chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLU4
Symptoms: Chest pain, Dyspnoea, Wrong product administered
Clinical narrative: chest pain; winded easily/ shortness of breath; This case was reported by a consumer and described the occurrence of chest pain in a male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number 292r2, expiry date unknown) for prophylaxis.   On 7th December 2021, the patient received FluLaval Quadrivalent 2021-2022 season. On 7th December 2021, 30 min after receiving FluLaval Quadrivalent 2021-2022 season, the patient experienced chest pain and shortness of breath. On an unknown date, the outcome of the chest pain and shortness of breath were not recovered/not resolved.   It was unknown if the reporter considered the chest pain and shortness of breath to be related to FluLaval Quadrivalent 2021-2022 season.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of FluLaval Quadrivalent 2021-2022 season and 30 minutes later developed shortness of breath, winded easily and chest pain. The patient went to emergency room immediately and had to go twice. Even after a week his symptoms was persist. The reporter also stated that the patient was given the wrong medication instead of Fluarix (which was intended to be given). The patient believed that the wrong medication was given had a lot number 292r2 which he believed was given to given. The reporter consented to follow-up.
Age: 1.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Extra dose administered, Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of overdose in a 1-year-old male patient who received HAV (Havrix adult) (batch number U95H7, expiry date 22nd May 2022) for prophylaxis. Co-suspect products included HAV (Havrix adult) (batch number U95H7, expiry date unknown) for prophylaxis. On 9th December 2021, the patient received the 3rd dose of Havrix adult. On an unknown date, the patient received the 2nd dose of Havrix adult. On 9th December 2021, unknown after receiving Havrix adult and not applicable after receiving Havrix adult, the patient experienced extra dose administered, adult product administered to child and overdose. On an unknown date, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose, adult product administered to child, extra dose administered, adult product administered to child and overdose were unknown. Additional details were provided as follows: The physician reported that the patient received adult dose of the Havrix vaccine inadvertently for his second and third dose of the series, which led to overdose, adult product administered to child and extra dose administered. The reporter consented to follow-up. No further information reported. This case had been linked with cases US2021254949 and US2021254948 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021254948:Same reporter. US-GLAXOSMITHKLINE-US2021254949:Same reporter.
Age: 1.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Extra dose administered, Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of overdose in a 1-year-old male patient who received HAV (Havrix adult) (batch number U95H7, expiry date 22nd May 2022) for prophylaxis.   Co-suspect products included HAV (Havrix adult) (batch number U95H7, expiry date unknown) for prophylaxis.   Previously administered products included Havrix (1st dose received on an unknown date).   On 9th December 2021, the patient received the 3rd dose of Havrix adult. On an unknown date, the patient received the 2nd dose of Havrix adult. On 9th December 2021, unknown after receiving Havrix adult and not applicable after receiving Havrix adult, the patient experienced extra dose administered, adult product administered to child and overdose. On an unknown date, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose, adult product administered to child, extra dose administered, adult product administered to child and overdose were unknown.  Additional details were provided as follows: The age at vaccination was not reported. Physician reported that the patient received adult dose of the Havrix vaccine inadvertently for his second and third dose of the series, which led to overdose, adult product administered to child and extra dose administered. No further information reported. The reporter consented to follow-up. This case has been linked with cases US2021254949 and US2021254932 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021254932:Same reporter. US-GLAXOSMITHKLINE-US2021254949:Same reporter.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Thrombosis
Clinical narrative: SYMPTOMS OF A BLOOD CLOT; SICK FOR 5 DAYS; This spontaneous report received from a parent via social media concerned an adult male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was previously treated with covid-19 vaccine from an unspecified manufacturer (form of admin, route of admin, and batch number were not reported, expiry: UNKNOWN), 1 in total, dose was not reported for prophylactic vaccination (Dose number in series 1). It was unknown whether patient had any adverse event following covid-19 vaccination (Dose number in series 1).  The patient received booster covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination (Dose number in series 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, following covid-19 vaccine ad26.cov2.s vaccination (Dose number in series 2), the patient was sick for 5 days. It was reported that one month later the patient was immediately taken to emergency room, as the patient experienced symptoms of a blood clot (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick for 5 days, and the outcome of symptoms of a blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211218623-covid-19 vaccine ad26.cov2.s-Blood clot symptoms. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Kidney infection
Clinical narrative: This spontaneous report received from a patient concerned an 81-year-old white female of unspecified ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: kidney infections and kidney stone (at the age of 27). The patient had anaphylaxis to several antibiotics (too many for her to list) (captured as antibiotic allergy) and a chlorine allergy. The patient is on medication for the rest of her life for kidney stone. The patient did not have drug abuse or illicit drug usage and does not consume alcohol or smoke. The patient was previously treated with chlorine. The patient received covid-19 vaccine (unspecified manufacturer) (suspension for injection, route of administration batch number and expiration date were not reported) 1 total, dose was not reported administered on unspecified day for prophylactic vaccination (dose number in series 1). The batch number was not reported and has been requested. Patient went to urologist on 09-DEC-2021 (Thursday) and confirmed diagnosis of kidney infection (on dose number in series 1) on the 13-DEC-2021. The patient reported that, she was on antibiotics after being diagnosed with kidney infection. The patient received covid-19 vaccine (suspension for injection, route of administration not reported, batch number: 1822811 and expiry: 20-MAR-2022) 1 total, dose was not reported, administered on right arm 13-DEC-2021 at about 10:00 for prophylactic vaccination (Dose number in series 2).  No concomitant medications were reported. The action taken with covid-19 vaccine was not applicable. The patient was recovering from kidney infection. This report was serious (other medically important condition).; Sender's Comments: V0- 20211233134- covid-19 vaccine Kidney Infection. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: FELT SOME SORENESS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced felt some soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt some soreness was not reported. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: a little bit but not that aggressive after Dose 1; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (a little bit but not that aggressive after Dose 1) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced VACCINATION COMPLICATION (a little bit but not that aggressive after Dose 1). At the time of the report, VACCINATION COMPLICATION (a little bit but not that aggressive after Dose 1) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No Treatment medications were provided. Patient also states that she has constipation issues, that in October it was very serious and started taking Miralax.   This case was linked to MOD-2021-418185 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeding disorder, Feeling cold, Headache, Myalgia
Clinical narrative: unable to eat after booster; feeling cold after booster; Feeling thirsty all the time after booster; after the booster dose: fever 102.8°F; headache persistent after Tylenol after booster; body ache persistent after Tylenol after booster; chills after booster; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (unable to eat after booster), FEELING COLD (feeling cold after booster), THIRST (Feeling thirsty all the time after booster), PYREXIA (after the booster dose: fever 102.8°F) and HEADACHE (headache persistent after Tylenol after booster) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Constipation. Concomitant products included MACROGOL 3350 (MIRALAX) for Constipation.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEEDING DISORDER (unable to eat after booster), FEELING COLD (feeling cold after booster), THIRST (Feeling thirsty all the time after booster), PYREXIA (after the booster dose: fever 102.8°F), HEADACHE (headache persistent after Tylenol after booster), MYALGIA (body ache persistent after Tylenol after booster) and CHILLS (chills after booster). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. At the time of the report, FEEDING DISORDER (unable to eat after booster), FEELING COLD (feeling cold after booster), THIRST (Feeling thirsty all the time after booster), PYREXIA (after the booster dose: fever 102.8°F), HEADACHE (headache persistent after Tylenol after booster), MYALGIA (body ache persistent after Tylenol after booster) and CHILLS (chills after booster) outcome was unknown.            No concomitant medications were reported. Patient also states that she has constipation issues, that in October it was very serious and started taking Miralax. She even saw a doctor a couple of times due to this.   This case was linked to MOD-2021-418185 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Thirst
Clinical narrative: unable to eat after booster; feeling cold after booster; Feeling thirsty all the time after booster; after the booster dose: fever 102.8°F; headache persistent after Tylenol after booster; body ache persistent after Tylenol after booster; chills after booster; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (unable to eat after booster), FEELING COLD (feeling cold after booster), THIRST (Feeling thirsty all the time after booster), PYREXIA (after the booster dose: fever 102.8°F) and HEADACHE (headache persistent after Tylenol after booster) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Constipation. Concomitant products included MACROGOL 3350 (MIRALAX) for Constipation.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEEDING DISORDER (unable to eat after booster), FEELING COLD (feeling cold after booster), THIRST (Feeling thirsty all the time after booster), PYREXIA (after the booster dose: fever 102.8°F), HEADACHE (headache persistent after Tylenol after booster), MYALGIA (body ache persistent after Tylenol after booster) and CHILLS (chills after booster). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. At the time of the report, FEEDING DISORDER (unable to eat after booster), FEELING COLD (feeling cold after booster), THIRST (Feeling thirsty all the time after booster), PYREXIA (after the booster dose: fever 102.8°F), HEADACHE (headache persistent after Tylenol after booster), MYALGIA (body ache persistent after Tylenol after booster) and CHILLS (chills after booster) outcome was unknown.            No concomitant medications were reported. Patient also states that she has constipation issues, that in October it was very serious and started taking Miralax. She even saw a doctor a couple of times due to this.   This case was linked to MOD-2021-418185 (Patient Link).
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter.  No treatment information was provided by reporter.   This case was linked to MOD-2021-417618 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Follow up information received contains significant information: Updated patient's details and product details.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vaccination complication
Clinical narrative: Strong reaction; Felt a little lightheaded; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Strong reaction) and DIZZINESS (Felt a little lightheaded) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION COMPLICATION (Strong reaction) and DIZZINESS (Felt a little lightheaded). At the time of the report, VACCINATION COMPLICATION (Strong reaction) and DIZZINESS (Felt a little lightheaded) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment includes Gatorade and water. Nurse reported that she received her first Moderna vaccine at the end of January 2021 and had a strong reaction on the same day.  She felt a little lightheaded the same day of her shot.    This case was linked to MOD-2021-408590 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Throat tightness
Clinical narrative: She started to feel her throat close up; She had a rash; This spontaneous case was reported by an other health care professional and describes the occurrence of THROAT TIGHTNESS (She started to feel her throat close up) and RASH (She had a rash) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced THROAT TIGHTNESS (She started to feel her throat close up) and RASH (She had a rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. In January 2021, THROAT TIGHTNESS (She started to feel her throat close up) and RASH (She had a rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   She takes no regular medications.  After receiving that dose of the vaccine, patient was waited at the vaccination facility for 30 minutes without issue then was driving home, and 15 minutes after leaving the pharmacy, patient were started to feeling throat close up and had a rash. Patient was called the pharmacist who instructed to take Benadryl. Her symptoms completely resolved within an hour.  The pharmacist also called patient on 3-FEB-2021 to inform that patient should not receive the second dose of the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not doing well; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (not doing well) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (not doing well). At the time of the report, MALAISE (not doing well) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Got 0.5ml (the administrator thought she was getting the first dose); This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Got 0.5ml (the administrator thought she was getting the first dose)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 18-Dec-2021, the patient experienced ACCIDENTAL OVERDOSE (Got 0.5ml (the administrator thought she was getting the first dose)). On 18-Dec-2021, ACCIDENTAL OVERDOSE (Got 0.5ml (the administrator thought she was getting the first dose)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication were provided.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in her arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027b21a, 004c21a and 045521a) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in her arm). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and IBUPROFEN SODIUM (IBUPROFEN [IBUPROFEN SODIUM]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (soreness in her arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication was not reported.   This case was linked to MOD-2021-417004, MOD-2021-416998 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccines administered after 12 hours puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered after 12 hours puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines administered after 12 hours puncture). On 16-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Vaccines administered after 12 hours puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was reported. Did the vial undergo any temperature excursions? No Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): It was not, it was kept in the fridge the whole time.
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, Vaccination complication
Clinical narrative: booster shot instead of third shot; side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) and ACCIDENTAL UNDERDOSE (booster shot instead of third shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Primary immunodeficiency syndrome.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced VACCINATION COMPLICATION (side effects). On 17-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (booster shot instead of third shot). On 17-Dec-2021, ACCIDENTAL UNDERDOSE (booster shot instead of third shot) had resolved. At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.            Patient received the booster shot by mistake, instead of the third full dose. Pharmacist called and Moderna said to give another booster shot as soon as possible. Reporter wanted to know if they can delay it as patient got side effects and Christmas is coming up. No concomitant medication were provided. No treatment information were given.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of administered expired product (administered an expired dose of the vaccine) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 085D21A) for COVID-19 immunization. No medical history reported. On Dec 15, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Dec 15, 2021, patient administered expired product (administered an expired dose of the vaccine). On Dec 15, 2021, administered expired product (administered an expired dose of the vaccine) resolved. No concomitant medication or treatment information provided. Patient did not have any adverse events.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Vaccination complication
Clinical narrative: has no antibodies after 3 doses of the vaccine/ not bad, a little, nothing major, just probably a migraine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (has no antibodies after 3 doses of the vaccine/ not bad, a little, nothing major, just probably a migraine) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A, 039A21A and 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (due to her medication Ocrevus) and Multiple sclerosis (at the age of 30, year late 1996- early 1997). Concomitant products included OCRELIZUMAB (OCREVUS) from an unknown date to 15-Dec-2012 for Multiple sclerosis.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, received third 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 COMPLICATION (has no antibodies after 3 doses of the vaccine/ not bad, a little, nothing major, just probably a migraine). At the time of the report, VACCINATION COMPLICATION (has no antibodies after 3 doses of the vaccine/ not bad, a little, nothing major, just probably a migraine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Dec-2021, Antibody test: non-reactive (abnormal) non-reactive, no antibodies after 3 doses of the vaccine.         Reporter stated that after 3rd dose it was not bad, a little, nothing major and just probably Migraine.  No treatment information was provided.   This case was linked to MOD-2021-294520, MOD-2021-294611 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: started to experience a rash on the arm,, itchiness; started to experience a rash on the arm,, itchiness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (started to experience a rash on the arm,, itchiness) and VACCINATION SITE RASH (started to experience a rash on the arm,, itchiness) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     Concurrent medical conditions included Depression. Concomitant products included MIRTAZAPINE for Depression, VITAMINS NOS and ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) for an unknown indication.   On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced VACCINATION SITE PRURITUS (started to experience a rash on the arm,, itchiness) and VACCINATION SITE RASH (started to experience a rash on the arm,, itchiness). At the time of the report, VACCINATION SITE PRURITUS (started to experience a rash on the arm,, itchiness) and VACCINATION SITE RASH (started to experience a rash on the arm,, itchiness) outcome was unknown.            No treatment medication was provided.  The patient reports having no problems with the first 2 doses. The rash was a pretty good sized rash.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weak). At the time of the report, ASTHENIA (weak) had not resolved.            No concomitant medication was reported. No treatment medication was reported. The patient states that this has been happening for the last two months and not just last week.   This case was linked to MOD-2021-417951 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Administrated a 0.25 mL booster shot,instead of 0.50 mL 3rd shot; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Administrated a 0.25 mL booster shot,instead of 0.50 mL 3rd shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Administrated a 0.25 mL booster shot,instead of 0.50 mL 3rd shot). At the time of the report, ACCIDENTAL UNDERDOSE (Administrated a 0.25 mL booster shot,instead of 0.50 mL 3rd shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided. Treatment information was not provided.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: booster dose of 0.25 mL, instead of the 0.5 mL third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (booster dose of 0.25 mL, instead of the 0.5 mL third dose) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 17-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (booster dose of 0.25 mL, instead of the 0.5 mL third dose). On 17-Dec-2021, ACCIDENTAL UNDERDOSE (booster dose of 0.25 mL, instead of the 0.5 mL third dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient is immunocompromised and needs the third dose. Concomitant medication was not provided. Treatment information was not provided.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Patient's left arm sore; patient had a headache.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Patient's left arm sore) and HEADACHE (patient had a headache.) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 23763) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, received second 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 (Patient's left arm sore) and HEADACHE (patient had a headache.). At the time of the report, VACCINATION SITE PAIN (Patient's left arm sore) and HEADACHE (patient had a headache.) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Injection site pain, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: fever up to 101 degrees F; headache; 16-year-old in Maryland was given Moderna booster on Friday; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (pain at the injection site), PYREXIA (fever up to 101 degrees F), HEADACHE (headache) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old in Maryland was given Moderna booster on Friday) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer Vaccine (First dose) on 17-Apr-2021 and Pfizer Vaccine (Second dose) on 08-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer Vaccine and Pfizer Vaccine.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 17-Dec-2021, the patient experienced INJECTION SITE PAIN (pain at the injection site) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old in Maryland was given Moderna booster on Friday). On an unknown date, the patient experienced PYREXIA (fever up to 101 degrees F) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form. On 17-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old in Maryland was given Moderna booster on Friday) had resolved. At the time of the report, INJECTION SITE PAIN (pain at the injection site), PYREXIA (fever up to 101 degrees F) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) Fever up to 101 degrees F.         The reporter states that, the patient experienced only the common side effects in the 46 hours since the injection. And all the events were mitigated by Advil.  Concomitant medication information was not reported
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patients were administered after the expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients were administered after the expiration date) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Dec-2021 at 3:49 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients were administered after the expiration date). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (patients were administered after the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was provided.  No treatment medications was provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Follow-up information received contains significant information. Updated patient's details and suspect product details.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.  Vaccine was kept in freezer at -24 degrees F until the day of use.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: 16 y/o was administered a 0.25 mL dose of Moderna by mistake; Patient had received Pfizer as a primary series; Did good except for her sore arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Did good except for her sore arm), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 y/o was administered a 0.25 mL dose of Moderna by mistake) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received Pfizer as a primary series) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: PFIZER BIONTECH COVID-19 VACCINE (Patient had received Pfizer as a primary series) and PFIZER BIONTECH COVID-19 VACCINE (Patient had received Pfizer as a primary series). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In December 2021, the patient experienced PAIN IN EXTREMITY (Did good except for her sore arm). On 16-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 y/o was administered a 0.25 mL dose of Moderna by mistake) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received Pfizer as a primary series). On 16-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 y/o was administered a 0.25 mL dose of Moderna by mistake) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received Pfizer as a primary series) had resolved. At the time of the report, PAIN IN EXTREMITY (Did good except for her sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of administered expired product (received expired vaccine) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 026C21A) for COVID-19 immunization. No medical history reported. On Dec 17, 2021, at 3:49 pm, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; .5mL. On Dec 17, 2021, patient administered expired product (received expired vaccine). On Dec 17, 2021, administered expired product (received expired vaccine) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. The expiration date of vaccine: Oct, 24 2021. Most recent follow-up information incorporated: On Dec 17, 2021: follow-up received included reporter's  updated address and confirmed email address.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Under age 18; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under age 18) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 16-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under age 18). On 16-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under age 18) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was not provided by the reporter.  No treatment was provided by the reporter.  Patient completed primary series with Moderna COVID-19 vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever of 100.6°F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 100.6°F) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced PYREXIA (fever of 100.6°F). At the time of the report, PYREXIA (fever of 100.6°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) fever of 100.6°F.         No concomitant medication was reported.  No treatment medication use was reported.   Reporter did not allow further contact
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: had first shot on 2April2021 second shot 18May2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had first shot on 2April2021 second shot 18May2021) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21-2A and 022C1A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had first shot on 2April2021 second shot 18May2021). On 18-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had first shot on 2April2021 second shot 18May2021) had resolved.            No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-416964 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Rash
Clinical narrative: a rash around hips and buttocks (since first dose) along with a headache; headache; This spontaneous case was reported by a consumer and describes the occurrence of RASH (a rash around hips and buttocks (since first dose) along with a headache) and HEADACHE (headache) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (a rash around hips and buttocks (since first dose) along with a headache) and HEADACHE (headache). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Adverse event, at an unspecified dose and frequency; PREDNISONE for Adverse event, at an unspecified dose and frequency; MENTHOL (GOLD BOND MEDICATED ORIGINAL STRENGTH BODY POWDER) for Adverse event, at an unspecified dose and frequency and PARAFFIN (MOISTURIZER) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH (a rash around hips and buttocks (since first dose) along with a headache) and HEADACHE (headache) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported.  Patient took second dose of Moderna COVID-19 Vaccine on 11-OCT-2021 in left arm (Lot number 040C21A).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: having a lot of itching since getting the Booster; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (having a lot of itching since getting the Booster) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (having a lot of itching since getting the Booster). At the time of the report, VACCINATION SITE PRURITUS (having a lot of itching since getting the Booster) outcome was unknown.            Concomitant medication was not reported. Treatment information was not reported.