chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: SARS-CoV-2 test, Ultrasound scan
Clinical narrative: Miscarriage occurred at home; Ultrasound revealed no heartbeat; Took Flu vaccine and Pfizer covid vaccine on same date of 13Oct2022; Took Flu vaccine and Pfizer covid vaccine on same date of 13Oct2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 3 (booster), single (Lot number: GH9702) at the age of 35 years for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 13Oct2022 as dose number unknown, single (Batch/Lot number: unknown), in arm. The patient's relevant medical history included: "If COVID prior vaccination: Yes" (unspecified if ongoing), notes: If COVID prior vaccination: Yes; "Test: Nasal Swab Result: Positive", start date: 05Feb2022 (unspecified if ongoing). Concomitant medication(s) included: FISH OIL; VITAMIN D3. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EW0181), administration date: 01Jul2022, when the patient was 34-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EW0178), administration date: 10Jun2022, when the patient was 34-year-old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 13Oct2022, outcome "unknown" and all described as "Took Flu vaccine and Pfizer covid vaccine on same date of 13Oct2022"; FOETAL HEART RATE ABNORMAL (congenital anomaly) with onset 22Dec2022, outcome "recovering", described as "Ultrasound revealed no heartbeat"; ABORTION SPONTANEOUS (congenital anomaly, medically significant) with onset 26Dec2022, outcome "recovering", described as "Miscarriage occurred at home". The patient underwent the following laboratory tests and procedures: Pregnancy test: (14Nov2022) Positive, notes: Positive pregnancy test recorded at physician 14Nov2022; SARS-CoV-2 test: (05Feb2022) Positive; Ultrasound scan: (22Dec2022) No heartbeat, notes: Ultrasound revealed no heartbeat on 22Dec2022. Therapeutic measures were not taken as a result of abortion spontaneous, foetal heart rate abnormal.  Additional information: Became pregnant approximately 21Oct2022. Positive pregnancy test recorded at physician 14Nov2022. Ultrasound revealed no heartbeat on 22Dec2022. Miscarriage occurred at home on 26Dec2022. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.
Age: 50.0
Sex: M
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 (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 14:45 as dose 4 (booster), single (Lot number: GJ2524) at the age of 50 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 had no relevant medical history. 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 "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective and covid-19 with Paxlovid treatment from 27Dec2022 to 31Dec2022.
Age: 46.0
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 (Consumer or other non-HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as DOSE 4 (BOOSTER), SINGLE (lot number: GJ6796) at the age of 46 years old, administered in the left arm for COVID-19 immunization; 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 immunization. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19." The patient underwent the following laboratory tests and procedures: COVID-19 test (SARS-CoV-2 test): Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of Drug ineffective, Covid-19 which included Paxlovid treatment from 29Dec2022 to 02Jan2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19/took Paxlovid for a mild COVID infection; Treatment of COVID-19/took Paxlovid for a mild COVID infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Jan2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 01Feb2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 02Oct2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), and all described as "Treatment of COVID-19/took Paxlovid for a mild COVID infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive again; Positive, notes: tested positive again; Negative, notes: tested negative on day 4; Negative, notes: tested negative on day 5; Negative, notes: tested negative on day 6; Negative, notes: tested negative on day 7. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: took Paxlovid for a mild COVID infection. Patient felt mostly better by day 3 and tested negative on day 4, 5, 6, and 7. On day 10, patient started to experience congestion, post nasal drip, and a cough along with aches and pains. This was actually worse than the original symptoms, patient took a new home antigen test and tested positive again. The outcome of the events was unknown.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product use issue, Sinusitis
Clinical narrative: Treatment of COVID-19/took Paxlovid for a mild COVID infection; Treatment of COVID-19/took Paxlovid for a mild COVID infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Jan2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 01Feb2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 02Oct2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), and all described as "Treatment of COVID-19/took Paxlovid for a mild COVID infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive again; Positive, notes: tested positive again; Negative, notes: tested negative on day 4; Negative, notes: tested negative on day 5; Negative, notes: tested negative on day 6; Negative, notes: tested negative on day 7. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: took Paxlovid for a mild COVID infection. Patient felt mostly better by day 3 and tested negative on day 4, 5, 6, and 7. On day 10, patient started to experience congestion, post nasal drip, and a cough along with aches and pains. This was actually worse than the original symptoms, patient took a new home antigen test and tested positive again. The outcome of the events was unknown.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team, Program ID: (Unknown). The reporter is the parent.  A 24-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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. Vaccination history included: BNT162b2 (dose 1, single; lot number: unknown), for COVID-19 immunization; BNT162b2 (dose 2, single; lot number: unknown), for COVID-19 immunization. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown". Clinical course: The patient's father reported that the patient (his son) got harmed after getting the Pfizer COVID-19 vaccine. The patient received first two shots of Pfizer COVID-19 vaccine in the time period he was supposed to and also got the booster. He did not have a problem that time. In the last few weeks prior to the time of the report, the patient got a heart condition. The father was complaining about the vaccine and how there is no plan on what to do with patients who developed myocarditis. The father stated, "You said that this was safe and effective...it turns out it is not safe." and mentioned a passing comment "there might be a class action lawsuit." Upon callback, the patient's father noted that his son became dizzy with heart palpitations and "struggles to take the trash out". He asked what "Pfizer is doing" about this event and how Pfizer is helping people with myocarditis "reclaim their health". He wanted to know how Pfizer is advising treatment. The father was advised to discuss the situation with the patient's HCP and noted that the patient has an appointment with a cardiologist the following week.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300010911 same patient and event; different dose and event (invalid);US-PFIZER INC-202300010981 same patient and event; different dose and event (invalid);
Age: 65.0
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 (other HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 13:00 as dose 5 (booster), single (batch/lot number: GH9694) at the age of 65 years, in left arm for covid-19 immunization; BNT162b2 (BNT162B2), on 13Jan2021 as dose 1, single (batch/lot number: EL3247), on 01Feb2021 as dose 2, single (batch/lot number: EL9264), on 17Aug2021 as dose 3 (booster), single (batch/lot number: F97485) and on 31Mar2022 as dose 4 (booster), single (batch/lot number: FK97485) for covid-19 immunization. The patient's relevant medical history included: "lupus" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "pre-diabetic" (unspecified if ongoing); "penicillin allergies" (unspecified if ongoing); "sulfa allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (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: positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Pavlovid with treatment start date 29Dec2022 and treatment stop date 02Jan2023.; Sender's Comments: Based on the known the information available the Causal relation between the events Vaccination failure, Covid 19 and suspect drug cannot be excluded completely
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Dec2022 at 14:30 as dose 5 (booster), single (Lot number: GJ3274) at the age of 67 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Aug2022 at 14:30 as dose 4 (booster), single (Lot number: FP7139), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; LIOTHYRONINE. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: antigen tested positive on day 13 prior antigen negative tests on day 9 and day 11; Negative, notes: antigen tested positive on day 13 prior antigen negative tests on day 9 and day 11; Negative, notes: antigen tested positive on day 13 prior antigen negative tests on day 9 and day 11. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Adverse event: new symptoms on day 12; only sinus congestion and fatigue antigen tested positive on day 13 prior antigen negative tests on day 9 and day 11.
Age: 44.0
Sex: F
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 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Apr2021 as dose 2, single (Lot number: EN6207, EW0161) at the age of 44 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: "Known allergies: sufla meds"; "Known allergies: latex". The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: codeine". 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 and included treatment with nirmatrelvir;ritonavir (PAXLOVID).  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: headaches; body pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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 but unknown manufacturer), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches"; PAIN (non-serious), outcome "unknown", described as "body pain".  Additional information: It was reported that the headache is pretty severe. Also, the body aches. The patient would like to know if these symptoms are known to occur, how long his symptoms typically last, and if he can take ibuprofen.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
Age: 64.0
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) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 64 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: ER8732), on 22Apr2021 as dose 2, single (Lot number: EW0170), on 25Oct2021 as dose 3 (booster), single (Lot number: 32030BO) and on 12May2022 as dose 4 (booster), single (Lot number: FM9992) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: under control; "high cholesterol" (unspecified if ongoing), notes: under control. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient had no known allergies. Patient received Paxlovid as treatment for Covid-19 from 29Dec2022 to 02Jan2023.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Vaccine: COVID-19; COVID-19 Vaccine: COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 59-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GJ2524) 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 included: "Fibromyalgia" (unspecified if ongoing); "COVID-19", start date: Feb2021 (unspecified if ongoing), notes: all got COVID-19 at the same time in Feb2021. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Dec2022, outcome "unknown" and all described as "COVID-19 Vaccine: COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Dec2022) Positive, notes: tested positive for COVID-19, he thinks on 29Dec2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300011224 same patient, different product and event;
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jul2022 at 10:00 as dose 4 (booster), single (Lot number: FP7138) at the age of 67 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "neuropathy" (unspecified if ongoing); "Sensitive to nightshades" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Valium, reaction(s): "Allergic to Valium", notes: Allergic to Valium. 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.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 15:45 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), 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: "High blood pressure" (unspecified if ongoing), notes: High blood pressured controlled with valsartan. Concomitant medication(s) included: VALSARTAN taken for hypertension, start date: 01Jan2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19/Positive for covid 19; Treatment of COVID-19/Positive for covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: Oj2524) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EL9266) at the age of 67 years, in left arm, on 29Mar2021 as dose 2, single (Lot number: Er8730) at the age of 67 years, in left arm, on 01Oct2021 as dose 3 (booster), single (Lot number: Ff2587) at the age of 68 years, in left arm and on 08Apr2022 as dose 4 (booster), single (Lot number: Fk9895) at the age of 68 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Jan2017; ATORVASTATIN, start date: 01Jan2006, stop date: 29Dec2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Dec2022, outcome "unknown" and all described as "Treatment of COVID-19/Positive for covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Dec2022) Positive, notes: Positive for covid 19. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Chest X-ray, Dyspnoea, Hypertension
Clinical narrative: extremely short of breath/shortness of breath; unable to do normal activities; unable to sleep; swelling in my legs and chest; swelling in my legs and chest; discoloration in my legs; high blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14May2021 at 11:00 as dose 2, single (Lot number: Ew0185) at the age of 45 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Ew0170, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 23Apr2021, when the patient was 45-year-old, for covid-19 immunisation. The following information was reported: SKIN DISCOLOURATION (non-serious) with onset 24May2021 at 12:00, outcome "unknown", described as "discoloration in my legs"; DYSPNOEA (non-serious) with onset 24May2021 at 12:00, outcome "unknown", described as "extremely short of breath/shortness of breath"; HYPERTENSION (non-serious) with onset 24May2021 at 12:00, outcome "unknown", described as "high blood pressure"; PERIPHERAL SWELLING (non-serious), SWELLING (non-serious) all with onset 24May2021 at 12:00, outcome "unknown" and all described as "swelling in my legs and chest"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 24May2021 at 12:00, outcome "unknown", described as "unable to do normal activities"; INSOMNIA (non-serious) with onset 24May2021 at 12:00, outcome "unknown", described as "unable to sleep". The events "extremely short of breath/shortness of breath", "unable to do normal activities", "unable to sleep", "swelling in my legs and chest", "discoloration in my legs" and "high blood pressure" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of dyspnoea, loss of personal independence in daily activities, insomnia, peripheral swelling, swelling, skin discolouration. Therapeutic measures were taken as a result of hypertension. Clinical course: The day after the second vaccination she became extremely short of breath and was unable to do normal activities she could before. The symptoms experienced were shortness of breath unable to sleep due to feeling like couldn't breathe, swelling in legs and chest also a discoloration in legs occurred as well from the swelling. She was unable to do anything at times and between walk in clinics and getting a new doctor no one looked at all symptoms as a whole instead would say it was high blood pressure but all blood pressure medications did not work. The blood tests were normal as well as the chest X-ray. Also tested to see if she had previously had Covid and it was negative.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Loss of personal independence in daily activities, Peripheral swelling, SARS-CoV-2 test, Skin discolouration
Clinical narrative: extremely short of breath/shortness of breath; unable to do normal activities; unable to sleep; swelling in my legs and chest; swelling in my legs and chest; discoloration in my legs; high blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14May2021 at 11:00 as dose 2, single (Lot number: Ew0185) at the age of 45 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Ew0170, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 23Apr2021, when the patient was 45-year-old, for covid-19 immunisation. The following information was reported: SKIN DISCOLOURATION (non-serious) with onset 24May2021 at 12:00, outcome "unknown", described as "discoloration in my legs"; DYSPNOEA (non-serious) with onset 24May2021 at 12:00, outcome "unknown", described as "extremely short of breath/shortness of breath"; HYPERTENSION (non-serious) with onset 24May2021 at 12:00, outcome "unknown", described as "high blood pressure"; PERIPHERAL SWELLING (non-serious), SWELLING (non-serious) all with onset 24May2021 at 12:00, outcome "unknown" and all described as "swelling in my legs and chest"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 24May2021 at 12:00, outcome "unknown", described as "unable to do normal activities"; INSOMNIA (non-serious) with onset 24May2021 at 12:00, outcome "unknown", described as "unable to sleep". The events "extremely short of breath/shortness of breath", "unable to do normal activities", "unable to sleep", "swelling in my legs and chest", "discoloration in my legs" and "high blood pressure" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of dyspnoea, loss of personal independence in daily activities, insomnia, peripheral swelling, swelling, skin discolouration. Therapeutic measures were taken as a result of hypertension. Clinical course: The day after the second vaccination she became extremely short of breath and was unable to do normal activities she could before. The symptoms experienced were shortness of breath unable to sleep due to feeling like couldn't breathe, swelling in legs and chest also a discoloration in legs occurred as well from the swelling. She was unable to do anything at times and between walk in clinics and getting a new doctor no one looked at all symptoms as a whole instead would say it was high blood pressure but all blood pressure medications did not work. The blood tests were normal as well as the chest X-ray. Also tested to see if she had previously had Covid and it was negative.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: extremely short of breath/shortness of breath; unable to do normal activities; unable to sleep; swelling in my legs and chest; swelling in my legs and chest; discoloration in my legs; high blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14May2021 at 11:00 as dose 2, single (Lot number: Ew0185) at the age of 45 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Ew0170, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 23Apr2021, when the patient was 45-year-old, for covid-19 immunisation. The following information was reported: SKIN DISCOLOURATION (non-serious) with onset 24May2021 at 12:00, outcome "unknown", described as "discoloration in my legs"; DYSPNOEA (non-serious) with onset 24May2021 at 12:00, outcome "unknown", described as "extremely short of breath/shortness of breath"; HYPERTENSION (non-serious) with onset 24May2021 at 12:00, outcome "unknown", described as "high blood pressure"; PERIPHERAL SWELLING (non-serious), SWELLING (non-serious) all with onset 24May2021 at 12:00, outcome "unknown" and all described as "swelling in my legs and chest"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 24May2021 at 12:00, outcome "unknown", described as "unable to do normal activities"; INSOMNIA (non-serious) with onset 24May2021 at 12:00, outcome "unknown", described as "unable to sleep". The events "extremely short of breath/shortness of breath", "unable to do normal activities", "unable to sleep", "swelling in my legs and chest", "discoloration in my legs" and "high blood pressure" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of dyspnoea, loss of personal independence in daily activities, insomnia, peripheral swelling, swelling, skin discolouration. Therapeutic measures were taken as a result of hypertension. Clinical course: The day after the second vaccination she became extremely short of breath and was unable to do normal activities she could before. The symptoms experienced were shortness of breath unable to sleep due to feeling like couldn't breathe, swelling in legs and chest also a discoloration in legs occurred as well from the swelling. She was unable to do anything at times and between walk in clinics and getting a new doctor no one looked at all symptoms as a whole instead would say it was high blood pressure but all blood pressure medications did not work. The blood tests were normal as well as the chest X-ray. Also tested to see if she had previously had Covid and it was negative.
Sex: F
Vaccine: COVID19-2
Symptoms: Pityriasis rubra pilaris
Clinical narrative: Pityriasis Rubra Pilaris rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: GJ5342) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Single, Lot EH9899), administration date: 09Jan2021, for Covid-19 immunization; BNT162b2 (Dose 2, Single Lot EL1284), administration date: 30Jan2021, for Covid-19 immunization; BNT162b2 (Dose 3 (Booster), Single, Lot FF8839), administration date: 04Oct2021, for Covid-19 immunization; BNT162b2 (Dose 4 (Booster), Single, Lot FM9992), administration date: 18Apr2022, for Covid-19 immunization. The following information was reported: PITYRIASIS RUBRA PILARIS (non-serious) with onset Sep2022, outcome "unknown", described as "Pityriasis Rubra Pilaris rash". The event "pityriasis rubra pilaris rash" required physician office visit. Additional Information: She was seeking any information on the adverse effect of Pityriasis Rubra Pilaris rash being reported from the Pfizer Covid booster. States she was originally seen by the doctor on 09Sep and diagnosed sometime in Oct (as reported). It is a life changing rash that has been going on for months. She is calling now because she was diagnosed with Pityriasis Rubra Pilaris in the middle of Aug2022, 2 weeks after the last booster approximately. At the time, no one she knew had this, don't know why this happened, she wondered to herself why everything could be. It's a rare rash, a very rare, an autoimmune issue, she doesn't know anyone with it, nothings changed, she's just dealt with it, this has been life changing for her. She read as much she could find but since its rare she is not finding much, she thought she will go back online to find new information, and this time all kinds of articles were tied to the covid booster. She is wondering she should get another booster or did she mess up her autoimmune system, when she asked the doctor they don't know anything. After providing her vaccine dates she clarified that she was wrong about being diagnosed with Pityriasis Rubra Pilaris in Aug2022, she does not know the specific date but it certain it was after the 3rd booster. The patient was diagnosed with pityriasis rubra pilaris last Sep (as reported) and would like information about how her Covid boosters may be involved in this. Should she get the next booster or she has already strained her immune system too far.
Age: 56.0
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 contactable reporter(s) (Consumer or other non-HCP) from product quality group. The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 18:30 as dose 4 (booster), single (Lot number: 300690345307) at the age of 56 years, in left arm for covid-19 immunization; 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 immunization. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypothyroidism" (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 Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid started on 27Dec2022 and stopped on 01Jan2023 as treatment for covid-19.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1 single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. 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 "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (2022) Negative; (04Jan2023) 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: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  An 86-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 5 (bivalent), single (Batch/Lot number: unknown) at the age of 86 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 4 (booster), 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: "htn" (unspecified if ongoing); "depression" (unspecified if ongoing); "gerd" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing). The patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Negative, notes: rebound covid positivity after completing course of paxlovid and testing negative for 2-3 days; (Jan2023) Positive, notes: rebound covid positivity after completing course of paxlovid and testing negative for 2-3 days. Therapeutic measures were taken as a result of covid-19, drug ineffective. The patient has not recovered from the event at the time of the report.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, an association between the reported events DRUG INEFFECTIVE  & COVID-19 and The suspected drug cannot be ruled out.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 47-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EL3247), on 16Mar2021 as dose 2, single (Lot number: EL3247) and on 26Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 46 years for covid-19 immunisation. It was unknown if prior to vaccination the patient was diagnosed with COVID-19. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 06Jan2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 06Jan2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jan2023) Positive, notes: Nasal Swab; (07Jan2023) Positive, notes: Nasal Swab; (06Jan2023) Positive; (07Jan2023) Positive. It was unknown if 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: As per the available information the causality of the events drug ineffective and covid-19 with the suspect can not be ruled out completely.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, SARS-CoV-2 test, Skin lesion
Clinical narrative: Bruise-like circular lesions around the toenail; single purple spots on other toes; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Dec2022 at 08:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Back pain" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing); "Complex regional pain syndrome in other foot" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Vicodin, reaction(s): "known allergies: Vicodin"; Ellavil, reaction(s): "known allergies: Ellavil". Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, Manufacturer Unknown), for COVID-19 Immunization; Bnt162b2 (Dose 4, lot number: Unknown, Left arm), for COVID-19 Immunization. The following information was reported: SKIN LESION (non-serious) with onset 30Dec2022 at 12:00, outcome "not recovered", described as "Bruise-like circular lesions around the toenail"; RASH MACULAR (non-serious) with onset 30Dec2022 at 12:00, outcome "not recovered", described as "single purple spots on other toes". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of skin lesion, rash macular.  Additional information: Also reported dose 4 Pfizer vaccine on 09Dec2022. The patient got Covid test at about 4 weeks after bivalent vaccine (dose 5). No covid prior vaccination and not covid tested post vaccination (as reported).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Muscle spasms, SARS-CoV-2 test
Clinical narrative: Muscle spasms in right jaw; Fatigue; Shortness in breath; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 03Jan2023 at 12:00 as dose 1, single (Lot number: FR2587) at the age of 31 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Spastic bowel syndrome" (unspecified if ongoing); "Gluten allergy" (unspecified if ongoing); "Yeast allergy" (unspecified if ongoing). Concomitant medication included: INFLUENZA VACCINE, on 29Dec2022 as dose 1, single. The following information was reported: FATIGUE (medically significant) with onset 04Jan2023 at 13:30, outcome "recovered with sequelae"; MUSCLE SPASMS (medically significant) with onset 04Jan2023 at 13:30, outcome "recovered with sequelae", described as "Muscle spasms in right jaw"; DYSPNOEA (medically significant) with onset 04Jan2023 at 13:30, outcome "recovered with sequelae", described as "Shortness in breath". The events "muscle spasms in right jaw", "fatigue" and "shortness in breath" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jan2023) Negative. Therapeutic measures were taken as a result of muscle spasms, fatigue, dyspnoea reported as "volume shot". Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Allergic to pumpkins" (unspecified if ongoing), notes: Known allergies: Allergic to pumpkins. Not allergic to any medications. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, 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, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.