chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
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 female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Feb2021 at 14:00 as dose 2, single (Batch/Lot number: unknown) 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) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No known allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. COVID-19 Treatment included Paxlovid from 11Jul2022 to 16Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 38.0
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 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EL9269), on 26Feb2021 as dose 2, single (Lot number: EN6202) and on 01Oct2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetes" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: HUMALOG, start date: Jan2001. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: After testing negative for 5 days; Positive; Positive, notes: I tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 at 11:30 as dose 1, single (Lot number: EL9267), in left arm, on 10Mar2021 at 11:30 as dose 2 , single (Lot number: EN6199), in left arm, on 27Sep2021 at 13:00 as dose 3 (booster) single (Lot number: FC3181), in right arm and on 02Apr2022 at 12:00 as dose 4 (booster), single (Lot number: TK9698) at the age of 77 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "frontal fibrosing alopecia" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing). Concomitant medication(s) included: ACETAMINOPHEN, start date: 30Jun2022, stop date: 07Aug2022. Past drug history included: Soma - causes GI upset, reaction(s): "causes GI upset". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Jul2022, outcome "recovered" (28Jul2022) and all described as "Treatment of COVID-19". The event "treatment of covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: tested negative for about two days; Positive, notes: tested positive; Negative, notes: tested negative again. Therapeutic measures were taken as a result of vaccination failure, covid-19. COVID-19 Treatment included Paxlovid from 05Jul2022 to 10Jul2022. The patient had a rebound case of COVID-19. The patient was diagnosed on 05Jul2022, after developing a cough and an upper respiratory infection. She went to a walk-in clinic and given Paxlovid, which she finished on 10Jul2022. That got rid of the cough. She still had a runny nose and felt weak. She tested negative for about two days and started feeling lousy. She tested positive and went to another walk-in clinic and received a prescription for Lagevrio. She finished the 5-day course of Lagevrio and tested negative again. It has taken her almost a month to regain her strength and not feel tired all the time. She still have a lingering cough.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 test Positive; COVID-19 test Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2022 as dose 4 (booster), single (Lot number: PFR FIC 9893) at the age of 83 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 included: "CLL" (unspecified if ongoing); "HBP" (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 22Jul2022, outcome "not recovered" and all described as "COVID-19 test Positive". No Known allergies. Patient tested positive for Covid on 22Jul2022. Patient started Paxlovid and took it for 5 days. On 02Aug2022 Patient tested positive again for Covid and had all the same symptoms as the first time. AE resulted in: None of the above. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jul2022) Positive; (02Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 64.0
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 contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 at 16:30 as dose 1, single (Lot number: EN6203), in right arm, on 01Apr2021 at 16:00 as dose 2, single (Lot number: EN6198), in right arm, on 09Oct2021 at 13:00 as dose 3 (booster), single (Lot number: 301458A), in right arm and on 11Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FK9896) at the age of 64 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient had no other medication in 2weeks. Past drug history included: Allergic to bactrim, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The event "covid 19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jul2022) Negative, notes: Tested negative on fourth day of medication; (30Jul2022) Negative, notes: continued to test negative days 5-8; (31Jul2022) Negative, notes: continued to test negative days 5-8; (01Aug2022) Negative, notes: continued to test negative days 5-8; (02Aug2022) Negative, notes: continued to test negative days 5-8; (03Aug2022) Positive, notes: then tested positive on day nine; (08Aug2022) Positive, notes: testing positive on day 14. Therapeutic measures were taken as a result of covid-19 included Paxlovid from 25Jul2022 to 30Jul2022.
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 a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 25-year-old male patient received BNT162b2 (BNT162B2), on 30Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 20Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: dairy" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Rebound covid beginning 5 days post finishing paxlovid treatment. Rebound lasted for 5 days before testing negative again. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: Rebound lasted for 5 days before testing negative again; Negative, notes: before testing negative again. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received COVID-19 treatment with Paxlovid from 29Jun2022 to 03Jul2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and vaccination failure cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and vaccination failure  is : expected. The case will be reassessed further upon receipt of additional information.
Age: 58.0
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 contactable reporter(s) (Other HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Aug2021 at 16:30 as dose 1, single (Lot number: FC3180), in right arm and on 03Sep2021 at 17:00 as dose 2, single (Lot number: FC3182) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Immune disorder" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "gerd" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL, start date: 01Nov2021; BUSPIRONE, start date: 01Nov2021; ROSUVASTATIN, start date: 01Sep2019; ESOMEPRAZOLE, start date: 01Sep2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 with anti viral started on 27Jul2022 and stopped on 01Aug2022.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and the suspect drug BNT162B2.
Age: 70.0
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 (Consumer or other non- HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EL9629), on 26Feb2021 as dose 2, single (Lot number: EN6200), on 25Sep2021 as dose 3 (booster), single (Lot number: FF2588), in right arm and on 08Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Spinal stenosis" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing), notes: known allergies: sulfa. Concomitant medication(s) included: LISINOPRIL; GABAPENTIN. 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: (unspecified date) Positive; (2022) Negative; (2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included pf-07321332, ritonavir (PAXLOVID) with treatment start date: 30Jun2022 and treatment stop date: 04Jul2022.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
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 (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EL9262), in left arm, on 23Feb2021 as dose 2, single (Lot number: EN6200), in left arm, on 18Aug2021 as dose 3 (booster), single (Lot number: FC3181), in left arm, on 03Jan2022 as dose 4 (booster), single (Lot number: FK9729), in left arm and on 06Jun2022 as dose 5 (booster), single (Lot number: FM7653) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing), notes: Other medical history: Psoriasis and Psoriatic Arthritis; "Psoriatic Arthritis" (unspecified if ongoing), notes: Other medical history: Psoriasis and Psoriatic Arthritis. Concomitant medication(s) included: METHOTREXATE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 included PF-07321332, ritonavir (PAXLOVID) with treatment start date 17Jun2022 and stop date 22Jun2022.
Age: 57.0
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 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jun2022 as dose 3 (booster), single (Lot number: FM7553) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28Oct2021 as dose 2, single (Lot number: 014F2119), in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 16Mar2021 as dose 1, single (Lot number: 1805018), in left arm for covid-19 immunisation. The patient's relevant medical history included: "hEDS" (unspecified if ongoing), notes: Other medical history: hEDS; "POTS" (unspecified if ongoing), notes: Other medical history: POTS; "Exocrine pancreatic insufficiency" (unspecified if ongoing), notes: Other medical history: Exocrine pancreatic insufficiency; "hypothyroidism" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "vasomotor symptoms" (unspecified if ongoing), notes: Other medical history: vasomotor symptoms; "interstitial cystitis" (unspecified if ongoing), notes: Other medical history: interstitial cystitis. Concomitant medication(s) included: LEVOTHYROXINE SODIUM; CLONIDINE; DESMOPRESSIN; MIDODRINE; PYRIDOSTIGMINE; TIZANIDINE; AMITRIPTYLINE; CREON; GABAPENTIN; ESTRADIOL TRANSDERMAL; PROGESTERONE; TRAZODONE; CBD OIL; CALCIUM + MAGNESIUM; FISH OIL; DHEA; MELATONIN; THERMOTABS. Past drug history included: Percocet, reaction(s): "Known allergies: Percocet", notes: Known allergies: Percocet; Dilaudid, reaction(s): "Known allergies: Dilaudid", notes: Known allergies: Dilaudid; Cymbalta, reaction(s): "Known allergies: Cymbalta (sensitivity)", notes: Known allergies: Cymbalta (sensitivity). Other medication in 2 weeks product also included multi-vitamin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient took the paxlovid for 5 days (from 31Jul2022 to 04Aug2022); felt a bit better. Then all the symptoms came roaring back for the most part. The patient was still sick after Day 10. The patient was in another country when she got sick and took the paxlovid. The patient flew back to her home country when she thought she was better. The patient also reported adverse event country as her home country. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Indication-Treatment of COVID-19; Indication-Treatment of 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 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 12Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm and in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Indication-Treatment of COVID-19". 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. Treatment included nirmatrelvir/ritonavir (PAXLOVID) from 19Jul2022 to 23Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2021 as dose 1, single (Lot number: ER8735), in right arm, on 05May2021 as dose 2, single (Lot number: EW0176), in right arm and on 21Nov2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 51 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN [ATORVASTATIN CALCIUM], start date: Jan1997, stop date: 24Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (2022) Negative, notes: Took the medication as prescribed for 5 days. Tested negative for the next 2 days; (2022) Positive, notes: Day 3 had a scratchy throat and tested positive by that evening. Resulted in full covid infection (fever, congestion, cough) for the next 7 days; (2022) Negative, notes: I now tested negative 2 weeks and two days after first testing positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: It was reported that patient received the COVID-19 treatment with Paxlovid from 23Jul2022 to 27Jul2022. It was also reported that patient Took the medication as prescribed for 5 days. Tested negative for the next 2 days. Day 3 had a scratchy throat and tested positive by that evening. Resulted in full covid infection (fever, congestion, cough) for the next 7 days and again tested negative 2 weeks and two days after first testing positive.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngeal swab, Polymerase chain reaction
Clinical narrative: Nasal Swab Positive; Nasal Swab Positive; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 10-year-old female patient received BNT162b2 (BNT162B2), as dose 1 (orange cap), single (Batch/Lot number: unknown) and as dose 2 (orange cap), 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 07Aug2022, outcome "unknown" and all described as "Nasal Swab Positive". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (unspecified date) Positive; (07Aug2022) Positive; Polymerase chain reaction: (unspecified date) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
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 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 31Mar2021 as dose 2, single (Lot number: ER8733), in right arm, on 07Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 19Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Shellfish" (unspecified if ongoing), notes: Known allergies: Shellfish, mango; "Known allergies: Mango" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I continued to have symptoms and test positive for another 5 days; Positive, notes: I tested positive again; Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received vaccine. Patient did not receive any other medication in 2 weeks.
Age: 79.0
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 a contactable reporter(s) (Other HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 79 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive for COVID again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: From 25JUN2022 to 29JUN2022, patient received COVID 19 Treatment.  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 limited information in the case , a possible causal association between   the reported events and the suspect drug cannot be excluded.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 80 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 26Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 02Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; METFORMIN; TRAZODONE.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested negative; Positive, notes: then tested positive again after a couple of days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was treated with Paxlovid for COVID-19 from May2022 to May2022. The patient was on other medications in 2 weeks.
Age: 29.0
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 31-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 at 14:30 as dose 1, single (Lot number: ER8734), in left arm and on 22Apr2021 at 14:30 as dose 2, single (Lot number: EW0170) at the age of 29 years, in left leg for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 08Dec2021 at 14:30 as dose 3 (booster), single (Lot number: 060H21A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Erythromycin, reaction(s): "Known Allergies: Erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: After 3 days of testing negative; Positive, notes: began testing positive again; Positive, notes: Treatment of COVID-19. Therapeutic measures were not taken as a result of drug ineffective, covid-19.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Rebound - Tested positive after several days testing negative; interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Lot number: EN200), in right arm and on 21Mar2021 as dose 2, single (Lot number: EN6206) at the age of 62 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Nov2021 at 17:00 as dose 3 (booster), single (Lot number: 071F), in right arm and on 02May2022 at 15:00 as dose 4 (booster), single (Lot number: 027L21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Clear cell carcinoma, right kidney (removed 11Jul2022)" (unspecified if ongoing); "Obese (204#, 5'8")" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Clear cell carcinoma, right kidney (removed 11Jul2022)", start date: 11Jul2022, stop date: 11Jul2022. No known allergies. There were no concomitant medications in 2 weeks.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 03Nov2021 at 17:00, outcome "unknown"; DISEASE RECURRENCE (medically significant) with onset 12Jun2022 at 17:00, outcome "recovered" (17Jun2022), described as "Rebound - Tested positive after several days testing negative"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient received paxlovid from 30May2022 to 03Jun2022 as treatment of COVID-19. On 12Jun2022 17:00, the patient experienced rebound - tested positive after several days testing negative. Therapeutic measures were not taken as a result of disease recurrence.
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 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing). No Known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (23Jul2022) and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as COVID 19 treatment from 10Jul2022 to 14Jul2022, covid rebound on 20Jul2022 and recovered on 23Jul2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: rebound infection/symptoms/test positivity; COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2022 (at 12:00 PM) as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 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 included: "diabetes" (unspecified if ongoing). Patient had no known allergies. Concomitant medication(s) included: METFORMIN, start date: 07Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" (01Aug2022) and all described as "COVID-19"; DISEASE RECURRENCE (medically significant) with onset 21Jul2022, outcome "recovered" (01Aug2022), described as "rebound infection/symptoms/test positivity". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (21Jul2022) Positive, notes: rebound infection/symptoms/test positivity. Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid from 12Jul2022 to 16Jul2022. Therapeutic measures were not taken as a result of disease recurrence.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: A contributory role of BNT162B2 to event COVID-19 and rebound infection/symptoms/test positivity cannot be excluded based on temporal association and available information.
Age: 49.0
Sex: F
Vaccine: 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 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Oct2021 as dose 2 (booster), single (Lot number: 320308D) at the age of 49 years for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 01Apr2021 as dose 1, single (Lot number: 042A21A) for covid-19 immunisation. The patient's relevant medical history included: "seronegative spondyloarthropathy" (unspecified if ongoing), notes: Other medical history: seronegative spondyloarthropathy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 63-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) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing), notes: Other medical history: COPD; "HBP" (unspecified if ongoing), notes: Other medical history: HBP; "Obesity" (unspecified if ongoing), notes: Other medical history: Obesity; "diabetes-2" (unspecified if ongoing), notes: Other medical history: diabetes-2. Concomitant medication(s) included: MUCINEX DM; ASPIRIN [ACETYLSALICYLIC ACID]; SYMBICORT; FLONASE [MOMETASONE FUROATE]. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective. Additional information: "paxlovid works. Despite having 2nd booster, with COPD, HBP, obesity, diabetes-2 & age 63, and symptoms that include everything-fever, body aches, thick lung congestions, breathing difficulties, sorest throat ever, cough, sneezing (which literally raked my throat every time-so bad the throat spray hurt worse than it helped), lethargy, dizziness, and stuffed sinuses with swallowing, I had a rough couple of days (really rough) but am sooo happy to say I think the worst is over! paxlovid leaves a bad, lingering, metallic aftertaste, the back of the throat but otherwise it was fine. Supplemented with mucinex-dm, aspirin, symbicort, & fluonase".   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: 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 68-year-old male patient received BNT162b2 (BNT162B2), on 12Oct2021 as dose 3 (booster), single (Lot number: FE3592) 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 was not reported. Concomitant medication(s) included: LISINOPRIL; LEVOTHYROXINE; ATORVASTATIN. 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: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 and included Paxlovid.  Clinical course: Anti-viral details: Product- COVID 19 Treatment (Paxlovid) was started from 28May2022. Rebound started from 30Jun2022.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Did you/the patient previously receive a COVID-19 Vaccine?: Yes; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, in Jul2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes"; COVID-19 (medically significant), outcome "not recovered", described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Rebound Covid infection. Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient was received other medication in 2weeks. She had no known allergies. And no other medical history. The Paxlovid used as treatment for COVID 19 and it was started on 11Jun2022 and stopped on 15Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 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 female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Lot number: ER8737), in left arm, on 24Apr2021 as dose 2, single (Lot number: ER8731), in left arm, on 01Nov2021 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 15Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Knwon allergies: sulfa drugs" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative, notes: I tested negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 04May2022  to 08May2022.  Clinical course: When she had COVID and was taking Paxlovid, she had sudden sharp jaw pain and blacked out. Also, after she finished Paxlovid, her symptoms were gone and she tested negative. Then, a few days later, her symptoms came back. For 10 days, she had an elevated temperature, cough, and fatigue.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: Experienced a large red circle around the injection site; Very hot to touch; 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 66-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 04Aug2022 as dose number unknown; single (Batch/Lot number: unknown) at the age of 66 years for immunisation. The patient's relevant medical history included: "Known allergies: egg products" (unspecified if ongoing), notes: allergic with egg products thats why she dont get flu shots. The patient's concomitant medications were not reported.The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 04Aug2022, outcome "unknown", described as "Experienced a large red circle around the injection site"; VACCINATION SITE WARMTH (non-serious) with onset 04Aug2022, outcome "unknown", described as "Very hot to touch". Additional information: Patient experienced a large red circle around the injection site and the are is very very hot to touch. caller wanted to know if that is normal with the vaccine. Caller said, its really large now but on the day of the injection, it started out as a size of a quarter then it went to 50cents. this morning, its bigger than silver dollar, producing heat, and red blockade inside the circle. Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Investigation, Therapeutic response unexpected
Clinical narrative: a potential solution to the treatment of Canker Sores; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84-year-old patient received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EL1283) for covid-19 immunisation. The patient's relevant medical history included: "Canker sores" (ongoing), notes: Sores in my mouth and on my tongue on a constant basis. This began as young as 4 years old. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "unknown", described as "a potential solution to the treatment of Canker Sores". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient was examined and treated by several Dentist for Canker Sores. There were times the Dentist told patient and patients parents that I had as many as 21 Canker Sores with some of them as large as a Dime. They could never eliminate them. Through patients adult life this continued and caused extreme discomfort. The patient always have had at least 4 to 5 Canker Sores in mouth.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Magnetic resonance imaging, Pain in extremity
Clinical narrative: the vaccine only left me with arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 19Mar2021 at 10:30 as dose 1, single (Lot number: ER2613) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Diabetes", start date: 2005 (ongoing), notes: Only take medication. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "the vaccine only left me with arm pain". Relevant laboratory tests and procedures are available in the appropriate section.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I have been vaxed and 3 boosters . I took paxlovid for five day; I have been vaxed and 3 boosters . I took paxlovid for five day; 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 75-year-old patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I have been vaxed and 3 boosters . I took paxlovid for five day". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I took paxlovid for five day; Positive, notes: tested positive for four days; Negative, notes: I am now negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient read there was only a two percent relapse which the patient think was miss leading. The patient was 75. The event awareness date was on 06Aug2022. The CEP Number: CEP 005570  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: Bell's palsy, Psychiatric symptom
Clinical narrative: Bell's Palsy; affected my self-confidence; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BELL'S PALSY (medically significant), outcome "unknown"; PSYCHIATRIC SYMPTOM (non-serious), outcome "unknown", described as "affected my self-confidence". The patient developed Bell's Palsy on the right side of the face after taking the Pfizer COVID vaccine. The patient's right eye still droops after taking the injection one year and three months ago. It has affected the patient's self-confidence and causes people to stare. The patient's ophthalmologist suggested to use a drop called Upneeq for special occasions that will help the eye not appear so diminished. These are expensive and the patient could not afford them. The patient have read that Bell's Palsy is a side effect of the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.