chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Rash, Vaccination site erythema
Clinical narrative: Sore arm; red 5-6 cm oval area at injection site on day 7/had flat edges and was hyperemic; more red than rest of the rash; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PAIN (Sore arm), VACCINATION SITE ERYTHEMA (red 5-6 cm oval area at injection site on day 7/had flat edges and was hyperemic) and RASH (more red than rest of the rash) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced INJECTION SITE PAIN (Sore arm), VACCINATION SITE ERYTHEMA (red 5-6 cm oval area at injection site on day 7/had flat edges and was hyperemic) and RASH (more red than rest of the rash). On 12-Jan-2021, INJECTION SITE PAIN (Sore arm), VACCINATION SITE ERYTHEMA (red 5-6 cm oval area at injection site on day 7/had flat edges and was hyperemic) and RASH (more red than rest of the rash) had resolved.        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.   Treatment includes cortisone cream.  Concomitant medication was not provided.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events 9 days after vaccination, a causal relationship cannot be excluded. Further information has been requested
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: fever; chills; body ache/muscle ache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), PYREXIA (fever), CHILLS (chills) and MYALGIA (body ache/muscle ache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 13-Jan-2021, the patient experienced PYREXIA (fever), CHILLS (chills) and MYALGIA (body ache/muscle ache). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of UNK dosage form and PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PAIN (sore arm), PYREXIA (fever), CHILLS (chills) and MYALGIA (body ache/muscle ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Pain in extremity, Vaccination site swelling
Clinical narrative: Headache; Neck was hot; Legs began hurting; Chills; Injection site arm is swollen; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Neck was hot), PAIN IN EXTREMITY (Legs began hurting), CHILLS (Chills), VACCINATION SITE SWELLING (Injection site arm is swollen) and HEADACHE (Headache) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 18-Dec-2020.    On 10-Jan-2021 at 11:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced FEELING HOT (Neck was hot), PAIN IN EXTREMITY (Legs began hurting), CHILLS (Chills) and VACCINATION SITE SWELLING (Injection site arm is swollen). On 11-Jan-2021, the patient experienced HEADACHE (Headache). On 10-Jan-2021, FEELING HOT (Neck was hot) and CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (Legs began hurting), VACCINATION SITE SWELLING (Injection site arm is swollen) and HEADACHE (Headache) 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.   Concomitant product use was not provided by the reporter. Treatment included Tylenol.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Sinusitis.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment Medications includes Cefomex 5 pills, for sinusitis   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Updated the Patient demographic details.Updated the second dose information.Updated the outcome of the event sore arm from recovering to Recovered/Resolved. Patient denied further follow up.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Malaise
Clinical narrative: Not feeling well; High blood pressure; This spontaneous case was reported by a health care professional and describes the occurrence of MALAISE (Not feeling well) and HYPERTENSION (High blood pressure) 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 event (No reported medical history.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Not feeling well) and HYPERTENSION (High blood pressure). At the time of the report, MALAISE (Not feeling well) and HYPERTENSION (High blood pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: (High) High blood pressure..     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 reported by investigator  No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Pyrexia, Tremor
Clinical narrative: Felt really cold; Shaking all over the place; Broke into chills; Fever; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FEELING COLD (Felt really cold), TREMOR (Shaking all over the place), CHILLS (Broke into chills) and PYREXIA (Fever) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced FEELING COLD (Felt really cold). 08-Jan-2021, the patient experienced TREMOR (Shaking all over the place), CHILLS (Broke into chills) and PYREXIA (Fever). On 08-Jan-2021, FEELING COLD (Felt really cold), TREMOR (Shaking all over the place), CHILLS (Broke into chills) and PYREXIA (Fever) had resolved.        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.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Slight headache; Left arm, near the injection site, is slightly sore, a pain level around 3-4/achiness; soreness and achiness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Left arm, near the injection site, is slightly sore, a pain level around 3-4/achiness; soreness and achiness at injection site) and HEADACHE (Slight headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy (Occasional), Allergy to plants, Ragweed allergy and Hypercholesterolemia since 15-Oct-2018. Concomitant products included ATORVASTATIN from 15-Oct-2018 to an unknown date for Hypercholesteraemia.    On 11-Jan-2021 at 10:43 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021 at 1:10 PM, the patient experienced VACCINATION SITE PAIN (Left arm, near the injection site, is slightly sore, a pain level around 3-4/achiness; soreness and achiness at injection site). On 12-Jan-2021, the patient experienced HEADACHE (Slight headache). The patient was treated with IBUPROFEN (ADVIL LIQUI GELS) on 12-Jan-2021 at a dose of 200 mg. On 12-Jan-2021, HEADACHE (Slight headache) had resolved. On 12-Jan-2021 at 5:10 PM, VACCINATION SITE PAIN (Left arm, near the injection site, is slightly sore, a pain level around 3-4/achiness; soreness and achiness at injection site) had resolved.            The patient reported her headache lasted for a few hours despite caffeine intake.   This case was linked to MOD-2021-212871 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up information received on 07 JUN 2021 contain: Patient demographics were updated,medical history updated, concomitant medication and treatment information was updated. Event Headache was added. Outcome of the event Vaccination site pain was updated from Unknown to recovered; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN (arm was sore after receiving the vaccine (where she received the shot)) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J020A) for COVID-19 vaccination.  No Medical History information was reported.  On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (arm was sore after receiving the vaccine (where she received the shot)). At the time of the report, VACCINATION SITE PAIN (arm was sore after receiving the vaccine (where she received the shot)) 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.   Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: pain and soreness in arm and shoulder; pain and soreness in arm and shoulder; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (pain and soreness in arm and shoulder) and ARTHRALGIA (pain and soreness in arm and shoulder) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain and soreness in arm and shoulder) and ARTHRALGIA (pain and soreness in arm and shoulder). At the time of the report, PAIN IN EXTREMITY (pain and soreness in arm and shoulder) and ARTHRALGIA (pain and soreness in arm and shoulder) 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 relevant concomitant medications were reported.    No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: heaviness of the left arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (heaviness of the left arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced LIMB DISCOMFORT (heaviness of the left arm). The patient was treated with PARACETAMOL (TYLENOL) from January 2021 to January 2021 for Limb discomfort, at a dose of 2 doses. On 08-Jan-2021, LIMB DISCOMFORT (heaviness of the left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow-up information received on 28-JUN-2021 contains non-significant information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Body temperature, Diarrhoea, Pyrexia
Clinical narrative: diarrhea; low grade fever; blood sugar went up; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (blood sugar went up), DIARRHOEA (diarrhea) and PYREXIA (low grade fever) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus (controlled with medication, no insulin dependence, usually fairly good blood sugar readings). Concomitant products included METFORMIN for Type 2 diabetes mellitus, LORATADINE, VALSARTAN and SIMVASTATIN for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced BLOOD GLUCOSE INCREASED (blood sugar went up) and PYREXIA (low grade fever). On 09-Jan-2021, the patient experienced DIARRHOEA (diarrhea). On 10-Jan-2021, DIARRHOEA (diarrhea) and PYREXIA (low grade fever) had resolved. At the time of the report, BLOOD GLUCOSE INCREASED (blood sugar went up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Blood glucose: 120 High, 160 High and 180 High. On 08-Jan-2021, Body temperature: around 99.5 degrees f High and 101.25 degrees f (maximum) High.     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 medications were not provided by reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.  Patient's underlying diabetes is considered a confounder for the event of blood glucose increased.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Injection site erythema, Injection site warmth, Rhinorrhoea, Swelling face
Clinical narrative: Eyes swelling; Face swelling; Runny nose; Hot at the injection site; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eyes swelling), SWELLING FACE (Face swelling), RHINORRHOEA (Runny nose), INJECTION SITE WARMTH (Hot at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Migraine. Concurrent medical conditions included Anxiety and Depression.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced EYE SWELLING (Eyes swelling), SWELLING FACE (Face swelling), RHINORRHOEA (Runny nose), INJECTION SITE WARMTH (Hot at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; LORATADINE (CLARITIN [LORATADINE]) for Allergy, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) at an unspecified dose and frequency. On 31-Dec-2020, EYE SWELLING (Eyes swelling) and SWELLING FACE (Face swelling) had resolved. At the time of the report, RHINORRHOEA (Runny nose), INJECTION SITE WARMTH (Hot at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant  medication includes antianxiety , depression and migraine medication .; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: site of injection was warm to touch; site of injection was red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (site of injection was warm to touch) and INJECTION SITE ERYTHEMA (site of injection was red) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced INJECTION SITE WARMTH (site of injection was warm to touch) and INJECTION SITE ERYTHEMA (site of injection was red). At the time of the report, INJECTION SITE WARMTH (site of injection was warm to touch) and INJECTION SITE ERYTHEMA (site of injection was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: He noticed in the area of the injcetion a big redness; Vaccination site warmth; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (He noticed in the area of the injcetion a big redness) and VACCINATION SITE WARMTH (Vaccination site warmth) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol high and Osteoporosis.    On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (He noticed in the area of the injcetion a big redness) and VACCINATION SITE WARMTH (Vaccination site warmth). At the time of the report, VACCINATION SITE ERYTHEMA (He noticed in the area of the injcetion a big redness) and VACCINATION SITE WARMTH (Vaccination site warmth) 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 medication includes for elevated cholesterol and for osteoporosis. Treatment information was not provided.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Eye pruritus, Periorbital oedema, Peripheral swelling
Clinical narrative: A spontaneous report was received from a 68 years female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced squashy neck and face, eyes dry, eye itchy and swollen arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 14-Jan-2021, prior to the onset of the events squashy neck and face, eyes dry, eye itchy and swollen arm, the patient received their first of two planned doses of mRNA-1273 (lot/batch: or unknown) via an unknown route in left arm for prophylaxis of COVID-19 infection.  On 14-Jan-2021, the patient experienced squashy neck and face, eyes dry, eye itchy and swollen arm.  Patient received steroid as treatment medication.  Action taken with mRNA-1273 in response to the events squashy neck and face, eyes dry, eye itchy and swollen arm was not reported.  The outcome of the events squashy neck and face, eyes dry, eye itchy and swollen arm was not provided.  The reporter did not provide the assessment assessed the events squashy neck and face, eyes dry, eye itchy and swollen arm to study drug.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; Loss of taste; Loss of smell; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste), ANOSMIA (Loss of smell) and COVID-19 (Tested positive for COVID-19) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell). On 10-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, AGEUSIA (Loss of taste), ANOSMIA (Loss of smell) and COVID-19 (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: This case concerns a 49-year-old female with nonserious unexpected events of COVID-19, ageusia, and anosmia. Event onset 6 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for covid-19 days after the first dose of moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for covid-19 days after the first dose of moderna vaccine) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037k20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Dyslipidemia and Depression.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for covid-19 days after the first dose of moderna vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for covid-19 days after the first dose of moderna vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, SARS-CoV-2 test positive: positive (Positive) POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included taking blood pressure medication, cholesterol medication and antidepressant medication.  Treatment for the events not reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: TCR; Sender's Comments: Based on reporter's causality  the event SARS-COV-2 TEST POSITIVE  is assessed as unlikely related to mRNA-1273.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain
Clinical narrative: inappropriate schedule of vaccine administered; Mild paresthesia on right thigh area like tingling sensation; tingling crawling sensation; Head ache; Pain and swelling site of injection; Localized pain; 1/2 inch diameter at site of injection; Hardness on area; This spontaneous case was reported by a nurse and describes the occurrence of PARAESTHESIA (Mild paresthesia on right thigh area like tingling sensation), FORMICATION (tingling crawling sensation), VACCINATION SITE INDURATION (Hardness on area), HEADACHE (Head ache) and INJECTION SITE SWELLING (Pain and swelling site of injection) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension in 2003, Allergy to animal dander (Allergic to cat dander) and Shellfish allergy (Allergic to raw shrimp). Concomitant products included LOSARTAN and HYDROCHLOROTHIAZIDE for Hypertension, MEDROXYPROGESTERONE, POTASSIUM CHLORIDE (K-TAB) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Dec-2020, the patient experienced VACCINATION SITE INDURATION (Hardness on area), INJECTION SITE SWELLING (Pain and swelling site of injection) and VACCINATION SITE PAIN (Localized pain; 1/2 inch diameter at site of injection). On 23-Dec-2020, the patient experienced PARAESTHESIA (Mild paresthesia on right thigh area like tingling sensation), FORMICATION (tingling crawling sensation) and HEADACHE (Head ache). On 05-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On 25-Dec-2020, VACCINATION SITE INDURATION (Hardness on area), INJECTION SITE SWELLING (Pain and swelling site of injection) and VACCINATION SITE PAIN (Localized pain; 1/2 inch diameter at site of injection) had resolved. On 05-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved. At the time of the report, PARAESTHESIA (Mild paresthesia on right thigh area like tingling sensation) and FORMICATION (tingling crawling sensation) had not resolved and HEADACHE (Head ache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient did not seek treatment or advise from her physician.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Medical history updated, patient demographic details updated, concomitant medications updated, event outcome updated, new event inappropriate schedule of vaccine added based on 2nd dose information received; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Burning; arm got a llittel red/red bump; bump started to become itchy; Little bump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (bump started to become itchy), VACCINATION SITE PAIN (Burning), VACCINATION SITE SWELLING (Little bump) and VACCINATION SITE ERYTHEMA (arm got a llittel red/red bump) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.  On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced VACCINATION SITE PAIN (Burning), VACCINATION SITE SWELLING (Little bump) and VACCINATION SITE ERYTHEMA (arm got a llittel red/red bump). On 08-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (bump started to become itchy). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Vaccination site swelling and Vaccination site pruritus, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (bump started to become itchy) had resolved, VACCINATION SITE PAIN (Burning) outcome was unknown and VACCINATION SITE SWELLING (Little bump) and VACCINATION SITE ERYTHEMA (arm got a llittel red/red bump) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Cyanosis, Feeling cold, Headache
Clinical narrative: Lips were blue; Shaking uncontrolably; Sweating; Skin was pale; Cold; Weak; Felt like she was dying; Puked; Backache; Injection site was red; Injection site was swollen; Headache; A spontaneous report was received from a female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, shaking uncontrollably, sweating, cold, puked, lips were blue, skin was pale, weak, backache, headache, felt like she was dying, injection site was red, and injection site was swollen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 14 Jan 2021 at 2 pm, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 14 Jan 2021, at 11 pm, when the patient stood up, immediately she was shaking uncontrollably, started to sweat, felt cold, weak, pale and felt like she was dying. She puked and her lips turned blue. The patient was unsure if her neck injury was contributing to her headache and backache or if it was caused by the vaccine. An ambulance was called and they stayed with the patient but opted to not take her to the hospital. No treatment information was provided.   On 17 Jan 2021, the patient reported that she was recuperating but her injection site was still red and swollen.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events, shaking uncontrollably, sweating, cold, puked, lips were blue, skin was pale, weak, backache, headache, and felt like she was dying, was considered resolving. The outcome for the events,  injection site was red and injection site was swollen, was considered not resolved.; Reporter's Comments: This case concerns a female patient, who experienced a non-serious unexpected event of cyanosis, tremor, hyperhidrosis, pallor, feeling cold, asthenia, malaise, and back pain, and non-serious expected events of injection site erythema, injection site swelling, headache, and vomiting. The events of cyanosis, tremor, hyperhidrosis, pallor, feeling cold, asthenia, malaise, and vomiting occurred 9 hrs. after first dose of mRNA-1273, lot # 012L20A. The event of injection site erythema, injection site swelling, and headache occurred on an unspecified date after first dose of mRNA-1273, lot # 012L20A. Treatment details was not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Injection site erythema, Injection site swelling, Malaise, Pallor
Clinical narrative: Lips were blue; Shaking uncontrolably; Sweating; Skin was pale; Cold; Weak; Felt like she was dying; Puked; Backache; Injection site was red; Injection site was swollen; Headache; A spontaneous report was received from a female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, shaking uncontrollably, sweating, cold, puked, lips were blue, skin was pale, weak, backache, headache, felt like she was dying, injection site was red, and injection site was swollen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 14 Jan 2021 at 2 pm, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 14 Jan 2021, at 11 pm, when the patient stood up, immediately she was shaking uncontrollably, started to sweat, felt cold, weak, pale and felt like she was dying. She puked and her lips turned blue. The patient was unsure if her neck injury was contributing to her headache and backache or if it was caused by the vaccine. An ambulance was called and they stayed with the patient but opted to not take her to the hospital. No treatment information was provided.   On 17 Jan 2021, the patient reported that she was recuperating but her injection site was still red and swollen.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events, shaking uncontrollably, sweating, cold, puked, lips were blue, skin was pale, weak, backache, headache, and felt like she was dying, was considered resolving. The outcome for the events,  injection site was red and injection site was swollen, was considered not resolved.; Reporter's Comments: This case concerns a female patient, who experienced a non-serious unexpected event of cyanosis, tremor, hyperhidrosis, pallor, feeling cold, asthenia, malaise, and back pain, and non-serious expected events of injection site erythema, injection site swelling, headache, and vomiting. The events of cyanosis, tremor, hyperhidrosis, pallor, feeling cold, asthenia, malaise, and vomiting occurred 9 hrs. after first dose of mRNA-1273, lot # 012L20A. The event of injection site erythema, injection site swelling, and headache occurred on an unspecified date after first dose of mRNA-1273, lot # 012L20A. Treatment details was not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: Lips were blue; Shaking uncontrolably; Sweating; Skin was pale; Cold; Weak; Felt like she was dying; Puked; Backache; Injection site was red; Injection site was swollen; Headache; A spontaneous report was received from a female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, shaking uncontrollably, sweating, cold, puked, lips were blue, skin was pale, weak, backache, headache, felt like she was dying, injection site was red, and injection site was swollen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 14 Jan 2021 at 2 pm, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 14 Jan 2021, at 11 pm, when the patient stood up, immediately she was shaking uncontrollably, started to sweat, felt cold, weak, pale and felt like she was dying. She puked and her lips turned blue. The patient was unsure if her neck injury was contributing to her headache and backache or if it was caused by the vaccine. An ambulance was called and they stayed with the patient but opted to not take her to the hospital. No treatment information was provided.   On 17 Jan 2021, the patient reported that she was recuperating but her injection site was still red and swollen.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events, shaking uncontrollably, sweating, cold, puked, lips were blue, skin was pale, weak, backache, headache, and felt like she was dying, was considered resolving. The outcome for the events,  injection site was red and injection site was swollen, was considered not resolved.; Reporter's Comments: This case concerns a female patient, who experienced a non-serious unexpected event of cyanosis, tremor, hyperhidrosis, pallor, feeling cold, asthenia, malaise, and back pain, and non-serious expected events of injection site erythema, injection site swelling, headache, and vomiting. The events of cyanosis, tremor, hyperhidrosis, pallor, feeling cold, asthenia, malaise, and vomiting occurred 9 hrs. after first dose of mRNA-1273, lot # 012L20A. The event of injection site erythema, injection site swelling, and headache occurred on an unspecified date after first dose of mRNA-1273, lot # 012L20A. Treatment details was not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: a lot of pain all the way to my neck and shoulder blade; a lot of pain all the way to my neck and shoulder blade; sore arm; A spontaneous report was received from a consumer concerning a 36 year old female patient who received Moderna's COVID-19 vaccine and experienced a sore arm and a lot of pain all the way to my neck and shoulder blade.  The patient's medical history was not provided. No concomitant medications were reported.   On 16-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number 042L20A) intramuscularly for prophylaxis of COVID-19 infection.  Patient stated that at first she did not have any serious side effects just a sore arm. Upon call back on 18-Jan-2021 patient stated that the vaccine was given in the left arm, almost to her shoulder bone/upper arm. She had a lot of pain all the way to her neck and shoulder blade. Patient reported that she is taking ibuprofen 400mg.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events sore arm and a lot of pain all the way to my neck and shoulder blade is unknown.; Reporter's Comments: This case concerns a 36-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 042L20A), and who experienced the non-serious listed event of Arthralgia and the non-serious unlisted events of Pain in extremity and Neck pain.  Based on the current available information and temporal association between the use of the product and the onset of events after vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pain in extremity
Clinical narrative: I'm on my first trimester of pregnancy; sore in arm for a couple of days; This spontaneous prospective pregnancy case was reported by a dietician and describes the occurrence of   in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 25-Aug-2021. Not Provided      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 medication information was not provided.  Treatment information was not provided.   Company Comment   This is a case of product exposure during pregnancy with associated event of pain in extremity for this 32-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. The event of exposure during pregnancy is assessed as not applicable. The event of pain in extremity is assessed to be possibly related to mRNA-1273.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow up received as no new information.; Sender's Comments: This is a case of product exposure during pregnancy with associated event of pain in extremity for this 32-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. The event of exposure during pregnancy is assessed as not applicable. The event of pain in extremity is assessed to be possibly related to mRNA-1273.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: swollen red hot spot at the injection site; swollen hot red spot on the injection site which was itchy; swollen red hot spot at the injection site; swollen red hot spot at the injection site; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE WARMTH (swollen red hot spot at the injection site), VACCINATION SITE PRURITUS (swollen hot red spot on the injection site which was itchy), VACCINATION SITE SWELLING (swollen red hot spot at the injection site) and VACCINATION SITE ERYTHEMA (swollen red hot spot at the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE WARMTH (swollen red hot spot at the injection site), VACCINATION SITE PRURITUS (swollen hot red spot on the injection site which was itchy), VACCINATION SITE SWELLING (swollen red hot spot at the injection site) and VACCINATION SITE ERYTHEMA (swollen red hot spot at the injection site). At the time of the report, VACCINATION SITE WARMTH (swollen red hot spot at the injection site), VACCINATION SITE PRURITUS (swollen hot red spot on the injection site which was itchy), VACCINATION SITE SWELLING (swollen red hot spot at the injection site) and VACCINATION SITE ERYTHEMA (swollen red hot spot at the injection site) 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. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Non-significant Follow Up append - Reporter Email Address updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Injection site urticaria; Injection site erythema; Injection site swelling; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an attorney (subsequently medically confirmed) and describes the occurrence of INJECTION SITE URTICARIA (Injection site urticaria), INJECTION SITE ERYTHEMA (Injection site erythema) and INJECTION SITE SWELLING (Injection site swelling) 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 event (no medical history 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 INJECTION SITE URTICARIA (Injection site urticaria), INJECTION SITE ERYTHEMA (Injection site erythema) and INJECTION SITE SWELLING (Injection site swelling). At the time of the report, INJECTION SITE URTICARIA (Injection site urticaria), INJECTION SITE ERYTHEMA (Injection site erythema) and INJECTION SITE SWELLING (Injection site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-005587 (Patient Link).