chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: received dose from a vial punctured more than 20 times; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (received dose from a vial punctured more than 20 times) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (received dose from a vial punctured more than 20 times). On 19-Nov-2021, PRODUCT ADMINISTRATION ERROR (received dose from a vial punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported. The reporter is pharmacy internship.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Received dose from a vial punctured more than 20 times; This spontaneous case was reported by a health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received dose from a vial punctured more than 20 times) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Received dose from a vial punctured more than 20 times). On 19-Nov-2021, ACCIDENTAL UNDERDOSE (Received dose from a vial punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that, the health care professional opened a Moderna vial and they were not aware that the vial could only be punctured 20 times, so they puncture the vial 24 times, and the patient received the dosage. The number of doses per vials was 4 doses in 1 vial.  No concomitant medications were reported.  No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: body aches for 2 months after second Moderna vaccine,sore arms for 2 months after second vaccine,sore legs for 2 months after second vaccine; body aches for 2 months after second Moderna vaccine,sore arms for 2 months after second vaccine,sore legs for 2 months after second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches for 2 months after second Moderna vaccine,sore arms for 2 months after second vaccine,sore legs for 2 months after second vaccine) and PAIN IN EXTREMITY (body aches for 2 months after second Moderna vaccine,sore arms for 2 months after second vaccine,sore legs for 2 months after second vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced MYALGIA (body aches for 2 months after second Moderna vaccine,sore arms for 2 months after second vaccine,sore legs for 2 months after second vaccine) and PAIN IN EXTREMITY (body aches for 2 months after second Moderna vaccine,sore arms for 2 months after second vaccine,sore legs for 2 months after second vaccine). In May 2021, MYALGIA (body aches for 2 months after second Moderna vaccine,sore arms for 2 months after second vaccine,sore legs for 2 months after second vaccine) and PAIN IN EXTREMITY (body aches for 2 months after second Moderna vaccine,sore arms for 2 months after second vaccine,sore legs for 2 months after second vaccine) had resolved.            No Concomitant medication was reported.     No treatment medications were reported.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombocytopenia
Clinical narrative: ecked her platelets and they had dropped from 80 in September to 15; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOCYTOPENIA (ecked her platelets and they had dropped from 80 in September to 15) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 017F21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, the patient experienced THROMBOCYTOPENIA (ecked her platelets and they had dropped from 80 in September to 15) (seriousness criterion medically significant). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, THROMBOCYTOPENIA (ecked her platelets and they had dropped from 80 in September to 15) outcome was unknown.            Concomitant medications were not reported .  Company Comment: This case concerns a 93-year-old, female patient, with medical history of immunocompromised state, who experienced the serious, unexpected, AESI event of thrombocytopenia. The event occurred  on unknown date after the first dose of mRNA 1273 vaccine. The rechallenge is not applicable as patient received treatment (prednisone) for event. The patient's immunocompromised state remains as a confounder to the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-395476, MOD-2021-392157 (Patient Link).; Sender's Comments: This case concerns a 93-year-old, female patient, with medical history of immunocompromised state, who experienced the serious, unexpected, AESI event of thrombocytopenia. The event occurred  on unknown date after the first dose of mRNA 1273 vaccine. The rechallenge is not applicable as patient received treatment (prednisone) for event. The patient's immunocompromised state remains as a confounder to the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Myelitis transverse, Paralysis
Clinical narrative: She nowhas Transverse Myelitis; Paralyzed from the waist down; This spontaneous case was reported by a consumer and describes the occurrence of MYELITIS TRANSVERSE (She nowhas Transverse Myelitis) and PARALYSIS (Paralyzed from the waist down) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYELITIS TRANSVERSE (She nowhas Transverse Myelitis) (seriousness criteria disability and medically significant) and PARALYSIS (Paralyzed from the waist down) (seriousness criteria disability and medically significant). At the time of the report, MYELITIS TRANSVERSE (She nowhas Transverse Myelitis) and PARALYSIS (Paralyzed from the waist down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that we have acquired numerous hospital bills and now have to modify our home and vehicle.  This case concerns a female subject of an unknown age, with no relevant history reported in this case, who experienced the serious unexpected events of Myelitis transverse (AESI) and Paralysis. The events occurred of an unknown date for an unknown date and schedule of administration of mRNA-1273 vaccine. The rechallenge is unknown for the events since no information about the dose sequence is provided. 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 case concerns a female subject of an unknown age, with no relevant history reported in this case, who experienced the serious unexpected events of Myelitis transverse (AESI) and Paralysis. The events occurred of an unknown date for an unknown date and schedule of administration of mRNA-1273 vaccine. The rechallenge is unknown for the events since no information about the dose sequence is provided. 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.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Urticaria
Clinical narrative: rush looked like hives; She was very tired; She was very sored; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (rush looked like hives), FATIGUE (She was very tired) and MYALGIA (She was very sored) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3004668) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (Batch: EL0739) on 03-Feb-2021 and Pfizer (Batch: AR1749) on 14-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced URTICARIA (rush looked like hives), FATIGUE (She was very tired) and MYALGIA (She was very sored). At the time of the report, URTICARIA (rush looked like hives), FATIGUE (She was very tired) and MYALGIA (She was very sored) outcome was unknown.            Patient was healthy does not take any concomitant medication.  Treatment medication include Antihistamine.; Sender's Comments: This case concerns a female patient with unknown age with no reported medical history, vaccinated first two doses with Pfizer Covid 19 vaccine , who experienced non-serious , unexpected event of urticaria and expected events of myalgia and fatigue which occurred on the night after vaccination with the 3rd dose ( booster dose ) using mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since the events occurred during the  third dose ( booster dose ) and no additional doses will be given and also the outcome of the events is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraines; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraines) in a 69-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (migraines). At the time of the report, MIGRAINE (migraines) outcome was unknown. Not Provided          This case was linked to MOD-2021-395778.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Pain, Pruritus, Rash
Clinical narrative: Redness in the face/Redness in the neck; throat itchy; arm itchy; She feels like little needles that prick; Patient is having a rash in the face/Patient is having a rash in the neck; Allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness in the face/Redness in the neck), THROAT IRRITATION (throat itchy), PRURITUS (arm itchy), PAIN (She feels like little needles that prick) and RASH (Patient is having a rash in the face/Patient is having a rash in the neck) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939909) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hyperthyroidism. Concomitant products included LEVOTHYROXINE for Hyperthyroidism.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced ERYTHEMA (Redness in the face/Redness in the neck), THROAT IRRITATION (throat itchy), PRURITUS (arm itchy), PAIN (She feels like little needles that prick), RASH (Patient is having a rash in the face/Patient is having a rash in the neck) and HYPERSENSITIVITY (Allergic reaction). At the time of the report, ERYTHEMA (Redness in the face/Redness in the neck), THROAT IRRITATION (throat itchy), PRURITUS (arm itchy), PAIN (She feels like little needles that prick), RASH (Patient is having a rash in the face/Patient is having a rash in the neck) and HYPERSENSITIVITY (Allergic reaction) outcome was unknown.            No concomitant medications were reported.   No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Redness in the face/Redness in the neck; throat itchy; arm itchy; She feels like little needles that prick; Patient is having a rash in the face/Patient is having a rash in the neck; Allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness in the face/Redness in the neck), THROAT IRRITATION (throat itchy), PRURITUS (arm itchy), PAIN (She feels like little needles that prick) and RASH (Patient is having a rash in the face/Patient is having a rash in the neck) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939909) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hyperthyroidism. Concomitant products included LEVOTHYROXINE for Hyperthyroidism.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced ERYTHEMA (Redness in the face/Redness in the neck), THROAT IRRITATION (throat itchy), PRURITUS (arm itchy), PAIN (She feels like little needles that prick), RASH (Patient is having a rash in the face/Patient is having a rash in the neck) and HYPERSENSITIVITY (Allergic reaction). At the time of the report, ERYTHEMA (Redness in the face/Redness in the neck), THROAT IRRITATION (throat itchy), PRURITUS (arm itchy), PAIN (She feels like little needles that prick), RASH (Patient is having a rash in the face/Patient is having a rash in the neck) and HYPERSENSITIVITY (Allergic reaction) outcome was unknown.            No concomitant medications were reported.   No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes virus infection, Interchange of vaccine products
Clinical narrative: started with herpes virus in "below" area two days ago; Interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of HERPES VIRUS INFECTION (started with herpes virus in "below" area two days ago) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer (given in left non-dominant arm. Lot number: Unknown) on 22-Mar-2021 and Pfizer (given in left non-dominant arm. Lot number: Unknown) on 12-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On 18-Nov-2021, the patient experienced HERPES VIRUS INFECTION (started with herpes virus in "below" area two days ago). On 16-Nov-2021, INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) had resolved. At the time of the report, HERPES VIRUS INFECTION (started with herpes virus in "below" area two days ago) had not resolved.            No concomitant medication were given.  Treatment include Little bit of cream
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: headache, a really bad headache; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache, a really bad headache) and MYALGIA (muscle aches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]) for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache, a really bad headache) and MYALGIA (muscle aches). At the time of the report, HEADACHE (headache, a really bad headache) and MYALGIA (muscle aches) outcome was unknown.            No concomitant medications were reported.  This is a spontaneous case concerning a patient of an unknown age and gender with no relevant medical history reported, who experienced non serious, expected events of headache and myalgia. The events occurred on an unknown date day after the third dose of mRNA-1273 vaccine. No information about first and second dose was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of an unknown age and gender with no relevant medical history reported, who experienced non serious, expected events of headache and myalgia. The events occurred on an unknown date day after the third dose of mRNA-1273 vaccine. No information about first and second dose was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Dysstasia, Fall, Vaccination site pain
Clinical narrative: fell back on the bed; She was unable to stand up on her own; dehydrated; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FALL (fell back on the bed), DYSSTASIA (She was unable to stand up on her own) and DEHYDRATION (dehydrated) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FALL (fell back on the bed) (seriousness criterion hospitalization), DYSSTASIA (She was unable to stand up on her own) (seriousness criterion hospitalization), DEHYDRATION (dehydrated) (seriousness criterion hospitalization) and VACCINATION SITE PAIN (sore arm). At the time of the report, FALL (fell back on the bed), DYSSTASIA (She was unable to stand up on her own) and DEHYDRATION (dehydrated) had resolved and VACCINATION SITE PAIN (sore arm) outcome was unknown.            The concomitant medication was not reported. Patient took IV liquids. Patient did not have any symptoms after leaving the emergency room.  Company Comment: This is a Spontaneous case concerning a female patient of unknown age with unknown medical history,  who experienced the unexpected serious (hospitalization) events of Fall, dehydration and dysstasia. The events occurred after the second dose of mRNA 1273 vaccine. Patient received IV hydration.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-393428, MOD-2021-393454 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a female patient of unknown age with unknown medical history,  who experienced the unexpected serious (hospitalization) events of Fall, dehydration and dysstasia. The events occurred after the second dose of mRNA 1273 vaccine. Patient received IV hydration.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 23.0
Sex: U
Vaccine: COVID19
Symptoms: Migraine, Tremor
Clinical narrative: Shaking in my hand; Very severe migraine; This is a spontaneous report from a contactable consumer or other non healthcare professional.     A 23-years-old patient of an unspecified gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot number: EW0183), via an unspecified route, administered in Arm Left on 06Jul2021 (at the age of 23 years), as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 15Jul2021, the patient experienced shaking in my hand and very severe migraine. The patient took Advil for migraine. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: first dose: left arm swollen like a cannonball; first dose: left arm swollen like a cannonball / it was hard, awful, and painful; This is a spontaneous report from a contactable consumer. This 59-year-old female consumer (patient) reported for herself that:   A female patient of an unspecified age received bnt162b2 (Pfizer COVID-19 vaccine, Formulation; Solution for Injection, Batch/Lot Number: EW0168 and expiry date was not provided), DOSE 1 via an unspecified route of administration, administered in Arm Left on 20Jul2021 (Age at vaccination was 58-years) as DOSE 1, SINGLE for Covid-19 Immunisation. And second dose was administered on 11Aug2021 with Lot Pfizer EW0170 in her right arm. The patient medical history and concomitant medications were not provided. The patient experienced First dose: Left arm Swollen like a Cannonball and first dose: left arm swollen like a cannonball / it was hard, awful, and painful on an unspecified date in 2021. The events were assessed as Non serious. The outcome of events was Unknown.    Follow-Up (27Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, SARS-CoV-2 test negative
Clinical narrative: I had a severe flare in my arthritis; This is a spontaneous report from a contactable consumer (Patient) or other non-HCP, who reported for herself.  A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was EW0153) via an unspecified route of administration on an unspecified date in May2021 as a DOSE 2, SINGLE for COVID-19 immunization. Relevant medical history included Rheumatoid arthritis from an unspecified date. The condition had been stable for several years. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination was tested for COVID-19. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration on an unspecified date as a DOSE 1, SINGLE for COVID-19 immunization. On an unspecified date in May2021, exactly 6 days after 2nd dose, the patient experienced I had a severe flare in my arthritis. An unspecified treatment was received for the adverse event. The patient underwent lab tests and medical procedure on an unspecified date in Aug2021 which included SARS-CoV-2 test negative. The clinical outcome of the event was Not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood cholesterol increased, Low density lipoprotein, Low density lipoprotein increased
Clinical narrative: two of his patients have had a significant increase in their total cholesterol and LDL levels a few days after receiving the BNT162B2 vaccine; two of his patients have had a significant increase in their total cholesterol and LDL levels a few days after receiving the BNT162B2 vaccine; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reported as that two of his patients have had a significant increase in their total cholesterol and LDL levels a few days after receiving the BNT162B2 vaccine. Pharmacist also added that these patients had no other change whether in their exercise routine or their dietary habits. They had not consumed food with large amounts of cholesterol. On an unspecified date, The patient experienced two of his patients have had a significant increase in their total cholesterol and ldl levels a few days after receiving the BNT162B2 vaccine. The patient underwent lab tests and procedures which included blood cholesterol: increase on, low density lipoprotein: increase on.  The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (07Oct2021): 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101103564 same drug/AE/reporter, different pt.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: numbness down left leg.; severe pain; tingling; This is a spontaneous report from a contactable consumer (patient).   A 42-year-old male patient the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0172) via unknown route of administration administered in left arm on 27Aug2021 03:30 PM (at age of 42 years) at single dose for COVID-19 immunisation. Medical history included herniating and protruding discs in 2018 (I have never had this much pain from the disc issues). Concomitant medications were not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0175) via unknown route of administration administered in left arm on 06Aug2021 02:00 PM (at age of 42 years) at single dose for COVID-19 immunization and had Back pain. Patient experienced the morning after the second dose woke up in severe pain with tingling and numbness down left leg on 28Aug2021. Events resulted Doctor or other healthcare professional office/clinic visit. Treatment was receievd with meds, steroid shot, physical therapy, awaiting mri. Outcome of the events was not recovered  Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate decreased, Palpitations, Somnolence
Clinical narrative: Experienced heart racing for 2 days after each dose/After second dose - heart was racing faster and felt more severe; Most significant was after the second pfizer. Had trouble getting heart rate down.; Had difficulty catching breath; Couldn't wake up from sleep to take medicine.; This is a spontaneous report from a contactable consumer. A 32-years-old female patient received bnt162b2 (BNT162B2; Batch/Lot Number: FA7485), via an unspecified route of administration, administered in Arm Right on 12Jul2021(at the age of 32 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included food allergy from an unknown date and unknown if ongoing. Concomitant medications included acetylsalicylic acid (ASPRIN); ibuprofen (MOTRIN); tretinoin; minoxidil (ROGAINE); convallaria majalis, crataegus laevigata, proxyphylline (OMEGA ). Known allergies included triple antibiotics (neosporin), cranberrys. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. The patient previously took neosporine and experienced drug hypersensitivity. Historical vaccine included first dose of bnt162b2(Batch/lot number: FA6780), via an unspecified route of administration, administered in right arm on 12Jul2021 10:00 AM for covid-19 immunisation and experienced palpitations. The patient experienced experienced heart racing for 2 days after each dose/after second dose - heart was racing faster and felt more severe on 13Jul2021 13:00, had difficulty catching breath on 12Jul2021 10:30, couldn't wake up from sleep to take medicine on 12Jul2021 10:30, most significant was after the second pfizer. had trouble getting heart rate down on 13Jul2021 13:00. The patient underwent lab tests and procedures which included heart rate: decreased on 13Jul2021. The outcome of the events was recovered on an unspecified date in Jul2021.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Cough, Dizziness, Feeling hot
Clinical narrative: dizzy; nausea; pain in stomach that lasted almost 5 days; Now I currently have a sore throat as well and coughing; I'm energy has been sparse Off and on; Now I currently have a sore throat as well and coughing; I feel hot most of the day; I felt better for 3 then became sick again with same symptoms; I get severe migraines; This is a spontaneous report from a contactable Other HCP. Patient reported that:  A 35-years-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 Vaccine, Solution for injection, Batch/Lot Number: 1474461-09258) via an unspecified route of administration, administered in Arm Right on 10Sep2021 14:30 (Age at vaccination 35-years-old) as DOSE 1, SINGLE for COVID-19 immunization. No medical history was reported. The patient had no known allergies. Concomitant medications included Gardasil the patient received second dose of Gardasil in left arm on 01Sep2021 within 4 weeks prior to the COVID vaccine and cyred for Birth Control. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19.  On Sep2021, the patient reported I get severe migraines, patient currently have a sore throat as well and coughing and patient energy has been sparse Off and on. On 10Sep2021 16:45, the patient experienced dizzy, Nausea, pain in stomach that lasted almost 5 days. It was reported that 2 hrs after injection: dizzy, nausia, and pain in stomach that lasted almost 5 days. I felt better for 3 then became sick again with same symptoms. I get severe migraines now that I have to take Advil for everyday or I can't think straight. And I'm energy has been sparse Off and on. Now I currently have a sore throat as well and coughing. I feel hot most of the day. I haven't felt like myself since. Feels like I got sick from it. I was told I would feel better by a Dr by day 4 and to keep taking Advil and drink water. Which I have done. Doctor or other healthcare professional office/clinic visit. The outcome was reported as unknown for patient energy has been sparse Off and on and not recovered for rest all of the events.    Follow-Up (23Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Migraine, Nausea, Oropharyngeal pain
Clinical narrative: dizzy; nausea; pain in stomach that lasted almost 5 days; Now I currently have a sore throat as well and coughing; I'm energy has been sparse Off and on; Now I currently have a sore throat as well and coughing; I feel hot most of the day; I felt better for 3 then became sick again with same symptoms; I get severe migraines; This is a spontaneous report from a contactable Other HCP. Patient reported that:  A 35-years-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 Vaccine, Solution for injection, Batch/Lot Number: 1474461-09258) via an unspecified route of administration, administered in Arm Right on 10Sep2021 14:30 (Age at vaccination 35-years-old) as DOSE 1, SINGLE for COVID-19 immunization. No medical history was reported. The patient had no known allergies. Concomitant medications included Gardasil the patient received second dose of Gardasil in left arm on 01Sep2021 within 4 weeks prior to the COVID vaccine and cyred for Birth Control. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19.  On Sep2021, the patient reported I get severe migraines, patient currently have a sore throat as well and coughing and patient energy has been sparse Off and on. On 10Sep2021 16:45, the patient experienced dizzy, Nausea, pain in stomach that lasted almost 5 days. It was reported that 2 hrs after injection: dizzy, nausia, and pain in stomach that lasted almost 5 days. I felt better for 3 then became sick again with same symptoms. I get severe migraines now that I have to take Advil for everyday or I can't think straight. And I'm energy has been sparse Off and on. Now I currently have a sore throat as well and coughing. I feel hot most of the day. I haven't felt like myself since. Feels like I got sick from it. I was told I would feel better by a Dr by day 4 and to keep taking Advil and drink water. Which I have done. Doctor or other healthcare professional office/clinic visit. The outcome was reported as unknown for patient energy has been sparse Off and on and not recovered for rest all of the events.    Follow-Up (23Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Full blood count, Magnetic resonance imaging head abnormal, Metabolic function test, Vitamin D
Clinical narrative: tired/the 2nd one made me tired; This is a spontaneous report from a contactable nurse (patient) and a physician. A 69-year-old female patient received second dose of BNT162B2 Intramuscular on 11Feb2021 on Deltoid Left (at age of 69-year-old, lot number: EN5318) at single dose for COVID-19 immunization. Medical history included ongoing RSD, ongoing Chronic cough, ongoing HTN and ongoing Reflux. Concomitant medications included unspecified medications. Prior vaccinations (within 4 weeks) was None. Historical vaccine included first dose of BNT162B2 intramuscular on right deltoid on 19Jan2021 (at age of 69-year-old) (lot number: EL8982) for COVID-19 immunization and experienced a whole lot of headache, Eye swelling, Swelling, Dizziness, Vomiting, Blurry vision, Vaccination site pain, Vaccination site swelling, Sweating, Frequency urinary, Absent-minded, Dysgeusia, Muscle spasms, Feeling unwell, Fall, Tiredness, Cry, Bad allergic reaction, Feeling dazed, Numbness, Loss of balance, Hives, weakness. Patient experienced tired in Feb2021. Relevant tests: Brain MRI, Date:06May2021, Result: normal, CMP, Date:08Apr2021, Result: normal, Vitamin D, Date:08Apr2021, Norm low, CBC, Date:08Apr2021, Result: hemoglobin, Norm high. The outcome of the event was unknown. Serious was reported as No. The patient provide information to physician regarding the reported adverse event(s) with the use of the product, physician consider the Pfizer product had a causal effect to the adverse event.   Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Oropharyngeal pain, Pain
Clinical narrative: Sore arm-swollen and red; Sore arm-swollen and red; tiredness; Headache; body aches; Sore throat; She also had a sore arm; This is a spontaneous report from a contactable consumer. A 75-year-old female patient reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 15Mar2021 (at 75-year-old) in right arm, as dose 2, single for COVID-19 immunization. The patient's medical history included allergies- rag weed seasonal allergies spring and fall. The patient's concomitant medications were not reported. The patient had not received other products and did not have any investigation assessment. On an unknown date Sore arm-swollen and red and tiredness. On an unknown date in Mar2021 the patient experienced headache, body aches, sore throat, she also had a sore arm. The outcome of Sore arm-swollen and red and tiredness was unknown. On an unknown date in Mar2021 headache, body aches, sore throat, she also had a sore arm recovered.  The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Sore arm-swollen and red; Sore arm-swollen and red; tiredness; Headache; body aches; Sore throat; She also had a sore arm; This is a spontaneous report from a contactable consumer. A 75-year-old female patient reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 15Mar2021 (at 75-year-old) in right arm, as dose 2, single for COVID-19 immunization. The patient's medical history included allergies- rag weed seasonal allergies spring and fall. The patient's concomitant medications were not reported. The patient had not received other products and did not have any investigation assessment. On an unknown date Sore arm-swollen and red and tiredness. On an unknown date in Mar2021 the patient experienced headache, body aches, sore throat, she also had a sore arm. The outcome of Sore arm-swollen and red and tiredness was unknown. On an unknown date in Mar2021 headache, body aches, sore throat, she also had a sore arm recovered.  The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Vertigo
Clinical narrative: Clogged ears; Severe vertigo; This is a spontaneous report from a contactable other healthcare professional.  This 51-year-old male other healthcare professional (patient) reported for himself that he received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL3248) intramuscularly into the left arm on 11Jan2021 (at the age of 51-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EK5730) intramuscularly into the left arm on 21Dec2020 (at the age of 51-year-old) as dose 1, single for COVID-19 immunisation. The patient also received dose 3 of BNT162B2 (Lot number: 30135BA) intramuscularly into the left arm on 29Sep2021. On an unspecified date in Jan2021, the patient experienced clogged ears and severe vertigo. After the second dose, the patient developed clogged ears and severe vertigo that would occur every week or so for several months, gradually getting better and less severe. It finally resolved and then he received the third shot and in less than a week had severely clogged ears and now tinnitus which had lasted for a full week now; adverse event start date was 26Sep2021; patient had not recovered. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Device date was reported to be 04Oct2021. Treatment received included MRI, CT scan, hearing test. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Outcome was resolved on an unspecified date in 2021 for both the events.  Follow-Up (12Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain
Clinical narrative: Severe hip and lower back painactually started after the 2nd dose; Severe hip and lower back painactually started after the 2nd dose; This is a spontaneous report from contactable female consumer (patient) reported for herself. A 62-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EK9231), dose 2 intramuscularly, administered in Deltoid Left on 12Jan2021 14:00 (age at the time of vaccination was 62-year-old) as dose 2, single for COVID-19 immunization. Medical history included ongoing diabetes mellitus, ongoing hyperlipidaemia, ongoing hypertension. There were no concomitant medications. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: EJ1685), dose 1 via an unspecified route of administration, administered in Arm Left on 22Dec2020 02:00 PM (age at the time of vaccination was 62-year-old) as dose 1, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. It was reported that the patient experienced severe hip and lower back pain actually started after the second dose on 14Jan2021 and was unable to get relief from going to the Chiropractor. She had been seeking care with a chiropractor. Outcome of both the events was reported as recovering at this time of the report.  Device Date : 04Oct2021  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: extremely sore left arm/"extreme pain in his left arm" where he received the Pfizer COVID-19 vaccine shot for the past 5 months; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in arm left on 06May2021 (Batch/Lot number was not reported) (at age 72-years-old) as dose number unknown, single for covid-19 immunisation.  Medical history included glaucoma from 1990 and ongoing. There were no concomitant medications. The patient experienced extremely sore left arm/ extreme pain in his left arm where he received the Pfizer covid-19 vaccine shot for the past 5 months. Patient wanted to find out how long he will have this reaction. He was scared to get the booster because he is scared he may get crippled in the arm. Stated that pain management wanted him to get X-rays because he knew what it was from and told them no. Patient reported that within 24 hours of getting the shot that he started having pain on May2021. Treatment included muscle relaxers. Outcome of the event was not recovered.  Follow-up attempts are completed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Heart rate, Heart rate increased, Immunisation
Clinical narrative: Booster dose; When I get really relax my heart starts beating up; fast heart beat; I urinate; I get frequent urine; I have no control over it; it's is basically at night not so much during the day; Dizzy; Shortness of breath; but stated he went to ER twice for congestion but he is better now.; This is a spontaneous report from a contactable consumer. This consumer reported that, A patient of unspecified age and gender received third dose (booster) of BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: not reported, Expiry date: not reported) via an unspecified route of administration, on an unspecified date as dose 3 (booster), single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: not reported, Expiry date: unknown) via an unspecified route of administration, on an unspecified date in Feb2021 as dose 1, single for COVID-19 immunization and took second dose of BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: not reported, Expiry date: unknown) via an unspecified route of administration, on an unspecified date in Feb2021 as dose 1, single for COVID-19 immunization. On an unspecified date, the patient takes booster dose and patient get really relax his heart starts beating up; fast heartbeat, patient urinate; get frequent urine; have no control over it; it's basically at night not so much during the day, dizzy, shortness of breath, but stated he went to er twice for congestion, but he is better now. It was reported that patient had the booster shot then having side effects. When patient get really relax patient heart starts beating up. The biggest problem patient urinate mean get frequent urine. Patient have no control over it, it's is basically at night not so much during the day. Patient feel dizzy, shortness of breath and fast heartbeat. On an unspecified date. the patient underwent lab tests and procedures which included heart rate: increased. The outcome of the event but stated he went to ER twice for congestion but he is better now recovering and for the other event was unknown.  Follow-up attempts have been completed and no further information is expected.