chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history 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 "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: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN D [VITAMIN D NOS]; NATURE MADE CALCIUM + D + K. Vaccination history included: Flu vaccine (Known allergies: I am allergic to flu vaccine), reaction(s): "Known allergies: flu vaccine"; Flu vaccine (Other medical history: had guillian barre syndrome after flu shot), reaction(s): "had guillian barre syndrome after flu shot".  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. No further information is expected.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective,covid-19.
Age: 32.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old patient received BNT162b2 (BNT162B2), on 26Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 32 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "peanuts" (unspecified if ongoing), notes: known allergies peanuts; "seasonal allergies" (unspecified if ongoing), notes: seasonal allergies; "acid reflux" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (Jul2022) Positive, notes: positive rapid test on day 17. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with paxlovid from 06Jul2022 to 10Jul2022.
Age: 50.0
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 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 26Mar2021 as dose 1, single (Lot number: FP4554), in right arm, on 16Apr2021 as dose 2, single (Lot number: 30155BA), in right arm, on 16Oct2021 as dose 3 (booster), single (Lot number: ER8731), in right arm and on 21Apr2022 at 10:30 as dose 4 (booster), single (Lot number: ER8730) at the age of 50 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing). Concomitant medication(s) included: REMICADE; METHOTREXATE; FOLIC ACID; IRON; VITAMIN D [VITAMIN D NOS]; OMEPRAZOLE; EFEXOR. Past drug history included: Flagyl, reaction(s): "known allergies: Flagyl". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19, Positive again; Negative, notes: Rebound - Got better, Neg test; Positive, notes: Positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid from 05Jul2022 to 09Jul2022 for the treatment of COVID-19. Rebound - Got better, Neg test and week later started coughing and lost of smell/taste -took test and Positive again.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Headache, Myalgia, Nervousness
Clinical narrative: her daughter is nervous; anxiety; swollen injection site that is red, warm; swollen injection site that is red, warm; swollen injection site that is red, warm; Headache; Fatigue; muscle aches; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the parent.  A 23-year-old female patient received BNT162b2 (BNT162B2), on 17Jul2022 as dose number unknown (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 immunisation. The following information was reported: FATIGUE (non-serious) with onset 21Jul2022, outcome "unknown"; HEADACHE (non-serious) with onset 21Jul2022, outcome "unknown"; MYALGIA (non-serious) with onset 21Jul2022, outcome "unknown", described as "muscle aches"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 21Jul2022, outcome "unknown" and all described as "swollen injection site that is red, warm"; NERVOUSNESS (non-serious), outcome "unknown", described as "her daughter is nervous"; ANXIETY (non-serious), outcome "unknown".  Additional information: The reporter called on behalf of her daughter that got the booster shot this past Sunday early evening (17Jul2022) and she had no side effects up until today (21Jul2022) and now (as reported) started experiencing adverse events. Relays fatigue, swollen injection site that is red, warm, feeling more fatigue, had a bad headache and bad muscle joints. Caller would like to verify this was a post reaction of the vaccine as it's been almost a week that she received the vaccine. Caller also clarified it was warm at the injection site and swollen, has a headache, fatigue and muscle aches. She wanted to know have we seen delayed symptoms 4 days after like this. Her daughter is not feeling well right now and she wants to know now, she has been on the phone half an hour and transferred many times and her daughter is nervous and suffers from anxiety. Does not want to report.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: her daughter is nervous; anxiety; swollen injection site that is red, warm; swollen injection site that is red, warm; swollen injection site that is red, warm; Headache; Fatigue; muscle aches; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the parent.  A 23-year-old female patient received BNT162b2 (BNT162B2), on 17Jul2022 as dose number unknown (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 immunisation. The following information was reported: FATIGUE (non-serious) with onset 21Jul2022, outcome "unknown"; HEADACHE (non-serious) with onset 21Jul2022, outcome "unknown"; MYALGIA (non-serious) with onset 21Jul2022, outcome "unknown", described as "muscle aches"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 21Jul2022, outcome "unknown" and all described as "swollen injection site that is red, warm"; NERVOUSNESS (non-serious), outcome "unknown", described as "her daughter is nervous"; ANXIETY (non-serious), outcome "unknown".  Additional information: The reporter called on behalf of her daughter that got the booster shot this past Sunday early evening (17Jul2022) and she had no side effects up until today (21Jul2022) and now (as reported) started experiencing adverse events. Relays fatigue, swollen injection site that is red, warm, feeling more fatigue, had a bad headache and bad muscle joints. Caller would like to verify this was a post reaction of the vaccine as it's been almost a week that she received the vaccine. Caller also clarified it was warm at the injection site and swollen, has a headache, fatigue and muscle aches. She wanted to know have we seen delayed symptoms 4 days after like this. Her daughter is not feeling well right now and she wants to know now, she has been on the phone half an hour and transferred many times and her daughter is nervous and suffers from anxiety. Does not want to report.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site pain
Clinical narrative: 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 male patient received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: ER2613) at the age of 61 years, in left arm for covid-19 immunization. The patient had no relevant medical history. Concomitant medication(s) included: CRESTOR; LISINOPRIL. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Soreness at shot location"; PYREXIA (non-serious) with onset 20Mar2021, outcome "recovered", described as "fever of 102.5". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Additional information:  No other vaccine in four weeks. Adverse event: Within 24 hours of the first dose, a fever of 102.5 developed and lasted about 12 hours. Soreness at shot location. Within 12 hours of second shot, a fever of 104.2 developed and lasted about 60 hours. He did not know where he was or why he was where he was. He did not recognize my own dog. His doctor was not sure if he should even think about getting a booster shot because of reaction to first two shots. He had covid prior vaccination. He was not tested covid post vaccination. Adverse event treatment: Fever reducer.; Sender's Comments: Linked Report(s) : PFIZER INC-202200996885 Same patient, same vaccine in different dose, partial same event;
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Lot number: EW0158) and in May2021 as dose 2, single (Lot number: EW0173) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 31May2022 as dose 4 (booster), single (Lot number: 037A22B) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications which include birth control medication. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (17Jul2022) Negative; (21Jul2022) Positive. Therapeutic measures were taken as a result of covid-19 which include Paxlovid from 13Jul2022 to 17Jul2022  Clinical course: The patient had no known allergies. After receiving the treatment, tested negative and asymptomatic by Day 5, but then tested positive and symptoms resurfaced on Day 9.  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: 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 70-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: "Asthma" (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, notes: product=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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Facial pain, Fatigue, Headache
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Jul2022 at 15:00 as dose 1, single (Lot number: FM7553) at the age of 54 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "depression" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "Covid-19", start date: Nov2020 (unspecified if ongoing), notes: I was diagnosed with COVID in Nov2020. Concomitant medication(s) included: PINDOLOL; LEVOTHYROXINE; LISINOPRIL; PRISTIQ. Past drug history included: Thimerosal, reaction(s): "known allergies: Thimerosal", notes: known allergies: Thimerosal. The following information was reported: HEADACHE (non-serious) with onset 17Jul2022, outcome "recovered" (Jul2022), described as "Mild headache"; FATIGUE (non-serious) with onset 18Jul2022 at 12:00, outcome "recovered" (Jul2022); PYREXIA (non-serious) with onset 18Jul2022 at 12:00, outcome "recovered" (Jul2022), described as "LGF 99.3"; FACIAL PAIN (non-serious) with onset 18Jul2022 at 12:00, outcome "recovered" (Jul2022), described as "felt like my face was "on fire""; BACK PAIN (non-serious) with onset 18Jul2022 at 12:00, outcome "recovered" (Jul2022), described as "lower back pain". The events "mild headache", "lower back pain", "lgf 99.3", "felt like my face was "on fire"" and "fatigue" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, back pain, pyrexia, facial pain, fatigue.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Jul2022 at 15:00 as dose 1, single (Lot number: FM7553) at the age of 54 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "depression" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "Covid-19", start date: Nov2020 (unspecified if ongoing), notes: I was diagnosed with COVID in Nov2020. Concomitant medication(s) included: PINDOLOL; LEVOTHYROXINE; LISINOPRIL; PRISTIQ. Past drug history included: Thimerosal, reaction(s): "known allergies: Thimerosal", notes: known allergies: Thimerosal. The following information was reported: HEADACHE (non-serious) with onset 17Jul2022, outcome "recovered" (Jul2022), described as "Mild headache"; FATIGUE (non-serious) with onset 18Jul2022 at 12:00, outcome "recovered" (Jul2022); PYREXIA (non-serious) with onset 18Jul2022 at 12:00, outcome "recovered" (Jul2022), described as "LGF 99.3"; FACIAL PAIN (non-serious) with onset 18Jul2022 at 12:00, outcome "recovered" (Jul2022), described as "felt like my face was "on fire""; BACK PAIN (non-serious) with onset 18Jul2022 at 12:00, outcome "recovered" (Jul2022), described as "lower back pain". The events "mild headache", "lower back pain", "lgf 99.3", "felt like my face was "on fire"" and "fatigue" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, back pain, pyrexia, facial pain, fatigue.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cognitive disorder, Disorientation, Pyrexia
Clinical narrative: I did not know where I was or why I was where I was/I did not recognize my own dog; I did not know where I was or why I was where I was/I did not recognize my own dog; fever of 104.2; 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 male patient received BNT162b2 (BNT162B2), on 10Apr2021 as dose 2, single (Lot number: EW0158) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. Concomitant medication(s) included: CRESTOR; LISINOPRIL. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: ER2613, Location of injection: Arm Left), administration date: 20Mar2021, when the patient was 61-year-old, for COVID-19 Immunization, reaction(s): "fever of 102.5", "Soreness at shot location". The following information was reported: PYREXIA (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "fever of 104.2"; DISORIENTATION (non-serious), COGNITIVE DISORDER (non-serious) all with onset 20Apr2021, outcome "unknown" and all described as "I did not know where I was or why I was where I was/I did not recognize my own dog". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: It was reported that within 24 hours of the first dose, a fever of 102.5 developed and lasted about 12 hours and within 12 hours of second shot, a fever of 104.2 developed and lasted about 60 hour. I did not know where I was or why I was where I was. I did not recognize my own dog. My doctor is not sure if I should even think about getting a booster shot because of reaction to first two shots. Patient received the treatment. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient has not been tested for COVID-19. No known allergies was reported.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200996478 Same patient, same vaccine in different dose, partial same event;
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Listless, Pyrexia
Clinical narrative: After Dose 1, fatigue for 12 hours after dose, 12 hours after Dose had fatigue & listlessness, 24 hours after dose had 101 fever and extreme fatigue that lasted another 24 hours.; After Dose 1, fatigue for 12 hours after dose, 12 hours after Dose had fatigue & listlessness, 24 hours after dose had 101 fever and extreme fatigue that lasted another 24 hours.; After Dose 1, fatigue for 12 hours after dose, 12 hours after Dose had fatigue & listlessness, 24 hours after dose had 101 fever and extreme fatigue that lasted another 24 hours.; After Dose 1, fatigue for 12 hours after dose, 12 hours after Dose had fatigue & listlessness, 24 hours after dose had 101 fever and extreme fatigue that lasted another 24 hours.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ESTRADIOL; PROGESTERONE. Past drug history included: Lovenox, reaction(s): "Known allergies: Lovenox", notes: Known allergies: Lovenox. The following information was reported: FATIGUE (non-serious), LISTLESS (non-serious), PYREXIA (non-serious), FATIGUE (non-serious) all with onset Oct2021, outcome "recovered" and all described as "After Dose 1, fatigue for 12 hours after dose, 12 hours after Dose had fatigue & listlessness, 24 hours after dose had 101 fever and extreme fatigue that lasted another 24 hours.". The events "after dose 1, fatigue for 12 hours after dose, 12 hours after dose had fatigue & listlessness, 24 hours after dose had 101 fever and extreme fatigue that lasted another 24 hours." required physician office visit. Therapeutic measures were not taken as a result of fatigue, listless, pyrexia,  fatigue.  Additional Information: No Other vaccine in four weeks. After Dose 1, fatigue for 12 hours after dose, 12 hours after Dose had fatigue & listlessness, 24 hours after dose had 101 fever and extreme fatigue that lasted another 24 hours. After Dose 3 had extreme fatigue, 101-102 degree fever for 3 days, muscle aches & extreme fatigue for 6 days including chest pain. CRP measure by doctor was elevated 3x normal.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 06Oct2021 as dose 1, single (Batch/Lot number: unknown) and on 18Dec2021 as dose 2, single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200996922 Same patient, drug/ different event;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Audiogram, Fatigue, Pain in extremity, SARS-CoV-2 test, Thirst
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient. A 46-year-old patient received BNT162b2 (BNT162B2), on 26Mar2021 as dose 2, single (Lot number: ER8730) intramuscular, in left deltoid for covid-19 immunization. The patient's relevant medical history included: "Hypothyroidism", start date: 1995 (ongoing); "Vitamin D deficiency", start date: 2018 (ongoing); "Thyroid" (ongoing); "Allergies" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE oral taken for thyroid disorder, start date: 1995 (ongoing); VITAMIN D NOS oral taken for vitamin d deficiency, start date: 2018 (ongoing); CLARITIN ALLERGIC oral taken for hypersensitivity, start date: 2017 (ongoing). Vaccination history included: BNT162b2 (Dose: 1, Date: 03Mar2021, Time: 07:30 AM, Anatomical site of injection: Left deltoid, Route of administration: Intramuscular, Batch/Lot number: EN6205), administration date: 03Mar2021, for COVID-19 immunization, reaction(s): "I tested positive for covid this week"; BNT162b2 (Dose: 1, Date: 03Mar2021, Time: 07:30 AM, Anatomical site of injection: Left deltoid, Route of administration: Intramuscular, Batch/Lot number: EN6205), administration date: 03Mar2021, for Covid-19 immunization, reaction(s): "I tested positive for covid this week", "bilateral tinnitus/ amplified", "taste salty", "arm soreness", "fatigue". The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "bilateral tinnitus/ amplified"; THIRST (non-serious), outcome "unknown", described as "extreme thirst"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness"; FATIGUE (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Side effects from 2 nd dose covid vaccine included arm soreness, fatigue, extreme thirst. Tinnitus never went away, on 16Jun2022, I noticed the tinnitus was marked by louder.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient. A 46-year-old patient received BNT162b2 (BNT162B2), on 26Mar2021 as dose 2, single (Lot number: ER8730) intramuscular, in left deltoid for covid-19 immunization. The patient's relevant medical history included: "Hypothyroidism", start date: 1995 (ongoing); "Vitamin D deficiency", start date: 2018 (ongoing); "Thyroid" (ongoing); "Allergies" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE oral taken for thyroid disorder, start date: 1995 (ongoing); VITAMIN D NOS oral taken for vitamin d deficiency, start date: 2018 (ongoing); CLARITIN ALLERGIC oral taken for hypersensitivity, start date: 2017 (ongoing). Vaccination history included: BNT162b2 (Dose: 1, Date: 03Mar2021, Time: 07:30 AM, Anatomical site of injection: Left deltoid, Route of administration: Intramuscular, Batch/Lot number: EN6205), administration date: 03Mar2021, for COVID-19 immunization, reaction(s): "I tested positive for covid this week"; BNT162b2 (Dose: 1, Date: 03Mar2021, Time: 07:30 AM, Anatomical site of injection: Left deltoid, Route of administration: Intramuscular, Batch/Lot number: EN6205), administration date: 03Mar2021, for Covid-19 immunization, reaction(s): "I tested positive for covid this week", "bilateral tinnitus/ amplified", "taste salty", "arm soreness", "fatigue". The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "bilateral tinnitus/ amplified"; THIRST (non-serious), outcome "unknown", described as "extreme thirst"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness"; FATIGUE (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Side effects from 2 nd dose covid vaccine included arm soreness, fatigue, extreme thirst. Tinnitus never went away, on 16Jun2022, I noticed the tinnitus was marked by louder.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient. A 46-year-old patient received BNT162b2 (BNT162B2), on 26Mar2021 as dose 2, single (Lot number: ER8730) intramuscular, in left deltoid for covid-19 immunization. The patient's relevant medical history included: "Hypothyroidism", start date: 1995 (ongoing); "Vitamin D deficiency", start date: 2018 (ongoing); "Thyroid" (ongoing); "Allergies" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE oral taken for thyroid disorder, start date: 1995 (ongoing); VITAMIN D NOS oral taken for vitamin d deficiency, start date: 2018 (ongoing); CLARITIN ALLERGIC oral taken for hypersensitivity, start date: 2017 (ongoing). Vaccination history included: BNT162b2 (Dose: 1, Date: 03Mar2021, Time: 07:30 AM, Anatomical site of injection: Left deltoid, Route of administration: Intramuscular, Batch/Lot number: EN6205), administration date: 03Mar2021, for COVID-19 immunization, reaction(s): "I tested positive for covid this week"; BNT162b2 (Dose: 1, Date: 03Mar2021, Time: 07:30 AM, Anatomical site of injection: Left deltoid, Route of administration: Intramuscular, Batch/Lot number: EN6205), administration date: 03Mar2021, for Covid-19 immunization, reaction(s): "I tested positive for covid this week", "bilateral tinnitus/ amplified", "taste salty", "arm soreness", "fatigue". The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "bilateral tinnitus/ amplified"; THIRST (non-serious), outcome "unknown", described as "extreme thirst"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness"; FATIGUE (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Side effects from 2 nd dose covid vaccine included arm soreness, fatigue, extreme thirst. Tinnitus never went away, on 16Jun2022, I noticed the tinnitus was marked by louder.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 21Jul2022 at 16:00, outcome "recovering", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid was started as treatment on 12Jul2022 and stopped on 16Jul2022. Patient had Rebound on 5th days of finishing treatment. There was no other medication in 2 weeks administered by patient.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Appendicectomy, Investigation, Pulmonary embolism, Pulmonary thrombosis
Clinical narrative: Pulmonary Embolism (blood clot) left lung; Pulmonary Embolism (blood clot) left lung; Also had to have an appendectomy 01May2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 16Dec2021 as dose 3 (booster), single (Lot number: FE3594) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LANSOPRAZOLE. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: ER8733, Location of injection: Arm Left), administration date: 30Mar2021, when the patient was 44-year-old, for COVID-19 immunization, reaction(s): "COVID-19"; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6202, Location of injection: Arm Left), administration date: 02Mar2021, when the patient was 44-year-old, for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: APPENDICECTOMY (medically significant) with onset 01May2022, outcome "unknown", described as "Also had to have an appendectomy 01May2022"; PULMONARY EMBOLISM (hospitalization, medically significant), PULMONARY THROMBOSIS (hospitalization, medically significant) all with onset 01May2022 at 04:30, outcome "not recovered" and all described as "Pulmonary Embolism (blood clot) left lung". The patient was hospitalized for pulmonary embolism, pulmonary thrombosis (hospitalization duration: 2 day(s)). The event "pulmonary embolism (blood clot) left lung" required emergency room visit. The patient underwent the following laboratory tests and procedures: nasal swab: (06Jul2022) Positive, notes: rapid antigen.  Clinical course: The event did not results in death, or life threatening. The event caused/prolonged hospitalization. The event did not cause disabling/Incapacitating or congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Vaccine suspected by doctor as cause of both AEs. Device Date : 21Jul2022.  Follow-Up (25Jul2022): Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Pulmonary Embolism (blood clot) left lung; Pulmonary Embolism (blood clot) left lung; Also had to have an appendectomy 01May2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 16Dec2021 as dose 3 (booster), single (Lot number: FE3594) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LANSOPRAZOLE. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: ER8733, Location of injection: Arm Left), administration date: 30Mar2021, when the patient was 44-year-old, for COVID-19 immunization, reaction(s): "COVID-19"; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6202, Location of injection: Arm Left), administration date: 02Mar2021, when the patient was 44-year-old, for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: APPENDICECTOMY (medically significant) with onset 01May2022, outcome "unknown", described as "Also had to have an appendectomy 01May2022"; PULMONARY EMBOLISM (hospitalization, medically significant), PULMONARY THROMBOSIS (hospitalization, medically significant) all with onset 01May2022 at 04:30, outcome "not recovered" and all described as "Pulmonary Embolism (blood clot) left lung". The patient was hospitalized for pulmonary embolism, pulmonary thrombosis (hospitalization duration: 2 day(s)). The event "pulmonary embolism (blood clot) left lung" required emergency room visit. The patient underwent the following laboratory tests and procedures: nasal swab: (06Jul2022) Positive, notes: rapid antigen.  Clinical course: The event did not results in death, or life threatening. The event caused/prolonged hospitalization. The event did not cause disabling/Incapacitating or congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Vaccine suspected by doctor as cause of both AEs. Device Date : 21Jul2022.  Follow-Up (25Jul2022): Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Appendicectomy, Investigation, Pulmonary embolism, Pulmonary thrombosis
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19?:Yes/Result: Positive; Since the vaccination, has the patient been tested for COVID-19?:Yes/Result: Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6202), in left arm, on 30Mar2021 as dose 2, single (Lot number: ER8733), in left arm and on 16Dec2021 as dose 3 (booster), single (Lot number: FE3594) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LANSOPRAZOLE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jul2022, outcome "unknown" and all described as "Since the vaccination, has the patient been tested for COVID-19: Yes/Result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jul2022) Positive, notes: COVID test type post vaccination: Nasal swab. Clinical Course: No other vaccine in four weeks. No COVID prior vaccination. COVID was tested post vaccination. Vaccination Facility Details available.  No follow-up attempts possible. No further information expected.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19?:Yes/Result: Positive; Since the vaccination, has the patient been tested for COVID-19?:Yes/Result: Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6202), in left arm, on 30Mar2021 as dose 2, single (Lot number: ER8733), in left arm and on 16Dec2021 as dose 3 (booster), single (Lot number: FE3594) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LANSOPRAZOLE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jul2022, outcome "unknown" and all described as "Since the vaccination, has the patient been tested for COVID-19: Yes/Result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jul2022) Positive, notes: COVID test type post vaccination: Nasal swab. Clinical Course: No other vaccine in four weeks. No COVID prior vaccination. COVID was tested post vaccination. Vaccination Facility Details available.  No follow-up attempts possible. No further information expected.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 55-year-old male patient received BNT162b2 (BNT162B2), on 18May2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 55 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL oral, start date: 05Jul2022, stop date: 07Jul2022; LISINOPRIL oral, stop date: 06Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2022) Positive, notes: Pt retested for Covid 13Jul2022 resulting positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received COVID 19 treatment with oral paxlovid from 06Jul2022 till 10Jul2022. The patient developed sore throat 2 days after completing 5 day treatment of paxlovid. The patient retested for Covid 13Jul2022 resulting positive. The patient reports improvement of symptoms since original diagnosis on 5Jul2022. The patient received other medication in 2 weeks. No Known allergies were reported.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  An 81-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) 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: "Hypothyroidism" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Anti viral drug Paxlovid was given orally to patient from 06Jul2022 to 11Jul2022 as a treatment for Covid-19. The patient did not have any known allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to  l the reported events Drug ineffective ,covid 19  cannot be completely excluded based on temporal association and known drug safety profile
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I got sick with Corona Virus; I was not feeling good; I got sick with Corona Virus; I was not feeling good; 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 patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown (booster), single (Batch/Lot number: unknown) and (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 06Jun2022, outcome "unknown" and all described as "I got sick with Corona Virus; I was not feeling good". The event "i got sick with corona virus; i was not feeling good" required physician office visit. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Report was not related to a study or programme. NDC and UPC number of COVID-19 Vaccine was Unknown. Consumer stated, "I am 53 (years) old, I had the Booster shot (Pfizer COVID-19 Vaccine), I have everything and now on 06Jun, I got sick with Corona Virus so, I was not feeling good, I called the doctor and he prescribed me this Paxlovid for COVID and I don't know how that, I would call COVID pills (Paxlovid)."When probed to clarify if consumer wants any information about Paxlovid: Consumer stated, "Yes exactly. Now since I took two dose like in the morning and in the night. I had a hives and stomach pain and Diarrhea at the timing of pain, a Diarrhea. Now I still have those symptoms like I would say a month." Consumer was informed about the role of Pfizer Drug Safety and Pfizer Medical Information for the concern. In response Consumer stated, "Yes because I felt, like I went to do my Endoscopy, I did it, I went to the Emergency room, okay can I have the number (MI Department)." When paraphrased the Booster shot as Pfizer COVID-19 Vaccine and concern: Consumer stated, "I had, I still have the stomach problem and now the Booster (Pfizer COVID-19 Vaccine) shot I got it. I was almost a year ago." When probed for further probing to file the safety report: Consumer stated, "No, it's okay, I am going to call them."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.