chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Diabetes mellitus, Feeling abnormal, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling pretty bad) and VOMITING (vomiting ,the vomiting  comes and goes/Vomiting still ongoing) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure, Cholesterol and Diabetes. Concomitant products included METFORMIN for an unknown indication. On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced FEELING ABNORMAL (feeling pretty bad) and VOMITING (vomiting ,the vomiting  comes and goes/Vomiting still ongoing). At the time of the report, FEELING ABNORMAL (feeling pretty bad) and VOMITING (vomiting ,the vomiting  comes and goes/Vomiting still ongoing) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jun-2021, Diabetes mellitus (95-140 mg/dl): 230 mg/dl (High) 197mg/dl when measured again. On 02-Jun-2021, Diabetes mellitus (95-140 mg/dl): 105 mg/dl normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication include Blood pressure medication.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like side effects; 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 INFLUENZA LIKE ILLNESS (flu like 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 INFLUENZA LIKE ILLNESS (flu like side effects). At the time of the report, INFLUENZA LIKE ILLNESS (flu like side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Head discomfort, Vaccination site erythema, Vaccination site pain
Clinical narrative: Head was weak and heavy; redness spread from the site of injection down her arm and to her chest; Injection site very red; Burning at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Head was weak and heavy), ERYTHEMA (redness spread from the site of injection down her arm and to her chest), VACCINATION SITE ERYTHEMA (Injection site very red) and VACCINATION SITE PAIN (Burning at the injection site) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Anaphylactic reaction to amoxicillin).    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced HEAD DISCOMFORT (Head was weak and heavy), ERYTHEMA (redness spread from the site of injection down her arm and to her chest), VACCINATION SITE ERYTHEMA (Injection site very red) and VACCINATION SITE PAIN (Burning at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK, q6h. At the time of the report, HEAD DISCOMFORT (Head was weak and heavy), ERYTHEMA (redness spread from the site of injection down her arm and to her chest), VACCINATION SITE ERYTHEMA (Injection site very red) and VACCINATION SITE PAIN (Burning at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Patient had no airway issues. An electrocardiography was done and monitored her at the clinic.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Asthenia, Diarrhoea, Hyperhidrosis
Clinical narrative: Doesn't feel like getting up; Diarrhea; Cramping along the lower gut; Has sweats; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Doesn't feel like getting up), DIARRHOEA (Diarrhea), ABDOMINAL PAIN LOWER (Cramping along the lower gut) and HYPERHIDROSIS (Has sweats) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   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 ASTHENIA (Doesn't feel like getting up), DIARRHOEA (Diarrhea), ABDOMINAL PAIN LOWER (Cramping along the lower gut) and HYPERHIDROSIS (Has sweats). At the time of the report, ASTHENIA (Doesn't feel like getting up), DIARRHOEA (Diarrhea), ABDOMINAL PAIN LOWER (Cramping along the lower gut) and HYPERHIDROSIS (Has sweats) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow-up information received on 27-Jul-2021 and does not contain any new information.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Eye pruritus, Feeling hot, Rash erythematous, Rash pruritic
Clinical narrative: red itchy eyes; Feeling hot; red,itchy rash in both armpits, mid abdomen, both outer thighs; itchy rash in both armpits, mid abdomen, both outer thighs; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red,itchy rash in both armpits, mid abdomen, both outer thighs), RASH PRURITIC (itchy rash in both armpits, mid abdomen, both outer thighs), EYE PRURITUS (red itchy eyes) and FEELING HOT (Feeling hot) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol. Concomitant products included ATORVASTATIN for High cholesterol, MULTIVITAMIN [VITAMINS NOS] for Nutritional supplement, ACETYLSALICYLIC ACID (ASPIRIN 81), ACETYLSALICYLIC ACID (BABY ASPIRIN) and MINERALS NOS, VITAMINS NOS (CENTRUM JR [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced RASH ERYTHEMATOUS (red,itchy rash in both armpits, mid abdomen, both outer thighs) and RASH PRURITIC (itchy rash in both armpits, mid abdomen, both outer thighs). On an unknown date, the patient experienced EYE PRURITUS (red itchy eyes) and FEELING HOT (Feeling hot). At the time of the report, RASH ERYTHEMATOUS (red,itchy rash in both armpits, mid abdomen, both outer thighs), RASH PRURITIC (itchy rash in both armpits, mid abdomen, both outer thighs), EYE PRURITUS (red itchy eyes) and FEELING HOT (Feeling hot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Biopsy: normal (normal) fungus or dermatitis negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-200973 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Updated with patient demographic information and newevent as feeling hot, itchy eyes. concomitant drug information added.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swelling of lymph nodes; This spontaneous case was reported by a patient and describes the occurrence of LYMPHADENOPATHY (Swelling of lymph nodes) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3001658) for COVID-19 vaccination.     no medical history was reported.     On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced LYMPHADENOPATHY (Swelling of lymph nodes). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, LYMPHADENOPATHY (Swelling of lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for covid/Antigen covid test; 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 COVID-19 (tested positive for covid/Antigen covid test) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced COVID-19 (tested positive for covid/Antigen covid test). At the time of the report, COVID-19 (tested positive for covid/Antigen covid test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jun-2021, SARS-CoV-2 test: positive (Positive) SARS-CoV-2 test positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Rhinorrhoea
Clinical narrative: runny nose; left arm little sore; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose) and MYALGIA (left arm little sore) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced RHINORRHOEA (runny nose) and MYALGIA (left arm little sore). On 26-Mar-2021, RHINORRHOEA (runny nose) and MYALGIA (left arm little sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.   This case was linked to MOD-2021-201025 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient went ahead and got a second dose somewhere else a week later after first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient went ahead and got a second dose somewhere else a week later after first dose) 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 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient went ahead and got a second dose somewhere else a week later after first dose). In May 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient went ahead and got a second dose somewhere else a week later after first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.  The patient was supposed to have the second dose on 02-Jun-2021.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: woke up being dizzy; 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 DIZZINESS (woke up being dizzy ) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 DIZZINESS (woke up being dizzy ). At the time of the report, DIZZINESS (woke up being dizzy ) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment was reported.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: over the last three to four weeks I have lost send of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (over the last three to four weeks I have lost send of taste) 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 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced AGEUSIA (over the last three to four weeks I have lost send of taste). At the time of the report, AGEUSIA (over the last three to four weeks I have lost send of taste) outcome was unknown.            No relevant concomitant medications were reported.   Treatment information was not provided.  The patient stated that she changed one of her medications, she is not sure the medication or the vaccine caused the side effect.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Mobility decreased, Nausea, Pain
Clinical narrative: Couldn't move my body; Body aches; Nauseous; Headache; Chills - literally body shaking; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Couldn't move my body), PAIN (Body aches), NAUSEA (Nauseous), HEADACHE (Headache) and CHILLS (Chills - literally body shaking) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from 30-Dec-2020 to January 2021 and Breast cancer in 2018. Previously administered products included for an unreported indication: Shingles, ANTIBIOTICS (Used to treat Covid) and STEROIDS (Used to treat Covid). Concomitant products included LEVOTHYROXINE, VITAMIN D [VITAMIN D NOS] and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication, ASPIRIN [ACETYLSALICYLIC ACID].    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced MOBILITY DECREASED (Couldn't move my body), PAIN (Body aches), NAUSEA (Nauseous), HEADACHE (Headache) and CHILLS (Chills - literally body shaking). On 19-May-2021, MOBILITY DECREASED (Couldn't move my body), NAUSEA (Nauseous), HEADACHE (Headache) and CHILLS (Chills - literally body shaking) had resolved. At the time of the report, PAIN (Body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient awoke at 11:45 pm and with what was described as a horrible reaction with every symptom. Due to her symptoms, the patient was afraid to get up and potentially pass out. At 2 AM, the patient called her daughter to come over because she was even unable to get up to get water. The symptoms lasted about 16-18 hours and by the next afternoon, she was feeling better. The patient reported that she still had some nausea and achiness at the time of reporting.  Treatment information was not provided by the reporter. Patient took shingles vaccine 2 months before the Moderna Covid vaccine
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ¨Potential AE ¨as CC reported; 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 ADVERSE EVENT (¨Potential AE ¨as CC reported) 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 ADVERSE EVENT (¨Potential AE ¨as CC reported). At the time of the report, ADVERSE EVENT (¨Potential AE ¨as CC reported) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not provided and Treatment medication not reported   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: felt weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt weak) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (felt weak). At the time of the report, ASTHENIA (felt weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No demographics provided. No dose information elaborated. No medical history, concomitant medication provided.   This case was linked to MOD-2021-201027 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore arm) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 006C21A) for COVID-19 immunization. Concurrent medical conditions included shellfish allergy. Concomitant products included lisinopril and Pepcid AC (famotidine) for an unknown indication. On Jun 1, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 1, 2021, patient experienced pain in extremity (sore arm). At the time of the report,  pain in extremity (sore arm) outcome: unknown. mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; dosing remained unchanged. Treatment medicine not reported. Most recent follow-up information incorporated: On Jun 2, 2021: Added medical history, updated action taken: no change; updated verbatim of event to pain in extremity.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: Sweating; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013m20a and 038k20a) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-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 HYPERHIDROSIS (Sweating). At the time of the report, HYPERHIDROSIS (Sweating) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment information in response to events was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: felt weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt weak) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 ASTHENIA (felt weak). At the time of the report, ASTHENIA (felt weak) outcome was unknown.            No Concomitant medications were reported. No Treatment information was reported.   This case was linked to MOD-2021-200997 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Bone pain, Illness
Clinical narrative: I'm very sick; My bones hurt; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of BONE PAIN (My bones hurt) and ILLNESS (I'm very sick) 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 BONE PAIN (My bones hurt) and ILLNESS (I'm very sick). At the time of the report, BONE PAIN (My bones hurt) and ILLNESS (I'm very sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not mentioned   Reporter did not allow further contact
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache, continuous since vaccination; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache, continuous since vaccination) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 HEADACHE (Headache, continuous since vaccination). At the time of the report, HEADACHE (Headache, continuous since vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not provided.  Treatment medication not provided.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Pyrexia, Rash
Clinical narrative: Arm they shot me is extremely swollen; Little bumps are forming on skin; Very itchy; Hot/fevered; 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 PERIPHERAL SWELLING (Arm they shot me is extremely swollen), RASH (Little bumps are forming on skin), PRURITUS (Very itchy) and PYREXIA (Hot/fevered) 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 31-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, the patient experienced RASH (Little bumps are forming on skin), PRURITUS (Very itchy) and PYREXIA (Hot/fevered). On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm they shot me is extremely swollen). At the time of the report, PERIPHERAL SWELLING (Arm they shot me is extremely swollen), RASH (Little bumps are forming on skin), PRURITUS (Very itchy) and PYREXIA (Hot/fevered) outcome was unknown.            No concomitant medications were reported.  Treatment taken was reported as PII(32):AQPe2qajnrpINIXa02Sr1UOiU19n77po and, reportedly, was no help.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) 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) dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. No treatment was reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: After receiving the 2nd vaccine, I have no pain in my neck and me feet. I'm not taking any new medications, and its the first time in years I'm not having any pain; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (After receiving the 2nd vaccine, I have no pain in my neck and me feet. I'm not taking any new medications, and its the first time in years I'm not having any pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Degenerative bone disease and Osteoarthritis.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (After receiving the 2nd vaccine, I have no pain in my neck and me feet. I'm not taking any new medications, and its the first time in years I'm not having any pain). On 17-Apr-2021, THERAPEUTIC RESPONSE UNEXPECTED (After receiving the 2nd vaccine, I have no pain in my neck and me feet. I'm not taking any new medications, and its the first time in years I'm not having any pain) had resolved. Not Provided          For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant product used included unspecified medications.  Treatment medication use was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Why do i feel so achy; 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 MYALGIA (Why do i feel so achy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 MYALGIA (Why do i feel so achy). At the time of the report, MYALGIA (Why do i feel so achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided. No concomitant medication was provided.   Reporter did not allow further contact
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm injection site) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Gout. Concomitant products included ALLOPURINOL for Gout.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm injection site). At the time of the report, VACCINATION SITE PAIN (sore arm injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Bad diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Bad diarrhea) 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 DIARRHOEA (Bad diarrhea). At the time of the report, DIARRHOEA (Bad diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter. No laboratory provided by reporter Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: I'm having very bad chills I got the vaccine yesterday; 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 CHILLS (I'm having very bad chills I got the vaccine yesterday) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (I'm having very bad chills I got the vaccine yesterday). At the time of the report, CHILLS (I'm having very bad chills I got the vaccine yesterday) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant  medications  were reported. No treatment information  was provided.   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: body aches; chills; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), CHILLS (chills) and PYREXIA (low grade fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HCTZ) for Hypertension.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (body aches), CHILLS (chills) and PYREXIA (low grade fever). At the time of the report, MYALGIA (body aches), CHILLS (chills) and PYREXIA (low grade fever) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment of these events were not provided.   This case was linked to MOD-2021-021849 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Dyspnoea, Feeling abnormal, Pain in extremity
Clinical narrative: Every time I breathe I have pain; Soreness in arm; Has asthma; When moving around more noticed being winded/ thought I slept wrong; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNEA (Every time I breathe I have pain), PAIN IN EXTREMITY (Soreness in arm), ASTHMA (Has asthma) and FEELING ABNORMAL (When moving around more noticed being winded/ thought I slept wrong) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced DYSPNEA (Every time I breathe I have pain), PAIN IN EXTREMITY (Soreness in arm), ASTHMA (Has asthma) and FEELING ABNORMAL (When moving around more noticed being winded/ thought I slept wrong). At the time of the report, DYSPNEA (Every time I breathe I have pain), PAIN IN EXTREMITY (Soreness in arm), ASTHMA (Has asthma) and FEELING ABNORMAL (When moving around more noticed being winded/ thought I slept wrong) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: adverse effects; taking three to four naps daily; difficult to carry on daily activities; these shots have made my life unbearable; my feet feel like ice cubes/ her toes are like ice; one severe headache; severe chills all over my body/freezing all over; severe fatigue/tired all the time; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (adverse effects), SOMNOLENCE (taking three to four naps daily), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficult to carry on daily activities), FEELING ABNORMAL (these shots have made my life unbearable) and PERIPHERAL COLDNESS (my feet feel like ice cubes/ her toes are like ice) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (adverse effects), SOMNOLENCE (taking three to four naps daily), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficult to carry on daily activities), FEELING ABNORMAL (these shots have made my life unbearable), PERIPHERAL COLDNESS (my feet feel like ice cubes/ her toes are like ice), HEADACHE (one severe headache), CHILLS (severe chills all over my body/freezing all over) and FATIGUE (severe fatigue/tired all the time). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at a dose of 1 dosage form. At the time of the report, ADVERSE EVENT (adverse effects), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficult to carry on daily activities), FEELING ABNORMAL (these shots have made my life unbearable), CHILLS (severe chills all over my body/freezing all over) and FATIGUE (severe fatigue/tired all the time) outcome was unknown and SOMNOLENCE (taking three to four naps daily), PERIPHERAL COLDNESS (my feet feel like ice cubes/ her toes are like ice) and HEADACHE (one severe headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient said that these shots have saved her life  Patient said that there were a lot of side effects     Patient stated that HCP was trying to set up a sleep test at the hospital for the fatigue  Patient stated she does not have a computer and requested information be mailed to her No concomitant medications were provided. No lab data has been provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up contains significant information event added as her toes are like ice.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Peripheral coldness, Somnolence
Clinical narrative: adverse effects; taking three to four naps daily; difficult to carry on daily activities; these shots have made my life unbearable; my feet feel like ice cubes/ her toes are like ice; one severe headache; severe chills all over my body/freezing all over; severe fatigue/tired all the time; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (adverse effects), SOMNOLENCE (taking three to four naps daily), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficult to carry on daily activities), FEELING ABNORMAL (these shots have made my life unbearable) and PERIPHERAL COLDNESS (my feet feel like ice cubes/ her toes are like ice) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (adverse effects), SOMNOLENCE (taking three to four naps daily), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficult to carry on daily activities), FEELING ABNORMAL (these shots have made my life unbearable), PERIPHERAL COLDNESS (my feet feel like ice cubes/ her toes are like ice), HEADACHE (one severe headache), CHILLS (severe chills all over my body/freezing all over) and FATIGUE (severe fatigue/tired all the time). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at a dose of 1 dosage form. At the time of the report, ADVERSE EVENT (adverse effects), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficult to carry on daily activities), FEELING ABNORMAL (these shots have made my life unbearable), CHILLS (severe chills all over my body/freezing all over) and FATIGUE (severe fatigue/tired all the time) outcome was unknown and SOMNOLENCE (taking three to four naps daily), PERIPHERAL COLDNESS (my feet feel like ice cubes/ her toes are like ice) and HEADACHE (one severe headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient said that these shots have saved her life  Patient said that there were a lot of side effects     Patient stated that HCP was trying to set up a sleep test at the hospital for the fatigue  Patient stated she does not have a computer and requested information be mailed to her No concomitant medications were provided. No lab data has been provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up contains significant information event added as her toes are like ice.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Hands swollen painful and red; Hands swollen painful and red; Hands swollen painful and red; 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 PAIN IN EXTREMITY (Hands swollen painful and red), PERIPHERAL SWELLING (Hands swollen painful and red) and ERYTHEMA (Hands swollen painful and red) 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 PAIN IN EXTREMITY (Hands swollen painful and red), PERIPHERAL SWELLING (Hands swollen painful and red) and ERYTHEMA (Hands swollen painful and red). At the time of the report, PAIN IN EXTREMITY (Hands swollen painful and red), PERIPHERAL SWELLING (Hands swollen painful and red) and ERYTHEMA (Hands swollen painful and red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. Treatment information not reported.
Sex: U
Vaccine: COVID19
Symptoms: Memory impairment
Clinical narrative: memory effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of MEMORY IMPAIRMENT (memory effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    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 MEMORY IMPAIRMENT (memory effects). At the time of the report, MEMORY IMPAIRMENT (memory effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not mentioned. Treatment medications were not reported   Reporter did not allow further contact
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Pfizer vaccine for her second dose in right deltoid; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Pfizer vaccine for her second dose in right deltoid) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 02-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Pfizer vaccine for her second dose in right deltoid). On 02-Jun-2021, INTERCHANGE OF VACCINE PRODUCTS (Pfizer vaccine for her second dose in right deltoid) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter. The treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received 29-JUL-2021. Added reporter's comment no AE experienced as a result of the event to the narrative.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: delayed full body rash; 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 RASH (delayed full body rash) 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 RASH (delayed full body rash). At the time of the report, RASH (delayed full body rash) outcome was unknown.            No concomitant and treatment medications were reported.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Wrong patient received product, Wrong product administered
Clinical narrative: accidentally gave Moderna Covid-19 vaccine to the wrong patient; accidentally gave the wrong medication to the wrong patient; vaccine was given subcutaneously; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of WRONG PRODUCT ADMINISTERED (accidentally gave Moderna Covid-19 vaccine to the wrong patient), WRONG PATIENT RECEIVED PRODUCT (accidentally gave the wrong medication to the wrong patient) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (vaccine was given subcutaneously) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     Concomitant products included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for an unknown indication.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 02-Jun-2021, the patient experienced WRONG PRODUCT ADMINISTERED (accidentally gave Moderna Covid-19 vaccine to the wrong patient), WRONG PATIENT RECEIVED PRODUCT (accidentally gave the wrong medication to the wrong patient) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (vaccine was given subcutaneously). On 02-Jun-2021, WRONG PRODUCT ADMINISTERED (accidentally gave Moderna Covid-19 vaccine to the wrong patient), WRONG PATIENT RECEIVED PRODUCT (accidentally gave the wrong medication to the wrong patient) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (vaccine was given subcutaneously) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   No treatment information provided by the reporter; Sender's Comments: This report refers to a case of Wrong product administrated, wrong patient received product and Incorrect route of drug administered  for mRNA-1273, lot # 033B21A with no associated AEs.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: My body is magnetic after de first schot; 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 FEELING ABNORMAL (My body is magnetic after de first schot) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (My body is magnetic after de first schot). At the time of the report, FEELING ABNORMAL (My body is magnetic after de first schot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were unknown.