chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: Severe case of brain fog; Itchy tiny little red bumps at injection site , red mark; Itchy tiny little red bumps at injection site , red mark; itchy tiny little red bumps at injection site , red mark; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Severe case of brain fog), VACCINATION SITE MASS (Itchy tiny little red bumps at injection site , red mark), FATIGUE (Fatigue), VACCINATION SITE PRURITUS (Itchy tiny little red bumps at injection site , red mark) and VACCINATION SITE ERYTHEMA (itchy tiny little red bumps at injection site , red mark) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-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 FATIGUE (Fatigue). On 19-Mar-2021, the patient experienced FEELING ABNORMAL (Severe case of brain fog), VACCINATION SITE MASS (Itchy tiny little red bumps at injection site , red mark), VACCINATION SITE PRURITUS (Itchy tiny little red bumps at injection site , red mark) and VACCINATION SITE ERYTHEMA (itchy tiny little red bumps at injection site , red mark). The patient was treated with HYDROCORTISONE at a dose of 1 dosage form. On 11-Mar-2021, FATIGUE (Fatigue) had resolved. On 20-Mar-2021, FEELING ABNORMAL (Severe case of brain fog), VACCINATION SITE MASS (Itchy tiny little red bumps at injection site , red mark), VACCINATION SITE PRURITUS (Itchy tiny little red bumps at injection site , red mark) and VACCINATION SITE ERYTHEMA (itchy tiny little red bumps at injection site , red mark) 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 was reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle contractions involuntary, Muscle twitching
Clinical narrative: "unusual muscle reaction"; "slight switch of muscles upper and lower lips"; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE CONTRACTIONS INVOLUNTARY ("unusual muscle reaction") and MUSCLE TWITCHING ("slight switch of muscles upper and lower lips") in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L26H and 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced MUSCLE CONTRACTIONS INVOLUNTARY ("unusual muscle reaction") and MUSCLE TWITCHING ("slight switch of muscles upper and lower lips"). At the time of the report, MUSCLE CONTRACTIONS INVOLUNTARY ("unusual muscle reaction") and MUSCLE TWITCHING ("slight switch of muscles upper and lower lips") outcome was unknown. Not Provided          No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Paraesthesia
Clinical narrative: Tingling on of the hands; This tingling sensation is worst when she put her hands under water; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling on of the hands) and CONDITION AGGRAVATED (This tingling sensation is worst when she put her hands under water) 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 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced PARAESTHESIA (Tingling on of the hands) and CONDITION AGGRAVATED (This tingling sensation is worst when she put her hands under water). At the time of the report, PARAESTHESIA (Tingling on of the hands) and CONDITION AGGRAVATED (This tingling sensation is worst when she put her hands under water) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medication information was provided.  No treatment medication information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and CHILLS (Chills) 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 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, MYALGIA (Body aches) and CHILLS (Chills) outcome was unknown. Not Provided          Treatment drugs were not provided concomitant drugs were not provided
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Hot to the touch at the injection site; Itchiness at injection site; Swelling at the injection site; Pain on left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to the touch at the injection site), VACCINATION SITE PRURITUS (Itchiness at injection site), VACCINATION SITE PAIN (Pain on left arm) and VACCINATION SITE ERYTHEMA (Swelling at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for an unknown indication.     Concurrent medical conditions included Type 2 diabetes mellitus and Asthma.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain on left arm). On 17-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot to the touch at the injection site), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Swelling at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at a dose of UNK dosage form. At the time of the report, VACCINATION SITE WARMTH (Hot to the touch at the injection site), VACCINATION SITE PRURITUS (Itchiness at injection site), VACCINATION SITE PAIN (Pain on left arm) and VACCINATION SITE ERYTHEMA (Swelling at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included medications for type 2 diabetes, asthma and blood pressure (name unspecified).  Treatment included ice pack.
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol increased
Clinical narrative: Cholesterol level went high after moderna vaccine administration; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD CHOLESTEROL INCREASED (Cholesterol level went high after moderna vaccine administration) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD CHOLESTEROL INCREASED (Cholesterol level went high after moderna vaccine administration). At the time of the report, BLOOD CHOLESTEROL INCREASED (Cholesterol level went high after moderna vaccine administration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported  Treatment information were not provided
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a lot of pain under her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a lot of pain under her arm) 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 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (a lot of pain under her arm). At the time of the report, PAIN IN EXTREMITY (a lot of pain under her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rash erythematous, Vaccination site swelling
Clinical narrative: red rash; itchy and hurts at the same time; itchy and hurts at the same time; 2x4 inches at injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash), PAIN (itchy and hurts at the same time), PRURITUS (itchy and hurts at the same time) and VACCINATION SITE SWELLING (2x4 inches at injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced RASH ERYTHEMATOUS (red rash), PAIN (itchy and hurts at the same time), PRURITUS (itchy and hurts at the same time) and VACCINATION SITE SWELLING (2x4 inches at injection site). At the time of the report, RASH ERYTHEMATOUS (red rash), PAIN (itchy and hurts at the same time), PRURITUS (itchy and hurts at the same time) and VACCINATION SITE SWELLING (2x4 inches at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: COVID-19 VIRUS TEST POSITIVE; COVID-19 VIRUS TEST POSITIVE; This spontaneous case was reported by an other health care professional and describes the occurrence of the first episode of SARS-COV-2 TEST POSITIVE (COVID-19 VIRUS TEST POSITIVE) and the second episode of SARS-COV-2 TEST POSITIVE (COVID-19 VIRUS TEST POSITIVE) in a 91-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 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced the first episode of SARS-COV-2 TEST POSITIVE (COVID-19 VIRUS TEST POSITIVE). On 17-Mar-2021, the patient experienced the second episode of SARS-COV-2 TEST POSITIVE (COVID-19 VIRUS TEST POSITIVE). At the time of the report, last episode of SARS-COV-2 TEST POSITIVE (COVID-19 VIRUS TEST POSITIVE) 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.   no Concomitant medications included. no treatment mentioned.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Orthostatic hypotension
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of DIZZINESS (Prolonged dizziness like orthostatic hypotension) and ORTHOSTATIC HYPOTENSION (Prolonged dizziness like orthostatic hypotension) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced DIZZINESS (Prolonged dizziness like orthostatic hypotension) and ORTHOSTATIC HYPOTENSION (Prolonged dizziness like orthostatic hypotension). At the time of the report, DIZZINESS (Prolonged dizziness like orthostatic hypotension) and ORTHOSTATIC HYPOTENSION (Prolonged dizziness like orthostatic hypotension) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site urticaria
Clinical narrative: Itchy hives at the site of injection; Red hives at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Itchy hives at the site of injection) and VACCINATION SITE ERYTHEMA (Red hives at the site of injection) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (Itchy hives at the site of injection) and VACCINATION SITE ERYTHEMA (Red hives at the site of injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and TRIAMCINOLONE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE URTICARIA (Itchy hives at the site of injection) and VACCINATION SITE ERYTHEMA (Red hives at the site of injection) had not resolved. Not Provided          No concomitant medications were provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Influenza like illness, Myalgia, Nasopharyngitis
Clinical narrative: Flu-like symptoms; Sweating; Cold; Little bit of body aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), HYPERHIDROSIS (Sweating), NASOPHARYNGITIS (Cold) and MYALGIA (Little bit of body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), HYPERHIDROSIS (Sweating), NASOPHARYNGITIS (Cold) and MYALGIA (Little bit of body aches). The patient was treated with IBUPROFEN for Flu-like symptoms, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Flu-like symptoms, at an unspecified dose and frequency. On 13-Feb-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms), HYPERHIDROSIS (Sweating), NASOPHARYNGITIS (Cold) and MYALGIA (Little bit of body aches) had resolved.            No relevant concomitant medications were provided.  The patient did not report and symptoms after first dose. After second dose, the patient had mild flu-like symptoms like (cold, sweating, little bit of body aches) and second day everything was fine.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included FAMOTIDINE from 04-Dec-2020 to 14-May-2021 for Acid reflux (esophageal), VALACYCLOVIR [VALACICLOVIR] from 06-Apr-2021 to 12-May-2021 for HSV infection.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 02-Aug-2020 and the estimated date of delivery was 04-May-2021. On 01-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-first week of the pregnancy. The vaginal delivery occurred on 13-May-2021, which was reported as Full-term. For neonate 1, the birth weight was 3330 grams (7lbs 5oz) with an APGAR score of 8 and 9 at (1, 5 minutes). The outcome was reported as Delivered NOS. Height of the female infant was 49.5 cm. Head circumference 34 cm APGAR Score was 8 at 1 minute and 9 at 5 minutes. The mother did not experience any problems during delivery. There were no complications, abnormalities or abnormalities at 1 month post partum for the infant. The mother was breastfeeding the infant at the time of this report. On 01-Jan-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. Unknown          No treatment information was provided. Delivery after 41+2 weeks of gestation was reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Vaccination site rash, Vaccination site swelling
Clinical narrative: Rash itchy; Rash at injection site size of a half dollar; The rash is raised and swollen; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash itchy), VACCINATION SITE RASH (Rash at injection site size of a half dollar) and VACCINATION SITE SWELLING (The rash is raised and swollen) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044a01a) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ESTRADIOL (ESTROGEN) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced RASH PRURITIC (Rash itchy), VACCINATION SITE RASH (Rash at injection site size of a half dollar) and VACCINATION SITE SWELLING (The rash is raised and swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Rash itchy), VACCINATION SITE RASH (Rash at injection site size of a half dollar) and VACCINATION SITE SWELLING (The rash is raised and swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Benadryl was used as treatment medication.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity
Clinical narrative: soreness in his arm; body aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in his arm), MYALGIA (body aches) and HEADACHE (headache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0021321A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 18-Feb-2021. Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ATORVASTATIN CALCIUM (LIPITOR), WARFARIN and TRAZODONE for an unknown indication.    On 19-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in his arm), MYALGIA (body aches) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (soreness in his arm), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Other concomitant medication included nitrates and nebulizer.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (Headache) and NAUSEA (Nausea) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-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) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced HEADACHE (Headache) and NAUSEA (Nausea). In February 2021, HEADACHE (Headache) and NAUSEA (Nausea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable  No concomitant medications were reported  No treatment drugs were reported
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cluster headache, Herpes zoster, Rash macular
Clinical narrative: Shingles; Red spots on patients eyelids and forehead; Severe headache lasting 8 days/ diagnosed as cluster headache; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) and CLUSTER HEADACHE (Severe headache lasting 8 days/ diagnosed as cluster headache) in a 60-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 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced CLUSTER HEADACHE (Severe headache lasting 8 days/ diagnosed as cluster headache). On 19-Mar-2021, the patient experienced HERPES ZOSTER (Shingles). On 19-Mar-2021, CLUSTER HEADACHE (Severe headache lasting 8 days/ diagnosed as cluster headache) had resolved. At the time of the report, HERPES ZOSTER (Shingles) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: event outcome updated and reporter denied further follow up
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Dizziness, Dyspnoea
Clinical narrative: severe stomach pain; left arm pain; racing heart; breathing felt off; uncontrollable body shakes and back spasm; neck pain; unable to eat; unable to sleep; weakness; lightheadedness; shoulder pain; headaches; 102.1 fever; nausea; weird tired-like-exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (severe stomach pain), PAIN IN EXTREMITY (left arm pain), PALPITATIONS (racing heart), DYSPNOEA (breathing felt off) and TREMOR (uncontrollable body shakes and back spasm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 036AZLA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Celiac disease. Concurrent medical conditions included Asthma.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-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 ABDOMINAL PAIN UPPER (severe stomach pain), PAIN IN EXTREMITY (left arm pain), PALPITATIONS (racing heart), DYSPNOEA (breathing felt off), TREMOR (uncontrollable body shakes and back spasm), NECK PAIN (neck pain), FEEDING DISORDER (unable to eat), INSOMNIA (unable to sleep), ASTHENIA (weakness), DIZZINESS (lightheadedness), ARTHRALGIA (shoulder pain), HEADACHE (headaches), PYREXIA (102.1 fever), NAUSEA (nausea) and FATIGUE (weird tired-like-exhaustion). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) at a dose of 4 mg. At the time of the report, ABDOMINAL PAIN UPPER (severe stomach pain), PAIN IN EXTREMITY (left arm pain), PALPITATIONS (racing heart), DYSPNOEA (breathing felt off), TREMOR (uncontrollable body shakes and back spasm), NECK PAIN (neck pain), FEEDING DISORDER (unable to eat), INSOMNIA (unable to sleep), ASTHENIA (weakness), DIZZINESS (lightheadedness), ARTHRALGIA (shoulder pain), HEADACHE (headaches), PYREXIA (102.1 fever), NAUSEA (nausea) and FATIGUE (weird tired-like-exhaustion) outcome was unknown.            No concomitant medications were reported.    This case was linked to MOD-2021-051486 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeding disorder, Headache, Insomnia, Nausea
Clinical narrative: severe stomach pain; left arm pain; racing heart; breathing felt off; uncontrollable body shakes and back spasm; neck pain; unable to eat; unable to sleep; weakness; lightheadedness; shoulder pain; headaches; 102.1 fever; nausea; weird tired-like-exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (severe stomach pain), PAIN IN EXTREMITY (left arm pain), PALPITATIONS (racing heart), DYSPNOEA (breathing felt off) and TREMOR (uncontrollable body shakes and back spasm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 036AZLA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Celiac disease. Concurrent medical conditions included Asthma.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-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 ABDOMINAL PAIN UPPER (severe stomach pain), PAIN IN EXTREMITY (left arm pain), PALPITATIONS (racing heart), DYSPNOEA (breathing felt off), TREMOR (uncontrollable body shakes and back spasm), NECK PAIN (neck pain), FEEDING DISORDER (unable to eat), INSOMNIA (unable to sleep), ASTHENIA (weakness), DIZZINESS (lightheadedness), ARTHRALGIA (shoulder pain), HEADACHE (headaches), PYREXIA (102.1 fever), NAUSEA (nausea) and FATIGUE (weird tired-like-exhaustion). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) at a dose of 4 mg. At the time of the report, ABDOMINAL PAIN UPPER (severe stomach pain), PAIN IN EXTREMITY (left arm pain), PALPITATIONS (racing heart), DYSPNOEA (breathing felt off), TREMOR (uncontrollable body shakes and back spasm), NECK PAIN (neck pain), FEEDING DISORDER (unable to eat), INSOMNIA (unable to sleep), ASTHENIA (weakness), DIZZINESS (lightheadedness), ARTHRALGIA (shoulder pain), HEADACHE (headaches), PYREXIA (102.1 fever), NAUSEA (nausea) and FATIGUE (weird tired-like-exhaustion) outcome was unknown.            No concomitant medications were reported.    This case was linked to MOD-2021-051486 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Palpitations, Pyrexia, Tremor
Clinical narrative: severe stomach pain; left arm pain; racing heart; breathing felt off; uncontrollable body shakes and back spasm; neck pain; unable to eat; unable to sleep; weakness; lightheadedness; shoulder pain; headaches; 102.1 fever; nausea; weird tired-like-exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (severe stomach pain), PAIN IN EXTREMITY (left arm pain), PALPITATIONS (racing heart), DYSPNOEA (breathing felt off) and TREMOR (uncontrollable body shakes and back spasm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 036AZLA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Celiac disease. Concurrent medical conditions included Asthma.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-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 ABDOMINAL PAIN UPPER (severe stomach pain), PAIN IN EXTREMITY (left arm pain), PALPITATIONS (racing heart), DYSPNOEA (breathing felt off), TREMOR (uncontrollable body shakes and back spasm), NECK PAIN (neck pain), FEEDING DISORDER (unable to eat), INSOMNIA (unable to sleep), ASTHENIA (weakness), DIZZINESS (lightheadedness), ARTHRALGIA (shoulder pain), HEADACHE (headaches), PYREXIA (102.1 fever), NAUSEA (nausea) and FATIGUE (weird tired-like-exhaustion). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) at a dose of 4 mg. At the time of the report, ABDOMINAL PAIN UPPER (severe stomach pain), PAIN IN EXTREMITY (left arm pain), PALPITATIONS (racing heart), DYSPNOEA (breathing felt off), TREMOR (uncontrollable body shakes and back spasm), NECK PAIN (neck pain), FEEDING DISORDER (unable to eat), INSOMNIA (unable to sleep), ASTHENIA (weakness), DIZZINESS (lightheadedness), ARTHRALGIA (shoulder pain), HEADACHE (headaches), PYREXIA (102.1 fever), NAUSEA (nausea) and FATIGUE (weird tired-like-exhaustion) outcome was unknown.            No concomitant medications were reported.    This case was linked to MOD-2021-051486 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: redness; hardness; arm swollen; warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness), INJECTION SITE INDURATION (hardness), INJECTION SITE SWELLING (arm swollen) and INJECTION SITE WARMTH (warm to touch) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-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 INJECTION SITE ERYTHEMA (redness), INJECTION SITE INDURATION (hardness), INJECTION SITE SWELLING (arm swollen) and INJECTION SITE WARMTH (warm to touch). At the time of the report, INJECTION SITE ERYTHEMA (redness), INJECTION SITE INDURATION (hardness), INJECTION SITE SWELLING (arm swollen) and INJECTION SITE WARMTH (warm to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Muscle tightness, Musculoskeletal stiffness, Myalgia, Pain in extremity
Clinical narrative: Muscle stiffness; Back pain; Pressure; Tense muscle; Sore arm; Muscle aches; Swollen injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Muscle stiffness), BACK PAIN (Back pain), VACCINATION SITE DISCOMFORT (Pressure), MUSCLE TIGHTNESS (Tense muscle) and VACCINATION SITE PAIN (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Muscle stiffness), BACK PAIN (Back pain), VACCINATION SITE DISCOMFORT (Pressure), MUSCLE TIGHTNESS (Tense muscle), VACCINATION SITE PAIN (Sore arm), MYALGIA (Muscle aches) and VACCINATION SITE SWELLING (Swollen injection site). At the time of the report, MUSCULOSKELETAL STIFFNESS (Muscle stiffness), BACK PAIN (Back pain), VACCINATION SITE DISCOMFORT (Pressure), MUSCLE TIGHTNESS (Tense muscle), VACCINATION SITE PAIN (Sore arm), MYALGIA (Muscle aches) and VACCINATION SITE SWELLING (Swollen injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site swelling
Clinical narrative: Muscle stiffness; Back pain; Pressure; Tense muscle; Sore arm; Muscle aches; Swollen injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Muscle stiffness), BACK PAIN (Back pain), VACCINATION SITE DISCOMFORT (Pressure), MUSCLE TIGHTNESS (Tense muscle) and VACCINATION SITE PAIN (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Muscle stiffness), BACK PAIN (Back pain), VACCINATION SITE DISCOMFORT (Pressure), MUSCLE TIGHTNESS (Tense muscle), VACCINATION SITE PAIN (Sore arm), MYALGIA (Muscle aches) and VACCINATION SITE SWELLING (Swollen injection site). At the time of the report, MUSCULOSKELETAL STIFFNESS (Muscle stiffness), BACK PAIN (Back pain), VACCINATION SITE DISCOMFORT (Pressure), MUSCLE TIGHTNESS (Tense muscle), VACCINATION SITE PAIN (Sore arm), MYALGIA (Muscle aches) and VACCINATION SITE SWELLING (Swollen injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication was not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm for 4 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (sore arm for 4 days) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm for 4 days). At the time of the report, VACCINATION SITE PAIN (sore arm for 4 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. No treatment medications were provided. .   This case was linked to MOD-2021-051495 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Hyperhidrosis, Malaise
Clinical narrative: feeling weak; could not get out of bed for day and a half; feeling tired; sweating profusely in the middle of the night; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating profusely in the middle of the night), FATIGUE (feeling tired), ASTHENIA (feeling weak) and MALAISE (could not get out of bed for day and a half) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for an unknown indication.     The patient's past medical history included No adverse event.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced HYPERHIDROSIS (sweating profusely in the middle of the night). On an unknown date, the patient experienced FATIGUE (feeling tired), ASTHENIA (feeling weak) and MALAISE (could not get out of bed for day and a half). At the time of the report, HYPERHIDROSIS (sweating profusely in the middle of the night), FATIGUE (feeling tired) and MALAISE (could not get out of bed for day and a half) outcome was unknown and ASTHENIA (feeling weak) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication provided. No treatment drugs were provided.    Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling at the injection site; Pain of the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain of the arm) and VACCINATION SITE SWELLING (Swelling at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 038A21A) for COVID-19 immunisation.     The patient's past medical history included No adverse event (no reported medical history).   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 18-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain of the arm). On 20-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at the injection site). At the time of the report, VACCINATION SITE PAIN (Pain of the arm) and VACCINATION SITE SWELLING (Swelling at the injection site) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (felt tired) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (felt tired). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details not provided.   This case was linked to MOD-2021-051494 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and MYALGIA (aches in muscles) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 023M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL and LOVASTATIN for an unknown indication. On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced FATIGUE (fatigue) and MYALGIA (aches in muscles). At the time of the report, FATIGUE (fatigue) and MYALGIA (aches in muscles) outcome was unknown. Not Provided. Action taken with mRNA-1273 in response to the events was not applicable. Concomitant medications included trinterene hctz and anastravole. No laboratory details were  provided. No treatment medications were reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Body temperature, Dizziness
Clinical narrative: moderate to severe headache; Weakness; Lightheadedness; shaking uncontrollably without any chills; Nausea; Shoulder pain; 102.1 fever; Back spasms; Neck pain; Unable to eat; Unable to sleep; stomach pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TREMOR (shaking uncontrollably without any chills), MUSCLE SPASMS (Back spasms), NECK PAIN (Neck pain), FEEDING DISORDER (Unable to eat) and INSOMNIA (Unable to sleep) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 036AZLA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heller's esophagomyotomy (hellermyotomy). Concurrent medical conditions included Asthma and Celiac disease.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced MUSCLE SPASMS (Back spasms), NECK PAIN (Neck pain), FEEDING DISORDER (Unable to eat), INSOMNIA (Unable to sleep), ABDOMINAL PAIN UPPER (stomach pain), ARTHRALGIA (Shoulder pain) and PYREXIA (102.1 fever). On 18-Mar-2021 at 7:00 PM, the patient experienced NAUSEA (Nausea). On 18-Mar-2021 at 9:00 PM, the patient experienced TREMOR (shaking uncontrollably without any chills). On 19-Mar-2021, the patient experienced ASTHENIA (Weakness) and DIZZINESS (Lightheadedness). On 20-Mar-2021, the patient experienced HEADACHE (moderate to severe headache). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) at a dose of 4 milligram. At the time of the report, TREMOR (shaking uncontrollably without any chills), MUSCLE SPASMS (Back spasms), NECK PAIN (Neck pain), FEEDING DISORDER (Unable to eat), INSOMNIA (Unable to sleep), ABDOMINAL PAIN UPPER (stomach pain), ASTHENIA (Weakness), DIZZINESS (Lightheadedness), NAUSEA (Nausea), ARTHRALGIA (Shoulder pain), PYREXIA (102.1 fever) and HEADACHE (moderate to severe headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 102.1 (High) Fever.         No concomitant medications provided.   This case was linked to MOD-2021-051475 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Additional information received included no new significant information
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Headache, Insomnia, Muscle spasms, Nausea
Clinical narrative: moderate to severe headache; Weakness; Lightheadedness; shaking uncontrollably without any chills; Nausea; Shoulder pain; 102.1 fever; Back spasms; Neck pain; Unable to eat; Unable to sleep; stomach pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TREMOR (shaking uncontrollably without any chills), MUSCLE SPASMS (Back spasms), NECK PAIN (Neck pain), FEEDING DISORDER (Unable to eat) and INSOMNIA (Unable to sleep) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 036AZLA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heller's esophagomyotomy (hellermyotomy). Concurrent medical conditions included Asthma and Celiac disease.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced MUSCLE SPASMS (Back spasms), NECK PAIN (Neck pain), FEEDING DISORDER (Unable to eat), INSOMNIA (Unable to sleep), ABDOMINAL PAIN UPPER (stomach pain), ARTHRALGIA (Shoulder pain) and PYREXIA (102.1 fever). On 18-Mar-2021 at 7:00 PM, the patient experienced NAUSEA (Nausea). On 18-Mar-2021 at 9:00 PM, the patient experienced TREMOR (shaking uncontrollably without any chills). On 19-Mar-2021, the patient experienced ASTHENIA (Weakness) and DIZZINESS (Lightheadedness). On 20-Mar-2021, the patient experienced HEADACHE (moderate to severe headache). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) at a dose of 4 milligram. At the time of the report, TREMOR (shaking uncontrollably without any chills), MUSCLE SPASMS (Back spasms), NECK PAIN (Neck pain), FEEDING DISORDER (Unable to eat), INSOMNIA (Unable to sleep), ABDOMINAL PAIN UPPER (stomach pain), ASTHENIA (Weakness), DIZZINESS (Lightheadedness), NAUSEA (Nausea), ARTHRALGIA (Shoulder pain), PYREXIA (102.1 fever) and HEADACHE (moderate to severe headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 102.1 (High) Fever.         No concomitant medications provided.   This case was linked to MOD-2021-051475 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Additional information received included no new significant information