chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Syncope, Vomiting
Clinical narrative: Fainted; Profusely sweat; severely sick; dont feel the same; Dizzy; Fatigue; Vomit; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high (Patient received unknown medication for high blood pressure).    On 03-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2022, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), HYPERHIDROSIS (Profusely sweat), ILLNESS (severely sick), FEELING ABNORMAL (dont feel the same), DIZZINESS (Dizzy), FATIGUE (Fatigue) and VOMITING (Vomit). At the time of the report, SYNCOPE (Fainted), HYPERHIDROSIS (Profusely sweat), ILLNESS (severely sick), FEELING ABNORMAL (dont feel the same), FATIGUE (Fatigue) and VOMITING (Vomit) outcome was unknown and DIZZINESS (Dizzy) and HEADACHE (Headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment information was not provided.  Company comment: This spontaneous case concerns a 62-year-old female patient, with medical history of high blood pressure, who experienced the serious (medically significant) unexpected event of syncope, among other non-serious events. No onset date was provided for the event; hence, latency to the first dose of mRNA-1273 vaccine, cannot be assessed. No further clinical information for medical reviewing and no treatment information were provided. The history of high blood pressure and concomitant dizziness could be contributing factors for the event. The benefit-risk relationship of the mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-480584 (Patient Link).; Sender's Comments: This spontaneous case concerns a 62-year-old female patient, with medical history of high blood pressure, who experienced the serious (medically significant) unexpected event of syncope, among other non-serious events. No onset date was provided for the event; hence, latency to the first dose of mRNA-1273 vaccine, cannot be assessed. No further clinical information for medical reviewing and no treatment information were provided. The history of high blood pressure and concomitant dizziness could be contributing factors for the event. The benefit-risk relationship of the mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I was out with Covid. I got it 2.5 weeks ago; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I was out with Covid. I got it 2.5 weeks ago) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced COVID-19 (I was out with Covid. I got it 2.5 weeks ago). At the time of the report, COVID-19 (I was out with Covid. I got it 2.5 weeks ago) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported. Patient had 2 shots of Moderna, either the end of 2020 or beginning of 2021. Patient was out with Covid. Patient got it 2.5 weeks ago. He was back to work, 10 days later. He was being told he had to get a booster shot.  Company Comment: This spontaneous case concerns a male patient of an unknown age, with no medical history reported, who experienced the unexpected AESI event of COVID-19. The event occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine. At the time of the report the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of an unknown age, with no medical history reported, who experienced the unexpected AESI event of COVID-19. The event occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine. At the time of the report the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Progressive facial hemiatrophy, Swelling face
Clinical narrative: She has facial atrophy and has to use fillers; Face is still puffy; the lump on her face is smaller and does not look as bad; This spontaneous case was reported by a consumer and describes the occurrence of PROGRESSIVE FACIAL HEMIATROPHY (She has facial atrophy and has to use fillers) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0031A21A, 013B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cholesterol (Generic Lipitor for cholesterol). Concurrent medical conditions included Hypothyroidism (takes Synthroid) and Seasonal allergy. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, DOXYCYCLINE for Red rash.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2022, the patient experienced PROGRESSIVE FACIAL HEMIATROPHY (She has facial atrophy and has to use fillers) (seriousness criterion medically significant), SWELLING FACE (Face is still puffy) and MASS (the lump on her face is smaller and does not look as bad). At the time of the report, PROGRESSIVE FACIAL HEMIATROPHY (She has facial atrophy and has to use fillers) and SWELLING FACE (Face is still puffy) had not resolved and MASS (the lump on her face is smaller and does not look as bad) was resolving.            Treatment reported as Steroid shot (Unknown name), Antibiotic Doxycycline 100mg BID, Saline injections, Another round of antibiotics.  Concomitant medication reported generic Lipitor. Patient reported her existing rash or lump on the face did not get worst.   This case was linked to MOD-2022-482189, MOD-2022-482209 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Chest discomfort
Clinical narrative: Seems my heart hurt; every bone in my body hurt; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Seems my heart hurt) and BONE PAIN (every bone in my body hurt) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included FISH OIL for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced CHEST DISCOMFORT (Seems my heart hurt) and BONE PAIN (every bone in my body hurt). The patient was treated with MELOXICAM at a dose of for a month. At the time of the report, CHEST DISCOMFORT (Seems my heart hurt) and BONE PAIN (every bone in my body hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that Patient received first dose on 02Mar2021, a week later he said it made him feel terrible, Seems like his heart hurt and every bone in his body hurt and Second dose was received on 01Apr2021.  I went to the ER on Jan.17, 2022, Xray and CT scan results were fine. Then I was treated for heart inflammation, which I got better after two weeks. Now I am back the same as I was."  Patient's pain scale level is 5 when he is sitting and 10 when getting up in the morning.   This case was linked to MOD-2022-483119 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Gait inability, Vaccination complication
Clinical narrative: He is not able to stand up; 2 months ago the symptoms started; Patient can't walk and has to use a walker; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Feb-2022 and was forwarded to Moderna on 15-Feb-2022.    This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (He is not able to stand up) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 044821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (allergic to amoxicillin) and Blood pressure management.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced GAIT INABILITY (Patient can't walk and has to use a walker). On an unknown date, the patient experienced DYSSTASIA (He is not able to stand up) (seriousness criterion disability) and VACCINATION COMPLICATION (2 months ago the symptoms started). At the time of the report, DYSSTASIA (He is not able to stand up), GAIT INABILITY (Patient can't walk and has to use a walker) and VACCINATION COMPLICATION (2 months ago the symptoms started) had not resolved.            He was taking other concomitant medications besides blood pressure.  Patient received both Moderna Covid-19 vaccines in his deltoid muscle.He didn't tested positive for Covid-19 and did not received any other vaccine within 1 month prior to Moderna Covid-19 vaccine. He doesn't had any acute or chronic illnesses.He didn't experienced any similar event on the past. The symptomsare ongoing and no treatment was applied.  Company Comment: This case refers to a 62-year-old male patient with no relevant reported medical history who experienced the unexpected event of Dysstasia on an unspecified date after a dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.   Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2022: Significant follow up appended. New events was added and date of 2nd dose was updated, add 1st dose details were updated; Sender's Comments: This case refers to a 62-year-old male patient with no relevant reported medical history who experienced the unexpected event of Dysstasia on an unspecified date after a dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersensitivity, Hypoaesthesia, Neck pain
Clinical narrative: Face paralysis; Neck pain; Eye lid palpitations; Problems with the eyes; Swelling  of the eyes; Eyes burn; Face numbness; Headache; Allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Face paralysis) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced FACIAL PARALYSIS (Face paralysis) (seriousness criterion medically significant), NECK PAIN (Neck pain), BLEPHAROSPASM (Eye lid palpitations), EYE DISORDER (Problems with the eyes), EYE SWELLING (Swelling  of the eyes), EYE IRRITATION (Eyes burn), HYPOAESTHESIA (Face numbness), HEADACHE (Headache) and HYPERSENSITIVITY (Allergic reaction). At the time of the report, FACIAL PARALYSIS (Face paralysis), NECK PAIN (Neck pain), BLEPHAROSPASM (Eye lid palpitations), EYE DISORDER (Problems with the eyes), EYE SWELLING (Swelling  of the eyes), EYE IRRITATION (Eyes burn), HYPOAESTHESIA (Face numbness), HEADACHE (Headache) and HYPERSENSITIVITY (Allergic reaction) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.    Patient had a COVID positive test or diagnosis in Jan2021. She had no past medical history or allergies before vaccination and hadn't took any other vaccines within 1 month prior to Moderna. She went to doctor office every week for a month and took Steroid that inflated her like a pig. Patient symptoms sometimes worsened and other times improved. Patient had the same symptoms after booster since 31-jan-2022.  Concomitant medication was not provided Treatment information was not reported.  Company comment: This is a spontaneous case concerning a 41-year-old female patient with no medical history reported, who experienced the expected serious(Medically significant) and AESI  event of facial paralysis, as well as non serious events of neck pain, blepharospasm, eye disorder, eye swelling, eye irritation, hypoaesthesia, headache and hypersensitivity after the first dose of mRNA1273 vaccine. The outcome of the events was not recovered. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-483642 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 41-year-old female patient with no medical history reported, who experienced the expected serious(Medically significant) and AESI  event of facial paralysis, as well as non serious events of neck pain, blepharospasm, eye disorder, eye swelling, eye irritation, hypoaesthesia, headache and hypersensitivity after the first dose of mRNA1273 vaccine. The outcome of the events was not recovered. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 12 year old received a dose of Moderna vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received a dose of Moderna vaccine.) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041JZ (2)1A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received a dose of Moderna vaccine.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received a dose of Moderna vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Patient did not get the second dose.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2022: Follow-up received and contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: got shingles after this shot; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (got shingles after this shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (got shingles after this shot). At the time of the report, HERPES ZOSTER (got shingles after this shot) outcome was unknown.            No concomitant medications were reported.  The patient had to spend three months with a catheter and was reluctant to get the booster dose of the vaccine. The patient was concerned about having no protection and would like to know if the booster shot would still be effective if the patient got it now.
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Inappropriate schedule of product administration
Clinical narrative: Received the J&J vaccine in November/received the Moderna as a booster last night. The gave us the 0.5ml dose; Received the J&J vaccine in November/received the Moderna as a booster last night.; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Received the J&J vaccine in November/received the Moderna as a booster last night. The gave us the 0.5ml dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the J&J vaccine in November/received the Moderna as a booster last night.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: J&J vaccine in November 2021. Past adverse reactions to the above products included No adverse event with J&J vaccine.    On 05-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 05-Feb-2021, the patient experienced ACCIDENTAL OVERDOSE (Received the J&J vaccine in November/received the Moderna as a booster last night. The gave us the 0.5ml dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the J&J vaccine in November/received the Moderna as a booster last night.). At the time of the report, ACCIDENTAL OVERDOSE (Received the J&J vaccine in November/received the Moderna as a booster last night. The gave us the 0.5ml dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the J&J vaccine in November/received the Moderna as a booster last night.) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-486930 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Patient received the J and J vaccine in November and received the Moderna as a booster last night. Gave the 0.5ml dose to the patient.; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Patient received the J and J vaccine in November and received the Moderna as a booster last night. Gave the 0.5ml dose to the patient.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: J&J vaccine in November 2021. Past adverse reactions to the above products included No adverse reaction with J&J vaccine.   In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In February 2022, the patient experienced ACCIDENTAL OVERDOSE (Patient received the J and J vaccine in November and received the Moderna as a booster last night. Gave the 0.5ml dose to the patient.). At the time of the report, ACCIDENTAL OVERDOSE (Patient received the J and J vaccine in November and received the Moderna as a booster last night. Gave the 0.5ml dose to the patient.) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were provided. Patient reported that, patient received the Moderna as a booster and 0.5ml dose. Patient concerned that got the full Moderna dose and not the booster dose. No treatment medications were provided.   This case was linked to MOD-2022-486909 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue for a day or two; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US092572_NS (Company)  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "fatigue for a day or two". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Tinnitus
Clinical narrative: took the second vaccine and the tinnitus increased in intensity and became louder; I experienced another migraine a week afterwards; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (administration time was03:00 PM, Dose 1, vaccine location Left arm.), administration date: 02Apr2021, when the patient was 38 years old, for COVID-19 Immunisation, reaction(s): "tinnitus"; Bnt162b2, administration date: 02Apr2021, when the patient was 38 years old, for Covid-19 immunisation, reaction(s): "severe migraine headache". The following information was reported: TINNITUS (non-serious) with onset 09Apr2021 23:00, outcome "not recovered", described as "took the second vaccine and the tinnitus increased in intensity and became louder"; MIGRAINE (non-serious) with onset 09Apr2021 23:00, outcome "not recovered", described as "I experienced another migraine a week afterwards". The events "took the second vaccine and the tinnitus increased in intensity and became louder" and "i experienced another migraine a week afterwards" were evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus, migraine.  Additional information: One week after vaccination I began experiencing tinnitus in my right ear, pressure in right ear, severe migraine headache. The next day the tinnitus spread to my left ear. It is a continuous high-pitched ringing. I have never had tinnitus before. The tinnitus began to subside after two weeks. Then I took the second vaccine and the tinnitus increased in intensity and became louder. I experienced another migraine a week afterwards. I visited an ENT and I have no ear infection, wax build-up, ear damage, significant hearing loss that would explain the tinnitus. The ENT suspected that I may be having a reaction to the vaccine. The patient was not tested positive for covid 19 since before and after vaccination. The patient had not received any vaccines within 4 weeks or other medications within 2 weeks. The patient received treatment with Antibiotics (urgent care suspected it was ear infection).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non 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 1), for covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine, for Covid-19 immunization.  The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tired".  Additional information: It was stated that maybe because patient drove 250 miles round trip in a snowstorm on 2nd round. No adverse effects except tired next day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: In my first vaccine my arm felt like it weighs 500 pounds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 17Apr2021 (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: LIMB DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "In my first vaccine my arm felt like it weighs 500 pounds".  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: Nausea, Vertigo
Clinical narrative: vertigo; nausea; 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 right, administration date 25Mar2021 11:45 (Batch/Lot number: unknown) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "preeclampsia while pregnant" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN B [VITAMIN B COMPLEX]; PROBIOTICS. The following information was reported: VERTIGO (non-serious) with onset 2021, outcome "unknown", described as "vertigo"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea". The events "vertigo" and "nausea" were evaluated at the physician office visit. Therapeutic measures were taken as a result of vertigo, nausea treated with allergy meds, Medrol pack, and physical therapy.  Additional Information: Vertigo and nausea lasted approx. 5 hours. The patient had Birth control medications in two weeks. No any other vaccine was received in four weeks. No Covid-19 was reported prior to the vaccination. No Covid-19 tested post vaccination. No known allergies  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: Prominent chills; body aches; headache; arm soreness the day after; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 18 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10May2021 12:00 (Batch/Lot number: unknown) at the age of 18 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Lot unknown reason: Unable to locate or read the details, Administration date: 19Apr2021, Administration time: 14:15 , Dose number: 1, Vaccine location: Left leg), administration date: 19Apr2021, when the patient was 18 years old, for Covid-19 Immunization, reaction(s): "Dose Number=1,vaccine location=Left leg".  The following information was reported: CHILLS (non-serious) with onset 11May2021 02:00, outcome "not recovered", described as "Prominent chills"; PAIN (non-serious) with onset 11May2021 02:00, outcome "not recovered", described as "body aches"; HEADACHE (non-serious) with onset 11May2021 02:00, outcome "not recovered", described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 11May2021 02:00, outcome "not recovered", described as "arm soreness the day after". Therapeutic measures were not taken as a result of chills, pain, headache, pain in extremity.  Additional information: The patient had no known allergies. Th patient had not received other vaccine in four weeks. Th patient had not received other medications in two weeks.  The patient had no COVID tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash papular
Clinical narrative: raised rash on her face/her ears; lymph nodes in her neck enlarged/lymph nodes in her collar bone enlarged; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): PFIZER INC-202101252772.  A 50 year-old female patient received bnt162b2 (COMIRNATY), administration date 12Sep2021 (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: RASH PAPULAR (non-serious) with onset Sep2021, outcome "unknown", described as "raised rash on her face/her ears"; LYMPHADENOPATHY (non-serious) with onset Sep2021, outcome "unknown", described as "lymph nodes in her neck enlarged/lymph nodes in her collar bone enlarged".  Additional information: The patient stated that she noticed events on Saturday. Stated that she had a raised rash on her face and ears the first week after the vaccination shot. She can feel that there were rashes more than she saw. The vaccine had an adverse effect on her system. On all three vaccinations one listed ingredient was similar to Miralax and she was asked if she was allergic. The ingredient did not work well with her system and that it did the opposite of what it was supposed to do.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  Follow-up (22Sep2021/27Oct2021): New information from a contactable Consumer included: the case became valid, events (lymph nodes in her neck enlarged,lymph nodes in her collar bone enlarged, raised rash on her face, raised rash on her ears)
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: pt developed rash after vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (054550).  A 58 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 58 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATIVAN; ZOLOFT; TRAZODONE HCL. The following information was reported: RASH (non-serious), outcome "unknown", described as "pt developed rash after vaccine".  Additional information: Adverse experiences: Date of event onset: Jul2021, Provide summary of ADE. Include description of severity: patient reports "Sinus infection in July" and that MD gave her antibiotic (Ceftin) at that time but did not have her hold/stop Xeljanz". MD aware. Provide summary of ADE. Include description of severity: Pt reported per MD instructions, Pt held Xeljanz dose 1 wk before covid vaccine. Pt developed Rash after vaccine and held Xeljanz additional 2 wks due to Rash. Pt confirmed Pain is worse while off Xeljanz. MD aware. List any medication(s) patient was using at or around the time of the adverse event and dates of therapy: Ativan 0.5 MG Tablet, Zoloft 25 MG Tablet, Trazadone HCL 50 MG Tablet. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: broke out with hives everywhere all over my body; everywhere, from head to toe; she experienced hives (not warts) and itching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4401058.  A 59 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) at the age of 59 years 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: URTICARIA (non-serious) with onset 2021, outcome "not recovered", described as "broke out with hives everywhere all over my body; everywhere, from head to toe"; PRURITUS (non-serious) with onset 2021, outcome "not recovered", described as "she experienced hives (not warts) and itching".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: cough; 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 73 year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, administration date Nov2020 (Batch/Lot number: unknown) as dose 1, single and administration date Dec2020 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Atrial fibrillation", start date: 2000 (ongoing); "Heart murmur", start date: 2000 (ongoing); "chickenpox" (unspecified if ongoing), notes: chickenpox 16 times until she was 16 years old and then she never had the chicken pox after that.; "Operations" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Flu vaccine (she was sick for 5 days; diarrhea; vomiting; fever; felt like crap). The following information was reported: COUGH (non-serious), outcome "unknown", described as "cough".  Additional information: Patient reported she already had 2 doses of a Covid-19 Vaccine but is not sure which one, she does not know because she lives in a new assisted living facility, and they gave her those Covid-19 Vaccine doses. Caller clarified that she called to ask if she can get Pfizer Covid-19 Vaccine relative to her clinical history, prior to considering being administered the Pfizer Covid-19 Vaccine. She mentioned on the paper she got it says everything about heart and all kinds of stuff, and that is scary you know, she does not know if she is allowed to get the Pfizer Covid-19 Vaccine or not. She hopes she does not die, she does not want to die. The inbound transfer agent advised caller to ask somebody there; but caller has only been there since 01Sep2021.   Follow-up (27Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Right and left hip area pain.  Pain leave on lefts side 5/6 and right side 2/3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Feb2021 12:00 (Lot number: EL3249) at the age of 61 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL0142, Location of injection: Arm Right, Vaccine Administration Time: 12:00 AM), administration date: 19Jan2021, for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset May2021, outcome "not recovered", described as "Right and left hip area pain.  Pain leave on lefts side 5/6 and right side 2/3". The event "right and left hip area pain.  pain leave on lefts side 5/6 and right side 2/3" was evaluated at the physician office visit. Therapeutic measures were taken as a result of arthralgia. Additional information: known allergies no. other medical history yes. Treatment received for the adverse event: To where my back brace. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: chest 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 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 09Apr2021 (Lot number: ER8734) at the age of 56 years as dose 2, single and administered in arm right, administration date 19Mar2021 (Lot number: EN6200) as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (ongoing), notes: Hospitalized for high blood pressure twice, once in 2018 and once in 2019. There were no concomitant medications. The following information was reported: CHEST PAIN (non-serious), outcome "recovered", described as "chest pain". Therapeutic measures were not taken as a result of chest pain.  Additional information: The patient was diagnosed with high blood pressure about 15 to 17 years ago. The patient was supposed to be getting her booster shot since she got the email, she has not made the appointment yet for the booster dose, she wanted to know if there are reported cases of chest pain after receiving the booster dose. The patient had thinks both primary doses were in the right upper arm, she cannot remember. On her vaccination card they have one of two doses for both dates for the first and second shot, she was wondering if she got the first dose twice. Chest pain started immediately after both doses, There was a doctor on site and she was observed. The chest pain recovered after 15 to 20 minutes, chest pain went away. She had to sit for observation a little longer to make sure there was nothing else. The nurse followed up with her every 5 to 10 minutes to check on her, treatment was declined. Post Authorization Experience: The following adverse reactions have been identified during post authorization use of Pfizer-BioNTech COVID-19 Vaccine, Cardiac Disorders: myocarditis, pericarditis. Because these reactions are reported voluntarily, it was not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Called Pfizer and spoke with someone who confirmed the 2 LOT numbers were from Pfizer however we cannot determine if it was 2 doses that were administered on her 1st dose. Caller agreed that she will call the pharmacy were she got the vaccine.She was wondering if someone experienced chest pain with first two shots, could someone experience chest pain with the booster dose. She does not have insurance. She thinks both doses were in the right upper arm, she cannot remember. She is not taking any medication but does have high blood pressure. Relevant Tests: none. Family Medical History Relevant to AE(s): no. No emergency room or physician office visit. She had no prior vaccinations (within 4 weeks).  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Loss of taste; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for a male patient (reporter's husband) that:  A male patient received bnt162b2 (BNT162B2), administration date 22Oct2021 (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: AGEUSIA (non-serious) with onset Oct2021, outcome "unknown", described as "Loss of taste".  Additional information: Reason for no lot number: of Covid-19 Vaccine: Complainant hung up abruptly/transfer incomplete Expiry Date of Covid-19 Vaccine: Unknown  Additional Context: Reporter stated, "I am calling on behalf of my husband (consumer), we have a question. "When probed for the concern, reporter stated, "My husband and I both had our Booster vaccination, the third vaccination on last Friday but my husband is now experiencing no taste (loss of taste). Is that a side effect?"   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (28Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Lymph node pain, Lymphadenopathy, Nausea
Clinical narrative: Dizziness; nausea; full body itch; itchy red arm; itchy red arm; Swollen/painful lymph node under arm; Swollen/painful lymph node; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Oct2021 16:00 (Lot number: FF9941) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Yes" (unspecified if ongoing), notes: known allergies: Yes, many. Concomitant medication(s) included: SINGULAIR; ZYRTEC ALLERGY; CLARITINE; BENADRYL; PREVACID. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 22Mar2021, when the patient was 55 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0158, Location of injection: Arm Right, Vaccine Administration Time: 09:00 AM), administration date: 12Apr2021, when the patient was 55 years old, for COVID-19 Immunization, reaction(s): "Dizziness", "Nausea", "full body itch,", "Itchy red arm", "Swollen/painful lymph node", "Swollen/painful lymph node". The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "Dizziness"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea"; PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "full body itch"; PRURITUS (non-serious), ERYTHEMA (non-serious) all with onset 2021, outcome "unknown" and all described as "itchy red arm"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "Swollen/painful lymph node under arm"; LYMPH NODE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Swollen/painful lymph node".  Additional information: It was reported that, the patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included Singulair, Zyrtec, Claritin, Benadryl, Prevacid. 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. Stated that, Dizziness, nausea, full body itch, itchy red arm. Swollen/painful lymph node under arm after 2nd and 3rd shots (not the first), Fever esp after 2nd shot. The reporter seriousness for the events was classified as non-serious. The device date was on 25Oct2021.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Dizziness; nausea; full body itch; itchy red arm; itchy red arm; Swollen/painful lymph node under arm; Swollen/painful lymph node; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Oct2021 16:00 (Lot number: FF9941) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Yes" (unspecified if ongoing), notes: known allergies: Yes, many. Concomitant medication(s) included: SINGULAIR; ZYRTEC ALLERGY; CLARITINE; BENADRYL; PREVACID. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 22Mar2021, when the patient was 55 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0158, Location of injection: Arm Right, Vaccine Administration Time: 09:00 AM), administration date: 12Apr2021, when the patient was 55 years old, for COVID-19 Immunization, reaction(s): "Dizziness", "Nausea", "full body itch,", "Itchy red arm", "Swollen/painful lymph node", "Swollen/painful lymph node". The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "Dizziness"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea"; PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "full body itch"; PRURITUS (non-serious), ERYTHEMA (non-serious) all with onset 2021, outcome "unknown" and all described as "itchy red arm"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "Swollen/painful lymph node under arm"; LYMPH NODE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Swollen/painful lymph node".  Additional information: It was reported that, the patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included Singulair, Zyrtec, Claritin, Benadryl, Prevacid. 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. Stated that, Dizziness, nausea, full body itch, itchy red arm. Swollen/painful lymph node under arm after 2nd and 3rd shots (not the first), Fever esp after 2nd shot. The reporter seriousness for the events was classified as non-serious. The device date was on 25Oct2021.  No follow-up attempts are possible. No further information is expected.