chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Immunisation
Clinical narrative: Diarrhea for about 10 days; Booster; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 09:45 (Lot number: 320308 D) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN; OXYBUTYNIN; CALCIUM CITRATE. Past drug history included: Erythromycin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Vaccine Administration Time: 08:30 AM, DOSE 2, SINGLE, Batch/Lot No: EN 6205, Location of injection: Arm Right), administration date: 15Mar2021, when the patient was 74 years old, for Covid-19 Immunization; Bnt162b2 (Vaccine Administration Time: 08:30 AM, DOSE 1, SINGLE, Batch/Lot No: EL 9266, Location of injection: Arm Left), administration date: 22Feb2021, when the patient was 73 years old, for Covid-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021 09:45, outcome "unknown", described as "Booster"; DIARRHOEA (non-serious) with onset 01Dec2021, outcome "not recovered", described as "Diarrhea for about 10 days". Therapeutic measures were taken as a result of diarrhoea. Additional information: No other vaccine was administered in four weeks. Patient's concomitant medication included multivitamin. The patient was treated with BRAT diet, Pedialyte, and occasionally with Immodium for Diarrhea. The patient did not have covid prior to vaccination. The patient was not tested covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Uveitis
Clinical narrative: Panuveitis with significant choroidal thickening and inflammation of the anterior chamber and vitreous; This is a literature report.  A 43-year-old female patient received bnt162b2 (BNT162B2, solution for injection) (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: Covid-19 vaccine (FIRST DOSE, (MANUFACTURER UNKNOWN)), for COVID-19 immunisation. The following information was reported: UVEITIS (medically significant), outcome "unknown", described as "Panuveitis with significant choroidal thickening and infammation of the anterior chamber and vitreous".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event UVEITIS and the vaccine (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: Feeling abnormal
Clinical narrative: described first experience in getting the vaccine as "bad" and "dramatic".; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) via COVID-19 Adverse Event Self-Reporting Solution (COVAES).  An adult female patient received COVID-19 Vaccine - Manufacturer Unknown, (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: Covid-19 vaccine (Dose Number: 1, manufacturer unknown), for Covid-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "described first experience in getting the vaccine as "bad" and "dramatic".".  Additional information: The case was reported as non-serious. The patient plans to get booster this month. They described first experience in getting the vaccine as "bad" and "dramatic". They are a Pfizer employee, so likely if it was the Pfizer shot they submitted an AE with the occurrence already.  The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Rash
Clinical narrative: Hearing loss/total deafness in one ear, and partial deafness in the other; rash around both ankles; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 55-year-old female patient received tofacitinib citrate (XELJANZ XR), oral since 19Feb2019 (ongoing) (Batch/Lot number: unknown) at 11 mg daily; COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADVAIR; FLUTICASONE; ALBUTEROL SULFATE; PREDNISONE; HYDROCODONE/ACETAMINOPHEN. Past drug history included: Covid-19 vaccine - manufacturer unknown for COVID-19 immunization, notes: Manufacturer Unknown, Dose 1; Covid-19 vaccine - manufacturer unknown for COVID-19 immunization, notes: Manufacturer Unknown, Dose 2. The following information was reported: DEAFNESS (medically significant), outcome "recovered", described as "Hearing loss/total deafness in one ear, and partial deafness in the other"; RASH (non-serious), outcome "unknown", described as "rash around both ankles". The event "hearing loss/total deafness in one ear, and partial deafness in the other" was evaluated at the emergency room visit. The action taken for tofacitinib citrate was dosage not changed. Therapeutic measures were taken as a result of deafness.  Clinical course: Patient Withheld stopped her Xeljanz XR for 5 days per md instructions to get her Covid-19 booster shot. A week later she developed a rash around both ankles, then a few days after that developed total deafness in one ear, and partial deafness in the other and went to the emergency room. was given prednisone and after 1 day hearing went back to normal.  The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.; Sender's Comments: based on the available information the causality between the suspect product and the reported adverse events and the suspect vaccine / BNT162B2 /XEliJANZ cannot be ruled out
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: I can't move my neck; very bad pain in the left side of my neck and armpit/ Sensitive to the touch; very bad pain in the left side of my neck and armpit/ Sensitive to the touch; moderate arm pain from top of arm to about middle of my hand; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received BNT162B2 (BNT162B2),solution for injection, administered in arm left, administration date 10Dec2021 at 12:30 (Lot number: FJ3757) at the age of 39 years as dose3(booster), single for covid-19 immunisation. The patient belonged to the age group Adult (18-64 Years). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left), administration date: 31Mar2021, when the patient was 38 years old, for COVID-19 immunization; BNT162B2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left), administration date: 11Mar2021, when the patient was 38 years old, for COVID-19 immunization. Patient did not receive any other vaccine in 4 weeks. The patient did not have covid prior vaccination and did not test for covid post vaccination.  The patient experienced IMMUNISATION (medically significant) with onset 10Dec2021, outcome "unknown", described as "booster"; NECK PAIN (medically significant), AXILLARY PAIN (medically significant) all with onset 12Dec2021, outcome "not recovered" and all described as "very bad pain in the left side of my neck and armpit/ Sensitive to the touch"; PAIN IN EXTREMITY (non-serious), with onset 11Dec2021, outcome "not recovered" and  described as "moderate arm pain from top of arm to about middle of my hand"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 13Dec2021, outcome "not recovered", described as "I can't move my neck". First day and half moderate arm pain from top of arm to about middle of her hand. Day 2: Sunday she woke up with very bad pain in the left side of her neck and armpit. Sensitive to the touch. It was Monday and it was still just as painful, very sensitive to the touch and she could not move her neck. Therapeutic measures were not taken as a result of neck pain, axillary pain, pain in extremity, pain in extremity, musculoskeletal stiffness.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Road traffic accident, Urticaria
Clinical narrative: Drug ineffective; caught covid19; broke out with bumps in between his knees/looked like hives; got into a car accident; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A male patient received bnt162b2 (BNT162B2), administration date 17Sep2021 (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 (medically significant) with onset 2021, outcome "unknown", described as "Drug ineffective"; COVID-19 (medically significant) with onset 2021, outcome "unknown", described as "caught covid19"; URTICARIA (non-serious) with onset 2021, outcome "unknown", described as "broke out with bumps in between his knees/looked like hives"; ROAD TRAFFIC ACCIDENT (non-serious) with onset 2021, outcome "unknown", described as "got into a car accident". Clinical course: When patient got the first shot he broke out with bumps in between his knees and it was a whole bunch and looked like hives and then he got the 2nd shot of the Pfizer vaccine; states he had the 1st shot on 17Sep2021 and then 21 days later he was supposed to take the 2nd shot on 08Oct2021 and caught covid19 and so he had to get quarantined for 14 days and some other stuff happened where he got into a car accident. He took the 2nd Pfizer shot and had to wait 24 or 30 days after he got covid to get the next dose and bot the next dose the other day of last week and on Friday or Thursday his whole body broke out in hives again on the upper body and back and lower back was covered in hives except for his arms. Patient wanted to know what he should do about the hives, does he go to his regular doctor or what. Patient is just not feeling well now and just got off the phone with friends.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Dyspnoea, Immunisation, Infection
Clinical narrative: booster; trouble breathing; weakness; it worsened; some kind of infection; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 80 year-old male patient received bnt162b2 (BNT162B2), administration date Nov2021 (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: Covid-19 vaccine (Dose 1; Primary Immunization series complete but unknown manufacturer); Covid-19 vaccine (Dose 2; Primary Immunization series complete but unknown manufacturer). The following information was reported: IMMUNISATION (hospitalization) with onset Nov2021, outcome "unknown", described as "booster"; DYSPNOEA (hospitalization) with onset 2021, outcome "unknown", described as "trouble breathing"; ASTHENIA (hospitalization) with onset 2021, outcome "unknown", described as "weakness"; CONDITION AGGRAVATED (hospitalization) with onset 2021, outcome "unknown", described as "it worsened"; INFECTION (hospitalization) with onset 2021, outcome "unknown", described as "some kind of infection". The patient was hospitalized for dyspnoea, asthenia, condition aggravated, infection (start date: 2021); the patient was hospitalized for immunisation (start date: 2021). HCP reported that she was not sure when did the patient received the booster dose but she knows it was a week before holiday. After the patient received the booster dose he experienced trouble breathing and weakness, it worsened and the patient is in the hospital currently. They were told that there's some kind of infection through patient body but they can't find and identify what infection it was.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; 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
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Immunisation, Suspected COVID-19
Clinical narrative: breakthrough Covid infection; breakthrough Covid infection; booster; 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 09Oct2021 (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 number: 1, after receiving Pfizer primary series and booster. Vaccines received 01Jan2021, 11Feb2021, and 09Oct2021.), administration date: 01Jan2021, for COVID-19 immunisation; Bnt162b2 (Dose number:2, after receiving Pfizer primary series and booster. Vaccines received 01Jan2021, 11Feb2021, and 09Oct2021.), administration date: 11Feb2021, for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "breakthrough Covid infection"; IMMUNISATION (medically significant) with onset 09Oct2021, outcome "unknown", described as "booster".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ageusia, COVID-19, Immunisation, Lower respiratory tract infection, SARS-CoV-2 test
Clinical narrative: breakthrough Covid infection; breakthrough Covid infection; booster; 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 09Oct2021 (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 number: 1, after receiving Pfizer primary series and booster. Vaccines received 01Jan2021, 11Feb2021, and 09Oct2021.), administration date: 01Jan2021, for COVID-19 immunisation; Bnt162b2 (Dose number:2, after receiving Pfizer primary series and booster. Vaccines received 01Jan2021, 11Feb2021, and 09Oct2021.), administration date: 11Feb2021, for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "breakthrough Covid infection"; IMMUNISATION (medically significant) with onset 09Oct2021, outcome "unknown", described as "booster".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination failure
Clinical narrative: breakthrough Covid infection; breakthrough Covid infection; booster; 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 09Oct2021 (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 number: 1, after receiving Pfizer primary series and booster. Vaccines received 01Jan2021, 11Feb2021, and 09Oct2021.), administration date: 01Jan2021, for COVID-19 immunisation; Bnt162b2 (Dose number:2, after receiving Pfizer primary series and booster. Vaccines received 01Jan2021, 11Feb2021, and 09Oct2021.), administration date: 11Feb2021, for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "breakthrough Covid infection"; IMMUNISATION (medically significant) with onset 09Oct2021, outcome "unknown", described as "booster".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Hypomenorrhoea
Clinical narrative: I had zero to little period for 2 months.; Now I have a period so bad every month that last 3 weeks long and the bleeding wont stop; This is a spontaneous report from a contactable reporter (Consumer or other non HCP). The reporter is the patient.   A 49year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jul2021 at 16:00 (Lot number: EW0180) at the age of 49 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, SINGLE, Lot Number: EW0180, Anatomical Location: Left arm, Administration time: 14:00, Route of administration: Unspecified), administration date: 17Jun2021, for COVID-19 immunisation.  The following information was reported: HYPOMENORRHOEA (non-serious) with onset 03Aug2021 at 12:00, outcome "not recovered", described as "I had zero to little period for 2 months"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset an unknown date in 2021, outcome "not recovered", described as "Now I have a period so bad every month that last 3 weeks long and the bleeding wont stop". It was unknown therapeutic measures were taken as a result of Hypomenorrhoea and Heavy menstrual bleeding.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid positive. symptomatic; covid positive. symptomatic; dose number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Oct2021 (Lot number: EW0217) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "no" (unspecified if ongoing), notes: other medical history: no. Concomitant medication(s) included: LO LOESTRIN FE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 09Feb2021, when the patient was 31 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 19Jan2021, when the patient was 31 years old, for Covid-19 immunization.The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Dec2021, outcome "unknown" and all described as "covid positive. symptomatic"; IMMUNISATION (non-serious) with onset 06Oct2021, outcome "unknown", described as "dose number=3". The event "covid positive. symptomatic" and "covid positive. symptomatic" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (14Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical Information: Allergies were reported as none. Other medical history was reported as none. There were no vaccine in four weeks. No covid prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation
Clinical narrative: I've had pain in my right hand finger joints since the next day of booster. Mainly ring finger; Dose received: 3; This is a spontaneous report received from contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 02Dec2021 at 12:00 (Lot number: FJ8762) at the age of 53 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: High blood pressure and "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulphas. Concomitant medications included: ATENOLOL, LOSARTAN and unspecified BIRTH CONTROL PILL. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EP7534, Route of Administration: Unspecified, Anatomical Location: Left arm, Time of Administration: 14:00), administration date: 16Mar2021, when the patient was 52 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW0150, Route of Administration: Unspecified, Anatomical Location: Left arm, Time of Administration: 14:00), administration date: 06Apr2021, when the patient was 53 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 at 12:00, outcome "unknown", described as "Dose received: 3"; ARTHRALGIA (non-serious) with onset 03Dec2021, outcome "not recovered", described as "I've had pain in my right hand finger joints since the next day of booster. Mainly ring finger". Therapeutic measures were not taken as a result of arthralgia.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation
Clinical narrative: Two of them are now fatally sick with COVID, confirmed COVID cases, vaccine failure; They are sick after booster (COVID Vaccine); People were sick; Two of them are now fatally sick with COVID, confirmed COVID cases, vaccine failure; They are sick after booster (COVID Vaccine); People were sick; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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 (Manufacturer unknown), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Two of them are now fatally sick with COVID, confirmed COVID cases, vaccine failure; They are sick after booster (COVID Vaccine); People were sick"; IMMUNISATION (medically significant), outcome "unknown", described as "booster".  Additional Context: Pfizer representative stated that, "I am Pfizer colleague (Pfizer representative), so I am trying to be in compliance on reporting an adverse event. So my daughter visited us this weekend and she then mentioned to me that she works at a small clinic in withheld and all the staff there, the small staff have received the Pfizer COVID Vaccine. She reported me that two of the people that received the COVID Vaccine and they were given about the same time, I think that they schedule to have all the staff vaccinated same time and two of them are now fatally sick with COVID, confirmed COVID cases (Split not made). So I do not know, you know I understand that we have vaccine failure, so I felt like I needed to report this to you guys because it is this small group receiving a same potentially same LOT of the vaccine and wanted to make sure that there was 'that' awareness reached." Is there a Product Complaint: Yes  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101798432 same reporter/drug/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: something happened about 22 days later, 24 days later I came down with the case of PMR; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administration date 19Apr2021 (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: Bnt162b2 (First dose), administration date: 22Mar2021, for COVID-19 Immunization. The following information was reported: POLYMYALGIA RHEUMATICA (medically significant) with onset 2021, outcome "unknown", described as "something happened about 22 days later, 24 days later I came down with the case of PMR". Reporter stated, he just want to inform that he had something that might be related to Pfizer, COVID vaccine. He had two Pfizer vaccines. So, he had those two, his wife and he was just looking at their calendar and something happened about 22 days later, 24 days later he came down with the case of PMR (further not clarified).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, Immunisation
Clinical narrative: booster; Two of them are now fatally sick with COVID, confirmed COVID cases, vaccine failure; They are sick after booster (COVID Vaccine); People were sick; Two of them are now fatally sick with COVID, confirmed COVID cases, vaccine failure; They are sick after booster (COVID Vaccine); People were sick; fatally sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (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: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Two of them are now fatally sick with COVID, confirmed COVID cases, vaccine failure; They are sick after booster (COVID Vaccine); People were sick"; ILLNESS (non-serious), outcome "unknown", described as "fatally sick". Reporter's daughter mentioned that she works at a small clinic in (Withheld) and all the staff there, the small staff have received the Pfizer COVID Vaccine. She reported that two of the people received the COVID Vaccine and they were given about the same time, reporter thought that they schedule to have all the staff vaccinated same time and two of them were now fatally sick with COVID, confirmed COVID cases. Reporter understand that have vaccine failure, so felt like needed to report, because it is a small group receiving a same potentially same lot of the vaccine. That they are sick after booster (COVID Vaccine). The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101798362 same reporter/drug/event, different patient
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation
Clinical narrative: Dose received: 3; Headache; This is a spontaneous report received from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 22-year-old female patient received bnt162b2 (BNT162B2), administration date an unknown date in 2021, (Lot number: unknown) at the age of 22 years 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, SINGLE, Lot number: UNKNOWN, Route of administration: unspecified) for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN, Route of administration: unspecified) for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset an unknown date in 2021, outcome "unknown", described as "Dose received: 3"; HEADACHE (non-serious) with onset an unknown date in 2021, outcome "unknown", described as "headache".  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: little bit of pain, 2 inch diameter, at the injection site; And just a little sort of fatigue. Like I got a kind of tired that afternoon.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 22Feb2021 (Lot number: EN6201) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid", start date: Nov2020 (unspecified if ongoing), notes: they tested positive for Covid in Nov. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "little bit of pain, 2 inch diameter, at the injection site"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "And just a little sort of fatigue. Like I got a kind of tired that afternoon.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: A (Age: 69, Unit: Unknown) male nurse reported for two patients (Himself and his wife). This is 1st of two reports. The caller stated he got the first dose of the vaccine on 22Feb2021 and was due for the second on 15Mar2021. He stated he didn't seem to have a side effect other than a little bit of pain, 2 inch diameter, at the injection site. He didn't feel anything at all. And just a little sort of fatigue. Like he got a kind of tired that afternoon. He stated many people over 70 told him that they had many more symptoms after the second than the first.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: body pain; chills; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (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: PAIN (non-serious), outcome "unknown", described as "body pain"; CHILLS (non-serious), outcome "unknown", described as "chills"; HEADACHE (non-serious), outcome "unknown", described as "headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore left arm at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 15:45 (Lot number: EJ1685) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: known allergies: Penicillin; "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: MULTIVITAMIN, SAMBUCUS NIGRA, SODIUM, ZINC. Past drug history included: Cephalosporins for Drug allergy, reaction(s): "Drug allergy"; Mastisol for Drug allergy, reaction(s): "Drug allergy to antibiotics"; Bactrim for Drug allergy, reaction(s): "Drug allergy"; Known allergies: cephalosporins, reaction(s): "known allergies: Cephalosporins"; Known allergies: mastisol, reaction(s): "known allergies: Mastisol". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 04Mar2021 19:00, outcome "recovered" (Mar2021), described as "Sore left arm at the injection site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The most recent COVID-19 vaccine was administered at Workplace clinic. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Multivitamin. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. While the AE reported was not resolved at the time the report was made, the AE was later resolved.  Follow-Up (17Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Muscular weakness, Myalgia
Clinical narrative: feeling "really tired"; sort of weak; muscle pain; Sort of weak, specifically in her legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021264134 (Pfizer).  A 76 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Feb2021 (Lot number: EN5318, Expiration Date: 31May2021) at the age of 76 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 05Mar2021, outcome "not recovered", described as "feeling "really tired""; ASTHENIA (non-serious) with onset 05Mar2021, outcome "not recovered", described as "sort of weak"; MYALGIA (non-serious) with onset 05Mar2021, outcome "not recovered", described as "muscle pain"; MUSCULAR WEAKNESS (non-serious) with onset 05Mar2021, outcome "not recovered", described as "Sort of weak, specifically in her legs". Additional information: Patient was a 76-years-old female who received her first dose of the Pfizer BioNTech COVID-19 vaccine on Wednesday (03Feb2021). She stated that yesterday and Thursday she was feeling okay but today reported feeling "really tired" and "sort of weak", specifically in her legs, as well as muscle pain on 05Mar2021.  She would like to know if these symptoms are coming from the vaccine and is concerned about how long they will last. She was not sure if she should get the second dose because of this. She would like to know what would happen if you only got the first dose of the Pfizer BioNTech COVID-19 vaccine. Patient stated she got the COVID vaccine on Wednesday 03Feb2021, stated she had been getting some weakness and feeling tired a lot since then, having some muscle pain, just got the thing Wednesday, yesterday she felt fine and the symptoms started today. She wanted to know when do these symptoms go away.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: has "major heart problems".; 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 (159558).  A 74 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as 1st dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "has "major heart problems". Additional information: Reporter stated that the patient (reporter's parent) was told by his primary care doctor that he needs to wait to receive the second dose until 3 months later/next doses are scheduled 3 months from 1st dose. Reporter queried on administering the second dose at any time longer than 6 weeks, specifically 3 months after.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Pain, Peripheral swelling
Clinical narrative: I got on my right upper hand it was very painful; I got on my right upper hand, I got swelling and on the wrist; I got on my right upper hand, I got swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 88 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 88 years 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: PAIN (non-serious), outcome "unknown", described as "I got on my right upper hand it was very painful"; JOINT SWELLING (non-serious), outcome "unknown", described as "I got on my right upper hand, I got swelling and on the wrist"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "I got on my right upper hand, I got swelling".  Additional information: "Consumer stated that 2 days later, she got on her right upper hand, she got swelling and on the wrist and it was very painful and she was calling to find out what can be done if anything (incomplete sentence)." When paraphrased the above concern, consumer stated that on the right palm of her right hand. Consumer stated that because, when she used the right hand, it was painful. Consumer stated that she wanted to talk to report this because it was still painful. Definitely because it was painful and she was probably going to the emergency room because it was not where the site, where the injection site was. It was not the area where she got the injection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymph node pain, Lymphadenopathy
Clinical narrative: chills; lymph nodes swollen; soreness of lymph node on the right side of her neck; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2021 (Lot number: EN6205) at the age of 52 years as 2nd dose, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: CLONIDINE taken for blood pressure abnormal, start date: 2014 (ongoing); HYDROCHLOROTHIAZIDE taken for blood pressure abnormal, start date: 2014 (ongoing). Vaccination history included: Bnt162b2 (1st Dose, She received the first dose on 09Feb2021 at 4:20pm, Lot: EM9809), administration date: 09Feb2021, when the patient was 52 years old, for Covid-19 Immunisation. The following information was reported: CHILLS (non-serious) with onset 03Mar2021, outcome "recovering", described as "chills"; LYMPHADENOPATHY (non-serious) with onset 02Mar2021, outcome "recovering", described as "lymph nodes swollen"; LYMPH NODE PAIN (non-serious) with onset 02Mar2021, outcome "recovering", described as "soreness of lymph node on the right side of her neck". No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Myalgia
Clinical narrative: Caller experienced pain in thigh; weakness a day after; 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 02Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for covid-19 immunisation. The following information was reported: MYALGIA (non-serious) with onset 03Mar2021, outcome "unknown", described as "Caller experienced pain in thigh"; ASTHENIA (non-serious) with onset 03Mar2021, outcome "unknown", described as "weakness a day after". Additional information: . Caller wanted to know whether it was a normal reaction after the dose. No any unaddressed medical questions referred or forwarded to Medical Information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Left arm where needle went in is all pink, very warm, kind of swollen, sore and itchy; Left arm where needle went in is all pink, very warm, kind of swollen, sore and itchy; Left arm where needle went in is all pink, very warm, kind of swollen, sore and itchy; Left arm where needle went in is all pink, very warm, kind of swollen, sore and itchy; Left arm where needle went in is all pink, very warm, kind of swollen, sore and itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 85 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Feb2021 12:30 (Lot number: EN6200) at the age of 85 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Lot number: EL3246, /Expiry: Unknown, this information is not on the CDC vaccine record card., Dose: Unknown strength/volume/dose injection to left arm at about 12:30., Route: Injection, Anatomical Location: Left arm), administration date: 03Feb2021, when the patient was 85 years old, for COVID-19 immunisation. The following information was reported: VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE DISCOLOURATION (non-serious), VACCINATION SITE WARMTH (non-serious), outcome "not recovered" and all described as "Left arm where needle went in is all pink, very warm, kind of swollen, sore and itchy". Additional information: After the Dose 2 administration around 5 days later or maybe more patient had experienced the onset of event. Event was ongoing and not getting better. Adverse event not required a visit to emergency room or physician office and hospitalization. No prior Vaccinations (within 4 weeks) (None other than first dose of Pfizer COVID-19 Vaccine). No patient medical history and no relevant tests has reported.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: painful that it would take away breath; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Agency and transmitted to Sanofi on 02-Dec-2021.  This case involves 75-year-old female patient who experienced painful that it would take away breath (pain) while receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious painful that it would take away breath (pain) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.