chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Malaise, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: He was a little off the next day with a little bit of achiness; He was a little off the next day with a little bit of achiness; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (He was a little off the next day with a little bit of achiness) and PAIN (He was a little off the next day with a little bit of achiness) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A, 024M201 and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced MALAISE (He was a little off the next day with a little bit of achiness) and PAIN (He was a little off the next day with a little bit of achiness). At the time of the report, MALAISE (He was a little off the next day with a little bit of achiness) and PAIN (He was a little off the next day with a little bit of achiness) outcome was unknown.            No concomitant medication was reported.  On 17-Feb-2021, the patient received second dose of Moderna COVID-19 Vaccine.  On 18-Feb-2021, the patient was a little off with a little bit of achiness.  On 26-Oct-2021, the patient received third dose of Moderna COVID-19 Vaccine.  On 27-Oct-2021, the patient was a little off with a little bit of achiness.  No treatment medication was reported.   This case was linked to MOD-2022-669169 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: I had reaction to my second moderna covid vaccination; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (I had reaction to my second moderna covid vaccination) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (I had reaction to my second moderna covid vaccination). At the time of the report, IMMUNISATION REACTION (I had reaction to my second moderna covid vaccination) outcome was unknown.            No concomitant medications were reported. It was reported that patient had three booster since with no reaction. No treatment medications were reported.
Age: 3.0
Sex: M
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 5-Nov-2022; No Adverse Event; Expired Moderna Covid-19 vaccine was given to 6 Pediatric Patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine was given to 6 Pediatric Patients), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 5-Nov-2022) and NO ADVERSE EVENT (No Adverse Event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine was given to 6 Pediatric Patients). 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 5-Nov-2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine was given to 6 Pediatric Patients), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 5-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 (Expired Moderna Covid-19 vaccine was given to 6 Pediatric Patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 5-Nov-2022).    No concomitant medications were provided.  It was reported that reporter called in to report that an expired Moderna Covid-19 Vaccine was given to 5 Pediatric patients ages 6 months and older.  Vaccine was given on 05 Nov 2022 around morning time.  No adverse event reported from any of the patients .  Affected vials were individual ones with size of 2.5 ml.  Vial was initially stored in the refrigerator on 29 Sept 2022 and did not undergo temperature excursions.  No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-669845 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669845:Same reporter
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; monovalent vaccine "Booster dose only" presentation administered instead of  bivalent; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (monovalent vaccine "Booster dose only" presentation administered instead of  bivalent) and NO ADVERSE EVENT (No adverse event) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 vaccination.     The patient had no medical history related to mentioned adverse events, both acute and chronic illness at the time of vaccination. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.     On 05-Nov-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (monovalent vaccine "Booster dose only" presentation administered instead of  bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (monovalent vaccine "Booster dose only" presentation administered instead of  bivalent) 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 WRONG PRODUCT ADMINISTERED (monovalent vaccine "Booster dose only" presentation administered instead of  bivalent).    No concomitant medication was reported.  No treatment medication was reported. The patient did not report any adverse event. The information was unknown whether the patient was provided any treatment or concomitant or regular medication.
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, expiration date was last 27-Oct-2022 and administered on 5-Nov-2022; No adverse event; Expired Moderna Covid-19 vaccine was given to Pediatric Patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine was given to Pediatric Patient), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022, expiration date was last 27-Oct-2022 and administered on 5-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 05-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine was given to Pediatric Patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022, expiration date was last 27-Oct-2022 and administered on 5-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine was given to Pediatric Patient), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022, expiration date was last 27-Oct-2022 and administered on 5-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 (Expired Moderna Covid-19 vaccine was given to Pediatric Patient) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022, expiration date was last 27-Oct-2022 and administered on 5-Nov-2022).    No Concomitant medications were provided.  Vaccine was given on 05 Nov 2022 around morning time. No adverse event reported from the patient. Affected vials were individual ones with size of 2.5 ml. Vial did not undergo temperature excursions.  No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-669841, US-MODERNATX, INC.-MOD-2022-669846, US-MODERNATX, INC.-MOD-2022-669847, US-MODERNATX, INC.-MOD-2022-669850 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669841:Same reporter US-MODERNATX, INC.-MOD-2022-669846:Same reporter US-MODERNATX, INC.-MOD-2022-669847:Same reporter US-MODERNATX, INC.-MOD-2022-669850:Same reporter
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 29Sept2022 and administered 05Nov2022; No Adverse Event; Expired Moderna Covid-19 vaccine was given to the Patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine was given to the Patient), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 29Sept2022 and administered 05Nov2022) and NO ADVERSE EVENT (No Adverse Event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 05-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine was given to the Patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 29Sept2022 and administered 05Nov2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine was given to the Patient), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 29Sept2022 and administered 05Nov2022) 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 (Expired Moderna Covid-19 vaccine was given to the Patient) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 29Sept2022 and administered 05Nov2022).    No concomitant medication details was reported. It was reported that no adverse event reported from the patients. Individual vials was used and vial size was 2.5ml. Vial was initially stored in the refrigerator on 29-Sep-2022. Vaccine was administered 05-Nov-2022 around morning time. The vial did not undergo any temperature excursions. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-669845 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669845:Same reporter
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 29Sept2022/administered on 05-Nov-2022; No Adverse Event; Patient received expired dose of Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna Covid-19 vaccine), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 29Sept2022/administered on 05-Nov-2022) and NO ADVERSE EVENT (No Adverse Event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 29Sept2022/administered on 05-Nov-2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna Covid-19 vaccine), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 29Sept2022/administered on 05-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 (Patient received expired dose of Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 29Sept2022/administered on 05-Nov-2022).    No concomitant medications were reported.  Vial size was 2.5ml The vial was initially stored in the refrigerator on 29-Sep-2022. The vial did not undergo any temperature excursions. The patient did not experienced any adverse events.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-669845, US-MODERNATX, INC.-MOD-2022-669850 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669845:Same reporter US-MODERNATX, INC.-MOD-2022-669850: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 5-Nov-2022; No Adverse Event; expired Moderna Covid-19 Vaccine was given to 5; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 Vaccine was given to 5), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 5-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 05-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 Vaccine was given to 5). 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 5-Nov-2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 Vaccine was given to 5), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 5-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 (expired Moderna Covid-19 Vaccine was given to 5) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 5-Nov-2022).    No concomitant medications was reported.  It was reported that reporter called in to report that an expired Moderna Covid-19 Vaccine was given to 5 Pediatric patients ages 6 months and older. Vaccine was given on 05 Nov 2022 around morning time. No adverse event reported from any of the patients . Affected vials were individual ones with size of 2.5 ml.  Vial was initially stored in the refrigerator on 29 Sept 2022 and did not undergo temperature excursions.  No treatment drug details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-669845, US-MODERNATX, INC.-MOD-2022-669841, US-MODERNATX, INC.-MOD-2022-669846, US-MODERNATX, INC.-MOD-2022-669847 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669845:Same reporter US-MODERNATX, INC.-MOD-2022-669841:Same reporter US-MODERNATX, INC.-MOD-2022-669846:Same reporter US-MODERNATX, INC.-MOD-2022-669847:Same reporter
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Malaise, Muscular weakness
Clinical narrative: arm weakness; Dizzy; all in the upper left arm muscle which remained sore for several days each time; headache; Fatigue; general feeling of being unwell; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (general feeling of being unwell), MUSCULAR WEAKNESS (arm weakness), DIZZINESS (Dizzy), VACCINATION SITE PAIN (all in the upper left arm muscle which remained sore for several days each time) and HEADACHE (headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced MALAISE (general feeling of being unwell), DIZZINESS (Dizzy), VACCINATION SITE PAIN (all in the upper left arm muscle which remained sore for several days each time), HEADACHE (headache) and FATIGUE (Fatigue). On 20-Feb-2021, the patient experienced MUSCULAR WEAKNESS (arm weakness). In February 2021, MALAISE (general feeling of being unwell), DIZZINESS (Dizzy), HEADACHE (headache) and FATIGUE (Fatigue) had resolved. In 2021, VACCINATION SITE PAIN (all in the upper left arm muscle which remained sore for several days each time) had resolved. At the time of the report, MUSCULAR WEAKNESS (arm weakness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant information was reported. Patient had injection, in the upper left arm muscle which remained sore for several days. Patient received second shot on 17-Feb-2021, event began about 3:00am and lasted 12 hours that was dizzy, headache, fatigue, general feeling of being unwell and then arm weakness started 4 days later. No treatment information was reported.   This case was linked to MOD-2022-669893, MOD-2022-668051, MOD-2022-662883, MOD-2022-662837 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm weakness; Dizzy; all in the upper left arm muscle which remained sore for several days each time; headache; Fatigue; general feeling of being unwell; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (general feeling of being unwell), MUSCULAR WEAKNESS (arm weakness), DIZZINESS (Dizzy), VACCINATION SITE PAIN (all in the upper left arm muscle which remained sore for several days each time) and HEADACHE (headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced MALAISE (general feeling of being unwell), DIZZINESS (Dizzy), VACCINATION SITE PAIN (all in the upper left arm muscle which remained sore for several days each time), HEADACHE (headache) and FATIGUE (Fatigue). On 20-Feb-2021, the patient experienced MUSCULAR WEAKNESS (arm weakness). In February 2021, MALAISE (general feeling of being unwell), DIZZINESS (Dizzy), HEADACHE (headache) and FATIGUE (Fatigue) had resolved. In 2021, VACCINATION SITE PAIN (all in the upper left arm muscle which remained sore for several days each time) had resolved. At the time of the report, MUSCULAR WEAKNESS (arm weakness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant information was reported. Patient had injection, in the upper left arm muscle which remained sore for several days. Patient received second shot on 17-Feb-2021, event began about 3:00am and lasted 12 hours that was dizzy, headache, fatigue, general feeling of being unwell and then arm weakness started 4 days later. No treatment information was reported.   This case was linked to MOD-2022-669893, MOD-2022-668051, MOD-2022-662883, MOD-2022-662837 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Croup infectious, Productive cough
Clinical narrative: Croup symptom/bronchitic productive cough x 1 wk; Croup symptom/bronchitic productive cough x 1 wk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): RA-2022M1120651 (RA).  This serious spontaneous report originated was received by Viatris on 26-Oct-2022. This initial case, received from consumer, non health professional, involved a 64-years-old female patient who reportedly experienced croup infectious, productive cough while receiving Celebrex (celecoxib). Medical history and concomitant medications were not reported. Current condition included arthritis. Non-company suspect medication included pfizer biontech covid-19 vaccine (tozinameran). Unknown date: The patient initiated celecoxib capsule at a dose of 100 milligram bid via unknown route for arthritis/for arthritis left thumb and the patient experienced croup symptom/bronchitic productive cough x 1 wk. The event Croup infectious was considered as medically significant. 13-Oct-2022: The patient initiated tozinameran injection at an unknown dose, unit, frequency via unknown route (batch/lot number 22581 and expiration date was 28-Feb-2023) for unknown indication. Action taken with celecoxib and tozinameran were not reported. At the time of reporting patient was recovering from the events croup infectious and productive cough.  Celebrex is under agreement with Viatris.  Causality Assessment: Drug: Celebrex for events Productive cough, Croup, Per Reporter /Company (Viatris) was Possible. Sender's Comments: Viatris Comment: Serious: Croup infectious and productive cough (non-serious) are listed events as per company of celecoxib. Causality of the reported events croup infectious and productive cough has been assessed as possible as the contributory role of suspect drug cannot be completely excluded with known safety profile of the drug.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: 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 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EN6198), in left arm, on 30Mar2021 as dose 2, single (Lot number: EP7533), in left arm, on 04Oct2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 19Sep2022 as dose 4 (booster), single (Lot number: FL3198) at the age of 67 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "glaucoma" (unspecified if ongoing); "Ehlers danlos" (unspecified if ongoing); "history of cancer" (unspecified if ongoing). Concomitant medication(s) included: SYNJARDY XR; CENTRUM SILVER WOMEN 50+. Past drug history included: Codein, reaction(s): "Known allergies: Codein"; Mucinex, reaction(s): "Known allergies: Mucinex". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (02Nov2022) Positive, notes: Tested positive again after finishing the Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Heart rate, Heart rate increased, Muscle fatigue, Syncope
Clinical narrative: 2 episodes of sycope; 2 episodes of vomiting; extreme muscle fatigue; weakness; fast heartbeat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 4 (booster), single (Lot number: GJ3275) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "POTS syndrome" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Covid-19 vaccine (DOSE 2, SINGLE, Lot number: Not reported), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Lot number: Not reported), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, Lot number: Not reported), for Covid-19 immunization. The following information was reported: SYNCOPE (medically significant) with onset 01Nov2022, outcome "unknown", described as "2 episodes of sycope"; VOMITING (non-serious) with onset 01Nov2022, outcome "unknown", described as "2 episodes of vomiting"; MUSCLE FATIGUE (non-serious) with onset 01Nov2022, outcome "unknown", described as "extreme muscle fatigue"; HEART RATE INCREASED (non-serious) with onset 01Nov2022, outcome "unknown", described as "fast heartbeat"; ASTHENIA (non-serious) with onset 01Nov2022, outcome "unknown", described as "weakness". The patient underwent the following laboratory tests and procedures: Heart rate: (01Nov2022) Fast. Therapeutic measures were not taken as a result of syncope, vomiting, muscle fatigue, asthenia, heart rate increased.  Clinical course: other medications in two weeks: Zyrtec, vitamins. 2 episodes of syncope, 2 episodes of vomiting, extreme muscle fatigue, weakness, and fast heartbeat on 01Nov2022.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: 2 episodes of sycope; 2 episodes of vomiting; extreme muscle fatigue; weakness; fast heartbeat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 4 (booster), single (Lot number: GJ3275) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "POTS syndrome" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Covid-19 vaccine (DOSE 2, SINGLE, Lot number: Not reported), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Lot number: Not reported), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, Lot number: Not reported), for Covid-19 immunization. The following information was reported: SYNCOPE (medically significant) with onset 01Nov2022, outcome "unknown", described as "2 episodes of sycope"; VOMITING (non-serious) with onset 01Nov2022, outcome "unknown", described as "2 episodes of vomiting"; MUSCLE FATIGUE (non-serious) with onset 01Nov2022, outcome "unknown", described as "extreme muscle fatigue"; HEART RATE INCREASED (non-serious) with onset 01Nov2022, outcome "unknown", described as "fast heartbeat"; ASTHENIA (non-serious) with onset 01Nov2022, outcome "unknown", described as "weakness". The patient underwent the following laboratory tests and procedures: Heart rate: (01Nov2022) Fast. Therapeutic measures were not taken as a result of syncope, vomiting, muscle fatigue, asthenia, heart rate increased.  Clinical course: other medications in two weeks: Zyrtec, vitamins. 2 episodes of syncope, 2 episodes of vomiting, extreme muscle fatigue, weakness, and fast heartbeat on 01Nov2022.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Facial paralysis, Headache, Sinusitis
Clinical narrative: her face seems droop; sinus infection; Headache; Ear infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 21-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: FACIAL PARALYSIS (medically significant), outcome "unknown", described as "her face seems droop"; SINUSITIS (non-serious), outcome "unknown", described as "sinus infection"; HEADACHE (non-serious), outcome "unknown"; EAR INFECTION (non-serious), outcome "unknown". The events "her face seems droop", "sinus infection", "headache" and "ear infection" required physician office visit. Therapeutic measures were taken as a result of facial paralysis, sinusitis, headache, ear infection. Clinical course: Reporter stated, was calling for daughter. The patient got the COVID Vaccine shot 11 months ago when they first came out. She has had no health conditions at all. After the two shot, a month later, she had got headache which reporter never thought nothing of it, never thought of about the COVID Vaccine, never thought about the other thing, reporter thought she had a ear infection or may be a sinus infection. Reporter took her to the doctor. The doctor gave her some antibiotic and he gave her a steroid shot even though he didn't find any infection because her face seems droop.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Pruritus, Rash
Clinical narrative: Headache; Itchy; red rashes all in my chest and around my neck; All of my breast is red around my neck; sometimes it feel like I get like short of breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "Acid reflux" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: moderna (first dose; lot: 034F21A), administration date: 22Oct2021, when the patient was 77-year-old, for COVID-19 immunization; moderna (second dose; 067F21A), administration date: 20Dec2021, when the patient was 77-year-old, for COVID-19 immunization; moderna (third dose; M8022-2A), administration date: 28Jun2022, when the patient was 78-year-old, for COVID-19 immunization.  The following information was reported: HEADACHE (non-serious), outcome "unknown"; PRURITUS (non-serious), outcome "unknown", described as "Itchy"; RASH (non-serious), outcome "unknown", described as "red rashes all in my chest and around my neck; All of my breast is red around my neck"; DYSPNOEA (non-serious), outcome "unknown", described as "sometimes it feel like I get like short of breath". The events "red rashes all in my chest and around my neck; all of my breast is red around my neck" required physician office visit. Therapeutic measures were taken as a result of rash.  At first patient just had a headache, like she had flu thing and like that and a little upset. Patient was wondering while she was itchy, but she did not know why she was itchy so and on Friday night she did not know but she did not pay no test finally, patient look around neck and looked all in her chest. Patient got red rashes all in chest and around neck. So, that was some of the side effect and sometimes it feels like she gets like short of breath.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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) from product quality group. The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: EW0158), in right arm, on 27Apr2021 as dose 2, single (Lot number: EW0169), in right arm and on 07Dec2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Cleft palette" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sulfamethoxazole, reaction(s): "known allergies: Sulfamethoxazole"; Ciprofloxacin, reaction(s): "known allergies: ciprofloxacin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19".  Therapeutic measures were taken as a result of vaccination failure, covid-19. Investigation result received on 05Nov2022. The complaint for lack of effect of the Pfizer-biontech covid-19 vaccine Injectable lot EW0158, EW0169 and FF2587 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EW0158, fill lot EP8693, bulk formulated drug product lot EW8072; lot EW0169, fill lot EP8700, and the bulk formulated drug product EP8602; lot FF2587, fill lot FF2556, and the formulated drug product lot FE5315. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: feel under the weather; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient received BNT162b2 (BNT162B2), on 12Jan2021 as dose 2, single (Lot number: EJ1686) at the age of 47 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (ongoing), notes: For Years; "Depression" (ongoing), notes: For Years; "Positive ANA", start date: 2019 (ongoing); "Hypertension" (ongoing), notes: For Years. Concomitant medication included: ASPIRIN (E.C.) oral; CYANOCOBALAMIN oral; CALCIUM CARBONATE;COLECALCIFEROL oral. Vaccination history included: BNT162b2 (Lot number: EJ1685; intramuscularly in left arm as dose 1, single), administration date: 22Dec2020, when the patient was 47-year-old, for COVID-19 Immunization, reaction(s): "feel under the weather". The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "feel under the weather".
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, White blood cell count, White blood cell count increased
Clinical narrative: his white blood cell count increased; his lymph nodes began to swell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4176868.  A 63-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: GAZYVA. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "not recovered", described as "his lymph nodes began to swell"; WHITE BLOOD CELL COUNT INCREASED (non-serious), outcome "not recovered", described as "his white blood cell count increased". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: after having the first COVID vaccine, the patient's lymph nodes began to swell and his white blood cell count increased. The events did not abate after the stopping the drug.  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-PV202200097131 same reporter/patient/event, different doses;
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Drug ineffective, Suspected COVID-19
Clinical narrative: Covid positive; Covid positive; I have serious side effects, I feel like I am about to die after I took your shot; This is a spontaneous report received from a non-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 number unknown (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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid positive"; ANXIETY (medically significant), outcome "unknown", described as "I have serious side effects, I feel like I am about to die after I took your shot".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Penis disorder
Clinical narrative: My penis does not work; It is all due to the vaccine. It is the vaccine, my penis does not work because of your vaccine; 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), 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: PENIS DISORDER (non-serious), outcome "unknown", described as "My penis does not work; It is all due to the vaccine. It is the vaccine, my penis does not work because of your vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Penis disorder
Clinical narrative: my penis does not work; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient 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: PENIS DISORDER (non-serious), outcome "unknown", described as "my penis does not work".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
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 contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Mar2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Positive, notes: Rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient has no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Rhinorrhoea, SARS-CoV-2 test, Syncope
Clinical narrative: fainting; runny nose; diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Oct2022 at 11:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 23 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Down Syndrome" (unspecified if ongoing); "asthma" (unspecified if ongoing); "encopresis" (unspecified if ongoing); "Known allergies: Gluten" (unspecified if ongoing). Concomitant medication(s) included: FAMOTIDINE. Vaccination history included: Covid-19 vaccine (Primary Immunisation Series Complete, Unknown Manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose 3 (booster), Unknown Manufacturer), for COVID-19 immunisation. The following information was reported: DIARRHOEA (non-serious) with onset 01Nov2022 at 12:00, outcome "unknown", described as "diarrhea"; SYNCOPE (medically significant) with onset 01Nov2022 at 12:00, outcome "unknown", described as "fainting"; RHINORRHOEA (non-serious) with onset 01Nov2022 at 12:00, outcome "unknown", described as "runny nose". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Aug2022) Negative, notes: Nasal Swab, Orange box. Therapeutic measures were taken as a result of syncope, rhinorrhoea, diarrhoea. Treatment for adverse events were Peptiva bismol, electrolytes and Tylenol Rapid Rel. The patient had no covid prior vaccination. The patient was covid tested post vaccination; Covid test post vaccination: Nasal Swab, Orange box, on 31Aug2022, result=Negative.  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: 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 contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 29Mar2021 as dose 2, single (Lot number: ER8732), in left arm, on 09Dec2021 as dose 3 (booster), single (Lot number: FE3584), in left arm and on 26Apr2022 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: "Hypertension" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "herniated discs" (unspecified if ongoing); "history of pericarditis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ALLER ZYR; MELOXICAM; LOSARTAN HCTZ; LEVOTHYROXINE SODIUM; GABAPENTIN. Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquin"; Avelox, reaction(s): "Known allergies: Avelox". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". After taking the antiviral (COVID 19 Treatment; brand: Pfizer), patient improved and tested negative the morning of 02Nov2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (02Nov2022) negative, notes: tested negative the morning of 02Nov2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: Chills at night; Muscle pain; 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 female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergy to penicillin" (unspecified if ongoing), notes: allergy to penicillin; "Strong Anesthesia" (unspecified if ongoing), notes: Gives her tachycardia when she receives very strong anesthesia.; "tachycardia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Iron, reaction(s): "allergy to iron", notes: allergy to iron. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills at night"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain".  Additional information: It was reported as caller wanted to get their fourth dose of the Pfizer COVID-19 vaccine and wants to know if the formulation has changed. The reporter assessed the events as non-serious. She wanted to know if she could receive her 4th dose and if are ingredients still the same to receive the forth dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.