chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069H21A, 026B21A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever) had not resolved.            Concomitant information was not provided.   This case was linked to MOD-2021-420951 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered 7 booster doses of the Moderna COVID-19 vaccineon 16Dec2021 from a vial which was initially sored in the refrigerator on 16Nov2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered 7 booster doses of the Moderna COVID-19 vaccineon 16Dec2021 from a vial which was initially sored in the refrigerator on 16Nov2021 ) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 027B21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021 at 2:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered 7 booster doses of the Moderna COVID-19 vaccineon 16Dec2021 from a vial which was initially sored in the refrigerator on 16Nov2021 ). On 16-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administered 7 booster doses of the Moderna COVID-19 vaccineon 16Dec2021 from a vial which was initially sored in the refrigerator on 16Nov2021 ) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided. The vial was initially stored in the refrigerator on 16-Nov-2021. On 16-Dec-2021, the vial was first punctured.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009c21a) for COVID-19 vaccination. No Medical History information was reported. On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant product use was reported. No treatment information was provided. This case was linked to MOD-2021-418891 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen under armpit), PAIN (soreness/pain) and PYREXIA (fever) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 3014M20A and 030120A) for COVID-19 vaccination. No Medical History information was reported. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced PERIPHERAL SWELLING (swollen under armpit), PAIN (soreness/pain) and PYREXIA (fever). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swollen under armpit), PAIN (soreness/pain) and PYREXIA (fever) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient reported not being on any concomitant medications.
Sex: U
Vaccine: COVID19
Symptoms: Animal scratch
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ANIMAL SCRATCH (scratched by a cat) 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 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANIMAL SCRATCH (scratched by a cat). At the time of the report, ANIMAL SCRATCH (scratched by a cat) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant drugs were reported. Treatment drugs includes IV antibiotics and oral antibiotics for scratches by cat patient was suppose to receive 2nd dose vaccine on 8feb2021 but didn't receive it since had question whether can get vaccine while on antibiotics .
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle Soreness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Ceftin), Drug allergy (Neomycin) and Allergy to grains (grains). On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced MYALGIA (Muscle Soreness). At the time of the report, MYALGIA (Muscle Soreness) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided by reporter. Patient weight was reported as 180. Treatment medications were not provided by reporter. This case was linked to MOD-2021-386869 (Patient Link).
Sex: U
Vaccine: MENB
Symptoms: Contraindicated product administered, Incomplete course of vaccination, Wrong product administered
Clinical narrative: Trumenba one year ago (never completed 2nd dose series); Bexero was mistakenly administered; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received meningococcal group b rlp2086 (TRUMENBA) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BEXSERO. The following information was reported: INCOMPLETE COURSE OF VACCINATION (non-serious), outcome "unknown", described as "Trumenba one year ago (never completed 2nd dose series)"; CONTRAINDICATED PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Bexero was mistakenly administered".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Mar2021 08:45 (Lot number: Er2613) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "tonsillectomy" (unspecified if ongoing); "cholecystectomy" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3. Past drug history included: Bactrim, reaction(s): "known allergies: lip itch", notes: Bactrim - lip itch is the result. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 21Mar2021, outcome "unknown", described as "sore arm".  Additional information: The patient took second dose of BNT162B2 (Lot number: Ew0151) on 11Apr2021 8:45 AM in arm left and experienced with a 24-hour onset of sore arm, body aches and chill. On around 06/06 patient developed an itchy lesion on patient inner thigh believed to resemble yeast or bacterial infections. patient treated this with over-the-counter topical yeast medications. 3 weeks later patient developed lesions on both breasts also resembling what patient believed was yeast and attempted to treat it the same way, but it did not go away.  After developing more lesions on patient back, legs, breast, arms patient decided to visit a dermatologist 23Jul2021, patient had a punch biopsy completed using samples from my arm and back. These samples came back as lichen Planus on 08Apr2021. It's now aggressively widespread and not responding to treatment. The patient did not take any other vaccine in four weeks prior to vaccination. The patient's other medications in two weeks were women's multi-vitamin. The patient signed up for vaccine side effects - reporting symptoms and incorrectly selected no side effects because she thought that her lesions were yeast induced. The patient did not have COVID prior vaccination and did not test COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: I have left shoulder pain and left arm pain.; I have left shoulder pain and left arm pain.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Sep2021 14:00 (Lot number: FC3180) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Coconut" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; CONCERTA. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer,, lot_number=Fc3181,, administration_date=29Aug2021,, administration_time=11:15 AM,, dose_number=1,, vaccine_location=Left arm), administration date: 29Aug2021, when the patient was 47 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 19Sep2021 22:00, outcome "not recovered" and all described as "I have left shoulder pain and left arm pain.". Therapeutic measures were not taken as a result of pain in extremity, arthralgia.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The shoulder pain kept him up at night. Adverse event resulted in none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medications Lisinopril, Concerta within 2 weeks of vaccination. 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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Albumin globulin ratio, Alopecia, Antibody test, Antinuclear antibody
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient. A 40 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 08:30 (Lot number: EW0171) at the age of 40 years as dose 2, single and administered in arm left, administration date 09Apr2021 08:30 (Lot number: EW0150) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 30Apr2021, outcome "not recovered", described as "have had my hair fall out in clumps"; ARTHRALGIA (non-serious) with onset 01May2021, outcome "unknown", described as "joints have been aching/ Sore Joints"; FATIGUE (non-serious) with onset 30Apr2021, outcome "not recovered", described as "extremely fatigue"; POLYMENORRHOEA (non-serious) with onset 11May2021, outcome "unknown", described as "my period has been 2 times a month since may."; BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "Glucose 105"; ANTINUCLEAR ANTIBODY POSITIVE (non-serious), outcome "unknown", described as "ANA screen IFA Positive"; ASTHENIA (non-serious) with onset 11May2021, outcome "unknown", described as "two menstrual cycles a month making me more weak ". The event "joints have been aching/ sore joints" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia. Additional information: Prior Vaccinations and Concomitant drugs were reported as none. Interpretation included: All three negative tiers indicate the absence of detectable antibodies to component analytes consisting of double stranded DNA (dsDNA), chromatin, RNP, RNP, (SM), SSA. SSB, JO-1, Scl-70, Centromere B, and ribosomal P. A negative result should be interpreted in the context of clinical and laboratory findings. Treatment for Sore Joints included meloxicam. No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody negative, Antinuclear antibody positive, Arthralgia, Aspartate aminotransferase, Asthenia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient. A 40 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 08:30 (Lot number: EW0171) at the age of 40 years as dose 2, single and administered in arm left, administration date 09Apr2021 08:30 (Lot number: EW0150) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 30Apr2021, outcome "not recovered", described as "have had my hair fall out in clumps"; ARTHRALGIA (non-serious) with onset 01May2021, outcome "unknown", described as "joints have been aching/ Sore Joints"; FATIGUE (non-serious) with onset 30Apr2021, outcome "not recovered", described as "extremely fatigue"; POLYMENORRHOEA (non-serious) with onset 11May2021, outcome "unknown", described as "my period has been 2 times a month since may."; BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "Glucose 105"; ANTINUCLEAR ANTIBODY POSITIVE (non-serious), outcome "unknown", described as "ANA screen IFA Positive"; ASTHENIA (non-serious) with onset 11May2021, outcome "unknown", described as "two menstrual cycles a month making me more weak ". The event "joints have been aching/ sore joints" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia. Additional information: Prior Vaccinations and Concomitant drugs were reported as none. Interpretation included: All three negative tiers indicate the absence of detectable antibodies to component analytes consisting of double stranded DNA (dsDNA), chromatin, RNP, RNP, (SM), SSA. SSB, JO-1, Scl-70, Centromere B, and ribosomal P. A negative result should be interpreted in the context of clinical and laboratory findings. Treatment for Sore Joints included meloxicam. No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood albumin, Blood alkaline phosphatase, Blood bilirubin, Blood calcium, Blood chloride
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient. A 40 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 08:30 (Lot number: EW0171) at the age of 40 years as dose 2, single and administered in arm left, administration date 09Apr2021 08:30 (Lot number: EW0150) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 30Apr2021, outcome "not recovered", described as "have had my hair fall out in clumps"; ARTHRALGIA (non-serious) with onset 01May2021, outcome "unknown", described as "joints have been aching/ Sore Joints"; FATIGUE (non-serious) with onset 30Apr2021, outcome "not recovered", described as "extremely fatigue"; POLYMENORRHOEA (non-serious) with onset 11May2021, outcome "unknown", described as "my period has been 2 times a month since may."; BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "Glucose 105"; ANTINUCLEAR ANTIBODY POSITIVE (non-serious), outcome "unknown", described as "ANA screen IFA Positive"; ASTHENIA (non-serious) with onset 11May2021, outcome "unknown", described as "two menstrual cycles a month making me more weak ". The event "joints have been aching/ sore joints" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia. Additional information: Prior Vaccinations and Concomitant drugs were reported as none. Interpretation included: All three negative tiers indicate the absence of detectable antibodies to component analytes consisting of double stranded DNA (dsDNA), chromatin, RNP, RNP, (SM), SSA. SSB, JO-1, Scl-70, Centromere B, and ribosomal P. A negative result should be interpreted in the context of clinical and laboratory findings. Treatment for Sore Joints included meloxicam. No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine, Blood glucose, Blood glucose increased, Blood potassium, Blood sodium
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient. A 40 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 08:30 (Lot number: EW0171) at the age of 40 years as dose 2, single and administered in arm left, administration date 09Apr2021 08:30 (Lot number: EW0150) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 30Apr2021, outcome "not recovered", described as "have had my hair fall out in clumps"; ARTHRALGIA (non-serious) with onset 01May2021, outcome "unknown", described as "joints have been aching/ Sore Joints"; FATIGUE (non-serious) with onset 30Apr2021, outcome "not recovered", described as "extremely fatigue"; POLYMENORRHOEA (non-serious) with onset 11May2021, outcome "unknown", described as "my period has been 2 times a month since may."; BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "Glucose 105"; ANTINUCLEAR ANTIBODY POSITIVE (non-serious), outcome "unknown", described as "ANA screen IFA Positive"; ASTHENIA (non-serious) with onset 11May2021, outcome "unknown", described as "two menstrual cycles a month making me more weak ". The event "joints have been aching/ sore joints" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia. Additional information: Prior Vaccinations and Concomitant drugs were reported as none. Interpretation included: All three negative tiers indicate the absence of detectable antibodies to component analytes consisting of double stranded DNA (dsDNA), chromatin, RNP, RNP, (SM), SSA. SSB, JO-1, Scl-70, Centromere B, and ribosomal P. A negative result should be interpreted in the context of clinical and laboratory findings. Treatment for Sore Joints included meloxicam. No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Carbon dioxide, Fatigue, Globulin, Glomerular filtration rate
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient. A 40 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 08:30 (Lot number: EW0171) at the age of 40 years as dose 2, single and administered in arm left, administration date 09Apr2021 08:30 (Lot number: EW0150) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 30Apr2021, outcome "not recovered", described as "have had my hair fall out in clumps"; ARTHRALGIA (non-serious) with onset 01May2021, outcome "unknown", described as "joints have been aching/ Sore Joints"; FATIGUE (non-serious) with onset 30Apr2021, outcome "not recovered", described as "extremely fatigue"; POLYMENORRHOEA (non-serious) with onset 11May2021, outcome "unknown", described as "my period has been 2 times a month since may."; BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "Glucose 105"; ANTINUCLEAR ANTIBODY POSITIVE (non-serious), outcome "unknown", described as "ANA screen IFA Positive"; ASTHENIA (non-serious) with onset 11May2021, outcome "unknown", described as "two menstrual cycles a month making me more weak ". The event "joints have been aching/ sore joints" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia. Additional information: Prior Vaccinations and Concomitant drugs were reported as none. Interpretation included: All three negative tiers indicate the absence of detectable antibodies to component analytes consisting of double stranded DNA (dsDNA), chromatin, RNP, RNP, (SM), SSA. SSB, JO-1, Scl-70, Centromere B, and ribosomal P. A negative result should be interpreted in the context of clinical and laboratory findings. Treatment for Sore Joints included meloxicam. No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Glucose-6-phosphate dehydrogenase, Polymenorrhoea, Protein total, Red blood cell sedimentation rate decreased, Renal function test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient. A 40 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 08:30 (Lot number: EW0171) at the age of 40 years as dose 2, single and administered in arm left, administration date 09Apr2021 08:30 (Lot number: EW0150) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 30Apr2021, outcome "not recovered", described as "have had my hair fall out in clumps"; ARTHRALGIA (non-serious) with onset 01May2021, outcome "unknown", described as "joints have been aching/ Sore Joints"; FATIGUE (non-serious) with onset 30Apr2021, outcome "not recovered", described as "extremely fatigue"; POLYMENORRHOEA (non-serious) with onset 11May2021, outcome "unknown", described as "my period has been 2 times a month since may."; BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "Glucose 105"; ANTINUCLEAR ANTIBODY POSITIVE (non-serious), outcome "unknown", described as "ANA screen IFA Positive"; ASTHENIA (non-serious) with onset 11May2021, outcome "unknown", described as "two menstrual cycles a month making me more weak ". The event "joints have been aching/ sore joints" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia. Additional information: Prior Vaccinations and Concomitant drugs were reported as none. Interpretation included: All three negative tiers indicate the absence of detectable antibodies to component analytes consisting of double stranded DNA (dsDNA), chromatin, RNP, RNP, (SM), SSA. SSB, JO-1, Scl-70, Centromere B, and ribosomal P. A negative result should be interpreted in the context of clinical and laboratory findings. Treatment for Sore Joints included meloxicam. No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Carditis, Chest pain, Chills, Dyspnoea, Pyrexia
Clinical narrative: Fever/Chill within 24 hours; Fever/Chill within 24 hours; chest pain; shortness of breath; Told to take advil for heart inflammation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 16:30 (Lot number: FC3183) at the age of 15 years as dose 2, single and administered in arm left, administration date 06Aug2021 16:30 (Lot number: FA7483) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: CARDITIS (medically significant) with onset 2021, outcome "unknown", described as "Told to take advil for heart inflammation"; PYREXIA (non-serious), CHILLS (non-serious) all with onset 30Aug2021 02:00, outcome "recovered" (2021) and all described as "Fever/Chill within 24 hours"; CHEST PAIN (non-serious) with onset 30Aug2021 02:00, outcome "recovered" (2021), described as "chest pain"; DYSPNOEA (non-serious) with onset 30Aug2021 02:00, outcome "recovered" (2021), described as "shortness of breath". The events "told to take advil for heart inflammation", "fever/chill within 24 hours", "fever/chill within 24 hours", "chest pain" and "shortness of breath" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of pyrexia, chills, chest pain, dyspnoea.  Clinical course: Injection was on Friday and produced usual side effects. Fever/Chill within 24 hours. At 48 hours chest pain and shortness of breath occurred. Told to take advil for heart inflammation. No Covid prior to vaccination. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Dizziness, Impaired work ability, Memory impairment
Clinical narrative: My first injection caused severe dizziness; ultimately unable to speak; unable to function; ultimately unable to remember; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Sep2021 16:30 (Batch/Lot number: unknown) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Two extensive spinal fusion surgeries" (unspecified if ongoing), notes: Other medical history: Two extensive spinal fusion surgeries; "Severe sensitivies to dairy" (unspecified if ongoing), notes: Known allergies: Severe sensitivies to dairy, sugars, and carbohydrates.; "Known allergies: sugars and carbohydrates" (unspecified if ongoing), notes: Known allergies: Severe sensitivies to dairy, sugars, and carbohydrates. Concomitant medication(s) included: BUDESONIDE; AZELASTINE; TRAMADOL. The following information was reported: DIZZINESS (non-serious) with onset 21Sep2021 20:30, outcome "recovered with sequelae", described as "My first injection caused severe dizziness"; APHASIA (non-serious) with onset 21Sep2021 20:30, outcome "recovered with sequelae", described as "ultimately unable to speak"; IMPAIRED WORK ABILITY (non-serious) with onset 21Sep2021 20:30, outcome "recovered with sequelae", described as "unable to function"; MEMORY IMPAIRMENT (non-serious) with onset 21Sep2021 20:30, outcome "recovered with sequelae", described as "ultimately unable to remember". The events "my first injection caused severe dizziness", "ultimately unable to speak", "unable to function" and "ultimately unable to remember" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of dizziness, aphasia, impaired work ability, memory impairment.  Additional information: Onset latency for the events was 4 hours from vaccination. AE treatment: Benadryl (no effect), Lorazepam. Patient did not had covid prior vaccination. Patient was not tested positive for covid post vaccination. Other vaccine in four weeks: No   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Immunisation, Lethargy
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Nov2021 11:30 (Batch/Lot number: unknown) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "Prior to vaccination, the patient was diagnosed with COVID-19" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 2, Location of injection: Arm Left), administration date: 01May2021, when the patient was 49 years old, for COVID-19 immunization, reaction(s): "lymph node swelling", "lymph node tenderness", "tenderness at the site of injection", "moderate lethargy"; Bnt162b2 (Dose 1), administration date: 01Apr2021, when the patient was 49 years old, for COVID-19 immunization, reaction(s): "lymph node swelling", "lymph node tenderness", "tenderness at the site of injection", "moderate lethargy". The following information was reported: IMMUNISATION (non-serious) with onset 04Nov2021 11:30, outcome "unknown", described as "booster"; PAIN (non-serious) with onset 05Nov2021 12:00, outcome "recovering", described as "severe body aches"; LETHARGY (non-serious) with onset 05Nov2021 12:00, outcome "recovering", described as "extreme lethargy"; CHILLS (non-serious) with onset 05Nov2021 12:00, outcome "recovering", described as "gave me the worst chills I have ever had in my life"; HEADACHE (non-serious) with onset 05Nov2021 12:00, outcome "recovering", described as "severe headache"; PYREXIA (non-serious) with onset 05Nov2021 12:00, outcome "recovering", described as "102.5 fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, lethargy, chills, headache, pyrexia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Nov2021 11:30 (Batch/Lot number: unknown) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "Prior to vaccination, the patient was diagnosed with COVID-19" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 2, Location of injection: Arm Left), administration date: 01May2021, when the patient was 49 years old, for COVID-19 immunization, reaction(s): "lymph node swelling", "lymph node tenderness", "tenderness at the site of injection", "moderate lethargy"; Bnt162b2 (Dose 1), administration date: 01Apr2021, when the patient was 49 years old, for COVID-19 immunization, reaction(s): "lymph node swelling", "lymph node tenderness", "tenderness at the site of injection", "moderate lethargy". The following information was reported: IMMUNISATION (non-serious) with onset 04Nov2021 11:30, outcome "unknown", described as "booster"; PAIN (non-serious) with onset 05Nov2021 12:00, outcome "recovering", described as "severe body aches"; LETHARGY (non-serious) with onset 05Nov2021 12:00, outcome "recovering", described as "extreme lethargy"; CHILLS (non-serious) with onset 05Nov2021 12:00, outcome "recovering", described as "gave me the worst chills I have ever had in my life"; HEADACHE (non-serious) with onset 05Nov2021 12:00, outcome "recovering", described as "severe headache"; PYREXIA (non-serious) with onset 05Nov2021 12:00, outcome "recovering", described as "102.5 fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, lethargy, chills, headache, pyrexia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Immunisation, Overdose, Product preparation issue
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 72 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in deltoid left, administration date 09Nov2021 13:42 (Lot number: FA6780, Expiration Date: Dec2021) at the age of 72 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1, Time: 1342, Route of administration: Intramuscular), administration date: 05Mar2021, when the patient was 72 years old, for COVID-19 immunization; Bnt162b2 (DOSE: 2, Route of administration: Intramuscular), administration date: 22Mar2021, when the patient was 72 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Nov2021 13:42, described as "Dose: 3rd"; OVERDOSE (non-serious) with onset 09Nov2021 13:42, described as "inadvertent vaccination with a higher dose of the Pfizer Covid vaccine"; PRODUCT PREPARATION ISSUE (non-serious) with onset 09Nov2021 13:42, described as "higher concentration than recommended"; HEADACHE (non-serious) with onset 10Nov2021, described as "Headache". Therapeutic measures were not taken as a result of headache.  Additional info: The caller is calling to report a patient who was vaccinated with the Pfizer covid vaccine using two different vials, so it was a higher than authorized dose. Caller states the patient was given 0.1 ml from an undiluted vial and 0.2ml from a diluted vial equaling the right volume but a higher concentration than recommended. Volunteer stated that she was trained more than 6months ago and did not remember that she was not supposed to mix vials, and she was not familiar with diluting vaccines (all other clinics, vaccine was pre-drawn). Drug result: Unrelated.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: developed heart problems after and got a heart stent; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 44 year-old male 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, single), for Covid-19 Immunization.  The following information was reported: CARDIAC DISORDER (medically significant), outcome "unknown", described as "developed heart problems after and got a heart stent". Therapeutic measures were taken as a result of cardiac disorder.  Clinical Course: The reporter has a friend who got his second dose of Pfizer covid-19 vaccine and developed heart problems after and got a heart stent. The reporter wanted to ask if there are people reporting side effects of the vaccine. Pfizer Covid 19 vaccine: had heart problems and had to get a stent  Related. The patient's doctors thought this was related to the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  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.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation, Myalgia, Pain
Clinical narrative: 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), administration date 15Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (2nd Dose), for Covid-19 immunization; Bnt162b2 (1st Dose), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "I am just  having access pain"; MYALGIA (non-serious) with onset Nov2021, outcome "unknown", described as "I had reaction like that has left me with my muscles are aching today"; ARTHRALGIA (non-serious) with onset Nov2021, outcome "unknown", described as "I had reaction like that has left me with my joints are aching today"; IMMUNISATION (non-serious) with onset 15Nov2021, outcome "unknown", described as "had the Pfizer COVID booster yesterday". Additional information: Probed for name and number: Consumer stated, (not alpha spelled hence note captured in tab) I had the Pfizer COVID booster yesterday and I had reaction like that has left me with my joints and muscles are aching today and I am just wondering I have read all of the 4 pages or 8 pages of the information that I was given can I take Tylenol to alleviate my symptoms. "Safety report : Consumer stated, "Actually why don't I wait and talk to the medical people because I had a side effect (voice distorted)."Lot #: Consumer stated, "I don't have it on me I am sorry but I will find it and 'call back'." Any further assistance: Consumer stated, "I am just having access pain and I can't find anything in the literature that says but or not it's safe for me take an analgesic to help relief the pain. All I remember seen at somewhere and now I can't find it. "Patient details, Product details and Pharmacy details could not be probed over the call as consumer was unwilling to answer further questions. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Lymphadenopathy, Ultrasound testes
Clinical narrative: lymph node on the top of his collarbone; 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 32 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Nov2021 (Lot number: 330268D) at the age of 32 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 (Dose 1, single location: Left arm, Lot: FF2593), administration date: 22Oct2021, when the patient was 32 years old, for Covid-19 immunization, reaction(s): "blurred vision in one eye", "lymph node on the top of his collarbone". The following information was reported: LYMPHADENOPATHY (non-serious) with onset Nov2021, outcome "unknown", described as "lymph node on the top of his collarbone". The event "lymph node on the top of his collarbone" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that the letters written on the patient card but thinks they are 330268D for the lot number; states his patient card had no expiry date or NDC written on it. It was reported that the patient had no prior vaccinations (within 4 weeks) and no relevant family medical history. No Relevant test done. The reported event does not require to visit Physician Office. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. It was reported that, most people and everyone in his family was pretty much healthy; states he was not on any new medications, and he does not have any medical issues.  Follow up attempts are completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Inappropriate schedule of product administration, Interchange of vaccine products, Off label use
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) from medical information team. A 20 year-old male patient received bnt162b2 (COMIRNATY), administration date 24Nov2021 (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; Janssen (had received the Jansen covid vaccine one month ago. instead of 2 months.). The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), IMMUNISATION (non-serious) all with onset 24Nov2021, outcome "unknown" and all described as "received a Pfizer BTC vaccine booster dose"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "had received a Jansen covid vaccine 2 months ago". Additional info: It was reported, Calling regarding a 20 y/o adult who received a Pfizer BTC vaccine booster dose (purple cap,12 and older formula ) today, 24Nov2021, and stated he had received a Jansen covid vaccine 2 months ago. After the shot was given the HCP was told he had received the Jansen covid vaccine one month ago. instead of 2 months. Are there any safety concerns we should be aware of? The lot number for bnt162b2 was not provided and will be requested during follow up.