chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Myalgia, Palpitations
Clinical narrative: Chest Tightness  (moves from Left to the right side back and forth and sometimes it is on both sides; Palpitation; Headache; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest Tightness  (moves from Left to the right side back and forth and sometimes it is on both sides), PALPITATIONS (Palpitation), HEADACHE (Headache) and MYALGIA (Muscle pain) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced HEADACHE (Headache) and MYALGIA (Muscle pain). On 23-Feb-2021, the patient experienced CHEST DISCOMFORT (Chest Tightness  (moves from Left to the right side back and forth and sometimes it is on both sides) and PALPITATIONS (Palpitation). On 19-Feb-2021, HEADACHE (Headache) and MYALGIA (Muscle pain) had resolved. At the time of the report, CHEST DISCOMFORT (Chest Tightness  (moves from Left to the right side back and forth and sometimes it is on both sides) and PALPITATIONS (Palpitation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No corrective treatment was provided.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Feeling hot, Oral discomfort
Clinical narrative: felt a burning inside; lips were burning; hot sensation; A spontaneous report was received from a consumer concerning a 28 years old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events felt a burning inside /burning sensation, lips were burning /oral discomfort, hot sensation /feeling hot.  The patient's medical history was not provided. Concomitant medications reported were levothyroxine, celecoxib for drug use for unknown indication.  On 28 Jan 2021, approximately 1 day prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced the event(s) felt a burning inside, lips were burning, hot sensation.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), felt a burning inside, lips were burning, hot sensation was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Hypertension, Injection site haemorrhage, Nausea
Clinical narrative: injected into a blood vessel; Her arm started to have a reaction/Her arm was swollen above the bandage; Big whelp and a rash that went up her upper arm/Rash was gone; "hard chills" which were chills with shaking; Nauseated; felt dizzy; Tachycardia; High blood pressure of 150/90; "jabbed her in the arm and there was blood running down the arm."; Hard, big knot; quarter size bruise on her arm; Experiencing soreness but today she can lift her arm much better; "hard chills" which were chills with shaking; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt dizzy), VACCINATION SITE SWELLING (Her arm started to have a reaction/Her arm was swollen above the bandage), TACHYCARDIA (Tachycardia), HYPERTENSION (High blood pressure of 150/90) and VACCINATION SITE RASH (Big whelp and a rash that went up her upper arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced DIZZINESS (felt dizzy), VACCINATION SITE SWELLING (Her arm started to have a reaction/Her arm was swollen above the bandage), TACHYCARDIA (Tachycardia), HYPERTENSION (High blood pressure of 150/90), VACCINATION SITE RASH (Big whelp and a rash that went up her upper arm), CHILLS ("hard chills" which were chills with shaking), TREMOR ("hard chills" which were chills with shaking), NAUSEA (Nauseated), INJECTION SITE HAEMORRHAGE ("jabbed her in the arm and there was blood running down the arm."), VACCINATION SITE MASS (Hard, big knot), VACCINATION SITE BRUISING (quarter size bruise on her arm) and PAIN IN EXTREMITY (Experiencing soreness but today she can lift her arm much better). On 08-Feb-2021, HYPERTENSION (High blood pressure of 150/90) had resolved. On 10-Feb-2021, VACCINATION SITE RASH (Big whelp and a rash that went up her upper arm) had resolved. At the time of the report, DIZZINESS (felt dizzy) and CHILLS ("hard chills" which were chills with shaking) had not resolved, VACCINATION SITE SWELLING (Her arm started to have a reaction/Her arm was swollen above the bandage), TACHYCARDIA (Tachycardia), NAUSEA (Nauseated), INJECTION SITE HAEMORRHAGE ("jabbed her in the arm and there was blood running down the arm."), VACCINATION SITE MASS (Hard, big knot), VACCINATION SITE BRUISING (quarter size bruise on her arm) and PAIN IN EXTREMITY (Experiencing soreness but today she can lift her arm much better) outcome was unknown and TREMOR ("hard chills" which were chills with shaking) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant product use was reported. The treatment details included diphenhydramine shot.   Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product administration error, Tachycardia, Tremor, Vaccination site bruising
Clinical narrative: injected into a blood vessel; Her arm started to have a reaction/Her arm was swollen above the bandage; Big whelp and a rash that went up her upper arm/Rash was gone; "hard chills" which were chills with shaking; Nauseated; felt dizzy; Tachycardia; High blood pressure of 150/90; "jabbed her in the arm and there was blood running down the arm."; Hard, big knot; quarter size bruise on her arm; Experiencing soreness but today she can lift her arm much better; "hard chills" which were chills with shaking; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt dizzy), VACCINATION SITE SWELLING (Her arm started to have a reaction/Her arm was swollen above the bandage), TACHYCARDIA (Tachycardia), HYPERTENSION (High blood pressure of 150/90) and VACCINATION SITE RASH (Big whelp and a rash that went up her upper arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced DIZZINESS (felt dizzy), VACCINATION SITE SWELLING (Her arm started to have a reaction/Her arm was swollen above the bandage), TACHYCARDIA (Tachycardia), HYPERTENSION (High blood pressure of 150/90), VACCINATION SITE RASH (Big whelp and a rash that went up her upper arm), CHILLS ("hard chills" which were chills with shaking), TREMOR ("hard chills" which were chills with shaking), NAUSEA (Nauseated), INJECTION SITE HAEMORRHAGE ("jabbed her in the arm and there was blood running down the arm."), VACCINATION SITE MASS (Hard, big knot), VACCINATION SITE BRUISING (quarter size bruise on her arm) and PAIN IN EXTREMITY (Experiencing soreness but today she can lift her arm much better). On 08-Feb-2021, HYPERTENSION (High blood pressure of 150/90) had resolved. On 10-Feb-2021, VACCINATION SITE RASH (Big whelp and a rash that went up her upper arm) had resolved. At the time of the report, DIZZINESS (felt dizzy) and CHILLS ("hard chills" which were chills with shaking) had not resolved, VACCINATION SITE SWELLING (Her arm started to have a reaction/Her arm was swollen above the bandage), TACHYCARDIA (Tachycardia), NAUSEA (Nauseated), INJECTION SITE HAEMORRHAGE ("jabbed her in the arm and there was blood running down the arm."), VACCINATION SITE MASS (Hard, big knot), VACCINATION SITE BRUISING (quarter size bruise on her arm) and PAIN IN EXTREMITY (Experiencing soreness but today she can lift her arm much better) outcome was unknown and TREMOR ("hard chills" which were chills with shaking) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant product use was reported. The treatment details included diphenhydramine shot.   Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site rash, Vaccination site swelling
Clinical narrative: injected into a blood vessel; Her arm started to have a reaction/Her arm was swollen above the bandage; Big whelp and a rash that went up her upper arm/Rash was gone; "hard chills" which were chills with shaking; Nauseated; felt dizzy; Tachycardia; High blood pressure of 150/90; "jabbed her in the arm and there was blood running down the arm."; Hard, big knot; quarter size bruise on her arm; Experiencing soreness but today she can lift her arm much better; "hard chills" which were chills with shaking; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt dizzy), VACCINATION SITE SWELLING (Her arm started to have a reaction/Her arm was swollen above the bandage), TACHYCARDIA (Tachycardia), HYPERTENSION (High blood pressure of 150/90) and VACCINATION SITE RASH (Big whelp and a rash that went up her upper arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced DIZZINESS (felt dizzy), VACCINATION SITE SWELLING (Her arm started to have a reaction/Her arm was swollen above the bandage), TACHYCARDIA (Tachycardia), HYPERTENSION (High blood pressure of 150/90), VACCINATION SITE RASH (Big whelp and a rash that went up her upper arm), CHILLS ("hard chills" which were chills with shaking), TREMOR ("hard chills" which were chills with shaking), NAUSEA (Nauseated), INJECTION SITE HAEMORRHAGE ("jabbed her in the arm and there was blood running down the arm."), VACCINATION SITE MASS (Hard, big knot), VACCINATION SITE BRUISING (quarter size bruise on her arm) and PAIN IN EXTREMITY (Experiencing soreness but today she can lift her arm much better). On 08-Feb-2021, HYPERTENSION (High blood pressure of 150/90) had resolved. On 10-Feb-2021, VACCINATION SITE RASH (Big whelp and a rash that went up her upper arm) had resolved. At the time of the report, DIZZINESS (felt dizzy) and CHILLS ("hard chills" which were chills with shaking) had not resolved, VACCINATION SITE SWELLING (Her arm started to have a reaction/Her arm was swollen above the bandage), TACHYCARDIA (Tachycardia), NAUSEA (Nauseated), INJECTION SITE HAEMORRHAGE ("jabbed her in the arm and there was blood running down the arm."), VACCINATION SITE MASS (Hard, big knot), VACCINATION SITE BRUISING (quarter size bruise on her arm) and PAIN IN EXTREMITY (Experiencing soreness but today she can lift her arm much better) outcome was unknown and TREMOR ("hard chills" which were chills with shaking) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant product use was reported. The treatment details included diphenhydramine shot.   Reporter did not allow further contact
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Oral pain, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: I got more sores on my legs, especially on my left leg; my throat started hurting; my mouth started hurting; I had a sore on my leg because of being old. Immediately after shot, it doubled; A spontaneous report was received from a consumer concerning a 71-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore on leg because of being old. immediately after shot, it doubled, got more sores on legs, especially on left leg, throat started hurting, mouth started hurting.  The patient's medical history included knee replacement. Concomitant medications reported were Lisinopril 20 mg once a day, Atenolol, Chlorthalidone, Amlodipine, Prazosin, Atorvastatin, Amitriptyline, Montelukast, Baclofen, Symbicort for unknown indication.  On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031M20A) via unknown route for prophylaxis of COVID-19 infection.  On 9 Feb 2021, after  few hours of vaccine administration the patient experienced the events  sore on leg because of being old. immediately after shot, it doubled. On an unknown date, the patient experienced the events got more sores on legs, especially on left leg, throat started hurting, mouth started hurting.  No treatment reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, sore on leg because of being old, immediately after shot, it doubled,  got more sores on legs especially on left leg was resolving and throat started hurting was resolved, and mouth started hurting was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: in bed sick for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (in bed sick for 4 days) in a 75-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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (in bed sick for 4 days). At the time of the report, ILLNESS (in bed sick for 4 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-027829 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-027829:Crosslinked case
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Oropharyngeal pain, Pain in extremity, Palpitations
Clinical narrative: Sore throat; Nauseous; Heart palpitations; Fever; Chills; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nauseous) and PALPITATIONS (Heart palpitations) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 24-Feb-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 25-Feb-2021, the patient experienced NAUSEA (Nauseous) and PALPITATIONS (Heart palpitations). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat). At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and CHILLS (Chills) had resolved and NAUSEA (Nauseous), PALPITATIONS (Heart palpitations) and OROPHARYNGEAL PAIN (Sore throat) outcome was unknown.            The concomitant medications were not provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Sore throat; Nauseous; Heart palpitations; Fever; Chills; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nauseous) and PALPITATIONS (Heart palpitations) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 24-Feb-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 25-Feb-2021, the patient experienced NAUSEA (Nauseous) and PALPITATIONS (Heart palpitations). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat). At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and CHILLS (Chills) had resolved and NAUSEA (Nauseous), PALPITATIONS (Heart palpitations) and OROPHARYNGEAL PAIN (Sore throat) outcome was unknown.            The concomitant medications were not provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Nausea
Clinical narrative: shortness of breath; extreme diarrhea; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), DIARRHOEA (extreme diarrhea) and NAUSEA (nausea) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DYSPNOEA (shortness of breath), DIARRHOEA (extreme diarrhea) and NAUSEA (nausea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) on 26-Feb-2021 for Diarrhea, at a dose of 4 Tab, within 36 hrs. At the time of the report, DYSPNOEA (shortness of breath), DIARRHOEA (extreme diarrhea) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: Aches; Headaches; chills; Fever (101-102); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), HEADACHE (Headaches), CHILLS (chills) and PYREXIA (Fever (101-102)) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-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 27-Feb-2021, the patient experienced PAIN (Aches), HEADACHE (Headaches), CHILLS (chills) and PYREXIA (Fever (101-102)). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Aches), HEADACHE (Headaches), CHILLS (chills) and PYREXIA (Fever (101-102)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Body temperature: 101-102 (High) 101-102 fever.         No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to events was not applicable.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Arm was red at the injection site; Arm was swollen at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Arm was red at the injection site) and VACCINATION SITE SWELLING (Arm was swollen at the injection site) in a 75-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm was red at the injection site) and VACCINATION SITE SWELLING (Arm was swollen at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Arm was red at the injection site) and VACCINATION SITE SWELLING (Arm was swollen at the injection site) outcome was unknown. Not Provided          Relevant concomitant product usage were not reported by the reporter. No treatment details were added.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever of 100 F; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 100 F) and PAIN (Body aches) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PYREXIA (Fever of 100 F) and PAIN (Body aches). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever of 100 F) and PAIN (Body aches) outcome was unknown.            Relevant concomitant product usage were not reported by the reporter.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Fatigue, Vomiting
Clinical narrative: Abdominal pain; Weakness; Vomiting through the night; Tiredness; This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN (Abdominal pain), ASTHENIA (Weakness), VOMITING (Vomiting through the night) and FATIGUE (Tiredness) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypercholesterolemia. Concomitant products included ALIROCUMAB (PRALUENT) for Cholesterol, DIMENHYDRINATE (DRAMAMINE), EZETIMIBE (ZETIA) and LEVOTHYROXINE for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN (Abdominal pain), ASTHENIA (Weakness), VOMITING (Vomiting through the night) and FATIGUE (Tiredness). At the time of the report, ABDOMINAL PAIN (Abdominal pain), ASTHENIA (Weakness), VOMITING (Vomiting through the night) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Non significant follow up appended.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Feeling abnormal, Pain in extremity, Pyrexia
Clinical narrative: I feel like I got hit by a truck; 101.5 fever; My arm got sore; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm got sore), FEELING ABNORMAL (I feel like I got hit by a truck), CHILLS (Chills) and PYREXIA (101.5 fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A2A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (My arm got sore) and CHILLS (Chills). On 26-Feb-2021, the patient experienced PYREXIA (101.5 fever). On an unknown date, the patient experienced FEELING ABNORMAL (I feel like I got hit by a truck). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CLONAZEPAM at an unspecified dose and frequency. On 26-Feb-2021, PYREXIA (101.5 fever) had resolved. At the time of the report, PAIN IN EXTREMITY (My arm got sore) had not resolved, FEELING ABNORMAL (I feel like I got hit by a truck) outcome was unknown and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature increased: increased (High) Bit higher than normal.         Relevant concomitant product usage were not reported by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD21-040423, MOD21-040424 (E2B Linked Report).; Sender's Comments:  MOD21-040423:Cross link MOD21-040424:Cross link
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Musculoskeletal stiffness, Pain
Clinical narrative: Stiffness of the neck; Weakness in the body; Headaches; A little achiness, gotten worse, feel achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (A little achiness, gotten worse, feel achy), MUSCULOSKELETAL STIFFNESS (Stiffness of the neck), ASTHENIA (Weakness in the body) and HEADACHE (Headaches) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN (A little achiness, gotten worse, feel achy). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness of the neck), ASTHENIA (Weakness in the body) and HEADACHE (Headaches). At the time of the report, PAIN (A little achiness, gotten worse, feel achy), MUSCULOSKELETAL STIFFNESS (Stiffness of the neck), ASTHENIA (Weakness in the body) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant product usage were not reported by the reporter. No treatment details were added.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Pruritus, Vaccination complication, Vaccination site erythema
Clinical narrative: Tired / Not myself; Redness; Itching; Itching at injection site; Redness at injection site; Sore at the injection site; Didn't feel real great; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Didn't feel real great), ERYTHEMA (Redness), PRURITUS (Itching), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION COMPLICATION (Didn't feel real great), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Sore at the injection site). On 08-Feb-2021, the patient experienced PRURITUS (Itching). On 09-Feb-2021, the patient experienced ERYTHEMA (Redness). On 10-Feb-2021, the patient experienced FATIGUE (Tired / Not myself). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event following immunisation, at an unspecified dose and frequency. On 01-Feb-2021, VACCINATION COMPLICATION (Didn't feel real great), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Sore at the injection site) had resolved. At the time of the report, ERYTHEMA (Redness), PRURITUS (Itching) and FATIGUE (Tired / Not myself) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: Tired / Not myself; Redness; Itching; Itching at injection site; Redness at injection site; Sore at the injection site; Didn't feel real great; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Didn't feel real great), ERYTHEMA (Redness), PRURITUS (Itching), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION COMPLICATION (Didn't feel real great), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Sore at the injection site). On 08-Feb-2021, the patient experienced PRURITUS (Itching). On 09-Feb-2021, the patient experienced ERYTHEMA (Redness). On 10-Feb-2021, the patient experienced FATIGUE (Tired / Not myself). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event following immunisation, at an unspecified dose and frequency. On 01-Feb-2021, VACCINATION COMPLICATION (Didn't feel real great), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Sore at the injection site) had resolved. At the time of the report, ERYTHEMA (Redness), PRURITUS (Itching) and FATIGUE (Tired / Not myself) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Hurt her back; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Hurt her back) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K2(or Z)0A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to a certain BP medication (name not provided)).    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced BACK PAIN (Hurt her back). At the time of the report, BACK PAIN (Hurt her back) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment information were reported.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: Achiness in the body; Shivering an shaking uncontrollably; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achiness in the body) and CHILLS (Shivering an shaking uncontrollably) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced MYALGIA (Achiness in the body) and CHILLS (Shivering an shaking uncontrollably). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MYALGIA (Achiness in the body) and CHILLS (Shivering an shaking uncontrollably) outcome was unknown.            Relevant concomitant product usage were not reported by the reporter. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pain, Pain in extremity
Clinical narrative: Sore arm (after the first and second dose); Woke up in the middle of the night (after the 2nd dose); Body achess (after the 2nd dose); Nausea (after the 2nd dose); Chills (after the first and second dose); Fatigue(after the first and second dose); 101°F fever (after the 2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm (after the first and second dose)), SLEEP DISORDER (Woke up in the middle of the night (after the 2nd dose)), PAIN (Body achess (after the 2nd dose)), NAUSEA (Nausea (after the 2nd dose)) and CHILLS (Chills (after the first and second dose)) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm (after the first and second dose)), SLEEP DISORDER (Woke up in the middle of the night (after the 2nd dose)), PAIN (Body achess (after the 2nd dose)), NAUSEA (Nausea (after the 2nd dose)), CHILLS (Chills (after the first and second dose)), FATIGUE (Fatigue(after the first and second dose)) and PYREXIA (101°F fever (after the 2nd dose)). At the time of the report, PAIN IN EXTREMITY (Sore arm (after the first and second dose)), SLEEP DISORDER (Woke up in the middle of the night (after the 2nd dose)), PAIN (Body achess (after the 2nd dose)), NAUSEA (Nausea (after the 2nd dose)), CHILLS (Chills (after the first and second dose)), FATIGUE (Fatigue(after the first and second dose)) and PYREXIA (101°F fever (after the 2nd dose)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: Sore arm (after the first and second dose); Woke up in the middle of the night (after the 2nd dose); Body achess (after the 2nd dose); Nausea (after the 2nd dose); Chills (after the first and second dose); Fatigue(after the first and second dose); 101°F fever (after the 2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm (after the first and second dose)), SLEEP DISORDER (Woke up in the middle of the night (after the 2nd dose)), PAIN (Body achess (after the 2nd dose)), NAUSEA (Nausea (after the 2nd dose)) and CHILLS (Chills (after the first and second dose)) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm (after the first and second dose)), SLEEP DISORDER (Woke up in the middle of the night (after the 2nd dose)), PAIN (Body achess (after the 2nd dose)), NAUSEA (Nausea (after the 2nd dose)), CHILLS (Chills (after the first and second dose)), FATIGUE (Fatigue(after the first and second dose)) and PYREXIA (101°F fever (after the 2nd dose)). At the time of the report, PAIN IN EXTREMITY (Sore arm (after the first and second dose)), SLEEP DISORDER (Woke up in the middle of the night (after the 2nd dose)), PAIN (Body achess (after the 2nd dose)), NAUSEA (Nausea (after the 2nd dose)), CHILLS (Chills (after the first and second dose)), FATIGUE (Fatigue(after the first and second dose)) and PYREXIA (101°F fever (after the 2nd dose)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Tenderness
Clinical narrative: little tenderness; slight sore arm; This spontaneous case was reported by a physician and describes the occurrence of TENDERNESS (little tenderness) and MYALGIA (slight sore arm) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 001A21A) for COVID-19 vaccination.     Concomitant products included METOPROLOL, LEVODOPA and AMANTADINE for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TENDERNESS (little tenderness) and MYALGIA (slight sore arm). At the time of the report, TENDERNESS (little tenderness) and MYALGIA (slight sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.    No treatment details were added. Action taken with mRNA-1273 in response to the event was not applicable
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Insomnia, Myalgia, Pyrexia, Vaccination site erythema
Clinical narrative: did not sleep much the night; fever; body aching; vomiting; injection site is red; injection site is swollen; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (did not sleep much the night), PYREXIA (fever), MYALGIA (body aching), VOMITING (vomiting) and VACCINATION SITE ERYTHEMA (injection site is red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CITALOPRAM for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced INSOMNIA (did not sleep much the night), PYREXIA (fever), MYALGIA (body aching), VOMITING (vomiting), VACCINATION SITE ERYTHEMA (injection site is red) and VACCINATION SITE SWELLING (injection site is swollen). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, INSOMNIA (did not sleep much the night), PYREXIA (fever), MYALGIA (body aching), VOMITING (vomiting), VACCINATION SITE ERYTHEMA (injection site is red) and VACCINATION SITE SWELLING (injection site is swollen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, Body temperature: 103 degree f High.         The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vomiting
Clinical narrative: did not sleep much the night; fever; body aching; vomiting; injection site is red; injection site is swollen; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (did not sleep much the night), PYREXIA (fever), MYALGIA (body aching), VOMITING (vomiting) and VACCINATION SITE ERYTHEMA (injection site is red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CITALOPRAM for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced INSOMNIA (did not sleep much the night), PYREXIA (fever), MYALGIA (body aching), VOMITING (vomiting), VACCINATION SITE ERYTHEMA (injection site is red) and VACCINATION SITE SWELLING (injection site is swollen). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, INSOMNIA (did not sleep much the night), PYREXIA (fever), MYALGIA (body aching), VOMITING (vomiting), VACCINATION SITE ERYTHEMA (injection site is red) and VACCINATION SITE SWELLING (injection site is swollen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, Body temperature: 103 degree f High.         The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient with seizure pulled off during vaccination and ended up receiving half dose of moderna vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of UNDERDOSE (Patient with seizure pulled off during vaccination and ended up receiving half dose of moderna vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Dementia.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced UNDERDOSE (Patient with seizure pulled off during vaccination and ended up receiving half dose of moderna vaccine). On 26-Feb-2021, UNDERDOSE (Patient with seizure pulled off during vaccination and ended up receiving half dose of moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided by reporter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Headache, Influenza like illness, Injection site pain
Clinical narrative: Big red angry rash at the injection site about the size of the palm of my hand,; Terrible headache; Low grade fever; Hot; Flu like Symptoms; Achy feeling; Itchy; Nausea; Very sore; Warm; Feeling horrible; Still feel miserable; Covid arm reaction 8 days later; Trunk rash right after the vaccine; Malaise; Soreness; Redness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (Redness), VACCINATION SITE RASH (Big red angry rash at the injection site about the size of the palm of my hand,), RASH (Trunk rash right after the vaccine), HEADACHE (Terrible headache) and PYREXIA (Low grade fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (Takes  Xyzal, Promethazine and a monthly shot of Xolair for allergy as suggested by her allergist based on her medical history.). Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), PROMETHAZINE and OMALIZUMAB (XOLAIR) for Allergy.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced ERYTHEMA (Redness), RASH (Trunk rash right after the vaccine), PAIN (Soreness) and MALAISE (Malaise). On 24-Feb-2021, the patient experienced INJECTION SITE RASH (Covid arm reaction 8 days later). On an unknown date, the patient experienced VACCINATION SITE RASH (Big red angry rash at the injection site about the size of the palm of my hand,), HEADACHE (Terrible headache), PYREXIA (Low grade fever), NAUSEA (Nausea), PAIN (Very sore), INJECTION SITE PAIN (Hot), INFLUENZA LIKE ILLNESS (Flu like Symptoms), PAIN (Achy feeling), PRURITUS (Itchy), VACCINATION SITE WARMTH (Warm), FEELING ABNORMAL (Feeling horrible) and FEELING ABNORMAL (Still feel miserable). The patient was treated with PARACETAMOL (TYLENOL) at a dose of unknown and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of unknown. At the time of the report, ERYTHEMA (Redness), VACCINATION SITE RASH (Big red angry rash at the injection site about the size of the palm of my hand,), RASH (Trunk rash right after the vaccine), HEADACHE (Terrible headache), PYREXIA (Low grade fever), INJECTION SITE RASH (Covid arm reaction 8 days later), NAUSEA (Nausea), PAIN (Very sore), PAIN (Soreness), INJECTION SITE PAIN (Hot), INFLUENZA LIKE ILLNESS (Flu like Symptoms), PAIN (Achy feeling), PRURITUS (Itchy), MALAISE (Malaise), VACCINATION SITE WARMTH (Warm), FEELING ABNORMAL (Feeling horrible) and FEELING ABNORMAL (Still feel miserable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient also stated it is not a bad as it was 2 days ago.; Reporter's Comments: Treatment taken was Tyenol and Allegra