chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered after the date of expiry on 02Dec2022 to 1 adult patient. Vaccine expired on 27Nov2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered after the date of expiry on 02Dec2022 to 1 adult patient. Vaccine expired on 27Nov2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered after the date of expiry on 02Dec2022 to 1 adult patient. Vaccine expired on 27Nov2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered after the date of expiry on 02Dec2022 to 1 adult patient. Vaccine expired on 27Nov2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered after the date of expiry on 02Dec2022 to 1 adult patient. Vaccine expired on 27Nov2022).    No concomitant and treatment medications are reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; administered 13 doses of Moderna COVID-19 Vaccine Bivalent BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine Bivalent BUD) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7166B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 13-Dec-2022,  after starting , the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine Bivalent BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine Bivalent BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine Bivalent BUD).    No relevant concomitant medications were reported.   Administered 13 doses of Moderna COVID-19 Vaccine Bivalent BUD. Vaccines were stored in the fridge since 11-Nov-2022 and administered on 13-Dec-2022.  No treatment information was provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Fatigue, Feeling abnormal, Limb discomfort, Nausea
Clinical narrative: not feeling good; her arm is killing; tiredness; nausea; two bivalent doses were given at the same day /she gave me another dose; It was a faulty needle or something that she's never had that happen before/two bivalent doses on the same day because of leaking; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (not feeling good), LIMB DISCOMFORT (her arm is killing), FATIGUE (tiredness), NAUSEA (nausea) and OVERDOSE (two bivalent doses were given at the same day /she gave me another dose) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 041h22a and 041h22a) 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 BIONTECH COVID-19 VACCINE on 08-Apr-2021 and PFIZER BIONTECH COVID-19 VACCINE on 29-Apr-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.   On 12-Dec-2022, 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 12-Dec-2022, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2022, the patient experienced FATIGUE (tiredness), NAUSEA (nausea), OVERDOSE (two bivalent doses were given at the same day /she gave me another dose) and DEVICE CONNECTION ISSUE (It was a faulty needle or something that she's never had that happen before/two bivalent doses on the same day because of leaking). On an unknown date, the patient experienced FEELING ABNORMAL (not feeling good) and LIMB DISCOMFORT (her arm is killing). At the time of the report, FEELING ABNORMAL (not feeling good), LIMB DISCOMFORT (her arm is killing), OVERDOSE (two bivalent doses were given at the same day /she gave me another dose) and DEVICE CONNECTION ISSUE (It was a faulty needle or something that she's never had that happen before/two bivalent doses on the same day because of leaking) outcome was unknown and FATIGUE (tiredness) and NAUSEA (nausea) had not resolved.            No concomitant medications were reported.  Patient stated that, she went to receive the bivalent booster shot and when health care professional (HCP) gave her the first shot, some of it went in her arm and the rest trip down of her arm. The HCP said, it was a faulty needle or something that never had that happen before. After that, HCP gave her another dose. The two bivalent doses were given at the same day. Patient also stated, she was experiencing tiredness, not feeling good, nausea, and her arm was killing her.  No treatment medications were reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: not feeling good; her arm is killing; tiredness; nausea; two bivalent doses were given at the same day /she gave me another dose; It was a faulty needle or something that she's never had that happen before/two bivalent doses on the same day because of leaking; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (not feeling good), LIMB DISCOMFORT (her arm is killing), FATIGUE (tiredness), NAUSEA (nausea) and OVERDOSE (two bivalent doses were given at the same day /she gave me another dose) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 041h22a and 041h22a) 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 BIONTECH COVID-19 VACCINE on 08-Apr-2021 and PFIZER BIONTECH COVID-19 VACCINE on 29-Apr-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.   On 12-Dec-2022, 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 12-Dec-2022, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2022, the patient experienced FATIGUE (tiredness), NAUSEA (nausea), OVERDOSE (two bivalent doses were given at the same day /she gave me another dose) and DEVICE CONNECTION ISSUE (It was a faulty needle or something that she's never had that happen before/two bivalent doses on the same day because of leaking). On an unknown date, the patient experienced FEELING ABNORMAL (not feeling good) and LIMB DISCOMFORT (her arm is killing). At the time of the report, FEELING ABNORMAL (not feeling good), LIMB DISCOMFORT (her arm is killing), OVERDOSE (two bivalent doses were given at the same day /she gave me another dose) and DEVICE CONNECTION ISSUE (It was a faulty needle or something that she's never had that happen before/two bivalent doses on the same day because of leaking) outcome was unknown and FATIGUE (tiredness) and NAUSEA (nausea) had not resolved.            No concomitant medications were reported.  Patient stated that, she went to receive the bivalent booster shot and when health care professional (HCP) gave her the first shot, some of it went in her arm and the rest trip down of her arm. The HCP said, it was a faulty needle or something that never had that happen before. After that, HCP gave her another dose. The two bivalent doses were given at the same day. Patient also stated, she was experiencing tiredness, not feeling good, nausea, and her arm was killing her.  No treatment medications were reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: feels achy all over especially in her arms and legs/It's gotten achier; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (feels achy all over especially in her arms and legs/It's gotten achier) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Dec-2022, 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 11-Dec-2022, the patient experienced MYALGIA (feels achy all over especially in her arms and legs/It's gotten achier). At the time of the report, MYALGIA (feels achy all over especially in her arms and legs/It's gotten achier) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   Treatment medications were not reported.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; expired vaccine for their first primary series dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine for their first primary series dose of the Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 58-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Dec-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 14-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine for their first primary series dose of the Moderna Covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine for their first primary series dose of the Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired vaccine for their first primary series dose of the Moderna Covid-19 vaccine).    Concomitant medications were not reported.  The patient reports no other adverse events. Treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE and SPIKEVAX. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE and SPIKEVAX.    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)) (Intramuscular) Additional Booster. On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related.    No concomitant medication information was reported. No treatment medication information was reported.  The patient stated I had Moderna Covid-19 2 regular shots and 3 boosters and denies being immunocompromised.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in a 26-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     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, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. Company comment-This literature-non-study case concerns a male patient aged 26 years with no medical history reported, who experienced the expected serious (medically significant) AESI event of Myocarditis about seven days after first dose of mRNA-1273 vaccine in covid-19 vaccination series. No information on risk factors, medical history, concomitant medications, detailed clinical course, lab details, cardiac studies, treatment received was available in the report. Outcome of the event was unknown at the time of report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-686175 (E2B Linked Report).; Sender's Comments: This literature-non-study case concerns a male patient aged 26 years with no medical history reported, who experienced the expected serious (medically significant) AESI event of Myocarditis about seven days after first dose of mRNA-1273 vaccine in covid-19 vaccination series. No information on risk factors, medical history, concomitant medications, detailed clinical course, lab details, cardiac studies, treatment received was available in the report. Outcome of the event was unknown at the time of report. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-686175:(27 YO female)
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: I gave the patient a Moderna peds booster instead of the adult bivalent booster; No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of WRONG PRODUCT ADMINISTERED (I gave the patient a Moderna peds booster instead of the adult bivalent booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender 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 WRONG PRODUCT ADMINISTERED (I gave the patient a Moderna peds booster instead of the adult bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (I gave the patient a Moderna peds booster instead of the adult bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (I gave the patient a Moderna peds booster instead of the adult bivalent booster).    No concomitant medicine were reported. No treatment medicine were reported.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Post-acute COVID-19 syndrome, SARS-CoV-2 test
Clinical narrative: experiencing long Covid syndrome/experiencing lingering symptoms; This spontaneous case was reported by a consumer and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (experiencing long Covid syndrome/experiencing lingering symptoms) in a 65-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    The patient's past medical history included COVID-19 (patient had COVID-19 4-5 times already). Concurrent medical conditions included Lupus syndrome (he had lupus underlying disease). Concomitant products included PREDNISONE for Lupus syndrome, BELIMUMAB (BENLYSTA) for an unknown indication.   On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (experiencing long Covid syndrome/experiencing lingering symptoms). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, POST-ACUTE COVID-19 SYNDROME (experiencing long Covid syndrome/experiencing lingering symptoms) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.         Patient had 10 doctors and a primary care physician that patient worked very closely with, as he had a lot going with his body at the time of report. Reporter reported that the patient wasn't fat. It was reported that patient got COVID-19 in June until now, but currently patient was not positive. Patient didn't had energy but after taking the Paxlovid, everything disappeared and within one day patient was cured and was able to walk on his energy. Patient got his energy back and didn't require walker to backup. Patient reported that he was prescribed with Paxlovid again last Tuesday and by Wednesday he got his energy back and he considered Paxlovid as a miracle drug as Paxlovid saved his quality of life. However, it was further reported that the patient still had symptoms. It was further reported that patient couldn't really treat his lupus during the COVID for 2 years because they were pretty similar.  Patient was going to visit Rheumatologist.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Tendonitis
Clinical narrative: Tendonitis; This spontaneous case was reported by a consumer and describes the occurrence of TENDONITIS (Tendonitis) in a 33-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) solution for injection for Crohn's disease.    Previously administered products included for COVID-19 vaccination: Pfizer BioNTech COVID-19 vaccine (1st dose; RoA: Intramuscular) on 01-Jun-2020 and Pfizer BioNTech COVID-19 vaccine (2nd dose; RoA: Intramuscular) on 01-Jul-2020. Past adverse reactions to the above products included No adverse event with Pfizer BioNTech COVID-19 vaccine and Pfizer BioNTech COVID-19 vaccine.   On 23-Sep-2022, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 600 milligram every four weeks. On 10-Oct-2022, 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 17-Oct-2022, the patient experienced TENDONITIS (Tendonitis). At the time of the report, TENDONITIS (Tendonitis) had not resolved.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No medical history was reported. No concomitant medications were reported. The patient had joint pains, the physician treated as tendonitis. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Chills, Cough, Headache
Clinical narrative: dry cough; bedridden; chills at night; headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (dry cough), BEDRIDDEN (bedridden), CHILLS (chills at night) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2022, the patient experienced COUGH (dry cough), BEDRIDDEN (bedridden), CHILLS (chills at night) and HEADACHE (headache). At the time of the report, COUGH (dry cough), BEDRIDDEN (bedridden), CHILLS (chills at night) and HEADACHE (headache) outcome was unknown.            Concomitant products were not reported.  It was reported that patient had first doses of Moderna COVID-19 immunization in Sep-2021. Patient also mentioned that she probably had COVID.  Treatment medications were not reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Hepatic enzyme increased, Liver function test
Clinical narrative: when patient had her second booster last week. It did the same thing; This spontaneous case was reported by a patient and describes the occurrence of HEPATIC ENZYME INCREASED (when patient had her second booster last week. It did the same thing) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013h22a) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Isoniazid in 2006. Past adverse reactions to the above products included Elevated liver enzymes with Isoniazid.    On 04-Dec-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In December 2022, the patient experienced HEPATIC ENZYME INCREASED (when patient had her second booster last week. It did the same thing). At the time of the report, HEPATIC ENZYME INCREASED (when patient had her second booster last week. It did the same thing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Liver function test: Significantly elevated.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   On 04-Dec-2022 patient received fourth dose as a bivalent second booster dose.  No concomitant medication were provided. No treatment medication were given.   This case was linked to MOD-2022-686359 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Trigeminal neuralgia
Clinical narrative: Shingles; Trigeminal neuralgia; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) and TRIGEMINAL NEURALGIA (Trigeminal neuralgia) in an 81-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 immunisation.     No Medical History information was reported.    In 2022, 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 HERPES ZOSTER (Shingles) and TRIGEMINAL NEURALGIA (Trigeminal neuralgia). At the time of the report, HERPES ZOSTER (Shingles) and TRIGEMINAL NEURALGIA (Trigeminal neuralgia) outcome was unknown.            No concomitant products reported.  It was reported that a patient started treatment on an unspecified date in 2021 with primary series of Moderna COVID-19 Vaccine (elasomeran) and a booster dose on an unspecified date in 2022 for COVID-19 immunization. It was reported that after the booster dose, the patient had a neurologic event in which the vaccine attacked her nervous systemand she developed shingles and trigeminal neuralgia. She did see her HCP who advised her to discontinue further Moderna mRNA vaccines and get Novavax as her second booster.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: My daughter has had Moderna shot (five also) and 6 weeks ago she got Covid; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (My daughter has had Moderna shot (five also) and 6 weeks ago she got Covid) in a female patient of an unknown age 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 fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In November 2022, the patient experienced COVID-19 (My daughter has had Moderna shot (five also) and 6 weeks ago she got Covid). At the time of the report, COVID-19 (My daughter has had Moderna shot (five also) and 6 weeks ago she got Covid) outcome was unknown.            Concomitant medication was not provided. It was reported that patient had received all 5 doses of vaccine. Treatment information was not reported.   Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 in once. and ADALIMUMAB (HUMIRA) (Subcutaneous) Single Dose Pen. On 28-Aug-2022, the patient experienced COVID-19 (COVID). On 14-Sep-2022, COVID-19 (COVID) had resolved.            No concomitant medications were reported.  No treatment medications were reported.  The reporter did not have the lot number information, because the packaging was discarded.  The reporter's causality for the event of COVID with adalimumab solution for injection was reasonable possibility.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: that she had bad reactions to the booster dose of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (that she had bad reactions to the booster dose of the Moderna vaccine) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    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 IMMUNISATION REACTION (that she had bad reactions to the booster dose of the Moderna vaccine). At the time of the report, IMMUNISATION REACTION (that she had bad reactions to the booster dose of the Moderna vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   It was reported that, the patient had bad reactions to the booster dose.  No treatment details were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Hypertension
Clinical narrative: States she talked to 2 other people who experienced the same thing; States she talked to 2 other people who experienced the same thing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 immunization.  The following information was reported: BLOOD PRESSURE ABNORMAL (non-serious), HYPERTENSION (non-serious), outcome "unknown" and all described as "States she talked to 2 other people who experienced the same thing". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated that she can only find 2 other people that this happened to. Her neighbor said it was on tv about this happening, about the vaccine affecting blood pressure medicines. She called Pfizer right after it happened, and all they told her was to contact the CDC.  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-202201361208 Same reporter, same product, same event, different patient;US-PFIZER INC-202201360920 Same reporter, same product, same event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Injection site indentation
Clinical narrative: The indentation is now around the size of a five cent piece that is dark and has been getting deeper in indentation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 72-year-old female patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "They got the first 2 doses 2 weeks apart"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE.), for COVID-19 immunization, reaction(s): "Soreness". The following information was reported: INJECTION SITE INDENTATION (non-serious) with onset 2022, outcome "unknown", described as "The indentation is now around the size of a five cent piece that is dark and has been getting deeper in indentation".  Additional information: Reporter stated that they had both had the series of Pfizer injections where they got the first 2 doses 2 weeks apart and then got the 3rd, 4th and 5th booster, caller stated they had a total of 5 injections. Caller stated after the 3rd dose, both of them experiences soreness that went away after 3 or 4 days. Caller stated after the 4th dose in the 4th month of this year, about 10-14 days after it made his wife's skin got brown and they thought it was bruising. Reporter stated her skin was dark and it started making like an indentation where it kept sinking where the injection site was. Reporter stated the indentation was then around the size of a five cent piece that was dark and had been getting deeper in indentation. Reporter stated it had gotten deeper over the last month. Reporter stated when they went to get their 5th injection, the pharmacist said she had never seen that before.  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-202201368860 same reporter and drug, different patient and event;
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Lymphadenopathy, Pain, Panic attack
Clinical narrative: panic attack; feeling body aches; short of breath; their left gland was inflamed; 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 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: PANIC ATTACK (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "feeling body aches"; DYSPNOEA (non-serious), outcome "unknown", described as "short of breath"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "their left gland was inflamed".  Additional information: In the beginning of the call, the agent confirmed twice with the user if they are a trial participant or not. They stated they were. They reported feeling body aches after a Pfizer Vaccine (at this point, it was not yet confirmed if this was Covid or a Clinical Trial), and that their left gland was inflamed. Following that, the agent asked them to confirm if they had their Emergency Contact Card with them, which they confirmed. They confirmed it was a physical card. While looking for the card, the person on the call started getting short of breath. The agent asked them if they were feeling okay and stated that if they were having a panic attack (as it sounded like it on the phone), and/or if their symptoms are worsening, they need to seek Emergency Medical Help. The caller advised that they were having a panic because 'they couldn't find their bag' and that 'the symptoms weren't worsening, they were just very worried'. Upon asking to confirm what was stated on the card, the agent advised them to not confirm any names/phone number (as at this point the agent still unsure if they are NOT a Pfizer Clinical Trial Participant) at the 'Sponsor Protocol Number' field, they said 'PFZ699'. As that did not sound like a study during the call, the agent asked them to confirm the Principal Investigator's name/s and if there would be a phone number on the card. They advised there was no such information present on this card, but rather, when they were distributed with a Covid Vaccine and the type of it. The agent asked the caller how they got our phone and they admitted they just searched it. After confirming that the line was for Pfizer Clinical Trials only, the caller asked what phone they should call.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Investigation, Pruritus, Rash
Clinical narrative: Diarrhea; a rash on my left arm and shoulder; itchiness; 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 male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Dec2022 as dose 5 (booster), single (Lot number: GJ6739) at the age of 78 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing), notes: Diabetic; "Blood pressure high" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 4, unknown manufacturer), for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset Dec2022, outcome "unknown", described as "Diarrhea"; RASH (non-serious) with onset Dec2022, outcome "unknown", described as "a rash on my left arm and shoulder"; PRURITUS (non-serious) with onset Dec2022, outcome "unknown", described as "itchiness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of diarrhoea, rash, pruritus.  Additional information: Case narrative including clinical course, therapeutic measures, outcome and additional relevant information. The report not related to a study or programme. Other Conditions was yes. Investigations were reported as yes. Reason for no lot number of COVID-19 Bivalent Vaccine: Other: Consumer stated, reporter think the LOT# is GJ6739. Expiry Date of COVID-19 Bivalent Vaccine was unknown.Reporter received patient fifth Pfizer shot (later clarified ad Pfizer COVID-19 Bivalent Vaccine) at the, Thursday, 08Dec2022 and patient had a reaction. Patient believe it is a reaction and diarrhea, a rash on my left arm and shoulder, itchiness. What can patient do, what can patient take to alleviate this. Consumer was informed about the role of Pfizer Drug Safety and also informed that Pfizer Medical Information is the right department to answer the question. In response to file a safety report, Consumer stated as yes, go ahead. Reporter stated, patient think the LOT# is GJ6739. It is the Pfizer Bivalent (clarified) and it was 08Dec2022. It is the fifth shot. Any prior vaccinations (within 4 weeks) was reporter stated was no. Other medical conditions and Concomitant medications: Consumer stated, Patient was a diabetic. Patient have high blood pressure and sugar diabetes. Treatment for the medical conditions consumer stated was yes. Name of the medications patient stated was no, not at this time. Reporter stated was yes, Thursday patient had blood drawn at the. Results of the test: Consumer stated, patient don't have the results. It went straight to the doctor. Treatment in response to adverse event was no. Reassurance was stated, not at this time.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Herpes zoster
Clinical narrative: diagnosed with shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Dec2022 at 17:00 as dose 4 (booster), single (Lot number: GH9703) at the age of 40 years, in right arm for covid-19 immunisation. The patient's family history included: "shingles" (unspecified if ongoing), notes: None, but my dad got shingles pretty early too (like 46?). There were no concomitant medications. Past drug history included: Cipro, reaction(s): "Allergies: Cipro". Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer unknown), for COVID-19 immunization, reaction(s): "COVID-19"; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer unknown), for COVID-19 immunization, reaction(s): "COVID-19"; Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer unknown), for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: HERPES ZOSTER (non-serious) with onset 09Dec2022 at 03:00, outcome "recovering", described as "diagnosed with shingles". The event "diagnosed with shingles" required physician office visit. Therapeutic measures were taken as a result of herpes zoster.  Additional information: Report about covid treatment: Yes. Dose received: More than 3. No other vaccine in four weeks. No other medications in two weeks. Adverse event: Two days after her second booster (4th shot, the newer one), She noticed a small rash on her left flank. (That would be her butt.) today, Monday, 5 days after the shot, the rash got pretty painful so she went to a doctor and got diagnosed with shingles. AE treatment: Too late to take antiviral, so just pain relievers. No covid prior vaccination and no covid tested post vaccination. Known allergies: Cipro. Other medical history: None, but her dad got shingles pretty early too (like 46?).
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Rash
Clinical narrative: diagnosed with shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Dec2022 at 17:00 as dose 4 (booster), single (Lot number: GH9703) at the age of 40 years, in right arm for covid-19 immunisation. The patient's family history included: "shingles" (unspecified if ongoing), notes: None, but my dad got shingles pretty early too (like 46?). There were no concomitant medications. Past drug history included: Cipro, reaction(s): "Allergies: Cipro". Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer unknown), for COVID-19 immunization, reaction(s): "COVID-19"; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer unknown), for COVID-19 immunization, reaction(s): "COVID-19"; Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer unknown), for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: HERPES ZOSTER (non-serious) with onset 09Dec2022 at 03:00, outcome "recovering", described as "diagnosed with shingles". The event "diagnosed with shingles" required physician office visit. Therapeutic measures were taken as a result of herpes zoster.  Additional information: Report about covid treatment: Yes. Dose received: More than 3. No other vaccine in four weeks. No other medications in two weeks. Adverse event: Two days after her second booster (4th shot, the newer one), She noticed a small rash on her left flank. (That would be her butt.) today, Monday, 5 days after the shot, the rash got pretty painful so she went to a doctor and got diagnosed with shingles. AE treatment: Too late to take antiviral, so just pain relievers. No covid prior vaccination and no covid tested post vaccination. Known allergies: Cipro. Other medical history: None, but her dad got shingles pretty early too (like 46?).
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Nausea, Pyrexia
Clinical narrative: dizziness; fever of 103; nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient in her 60's received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PREMARIN; ESTRADIOL. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown Manufacturer), for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever of 103"; NAUSEA (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller also noted AE experienced from the PfizerCovid19 vaccine: really uncomfortable reactions. With the second one she had fever of 103, dizziness, nausea, also with the booster, same reaction, but not as bad, she was still sick for 3 days. She is a senior citizen, and she was a wreck thinking of taking booster. She stated she had reported this experience to Pfizer before. Caller asked about receiving the new booster dose of the Pfizer Covid19 vaccine, Bivalent, gray cap and how many doses are recommended and what it is covering. She wanted to know about reports of blood clots.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Illness, Nausea, Pyrexia
Clinical narrative: fever of 103; dizziness; nausea; still was sick for 3 days; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient in her 60's received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PREMARIN; ESTRADIOL. Vaccination history included: Covid-19 vaccine (Dose 1; Manufactuerer Unknown), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "dizziness", "nausea", "fever of 103". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever of 103"; DIZZINESS (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; ILLNESS (non-serious), outcome "recovered", described as "still was sick for 3 days". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reported AE experienced from the Pfizer Covid19 vaccine, really uncomfortable reactions. With the second one patient had a fever of 103, dizziness, nausea, also with the booster, same reaction, but not as bad, she was still was sick for 3 days. Patient is a senior citizen, and is a wreck thinking of taking this booster." She states she's reported this experience to Pfizer before. Patient was asking about receiving the new booster dose of the Pfizer Covid19 vaccine, Bivalent, GRAY cap. She also wanted to know about reports of blood clots.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.