chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Blood test, Body temperature, Chills
Clinical narrative: Breathing was fast; very weak; peeing straight blood; Second shot was just a lot tiredness; Feeling body aches; Feeling cold and shaking; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TACHYPNOEA (Breathing was fast), ASTHENIA (very weak), HAEMATURIA (peeing straight blood), FATIGUE (Second shot was just a lot tiredness) and MYALGIA (Feeling body aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included UTI.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TACHYPNOEA (Breathing was fast), ASTHENIA (very weak), HAEMATURIA (peeing straight blood), FATIGUE (Second shot was just a lot tiredness), MYALGIA (Feeling body aches), CHILLS (Feeling cold and shaking) and PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date for Tiredness, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever, at a dose of 1 dosage form. At the time of the report, TACHYPNOEA (Breathing was fast), ASTHENIA (very weak), HAEMATURIA (peeing straight blood), FATIGUE (Second shot was just a lot tiredness), MYALGIA (Feeling body aches), CHILLS (Feeling cold and shaking) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) High. On an unknown date, Blood test: inconclusive (Inconclusive) Inconclusive. On an unknown date, Body temperature: 103.5 (High) 103.5, 101.5 (High) 101.5 and 101.1 (High) 101.1. On an unknown date, Electrocardiogram: inconclusive (Inconclusive) Inconclusive. On an unknown date, Heart rate: 115 to 120 (High) 115 to 120. On an unknown date, X-ray: inconclusive (Inconclusive) Inconclusive.         Concomitant medication information was not reported by the reporter.  The patient was put on IV fluids at some point.  The action taken with m-RNA with the events was considered as not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Haematuria, Heart rate, Myalgia
Clinical narrative: Breathing was fast; very weak; peeing straight blood; Second shot was just a lot tiredness; Feeling body aches; Feeling cold and shaking; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TACHYPNOEA (Breathing was fast), ASTHENIA (very weak), HAEMATURIA (peeing straight blood), FATIGUE (Second shot was just a lot tiredness) and MYALGIA (Feeling body aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included UTI.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TACHYPNOEA (Breathing was fast), ASTHENIA (very weak), HAEMATURIA (peeing straight blood), FATIGUE (Second shot was just a lot tiredness), MYALGIA (Feeling body aches), CHILLS (Feeling cold and shaking) and PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date for Tiredness, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever, at a dose of 1 dosage form. At the time of the report, TACHYPNOEA (Breathing was fast), ASTHENIA (very weak), HAEMATURIA (peeing straight blood), FATIGUE (Second shot was just a lot tiredness), MYALGIA (Feeling body aches), CHILLS (Feeling cold and shaking) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) High. On an unknown date, Blood test: inconclusive (Inconclusive) Inconclusive. On an unknown date, Body temperature: 103.5 (High) 103.5, 101.5 (High) 101.5 and 101.1 (High) 101.1. On an unknown date, Electrocardiogram: inconclusive (Inconclusive) Inconclusive. On an unknown date, Heart rate: 115 to 120 (High) 115 to 120. On an unknown date, X-ray: inconclusive (Inconclusive) Inconclusive.         Concomitant medication information was not reported by the reporter.  The patient was put on IV fluids at some point.  The action taken with m-RNA with the events was considered as not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Tachypnoea, X-ray
Clinical narrative: Breathing was fast; very weak; peeing straight blood; Second shot was just a lot tiredness; Feeling body aches; Feeling cold and shaking; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TACHYPNOEA (Breathing was fast), ASTHENIA (very weak), HAEMATURIA (peeing straight blood), FATIGUE (Second shot was just a lot tiredness) and MYALGIA (Feeling body aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included UTI.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TACHYPNOEA (Breathing was fast), ASTHENIA (very weak), HAEMATURIA (peeing straight blood), FATIGUE (Second shot was just a lot tiredness), MYALGIA (Feeling body aches), CHILLS (Feeling cold and shaking) and PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date for Tiredness, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever, at a dose of 1 dosage form. At the time of the report, TACHYPNOEA (Breathing was fast), ASTHENIA (very weak), HAEMATURIA (peeing straight blood), FATIGUE (Second shot was just a lot tiredness), MYALGIA (Feeling body aches), CHILLS (Feeling cold and shaking) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) High. On an unknown date, Blood test: inconclusive (Inconclusive) Inconclusive. On an unknown date, Body temperature: 103.5 (High) 103.5, 101.5 (High) 101.5 and 101.1 (High) 101.1. On an unknown date, Electrocardiogram: inconclusive (Inconclusive) Inconclusive. On an unknown date, Heart rate: 115 to 120 (High) 115 to 120. On an unknown date, X-ray: inconclusive (Inconclusive) Inconclusive.         Concomitant medication information was not reported by the reporter.  The patient was put on IV fluids at some point.  The action taken with m-RNA with the events was considered as not applicable.
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 female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (Urinary tract infection). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for Urinary tract infection, at a dose of 1 dosage form. At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) outcome was unknown.            Concomitant medication was not provided.   This case was linked to MOD-2021-231269 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Very low fever; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Very low fever) and MYALGIA (Body ache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 022C21A) for COVID-19 vaccination.     No medical history information was rported.  Concomitant products included MINOCYCLINE for Rheumatoid arthritis, DILTIAZEM HCL and NAPROXEN 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 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PYREXIA (Very low fever) and MYALGIA (Body ache). On 09-Apr-2021, PYREXIA (Very low fever) and MYALGIA (Body ache) had resolved.            Patient reported that she did Antibody test 20 days after the 1st dose and the report came as no antibodies detected. Patient did Antibody test after 2nd dose as well and report awaited. No Treatment information provided
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersomnia
Clinical narrative: Slept a lot; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept a lot) and HEADACHE (Headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     The patient's past medical history included Vertigo. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (Slept a lot) and HEADACHE (Headache). At the time of the report, HYPERSOMNIA (Slept a lot) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medications were provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product dose omission issue
Clinical narrative: Did not receive the second dose of the Moderna COVID-19 vaccine; Sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PRODUCT DOSE OMISSION ISSUE (Did not receive the second dose of the Moderna COVID-19 vaccine) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), PARACETAMOL (TYLENOL), IBUPROFEN, GABAPENTIN, ROPINIROLE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), SERTRALINE HYDROCHLORIDE (ZOLOFT) and CEFIXIME (FLEXERIL [CEFIXIME]) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not receive the second dose of the Moderna COVID-19 vaccine). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Did not receive the second dose of the Moderna COVID-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication information was reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: she had pain at the injection site that started at night, the day she received the vaccine (03MAY2021), and it was sore the next day; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (she had pain at the injection site that started at night, the day she received the vaccine (03MAY2021), and it was sore the next day) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included FAMOTIDINE for GERD, CALCIUM, MAGNESIUM, COPPER, ZINC, VITAMIN D [VITAMIN D NOS], OMEGA-3 NOS, MENAQUINONE-7 (K2) and PROBIOTICS NOS for an unknown indication.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced INJECTION SITE PAIN (she had pain at the injection site that started at night, the day she received the vaccine (03MAY2021), and it was sore the next day). At the time of the report, INJECTION SITE PAIN (she had pain at the injection site that started at night, the day she received the vaccine (03MAY2021), and it was sore the next day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       treatment to the events not provided.
Sex: F
Vaccine: COVID19
Symptoms: Eye infection, Hypoaesthesia, Neuropathy peripheral, Paraesthesia, Pyrexia
Clinical narrative: She feels like its neuropathy; Tingling feeling like pins and needles in both feet; Numbness particularly in her left foot; Eye infection; Arm was redder/spread was bigger at the injection site; A larger pinkness to the arm; Low grade temperature; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (she feels like its neuropathy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FAMOTIDINE for GERD, CALCIUM, MAGNESIUM, COPPER, ZINC, VITAMIN D NOS, OMEGA-3 FATTY ACIDS and MENAQUINONE-7 (K2) for an unknown indication.    On 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced VACCINATION SITE DISCOLOURATION (a larger pinkness to the arm), VACCINATION SITE PAIN )pain at the injection site), and PYREXIA (low grade temperature). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (she feels like its neuropathy) (seriousness criterion medically significant), PARAESTHESIA (tingling feeling like pins and needles in both feet), HYPOAESTHESIA (Numbness particularly in her left foot), EYE INFECTION (eye infection) and VACCINATION SITE ERYTHEMA (Arm was redder/spread was bigger at the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 01-Jun-2021, PYREXIA (low grade temperature) had resolved. At the time of the report, NEUROPATHY PERIPHERAL (she feels like its neuropathy), PARAESTHESIA (tingling feeling like pins and needles in both feet), HYPOAESTHESIA (Numbness particularly in her left foot), EYE INFECTION (eye infection), VACCINATION SITE ERYTHEMA (Arm was redder/spread was bigger at the injection site), VACCINATION SITE PAIN )pain at the injection site),  and VACCINATION SITE DISCOLOURATION (a larger pinkness to the arm) outcome was unknown.            Concomitant medication included  Probiotic used for unknown indication. Reported  treatment information included  amox/clav for 10 days and  steroid eye drop.; 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. The neuropathy was considered as non-serious due to medical judgement.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site erythema, Vaccination site pain
Clinical narrative: She feels like its neuropathy; Tingling feeling like pins and needles in both feet; Numbness particularly in her left foot; Eye infection; Arm was redder/spread was bigger at the injection site; A larger pinkness to the arm; Low grade temperature; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (she feels like its neuropathy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FAMOTIDINE for GERD, CALCIUM, MAGNESIUM, COPPER, ZINC, VITAMIN D NOS, OMEGA-3 FATTY ACIDS and MENAQUINONE-7 (K2) for an unknown indication.    On 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced VACCINATION SITE DISCOLOURATION (a larger pinkness to the arm), VACCINATION SITE PAIN )pain at the injection site), and PYREXIA (low grade temperature). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (she feels like its neuropathy) (seriousness criterion medically significant), PARAESTHESIA (tingling feeling like pins and needles in both feet), HYPOAESTHESIA (Numbness particularly in her left foot), EYE INFECTION (eye infection) and VACCINATION SITE ERYTHEMA (Arm was redder/spread was bigger at the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 01-Jun-2021, PYREXIA (low grade temperature) had resolved. At the time of the report, NEUROPATHY PERIPHERAL (she feels like its neuropathy), PARAESTHESIA (tingling feeling like pins and needles in both feet), HYPOAESTHESIA (Numbness particularly in her left foot), EYE INFECTION (eye infection), VACCINATION SITE ERYTHEMA (Arm was redder/spread was bigger at the injection site), VACCINATION SITE PAIN )pain at the injection site),  and VACCINATION SITE DISCOLOURATION (a larger pinkness to the arm) outcome was unknown.            Concomitant medication included  Probiotic used for unknown indication. Reported  treatment information included  amox/clav for 10 days and  steroid eye drop.; 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. The neuropathy was considered as non-serious due to medical judgement.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: soreness in arm; Felt pin prick; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm) and PAIN (Felt pin prick) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004m20a) 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 22-Feb-2021, the patient experienced PAIN (Felt pin prick). On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm). On 22-Feb-2021, PAIN (Felt pin prick) had resolved. At the time of the report, PAIN IN EXTREMITY (soreness in arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided  Treatment medication was not provided   This case was linked to MOD-2021-056939 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Significant follow-up, event outcome updated.
Age: 31.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Vaccination complication
Clinical narrative: Vaccination adverse reaction; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jun-2021 and was forwarded to Moderna on 23-Jun-2021.    This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Psoriasis, Skin wound, Wound haemorrhage
Clinical narrative: Psoriasis; Wound bleeding; Skin wound; Tiredness; This spontaneous case was reported by a physician and describes the occurrence of PSORIASIS (Psoriasis), WOUND HAEMORRHAGE (Wound bleeding), SKIN WOUND (Skin wound) and FATIGUE (Tiredness) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for an unknown indication.    No Medical History information was reported.   On 09-Apr-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 11-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced PSORIASIS (Psoriasis), WOUND HAEMORRHAGE (Wound bleeding), SKIN WOUND (Skin wound) and FATIGUE (Tiredness). The patient was treated with Wound care for Wound haemorrhage. In June 2021, SKIN WOUND (Skin wound) and FATIGUE (Tiredness) had resolved. At the time of the report, PSORIASIS (Psoriasis) outcome was unknown and WOUND HAEMORRHAGE (Wound bleeding) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported.  It was reported that the in Jun-2021, the patient experienced felt very tired for a few days after second COVID Vaccine, she had an open wound, small open area on back of head that continued to bleed, patient felt it was due to psoriasis. She needed to be seen in urgent care for a small open area on the back of her head that continued to bleed, the area was cauterized without any further problems. She stated physician felt it was due to Psoriasis. It was unknown if patient was enrolled in a COVID-19 vaccine trial.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Feeling hot, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: adverse reaction; swelling at injection site; itching at injection site; redness at injection site; hot to touch; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jun-2021 and was forwarded to Moderna on 22-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hot to touch), ADVERSE REACTION (adverse reaction), INJECTION SITE SWELLING (swelling at injection site), INJECTION SITE PRURITUS (itching at injection site) and INJECTION SITE ERYTHEMA (redness at injection site) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Asymptomatic COVID-19. Concurrent medical conditions included Sulfonamide allergy (Sulfa). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), PARACETAMOL (TYLENOL), OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) and GABAPENTIN for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced FEELING HOT (hot to touch), INJECTION SITE SWELLING (swelling at injection site), INJECTION SITE PRURITUS (itching at injection site) and INJECTION SITE ERYTHEMA (redness at injection site). On an unknown date, the patient experienced ADVERSE REACTION (adverse reaction). At the time of the report, FEELING HOT (hot to touch), ADVERSE REACTION (adverse reaction), INJECTION SITE SWELLING (swelling at injection site), INJECTION SITE PRURITUS (itching at injection site) and INJECTION SITE ERYTHEMA (redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       BP medicines & antibiotic were used as concomitant medications. No treatment medications were provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: New event Adverse reaction added.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Hiccups
Clinical narrative: Hiccups; Bedridden; This spontaneous case was reported by a consumer and describes the occurrence of HICCUPS (Hiccups) and BEDRIDDEN (Bedridden) in an 80-year-old male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HICCUPS (Hiccups) and BEDRIDDEN (Bedridden). At the time of the report, HICCUPS (Hiccups) and BEDRIDDEN (Bedridden) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Heart rate increased, Paraesthesia
Clinical narrative: heart rate was high; tingling all over my body; dizzy spells; bad shivers; This spontaneous case was reported by an other health care professional and describes the occurrence of HEART RATE INCREASED (heart rate was high), PARAESTHESIA (tingling all over my body), DIZZINESS (dizzy spells) and CHILLS (bad shivers) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism, Psoriasis and Asthma. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, MOMETASONE FUROATE for Psoriasis.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (heart rate was high), PARAESTHESIA (tingling all over my body), DIZZINESS (dizzy spells) and CHILLS (bad shivers). The patient was treated with COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) at a dose of 1 dosage form; VITAMIN C [ASCORBIC ACID] at a dose of 1 dosage form; CYANOCOBALAMIN (VITAMIN B COMPLEX [CYANOCOBALAMIN]) at a dose of 1 dosage form; COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE] at a dose of 1 dosage form; MAGNESIUM GLYCINATE at a dose of 1 dosage form; MECLIZINE [MECLOZINE] at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, HEART RATE INCREASED (heart rate was high), PARAESTHESIA (tingling all over my body), DIZZINESS (dizzy spells) and CHILLS (bad shivers) 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.   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.   This case was linked to MOD-2021-232185, MOD-2021-232186 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity
Clinical narrative: sore arm; can't sleep; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and INSOMNIA (can't sleep) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and INSOMNIA (can't sleep). At the time of the report, PAIN IN EXTREMITY (sore arm) and INSOMNIA (can't sleep) had not resolved.            Treatment Information was not provided by the reporter Action taken with the drug in response to the events was not provided by the reporter
Age: 27.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dizziness, Paraesthesia, Tachycardia
Clinical narrative: dizzy spells; heart rate was real high; tingling all over my body like mini shivers inside my body; bad shivers, it was making my body tremble bad; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (dizzy spells), TACHYCARDIA (heart rate was real high), PARAESTHESIA (tingling all over my body like mini shivers inside my body) and CHILLS (bad shivers, it was making my body tremble bad) in a 27-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizzy spells). an unknown date, the patient experienced TACHYCARDIA (heart rate was real high), PARAESTHESIA (tingling all over my body like mini shivers inside my body) and CHILLS (bad shivers, it was making my body tremble bad). At the time of the report, DIZZINESS (dizzy spells), TACHYCARDIA (heart rate was real high), PARAESTHESIA (tingling all over my body like mini shivers inside my body) and CHILLS (bad shivers, it was making my body tremble bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up received on 20-JULY-2021 does not contain any new information.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Lymphadenopathy, Nausea, Paraesthesia, Vertigo
Clinical narrative: Tingling all over my body like mini shiversinside my body; Dizzy spells; I experience my own little wacko earthquake senation, like everything around me is heaving or rolling; Nausea; swollen neck lymph nodes; Wrong drug administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (Wrong drug administered), PARAESTHESIA (Tingling all over my body like mini shiversinside my body), DIZZINESS (Dizzy spells), VERTIGO (I experience my own little wacko earthquake senation, like everything around me is heaving or rolling) and NAUSEA (Nausea) in a patient of an unknown age and gender 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 28-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced WRONG PRODUCT ADMINISTERED (Wrong drug administered). On an unknown date, the patient experienced PARAESTHESIA (Tingling all over my body like mini shiversinside my body), DIZZINESS (Dizzy spells), VERTIGO (I experience my own little wacko earthquake senation, like everything around me is heaving or rolling), NAUSEA (Nausea) and LYMPHADENOPATHY (swollen neck lymph nodes). On 28-Mar-2021, WRONG PRODUCT ADMINISTERED (Wrong drug administered) had resolved. At the time of the report, PARAESTHESIA (Tingling all over my body like mini shiversinside my body), DIZZINESS (Dizzy spells), VERTIGO (I experience my own little wacko earthquake senation, like everything around me is heaving or rolling), NAUSEA (Nausea) and LYMPHADENOPATHY (swollen neck lymph nodes) outcome was unknown.            The concomitant medication was not provided.  The treatment information was not provided.  The action taken with mRNA 1273 with the events was considered as not applicable.   This case was linked to MOD-2021-232182, MOD-2021-232186 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Tingling all over my body like mini shiversinside my body; Dizzy spells; I experience my own little wacko earthquake senation, like everything around me is heaving or rolling; Nausea; swollen neck lymph nodes; Wrong drug administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (Wrong drug administered), PARAESTHESIA (Tingling all over my body like mini shiversinside my body), DIZZINESS (Dizzy spells), VERTIGO (I experience my own little wacko earthquake senation, like everything around me is heaving or rolling) and NAUSEA (Nausea) in a patient of an unknown age and gender 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 28-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced WRONG PRODUCT ADMINISTERED (Wrong drug administered). On an unknown date, the patient experienced PARAESTHESIA (Tingling all over my body like mini shiversinside my body), DIZZINESS (Dizzy spells), VERTIGO (I experience my own little wacko earthquake senation, like everything around me is heaving or rolling), NAUSEA (Nausea) and LYMPHADENOPATHY (swollen neck lymph nodes). On 28-Mar-2021, WRONG PRODUCT ADMINISTERED (Wrong drug administered) had resolved. At the time of the report, PARAESTHESIA (Tingling all over my body like mini shiversinside my body), DIZZINESS (Dizzy spells), VERTIGO (I experience my own little wacko earthquake senation, like everything around me is heaving or rolling), NAUSEA (Nausea) and LYMPHADENOPATHY (swollen neck lymph nodes) outcome was unknown.            The concomitant medication was not provided.  The treatment information was not provided.  The action taken with mRNA 1273 with the events was considered as not applicable.   This case was linked to MOD-2021-232182, MOD-2021-232186 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (dizziness) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced DIZZINESS (dizziness). The patient was treated with VITAMIN C [ASCORBIC ACID] ongoing since an unknown date for Adverse event, at a dose of 1 dosage form; VITAMIN D [VITAMIN D NOS] ongoing since an unknown date for Adverse event, at a dose of 1 dosage form; UBIDECARENONE (COQ10 [UBIDECARENONE]) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form; MAGNESIUM GLYCINATE ongoing since an unknown date for Adverse event, at a dose of 1 dosage form and VITAMIN B NOS ongoing since an unknown date for Adverse event, at a dose of 1 dosage form. At the time of the report, DIZZINESS (dizziness) was resolving.        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.   The patient also reported using light blocking glasses and cutting out diet soda.   This case was linked to MOD-2021-232182, MOD-2021-232185 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  No treatment was provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Insomnia, Irritable bowel syndrome
Clinical narrative: IBS attack; Very Dizzy; Pain is not right (Unusual); Can not sleep; Extremely Sore Right Arm from Shoulder Blade to Hand; Chills; Fever 100F; Nausea; can not make a fist and can not pick up a pillow, Can not move the right arm it hurts; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABLE BOWEL SYNDROME (IBS attack), DIZZINESS (Very Dizzy), PAIN (Pain is not right (Unusual)), INSOMNIA (Can not sleep) and PAIN IN EXTREMITY (Extremely Sore Right Arm from Shoulder Blade to Hand) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-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 22-Feb-2021, the patient experienced IRRITABLE BOWEL SYNDROME (IBS attack), DIZZINESS (Very Dizzy), PAIN (Pain is not right (Unusual)), INSOMNIA (Can not sleep), PAIN IN EXTREMITY (Extremely Sore Right Arm from Shoulder Blade to Hand), CHILLS (Chills), PYREXIA (Fever 100F), NAUSEA (Nausea) and VACCINATION SITE PAIN (can not make a fist and can not pick up a pillow, Can not move the right arm it hurts). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, IRRITABLE BOWEL SYNDROME (IBS attack), DIZZINESS (Very Dizzy), PAIN (Pain is not right (Unusual)), INSOMNIA (Can not sleep), PAIN IN EXTREMITY (Extremely Sore Right Arm from Shoulder Blade to Hand), CHILLS (Chills), PYREXIA (Fever 100F), NAUSEA (Nausea) and VACCINATION SITE PAIN (can not make a fist and can not pick up a pillow, Can not move the right arm it hurts) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, Body temperature: 100 (Inconclusive) Fever.         No concomitant drugs were provided.  Treatment :  Ice pack   This case was linked to MOD-2021-021880 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: IBS attack; Very Dizzy; Pain is not right (Unusual); Can not sleep; Extremely Sore Right Arm from Shoulder Blade to Hand; Chills; Fever 100F; Nausea; can not make a fist and can not pick up a pillow, Can not move the right arm it hurts; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABLE BOWEL SYNDROME (IBS attack), DIZZINESS (Very Dizzy), PAIN (Pain is not right (Unusual)), INSOMNIA (Can not sleep) and PAIN IN EXTREMITY (Extremely Sore Right Arm from Shoulder Blade to Hand) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-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 22-Feb-2021, the patient experienced IRRITABLE BOWEL SYNDROME (IBS attack), DIZZINESS (Very Dizzy), PAIN (Pain is not right (Unusual)), INSOMNIA (Can not sleep), PAIN IN EXTREMITY (Extremely Sore Right Arm from Shoulder Blade to Hand), CHILLS (Chills), PYREXIA (Fever 100F), NAUSEA (Nausea) and VACCINATION SITE PAIN (can not make a fist and can not pick up a pillow, Can not move the right arm it hurts). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, IRRITABLE BOWEL SYNDROME (IBS attack), DIZZINESS (Very Dizzy), PAIN (Pain is not right (Unusual)), INSOMNIA (Can not sleep), PAIN IN EXTREMITY (Extremely Sore Right Arm from Shoulder Blade to Hand), CHILLS (Chills), PYREXIA (Fever 100F), NAUSEA (Nausea) and VACCINATION SITE PAIN (can not make a fist and can not pick up a pillow, Can not move the right arm it hurts) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, Body temperature: 100 (Inconclusive) Fever.         No concomitant drugs were provided.  Treatment :  Ice pack   This case was linked to MOD-2021-021880 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Flatulence, Insomnia, Nausea, Parosmia
Clinical narrative: Loss of energy; Altered smell sensation; Sleep disturbance; gas; Naseau/Ongoing Naseau throughout the day; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Loss of energy), PAROSMIA (Altered smell sensation), INSOMNIA (Sleep disturbance), FLATULENCE (gas) and NAUSEA (Naseau/Ongoing Naseau throughout the day) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Allergy to penicillin), Drug allergy (Allergy to Aspirin), Allergy to antibiotic (Allergy to Erythromycin), Acid reflux (oesophageal) (acid reflux) and Drug allergy. Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Acid reflux (esophageal), LEVOCETIRIZINE for Blood pressure, PANTOPRAZOLE for an unknown indication.   On 15-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced NAUSEA (Naseau/Ongoing Naseau throughout the day). On an unknown date, the patient experienced ASTHENIA (Loss of energy), PAROSMIA (Altered smell sensation) and INSOMNIA (Sleep disturbance). an unknown date, the patient experienced FLATULENCE (gas). At the time of the report, ASTHENIA (Loss of energy), PAROSMIA (Altered smell sensation) and INSOMNIA (Sleep disturbance) outcome was unknown and FLATULENCE (gas) and NAUSEA (Naseau/Ongoing Naseau throughout the day) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient ate smaller meals snack on pretzels, yogurt helps relieve the nausea along with gas. No Treatment medications were provided by the reporter.   This case was linked to MOD-2021-081368 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Significant follow-up Appended.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: very sore throat today; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (very sore throat today) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced OROPHARYNGEAL PAIN (very sore throat today). At the time of the report, OROPHARYNGEAL PAIN (very sore throat today) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Confusional state
Clinical narrative: extreme confusion; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (extreme confusion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONFUSIONAL STATE (extreme confusion). At the time of the report, CONFUSIONAL STATE (extreme confusion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: woke up with a big headache; This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (woke up with a big headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced HEADACHE (woke up with a big headache). At the time of the report, HEADACHE (woke up with a big headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.