chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Nausea
Clinical narrative: inability to eat, clarified as feeling queasy.; inability to eat, clarified as feeling queasy.; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (inability to eat, clarified as feeling queasy.) and NAUSEA (inability to eat, clarified as feeling queasy.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Shingles. Concurrent medical conditions included Bell's palsy.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, 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 experienced FEEDING DISORDER (inability to eat, clarified as feeling queasy.) and NAUSEA (inability to eat, clarified as feeling queasy.). At the time of the report, FEEDING DISORDER (inability to eat, clarified as feeling queasy.) and NAUSEA (inability to eat, clarified as feeling queasy.) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-337833 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: slighty swollen sore arm with both vaccines; slighty swollen sore arm with both vaccines; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (slighty swollen sore arm with both vaccines) and VACCINATION SITE PAIN (slighty swollen sore arm with both vaccines) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included Heart valve disorders (history of heart valves). Concurrent medical conditions included Overweight (slightly overweight).   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE SWELLING (slighty swollen sore arm with both vaccines) and VACCINATION SITE PAIN (slighty swollen sore arm with both vaccines). At the time of the report, VACCINATION SITE SWELLING (slighty swollen sore arm with both vaccines) and VACCINATION SITE PAIN (slighty swollen sore arm with both vaccines) outcome was unknown.            No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   This case was linked to MOD-2021-337936 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, COVID-19, Drug ineffective, Fatigue, Illness
Clinical narrative: Arm pain forever; Bursitis; Sick; injection site pain; Some fatigue; COVID positive / just getting over COVID; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain forever), BURSITIS (Bursitis), ILLNESS (Sick), COVID-19 (COVID positive / just getting over COVID) and DRUG INEFFECTIVE (Lack of drug effect) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shoulder replacement. Previously administered products included for an unreported indication: FLU. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and ALENDRONATE SODIUM (FOSAMAX) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Sep-2021, the patient experienced COVID-19 (COVID positive / just getting over COVID) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain forever), BURSITIS (Bursitis), ILLNESS (Sick), INJECTION SITE PAIN (injection site pain) and FATIGUE (Some fatigue). At the time of the report, PAIN IN EXTREMITY (Arm pain forever), BURSITIS (Bursitis), ILLNESS (Sick), COVID-19 (COVID positive / just getting over COVID), DRUG INEFFECTIVE (Lack of drug effect), INJECTION SITE PAIN (injection site pain) and FATIGUE (Some fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Sep-2021, SARS-CoV-2 test: positive (Positive) COVID positive.         No Treatment were reported. Patient mentioned flu shot caused bursitis and tendonitis.   Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: follow up received on 29-SEP-2021 includes Event was added On 04-Oct-2021: follow up received contains medical history , events for flu shot; Sender's Comments: This case concerns a 71-year-old, female with reported history of Flu vaccination and shoulder replacement, who experienced the unexpected AESI event of Drug ineffective because of COVID 19 infection more than 15 days after the second dose of the vaccine within a correct interval with the first dose. The event occurred approximately 7 months and 26 days after the first dose and 6 month and 27 days after the most recent dose (second dose) of mRNA-1273 Moderna vaccine (Spikevax). The rechallenge was unknown since the patient is planning on getting the booster. Several other non serious or AESI events were reported, such as pain in extremity, tendinitis and bursitis that could be confounded by the history of shoulder replacement and the co suspect of flu vaccine. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Arm pain forever; Bursitis; Sick; injection site pain; Some fatigue; COVID positive / just getting over COVID; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain forever), BURSITIS (Bursitis), ILLNESS (Sick), COVID-19 (COVID positive / just getting over COVID) and DRUG INEFFECTIVE (Lack of drug effect) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shoulder replacement. Previously administered products included for an unreported indication: FLU. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and ALENDRONATE SODIUM (FOSAMAX) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Sep-2021, the patient experienced COVID-19 (COVID positive / just getting over COVID) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain forever), BURSITIS (Bursitis), ILLNESS (Sick), INJECTION SITE PAIN (injection site pain) and FATIGUE (Some fatigue). At the time of the report, PAIN IN EXTREMITY (Arm pain forever), BURSITIS (Bursitis), ILLNESS (Sick), COVID-19 (COVID positive / just getting over COVID), DRUG INEFFECTIVE (Lack of drug effect), INJECTION SITE PAIN (injection site pain) and FATIGUE (Some fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Sep-2021, SARS-CoV-2 test: positive (Positive) COVID positive.         No Treatment were reported. Patient mentioned flu shot caused bursitis and tendonitis.   Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: follow up received on 29-SEP-2021 includes Event was added On 04-Oct-2021: follow up received contains medical history , events for flu shot; Sender's Comments: This case concerns a 71-year-old, female with reported history of Flu vaccination and shoulder replacement, who experienced the unexpected AESI event of Drug ineffective because of COVID 19 infection more than 15 days after the second dose of the vaccine within a correct interval with the first dose. The event occurred approximately 7 months and 26 days after the first dose and 6 month and 27 days after the most recent dose (second dose) of mRNA-1273 Moderna vaccine (Spikevax). The rechallenge was unknown since the patient is planning on getting the booster. Several other non serious or AESI events were reported, such as pain in extremity, tendinitis and bursitis that could be confounded by the history of shoulder replacement and the co suspect of flu vaccine. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: administered the first dose of Moderna then contracted COVID; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (administered the first dose of Moderna then contracted COVID) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (administered the first dose of Moderna then contracted COVID). At the time of the report, COVID-19 (administered the first dose of Moderna then contracted COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient wants to know whether safe to take her second dose . Concomitant medication use was unknown Treatment information was unknown; Sender's Comments: This case concerns  a female with unknown age with no reported relevant medical history , who experienced the unexpected event of Covid 19. This event occurred on an unknown date after the 1st dose of mRNA-1273 (Moderna) .  The rechallenge is  not applicable. The benefit-risk relationship of Moderna is not affected by this report.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A, 015M20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021 at 10:59 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021 at 9:18 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-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 experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A, 031M20A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not reported. Treatment medications was not reported.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A, 016M20A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Sep-2015, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported vaccine administered to patient on SEP 01 2021 as a third dose without any adverse effect
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A, 012M20A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021 at 1:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021 at 3:09 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021 at 4:21 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No Treatment medication information was provided
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A, 010A21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication details were provided. No Treatment medication details were provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.   This case was linked to MOD-2021-306137 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A, 029A21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021 at 1:13 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021 at 1:21 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication were reported.  No treatment medication were reported.  Moderna vaccine 044A21A expired on 31 Aug 2021. Vaccine administered to client on 01 Sep 2021 as a third dose.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A, 031M20A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergies to medications), Food allergy and Allergy (Other products).   On 16-Jan-2021 at 11:42 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021 at 10:03 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that there was no adverse event noted.  Concomitant medication information was not reported  Treatment information was not reported
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A, 030L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest discomfort, Diarrhoea, Muscle tightness, Nausea
Clinical narrative: Saturday-Tuesday tight chest; Saturday-Tuesday tight chest, should and pectoral muscle; Wednesday- nausea; stomach cramps; watery diarrhea; This is a spontaneous report from a contactable other hcp. A 27-years-old female (non-pregnant) patient received bnt162b2 (Formulation: Solution for injection in pre-filled syringe, Batch/lot number : unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 17Jul2021 14:00 (age at vaccination: 27 years old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Hashimotos thyroiditis from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (B12 [CYANOCOBALAMIN]) taken for an unspecified indication, start and stop date were not reported; zinc (ZINC) taken for an unspecified indication, start and stop date were not reported; ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid, caffeine (BC [ACETYLSALICYLIC ACID;CAFFEINE]) taken for an unspecified indication, start and stop date were not reported; loratadine (CLARITIN [LORATADINE]) taken for an unspecified indication, start and stop date were not reported.  The patient previously took nickel and experienced allergy to metals.  The patient had covid prior vaccination and covid not tested post vaccination.On 21Jul2021, 08:00 AM Patient experienced, Saturday to tuesday tight chest, shoulder and pectoral muscle, Wednesday nausea, stomach cramps, watery diarrhea (as reported). The outcome of all events reported as not recovered.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness
Clinical narrative: lightheadedness and stomach pain at night; lightheadedness and stomach pain at night; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself) via Medical Information Team. A 17-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 22Jul2021 as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date in Jul2021, the patient experienced light-headedness and stomach pain at night. The patient was asking if these are normal side effects of the vaccine or if she needs to see a doctor. The outcome of the event was unknown.    Information about lot/Batch number has been requested.  Information about lot/batch number cannot be obtained. No further information expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Headache, Pain, Vaccination site pain
Clinical narrative: Body aches; tired; headaches; Just overall a not feeling well arm sore at injection site; Just overall a not feeling well arm sore at injection site; Some chest pain very minor; This is a spontaneous report from a contactable consumer or other non hcp. A 52-years-old male patient received BNT162b2 (CONMINTARY, Solution for injection, Lot No: was not reported), via an unspecified route of administration, administered in Arm Left on 23Jul2021 17:30 as 2nddose, single for covid-19 immunisation (age at vaccination was 52 years). Historical vaccine was A 52-years-old male patient received BNT162b2 (CONMINTARY, Solution for injection, Lot No: was not reported), via an unspecified route of administration, administered in Arm Left on 02Jul2021, 04:30 PM as 1st dose, single for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications were not reported.  The patient experienced body aches, tired, headaches, just overall a not feeling well arm sore at injection site, just overall a not feeling well arm sore at injection site, some chest pain very minor on 24Jul2021 10:00. No treatment was received. No, covid prior vaccination. If covid tested post vaccination was no. The clinical outcome of the events was recovering.    Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Body aches; tired; headaches; Just overall a not feeling well arm sore at injection site; Just overall a not feeling well arm sore at injection site; Some chest pain very minor; This is a spontaneous report from a contactable consumer or other non hcp. A 52-years-old male patient received BNT162b2 (CONMINTARY, Solution for injection, Lot No: was not reported), via an unspecified route of administration, administered in Arm Left on 23Jul2021 17:30 as 2nddose, single for covid-19 immunisation (age at vaccination was 52 years). Historical vaccine was A 52-years-old male patient received BNT162b2 (CONMINTARY, Solution for injection, Lot No: was not reported), via an unspecified route of administration, administered in Arm Left on 02Jul2021, 04:30 PM as 1st dose, single for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications were not reported.  The patient experienced body aches, tired, headaches, just overall a not feeling well arm sore at injection site, just overall a not feeling well arm sore at injection site, some chest pain very minor on 24Jul2021 10:00. No treatment was received. No, covid prior vaccination. If covid tested post vaccination was no. The clinical outcome of the events was recovering.    Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis, SARS-CoV-2 test
Clinical narrative: I developed diagnosed psoriasis after the second dose of my covid vaccine.  The symptoms is moderate to severe with plague psoriasis through my entire scalp, face, chest, back, arms, legs and througho; This is a spontaneous report from a non-contactable consumer (patient himself).   A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number: Not reported) via an unspecified route, administered in Right arm on 17Mar2021 (41-year-old at vaccination) as a Dose 2, Single for Covid-19 immunization. Facility type vaccine was reported as Pharmacy or Drug Store. The patient's medical history included elevated sugar level, elevated cholesterol, chronic ear medical condition and known allergies to Ciprofloxin. The patient's family medical history included genetic predisposed with his father and sister having mild psoriasis or eczema. The patient's concomitant medications were not reported. The patient had not received any other vaccine within four weeks prior to vaccination. The patient was not diagnosed for covid prior vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number: Not reported) via an unspecified route, administered in Right arm on 24Feb2021 (41-year-old at vaccination) as a Dose 1, Single for Covid-19 immunization. The patient developed diagnosed psoriasis after the second dose of his covid vaccine. The symptoms was moderate to severe with plague psoriasis through his entire scalp, face, chest, back, arms, legs and throughout body. He had never had psoriasis but genetic predisposed with his father and sister having mild psoriasis or eczema. He had been prescribed steroid cream, steroid pills and Tacrolimus but had not healed after 3 months of therapy. Currently he would start systemic injections (Skyrizi, immunosuppressant biologics) due to the fact that it's spreading, and symptoms are not improving. Additionally, he would have to joined a Psoriasis support group on social media and various others have reported psoriasis flare up after their Covid vaccine after being in remission for years. These adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab test and procedure which included Sars CoV-2 test (Nasal swab): result unspecified, post vaccination. The outcome of the event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Ear infection
Clinical narrative: she got ear infection and she was on antibiotic therapy; This is a spontaneous report from a contactable consumer (patient) via regulatory authority (CEP ID: 159558). A female patient of an unspecified age 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 30Jun2021, as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient got ear infection. She said that her 2nd dose is scheduled today (05Aug2021). She wants to know if it is safe for her to do air travel after getting the 2nd dose. She added that she got the 1st dose of the Covid-19 vaccine last 30Jun2021 and originally, her 2nd dose schedule was on 30Jul2021, but she got ear infection and she was on antibiotic therapy that is why she did not get the 2nd dose on its scheduled date. Submitted a manual AE form because of ear infection after taking the 1st dose of the Covid-19 vaccine. Therapeutic measures were taken as a result of the event with antibiotic therapy. The outcome of event ear infection was unknown.   Follow-up attempts are completed. No further information is expected
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, Pyrexia
Clinical narrative: Short of breath; Slightly elevated heart rate if I am at rest like talking to you it is normal but if I get up and do anything slightly elevate heart rate; I am on oxygen; Fever; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 30Jul2021 (Lot Number: IFA7485, expiration date: Oct2021) as a single dose for COVID-19 immunization. Medical history included diabetes and COVID-19- hospitalized from 06Jul2021 to 19Jul2021. Concomitant medication included metformin taken for diabetes. The patient had COVID-19 and was in the hospital from 06Jul2021 to 19Jul2021. He was not given plasma in hospital. He waited 2 weeks (further not clarified) and then got the first BNT162b2 dose. Within 3 days after he got the shot he started getting really short of breath. He wanted to know if he needed to see a doctor about it or if it would go away. He had slightly elevated heart rate. When at rest, it was normal but if he got up and did anything, slightly elevated heart rate. He feels short of breath. Recently he had fever and that went away. When probed for any treatment for the event, the patient stated, "No, I am on oxygen, oxygen concentrator from hospital not from home, that's the only treatment." The outcome of short of breath, elevated heart rate and fever was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Hypoacusis, Sleep disorder, Tinnitus, Urinary tract infection
Clinical narrative: It was clarified the hearing screening showed a little bit of hearing loss in right ear; buzzing in her ear; UTI; normal pain that went away, this was at the injection site; is interfering with her sleep; This is a spontaneous report from a contactable consumer reported for herself. A 71-years-old female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: ER8730), dose 1 via an unspecified route of administration, administered in left arm on 26Mar2021 (at around 10-11am) (at the age of 71-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included, lyme disease (had Lyme's disease and was given antibiotics, this was years ago) from an unknown date and unknown if ongoing. Concomitant medication was not reported. Historical vaccination include, PNEUMOCOCCAL VACCINE on Aug2020, patient experienced rash pruritic (With the pneumonia shot patient had a rash on lower back that patient thought was shingles. It was itchy and lasted 3-4 weeks with a little pain but was not like what was normally reported for shingles. Maybe it was not but thought it was. Patient did not have it looked at because patient did not want to go to the doctor at that time due to COVID. The shot was done in Aug2020. Patient had no product name, NDC, Lot, or Expiry for this product, it was given by primary care doctor). History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) and additional Vaccines Administered on Same Date of the Pfizer Suspect reported as none. Prior Vaccinations (within 4 weeks) and adverse events following prior vaccinations reported as none. Patient did hot have medical history (including any illness at time of vaccination). Patient take no medication other than supplements. Investigation assessment reported as yes. Vaccine not administered at military facility. On 2021, it was clarified the hearing screening showed a little bit of hearing loss in right ear, buzzing in ear, uti (urinary tract infection) and normal pain that went away, this was at the injection site and it was interfering with sleep. The patient underwent lab tests and procedures which included acoustic stimulation tests: unknown on 2021. Patient did not visited to Emergency Room and Physician Office, patient went for normal check up at the doctor and mentioned this. The outcome of the event Urinary tract infections and vaccination site pain was recovered on 2021, tinnitus was not recovered while other events were unknown.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: It was clarified the hearing screening showed a little bit of hearing loss in right ear; buzzing in her ear; UTI; normal pain that went away, this was at the injection site; is interfering with her sleep; This is a spontaneous report from a contactable consumer reported for herself. A 71-years-old female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: ER8730), dose 1 via an unspecified route of administration, administered in left arm on 26Mar2021 (at around 10-11am) (at the age of 71-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included, lyme disease (had Lyme's disease and was given antibiotics, this was years ago) from an unknown date and unknown if ongoing. Concomitant medication was not reported. Historical vaccination include, PNEUMOCOCCAL VACCINE on Aug2020, patient experienced rash pruritic (With the pneumonia shot patient had a rash on lower back that patient thought was shingles. It was itchy and lasted 3-4 weeks with a little pain but was not like what was normally reported for shingles. Maybe it was not but thought it was. Patient did not have it looked at because patient did not want to go to the doctor at that time due to COVID. The shot was done in Aug2020. Patient had no product name, NDC, Lot, or Expiry for this product, it was given by primary care doctor). History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) and additional Vaccines Administered on Same Date of the Pfizer Suspect reported as none. Prior Vaccinations (within 4 weeks) and adverse events following prior vaccinations reported as none. Patient did hot have medical history (including any illness at time of vaccination). Patient take no medication other than supplements. Investigation assessment reported as yes. Vaccine not administered at military facility. On 2021, it was clarified the hearing screening showed a little bit of hearing loss in right ear, buzzing in ear, uti (urinary tract infection) and normal pain that went away, this was at the injection site and it was interfering with sleep. The patient underwent lab tests and procedures which included acoustic stimulation tests: unknown on 2021. Patient did not visited to Emergency Room and Physician Office, patient went for normal check up at the doctor and mentioned this. The outcome of the event Urinary tract infections and vaccination site pain was recovered on 2021, tinnitus was not recovered while other events were unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Haemoptysis
Clinical narrative: When I cough, I am coughing blood; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: FA7485 and Expiration date were not provided), via an unspecified route of administration, on unknown date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced when I cough, I am coughing blood. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Nausea, Vertigo
Clinical narrative: Very dizzy/Vertigo; Very dizzy/Vertigo; Nausea; diarrhea; This is a spontaneous report from a contactable other hcp.    A 50-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 13Aug2021 14:30 as dose 1, single for covid-19 immunisation.Medical history included rheumatoid arthritis, food allergy. known allergies: dairy, strawberries, latex, penicillin, hypersensitivity.The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was reported that, on 14Aug2021 03:00, the patient experienced very dizzy/vertigo and Diarrhoea with outcome of not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Headache, Nausea
Clinical narrative: Dizzy; Nausea; Vomited; I had chills; Whole body like aching; Headache too, my head hurts too; Fever; My right arm was so sore; weak; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: WS2736, expiry date: not reported, Age at vaccination: 53-year-old) via an unspecified route of administration in arm right on 13Aug2021 as DOSE 1, SINGLE for COVID-19 immunization. Medical history included blood pressure high and diabetes. Concomitant medications included INSULIN, AMLODIPINE BESYLATE, HYDROCHLOROTHIAZIDE, LISINOPRIL, METFORMIN. On ana unspecified date, patient experienced dizzy, nausea, vomited, i had chills, whole body like aching, headache too, my head hurts too, fever, my right arm was so sore, weak. Patient also stated I took the vaccine (confirmed as Pfizer COVID-19 Vaccine), my first vaccine shot two days ago (confirmed as 13Aug2021) on Friday and yesterday I started to get dizzy, nausea and I vomited, I had chills and my whole body is like aching, I know some of those side effects are some of the side effects. I am having headache too. I said still experiencing weak, I am still feeling dizzy and weak. I took Tylenol (for fever). Patient stated, the day the vaccination happened all I feel was dizzy then the next day, yesterday, I am diabetic and I take insulin as I got over, I took my Insulin and then I started aching all over, getting chills, vomiting and my head was hurting. I got my vaccination shot in right arm and I took my, my other shot, I took it in my left arm. Because that arm was, my right arm was so sore. I usually take (insulin shot) in right arm every day, since it was so sore, I took the shot of Insulin in my left arm. The outcome of fever was unknown and for other events, was recovering.  Information about lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Dizzy; Nausea; Vomited; I had chills; Whole body like aching; Headache too, my head hurts too; Fever; My right arm was so sore; weak; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: WS2736, expiry date: not reported, Age at vaccination: 53-year-old) via an unspecified route of administration in arm right on 13Aug2021 as DOSE 1, SINGLE for COVID-19 immunization. Medical history included blood pressure high and diabetes. Concomitant medications included INSULIN, AMLODIPINE BESYLATE, HYDROCHLOROTHIAZIDE, LISINOPRIL, METFORMIN. On ana unspecified date, patient experienced dizzy, nausea, vomited, i had chills, whole body like aching, headache too, my head hurts too, fever, my right arm was so sore, weak. Patient also stated I took the vaccine (confirmed as Pfizer COVID-19 Vaccine), my first vaccine shot two days ago (confirmed as 13Aug2021) on Friday and yesterday I started to get dizzy, nausea and I vomited, I had chills and my whole body is like aching, I know some of those side effects are some of the side effects. I am having headache too. I said still experiencing weak, I am still feeling dizzy and weak. I took Tylenol (for fever). Patient stated, the day the vaccination happened all I feel was dizzy then the next day, yesterday, I am diabetic and I take insulin as I got over, I took my Insulin and then I started aching all over, getting chills, vomiting and my head was hurting. I got my vaccination shot in right arm and I took my, my other shot, I took it in my left arm. Because that arm was, my right arm was so sore. I usually take (insulin shot) in right arm every day, since it was so sore, I took the shot of Insulin in my left arm. The outcome of fever was unknown and for other events, was recovering.  Information about lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Lagophthalmos, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: Experiencing tingling; Partial numbness all over my body; Dizziness; Having difficulties focusing up close with my eyes; This is a spontaneous report from a contactable consumer or other non hcp.  A 35-year-old female non-Pregnant patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 01Jun2021 13:00 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included covid-19. There were no concomitant medications. The patient was not pregnant at the time of vaccination. Patient previously took first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm left (Batch/Lot Number was unknown) as single dose for covid-19 immunisation. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was Reported on 03Jul2021 02:30, about a month after receiving her second dose, she was experienced tingling and partial numbness all over my body. It started in just my arms and legs, had three MRIs and a spinal tap, all our normal. She had dizziness. Also sometimes having difficulties focusing up close with my eyes. Main symptoms are the partial numbness and dizziness. The outcome of the events was not recovered. No treatment was received before, and patient was not hospitalized. The patient underwent lab tests and procedures which included lumbar puncture: normal in 2021, magnetic resonance imaging: normal on 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Experiencing tingling; Partial numbness all over my body; Dizziness; Having difficulties focusing up close with my eyes; This is a spontaneous report from a contactable consumer or other non hcp.  A 35-year-old female non-Pregnant patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 01Jun2021 13:00 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included covid-19. There were no concomitant medications. The patient was not pregnant at the time of vaccination. Patient previously took first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm left (Batch/Lot Number was unknown) as single dose for covid-19 immunisation. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was Reported on 03Jul2021 02:30, about a month after receiving her second dose, she was experienced tingling and partial numbness all over my body. It started in just my arms and legs, had three MRIs and a spinal tap, all our normal. She had dizziness. Also sometimes having difficulties focusing up close with my eyes. Main symptoms are the partial numbness and dizziness. The outcome of the events was not recovered. No treatment was received before, and patient was not hospitalized. The patient underwent lab tests and procedures which included lumbar puncture: normal in 2021, magnetic resonance imaging: normal on 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up