chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A 14-year-old male patient received BNT162b2 (BNT162B2), on 05Aug2022 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: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer.), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever/ 102 something up, the fever"; HEADACHE (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: Reporter stated, "I have a question. My 14-year-old got his first booster ( Pfizer-BioNTech COVID-19 Vaccine) yesterday and he has a headache a 102 something up, the fever. The paperwork says that this over a 100.4. Can he take anything about fever" Reporter was informed about the Role of Pfizer Drug Safety. Reporter was informed that Pfizer Medical Information Department was closed due to weekend and was requested to contact any of the health care providers like nurse, physician or a pharmacist or visit the nearest emergency room. Reporter stated, "They did not tell me anything. But I will call my doctor. Thank you!" Product details (LOT, NDC, UPC and Expiration date) and Pharmacy details were not available over the call as the reporter hung up abruptly. Further details could not be probed as the reporter hung up the call abruptly. Hence, further probing could not be done.  Thus limited information available over the call. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid-19; covid-19; symptoms returned (cough, fatigue, congestion). Tested positive again 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 28-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 26Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 years, in left arm for COVID-19 immunisation; COVID-19 vaccine (manufacturer unspecified), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19"; DISEASE RECURRENCE (medically significant) with onset 06Aug2022, outcome "unknown", described as "symptoms returned (cough, fatigue, congestion). Tested positive again for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive, notes: Tested positive again for COVID-19. The patient received PAXLOVID from 26Jul2022 to 30Jul2022 for treatment of COVID-19. Symptoms of COVID-19 had initially improved for approximately one week after taking PAXLOVID. On Day 8 (06Aug2022), symptoms returned (cough, fatigue, congestion) and the patient tested positive again for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Menstrual cycle used to be 4 weeks on the dot. Now it is 6-7 weeks between cycles.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Sep2021 as dose 2, single (Lot number: FF2588) at the age of 16 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "gluten" (unspecified if ongoing), notes: Known allergies: gluten, dairy; "dairy" (unspecified if ongoing), notes: Known allergies: gluten, dairy. Concomitant medication(s) included: JUICE PLUS. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; lot number: FC3180, vaccine location: Left arm.), administration date: 13Aug2021, when the patient was 16-year-old, for Covid-19 immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 01Oct2021, outcome "not recovered", described as "Menstrual cycle used to be 4 weeks on the dot. Now it is 6-7 weeks between cycles.". Therapeutic measures were not taken as a result of menstruation irregular.  Additional information: The patient menstrual cycle used to be 4 weeks on the dot. Now it is 6-7 weeks between cycles. The patient did not have covid prior to vaccination. Also, the patient was not tested for covid post vaccination. The patient was also taking Lauricidin as concomitant drug. The patient had no other vaccine in four weeks.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: took a Pfizer Vaccine as their first round. They had two subsequent rounds and they did contract COVID within the last 24 hours.; contract COVID within the last 24 hours; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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), outcome "unknown", described as "took a Pfizer Vaccine as their first round. They had two subsequent rounds and they did contract COVID within the last 24 hours."; COVID-19 (medically significant), outcome "unknown", described as "contract COVID within the last 24 hours". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Unknown results, notes: they did contract COVID.  Clinical course: Reporter stated that one of my family members (consumer) took a Pfizer vaccine as their first round. They had two subsequent rounds and they did contract Covid within the last 24 hours. I do not know if we were supposed to report that because I know there are a lot of variants out there that are being covered by the vaccine and it was the very first one that this person took versus taking two additional ones after that, the second round and the Booster. It was the Pfizer I believe it was just that first round of the Pfizer Covid-19 Vaccine, yes, the first round, I do not know what that's called. Confirmed as Pfizer Covid-19 Vaccine. No, everything has been fine and hopefully but I thought if we were supposed to report that one of these new variants overcame, I do not even know like I said after three rounds, the other two rounds I do not know if they were Pfizer drugs or if they were Moderna or anybody else.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 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), on 04Apr2022 at 20:00 as dose 4 (booster), single (Lot number: FS6369) at the age of 64 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 and no known allergies. Concomitant medication(s) included: CARBAMAZEPINE, start date: 01Jan2018, stop date: 24Jul2022; ROSUVASTATIN, start date: 01Jan2020; METAMUCIL [PLANTAGO OVATA]; BIOTIN; KRILL OIL; COQ10 [UBIDECARENONE]; MVI [ASCORBIC ACID; DEXPANTHENOL; ERGOCALCIFEROL; NICOTINAMIDE; PYRIDOXINE HYDROCHLORIDE; RETINOL; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; TOCOPHERYL ACETATE]; VIT D3; VIT C; CALCIUM + MAGNESIUM + ZINK; TURMERIC [CURCUMA LONGA RHIZOME]. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 08Aug2022 at 09:00, outcome "recovering", described as "After Paxlovid tested neg on 30Jul22 & tested positive on 08Aug22"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jul2022) Negative; (02Aug2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19: the patient received Paxlovid (Lot number=NDC: 00069-1085-30) as COVID 19 treatment from 24Jul2022 to 29Jul2022. No treatment received for "After Paxlovid tested neg on 30Jul22 & tested positive on 08Aug22" as reported. Clinical course: After Paxlovid tested neg on 30Jul2022 & tested positive on 02Aug2022. Fever, cold, cough, tired, aches, worse then very minor 3 days of SX with Paxlovid.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Paraesthesia, Thirst
Clinical narrative: Feeling cold; It is making her very thirsty; Tingling all over; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), in 2022 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: FEELING COLD (non-serious) with onset 2022, outcome "unknown"; THIRST (non-serious) with onset 2022, outcome "unknown", described as "It is making her very thirsty"; PARAESTHESIA (non-serious) with onset 2022, outcome "unknown", described as "Tingling all over". Additional information: reporter stated that they just gave the patient the Pfizer COVID-19 vaccine and it has been about 10 minutes, she said that she was feeling cold and tingling all over. They gave her water because she said it was making her very thirsty. She said the last time she ate was last night. Reporter was not sure what was the last time she has eaten.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient. A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "History of breast cancer" (unspecified if ongoing), notes: History of breast cancer; "hypertension" (ongoing); "TPF right leg" (unspecified if ongoing), notes: TPF right leg. The patient's concomitant medications were not reported. Past drug history included: Flagyl, reaction(s): "known allergies Flagyl", notes: known allergies Flagyl; Celexa, reaction(s): "known allergies celexa", notes: known allergies celexa. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. 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: Based on the available reported information, the causal association between the event and the suspect drug BNT162B2 cannot be excluded.
Age: 53.0
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 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 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.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 18Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 23Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Ceftin, reaction(s): "Known allergies: Ceftin". The following information was reported: VACCINATION FAILURE (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: (2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient has undergone COVID 19 treatment with Paxlovid from 27Jul2022 to 01Aug2022. She had rebound symptoms after 5-day of Paxlovid treatment on 07Aug2022 and the patient was recovering from rebound symptoms. She has not received other medications within 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid; covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There is no known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Aug2022, outcome "recovering" and all described as "covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Aug2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Additional information: there is no other vaccine in fourweeks, no other medication in 2 weeks. There is no treatment for AE, no covid prior vaccination. Covid tested post vaccination with Nasal Swab on 03Aug2022, covid test result was positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 35.0
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 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Dec2021 as dose 2, single (Lot number: FL3197) at the age of 35 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Did you/the patient previously receive a COVID-19 Vaccine?: Yes; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 61-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 had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset Jul2022, outcome "recovering", described as "COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset Jul2022, outcome "recovering", described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment/ Rebounded and test positive 2 weeks after testing negative; COVID 19 Treatment/ Rebounded and test positive 2 weeks after testing negative; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: ER8731), in left arm and on 06May2021 as dose 2, single (Lot number: ER8736) at the age of 49 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "not recovered", COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment/ Rebounded and test positive 2 weeks after testing negative". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID-19 Treatment; Negative, notes: after testing negative; Positive, notes: Rebounded and test positive 2 weeks. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I've been boosted once and got covid; I've been boosted once and got covid; This is a spontaneous report received from a non-contactable nurse from medical information team. The reporter is the patient. A male patient received BNT162b2 (COMIRNATY), as dose number unknown (booster), single (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), COVID-19 (medically significant), outcome "unknown" and all described as "I've been boosted once and got covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: Product: COMIRNATY. Question: Your not going to use anything with my information are you? The only part I don't like is the part that you will share my information with other companies. Will you erase my information?  I don't want Pfizer sharing my information. Caller is a RN that wishes to remain anonymous. I've been boosted once and got covid and now trying to decide to get second booster or wait until the one that covers the two or three variants. Question: When will the booster for Covid be available to cover the three new variants?  I've been boosted once and got Covid and now am trying to decide to get second booster or wait until the one that covers the two or three variants. The new vaccine that is coming out in the fall. You don't have any recommendations for someone trying to decide do you?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected BNT162b2 (COMIRNATY) in this patient cannot be completely excluded.  However, vaccine efficacy varies from one patient to another and can be affected by different factors. Further information like vaccination date and COVID infection date and co-suspect covid-19 vaccines (manufacturer unknown) needed for better medical assessment.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Batch/Lot number: unknown), on 19Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 05Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMLODIPINE; ATORVASTATIN CALCIUM; BENAZEPRIL; D3; DICLOFENAC SODIUM; VITAMIN B-COMPLEX WITH VITAMIN C [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CHOLINE BITARTRATE;CYANOCOBALAMIN;FOLIC ACID;INOSITOL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE MONONITRATE]; FISH OIL; OMEGA-3-ACID ETHYL ESTER. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Faint Positive, notes: Started Paxlovid after 2 home tests. Were ''faint Positive''; (03Aug2022) Faint Positive, notes: Still ''faint positive'' 03Aug2022; (05Aug2022) Very robust positive, notes: 05Aug2022 ''very robust positive'' at home test; (07Aug2022) Very robust positive, notes: 07Aug2022 ''very robust positive'' at home test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient started Paxlovid after 2 home tests were "faint Positive". Ended treatment 01Aug2022. Still "faint positive" 03Aug2022. 05Aug2022 "very robust positive" at- test. 07Aug2022 still "very robust positive" with at-home test. May have started treatment too soon. COVID 19 Treatment was started (Brand=Paxlovid) Treatment start date=28Jul2022,  Treatment stop date=01Aug2022,  Indication=Treatment of COVID-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: friend got very sick within two weeks of getting their so called safe and effective profit shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "friend got very sick within two weeks of getting their so called safe and effective profit shots". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: friend got VERY sick within two weeks of getting their so called "safe & effective" profit shots/the Pfizer shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP..  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "friend got VERY sick within two weeks of getting their so called "safe & effective" profit shots/the Pfizer shot".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Headache, Lacrimation increased, Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 53-year-old female patient received BNT162b2 (BNT162B2), on 07Aug2022 as dose 1, single (Lot number: FP7138) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (ongoing), notes: Diabetic From: 14 years ago. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 07Aug2022, outcome "not recovered"; PYREXIA (non-serious) with onset 07Aug2022, outcome "not recovered", described as "Mild fever of 100.3 degrees Fahrenheit"; SUSPECTED COVID-19 (non-serious) with onset 07Aug2022, outcome "not recovered", described as "caller's kids think caller has Covid and caller is asking if caller had Covid"; LACRIMATION INCREASED (non-serious) with onset 07Aug2022, outcome "not recovered", described as "eyes feel weird/kind of watery"; PAIN IN EXTREMITY (non-serious) with onset 07Aug2022, outcome "not recovered", described as "her legs were hurting a lot"; BACK PAIN (non-serious) with onset 07Aug2022, outcome "not recovered", described as "low back hurting". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Additional information: Yesterday afternoon caller got the Pfizer shot, clarified caller got the Pfizer COVID-19 vaccine yesterday. Has a few questions because after getting the vaccine yesterday afternoon caller got a mild fever of 100.3 degrees Fahrenheit which caller took Tylenol for and still has the fever. Caller's legs hurt a lot, legs are still hurting a lot and low back is hurting. Caller has all these symptoms, caller's kids think caller has Covid and caller is asking if caller had Covid, could caller give Covid to kids. Caller is asking if when caller got the vaccine, could caller have gotten Covid? Caller eyes feel weird, kind of watery, like sunk, which started 07Aug2022. Has a headache, started 07Aug2022.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 53-year-old female patient received BNT162b2 (BNT162B2), on 07Aug2022 as dose 1, single (Lot number: FP7138) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (ongoing), notes: Diabetic From: 14 years ago. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 07Aug2022, outcome "not recovered"; PYREXIA (non-serious) with onset 07Aug2022, outcome "not recovered", described as "Mild fever of 100.3 degrees Fahrenheit"; SUSPECTED COVID-19 (non-serious) with onset 07Aug2022, outcome "not recovered", described as "caller's kids think caller has Covid and caller is asking if caller had Covid"; LACRIMATION INCREASED (non-serious) with onset 07Aug2022, outcome "not recovered", described as "eyes feel weird/kind of watery"; PAIN IN EXTREMITY (non-serious) with onset 07Aug2022, outcome "not recovered", described as "her legs were hurting a lot"; BACK PAIN (non-serious) with onset 07Aug2022, outcome "not recovered", described as "low back hurting". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Additional information: Yesterday afternoon caller got the Pfizer shot, clarified caller got the Pfizer COVID-19 vaccine yesterday. Has a few questions because after getting the vaccine yesterday afternoon caller got a mild fever of 100.3 degrees Fahrenheit which caller took Tylenol for and still has the fever. Caller's legs hurt a lot, legs are still hurting a lot and low back is hurting. Caller has all these symptoms, caller's kids think caller has Covid and caller is asking if caller had Covid, could caller give Covid to kids. Caller is asking if when caller got the vaccine, could caller have gotten Covid? Caller eyes feel weird, kind of watery, like sunk, which started 07Aug2022. Has a headache, started 07Aug2022.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had both doses of the Pfizer BioNTech Covid-19 vaccine and had the booster too and got diagnosed with Covid today; had both doses of the Pfizer BioNTech Covid-19 vaccine and had the booster too and got diagnosed with Covid today; 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), 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 08Aug2022, outcome "not recovered" and all described as "had both doses of the Pfizer BioNTech Covid-19 vaccine and had the booster too and got diagnosed with Covid today". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Aug2022) Positive, notes: got diagnosed with Covid today. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Additional information: The caller stated he had both doses of the Pfizer BioNTech Covid-19 vaccine and had the booster too and got diagnosed with Covid today. He stated he got Paxlovid and the air conditioner is out in his house and the temperature right now is 82F in his house. He wanted to know if there are recommendations for this, especially if it gets warmer. Should it get placed in the fridge?  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: Anxiety
Clinical narrative: My friend thought she was going to die after getting the PBCV and it went away in one day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANXIETY (non-serious), outcome "recovered", described as "My friend thought she was going to die after getting the PBCV and it went away in one day".  Clinical course: Reporter stated that her friend thought she was going to die after getting the PBCV and it went away in one day.  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: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4493405-00.  A 74-year-old female patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown) and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), first regimen (Batch/Lot number: unknown) at unk, pre filled pen and second regimen since Feb2021 (Batch/Lot number: unknown) at unk, pre filled pen, all subcutaneous for psoriasis. 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 04Jul2022, outcome "unknown" and all described as "COVID". The action taken for risankizumab was unknown.  Additional information: Causality as per reporter was reported as Possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 22Mar2022 as dose 4 (booster), single (Lot number: 04C21A) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma; "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient received other vaccines and Other medications in 2 weeks.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage subcutaneous
Clinical narrative: Husband and wife received their second Covid vaccination and developed immediately blood in their hands and fingers underneath the skin; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A male patient (husband) received BNT162b2 (BNT162B2), as dose 2, 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 (DOSE: 1, Manufacturer unknown), for covid 19 immunization. The following information was reported: HAEMORRHAGE SUBCUTANEOUS (non-serious), outcome "unknown", described as "Husband and wife received their second Covid vaccination and developed immediately blood in their hands and fingers underneath the skin".  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-PV202200039429 Same reporter/drug/event, different patient;
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 21Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 31Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (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: "Diabetic" (unspecified if ongoing); "History of heart surgery" (not ongoing). Concomitant medication(s) included: NOVOLOG; ATORVASTATIN; CILOSTAZOL; METOPROLOL; VASCEPA; AMLODIPINE BESILATE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Jul2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient had no known allergies. The patient received treatment as Paxlovid for COVID-19 from 22Jul2022 to 26Jul2022. Received Paxlovid after positive COVID test on 22Jul2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 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: "high blood pressure" (unspecified if ongoing); "overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jul2022, outcome "unknown", COVID-19 (medically significant) with onset Jul2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Aug2022) positive. Therapeutic measures were taken as a result of covid-19.  Additional information: Serious, Seriousness criteria-Results in death, Seriousness criteria-Life threatening, Seriousness criteria-Caused/prolonged hospitalization, Seriousness criteria-Disabling/Incapacitating and Seriousness criteria-Congenital anomaly/birth defect: No; Relevant past drug history: Name of Drug as Reported: No/ Reaction: Allergy. If vaccine received: Yes; other medication in 2weeks: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; 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 drug BNT162B2 to the reported events drug ineffective and COVID-19 cannot be ruled out.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Lot number: EW0151), in left arm, on 26Apr2021 as dose 2, single (Lot number: EW0165), in left arm and on 05Jan2022 as dose 3 (booster), single (Lot number: 3313013A) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hashimoto thyroiditis" (unspecified if ongoing); "high bp" (unspecified if ongoing); "adult HSP that caused some kidney damage" (unspecified if ongoing); "adult HSP that caused some kidney damage" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; SYNTHROID; ZYRTEC [CETIRIZINE HYDROCHLORIDE].  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient was treated with Paxlovid from 25Jul2022 to 29Jul2022. Patient had no allergy. The patient received other medications/products within 2 weeks of starting COVID-19 treatment. patient previously receive a COVID-19 Vaccine. Device Date : 08Aug2022.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid 19; Covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: Em9804) and on 01Oct2021 as dose 2, single (Lot number: Ff2587) at the age of 48 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "Covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient has not taken other medication in 2weeks. The patient has no Known allergies and no other medical history. The patient started paxlovid for treatment of COVID-19 on 29Jul2022.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 11Jan2021 as dose 2, single (Batch/Lot number: unknown), on 20Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 08Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipemia" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing), the patient had no known allergies. Concomitant medication(s) included: ROSUVASTATIN, start date: 12Jan2017; FINASTERIDE, start date: 01Jan2017. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient was treated with Paxlovid for Covid-19 treatment from 22Jul2022 to 27Jul2022. The reason for unknown lot number for all the doses of vaccine was misplaced/discarded.  The lot number for [BNT162b2], was not provided and will be requested during follow up.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to vaccination failure and COVID-19 cannot be ruled out.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive test for COVID 19; 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 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 at 17:00 as dose 1, single (Lot number: 9264), in left arm, on 18Feb2021 at 14:00 as dose 2, single (Lot number: En6203), in left arm, on 06Oct2021 at 10:00 as dose 3 (booster), single (Lot number: Ff8841), in right arm and on 11Apr2022 at 13:00 as dose 4 (booster), single (Lot number: Fj4989) at the age of 69 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Jul2022, outcome "unknown" and all described as "COVID 19"; DISEASE RECURRENCE (medically significant) with onset 08Aug2022, outcome "unknown", described as "Positive test for COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Jul2022) Positive; (05Aug2022) Negative; (08Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Negative test for COVID 05Aug2022. Positive test on 08Aug2022. First tested positive on 26Jul2022 started paxlovid that day for total of ten doses over five days.