chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP, HEPA, TDAP
Symptoms: Product storage error
Clinical narrative: Vaccines administered after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included HAV (Havrix) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Boostrix, Havrix and Engerix B. On an unknown date, unknown after receiving Boostrix, Havrix and Engerix B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 30-SEP-2022 Reporter's Comment:The reporter stated that, Boostrix, Havrix, and Engerix-B were exposed to 26 degree F for 1 month. The vaccines were administered to an unknown number of patients. No demographics or vaccine lots or expiration dates available at this time. The reporter consented to follow up via postal. Additional Supportive Information: The reporter stated that, Boostrix, Havrix, and Engerix-B were exposed to 26 degree F for 1 month, which led to incorrect storage of drug. From the narrative formulation of vaccines was not clear, hence conservatively coded as solution for injection. As per narrative the call center representative picked PFS for the vaccines at it was unknown, so they were updated to Solution for Injection.
Sex: U
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Possible partial dose administered/ unclear if a full or partial dose was given to patient; This case was reported by a other health professional via sales rep and described the occurrence of underdose in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced underdose. On an unknown date, the outcome of the underdose was unknown.   Additional Information: GSK Receipt Date: 30-SEP-2022 Reporter's Comments: The veevaCRM came to medical information were stating the following, If it was unclear whether a full dose or partial dose was actually given to patient since patient and vaccinator's were contradicting. The reporter wanted to know that it would be still safe for patient to receive a full dose of Flulaval dose, if the answer was yes, would it be safe for the patient to receive the Flulaval vaccine anytime or would they need to wait some period of time before they can receive their repeat dose. The reporter reported that please contact the sales rep for additional information.  The person did not speak with the medical assistant at any point.  The reporter did not consent to follow up. Additional Supportive Information: The patient administered full dose or partial dose, which led to underdose. Since reporter was planning replacement dose, the event underdose was coded conservatively.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered only the liquid component; Administered only the liquid component; Menveo administered to a 64 y/o; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 64-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA652A, expiry date 31st July 2023) for prophylaxis.   On 30th September 2022, the patient received Menveo. On 30th September 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 30-SEP-2022 Reporter's Comments: The nurse called to ask information about the administration of only the liquid component of Menveo without the meningococcal A lyophilized conjugate vaccine component, to a 64 years old patient. The nurse asked for recommendation about revaccination. The reporter consent to follow up. Additional Supportive Information: The patient received only the liquid component of Menveo without the meningococcal A lyophilized conjugate vaccine component which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. 64 years old patient received Menveo, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose 21-Sep-2021, has not received dose two.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 46-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 21 September 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-OCT-2022 Reporter's Comment: The reporter was a pharmacist. The reporter reported that the patient had not received second dose of Shingrix vaccine. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter did consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose, about a year ago, never got second; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received a year ago prior to the reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 04-OCT-2022 Reporter's Comment: The reporter was a physician. The reporter reported that the patient received first dose of Shingrix vaccine about a year ago and never got a second dose. The reporter did not ask about follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: expired vaccine administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 22-year-old female patient who received HBV (Engerix B adult) (batch number k2l79, expiry date 12th August 2022) for prophylaxis.   On 3rd October 2022, the patient received Engerix B adult. On 3rd October 2022, unknown after receiving Engerix B adult, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 04-OCT-2022 Reporter's Comment: The pharmacist reported that a dose of Engerix B Adult given to the patient and it was already expired.  The reporter did not consent to follow up.  Additional Supportive Information: The use of Engerix B Adult dose, which was already expired on 12th August 2022, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second vaccine 8-26-2019, first on 9-17-2018; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 17th September 2018).   On 26th August 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 26th August 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 04-OCT-2022 Reporter's Comments: The case was self reported by the patient. The patient received second dose of Shingrix on an unknown arm more than six months after the first dose of Shingrix vaccine. (Inappropriate schedule of vaccine). The reporter did not consent to follow up. Additional Supportive Information: The patient received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered only the adjuvant; Administered only the adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th October 2022, the patient received Shingrix. On 4th October 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 04-Oct-2022 Reporter's comment: The pharmacist reported an adverse event for Shingrix with limited information.  The pharmacist stated that a patient was given just the adjuvant of the Shingrix and it was not reconstituted with the antigen.  The pharmacist had not furthered information in regard to the patient demographics, event, or vaccine itself.  The reporter did not consent to follow up. Additional Supportive Information: The patient was given just adjuvant of the Shingrix and it was not reconstituted with the antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered only the diluent; Administered only the diluent; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number XX474, expiry date unknown) for prophylaxis.   On 3rd October 2022, the patient received Shingrix. On 3rd October 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 04-Oct-2022 Reporter's comment: The vaccine coordinator reported that a patient received a vial of Shingrix diluent without reconstitution with the antigen powder.  The reporter believed this happened on 3rd October 2022.  The reporter consented to follow up. Additional Supportive Information: The patient received a vial of Shingrix diluent without reconstitution with the antigen powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: Lupus flairups that are relentless; This spontaneous case was reported by a patient and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flairups that are relentless) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Systemic lupus erythematosus.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flairups that are relentless) (seriousness criterion medically significant). At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flairups that are relentless) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       The concomitant and treatment medication was not reported. The patient was asking where to get Moderna booster shot and the 6 month follow up shots. Treatment information was not provided.  Company Comment: This is a spontaneous case concerning a patient of unknown age and gender, with a concurrent medical condition of Systemic lupus erythematosus, who experienced the unexpected serious (medically significant) event of Systemic lupus erythematosus aggravated (lupus flare-ups that are relentless) which occurred unknown number of days after receiving a dose of COVID-19 vaccine mRNA-1273, dose number unknown. There is no available information regarding clinical course, diagnostic tests/procedures, and treatment medication. The patient's concurrent medical condition of Systemic lupus erythematosus, which can have flares and remissions, remains a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender, with a concurrent medical condition of Systemic lupus erythematosus, who experienced the unexpected serious (medically significant) event of Systemic lupus erythematosus aggravated (lupus flare-ups that are relentless) which occurred unknown number of days after receiving a dose of COVID-19 vaccine mRNA-1273, dose number unknown. There is no available information regarding clinical course, diagnostic tests/procedures, and treatment medication. The patient's concurrent medical condition of Systemic lupus erythematosus, which can have flares and remissions, remains a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Malaise, Skin cancer
Clinical narrative: skin cancer; did not feel well; This spontaneous case was reported by a consumer and describes the occurrence of SKIN CANCER (skin cancer) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In March 2021, the patient experienced MALAISE (did not feel well). In August 2022, the patient experienced SKIN CANCER (skin cancer) (seriousness criterion medically significant). At the time of the report, SKIN CANCER (skin cancer) and MALAISE (did not feel well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, Biopsy: some type of skin cancer.         Concomitant product use was not provided by the reporter.   In Aug 2022, patient saw the physician and removed a small bump on patient's neck. Sent it off for a biopsy and said that it was some type of skin cancer which the patient could not remember, and patient did not feel well after the second Moderna vaccine and decided not to have any more. This was prior to starting Humira.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  Treatment medication was not provided.  Company Comment: This spontaneous case reported by a consumer concerns a 69-year-old male patient, with use of co-suspect non-company product Adalimumab solution of injection for plaque psoriasis, who experienced unexpected, serious (medically significant) event skin cancer, approximately 1 year and 5 months after vaccination with a second dose of mRNA-1273.  The patient reports having a small bump on his neck.  It was removed and sent for biopsy which revealed some type of skin cancer which the patient could not remember.  Further clinical course and treatment details not reported.  The outcome was unknown.  The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer concerns a 69-year-old male patient, with use of co-suspect non-company product Adalimumab solution of injection for plaque psoriasis, who experienced unexpected, serious (medically significant) event skin cancer, approximately 1 year and 5 months after vaccination with a second dose of mRNA-1273.  The patient reports having a small bump on his neck.  It was removed and sent for biopsy which revealed some type of skin cancer which the patient could not remember.  Further clinical course and treatment details not reported.  The outcome was unknown.  The benefit risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was stored in fridge for more than 12 hrs post puncture and then administered; No Adverse Event; vial was punctured on 3-Oct-2022 and administered on 4-Oct-2022/Dose administered more then 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (vial was stored in fridge for more than 12 hrs post puncture and then administered), EXPIRED PRODUCT ADMINISTERED (vial was punctured on 3-Oct-2022 and administered on 4-Oct-2022/Dose administered more then 12 hours post puncture) and 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. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Oct-2022 at 8:15 AM, 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 04-Oct-2022 at 8:15 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial was punctured on 3-Oct-2022 and administered on 4-Oct-2022/Dose administered more then 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was stored in fridge for more than 12 hrs post puncture and then administered) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT STORAGE ERROR (vial was stored in fridge for more than 12 hrs post puncture and then administered), EXPIRED PRODUCT ADMINISTERED (vial was punctured on 3-Oct-2022 and administered on 4-Oct-2022/Dose administered more then 12 hours post puncture) 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 assessments were provided for PRODUCT STORAGE ERROR (vial was stored in fridge for more than 12 hrs post puncture and then administered) and EXPIRED PRODUCT ADMINISTERED (vial was punctured on 3-Oct-2022 and administered on 4-Oct-2022/Dose administered more then 12 hours post puncture).    No concomitant medications was reported. The size of vial was 2.5 ml. The vial was initially stored in the refrigerator on 02-Oct-2022. The vial was first punctured on 03-Oct-2022 at 3:30 pm and administered on 04-Oct-2022 at 8:15 am. The vial was stored in fridge post puncture. The vial did not undergo any temperature excursions. The vial was exposed to room temperature range 8° to 25°C= 46° to 77°F for less than 24 hours. No treatment drug details was reported.
Sex: M
Vaccine: COVID19
Symptoms: Aphonia, Ear disorder, Hypersensitivity, Oropharyngeal discomfort, Sinus disorder
Clinical narrative: Sinuses affected; throat affected/trying to get voice back; ears affected; throat affected/trying to get voice back; severe allergy reaction like he was exposed to dust or mold; This spontaneous case was reported by a patient and describes the occurrence of SINUS DISORDER (Sinuses affected), OROPHARYNGEAL DISCOMFORT (throat affected/trying to get voice back), EAR DISORDER (ears affected), APHONIA (throat affected/trying to get voice back) and HYPERSENSITIVITY (severe allergy reaction like he was exposed to dust or mold) in a male 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 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 SINUS DISORDER (Sinuses affected), OROPHARYNGEAL DISCOMFORT (throat affected/trying to get voice back), EAR DISORDER (ears affected), APHONIA (throat affected/trying to get voice back) and HYPERSENSITIVITY (severe allergy reaction like he was exposed to dust or mold). At the time of the report, SINUS DISORDER (Sinuses affected), OROPHARYNGEAL DISCOMFORT (throat affected/trying to get voice back), EAR DISORDER (ears affected) and HYPERSENSITIVITY (severe allergy reaction like he was exposed to dust or mold) outcome was unknown and APHONIA (throat affected/trying to get voice back) was resolving.            No concomitant medications were reported. The sinuses, throat and ears were affected as if it were an allergy reaction.  Patient's voice was bad for the first three days. No treatment medications were reported.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose of Moderna Bivalent administered after more than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose of Moderna Bivalent administered after more than 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) in a 55-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     The patient's past medical history included Cataract bilateral NOS and Hepatitis C. Previously administered products included for Flu vaccination: Influenza vaccine on 29-Sep-2022. Past adverse reactions to the above products included No adverse event with Influenza vaccine. Concurrent medical conditions included Drug allergy (Hydromorphone), Penicillin allergy, Allergic reaction to antibiotics (Levaquin), Renal disease, HIV disease, Hypertension, Hyperlipidemia, Anemia, Aortic arteriosclerosis, Chronic hepatitis B, Secondary hypothyroidism and Prediabetes. Concomitant products included CALCIUM CARBONATE (ANTACID [CALCIUM CARBONATE]), ATORVASTATIN, VITAMINS NOS, FLUTICASONE PROPIONATE, COBICISTAT, ELVITEGRAVIR, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (GENVOYA), METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA (MIRCERA), NIFEDIPINE, PANTOPRAZOLE, OLOPATADINE HYDROCHLORIDE (PATADAY), DARUNAVIR ETHANOLATE (PREZISTA) and SUCROFERRIC OXYHYDROXIDE (VELPHORO) for an unknown indication.    On 05-Oct-2022 at 3:29 AM, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 05-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose of Moderna Bivalent administered after more than 12 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose of Moderna Bivalent administered after more than 12 hours post puncture) 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 EXPIRED PRODUCT ADMINISTERED (Dose of Moderna Bivalent administered after more than 12 hours post puncture).    Patient did not have provided information about COVID positive test.  Date the vial was initially stored in the refrigerator was 23-Sep-2022.  The vial was first punctured on 04-Oct-2022 at 10:13 am.  On 05-Oct-2022, the patient received Moderna bivalent booster dose after more than 12 hours post puncture.  The vial did not undergone any temperature excursions.  Treatment information was not provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient tested positive to COVID-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Patient tested positive to COVID-19) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 vaccination.     Patient had no medical history relating to mentioned adverse event and both acute and chronic illnesses at the time of vaccination.  Patient did not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Allergy to antibiotic (Allergy to unspecified antibiotics.).    On 22-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 26-Sep-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (Patient tested positive to COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at a dose of UNK, during 5 days. At the time of the report, COVID-19 (Patient tested positive to COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Sep-2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant information provided  Patient got 1st dose of Moderna COVID-19 Vaccine on an unknown date in Jan-2021, 2nd dose on an unknown date in Feb-2021, 1st booster on 25-Oct-2021, 2nd booster on an unknown date Apr-2022 and the bivalent booster dose on 22-Sep-2022. For bivalent booster, one day later patient started to feel sore throat, cough and sneezing, and 4 days after the vaccine patient went to the doctor and tested positive to COVID-19.   Treatment given was Paxlovid during 5 days.   This case was linked to US-MODERNATX, INC.-MOD-2022-656135, US-MODERNATX, INC.-MOD-2022-656141 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-656135:Wife's case, bivalent booster US-MODERNATX, INC.-MOD-2022-656141:Wife's case
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient tested positive to COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient tested positive to COVID-19) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis.     Patient had no Medical Hx relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. Patient did not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Allergy to antibiotic (unspecified antibiotics) and Blood pressure abnormal.    On 22-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 26-Sep-2022, the patient experienced COVID-19 (Patient tested positive to COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Patient tested positive to COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Sep-2022, SARS-CoV-2 test: (Positive) positive.         Patient concomitant medications included unspecified blood pressure medications. It was reported that patient received first dose of Moderna COVID-19 Vaccine on Jan 2021 via intramuscular route , second dose on Feb 2021, first booster on 25Oct2021 and second on Apr 2022. On 24Sep2022 (two days later), patient started to feel sore throat, cough and sneezing, and 4 days after the vaccine went to the doctor and tested positive to COVID-19. It was unknown whether patient experienced a similar event in the past. AE outcome was rebound, still ongoing and symptoms were same neither improved or worsened. Patient treatment included Paxlovid during 5 days but had a rebound from COVID-19 and symptoms were still ongoing.   This case was linked to MOD-2022-656141 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) 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)) 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 PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) 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 concomitant medication were reported.  Patient received the last shot the bivalent and wanted to know how long the sore arm was going to last.             No treatment information was provided by the reporter.   Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: mild symptoms like sore arm during maybe 2 days; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (mild symptoms like sore arm during maybe 2 days) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had no Medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. Patient did not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Blood pressure abnormal and Allergy to antibiotic (unspecified).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (mild symptoms like sore arm during maybe 2 days). At the time of the report, PAIN IN EXTREMITY (mild symptoms like sore arm during maybe 2 days) outcome was unknown.            Concomitant medication include unspecified blood pressure medications.  Patient experienced mild symptoms like sore arm during maybe 2 days with all doses.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-656089, US-MODERNATX, INC.-MOD-2022-656089. This case was linked to MOD-2022-656135 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-656089:Husband's case US-MODERNATX, INC.-MOD-2022-656089:Wife's case
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash all over the body within a few hours after Bivalent Booster/ The rash started on chest and then spread; This spontaneous case was reported by a patient and describes the occurrence of RASH (Rash all over the body within a few hours after Bivalent Booster/ The rash started on chest and then spread) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A87163B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Oct-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 04-Oct-2022, the patient experienced RASH (Rash all over the body within a few hours after Bivalent Booster/ The rash started on chest and then spread). At the time of the report, RASH (Rash all over the body within a few hours after Bivalent Booster/ The rash started on chest and then spread) had not resolved.            No concomitant medications were reported.  On 10-Feb-2021, the patient received the first dose of Moderna COVID-19 vaccine (Lot number: 031L20A). On 11-Mar-2021, the patient received the second dose of Moderna COVID-19 vaccine (Lot number: 048A21A). On 21-Oct-2021, the patient received the first booster dose of Moderna COVID-19 vaccine (Lot number: 026O21A). On 04-Apr-2022, the patient received the second booster dose of Moderna COVID-19 vaccine (Lot number: 002M21A).  The patient had not seen a physician and had not reported this effect to her physician. The rash was persisting 2 days after administration of bivalent booster dose.  No treatment medications were reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Rash papular, Vaccination site pain
Clinical narrative: I started getting a rash. It looks slightly red and like a bunch of little bumps in patches. They're on both arm and legs, my back and stomach; I started getting a rash. It looks slightly red and like a bunch of little bumps in patches. They're on both arm and legs, my back and stomach; Itching. Can't recall where it started itching; I had a sore left arm at the injection site.; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Itching. Can't recall where it started itching), RASH PAPULAR (I started getting a rash. It looks slightly red and like a bunch of little bumps in patches. They're on both arm and legs, my back and stomach), RASH ERYTHEMATOUS (I started getting a rash. It looks slightly red and like a bunch of little bumps in patches. They're on both arm and legs, my back and stomach) and VACCINATION SITE PAIN (I had a sore left arm at the injection site.) in a 66-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-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 26-Sep-2022, the patient experienced VACCINATION SITE PAIN (I had a sore left arm at the injection site.). On 28-Sep-2022, the patient experienced PRURITUS (Itching. Can't recall where it started itching). On 30-Sep-2022, the patient experienced RASH PAPULAR (I started getting a rash. It looks slightly red and like a bunch of little bumps in patches. They're on both arm and legs, my back and stomach) and RASH ERYTHEMATOUS (I started getting a rash. It looks slightly red and like a bunch of little bumps in patches. They're on both arm and legs, my back and stomach). At the time of the report, PRURITUS (Itching. Can't recall where it started itching), RASH PAPULAR (I started getting a rash. It looks slightly red and like a bunch of little bumps in patches. They're on both arm and legs, my back and stomach), RASH ERYTHEMATOUS (I started getting a rash. It looks slightly red and like a bunch of little bumps in patches. They're on both arm and legs, my back and stomach) and VACCINATION SITE PAIN (I had a sore left arm at the injection site.) outcome was unknown.            No Concomitant medication was reported.  On 12-Mar-2021, the patient received first dose of Moderna Covid-19 vaccine, batch number 001B21A. On 09-Apr-2021, the patient received second dose of Moderna Covid-19 vaccine, batch number 019B21A. On 01-Nov-2021, the patient received first booster dose of Moderna Covid-19 vaccine, batch number 058F21A. On 21-Apr-2022, the patient received second booster dose of Moderna Covid-19 vaccine, batch number 001M21A.  No treatment information was provided.    This case was linked to MOD-2022-656155 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Had a sore left arm at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Had a sore left arm at the injection site) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A, 019B21A, 058F21A and 001M21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (Had a sore left arm at the injection site). At the time of the report, VACCINATION SITE PAIN (Had a sore left arm at the injection site) outcome was unknown.            No concomitant medications were reported.  On 01-Nov-2021, the patient received first booster dose of Moderna COVID-19 vaccine.  On 21-Apr-2022, the patient received second booster dose of Moderna COVID-19 vaccine.  On 12-Mar-2021, 09-Apr-2021, 01-Nov-2021 and 21-Apr-2022, the patient had a sore left arm at the injection site.  No treatment medications were reported.   This case was linked to MOD-2022-656149 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Dose 1 on 01-Mar-2021, dose 2 on 22-Mar-2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 01-Mar-2021, dose 2 on 22-Mar-2021) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No acute illness at the time of vaccination and one month prior.  Concurrent medical conditions included Hyperlipidemia, Chronic kidney disease, Hypofunction testicle and Allergy to antibiotic (Clindamycin).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 01-Mar-2021, dose 2 on 22-Mar-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 01-Mar-2021, dose 2 on 22-Mar-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 01-Mar-2021, dose 2 on 22-Mar-2021).    Patient had first dose of Flu vaccine intramuscular, left deltoid with lot number 9249L. Concomitant medication list was not provided. Treatment information was not provided.   This case was linked to MOD-2022-651873 (Patient Link).
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19 1-Apr-2022; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for COVID-19 1-Apr-2022) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2022, the patient experienced COVID-19 (tested positive for COVID-19 1-Apr-2022). At the time of the report, COVID-19 (tested positive for COVID-19 1-Apr-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2022, SARS-CoV-2 test: (Positive) Positive.         Concomitant products were not reported.  The patient experienced body ache and chills after 24 hours of booster. The patient recovered after 24 hours. It was reported that patient took both the vaccines on shoulder.  It was reported that event did not cause the patient to seek medical care. There was no other potential causes for the event to occur.  Treatment medications were not reported.   This case was linked to MOD-2022-656244, MOD-2022-654618 (Patient Link).
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: Body aches; Chills; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Body aches) and CHILLS (Chills) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 036B21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, MYALGIA (Body aches) and CHILLS (Chills) had resolved.     No concomitant medications were reported.  It was reported that patient took both the vaccines on shoulder.  It was reported that event did not cause the patient to seek medical care. There was no other potential causes for the event to occur.  No treatment medications were reported.   This case was linked to MOD-2022-656236, MOD-2022-654618 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Went bald after a booster dose of the Moderna Covid19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (Went bald after a booster dose of the Moderna Covid19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had no allergies reported.    In December 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ALOPECIA (Went bald after a booster dose of the Moderna Covid19 vaccine). At the time of the report, ALOPECIA (Went bald after a booster dose of the Moderna Covid19 vaccine) outcome was unknown.     No concomitant medications were reported.  It was reported that the patient received booster dose in Dec-2021 and 30 days after she started noticing the baldness. Patient received treatment, no oral medications.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Felt a little sore arm with the other doses /His arm always get a little sore after receiving a vaccine/felt something in his arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Felt a little sore arm with the other doses /His arm always get a little sore after receiving a vaccine/felt something in his arm) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060A22A, 006B21A, 040B21A and 939904) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Felt a little sore arm with the other doses /His arm always get a little sore after receiving a vaccine/felt something in his arm). At the time of the report, VACCINATION SITE PAIN (Felt a little sore arm with the other doses /His arm always get a little sore after receiving a vaccine/felt something in his arm) had resolved.            No concomitant medication was reported.  Patient never had covid positive test. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  No treatment information was reported.   This case was linked to MOD-2022-656362 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: His arm always get a little sore after receiving a vaccine/felt something in his arm; Felt something in his arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (His arm always get a little sore after receiving a vaccine/felt something in his arm) and LIMB DISCOMFORT (Felt something in his arm) in a 68-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.     Patient had no allergies, had No covid test or diagnosis and patient had no Acute and Chronic illnesses at the time of vaccination.  Concurrent medical conditions included Blood pressure high.    On 30-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 PAIN IN EXTREMITY (His arm always get a little sore after receiving a vaccine/felt something in his arm) and LIMB DISCOMFORT (Felt something in his arm). At the time of the report, PAIN IN EXTREMITY (His arm always get a little sore after receiving a vaccine/felt something in his arm) and LIMB DISCOMFORT (Felt something in his arm) had resolved.            Patient did not receive any other vaccines within 1 month prior to Moderna COVID-19 vaccine.  No concomitant medications were reported.   It was reported that the patient had received the Bivalent Booster and it was the best one. Patient arm always get a little sore after receiving a vaccine. Patient doesn´t believe this was a side effect at all, he said that he felt something in his arm because of the injection and patient feels this with every vaccine that he receives.  No treatment details were reported.