chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Immunisation, Interchange of vaccine products, Off label use, Pain in extremity
Clinical narrative: feel like vomiting; dizzy; Booster; Off label use; Interchange of vaccine products; arm hurt; 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 41 year-old female patient received bnt162b2 (COMIRNATY), administration date 27Nov2021 (Batch/Lot number: unknown) at the age of 41 years as dose 2 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine from johnson & johnson (DOSE 1, received her first dose of COVID-19 vaccine from Johnson & Johnson on 17Mar2021), administration date: 17Mar2021, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Nov2021, outcome "unknown", described as "Booster"; OFF LABEL USE (non-serious) with onset 27Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 27Nov2021, outcome "unknown", described as "Interchange of vaccine products"; PAIN IN EXTREMITY (non-serious) with onset 27Nov2021, outcome "recovered" (29Nov2021), described as "arm hurt"; VOMITING (non-serious) with onset 06Dec2021, outcome "recovered" (Dec2021), described as "feel like vomiting"; DIZZINESS (non-serious) with onset 06Dec2021, outcome "not recovered", described as "dizzy".  Additional information: female patient received her first dose of COVID-19 vaccine from Johnson & Johnson on 17Mar2021, she mentioned that she got scared of what she heard about the Johnson & Johnson vaccine. She got the booster dose of Pfizer COVID-19 vaccination on Saturday 27Nov2021 and reported: "Tomorrow it'll be 2 weeks from getting her Pfizer booster, she had a reaction; arm hurt only for a day and a half, and then it subsided, she got the shot and the next day, and by Monday she was fine. Last Monday (06Dec2021) started to feel like vomiting and felt dizzy. She spent 2 or 3 days with the feeling of vomiting and not being able to eat well due to vomiting, then the vomiting stopped but the dizziness continues still, although the feeling has decreased a little bit. It has affected in daily activities, she have hardly worked, because still feel a little dizzy to work.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: feel like vomiting; dizzy; Booster; Off label use; Interchange of vaccine products; arm hurt; 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 41 year-old female patient received bnt162b2 (COMIRNATY), administration date 27Nov2021 (Batch/Lot number: unknown) at the age of 41 years as dose 2 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine from johnson & johnson (DOSE 1, received her first dose of COVID-19 vaccine from Johnson & Johnson on 17Mar2021), administration date: 17Mar2021, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Nov2021, outcome "unknown", described as "Booster"; OFF LABEL USE (non-serious) with onset 27Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 27Nov2021, outcome "unknown", described as "Interchange of vaccine products"; PAIN IN EXTREMITY (non-serious) with onset 27Nov2021, outcome "recovered" (29Nov2021), described as "arm hurt"; VOMITING (non-serious) with onset 06Dec2021, outcome "recovered" (Dec2021), described as "feel like vomiting"; DIZZINESS (non-serious) with onset 06Dec2021, outcome "not recovered", described as "dizzy".  Additional information: female patient received her first dose of COVID-19 vaccine from Johnson & Johnson on 17Mar2021, she mentioned that she got scared of what she heard about the Johnson & Johnson vaccine. She got the booster dose of Pfizer COVID-19 vaccination on Saturday 27Nov2021 and reported: "Tomorrow it'll be 2 weeks from getting her Pfizer booster, she had a reaction; arm hurt only for a day and a half, and then it subsided, she got the shot and the next day, and by Monday she was fine. Last Monday (06Dec2021) started to feel like vomiting and felt dizzy. She spent 2 or 3 days with the feeling of vomiting and not being able to eat well due to vomiting, then the vomiting stopped but the dizziness continues still, although the feeling has decreased a little bit. It has affected in daily activities, she have hardly worked, because still feel a little dizzy to work.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity, Peripheral swelling
Clinical narrative: Swollen right arm pit; right arm pain; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 2021 (Lot number: FD#218) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CLARITIN-D. Vaccination history included: Covid-19 vaccine (1st dose), for COVID-19 immunization; Covid-19 vaccine (2nd dose), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "Booster"; PERIPHERAL SWELLING (non-serious) with onset 12Dec2021 10:00, outcome "not recovered", described as "Swollen right arm pit"; PAIN IN EXTREMITY (non-serious) with onset 12Dec2021 10:00, outcome "not recovered", described as "right arm pain". The events "swollen right arm pit" and "right arm pain" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of peripheral swelling, pain in extremity.  Additional information: The reporter stating events as non serious. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient did not have any known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site pain
Clinical narrative: Arm was sore from the injection; Received his Pfizer/BioNTech COVID-19 vaccine Booster on 09Dec; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A male patient received bnt162b2 (BNT162B2), administration date 09Dec2021 (Formulation: solution for injection, Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021, outcome "unknown", described as "Received his Pfizer/BioNTech COVID-19 vaccine Booster on 09Dec"; VACCINATION SITE PAIN (non-serious) with onset 10Dec2021, outcome "unknown", described as "Arm was sore from the injection".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Menstrual disorder, SARS-CoV-2 test
Clinical narrative: Booster; Noted missed periods following each vaccine shot and booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 31Oct2021 (Batch/Lot number: unknown) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medication(s) included: LEVOTHYROXINE; METFORMIN; TYLENOL; ADVIL [IBUPROFEN]. Vaccination history included: Bnt162b2 (Dose Number: 2), administration date: 10Apr2021, when the patient was 42 years old, for COVID-19 immunization, reaction(s): "missed periods following each vaccine"; Bnt162b2 (Dose Number: 1), for COVID-19 immunization, reaction(s): "missed periods following each vaccine". The following information was reported: IMMUNISATION (non-serious) with onset 31Oct2021, outcome "unknown", described as "Booster"; MENSTRUAL DISORDER (non-serious) with onset 31Oct2021, outcome "unknown", described as "Noted missed periods following each vaccine shot and booster". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstrual disorder. The device date was given as 12Dec2021.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was noted that missed periods following each vaccine shot and booster. Last shot was on 31Oct2021 as of 12Nov2021 no period. Occurred with after each shot in series as well. No hospitalization prolonged. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The device date was given as 12Dec2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Erythema, Immunisation, Pain in extremity, Peripheral swelling
Clinical narrative: Arm is painful, red, and swollen from her armpit to her breast; Pain in her left arm; Pain in her left arm where the injection site; Arm is painful, red, and swollen from her armpit to her breast; Arm is painful, red, and swollen from her armpit to her breast; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 18:00 (Batch/Lot number: unknown) at the age of 61 years as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 18:00, outcome "unknown", described as "Booster"; PERIPHERAL SWELLING (non-serious), ERYTHEMA (non-serious), AXILLARY PAIN (non-serious) all with onset 10Dec2021, outcome "not recovered" and all described as "Arm is painful, red, and swollen from her armpit to her breast"; PAIN IN EXTREMITY (non-serious) with onset 10Dec2021, outcome "not recovered", described as "Pain in her left arm"; VACCINATION SITE PAIN (non-serious) with onset 10Dec2021, outcome "not recovered", described as "Pain in her left arm where the injection site". Therapeutic measures were not taken as a result of peripheral swelling, pain in extremity, vaccination site pain, erythema, axillary pain.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm is painful, red, and swollen from her armpit to her breast; Pain in her left arm; Pain in her left arm where the injection site; Arm is painful, red, and swollen from her armpit to her breast; Arm is painful, red, and swollen from her armpit to her breast; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 18:00 (Batch/Lot number: unknown) at the age of 61 years as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 18:00, outcome "unknown", described as "Booster"; PERIPHERAL SWELLING (non-serious), ERYTHEMA (non-serious), AXILLARY PAIN (non-serious) all with onset 10Dec2021, outcome "not recovered" and all described as "Arm is painful, red, and swollen from her armpit to her breast"; PAIN IN EXTREMITY (non-serious) with onset 10Dec2021, outcome "not recovered", described as "Pain in her left arm"; VACCINATION SITE PAIN (non-serious) with onset 10Dec2021, outcome "not recovered", described as "Pain in her left arm where the injection site". Therapeutic measures were not taken as a result of peripheral swelling, pain in extremity, vaccination site pain, erythema, axillary pain.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Product expiration date issue
Clinical narrative: Booster; When she got the booster dose the expiration date of the vials is beyonddate. The HCP who administered the vaccine wrote a different expiration date on thevaccination card.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program . The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Lot number: FT8757) 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 (non-serious), outcome "unknown", described as "Booster"; PRODUCT EXPIRATION DATE ISSUE (non-serious), outcome "unknown", described as "When she got the booster dose the expiration date of the vials is beyonddate. The HCP who administered the vaccine wrote a different expiration date on thevaccination card.".  Additional information: Patient wants to check the expiration of the lot number. She provided the Lot number FT8757, she said that the Lot number is not clear and she wants to verify the expiration date. When she got the booster dose the expiration date of the vials is beyond date. The HCP who administered the vaccine wrote a different expiration date on the vaccination card.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Impaired driving ability, Loss of personal independence in daily activities, Vision blurred
Clinical narrative: booster; blurred vision; she couldn't read; she couldn't drive to work; 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). The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11Dec2021 05:15 (Lot number: SJ8757) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LITHIUM (ongoing); ZYPREXA (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, lot number CR8731), administration date: 15Apr2021, when the patient was 41 years old, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE, lot number EW0182), administration date: 06May2021, when the patient was 41 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 11Dec2021, outcome "unknown", described as "booster "; VISION BLURRED (non-serious) with onset 11Dec2021, outcome "not recovered", described as "blurred vision"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Dec2021, outcome "unknown", described as "she couldn't read"; IMPAIRED DRIVING ABILITY (non-serious) with onset Dec2021, outcome "unknown", described as "she couldn't drive to work ". Therapeutic measures were taken as a result of vision blurred.  Additional information: The reporter indicates that she developed blurred vision immediately after getting the booster shot of the pfizer covid 19 vaccine. On 11Dec2021 (Saturday), she could not read, she was better on 13Dec2021 (reported as today). She cannot see without her glasses which is not common on her. She got the booster dose on 11Dec2021 at 5:15pm. The blurred vision happened as soon as he jabbed her. It was instant. She sat down for 15 minutes, and when she got up to walk out, she realized she couldn't read the lettering on the signs and she usually can with her glasses. She went ahead and drove home because she only lives 2 blocks away. She was wondering if it was a side effect. She had to work from home today because she couldn't drive to work this morning. The blurred vision was really bad on 11Dec2021 (Saturday) and 12Dec2021 (Sunday). On 13Dec2021 (Today), she still needs to wear glasses as long as she was awake. Usually at home, she can take them off and see fine. Now she has to wear her glasses at all times. That was unusual for her. She tried making an eye doctor appointment, but they had no openings. She was hoping they could give her drops or something. She has been using Refresh tears for the blurred vision, and It wasn't 100% helping, but it was helping some. It has lot number T0156. The patient received her booster vaccine in a   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Chills, Ear discomfort, Headache, Immunisation, Nausea
Clinical narrative: slight discomfort in ears; ringing in the ears; Booster; he also received the Flu vaccine on the same date as this one; Chills; Headache; Nausea; 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 46 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 09Dec2021 11:30 (Batch/Lot number: unknown) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), intramuscular, administered in arm right, administration date 09Dec2021 (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 02), administration date: 19Apr2021, when the patient was 46 years old, for Covid-19 immunization, reaction(s): "Tired"; Bnt162b2 (Dose: 01), administration date: 28Mar2021, when the patient was 46 years old, for Covid-19 immunization, reaction(s): "Tired". The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 11:30, outcome "unknown", described as "Booster"; PRODUCT USE ISSUE (non-serious) with onset 09Dec2021, outcome "unknown", described as "he also received the Flu vaccine on the same date as this one"; TINNITUS (non-serious) with onset 09Dec2021 21:00, outcome "not recovered", described as "ringing in the ears"; CHILLS (non-serious) with onset 09Dec2021, outcome "recovering", described as "Chills"; HEADACHE (non-serious) with onset 09Dec2021, outcome "recovering", described as "Headache"; NAUSEA (non-serious) with onset 09Dec2021, outcome "recovering", described as "Nausea"; EAR DISCOMFORT (non-serious) with onset 09Dec2021 22:00, outcome "unknown", described as "slight discomfort in ears".  Additional information: Expiry Date of Pfizer COVID vaccine booster: Unknown. He did not have a manufacturer, lot or expiration. Family Medical History Relevant to AE(s): none Relevant Tests: None. Ringing in ears was reported as worsened. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): none.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Product use issue, Tinnitus
Clinical narrative: slight discomfort in ears; ringing in the ears; Booster; he also received the Flu vaccine on the same date as this one; Chills; Headache; Nausea; 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 46 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 09Dec2021 11:30 (Batch/Lot number: unknown) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), intramuscular, administered in arm right, administration date 09Dec2021 (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 02), administration date: 19Apr2021, when the patient was 46 years old, for Covid-19 immunization, reaction(s): "Tired"; Bnt162b2 (Dose: 01), administration date: 28Mar2021, when the patient was 46 years old, for Covid-19 immunization, reaction(s): "Tired". The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 11:30, outcome "unknown", described as "Booster"; PRODUCT USE ISSUE (non-serious) with onset 09Dec2021, outcome "unknown", described as "he also received the Flu vaccine on the same date as this one"; TINNITUS (non-serious) with onset 09Dec2021 21:00, outcome "not recovered", described as "ringing in the ears"; CHILLS (non-serious) with onset 09Dec2021, outcome "recovering", described as "Chills"; HEADACHE (non-serious) with onset 09Dec2021, outcome "recovering", described as "Headache"; NAUSEA (non-serious) with onset 09Dec2021, outcome "recovering", described as "Nausea"; EAR DISCOMFORT (non-serious) with onset 09Dec2021 22:00, outcome "unknown", described as "slight discomfort in ears".  Additional information: Expiry Date of Pfizer COVID vaccine booster: Unknown. He did not have a manufacturer, lot or expiration. Family Medical History Relevant to AE(s): none Relevant Tests: None. Ringing in ears was reported as worsened. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): none.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Fatigue, Immunisation, Malaise
Clinical narrative: the booster dose which was her third dose of Pfizer Covid Vaccine today, 13Dec2021 at around 11:45; She did not know she was not supposed to get booster dose because she is on blood thinner: Atorvastatin; Does not feel good; Really tired; 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 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13Dec2021 11:45 (Batch/Lot number: unknown) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN taken for anticoagulant therapy, start date: 2021 (ongoing). Vaccination history included: Bnt162b2 (First dose: Lot/NDC/Expiry: Unknown, the only only number on the card is unlabeled and is: RA721), administration date: 03Feb2021, when the patient was 64 years old, for Covid-19 immunization; Bnt162b2 (second dose: Lot/NDC/Expiry: Unknown, the only only number on the card is unlabeled and is: RA721), administration date: 24Feb2021, when the patient was 64 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Dec2021 11:45, outcome "unknown", described as "the booster dose which was her third dose of Pfizer Covid Vaccine today, 13Dec2021 at around 11:45"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious) with onset 13Dec2021, outcome "unknown", described as "She did not know she was not supposed to get booster dose because she is on blood thinner: Atorvastatin"; MALAISE (non-serious) with onset 13Dec2021, outcome "not recovered", described as "Does not feel good"; FATIGUE (non-serious) with onset 13Dec2021, outcome "not recovered", described as "Really tired".  Additional Information: Patient stated that she got the booster dose of the Pfizer Covid Vaccine and she didn't know she wasn't supposed to get it because she is on blood thinners; She clarified only on 1 product she provided as a blood thinner: Atorvastatin. She didn't feel good after receiving the shot. She clarified that she does not feel good, really tired since after she was administered booster dose of Pfizer Covid Vaccine. Time of onset of events queried but only provided by patient as when she came home; she felt alright when she was out, but when she came home that was when she started to not feel good and feel really tired. She stated that for the lot number of the suspect product that the only number on the card was unlabeled and that was RA721. Atorvastatin Start date was unknown other than about 1-2 months ago in 2021. This dose completed her prescribed therapy.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: she had a left sore arm/the big red spot is hurting/injection site reaction of pain; Stated that she has a big red spot on it now. Stated that it  was an injection site reaction/redness 5cmX 10cm in size; injection site swelling; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 (Lot number: SD0809) at the age of 53 years as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021, outcome "unknown", described as "booster"; VACCINATION SITE PAIN (non-serious) with onset 13Dec2021 01:00, outcome "not recovered", described as "she had a left sore arm/the big red spot is hurting/injection site reaction of pain"; VACCINATION SITE ERYTHEMA (non-serious) with onset 13Dec2021 01:00, outcome "not recovered", described as "Stated that she has a big red spot on it now. Stated that it  was an injection site reaction/redness 5cmX 10cm in size"; VACCINATION SITE SWELLING (non-serious) with onset 13Dec2021 01:00, outcome "unknown", described as "injection site swelling". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site erythema, vaccination site swelling.  Clinical course: Report not related to study or programme. No investigation assessment.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Photopsia
Clinical narrative: her eyes were having flashes of bright and fast/ rescue truck having the red lights on and they would be flashing really Both eyes; booster shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A 84 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (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 2, manufacturer unknown), administration date: 2021, for Covid-19 immunization; Covid-19 vaccine (Dose 1, manufacturer unknown), administration date: 2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster shots"; PHOTOPSIA (non-serious) with onset 11Dec2021, outcome "unknown", described as "her eyes were having flashes of bright and fast/ rescue truck having the red lights on and they would be flashing really Both eyes".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Myalgia, Vaccination site pain
Clinical narrative: Mild muscle aches; Muscle soreness at site of injection; Received Pfizer BioNTech Covid 19 vaccine booster shot; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 13Dec2021 10:15 (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 (MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Dec2021, outcome "unknown", described as "Received Pfizer BioNTech Covid 19 vaccine booster shot"; VACCINATION SITE PAIN (non-serious) with onset 13Dec2021 15:15, outcome "recovering", described as "Muscle soreness at site of injection"; MYALGIA (non-serious) with onset 13Dec2021 21:15, outcome "recovering", described as "Mild muscle aches". Therapeutic measures were taken as a result of vaccination site pain, myalgia.  Additional information: Event took place after use of product. Patient responded to Tylenol & ibuprofen.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Immunisation, Pyrexia
Clinical narrative: 3rd dose; Fever >102; Fatigue; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) at the age of 54 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: Covid-19 vaccine (MANUFACTURER UNKNOWN, Dose:1), when the patient was 54 years old, for COVID-19 immunization; Covid-19 vaccine (MANUFACTURER UNKNOWN, Dose:2), when the patient was 54 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "3rd dose"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever >102"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional comment: Events took place after use of product.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Inappropriate schedule of product administration, Intentional product misuse, Sinusitis
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Sep2021 (Lot number: FE3592) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE taken for rheumatoid arthritis (ongoing); PREDNISONE taken for rheumatoid arthritis (ongoing); FOLIC ACID taken for rheumatoid arthritis (ongoing); NAPRELAN taken for rheumatoid arthritis (ongoing); REMICADE taken for rheumatoid arthritis (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Lot: EN6206, Expiry: Unknown, Anatomical site: Arm left), administration date: 07Mar2021, when the patient was 50 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2, Lot: EP6955, Expiry: Unknown, Anatomical site: Arm left), administration date: 27Mar2021, when the patient was 50 years old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 2021, outcome "unknown", INTENTIONAL PRODUCT MISUSE (non-serious), outcome "unknown" and all described as "she asked him to just prescribe her the vaccine every 3 months"; IMMUNISATION (non-serious) with onset 07Sep2021, outcome "unknown", described as "1st dose received on 07Mar2021./2nd dose received on 27Mar2021./Booster received on 07Sep2021."; SINUSITIS (non-serious), outcome "unknown", described as "sinus infection". Therapeutic measures were taken as a result of sinusitis. No follow-up attempts are possible. No further information is expected. Follow-up (17Dec2021): This is a spontaneous follow-up report from a contactable Physician. This Physician reported in response to HCP telephonic follow up activity which included that: Dosage Regimen, Event Onset date for Booster event. Follow-Up (28Dec2021): Follow-up attempts are completed. No further information is expected. Additional information: treatment for sinusitis: antibiotics for a sinus infection recently.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation, Influenza like illness, Malaise, Pyrexia
Clinical narrative: Booster; Flu like symptoms; Fever; Chills; Malaise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 2021 (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 (MANUFACTURER UNKNOWN, Dose1), for COVID-19 immunization; Covid-19 vaccine (MANUFACTURER UNKNOWN, Dose 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "Booster"; INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Flu like symptoms"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fever"; CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Chills"; MALAISE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Malaise".  Additional information- I learned from an acquaintance, who was a woman roughly in her 40s or 50s, that she received a third dose of PFE vaccine (booster) in withheld, and after receiving the vaccine experience flu like symptoms, including fever, chills, and malaise. Those symptoms cleared up within 1 day. I do not have additional information. I was not the patient and do not know the patient; I simply met her once. I have no additional information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Flushing, Heart rate, Heart rate increased, Illness
Clinical narrative: booster; Developed edema in her ankles and legs; Skin flushing; Feeling off balance; Developed rash over whole body; Seemed to develop rapid heartbeat 10-30 minutes after injection; illness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2021US003088.  A 77 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 77 years as dose number unknown (booster), single for covid-19 immunisation; abaloparatide (TYMLOS), subcutaneous since 18Jun2021 (ongoing) (Batch/Lot number: unknown) at 80 ug daily for senile osteoporosis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (2nd dose, Unknown manufacturer), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; OEDEMA PERIPHERAL (non-serious) with onset May2021, outcome "unknown", described as "Developed edema in her ankles and legs"; FLUSHING (non-serious) with onset May2021, outcome "unknown", described as "Skin flushing"; BALANCE DISORDER (non-serious) with onset May2021, outcome "unknown", described as "Feeling off balance"; RASH (non-serious) with onset May2021, outcome "unknown", described as "Developed rash over whole body"; HEART RATE INCREASED (non-serious) with onset May2021, outcome "unknown", described as "Seemed to develop rapid heartbeat 10-30 minutes after injection"; ILLNESS (non-serious) with onset May2021, outcome "unknown", described as "illness". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for abaloparatide was dosage not changed. Additional Information: The patient experienced rash (start date first month, duration two weeks); heart rate increase (start date first month ,duration 30 minutes); oedema peripheral (start date second month); flushing and balance disorder. Treatment information was not provided.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Oedema peripheral, Rash
Clinical narrative: booster; Developed edema in her ankles and legs; Skin flushing; Feeling off balance; Developed rash over whole body; Seemed to develop rapid heartbeat 10-30 minutes after injection; illness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2021US003088.  A 77 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 77 years as dose number unknown (booster), single for covid-19 immunisation; abaloparatide (TYMLOS), subcutaneous since 18Jun2021 (ongoing) (Batch/Lot number: unknown) at 80 ug daily for senile osteoporosis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (2nd dose, Unknown manufacturer), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; OEDEMA PERIPHERAL (non-serious) with onset May2021, outcome "unknown", described as "Developed edema in her ankles and legs"; FLUSHING (non-serious) with onset May2021, outcome "unknown", described as "Skin flushing"; BALANCE DISORDER (non-serious) with onset May2021, outcome "unknown", described as "Feeling off balance"; RASH (non-serious) with onset May2021, outcome "unknown", described as "Developed rash over whole body"; HEART RATE INCREASED (non-serious) with onset May2021, outcome "unknown", described as "Seemed to develop rapid heartbeat 10-30 minutes after injection"; ILLNESS (non-serious) with onset May2021, outcome "unknown", described as "illness". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for abaloparatide was dosage not changed. Additional Information: The patient experienced rash (start date first month, duration two weeks); heart rate increase (start date first month ,duration 30 minutes); oedema peripheral (start date second month); flushing and balance disorder. Treatment information was not provided.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Immunisation, Myalgia, Nausea
Clinical narrative: had arm pain; muscle aches; fever; chills; Booster; had severe nausea; vomiting; diarrhea; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 06Dec2021 (Lot number: FD0809) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergies: PCN" (unspecified if ongoing), notes: known allergies: PCN, codeine. Concomitant medication(s) included: ELIQUIS. Past drug history included: Codeine, reaction(s): "Allergy: Codeine", notes: known allergies: PCN, codeine. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0153), administration date: 08Apr2021, when the patient was 64 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER2613), administration date: 18Mar2021, when the patient was 64 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (non-serious) with onset 07Dec2021, outcome "recovered" (Dec2021), described as "had arm pain"; MYALGIA (non-serious) with onset 07Dec2021, outcome "recovered" (Dec2021), described as "muscle aches"; PYREXIA (non-serious) with onset 07Dec2021, outcome "recovered" (Dec2021), described as "fever"; CHILLS (non-serious) with onset 07Dec2021, outcome "recovered" (Dec2021), described as "chills"; NAUSEA (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "had severe nausea"; VOMITING (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "vomiting"; DIARRHOEA (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "diarrhea". Therapeutic measures were not taken as a result of pain in extremity, myalgia, pyrexia, chills, nausea, vomiting, diarrhoea.  Additional information: Facility where the most recent COVID-19 vaccine was administered was public health clinic/veterans administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 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. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: had arm pain; muscle aches; fever; chills; Booster; had severe nausea; vomiting; diarrhea; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 06Dec2021 (Lot number: FD0809) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergies: PCN" (unspecified if ongoing), notes: known allergies: PCN, codeine. Concomitant medication(s) included: ELIQUIS. Past drug history included: Codeine, reaction(s): "Allergy: Codeine", notes: known allergies: PCN, codeine. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0153), administration date: 08Apr2021, when the patient was 64 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER2613), administration date: 18Mar2021, when the patient was 64 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (non-serious) with onset 07Dec2021, outcome "recovered" (Dec2021), described as "had arm pain"; MYALGIA (non-serious) with onset 07Dec2021, outcome "recovered" (Dec2021), described as "muscle aches"; PYREXIA (non-serious) with onset 07Dec2021, outcome "recovered" (Dec2021), described as "fever"; CHILLS (non-serious) with onset 07Dec2021, outcome "recovered" (Dec2021), described as "chills"; NAUSEA (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "had severe nausea"; VOMITING (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "vomiting"; DIARRHOEA (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "diarrhea". Therapeutic measures were not taken as a result of pain in extremity, myalgia, pyrexia, chills, nausea, vomiting, diarrhoea.  Additional information: Facility where the most recent COVID-19 vaccine was administered was public health clinic/veterans administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 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. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Peripheral swelling
Clinical narrative: booster; soreness under the arm; Swelling under the arm/Swelling on the arm after receiving the booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 18Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Memory loss", start date: May2021 (unspecified if ongoing), notes: daughter may start with memory loss at 26 years old. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose, Exp: Unknown , NDC :Unknown), for COVID-19 immunization, reaction(s): "headache", "soreness in the arm"; Bnt162b2 (Second dose), for COVID-19 immunization.The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; AXILLARY PAIN (non-serious), outcome "unknown", described as "soreness under the arm"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Swelling under the arm/Swelling on the arm after receiving the booster dose".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101780739 same vaccine, different patient and AE