chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Ankylosing spondylitis, Immunisation
Clinical narrative: patient received booster dose COVID-19 vaccine; Ankylosing spondylitis flare up; 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): 21K-163-4195489-00 (Agency).  A 41 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Nov2021 (Batch/Lot number: unknown) at the age of 41 years as dose number unknown (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) as unk, citrate free for ankylosing spondylitis. 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: IMMUNISATION (medically significant) with onset Nov2021, outcome "unknown", described as "patient received booster dose COVID-19 vaccine"; ANKYLOSING SPONDYLITIS (medically significant) with onset Nov2021, outcome "unknown", described as "Ankylosing spondylitis flare up". The action taken for adalimumab was unknown.  Clinical course: There was no reported medical history. In Nov2021, the patient experienced Ankylosing Spondylitis flare up. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On Nov2021 patient received booster dose COVID-19 Vaccine manufactured by Pfizer/Biontech.  The reporter's causality for the event of Ankylosing Spondylitis flare up with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event of Ankylosing Spondylitis flare up with Pfizer BioNTech Covid-19 Vaccine was possible. It was not applicable if event abate after stopping drug. Concomitant drugs, other relevant history and dates of administration were not reported.   The reporter considered "patient received booster dose covid-19 vaccine" and "ankylosing spondylitis flare up" related to bnt162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information and possible causal association between suspect product BNT162B2 to the reported events ankylosing spondylitis aggravated cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Chills, Hypotension, Loss of consciousness
Clinical narrative: passed out; she is aching all over; her blood pressure drops low; a temperature of 98.8 where her normal temperature is 97.6; real bad chills; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "passed out"; PAIN (non-serious), outcome "unknown", described as "she is aching all over"; HYPOTENSION (non-serious), outcome "unknown", described as "her blood pressure drops low"; PYREXIA (non-serious), outcome "unknown", described as "a temperature of 98.8 where her normal temperature is 97.6"; CHILLS (non-serious) with onset 2021, outcome "recovering", described as "real bad chills". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (2021) low/decreased; body temperature: (unspecified date) 97.6, notes: normal temperature is 97.6; (2021) 98.8, notes: temperature of 98.8. It is hard to get a test right now and they do not do it over the phone. She just wanted to know the side effects of the new variant, she already had the first 2 doses and supposed to get the third one by the end of this month or 1st week of next month.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: passed out; she is aching all over; her blood pressure drops low; a temperature of 98.8 where her normal temperature is 97.6; real bad chills; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "passed out"; PAIN (non-serious), outcome "unknown", described as "she is aching all over"; HYPOTENSION (non-serious), outcome "unknown", described as "her blood pressure drops low"; PYREXIA (non-serious), outcome "unknown", described as "a temperature of 98.8 where her normal temperature is 97.6"; CHILLS (non-serious) with onset 2021, outcome "recovering", described as "real bad chills". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (2021) low/decreased; body temperature: (unspecified date) 97.6, notes: normal temperature is 97.6; (2021) 98.8, notes: temperature of 98.8. It is hard to get a test right now and they do not do it over the phone. She just wanted to know the side effects of the new variant, she already had the first 2 doses and supposed to get the third one by the end of this month or 1st week of next month.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Muscle strain, Vaccination complication
Clinical narrative: Accidentally pulled her arm while getting the Pfizer COvid-19 vaccine; unsure if she is fully vaccinated or not; Accidentally pulled her arm while getting the Pfizer COvid-19 vaccine; unsure if she is fully vaccinated or not; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 9 year-old female patient received bnt162b2 (BNT162B2), administered in arm (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: VACCINATION COMPLICATION (non-serious), MUSCLE STRAIN (non-serious), outcome "unknown" and all described as "Accidentally pulled her arm while getting the Pfizer COvid-19 vaccine; unsure if she is fully vaccinated or not". The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Fatigue, Immunisation, Product use issue, Vaccination site erythema, Vaccination site pain
Clinical narrative: Injection site pain; injection site redness; injection site swelling; mild fatigue; dose_received: 3; product use for unapproved combination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Dec2021 10:45 (Lot number: FE3594) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine inact split 4v (FLUARIX QUADRIVALENT), administered in arm right, administration date 17Dec2021 (Batch/Lot number: unknown) as dose 1, 0.5 ml single for immunisation. Relevant medical history included: "known_allergies:latex" (unspecified if ongoing), notes: known allergies: latex. Concomitant medication(s) included: SPIRONOLACTONE; LEVOTHYROXINE; ZYTREC; TYLENOL. Past drug history included: Wellbutrin, reaction(s): "known allergies: Wellbutrin", notes: known allergies: Wellbutrin; Benadryl, reaction(s): "known allergies: Benadryl", notes: known allergies: Benadryl. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0187, Location of injection: Left Arm, Vaccine Administration Time: 06:00 PM), administration date: 24May2021, when the patient was 49 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0176, Location of injection: Left Arm, Vaccine Administration Time: 04:00 PM), administration date: 03May2021, when the patient was 49 years old, for COVID-19 Immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021 10:45, outcome "unknown", described as "dose_received: 3"; VACCINATION SITE PAIN (non-serious) with onset 18Dec2021 00:30, outcome "recovering", described as "Injection site pain"; VACCINATION SITE ERYTHEMA (non-serious) with onset 18Dec2021 00:30, outcome "recovering", described as "injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset 18Dec2021 00:30, outcome "recovering", described as "injection site swelling"; FATIGUE (non-serious) with onset 18Dec2021 00:30, outcome "recovering", described as "mild fatigue"; PRODUCT USE ISSUE (non-serious) with onset 17Dec2021, outcome "unknown", described as "product use for unapproved combination". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site erythema, vaccination site swelling, fatigue.  Additional information: if other vaccine in four weeks: No if covid prior vaccination: No if covid tested post vaccination: No  No follow-up attempts are possible. No information is required.
Age: 49.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Vaccination site swelling
Clinical narrative: Injection site pain; injection site redness; injection site swelling; mild fatigue; dose_received: 3; product use for unapproved combination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Dec2021 10:45 (Lot number: FE3594) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine inact split 4v (FLUARIX QUADRIVALENT), administered in arm right, administration date 17Dec2021 (Batch/Lot number: unknown) as dose 1, 0.5 ml single for immunisation. Relevant medical history included: "known_allergies:latex" (unspecified if ongoing), notes: known allergies: latex. Concomitant medication(s) included: SPIRONOLACTONE; LEVOTHYROXINE; ZYTREC; TYLENOL. Past drug history included: Wellbutrin, reaction(s): "known allergies: Wellbutrin", notes: known allergies: Wellbutrin; Benadryl, reaction(s): "known allergies: Benadryl", notes: known allergies: Benadryl. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0187, Location of injection: Left Arm, Vaccine Administration Time: 06:00 PM), administration date: 24May2021, when the patient was 49 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0176, Location of injection: Left Arm, Vaccine Administration Time: 04:00 PM), administration date: 03May2021, when the patient was 49 years old, for COVID-19 Immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021 10:45, outcome "unknown", described as "dose_received: 3"; VACCINATION SITE PAIN (non-serious) with onset 18Dec2021 00:30, outcome "recovering", described as "Injection site pain"; VACCINATION SITE ERYTHEMA (non-serious) with onset 18Dec2021 00:30, outcome "recovering", described as "injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset 18Dec2021 00:30, outcome "recovering", described as "injection site swelling"; FATIGUE (non-serious) with onset 18Dec2021 00:30, outcome "recovering", described as "mild fatigue"; PRODUCT USE ISSUE (non-serious) with onset 17Dec2021, outcome "unknown", described as "product use for unapproved combination". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site erythema, vaccination site swelling, fatigue.  Additional information: if other vaccine in four weeks: No if covid prior vaccination: No if covid tested post vaccination: No  No follow-up attempts are possible. No information is required.
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Immunisation, Pain in extremity
Clinical narrative: booster; Sore arm; COVID-19 Back; COVID-19 Back; Solicited report from the (redacted) by a consumer of a 26 year old male with events of non-serious SORE ARM AFTER THREE COVID VACCINE and COVID-19 BACK with HUMIRA (ADALIMUMAB). There was no reported medical history.  On an unknown date, the patient experienced SORE ARM AFTER THREE COVID VACCINE. In Nov2021, the patient experienced COVID-19 BACK. In 2021, the COVID-19 BACK resolved. On an unknown date, SORE ARM AFTER THREE COVID VACCINE resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On an unknown, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. On an unknown, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer. On an unknown, patient received 3rd dose COVID-19 Vaccine manufactured by Pfizer. DID EVENT ABATE AFTER STOPPING DRUG?: NA Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of SORE ARM AFTER THREE COVID VACCINE and COVID-19 BACK was not provided.  CONCOMITANT DRUGS AND DATES OF ADMINISTRATION: Concomitant Drugs Not Reported  OTHER RELEVANT HISTORY: No relevant medical history Seq.No. : 1 Drug: HUMIRA(Solution for injection in pre-filled pen)(ADALIMUMAB) Causality: 1)Vaccination site pain (Vaccination site pain) Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Dechallenge:  N/A  Seq.No. : 2 Drug : PFIZER BIONTECH COVID-19  VACCINE(TOZINAMERAN)(TOZINAMERAN),UNKNOWN,UNKNOWN,UNKNOWN Daily Dose : 1)1st dose (1 in 1 Once) 2)2nd dose (1 in 1 Once) 3)3rd dose (1 in 1 Once) Route of Admin : 1)Intra-muscular 2)Intra-muscular 3)Intra-muscular Causality 1)Vaccination site pain (Vaccination site pain) Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Possible Dechallenge :  N/A 2)COVID-19 recurrent (COVID-19) Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Dechallenge :  N/A  2)COVID-19 recurrent (COVID-19) Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Dechallenge:  N/A; Sender's Comments: As per available information, the causal association between the events Drug ineffective, COVID-19 recurrent, Booster, and Pain in arm 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.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Endodontic procedure, Fatigue, Infection
Clinical narrative: COVID; COVID; Root canal; Potential rheumatoid arthritis flare up; Pulled muscle in calf; Stress; Inflammation; Infection; Pain; Sorearm; Fatigue; Swelling; HUMIRA is not working; 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.  A 48 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Apr2021 (Batch/Lot number: unknown) at the age of 48 years as dose 2, single and intramuscular, administration date 20Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at 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), COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "COVID"; ENDODONTIC PROCEDURE (medically significant) with onset Sep2021, outcome "recovered" (Sep2021), described as "Root canal"; RHEUMATOID ARTHRITIS (medically significant) with onset Sep2021, outcome "not recovered", described as "Potential rheumatoid arthritis flare up"; MUSCLE STRAIN (medically significant) with onset 2021, outcome "unknown", described as "Pulled muscle in calf"; STRESS (medically significant) with onset 2021, outcome "not recovered", described as "Stress"; INFLAMMATION (medically significant) with onset 2021, outcome "unknown", described as "Inflammation"; INFECTION (medically significant) with onset 2021, outcome "unknown", described as "Infection"; PAIN (medically significant) with onset 2021, outcome "unknown", described as "Pain"; PAIN IN EXTREMITY (medically significant) with onset 2021, outcome "unknown", described as "Sore arm"; FATIGUE (medically significant) with onset 2021, outcome "unknown", described as "Fatigue"; SWELLING (medically significant) with onset 2021, outcome "unknown", described as "Swelling"; DRUG INEFFECTIVE (medically significant) with onset 2021, outcome "unknown", described as "HUMIRA is not working". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of endodontic procedure, rheumatoid arthritis, inflammation, infection, pain and included treatment with antibiotics, and was on steroid tapper. Clinical Course: The reporter's assessment of the causal relationship of the events with the suspect product was not reported at the time of this report.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Muscle strain, Pain, Pain in extremity, Rheumatoid arthritis
Clinical narrative: COVID; COVID; Root canal; Potential rheumatoid arthritis flare up; Pulled muscle in calf; Stress; Inflammation; Infection; Pain; Sorearm; Fatigue; Swelling; HUMIRA is not working; 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.  A 48 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Apr2021 (Batch/Lot number: unknown) at the age of 48 years as dose 2, single and intramuscular, administration date 20Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at 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), COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "COVID"; ENDODONTIC PROCEDURE (medically significant) with onset Sep2021, outcome "recovered" (Sep2021), described as "Root canal"; RHEUMATOID ARTHRITIS (medically significant) with onset Sep2021, outcome "not recovered", described as "Potential rheumatoid arthritis flare up"; MUSCLE STRAIN (medically significant) with onset 2021, outcome "unknown", described as "Pulled muscle in calf"; STRESS (medically significant) with onset 2021, outcome "not recovered", described as "Stress"; INFLAMMATION (medically significant) with onset 2021, outcome "unknown", described as "Inflammation"; INFECTION (medically significant) with onset 2021, outcome "unknown", described as "Infection"; PAIN (medically significant) with onset 2021, outcome "unknown", described as "Pain"; PAIN IN EXTREMITY (medically significant) with onset 2021, outcome "unknown", described as "Sore arm"; FATIGUE (medically significant) with onset 2021, outcome "unknown", described as "Fatigue"; SWELLING (medically significant) with onset 2021, outcome "unknown", described as "Swelling"; DRUG INEFFECTIVE (medically significant) with onset 2021, outcome "unknown", described as "HUMIRA is not working". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of endodontic procedure, rheumatoid arthritis, inflammation, infection, pain and included treatment with antibiotics, and was on steroid tapper. Clinical Course: The reporter's assessment of the causal relationship of the events with the suspect product was not reported at the time of this report.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Stress, Swelling
Clinical narrative: COVID; COVID; Root canal; Potential rheumatoid arthritis flare up; Pulled muscle in calf; Stress; Inflammation; Infection; Pain; Sorearm; Fatigue; Swelling; HUMIRA is not working; 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.  A 48 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Apr2021 (Batch/Lot number: unknown) at the age of 48 years as dose 2, single and intramuscular, administration date 20Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at 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), COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "COVID"; ENDODONTIC PROCEDURE (medically significant) with onset Sep2021, outcome "recovered" (Sep2021), described as "Root canal"; RHEUMATOID ARTHRITIS (medically significant) with onset Sep2021, outcome "not recovered", described as "Potential rheumatoid arthritis flare up"; MUSCLE STRAIN (medically significant) with onset 2021, outcome "unknown", described as "Pulled muscle in calf"; STRESS (medically significant) with onset 2021, outcome "not recovered", described as "Stress"; INFLAMMATION (medically significant) with onset 2021, outcome "unknown", described as "Inflammation"; INFECTION (medically significant) with onset 2021, outcome "unknown", described as "Infection"; PAIN (medically significant) with onset 2021, outcome "unknown", described as "Pain"; PAIN IN EXTREMITY (medically significant) with onset 2021, outcome "unknown", described as "Sore arm"; FATIGUE (medically significant) with onset 2021, outcome "unknown", described as "Fatigue"; SWELLING (medically significant) with onset 2021, outcome "unknown", described as "Swelling"; DRUG INEFFECTIVE (medically significant) with onset 2021, outcome "unknown", described as "HUMIRA is not working". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of endodontic procedure, rheumatoid arthritis, inflammation, infection, pain and included treatment with antibiotics, and was on steroid tapper. Clinical Course: The reporter's assessment of the causal relationship of the events with the suspect product was not reported at the time of this report.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Vomiting
Clinical narrative: within 48hrs severe chest pain; 12 hours of vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 34 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Sep2021 (Lot number: FF2588) at the age of 34 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEXIPRON; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; PANTOPRAZOLE; DICYCLOMINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FF2588, Location of injection: Arm Left), administration date: 05Sep2021, when the patient was 34 years old, for covid-19 immunization, reaction(s): "pain in the injection area", "Five days of headaches", "Chills", "Aches", "fatigue". The following information was reported: CHEST PAIN (hospitalization), outcome "recovering", described as "within 48hrs severe chest pain"; VOMITING (hospitalization), outcome "recovering", described as "12 hours of vomiting". The events "within 48hrs severe chest pain" and "12 hours of vomiting" were evaluated at the physician office visit and emergency room visit. It was unknown if therapeutic measures were taken as a result of chest pain, vomiting.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: started showing symptoms of COVID (fever, headache, sore throat and cough)/tested positive for COVID-19; started showing symptoms of COVID (fever, headache, sore throat and cough)/tested positive for COVID-19; patient had his booster on 16Dec2021 the day before symptoms started; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from quality group. The reporter is the parent.  A 16 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Dec2021 (Lot number: FL3197, Expiration Date: 30Jan2022) at the age of 16 years as dose 3 (booster), single, administration date 25May2021 (Lot number: EP7533) as dose 2, single and administration date 04May2021 (Lot number: EP7533) as dose 1, single 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) all with onset 17Dec2021, outcome "unknown" and all described as "started showing symptoms of COVID (fever, headache, sore throat and cough)/tested positive for COVID-19"; IMMUNISATION (medically significant) with onset 16Dec2021, outcome "unknown", described as "patient had his booster on 16Dec2021 the day before symptoms started". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Dec2021) positive; (18Dec2021) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19; patient was given Tylenol.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101841610 same patient, different dose/event
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Felt tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A female patient received bnt162b2 (BNT162B2) (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19"; FATIGUE (non-serious), outcome "unknown", described as "Felt tired". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Soreness on first day/Aches and body pain; Chills; Low grade fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: EP6955) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Soreness on first day/Aches and body pain"; CHILLS (non-serious), outcome "unknown", described as "Chills"; PYREXIA (non-serious), outcome "unknown", described as "Low grade fever".  Additional information: No underlying conditions. Event took place after use of product.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Axillary mass, Biopsy, Chills, Influenza like illness, Limb discomfort
Clinical narrative: Flu like symptoms; Body ache; Low grade fever; Chills; Heaviness on both legs; Nasal congestion; Lump under the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 35 year-old patient received bnt162b2 (BNT162B2) (Lot number: EN6205) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms"; PAIN (non-serious), outcome "unknown", described as "Body ache"; PYREXIA (non-serious), outcome "unknown", described as "Low grade fever"; CHILLS (non-serious), outcome "unknown", described as "Chills"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "Heaviness on both legs"; NASAL CONGESTION (non-serious), outcome "unknown", described as "Nasal congestion"; AXILLARY MASS (non-serious), outcome "not recovered", described as "Lump under the arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of axillary mass.  Additional information:No underlying condition was reported. Event was  took place after use of product.
Sex: U
Vaccine: COVID19
Symptoms: Nasal congestion, Pain, Pyrexia
Clinical narrative: Flu like symptoms; Body ache; Low grade fever; Chills; Heaviness on both legs; Nasal congestion; Lump under the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 35 year-old patient received bnt162b2 (BNT162B2) (Lot number: EN6205) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms"; PAIN (non-serious), outcome "unknown", described as "Body ache"; PYREXIA (non-serious), outcome "unknown", described as "Low grade fever"; CHILLS (non-serious), outcome "unknown", described as "Chills"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "Heaviness on both legs"; NASAL CONGESTION (non-serious), outcome "unknown", described as "Nasal congestion"; AXILLARY MASS (non-serious), outcome "not recovered", described as "Lump under the arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of axillary mass.  Additional information:No underlying condition was reported. Event was  took place after use of product.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Head discomfort, Nasal congestion, Nausea, SARS-CoV-2 test
Clinical narrative: COVID test positive; COVID test positive; congestion; head pressure; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Feb2021 (Lot number: EN6203) at the age of 27 years as dose 2, single and intramuscular, administered in arm left, administration date 06Feb2021 (Lot number: EM9809) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Dec2021, outcome "not recovered" and all described as "COVID test positive"; NASAL CONGESTION (non-serious) with onset 20Dec2021, outcome "not recovered", described as "congestion"; HEAD DISCOMFORT (non-serious) with onset 20Dec2021, outcome "not recovered", described as "head pressure"; NAUSEA (non-serious) with onset 20Dec2021, outcome "not recovered", described as "nausea". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, nasal congestion, head discomfort, nausea.  The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed as COVID-19. Since the vaccination, the patient had been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: COVID test positive; COVID test positive; congestion; head pressure; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Feb2021 (Lot number: EN6203) at the age of 27 years as dose 2, single and intramuscular, administered in arm left, administration date 06Feb2021 (Lot number: EM9809) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Dec2021, outcome "not recovered" and all described as "COVID test positive"; NASAL CONGESTION (non-serious) with onset 20Dec2021, outcome "not recovered", described as "congestion"; HEAD DISCOMFORT (non-serious) with onset 20Dec2021, outcome "not recovered", described as "head pressure"; NAUSEA (non-serious) with onset 20Dec2021, outcome "not recovered", described as "nausea". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, nasal congestion, head discomfort, nausea.  The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed as COVID-19. Since the vaccination, the patient had been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Ventricular tachycardia
Clinical narrative: Ventricular tachycardia; Heart trouble; 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 71 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose:1), for Covid-19 immunization. The following information was reported: VENTRICULAR TACHYCARDIA (medically significant), outcome "unknown", described as "Ventricular tachycardia"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "Heart trouble". Caller stated she spoke to a representative earlier wherein she reported that after getting the 2nd dose of Comirnaty, she developed ventricular tachycardia. Caller added that no doctor can say if it was or it wasn't from Comirnaty but she said she did have heart trouble after the 2nd dose. Caller said she was curious if had this been reported and said that she doubted that she was the only one who experienced this. She mentioned she had all 3 doses although she was very leery to take the booster dose. Caller added this was just something she wanted to report as she's never had heart trouble and this started after the 2nd dose.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Breakthrough case of Covid 19; Breakthrough case of Covid 19; breakthrough case as booster dose of Pfizer vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 09Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for covid 19 immunization; Bnt162b2 (Dose 2), for covid 19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 09Dec2021, outcome "unknown", described as "breakthrough case as booster dose of Pfizer vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Dec2021, outcome "unknown" and all described as "Breakthrough case of Covid 19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Dec2021) positive. Symptoms included: cough and mild nasal congestion.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101842425 Same reporter/drug, different patient
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hair injury, Illness, Immunisation
Clinical narrative: Flu like symptoms; chills; his hair hurt; sick; Received booster shot on 07Dec21 with ongoing leg and large muscle pain/muscle pain was in his legs and arms; booster; Received booster shot on 07Dec21 with ongoing leg and large muscle pain; fatigue; Achy/everything hurt; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from information team. The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Dec2021 10:00 (Lot number: FH8030) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "muscle relaxer" (unspecified if ongoing). Concomitant medication(s) included: METHOCARBAMOL taken for muscle relaxant therapy. Vaccination history included: Bnt162b2 (Dose of Covid-19 Shot, Lot- EW0171: Exp- Unknown; Administered in left arm), administration date: 23Apr2021, when the patient was 58 years old, for COVID-19 Immunization, reaction(s): "slight fatigue", "muscle soreness"; Bnt162b2 (Second Dose of Covid-19 Shot, Lot- EW0183; Exp- Unknown; Administered in left arm), administration date: 17May2021, when the patient was 58 years old, for COVID-19 Immunization, reaction(s): "slight fatigue", "muscle soreness". The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021 10:00, outcome "unknown", described as "booster"; PAIN IN EXTREMITY (non-serious) with onset 07Dec2021, outcome "not recovered", described as "Received booster shot on 07Dec21 with ongoing leg and large muscle pain"; MYALGIA (non-serious) with onset 07Dec2021 10:00, outcome "not recovered", described as "Received booster shot on 07Dec21 with ongoing leg and large muscle pain/muscle pain was in his legs and arms"; INFLUENZA LIKE ILLNESS (non-serious) with onset 08Dec2021, outcome "recovering", described as "Flu like symptoms"; PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "Achy/everything hurt"; FATIGUE (non-serious) with onset 07Dec2021, outcome "not recovered", described as "fatigue"; CHILLS (non-serious) with onset 08Dec2021, outcome "unknown", described as "chills"; HAIR INJURY (non-serious) with onset 08Dec2021, outcome "unknown", described as "his hair hurt"; ILLNESS (non-serious) with onset 08Dec2021, outcome "unknown", described as "sick".  No follow-up attempts are possible. No further information is expected.  Follow-up (21Dec2021): This is a spontaneous follow-up report received from a same contactable consumer. This 58 year old female consumer (patient) reporter for her self that: Updated information: Events Added. Historical vaccine details updated. Vaccination facility information updated. Concomitant information updated.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Pain, Pain in extremity
Clinical narrative: Flu like symptoms; chills; his hair hurt; sick; Received booster shot on 07Dec21 with ongoing leg and large muscle pain/muscle pain was in his legs and arms; booster; Received booster shot on 07Dec21 with ongoing leg and large muscle pain; fatigue; Achy/everything hurt; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from information team. The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Dec2021 10:00 (Lot number: FH8030) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "muscle relaxer" (unspecified if ongoing). Concomitant medication(s) included: METHOCARBAMOL taken for muscle relaxant therapy. Vaccination history included: Bnt162b2 (Dose of Covid-19 Shot, Lot- EW0171: Exp- Unknown; Administered in left arm), administration date: 23Apr2021, when the patient was 58 years old, for COVID-19 Immunization, reaction(s): "slight fatigue", "muscle soreness"; Bnt162b2 (Second Dose of Covid-19 Shot, Lot- EW0183; Exp- Unknown; Administered in left arm), administration date: 17May2021, when the patient was 58 years old, for COVID-19 Immunization, reaction(s): "slight fatigue", "muscle soreness". The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021 10:00, outcome "unknown", described as "booster"; PAIN IN EXTREMITY (non-serious) with onset 07Dec2021, outcome "not recovered", described as "Received booster shot on 07Dec21 with ongoing leg and large muscle pain"; MYALGIA (non-serious) with onset 07Dec2021 10:00, outcome "not recovered", described as "Received booster shot on 07Dec21 with ongoing leg and large muscle pain/muscle pain was in his legs and arms"; INFLUENZA LIKE ILLNESS (non-serious) with onset 08Dec2021, outcome "recovering", described as "Flu like symptoms"; PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "Achy/everything hurt"; FATIGUE (non-serious) with onset 07Dec2021, outcome "not recovered", described as "fatigue"; CHILLS (non-serious) with onset 08Dec2021, outcome "unknown", described as "chills"; HAIR INJURY (non-serious) with onset 08Dec2021, outcome "unknown", described as "his hair hurt"; ILLNESS (non-serious) with onset 08Dec2021, outcome "unknown", described as "sick".  No follow-up attempts are possible. No further information is expected.  Follow-up (21Dec2021): This is a spontaneous follow-up report received from a same contactable consumer. This 58 year old female consumer (patient) reporter for her self that: Updated information: Events Added. Historical vaccine details updated. Vaccination facility information updated. Concomitant information updated.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Feeling abnormal, Thrombosis
Clinical narrative: had a blood clot 9 days after receiving the vaccine; It turns your world upside down, she was perfectly healthy and it tips you upside down; 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 53 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "had a blood clot 9 days after receiving the vaccine"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "It turns your world upside down, she was perfectly healthy and it tips you upside down". The patient underwent the following laboratory tests and procedures: blood test: no other reason, notes: no other reason why this would happen. Additional information: She had a blood clot 9 days after receiving the vaccine and she did not get her second dose. She stated she sees stuff on J&J. She stated nothing is going to prove what happened but she had no medical history and they have dose blood tests, and there is no other reason why this would happen. The doctor has noted it in the file that after looking at all her history and extensive testing and trying to rule out other things. She said it could be a blood clotting disorder that she did not know about but they think she may just be one of the ones that experience this after the vaccine. She said they are seeing more people have these types of things. It turns your world upside down, she was perfectly healthy and it tips you upside down.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Mild cold-like symptoms developed on 17Dec2021.  Breakthrough COVID case identified on 19Dec2021 (Abbott IDNow). Mild symptoms (runny nose, sore throat, cough) have improved as of 21Dec2021; Mild cold-like symptoms developed on 17Dec2021.  Breakthrough COVID case identified on 19Dec2021 (Abbott IDNow). Mild symptoms (runny nose, sore throat, cough) have improved as of 21Dec2021; Booster; This is a spontaneous report received from a contactable reporter (Consumer or other non- HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 20Oct2021 (Batch/Lot number: unknown) at the age of 59 years as dose 3 (booster), single, administered in arm left, administration date 24Mar2021 (Batch/Lot number: EP6955) as dose 2, single and administered in arm left, administration date 03Mar2021 (Batch/Lot number: EL3248) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy: Penicillin" (unspecified if ongoing), notes: Known allergy: Penicilin. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 20Oct2021, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Dec2021, outcome "recovering" and all described as "Mild cold-like symptoms developed on 17Dec2021.  Breakthrough COVID case identified on 19Dec2021 (Abbott IDNow). Mild symptoms (runny nose, sore throat, cough) have improved as of 21Dec2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Dec2021) positive, notes: Abbott ID Now. Therapeutic measures were not taken as a result of vaccination failure, COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.