chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: An adult female patient received by error Engerix-B pediatric; An adult female patient received by error Engerix-B pediatric; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 26-year-old female patient who received HBV (Engerix B pediatric) (batch number F5L5E, expiry date 11-APR-2025) for prophylaxis.   On 25-JUL-2023, the patient received the 1st dose of Engerix B pediatric. On 25-JUL-2023, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: An adult female patient received by error Engerix-B pediatric) and underdose (Verbatim: An adult female patient received by error Engerix-B pediatric).  The outcome of the adult use of a child product and underdose were unknown.   Additional Information: GSK Receipt Date: 18-SEP-2023 The medical assistant supervisor reported that an adult female patient received Engerix-B pediatric by error, which led to adult use of a child product and underdose. The reporter consented to follow up via email.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Headache; Dizziness; Nausea; Fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 05-SEP-2023, the patient received the 1st dose of Shingrix (right arm). On 06-SEP-2023, 1 days after receiving Shingrix, the patient experienced fever (Verbatim: Fever) and headache (Verbatim: Headache). In SEP-2023, the patient experienced dizziness (Verbatim: Dizziness) and nausea (Verbatim: Nausea).  The outcome of the fever was resolved (duration 24 hrs) and the outcome of the headache, dizziness and nausea were not resolved.   It was unknown if the reporter considered the fever, headache, dizziness and nausea to be related to Shingrix.     It was unknown if the company considered the fever, headache, dizziness and nausea to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-SEP-2023 The patient reported next day of vaccine administration she had fever and headache. Her fever went after 24 hours but she was still suffering with headache till time of reporting. She also had dizziness and nausea which was not going. The reporter consented to followup.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose of Shingrix over a year ago and has not received a second dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose over a year ago).   On an unknown date, the patient did not receive Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received the first dose of Shingrix over a year ago and has not received a second dose yet).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date 19 Sep 2023 The pharmacist reported a patient received the first dose of Shingrix over a year ago and had not received a second dose yet. HCP email was provided prior to abandoning if you want to follow up. Till the time of reporting patient did not received 2nd dose of shingrix which led to incomplete course of vaccination.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness in arm and down to her hand; tingling in arm and down to her hand; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of numbness of upper extremities in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 29GB3, expiry date 16-SEP-2025) for prophylaxis.   On 19-SEP-2023 10:00, the patient received Shingrix (left deltoid). On 19-SEP-2023, immediately after receiving Shingrix, the patient experienced numbness of upper extremities (Verbatim: Numbness in arm and down to her hand) and tingling of extremity (Verbatim: tingling in arm and down to her hand).  The outcome of the numbness of upper extremities and tingling of extremity were not resolved.   It was unknown if the reporter considered the numbness of upper extremities and tingling of extremity to be related to Shingrix.     It was unknown if the company considered the numbness of upper extremities and tingling of extremity to be related to Shingrix.   Additional Information: GSK Receipt date: 19-SEP-2023  A pharmacist reported that Shingrix was administered to a patient this morning at 10 AM and the patient immediately stated that she was experiencing numbness and tingling in the injected arm.  The patient went home and called back around 1 PM stating that she was still experiencing the symptoms and that they had gone all the down to her hand.  The reporter consented to follow up via postal.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Soreness; This non-serious case was reported by a physician via call center representative and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: Soreness).  The outcome of the pain was resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-SEP-2023 The reporter reported that the patient received Shingrix vaccine and had adverse reaction of severe soreness for multiple weeks and was now apprehensive to receive the second dose.  The reporter was curious how to approach with patient for second dose. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023128911:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Shingrix vaccination that was reconstituted with normal saline; Shingrix vaccination that was reconstituted with normal saline; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number X006002, expiry date 08-JUL-2024) for prophylaxis.   On 15-SEP-2023, the patient received Shingrix. On 15-SEP-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Shingrix vaccination that was reconstituted with normal saline) and inappropriate dose of vaccine administered (Verbatim: Shingrix vaccination that was reconstituted with normal saline).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-SEP-2023 The reporter was a clinic supervisor reported that the patient received Shingrix vaccination that was reconstituted with normal saline, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up via email.
Sex: F
Vaccine: COVID19
Symptoms: Contrast media allergy
Clinical narrative: ALLERGIC TO CONTRAST DYE FROM CT SCANS AND MRI AFTER GETTING COVID VACCINE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's weight was 45.5 kilograms, and height was not reported. The patient's concurrent conditions included: secondary pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. Concomitant medications included selexipag for pulmonary hypertension secondary, and sildenafil citrate. On an unspecified date, the patient experienced allergic to contrast dye from ct scans and mri after getting covid vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of allergic to contrast dye from ct scans and mri after getting covid vaccine was not reported. This report was non-serious. This case, involving the same patient is linked to 20230440127.
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Hypertension, Malaise, Myalgia, Nausea, Pyrexia
Clinical narrative: general malaise; sleep disturbance; hypertensive spikes, 155/99-73; muscle aches; increased nausea; near vomiting; low grade fever 99.2; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (general malaise), SLEEP DISORDER (sleep disturbance), HYPERTENSION (hypertensive spikes, 155/99-73), MYALGIA (muscle aches) and NAUSEA (increased nausea) in a 74-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 202F234) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 20-Sep-2023, the patient experienced MALAISE (general malaise), SLEEP DISORDER (sleep disturbance), HYPERTENSION (hypertensive spikes, 155/99-73), MYALGIA (muscle aches), NAUSEA (increased nausea), VOMITING (near vomiting) and PYREXIA (low grade fever 99.2). At the time of the report, MALAISE (general malaise), SLEEP DISORDER (sleep disturbance), HYPERTENSION (hypertensive spikes, 155/99-73), MYALGIA (muscle aches), NAUSEA (increased nausea), VOMITING (near vomiting) and PYREXIA (low grade fever 99.2) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 155/99-73. On an unknown date, Body temperature: 99.2.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was unknown if the patient experienced any additional symptoms/events. Treatment medications were not reported.
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Sleep disorder, Vomiting
Clinical narrative: general malaise; sleep disturbance; hypertensive spikes, 155/99-73; muscle aches; increased nausea; near vomiting; low grade fever 99.2; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (general malaise), SLEEP DISORDER (sleep disturbance), HYPERTENSION (hypertensive spikes, 155/99-73), MYALGIA (muscle aches) and NAUSEA (increased nausea) in a 74-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 202F234) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 20-Sep-2023, the patient experienced MALAISE (general malaise), SLEEP DISORDER (sleep disturbance), HYPERTENSION (hypertensive spikes, 155/99-73), MYALGIA (muscle aches), NAUSEA (increased nausea), VOMITING (near vomiting) and PYREXIA (low grade fever 99.2). At the time of the report, MALAISE (general malaise), SLEEP DISORDER (sleep disturbance), HYPERTENSION (hypertensive spikes, 155/99-73), MYALGIA (muscle aches), NAUSEA (increased nausea), VOMITING (near vomiting) and PYREXIA (low grade fever 99.2) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 155/99-73. On an unknown date, Body temperature: 99.2.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was unknown if the patient experienced any additional symptoms/events. Treatment medications were not reported.
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Lymphadenopathy, Nausea, Pyrexia, Tremor
Clinical narrative: violent shaking; high fever; swollen lymph node; headache; nausea, like the gamut; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (violent shaking), PYREXIA (high fever), LYMPHADENOPATHY (swollen lymph node), HEADACHE (headache) and NAUSEA (nausea, like the gamut) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (violent shaking), PYREXIA (high fever), LYMPHADENOPATHY (swollen lymph node), HEADACHE (headache) and NAUSEA (nausea, like the gamut). At the time of the report, TREMOR (violent shaking), PYREXIA (high fever), LYMPHADENOPATHY (swollen lymph node), HEADACHE (headache) and NAUSEA (nausea, like the gamut) had resolved.            Co-suspect included unspecified steroid.  Concomitant product use was not provided by the reporter.  It was reported that Every time she gets the vaccines the first two, then all the boosters, and the one that just became available, she gets every side effect on steroids. They are really bad. She did not know if they were allergic reactions or not. All the side effects she gets, like violent shaking, high fever, swollen lymph node, headache, nausea, like the gamut.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-741364 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741364:Mono valent dose
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Chills, Headache, Muscle spasms, Myalgia
Clinical narrative: muscle cramps; weakness; muscle pain; very high fever; chills; severe headache; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (muscle cramps), ASTHENIA (weakness), MYALGIA (muscle pain), PYREXIA (very high fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer (Previous vaccines were of Pfizer). Past adverse reactions to the above products included No adverse event with Pfizer.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (muscle cramps), ASTHENIA (weakness), MYALGIA (muscle pain), PYREXIA (very high fever), CHILLS (chills) and HEADACHE (severe headache). At the time of the report, MUSCLE SPASMS (muscle cramps), ASTHENIA (weakness), MYALGIA (muscle pain), PYREXIA (very high fever), CHILLS (chills) and HEADACHE (severe headache) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant medication information was not provided.  The patient was wondering if these adverse effects were common and were to be expected. The patient had several patients who experienced similar severe reactions from Moderna vaccine. She never had a reaction like this strong before (previous vaccines were Pfizer).  Treatment information was not provided.
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: muscle cramps; weakness; muscle pain; very high fever; chills; severe headache; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (muscle cramps), ASTHENIA (weakness), MYALGIA (muscle pain), PYREXIA (very high fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer (Previous vaccines were of Pfizer). Past adverse reactions to the above products included No adverse event with Pfizer.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (muscle cramps), ASTHENIA (weakness), MYALGIA (muscle pain), PYREXIA (very high fever), CHILLS (chills) and HEADACHE (severe headache). At the time of the report, MUSCLE SPASMS (muscle cramps), ASTHENIA (weakness), MYALGIA (muscle pain), PYREXIA (very high fever), CHILLS (chills) and HEADACHE (severe headache) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant medication information was not provided.  The patient was wondering if these adverse effects were common and were to be expected. The patient had several patients who experienced similar severe reactions from Moderna vaccine. She never had a reaction like this strong before (previous vaccines were Pfizer).  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Therapeutic response unexpected
Clinical narrative: According to the caller, it makes everything better. It helps his numbers in his condition better. He added that after his previous Moderna COVID 19 shots, it has positive impact in his laboratory numbers. He would like to report it to Moderna.; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (According to the caller, it makes everything better. It helps his numbers in his condition better. He added that after his previous Moderna COVID 19 shots, it has positive impact in his laboratory numbers. He would like to report it to Moderna.) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (According to the caller, it makes everything better. It helps his numbers in his condition better. He added that after his previous Moderna COVID 19 shots, it has positive impact in his laboratory numbers. He would like to report it to Moderna.) and NO ADVERSE EVENT (No adverse event). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (According to the caller, it makes everything better. It helps his numbers in his condition better. He added that after his previous Moderna COVID 19 shots, it has positive impact in his laboratory numbers. He would like to report it to Moderna.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Reporter reported it makes everything better. It helped his numbers in his condition better. He added that after his previous Moderna COVID 19 shots, it had positive impact in his laboratory numbers.   Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-Sep-2023: Live Follow-up information received included no new information.
Age: 57.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Injection site pain, Myalgia, Nausea, Vaccination site pain
Clinical narrative: injection site hurts a little; She feels tired; Body aches; nausea; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Body aches), NAUSEA (nausea), VACCINATION SITE PAIN (injection site hurts a little) and FATIGUE (She feels tired) in a 57-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 035580) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (First Primary monovalent dose) on 07-Jan-2021, Moderna COVID-19 vaccine (Second Primary monovalent dose) on 04-Feb-2021, Moderna COVID-19 vaccine (First Monovalent Booster dose) on 12-Feb-2022 and Bivalent Booster dose on 22-Mar-2023. Past adverse reactions to the above products included No adverse event with Bivalent Booster dose, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine and Moderna COVID-19 vaccine.   On 19-Sep-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 19-Sep-2023, the patient experienced MYALGIA (Body aches), NAUSEA (nausea) and FATIGUE (She feels tired). On 20-Sep-2023, the patient experienced VACCINATION SITE PAIN (injection site hurts a little). At the time of the report, MYALGIA (Body aches) and NAUSEA (nausea) had not resolved and VACCINATION SITE PAIN (injection site hurts a little) and FATIGUE (She feels tired) outcome was unknown.            No concomitant medication was reported. It was reported that after the four shots patient didn't have any side effects. No treatment medication was reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Nausea, Pyrexia, Tremor
Clinical narrative: violent shaking; high fever; swollen lymph node; headache; nausea, like the gamut; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (violent shaking), PYREXIA (high fever), LYMPHADENOPATHY (swollen lymph node), HEADACHE (headache) and NAUSEA (nausea, like the gamut) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TREMOR (violent shaking), PYREXIA (high fever), LYMPHADENOPATHY (swollen lymph node), HEADACHE (headache) and NAUSEA (nausea, like the gamut). At the time of the report, TREMOR (violent shaking), PYREXIA (high fever), LYMPHADENOPATHY (swollen lymph node), HEADACHE (headache) and NAUSEA (nausea, like the gamut) had resolved.            Co-suspect included unspecified steroid.  Concomitant product use was not provided by the reporter.  It was reported that Every time she gets the vaccines the first two, then all the boosters, and the one that just became available, she gets every side effect on steroids. They are really bad. She did not know if they were allergic reactions or not. All the side effects she gets, like violent shaking, high fever, swollen lymph node, headache, nausea, like the gamut.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-741651 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741651:Bivalent dose
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Headache
Clinical narrative: bad headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (bad headache) in a 74-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose-1, Lot#028L20A) on 21-Jan-2021, Moderna COVID-19 Vaccine (Dose-2, 022M20A) on 18-Aug-2021, Moderna COVID-19 Vaccine (Dose-3, Lot#077C21B) on 29-Oct-2021, Moderna COVID-19 Vaccine (Dose-4 (Booster dose), Lot#056A22A) on 06-Apr-2022, Moderna COVID-19 Vaccine (Dose-5 and Lot#AS7145B) on 12-Sep-2022; for Drug use for unknown indication: CoQ10, Calcium with D3, Probiotic gummies, pantoprazole, famotidine, levothyroxine, B12 gummies (B12 gummies), Lisinopril and amlodipine. Past adverse reactions to the above products included No adverse event with B12 gummies, Calcium with D3, CoQ10, Lisinopril, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Probiotic gummies, amlodipine, famotidine, levothyroxine and pantoprazole. Concurrent medical conditions included Seasonal allergy and Drug allergy (Sulfa).    On 20-Sep-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 21-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced HEADACHE (bad headache). At the time of the report, HEADACHE (bad headache) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient did not received any other vaccines in 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. It was also reported that patient would like to know it it was okay to take ibuprofen or tylenol. Treatment details was not reported by the reporter.
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Limb discomfort
Clinical narrative: slight headache; her arm is bothering her; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (slight headache) and LIMB DISCOMFORT (her arm is bothering her) in a 73-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient had no relevant medical history/conditions, allergy, concomitant diseases and risk factor.     On an unknown date, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 21-Sep-2023, the patient experienced HEADACHE (slight headache) and LIMB DISCOMFORT (her arm is bothering her). At the time of the report, HEADACHE (slight headache) and LIMB DISCOMFORT (her arm is bothering her) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The Dosage text of the suspect was reported as unknown. The patient took the 5th dose on 21-Dec-2022. No treatment medication was reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: flu; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (flu) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 22-Sep-2023, the patient experienced INFLUENZA (flu). At the time of the report, INFLUENZA (flu) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reportedly, patient mentioned that she needed to be checked for an urgent care because she felt like she had a flu and she wanted to confirm if it was COVID.  Patient confirmed that she previously received COVID-19 Vaccine.  No treatment information was provided.   Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). 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 21Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HB" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: ibuprofen, reaction(s): "Known allergies: Ibuprofen"; Known allergies: aspirin, reaction(s): "Known allergies: aspirin"; Known allergies: cox- 1&2 inhibitors, reaction(s): "Known allergies: Cox- 1&2 inhibitors". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Sep2023) positive, notes: tested (+) and began paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid from 07Sep2023 to 12Sep2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Treatment failure
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 62-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 at 10:00 as dose 5 (booster), single (Lot number: 6j6739), in left arm and on 01May2023 at 16:30 as dose 6 (booster), single (Lot number: Gj3260) at the age of 62 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: Er2613), in left arm, on 15Apr2021 as dose 2, single (Lot number: Ew0169), in left arm, on 15Dec2021 at 08:30 as dose 3 (booster), single (Lot number: Fj8757), in left arm and on 19Jul2022 at 00:15 as dose 4 (booster), single (Lot number: Pp7139), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pre diabetic" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "obese" (unspecified if ongoing); "sports injuries" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TREATMENT FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of treatment failure, covid-19 with Paxlovid from 10Sep2023 to 15Sep2023.
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).  A 15-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Weather induced asthma" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing). Known allergies reported as o. 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 which included Paxlovid from 30Aug2023 to 04Sep2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
Age: 31.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "known allergies Sulfa" (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 included Paxlovid from 14Sep2023 to 19Sep2023 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.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: gotten 5 Pfizer covid vaccines with last dose administered on 20OCT2022/got covid; gotten 5 Pfizer covid vaccines with last dose administered on 20OCT2022/got covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 73-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and on 20Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Mmr vaccine, for Immunisation; Shingles vaccine, for Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "gotten 5 Pfizer covid vaccines with last dose administered on 20OCT2022/got covid". The event "gotten 5 pfizer covid vaccines with last dose administered on 20oct2022/got covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Caller was a 73-year-old female patient who got covid/diagnosed with COVID Monday morning and was prescribed with Paxlovid 300mg/100mg dose pack. She mentioned that she took her first dose at 1:15 PM today. She mentioned that the covid symptoms she had were, no taste buds, still experiencing dizziness, had high fever prior to taking Paxlovid. She added that she contacted her doctor about this but the doctor did not get back to her. Caller mentioned before that she "MMR vaccine" before which she had a reaction, she also had shingles vaccine. She also mentioned at the latter part of the call that she had gotten 5 Pfizer covid vaccines with last dose administered on 20Oct2022. She mentioned that she had a minor reaction, fever, for it. She mentioned that she had gotten a five vaccines of Pfizer COVID 19 vaccine and to the last dose was Oct2022 and she had now COVID and taking Paxlovid.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300308080 same patient/ product/ different dose (dose 5)/ events;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: gotten 5 Pfizer covid vaccines with last dose administered on 20OCT2022/got covid; gotten 5 Pfizer covid vaccines with last dose administered on 20OCT2022/got covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 73-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and on 20Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Mmr vaccine, for Immunisation; Shingles vaccine, for Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "gotten 5 Pfizer covid vaccines with last dose administered on 20OCT2022/got covid". The event "gotten 5 pfizer covid vaccines with last dose administered on 20oct2022/got covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Caller was a 73-year-old female patient who got covid/diagnosed with COVID Monday morning and was prescribed with Paxlovid 300mg/100mg dose pack. She mentioned that she took her first dose at 1:15 PM today. She mentioned that the covid symptoms she had were, no taste buds, still experiencing dizziness, had high fever prior to taking Paxlovid. She added that she contacted her doctor about this but the doctor did not get back to her. Caller mentioned before that she "MMR vaccine" before which she had a reaction, she also had shingles vaccine. She also mentioned at the latter part of the call that she had gotten 5 Pfizer covid vaccines with last dose administered on 20Oct2022. She mentioned that she had a minor reaction, fever, for it. She mentioned that she had gotten a five vaccines of Pfizer COVID 19 vaccine and to the last dose was Oct2022 and she had now COVID and taking Paxlovid.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300308080 same patient/ product/ different dose (dose 5)/ events;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 73-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 4 (booster), Single), for COVID-19 immunisation; Comirnaty (Dose 3 (booster), Single), for COVID-19 immunisation; Comirnaty (Dose 2, Single), for COVID-19 immunisation; Comirnaty (Dose 1, Single), for COVID-19 immunisation; Mmr vaccine, for Immunisation; Shingles vaccine, for Immunisation. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever".  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300308081 Same patient and product, Different dose and events (LOE);US-PFIZER INC-202300307963 Same patient, different product and different event.;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 73-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 4 (booster), Single), for COVID-19 immunisation; Comirnaty (Dose 3 (booster), Single), for COVID-19 immunisation; Comirnaty (Dose 2, Single), for COVID-19 immunisation; Comirnaty (Dose 1, Single), for COVID-19 immunisation; Mmr vaccine, for Immunisation; Shingles vaccine, for Immunisation. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever".  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300308081 Same patient and product, Different dose and events (LOE);US-PFIZER INC-202300307963 Same patient, different product and different event.;
Age: 58.0
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 59-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 01Sep2022 as dose 5 (booster), single (Lot number: FN2908) at the age of 58 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Auto immune disease, undetermined" (unspecified if ongoing); "asthma" (unspecified if ongoing); "blood clotting disorder" (unspecified if ongoing); "chronic pain" (unspecified if ongoing); "known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was on treatment with Paxlovid from 12Sep2023 to 16Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300308115 Same patient, different drug and different event (Paxlovid case);
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Name of Drug as Reported: Pfizer / BioNTech, Historical vaccine: Yes; Name of Drug as Reported: Moderna, Historical vaccine: Yes; 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 49-year-old female patient (not pregnant) 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; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "Known allergies:multiple antibiotics" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Name of Drug as Reported: Pfizer / BioNTech, Historical vaccine: Yes; Name of Drug as Reported: Moderna, Historical vaccine: Yes". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 28Aug2023 to 02Sep2023 as Treatment of COVID-19.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE), Covid 19 and interchange of vaccine of products  cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300308150 same patient, different drug/event;
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 51-year-old male patient received bnt162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Batch/Lot number: unknown), on 01Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "known allergies: Keflex", notes: known allergies: Keflex. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 61.0
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years, in left arm 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 Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid received from 10Sep2023 to 15Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.