chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy, Mobility decreased, Pain
Clinical narrative: Extremely swollen arm pit lymph node, size of a golf ball; Pain radiates through chest and fingers/joints; Cannot move arm, cannot lay arm flat against my side; dose number=3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 (Lot number: 330308D) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VENLAFAXINE. Vaccination history included: Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021, outcome "unknown", described as "dose number=3"; LYMPHADENOPATHY (non-serious) with onset 01Dec2021, outcome "unknown", described as "Extremely swollen arm pit lymph node, size of a golf ball"; PAIN (non-serious) with onset 01Dec2021, outcome "unknown", described as "Pain radiates through chest and fingers/joints"; MOBILITY DECREASED (non-serious) with onset 01Dec2021, outcome "unknown", described as "Cannot move arm, cannot lay arm flat against my side". The events "extremely swollen arm pit lymph node, size of a golf ball", "pain radiates through chest and fingers/joints" and "cannot move arm, cannot lay arm flat against my side" were evaluated at the physician office visit.  Additional information: The patient was administered COVID-19 vaccine in a pharmacy. The patient was not diagnosed with covid-19 prior to vaccination and had not been tested for covid-19 since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the covid vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: tired; Approximately 18.5 hrs after the 2nd vaccination, the patient had a headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 7 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Nov2021 19:00 (Lot number: FK5618) at the age of 7 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: XYZAL. Past drug history included: No, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK5127, Location of injection: Arm Left, Vaccine Administration Time: 07:00 PM, Route of Administration: Intramuscular), administration date: 09Nov2021, for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 01Dec2021 13:30, outcome "recovered" (Dec2021), described as "tired"; HEADACHE (non-serious) with onset 01Dec2021 13:30, outcome "recovered" (Dec2021), described as "Approximately 18.5 hrs after the 2nd vaccination, the patient had a headache". Therapeutic measures were taken as a result of fatigue, headache.  Additional information: Patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination: Xyzal day of and Allergy shot 7 days prior. 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Pain
Clinical narrative: fatigue; general aching; dose received: 3; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the parent.  A 29-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 01:00 (Batch/Lot number: unknown) at the age of 29 years as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 07Apr2021, when the patient was 28 years old, for Covid-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: Mar2021, when the patient was 28 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 01:00, outcome "unknown", described as "dose received: 3"; FATIGUE (non-serious) with onset 02Dec2021 17:00, outcome "recovering", described as "fatigue"; PAIN (non-serious) with onset 02Dec2021 17:00, outcome "recovering", described as "general aching". Therapeutic measures were not taken as a result of fatigue, pain.  Additional information: The patient did not receive any other vaccine in four weeks of covid-19 vaccine. The patient was neither diagnosed with Covid prior vaccination nor tested for Covid post vaccination. It was unknown whether patient had any known allergies.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hypoaesthesia, Immunisation, Pain
Clinical narrative: tingly sensation on left arm; some sort of numbness at night; really bad head ache and body ache; really bad head ache and body ache; continue with chills; got covid booster shot; 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 male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm, administration date 02Dec2021 10:00 (Lot number: FJ8762) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation in Pharmacy/drug store. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, Anatomical site of injection: Arm, Route of administration: Intramuscular, Batch/Lot number: #EL3247), administration date: 10Mar2021, when the patient was 38 years old, for Covid-19 immunization; Bnt162b2 (2nd dose, Anatomical site of injection: Arm, Route of administration: Intramuscular, Batch/Lot number: #EL3247), administration date: 31Mar2021, when the patient was 38 years old, for Covid-19 immunization, reaction(s): "Sore muscles/ Muscle aches", "Chills", "Headache", "Little bit of fever". The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 10:00, outcome "unknown", described as "got covid booster shot"; PARAESTHESIA (non-serious), outcome "unknown", described as "tingly sensation on left arm"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "some sort of numbness at night"; HEADACHE (non-serious), PAIN (non-serious), outcome "unknown" and all described as "really bad head ache and body ache"; CHILLS (non-serious), outcome "unknown", described as "continue with chills". Additional information: The patient received booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious covid-19 complications). Patient did not receive any prior vaccinations within 4 weeks. There was no relevant tests and no specific relevant test for thromboembolic events with thrombocytopenia.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingly sensation on left arm; some sort of numbness at night; really bad head ache and body ache; really bad head ache and body ache; continue with chills; got covid booster shot; 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 male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm, administration date 02Dec2021 10:00 (Lot number: FJ8762) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation in Pharmacy/drug store. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, Anatomical site of injection: Arm, Route of administration: Intramuscular, Batch/Lot number: #EL3247), administration date: 10Mar2021, when the patient was 38 years old, for Covid-19 immunization; Bnt162b2 (2nd dose, Anatomical site of injection: Arm, Route of administration: Intramuscular, Batch/Lot number: #EL3247), administration date: 31Mar2021, when the patient was 38 years old, for Covid-19 immunization, reaction(s): "Sore muscles/ Muscle aches", "Chills", "Headache", "Little bit of fever". The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 10:00, outcome "unknown", described as "got covid booster shot"; PARAESTHESIA (non-serious), outcome "unknown", described as "tingly sensation on left arm"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "some sort of numbness at night"; HEADACHE (non-serious), PAIN (non-serious), outcome "unknown" and all described as "really bad head ache and body ache"; CHILLS (non-serious), outcome "unknown", described as "continue with chills". Additional information: The patient received booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious covid-19 complications). Patient did not receive any prior vaccinations within 4 weeks. There was no relevant tests and no specific relevant test for thromboembolic events with thrombocytopenia.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate abnormal, Immunisation, Vision blurred
Clinical narrative: Blurred vision (particularly on left side); noticeable change in heart beat in response to excitement about 6 hours post vaccine; dose number: 3 (Booster); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Dec2021 14:45 (Lot number: Ff2587) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "allergies: Some pet dander allergy" (unspecified if ongoing), notes: Known allergies: Some pet dander allergy. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0173, Location of injection: Arm Left), administration date: 09May2021, when the patient was 33 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Er8735, Location of injection: Arm Left), administration date: 18Apr2021, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021 14:45, outcome "unknown", described as "dose number: 3 (Booster)"; VISION BLURRED (non-serious) with onset 07Dec2021 20:45, outcome "recovered" (2021), described as "Blurred vision (particularly on left side)"; HEART RATE ABNORMAL (non-serious) with onset 07Dec2021 20:45, outcome "recovered" (2021), described as "noticeable change in heart beat in response to excitement about 6 hours post vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vision blurred, heart rate abnormal. Additional information: known allergies: Some pet dander allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has not been tested for COVID-19. Blurred vision (particularly on left side) and noticeable change in heart beat in response to excitement about 6 hours post vaccine. AE resulted in any of the seriousness conditions. Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Immunisation, Musculoskeletal pain, Neck pain
Clinical narrative: booster dose; has pain in his shoulder blade and in his neck a little bit; has pain in his shoulder blade and in his neck a little bit; Caller added that he has loose bowel which is not totally diarrhea but it's close.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from information team. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm (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 (1st dose), for COVID-19 immunization; Bnt162b2 (2nd dose, nausea on the second day), for Covid-19 immunization, reaction(s): "I had some big time nausea with that second shot on the second day"; Bnt162b2 (2nd dose), for Covid-19 immunization, reaction(s): "general malaise", "some fever". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster dose"; NECK PAIN (non-serious), MUSCULOSKELETAL PAIN (non-serious), outcome "recovering" and all described as "has pain in his shoulder blade and in his neck a little bit"; DIARRHOEA (non-serious), outcome "unknown", described as "Caller added that he has loose bowel which is not totally diarrhea but it's close."  Additional Information: Patient stated that he got mobility and can swing his arm like throwing a baseball but it does hurt as he got the shot in his arm.   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: Immunisation, Lymphadenopathy
Clinical narrative: enlarged lymph node in the left armpit; dose number=3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 06Dec2021 10:00 (Lot number: FH8027) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Comirnaty (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 09Mar2021, when the patient was 51 years old, for COVID-19 Immunization; Comirnaty (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM, Route of Administration: Intramuscular), administration date: 30Mar2021, when the patient was 51 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021 10:00, outcome "unknown", described as "dose number=3"; LYMPHADENOPATHY (non-serious) with onset 07Dec2021 07:00, outcome "not recovered", described as "enlarged lymph node in the left armpit". Therapeutic measures were not taken as a result of lymphadenopathy. Additional information: The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the 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.  Follow-Up (17Dec2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Immunisation
Clinical narrative: Booster; patient reports feeling "sick" for a few days after receiving covid; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 83 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Urinary tract infection" (unspecified if ongoing), notes: Patient notes in the past she has had issues with urinary tract infections; "left knee issue but states it has now moved to the right knee" (unspecified if ongoing), notes: patient notes pre-existing left knee issue but states it has now moved to the right knee; "right knee required surgery", start date: Oct2020 (unspecified if ongoing), notes: right knee required surgery in Oct2020; "Low blood pressure" (unspecified if ongoing), notes: Low BP (pre-existing history of syncope and low blood pressures) and hurt her back; "Syncope" (unspecified if ongoing), notes: Low BP (pre-existing history of syncope and low blood pressures) and hurt her back; "hurt her back" (unspecified if ongoing), notes: Low BP (pre-existing history of syncope and low blood pressures) and hurt her back. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation; PROLIA taken for immunisation. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER: UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, MANUFACTURER: UNKNOWN), for covid 19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; ILLNESS (non-serious), outcome "recovered", described as "patient reports feeling "sick" for a few days after receiving Covid".  Additional information: Other Relevant History, Including Preexisting Medical Conditions: Patient reports she passed out in md office last month due to low BP (pre-existing history of syncope and low blood pressures) and hurt her back and was told she had a ruptured disc, patient was discharged from hospital same day. No further details provided.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Fatigue, Immunisation, Vaccination site pain
Clinical narrative: Injection site pain migrating to underarm area; Injection site pain; fatigue; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 06Dec2021 19:15 (Batch/Lot number: unknown) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ROSUVASTATIN; FISH OIL; EMERGEN-C. Vaccination history included: Comirnaty (Dose Number: 2, Batch/Lot No: P22089500682, Location of injection: Arm Left, Vaccine Administration Time: 08:30 AM, Route of Administration: Intramuscular), administration date: 02Oct2020, when the patient was 46 years old, for COVID-19 Immunization; Comirnaty (Dose Number: 1, Batch/Lot No: P22089500682, Location of injection: Arm Left, Vaccine Administration Time: 08:30 AM, Route of Administration: Intramuscular), administration date: 11Sep2020, when the patient was 46 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021 19:15, outcome "unknown", described as "booster"; FATIGUE (non-serious) with onset 07Dec2021, outcome "recovering", described as "fatigue"; VACCINATION SITE PAIN (non-serious) with onset 07Dec2021 07:00, outcome "recovering", described as "Injection site pain"; AXILLARY PAIN (non-serious) with onset 08Dec2021, outcome "recovering", described as "Injection site pain migrating to underarm area". Therapeutic measures were not taken as a result of fatigue, vaccination site pain, axillary pain.  Additional information: Patient not had other vaccine in four weeks. He did not have covid prior to vaccination, and was not tested for covid since vaccination. Patient had no known allergies.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Injection site pain migrating to underarm area; Injection site pain; fatigue; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 06Dec2021 19:15 (Batch/Lot number: unknown) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ROSUVASTATIN; FISH OIL; EMERGEN-C. Vaccination history included: Comirnaty (Dose Number: 2, Batch/Lot No: P22089500682, Location of injection: Arm Left, Vaccine Administration Time: 08:30 AM, Route of Administration: Intramuscular), administration date: 02Oct2020, when the patient was 46 years old, for COVID-19 Immunization; Comirnaty (Dose Number: 1, Batch/Lot No: P22089500682, Location of injection: Arm Left, Vaccine Administration Time: 08:30 AM, Route of Administration: Intramuscular), administration date: 11Sep2020, when the patient was 46 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021 19:15, outcome "unknown", described as "booster"; FATIGUE (non-serious) with onset 07Dec2021, outcome "recovering", described as "fatigue"; VACCINATION SITE PAIN (non-serious) with onset 07Dec2021 07:00, outcome "recovering", described as "Injection site pain"; AXILLARY PAIN (non-serious) with onset 08Dec2021, outcome "recovering", described as "Injection site pain migrating to underarm area". Therapeutic measures were not taken as a result of fatigue, vaccination site pain, axillary pain.  Additional information: Patient not had other vaccine in four weeks. He did not have covid prior to vaccination, and was not tested for covid since vaccination. Patient had no known allergies.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Rash, Urticaria
Clinical narrative: I am experiencing hives and rashes on my legs and arms; I am experiencing hives and rashes on my legs and arms; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 22:00 (Lot number: 3302180) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Fw0150, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 07Apr2021, when the patient was 33 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: En6206, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 12Mar2021, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021 22:00, outcome "unknown", described as "booster"; RASH (non-serious), URTICARIA (non-serious) all with onset 07Dec2021 20:00, outcome "not recovered" and all described as "I am experiencing hives and rashes on my legs and arms".  Additional information: Patient did not had other vaccine in four-weeks. Patient had no COVID prior vaccination. Patient was not tested COVID post vaccination. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Immunisation, Rash
Clinical narrative: booster; Rash on neck - warm, but not itchy. Resolved after Benadryl.; Rash on neck - warm, but not itchy. Resolved after Benadryl.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 53 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1), for COVID-19 Immunization; Bnt162b2 (DOSE: 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; RASH (non-serious), FEELING HOT (non-serious), outcome "recovered" (2021) and all described as "Rash on neck - warm, but not itchy. Resolved after Benadryl.". Therapeutic measures were taken as a result of rash, feeling hot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Immunisation
Clinical narrative: Booster; she developed an inflammation under the left armpit (same arm where she received the vaccine). I got a ball she indicates that she has pain; she developed an inflammation under the left armpit (same arm where she received the vaccine). I got a ball she indicates that she has pain; 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 female patient received bnt162b2 (COMIRNATY), administration date 08Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021, outcome "unknown", described as "Booster"; AXILLARY PAIN (non-serious), AXILLARY MASS (non-serious) all with onset 2021, outcome "unknown" and all described as "she developed an inflammation under the left armpit (same arm where she received the vaccine). I got a ball she indicates that she has pain".  Additional information: It was reported that, the caller was a consumer. She stated that, the day after receiving the Covid 19 Pfizer vaccine Booster, she developed an inflammation under the left armpit (same arm where she received the vaccine). Stated that, she got a ball she indicated that she has pain, the pain was not excessive but it hurts sometimes. Enquired that, was this normal. Should the patient call her doctor or not. Stated that, 3rd dose was administered on Wednesday, 08Dec2021. Stated that, the patient was going to wait and if not, she will talk to the doctor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Bed rest, Fatigue, Illness, Immunisation, Influenza like illness
Clinical narrative: ill the next day; was in bed; had flu like symptoms 12-36 hours after booster shot; I started feeling very tired; booster; 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), intramuscular, administered in arm left, administration date 08Dec2021 (Lot number: FF8841) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOXYL; VITAMIN D [COLECALCIFEROL]. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3248, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 23Mar2021, when the patient was 43 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3248, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 03Mar2021, when the patient was 43 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021, outcome "unknown", described as "booster"; INFLUENZA LIKE ILLNESS (non-serious) with onset 08Dec2021 21:00, outcome "recovered" (2021), described as "had flu like symptoms 12-36 hours after booster shot"; FATIGUE (non-serious) with onset 08Dec2021, outcome "unknown", described as "I started feeling very tired"; ILLNESS (non-serious) with onset 09Dec2021, outcome "unknown", described as "ill the next day"; BED REST (non-serious) with onset 09Dec2021, outcome "unknown", described as "was in bed". Therapeutic measures were taken as a result of influenza like illness.  Additional information: The patient was not pregnant at the time of vaccination. The patient had no known allergies. 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, has the patient been tested for COVID-19 was reported as no. It was reported that, the patient got the booster (which was on 08Dec2021). Stated that, she started feeling very tired with flu-like symptoms that evening and was in bed/ill the next day. Stated that, the following day, she reported it. Stated that, this is why there was a delay. Stated that, she wasn't in a position to report her symptoms as she was having them. Stated that, the patient was having flu-like symptoms and was in a haze and did not report until after the symptoms had passed. The reporter seriousness for the events was reported as non-serious. Treatment medication included Advil taken for the event influenza like illness.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Pyrexia
Clinical narrative: Symptoms of headache like feeling her head is exploding; Nausea; Chills; Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 27 year-old female patient received bnt162b2 (COMIRNATY), administration date 06Dec2021 (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 (DOSE 1), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 09Dec2021, outcome "recovered" (12Dec2021), described as "Symptoms of headache like feeling her head is exploding"; NAUSEA (non-serious) with onset 09Dec2021, outcome "recovered" (12Dec2021), described as "Nausea"; CHILLS (non-serious) with onset 09Dec2021, outcome "recovered" (12Dec2021), described as "Chills"; PYREXIA (non-serious) with onset 09Dec2021, outcome "recovered" (12Dec2021), described as "Fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated that he was reporting for his wife, she got the Pfizer vaccine the second dose on 06Dec and three days later she started getting symptoms of headache like feeling her head is exploding, nausea, chills and fever and today is 12Dec and the symptoms have not resided."  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: losing hair/also happened to other people and to the patient; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "losing hair/also happened to other people and to the patient".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Pain in extremity
Clinical narrative: pain in the arm after the shot. He got it with first shot too; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Feb2021 (Batch/Lot number: unknown) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: Patient History: No. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "pain in the arm after the shot. He got it with first shot too". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Both he and wife at 72 and 73, take no medications. They just take vitamins.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: arthritis got worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a sponsored program. The reporter is the patient.  A 61 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing), notes: stopped taking the Hydroxychloroquine, which she takes for her arthritis 3 weeks before. The patient's concomitant medications were not reported. The following information was reported: ARTHRITIS (non-serious), outcome "unknown", described as "arthritis got worse".  Additional Information: The patient stated that she got her first and second vaccine doses and she "doctored herself" and stopped taking the Hydroxychloroquine, which she takes for her arthritis, 3 weeks before and 3 weeks after the vaccine doses and her arthritis got worse. The patient even stopped taking Hydroxychloroquine prior and after her initial covid vaccine series doses for fear it would interfere with the vaccine effectiveness. Also now taking Valacyclovir.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, Immunisation, Nausea, Pain in extremity, Stress
Clinical narrative: booster; under a lot of stress right now; nausea; soreness in her left arm; 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 70 year-old female patient received bnt162b2 (BNT162B2), administration date 11Dec2021 (Lot number: 330308D) as dose 3 (booster) , single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose:1, Lot EL9265), administration date: 20Feb2021, when the patient was 70 years old, for Covid-19 Immunization; Bnt162b2 (Dose:2, Lot EL9264), administration date: 13Mar2021, when the patient was 70 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; PAIN IN EXTREMITY (non-serious) with onset 12Dec2021, outcome "recovering", described as "soreness in her left arm"; NAUSEA (non-serious) with onset 13Dec2021, outcome "not recovered", described as "nausea"; STRESS (non-serious), outcome "unknown", described as "under a lot of stress right now". Relevant laboratory tests and procedures are available in the appropriate section.   Additional information: Time the Vaccination between 11:45-12:00 as patient reported. Additional vaccines administered on same date of the Pfizer suspect: None. Prior vaccinations (within 4 weeks): None. AE(s) following prior vaccinations: None. Event nausea was reported as worsened. She was having no other respiratory signs and her energy level has not been impacted really. She was not going to worry about it unless she gets a lot sicker. AE(s) did not require a visit to emergency room and physician office. Investigation assessment: No  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fibromyalgia, Immunisation, Influenza like illness, Pain
Clinical narrative: Booster; Body ache and pain similar to the flu or even fibromyalgia; Body ache and pain similar to the flu or even fibromyalgia; Body ache and pain similar to the flu or even fibromyalgia; Low grade temperature 99.9. 100; This is a spontaneous report received from a contactable Consumer or other non HCP. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; FIBROMYALGIA (non-serious), PAIN (non-serious), INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered" and all described as "Body ache and pain similar to the flu or even fibromyalgia"; PYREXIA (non-serious), outcome "recovered", described as "Low grade temperature 99.9. 100". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Body ache and pain similar to the flu or even fibromyalgia. Low grade temperature 99.9. 100 This lasted for 3 days.Event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Booster; Body ache and pain similar to the flu or even fibromyalgia; Body ache and pain similar to the flu or even fibromyalgia; Body ache and pain similar to the flu or even fibromyalgia; Low grade temperature 99.9. 100; This is a spontaneous report received from a contactable Consumer or other non HCP. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; FIBROMYALGIA (non-serious), PAIN (non-serious), INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered" and all described as "Body ache and pain similar to the flu or even fibromyalgia"; PYREXIA (non-serious), outcome "recovered", described as "Low grade temperature 99.9. 100". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Body ache and pain similar to the flu or even fibromyalgia. Low grade temperature 99.9. 100 This lasted for 3 days.Event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation, Pain in extremity
Clinical narrative: Left arm pain; Chills; Fatigue; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Dec2021 10:30 (Lot number: FJ8762) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Atrial fibrillation" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EO6955, Location of injection: Left arm, Vaccine Administration Time: 04:00 PM, Route of Administration: Intramuscular), administration date: 14Apr2021, when the patient was 51 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Left arm, Vaccine Administration Time: 11:00 AM, Route of Administration: Intramuscular), administration date: 22Mar2021, when the patient was 51 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 10:30, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (non-serious) with onset 09Dec2021 22:00, outcome "recovered" (Dec2021), described as "Left arm pain"; CHILLS (non-serious) with onset 09Dec2021 22:00, outcome "recovered" (Dec2021), described as "Chills"; FATIGUE (non-serious) with onset 09Dec2021 22:00, outcome "recovered" (Dec2021), described as "Fatigue". Therapeutic measures were taken as a result of pain in extremity, chills, fatigue.  Additional information: patient did not receive any other vaccine in four weeks. Patient received treatment for the events with Tylenol. Patient was not diagnosed with covid prior to vaccination. since vaccination patient was not tested for covid.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dysuria, Feeling cold, Immunisation, Irritability
Clinical narrative: strong chills; shaking; cold; feverish irritated; hurt to pee; feverish irritated; dose received 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 57 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Dec2021 10:00 (Lot number: FL3197) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: GABAPENTIN; TIZANIDINE; ZOMIG; EXCEDRIN ASPIRIN FREE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955), administration date: 12Apr2021, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955), administration date: 22Mar2021, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 10:00, outcome "unknown", described as "dose received 3"; CHILLS (non-serious) with onset 17Dec2021 01:00, outcome "recovered" (Dec2021), described as "strong chills"; TREMOR (non-serious) with onset 17Dec2021 01:00, outcome "recovered" (Dec2021), described as "shaking"; FEELING COLD (non-serious) with onset 17Dec2021 01:00, outcome "recovered" (Dec2021), described as "cold"; PYREXIA (non-serious), IRRITABILITY (non-serious) all with onset 17Dec2021 01:00, outcome "recovered" (Dec2021) and all described as "feverish irritated"; DYSURIA (non-serious) with onset 17Dec2021 01:00, outcome "recovered" (Dec2021), described as "hurt to pee". Therapeutic measures were not taken as a result of chills, tremor, feeling cold, pyrexia, dysuria, irritability.  Additional information: 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: M
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: strong chills; shaking; cold; feverish irritated; hurt to pee; feverish irritated; dose received 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 57 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Dec2021 10:00 (Lot number: FL3197) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: GABAPENTIN; TIZANIDINE; ZOMIG; EXCEDRIN ASPIRIN FREE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955), administration date: 12Apr2021, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955), administration date: 22Mar2021, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 10:00, outcome "unknown", described as "dose received 3"; CHILLS (non-serious) with onset 17Dec2021 01:00, outcome "recovered" (Dec2021), described as "strong chills"; TREMOR (non-serious) with onset 17Dec2021 01:00, outcome "recovered" (Dec2021), described as "shaking"; FEELING COLD (non-serious) with onset 17Dec2021 01:00, outcome "recovered" (Dec2021), described as "cold"; PYREXIA (non-serious), IRRITABILITY (non-serious) all with onset 17Dec2021 01:00, outcome "recovered" (Dec2021) and all described as "feverish irritated"; DYSURIA (non-serious) with onset 17Dec2021 01:00, outcome "recovered" (Dec2021), described as "hurt to pee". Therapeutic measures were not taken as a result of chills, tremor, feeling cold, pyrexia, dysuria, irritability.  Additional information: 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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Insomnia, Pain
Clinical narrative: Felt intoxicated; Severe whole body pain; Chills; Headache; Unable to sleep; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient received bnt162b2 (BNT162B2) (Lot number: ew0153) as dose 1, single and (Lot number: ew0176) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SAVELLA; LEXAPRO; PROPANOLOL [PROPRANOLOL]; JUNEL. The following information was reported: FEELING ABNORMAL (non-serious) with onset 17Dec2021 21:00, outcome "not recovered", described as "Felt intoxicated"; PAIN (non-serious) with onset 17Dec2021 21:00, outcome "not recovered", described as "Severe whole body pain"; CHILLS (non-serious) with onset 17Dec2021 21:00, outcome "not recovered", described as "Chills"; HEADACHE (non-serious) with onset 17Dec2021 21:00, outcome "not recovered", described as "Headache"; INSOMNIA (non-serious) with onset 17Dec2021 21:00, outcome "not recovered", described as "Unable to sleep". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of feeling abnormal, pain, chills, headache, insomnia. The patient had not taken other vaccine in 4 weeks. The patient received dose 3 (Lot number: fd0809) on 18Dec2021 12:00 pm.  No follow-up attempts possible. No further information is expected.