chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; adult patient received Moderna Covid-19 vaccine past it's 30 day use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (adult patient received Moderna Covid-19 vaccine past it's 30 day use by date.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (adult patient received Moderna Covid-19 vaccine past it's 30 day use by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (adult patient received Moderna Covid-19 vaccine past it's 30 day use by date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (adult patient received Moderna Covid-19 vaccine past it's 30 day use by date.).    No concomitant medication information provided.  Individual vials or unbroken cartons: 1 individual vial.   Vial size was 5.5ml  Date the vial was initially stored in the refrigerator was unknown.  The vial did not undergone any temperature excursions.  No treatment information provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: only had a little headache after the first two doses; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (only had a little headache after the first two doses) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included Muscle relaxant since an unknown date. Concurrent medical conditions included Allergy to chemicals (Iodine). Concomitant products included TIZANIDINE for Muscle relaxant.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced HEADACHE (only had a little headache after the first two doses). At the time of the report, HEADACHE (only had a little headache after the first two doses) outcome was unknown.            No treatment medications was reported.   This case was linked to MOD-2022-668059 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: heavy cold; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (heavy cold) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient did not have COVID-19 in the past. Patient was not given any other vaccine within 1 month prior to Moderna COVID-19 vaccine.Patient did not have any history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination.  Concurrent medical conditions included Penicillin allergy, Drug allergy (lisinopril) and Drug allergy (amlodipine).   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2022, the patient experienced NASOPHARYNGITIS (heavy cold). On 28-Oct-2022, NASOPHARYNGITIS (heavy cold) had resolved.            No concomitant medications were reported.   No treatment medications were reported.   Reporter did not allow further contact
Age: 1.08
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 6 doses administered after 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 doses administered after 30-day use by date) and NO ADVERSE EVENT (No adverse event) in a 13-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 doses administered after 30-day use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 doses administered after 30-day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (6 doses administered after 30-day use by date).    No concomitant medication was reported.    Date the vial was initially stored in the refrigerator on 29-Sep-2022. The vial did not undergo any temperature excursions. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-668207, US-MODERNATX, INC.-MOD-2022-668172, US-MODERNATX, INC.-MOD-2022-668208, US-MODERNATX, INC.-MOD-2022-668214, US-MODERNATX, INC.-MOD-2022-668215 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-668207:Same reporter US-MODERNATX, INC.-MOD-2022-668172:Same reporter US-MODERNATX, INC.-MOD-2022-668208:Same reporter US-MODERNATX, INC.-MOD-2022-668214:Same reporter US-MODERNATX, INC.-MOD-2022-668215:Same reporter
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 1-Nov-2022; No adverse event; 6 doses administered after 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 doses administered after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 1-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 01-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 doses administered after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 1-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 doses administered after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 1-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (6 doses administered after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 1-Nov-2022).    Concomitant medications details were not reported by the reporter. Date the vial was initially stored in the refrigerator on 29-Sep-2022. The vial did not undergo any temperature excursions. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-668207, US-MODERNATX, INC.-MOD-2022-668074, US-MODERNATX, INC.-MOD-2022-668208, US-MODERNATX, INC.-MOD-2022-668215, US-MODERNATX, INC.-MOD-2022-668214 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-668207:Same reporter US-MODERNATX, INC.-MOD-2022-668074:Same reporter US-MODERNATX, INC.-MOD-2022-668208:Same reporter US-MODERNATX, INC.-MOD-2022-668215:Same reporter US-MODERNATX, INC.-MOD-2022-668214:Same reporter
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Joint swelling, Pain in extremity, Pruritus
Clinical narrative: fluid on the knee; itches/whole body is itchy like a dog with fleas; armpit was sore; big sacks underneath armpit/like fluid in the sack/it's skin but a sack underneath; arms were sore; This spontaneous case was reported by a patient family member or friend and describes the occurrence of JOINT SWELLING (fluid on the knee), PRURITUS (itches/whole body is itchy like a dog with fleas), PAIN IN EXTREMITY (arms were sore), AXILLARY PAIN (armpit was sore) and AXILLARY MASS (big sacks underneath armpit/like fluid in the sack/it's skin but a sack underneath) in a 57-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 vaccination: Moderna (Dose 1, Lot No.040B21A) on 16-Apr-2021, Moderna (Dose 2 and Lot No. 022C21A) on 14-May-2021. Past adverse reactions to the above products included No adverse event with Moderna and Moderna.    On 31-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Nov-2022, the patient experienced PAIN IN EXTREMITY (arms were sore). On 02-Nov-2022, the patient experienced JOINT SWELLING (fluid on the knee), PRURITUS (itches/whole body is itchy like a dog with fleas), AXILLARY PAIN (armpit was sore) and AXILLARY MASS (big sacks underneath armpit/like fluid in the sack/it's skin but a sack underneath). At the time of the report, JOINT SWELLING (fluid on the knee), PRURITUS (itches/whole body is itchy like a dog with fleas), PAIN IN EXTREMITY (arms were sore), AXILLARY PAIN (armpit was sore) and AXILLARY MASS (big sacks underneath armpit/like fluid in the sack/it's skin but a sack underneath) outcome was unknown.            No concomitant information was reported. It was reported that patient had not taken any medications following the vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2022-668061 (E2B Linked Report).
Age: 0.58
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 1-Nov-2022; No adverse event; 6 doses administered after 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 doses administered after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 1-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 7-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 01-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 doses administered after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 1-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 doses administered after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 1-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (6 doses administered after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 1-Nov-2022).    No concomitant medications were provided. The vial size was 2.5 ml. The vial was initially stored in the refrigerator on 29-Sep-2022. The vial did not undergo any temperature excursion. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-668074, US-MODERNATX, INC.-MOD-2022-668172, US-MODERNATX, INC.-MOD-2022-668208, US-MODERNATX, INC.-MOD-2022-668214, US-MODERNATX, INC.-MOD-2022-668215 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-668074:Same reporter US-MODERNATX, INC.-MOD-2022-668172:Same reporter US-MODERNATX, INC.-MOD-2022-668208:Same reporter US-MODERNATX, INC.-MOD-2022-668214:Same reporter US-MODERNATX, INC.-MOD-2022-668215:Same reporter
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 10:30 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). The patient had no known allergies. There were no concomitant medications. The patient did not receive other medications in 2 weeks.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient tested positive on an unspecified date in Oct2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Positive. Therapeutic measures were taken as a result of covid-19 which included Paxlovid.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: my teeth are hurting so bad; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 61-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "I had the tooth problem"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "I had the tooth problem". The following information was reported: TOOTHACHE (non-serious), outcome "unknown", described as "my teeth are hurting so bad". The event "my teeth are hurting so bad" required physician office visit. Therapeutic measures were taken as a result of toothache.  Additional information: It was also reported that the first two time patient had the tooth problem, he/she thought it was dental related, he/she really did not pay much attention, just went to the dentist, they gave him/her the pain medicine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: treatment of COVID-19; treatment of COVID-19; This is a spontaneous report received from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (batch/lot number: EL3248), in right arm, on 09Mar2021 as dose 2, single (batch/lot number: EN6206), in right arm and on 19Oct2021 as dose 3 (booster), single (batch/lot number: FF2593) at the age of 68 years, in right arm for COVID-19 immunization. The patient's relevant medical history included: "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "treatment of COVID-19". The patient underwent the following laboratory tests and procedures: COVID 19 test: positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 19Oct2022 to 23Oct2022.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), as dose number (unknown), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Headache; Dizziness; This is a spontaneous report received from contactable reporter (Nurse). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (COMIRNATY), on 21Oct2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 68 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (ongoing), notes: Diagnosed with a long time ago, doesn't remember when diagnosed with. The patient's concomitant medications were not reported. Vaccination history included: covid-19 vaccine (DOSE 3 BOOSTER, lot: FH8020, NDC: unknown , expiration: unknown , route of administration: right deltoid), administration date: 09Nov2021, for Covid-19 Immunization; covid-19 vaccine (DOSE 2, SINGLE, lot: ENK1810, NDC: unknown , Expiration: unknown , Route of administration: left deltoid), administration date: 19Feb2021, for Covid-19 Immunization; covid-19 vaccine (DOSE 1 ,SINGLE, lot: EN9581, NDC: unknown , Expiration: Unknown, route of administration: right deltoid), administration date: 29Jan2001, for Covid-19 immunization. The following information was reported: DIZZINESS (medically significant) with onset 21Oct2022, outcome "not recovered"; HEADACHE (medically significant) with onset 21Oct2022, outcome "not recovered". Clinical course: Patient received the Comirnaty booster dose a week ago last Friday, 21Oct2022. She has had a headache and dizziness since. Stated that it is kind of strange because the dizziness is worse at night. Especially when she lays down flat on back.; Sender's Comments: Based on the available information, the reported serious events cannot be excluded for the suspect drug BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: had 3 doses of the Pfizer COVID-19 vaccine, had COVID again; had 3 doses of the Pfizer COVID-19 vaccine, had COVID again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing). Concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "had 3 doses of the Pfizer COVID-19 vaccine, had COVID again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: for the first time he tested negative in two weeks.  Clinical course: Caller stated he had had 3 doses of the Pfizer COVID-19 vaccine, had COVID again and just for the first time he tested negative in two weeks. Caller wanted to know how soon he can get the second booster shot or fourth dose. Caller confirmed he was calling for the booster dose but was unable to specify which presentation he was referring to.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Off label use, Product use issue, Wheezing
Clinical narrative: wheezing as if I had Asthma; Pfizer: 28Oct2022. Moderna: 28Oct2022; Pfizer - Dose Number: 4; Moderna - Dose Number: 3; Pfizer: 28Oct2022. Moderna: 28Oct2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 25-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 at 15:00 as dose 4 (booster), single (Lot number: GH9697) at the age of 25 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single (Lot number: 031C20H) for 1 day, as dose 2, single (Lot number: 003B21A) for 1 day and as dose 3 (booster), single (Lot number: 031H21H) for 1 day for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 28Oct2022, outcome "unknown", described as "Pfizer - Dose Number: 4; Moderna - Dose Number: 3"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 28Oct2022, outcome "unknown" and all described as "Pfizer: 28Oct2022. Moderna: 28Oct2022"; WHEEZING (non-serious) with onset 30Oct2022 at 10:00, outcome "unknown", described as "wheezing as if I had Asthma". Therapeutic measures were not taken as a result of wheezing.  Additional Information: It was reported that the patient went on a run two days after receiving the vaccine and she began wheezing as if she had asthma. She had never wheezed during a run before, and this type of run was a regular part of her routine. She had known allergies to Penicillin. Patient had no other vaccines in 4 weeks and no other medications in two weeks. Patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post the vaccination. No treatment was received for the adverse event wheezing. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Developed Covid symptoms and tested positive for Covid after completing Paxlovid treatment; Developed Covid symptoms and tested positive for Covid after completing Paxlovid treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6202) intramuscular, in right arm, as dose 2, single (Lot number: ER8732) intramuscular, in right arm, on 23Nov2021 at 10:00 as dose 3 (booster), single (Lot number: FJ1620) intramuscular, in right arm, as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Developed Covid symptoms and tested positive for Covid after completing Paxlovid treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment: Paxlovid; Positive, notes: After six days of feeling well, she developed Covid symptoms, and tested positive for the Covid virus after completing Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Rashes all over body; Hives/ welts; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 22Jul2022 at 13:00 as dose 4 (booster), single (Lot number: FP7139) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". Vaccination history included: Covid-19 vaccine (Dose: 3, Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose: 2, Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose: 1, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: URTICARIA (non-serious) with onset 23Jul2022, outcome "not recovered", described as "Hives/ welts"; RASH (non-serious) with onset 23Jul2022, outcome "not recovered", described as "Rashes all over body". Therapeutic measures were not taken as a result of rash, urticaria. Additional information: The patient had no covid prior vaccination and has not been covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Dyspnoea, Nasal congestion, Nasal inflammation
Clinical narrative: loss of taste and smell; loss of taste and smell; he has difficulty breathing through his nose; inflammation in his nose; congestion in his nose; he has congestion in his chest and head; he has congestion in his chest and head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 as dose 4 (booster), single (Lot number: GH9697) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (ongoing). Concomitant medication(s) included: AMLODIPINE oral taken for hypertension (ongoing); LOSARTAN oral taken for hypertension (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Anatomical Site of injection: left arm , Route of Administration: Intramuscular, Batch/Lot number: EL9267), administration date: 11Feb2021, when the patient was 71-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Anatomical Site of injection: left arm, Route of Administration: Intramuscular, Batch/Lot number: EN6205), administration date: 04Mar2021, when the patient was 71-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Anatomical Site of injection: left arm , Route of Administration: Intramuscular, Batch/Lot number: F31611), administration date: 24Nov2021, when the patient was 72-year-old, for COVID-19 Immunization.  The following information was reported: UPPER RESPIRATORY TRACT CONGESTION (non-serious), RESPIRATORY TRACT CONGESTION (non-serious) all with onset Oct2022, outcome "unknown" and all described as "he has congestion in his chest and head"; NASAL CONGESTION (non-serious) with onset 28Oct2022 at 20:00, outcome "not recovered", described as "congestion in his nose"; DYSPNOEA (non-serious) with onset 30Oct2022, outcome "not recovered", described as "he has difficulty breathing through his nose"; NASAL INFLAMMATION (non-serious) with onset 30Oct2022, outcome "not recovered", described as "inflammation in his nose"; AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 30Oct2022, outcome "not recovered" and all described as "loss of taste and smell". Therapeutic measures were not taken as a result of nasal congestion, ageusia, anosmia, dyspnoea, nasal inflammation, upper respiratory tract congestion, respiratory tract congestion.  Additional information: The reporter stated that  he had difficulty breathing through his nose. Clarified as congestion in his nose, inflammation in his nose from using a tissue. he had congestion in his chest and head and loss of taste and smell.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory tract congestion, Upper respiratory tract congestion
Clinical narrative: loss of taste and smell; loss of taste and smell; he has difficulty breathing through his nose; inflammation in his nose; congestion in his nose; he has congestion in his chest and head; he has congestion in his chest and head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 as dose 4 (booster), single (Lot number: GH9697) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (ongoing). Concomitant medication(s) included: AMLODIPINE oral taken for hypertension (ongoing); LOSARTAN oral taken for hypertension (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Anatomical Site of injection: left arm , Route of Administration: Intramuscular, Batch/Lot number: EL9267), administration date: 11Feb2021, when the patient was 71-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Anatomical Site of injection: left arm, Route of Administration: Intramuscular, Batch/Lot number: EN6205), administration date: 04Mar2021, when the patient was 71-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Anatomical Site of injection: left arm , Route of Administration: Intramuscular, Batch/Lot number: F31611), administration date: 24Nov2021, when the patient was 72-year-old, for COVID-19 Immunization.  The following information was reported: UPPER RESPIRATORY TRACT CONGESTION (non-serious), RESPIRATORY TRACT CONGESTION (non-serious) all with onset Oct2022, outcome "unknown" and all described as "he has congestion in his chest and head"; NASAL CONGESTION (non-serious) with onset 28Oct2022 at 20:00, outcome "not recovered", described as "congestion in his nose"; DYSPNOEA (non-serious) with onset 30Oct2022, outcome "not recovered", described as "he has difficulty breathing through his nose"; NASAL INFLAMMATION (non-serious) with onset 30Oct2022, outcome "not recovered", described as "inflammation in his nose"; AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 30Oct2022, outcome "not recovered" and all described as "loss of taste and smell". Therapeutic measures were not taken as a result of nasal congestion, ageusia, anosmia, dyspnoea, nasal inflammation, upper respiratory tract congestion, respiratory tract congestion.  Additional information: The reporter stated that  he had difficulty breathing through his nose. Clarified as congestion in his nose, inflammation in his nose from using a tissue. he had congestion in his chest and head and loss of taste and smell.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Mar2021 at 11:00 as dose 1, single (Lot number: ER8727), in left arm, on 10Apr2021 at 09:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 27Oct2021 at 13:00 as dose 3 (booster), single (Lot number: 30135BA), in left arm and on 06Jul2022 at 12:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Reflux" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, COVID-19. Additional information: The patient took Paxlovid from 19Oct2022 to 24Oct2022 for treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Arthropod bite, Rash
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete; Unknown manufacturer), for COVID-19 Immunization.  The following information was reported: ARTHROPOD BITE (non-serious), RASH (non-serious), outcome "unknown" and all described as "got bit by a tick recently and I have a rash on my arm".  Additional information: Patient stated "I have gotten my Pfizer original, and booster shots and I have an appointment to get the second booster for the Omicron variants. I got bit by a tick recently and I have a rash on my arm. Is there any issue with me getting that booster dose while having this rash?"  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Peripheral swelling, Pyrexia
Clinical narrative: swollenness in the arm; chest pain; fever; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 17-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swollenness in the arm"; CHEST PAIN (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever"; FATIGUE (non-serious), outcome "unknown".  Additional information: The reporter is the parent of the patient. The reporter confirmed product as Trumenba. The caller stated that her daughter's (17-year-old female) experience with the Trumenba was similar to the Pfizer COVID-19 vaccine, stating "she almost didn't have the exact same symptoms as the COVID vaccine, swollenness in the arm, and chest pain, and running fever and a little fatigue".   Transferring agent stated that the caller was a consumer calling about her 17- year-old daughter's reaction to Trumenba. The caller was asking if the Trumenba vaccine was a mRNA vaccine because her daughter had a similar reaction to the COVID Vaccine, a swollen arm and fatigue. The reporter came onto the line and verified information received from the transferring agent. Caller clarified that no, her daughter did not had a similar reaction to a COVID Vaccine; just to that Trumenba, Meningitis B Vaccine. Caller agreed to safety report. The reporter declined to provide mailing address. The caller stated that her daughter received the Trumenba Vaccine 9 or 10 days ago and is totally fine at the time of reporting. Caller stated that she did not call to make a report she just had questions about the vaccine. Caller stated that her daughter had a swollen arm, fatigue, chills, body aches, pain in the upper back. Caller stated that the pain in the upper back seemed bizarre and had the caller worried because she knows people have that kind of pain with a heart attack. Caller was probed for outcome and time frame for all her daughter's symptoms but replied only with saying that her daughter's upper back pain only lasted a couple of hours. Caller then stated that her daughter also had joint pain. Caller asked if these symptoms are normal.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 21-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19 with nirmatrelvir/ritonavir (PAXLOVID) from 31Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "autoimmune hepatitis" (unspecified if ongoing); "rheumatoid arthritis" (unspecified if ongoing); "lupus" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine"; Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Oct2022) Negative; (26Oct2022) Negative; (29Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid from 19Oct2022 to 23Oct2022.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Diarrhoea, Loss of personal independence in daily activities, Vomiting
Clinical narrative: Diarrhea; Anything I eat or drink comes; I have not had a solid bowl movement; It is interfering with my daily life now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown), for COVID-19 Immunization. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; VOMITING (non-serious), outcome "unknown", described as "Anything I eat or drink comes"; BOWEL MOVEMENT IRREGULARITY (non-serious), outcome "unknown", described as "I have not had a solid bowl movement"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "It is interfering with my daily life now".  Additional information: Consumer stated that the patient had the Pfizer BioNTech, the patient had two other vaccines with one of the booster, had constant diarrhea since, the patient was part of the three percent and the patient need all to send the doctor something, or something because the patient mean it was interfering with the patient's daily life now, the patient cannot. 24 hours almost, anything the patient eat or drink comes, the patient had not had a solid bowl movement since the patient had both vaccines and a booster. The patient had constant diarrhea. The patient had not had a solid bowl movement since the patient had taken vaccine and booster. When clarified the suspect as Pfizer COVID-19 vaccine: Consumer stated, both and a booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "anxiety" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid from 19Oct2022 to 24Oct2022 as treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 26May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Oct2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable consumer. The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 OMI ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for COVID-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.