chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EL3248), in left arm and on 24Mar2021 as dose 2, single (Lot number: EL3248) at the age of 40 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Celiac Disease", start date: Apr2019 (ongoing); "Factor V Leiden" (ongoing); "Anxiety" (unspecified if ongoing), notes: Concomitant Drugs: , Drug name: Fluvoxamine, Reason for use: Anxiety. Concomitant medication(s) included: FLUVOXAMINE oral taken for anxiety, start date: 2021 (ongoing). The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat". Therapeutic measures were taken as a result of oropharyngeal pain.  Additional information: Patient taken 3rd dose on 16Nov2021. Patient received vaccine in workplace clinic facility. Patient had not administered vaccine at Military facility.  Follow-up attempts are completed. No further information is expected. Sender's Comments: Linked Report(s) : PFIZER INC-202200793384 same patient, 3 dose case;
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Seizure
Clinical narrative: Covid vaccine caused me to have seizures; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ave bad arthritis and my bones are decaying" (unspecified if ongoing); "ave bad arthritis and my bones are decaying" (unspecified if ongoing); "I bled half my body out and had an out-of body", start date: 1989 (unspecified if ongoing); "quit smoking", start date: 1983 (unspecified if ongoing), notes: quit smoking way back around 1983. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacturer), for Covid-19 Immunization; Flu vaccine (Last year I got boosted for Covid, Shingles, the flu vaccine and the phenome shot.), for immunisation. The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "Covid vaccine caused me to have seizures". The patient underwent the following laboratory tests and procedures: Blood test: Blood test show nothing. Clinical course: Patient does  not know if the Covid vaccine caused me to have seizures, but patient had one after the 2nd Covid vaccine and seizures supposedly after the over 65 Covid vaccine. I never had seizures in life before. Patient asked the physician if it caused the seizures but he was not sure. He said he has heard of the Shingles vaccine sometimes doing that but no proof. Last year patient got boosted for Covid, Shingles, the flue vaccine and the phenome shot. These were all given withing the allotted time spaces. Patient was now on medicine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200826844 same patient/drug, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: He stated that after receiving their second Pfizer Covid-19 booster, they have chills and feel exhausted; He stated that after receiving their second Pfizer Covid-19 booster, they have chills and feel exhausted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A female patient received BNT162b2 (BNT162B2), on 03Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 Immunization; Comirnaty (Dose 3, booster), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious), CHILLS (non-serious) all with onset 2022, outcome "unknown" and all described as "He stated that after receiving their second Pfizer Covid-19 booster, they have chills and feel exhausted". Additional information: Reporter also mentioned that he and his wife were at the doctor's office all day. He was told by the doctor that people can feel like they have COVID after receiving the vaccine. He stated that after receiving their second Pfizer Covid-19 booster, they have chills and feel exhausted. He is not happy with Pfizer right now.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200826843 same reporter, vaccine, event with different patients;
Age: 52.0
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 a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 04May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 22Jan2021 as dose 1, single (Lot number: 013L20A), in left arm, on 19Feb2021 as dose 2, single (Lot number: 004M20A), in left arm and on 07Nov2021 as dose 3 (booster), single (Lot number: 039F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing); "slightly high cholesterol" (unspecified if ongoing), notes: Other medical history: slightly high cholesterol; "Known allergies: Almonds" (unspecified if ongoing), notes: Known allergies: Almonds; "Known allergies: some fruit skins" (unspecified if ongoing), notes: Known allergies: some fruit skins. There were no concomitant medications. The patient did not receive other medication in 2 weeks.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27May2022) positive, notes: original Covid occurred 27May/ Treatment of COVID-19; (07Jun2022) positive, notes: Covid Rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment with Pfizer Paxlovid from 28May2022 to 01Jun2022 for treatment of COVID-19. Covid Rebound - sinus congestion and headache - original Covid occurred 27May and had fever and sore throat.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I tested positive on 22May2022; I tested positive on 22May2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL8982), in left arm, on 17Feb2021 as dose 2, single (Lot number: EM9809), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: EW1062), in left arm and on 28Apr2022 as dose 4 (booster), single (Lot number: FH8027) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Glaucoma" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "GERD" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Avelox, reaction(s): "known allergies: Avelox Allergy", notes: known allergies: Avelox Allergy. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22May2022, outcome "not recovered" and all described as "I tested positive on 22May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22May2022) Positive, notes: I tested positive on 22May2022; (06Jun2022) Positive, notes: I tested positive again on 06Jun. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had not taken other medication in 2weeks. Anti-viral details: Product COVID 19 Treatment, Brand-Paxlovid, Treatment start date-25May2022, Treatment stop date-29May2022, indication=Treatment of COVID-19. Adverse event: He tested positive on 22May2022. Extremely sore throat. Started Paxlovid on 25May, finished 29May. Sore throat diminished about 3 days after starting Paxlovid. Continued to have excess phlegm and coughing for another few (maybe 2 or 3) days. Did not have any symptoms but he tested positive again on 06Jun. The reason he did the test was his wife tested positive on 06Jun also. Her story: She first tested positive on 18May2022. Slightly elevated temperature and sore throat. Started Paxlovid on 19May. Her symptoms diminished about 3-4 days after starting Paxlovid regimen. Somewhere around 03Jun, maybe 04Jun, she developed congestion in her chest with a cough. She decided to do a home test on June 6 and tested positive. He also did the test, but only because she tested positive, he had no symptoms. Of course, he don't know if he might develop symptoms going forward. We isolated for 10 days after testing positive the first time and will do the same this 2nd time. Adverse event start date: 06Jun2022, If patient recovered: Recovering, If treatment ae: No.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma; "Known allergies: Shellfish" (unspecified if ongoing); "interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: PROBIOTICS; ZINC; NYQUIL.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. 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: 47.0
Sex: F
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 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 24Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no relevant medical history. No known allergies. No other medical history. Concomitant medication(s) included: METFORMIN; COQ 10; VITAMIN D [VITAMIN D NOS]; WELLBUTRIN; SERTRALINE HCL.  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: (unspecified date) Positive, notes: Relapse infection after 5day course of Paxlovid. Patient received COVID 19 treatment with Paxlovid from 30May2022 to 03Jun2022. Relapse infection after 5day course of Paxlovid. Tested negative days 6-10. Positive again starting day 11. Currently still sick (and testing positive) 13 days after starting Paxlovid. Also had the terrible taste in mouth while taking, but it went away as soon as she stopped the meds.  Treatment of COVID-19; (04Jun2022) Negative, notes: Tested negative days 6-10; (05Jun2022) Negative, notes: Tested negative days 6-10; (06Jun2022) Negative, notes: Tested negative days 6-10; (07Jun2022) Negative, notes: Tested negative days 6-10; (08Jun2022) Negative, notes: Tested negative days 6-10; (09Jun2022) Positive, notes: Positive again starting day 11. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 35-year-old male patient received BNT162b2 (BNT162B2), on 02Oct2021 as dose 3 (booster), single (Lot number: 30155RA) at the age of 35 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Prednisone, reaction(s): "known allergies: Prednisone", notes: Prednisone Allergy.  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. It was reported that patient received treatment of Paxlovid treatment from 27May2022.   No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2022 as dose 4 (booster), single (Batch/Lot number: Unknown) at the age of 74 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 relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". 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.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2021 as dose 2, single (Lot number: En5318) at the age of 66 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: "HBP" (unspecified if ongoing), notes: HBP; "prediabetes" (unspecified if ongoing), notes: prediabetes. There were no concomitant medications. Past drug history included: Lisinopril, reaction(s): "known allergies Lisinopril", notes: known allergies Lisinopril; Losartan, reaction(s): "known allergies losartan", notes: known allergies losartan.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED 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: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; 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 37-year-old female patient (not pregnant) 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: "Known allergies: Sulfa" (unspecified if ongoing). 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive for Covid after completing paxlovid and testing negative; Negative, notes: Tested positive for Covid after completing paxlovid and testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.T he patient received other medication in 2 weeks was reported as No. COVID 19 Treatment with Paxlovid from 26May2022 to 31May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Other medical history: no. Other medications in two weeks: No. Known allergies: no. Anti-viral details: Product: COVID 19 treatment, Brand: Paxlovid, Treatment start date: 08Jun2022, Treatment stop date: 08Jun2022, Lot number: GA1529, Indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective cannot be ruled out
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: gluten" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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 in the case, the causal association between the event Drug ineffective, COVID-19 and the suspect drug BNT162B2 cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 at 12:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical Course: As a therapeutic measures, the patient have taken Paxlovid from 02Jun2022 to 07Jun2022.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL1283), in right arm, on 19Feb2021 as dose 2, single (Lot number: EN6200), in right arm and on 28Sep2021 as dose 3 (booster), single (Lot number: 301308A) at the age of 42 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "POTS" (unspecified if ongoing), notes: POTS; "asthma" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Penicillin, reaction(s): "known allergies Penicillin", notes: known allergies Penicillin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medications in two weeks: No. Anti-viral details. Product= COVID 19 treatment. Brand=Paxlovid. Treatment start date= 01Jun2022. Treatment stop date= 05Jun2022. Indication= Treatment of COVID-19. Adverse event: Rebound 4 days after ending treatment, 2 days after negative test. Adverse event start date: 09Jun2022. If patient recovered: Not recovered. If treatment ae: No (as reported).
Age: 44.0
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 a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 16Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: No other medications in 2 weeks and no known allergies reported. Adverse event: dysgeusia within a few hours of first dose on 09Jun2022.  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 current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies Penicillin. Concomitant medication(s) included: ATORVASTATIN, start date: 10Jun2015, stop date: 08Jun2022. 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. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: Anti viral details included product COVID 19 Treatment, treatment start date was 09Jun2022, treatment stop date was 10Jun2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Severe Pain in left neck and left arm; Severe Pain in left neck and left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), on 07Jan2022 at 16:00 as dose 3 (booster), single (Lot number: Fl3209), in left arm for covid-19 immunisation. The patient's relevant medical history included: "neck diagnosis issue" (unspecified if ongoing). Concomitant medication(s) included: NASONEX; SUDAFED 12 HOUR. Vaccination history included: BNT162b2 (Dose 1, Prev dose product: COVID 19, Prev dose brand: Pfizer BioNTech, Prev dose lot number: En6199, Prev dose administration time=03:00 PM, Prev dose vaccine location=Left arm), administration date: 13Mar2021, for Covid-19 immunization; BNT162b2 (Dose 2, Prev dose product: COVID 19, Prev dose brand: Pfizer biontech, Prev dose lot number: Er8734, Prev dose administration time=02:00 PM, Prev dose vaccine location=Left arm), administration date: 03Apr2021, for COVID-19 immunization. The following information was reported: NECK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 02May2022 at 15:00, outcome "not recovered" and all described as "Severe Pain in left neck and left arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of neck pain, pain in extremity.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200828047 same reporter/product/event, different patient;
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Vaccination site pain
Clinical narrative: Severe Pain in left neck and left arm; Severe Pain in left neck and left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), on 07Jan2022 at 16:00 as dose 3 (booster), single (Lot number: Fl3209), in left arm for covid-19 immunisation. The patient's relevant medical history included: "neck diagnosis issue", notes: from over 10 years ago. Concomitant medication(s) included: NASONEX; SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]. Vaccination history included: BNT162b2 (DOSE 1, LOT NO: En6199, LOCATION: Left arm), administration date: 13Mar2021, for COVID-19 immunization; BNT162b2 (DOSE 2, LOT NO: Er8734, LOCATION: Left arm), administration date: 03Apr2021, for COVID-19 immunization. The following information was reported: NECK PAIN (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "Severe Pain in left neck and left arm". Therapeutic measures were taken as a result of neck pain, vaccination site pain. Additional information: The patient have no known allergies. Patient have no other vaccine in four weeks. Patient have no COVID prior to vaccination. None of us have had any issues with our necks or arms up to this year from previous issue. Seems like to much of a coincidence that it's not either a side effect of the vaccine or a side effect of COVID. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200828045 same reporter/product/event, different patient; US-PFIZER INC-202200828043 same reporter/product/event, different patient; US-PFIZER INC-202200828046 same reporter/patient, different dose/event;
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 04Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 13Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OSCILLOCOCCINUM, start date: 02Jun2022, stop date: 05Jun2022. Past drug history included: Tetrocycline, reaction(s): "known allergies;Tetracycline". 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: (10Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary retention
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: Unknown. The reporter is the parent. A 17-year-old female patient received BNT162b2 (BNT162B2), on 16Apr2021 as dose 1, single (Lot number: EW0153) at the age of 17 years for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No additional vaccines administered on same date of the Pfizer Suspect. Prior vaccinations (within 4 weeks), no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). The following information was reported: URINARY RETENTION (medically significant) with onset 18Apr2021, outcome "recovered", described as "my daughter could not urinate and had to be taken to an ER room to have a catheter placed in her bladder to release her urine". The events "my daughter could not urinate and had to be taken to an ER room to have a catheter placed in her bladder to release her urine" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of urinary retention. Clinical course: Consumer's daughter received Pfizer Covid vaccine in Apr2021. Two days after receiving the first dose, Consumer's daughter could not urinate and had to be taken to an ER room to have a catheter placed in her bladder to release her urine. Then she was normal. She developed the same symptom again after 2nd. The symptom of urinary retention has gotten worse ever since. Was Pfizer aware of this issue? Can Pfizer suggest a treatment? This is urgent and I look forward to receiving any information. The consumer was inquiring about his 17 year old daughter, who had the first two shots of the Pfizer Covid vaccine, the first one in Apr2021 and the second one 3 weeks later. The consumer reported his daughter did receive a booster of the Moderna Covid vaccine. Consumer reported that two days after the first vaccine, his daughter experienced urinary retention. Consumer stated that a catheter was placed in the emergency room, and it resolved. Consumer stated that 3 weeks after the second dose this event happened again. Consumer stated that the symptoms of urinary retention has gotten worse, despite going to many doctors, who have no explanation for the event. From 2 days after the first vaccine. Reported his daughter was released from the emergency room. He reported his daughter went to several doctors such as a Urologist and Primary Care doctors and there was no explanation for the event. Vaccination facility type was reported as either clinic or a hospital. No relevant tests. Sender's Comments: Linked Report(s): US-PFIZER INC-202200828704 Same patient, drug, and event separated in time.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain, Pyrexia
Clinical narrative: Chills; mild fever; Very very very bad muscle aches; pains; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), on 08Jun2022 at 09:45 as dose 4 (booster), single (Lot number: FL3197, Expiration Date: 30Jun2022) at the age of 50 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 3, Single, LOT: FH8027), administration date: 09Dec2021, when the patient was 50-year-old, for covid-19 immunization; BNT162b2 (Dose 2, Single, LOT: EP6955), administration date: 30Mar2021, when the patient was 49-year-old, for covid-19 immunization; BNT162b2 (Dose 1, Single, LOT: EL3247 (handwriting is hard to read)), administration date: 09Mar2021, when the patient was 49-year-old, for covid-19 immunization; Flu shot, administration date: Oct2021, reaction(s): "sore arm".  The following information was reported: CHILLS (non-serious) with onset 08Jun2022, outcome "recovered" (Jun2022); MYALGIA (non-serious) with onset 08Jun2022, outcome "recovered" (Jun2022), described as "Very very very bad muscle aches"; PYREXIA (non-serious) with onset 08Jun2022, outcome "recovered" (Jun2022), described as "mild fever"; PAIN (non-serious) with onset 08Jun2022, outcome "recovered" (2022), described as "pains".  Additional information: No additional vaccines administered on Same Date of the Pfizer Suspect and no prior vaccinations (within 4 weeks). No emergency room visit, and physician office visit required for AEs. The patient stated that she did not feel great, but it wasn't that bad. After second booster shot about 0945 yesterday morning. Late last evening, started feeling chills, mild fever, very very very bad muscle aches and pains that persisted throughout the course of the evening.All symptoms have completely resolved.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient had Rebound Covid infection after this for which he was recovering and no treatment was given for it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Urinary retention
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: Unknown. The reporter is the parent. A 17-year-old female patient received BNT162b2 (BNT162B2), on 07May2021 as dose 2, single (Lot number: EW0171) at the age of 17 years for Covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (First Covid vaccine: 16Apr2021, Vaccine Lot Number: EW0153), administration date: 16Apr2021, when the patient was 17-year-old, for COVID-19 immunization, reaction(s): "urinary retention". The following information was reported: URINARY RETENTION (medically significant), CONDITION AGGRAVATED (medically significant) all with onset 28May2021, outcome "not recovered" and all described as "The symptom of urinary retention has gotten worse ever since". The event "the symptom of urinary retention has gotten worse ever since" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of urinary retention, condition aggravated. Clinical course: The consumer's daughter received Pfizer Covid vaccine. Two days after receiving the first dose, the consumer's daughter could not urinate and had to be taken to an ER room to have a catheter placed in her bladder to release her urine. Then she was normal. She developed the same symptom again after 2nd. The symptom of urinary retention had gotten worse ever since. The consumer was inquiring about his 17 year old daughter, who had the first two shots of the Pfizer Covid vaccine, the first one in Apr2021 and the second one 3 weeks later. The consumer reported his daughter did receive a booster of the Moderna Covid vaccine. Reported that two days after the first vaccine, his daughter experienced urinary retention. A catheter was placed in the emergency room, and it resolved. 3 weeks after the second dose this event happened again. Stated that the symptoms of urinary retention has gotten worse, despite going to many doctors, who had no explanation for the event. Reported his daughter was released from the emergency room. He reported his daughter went to several doctors such as a Urologist and Primary Care doctors and there was no explanation for the event. He stated that this was a booster vaccine that was given to his daughter. He stated that his daughter had continued symptoms after this booster as well. Prior Vaccinations (within 4 weeks), no other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). Sender's Comments: Linked Report(s): US-PFIZER INC-202200828361 Same patient, drug, and event separated in time.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Lot number: EL0140), in left arm, on 11Jan2021 as dose 2, single (Lot number: EL3248), in left arm, on 24Sep2021 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 11Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Atrial fibrillation" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing). It was reported that the patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset May2022, outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19. Treatment of COVID-19 was received with Paxlovid, treatment start date was 26May2022 and treatment stop date was 30May2022. It was reported that patient experienced COVID rebound after Paxlovid on 06Jun2022.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 as dose number unknown, single (Lot number: 8025) at the age of 49 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR; ZOLOFT; VITAMIN D3.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the lack of efficacy  cannot be ruled out.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19. Reporter classified events as non serious. Patient did not have known allergies. But my mouth tasted like pennies the whole time taking Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech: Batch/Lot No: Unknown; Paxlovid: Treatment of COVID-19; Pfizer / BioNTech: Batch/Lot No: Unknown; Paxlovid: 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 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunization. The patient had no relevant medical history. Patient had no known allergies. There were no concomitant medications, also reported as other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Pfizer / BioNTech: Batch/Lot No: Unknown; Paxlovid: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results; (May2022) Positive; (May2022) Negative, notes: Day 9 and Day 10. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Anti viral Paxlovid, started on 21May2022 and stopped on 26May2022. Clinical course was reported as, on Day 11 on 31May2022 at 13:00, patient had cold like symptoms and tested positive again after testing negative on Day 9. Patient had no symptoms during the first round of Covid. However starting on day 11, she had a bad cold and a low-grade cough and very tired. She lost sense of smell but retained taste. While the cold symptoms subsided she continue to have a low-grade cough. It's now day 11 of round two. Patient tested negative on day 10. She was extremely lethargic and was very active and exercised regularly but have no energy to do anything. Very concerned. Patient received no treatment for symptoms and not recovered from symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.