chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Sitting disability
Clinical narrative: not been able to sleep; not been able to stand up; sitting up was hard; COVID/upper congestion/coughing/sitting up was hard/severe ill with COVID/he couldn't stand up and it took him 4 days to get off the bed; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Lack of drug effect), INSOMNIA (not been able to sleep), COVID-19 (COVID/upper congestion/coughing/sitting up was hard/severe ill with COVID/he couldn't stand up and it took him 4 days to get off the bed), DYSSTASIA (not been able to stand up) and SITTING DISABILITY (sitting up was hard) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031a21a and 027b21) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jul-2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (COVID/upper congestion/coughing/sitting up was hard/severe ill with COVID/he couldn't stand up and it took him 4 days to get off the bed). On an unknown date, the patient experienced INSOMNIA (not been able to sleep), DYSSTASIA (not been able to stand up) and SITTING DISABILITY (sitting up was hard). At the time of the report, DRUG INEFFECTIVE (Lack of drug effect), INSOMNIA (not been able to sleep), COVID-19 (COVID/upper congestion/coughing/sitting up was hard/severe ill with COVID/he couldn't stand up and it took him 4 days to get off the bed), DYSSTASIA (not been able to stand up) and SITTING DISABILITY (sitting up was hard) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2022, SARS-CoV-2 test positive: positive (Positive) positive.         No concomitant medication was reported.  No treatment medication was reported.  It was reported patient was good except for the upper congestion that won't go away.  Company Comment: This case refers to a 66-year-old male patient with no known medical history who experienced the unexpected events of Drug ineffective and COVID-19 approximately 3 months after the second dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case refers to a 66-year-old male patient with no known medical history who experienced the unexpected events of Drug ineffective and COVID-19 approximately 3 months after the second dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Having pain on the right side of my torso (by Brest); My arm hurts; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Having pain on the right side of my torso (by Brest)) and PAIN IN EXTREMITY (My arm hurts) 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 PAIN (Having pain on the right side of my torso (by Brest)) and PAIN IN EXTREMITY (My arm hurts). At the time of the report, PAIN (Having pain on the right side of my torso (by Brest)) outcome was unknown and PAIN IN EXTREMITY (My arm hurts) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.   It was reported that the patient arm hurts too but not bad after two days.  Treatment information not provided.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised and didn't get the full 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 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised and didn't get the full third dose). On 28-Dec-2021, ACCIDENTAL UNDERDOSE (immunocompromised and didn't get the full third dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant and treatment medications were not provided. Patient received the half dose booster on 28-Dec-2021 after receiving the first two primary series. Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Muscle spasms, Pain, Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (She began having pain & soreness then a rash that a chiropractor told her was shingles. She broke out on right side on her front just under breastbone & it wrapped around to her back), MUSCLE SPASMS (She was having spasms just like when she was pregnant with her son, & he would kick), PAIN (She began having pain & soreness then a rash that a chiropractor told her was shingles) and RASH (She began having pain & soreness then a rash that a chiropractor told her was shingles) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Epidermolysis bullosa (she has a history of a rare skin condition called epidermolysis bullosa that causes skin blistering), Fibromyalgia, Chronic fatigue and Diabetes mellitus insulin-dependent (Patient uses insulin). Concomitant products included INSULIN for Diabetes mellitus, SILVER (COLLOIDAL SILVER), LINUM USITATISSIMUM OIL (FLAXSEED OIL [LINUM USITATISSIMUM OIL]) and VITAMINS NOS for an unknown indication. On 23-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced HERPES ZOSTER (She began having pain & soreness then a rash that a chiropractor told her was shingles/She broke out on right side on her front just under breastbone & it wrapped around to her back). In January 2022, the patient experienced MUSCLE SPASMS (She was having spasms just like when she was pregnant with her son, & he would kick), PAIN (She began having pain & soreness then a rash that a chiropractor told her was shingles) and RASH (She began having pain & soreness then a rash that a chiropractor told her was shingles). At the time of the report, HERPES ZOSTER (She began having pain & soreness then a rash that a chiropractor told her was shingles/She broke out on right side on her front just under breastbone & it wrapped around to her back), MUSCLE SPASMS (She was having spasms just like when she was pregnant with her son, & he would kick), PAIN (She began having pain & soreness then a rash that a chiropractor told her was shingles) and RASH (She began having pain & soreness then a rash that a chiropractor told her was shingles) outcome was unknown. 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. Other concomitant medications included herbs. No treatment information was provided. The patient stated that 15 days after 1st dose she experienced the events. She broke out on her right side on her front just under breastbone & it wrapped around to her back.  She thought it was a gall bladder attack or that she had a rib out.  She was having spasms just like when she was pregnant with her son, & he would kick.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Maternal exposure during pregnancy, Palpitations
Clinical narrative: Chest pains; Trouble breathing; Heart keeps racing; Pregnant; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of CHEST PAIN (Chest pains), DYSPNOEA (Trouble breathing), PALPITATIONS (Heart keeps racing) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced CHEST PAIN (Chest pains), DYSPNOEA (Trouble breathing), PALPITATIONS (Heart keeps racing) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, CHEST PAIN (Chest pains), DYSPNOEA (Trouble breathing) and PALPITATIONS (Heart keeps racing) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication and treatment information was not reported by the reporter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Illness, Movement disorder, Pain
Clinical narrative: could not move; had aches and pains; felt so very cold; pinkish red rash on their torso that cleared up yesterday; Sick; splitting headache; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (could not move), PAIN (had aches and pains), FEELING COLD (felt so very cold), RASH ERYTHEMATOUS (pinkish red rash on their torso that cleared up yesterday) and ILLNESS (Sick) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 044B21A and 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and Cholesterol. Concomitant products included ENALAPRIL for Blood pressure high, ATORVASTATIN for Cholesterol, ERGOCALCIFEROL (VITAMIN D2), ACETYLSALICYLIC ACID (BABY ASPIRIN) and VITAMINS NOS for an unknown indication.   On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced MOVEMENT DISORDER (could not move), PAIN (had aches and pains), FEELING COLD (felt so very cold), RASH ERYTHEMATOUS (pinkish red rash on their torso that cleared up yesterday), ILLNESS (Sick) and HEADACHE (splitting headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Headache and Pain, at an unspecified dose and frequency. In January 2022, MOVEMENT DISORDER (could not move), PAIN (had aches and pains), FEELING COLD (felt so very cold), RASH ERYTHEMATOUS (pinkish red rash on their torso that cleared up yesterday), ILLNESS (Sick) and HEADACHE (splitting headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   After the booster they were sick with side effects for 2.5 days.   This case was linked to MOD-2022-453539, MOD-2022-453520 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: could not move; had aches and pains; felt so very cold; pinkish red rash on their torso that cleared up yesterday; Sick; splitting headache; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (could not move), PAIN (had aches and pains), FEELING COLD (felt so very cold), RASH ERYTHEMATOUS (pinkish red rash on their torso that cleared up yesterday) and ILLNESS (Sick) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 044B21A and 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and Cholesterol. Concomitant products included ENALAPRIL for Blood pressure high, ATORVASTATIN for Cholesterol, ERGOCALCIFEROL (VITAMIN D2), ACETYLSALICYLIC ACID (BABY ASPIRIN) and VITAMINS NOS for an unknown indication.   On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced MOVEMENT DISORDER (could not move), PAIN (had aches and pains), FEELING COLD (felt so very cold), RASH ERYTHEMATOUS (pinkish red rash on their torso that cleared up yesterday), ILLNESS (Sick) and HEADACHE (splitting headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Headache and Pain, at an unspecified dose and frequency. In January 2022, MOVEMENT DISORDER (could not move), PAIN (had aches and pains), FEELING COLD (felt so very cold), RASH ERYTHEMATOUS (pinkish red rash on their torso that cleared up yesterday), ILLNESS (Sick) and HEADACHE (splitting headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   After the booster they were sick with side effects for 2.5 days.   This case was linked to MOD-2022-453539, MOD-2022-453520 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Normal stuff that everyone else had; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Normal stuff that everyone else had) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 immunisation.     Concurrent medical conditions included Allergy to vaccine (flu vaccine).    On 13-Oct-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 VACCINATION COMPLICATION (Normal stuff that everyone else had). At the time of the report, VACCINATION COMPLICATION (Normal stuff that everyone else had) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   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.   This case was linked to MOD-2022-453811 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Hypersensitivity, Rash macular, Throat tightness
Clinical narrative: Problems swallowing; Throat started feeling like it was starting to close up; Red blotches on both upper arms; allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Problems swallowing), THROAT TIGHTNESS (Throat started feeling like it was starting to close up), RASH MACULAR (Red blotches on both upper arms) and HYPERSENSITIVITY (allergic reaction) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A and 003C21A) for COVID-19 immunisation.     Concurrent medical conditions included Allergy to vaccine (Every flu vaccine).   On 13-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, the patient experienced HYPERSENSITIVITY (allergic reaction). On an unknown date, the patient experienced DYSPHAGIA (Problems swallowing), THROAT TIGHTNESS (Throat started feeling like it was starting to close up) and RASH MACULAR (Red blotches on both upper arms). The patient was treated with CORTISONE for Allergic reaction, at a dose of unknown. At the time of the report, DYSPHAGIA (Problems swallowing), THROAT TIGHTNESS (Throat started feeling like it was starting to close up), RASH MACULAR (Red blotches on both upper arms) and HYPERSENSITIVITY (allergic reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   During emergency room visit they gave her prescription for some kind of steroid for 5 days. No concomitant medication information was provided.   This case was linked to MOD-2022-453776 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: Pain; Massive headache; Low grade fever; Nausea; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN (Pain), HEADACHE (Massive headache), PYREXIA (Low grade fever) and NAUSEA (Nausea) 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 14-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced PAIN (Pain), HEADACHE (Massive headache), PYREXIA (Low grade fever) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN (Pain), HEADACHE (Massive headache), PYREXIA (Low grade fever) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Product dose omission issue, Vaccination site pain
Clinical narrative: pain at the injection site; More than 35 days between Covid-19 vaccinations; dizzy spell which passed after a day; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy spell which passed after a day), VACCINATION SITE PAIN (pain at the injection site) and PRODUCT DOSE OMISSION ISSUE (More than 35 days between Covid-19 vaccinations) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Oct-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizzy spell which passed after a day), VACCINATION SITE PAIN (pain at the injection site) and PRODUCT DOSE OMISSION ISSUE (More than 35 days between Covid-19 vaccinations). At the time of the report, DIZZINESS (dizzy spell which passed after a day) and PRODUCT DOSE OMISSION ISSUE (More than 35 days between Covid-19 vaccinations) had resolved and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.        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 information was provided.  No treatment medication were provided.  Patient did not go back to receive her second Moderna Covid-19 vaccine from her Physician.  Reporter asked whether patient can receive her second Moderna covid-19 vaccine 3 months after receiving her first Moderna Covid-19 vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jan-2022: Non-significant follow up contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Palpitations
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations) and CHEST DISCOMFORT (fluttering in the chest) 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. In June 2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (heart palpitations) and CHEST DISCOMFORT (fluttering in the chest). At the time of the report, PALPITATIONS (heart palpitations) and CHEST DISCOMFORT (fluttering in the chest) had resolved. Concomitant medications were not reported. Treatment medications were not reported. These symptoms were on and off and they had lasted for the last two months. These symptoms appear after she drinks caffeine.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: minor skin eruption; This spontaneous case was reported by a consumer and describes the occurrence of RASH (minor skin eruption) 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 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 RASH (minor skin eruption). At the time of the report, RASH (minor skin eruption) outcome was unknown.            No Treatment medications were provided No  Concomitant medications were provided  Patient reported he broke out with minor skin eruption. He visited a medical doctor and a dermatologist, and was prescribed an antihistamine and a steroid pack The symptoms were starting to resolve after taking an antihistamine (either Zyrtec or Claritin)   This case was linked to MOD-2022-454183, MOD-2022-455291 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Big red circle on injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Big red circle on injection site) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2022, the patient experienced VACCINATION SITE ERYTHEMA (Big red circle on injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Big red circle on injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I am having some mild side effects from my booster yesterday; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (I am having some mild side effects from my booster yesterday) 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 18-Jan-2022, the patient experienced VACCINATION COMPLICATION (I am having some mild side effects from my booster yesterday). At the time of the report, VACCINATION COMPLICATION (I am having some mild side effects from my booster yesterday) outcome was unknown.        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 provided.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Muscle spasms, Neck pain, Product dose omission issue
Clinical narrative: it turned into pain at the base of his neck down into his spine; hasn't been able to work because of this; has not gotten 2nd dose; had a cramp in his neck; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (had a cramp in his neck), NECK PAIN (it turned into pain at the base of his neck down into his spine), IMPAIRED WORK ABILITY (hasn't been able to work because of this) and PRODUCT DOSE OMISSION ISSUE (has not gotten 2nd dose) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Oct-2021, the patient experienced MUSCLE SPASMS (had a cramp in his neck). On an unknown date, the patient experienced NECK PAIN (it turned into pain at the base of his neck down into his spine), IMPAIRED WORK ABILITY (hasn't been able to work because of this) and PRODUCT DOSE OMISSION ISSUE (has not gotten 2nd dose). The patient was treated with Physical therapy (physical therapy) for Neck pain. At the time of the report, MUSCLE SPASMS (had a cramp in his neck), NECK PAIN (it turned into pain at the base of his neck down into his spine) and IMPAIRED WORK ABILITY (hasn't been able to work because of this) had not resolved and PRODUCT DOSE OMISSION ISSUE (has not gotten 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided.  Patient had not received the 2nd dose. The day after getting the dose he thought he slept wrong and he had a cramp in his neck, and thought it would go away but it continued, so he saw his doctor who said it should go away, but it didn't, and it turned into pain at the base of his neck down into his spine. Patient was now doing physical therapy & would be getting an MRI.   No treatment medication were given.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: injection site itched after every shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site itched after every shot) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A, 023M20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE BESYLATE for Blood pressure high, FAMOTIDINE, TIMOLOL MALEATE (TIMOPTIC), BIMATOPROST (LUMIGAN) and PRAVASTATIN for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced VACCINATION SITE PRURITUS (injection site itched after every shot). In November 2021, VACCINATION SITE PRURITUS (injection site itched after every shot) had resolved.            Treatment medications were not provided.  It was reported that patient had event on the day of vaccination or next day which lasted for 10 days or 2 weeks.   This case was linked to MOD-2022-454488, MOD-2022-454465 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Vaccination complication
Clinical narrative: Patient was still sick; Had a bad reaction to the booster; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Patient was still sick) and VACCINATION COMPLICATION (Had a bad reaction to the booster) in a 62-year-old female patient 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 ILLNESS (Patient was still sick) and VACCINATION COMPLICATION (Had a bad reaction to the booster). At the time of the report, ILLNESS (Patient was still sick) had not resolved and VACCINATION COMPLICATION (Had a bad reaction to the booster) outcome was unknown.            No concomitant and treatment medications were reported. Patient had a bad reaction to the booster it had been 19 days and was still sick.   This case was linked to MOD-2021-435816, MOD-2021-435845 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Urticaria
Clinical narrative: experienced similar welts/hives; burning sensations a couple of weeks after the booster/still experiences burning; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (experienced similar welts/hives) and BURNING SENSATION (burning sensations a couple of weeks after the booster/still experiences burning) 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 URTICARIA (experienced similar welts/hives) and BURNING SENSATION (burning sensations a couple of weeks after the booster/still experiences burning). At the time of the report, URTICARIA (experienced similar welts/hives) outcome was unknown and BURNING SENSATION (burning sensations a couple of weeks after the booster/still experiences burning) was resolving.            No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.  Patient still experiences burning, but not as bad.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Vaccination complication
Clinical narrative: Side effects from the second dose were LESS severe than expected (no fever); The pain more or less subsided within 36 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Side effects from the second dose were LESS severe than expected (no fever)) and PAIN (The pain more or less subsided within 36 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 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 VACCINATION COMPLICATION (Side effects from the second dose were LESS severe than expected (no fever)) and PAIN (The pain more or less subsided within 36 hours). At the time of the report, VACCINATION COMPLICATION (Side effects from the second dose were LESS severe than expected (no fever)) outcome was unknown and PAIN (The pain more or less subsided within 36 hours) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported. It was reported that the pain was more or less subsided within 36 hours.   Reporter did not allow further contact
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) and PYREXIA (Fever) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047b11a and 046a21a) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included GABAPENTIN for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced MYALGIA (body aches) and PYREXIA (Fever). At the time of the report, MYALGIA (body aches) and PYREXIA (Fever) outcome was unknown.            Treatment information was unknown.   This case was linked to MOD-2022-454610 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (just felt a little tired and achy) and FATIGUE (just felt a little tired and achy) 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 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-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 PAIN (just felt a little tired and achy) and FATIGUE (just felt a little tired and achy). At the time of the report, PAIN (just felt a little tired and achy) and FATIGUE (just felt a little tired and achy) outcome was unknown. No concomitant medications were reported. No treatment medications were reported. Patient had no fever. This case was linked to MOD-2022-454620, MOD-2022-451926 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itchiness on her body; rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness on her body) and RASH (rash) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059h21a) for COVID-19 vaccination.     Concomitant products included GABAPENTIN for an unknown indication.    On 06-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 PRURITUS (itchiness on her body) and RASH (rash). The patient was treated with CALAMINE for Adverse event, at an unspecified dose and frequency; LORATADINE (CLARITIN [LORATADINE]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (itchiness on her body) and RASH (rash) was resolving.            It was reported that after 3 days Calamine, Claritin, Benadryl which didn't helped.   This case was linked to MOD-2022-454578 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Feeling abnormal, Nausea, Pain
Clinical narrative: aches; felt very bad; diarrhea; fever; vomiting; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), FEELING ABNORMAL (felt very bad), DIARRHOEA (diarrhea), PYREXIA (fever) and VOMITING (vomiting) in a patient of an unknown age and gender 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 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (aches), FEELING ABNORMAL (felt very bad), DIARRHOEA (diarrhea), PYREXIA (fever), VOMITING (vomiting) and NAUSEA (nausea). At the time of the report, PAIN (aches), FEELING ABNORMAL (felt very bad), DIARRHOEA (diarrhea), PYREXIA (fever), VOMITING (vomiting) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) 103.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were not reported.   This case was linked to MOD-2022-454606, MOD-2022-451926 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: aches; felt very bad; diarrhea; fever; vomiting; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), FEELING ABNORMAL (felt very bad), DIARRHOEA (diarrhea), PYREXIA (fever) and VOMITING (vomiting) in a patient of an unknown age and gender 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 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (aches), FEELING ABNORMAL (felt very bad), DIARRHOEA (diarrhea), PYREXIA (fever), VOMITING (vomiting) and NAUSEA (nausea). At the time of the report, PAIN (aches), FEELING ABNORMAL (felt very bad), DIARRHOEA (diarrhea), PYREXIA (fever), VOMITING (vomiting) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) 103.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were not reported.   This case was linked to MOD-2022-454606, MOD-2022-451926 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: A patient said she had a reaction following vaccination; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (A patient said she had a reaction following vaccination) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (A patient said she had a reaction following vaccination). At the time of the report, VACCINATION COMPLICATION (A patient said she had a reaction following vaccination) outcome was unknown.        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 product use was reported.  The patient stated that they had a reaction following vaccination and the patient mentioned to the HCP that they had already reported it to the manufacturer.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jan-2022: Follow-up received and contains no new information.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Paraesthesia, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Felt tingling going through her neck), PYREXIA (Fever) and CHILLS (Chills) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. No Medical History information was reported. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On an unknown date, the patient experienced PARAESTHESIA (Felt tingling going through her neck). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Felt tingling going through her neck) outcome was unknown and PYREXIA (Fever) and CHILLS (Chills) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. This case was linked to MOD-2022-454758, MOD-2022-454759 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Dyspepsia, Lymphadenopathy, Oxygen saturation
Clinical narrative: Heartburn, initially mild but became worse and annoying; Lymph nodes under both his arms but notable on the left arm where the injection was given; Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Heartburn, initially mild but became worse and annoying), VACCINATION SITE LYMPHADENOPATHY (Lymph nodes under both his arms but notable on the left arm where the injection was given) and LYMPHADENOPATHY (Swollen lymph nodes) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 022C21A and 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-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 DYSPEPSIA (Heartburn, initially mild but became worse and annoying), VACCINATION SITE LYMPHADENOPATHY (Lymph nodes under both his arms but notable on the left arm where the injection was given) and LYMPHADENOPATHY (Swollen lymph nodes). The patient was treated with OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPEPSIA (Heartburn, initially mild but became worse and annoying), VACCINATION SITE LYMPHADENOPATHY (Lymph nodes under both his arms but notable on the left arm where the injection was given) and LYMPHADENOPATHY (Swollen lymph nodes) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) Normal. On an unknown date, Body temperature: normal (normal) Normal. On an unknown date, Oxygen saturation: normal (normal) NORMAL.         Concomitant medications were not reported.  A after receiving the booster dose, patient experienced heartburn which initially started as mild and patient did not give much attention. But it gets worsened and more annoying 4 to 5 days ago. Patient reported that it is still coming and ongoing. Patient also had a swollen lymph node under both his arm and he describes it like the size of half of plum and filled with fluid.  Treatment medications also include antacids.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: Heartburn, initially mild but became worse and annoying; Lymph nodes under both his arms but notable on the left arm where the injection was given; Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Heartburn, initially mild but became worse and annoying), VACCINATION SITE LYMPHADENOPATHY (Lymph nodes under both his arms but notable on the left arm where the injection was given) and LYMPHADENOPATHY (Swollen lymph nodes) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 022C21A and 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-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 DYSPEPSIA (Heartburn, initially mild but became worse and annoying), VACCINATION SITE LYMPHADENOPATHY (Lymph nodes under both his arms but notable on the left arm where the injection was given) and LYMPHADENOPATHY (Swollen lymph nodes). The patient was treated with OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPEPSIA (Heartburn, initially mild but became worse and annoying), VACCINATION SITE LYMPHADENOPATHY (Lymph nodes under both his arms but notable on the left arm where the injection was given) and LYMPHADENOPATHY (Swollen lymph nodes) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) Normal. On an unknown date, Body temperature: normal (normal) Normal. On an unknown date, Oxygen saturation: normal (normal) NORMAL.         Concomitant medications were not reported.  A after receiving the booster dose, patient experienced heartburn which initially started as mild and patient did not give much attention. But it gets worsened and more annoying 4 to 5 days ago. Patient reported that it is still coming and ongoing. Patient also had a swollen lymph node under both his arm and he describes it like the size of half of plum and filled with fluid.  Treatment medications also include antacids.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Headache, Migraine, Pyrexia
Clinical narrative: Diarrhea; Migraine; Fever of 101.7F; Headache or something; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), MIGRAINE (Migraine), PYREXIA (Fever of 101.7F) and HEADACHE (Headache or something) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009J212A, 045B21A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2022, the patient experienced MIGRAINE (Migraine), PYREXIA (Fever of 101.7F) and HEADACHE (Headache or something). On 11-Jan-2022, the patient experienced DIARRHOEA (Diarrhea). In January 2022, MIGRAINE (Migraine), PYREXIA (Fever of 101.7F) and HEADACHE (Headache or something) had resolved. At the time of the report, DIARRHOEA (Diarrhea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2022, Body temperature: 101.7 (High) Fever of 101.7F.         No concomitant medications were reported. No treatment medications were reported.  Patient reported that the first and second doses were given through an off site health care facility.