chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of SYNCOPE (like I was going to faint), ILLNESS (Felt really sick), HOT FLUSH (Hot and cold flashes), PAIN (Aching) and HYPERHIDROSIS (Sweating) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 011L20A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2021, the patient experienced SYNCOPE (like I was going to faint), ILLNESS (Felt really sick), HOT FLUSH (Hot and cold flashes), PAIN (Aching), HYPERHIDROSIS (Sweating), FEELING ABNORMAL (It was awful), DIZZINESS (Very dizzy), PYREXIA (Had a little fever), CHILLS (Chills) and EXPIRED PRODUCT ADMINISTERED (Vaccine had expired or was left out of the fridge too long). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Incorrect product storage). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 15-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine had expired or was left out of the fridge too long) had resolved. On 16-Dec-2021, SYNCOPE (like I was going to faint), ILLNESS (Felt really sick), HOT FLUSH (Hot and cold flashes), PAIN (Aching), HYPERHIDROSIS (Sweating), FEELING ABNORMAL (It was awful), DIZZINESS (Very dizzy), PYREXIA (Had a little fever) and CHILLS (Chills) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Incorrect product storage) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Patient received the booster dose of the vaccine at 2:00 AM and by 4:30 AM she felt really sick, very dizzy, like she was going to faint, and she had a little fever.  She took ibuprofen for symptoms and they resolved within 24 hours.  Also after receiving the booster dose of the vaccine, she was told that the vaccine had been stored improperly prior to administration. She believed that the vaccine had expired or was left out of the refrigerator for longer than it was supposed to.   This case was linked to MOD-2022-448411 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chills, Weight increased
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Blood disorder NOS (Patient reported he was in hospital in April 2021 due to blood infection) in April 2021. Concurrent medical conditions included Acute leukemia. Concomitant products included gilteritinib from 14-Apr-2021 to an unknown date for Acute myeloblastic leukemia. On 26-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced CHILLS (Chills). In August 2021, CHILLS (Chills) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Blood test: abnormal (abnormal) Lab numbers are up and down- No concern. In November 2021, Weight increased: 230 (High) weight gain from 205 to 230 pounds. Patient reported antibiotic medication as treatment for cough and pneumonia. Patient reported that he got chills, eats too much, gained weight and his lab numbers were up and down, patient reported that he used blankets for chills and was eating less for gained weight. Patient was enrolled in local sponsored patient support program- Patient Assist Program. Patient was taking Xospata 80 mg once daily tablet for acute myeloblastic leukemia with lot no 1787120 with expiry date of 31 Mar 2024 and therapy start date was reported as 14 April 2021.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.  The vials were placed in refrigerator on 06-Dec-2021.   This case was linked to MOD-2022-449524 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Medication error was done by giving Moderna covid 19 booster as a transdermal injection; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Medication error was done by giving Moderna covid 19 booster as a transdermal injection) 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) (Transdermal) 1 dosage form. On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Medication error was done by giving Moderna covid 19 booster as a transdermal injection). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Medication error was done by giving Moderna covid 19 booster as a transdermal injection) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Transdermal), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were reported.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Given after being punctured for 28 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given after being punctured for 28 hours) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) 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 13-Jan-2022 at 2:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given after being punctured for 28 hours). On 13-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Given after being punctured for 28 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. It was reported that the vial was  initially punctured on 12JAN2022 at 8:55 AM and administered at 2:30 PM on 13JAN2022 and not reported any symptoms. Date on which the vial was initially stored in the refrigerator 10 Jan 2022 and the total amount of time the vial was exposed to room temperature range from  12JAN2022 8:55 AM to 13JAN2022 2:30 PM .
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Immunocompromised patient received booster dose instead of third dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Immunocompromised patient received booster dose instead of third dose.) 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) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Immunocompromised patient received booster dose instead of third dose.). At the time of the report, INCORRECT DOSE ADMINISTERED (Immunocompromised patient received booster dose instead of third dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were reported.  A patient got the first two shots of the Moderna vaccine. Later, patient received the Moderna booster shot. Two weeks AFTER the booster, the patient found out they are immunocompromised.  Company comment:  This case concerns a patient of an unknown age and gender who was Immunocompromised received the booster dose instead of the full dose of the vaccine. Reportedly, two weeks after vaccination with the booster dose, the patient found out that the patient was immunocompromised. The patient received the booster dose instead of full dose of the vaccine, which is considered to be Incorrect dose administered. No adverse events were reported. The company causality for this event is not applicable. Sender's Comments: This case concerns a patient of an unknown age and gender who was Immunocompromised received the booster dose instead of the full dose of the vaccine. Reportedly, two weeks after vaccination with the booster dose, the patient found out that the patient was immunocompromised. The patient received the booster dose instead of full dose of the vaccine, which is considered to be Incorrect dose administered. No adverse events were reported. The company causality for this event is not applicable.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea, Pyrexia
Clinical narrative: felling awful in general; severe nausea; she is not sure  if she has a fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felling awful in general), NAUSEA (severe nausea) and PYREXIA (she is not sure  if she has a fever) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson vaccine and Johnson vaccine. Past adverse reactions to the above products included No adverse event with Johnson vaccine and Johnson vaccine. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felling awful in general), NAUSEA (severe nausea) and PYREXIA (she is not sure  if she has a fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felling awful in general), NAUSEA (severe nausea) and PYREXIA (she is not sure  if she has a fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling jittery, Skin reaction
Clinical narrative: Localized skin reaction on neck/Approx.4x4 Inch in size extending from just above breasts to middle of neck; Feeling jittery, like she had drank too much caffiene; Marks were placed on neck to assess if redness was extending, which it did not; This spontaneous case was reported by an other health care professional and describes the occurrence of SKIN REACTION (Localized skin reaction on neck/Approx.4x4 Inch in size extending from just above breasts to middle of neck), FEELING JITTERY (Feeling jittery, like she had drank too much caffiene) and ERYTHEMA (Marks were placed on neck to assess if redness was extending, which it did not) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     Concurrent medical conditions included Egg allergy, Shellfish allergy and Asthma.    On 13-Jan-2022 at 2:45 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2022 at 3:05 AM, the patient experienced SKIN REACTION (Localized skin reaction on neck/Approx.4x4 Inch in size extending from just above breasts to middle of neck) and ERYTHEMA (Marks were placed on neck to assess if redness was extending, which it did not). 13-Jan-2022 at 3:05 AM, the patient experienced FEELING JITTERY (Feeling jittery, like she had drank too much caffiene). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) on 13-Jan-2022 for Localized skin reaction, at a dose of 50 mg. At the time of the report, SKIN REACTION (Localized skin reaction on neck/Approx.4x4 Inch in size extending from just above breasts to middle of neck), FEELING JITTERY (Feeling jittery, like she had drank too much caffiene) and ERYTHEMA (Marks were placed on neck to assess if redness was extending, which it did not) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient had Shingles after previous vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Tachycardia
Clinical narrative: Tachycardia/ Rapid heart rate; This spontaneous case was reported by a nurse and describes the occurrence of TACHYCARDIA (Tachycardia/ Rapid heart rate) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (Tachycardia/ Rapid heart rate). At the time of the report, TACHYCARDIA (Tachycardia/ Rapid heart rate) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) Rapid heart rate.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided by the reporter. No treatment information provided.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Peripheral swelling, Rash, Rash erythematous, Skin papilloma
Clinical narrative: a red  rash, that started on the injection area and is a constant rash; a rash all the way from her arm to her feet to behind her ears,like wards; arm swell; a red  rash, that started on the injection area and is a constant rash; got a sever allergic reaction; got a rash all the way from her  arm to her feet to behind her ears; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (a red  rash, that started on the injection area and is a constant rash), SKIN PAPILLOMA (a rash all the way from her arm to her feet to behind her ears,like wards), PERIPHERAL SWELLING (arm swell), VACCINATION SITE RASH (a red  rash, that started on the injection area and is a constant rash) and HYPERSENSITIVITY (got a sever allergic reaction) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced RASH ERYTHEMATOUS (a red  rash, that started on the injection area and is a constant rash), SKIN PAPILLOMA (a rash all the way from her arm to her feet to behind her ears,like wards), PERIPHERAL SWELLING (arm swell), VACCINATION SITE RASH (a red  rash, that started on the injection area and is a constant rash), HYPERSENSITIVITY (got a sever allergic reaction) and RASH (got a rash all the way from her  arm to her feet to behind her ears). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 07-Jan-2022, PERIPHERAL SWELLING (arm swell) had resolved. At the time of the report, RASH ERYTHEMATOUS (a red  rash, that started on the injection area and is a constant rash) and VACCINATION SITE RASH (a red  rash, that started on the injection area and is a constant rash) had not resolved and SKIN PAPILLOMA (a rash all the way from her arm to her feet to behind her ears,like wards), HYPERSENSITIVITY (got a sever allergic reaction) and RASH (got a rash all the way from her  arm to her feet to behind her ears) outcome was unknown.            No concomitant medications were reported. Patient was prescribed Steroids, and also to the dermatologist that told them not to take steroids but antibacterial cream and Benadryl, and read that the CDC recommend the EpiPen, and wants to know what could be done.   Reporter did not allow further contact
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: a red  rash, that started on the injection area and is a constant rash; a rash all the way from her arm to her feet to behind her ears,like wards; arm swell; a red  rash, that started on the injection area and is a constant rash; got a sever allergic reaction; got a rash all the way from her  arm to her feet to behind her ears; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (a red  rash, that started on the injection area and is a constant rash), SKIN PAPILLOMA (a rash all the way from her arm to her feet to behind her ears,like wards), PERIPHERAL SWELLING (arm swell), VACCINATION SITE RASH (a red  rash, that started on the injection area and is a constant rash) and HYPERSENSITIVITY (got a sever allergic reaction) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced RASH ERYTHEMATOUS (a red  rash, that started on the injection area and is a constant rash), SKIN PAPILLOMA (a rash all the way from her arm to her feet to behind her ears,like wards), PERIPHERAL SWELLING (arm swell), VACCINATION SITE RASH (a red  rash, that started on the injection area and is a constant rash), HYPERSENSITIVITY (got a sever allergic reaction) and RASH (got a rash all the way from her  arm to her feet to behind her ears). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 07-Jan-2022, PERIPHERAL SWELLING (arm swell) had resolved. At the time of the report, RASH ERYTHEMATOUS (a red  rash, that started on the injection area and is a constant rash) and VACCINATION SITE RASH (a red  rash, that started on the injection area and is a constant rash) had not resolved and SKIN PAPILLOMA (a rash all the way from her arm to her feet to behind her ears,like wards), HYPERSENSITIVITY (got a sever allergic reaction) and RASH (got a rash all the way from her  arm to her feet to behind her ears) outcome was unknown.            No concomitant medications were reported. Patient was prescribed Steroids, and also to the dermatologist that told them not to take steroids but antibacterial cream and Benadryl, and read that the CDC recommend the EpiPen, and wants to know what could be done.   Reporter did not allow further contact
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to animal, Lacrimation increased, Pruritus, Seasonal allergy
Clinical narrative: Allergic to fur of the Cat hair/allergic to Cat hair; Feels like Hay fever; Watery eye; Itching; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO ANIMAL (Allergic to fur of the Cat hair/allergic to Cat hair), SEASONAL ALLERGY (Feels like Hay fever), LACRIMATION INCREASED (Watery eye) and PRURITUS (Itching) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO ANIMAL (Allergic to fur of the Cat hair/allergic to Cat hair), SEASONAL ALLERGY (Feels like Hay fever), LACRIMATION INCREASED (Watery eye) and PRURITUS (Itching). At the time of the report, ALLERGY TO ANIMAL (Allergic to fur of the Cat hair/allergic to Cat hair), SEASONAL ALLERGY (Feels like Hay fever), LACRIMATION INCREASED (Watery eye) and PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. It was reported that the patient had an unusual side effect after completing primary series of vaccine of Moderna COVID-19 Vaccine. It was mentioned that the patient had never had any sort of complication in the past medically nor with pets. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route of administration). No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose, Expired product administered, Product storage error
Clinical narrative: Vaccine that was left at room temperature following punctuation for 26 hours; Vaccine that was left at room temperature following punctuation for 26 hours; Was dosed with 100ug for a booster instead of 50ug; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that was left at room temperature following punctuation for 26 hours), ACCIDENTAL OVERDOSE (Was dosed with 100ug for a booster instead of 50ug) and PRODUCT STORAGE ERROR (Vaccine that was left at room temperature following punctuation for 26 hours) 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 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 100 microgram. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that was left at room temperature following punctuation for 26 hours) and ACCIDENTAL OVERDOSE (Was dosed with 100ug for a booster instead of 50ug). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine that was left at room temperature following punctuation for 26 hours). On 01-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine that was left at room temperature following punctuation for 26 hours), ACCIDENTAL OVERDOSE (Was dosed with 100ug for a booster instead of 50ug) and PRODUCT STORAGE ERROR (Vaccine that was left at room temperature following punctuation for 26 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine-like headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine-like headache) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson and Johnson COVID-19 vaccine (2nd dose) and Johnson and Johnson COVID-19 vaccine (1st dose). Past adverse reactions to the above products included No adverse event with Johnson and Johnson COVID-19 vaccine and Johnson and Johnson COVID-19 vaccine.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced MIGRAINE (Migraine-like headache). On 10-Jan-2022, MIGRAINE (Migraine-like headache) had resolved.            Concomitant and treatment medication was not reported.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Inappropriate schedule of product administration, Nausea
Clinical narrative: Feel weak; Dizziness; Sharp joint pain when moving hand; Nausea; First dose on 18 Nov 2021 and second dose on 13 Jan 2022; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feel weak), DIZZINESS (Dizziness), ARTHRALGIA (Sharp joint pain when moving hand), NAUSEA (Nausea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18 Nov 2021 and second dose on 13 Jan 2022) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2022, the patient experienced ASTHENIA (Feel weak), DIZZINESS (Dizziness), ARTHRALGIA (Sharp joint pain when moving hand), NAUSEA (Nausea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18 Nov 2021 and second dose on 13 Jan 2022). On 13-Jan-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18 Nov 2021 and second dose on 13 Jan 2022) had resolved. At the time of the report, ASTHENIA (Feel weak), DIZZINESS (Dizziness), ARTHRALGIA (Sharp joint pain when moving hand) and NAUSEA (Nausea) outcome was unknown.            No concomitant medications reported.  No treatment information was provided.  An hour after the second vaccination, patient started experiencing the adverse events.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.  Patient did not report side effects, so far.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received expired Moderna COVID-19 vaccine for their booster dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired Moderna COVID-19 vaccine for their booster dose.) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired Moderna COVID-19 vaccine for their booster dose.). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (received expired Moderna COVID-19 vaccine for their booster dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient received expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days. No concomitant medications were reported. No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Exposure to SARS-CoV-2, Nasopharyngitis, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Cold like symptoms; runny nose; scratchy throat; cough that is on and off; close contact with someone who tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold like symptoms), RHINORRHOEA (runny nose), THROAT IRRITATION (scratchy throat), COUGH (cough that is on and off) and EXPOSURE TO SARS-COV-2 (close contact with someone who tested positive for COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-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 NASOPHARYNGITIS (Cold like symptoms), RHINORRHOEA (runny nose), THROAT IRRITATION (scratchy throat), COUGH (cough that is on and off) and EXPOSURE TO SARS-COV-2 (close contact with someone who tested positive for COVID-19). At the time of the report, NASOPHARYNGITIS (Cold like symptoms), RHINORRHOEA (runny nose), THROAT IRRITATION (scratchy throat) and COUGH (cough that is on and off) had not resolved and EXPOSURE TO SARS-COV-2 (close contact with someone who tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: results pending Results pending.         No concomitant medication was provided by the reporter.  No treatment information was provided.  Patient would like to know if he should go ahead to receive the booster shot tomorrow.
Sex: M
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Cold like symptoms; runny nose; scratchy throat; cough that is on and off; close contact with someone who tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold like symptoms), RHINORRHOEA (runny nose), THROAT IRRITATION (scratchy throat), COUGH (cough that is on and off) and EXPOSURE TO SARS-COV-2 (close contact with someone who tested positive for COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-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 NASOPHARYNGITIS (Cold like symptoms), RHINORRHOEA (runny nose), THROAT IRRITATION (scratchy throat), COUGH (cough that is on and off) and EXPOSURE TO SARS-COV-2 (close contact with someone who tested positive for COVID-19). At the time of the report, NASOPHARYNGITIS (Cold like symptoms), RHINORRHOEA (runny nose), THROAT IRRITATION (scratchy throat) and COUGH (cough that is on and off) had not resolved and EXPOSURE TO SARS-COV-2 (close contact with someone who tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: results pending Results pending.         No concomitant medication was provided by the reporter.  No treatment information was provided.  Patient would like to know if he should go ahead to receive the booster shot tomorrow.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Malaise
Clinical narrative: Now it is the next evening and I feel somewhat better but have developed a little cough; By evening I was not feeling well at all; This spontaneous case was reported by an other health care professional and describes the occurrence of COUGH (Now it is the next evening and I feel somewhat better but have developed a little cough) and MALAISE (By evening I was not feeling well at all) 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 12-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2022, the patient experienced MALAISE (By evening I was not feeling well at all). On 13-Jan-2022, the patient experienced COUGH (Now it is the next evening and I feel somewhat better but have developed a little cough). At the time of the report, COUGH (Now it is the next evening and I feel somewhat better but have developed a little cough) outcome was unknown and MALAISE (By evening I was not feeling well at all) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 12.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: injected the Moderna full dose to a child who is 12 years old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (injected the Moderna full dose to a child who is 12 years old) in a 12-year-old patient of an unknown 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (injected the Moderna full dose to a child who is 12 years old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (injected the Moderna full dose to a child who is 12 years old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Epistaxis, Head discomfort, Headache
Clinical narrative: Upset stomach; he feels like he wants to throw up; Sense of pressure in the head; Body aches; Feeling dizzy; Light nose bleeds/he would smell his own blood, sneezes, and blood would come out; Headache; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Light nose bleeds/he would smell his own blood, sneezes, and blood would come out), ABDOMINAL DISCOMFORT (Upset stomach; he feels like he wants to throw up), HEAD DISCOMFORT (Sense of pressure in the head), DIZZINESS (Feeling dizzy) and MYALGIA (Body aches) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Jan-2022, 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. On 12-Jan-2022, the patient experienced HEADACHE (Headache). On 13-Jan-2022, the patient experienced EPISTAXIS (Light nose bleeds/he would smell his own blood, sneezes, and blood would come out) and DIZZINESS (Feeling dizzy). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach; he feels like he wants to throw up), HEAD DISCOMFORT (Sense of pressure in the head) and MYALGIA (Body aches). At the time of the report, EPISTAXIS (Light nose bleeds/he would smell his own blood, sneezes, and blood would come out), ABDOMINAL DISCOMFORT (Upset stomach; he feels like he wants to throw up), HEAD DISCOMFORT (Sense of pressure in the head), DIZZINESS (Feeling dizzy), MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. On 12-Jan-2021, the patient had a headache all day yesterday. This was an expected side effect, so the patient was not so concerned. But the patient woke up todayon 13-Jan-2022 and started having light nose bleeds and had been feeling dizzy. The patient would smell his own blood, sneezes, and blood would come out. The patient was also experiencing upset stomach; feels like wants to throw up, body aches, and a sense of pressure in the head. Treatment medications were not reported.   This case was linked to MOD-2022-451004 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Upset stomach; he feels like he wants to throw up; Sense of pressure in the head; Body aches; Feeling dizzy; Light nose bleeds/he would smell his own blood, sneezes, and blood would come out; Headache; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Light nose bleeds/he would smell his own blood, sneezes, and blood would come out), ABDOMINAL DISCOMFORT (Upset stomach; he feels like he wants to throw up), HEAD DISCOMFORT (Sense of pressure in the head), DIZZINESS (Feeling dizzy) and MYALGIA (Body aches) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Jan-2022, 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. On 12-Jan-2022, the patient experienced HEADACHE (Headache). On 13-Jan-2022, the patient experienced EPISTAXIS (Light nose bleeds/he would smell his own blood, sneezes, and blood would come out) and DIZZINESS (Feeling dizzy). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach; he feels like he wants to throw up), HEAD DISCOMFORT (Sense of pressure in the head) and MYALGIA (Body aches). At the time of the report, EPISTAXIS (Light nose bleeds/he would smell his own blood, sneezes, and blood would come out), ABDOMINAL DISCOMFORT (Upset stomach; he feels like he wants to throw up), HEAD DISCOMFORT (Sense of pressure in the head), DIZZINESS (Feeling dizzy), MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. On 12-Jan-2021, the patient had a headache all day yesterday. This was an expected side effect, so the patient was not so concerned. But the patient woke up todayon 13-Jan-2022 and started having light nose bleeds and had been feeling dizzy. The patient would smell his own blood, sneezes, and blood would come out. The patient was also experiencing upset stomach; feels like wants to throw up, body aches, and a sense of pressure in the head. Treatment medications were not reported.   This case was linked to MOD-2022-451004 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Illness
Clinical narrative: Got very sick after my second vaccine shot; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (Got very sick after my second vaccine 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 Cancer.    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, the patient experienced ILLNESS (Got very sick after my second vaccine shot). At the time of the report, ILLNESS (Got very sick after my second vaccine shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: got no antibodies Got no antibodies.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.  Patient reported that, the patient got very sick after second vaccine shot and got no antibodies.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included METFORMIN for Type 2 diabetes mellitus, PRAVASTATIN and HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HYDROCHLOROTHIAZIDE) for an unknown indication.   On 11-Jan-2022, 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. On an unknown date, the patient experienced RASH (Rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Rash) had not resolved.            Patient stated they have stopped taking their daily medicine due to the rash.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination complication
Clinical narrative: adverse event after my booster; really bad hives/aren't seeming to go away; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (really bad hives/aren't seeming to go away) and VACCINATION COMPLICATION (adverse event after my booster) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 93967G and 011D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, the patient experienced URTICARIA (really bad hives/aren't seeming to go away). On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse event after my booster). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and HYDROXYZINE HCL for Adverse event, at a dose of 25 mg. At the time of the report, URTICARIA (really bad hives/aren't seeming to go away) had not resolved and VACCINATION COMPLICATION (adverse event after my booster) outcome was unknown.            No concomitant medication reported. No treatment information was provided
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: patient received a half dose, but she should have received a full dose because she is immunocompromised; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (patient received a half dose, but she should have received a full dose because she is immunocompromised) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (patient received a half dose, but she should have received a full dose because she is immunocompromised). At the time of the report, ACCIDENTAL UNDERDOSE (patient received a half dose, but she should have received a full dose because she is immunocompromised) had resolved.        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: U
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pyrexia
Clinical narrative: After 2nd dose was sick for 10 days with temp as high as 104.3; extremely nauseous/So nauseous; This spontaneous case was reported by a pharmacist and describes the occurrence of NAUSEA (extremely nauseous/So nauseous) and PYREXIA (After 2nd dose was sick for 10 days with temp as high as 104.3) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2022, the patient experienced NAUSEA (extremely nauseous/So nauseous). On an unknown date, the patient experienced PYREXIA (After 2nd dose was sick for 10 days with temp as high as 104.3). At the time of the report, NAUSEA (extremely nauseous/So nauseous) outcome was unknown and PYREXIA (After 2nd dose was sick for 10 days with temp as high as 104.3) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104.3 (High) 104.3.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.   Reporter did not allow further contact