chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Muscle spasms, Pain in extremity, Pyrexia
Clinical narrative: lightheaded; hands started crumping; fever; arm  hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm  hurt), DIZZINESS (lightheaded), MUSCLE SPASMS (hands started crumping) and PYREXIA (fever) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm  hurt) and PYREXIA (fever). On 13-Apr-2021, the patient experienced DIZZINESS (lightheaded) and MUSCLE SPASMS (hands started crumping). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm  hurt) and PYREXIA (fever) had resolved and DIZZINESS (lightheaded) and MUSCLE SPASMS (hands started crumping) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Po concomitant medications were reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Thinking abnormal
Clinical narrative: not been able to move very well; thinking not very well; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (not been able to move very well) and THINKING ABNORMAL (thinking not very well) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 036A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced HYPOKINESIA (not been able to move very well) and THINKING ABNORMAL (thinking not very well). The patient was treated with PARACETAMOL (TYLENOL) at a dose of unk dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, HYPOKINESIA (not been able to move very well) and THINKING ABNORMAL (thinking not very well) had resolved. Not Provided          Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant product use was not provided by the reporter.      Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: event outcome was updated
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Menstruation irregular, Rash
Clinical narrative: menstrual cycle early; rash on chest; rapid heart rate; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heart rate), MENSTRUATION IRREGULAR (menstrual cycle early), RASH (rash on chest), FATIGUE (fatigue) and HEADACHE (headache) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced FATIGUE (fatigue) and HEADACHE (headache). On 11-Apr-2021, the patient experienced HEART RATE INCREASED (rapid heart rate). On 12-Apr-2021, the patient experienced MENSTRUATION IRREGULAR (menstrual cycle early) and RASH (rash on chest). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 10-Apr-2021, FATIGUE (fatigue) and HEADACHE (headache) had resolved. On 13-Apr-2021, RASH (rash on chest) had resolved. At the time of the report, HEART RATE INCREASED (rapid heart rate) and MENSTRUATION IRREGULAR (menstrual cycle early) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: little discomfort at site of the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (little discomfort at site of the shot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included Hives. Concurrent medical conditions included Drug allergy (Allergic to niacin, causes hives/rash all over), Hypercholesterolemia since 2012, Meningioma since 2018, GERD and Migraine. Concomitant products included PANTOPRAZOLE for GERD, SIMVASTATIN for Hypercholesterolemia, TOPIRAMATE and UBIDECARENONE (COQ10 [UBIDECARENONE]) for Migraine, RIZATRIPTAN for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE DISCOMFORT (little discomfort at site of the shot). On 19-Mar-2021, VACCINATION SITE DISCOMFORT (little discomfort at site of the shot) had resolved.            Treatment information for the first dose event was not reported.   This case was linked to INC.-MOD-2021-075083 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up information received on 3-May-2021 contains medical history and pt. demographics.; Sender's Comments:  INC.-MOD-2021-075083:for 2nd dose
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node moves and it is size of lima bean/Swollen lymph node above collar bone; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node moves and it is size of lima bean/Swollen lymph node above collar bone) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to Erythromycin).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph node moves and it is size of lima bean/Swollen lymph node above collar bone). At the time of the report, LYMPHADENOPATHY (Swollen lymph node moves and it is size of lima bean/Swollen lymph node above collar bone) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that she was evaluated by her physician.  Patient stated that her physician recommends the COVID-19 vaccination.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Pain, Pain in extremity, Pyrexia
Clinical narrative: numbness in the arm of the injection; body aches,pain all over the body; extremly sore arm; A lot of fatigue; fever of 100-101F; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in the arm of the injection), PAIN (body aches,pain all over the body), PAIN IN EXTREMITY (extremly sore arm), FATIGUE (A lot of fatigue) and PYREXIA (fever of 100-101F) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced HYPOAESTHESIA (numbness in the arm of the injection), PAIN (body aches,pain all over the body), PAIN IN EXTREMITY (extremly sore arm), FATIGUE (A lot of fatigue) and PYREXIA (fever of 100-101F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (numbness in the arm of the injection), PAIN (body aches,pain all over the body), PAIN IN EXTREMITY (extremly sore arm), FATIGUE (A lot of fatigue) and PYREXIA (fever of 100-101F) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain, Vaccination site pain
Clinical narrative: 2 weeks ago, she started feeling achy; muscle aches; knees are sore; if rub arm at injection site it is still a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (2 weeks ago, she started feeling achy), MYALGIA (muscle aches), ARTHRALGIA (knees are sore) and VACCINATION SITE PAIN (if rub arm at injection site it is still a little sore) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (2 weeks ago, she started feeling achy), MYALGIA (muscle aches), ARTHRALGIA (knees are sore) and VACCINATION SITE PAIN (if rub arm at injection site it is still a little sore). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (2 weeks ago, she started feeling achy), MYALGIA (muscle aches), ARTHRALGIA (knees are sore) and VACCINATION SITE PAIN (if rub arm at injection site it is still a little sore) outcome was unknown.            Treatment included heated up rice bag. Concomitant medication information was not reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Premenstrual syndrome
Clinical narrative: Pre-menstrual symptoms; Belly cramping; This spontaneous case was reported by a consumer and describes the occurrence of PREMENSTRUAL SYNDROME (Pre-menstrual symptoms) and ABDOMINAL PAIN (Belly cramping) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PREMENSTRUAL SYNDROME (Pre-menstrual symptoms) and ABDOMINAL PAIN (Belly cramping). At the time of the report, PREMENSTRUAL SYNDROME (Pre-menstrual symptoms) and ABDOMINAL PAIN (Belly cramping) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-173201, MOD-2021-041184, MOD-2021-082803 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Reporter email was updated.
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: Not got a schedule for my second dose and it is going to be after 42 days; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Not got a schedule for my second dose and it is going to be after 42 days) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Not got a schedule for my second dose and it is going to be after 42 days). At the time of the report, OFF LABEL USE (Not got a schedule for my second dose and it is going to be after 42 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  The patient stated that she received her first dose of Moderna Covid-19 vaccine on 06-MAR-2021. They were supposed to call her to schedule dose but they did  not call her back and it was going to be 42 days on 16-APR-2021 and she still did not have an appointment.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pruritus, Rash
Clinical narrative: Shingles; tchy, painful spot on center front of neck noticed about 3/11/21; painful spot on center front of neck noticed, I noticed more spots on neck; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles), PRURITUS (tchy, painful spot on center front of neck noticed about 3/11/21) and RASH (painful spot on center front of neck noticed, I noticed more spots on neck) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 025L20A) for COVID-19 vaccination.     No medical history was reported.  Concurrent medical conditions included Blood pressure high, Edema and High cholesterol. Concomitant products included ATENOLOL and LOSARTAN POTASSIUM (LOSARTIN) for Blood pressure high, HCTZ for Edema, LOVASTATIN for High cholesterol, ACETYLSALICYLIC ACID (ASPIRINE) for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced HERPES ZOSTER (Shingles), PRURITUS (tchy, painful spot on center front of neck noticed about 3/11/21) and RASH (painful spot on center front of neck noticed, I noticed more spots on neck). The patient was treated with ANTIVIRALS for Shingles, at an unspecified dose and frequency. On 11-Apr-2021, HERPES ZOSTER (Shingles) had resolved. At the time of the report, PRURITUS (tchy, painful spot on center front of neck noticed about 3/11/21) and RASH (painful spot on center front of neck noticed, I noticed more spots on neck) had resolved.            The patient reported she got a steroid injection on 5-Mar-2021 into her shoulder for a torn rotator cuff injury.  She was not sure if it could have affected her in this manner.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up information contains Patient Demographics, Medical history.  Concomitant medication. Event Outcome.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 01-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced COVID-19 (Covid-19). The patient was treated with VITAMINS NOS at a dose of UNK dosage form and PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was not reported.  Other treatment medication included cough medication.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: hot to touch at injection site; itchy/area is a little itchy, red; a red mark at the injection site/red between 1 to 2 inches in diameter; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to touch at injection site), VACCINATION SITE PRURITUS (itchy/area is a little itchy, red), VACCINATION SITE PAIN (Pain in arm) and VACCINATION SITE ERYTHEMA (a red mark at the injection site/red between 1 to 2 inches in diameter) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain in arm). On 10-Apr-2021, the patient experienced VACCINATION SITE WARMTH (hot to touch at injection site), VACCINATION SITE PRURITUS (itchy/area is a little itchy, red) and VACCINATION SITE ERYTHEMA (a red mark at the injection site/red between 1 to 2 inches in diameter). At the time of the report, VACCINATION SITE WARMTH (hot to touch at injection site), VACCINATION SITE PRURITUS (itchy/area is a little itchy, red), VACCINATION SITE PAIN (Pain in arm) and VACCINATION SITE ERYTHEMA (a red mark at the injection site/red between 1 to 2 inches in diameter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided.   Treatment information was not provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema, Pain in extremity, Paraesthesia
Clinical narrative: soreness over the injection arm; Redness over the injection arm; tingling, "pins and needles" sensation; black and blue bruising over the injection arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (soreness over the injection arm), ERYTHEMA (Redness over the injection arm), PARAESTHESIA (tingling, "pins and needles" sensation) and CONTUSION (black and blue bruising over the injection arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness over the injection arm), ERYTHEMA (Redness over the injection arm), PARAESTHESIA (tingling, "pins and needles" sensation) and CONTUSION (black and blue bruising over the injection arm). At the time of the report, PAIN IN EXTREMITY (soreness over the injection arm), ERYTHEMA (Redness over the injection arm), PARAESTHESIA (tingling, "pins and needles" sensation) and CONTUSION (black and blue bruising over the injection arm) had resolved. Not Provided      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 medication reported.  The patient was in line to get the second dose of the vaccine and reported side effects from the first dose. The patient experienced soreness, redness, tingling, "pins and needles", and black and blue bruising over the injection arm. These side effects persisted for up to two weeks after receiving the vaccine but were not longer present at this time.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm  pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm  pain) 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 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm  pain). At the time of the report, PAIN IN EXTREMITY (arm  pain) had not resolved.            No concomitant medications were provided by the reporter.  Treatment information was not provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Infection, Pyrexia
Clinical narrative: some type of infection or Virus; Fatigue; Heavy fever of 102.7 degrees Fahrenheit; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFECTION (some type of infection or Virus), PYREXIA (Heavy fever of 102.7 degrees Fahrenheit), CHILLS (Chills) and FATIGUE (Fatigue) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included Surgery (surgery for rectal cancer in 2013 where rectum was removed). Concurrent medical conditions included Rectal cancer. Concomitant products included LOPERAMIDE HYDROCHLORIDE (IMODIUM) for an unknown indication.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PYREXIA (Heavy fever of 102.7 degrees Fahrenheit) and CHILLS (Chills). On an unknown date, the patient experienced INFECTION (some type of infection or Virus) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Chills, at an unspecified dose and frequency. On 27-Apr-2021, PYREXIA (Heavy fever of 102.7 degrees Fahrenheit) had resolved. At the time of the report, INFECTION (some type of infection or Virus) and CHILLS (Chills) outcome was unknown and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Body temperature: 102.7 (High) 102.7 degrees Fahrenheit. On 11-Apr-2021, Body temperature: 101.7 (High) 101.7 degrees Fahrenheit. On 13-Apr-2021, Body temperature: 97.7 (normal) 97.7 degrees Fahrenheit. On 19-Apr-2021, White blood cell count: 17.8 (High) high white blood cell count(17.8).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Additional information included new events, medical history, laboratory data and updated outcome of the event pyrexia.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count
Clinical narrative: some type of infection or Virus; Fatigue; Heavy fever of 102.7 degrees Fahrenheit; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFECTION (some type of infection or Virus), PYREXIA (Heavy fever of 102.7 degrees Fahrenheit), CHILLS (Chills) and FATIGUE (Fatigue) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included Surgery (surgery for rectal cancer in 2013 where rectum was removed). Concurrent medical conditions included Rectal cancer. Concomitant products included LOPERAMIDE HYDROCHLORIDE (IMODIUM) for an unknown indication.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PYREXIA (Heavy fever of 102.7 degrees Fahrenheit) and CHILLS (Chills). On an unknown date, the patient experienced INFECTION (some type of infection or Virus) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Chills, at an unspecified dose and frequency. On 27-Apr-2021, PYREXIA (Heavy fever of 102.7 degrees Fahrenheit) had resolved. At the time of the report, INFECTION (some type of infection or Virus) and CHILLS (Chills) outcome was unknown and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Body temperature: 102.7 (High) 102.7 degrees Fahrenheit. On 11-Apr-2021, Body temperature: 101.7 (High) 101.7 degrees Fahrenheit. On 13-Apr-2021, Body temperature: 97.7 (normal) 97.7 degrees Fahrenheit. On 19-Apr-2021, White blood cell count: 17.8 (High) high white blood cell count(17.8).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Additional information included new events, medical history, laboratory data and updated outcome of the event pyrexia.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: entire arm painful; a lot of pain at the injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (entire arm painful) and VACCINATION SITE PAIN (a lot of pain at the injection) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (entire arm painful) and VACCINATION SITE PAIN (a lot of pain at the injection). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (entire arm painful) and VACCINATION SITE PAIN (a lot of pain at the injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: "sore arm"; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY ("sore arm") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Herniated disc (herniated disc in neck). Concomitant products included GABAPENTIN and PARACETAMOL (TYLENOL) for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY ("sore arm"). At the time of the report, PAIN IN EXTREMITY ("sore arm") outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included a steroid (unspecified). No treatment drugs are not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-075089 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075089:Link to Dose 2 case
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: ended up having rebound headaches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Apr-2021 and was forwarded to Moderna on 13-Apr-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of HEADACHE (ended up having rebound headaches) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included GALCANEZUMAB (EMGALITY [GALCANEZUMAB]) for Migraine.    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 HEADACHE (ended up having rebound headaches). At the time of the report, HEADACHE (ended up having rebound headaches) outcome was unknown. Not Provided      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 information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Rash
Clinical narrative: soreness on her arm; a circular rash; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness on her arm), RASH (a circular rash) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness on her arm), RASH (a circular rash) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (soreness on her arm), RASH (a circular rash) and PYREXIA (fever) outcome was unknown.            No concomitant medications were provided by the reporter.  Treatment information was not provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Rash, Urticaria, Vaccination site pain
Clinical narrative: Hypersensitivity; hives that spread to my legs and arms like welts; itching; horrible rash all overy my trunk; bit of soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY, URTICARIA, PRURITUS, RASH, and VACCINATION SITE PAIN in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 031A21A) for COVID-19 vaccination.     The patient's past medical history included Hives. Concurrent medical conditions included Hypercholesterolemia since 2012, Meningioma since 2018, GERD, Migraine, and Drug allergy (Niacin (hives or rash all over)). Concomitant products included PANTOPRAZOLE for GERD, SIMVASTATIN for Hypercholesterolemia, TOPIRAMATE, and COQ10 for Migraine, VITAMINS, and RIZATRIPTAN for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN. On 12-Apr-2021, the patient experienced RASH. On 13-Apr-2021, the patient experienced URTICARIA and PRURITUS. On an unknown date, the patient experienced HYPERSENSITIVITY. The patient was treated with BENADRYL for Hives and Rash, at a dose of 2 dosage form and CORTISONE (topical) for Hives and Rash, at a dose of UNK. At the time of the report, HYPERSENSITIVITY and VACCINATION SITE PAIN outcome was unknown and URTICARIA, PRURITUS, and RASH had resolved.            This case was linked to US-MODERNATX, INC MOD-2021-075061.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: ADR Form was received and medical history, patient demographics and concomitant product details were updated. Sender's Comments:  US-MODERNATX, INC-MOD-2021-075061: 1st dose.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache, Myalgia, Tinnitus
Clinical narrative: ringing on ears; achy lower back; body pain; achy hips; slight headache; pain on injection site; This spontaneous case was reported by a physician and describes the occurrence of TINNITUS (ringing on ears), BACK PAIN (achy lower back), MYALGIA (body pain), ARTHRALGIA (achy hips) and HEADACHE (slight headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included LOSARTAN, ROSUVASTATIN, VENLAFAXINE, MULTIVITAMINS [VITAMINS NOS] and CALCIUM for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced TINNITUS (ringing on ears), BACK PAIN (achy lower back), MYALGIA (body pain), ARTHRALGIA (achy hips), HEADACHE (slight headache) and VACCINATION SITE PAIN (pain on injection site). At the time of the report, TINNITUS (ringing on ears), BACK PAIN (achy lower back), MYALGIA (body pain), ARTHRALGIA (achy hips), HEADACHE (slight headache) and VACCINATION SITE PAIN (pain on injection site) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. Action taken with mRNA-1273 in response to events was not applicable.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: ringing on ears; achy lower back; body pain; achy hips; slight headache; pain on injection site; This spontaneous case was reported by a physician and describes the occurrence of TINNITUS (ringing on ears), BACK PAIN (achy lower back), MYALGIA (body pain), ARTHRALGIA (achy hips) and HEADACHE (slight headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included LOSARTAN, ROSUVASTATIN, VENLAFAXINE, MULTIVITAMINS [VITAMINS NOS] and CALCIUM for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced TINNITUS (ringing on ears), BACK PAIN (achy lower back), MYALGIA (body pain), ARTHRALGIA (achy hips), HEADACHE (slight headache) and VACCINATION SITE PAIN (pain on injection site). At the time of the report, TINNITUS (ringing on ears), BACK PAIN (achy lower back), MYALGIA (body pain), ARTHRALGIA (achy hips), HEADACHE (slight headache) and VACCINATION SITE PAIN (pain on injection site) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. Action taken with mRNA-1273 in response to events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE RASH (rash at the injection site). At the time of the report, VACCINATION SITE RASH (rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Injection site Reactions on the left arm as redness,warm,Hard and itchy; Injection site Reactions on the left arm as redness,warm,Hard and itchy; Injection site Reactions on the left arm as redness,warm,Hard and itchy; Injection site Reactions on the left arm as redness (redness around 5X 3 inches); This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Injection site Reactions on the left arm as redness,warm,Hard and itchy), VACCINATION SITE MASS (Injection site Reactions on the left arm as redness,warm,Hard and itchy), VACCINATION SITE PRURITUS (Injection site Reactions on the left arm as redness,warm,Hard and itchy) and VACCINATION SITE ERYTHEMA (Injection site Reactions on the left arm as redness (redness around 5X 3 inches)) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Injection site Reactions on the left arm as redness,warm,Hard and itchy), VACCINATION SITE MASS (Injection site Reactions on the left arm as redness,warm,Hard and itchy), VACCINATION SITE PRURITUS (Injection site Reactions on the left arm as redness,warm,Hard and itchy) and VACCINATION SITE ERYTHEMA (Injection site Reactions on the left arm as redness (redness around 5X 3 inches)). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Injection site Reactions on the left arm as redness,warm,Hard and itchy), VACCINATION SITE MASS (Injection site Reactions on the left arm as redness,warm,Hard and itchy), VACCINATION SITE PRURITUS (Injection site Reactions on the left arm as redness,warm,Hard and itchy) and VACCINATION SITE ERYTHEMA (Injection site Reactions on the left arm as redness (redness around 5X 3 inches)) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Patient also used an anti-itch moisturizer as treatment for the events.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bradykinesia, Pain
Clinical narrative: a variety of different things are hurting/He hurts in a lot of places he never hurt before; Both shoulders are taking turns hurting noticeably/hip is hurting; It's kind of slowing him down a bit; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (a variety of different things are hurting/He hurts in a lot of places he never hurt before), ARTHRALGIA (Both shoulders are taking turns hurting noticeably/hip is hurting) and BRADYKINESIA (It's kind of slowing him down a bit) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 030A21A) for COVID-19 vaccination.     The patient's past medical history included Hip replacement.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (a variety of different things are hurting/He hurts in a lot of places he never hurt before), ARTHRALGIA (Both shoulders are taking turns hurting noticeably/hip is hurting) and BRADYKINESIA (It's kind of slowing him down a bit). At the time of the report, PAIN (a variety of different things are hurting/He hurts in a lot of places he never hurt before), ARTHRALGIA (Both shoulders are taking turns hurting noticeably/hip is hurting) and BRADYKINESIA (It's kind of slowing him down a bit) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Joint stiffness, Lymph node pain, Lymphadenopathy, Pain in extremity
Clinical narrative: sore arm; Tired; Left jaw feels tight, stiff and hard to open; Tender to touch; Both lymph nodes on back of her head have swollen; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (Left jaw feels tight, stiff and hard to open), LYMPH NODE PAIN (Tender to touch), LYMPHADENOPATHY (Both lymph nodes on back of her head have swollen), PAIN IN EXTREMITY (sore arm) and FATIGUE (Tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Herniated disc (herniated disc in neck). Concomitant products included GABAPENTIN and PARACETAMOL (TYLENOL) for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (Both lymph nodes on back of her head have swollen). On 12-Apr-2021, the patient experienced JOINT STIFFNESS (Left jaw feels tight, stiff and hard to open) and LYMPH NODE PAIN (Tender to touch). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (Tired). At the time of the report, JOINT STIFFNESS (Left jaw feels tight, stiff and hard to open), LYMPH NODE PAIN (Tender to touch), LYMPHADENOPATHY (Both lymph nodes on back of her head have swollen), PAIN IN EXTREMITY (sore arm) and FATIGUE (Tired) outcome was unknown.            Additional concomitant medication included a steroid (unspecified).  On 12APR2021, lymph nodes on back of her head became more swollen.   Treatment medication information was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-075078 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075078:Link to Dose 1 case
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: Near-miss for early vaccination for second dose of vaccine; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Near-miss for early vaccination for second dose of vaccine) and VACCINATION SITE PAIN (Vaccination site pain) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 02-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Near-miss for early vaccination for second dose of vaccine). On 02-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Near-miss for early vaccination for second dose of vaccine) had resolved. At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment medications were provided
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore and achy arm; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of MYALGIA (sore and achy arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history reported) since an unknown date. Concomitant products included LOSARTAN, ROSUVASTATIN, CALCIUM, VENLAFAXINE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (sore and achy arm). On 16-Mar-2021, MYALGIA (sore and achy arm) 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.   This case was linked to MOD-2021-075084 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Platelet count decreased
Clinical narrative: Low platelet counts from 145 to 120; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PLATELET COUNT DECREASED (Low platelet counts from 145 to 120) 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 Cardiac operation NOS (Heart surgery five years ago). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced PLATELET COUNT DECREASED (Low platelet counts from 145 to 120). At the time of the report, PLATELET COUNT DECREASED (Low platelet counts from 145 to 120) outcome was unknown.            Treatment information was not provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling abnormal, Nausea
Clinical narrative: some chills; light headedness; feeling out of it; fatigue; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headedness), FEELING ABNORMAL (feeling out of it), FATIGUE (fatigue), NAUSEA (nausea) and CHILLS (some chills) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 037A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced DIZZINESS (light headedness), FEELING ABNORMAL (feeling out of it), FATIGUE (fatigue) and NAUSEA (nausea). On an unknown date, the patient experienced CHILLS (some chills). On 04-May-2021, DIZZINESS (light headedness), FEELING ABNORMAL (feeling out of it), FATIGUE (fatigue) and NAUSEA (nausea) had resolved. At the time of the report, CHILLS (some chills) had resolved.            No information on concomitant products were reported. No information on medical history was reported. No information on Treatment medications were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Event outcome was resolved. On 05-Aug-2021: Significant Follow-up included, Updated reporter information from HCP to consumer, Dose 2 information and events were added.