chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: itching near the injection site; it swelled up/ little swollen; little red; lot of soreness on the arm near the injection site/ it was sore to touch/ couldn't sleep on the left side because of the pain; had little swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching near the injection site), VACCINATION SITE SWELLING (it swelled up/ little swollen), VACCINATION SITE ERYTHEMA (little red), VACCINATION SITE PAIN (lot of soreness on the arm near the injection site/ it was sore to touch/ couldn't sleep on the left side because of the pain) and VACCINATION SITE SWELLING (had little swelling) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy (Occasional summer allergies). Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Seasonal allergy.    On 05-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jul-2021, the patient experienced VACCINATION SITE PAIN (lot of soreness on the arm near the injection site/ it was sore to touch/ couldn't sleep on the left side because of the pain) and VACCINATION SITE SWELLING (had little swelling). On 13-Jul-2021, the patient experienced VACCINATION SITE PRURITUS (itching near the injection site), VACCINATION SITE SWELLING (it swelled up/ little swollen) and VACCINATION SITE ERYTHEMA (little red). On 07-Jul-2021, VACCINATION SITE PAIN (lot of soreness on the arm near the injection site/ it was sore to touch/ couldn't sleep on the left side because of the pain) and VACCINATION SITE SWELLING (had little swelling) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itching near the injection site), VACCINATION SITE SWELLING (it swelled up/ little swollen) and VACCINATION SITE ERYTHEMA (little red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was received for the events experienced.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Inappropriate schedule of product administration, Malaise, Neck pain
Clinical narrative: Second dose not received in allowed time; Head pain; Neck Pain; Not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck Pain), MALAISE (Not feeling well), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose not received in allowed time) and HEADACHE (Head pain) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 021B21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE for Hypertension.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 14-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (Not feeling well). On 19-May-2021, the patient experienced NECK PAIN (Neck Pain) and HEADACHE (Head pain). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose not received in allowed time). At the time of the report, NECK PAIN (Neck Pain), MALAISE (Not feeling well) and HEADACHE (Head pain) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose not received in allowed time) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, Blood pressure measurement: 112/78 (normal) 112/78. On an unknown date, Blood pressure measurement: 212/98 (High) 212/98.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications include ice pack.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: COVID19 Positive after fully vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID19 Positive after fully vaccinated) 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, 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 SARS-COV-2 TEST POSITIVE (COVID19 Positive after fully vaccinated). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID19 Positive after fully vaccinated) outcome was unknown.            Concomitant medications were not reported by the reporter Treatment drugs were not reported by the reporter
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: COVID19 Positive after fully vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID19 Positive after fully vaccinated) 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 SARS-COV-2 TEST POSITIVE (COVID19 Positive after fully vaccinated). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID19 Positive after fully vaccinated) outcome was unknown.            Concomitant drug was not reported. Treatment medication was not reported.   This case was linked to MOD-2021-255524 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Rash on left arm; Body aches; Fluctuating Fever; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on left arm), MYALGIA (Body aches), PYREXIA (Fluctuating Fever), HEADACHE (Headache) and CHILLS (Chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A, and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-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 RASH (Rash on left arm), MYALGIA (Body aches), PYREXIA (Fluctuating Fever), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, RASH (Rash on left arm), MYALGIA (Body aches), PYREXIA (Fluctuating Fever), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99-101.7 (abnormal) fluctuated from 99.0 to 101.7. and 99 (normal) back down again to 99 to normal 97-98 range..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medications are provided. treatment to the events not reported.   This case was linked to MOD-2021-023247 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on left arm; Body aches; Fluctuating Fever; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on left arm), MYALGIA (Body aches), PYREXIA (Fluctuating Fever), HEADACHE (Headache) and CHILLS (Chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A, and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-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 RASH (Rash on left arm), MYALGIA (Body aches), PYREXIA (Fluctuating Fever), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, RASH (Rash on left arm), MYALGIA (Body aches), PYREXIA (Fluctuating Fever), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99-101.7 (abnormal) fluctuated from 99.0 to 101.7. and 99 (normal) back down again to 99 to normal 97-98 range..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medications are provided. treatment to the events not reported.   This case was linked to MOD-2021-023247 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Hurt) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Hurt). At the time of the report, PAIN (Hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were nor provided
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dysphagia, Dyspnoea, Gait disturbance
Clinical narrative: dizziness; weakness; heart is acting up; cannot swallow; difficulty on breathing; difficulty on walking; legs are hurting /  toes are hurting; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), ASTHENIA (weakness), PALPITATIONS (heart is acting up), DYSPHAGIA (cannot swallow) and DYSPNOEA (difficulty on breathing) in a female patient of an unknown age 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 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced DIZZINESS (dizziness), ASTHENIA (weakness), PALPITATIONS (heart is acting up), DYSPHAGIA (cannot swallow), DYSPNOEA (difficulty on breathing), GAIT DISTURBANCE (difficulty on walking), PAIN IN EXTREMITY (legs are hurting /  toes are hurting) and MYALGIA (sore arm). At the time of the report, DIZZINESS (dizziness), ASTHENIA (weakness), PALPITATIONS (heart is acting up), DYSPHAGIA (cannot swallow), DYSPNOEA (difficulty on breathing), GAIT DISTURBANCE (difficulty on walking), PAIN IN EXTREMITY (legs are hurting /  toes are hurting) and MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided. Patient states that is upset because wasn't told that the vaccine is an experimental drug, and may be poisoning us and doesn't want to receive the second dose.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Palpitations
Clinical narrative: dizziness; weakness; heart is acting up; cannot swallow; difficulty on breathing; difficulty on walking; legs are hurting /  toes are hurting; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), ASTHENIA (weakness), PALPITATIONS (heart is acting up), DYSPHAGIA (cannot swallow) and DYSPNOEA (difficulty on breathing) in a female patient of an unknown age 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 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced DIZZINESS (dizziness), ASTHENIA (weakness), PALPITATIONS (heart is acting up), DYSPHAGIA (cannot swallow), DYSPNOEA (difficulty on breathing), GAIT DISTURBANCE (difficulty on walking), PAIN IN EXTREMITY (legs are hurting /  toes are hurting) and MYALGIA (sore arm). At the time of the report, DIZZINESS (dizziness), ASTHENIA (weakness), PALPITATIONS (heart is acting up), DYSPHAGIA (cannot swallow), DYSPNOEA (difficulty on breathing), GAIT DISTURBANCE (difficulty on walking), PAIN IN EXTREMITY (legs are hurting /  toes are hurting) and MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided. Patient states that is upset because wasn't told that the vaccine is an experimental drug, and may be poisoning us and doesn't want to receive the second dose.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: side effects on the menstrual cycle after getting the 2nd shot of Moderna.; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (side effects on the menstrual cycle after getting the 2nd shot of Moderna.) 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 MENSTRUAL DISORDER (side effects on the menstrual cycle after getting the 2nd shot of Moderna.). At the time of the report, MENSTRUAL DISORDER (side effects on the menstrual cycle after getting the 2nd shot of Moderna.) outcome was unknown.            No relevant Concomitant Medications were reported. No Treatment Information Provided.
Sex: U
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: Blood Pressure High; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood Pressure High) 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, 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 HYPERTENSION (Blood Pressure High). At the time of the report, HYPERTENSION (Blood Pressure High) had resolved.            No concomitant medication was reported. No treatment medications were reported Patient's blood pressure was elevated for about 30- 40 days after 2nd shot. His blood pressure returned to normal.   This case was linked to MOD-2021-033879 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue, Vaccination complication
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of product dose omission issue (more than 35 days since the first shot) and vaccination complication (health issues after receiving the vaccine) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the 1st dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced product dose omission issue (more than 35 days since the first shot) and vaccination complication (health issues after receiving the vaccine). At the time of the report, product dose omission issue (more than 35 days since the first shot) and vaccination complication (health issues after receiving the vaccine) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported. Patient also reported experiencing some medical issues.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: doctor told her not to receive the second shot since she had an allergic reaction; This spontaneous case was reported by a patient and describes the occurrence of HYPERSENSITIVITY (doctor told her not to receive the second shot since she had an allergic reaction) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (doctor told her not to receive the second shot since she had an allergic reaction). At the time of the report, HYPERSENSITIVITY (doctor told her not to receive the second shot since she had an allergic reaction) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No concomitant medications were reported. No treatment medications were reported.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Gait disturbance, Hypoaesthesia
Clinical narrative: started feeling weird; numbness on his legs, entirely/ numbness on intimate parts/ numbness on anus; he could not walk; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (started feeling weird), HYPOAESTHESIA (numbness on his legs, entirely/ numbness on intimate parts/ numbness on anus) and GAIT DISTURBANCE (he could not walk) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Cholesterol. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 27-Apr-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 FEELING ABNORMAL (started feeling weird), HYPOAESTHESIA (numbness on his legs, entirely/ numbness on intimate parts/ numbness on anus) and GAIT DISTURBANCE (he could not walk). The patient was treated with GABAPENTIN at a dose of 300 mg twice a day. At the time of the report, FEELING ABNORMAL (started feeling weird), HYPOAESTHESIA (numbness on his legs, entirely/ numbness on intimate parts/ numbness on anus) and GAIT DISTURBANCE (he could not walk) 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.   Concomitant medications included high blood pressure medication, cholesterol medication. Patient had an MRI done from his cervical spine down and his Neurosurgeon told him that he had something (caller mentioned doctor used a term he could not recall) related to a virus On 04 Jun 2021 it was the last day he could go to work and then he went to the ER and had several studies done, it's been 6 weeks since he cannot go to work.   This case was linked to MOD-2021-256809 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm  was a little sore) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     The patient's past medical history included Accident (car accident). Concurrent medical conditions included ADHD and Allergy to vaccine (reactions to the flu shot).    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm  was a little sore). On 05-Apr-2021, PAIN IN EXTREMITY (arm  was a little sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was not given.   This case was linked to MOD-2021-255614 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: Heart condition; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (Heart condition) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 CARDIAC DISORDER (Heart condition). At the time of the report, CARDIAC DISORDER (Heart condition) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Asthenia, Chest pain, Dizziness, Dyspnoea
Clinical narrative: pain in her arm; feel unwell; weakness in all her body,her strength leaves her; legs and arms shake; tingling sensation in all her body from head to toe; feels desperate; chest hurts; she can't breathe fast; can't speak; dizzy; feels very very cold; she can't go to work anymore; headaches; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in her arm), VACCINATION COMPLICATION (feel unwell), ASTHENIA (weakness in all her body,her strength leaves her), TREMOR (legs and arms shake) and PARAESTHESIA (tingling sensation in all her body from head to toe) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D__A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2021, the patient experienced VACCINATION COMPLICATION (feel unwell), ASTHENIA (weakness in all her body,her strength leaves her), TREMOR (legs and arms shake), PARAESTHESIA (tingling sensation in all her body from head to toe), FEELING ABNORMAL (feels desperate), CHEST PAIN (chest hurts), DYSPNOEA (she can't breathe fast), APHASIA (can't speak), DIZZINESS (dizzy), FEELING COLD (feels very very cold), IMPAIRED WORK ABILITY (she can't go to work anymore), HEADACHE (headaches) and NAUSEA (nauseous). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in her arm). The patient was treated with MECLIZINE [MECLOZINE] for Adverse event, at a dose of 25 milligram, Pills. At the time of the report, PAIN IN EXTREMITY (pain in her arm), VACCINATION COMPLICATION (feel unwell), ASTHENIA (weakness in all her body,her strength leaves her), TREMOR (legs and arms shake), PARAESTHESIA (tingling sensation in all her body from head to toe), FEELING ABNORMAL (feels desperate), CHEST PAIN (chest hurts), DYSPNOEA (she can't breathe fast), APHASIA (can't speak), DIZZINESS (dizzy), FEELING COLD (feels very very cold), IMPAIRED WORK ABILITY (she can't go to work anymore), HEADACHE (headaches) and NAUSEA (nauseous) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that she doesn't take any concomitant medications. Patient went twice to the hospital, the second time on ambulance and she was there one whole night but she says the treatment medication don't work. Doctors didn't find anything wrong with her. Patient took some pills for anxiety but that too didn't work either. Patient was reported to be hesitant to take the second dose because of the reactions that she had been experiencing. Patient reported that these episodes of symptoms last 10-30 minutes and once they stop she feels very very cold and then the new episode starts again.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling cold, Headache, Impaired work ability, Nausea
Clinical narrative: pain in her arm; feel unwell; weakness in all her body,her strength leaves her; legs and arms shake; tingling sensation in all her body from head to toe; feels desperate; chest hurts; she can't breathe fast; can't speak; dizzy; feels very very cold; she can't go to work anymore; headaches; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in her arm), VACCINATION COMPLICATION (feel unwell), ASTHENIA (weakness in all her body,her strength leaves her), TREMOR (legs and arms shake) and PARAESTHESIA (tingling sensation in all her body from head to toe) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D__A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2021, the patient experienced VACCINATION COMPLICATION (feel unwell), ASTHENIA (weakness in all her body,her strength leaves her), TREMOR (legs and arms shake), PARAESTHESIA (tingling sensation in all her body from head to toe), FEELING ABNORMAL (feels desperate), CHEST PAIN (chest hurts), DYSPNOEA (she can't breathe fast), APHASIA (can't speak), DIZZINESS (dizzy), FEELING COLD (feels very very cold), IMPAIRED WORK ABILITY (she can't go to work anymore), HEADACHE (headaches) and NAUSEA (nauseous). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in her arm). The patient was treated with MECLIZINE [MECLOZINE] for Adverse event, at a dose of 25 milligram, Pills. At the time of the report, PAIN IN EXTREMITY (pain in her arm), VACCINATION COMPLICATION (feel unwell), ASTHENIA (weakness in all her body,her strength leaves her), TREMOR (legs and arms shake), PARAESTHESIA (tingling sensation in all her body from head to toe), FEELING ABNORMAL (feels desperate), CHEST PAIN (chest hurts), DYSPNOEA (she can't breathe fast), APHASIA (can't speak), DIZZINESS (dizzy), FEELING COLD (feels very very cold), IMPAIRED WORK ABILITY (she can't go to work anymore), HEADACHE (headaches) and NAUSEA (nauseous) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that she doesn't take any concomitant medications. Patient went twice to the hospital, the second time on ambulance and she was there one whole night but she says the treatment medication don't work. Doctors didn't find anything wrong with her. Patient took some pills for anxiety but that too didn't work either. Patient was reported to be hesitant to take the second dose because of the reactions that she had been experiencing. Patient reported that these episodes of symptoms last 10-30 minutes and once they stop she feels very very cold and then the new episode starts again.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Tremor, Vaccination complication
Clinical narrative: pain in her arm; feel unwell; weakness in all her body,her strength leaves her; legs and arms shake; tingling sensation in all her body from head to toe; feels desperate; chest hurts; she can't breathe fast; can't speak; dizzy; feels very very cold; she can't go to work anymore; headaches; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in her arm), VACCINATION COMPLICATION (feel unwell), ASTHENIA (weakness in all her body,her strength leaves her), TREMOR (legs and arms shake) and PARAESTHESIA (tingling sensation in all her body from head to toe) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D__A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2021, the patient experienced VACCINATION COMPLICATION (feel unwell), ASTHENIA (weakness in all her body,her strength leaves her), TREMOR (legs and arms shake), PARAESTHESIA (tingling sensation in all her body from head to toe), FEELING ABNORMAL (feels desperate), CHEST PAIN (chest hurts), DYSPNOEA (she can't breathe fast), APHASIA (can't speak), DIZZINESS (dizzy), FEELING COLD (feels very very cold), IMPAIRED WORK ABILITY (she can't go to work anymore), HEADACHE (headaches) and NAUSEA (nauseous). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in her arm). The patient was treated with MECLIZINE [MECLOZINE] for Adverse event, at a dose of 25 milligram, Pills. At the time of the report, PAIN IN EXTREMITY (pain in her arm), VACCINATION COMPLICATION (feel unwell), ASTHENIA (weakness in all her body,her strength leaves her), TREMOR (legs and arms shake), PARAESTHESIA (tingling sensation in all her body from head to toe), FEELING ABNORMAL (feels desperate), CHEST PAIN (chest hurts), DYSPNOEA (she can't breathe fast), APHASIA (can't speak), DIZZINESS (dizzy), FEELING COLD (feels very very cold), IMPAIRED WORK ABILITY (she can't go to work anymore), HEADACHE (headaches) and NAUSEA (nauseous) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that she doesn't take any concomitant medications. Patient went twice to the hospital, the second time on ambulance and she was there one whole night but she says the treatment medication don't work. Doctors didn't find anything wrong with her. Patient took some pills for anxiety but that too didn't work either. Patient was reported to be hesitant to take the second dose because of the reactions that she had been experiencing. Patient reported that these episodes of symptoms last 10-30 minutes and once they stop she feels very very cold and then the new episode starts again.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Histamine intolerance, Scar, Urticaria
Clinical narrative: developed full body chronic hives within 3 weeks of her 1st dose of the vaccine/full body chronic hives/Urticaria; dizzy; scarring due to the hives; doctor thinks she has histamine intolerance from the vaccine and says they called it urticaria; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (developed full body chronic hives within 3 weeks of her 1st dose of the vaccine/full body chronic hives/Urticaria), DIZZINESS (dizzy), SCAR (scarring due to the hives) and HISTAMINE INTOLERANCE (doctor thinks she has histamine intolerance from the vaccine and says they called it urticaria) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 11-Apr-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 URTICARIA (developed full body chronic hives within 3 weeks of her 1st dose of the vaccine/full body chronic hives/Urticaria), DIZZINESS (dizzy), SCAR (scarring due to the hives) and HISTAMINE INTOLERANCE (doctor thinks she has histamine intolerance from the vaccine and says they called it urticaria). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency; LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (developed full body chronic hives within 3 weeks of her 1st dose of the vaccine/full body chronic hives/Urticaria), DIZZINESS (dizzy), SCAR (scarring due to the hives) and HISTAMINE INTOLERANCE (doctor thinks she has histamine intolerance from the vaccine and says they called it urticaria) 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.   Treatment drug included STEROIDS.   This case was linked to MOD-2021-255960 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Felt weird; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt weird) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Felt weird). At the time of the report, FEELING ABNORMAL (Felt weird) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information not provided.   This case was linked to MOD-2021-255604 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: flu-like symptoms; felt like her heart was inflamed; fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING ABNORMAL (felt like her heart was inflamed), PYREXIA (fever) and MYALGIA (body aches) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING ABNORMAL (felt like her heart was inflamed), PYREXIA (fever) and MYALGIA (body aches). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING ABNORMAL (felt like her heart was inflamed), PYREXIA (fever) and MYALGIA (body aches) outcome was unknown.            Concomitant medication use was unknown Treatment information  was unknown   This case was linked to MOD-2021-255603 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Pain in extremity, Vomiting
Clinical narrative: My arm was a bit sore and that was it.; Inappropriate route of vaccination; I had a 12 hour vomitting bug 15 days after that vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (My arm was a bit sore and that was it.), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) and VOMITING (I had a 12 hour vomitting bug 15 days after that vaccine) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 012L20A) for COVID-19 vaccination.     No medical history reported by the reporter.  Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for Asthma.   On 24-Jan-2021 at 2:53 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 02-Mar-2021 at 4:27 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 02-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination). On an unknown date, the patient experienced PAIN IN EXTREMITY (My arm was a bit sore and that was it.) and VOMITING (I had a 12 hour vomitting bug 15 days after that vaccine). On 02-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) had resolved. At the time of the report, PAIN IN EXTREMITY (My arm was a bit sore and that was it.) and VOMITING (I had a 12 hour vomitting bug 15 days after that vaccine) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   No treatment medication provided by the reporter It was reported that the administration site of both the dose 1 and dose 2 were upper arm Patient reported that she had consulted with her general practitioner and also infectious disease neurology and allergy and immunology along with a  lot of lab blood work then only she made the decision to took vaccine   This case was linked to MOD-2021-031380 (Patient Link).
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Muscle discomfort, Myalgia
Clinical narrative: It's not too too painful it feels like the muscle is been torn apart; Same exact ripping sensation; The first couple of days it was a dull pain and then it was a transition and felt the same exact ripping sensation; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE DISCOMFORT (It's not too too painful it feels like the muscle is been torn apart), LIMB DISCOMFORT (Same exact ripping sensation) and MYALGIA (The first couple of days it was a dull pain and then it was a transition and felt the same exact ripping sensation) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. RA6059) for COVID-19 vaccination.     The patient's past medical history included Surgery (The patient had 7 surgeries from breaking bones (patient played rugby)).   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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE DISCOMFORT (It's not too too painful it feels like the muscle is been torn apart), LIMB DISCOMFORT (Same exact ripping sensation) and MYALGIA (The first couple of days it was a dull pain and then it was a transition and felt the same exact ripping sensation). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCLE DISCOMFORT (It's not too too painful it feels like the muscle is been torn apart), LIMB DISCOMFORT (Same exact ripping sensation) and MYALGIA (The first couple of days it was a dull pain and then it was a transition and felt the same exact ripping sensation) outcome was unknown.            No concomitant medication were reported.  Patient reported that it freaking hurts and it was freaking unusual, like tearing your muscle from two different sites. The patient said that was still feeling it when it stretch arm. The patient said have not been sick in life. Treatment details include BPC 157 and healing peptides.   This case was linked to MOD-2021-255478 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: He "felt a little frog in his arm"at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (He "felt a little frog in his arm"at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE REACTION (He "felt a little frog in his arm"at the injection site). At the time of the report, VACCINATION SITE REACTION (He "felt a little frog in his arm"at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Headache, Myalgia, Nasal congestion, Rhinorrhoea
Clinical narrative: Nasal congestion; Runny nose; COVID; Headache; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Nasal congestion), RHINORRHOEA (Runny nose), COVID-19 (COVID), HEADACHE (Headache) and MYALGIA (Myalgia) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jul-2021, the patient experienced NASAL CONGESTION (Nasal congestion), RHINORRHOEA (Runny nose), COVID-19 (COVID), HEADACHE (Headache) and MYALGIA (Myalgia). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, NASAL CONGESTION (Nasal congestion), RHINORRHOEA (Runny nose), COVID-19 (COVID), HEADACHE (Headache) and MYALGIA (Myalgia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.         No Concomitant medication were reported by the reporter. Hot water bath improved his symptoms.   This case was linked to MOD-2021-255442 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: Follow up TCR received and event added COVID-19 from previous version
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Nasal congestion; Runny nose; COVID; Headache; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Nasal congestion), RHINORRHOEA (Runny nose), COVID-19 (COVID), HEADACHE (Headache) and MYALGIA (Myalgia) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jul-2021, the patient experienced NASAL CONGESTION (Nasal congestion), RHINORRHOEA (Runny nose), COVID-19 (COVID), HEADACHE (Headache) and MYALGIA (Myalgia). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, NASAL CONGESTION (Nasal congestion), RHINORRHOEA (Runny nose), COVID-19 (COVID), HEADACHE (Headache) and MYALGIA (Myalgia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.         No Concomitant medication were reported by the reporter. Hot water bath improved his symptoms.   This case was linked to MOD-2021-255442 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: Follow up TCR received and event added COVID-19 from previous version
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I would like to put in a complaint for the Moderna vaccine shot that I got; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I would like to put in a complaint for the Moderna vaccine shot that I got) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I would like to put in a complaint for the Moderna vaccine shot that I got). At the time of the report, VACCINATION COMPLICATION (I would like to put in a complaint for the Moderna vaccine shot that I got) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment details were reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod sting, Peripheral swelling
Clinical narrative: arm that swelled after a wasp stung; arm swelled all the way up to the elbow/it just kept swelling; This spontaneous case was reported by a consumer and describes the occurrence of ARTHROPOD STING (arm that swelled after a wasp stung) and PERIPHERAL SWELLING (arm swelled all the way up to the elbow/it just kept swelling) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 03B21A) 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) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced ARTHROPOD STING (arm that swelled after a wasp stung) and PERIPHERAL SWELLING (arm swelled all the way up to the elbow/it just kept swelling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Wasp sting, at a dose of 1 dosage form every four hours. At the time of the report, ARTHROPOD STING (arm that swelled after a wasp stung) and PERIPHERAL SWELLING (arm swelled all the way up to the elbow/it just kept swelling) outcome was unknown.            No concomitant medications were provided by the reporter.   Patient was stung in early June and late June. She did not have any other bad reactions after vaccination.