chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: 3 weeks after 1st dose my heart started beating out control and got up 160 or more beats per minutes.; This spontaneous case was reported by a patient and describes the occurrence of PALPITATIONS (3 weeks after 1st dose my heart started beating out control and got up 160 or more beats per minutes.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient did not had COVID positive test or diagnosis ever.  Previously administered products included for Product used for unknown indication: FLU [INFLUENZA VACCINE] (Had other reactions with Flu vaccine and had to take the low dose flu vaccine.), pneumonia vaccine (Had other reactions with pneumonia vaccine.) and shingles vaccine (Had other reactions with shingles vaccine.). Past adverse reactions to the above products included Fever with FLU [INFLUENZA VACCINE], pneumonia vaccine and shingles vaccine. Concurrent medical conditions included Sulfonamide allergy, Acid reflux (esophageal) and Blood pressure high. Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for Acid reflux (esophageal), SPIRONOLACTONE, LOSARTAN and HYDROCHLOROTHIAZIDE for Blood pressure high, VITAMIN D NOS for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. In March 2021, the patient experienced PALPITATIONS (3 weeks after 1st dose my heart started beating out control and got up 160 or more beats per minutes.). At the time of the report, PALPITATIONS (3 weeks after 1st dose my heart started beating out control and got up 160 or more beats per minutes.) outcome was unknown.           mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that 3 weeks after the 1st dose patient  heart started beating out control and got up 160 or more beats per minutes. Cardiologist believed that she might have experienced some cardiac injury at some point in her life.  No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Treatment medication information was reported.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac stress test, Electrocardiogram, Heart rate, Palpitations, Ultrasound scan
Clinical narrative: 3 weeks after 1st dose my heart started beating out control and got up 160 or more beats per minutes.; This spontaneous case was reported by a patient and describes the occurrence of PALPITATIONS (3 weeks after 1st dose my heart started beating out control and got up 160 or more beats per minutes.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient did not had COVID positive test or diagnosis ever.  Previously administered products included for Product used for unknown indication: FLU [INFLUENZA VACCINE] (Had other reactions with Flu vaccine and had to take the low dose flu vaccine.), pneumonia vaccine (Had other reactions with pneumonia vaccine.) and shingles vaccine (Had other reactions with shingles vaccine.). Past adverse reactions to the above products included Fever with FLU [INFLUENZA VACCINE], pneumonia vaccine and shingles vaccine. Concurrent medical conditions included Sulfonamide allergy, Acid reflux (esophageal) and Blood pressure high. Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for Acid reflux (esophageal), SPIRONOLACTONE, LOSARTAN and HYDROCHLOROTHIAZIDE for Blood pressure high, VITAMIN D NOS for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. In March 2021, the patient experienced PALPITATIONS (3 weeks after 1st dose my heart started beating out control and got up 160 or more beats per minutes.). At the time of the report, PALPITATIONS (3 weeks after 1st dose my heart started beating out control and got up 160 or more beats per minutes.) outcome was unknown.           mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that 3 weeks after the 1st dose patient  heart started beating out control and got up 160 or more beats per minutes. Cardiologist believed that she might have experienced some cardiac injury at some point in her life.  No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Treatment medication information was reported.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: tested positive for COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (tested positive for COVID-19) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067H21A, 029K20A and 025J20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Dec-2020 at 12:27 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Jan-2021 at 8:37 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 17-Dec-2021 at 12:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 25-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (tested positive for COVID-19). At the time of the report, COVID-19 (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment medication was not reported.  On 25-Jan-2022 patient was tested positive for COVID-19 in PCR test conducted by health employee.   This case was linked to MOD-2022-657334, MOD-2022-655862 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2022: Live follow-up received contains no new information.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (tested positive for COVID-19) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067H21A, 029K20A and 025J20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Dec-2020 at 12:27 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Jan-2021 at 8:37 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 17-Dec-2021 at 12:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 25-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (tested positive for COVID-19). At the time of the report, COVID-19 (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment medication was not reported.  On 25-Jan-2022 patient was tested positive for COVID-19 in PCR test conducted by health employee.   This case was linked to MOD-2022-657334, MOD-2022-655862 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2022: Live follow-up received contains no new information.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Malaise, Nausea, Vertigo
Clinical narrative: Vertigo, queasy stomach, malaise
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Tinnitus, Vomiting
Clinical narrative: Mild Tinnitus persisting in 10/12/2022 at time of report.  Nausea and vomiting that started 10/11/2022.  Fever in excess of 100 degrees.
Age: 34.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Sig and painful axillary lymphatonopathy. Still present on 10/12/22@ 2100. No associated erythema, malaise, fevers or chills. No other lymphadenopathy.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone decreased, Hyperthyroidism, Laboratory test, Oedema, Thyroxine free increased
Clinical narrative: Hyperthyroidism
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tri-iodothyronine increased
Clinical narrative: Hyperthyroidism
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: Dizziness , light headed never fainted but needed to rush to sit down until I felt well enough to stand again. Hours later I was still light headed but the room was no longer spinning.
Age: 73.0
Sex: F
Vaccine: FLUC4
Symptoms: Wrong product administered
Clinical narrative: SHE GOT THE FLU VACCINE, ALSO NOT THE DOSE FOR 65 YEARS AND OLDER AT 2 PM ON 7/28/2022 AT CENTER. SHE MEANT TO GET COVID VACCINE BIVALENT , BUT I ACCIDENTALLY GAVE HER THE FLUCELVAX INSTEAD,  UPON RECOGNITION , I THEN GAVE HER THE CORRECT BIVALENT COVID VACCINE ON THE LEFT ARM, AND TOLD HER WHAT HAS HAPPENED, THAT WHAT I JUST GAVE HER ON HER RIGHT ARM WAS THE FLUCELVAX VACCINE
Age: 35.0
Sex: M
Vaccine: COVID19-2
Symptoms: Facial pain, Trigeminal neuralgia
Clinical narrative: Minor trigeminal neuralgia style of pain on left side of face. I think this also happened for the first and only time ever after my last booster shot last November but I thought it was a coincidence. It completely resolved and suddenly came back 48 hours after this new booster. Hoping it also goes away on its own soon.
Age: 37.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Cold sweat, Decreased appetite, Fatigue, Headache
Clinical narrative: At approximately 10 PM on the day of the vaccination (7 hours after the vaccination time of 3 PM), patient became extremely fatigued and went to bed. Patient slept from approximately 10 PM on Sunday October 9th through approximately 9 AM Thursday October 13th, 2022, with occasional trips to the bathroom or for water.  Patient did not eat anything on Monday the 10th, but tolerated dinner on Tuesday the 11th and Wednesday the 12th.  Patient experienced headache, chills, fever of approximately 102 Fahrenheit, off and on throughout this period, and cold sweats.  For approximately 2.5 hours between 1 AM and 3:30 AM on Thursday, October 13th, patient had to be assisted to take a shower and eat, then was returned to bed.  At approximately 9 AM Thursday October 13th, patient woke up and resumed normal activities of daily living and appears to have completely recovered.   Patient was unable to work and had to take two sick days in addition to normally scheduled day off.
Age: 37.0
Sex: M
Vaccine: COVID19-2
Symptoms: Impaired work ability, Loss of personal independence in daily activities, Pyrexia, Somnolence
Clinical narrative: At approximately 10 PM on the day of the vaccination (7 hours after the vaccination time of 3 PM), patient became extremely fatigued and went to bed. Patient slept from approximately 10 PM on Sunday October 9th through approximately 9 AM Thursday October 13th, 2022, with occasional trips to the bathroom or for water.  Patient did not eat anything on Monday the 10th, but tolerated dinner on Tuesday the 11th and Wednesday the 12th.  Patient experienced headache, chills, fever of approximately 102 Fahrenheit, off and on throughout this period, and cold sweats.  For approximately 2.5 hours between 1 AM and 3:30 AM on Thursday, October 13th, patient had to be assisted to take a shower and eat, then was returned to bed.  At approximately 9 AM Thursday October 13th, patient woke up and resumed normal activities of daily living and appears to have completely recovered.   Patient was unable to work and had to take two sick days in addition to normally scheduled day off.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Depression, Discomfort, Feeling abnormal, Influenza like illness
Clinical narrative: Discomfort, Flu like symptoms, depression, death.  Its been over a year so I am able to try and cough up my data now.  On Friday May 28th, 2021, Patient age 37, got his second dose of Moderna Covid-19 vaccine, at 9:30am.  He left work early that day, sunk into the usual effects the next, so I delivered him pizza. from afar  I was finishing up a job so I was not home that weekend.  He was home alone.   On Sunday May 30th, he started out feeling somewhat better, but was not feeling great.  But then slunk into a depression. By the evening he was drinking and feeling bad.   At any rate, he was found deceased in our home on Tuesday June 2, 2022.
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AEs were reported.; male patient received 3 doses of either GARDASIL or GARDASIL 9 in the past and now recently received additional 2 doses of GARDASIL 9; This spontaneous report was received from a physician and refers to a male patient of unknown age. The patient's medical history, concomitant therapies, and concurrent conditions were not provided.  On an unknown dates (reported as "in the past"), the patient was vaccinated with 3 doses of either quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (dose, strength, route and site of administration, lot # and expiration date were not provided) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, strength, route and site of administration, lot # and expiration date were not provided) for prophylaxis [it was not possible to verify if they were quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection].  On an unknown date in 2022 (reported as "now recently"), the patient received additional 2 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, strength, route and site of administration, lot # and expiration date were not provided) for prophylaxis (extra dose administered). No additional adverse events were reported (no adverse event).
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AEs; product was quarantined in freezer awaiting instructions for return/ Improperly stored vaccine that experienced shipping temperature excursion on 8/31/22 was administered to patient on 9/19/22.; PROQUAD shipment, which was received late on 8/31/22 past must receive by date 8/30/22, late shipment; This spontaneous report was received from a clinic director/ office manager referring to a 4 years old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) shipment, which was received late on 31-AUG-2022 past must receive by date 30-AUG-2022 (product distribution issue). The late shipment had already been reported the agency. The improperly stored vaccine that experienced shipping temperature excursion on 31-AUG-2022.  The product was quarantined in freezer awaiting instructions for return. But on 19-SEP-2022, the vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot # W019626, 19-DEC-2023; 0.5 milliliter, once; strength and route were not reported) was accidentally administered to the patient for prophylaxis (product storage error). No additional AEs (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AEs; an improperly stored vaccine was administered to a patient; This spontaneous report was received from a medical assistant regarding to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-OCT-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human Albumin (rHA) (PROQUAD) lot #W023868, expiration date: 24-JAN-2024 (dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis (product storage error).  The improperly stored vaccine underwent a temperature excursion of 10.8 degrees Fahrenheit (F) for 1 hour, 39 minutes and 0 seconds without previous excursions. No adverse events were reported.  This case was one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2210USA002172: US-009507513-2210USA002083: US-009507513-2210USA002508: US-009507513-2210USA002276:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: no adverse event; HCP reporting an improperly stored vaccine was administered to a patient.; This spontaneous report was received from other health professional and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unspecified date, doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) underwent a temperature excursion of 10.8 fahrenheit degrees for 1 hour and 39 minutes.  On 06-OCT-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) lot #W017574, expiration date: 29-NOV-2023 (strength, dosage regimen, anatomical location, and route of administration were not provided) as prophylaxis. No adverse event was reported.  This is one if several cases reported by the same reporter.; Sender's Comments:  US-009507513-2210USA002172: US-009507513-2210USA002083: US-009507513-2210USA002276: US-009507513-2210USA002508:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AEs; The physician reported that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) PROQUAD (w017571   11/29/2023) Temperature: 10.1F  Time frame; This spontaneous report was received from a physician and refers to a patient of unknown gender and age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-OCT-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, 1 dose, lot number w017571, expiration date: 29-NOV-2023, administered for prophylaxis (exact dose, strength, and route of administration were not provided). It was reported that before administration, the vaccine was improperly stored (temperature: 10.1 Fahrenheit, time frame: 51 hours, no previous temperature excursion) (product storage error). No additional adverse events reported (no adverse event).
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; RN calling to report administration of expired vaccine to patient. Caller reports that MMR II lot expired on 8/26/22 and was inadvertently administered today 10/10/22. No additional AEs, no PQCs reported.; This spontaneous report has been received from a nurse and refers to a 4-year-old female patient. The patient's medical history, concurrent, previous drug allergies or reactions and concomitant therapies were not reported.  On an 10-OCT-2022, the patient was vaccinated with a expired vaccine of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (Albumin status of rHA (recombinant human albumin)) (M-M-R II) subcutaneous injection, 0.5 milligram (ml) once, lot number T028935, expiration date reported as 26-AUG-2022, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered). No additional adverse event reported.
Age: 27.0
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No additional AEs; PROQUAD administered to a 27 year old; This spontaneous report was received from a Medical Assistant and refers to a 27-year-old patient of unspecified gender.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 24-AUG-2022, at the age of 27 years, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin) (PROQUAD), subcutaneous injection, 0.5 milliliter (lot #W010525 has been verified to be a valid lot number, expiration date: 25-SEP-2023) administered subcutaneously for prophylaxis (Product administered to patient of inappropriate age). No other information was provided. No additional adverse events (AEs) reported (No adverse event).
Sex: U
Vaccine: HEPA, MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; Caller reports that the PROQUAD and VAQTA was "assumed to be in normal storage range", but could not confirm if a temperature had occurred prior to the administration; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not reported.   On 10-OCT-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) injection, 0.5 milliliter, lot #W002894, expiration date: 06-MAR-2023, administered as prophylaxis (strength, and route of administration were not provided); and vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, lot #W023869, expiration date: 24-JAN-2024, administered also as prophylaxis (strength, and route of administration were not provided). The nurse reported that her data logger died and did not record temperatures for about a week. She also reported that the vaccines were assumed to be in normal storage range. However, she could not confirm if a temperature excursion had occurred prior to the administration. The temperature, time frame, and previous temperature excursion were unknown by the reporter.   No additional adverse event (AE) reported.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 2019, 2nd dose not administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 16th October 2019).   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: 05-OCT-2022 Reporters comment:  The 2nd dose had not been administered yet. Pharmacy did not keep record of vaccine lot number or expiration date. The Vaccine Administration Facility is the same as Primary Reporter. Consented to follow up.  Additional Supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Insomnia
Clinical narrative: Couldn't sleep/she was not able to sleep at all; Hips were in tremendous pain/Sunday (9OCT2022) night it became worse; This spontaneous case was reported by a patient and describes the occurrence of INSOMNIA (Couldn't sleep/she was not able to sleep at all) and ARTHRALGIA (Hips were in tremendous pain/Sunday (9OCT2022) night it became worse) in an 83-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7163B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 1), Pfizer vaccine (Booster 2), Pfizer vaccine (Booster 1) and Pfizer vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer vaccine, Pfizer vaccine, Pfizer vaccine and Pfizer vaccine.    On 07-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 07-Oct-2022, the patient experienced INSOMNIA (Couldn't sleep/she was not able to sleep at all) and ARTHRALGIA (Hips were in tremendous pain/Sunday (9OCT2022) night it became worse). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INSOMNIA (Couldn't sleep/she was not able to sleep at all) and ARTHRALGIA (Hips were in tremendous pain/Sunday (9OCT2022) night it became worse) had not resolved.            The concomitant medication was not reported by reporter.  It was reported that on that night both of patient's hips were in tremendous pain and could not sleep. On 08-Oct-2022, (Saturday) the pain became lesser, and patient thought it was going away. On 09-Oct-2022 (Sunday) night it became worse, and patient was not able to sleep at all. Patient took Tylenol to help with her symptoms, however patient continued to be unable to sleep.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; A dose of the Moderna COVID-19 vaccine bivalent was given at 0.25mL by intramuscular injection; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (A dose of the Moderna COVID-19 vaccine bivalent was given at 0.25mL by intramuscular injection) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 03-Oct-2022, the patient experienced UNDERDOSE (A dose of the Moderna COVID-19 vaccine bivalent was given at 0.25mL by intramuscular injection). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (A dose of the Moderna COVID-19 vaccine bivalent was given at 0.25mL by intramuscular injection) 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 UNDERDOSE (A dose of the Moderna COVID-19 vaccine bivalent was given at 0.25mL by intramuscular injection).    No concomitant medications were reported.  A dose of the Moderna COVID-19 vaccine bivalent was given at 0.25mL by intramuscular injection.  The patient has not reported any symptoms. No additional doses, medications or treatments have been administered at this time.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Myalgia, Vaccination site pain
Clinical narrative: Severe diarrhea; body ache; pain in the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of DIARRHOEA (Severe diarrhea), MYALGIA (body ache) and VACCINATION SITE PAIN (pain in the injection site) in a 62-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 942371) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2020 and COVID-19 in October 2020. Concurrent medical conditions included Celiac disease and Gluten sensitivity.    On 09-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 an unknown date, the patient experienced DIARRHOEA (Severe diarrhea), MYALGIA (body ache) and VACCINATION SITE PAIN (pain in the injection site). At the time of the report, DIARRHOEA (Severe diarrhea) and VACCINATION SITE PAIN (pain in the injection site) had resolved and MYALGIA (body ache) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The patient height was reported as 5.3. Events Intestinal issues,  Abdominal pain upper, Asthenia ,Pyrexia and Vomiting are subsumed under the event Diarrhoea. It was reported that patient was taking thyroid medication, acid reflux medication and blood pressure medication. Patient was allergic to all pain medications & preservatives in medications. Patient had intestinal issues, low grade fever, pain in the injection site, severe diarrhea and real bad stomach cramping. This went for hours and hours. Throwed up. She experienced this with every vaccine. This were the same symptoms that she experiences when she was contaminated with gluten. Patient received Dose Number: 1 of Moderna with Lot number: 026A21A on 09Mar2021 Patient received Dose Number: 2 of Moderna with Lot number: 038A21A on 12Apr2021 Patient received Dose Number: 3 of Moderna with Lot number: 032F21A on 25Oct2021 Patient received Dose Number: 4 of Moderna with Lot number: 0542AA2on 18May2022  No treatment information provided   This case was linked to MOD-2022-657008 (Patient Link).
Sex: F
Vaccine: COVID19-2
Symptoms: Death
Clinical narrative: Patient died after getting the Moderna COVID-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient died after getting the Moderna COVID-19 Vaccine) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medications were reported. Caller stated her mother died after getting the Moderna COVID-19 Vaccine and that a lot of people was dying from the vaccine (caller did not provide more details about other people or his mother's case). Patient mentioned Moderna was hiding information and lying about people dying from the vaccine. Treatment information was not provided.  Company Comment: This is a spontaneus case concerning a female patient of an unknown age with no medical history reported, who experienced the serious unexpected event of Death, reported as patient died after getting the Moderna COVID-19 Vaccine. The date of mRNA-1273 BIVALENT vaccine dose and death date were not provided. Very limited information regarding this event has been provided at this time, the cause of death was not reported, and it is unknown if an autopsy was performed. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273 BIVALENT) is not affected by this report.; Sender's Comments: This is a spontaneus case concerning a female patient of an unknown age with no medical history reported, who experienced the serious unexpected event of Death, reported as patient died after getting the Moderna COVID-19 Vaccine. The date of mRNA-1273 BIVALENT vaccine dose and death date were not provided. Very limited information regarding this event has been provided at this time, the cause of death was not reported and it is unknown if an autopsy was performed. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273 BIVALENT) is not affected by this report.; Reported Cause(s) of Death: Patient died after getting the Moderna COVID-19 Vaccine
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: He also mentioned that he was COVID Positive in FEB2022 but did not have any symptoms. He is very thankful for the Moderna COVID-19 vaccine / Positive PCR after first booster vaccination; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (He also mentioned that he was COVID Positive in FEB2022 but did not have any symptoms. He is very thankful for the Moderna COVID-19 vaccine / Positive PCR after first booster vaccination) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  The patient's past medical history included Herpes simplex. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2022, the patient experienced COVID-19 (He also mentioned that he was COVID Positive in FEB2022 but did not have any symptoms. He is very thankful for the Moderna COVID-19 vaccine / Positive PCR after first booster vaccination). At the time of the report, COVID-19 (He also mentioned that he was COVID Positive in FEB2022 but did not have any symptoms. He is very thankful for the Moderna COVID-19 vaccine / Positive PCR after first booster vaccination) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, SARS-CoV-2 test: (Positive) Positive. No concomitant medications were reported.  Patient was a clinical trial participant and received the first 3 primary doses on 17AUG2020, 11SEP2020 and 17MAY2021. The first 3 shots were received while participating in the Moderna COVID-19 Vaccine Clinical Trial. Patient reported  that he was COVID Positive in FEB2022 but did not have any symptoms.   No treatment medications were reported.   This case was linked to MOD-2022-657017 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: My husband got a little swelling at the injection site; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE SWELLING (My husband got a little swelling at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced VACCINATION SITE SWELLING (My husband got a little swelling at the injection site). At the time of the report, VACCINATION SITE SWELLING (My husband got a little swelling at the injection site) outcome was unknown.            No Concomitant medications were provided. No treatment medications were provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Skin odour abnormal, Vaccination site erythema, Vaccination site swelling
Clinical narrative: It smelled like a decomposing body on my fingers/It was like every finger was expelling this deceased smell; it literally deflated/just slapped; swelling the size of my fist at the injection site; It was a big red blob; This spontaneous case was reported by a patient and describes the occurrence of SKIN ODOUR ABNORMAL (It smelled like a decomposing body on my fingers/It was like every finger was expelling this deceased smell), DISCOMFORT (it literally deflated/just slapped), VACCINATION SITE SWELLING (swelling the size of my fist at the injection site) and VACCINATION SITE ERYTHEMA (It was a big red blob) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 007F21A, 040B21A and 044A21A) for COVID-19 vaccination.     The patient's past medical history included Thyroidectomy. Concurrent medical conditions included Drug allergy (Epinephrine), Sulfonamide allergy (Sulfur), Reaction to food additive (Red dye (in pills)) and Contrast media allergy (Contrast dye).   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, the patient experienced VACCINATION SITE SWELLING (swelling the size of my fist at the injection site) and VACCINATION SITE ERYTHEMA (It was a big red blob). On 11-Apr-2022, the patient experienced SKIN ODOUR ABNORMAL (It smelled like a decomposing body on my fingers/It was like every finger was expelling this deceased smell) and DISCOMFORT (it literally deflated/just slapped). At the time of the report, SKIN ODOUR ABNORMAL (It smelled like a decomposing body on my fingers/It was like every finger was expelling this deceased smell) and DISCOMFORT (it literally deflated/just slapped) outcome was unknown and VACCINATION SITE SWELLING (swelling the size of my fist at the injection site) and VACCINATION SITE ERYTHEMA (It was a big red blob) had resolved.            Concomitant product use was not provided by the reporter. The patient had long list of allergy. On 05-Apr-2022, the patient got the second booster dose of Moderna COVID-19 vaccine. Within an hour of getting the injection the patient had a swelling the size of their fist at the injection site which lasted for 7 days. It was a big red blob. On 11-Apr-2022 the seventh day, the patient just slapped it and it literally deflated. It smelled like a decomposing body on their fingers. It was like every finger was expelling that deceased smell. The patient had found deceased family members so they knew what that smell was. Treatment information was not provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (opened a vial last Friday, October 7 and the vial was not discarded at the end of the day. So today, the vial was still in the fridge and was accidentally given to a patient), PRODUCT STORAGE ERROR (opened a vial last Friday, October 7 and the vial was not discarded at the end of the day. So today, the vial was still in the fridge and was accidentally given to a patient) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.   On 10-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (opened a vial last Friday, October 7 and the vial was not discarded at the end of the day. So today, the vial was still in the fridge and was accidentally given to a patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (opened a vial last Friday, October 7 and the vial was not discarded at the end of the day. So today, the vial was still in the fridge and was accidentally given to a patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (opened a vial last Friday, October 7 and the vial was not discarded at the end of the day. So today, the vial was still in the fridge and was accidentally given to a patient), PRODUCT STORAGE ERROR (opened a vial last Friday, October 7 and the vial was not discarded at the end of the day. So today, the vial was still in the fridge and was accidentally given to a patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     No concomitant medication information was provided. It was reported that a vial was opened on last Friday, 07-Oct-2022 and the vial was not discarded at the end of the day. So the vial was still in the fridge and was accidentally given to a patient. No treatment information was provided.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; Patient received 0.25 ml vaccine for 6 months to age 5 year; Patient received 0.25 ml vaccine  instead of 0.5 ml vaccine; This spontaneous case was reported by a physician and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient received 0.25 ml vaccine for 6 months to age 5 year), ACCIDENTAL UNDERDOSE (Patient received 0.25 ml vaccine  instead of 0.5 ml vaccine) and NO ADVERSE EVENT (No adverse event) in an 8-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 10-Oct-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Patient received 0.25 ml vaccine for 6 months to age 5 year) and ACCIDENTAL UNDERDOSE (Patient received 0.25 ml vaccine  instead of 0.5 ml vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Patient received 0.25 ml vaccine for 6 months to age 5 year), ACCIDENTAL UNDERDOSE (Patient received 0.25 ml vaccine  instead of 0.5 ml vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INCORRECT DOSE ADMINISTERED (Patient received 0.25 ml vaccine for 6 months to age 5 year) and ACCIDENTAL UNDERDOSE (Patient received 0.25 ml vaccine  instead of 0.5 ml vaccine).    Concomitant medication was not provided.  Treatment information was not provided.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; received the monovalent Moderna Covid-19 vaccine as a booster dose about two weeks ago instead of the bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (received the monovalent Moderna Covid-19 vaccine as a booster dose about two weeks ago instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In September 2022, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2022, the patient experienced WRONG PRODUCT ADMINISTERED (received the monovalent Moderna Covid-19 vaccine as a booster dose about two weeks ago instead of the bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received the monovalent Moderna Covid-19 vaccine as a booster dose about two weeks ago instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (received the monovalent Moderna Covid-19 vaccine as a booster dose about two weeks ago instead of the bivalent vaccine).    No concomitant medications were reported. Patient received the monovalent Moderna Covid-19 vaccine as a booster dose about two weeks ago instead of the bivalent vaccine. The patient received his Moderna Covid-19 vaccine primary series and also the first two booster doses.   No treatment medications were reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (Caller's brother has been sick) in a male patient of an unknown age who received mRNA-1273  for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273  (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS . At the time of the report, ILLNESS outcome was unknown.        The action taken with mRNA-1273 (Unknown) was unknown.       No concomitant medications were reported.  Patient had been sick for constantly 5 day.  No treatment medications were reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive for COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Tested positive for COVID-19) in a 39-year-old female patient who received mRNA-1273 (Moderna        On 30-Dec-2020 at 1:36 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 28-Jan-2021 at 9:39 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 18-Nov-2021 at 11:57 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 02-Feb-2022, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient did not have allergies to medications, food, and other products. Patient had no acute illnesses at the time of vaccination and up to one month before. Had no chronic or long-standing health conditions. No prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event.  No treatment information was provided.      Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2022: Follow up received contains no newinformation.