chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at the vaccination site after his first Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the vaccination site after his first Moderna Covid-19 vaccine) in a 40-year-old male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at the vaccination site after his first Moderna Covid-19 vaccine). At the time of the report, VACCINATION SITE PAIN (pain at the vaccination site after his first Moderna Covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient has misplaced his vaccination card and does not have the exact dates of administration or the lot numbers. No concomitant medications were mentioned. No treatment details were reported.   This case was linked to MOD-2021-416982 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Somnolence
Clinical narrative: Felt "sickly"; Slept all the time; They Experienced fatigue, tired for about 3 days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt "sickly"), SOMNOLENCE (Slept all the time) and FATIGUE (They Experienced fatigue, tired for about 3 days) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy (She also reported eye issues and coughing which she relates to pollen.). Concomitant products included ARIPIPRAZOLE (ABILIFY) for Bipolar depression, MIDODRINE for Blood pressure management, BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) for Migraine headache, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), DULOXETINE HYDROCHLORIDE (CYMBALTA), COLECALCIFEROL (VITAMIN D3), CLOPIDOGREL BISULFATE (PLAVIX), LEVOTHYROXINE and METOPROLOL TARTRATE for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ILLNESS (Felt "sickly") and SOMNOLENCE (Slept all the time). On an unknown date, the patient experienced FATIGUE (They Experienced fatigue, tired for about 3 days). At the time of the report, ILLNESS (Felt "sickly") and SOMNOLENCE (Slept all the time) outcome was unknown and FATIGUE (They Experienced fatigue, tired for about 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Products included Adderall for Stimulant to stay awake, Cymbalta for joints, Metoprolol tartrate, Heart medication.   This case was linked to MOD-2021-418050 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Vaccination complication
Clinical narrative: severe neck and shoulder pain, several times now; adverse reaction to Moderna covid vaccination; severe neck and shoulder pain, several times now; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (severe neck and shoulder pain, several times now), VACCINATION COMPLICATION (adverse reaction to Moderna covid vaccination) and ARTHRALGIA (severe neck and shoulder pain, several times now) 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 NECK PAIN (severe neck and shoulder pain, several times now), VACCINATION COMPLICATION (adverse reaction to Moderna covid vaccination) and ARTHRALGIA (severe neck and shoulder pain, several times now). At the time of the report, NECK PAIN (severe neck and shoulder pain, several times now), VACCINATION COMPLICATION (adverse reaction to Moderna covid vaccination) and ARTHRALGIA (severe neck and shoulder pain, several times now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information provided.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Dysstasia, Feeling cold
Clinical narrative: Something running on her spine; Felt something cold; Couldn't stand up; Hurt in her waist and her hip; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Something running on her spine), FEELING COLD (Felt something cold), DYSSTASIA (Couldn't stand up) and ARTHRALGIA (Hurt in her waist and her hip) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045521a, 004c21a and 027b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, the patient experienced DISCOMFORT (Something running on her spine), FEELING COLD (Felt something cold), DYSSTASIA (Couldn't stand up) and ARTHRALGIA (Hurt in her waist and her hip). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, DISCOMFORT (Something running on her spine), FEELING COLD (Felt something cold), DYSSTASIA (Couldn't stand up) and ARTHRALGIA (Hurt in her waist and her hip) outcome was unknown.            No concomitant medications were reported.   This case was linked to MOD-2021-417004, MOD-2021-417005 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, Rash
Clinical narrative: it was an immune response; rashes all over his body but more specifically on his hands and feet that have continued up until today; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (it was an immune response) and RASH (rashes all over his body but more specifically on his hands and feet that have continued up until today) 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 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Dec-2021, the patient experienced IMMUNISATION REACTION (it was an immune response) and RASH (rashes all over his body but more specifically on his hands and feet that have continued up until today). At the time of the report, IMMUNISATION REACTION (it was an immune response) and RASH (rashes all over his body but more specifically on his hands and feet that have continued up until today) had not resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that, 10 days after dose patient experienced rashes all over body but more specifically on his hands and feet that continued up until the day. Patient went to the emergency room and had spoken to an allergist regarding his symptoms. The allergist stated it was an immune response to something. Because of that, they believed it was the vaccine.  No concomitant medication was provided.  No treatment information was given.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: received a quarter dose for booster; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (received a quarter dose for booster) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034FZ1A) for COVID-19 vaccination. No Medical History information was reported. On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 16-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (received a quarter dose for booster). On 16-Dec-2021, ACCIDENTAL UNDERDOSE (received a quarter dose for booster) had resolved.            No concomitant medications reported by reporter No treatment medications provided by the reporter.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Decreased appetite, Lethargy, Product administered to patient of inappropriate age
Clinical narrative: chest pain; typical side effects; lethargic; doesn't want to eat; cough; fever; administered to a 7-year-old; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), VACCINATION COMPLICATION (typical side effects), LETHARGY (lethargic), DECREASED APPETITE (doesn't want to eat) and COUGH (cough) in a 7-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 01-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered to a 7-year-old). On an unknown date, the patient experienced CHEST PAIN (chest pain), VACCINATION COMPLICATION (typical side effects), LETHARGY (lethargic), DECREASED APPETITE (doesn't want to eat), COUGH (cough) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. On 01-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered to a 7-year-old) outcome was unknown. At the time of the report, CHEST PAIN (chest pain), VACCINATION COMPLICATION (typical side effects), LETHARGY (lethargic), DECREASED APPETITE (doesn't want to eat), COUGH (cough) and PYREXIA (fever) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Reporter reported that, patient received the Moderna vaccine full dose for adults and was younger than 12 years old and experienced almost right away chest pain which diminished the next day and then it came back. After 2-3 hours daughter experienced typical side effects. This has been on and off. Doctors didn't run any tests, they only listened to her heart with a stethoscope. Doctor said the heart sounded fine.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: chest pain; typical side effects; lethargic; doesn't want to eat; cough; fever; administered to a 7-year-old; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), VACCINATION COMPLICATION (typical side effects), LETHARGY (lethargic), DECREASED APPETITE (doesn't want to eat) and COUGH (cough) in a 7-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 01-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered to a 7-year-old). On an unknown date, the patient experienced CHEST PAIN (chest pain), VACCINATION COMPLICATION (typical side effects), LETHARGY (lethargic), DECREASED APPETITE (doesn't want to eat), COUGH (cough) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. On 01-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered to a 7-year-old) outcome was unknown. At the time of the report, CHEST PAIN (chest pain), VACCINATION COMPLICATION (typical side effects), LETHARGY (lethargic), DECREASED APPETITE (doesn't want to eat), COUGH (cough) and PYREXIA (fever) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Reporter reported that, patient received the Moderna vaccine full dose for adults and was younger than 12 years old and experienced almost right away chest pain which diminished the next day and then it came back. After 2-3 hours daughter experienced typical side effects. This has been on and off. Doctors didn't run any tests, they only listened to her heart with a stethoscope. Doctor said the heart sounded fine.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old received Moderna booster; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received Moderna booster) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer.    On 18-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received Moderna booster). On 18-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received Moderna booster) had resolved.            Patient was administered with Pfizer vaccine and then received the Moderna booster accidentally.  No concomitant medications reported by reporter No treatment medications provided by the reporter.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Hypoaesthesia, Influenza like illness, Myalgia
Clinical narrative: Lips got numb like Novocain from the dentist; Flu-like symptoms; Aches; Headache; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Lips got numb like Novocain from the dentist), INFLUENZA LIKE ILLNESS (Flu-like symptoms), MYALGIA (Aches), HEADACHE (Headache) and ARTHRALGIA (Joint pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced HYPOAESTHESIA (Lips got numb like Novocain from the dentist), INFLUENZA LIKE ILLNESS (Flu-like symptoms), MYALGIA (Aches), HEADACHE (Headache) and ARTHRALGIA (Joint pain). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Lips got numb like Novocain from the dentist), INFLUENZA LIKE ILLNESS (Flu-like symptoms), MYALGIA (Aches), HEADACHE (Headache) and ARTHRALGIA (Joint pain) outcome was unknown.            Concomitant medication was not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: really bad headaches after each dose; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (really bad headaches after each dose) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-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 HEADACHE (really bad headaches after each dose). At the time of the report, HEADACHE (really bad headaches after each dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-417050, MOD-2021-417051 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Swelling
Clinical narrative: Pain in the lymph nodes; swelling like bumps under her armpit in the same side of the injection, in the lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling like bumps under her armpit in the same side of the injection, in the lymph nodes) and LYMPH NODE PAIN (Pain in the lymph nodes) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Dec-2021, the patient experienced SWELLING (swelling like bumps under her armpit in the same side of the injection, in the lymph nodes). On an unknown date, the patient experienced LYMPH NODE PAIN (Pain in the lymph nodes). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, SWELLING (swelling like bumps under her armpit in the same side of the injection, in the lymph nodes) and LYMPH NODE PAIN (Pain in the lymph nodes) outcome was unknown.            No concomitant drug details were reported.   Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: really bad headaches after each dose; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (really bad headaches after each dose) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 033C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced HEADACHE (really bad headaches after each dose). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (really bad headaches after each dose) outcome was unknown.            No Concomitant Drug details were reported.   This case was linked to MOD-2021-417033, MOD-2021-417051 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Patient stated that she has a rash in al over her body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Patient stated that she has a rash in al over her body) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 RASH (Patient stated that she has a rash in al over her body). At the time of the report, RASH (Patient stated that she has a rash in al over her body) had not resolved.            No Concomitant product use was reported. No treatment information was provided.  The patient stated that they got the booster dose and had a rash in all over their body.   This case was linked to MOD-2021-417079 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: welts on her legs, arms and face/hives all over her body/hives on their face/hives on their extremities; Rash/developed body rash mainly on her torso; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (welts on her legs, arms and face/hives all over her body/hives on their face/hives on their extremities) and RASH (Rash/developed body rash mainly on her torso) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL for Blood pressure management.    On 03-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Dec-2021, the patient experienced URTICARIA (welts on her legs, arms and face/hives all over her body/hives on their face/hives on their extremities) and RASH (Rash/developed body rash mainly on her torso). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (welts on her legs, arms and face/hives all over her body/hives on their face/hives on their extremities) and RASH (Rash/developed body rash mainly on her torso) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had blood pressure.   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Significant follow-up was received and patient demographics, lot number, past medical history, concomitant medication were updated.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itch in legs, arms, hips, and all over his body; rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itch in legs, arms, hips, and all over his body) and RASH (rash) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 046A21A and 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Thyroid disorder NOS (thyroid medication).   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced PRURITUS (itch in legs, arms, hips, and all over his body) and RASH (rash). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (itch in legs, arms, hips, and all over his body) and RASH (rash) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other concomitant medication included high blood pressure medication and thyroid medication.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza, Malaise, Pain
Clinical narrative: He threw up his dinner; Running a low grade fever of 103°F; Body aches; Has not been feeling well; It felt like he had the flu; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache), VOMITING (He threw up his dinner), PYREXIA (Running a low grade fever of 103°F) and PAIN (Body aches) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031421A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Dec-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache), PYREXIA (Running a low grade fever of 103°F), PAIN (Body aches), MALAISE (Has not been feeling well) and INFLUENZA (It felt like he had the flu). On 16-Dec-2021, the patient experienced VOMITING (He threw up his dinner). At the time of the report, CHILLS (Chills), HEADACHE (Headache), VOMITING (He threw up his dinner), PYREXIA (Running a low grade fever of 103°F), PAIN (Body aches), MALAISE (Has not been feeling well) and INFLUENZA (It felt like he had the flu) had not resolved.            No concomitant medications provided. No treatment medications provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: He threw up his dinner; Running a low grade fever of 103°F; Body aches; Has not been feeling well; It felt like he had the flu; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache), VOMITING (He threw up his dinner), PYREXIA (Running a low grade fever of 103°F) and PAIN (Body aches) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031421A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Dec-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache), PYREXIA (Running a low grade fever of 103°F), PAIN (Body aches), MALAISE (Has not been feeling well) and INFLUENZA (It felt like he had the flu). On 16-Dec-2021, the patient experienced VOMITING (He threw up his dinner). At the time of the report, CHILLS (Chills), HEADACHE (Headache), VOMITING (He threw up his dinner), PYREXIA (Running a low grade fever of 103°F), PAIN (Body aches), MALAISE (Has not been feeling well) and INFLUENZA (It felt like he had the flu) had not resolved.            No concomitant medications provided. No treatment medications provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 41-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.            No concomitant medications reported. No treatment reported.   This case was linked to MOD-2021-417058 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) 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 VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were Reported. No treatments were Reported.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Nurse vaccinated a patient 4 days before her second dose was due; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Nurse vaccinated a patient 4 days before her second dose was due) 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 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Nurse vaccinated a patient 4 days before her second dose was due). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Nurse vaccinated a patient 4 days before her second dose was due) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Patient administered full 3rd dose of vaccine rather than 50mcg dose (patient not immunocompromised); This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Patient administered full 3rd dose of vaccine rather than 50mcg dose (patient not immunocompromised)) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029H21B, 019B21A and 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 16-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Dec-2021, the patient experienced ACCIDENTAL OVERDOSE (Patient administered full 3rd dose of vaccine rather than 50mcg dose (patient not immunocompromised)). On 16-Dec-2021, ACCIDENTAL OVERDOSE (Patient administered full 3rd dose of vaccine rather than 50mcg dose (patient not immunocompromised)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: had a cold; fever; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (had a cold) and PYREXIA (fever) 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 NASOPHARYNGITIS (had a cold) and PYREXIA (fever). The patient was treated with PREDNISONE for Adverse reaction, at a dose of 20mg in a 5 days cycle and TETRACYCLINE for Adverse reaction, at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (had a cold) outcome was unknown and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.   Reporter did not allow further contact
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Insomnia
Clinical narrative: because of elbow pain it is hard to sleep at night; numbness in fingers of same arm; pain that moved down to the elbow of injected arm; This spontaneous case was reported by a pharmacist and describes the occurrence of INSOMNIA (because of elbow pain it is hard to sleep at night), HYPOAESTHESIA (numbness in fingers of same arm) and ARTHRALGIA (pain that moved down to the elbow of injected arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Oct-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 INSOMNIA (because of elbow pain it is hard to sleep at night), HYPOAESTHESIA (numbness in fingers of same arm) and ARTHRALGIA (pain that moved down to the elbow of injected arm). At the time of the report, INSOMNIA (because of elbow pain it is hard to sleep at night), HYPOAESTHESIA (numbness in fingers of same arm) and ARTHRALGIA (pain that moved down to the elbow of injected arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The patient had used heating pad as treatment.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Hey why is my injection site magnetic why is my injection site magnetic" "Why is my injection site magnetic I can it'll hold paper clips and Staples; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE REACTION (Hey why is my injection site magnetic why is my injection site magnetic" "Why is my injection site magnetic I can it'll hold paper clips and Staples) 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 VACCINATION SITE REACTION (Hey why is my injection site magnetic why is my injection site magnetic" "Why is my injection site magnetic I can it'll hold paper clips and Staples). At the time of the report, VACCINATION SITE REACTION (Hey why is my injection site magnetic why is my injection site magnetic" "Why is my injection site magnetic I can it'll hold paper clips and Staples) 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 asked why their injection site was magnetic and stated that it could hold paper clips and staples.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Very intense body aches; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Very intense body aches) and HEADACHE (Headaches) 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 MYALGIA (Very intense body aches) and HEADACHE (Headaches). At the time of the report, MYALGIA (Very intense body aches) and HEADACHE (Headaches) outcome was unknown. Not Provided          Concomitant medications were not provided Treatment medications were not provided Patient took booster dose and experienced events.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: heart  is pounding/e a few like plundering, palpitations/not racing but that is going so much faster,/more like the felling of pounding; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart  is pounding/e a few like plundering, palpitations/not racing but that is going so much faster,/more like the felling of pounding) 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 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced PALPITATIONS (heart  is pounding/e a few like plundering, palpitations/not racing but that is going so much faster,/more like the felling of pounding). At the time of the report, PALPITATIONS (heart  is pounding/e a few like plundering, palpitations/not racing but that is going so much faster,/more like the felling of pounding) outcome was unknown.            No concomitant and treatment information were reported by the reporter
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I am having some reaction to the booster shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I am having some reaction to the booster shot) 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 VACCINATION COMPLICATION (I am having some reaction to the booster shot). At the time of the report, VACCINATION COMPLICATION (I am having some reaction to the booster shot) outcome was unknown.            The patient stated that they were having some reaction to the booster shot.   No Concomitant product use was reported. No treatment information was provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Feeling of body temperature change, Gait disturbance, Headache
Clinical narrative: hives on head; arm started itching like a hive; hurts to walk; clicking in my left ear; stomach ache; sensation of hot and cold; a sore arm; big hard place on my arm like a big rock; whole body hurts; Bad headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on head), PRURITUS (arm started itching like a hive), GAIT DISTURBANCE (hurts to walk), TINNITUS (clicking in my left ear) and ABDOMINAL PAIN UPPER (stomach ache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer (intramuscular injection) on 27-Mar-2021 and Pfizer (intramuscular injection) on 17-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 15-Dec-2021 at 10:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Dec-2021, the patient experienced URTICARIA (hives on head), PRURITUS (arm started itching like a hive), GAIT DISTURBANCE (hurts to walk), TINNITUS (clicking in my left ear), ABDOMINAL PAIN UPPER (stomach ache), FEELING OF BODY TEMPERATURE CHANGE (sensation of hot and cold), INDURATION (big hard place on my arm like a big rock), MYALGIA (whole body hurts), HEADACHE (Bad headache) and CHILLS (chills). 15-Dec-2021, the patient experienced PAIN IN EXTREMITY (a sore arm). The patient was treated with ACETAMINOPHEN 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, URTICARIA (hives on head), PRURITUS (arm started itching like a hive), GAIT DISTURBANCE (hurts to walk), TINNITUS (clicking in my left ear), ABDOMINAL PAIN UPPER (stomach ache), FEELING OF BODY TEMPERATURE CHANGE (sensation of hot and cold), PAIN IN EXTREMITY (a sore arm), INDURATION (big hard place on my arm like a big rock), MYALGIA (whole body hurts), HEADACHE (Bad headache) and CHILLS (chills) had not resolved.            No concomitant medication was reported by the reporter. After receiving the Moderna vaccine around 7:00 PM that evening, patient started experiencing symptoms.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Myalgia, Pain in extremity, Pruritus, Tinnitus
Clinical narrative: hives on head; arm started itching like a hive; hurts to walk; clicking in my left ear; stomach ache; sensation of hot and cold; a sore arm; big hard place on my arm like a big rock; whole body hurts; Bad headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on head), PRURITUS (arm started itching like a hive), GAIT DISTURBANCE (hurts to walk), TINNITUS (clicking in my left ear) and ABDOMINAL PAIN UPPER (stomach ache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer (intramuscular injection) on 27-Mar-2021 and Pfizer (intramuscular injection) on 17-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 15-Dec-2021 at 10:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Dec-2021, the patient experienced URTICARIA (hives on head), PRURITUS (arm started itching like a hive), GAIT DISTURBANCE (hurts to walk), TINNITUS (clicking in my left ear), ABDOMINAL PAIN UPPER (stomach ache), FEELING OF BODY TEMPERATURE CHANGE (sensation of hot and cold), INDURATION (big hard place on my arm like a big rock), MYALGIA (whole body hurts), HEADACHE (Bad headache) and CHILLS (chills). 15-Dec-2021, the patient experienced PAIN IN EXTREMITY (a sore arm). The patient was treated with ACETAMINOPHEN 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, URTICARIA (hives on head), PRURITUS (arm started itching like a hive), GAIT DISTURBANCE (hurts to walk), TINNITUS (clicking in my left ear), ABDOMINAL PAIN UPPER (stomach ache), FEELING OF BODY TEMPERATURE CHANGE (sensation of hot and cold), PAIN IN EXTREMITY (a sore arm), INDURATION (big hard place on my arm like a big rock), MYALGIA (whole body hurts), HEADACHE (Bad headache) and CHILLS (chills) had not resolved.            No concomitant medication was reported by the reporter. After receiving the Moderna vaccine around 7:00 PM that evening, patient started experiencing symptoms.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives on head; arm started itching like a hive; hurts to walk; clicking in my left ear; stomach ache; sensation of hot and cold; a sore arm; big hard place on my arm like a big rock; whole body hurts; Bad headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on head), PRURITUS (arm started itching like a hive), GAIT DISTURBANCE (hurts to walk), TINNITUS (clicking in my left ear) and ABDOMINAL PAIN UPPER (stomach ache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer (intramuscular injection) on 27-Mar-2021 and Pfizer (intramuscular injection) on 17-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 15-Dec-2021 at 10:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Dec-2021, the patient experienced URTICARIA (hives on head), PRURITUS (arm started itching like a hive), GAIT DISTURBANCE (hurts to walk), TINNITUS (clicking in my left ear), ABDOMINAL PAIN UPPER (stomach ache), FEELING OF BODY TEMPERATURE CHANGE (sensation of hot and cold), INDURATION (big hard place on my arm like a big rock), MYALGIA (whole body hurts), HEADACHE (Bad headache) and CHILLS (chills). 15-Dec-2021, the patient experienced PAIN IN EXTREMITY (a sore arm). The patient was treated with ACETAMINOPHEN 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, URTICARIA (hives on head), PRURITUS (arm started itching like a hive), GAIT DISTURBANCE (hurts to walk), TINNITUS (clicking in my left ear), ABDOMINAL PAIN UPPER (stomach ache), FEELING OF BODY TEMPERATURE CHANGE (sensation of hot and cold), PAIN IN EXTREMITY (a sore arm), INDURATION (big hard place on my arm like a big rock), MYALGIA (whole body hurts), HEADACHE (Bad headache) and CHILLS (chills) had not resolved.            No concomitant medication was reported by the reporter. After receiving the Moderna vaccine around 7:00 PM that evening, patient started experiencing symptoms.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient was administered a fourth dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient was administered a fourth dose of the Moderna COVID-19 vaccine) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0311H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 100 mcg. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 100 mcg. On 22-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 100 mcg. On 07-Dec-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 50 mcg. On 07-Dec-2021, the patient experienced EXTRA DOSE ADMINISTERED (Patient was administered a fourth dose of the Moderna COVID-19 vaccine). On 07-Dec-2021, EXTRA DOSE ADMINISTERED (Patient was administered a fourth dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.  The first three doses were of full doses. The patient reports experiencing no symptoms as of yet.