chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: Pain is in the joint of his shoulder and arm; Pain is in the joint of his shoulder and arm; Pain in his neck; 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 75-years-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 75 years as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "spine surgery" (unspecified if ongoing), notes: Caller reported he had spine surgery. The patient's concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious), outcome "not recovered" and all described as "Pain is in the joint of his shoulder and arm"; NECK PAIN (non-serious), outcome "not recovered", described as "Pain in his neck". The events "pain is in the joint of his shoulder and arm", "pain is in the joint of his shoulder and arm" and "pain in his neck" were evaluated at the physician office visit.  Additional Information: Caller with dob 23Dec1945, stated he has had all 3 doses of the PFIZER COVID-19 vaccine. Caller did report pain in his neck and shoulder. Caller reported he had spine surgery. Caller reported the pain is in the joint of his shoulder and arm and has been going on for 8 months. Caller stated he took the booster dose and it got worse again but now it was better again, but it never goes away. Caller stated he sees a therapist. Caller stated he told the therapist at the beginning of therapy his pain was a 10. Caller stated his last appointment was today and his pain is now 1-2. Caller wanted to know if other people have reported pain in the shoulder after the vaccines. Caller asked how long does it last and is it going to go away. Caller asked could it be nerve issue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick from work; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An adult patient received bnt162b2 (BNT162B2) (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 Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick from work".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Daydreaming, Dizziness, Headache, SARS-CoV-2 test
Clinical narrative: terrible headache; dreaming or recalling a dream while standing up awake; feelng faint out of the blue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administration date 01Dec2021 (Lot number: 4) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 01Dec2021, outcome "recovered with sequelae", described as "terrible headache"; DAYDREAMING (non-serious) with onset 01Dec2021, outcome "recovered with sequelae", described as "dreaming or recalling a dream while standing up awake"; DIZZINESS (non-serious) with onset 01Dec2021, outcome "recovered with sequelae", described as "feelng faint out of the blue". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible. No further information is expected.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19.
Age: 50.0
Sex: F
Vaccine: COVID19, FLUX, VARZOS
Symptoms: Parosmia
Clinical narrative: 1 week later developed strange scent in nose, smells like stale cigarette smoke. Have had this for a couple weeks now.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2, solution for injection), administered in arm left, administration date 17Nov2021 16:30 (Batch/Lot number: unknown) at the age of 50 years as dose 1, single for covid-19 immunisation; influenza vaccine (INFLUENZA), administered in arm, administration date 17Nov2021 (Batch/Lot number: unknown) as dose 1, single for immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), administered in arm, administration date 17Nov2021 (Batch/Lot number: unknown) as dose 1, single for immunisation. The patient had no relevant medical history. Concomitant medication(s) included: METFORMIN; TERBINAFINE; PHENTERMINE; TRAZODONE. The following information was reported: PAROSMIA (non-serious) with onset 26Nov2021, outcome "not recovered", described as "1 week later developed strange scent in nose, smells like stale cigarette smoke. Have had this for a couple weeks now.". Therapeutic measures were not taken as a result of parosmia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: sore arm at injection site; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 10 year-old male patient received bnt162b2 (COMIRNATY), administered in arm (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: No medications or underlying conditions. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore arm at injection site"; FATIGUE (non-serious), outcome "unknown", described as "fatigue".  Additional information: It was reported, 12 hours following his second vaccine dose of comirnaty (5-11 yo), reported sore arm at injection site and fatigue. Event 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.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: sore arm at injection site; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 10 year-old male patient received bnt162b2 (COMIRNATY), administered in arm (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: No medications or underlying conditions. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore arm at injection site"; FATIGUE (non-serious), outcome "unknown", described as "fatigue".  Additional information: It was reported, 12 hours following his second vaccine dose of comirnaty (5-11 yo), reported sore arm at injection site and fatigue. Event 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Alopecia, Amnesia, Anosmia, Lethargy
Clinical narrative: Lethargic; sore arm; fever; loss of taste; loss of smell; loss of hair; loss of memory; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Feb2021 14:00 (Batch/Lot number: unknown) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing). Concomitant medication(s) included: TRESIBA; VERAPAMIL. Past drug history included: Allergy: amlodopine, reaction(s): "Allergy: Amlodopine"; Allergy: lisinopril, reaction(s): "Allergy: lisinopril". The following information was reported: LETHARGY (non-serious) with onset 20Feb2021 04:00, outcome "not recovered", described as "Lethargic"; PAIN IN EXTREMITY (non-serious) with onset 20Feb2021 04:00, outcome "not recovered", described as "sore arm"; PYREXIA (non-serious) with onset 20Feb2021 04:00, outcome "not recovered", described as "fever"; AGEUSIA (non-serious) with onset 20Feb2021 04:00, outcome "not recovered", described as "loss of taste"; ANOSMIA (non-serious) with onset 20Feb2021 04:00, outcome "not recovered", described as "loss of smell"; ALOPECIA (non-serious) with onset 20Feb2021 04:00, outcome "not recovered", described as "loss of hair"; AMNESIA (non-serious) with onset 20Feb2021 04:00, outcome "not recovered", described as "loss of memory". Therapeutic measures were not taken as a result of lethargy, pain in extremity, pyrexia, ageusia, anosmia, alopecia, amnesia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Lethargic; sore arm; fever; loss of taste; loss of smell; loss of hair; loss of memory; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Feb2021 14:00 (Batch/Lot number: unknown) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing). Concomitant medication(s) included: TRESIBA; VERAPAMIL. Past drug history included: Allergy: amlodopine, reaction(s): "Allergy: Amlodopine"; Allergy: lisinopril, reaction(s): "Allergy: lisinopril". The following information was reported: LETHARGY (non-serious) with onset 20Feb2021 04:00, outcome "not recovered", described as "Lethargic"; PAIN IN EXTREMITY (non-serious) with onset 20Feb2021 04:00, outcome "not recovered", described as "sore arm"; PYREXIA (non-serious) with onset 20Feb2021 04:00, outcome "not recovered", described as "fever"; AGEUSIA (non-serious) with onset 20Feb2021 04:00, outcome "not recovered", described as "loss of taste"; ANOSMIA (non-serious) with onset 20Feb2021 04:00, outcome "not recovered", described as "loss of smell"; ALOPECIA (non-serious) with onset 20Feb2021 04:00, outcome "not recovered", described as "loss of hair"; AMNESIA (non-serious) with onset 20Feb2021 04:00, outcome "not recovered", described as "loss of memory". Therapeutic measures were not taken as a result of lethargy, pain in extremity, pyrexia, ageusia, anosmia, alopecia, amnesia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred, Visual impairment
Clinical narrative: sudden onset blurry and multiple vision both eyes; sudden onset blurry and multiple vision both eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6 year-old male patient received bnt162b2 (BNT162B2), administration date 04Dec2021 16:00 (Lot number: FK5618) at the age of 6 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU taken for immunisation, administration date 22Nov2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK5127, Vaccine Administration Time: 03:00 PM), administration date: 13Nov2021, when the patient was 6 years old, for COVID-19 immunization. The following information was reported: VISION BLURRED (non-serious), VISUAL IMPAIRMENT (non-serious) all with onset 06Dec2021 12:00, outcome "not recovered" and all described as "sudden onset blurry and multiple vision both eyes". The event "sudden onset blurry and multiple vision both eyes" and "sudden onset blurry and multiple vision both eyes" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of vision blurred, visual impairment.  Additional Information: Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient not been tested for COVID-19. There were no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: very mild soreness at infection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single and administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "molds allergy" (unspecified if ongoing); "dust allergy" (unspecified if ongoing); "pollen allergy" (unspecified if ongoing); "some foods allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "very mild soreness at infection site".  Additional information: The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Nausea, Vomiting
Clinical narrative: Weakness; Vomiting; Nausea; Loss of appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 9 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 14:30 (Lot number: FK5618) at the age of 9 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Failure to thrive" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: ASTHENIA (non-serious) with onset 04Dec2021 14:00, outcome "recovered" (Dec2021), described as "Weakness"; VOMITING (non-serious) with onset 04Dec2021 14:00, outcome "recovered" (Dec2021), described as "Vomiting"; NAUSEA (non-serious) with onset 04Dec2021 14:00, outcome "recovered" (Dec2021), described as "Nausea"; DECREASED APPETITE (non-serious) with onset 04Dec2021 14:00, outcome "recovered" (Dec2021), described as "Loss of appetite". Therapeutic measures were not taken as a result of asthenia, vomiting, nausea, decreased appetite.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye inflammation
Clinical narrative: Developed some severe inflammation in her eye; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (141010). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (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: EYE INFLAMMATION (non-serious) with onset 2021, outcome "not recovered", described as "Developed some severe inflammation in her eye".  Additional information: Patient reports that she held a dose of her Xeljanz 5mg for 3 days following the COVID vaccine   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Menstrual disorder
Clinical narrative: prev dose administration date=24Feb2021/prev dose administration date=03Mar2021; got my period 2 days after shot which is one week early. i have tracked my period for the last year and i have consistently gotten it every 28 days, except this month and the months of Mar and Apr; 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), administration date 03Mar2021 (Lot number: pfizerer8730) at the age of 34 years as dose 2, single and administration date 24Feb2021 (Lot number: pfizerer6198) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 03Mar2021, outcome "unknown", described as "prev dose administration date=24Feb2021/prev dose administration date=03Mar2021"; MENSTRUAL DISORDER (non-serious) with onset 2021, outcome "unknown", described as "got my period 2 days after shot which is one week early. i have tracked my period for the last year and i have consistently gotten it every 28 days, except this month and the months of Mar and Apr". Therapeutic measures were not taken as a result of menstrual disorder. Additional information: Patient received dose 3 on 06Dec2021 05:15 PM (Lot number: fj1620). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications received within 2 weeks of vaccination was birth control pill. Patient got her period 2 days after shot which was one week early. She has tracked her period for the last year and have consistently gotten it every 28 days, except this month and the months of Mar and Apr (which was around the time of her first and second shot). Adverse event start date and time was reported as 08Dec2021 06:00 PM. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Device Date: 08Dec2021  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Body temperature, Illness, Off label use, Product use issue, Pyrexia
Clinical narrative: the next day after his vaccine had a 102 degree fever; Got so sick; He got his along with the flu shot; He got his along with the flu shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; influenza vaccine (FLU) (Batch/Lot number: unknown) as dose number unknown, single. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "the next day after his vaccine had a 102 degree fever"; ILLNESS (non-serious), outcome "unknown", described as "Got so sick"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "He got his along with the flu shot". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reporter stated that her son in law, the next day after his vaccine had a 102 degree fever. Stated that he got his along with the flu shot, and he got so sick. He lives in with her daughter. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: felt a little tired; felt drowsy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (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: FATIGUE (non-serious), outcome "unknown", described as "felt a little tired"; SOMNOLENCE (non-serious), outcome "unknown", described as "felt drowsy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Pain
Clinical narrative: Slight headache; Body aches; Weakness; Fatigue; 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 male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Dec2021 16:30 (Lot number: 33130BA) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pre-diabetes" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 08Dec2021 14:00, outcome "not recovered", described as "Slight headache"; PAIN (non-serious) with onset 08Dec2021 14:00, outcome "not recovered", described as "Body aches"; ASTHENIA (non-serious) with onset 08Dec2021 14:00, outcome "not recovered", described as "Weakness"; FATIGUE (non-serious) with onset 08Dec2021 14:00, outcome "not recovered", described as "Fatigue". Therapeutic measures were not taken as a result of headache, pain, asthenia, fatigue.  Additional information: No vaccine in four weeks. Mens one-a-day multivitamin in two weeks. No covid prior vaccination and not tested post vaccination. No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: bad migraine; subtle headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Nov2021 (Lot number: FF2593) at the age of 29 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII, start date: 25Oct2021, stop date: 25Oct2021. Past drug history included: No. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FF2593, Location of injection: Arm Left), administration date: 25Oct2021, when the patient was 29 years old, for COVID-19 Immunization. The following information was reported: MIGRAINE (non-serious) with onset 20Nov2021, outcome "recovered with sequelae", described as "bad migraine"; HEADACHE (non-serious) with onset 20Nov2021, outcome "recovered with sequelae", described as "subtle headache". The events "bad migraine" and "subtle headache" were evaluated at the physician office visit. Therapeutic measures were taken as a result of migraine, headache.  Additional information: other vaccine 4weeks product was Flu Shot. No other medications in two weeks. It was reported  4 days after receiving second shot, experience a very bad migraine, which lasted for 3 days before subsiding to just a subtle headache. Tylenol was taken to alleviate migraine/headache, at the recommendation of doctor office. Headache still comes and goes periodically, now 3 weeks since receiving that second Pfizer shot, taking Tylenol whenever he experience that. Unsure how long symptoms will continue. AE resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment Tylenol (650 mg) for AE. No covid prior vaccination. covid was not tested post vaccination. No known allergies  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pityriasis rosea, SARS-CoV-2 test, Skin disorder
Clinical narrative: Development of Pityriasis Rosea 6 weeks after receiving second vaccine; skin issue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 14Jan2021 (Lot number: EL3247) at the age of 53 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ALEVE. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex". Vaccination history included: Bnt162b2 (Previous Dose Product: COVID-19, Previous Dose brand = Pfizer BionTech, Dose Number: 1, Batch/Lot No: EK5730, Vaccine Location : Arm Right), administration date: 18Dec2020, when the patient was 53 years old, for Covid-19 immunization, reaction(s): "Covid". The following information was reported: PITYRIASIS ROSEA (non-serious) with onset 01Mar2021, outcome "not recovered", described as "Development of Pityriasis Rosea 6 weeks after receiving second vaccine"; SKIN DISORDER (non-serious) with onset 01Mar2021, outcome "not recovered", described as "skin issue". The events "development of pityriasis rosea 6 weeks after receiving second vaccine" and "skin issue" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Dec2020) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of pityriasis rosea, skin disorder.  Additional information: Patient did not receive other vaccine in four weeks. Patient reported no covid prior vaccination. Patient reported covid tested post vaccination. Steroids. Antibiotics, and steroid creams were taken as treatment received for the events.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Dry eye, Eczema, Eczema eyelids
Clinical narrative: Dryness / eczema around eyes; eczema around eyes; eczema around eyes; 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 (BNT162B2), intramuscular, administered in arm left, administration date 29Nov2021 12:45 (Lot number: FH8028) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administered in arm left, administration date 29Nov2021 (Batch/Lot number: unknown) as dose 1, single. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 24Feb2021, when the patient was 38 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 03Feb2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: DRY EYE (non-serious) with onset 08Dec2021, outcome "recovering", described as "Dryness / eczema around eyes"; ECZEMA (non-serious), ECZEMA EYELIDS (non-serious) all with onset 08Dec2021, outcome "recovering" and all described as "eczema around eyes". Therapeutic measures were not taken as a result of dry eye, eczema, eczema eyelids.  Additional information: No other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Feeling abnormal, Heart rate, Heart rate increased, Hyperhidrosis
Clinical narrative: HR 140s; diaphoretic; feeling "weird" in chest; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the parent.  A 9 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Nov2021 18:30 (Lot number: FL0007) at the age of 9 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU, administration date 2021. The following information was reported: HEART RATE INCREASED (non-serious) with onset Nov2021, outcome "recovering", described as "HR 140s"; HYPERHIDROSIS (non-serious) with onset Nov2021, outcome "recovering", described as "diaphoretic"; FEELING ABNORMAL (non-serious) with onset Nov2021, outcome "recovering", described as "feeling "weird" in chest". The events "hr 140s", "diaphoretic" and "feeling "weird" in chest" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, hyperhidrosis, feeling abnormal.  Additional info: Prior to vaccination, the patient was  not diagnosed with COVID-19. No known allergies. No other medications received within 2 weeks of vaccination. Patient stated, Aprox 2 weeks after 1st dose, aprox 7 days of episodes 1-2 a day, HR 140s, diaphoretic, feeling "weird" in chest. On 3rd day of occurrence went to ED, EKG performed which showed T wave changes, performed Cardiac labs, all negative. D/c home, episode occurred for few more nights then stopped.   No follow-up attempts are possible. No further information is expected.  Follow-Up (14Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, SARS-CoV-2 test
Clinical narrative: HR 140s; diaphoretic; feeling "weird" in chest; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the parent.  A 9 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Nov2021 18:30 (Lot number: FL0007) at the age of 9 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU, administration date 2021. The following information was reported: HEART RATE INCREASED (non-serious) with onset Nov2021, outcome "recovering", described as "HR 140s"; HYPERHIDROSIS (non-serious) with onset Nov2021, outcome "recovering", described as "diaphoretic"; FEELING ABNORMAL (non-serious) with onset Nov2021, outcome "recovering", described as "feeling "weird" in chest". The events "hr 140s", "diaphoretic" and "feeling "weird" in chest" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, hyperhidrosis, feeling abnormal.  Additional info: Prior to vaccination, the patient was  not diagnosed with COVID-19. No known allergies. No other medications received within 2 weeks of vaccination. Patient stated, Aprox 2 weeks after 1st dose, aprox 7 days of episodes 1-2 a day, HR 140s, diaphoretic, feeling "weird" in chest. On 3rd day of occurrence went to ED, EKG performed which showed T wave changes, performed Cardiac labs, all negative. D/c home, episode occurred for few more nights then stopped.   No follow-up attempts are possible. No further information is expected.  Follow-Up (14Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: they must have hit a nerve or something because she immediately developed numbness and tingling in her fingers for several hours; they must have hit a nerve or something because she immediately developed numbness and tingling in her fingers for several hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Apr2021 (Lot number: EW0179) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Overweight" (unspecified if ongoing), notes: She states she is definitely overweight. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, Vaccine Name: First dose , Lot Number / Expiry Date: EW0162/ Unknown, Route, Anatomical Location:  Left arm , No. of Previous Doses: This was dose 1, Date: 07Apr2021), administration date: 07Apr2021, when the patient was 47 years old, for COVID-19 immunization.  The following information was reported: PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 29Apr2021, outcome "recovered" and all described as "they must have hit a nerve or something because she immediately developed numbness and tingling in her fingers for several hours". The event "they must have hit a nerve or something because she immediately developed numbness and tingling in her fingers for several hours" and "they must have hit a nerve or something because she immediately developed numbness and tingling in her fingers for several hours" was evaluated at the emergency room visit.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: immune thing; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "immune thing".  Additional information: Caller's concern Caller (name withheld) asks if her wife is due to get her booster shot not until Mar asking if there is a reason why she can't get it early. He also said that her wife has some immune thing asking if she can safely take the booster dose after four weeks.   No follow-up attempts are possible;information about lot/batch number cannot be obtained.No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Stomach ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 7 year-old female patient received bnt162b2 (COMIRNATY) (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: ABDOMINAL PAIN UPPER (non-serious), outcome "recovered" (2021), described as "Stomach ache".  Additional information: The patient felt better soon after the stomach ache. Event 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.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Pain in shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "Pain in shoulder".  Additional Context: Report 2 of 2, Caller reports on his sister.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Off label use
Clinical narrative: For his first and second dose, He was eligible for the first and second dose while and so he got a second first and second dose there; For his first and second dose, He was eligible for the first and second dose  and so he got a second first and second dose there; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 4 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), administration date: Feb2021, for covid-19 immunization; Bnt162b2 (Dose 2, single), administration date: Feb2021, for covid-19 immunization; Bnt162b2 (Dose 3 (Booster), single), for covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious), outcome "unknown" and all described as "For his first and second dose. He was eligible for the first and second dose and so he got a second first and second dose there".  Additional information: Patient got his first and second doses in Feb but had to repeat the vaccine. He was calling now to see if it was ok to not get the booster dose.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Hyperhidrosis, Pain, Pain in extremity
Clinical narrative: Aside from pain in her arm (which she expected), she felt like someone literally beat her body.; chills; sweats; ached; she felt terrible/ she felt like someone literally beat her body.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 24Nov2021, outcome "recovered" (2021), described as "Aside from pain in her arm (which she expected), she felt like someone literally beat her body."; CHILLS (non-serious) with onset 24Nov2021, outcome "recovered" (2021), described as "chills"; HYPERHIDROSIS (non-serious) with onset 24Nov2021, outcome "recovered" (2021), described as "sweats"; PAIN (non-serious) with onset 24Nov2021, outcome "recovered" (2021), described as "ached"; FEELING ABNORMAL (non-serious) with onset 24Nov2021, outcome "recovered" (2021), described as "she felt terrible/ she felt like someone literally beat her body.". It was unknown if therapeutic measures were taken as a result of pain in extremity, chills, hyperhidrosis, pain, feeling abnormal. Additional information: The patient did not receive any other vaccine within 4 weeks prior to Covid vaccine. Prior to vaccine the patient was not diagnosed to Covid-19 vaccine. Since vaccination the patient has not been tested for Covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: minor chills; body ache; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Jan2021 17:00 (Lot number: EL3247) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Prev dose product=COVID 19,, Prev dose brand=Pfizer,, Prev dose brand unknown=False,, Prev dose lot number=EK9231,, Prev dose lot unknown=False,, Prev dose administration date=09Jan2021,, Prev dose administration time=02:00PM, Prev dose dose number=1,, Prev dose vaccine location=Left arm), administration date: 09Jan2021, when the patient was 51 years old, for Covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 07Dec2021 20:00, outcome "recovered", described as "minor chills"; PAIN (non-serious) with onset 07Dec2021 20:00, outcome "recovered", described as "body ache"; HEADACHE (non-serious) with onset 07Dec2021 20:00, outcome "recovered", described as "headache". Therapeutic measures were not taken as a result of chills, pain, headache.  Additional information: The patient did not receive any other vaccine within four weeks of vaccination. The patient did not receive any other medications within two 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 known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: can not talk right; having difficulty in talking; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SPEECH DISORDER (non-serious), outcome "unknown", described as "can not talk right; having difficulty in talking". Additional information: Reporter stated that, her sister in-law after taking the Pfizer vaccine (further clarified as COVID vaccine) shot, developed a side effect that is, that she can not talk right and she is having difficulty in talking."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Decreased appetite, Eye disorder, Headache
Clinical narrative: second dose: blood pressure has been a little high; right eye was affected somehow; second shot: swelling of left arm; second shot: headache; second shot :could not eat for three days; second shot: had normal aches and pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: ER8732) at the age of 66 years as dose 2, single. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: Pain(non-serious) with onset 24Mar2021, outcome "recovered" (25Mar2021), described as "second shot: had normal aches and pains"; Peripheral Swelling(non-serious) with onset 14Apr2021, outcome "recovered" (17Apr2021), described as "second shot: swelling of left arm"; Headache(non-serious) with onset 14Apr2021, outcome "recovered" (17Apr2021), described as "second shot: headache"; Decreased appetite(non-serious) with onset 14Apr2021, outcome "recovered" (17Apr2021), described as "second shot :could not eat for three days"; Blood pressure increased (non-serious) with onset 17Apr2021, outcome "not recovered", described as "second dose: blood pressure has been a little high"; Eye disorder(non-serious) with onset 16Apr2021, outcome "not recovered", described as "right eye was affected somehow". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up (23Dec2021): Follow-up attempts are completed. No further information is expected.  Additional Information:Why was the patient taking Covid vaccine (Verbatim): trying to follow what they thought would be the best thing in the Covid situation Physician details: Stated that she went to the Health Department. Stated there was no doctor. Occupation/specialty, consent to contact, address, phone number and email address not provided.Treatment: Stated that she took Tylenol and cold compress for swelling of left arm. Stated that she went to the doctor and is monitoring her blood pressure.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101767816 Same patient and drug, different event separated in time
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Peripheral swelling
Clinical narrative: second dose: blood pressure has been a little high; right eye was affected somehow; second shot: swelling of left arm; second shot: headache; second shot :could not eat for three days; second shot: had normal aches and pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: ER8732) at the age of 66 years as dose 2, single. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: Pain(non-serious) with onset 24Mar2021, outcome "recovered" (25Mar2021), described as "second shot: had normal aches and pains"; Peripheral Swelling(non-serious) with onset 14Apr2021, outcome "recovered" (17Apr2021), described as "second shot: swelling of left arm"; Headache(non-serious) with onset 14Apr2021, outcome "recovered" (17Apr2021), described as "second shot: headache"; Decreased appetite(non-serious) with onset 14Apr2021, outcome "recovered" (17Apr2021), described as "second shot :could not eat for three days"; Blood pressure increased (non-serious) with onset 17Apr2021, outcome "not recovered", described as "second dose: blood pressure has been a little high"; Eye disorder(non-serious) with onset 16Apr2021, outcome "not recovered", described as "right eye was affected somehow". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up (23Dec2021): Follow-up attempts are completed. No further information is expected.  Additional Information:Why was the patient taking Covid vaccine (Verbatim): trying to follow what they thought would be the best thing in the Covid situation Physician details: Stated that she went to the Health Department. Stated there was no doctor. Occupation/specialty, consent to contact, address, phone number and email address not provided.Treatment: Stated that she took Tylenol and cold compress for swelling of left arm. Stated that she went to the doctor and is monitoring her blood pressure.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101767816 Same patient and drug, different event separated in time