chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Maternal exposure during pregnancy, No adverse event
Clinical narrative: No adverse event; drug exposure during pregnancy; inadvertently gave an expired dose to a patient on 13Feb2023; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy), EXPIRED PRODUCT ADMINISTERED (inadvertently gave an expired dose to a patient on 13Feb2023) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 052C22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 13-Feb-2023, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) and EXPIRED PRODUCT ADMINISTERED (inadvertently gave an expired dose to a patient on 13Feb2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 13-Feb-2023, MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently gave an expired dose to a patient on 13Feb2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) and EXPIRED PRODUCT ADMINISTERED (inadvertently gave an expired dose to a patient on 13Feb2023).    No concomitant and treatment medications were reported.  Individual vial size reported as 5.5 mL   Vial was refrigerated on 13-feb-2023.  Vial did not undergo any temperature excursions.  Company comment: This spontaneous case concerns a pregnant woman of unknown age with no relevant medical history reported, who experienced unexpected non-serious event of Maternal exposure during pregnancy(drug exposure during pregnancy) with no adverse event that occurred in the context of first dose of mRNA-1273 vaccine in COVID-19 vaccination series. Additionally, Expired product administered was also reported as a non-serious event. It was reported that, inadvertently expired dose was administered( Dose administered after 30-day Use By Date or after manufacturer date of expiry). No further information regarding patient's medical history, menstrual history , obstetric history, last menstrual period, estimated date of delivery, outcome of pregnancy, relevant imaging studies were provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Vaccination site pain
Clinical narrative: They had sore injection site arms; Felt slightly fatigued; Arm was sore for a day; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (They had sore injection site arms), FATIGUE (Felt slightly fatigued) and PAIN IN EXTREMITY (Arm was sore for a day) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 001B21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu vaccine (Slightly fatigued) and Flu vaccine (sore injection site arms). Past adverse reactions to the above products included Fatigue with Flu vaccine; and Vaccination site pain with Flu vaccine.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form, third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form, fourth dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form and fifth dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (They had sore injection site arms), FATIGUE (Felt slightly fatigued) and PAIN IN EXTREMITY (Arm was sore for a day). At the time of the report, VACCINATION SITE PAIN (They had sore injection site arms) and FATIGUE (Felt slightly fatigued) outcome was unknown and PAIN IN EXTREMITY (Arm was sore for a day) had resolved.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  It was reported that the patient had received 5 Moderna doses and loves Moderna'. The patient had no other side effects and reported that she doesn't feel that this was an adverse event.   Treatment medication information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-710705 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710705:Master case
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; inadvertently administered one dose of the monovalent vaccine on 12Feb2023 which expired on 06Feb2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administered one dose of the monovalent vaccine on 12Feb2023 which expired on 06Feb2023) and NO ADVERSE EVENT (no adverse event) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administered one dose of the monovalent vaccine on 12Feb2023 which expired on 06Feb2023). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administered one dose of the monovalent vaccine on 12Feb2023 which expired on 06Feb2023) and NO ADVERSE EVENT (no adverse event) 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 considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (inadvertently administered one dose of the monovalent vaccine on 12Feb2023 which expired on 06Feb2023).    No concomitant medications were reported. No treatment medications were reported.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Product storage error; no adverse event; the vaccine was expired by 3 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (the vaccine was expired by 3 days), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event) in a 23-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Feb-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (the vaccine was expired by 3 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (the vaccine was expired by 3 days), PRODUCT STORAGE ERROR (Product storage error) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (the vaccine was expired by 3 days) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant products reported.  Health care professional stated that she just a client the vaccine on 15 Feb 2023 and when she went to put it in the system it showed that the vaccine was expired by 3 days. No adverse events were reported.  No treatment products reported.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 2 patients received expired 2nd dose Monovalent Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 patients received expired 2nd dose Monovalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Feb-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (2 patients received expired 2nd dose Monovalent Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 patients received expired 2nd dose Monovalent Moderna COVID-19 vaccine) 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 (2 patients received expired 2nd dose Monovalent Moderna COVID-19 vaccine).    Concomitant products were not provided. Treatment medication were not reported.  2.5 ml vial was initially stored in the refrigerator on 14FEB2023. It was reported that there was no temperature excursion.   This case was linked to US-MODERNATX, INC.-MOD-2023-710773 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710773:Male child case
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patients reported no reaction; The vaccine was administered to two patients after expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine was administered to two patients after expiration date) and NO ADVERSE EVENT (The patients reported no reaction) in a 29-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine was administered to two patients after expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (The patients reported no reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine was administered to two patients after expiration date) and NO ADVERSE EVENT (The patients reported no reaction) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (The patients reported no reaction) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The vaccine was administered to two patients after expiration date).    No concomitant medicine were reported. The Moderna monovalent vaccine was administered to two patients. Date the vial was initially stored in the refrigerator was 13-Feb-2023. Vial did not undergo any temperature excursions. No treatment medicine were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-710742 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710742:Another patient case
Age: 0.5
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: A 6 month old patient received 2 doses of the Moderna COVID-19 Vaccine primary series 8 days apart instead of one month apart.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A 6 month old patient received 2 doses of the Moderna COVID-19 Vaccine primary series 8 days apart instead of one month apart.) and NO ADVERSE EVENT (No adverse event) in a 6-month-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A 6 month old patient received 2 doses of the Moderna COVID-19 Vaccine primary series 8 days apart instead of one month apart.) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A 6 month old patient received 2 doses of the Moderna COVID-19 Vaccine primary series 8 days apart instead of one month apart.) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A 6 month old patient received 2 doses of the Moderna COVID-19 Vaccine primary series 8 days apart instead of one month apart.).    Concomitant medications were not reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that a 6-month-old patient received 2 doses of the Moderna COVID-19 Vaccine primary series 8 days apart instead of one month apart. The HCP would like to know if they need to repeat the second primary series dose or if they can move on to give the Moderna COVID-19 Vaccine, Bivalent booster.  No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Drug ineffective, Immunisation, Off label use
Clinical narrative: COVID-19; COVID-19; Off label use; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 5 (booster), single (Lot number: G53277) at the age of 67 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6205), on 27Mar2021 as dose 2, single (Lot number: ER8732), on 28Sep2021 as dose 3 (booster), single (Lot number: FE3592) and on 11Apr2022 as dose 4 (booster), single (Lot number: FJ9943) for covid-19 immunisation. The patient's relevant medical history included: "cutaneous lupus" (unspecified if ongoing); "Calcium pyrophosphate deposition disease" (unspecified if ongoing); "Mild intermittent asthma" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Macular degeneration" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tmp/smx, reaction(s): "Drug Allergy". The following information was reported: IMMUNISATION (medically significant) with onset 28Sep2022, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 28Sep2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19.; Sender's Comments: The efficacy of a vaccine varies individually and can be affected by different factors including product potency; however, a contributory role of BNT162B2 and BNT162B2, BNT162B2 OMI BA.4-5 to the events COVID-19 and drug ineffective cannot be ruled out.
Sex: F
Vaccine: 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 contactable reporter(s) (Other HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obese" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Eustachian Tube Dysfunction" (unspecified if ongoing); "sinusitus" (unspecified if ongoing). Concomitant medication(s) included: ACETAMINOPHEN. Past drug history included: Cipro, reaction(s): "allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested negative; Positive, notes: Tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medication in 2weeks product: Acetaminifin and Kirkland. Product: COVID 19 Treatment. Brand: Paxlovid. Treatment start date: 30Jan2023, treatment stop date: 05Feb2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a possible contributory role of the subject product BNT162b2 vaccine,  cannot be excluded for suspected LOE.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 63-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 at 12:30 as dose 5 (booster), single (Lot number: GJ3275) at the age of 62 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: EH9899), in left arm, on 14Jan2021 at 11:45 as dose 2, single (Lot number: EL3246), in left arm, on 05Oct2021 at 16:00 as dose 3 (booster), single (Lot number: CJ511-06), in left arm and on 08Apr2022 at 09:30 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "obesity" (unspecified if ongoing); "elevated intraocular pressure" (unspecified if ongoing); "lobster" (unspecified if ongoing); "mango" (unspecified if ongoing); "vomit" (unspecified if ongoing); "diarrhea" (unspecified if ongoing); "nausea" (unspecified if ongoing); "rash" (unspecified if ongoing). Concomitant medication(s) included: LATANOPROST, start date: 22Aug2022. Past drug history included: Tetracycline, reaction(s): "G.i"; Fentanyl, reaction(s): "Nausea"; Fentanyl, reaction(s): "Vomit"; Fentanyl, reaction(s): "itch". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: The efficacy of a vaccine varies individually and can be affected by different factors including product potency; however, a contributory role of BNT162B2 and BNT162b2, BNT162b2 omi ba.4-5 to vaccination failure cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site inflammation, Vaccination site pruritus
Clinical narrative: inflamed arm at the injection site; inflamed arm at the injection site; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  An adult female patient received BNT162b2 (COMIRNATY), on 14Dec2021 as dose 3 (booster), single (Lot number: 33130BA) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: VACCINATION SITE INFLAMMATION (non-serious), VACCINATION SITE PRURITUS (non-serious), outcome "recovering" and all described as "inflamed arm at the injection site". Therapeutic measures were not taken as a result of vaccination site inflammation, vaccination site pruritus.  Additional information: Patient reports itchy and inflamed arm at the injection site of last vaccine administration months after receiving dose. The patient did not have COVID prior vaccination and it was unknown if the patient was tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Positive; COVID 19 Positive; Interchange of vaccine products; This is a spontaneous report received from contactable reporter (Consumer) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31May2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 65 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Jan2021 as dose 1, single (Lot number: 026L20A), on 12Feb2021 as dose 2, single (Lot number: 006M20A), on 01Nov2021 as dose 3 (booster), single (Lot number: 039F21A) and on 26Sep2022 as dose 5 (booster), single (Lot number: A57163B) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "bronchiectasis" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: 15Sep2022, stop date: 04Feb2023; AMLODIPINE, start date: 01Sep2018, stop date: 04Feb2023; LEVOTHYROXINE, start date: 01Jan2010. Past drug history included: Tetracycline, reaction(s): "known allergies: tetracycline", notes: known allergies: tetracycline. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31May2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Home test was negative on Day 7; (Feb2023) Positive, notes: positive home test on Day 10 of original infection. Therapeutic measures were taken as a result of drug ineffective, covid-19; Patient took Paxlovid from 04Feb2023 to 08Feb2023.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Received 5 Pfizer vaccines, still tested positive with Covid; Received 5 Pfizer vaccines, still tested positive with Covid; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old male patient received BNT162b2 (BNT162B2), 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), as dose 4 (booster), single (Batch/Lot number: unknown) and in 2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: PNEUMOCOCCAL 13 VALENT VACCINE taken for immunisation as dose number unknown, single. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Received 5 Pfizer vaccines, still tested positive with Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Feb2023) Positive. 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: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose #1: Pfizer/ Dose #2: Pfizer/ Dose #3: Pfizer/ Dose #4: Moderna/ Dose #5: Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 17:00 as dose 5 (booster), single (Lot number: GJ2524) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Mar2021 at 11:00 as dose 1, single (Lot number: EN6208), in left arm, on 31Mar2021 at 11:00 as dose 2, single (Lot number: EW0150), in left arm and on 01Dec2021 at 17:00 as dose 3 (booster), single (Lot number: FJ1620), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 14Apr2022 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type II Diabetes" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "Acid Reflux" (unspecified if ongoing). The patient took concomitant medications (other medication in two weeks). Past drug history included: Known allergies: clindamycin for Known allergies: Clindamycin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 14Apr2022, outcome "unknown", described as "Dose #1: Pfizer/ Dose #2: Pfizer/ Dose #3: Pfizer/ Dose #4: Moderna/ Dose #5: Pfizer"; VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid was given from 11Feb2023 to 13Feb2023.
Sex: F
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: Bad asthma; when she has an attack, she can't breathe; This is a spontaneous report received from a contactable consumer from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Does not drink" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ASTHMA (non-serious), outcome "unknown", described as "Bad asthma; when she has an attack, she can't breathe". Therapeutic measures were taken as a result of asthma.  Additional Information: The patient received all her COVID-19 Vaccines through Pfizer and never had a reaction to them and has never had COVID-19 and is perfectly healthy, except that she has bad asthma. When she has an attack, she can't breathe. The patient has an inhaler.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300041333 Same patient and product; different event and dose;
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 as dose 5 (booster), single (Lot number: GJ6665) at the age of 59 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: EH3899), in left arm, on 12Jan2021 as dose 2, single (Lot number: EL1283), in left arm, on 30Sep2021 as dose 3 (booster), single (Lot number: 301358BA), in left arm and on 01Jul2022 as dose 4 (booster), single (Lot number: FM7553), 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Feb2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Feb2023) Positive, notes: First tested positive on 01Feb2023 and started Paxlovid that evening; (09Feb2023) Negative, notes: I tested negative on 09Feb2023, day #8, after finishing Paxlovid on 02/06/23; (10Feb2023) Positive, notes: On Friday Feb 10th in the morning I woke up with nasal congestion and headache and tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 01Feb2023 to 06Feb2023.  Additional information: I tested negative on 09Feb2023, day #8, after finishing Paxlovid on 06Feb2023. First tested positive on 01Feb2023 and started Paxlovid that evening. On Friday Feb 10th in the morning I woke up with nasal congestion and headache and tested positive again  No follow-up attempts are possible. No further information is expected.; Sender's Comments: A contributory role of BNT162B2 to event COVID-19 cannot be excluded based on temporal association and available information.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: arm hurt; arm hurt right away and then hurt for 2 years at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Lot number: EL3249) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart Catheter", start date: 2020 (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 23Jan2021, outcome "unknown", described as "arm hurt"; VACCINATION SITE PAIN (non-serious) with onset 23Jan2021, outcome "unknown", described as "arm hurt right away and then hurt for 2 years at injection site".  Additional Information: The caller reported that right after her husband received the first dose of the primary series of the vaccine his arm hurt right away at the injection site and continued to hurt for 2 years. The arm pain began immediately after the vaccines on 23Jan2021 and verified that this pain continued for 2 years.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300069251 Same patient/vaccine, different dose/event;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Took all the Pfizer Covid shots said to take and went to doctor today and told has Covid.; Took all the Pfizer Covid shots said to take and went to doctor today and told has Covid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2 NOS), 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 14Feb2023, outcome "unknown" and all described as "Took all the Pfizer Covid shots said to take and went to doctor today and told has Covid.". The events "took all the pfizer covid shots said to take and went to doctor today and told has covid." required physician office visit. Clinical course: Patient took all the Pfizer Covid shots said to take and went to doctor on the day of reporting and told has Covid.  Then was given a medicine to take called Paxlovid. Patient asked if Paxlovid is the same thing as the Pfizer Covid shot was. Patient wants to take medicine. Has got a sick one at home, clarified he is also taking care of somebody else. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19-2, SMALLMNK
Symptoms: Dysphonia, Vaccination site macule
Clinical narrative: Hoarse Voice; I still have the red dot like a mark from the first Vaccine but he refers that it was from the Jynneos; second one already disappeared with left a little blueish; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 25-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Jan2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; smallpox vaccine live (mav-bn) (JYNNEOS), on 12Jan2023 as dose 1, single (Lot number: FDP00018) for monkeypox, prophylaxis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: DYSPHONIA (non-serious), outcome "not recovered", described as "Hoarse Voice"; VACCINATION SITE MACULE (non-serious), outcome "not recovered", described as "I still have the red dot like a mark from the first Vaccine but he refers that it was from the Jynneos; second one already disappeared with left a little blueish". Therapeutic measures were not taken as a result of dysphonia, vaccination site macule.  Additional information: Patient reported some adverse reaction on one of our vaccines but also mentioned that he had the COVID-19 Booster (Clarified as Pfizer COVID-19 Vaccine Booster). The patient had the COVID-19 Booster on 12Jan2023, and also had the first dose of the Jynneos Vaccine for the Monkeypox of Prophylaxis it on the same day. Patient had second shot of Jynneos on this Friday and started with this Hoarse Voice as possibly had noticed already, as the first dose was 4 weeks ago and one day noticed it together and  had it together with the COVID-19 Booster Vaccine from Pfizer. Patient still had the red dot like a mark from the first Vaccine but refers that it was from the Jynneos and the second one already disappeared with left a little blueish, but the first one's mark was still there. No fever but Hoarseness was getting worse. Patient did not feel sick, and also mentioned, not even considered a risk with the Monkeypox Vaccine but had it as patient was about to start a Biologic drug.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pyrexia
Clinical narrative: Gets a little fever every once in a while; Sicknesses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 9-year-old female patient received BNT162b2 (BNT162B2), on 06Nov2021 as dose 1 (orange cap), single (Batch/Lot number: unknown) at the age of 8 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Gets a little fever every once in a while"; ILLNESS (non-serious), outcome "unknown", described as "Sicknesses".  Additional information: Daughter did not get sick or anything; did not remember her daughter ever really being sick. Took all her vaccines. Just got a little fever every once in a while. Just normal sicknesses, but that was  it. Had not received any other no other vaccines four weeks prior to the COVID-19 vaccines. Daughter had not received any other vaccines since then either.  Planning on getting medical tests done, but none had been done at this point. No other conditions.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, SARS-CoV-2 test, Swelling
Clinical narrative: Light pain in the left facial area.; left side neck swelling; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Feb2023 at 15:00 as dose 4 (booster), single (Lot number: GL0087) at the age of 47 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Known allergies: Melons" (unspecified if ongoing); "Known allergies: Pistachio" (unspecified if ongoing); "Known allergies: Red Dye" (unspecified if ongoing); "Known allergies: Peach" (unspecified if ongoing); "Known allergies: Plum" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE [AMLODIPINE BESILATE]. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: FACIAL PAIN (non-serious) with onset 12Feb2023 at 07:00, outcome "recovering", described as "Light pain in the left facial area."; SWELLING (non-serious) with onset 12Feb2023 at 07:00, outcome "recovering", described as "left side neck swelling". The events "light pain in the left facial area." and "left side neck swelling" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of facial pain, swelling.
Sex: M
Vaccine: COVID19, 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 47-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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: "MS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, 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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Lot number: 6H9703) for covid-19 immunisation; BNT162b2 (BNT162B2), in Mar2022 as dose 4 (booster), single (Lot number: FK9729) for covid-19 immunization; 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 immunization. The patient's relevant medical history included: "NSCLC" (unspecified if ongoing), notes: NSCLC; "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: ERLOTINIB, start date: Mar2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from9Feb2023 to 13feb2023.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: because he got 2 Pfizer COVID-19 vaccines and a booster;where he got a SOFIA FIA nasal test because he had chills and body aches, and that's when he was prescribed with Paxlovid; because he got 2 Pfizer COVID-19 vaccines and a booster;where he got a SOFIA FIA nasal test because he had chills and body aches, and that's when he was prescribed with Paxlovid; 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), in 2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and in 2021 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), outcome "unknown" and all described as "because he got 2 Pfizer COVID-19 vaccines and a booster;where he got a SOFIA FIA nasal test because he had chills and body aches, and that's when he was prescribed with Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: could test positive after a certain time. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Additional information:  He then added that before starting Paxlovid, he went to a walk-in clinic, where he got a SOFIA FIA nasal test because he had chills and body aches, and that is when he was prescribed with Paxlovid.He also wanted to know if he was still contagious because he no longer had COVID-19 symptoms, he stated so far, so good and added that he no longer had body aches nor coughing. He also showed interested in knowing Paxlovid develops antibodies, because he got 2 Pfizer COVID-19 vaccines and a booster, possibly monovalent as he received it on late 2021, but he feels scared of getting the new booster because of the stories in the news of people getting sick from vaccine, mentioning the cases of blood clots and heart problems. He then showed interest in learning information about the Pfizer COVID-19 Booster, including if he could receive it while having a recent COVID-19 infection and the possible side effects for people 65 years of age and older, which he then confirmed was his age group, mentioning he was in his 70s. He finally added that he had some side effects when he took the vaccines, but they did not last long and did not had a reaction.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300069211 same reporter/patient/product, different dose/event.;US-PFIZER INC-2021015210 same reporter/patient/product, different dose/event.;
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Lot number: FK9894) at the age of 72 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Oct2021 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 22Apr2022 as dose 4 (booster), single (Lot number: 027EZZA), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EL9264), in left arm and on 27Feb2021 as dose 2, single (Lot number: EN6201), in left arm for covid-19 immunisation. The patient's relevant medical history included: "slightly overweight" (unspecified if ongoing), notes: BMI about 25 so slightly overweight; "osteopenia" (unspecified if ongoing). Concomitant medication(s) included: NATURE MADE VITAMIN D3, start date: 01Sep2020; D MANNOSE, start date: 01Sep2022; VIACTIV [CALCIUM], start date: 01Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body mass index: (unspecified date) 25, notes: BMI about 25 so slightly overweight; SARS-CoV-2 test: (22Dec2022) Negative, notes: testing negative on Thursday, 22Dec2022; (30Dec2022) Positive, notes: tested positive again on Friday, 30Dec2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300071007 Same patient/vaccine, different dose/event;
Age: 55.0
Sex: F
Vaccine: COVID19, 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 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 at 16:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 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, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: sulfa antibiotics" (unspecified if ongoing), notes: known allergies: sulfa antibiotics. Concomitant medication(s) included: ATENOLOL, start date: 01Dec2021; PEPCID [FAMOTIDINE], start date: 06Nov2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, 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.