomach ache, soreness at site of hip replacement, hot flashes treatment included Zofran.  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: I tested and also got a positive; I tested and also got a positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EL9269), in right arm, on 02Mar2021 as dose 2, single (Lot number: FH8020), in right arm, on 12Oct2021 as dose 3 (booster), single (Lot number: FH8020), in right arm and on 06Apr2022 as dose 4 (booster), single (Lot number: FM0698), in right arm for covid-19 immunisation. The patient's relevant medical history included: "heart arrhythmias" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN, stop date: 17May2022; VENLAFAXINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I tested and also got a positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Other medication in 2weeks reported as yes. Patient's covid symptoms started on 17May2022. Patient's husband had a positive antigen test that day, so patient tested and also got a positive. Patient started Paxlovid two days later so that patient could stop taking simvastatin two days prior to start of Paxlovid. Patient's covid symptoms were body aches, chills and fatigue, lasting for 5 days. On day 13, patient started symptoms of a head cold and got a positive antigen test. These symptoms lasted 5 days. Patient did a second full quarantine. other medication in 2weeks product reported as simvastatin and venlafaxine. Treatment started on 19May2022 and stop on 24May2022.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable healthcare professional (HCP). A 46-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergy: Iodinated contrast media" (unspecified if ongoing); "Fatty liver" (unspecified if ongoing); "overweight" (unspecified if ongoing). There were no concomitant medications. Patient did not receive other medication in 2weeks. It was reported that patient initially tested 24May2022 and given oral Paxlovid from 24May2022 to 29May2022. Completed treatment and symptoms resolved. Symptoms returned 06Jun2022 with a new positive test on 06Jun2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2022) Positive; (06Jun2022) Positive. Outcome of the events was recovered.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the reported events cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Feeling hot, Syncope
Clinical narrative: Fainting; Back pain; she was little warm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16-year-old female patient received BNT162b2 (BNT162B2), on 04Jun2022 as dose number unknown (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: SYNCOPE (medically significant), outcome "unknown", described as "Fainting"; BACK PAIN (non-serious), outcome "unknown"; FEELING HOT (non-serious), outcome "unknown", described as "she was little warm".  Clinical Information:Reporter stated, Yes, I think it's a question and a record actually.Before, yesterday she had the boost for COVID Vaccine. So, Yesterday she felt like fainting, fainted and we brought her home she slept, she was little warm but today she is complaining a lot of back pain.When paraphrased the concern: Reporter stated, Yes, she got her booster the day before yesterday.Other Concomitant Medication: Reporter stated, No. She take multi vitamin. She was taking it for extra medication but she is not taking it right now.No treatment was received for adverse event.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 05Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 04Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Patient had no known allergies. 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: (unspecified date) Unknown Results, notes: Product: COVID 19 Treatment; (05Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient did not received other medication in 2 weeks. Treatment start date: 29May2022, Treatment stop date: 02Jun2022, After taking all the pills as directed and treating at home with very faint line for positive on the 3rd test the test lone was very bold and symptoms returned just as when first.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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 68-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "MI" (unspecified if ongoing); "stroke" (unspecified if ongoing); "afib" (unspecified if ongoing); "cardiomyopathy" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Known allergies: iodine based contrast, reaction(s): "Known allergies: Iodine based contrast", notes: Known allergies: Iodine based contrast; Known allergies: keflex, reaction(s): "Known allergies: Keflex", notes: Known allergies: Keflex; Known allergies: opioids, reaction(s): "Known allergies: opioids", notes: Known allergies: opioids. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED 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: COVID 19 Treatment; Negative, notes: Paxlovid rebound 5 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Patient had received vaccine. Had other medications in two weeks which were too many to list. Patient had COVID-19 treatment from 26May2022, to 01Jun2022. Vaccine lot unknown reason: Misplaced/discarded. Patient had Paxlovid rebound 5 days after testing negative on 07Jun2022 04:30 AM. Outcome was not recovered and did not receive treatment.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment/ positive PCR on the 25th; COVID 19 Treatment/ positive PCR on the 25th; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 49 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: "Follicular lymphoma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Levothyroxine, start date: 01Mar2015. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25May2022, outcome "unknown" and all described as "COVID 19 Treatment/ positive PCR on the 25th". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2022) Negative, notes: had a negative antigen test on the 24th,; (25May2022) Positive, notes: but positive PCR on the 25th. Therapeutic measures were taken as a result of covid-19 which include Paxlovid via Oral route from early hours of 26May2022 to 30May2022.   Clinical course: The patient did not have COVID prior to this. He began to feel unwell overnight on 23May2022. His symptoms were initially a sore throat (brief), fevers, significant body aches, fatigue, and SOB.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.
Age: 40.0
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) (Other HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 as dose 1, single (Batch/Lot number: unknown), on 05May2021 as dose 2, single (Batch/Lot number: unknown) and on 11Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Lobster allergy" (unspecified if ongoing); "Bees allergy" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing). The patient's concomitant medications and other medications the patient received in 2 weeks were unknown. 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: (2022) Positive, notes: I have tested positive for COVID; (2022) Negative, notes: I tested negative twice; (2022) Negative, notes: I tested negative twice. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 24May2022 to 29May2022. The patient tested negative twice after taking 5 days after completing Paxlovid. Now, 8 days later, the patient had tested positive for COVID. She now had a cough as well.  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 the known product safety profile a causal relationship between the reported events, COVID 19, Vaccination failure and BNT162B2 is considered possible.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 59-year-old patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes & HBP" (unspecified if ongoing); "HBP" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 03Jun2022, latency 20 days after the suspect product(s) administration, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course:No other medication in 2 weeks. Anti-viral Treatment of COVID-19 started on 14May2022 and stopped on 15May2022. Adverse event started on 03Jun2022 were severe cold/flu/covid symptoms. Sore throat, productive cough, asthma exacerbation & headache. No known allergies were reported.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
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 contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2022 as dose 4 (booster), single (Lot number: fic9729) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 1, single (Lot number: 011l20a), in left arm, on 03Feb2021 as dose 2, single (Lot number: 030l20a), in left arm and on 16Aug2021 as dose 3 (booster), single (Lot number: 0939902), in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "bp" (unspecified if ongoing); "depression" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "Interchange of vaccine product" (unspecified if ongoing). Concomitant medication(s) included: PRIMIDONE; ATORVASTAN; WELLBUTRIN; CELEXA [CELECOXIB]; MONTELUKAST; CITALOPRAM; LISINOPRIL; ZINC; VITAMIN D3; RESVERATROL [REYNOUTRIA JAPONICA;VITIS VINIFERA]; VIT C. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26May2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jun2022) negative, notes: tested on Friday, after 5 day treatment with Paxlovid; (05Jun2022) negative, notes: tested on Sunday, after 5 day treatment with Paxlovid; (07Jun2022) Positive, notes: tested positive again; (2022) Positive, notes: unknown date. Therapeutic measures were taken as a result of drug ineffective, covid-19. The clinical course was reported as the patient stated that she was fully vaccinated with Pfizer's COVID-19 Vaccine and tested positive for COVID-19. The patient came down with COVID-19 on 26May2022. Her doctor prescribed Paxlovid and she took it for 5 days. Treatment start date was 26May2022 and stop date was 31May2022. Afterwards She had 2 negative tests on friday and sunday. However, today on 07Jun2022 she tested positive again and she was not feeling good. She would like to report this COVID rebound and reported that her head was killing her. She also has a runny nose and some ear pain when she coughs.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
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) (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 27Nov2021 as dose 3 (booster), single (Lot number: EW0196) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15Mar2021 as dose 1, single (Lot number: 001B21A), in left arm and on 12Apr2021 as dose 2, single (Lot number: 042B21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SPIRONOLACTONE. 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: (06Jun2022) Positive, notes: positive test noted on Day 9 post treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other concomitant medication of the patient includes Women's Health Vitamin. Patient had COVID-19 treatment with Paxlovid from 23May2022 to 28May2022.
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Joint swelling, SARS-CoV-2 test
Clinical narrative: now feels like arthritic knee; Left knee swollen; 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 male patient received BNT162b2 (BNT162B2), on 01Jun2022 as dose 3 (booster), single (Lot number: el3249), in left arm for covid-19 immunisation. The patient's relevant medical history included: "heart disease" (unspecified if ongoing), notes: heart disease; "Known allergies: milk proteens" (unspecified if ongoing), notes: milk proteens. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: efj4989, Anatomical location: arm Left), administration date: 21Jan2021, when the patient was 66-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot number: EL9265, Anatomical location: arm Left), administration date: 10Feb2021, when the patient was 66-year-old, for Covid-19 immunization. The following information was reported: JOINT SWELLING (non-serious) with onset 02Jun2022, outcome "recovered with sequelae", described as "Left knee swollen"; ARTHRITIS (non-serious) with onset 02Jun2022, outcome "recovered with sequelae", described as "now feels like arthritic knee". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of arthritis, joint swelling.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 09Apr2022 as dose 4 (booster), single (Lot number: FK9896) at the age of 67 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "SVT" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Known allergies: Sulfa" (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 06Jun2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: three negative COVID antigen tests; (unspecified date) Negative, notes: three negative COVID antigen tests; (unspecified date) Negative, notes: three negative COVID antigen tests; (unspecified date) Unknown results, notes: COVID 19 Treatment; (06Jun2022) Positive, notes: antigen test was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: After three negative COVID antigen tests symptoms returned and antigen test was positive. This was four days after finishing my course of Paxlovid. I am fully vaccinated with two vaccinations and two boosters. The patient was treated with anti-viral drug of Paxlovid from 28May2022 to 02Jun2022 for COVID-19.  No follow-up attempts possible. No further information expected.
Age: 68.0
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 contactable reporter(s) (Consumer or other non-HCP) from product quality group. The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 27Sep2021 as dose 3 (booster), single (Lot number: 30130BA), in right arm and on 07Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 68 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 was not reported. There were no concomitant medications. 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: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The did not received any other medication in 2 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19/I got covid again; Treatment of COVID-19/I got covid again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovering" and all described as "Treatment of COVID-19/I got covid again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not receive any other medications within 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Diarrhoea, Headache, Hyperhidrosis
Clinical narrative: Covid-19; chills; fever; headaches; body aches; muscle aches; vomitting; diarhea; sweating; This is a spontaneous report received from 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 03Jun2022 at 09:15 as dose 1, single (Batch/Lot number: unknown) at the age of 47 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Diclofenac, reaction(s): "Known allergies: Diclofenac", notes: Known allergies: Diclofenac. The following information was reported: PAIN (non-serious) with onset 03Jun2022 at 23:00, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 03Jun2022 at 23:00, outcome "recovering"; DIARRHOEA (non-serious) with onset 03Jun2022 at 23:00, outcome "recovering", described as "diarhea"; PYREXIA (non-serious) with onset 03Jun2022 at 23:00, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 03Jun2022 at 23:00, outcome "recovering", described as "headaches"; MYALGIA (non-serious) with onset 03Jun2022 at 23:00, outcome "recovering", described as "muscle aches"; HYPERHIDROSIS (non-serious) with onset 03Jun2022 at 23:00, outcome "recovering", described as "sweating"; VOMITING (non-serious) with onset 03Jun2022 at 23:00, outcome "recovering", described as "vomitting"; COVID-19 (non-serious) with onset 07Jun2022, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia, headache, pain, myalgia, vomiting, diarrhoea, hyperhidrosis.  Additional Information: Patient did not receive other vaccine in four weeks. Patient had not COVID prior vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: Covid-19; chills; fever; headaches; body aches; muscle aches; vomitting; diarhea; sweating; This is a spontaneous report received from 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 03Jun2022 at 09:15 as dose 1, single (Batch/Lot number: unknown) at the age of 47 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Diclofenac, reaction(s): "Known allergies: Diclofenac", notes: Known allergies: Diclofenac. The following information was reported: PAIN (non-serious) with onset 03Jun2022 at 23:00, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 03Jun2022 at 23:00, outcome "recovering"; DIARRHOEA (non-serious) with onset 03Jun2022 at 23:00, outcome "recovering", described as "diarhea"; PYREXIA (non-serious) with onset 03Jun2022 at 23:00, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 03Jun2022 at 23:00, outcome "recovering", described as "headaches"; MYALGIA (non-serious) with onset 03Jun2022 at 23:00, outcome "recovering", described as "muscle aches"; HYPERHIDROSIS (non-serious) with onset 03Jun2022 at 23:00, outcome "recovering", described as "sweating"; VOMITING (non-serious) with onset 03Jun2022 at 23:00, outcome "recovering", described as "vomitting"; COVID-19 (non-serious) with onset 07Jun2022, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia, headache, pain, myalgia, vomiting, diarrhoea, hyperhidrosis.  Additional Information: Patient did not receive other vaccine in four weeks. Patient had not COVID prior vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.