chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Vaccination complication, Vaccination site pruritus, Vaccination site rash
Clinical narrative: COVID arm; Rash and itches below site of injection; Rash and itches below site of injection; Like a spider bite; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID arm), VACCINATION SITE PRURITUS (Rash and itches below site of injection), VACCINATION SITE RASH (Rash and itches below site of injection) and ARTHROPOD BITE (Like a spider bite) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included LISINOPRIL, AMLODIPINE and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (COVID arm), VACCINATION SITE PRURITUS (Rash and itches below site of injection), VACCINATION SITE RASH (Rash and itches below site of injection) and ARTHROPOD BITE (Like a spider bite). At the time of the report, VACCINATION COMPLICATION (COVID arm), VACCINATION SITE PRURITUS (Rash and itches below site of injection), VACCINATION SITE RASH (Rash and itches below site of injection) and ARTHROPOD BITE (Like a spider bite) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were levities and medicine for eyes for drug use for unknown indication. No Treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: Potential Adverse Event because of a infection that occurred after receiving the first dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (Potential Adverse Event because of a infection that occurred after receiving the first dose of Moderna COVID-19 vaccine) 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 16-Jan-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 INFECTION (Potential Adverse Event because of a infection that occurred after receiving the first dose of Moderna COVID-19 vaccine). At the time of the report, INFECTION (Potential Adverse Event because of a infection that occurred after receiving the first dose of Moderna COVID-19 vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information was provided. No relevant Concomitant medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Symptom recurrence
Clinical narrative: I'm having symptoms just like the ones I had during my COVID experience; This spontaneous case was reported by a consumer and describes the occurrence of SYMPTOM RECURRENCE (I'm having symptoms just like the ones I had during my COVID experience) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 21-Jan-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 SYMPTOM RECURRENCE (I'm having symptoms just like the ones I had during my COVID experience). At the time of the report, SYMPTOM RECURRENCE (I'm having symptoms just like the ones I had during my COVID experience) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive description as a covid survivor..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported. Treatment details were not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Skin reaction, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Delayed Reaction; Itching Injection Site came back worst than the first time/Erythema and Redness restarted larger area 4-5" Site of injection; Moderate Itching Injection Site; Moderate Erythema Injection Site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Jan-2021 and was forwarded to Moderna on 28-Jan-2021.    This spontaneous case was reported by a physician and describes the occurrence of SKIN REACTION (Delayed Reaction), CONDITION AGGRAVATED (Itching Injection Site came back worst than the first time/Erythema and Redness restarted larger area 4-5" Site of injection), VACCINATION SITE PRURITUS (Moderate Itching Injection Site) and VACCINATION SITE ERYTHEMA (Moderate Erythema Injection Site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-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 VACCINATION SITE PRURITUS (Moderate Itching Injection Site) and VACCINATION SITE ERYTHEMA (Moderate Erythema Injection Site). On 18-Jan-2021, the patient experienced SKIN REACTION (Delayed Reaction) and CONDITION AGGRAVATED (Itching Injection Site came back worst than the first time/Erythema and Redness restarted larger area 4-5" Site of injection). On 11-Jan-2021, VACCINATION SITE PRURITUS (Moderate Itching Injection Site) and VACCINATION SITE ERYTHEMA (Moderate Erythema Injection Site) had resolved. On 22-Jan-2021, SKIN REACTION (Delayed Reaction) and CONDITION AGGRAVATED (Itching Injection Site came back worst than the first time/Erythema and Redness restarted larger area 4-5" Site of injection) 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.   No concomitant medications were reported.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: No specific follow-up information recorded.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Felt a little dizzy no more than 15 minutes after; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt a little dizzy no more than 15 minutes after) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced DIZZINESS (Felt a little dizzy no more than 15 minutes after). On 02-Feb-2021, DIZZINESS (Felt a little dizzy no more than 15 minutes after) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported. No Treatment information was provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Chills, Pyrexia
Clinical narrative: Abdominal pain in the upper right quadrant; Fever; Chills; This spontaneous case was reported by a health care professional and describes the occurrence of ABDOMINAL PAIN UPPER (Abdominal pain in the upper right quadrant), PYREXIA (Fever) and CHILLS (Chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included GERD.    On 07-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Abdominal pain in the upper right quadrant). At the time of the report, ABDOMINAL PAIN UPPER (Abdominal pain in the upper right quadrant), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Body temperature: 101.5 f High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant Concomitant medications were reported. Treatment details included Tylenol and Pepcid AC.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Nausea
Clinical narrative: Diarrhea; Chills; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), CHILLS (Chills) and NAUSEA (Nauseous) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), CHILLS (Chills) and NAUSEA (Nauseous). At the time of the report, DIARRHOEA (Diarrhea), CHILLS (Chills) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysstasia, Insomnia, Myalgia, Pain in extremity
Clinical narrative: feels like an old lady; can't stand; having trouble sleeping; hand hurts; Muscles ache, body ache; High Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feels like an old lady), DYSSTASIA (can't stand), INSOMNIA (having trouble sleeping), PAIN IN EXTREMITY (hand hurts) and MYALGIA (Muscles ache, body ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart disease, unspecified.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced ASTHENIA (feels like an old lady), DYSSTASIA (can't stand), INSOMNIA (having trouble sleeping), PAIN IN EXTREMITY (hand hurts), MYALGIA (Muscles ache, body ache) and PYREXIA (High Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ASTHENIA (feels like an old lady), DYSSTASIA (can't stand), INSOMNIA (having trouble sleeping), PAIN IN EXTREMITY (hand hurts), MYALGIA (Muscles ache, body ache) and PYREXIA (High Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: reporter contact details updated (email ID).
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: feels like an old lady; can't stand; having trouble sleeping; hand hurts; Muscles ache, body ache; High Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feels like an old lady), DYSSTASIA (can't stand), INSOMNIA (having trouble sleeping), PAIN IN EXTREMITY (hand hurts) and MYALGIA (Muscles ache, body ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart disease, unspecified.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced ASTHENIA (feels like an old lady), DYSSTASIA (can't stand), INSOMNIA (having trouble sleeping), PAIN IN EXTREMITY (hand hurts), MYALGIA (Muscles ache, body ache) and PYREXIA (High Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ASTHENIA (feels like an old lady), DYSSTASIA (can't stand), INSOMNIA (having trouble sleeping), PAIN IN EXTREMITY (hand hurts), MYALGIA (Muscles ache, body ache) and PYREXIA (High Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: reporter contact details updated (email ID).
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Rash, Serum sickness, Vaccination site swelling, Vaccination site warmth
Clinical narrative: warmth to the area; evolved into a larger rash; swelling to the area; Serum sickness-like reaction; joint pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (warmth to the area), RASH (evolved into a larger rash), VACCINATION SITE SWELLING (swelling to the area), SERUM SICKNESS (Serum sickness-like reaction) and ARTHRALGIA (joint pain) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (warmth to the area), RASH (evolved into a larger rash), VACCINATION SITE SWELLING (swelling to the area), SERUM SICKNESS (Serum sickness-like reaction) and ARTHRALGIA (joint pain). At the time of the report, VACCINATION SITE WARMTH (warmth to the area), RASH (evolved into a larger rash), VACCINATION SITE SWELLING (swelling to the area), SERUM SICKNESS (Serum sickness-like reaction) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and Concomitant medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Exhaustion; Headaches after the Moderna COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Exhaustion) and HEADACHE (Headaches after the Moderna COVID-19) in a female patient of an unknown age 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-Feb-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Exhaustion) and HEADACHE (Headaches after the Moderna COVID-19). At the time of the report, FATIGUE (Exhaustion) and HEADACHE (Headaches after the Moderna COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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. 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. MOD-2021-025616:patient case
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (I have a 10 month old and she is currently nursing) in a 10-month-old female infant exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination. MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding. No Medical History information was reported. On 04-Feb-2021, the mother received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the infant was diagnosed with EXPOSURE VIA BREAST MILK (I have a 10 month old and she is currently nursing). At the time of the report, EXPOSURE VIA BREAST MILK (I have a 10 month old and she is currently nursing) outcome was unknown. No relevant concomitant medications reported. No treatment information was provided.; Sender's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness around the injection site; swelling around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness around the injection site) and INJECTION SITE SWELLING (swelling around the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation. Concomitant products included METOPROLOL TARTRATE, ATORVASTATIN CALCIUM (ATORVASTATIN +PHARMA), OMEPRAZOLE SODIUM (OMEPRAZOLE [OMEPRAZOLE SODIUM]) and COLECALCIFEROL (D) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (redness around the injection site) and INJECTION SITE SWELLING (swelling around the injection site). The patient was treated with LORATADINE (CLARITINE) at an unspecified dose and frequency; VITAMINS NOS (MULTIVITAMINUM) at an unspecified dose and frequency and BIOTIN at an unspecified dose and frequency. At the time of the report, INJECTION SITE ERYTHEMA (redness around the injection site) and INJECTION SITE SWELLING (swelling around 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.; 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: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: unusual amount of bleeding; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE HAEMORRHAGE (unusual amount of bleeding) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (unusual amount of bleeding). The patient was treated with VITAMINS NOS ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, VACCINATION SITE HAEMORRHAGE (unusual amount of bleeding) 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 medications were not provided by reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: General symptom
Clinical narrative: Having Symptoms from second dose of the COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of GENERAL SYMPTOM (Having Symptoms from second dose of the COVID vaccine) 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 30-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GENERAL SYMPTOM (Having Symptoms from second dose of the COVID vaccine). At the time of the report, GENERAL SYMPTOM (Having Symptoms from second dose of the COVID vaccine) outcome was unknown.            Treatment and Concomitant medications were not provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain in extremity, Peripheral swelling
Clinical narrative: Arm was sore; Arm was swollen; Arm was hot to touch; Arm was red; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm was sore, swollen, red, hot to touch.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their dose of two planned doses of mRNA-1273 (lot/batch: Not provided) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, arm was sore, swollen, red and hot to touch.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events arm was sore, swollen, red and hot to touch were unknown.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pruritus, Pyrexia
Clinical narrative: Itchy; Fever; Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (Itchy), PYREXIA (Fever) and HEADACHE (Headache) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchy), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, PRURITUS (Itchy), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: flu-like symptoms; general soreness; fever of 101.5; headache; substantial soreness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (general soreness), PYREXIA (fever of 101.5), HEADACHE (headache) and VACCINATION SITE PAIN (substantial soreness at the injection site) 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 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (general soreness), PYREXIA (fever of 101.5), HEADACHE (headache) and VACCINATION SITE PAIN (substantial soreness at the injection site). On 26-Jan-2021, PYREXIA (fever of 101.5) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (general soreness), HEADACHE (headache) and VACCINATION SITE PAIN (substantial soreness at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 101.5 (High) Fever.         Treatment information was not provided. Concomitant medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: flu-like symptoms; general soreness; fever of 101.5; headache; substantial soreness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (general soreness), PYREXIA (fever of 101.5), HEADACHE (headache) and VACCINATION SITE PAIN (substantial soreness at the injection site) 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 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (general soreness), PYREXIA (fever of 101.5), HEADACHE (headache) and VACCINATION SITE PAIN (substantial soreness at the injection site). On 26-Jan-2021, PYREXIA (fever of 101.5) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (general soreness), HEADACHE (headache) and VACCINATION SITE PAIN (substantial soreness at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 101.5 (High) Fever.         Treatment information was not provided. Concomitant medications were not reported.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash erythematous
Clinical narrative: Severe itching; Redness; Big red blotch; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (Severe itching), ERYTHEMA (Redness) and RASH ERYTHEMATOUS (Big red blotch) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00042780) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Severe itching), ERYTHEMA (Redness) and RASH ERYTHEMATOUS (Big red blotch). At the time of the report, PRURITUS (Severe itching), ERYTHEMA (Redness) and RASH ERYTHEMATOUS (Big red blotch) 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.   Treatment and concomitant medications were not provided by reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pain, Lymphadenopathy, Vaccination site erythema
Clinical narrative: Red streak around the arm; Arm  sore at the injection site; Redness about 2 inches wide; Lymphnodes underneath her armpit down to her breast; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red streak around the arm), INJECTION SITE PAIN (Arm  sore at the injection site), VACCINATION SITE ERYTHEMA (Redness about 2 inches wide) and LYMPHADENOPATHY (Lymphnodes underneath her armpit down to her breast) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 05-Feb-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 06-Feb-2021, the patient experienced ERYTHEMA (Red streak around the arm), INJECTION SITE PAIN (Arm  sore at the injection site), VACCINATION SITE ERYTHEMA (Redness about 2 inches wide) and LYMPHADENOPATHY (Lymphnodes underneath her armpit down to her breast). At the time of the report, ERYTHEMA (Red streak around the arm), INJECTION SITE PAIN (Arm  sore at the injection site), VACCINATION SITE ERYTHEMA (Redness about 2 inches wide) and LYMPHADENOPATHY (Lymphnodes underneath her armpit down to her breast) had resolved.            Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: TCR : AE outcome added
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: unusual side effect; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (unusual side effect) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ADVERSE REACTION (unusual side effect). At the time of the report, ADVERSE REACTION (unusual side effect) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site pain
Clinical narrative: at injection site my skin turned yellow like a big spot about 3-4" across; arm a little sore; A spontaneous report  was received from an 81 year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed vaccination site discolouration and vaccination site pain.  The patient's medical history was not provided. Concomitant medications included metformin, simvastatin, prazosin, tiotropium, losartan, nifedipine, spironolactone, mirtazapine, ergocalciferol, lansoprazole, atenolol, baby aspirin, lantus, oxybutynin, albuterol, venlafaxine, pramipexole dihydrochloride, and apixaban.  On 22-JAN-2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (lot#: 013L20A) in the right arm for the prophylaxis of COVID-19 infection.  On 22-JAN-2021, the patient developed little soreness in the arm. On 26-JAN-2021, the patient noticed that at injection site the skin turned yellow like a big spot about 3-4 across. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events, vaccination site discolouration and vaccination site pain, were unknown.; Reporter'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: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness at the injection site; Itchiness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Redness at the injection site) and INJECTION SITE PRURITUS (Itchiness at the injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (Redness at the injection site) and INJECTION SITE PRURITUS (Itchiness at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE ERYTHEMA (Redness at the injection site) and INJECTION SITE PRURITUS (Itchiness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site erythema, Vaccination site movement impairment, Vaccination site warmth
Clinical narrative: Can't move the arm; injection site redness; warm; weakness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move the arm), VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE WARMTH (warm) and VACCINATION COMPLICATION (weakness) 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-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move the arm), VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE WARMTH (warm) and VACCINATION COMPLICATION (weakness). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move the arm), VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE WARMTH (warm) and VACCINATION COMPLICATION (weakness) 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.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Chills, Hypoaesthesia oral, Muscle spasms, Pyrexia
Clinical narrative: numbness on tongue and upper lip; right foot was spasming; blood pressure was crashing; shaky; chills (freezing like ice); Sore arm; felt feverish but did not have a fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA ORAL (numbness on tongue and upper lip), MUSCLE SPASMS (right foot was spasming), BLOOD PRESSURE DECREASED (blood pressure was crashing), TREMOR (shaky) and CHILLS (chills (freezing like ice)) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057G20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOAESTHESIA ORAL (numbness on tongue and upper lip), MUSCLE SPASMS (right foot was spasming), BLOOD PRESSURE DECREASED (blood pressure was crashing), TREMOR (shaky), CHILLS (chills (freezing like ice)), VACCINATION SITE PAIN (Sore arm) and PYREXIA (felt feverish but did not have a fever). At the time of the report, HYPOAESTHESIA ORAL (numbness on tongue and upper lip), MUSCLE SPASMS (right foot was spasming), TREMOR (shaky), CHILLS (chills (freezing like ice)), VACCINATION SITE PAIN (Sore arm) and PYREXIA (felt feverish but did not have a fever) outcome was unknown and BLOOD PRESSURE DECREASED (blood pressure was crashing) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient put ice pack on sore arm for 2 hours.; 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: Tremor, Vaccination site pain
Clinical narrative: numbness on tongue and upper lip; right foot was spasming; blood pressure was crashing; shaky; chills (freezing like ice); Sore arm; felt feverish but did not have a fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA ORAL (numbness on tongue and upper lip), MUSCLE SPASMS (right foot was spasming), BLOOD PRESSURE DECREASED (blood pressure was crashing), TREMOR (shaky) and CHILLS (chills (freezing like ice)) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057G20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOAESTHESIA ORAL (numbness on tongue and upper lip), MUSCLE SPASMS (right foot was spasming), BLOOD PRESSURE DECREASED (blood pressure was crashing), TREMOR (shaky), CHILLS (chills (freezing like ice)), VACCINATION SITE PAIN (Sore arm) and PYREXIA (felt feverish but did not have a fever). At the time of the report, HYPOAESTHESIA ORAL (numbness on tongue and upper lip), MUSCLE SPASMS (right foot was spasming), TREMOR (shaky), CHILLS (chills (freezing like ice)), VACCINATION SITE PAIN (Sore arm) and PYREXIA (felt feverish but did not have a fever) outcome was unknown and BLOOD PRESSURE DECREASED (blood pressure was crashing) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient put ice pack on sore arm for 2 hours.; 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: Pruritus, Rash erythematous
Clinical narrative: bullseye rash; itching; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (bullseye rash) and PRURITUS (itching) 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 16-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (bullseye rash) and PRURITUS (itching). At the time of the report, RASH ERYTHEMATOUS (bullseye rash) and PRURITUS (itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not provided
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Feeling hot, Hypoaesthesia, Paraesthesia
Clinical narrative: metallic taste in her mouth; numbness on the left side of her body, mouth, tongue, and face; felt a prickly sensation on the left side of her head and left foot, "like ants were crawling on it; felt like her throat was swollen, and like her "insides were hot; felt like her throat was swollen, and like her "insides were hot; fatigue; This spontaneous case was reported by a physician and describes the occurrence of DYSGEUSIA (metallic taste in her mouth), HYPOAESTHESIA (numbness on the left side of her body, mouth, tongue, and face), PARAESTHESIA (felt a prickly sensation on the left side of her head and left foot, "like ants were crawling on it), PHARYNGEAL SWELLING (felt like her throat was swollen, and like her "insides were hot) and FEELING HOT (felt like her throat was swollen, and like her "insides were hot) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced DYSGEUSIA (metallic taste in her mouth), HYPOAESTHESIA (numbness on the left side of her body, mouth, tongue, and face), PARAESTHESIA (felt a prickly sensation on the left side of her head and left foot, "like ants were crawling on it), PHARYNGEAL SWELLING (felt like her throat was swollen, and like her "insides were hot), FEELING HOT (felt like her throat was swollen, and like her "insides were hot) and FATIGUE (fatigue). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form. On 07-Feb-2021, DYSGEUSIA (metallic taste in her mouth), HYPOAESTHESIA (numbness on the left side of her body, mouth, tongue, and face), PARAESTHESIA (felt a prickly sensation on the left side of her head and left foot, "like ants were crawling on it), PHARYNGEAL SWELLING (felt like her throat was swollen, and like her "insides were hot), FEELING HOT (felt like her throat was swollen, and like her "insides were hot) and FATIGUE (fatigue) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications  were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow up received on 21-4-2021, Patient demographics( Height, Weight, Race, Ethinicity)added. Second dose information added.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: metallic taste in her mouth; numbness on the left side of her body, mouth, tongue, and face; felt a prickly sensation on the left side of her head and left foot, "like ants were crawling on it; felt like her throat was swollen, and like her "insides were hot; felt like her throat was swollen, and like her "insides were hot; fatigue; This spontaneous case was reported by a physician and describes the occurrence of DYSGEUSIA (metallic taste in her mouth), HYPOAESTHESIA (numbness on the left side of her body, mouth, tongue, and face), PARAESTHESIA (felt a prickly sensation on the left side of her head and left foot, "like ants were crawling on it), PHARYNGEAL SWELLING (felt like her throat was swollen, and like her "insides were hot) and FEELING HOT (felt like her throat was swollen, and like her "insides were hot) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced DYSGEUSIA (metallic taste in her mouth), HYPOAESTHESIA (numbness on the left side of her body, mouth, tongue, and face), PARAESTHESIA (felt a prickly sensation on the left side of her head and left foot, "like ants were crawling on it), PHARYNGEAL SWELLING (felt like her throat was swollen, and like her "insides were hot), FEELING HOT (felt like her throat was swollen, and like her "insides were hot) and FATIGUE (fatigue). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form. On 07-Feb-2021, DYSGEUSIA (metallic taste in her mouth), HYPOAESTHESIA (numbness on the left side of her body, mouth, tongue, and face), PARAESTHESIA (felt a prickly sensation on the left side of her head and left foot, "like ants were crawling on it), PHARYNGEAL SWELLING (felt like her throat was swollen, and like her "insides were hot), FEELING HOT (felt like her throat was swollen, and like her "insides were hot) and FATIGUE (fatigue) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications  were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow up received on 21-4-2021, Patient demographics( Height, Weight, Race, Ethinicity)added. Second dose information added.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: lips and face swelled; lips and face swelled; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (lips and face swelled) and SWELLING FACE (lips and face swelled) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032LZ0A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-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 LIP SWELLING (lips and face swelled) and SWELLING FACE (lips and face swelled). At the time of the report, LIP SWELLING (lips and face swelled) and SWELLING FACE (lips and face swelled) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter.   Treatment medication included 2 doses of diphenhydramine (Benadryl) within a 24-hour period.     Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: form was attached and it contains NNI
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Illness, Non-cardiac chest pain, Pain in extremity
Clinical narrative: fast heartbeat; pains in her upper chest; seriously ill; dizziness; weakness; pain in her legs; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PALPITATIONS (fast heartbeat), NON-CARDIAC CHEST PAIN (pains in her upper chest), ILLNESS (seriously ill), DIZZINESS (dizziness) and ASTHENIA (weakness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PALPITATIONS (fast heartbeat), NON-CARDIAC CHEST PAIN (pains in her upper chest), ILLNESS (seriously ill), DIZZINESS (dizziness), ASTHENIA (weakness) and PAIN IN EXTREMITY (pain in her legs). At the time of the report, PALPITATIONS (fast heartbeat), NON-CARDIAC CHEST PAIN (pains in her upper chest), ILLNESS (seriously ill), DIZZINESS (dizziness), ASTHENIA (weakness) and PAIN IN EXTREMITY (pain in her legs) outcome was unknown.            No relevant concomitant medications were reported. Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up received: Second dose and hospitalization reported via email to be reported with Dose 2