chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Chronic fatigue syndrome, Hypersomnia
Clinical narrative: Chronic fatigue syndrome (slept for 6 weeks); slept for 6 weeks; This case was reported by a consumer via other manufacturer and described the occurrence of chronic fatigue syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chronic fatigue syndrome and sleep excessive. On an unknown date, the outcome of the chronic fatigue syndrome was unknown and the outcome of the sleep excessive was recovered/resolved.   The reporter considered the chronic fatigue syndrome and sleep excessive to be related to Shingrix.  Additional Information: GSK receipt Date: 21-DEC-2022 Reporter's Comment: The patient got Shingrix and it kicked up his/her chronic fatigue syndrome. The patient slept for 6 weeks.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Papule, Skin warm, Swelling
Clinical narrative: Swollen spot on arm (dime size); Warm spot on arm (dime size); she noticed a spot on her left arm yesterday which was the size of the dime; This case was reported by a consumer via call center representative and described the occurrence of swelling in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number lg2xj, expiry date 10th September 2023) for prophylaxis.   On 14th December 2022, the patient received the 1st dose of Shingrix. On 19th December 2022, 5 days after receiving Shingrix, the patient experienced swelling, skin warm and papule. On an unknown date, the outcome of the swelling, skin warm and papule were not recovered/not resolved.   It was unknown if the reporter considered the swelling, skin warm and papule to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-DEC-2022 Reporter's Comment: The reporter was the patient, who received her Shingrix last Wednesday. The reporter stated that she noticed a spot on her left arm yesterday which was the size of the dime which was warm and swollen.  The spot was increased today and it was still warm and swollen.  The reporter stated that it was not raised, but the swelling was under the skin. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: SUDDEN HEART ATTACKS; This spontaneous report received from a consumer via social media (J and J Corporate) via a company representative concerned multiple patients (2 male patients) in mid 40s of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patients were healthy. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, 2 to 3 weeks post vaccination the patients died from sudden heart attacks. Reporter stated, "I have (had) 2 friends. Both health mid 40s men...died sudden heart attacks 2-3 weeks post vaccination (poisoned)". It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20221258720-Sudden Heart attack. The event has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: HEART ATTACK
Age: 81.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; Moderna Covid-19 Bivalent was administered to patient after BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 Bivalent was administered to patient after BUD) and NO ADVERSE EVENT (No Adverse Event) in an 81-year-old 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. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-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 20-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 Bivalent was administered to patient after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 Bivalent was administered to patient after BUD) 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 EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 Bivalent was administered to patient after BUD).    Concomitant medication list was not provided. It was reported that Moderna COVID-19 Bivalent were administered with BUD 17-Dec-2022 (lot number 019H22A) on 20-Dec-2022 to 3 patients and BUD 16-Dec-2022 (lot number 015H22A) on 19-Dec-2022 to 4 patients. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-690257, US-MODERNATX, INC.-MOD-2022-692423, US-MODERNATX, INC.-MOD-2022-692429, US-MODERNATX, INC.-MOD-2022-692430, US-MODERNATX, INC.-MOD-2022-692431, US-MODERNATX, INC.-MOD-2022-692432 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-690257:same reporter US-MODERNATX, INC.-MOD-2022-692423:same reporter US-MODERNATX, INC.-MOD-2022-692429:same reporter US-MODERNATX, INC.-MOD-2022-692430:same reporter US-MODERNATX, INC.-MOD-2022-692431:same reporter US-MODERNATX, INC.-MOD-2022-692432:same reporter
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Overdose
Clinical narrative: No Adverse Event; 0.5 ml dose; This spontaneous case was reported by an other health care professional and describes the occurrence of OVERDOSE (0.5 ml dose) and NO ADVERSE EVENT (No Adverse Event) in a 4-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-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 19-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced OVERDOSE (0.5 ml dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, OVERDOSE (0.5 ml dose) 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 OVERDOSE (0.5 ml dose).    Concomitant medications details were not reported by the reporter. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment details were not reported by the reporter.
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: Tested positive for Covid-19.
Age: 16.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Child received COVID Bivalent booster without having primary series.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; a patient was inadvertently administered PROQUAD and VARIVAX concomitantly; This spontaneous report has been received from a nurse referring to a 12 months 29 days patient of unspecified gender. Information of pertinent medical history, concomitant medication and drug reactions/allergies was not reported.  On 29-NOV-2022, the patient was inadvertently administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter (mL) subcutaneous injection (0.5 mL, lot# W024551, expiration date 31-JAN-2024, therapy type: rHA, anatomical location and route of administration were unknown) for prophylaxis, and varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 mL subcutaneous injection (0.5 mL, lot# W018824, expiration date 14-JUN-2024, anatomical location and route of administration were unknown) for prophylaxis concomitantly (inappropriate schedule of product administration). No additional adverse event (AE) was reported (no adverse event).
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, Overdose, Product administered to patient of inappropriate age
Clinical narrative: Expired Havrix administered; 11 YO received Adult Havrix; 11 YO received Adult Havrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 13-year-old female patient who received HAV (Havrix adult) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   On 22nd December 2022, the patient received Havrix adult. On 22nd December 2022, unknown after receiving Havrix adult, the patient experienced expired vaccine used, overdose and adult product administered to child. On an unknown date, the outcome of the expired vaccine used, overdose and adult product administered to child were unknown.   Additional Information: GSK receipt date: 22-Dec-2022 Reporter's comment: The patient received an expired adult dose of Havrix at 13 years of age. The reporter did not have patient initials available. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email.  Additional supportive information: The patient received an adult dose of Havrix beyond expiry date, which led to expired vaccine used, overdose and adult product administered to child.
Sex: U
Vaccine: COVID19
Symptoms: Laboratory test, Rheumatoid arthritis
Clinical narrative: RHEUMATOID ARTHRITIS; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patient received booster dose with covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, 6 weeks after booster, the patient experienced symptoms of rheumatoid arthritis and after 9 months of suffering patient was diagnosed with rheumatoid arthritis (Dose number in series 2). Laboratory data (dates unspecified) included: Laboratory test diagnosed with rheumatoid arthritis. It was reported as "6 weeks after the J and J booster, I had symptoms of Rheumatoid Arthritis. After 9 months of suffering, I was diagnosed. I am sure the booster made my immune system start attacking my joints. I have had to give up my job, and am paying a lot for medical treatments due to this". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rheumatoid arthritis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221259577- Rheumatoid arthritis.  The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; Moderna Covid-19 Bivalent were administered BUD (17Dec2022) on 19Dec2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 Bivalent were administered BUD (17Dec2022) on 19Dec2022) and NO ADVERSE EVENT (No Adverse Event) in a 79-year-old 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. 015H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-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 19-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 Bivalent were administered BUD (17Dec2022) on 19Dec2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 Bivalent were administered BUD (17Dec2022) on 19Dec2022) 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 did not provide any causality assessments.   No concomitant medications were reported.  It was reported that Moderna COVID-19 Bivalent were administered with BUD 17-Dec-2022 (lot number 019H22A) on 20-Dec-2022 to 3 patients and BUD 16-Dec-2022 (lot number 015H22A) on 19-Dec-2022 to 4 patients.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-692428, US-MODERNATX, INC.-MOD-2022-692431, US-MODERNATX, INC.-MOD-2022-692432, US-MODERNATX, INC.-MOD-2022-690257, US-MODERNATX, INC.-MOD-2022-692423 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-692428:same reporter US-MODERNATX, INC.-MOD-2022-692431:same reporter US-MODERNATX, INC.-MOD-2022-692423:same reporter US-MODERNATX, INC.-MOD-2022-690257:same reporter US-MODERNATX, INC.-MOD-2022-692432:same reporter
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; Moderna Covid-19 Bivalent were administered BUD (17Dec2022) on 19Dec2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 Bivalent were administered BUD (17Dec2022) on 19Dec2022) and NO ADVERSE EVENT (No Adverse Event) in a 41-year-old 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. 015H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-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 19-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 Bivalent were administered BUD (17Dec2022) on 19Dec2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 Bivalent were administered BUD (17Dec2022) on 19Dec2022) 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 EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 Bivalent were administered BUD (17Dec2022) on 19Dec2022).    No concomitant medications were reported.   It was reported that Moderna COVID-19 Bivalent were administered with BUD 17-Dec-2022 (lot number 019H22A) on 20-Dec-2022 to 3 patients and BUD 16-Dec-2022 (lot number 015H22A) on 19-Dec-2022 to 4 patients. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-692428, US-MODERNATX, INC.-MOD-2022-692431, US-MODERNATX, INC.-MOD-2022-690257, US-MODERNATX, INC.-MOD-2022-692423, US-MODERNATX, INC.-MOD-2022-692429, US-MODERNATX, INC.-MOD-2022-692430 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-692428:same reporter US-MODERNATX, INC.-MOD-2022-692431:same reporter US-MODERNATX, INC.-MOD-2022-690257:same reporter US-MODERNATX, INC.-MOD-2022-692423:same reporter US-MODERNATX, INC.-MOD-2022-692429:same reporter US-MODERNATX, INC.-MOD-2022-692430:same reporter
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction; got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD) and NO ADVERSE EVENT (No adverse reaction) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD).    No concomitant medications were reported.  It was reported that, the patient received vaccine after the beyond use-by date.  No treatment medications were reported.
Age: 82.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse Event; patient got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) in an 82-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient got vaccinated after BUD).    No relevant concomitant medications were reported.  No treatment information was provided.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse Event; got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD).    No concomitant medications were reported.  It was reported that, the patient received vaccine after the beyond use-by date.  No treatment medications were reported.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse Event; patient got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient got vaccinated after BUD).    No relevant concomitant medications were reported.  No treatment information was provided.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: never completed primary vaccination series before receiving a dose of the bivalent vaccine.; No Adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (never completed primary vaccination series before receiving a dose of the bivalent vaccine.) and NO ADVERSE EVENT (No Adverse event) in a 20-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Nov-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (never completed primary vaccination series before receiving a dose of the bivalent vaccine.) and NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT DOSE OMISSION ISSUE (never completed primary vaccination series before receiving a dose of the bivalent vaccine.) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for PRODUCT DOSE OMISSION ISSUE (never completed primary vaccination series before receiving a dose of the bivalent vaccine.).    Concomitant medications were not reported.  Patient received first Moderna shot was on 25AUG2022 (lot number 053B22A). Treatment medications were not reported.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse Event; Patient got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD).    No concomitant medications were reported.  It was reported that, the patient received vaccine after the beyond use-by date.  No treatment medications were reported.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction; Patient got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse reaction) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD).    No concomitant medications were reported.  It was reported that, the patient received vaccine after the beyond use-by date.  No treatment medications were reported.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse Event; got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD).    No concomitant medications were reported.  It was reported that, the patient received vaccine after the beyond use-by date.  No treatment medications were reported.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received Bivalent Moderna COVID-19 vaccine as their first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received Bivalent Moderna COVID-19 vaccine as their first dose) and NO ADVERSE EVENT (No adverse event) in a 24-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Nov-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 28-Nov-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient received Bivalent Moderna COVID-19 vaccine as their first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received Bivalent Moderna COVID-19 vaccine as their first dose) 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 (Patient received Bivalent Moderna COVID-19 vaccine as their first dose).    Concomitant medications were not reported.  It was reported no reported symptoms. Treatment medications were not reported.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction; Patient got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse reaction) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD).    No concomitant medications were reported.  It was reported that, the patient received vaccine after the beyond use-by date.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Doses were administered after the 30 day BUD; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day 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. ASKU) 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 EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) 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 EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD).    No concomitant medications were reported. HCP confirmed that doses were administered after the 30 day BUD and had 3 lot numbers,but the does not have information regarding the situation. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.Previous COVID-19 vaccination doses information was unknown. No treatment information was provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: He had only a sore arm after each shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (He had only a sore arm after each shot) in a 62-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 03-Sep-2022, 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. On an unknown date, the patient experienced VACCINATION SITE PAIN (He had only a sore arm after each shot). At the time of the report, VACCINATION SITE PAIN (He had only a sore arm after each shot) had resolved. Not Provided   Concomitant product use was not provided by the reporter.  Dosage text was reported as Bivalent Booster.  Treatment information was not provided.   This case was linked to MOD-2022-692275 (Patient Link).
Age: 13.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Child received a bivalent booster without a primary series dose.
Age: 15.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received a bivalent booster dose without a primary series completed.
Age: 13.0
Sex: M
Vaccine: COVID19-2
Symptoms: Osteoarthritis
Clinical narrative: Systemic: onset of arthritis at the elbow due to vaccine-Severe
Age: 19.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild
Age: 72.0
Sex: M
Vaccine: FLUA4
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: Patient reports the pain is getting less. Will see MD if doesnt resolve.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Musculoskeletal stiffness, Nodule, Pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: according to pt the pain on her right arm started about 2 days after injection. she had mentioned this to someone at one point. She complained about pain/tenderness, shooting pain sometimes from the inner side of her elbow going upwards, also had neck stiffness. A knot formed on the inside part of her elbow and it was tender for awhile and still is.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Tenderness
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: according to pt the pain on her right arm started about 2 days after injection. she had mentioned this to someone at one point. She complained about pain/tenderness, shooting pain sometimes from the inner side of her elbow going upwards, also had neck stiffness. A knot formed on the inside part of her elbow and it was tender for awhile and still is.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 10/12/21, 11/2/21. Positive on 12/29/22
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product administration error
Clinical narrative: No adverse event. Administration error.
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product administration error
Clinical narrative: No adverse event. Administration error.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test positive, Upper-airway cough syndrome
Clinical narrative: 12/11/22    I had a sore throat, runny nose, around 100 degree fever that was gone by nighttime.  I tested with a home COVID test and tested positive. 12/12/22, I called my doctor?s office and spoke with his APN. She prescribed Lagevrio. I did not have many more symptoms for two or three days. I had a lot of postnasal drip and runny nose, very minor symptoms. I continued to test positive for ten days. I have recovered.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Biopsy skin, Endoscopy upper gastrointestinal tract abnormal, Gastrointestinal haemorrhage, Gastrointestinal ulcer
Clinical narrative: Abdominal pain, nausea and vomiting with GI bleed was hospitalized for 5 days for GI bleed. Enlarged spleen and upper endoscopy showed ulcerations probable cause of bleed.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Skin discolouration, Skin lesion, Splenomegaly, Vomiting
Clinical narrative: Abdominal pain, nausea and vomiting with GI bleed was hospitalized for 5 days for GI bleed. Enlarged spleen and upper endoscopy showed ulcerations probable cause of bleed.
Age: 59.0
Sex: M
Vaccine: TYP
Symptoms: Immediate post-injection reaction, Injection site haematoma, Injection site haemorrhage, Pain
Clinical narrative: Patient described immediate pain and experienced bleeding after the injection. Upon removal of needle patient experienced bleeding, potentially from a punctured vein in the deltoid muscle of the right arm. Patient quickly developed a hematoma at the site of injection and bleeding stopped with direct pressure at the site.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Oligomenorrhoea
Clinical narrative: Increase flow and length of menstrual cycle. 2nd dose was received 11/20/21- Pfizer FF2593  Over a year out from the last dose and menstrual cycle is still producing substantially more fluid, heavier menstrual cramps and a longer period, consistently, every single month.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiovascular evaluation, Extrasystoles, Ventricular extrasystoles
Clinical narrative: PVCs started on 12/29/2022; no treatment at this time; not continuous like the last two events (first event I had bigemeny at times and had a full cardiac workup, PVCs went away 6 months later and the second event only lasted a week), just lasts an hour or so
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Asthenia, COVID-19, Headache, Influenza A virus test negative
Clinical narrative: 11/28/22  I had sinus congestion. I went to the doctor. Was going to prescribe antibiotics, I decided not to. He said if it did not go away, that I need to return. I was tested for Flu and RSV which was negative.  The next day, I had no energy and  I also had a mild headache. I went to the Emergency Room and was tested for COVID and told me to go home.  That evening I received my results, positive for COVID.  The only symptoms I had were sinus congestion, joint pain and a mild headache.  The joint pain was the most difficult especially in my hip, it was the worst pain I have had. By that week-end , I was back to normal.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Respiratory syncytial virus test negative, SARS-CoV-2 test positive, Sinus congestion
Clinical narrative: 11/28/22  I had sinus congestion. I went to the doctor. Was going to prescribe antibiotics, I decided not to. He said if it did not go away, that I need to return. I was tested for Flu and RSV which was negative.  The next day, I had no energy and  I also had a mild headache. I went to the Emergency Room and was tested for COVID and told me to go home.  That evening I received my results, positive for COVID.  The only symptoms I had were sinus congestion, joint pain and a mild headache.  The joint pain was the most difficult especially in my hip, it was the worst pain I have had. By that week-end , I was back to normal.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Headache, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: I had a really high fever between 103-104 over a 2-day period. I had coughing and body aches with a headache.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: None stated.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain upper, Blood pressure increased, Cold sweat, Condition aggravated, Hot flush
Clinical narrative: Since vaccination patient is experiencing nausea and vomiting when eating anything. She cannot keep food down. Last night she experienced severe epigastric pain (points to xiphoid process and sternum). She has had a similar sensation twice before this month as well, before receiving the vaccine. At the time of vaccine administration her BP was in normal range 122/82, today it is much elevated 151/98. Additionally, her hot flashes were under control but had a bad flash last night, currently is sweaty and clammy.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Since vaccination patient is experiencing nausea and vomiting when eating anything. She cannot keep food down. Last night she experienced severe epigastric pain (points to xiphoid process and sternum). She has had a similar sensation twice before this month as well, before receiving the vaccine. At the time of vaccine administration her BP was in normal range 122/82, today it is much elevated 151/98. Additionally, her hot flashes were under control but had a bad flash last night, currently is sweaty and clammy.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Body aches, fatigue, chills
Age: 68.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: COVID-19, Cough, Dysphonia, Lacrimation increased, Rhinorrhoea
Clinical narrative: I started out with a horse voice and the next day I had watery eyes, runny nose, and a cough. I then tested for COVID-19 and it was positive then I went to a Urgent Care Clinic and it was positive as well.  I was given the antiviral PO4 Cough, and they both helped and within 4 days I had recovered. I do think it was a very mild case.
Age: 68.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I started out with a horse voice and the next day I had watery eyes, runny nose, and a cough. I then tested for COVID-19 and it was positive then I went to a Urgent Care Clinic and it was positive as well.  I was given the antiviral PO4 Cough, and they both helped and within 4 days I had recovered. I do think it was a very mild case.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blood electrolytes, COVID-19, Computerised tomogram thorax abnormal, Condition aggravated, Electrolyte substitution therapy
Clinical narrative: Discharge Physician: DO Primary Care Physician: DO  Date of Admission: 12/26/2022 Discharge Date: 12/28/2022 COVID positive 12/26/2022 PRESENTING PROBLEM: Ketosis (HCC) [E88.89] DKA, type 2, not at goal (HCC) [E11.10] Diabetic ketoacidosis without coma associated with type 2 diabetes mellitus (HCC) [E11.10] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 73yo male who presented to hospital with euglycemic DKA, believed to be secondary to his initiation of Jardiance a month prior plus decreased oral intake secondary to covid. He was also found to be COVID positive but was asymptomatic from this, with no cough or fever, an no hypoxia. He was started on D5 and insulin drips and admitted to the ICU with frequent electrolyte monitoring.    CT imaging, obtained for PE ruleout in the setting of elevated D Dimer, did show diffuse ground glass opacities suggestive of viral pneumonia, but no pulmonary embolism.    His labs corrected and he was able to come off of the insuline drip and transitioned to basal bolus insulin. He tolerated a diet and was viewed as medically stable for discharge to home.   He has been instructed to remain off Jardiance at this time, he is to resume metformin and actos.   Electrolytes were monitored and repleted PRN throughout the admission. Patient clinically improved and hemodynamically stable for discharge.  Discussed plan of care discharge with patient including outpatient follow-up PCP as scheduled on 12/30. Patient voiced understanding was agreeable with plan of care discharge.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Euglycaemic diabetic ketoacidosis, Fibrin D dimer increased, Hypophagia, Intensive care, Ketosis
Clinical narrative: Discharge Physician: DO Primary Care Physician: DO  Date of Admission: 12/26/2022 Discharge Date: 12/28/2022 COVID positive 12/26/2022 PRESENTING PROBLEM: Ketosis (HCC) [E88.89] DKA, type 2, not at goal (HCC) [E11.10] Diabetic ketoacidosis without coma associated with type 2 diabetes mellitus (HCC) [E11.10] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 73yo male who presented to hospital with euglycemic DKA, believed to be secondary to his initiation of Jardiance a month prior plus decreased oral intake secondary to covid. He was also found to be COVID positive but was asymptomatic from this, with no cough or fever, an no hypoxia. He was started on D5 and insulin drips and admitted to the ICU with frequent electrolyte monitoring.    CT imaging, obtained for PE ruleout in the setting of elevated D Dimer, did show diffuse ground glass opacities suggestive of viral pneumonia, but no pulmonary embolism.    His labs corrected and he was able to come off of the insuline drip and transitioned to basal bolus insulin. He tolerated a diet and was viewed as medically stable for discharge to home.   He has been instructed to remain off Jardiance at this time, he is to resume metformin and actos.   Electrolytes were monitored and repleted PRN throughout the admission. Patient clinically improved and hemodynamically stable for discharge.  Discussed plan of care discharge with patient including outpatient follow-up PCP as scheduled on 12/30. Patient voiced understanding was agreeable with plan of care discharge.