chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Alopecia areata, Pharyngeal hypoaesthesia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pharyngeal hypoesthesia (numb throat) and alopecia areata (hair loss/now has a bald spot on her head/they said she has alopecia areata) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 039B21A) for COVID-19 immunization. Concurrent medical conditions included alopecia areata. Concomitant products included low-dose Aspirin (acetylsalicylic acid) for an unknown indication. On Apr 21, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 21, 2021, patient experienced pharyngeal hypoesthesia (numb throat). On May 18, 2021, patient experienced alopecia areata (hair loss). On an unknown date, patient experienced alopecia areata (now has a bald spot on her head/they said she has alopecia areata). On Apr 22, 2021, pharyngeal hypoesthesia (numb throat) outcome: unknown. At the time of the report, alopecia areata (hair loss/now has a bald spot on her head/they said she has alopecia areata) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Treatment medication not reported. Patient reported visiting a dermatologist and was concerned if the condition (alopecia areata) is related to vaccination.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm hurts for 2 to 3 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurts for 2 to 3 days) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE PAIN (Arm hurts for 2 to 3 days). On 22-Apr-2021, VACCINATION SITE PAIN (Arm hurts for 2 to 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided. No lab data has been provided by the reporter.   This case was linked to MOD-2021-148128 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Non-significant Follow up Appended - NNI received
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: vaccine started to spill; Patient did not receive full dose of the second Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (vaccine started to spill) and UNDERDOSE (Patient did not receive full dose of the second Covid-19 vaccine) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-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. On 19-May-2021, the patient experienced DEVICE CONNECTION ISSUE (vaccine started to spill) and UNDERDOSE (Patient did not receive full dose of the second Covid-19 vaccine). At the time of the report, DEVICE CONNECTION ISSUE (vaccine started to spill) and UNDERDOSE (Patient did not receive full dose of the second Covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use was unknown. Treatment information was unknown. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed his scheduled second dose and is past the 42 day mark; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed his scheduled second dose and is past the 42 day mark) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed his scheduled second dose and is past the 42 day mark). On 04-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Missed his scheduled second dose and is past the 42 day mark) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment medication was not provided by the reporter.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Confusional state, Dizziness, Dysarthria
Clinical narrative: Couldn't eat or drink; Vomited; Chills; Very confused; Responding in slow motion; She could not process conversation; Metallic taste in mouth; Dizzy; Bad stomach pains; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Very confused), HYPOKINESIA (Responding in slow motion), DYSARTHRIA (She could not process conversation), DYSGEUSIA (Metallic taste in mouth) and DIZZINESS (Dizzy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergic to many medications.).    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced CONFUSIONAL STATE (Very confused), HYPOKINESIA (Responding in slow motion), DYSARTHRIA (She could not process conversation), DYSGEUSIA (Metallic taste in mouth), DIZZINESS (Dizzy), ABDOMINAL PAIN UPPER (Bad stomach pains), VOMITING (Vomited) and CHILLS (Chills). On 24-Apr-2021, the patient experienced FEEDING DISORDER (Couldn't eat or drink). At the time of the report, CONFUSIONAL STATE (Very confused), HYPOKINESIA (Responding in slow motion), DYSARTHRIA (She could not process conversation), DYSGEUSIA (Metallic taste in mouth), DIZZINESS (Dizzy), ABDOMINAL PAIN UPPER (Bad stomach pains), FEEDING DISORDER (Couldn't eat or drink), VOMITING (Vomited) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Feeding disorder, Hypokinesia, Vomiting
Clinical narrative: Couldn't eat or drink; Vomited; Chills; Very confused; Responding in slow motion; She could not process conversation; Metallic taste in mouth; Dizzy; Bad stomach pains; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Very confused), HYPOKINESIA (Responding in slow motion), DYSARTHRIA (She could not process conversation), DYSGEUSIA (Metallic taste in mouth) and DIZZINESS (Dizzy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergic to many medications.).    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced CONFUSIONAL STATE (Very confused), HYPOKINESIA (Responding in slow motion), DYSARTHRIA (She could not process conversation), DYSGEUSIA (Metallic taste in mouth), DIZZINESS (Dizzy), ABDOMINAL PAIN UPPER (Bad stomach pains), VOMITING (Vomited) and CHILLS (Chills). On 24-Apr-2021, the patient experienced FEEDING DISORDER (Couldn't eat or drink). At the time of the report, CONFUSIONAL STATE (Very confused), HYPOKINESIA (Responding in slow motion), DYSARTHRIA (She could not process conversation), DYSGEUSIA (Metallic taste in mouth), DIZZINESS (Dizzy), ABDOMINAL PAIN UPPER (Bad stomach pains), FEEDING DISORDER (Couldn't eat or drink), VOMITING (Vomited) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nasal congestion, Sinus disorder
Clinical narrative: Got really tired; My sinuses were greatly affected; Congestion; This spontaneous case was reported by a consumer and describes the occurrence of SINUS DISORDER (My sinuses were greatly affected), NASAL CONGESTION (Congestion) and FATIGUE (Got really tired) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     Concomitant products included TAMSULOSIN for an unknown indication.    On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SINUS DISORDER (My sinuses were greatly affected), NASAL CONGESTION (Congestion) and FATIGUE (Got really tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SINUS DISORDER (My sinuses were greatly affected), NASAL CONGESTION (Congestion) and FATIGUE (Got really tired) outcome was unknown.            This case was linked to MOD-2021-080105 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Amnesia, Back pain, Dizziness, Fatigue
Clinical narrative: bad taste in her mouth; lost memory; pain in her back; fatigue; upset stomach; Pain in her teeth; dizzy; rash; Fever; This spontaneous case was reported by a patient and describes the occurrence of TASTE DISORDER (bad taste in her mouth), AMNESIA (lost memory), BACK PAIN (pain in her back), FATIGUE (fatigue) and ABDOMINAL DISCOMFORT (upset stomach) in a 66-year-old female patient 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 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 TASTE DISORDER (bad taste in her mouth), AMNESIA (lost memory), BACK PAIN (pain in her back), FATIGUE (fatigue), ABDOMINAL DISCOMFORT (upset stomach), TOOTHACHE (Pain in her teeth), DIZZINESS (dizzy), RASH (rash) and PYREXIA (Fever).   At the time of the report, TASTE DISORDER (bad taste in her mouth), AMNESIA (lost memory), BACK PAIN (pain in her back), FATIGUE (fatigue), ABDOMINAL DISCOMFORT (upset stomach), TOOTHACHE (Pain in her teeth), DIZZINESS (dizzy), RASH (rash) and PYREXIA (Fever) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   This case was linked to MOD-2021-147949 (Patient Link).   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Taste disorder, Toothache
Clinical narrative: bad taste in her mouth; lost memory; pain in her back; fatigue; upset stomach; Pain in her teeth; dizzy; rash; Fever; This spontaneous case was reported by a patient and describes the occurrence of TASTE DISORDER (bad taste in her mouth), AMNESIA (lost memory), BACK PAIN (pain in her back), FATIGUE (fatigue) and ABDOMINAL DISCOMFORT (upset stomach) in a 66-year-old female patient 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 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 TASTE DISORDER (bad taste in her mouth), AMNESIA (lost memory), BACK PAIN (pain in her back), FATIGUE (fatigue), ABDOMINAL DISCOMFORT (upset stomach), TOOTHACHE (Pain in her teeth), DIZZINESS (dizzy), RASH (rash) and PYREXIA (Fever).   At the time of the report, TASTE DISORDER (bad taste in her mouth), AMNESIA (lost memory), BACK PAIN (pain in her back), FATIGUE (fatigue), ABDOMINAL DISCOMFORT (upset stomach), TOOTHACHE (Pain in her teeth), DIZZINESS (dizzy), RASH (rash) and PYREXIA (Fever) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   This case was linked to MOD-2021-147949 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose on the 21january2021 and the second dose on the 22april2021; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on the 21january2021 and the second dose on the 22april2021) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concomitant products included LORAZEPAM, THIAMINE, VALPROATE SEMISODIUM (DIVALPROEX), HEPARIN and FOLIC ACID.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on the 21january2021 and the second dose on the 22april2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on the 21january2021 and the second dose on the 22april2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Urinary tract infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21B) for COVID-19 vaccination.     The patient's past medical history included Immunocompromised. Concurrent medical conditions included Multiple sclerosis.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced URINARY TRACT INFECTION (Urinary tract infection). At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported on 19May2021 that she received 1st dose of Moderna vaccine on 22Apr2021 and no symptom after vaccine administration. Yesterday she was diagnosed urinary tract infection and antibiotics was prescribed. She is patient of Multiple sclerosis and immunocompromised. No information of HCP, concomitant medication or expiration date of Vaccine. She schedule for 2nd dose of Moderna vaccine tomorrow. Her concern: Can she receive 2nd dose tomorrow? She agreed for verbal follow up with Safety.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: patient received 3rd Moderna vaccine dose in error; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (patient received 3rd Moderna vaccine dose in error) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A, 016C21A and 016C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced ACCIDENTAL OVERDOSE (patient received 3rd Moderna vaccine dose in error). At the time of the report, ACCIDENTAL OVERDOSE (patient received 3rd Moderna vaccine dose in error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Action taken in response to mRNA-1273 was considered to be not applicable.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Myalgia, Product dose omission issue, Pyrexia
Clinical narrative: Missed second Dose ( beyond day 35); Fever 102.4 F; Soreness of the right arm; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second Dose ( beyond day 35)), PYREXIA (Fever 102.4 F) and MYALGIA (Soreness of the right arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     The patient's past medical history included Cancer (Cancer few years back). Concomitant products included AMLODIPINE, LEVOTHYROXINE, ASPIRIN [ACETYLSALICYLIC ACID], OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (SUBOXONE), ZOLPIDEM TARTRATE (AMBIEN), ONDANSETRON (ZOFRAN [ONDANSETRON]) and RANITIDINE HYDROCHLORIDE (ZANTAC) for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced MYALGIA (Soreness of the right arm). On 06-May-2021, the patient experienced PYREXIA (Fever 102.4 F). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second Dose ( beyond day 35)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second Dose ( beyond day 35)) and MYALGIA (Soreness of the right arm) had resolved and PYREXIA (Fever 102.4 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2021, Body temperature: 102.4 (High) Fever of 102.4 F. On an unknown date, COVID-19: negative (Negative) Covid-19 test was done and report came negative..     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication list also included Rheo inhaler. Treatment information was not provided. Patient reported that she had a fever of 102.4 F when she went for the scheduled second dose on 6th May 2021, so vaccination facility did not administer the second dose.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Body temperature, Chills, Decreased appetite, SARS-CoV-2 test
Clinical narrative: loss of smell; Loss of appetite; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANOSMIA (loss of smell), DECREASED APPETITE (Loss of appetite) and CHILLS (chills) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced ANOSMIA (loss of smell), DECREASED APPETITE (Loss of appetite) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-Mar-2021, ANOSMIA (loss of smell), DECREASED APPETITE (Loss of appetite) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Body temperature: 99 (Inconclusive) had a little fever at night that got to 99 but never want above. On 29-Mar-2021, SARS-CoV-2 test: negative (Negative) negative.         Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Non significant follow up received on 07 JUL 2021. reporter details were updated.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dysgeusia, Fatigue, Taste disorder
Clinical narrative: Things taste bad after the vaccine; Half and Half tasted like sour milk after 1st dose; Mouth feels like it's always dry now after vaccine; Very tired after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Things taste bad after the vaccine), DYSGEUSIA (Half and Half tasted like sour milk after 1st dose), DRY MOUTH (Mouth feels like it's always dry now after vaccine) and FATIGUE (Very tired after 1st dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0dlbz1a) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-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 TASTE DISORDER (Things taste bad after the vaccine), DYSGEUSIA (Half and Half tasted like sour milk after 1st dose), DRY MOUTH (Mouth feels like it's always dry now after vaccine) and FATIGUE (Very tired after 1st dose). At the time of the report, TASTE DISORDER (Things taste bad after the vaccine), DYSGEUSIA (Half and Half tasted like sour milk after 1st dose), DRY MOUTH (Mouth feels like it's always dry now after vaccine) and FATIGUE (Very tired after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided. No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-148216 (E2B Linked Report). This case was linked to MOD-2021-148165 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: The live follow-up received included the son event AE chills.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-148216:Case for son
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Arm hurting; Stinging around site of injection after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurting) and VACCINATION SITE PAIN (Stinging around site of injection after second dose) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced PAIN IN EXTREMITY (Arm hurting) and VACCINATION SITE PAIN (Stinging around site of injection after second dose). At the time of the report, PAIN IN EXTREMITY (Arm hurting) and VACCINATION SITE PAIN (Stinging around site of injection after second dose) outcome was unknown.            Treatment information included the patient took rest and a warm shower. The patient felt still hurting but not as bad. She describes it as "stinging," and "feels like somebody punched me." No concomitant product use was provided by the reporter.   This case was linked to MOD-2021-148041 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Insomnia
Clinical narrative: Difficulty sleeping; A little dizzy; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Difficulty sleeping), DIZZINESS (A little dizzy) and ARTHRALGIA (Joint pain) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 041821A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced INSOMNIA (Difficulty sleeping), DIZZINESS (A little dizzy) and ARTHRALGIA (Joint pain). The patient was treated with PARACETAMOL (TYLENOL) on 18-May-2021 for Joint pain, at a dose of 500 milligram as required. At the time of the report, INSOMNIA (Difficulty sleeping) and DIZZINESS (A little dizzy) outcome was unknown and ARTHRALGIA (Joint pain) had not resolved.            Concomitant medication list was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypersensitivity, Insomnia, Myalgia, Nasal congestion
Clinical narrative: allergy issues; runny nose; sneezing; shortness of breath at times during the night; blockage of one nostril; difficulty sleeping; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergy issues), RHINORRHOEA (runny nose), SNEEZING (sneezing), DYSPNOEA (shortness of breath at times during the night) and NASAL CONGESTION (blockage of one nostril) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes mellitus. Concomitant products included SITAGLIPTIN PHOSPHATE (JANUVIA) for Diabetes mellitus, LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced MYALGIA (sore arm). In May 2021, the patient experienced HYPERSENSITIVITY (allergy issues), RHINORRHOEA (runny nose), SNEEZING (sneezing), DYSPNOEA (shortness of breath at times during the night), NASAL CONGESTION (blockage of one nostril) and INSOMNIA (difficulty sleeping). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (allergy issues), RHINORRHOEA (runny nose), SNEEZING (sneezing), DYSPNOEA (shortness of breath at times during the night), NASAL CONGESTION (blockage of one nostril), INSOMNIA (difficulty sleeping) and MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: allergy issues; runny nose; sneezing; shortness of breath at times during the night; blockage of one nostril; difficulty sleeping; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergy issues), RHINORRHOEA (runny nose), SNEEZING (sneezing), DYSPNOEA (shortness of breath at times during the night) and NASAL CONGESTION (blockage of one nostril) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes mellitus. Concomitant products included SITAGLIPTIN PHOSPHATE (JANUVIA) for Diabetes mellitus, LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced MYALGIA (sore arm). In May 2021, the patient experienced HYPERSENSITIVITY (allergy issues), RHINORRHOEA (runny nose), SNEEZING (sneezing), DYSPNOEA (shortness of breath at times during the night), NASAL CONGESTION (blockage of one nostril) and INSOMNIA (difficulty sleeping). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (allergy issues), RHINORRHOEA (runny nose), SNEEZING (sneezing), DYSPNOEA (shortness of breath at times during the night), NASAL CONGESTION (blockage of one nostril), INSOMNIA (difficulty sleeping) and MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine vial opened on (14-may-2021) ,administered to the patient on (19-may-2021); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine vial opened on (14-may-2021) ,administered to the patient on (19-may-2021)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine vial opened on (14-may-2021) ,administered to the patient on (19-may-2021)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine vial opened on (14-may-2021) ,administered to the patient on (19-may-2021)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no treatment information was reported no concomitant mediation were reported   Reporter did not allow further contact
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Product administration error
Clinical narrative: first dose>36 days; also received a dose of Pfizer vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (also received a dose of Pfizer vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose>36 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 19-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTRATION ERROR (also received a dose of Pfizer vaccine). On 19-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose>36 days). On 04-Feb-2021, PRODUCT ADMINISTRATION ERROR (also received a dose of Pfizer vaccine) had resolved. On 19-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose>36 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants were reported. No treatment was reported.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nasal congestion, Productive cough
Clinical narrative: cough along with phlegm which is annoying; congestion; sore; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (cough along with phlegm which is annoying), NASAL CONGESTION (congestion) and MYALGIA (sore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced MYALGIA (sore). On 13-May-2021, the patient experienced PRODUCTIVE COUGH (cough along with phlegm which is annoying) and NASAL CONGESTION (congestion). On 13-May-2021, MYALGIA (sore) outcome was unknown. At the time of the report, PRODUCTIVE COUGH (cough along with phlegm which is annoying) and NASAL CONGESTION (congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dysgeusia, Myalgia, Taste disorder
Clinical narrative: Things taste bad after the vaccine; Mouth feels like it's always dry now after vaccine; Milk tasted really sour after 2nd dose; Arm hurts after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Things taste bad after the vaccine), DRY MOUTH (Mouth feels like it's always dry now after vaccine), DYSGEUSIA (Milk tasted really sour after 2nd dose) and MYALGIA (Arm hurts after 2nd dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033b21a and 0dlbz1a) for COVID-19 vaccination.     The patient has no reported medical history.  Concurrent medical conditions included Rheumatoid arthritis.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-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 TASTE DISORDER (Things taste bad after the vaccine), DRY MOUTH (Mouth feels like it's always dry now after vaccine), DYSGEUSIA (Milk tasted really sour after 2nd dose) and MYALGIA (Arm hurts after 2nd dose). At the time of the report, TASTE DISORDER (Things taste bad after the vaccine), DRY MOUTH (Mouth feels like it's always dry now after vaccine) and MYALGIA (Arm hurts after 2nd dose) outcome was unknown and DYSGEUSIA (Milk tasted really sour after 2nd dose) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was provided.  No treatment medications information was provided.  Patient had RA which makes her feel fatigue.   This case was linked to MOD-2021-148126 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Additional details included event outcome and medical history.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Lymphadenopathy, Myalgia
Clinical narrative: sinus head ache; Rash on right arm at the injection; Right arm at the injection site was sore; chills/teeth catering; swollen lymph node under right arm; fatigue; Rash was a large red area; Sore joints; Body aches and pains; Rash was itchy; This spontaneous case was reported by a patient and describes the occurrence of RASH PRURITIC (Rash was itchy), SINUS HEADACHE (sinus head ache), VACCINATION SITE RASH (Rash on right arm at the injection), VACCINATION SITE PAIN (Right arm at the injection site was sore) and CHILLS (chills/teeth catering) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced RASH PRURITIC (Rash was itchy), VACCINATION SITE RASH (Rash on right arm at the injection), VACCINATION SITE PAIN (Right arm at the injection site was sore), CHILLS (chills/teeth catering), LYMPHADENOPATHY (swollen lymph node under right arm), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (Rash was a large red area), ARTHRALGIA (Sore joints) and MYALGIA (Body aches and pains). On 06-May-2021, the patient experienced SINUS HEADACHE (sinus head ache). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. On 06-May-2021, RASH PRURITIC (Rash was itchy), SINUS HEADACHE (sinus head ache), VACCINATION SITE RASH (Rash on right arm at the injection), VACCINATION SITE PAIN (Right arm at the injection site was sore), CHILLS (chills/teeth catering), LYMPHADENOPATHY (swollen lymph node under right arm), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (Rash was a large red area), ARTHRALGIA (Sore joints) and MYALGIA (Body aches and pains) had resolved.            No concomitant drugs was provided.  Action taken with the drug in response to events was not applicable.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Sinus headache, Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: sinus head ache; Rash on right arm at the injection; Right arm at the injection site was sore; chills/teeth catering; swollen lymph node under right arm; fatigue; Rash was a large red area; Sore joints; Body aches and pains; Rash was itchy; This spontaneous case was reported by a patient and describes the occurrence of RASH PRURITIC (Rash was itchy), SINUS HEADACHE (sinus head ache), VACCINATION SITE RASH (Rash on right arm at the injection), VACCINATION SITE PAIN (Right arm at the injection site was sore) and CHILLS (chills/teeth catering) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced RASH PRURITIC (Rash was itchy), VACCINATION SITE RASH (Rash on right arm at the injection), VACCINATION SITE PAIN (Right arm at the injection site was sore), CHILLS (chills/teeth catering), LYMPHADENOPATHY (swollen lymph node under right arm), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (Rash was a large red area), ARTHRALGIA (Sore joints) and MYALGIA (Body aches and pains). On 06-May-2021, the patient experienced SINUS HEADACHE (sinus head ache). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. On 06-May-2021, RASH PRURITIC (Rash was itchy), SINUS HEADACHE (sinus head ache), VACCINATION SITE RASH (Rash on right arm at the injection), VACCINATION SITE PAIN (Right arm at the injection site was sore), CHILLS (chills/teeth catering), LYMPHADENOPATHY (swollen lymph node under right arm), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (Rash was a large red area), ARTHRALGIA (Sore joints) and MYALGIA (Body aches and pains) had resolved.            No concomitant drugs was provided.  Action taken with the drug in response to events was not applicable.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2
Clinical narrative: a week later contracted COVID from son; This spontaneous case was reported by a patient and describes the occurrence of EXPOSURE TO SARS-COV-2 (a week later contracted COVID from son) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced EXPOSURE TO SARS-COV-2 (a week later contracted COVID from son). At the time of the report, EXPOSURE TO SARS-COV-2 (a week later contracted COVID from son) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2021, COVID-19: (Positive) A week later (first week of may) he contracted COVID from his son.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information is provided.  Patient stated that a week later (first week of May) he contracted COVID-19 from his son. He had mild case. He said he is three weeks past the onset of symptoms and is scheduled for the 2nd dose 20May2021.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: fatigue; pain in injection site left first; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (fatigue) and VACCINATION SITE PAIN (pain in injection site left first) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (High Blood Pressure) and Fibromyalgia.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced FATIGUE (fatigue) and VACCINATION SITE PAIN (pain in injection site left first). On 23-Apr-2021, FATIGUE (fatigue) had resolved. On 04-May-2021, VACCINATION SITE PAIN (pain in injection site left first) 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 was provided. Patient treatment information was not provided.   This case was linked to MOD-2021-148240 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: Stiffness in neck and shoulder; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness in neck and shoulder) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Provided) for COVID-19 vaccination.     The patient's past medical history included Colonoscopy (scheduled on 25-MAY-2021).    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness in neck and shoulder). On 02-May-2021, MUSCULOSKELETAL STIFFNESS (Stiffness in neck and shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications are not provided. Treatment information does not provided by the reporter.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever; Headaches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headaches) and CHILLS (Chills) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014c21a and 046a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headaches) and CHILLS (Chills). At the time of the report, PYREXIA (Fever), HEADACHE (Headaches) and CHILLS (Chills) had not resolved.            No concomitant medications were used by patient.  No treatment medications were taken by patient.  Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Adverse event, Constipation, Headache, Hyperhidrosis
Clinical narrative: Horrible reaction to 2nd dose; Soaking wet with sweat; Very constipated after 2nd dose; Sneezing for the past 2-3 days; Upset stomach; Sore arm; Sleeping a lot since 2nd dose; Headache; Fever after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Horrible reaction to 2nd dose), HYPERHIDROSIS (Soaking wet with sweat), CONSTIPATION (Very constipated after 2nd dose), SNEEZING (Sneezing for the past 2-3 days) and ABDOMINAL DISCOMFORT (Upset stomach) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037b21a and 027c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-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 ADVERSE EVENT (Horrible reaction to 2nd dose), HYPERHIDROSIS (Soaking wet with sweat), CONSTIPATION (Very constipated after 2nd dose), SNEEZING (Sneezing for the past 2-3 days), ABDOMINAL DISCOMFORT (Upset stomach), PAIN IN EXTREMITY (Sore arm), SOMNOLENCE (Sleeping a lot since 2nd dose), HEADACHE (Headache) and PYREXIA (Fever after 2nd dose). At the time of the report, ADVERSE EVENT (Horrible reaction to 2nd dose), HYPERHIDROSIS (Soaking wet with sweat), CONSTIPATION (Very constipated after 2nd dose), SNEEZING (Sneezing for the past 2-3 days), ABDOMINAL DISCOMFORT (Upset stomach), PAIN IN EXTREMITY (Sore arm), SOMNOLENCE (Sleeping a lot since 2nd dose), HEADACHE (Headache) and PYREXIA (Fever after 2nd dose) outcome was unknown.            The reporter was calling on behalf of their son who received both shots of the Moderna vaccine. The patient post receiving their second dose of vaccine experienced horrible reactions. The reporter said the patient had fevers and was soaking wet with sweat. The patient also had sore arms.  Reportedly, the patient was a brittle diabetic. The reporter states that the patient has been sleeping a lot and also had a headache, upset stomach and was very constipated after the 2nd dose. The reporter also mentioned that the patient has been sneezing for the past 2-3 days.   No Concomitant product use was reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-148969 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-148969:Husbands case