chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Pneumonia, Pulmonary thrombosis
Clinical narrative: he had 3 blood clots in his lungs; hospitalized, pneumonia in both lungs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number unknown, MANUFACTURER: UNKNOWN), for COVID-19 immunization. The following information was reported: PULMONARY THROMBOSIS (hospitalization), outcome "unknown", described as "he had 3 blood clots in his lungs"; PNEUMONIA (hospitalization), outcome "unknown", described as "hospitalized, pneumonia in both lungs". The lot number for bnt162b2 was not provided and will be requested during follow up.  Clinical course: Caller knows of 2 cases : "one was a cardiologist who had his primary series and was boostered. He came down with covid-19 and was hospitalized, pneumonia in both lungs and also he had 3 blood clots in his lungs." Caller also says she knows people who had the booster who got very sick and some people didn't get sick at all.
Sex: M
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: he now has a round purple mark on his hand; 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), administration date 07Feb2022 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SKIN DISCOLOURATION (non-serious) with onset Feb2022, outcome "unknown", described as "he now has a round purple mark on his hand".  Additional Information: Patient received a Pfizer BioNTech covid 19 vaccines yesterday and he now has a round purple mark on his hand.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I ended up w Covid in Jan2022; I ended up w Covid in Jan2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200230352 (Pfizer).  A female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jan2022, outcome "unknown" and all described as "I ended up w Covid in Jan2022". The patient initially received 2 doses of Pfizer in Feb2021. Boosters came out way later and I boosted in Dec2021. I ended up w Covid in Jan2022. I question whether the length of time between initially dosing, and booster was too long, and I am now in effect not fully covered (recent Covid antibodies aside). At what point do I re-vaccinate. 1. Advise caller that there is no information in the current PI ( Revised: 31Jan2022) on the maximum duration limit between the Pifzer BioNTech Covid-19 Vaccine second dose and booster dose. There is also no information in the PI that supports the booster dose is no longer effective if the duration from the second dose was too long. 2, Advise caller of the current vaccination schedule in the PI for booster doses (non-immunocompromised): 2.3 Vaccination Schedule Booster Dose. A single Pfizer-BioNTech COVID-19 Vaccine booster dose (0.3 mL) may be administered at least 5 months after completing a primary series of the Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY to individuals 12 years of age and older. 3. Refer to HCP as Pfizer is unable to provide treatment recommendations for individual patients.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 virus test positive; COVID-19; Allergy to vaccine; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4256643-00.  A 51 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 10Mar2021 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 25Jan2022, outcome "unknown", described as "COVID-19 virus test positive"; COVID-19 (medically significant) with onset 25Jan2022, outcome "unknown", described as "COVID-19"; ALLERGY TO VACCINE (non-serious) with onset 10Mar2021, outcome "unknown", described as "Allergy to vaccine". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Jan2022) positive. The action taken for adalimumab was unknown.  Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for adalimumab (HUMIRA) - The reporter's causality for the event(s) of PFIZER VACCINE ALLERGIC REACTION and COVID-19 TESTED POSITIVE was not provided. The reporter's causality for the event(s) of Allergy to vaccine was provided as possible and causality for COVID-19 virus test positive was provided as not reported for PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN),  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Drug ineffective, COVID-19 and the use of suspect product BNT162B2 cannot be fully excluded.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Immunosuppression, Investigation, Suspected COVID-19
Clinical narrative: patient experienced COVID-19; patient experienced COVID-19; Lowered antibodies in immune sysytem; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4252311-00.  A 62 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (Batch/Lot number: unknown) at 40 mg (citrate free (40 mg,1 in 2 wk)) and second regimen subcutaneous (Batch/Lot number: unknown) till Jan2022 at 40 mg (citrate free (40 mg,1 in 2 wk)) for colitis ulcerative, crohn's disease. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "patient experienced COVID-19"; IMMUNOSUPPRESSION (medically significant), outcome "unknown", described as "Lowered antibodies in immune sysytem". The patient underwent the following laboratory tests and procedures: investigation: unknown results. The action taken for adalimumab was unknown.  The reporter's causality for the event(s) of COVID-19 with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of LOWERED ANTIBODIES IN IMMUNE SYSTEM was not provided.  The reporter's causality for the event(s) of COVID-19 with PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN) was possible. The reporter's causality for the event(s) of LOWERED ANTIBODIES IN IMMUNE SYSTEM was not provided  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 25.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Urinary tract infection
Clinical narrative: COVID-19; COVID-19; Urinary tract infection; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4257593-0.  A 25 year-old patient received bnt162b2 (BNT162B2), intramuscular, administration date 09Aug2021 (Batch/Lot number: unknown) at the age of 25 years as dose 2, single and intramuscular, administration date 19Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (Batch/Lot number: unknown), second regimen subcutaneous from 2021 (Batch/Lot number: unknown) to Nov2021 and third regimen subcutaneous since 22Jan2022 (Batch/Lot number: unknown) for rheumatoid arthritis. 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) all with onset Dec2021, outcome "unknown" and all described as "COVID-19"; URINARY TRACT INFECTION (non-serious) with onset 2021, outcome "unknown", described as "Urinary tract infection". The reporter's assessment of the causal relationship of the event with the suspect product was possible at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on limited information in the case , a possible causal association between the reported  events Drug ineffective , covid 19 , Urinary tract infection and the suspect drug BNT162B2 cannot be excluded
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Chills, Drug ineffective
Clinical narrative: non-serious COVID but no symptoms; non-serious COVID but no symptoms; Chills; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4253927-00.  A 28 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 21Dec2021 (Batch/Lot number: unknown) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), intramuscular, administration date 20Jan2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 20Dec2020 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; risankizumab rzaa (SKYRIZI), subcutaneous (Batch/Lot number: unknown) for psoriasis. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", ASYMPTOMATIC COVID-19 (medically significant), outcome "recovered" and all described as "non-serious COVID but no symptoms"; CHILLS (non-serious), outcome "recovered", described as "Chills". The action taken for risankizumab rzaa was unknown.  Clinical course: It was unknown if patient was enrolled in a COVID-19 vaccine trial. Other relevant history: No known allergies. The reporter's causality for the event(s) of Covid but no symptoms and chills with Skyrizi (Risankizumab) was no reasonable possibility. The reporter's causality for the event(s) of Covid but no symptoms and chills with Moderna Covid-19 vaccine was no Not Related.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: experiencing her arm still hurting until now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 28Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single 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; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "experiencing her arm still hurting until now".  Additional information: NDC number of Pfizer Covid-19 Vaccine Booster Shot was not provided. Reason for no lot number of Pfizer Covid-19 Vaccine Booster Shot was caller unwilling to complete the report. Expiry Date of Pfizer Covid-19 Vaccine Booster Shot was not provided.  This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Anaemia, Blood test, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: anemic; tested positive for Covid after receiving both doses Covid vaccine; tested positive for Covid after receiving both doses Covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date 27Apr2021 (Batch/Lot number: unknown) at the age of 62 years as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; rituximab (RUXIENCE [RITUXIMAB]) (Batch/Lot number: unknown) at every 6 months for rheumatoid arthritis. Relevant medical history included: "legally blind" (unspecified if ongoing), notes: Verbatim: legally blind. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31Dec2021, outcome "unknown" and all described as "tested positive for Covid after receiving both doses Covid vaccine"; ANAEMIA (non-serious), outcome "unknown", described as "anemic". The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) she states she is anemic, notes: She states she is anemic and that it is only one point down; sars-cov-2 test: (31Dec2021) positive. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, COVID-19, Depression, Drug ineffective
Clinical narrative: COVID-19; abscess under arms; anxiety; Depression; Weight loss; COVID-19; Vaccination site pain; Feeling of weakness after vaccines; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4257003-00.  A 29 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 25Mar2021 (Batch/Lot number: unknown) at the age of 28 years as dose 1, single and intramuscular, administration date 15Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) as unk (citrate free) for psoriasis, hidradenitis. Relevant medical history included: "covid", start date: 2019 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset 21Dec2021, outcome "recovered" and all described as "COVID-19"; SUBCUTANEOUS ABSCESS (non-serious), outcome "unknown", described as "abscess under arms"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Vaccination site pain"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Feeling of weakness after vaccines"; ANXIETY (non-serious), outcome "recovering", described as "anxiety"; DEPRESSION (non-serious), outcome "recovering", described as "Depression"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Weight loss". The patient underwent the following laboratory tests and procedures: weight: lost nine. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of subcutaneous abscess.   The reporter's assessment of the causal relationship of the event Vaccination site pain with the suspect product was possible and for other events of the causal relationship was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of Drug ineffective, COVID-19, subcutaneous abscess, vaccination site pain, Asthenia, anxiety, Depression, and weight decreased.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Subcutaneous abscess, Vaccination site pain, Weight, Weight decreased
Clinical narrative: COVID-19; abscess under arms; anxiety; Depression; Weight loss; COVID-19; Vaccination site pain; Feeling of weakness after vaccines; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4257003-00.  A 29 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 25Mar2021 (Batch/Lot number: unknown) at the age of 28 years as dose 1, single and intramuscular, administration date 15Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) as unk (citrate free) for psoriasis, hidradenitis. Relevant medical history included: "covid", start date: 2019 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset 21Dec2021, outcome "recovered" and all described as "COVID-19"; SUBCUTANEOUS ABSCESS (non-serious), outcome "unknown", described as "abscess under arms"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Vaccination site pain"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Feeling of weakness after vaccines"; ANXIETY (non-serious), outcome "recovering", described as "anxiety"; DEPRESSION (non-serious), outcome "recovering", described as "Depression"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Weight loss". The patient underwent the following laboratory tests and procedures: weight: lost nine. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of subcutaneous abscess.   The reporter's assessment of the causal relationship of the event Vaccination site pain with the suspect product was possible and for other events of the causal relationship was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of Drug ineffective, COVID-19, subcutaneous abscess, vaccination site pain, Asthenia, anxiety, Depression, and weight decreased.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 55 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 55 years as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "Covid". The patient had 2 doses of Pfizer Bio N Tech vaccine and developed covid and was subsequently hospitalized.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events drug ineffective and COVID-19 cannot be totally excluded.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Overdose, Pain in extremity, Product administration error
Clinical narrative: My children were given an unknown concentrated dose of Covid-19 Vaccine/Second dose vaccine administered improperly; administered 1.5ml Pediatric Pfizer Covid 19 Vaccine; sore arm; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent.  A 11 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 02Feb2022 (Lot number: FL0007) at the age of 11 years as dose 2, 1.5 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, lot: FL8094, Route of administration: one of arms, not sure which arm), administration date: 12Jan2022, when the patient was 10 years old, for COVID-19 Immunization. The following information was reported: PRODUCT ADMINISTRATION ERROR (non-serious) with onset 02Feb2022, outcome "unknown", described as "My children were given an unknown concentrated dose of Covid-19 Vaccine/Second dose vaccine administered improperly"; OVERDOSE (non-serious) with onset 02Feb2022, outcome "unknown", described as "administered 1.5ml Pediatric Pfizer Covid 19 Vaccine"; PAIN IN EXTREMITY (non-serious) with onset 02Feb2022, outcome "recovered" (07Feb2022), described as "sore arm"; ILLNESS (non-serious) with onset 02Feb2022, outcome "recovered" (07Feb2022), described as "sick".  Additional information included: The caller was a consumer who called Pfizer earlier and was not able to complete everything because the caller was driving. The call was regarding both the Adult Pfizer Covid 19 Vaccine and the Pediatric Pfizer Covid 19 Vaccine. The second dose Pfizer Covid 19 Vaccine was administered improperly to the patients. The kids were okay a week later but were sick. The patient had the least amount of reaction after receiving second dose Pediatric Pfizer Covid 19 Vaccine. The patient had a sore arm. second dose vaccine was administered improperly: The patient was administered an excessive amount of fluid in the deltoid, was administered 1.5ml Pediatric Pfizer Covid 19 Vaccine in the deltoid, not 0.3ml or 0.2ml as necessary, a lot. sore arm.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200228960 Same reporter/drug/AE, different patient;US-PFIZER INC-202200229781 Same reporter/drug/AE, different patient
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Overdose, Product preparation error
Clinical narrative: My children were given an unknown concentrated dose of Covid-19 Vaccine; The nurse took out 0.2ml of the Pediatric Pfizer Covid 19 Vaccine concentrate and then added that to 1.3ml dilution in the syringe and injected all of that into the patient's arm; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the parent.  A 8 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 02Feb2022 (Lot number: FL0007) at the age of 8 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, lot: FL8094, NDC: Unknown , Expiration: unknown , Route of administration: One of arms, doesn't know which arm.), administration date: 12Jan2022, when the patient was 8 years old, for COVID-19 immunization. The following information was reported: PRODUCT PREPARATION ERROR (non-serious) with onset 02Feb2022, outcome "unknown", described as "My children were given an unknown concentrated dose of Covid-19 Vaccine"; OVERDOSE (non-serious) with onset 02Feb2022, outcome "unknown", described as "The nurse took out 0.2ml of the Pediatric Pfizer Covid 19 Vaccine concentrate and then added that to 1.3ml dilution in the syringe and injected all of that into the patient's arm"; ILLNESS (non-serious) with onset 2022, outcome "recovered", described as "sick".  Additional information: The reporter taking three oldest kids who are 14, 11 and 8 to receive the second dose Pfizer Covid 19 Vaccine on 02Feb2022. The second dose Pfizer Covid 19 Vaccine was administered improperly to the patients. The kids were okay a week later but were sick. Reporters children were given an unknown concentrated dose of Covid-19 Vaccine. This consumer is the parent of the 3 patients who were each given their second Pfizer Covid-19 Vaccine incorrectly on 02Feb. The second dose Pfizer Covid 19 Vaccine was administered improperly to the patients. The kids were okay a week later but were sick. Does not knew height, patient is tall for age. weight was 68 to 70lbs. The nurse took out 0.2ml of the Pediatric Pfizer Covid 19 Vaccine concentrate and then added that to 1.3ml dilution in the syringe and injected all of that into the patient's arm.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200229780 Same reporter/drug/AE, different patient;US-PFIZER INC-202200228960 Same reporter/drug/AE, different patient
Age: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Neuralgia, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; Nerve pain in left arm and down to fingers for some months; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program (FACILITATED COLLECT). The reporter is the patient. Other Case identifier(s): 22K-163-4256098-00.  A 48 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Oct2021 (Batch/Lot number: unknown) at the age of 47 years as dose 2, single and intramuscular, administration date 01Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for colitis ulcerative, crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19"; NEURALGIA (non-serious), outcome "recovering", described as "Nerve pain in left arm and down to fingers for some months". The action taken for adalimumab was unknown.  The reporter's causality for the event second vaccine caused nerve pain in left arm down to fingers for some months and COVID with HUMIRA was not provided. The reporter's causality for the event second vaccine caused nerve pain in left arm down to fingers for some months and COVID with PFIZER BIONTECH COVID-19 VACCINE reported as possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of Suspected COVID-19  and Drug ineffective.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4257283-00.  A 39 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 1, single and intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (non-serious) with onset Mar2021, outcome "unknown", described as "COVID-19";DRUG INEFFECTIVE (serious) with onset Aug2021, outcome "unknown", described as "Flu like symptoms after second covid vaccination". The action taken for adalimumab was unknown.  Additional information: Events of non-serious COVID-19 and flu like symptoms after second covid vaccination with Humira (adalimumab). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient took Booster on 03Aug 2021.  Causality assessment for Drug HUMIRA (Solution for injection in pre-filled pen) (ADALIMUMAB): Event Covid 19 and Flu like symptoms, As per reporter:Not Reported. Dechallenge: N/A. Causality assessment for PFIZER BIONTECH COVID-19: Event Covid 19, As per reporter:Not Reported and for event Flu like symptoms, as per reported: Possible, Dechallenge:  N/A.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202200268978 same patient/vaccine, different dose /event
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Weight decreased
Clinical narrative: lost about 14lbs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Dec2021 (Lot number: FJ8762) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU taken for immunisation, administration date Nov2021. Vaccination history included: Bnt162b2 (Dose 1, Lot: ER2613, Anatomical location: Right arm), administration date: 22Mar2021, when the patient was 64 years old, for COVID-19 Immunization, reaction(s): "Arm pain"; Bnt162b2 (Dose 2, Lot: ER8729, Expiration: Unknown, Anatomical location: Right arm), administration date: 19Apr2021, when the patient was 64 years old, for COVID-19 Immunization, reaction(s): "Tiredness", "more pain with the second dose, he stated that the muscle pain has turned more to soreness". The following information was reported: WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "lost about 14lbs". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): Flu shot was a month ago in Nov2021. Additional vaccines administered on same date of the Pfizer Suspect was none. No other products. Patient reported he had lost about 14lbs since getting the series. The patient said that he spoke to the RA about his weight loss. He said that he does not know if the vaccine caused his weight loss. No emergency Room/Physician Office. He asked for the booster dose in the left arm. He has not had any problems with the booster dose yet. He had complete blood work for the weight loss, and they could not find anything. He said that the blood work came back normal. He said that he always had high cholesterol though.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Multiple sclerosis, Urticaria
Clinical narrative: Mutliple sclerosis; hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4389781 (Genetech).  A 57 year-old female patient received bnt162b2 (BNT162B2, solution for injection) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergy" (unspecified if ongoing); "Unable to walk" (unspecified if ongoing); "Allergies to nickel" (unspecified if ongoing); "Perfumes" (unspecified if ongoing); "Citrus fruits" (unspecified if ongoing); "Peanuts" (unspecified if ongoing); "Weakness" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "COVID-19" (unspecified if ongoing); "UTI" (unspecified if ongoing); "Blood clot" (unspecified if ongoing); "loss of right hand function" (unspecified if ongoing). Concomitant medication(s) included: OCREVUS; SENOKOT; IBUPROFEN; VITAMIN B6; VITAMIN B12 NOS; DALFAMPRIDINE. The following information was reported: MULTIPLE SCLEROSIS (medically significant), outcome "not recovered", described as "Mutliple sclerosis"; URTICARIA (non-serious) with onset 08Feb2021, outcome "recovered", described as "hives". Patient's concomitant medication included blood thinner, multivitamin and antihistamine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Respiratory tract congestion, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid test it came back positive; Covid test it came back positive; Respiratory tract congestion; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4256978-00.  A 67 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Sep2021 (Batch/Lot number: unknown) at the age of 66 years as dose 3 (booster), single, administration date 15Mar2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 15Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA) (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "Covid test it came back positive"; RESPIRATORY TRACT CONGESTION (non-serious), outcome "recovered", described as "Respiratory tract congestion". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The action taken for adalimumab was unknown.  Causality for Humira(Adalimumab): The reporter's causality for the event(s) of covid test it came back positive/congestion unknown onset, had first covid vaccine was tender at the injection site, soreness in arm with covid booster and covid test it came back positive/congestion unknown onset was not provided.  Causality for Pfizer Biontech Covid-19 Vaccine:COVID-19 virus test positive Probable and Respiratory tract congestion Probable.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of COVID-19, Vaccination failure, Respiratory congestion.
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Arthralgia, Back pain, Diabetes mellitus, Drug ineffective
Clinical narrative: COVID-19; COVID-19; Neuropathy; Diabetes; had no voice; sore arm; Psoriasis; Lower back pain; hip pain; Thyroid; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4251967-00 (AbbVie).  A 72 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19"; NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "Neuropathy"; DIABETES MELLITUS (medically significant), outcome "unknown", described as "Diabetes"; APHONIA (non-serious), outcome "unknown", described as "had no voice"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; PSORIASIS (non-serious), outcome "unknown", described as "Psoriasis"; BACK PAIN (non-serious), outcome "recovering", described as "Lower back pain"; ARTHRALGIA (non-serious), outcome "recovering", described as "hip pain"; THYROID DISORDER (non-serious), outcome "unknown", described as "Thyroid". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on limited information in the case , a possible causal association between all  the reported  events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Pain in extremity, Psoriasis, Suspected COVID-19, Thyroid disorder
Clinical narrative: COVID-19; COVID-19; Neuropathy; Diabetes; had no voice; sore arm; Psoriasis; Lower back pain; hip pain; Thyroid; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4251967-00 (AbbVie).  A 72 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19"; NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "Neuropathy"; DIABETES MELLITUS (medically significant), outcome "unknown", described as "Diabetes"; APHONIA (non-serious), outcome "unknown", described as "had no voice"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; PSORIASIS (non-serious), outcome "unknown", described as "Psoriasis"; BACK PAIN (non-serious), outcome "recovering", described as "Lower back pain"; ARTHRALGIA (non-serious), outcome "recovering", described as "hip pain"; THYROID DISORDER (non-serious), outcome "unknown", described as "Thyroid". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on limited information in the case , a possible causal association between all  the reported  events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: U
Vaccine: COVID19
Symptoms: Bradycardia
Clinical narrative: intermittent bradycardia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BRADYCARDIA (medically significant), outcome "unknown", described as "intermittent bradycardia". Addition information: Customer Verbatim: Is it possible to receive a medical exemption from Pfizer if I am experiencing intermittent bradycardia since receiving both covid vaccinations last year. I understandably do not want to take the booster shot but am mandated to do so as. (Place withheld) healthcare professional.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Ageusia, Anosmia, Body temperature, Drug ineffective, Headache
Clinical narrative: COVID-19; COVID-19; bad headache; had loss of smell and taste; had loss of smell and taste; fever 101-102; night sweats; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4251995-00.  A 49 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization; upadacitinib (RINVOQ), oral (Lot number: 1150526) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jan2022, outcome "unknown",  SUSPECTED COVID-19 (medically significant) with onset Jan2022, outcome "recovering" and all described as "COVID-19"; HEADACHE (non-serious) with onset Jan2022, outcome "recovering", described as "bad headache"; ANOSMIA (non-serious), AGEUSIA (non-serious) all with onset Jan2022, outcome "recovering" and all described as "had loss of smell and taste"; PYREXIA (non-serious) with onset Jan2022, outcome "recovering", described as "fever 101-102"; NIGHT SWEATS (non-serious) with onset Jan2022, outcome "recovering", described as "night sweats". The patient underwent the following laboratory tests and procedures: body temperature: (Jan2022) 101-102, notes: fever. The action taken for upadacitinib was unknown. It was reported that, solicited report from the privacy by a consumer of a 49-year-old female with an event of non-serious COVID-19 with Rinvoq (upadacitinib). Pfizer biontech covid-19 vaccine (tozinameran) was also considered as suspect. On an unspecified date in Jan2022, two weeks ago the patient had loss of smell and taste, fever 101-102, night sweats and bad headache. It was unknown whether the patient was enrolled in a COVID-19 Vaccine trial.  Causality for Rinvoq (upadacitinib) The reporter's assessment of the causal relationship for the event(s) of COVID-19 with Rinvoq (upadacitinib) was no reasonable possibility. The reporter's assessment of the causal relationship for the event(s) of COVID-19 with Pfizer biontech covid-19 vaccine (tozinameran) was not reported.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, lack of efficacy ,anosmia, ageusia, headache, pyrexia, and night sweats of the suspected vaccine BNT162B2 cannot be completely excluded.