chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Pain in the right side of stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Pain in the right side of stomach) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Pain in the right side of stomach). At the time of the report, ABDOMINAL PAIN UPPER (Pain in the right side of stomach) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications are reported. No treatment information were reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Phlebitis superficial, Skin discolouration
Clinical narrative: difference in vein struture in left arm after second dose; left arm had different color of skin than right arm; left arm area had a sharp stinging effect like a bee sting; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Apr-2021 and was forwarded to Moderna on 16-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN OF SKIN (left arm area had a sharp stinging effect like a bee sting), SKIN DISCOLOURATION (left arm had different color of skin than right arm) and PHLEBITIS SUPERFICIAL (difference in vein struture in left arm after second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN OF SKIN (left arm area had a sharp stinging effect like a bee sting). On 16-Apr-2021, the patient experienced SKIN DISCOLOURATION (left arm had different color of skin than right arm). On an unknown date, the patient experienced PHLEBITIS SUPERFICIAL (difference in vein struture in left arm after second dose). At the time of the report, PAIN OF SKIN (left arm area had a sharp stinging effect like a bee sting), SKIN DISCOLOURATION (left arm had different color of skin than right arm) and PHLEBITIS SUPERFICIAL (difference in vein struture in left arm after second dose) outcome was unknown.            no concomitant medications are provided.  no treatment medications are provided.   This case was linked to MOD-2021-079466 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Additional information received on 19 Apr 2021, contains both the doses details. On 18-May-2021: Additional information received on 18 May 2021 contains No New Information On 27-Jul-2021: Additional information received on 27 Jul 2021, patient needs help for filling AE form; Sender's Comments:  MOD-2021-079466:First dose of vaccine case
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (soreness in the arm) and fatigue in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 046A21A) for COVID-19 immunization. The patient's past medical history included no adverse event. On Apr 7, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 7, 2021, patient experienced pain in extremity (soreness in the arm) and fatigue. At the time of the report, pain in extremity (soreness in the arm) and fatigue outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: slight vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (slight vertigo) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced VERTIGO (slight vertigo). At the time of the report, VERTIGO (slight vertigo) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided. No treatment information provided.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling hot
Clinical narrative: Felt Hot; Fatigue; Dizziness; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Dizziness), FEELING HOT (Felt Hot) and FATIGUE (Fatigue) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.   No Medical History information was reported.  On 11-Apr-2021 at 10:00 PM, 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) (Intramuscular) 1 dosage form. On 11-Apr-2021 at 10:30 PM, the patient experienced DIZZINESS (Dizziness) and FATIGUE (Fatigue). On an unknown date, the patient experienced FEELING HOT (Felt Hot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) ongoing since an unknown date at a dose of 25 mg. At the time of the report, DIZZINESS (Dizziness), FEELING HOT (Felt Hot) and FATIGUE (Fatigue) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient experienced dizziness and fatigue approximately 30 minutes after the injection. He was treated with Diphenhydramine 25 mg per oral and was monitored by a registered nurse for additional 30 minutes.   This case was linked to MOD-2021-079489 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up information was received on 21-May-2021 contains information regarding patient's demographics, dosage details of Moderna vaccination, treatment details, and additional event felt hot was added.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: body pain; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body pain) and MYALGIA (Muscle pain) 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 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced PAIN (body pain) and MYALGIA (Muscle pain). At the time of the report, PAIN (body pain) and MYALGIA (Muscle pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information provided by Reporter.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Malaise, Pain, Pyrexia
Clinical narrative: Flu like symptoms; Body aches; Feels like garbage; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Body aches), MALAISE (Feels like garbage), CHILLS (Chills) and PYREXIA (Fever) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) 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 16-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Body aches), MALAISE (Feels like garbage), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Body aches), MALAISE (Feels like garbage), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included High Blood Pressure Medications and Diabetic Medications.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature fluctuation, Diplopia, Migraine
Clinical narrative: Migraine headaches; Sore/pain all over; Back pain; Jaw pain; Teeth pain; Scalp pain; Vision affected cant focus; Eyes feel like they have sand in them/had to look out of one eye while driving; Close one eye the other eye is fuzzy; Seeing doubles/while he was driving he had double vision; Knuckles pain; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine headaches), PAIN (Sore/pain all over), BACK PAIN (Back pain), PAIN IN JAW (Jaw pain) and TOOTHACHE (Teeth pain) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 300117) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Shortness of breath. Concomitant products included PARACETAMOL (TYLENOL ARTHRITIS) for Arthritis, TIOTROPIUM BROMIDE (SPIRIVA RESPIMAT), TIOTROPIUM BROMIDE MONOHYDRATE, FUROSEMIDE (FUROSIMIDE), ZOLMITRIPTAN, BECLOMETASONE DIPROPIONATE (MYLAN BECLO AQ) and LORAZEPAM (ATIVAN) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced MIGRAINE (Migraine headaches), PAIN (Sore/pain all over), BACK PAIN (Back pain), PAIN IN JAW (Jaw pain), TOOTHACHE (Teeth pain), PAIN OF SKIN (Scalp pain), VISUAL IMPAIRMENT (Vision affected cant focus), OCULAR DISCOMFORT (Eyes feel like they have sand in them/had to look out of one eye while driving), VISION BLURRED (Close one eye the other eye is fuzzy), DIPLOPIA (Seeing doubles/while he was driving he had double vision) and ARTHRALGIA (Knuckles pain). At the time of the report, MIGRAINE (Migraine headaches), PAIN (Sore/pain all over), BACK PAIN (Back pain), PAIN IN JAW (Jaw pain), TOOTHACHE (Teeth pain), PAIN OF SKIN (Scalp pain), VISUAL IMPAIRMENT (Vision affected cant focus), OCULAR DISCOMFORT (Eyes feel like they have sand in them/had to look out of one eye while driving), VISION BLURRED (Close one eye the other eye is fuzzy), DIPLOPIA (Seeing doubles/while he was driving he had double vision) and ARTHRALGIA (Knuckles pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Body temperature fluctuation: abnormal (abnormal) temperature varies from 35.7C to above 36.8C.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Ocular discomfort, Pain, Pain in jaw, Pain of skin, Toothache
Clinical narrative: Migraine headaches; Sore/pain all over; Back pain; Jaw pain; Teeth pain; Scalp pain; Vision affected cant focus; Eyes feel like they have sand in them/had to look out of one eye while driving; Close one eye the other eye is fuzzy; Seeing doubles/while he was driving he had double vision; Knuckles pain; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine headaches), PAIN (Sore/pain all over), BACK PAIN (Back pain), PAIN IN JAW (Jaw pain) and TOOTHACHE (Teeth pain) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 300117) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Shortness of breath. Concomitant products included PARACETAMOL (TYLENOL ARTHRITIS) for Arthritis, TIOTROPIUM BROMIDE (SPIRIVA RESPIMAT), TIOTROPIUM BROMIDE MONOHYDRATE, FUROSEMIDE (FUROSIMIDE), ZOLMITRIPTAN, BECLOMETASONE DIPROPIONATE (MYLAN BECLO AQ) and LORAZEPAM (ATIVAN) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced MIGRAINE (Migraine headaches), PAIN (Sore/pain all over), BACK PAIN (Back pain), PAIN IN JAW (Jaw pain), TOOTHACHE (Teeth pain), PAIN OF SKIN (Scalp pain), VISUAL IMPAIRMENT (Vision affected cant focus), OCULAR DISCOMFORT (Eyes feel like they have sand in them/had to look out of one eye while driving), VISION BLURRED (Close one eye the other eye is fuzzy), DIPLOPIA (Seeing doubles/while he was driving he had double vision) and ARTHRALGIA (Knuckles pain). At the time of the report, MIGRAINE (Migraine headaches), PAIN (Sore/pain all over), BACK PAIN (Back pain), PAIN IN JAW (Jaw pain), TOOTHACHE (Teeth pain), PAIN OF SKIN (Scalp pain), VISUAL IMPAIRMENT (Vision affected cant focus), OCULAR DISCOMFORT (Eyes feel like they have sand in them/had to look out of one eye while driving), VISION BLURRED (Close one eye the other eye is fuzzy), DIPLOPIA (Seeing doubles/while he was driving he had double vision) and ARTHRALGIA (Knuckles pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Body temperature fluctuation: abnormal (abnormal) temperature varies from 35.7C to above 36.8C.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred, Visual impairment
Clinical narrative: Migraine headaches; Sore/pain all over; Back pain; Jaw pain; Teeth pain; Scalp pain; Vision affected cant focus; Eyes feel like they have sand in them/had to look out of one eye while driving; Close one eye the other eye is fuzzy; Seeing doubles/while he was driving he had double vision; Knuckles pain; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine headaches), PAIN (Sore/pain all over), BACK PAIN (Back pain), PAIN IN JAW (Jaw pain) and TOOTHACHE (Teeth pain) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 300117) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Shortness of breath. Concomitant products included PARACETAMOL (TYLENOL ARTHRITIS) for Arthritis, TIOTROPIUM BROMIDE (SPIRIVA RESPIMAT), TIOTROPIUM BROMIDE MONOHYDRATE, FUROSEMIDE (FUROSIMIDE), ZOLMITRIPTAN, BECLOMETASONE DIPROPIONATE (MYLAN BECLO AQ) and LORAZEPAM (ATIVAN) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced MIGRAINE (Migraine headaches), PAIN (Sore/pain all over), BACK PAIN (Back pain), PAIN IN JAW (Jaw pain), TOOTHACHE (Teeth pain), PAIN OF SKIN (Scalp pain), VISUAL IMPAIRMENT (Vision affected cant focus), OCULAR DISCOMFORT (Eyes feel like they have sand in them/had to look out of one eye while driving), VISION BLURRED (Close one eye the other eye is fuzzy), DIPLOPIA (Seeing doubles/while he was driving he had double vision) and ARTHRALGIA (Knuckles pain). At the time of the report, MIGRAINE (Migraine headaches), PAIN (Sore/pain all over), BACK PAIN (Back pain), PAIN IN JAW (Jaw pain), TOOTHACHE (Teeth pain), PAIN OF SKIN (Scalp pain), VISUAL IMPAIRMENT (Vision affected cant focus), OCULAR DISCOMFORT (Eyes feel like they have sand in them/had to look out of one eye while driving), VISION BLURRED (Close one eye the other eye is fuzzy), DIPLOPIA (Seeing doubles/while he was driving he had double vision) and ARTHRALGIA (Knuckles pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Body temperature fluctuation: abnormal (abnormal) temperature varies from 35.7C to above 36.8C.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Oral mucosal blistering, Rash morbilliform
Clinical narrative: Blood blisters in mouth; Rash on upper body that looks like measles but without the itching; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of ORAL MUCOSAL BLISTERING (Blood blisters in mouth), RASH MORBILLIFORM (Rash on upper body that looks like measles but without the itching) and ASTHENIA (Weakness) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-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 ORAL MUCOSAL BLISTERING (Blood blisters in mouth), RASH MORBILLIFORM (Rash on upper body that looks like measles but without the itching) and ASTHENIA (Weakness). At the time of the report, ORAL MUCOSAL BLISTERING (Blood blisters in mouth) and RASH MORBILLIFORM (Rash on upper body that looks like measles but without the itching) had not resolved and ASTHENIA (Weakness) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient received their first dose of Moderna vaccine and on an unknown date experienced weakness which resolved on an unknown date.  Reportedly, the patient also developed blood blisters in their mouth and rash on upper body that looks like measles but without the itching. Both these symptoms were still ongoing.  No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-079485 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Limb discomfort, Oral discomfort, Oropharyngeal discomfort, Paraesthesia oral
Clinical narrative: Tingling lips; arm felt heavy; numb lip; funny feeling in throat; felt like she had been to a dentist office; Chemical in throat feeling; wake up every 2 hours during sleep to drink a glass of water to help with the feeling; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (numb lip), OROPHARYNGEAL DISCOMFORT (funny feeling in throat), ORAL DISCOMFORT (felt like she had been to a dentist office), THROAT IRRITATION (Chemical in throat feeling) and SLEEP DISORDER (wake up every 2 hours during sleep to drink a glass of water to help with the feeling) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Allergy to chemicals (IV Iodine), Soy allergy, Latex allergy, Seafood allergy and Asthma. Concomitant products included GABAPENTIN for Back pain, ZOLPIDEM for Insomnia.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (funny feeling in throat), ORAL DISCOMFORT (felt like she had been to a dentist office), THROAT IRRITATION (Chemical in throat feeling) and SLEEP DISORDER (wake up every 2 hours during sleep to drink a glass of water to help with the feeling). On 05-Apr-2021 at 4:05 AM, the patient experienced HYPOAESTHESIA ORAL (numb lip). On an unknown date, the patient experienced PARAESTHESIA ORAL (Tingling lips) and LIMB DISCOMFORT (arm felt heavy). On 15-Mar-2021, LIMB DISCOMFORT (arm felt heavy) had resolved. On 06-Apr-2021, ORAL DISCOMFORT (felt like she had been to a dentist office), THROAT IRRITATION (Chemical in throat feeling) and SLEEP DISORDER (wake up every 2 hours during sleep to drink a glass of water to help with the feeling) had resolved. On 08-Apr-2021, HYPOAESTHESIA ORAL (numb lip), OROPHARYNGEAL DISCOMFORT (funny feeling in throat) and PARAESTHESIA ORAL (Tingling lips) had resolved. Not Provided      Action taken with mRNA-1273 in response to the events was not applicable.  Patient would wake up every 2 hours during sleep to drink a glass of water to help with the feeling.   This case was linked to US-MODERNATX, INC.-MOD-2021-079459 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Reporter's address, Patient demographic details, Medical history, Product and concomitant information and event details were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079459:1st dose
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Throat irritation
Clinical narrative: Tingling lips; arm felt heavy; numb lip; funny feeling in throat; felt like she had been to a dentist office; Chemical in throat feeling; wake up every 2 hours during sleep to drink a glass of water to help with the feeling; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (numb lip), OROPHARYNGEAL DISCOMFORT (funny feeling in throat), ORAL DISCOMFORT (felt like she had been to a dentist office), THROAT IRRITATION (Chemical in throat feeling) and SLEEP DISORDER (wake up every 2 hours during sleep to drink a glass of water to help with the feeling) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Allergy to chemicals (IV Iodine), Soy allergy, Latex allergy, Seafood allergy and Asthma. Concomitant products included GABAPENTIN for Back pain, ZOLPIDEM for Insomnia.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (funny feeling in throat), ORAL DISCOMFORT (felt like she had been to a dentist office), THROAT IRRITATION (Chemical in throat feeling) and SLEEP DISORDER (wake up every 2 hours during sleep to drink a glass of water to help with the feeling). On 05-Apr-2021 at 4:05 AM, the patient experienced HYPOAESTHESIA ORAL (numb lip). On an unknown date, the patient experienced PARAESTHESIA ORAL (Tingling lips) and LIMB DISCOMFORT (arm felt heavy). On 15-Mar-2021, LIMB DISCOMFORT (arm felt heavy) had resolved. On 06-Apr-2021, ORAL DISCOMFORT (felt like she had been to a dentist office), THROAT IRRITATION (Chemical in throat feeling) and SLEEP DISORDER (wake up every 2 hours during sleep to drink a glass of water to help with the feeling) had resolved. On 08-Apr-2021, HYPOAESTHESIA ORAL (numb lip), OROPHARYNGEAL DISCOMFORT (funny feeling in throat) and PARAESTHESIA ORAL (Tingling lips) had resolved. Not Provided      Action taken with mRNA-1273 in response to the events was not applicable.  Patient would wake up every 2 hours during sleep to drink a glass of water to help with the feeling.   This case was linked to US-MODERNATX, INC.-MOD-2021-079459 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Reporter's address, Patient demographic details, Medical history, Product and concomitant information and event details were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079459:1st dose
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Ocular discomfort
Clinical narrative: pressure behind right eye; annoying headache, which comes now and then usually when he wakes up; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OCULAR DISCOMFORT (pressure behind right eye) and HEADACHE (annoying headache, which comes now and then usually when he wakes up) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced OCULAR DISCOMFORT (pressure behind right eye) and HEADACHE (annoying headache, which comes now and then usually when he wakes up). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, OCULAR DISCOMFORT (pressure behind right eye) and HEADACHE (annoying headache, which comes now and then usually when he wakes up) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  No relevant concomitant medications were reported.   Other treatment information included, prescription eye drops was provided.  Patient stated that ophthalmologist was draining his eye in every visit.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up information received on 17-JUN-2021 contains no new information.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Dizziness, Erythema
Clinical narrative: Arm is sore; dizzy; Leg is swollen; Leg starting to hurt; Knee cap is the size of her thigh; Knee  cap is the size of her thigh, hot, blood red and looks like fluid in it; knee hurt; Chills; Fever; Diarrhea; Has been so sick; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Apr-2021 and was forwarded to Moderna on 16-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), DIARRHOEA (Diarrhea), MYALGIA (Arm is sore) and DIZZINESS (dizzy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 04-Apr-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever), DIARRHOEA (Diarrhea) and ILLNESS (Has been so sick). On 06-Apr-2021, the patient experienced MYALGIA (Arm is sore), DIZZINESS (dizzy), PERIPHERAL SWELLING (Leg is swollen), PAIN IN EXTREMITY (Leg starting to hurt), JOINT SWELLING (Knee cap is the size of her thigh), ERYTHEMA (Knee  cap is the size of her thigh, hot, blood red and looks like fluid in it) and ARTHRALGIA (knee hurt). At the time of the report, CHILLS (Chills), PYREXIA (Fever), DIARRHOEA (Diarrhea), MYALGIA (Arm is sore), DIZZINESS (dizzy), PERIPHERAL SWELLING (Leg is swollen), PAIN IN EXTREMITY (Leg starting to hurt), JOINT SWELLING (Knee cap is the size of her thigh), ERYTHEMA (Knee  cap is the size of her thigh, hot, blood red and looks like fluid in it), ILLNESS (Has been so sick) and ARTHRALGIA (knee hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test negative: negative (Negative) Patient states she tested negative for covid..         Concomitant Product: Antibiotic No treatment details were added.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Joint swelling, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: Arm is sore; dizzy; Leg is swollen; Leg starting to hurt; Knee cap is the size of her thigh; Knee  cap is the size of her thigh, hot, blood red and looks like fluid in it; knee hurt; Chills; Fever; Diarrhea; Has been so sick; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Apr-2021 and was forwarded to Moderna on 16-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), DIARRHOEA (Diarrhea), MYALGIA (Arm is sore) and DIZZINESS (dizzy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 04-Apr-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever), DIARRHOEA (Diarrhea) and ILLNESS (Has been so sick). On 06-Apr-2021, the patient experienced MYALGIA (Arm is sore), DIZZINESS (dizzy), PERIPHERAL SWELLING (Leg is swollen), PAIN IN EXTREMITY (Leg starting to hurt), JOINT SWELLING (Knee cap is the size of her thigh), ERYTHEMA (Knee  cap is the size of her thigh, hot, blood red and looks like fluid in it) and ARTHRALGIA (knee hurt). At the time of the report, CHILLS (Chills), PYREXIA (Fever), DIARRHOEA (Diarrhea), MYALGIA (Arm is sore), DIZZINESS (dizzy), PERIPHERAL SWELLING (Leg is swollen), PAIN IN EXTREMITY (Leg starting to hurt), JOINT SWELLING (Knee cap is the size of her thigh), ERYTHEMA (Knee  cap is the size of her thigh, hot, blood red and looks like fluid in it), ILLNESS (Has been so sick) and ARTHRALGIA (knee hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test negative: negative (Negative) Patient states she tested negative for covid..         Concomitant Product: Antibiotic No treatment details were added.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Arm is sore; dizzy; Leg is swollen; Leg starting to hurt; Knee cap is the size of her thigh; Knee  cap is the size of her thigh, hot, blood red and looks like fluid in it; knee hurt; Chills; Fever; Diarrhea; Has been so sick; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Apr-2021 and was forwarded to Moderna on 16-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), DIARRHOEA (Diarrhea), MYALGIA (Arm is sore) and DIZZINESS (dizzy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 04-Apr-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever), DIARRHOEA (Diarrhea) and ILLNESS (Has been so sick). On 06-Apr-2021, the patient experienced MYALGIA (Arm is sore), DIZZINESS (dizzy), PERIPHERAL SWELLING (Leg is swollen), PAIN IN EXTREMITY (Leg starting to hurt), JOINT SWELLING (Knee cap is the size of her thigh), ERYTHEMA (Knee  cap is the size of her thigh, hot, blood red and looks like fluid in it) and ARTHRALGIA (knee hurt). At the time of the report, CHILLS (Chills), PYREXIA (Fever), DIARRHOEA (Diarrhea), MYALGIA (Arm is sore), DIZZINESS (dizzy), PERIPHERAL SWELLING (Leg is swollen), PAIN IN EXTREMITY (Leg starting to hurt), JOINT SWELLING (Knee cap is the size of her thigh), ERYTHEMA (Knee  cap is the size of her thigh, hot, blood red and looks like fluid in it), ILLNESS (Has been so sick) and ARTHRALGIA (knee hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test negative: negative (Negative) Patient states she tested negative for covid..         Concomitant Product: Antibiotic No treatment details were added.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Fatigue, Lethargy, Musculoskeletal stiffness
Clinical narrative: pain in her right hand/ pain in hips, hands, neck/ pain in back/ felt like she got hit by truck; She felt very tired; She felt weak; lethargic; She had diarrhea as well; Her right hand has not healed, it feels swollen and tight; Her right hand has not healed, it feels swollen and tight; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain in her right hand/ pain in hips, hands, neck/ pain in back/ felt like she got hit by truck), FATIGUE (She felt very tired), ASTHENIA (She felt weak), LETHARGY (lethargic) and DIARRHOEA (She had diarrhea as well) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pain in her right hand/ pain in hips, hands, neck/ pain in back/ felt like she got hit by truck), FATIGUE (She felt very tired), ASTHENIA (She felt weak), LETHARGY (lethargic), DIARRHOEA (She had diarrhea as well), PERIPHERAL SWELLING (Her right hand has not healed, it feels swollen and tight) and MUSCULOSKELETAL STIFFNESS (Her right hand has not healed, it feels swollen and tight). At the time of the report, PAIN (pain in her right hand/ pain in hips, hands, neck/ pain in back/ felt like she got hit by truck), FATIGUE (She felt very tired), ASTHENIA (She felt weak), LETHARGY (lethargic), DIARRHOEA (She had diarrhea as well), PERIPHERAL SWELLING (Her right hand has not healed, it feels swollen and tight) and MUSCULOSKELETAL STIFFNESS (Her right hand has not healed, it feels swollen and tight) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication details was reported. No treatment medication details was reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling
Clinical narrative: pain in her right hand/ pain in hips, hands, neck/ pain in back/ felt like she got hit by truck; She felt very tired; She felt weak; lethargic; She had diarrhea as well; Her right hand has not healed, it feels swollen and tight; Her right hand has not healed, it feels swollen and tight; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain in her right hand/ pain in hips, hands, neck/ pain in back/ felt like she got hit by truck), FATIGUE (She felt very tired), ASTHENIA (She felt weak), LETHARGY (lethargic) and DIARRHOEA (She had diarrhea as well) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pain in her right hand/ pain in hips, hands, neck/ pain in back/ felt like she got hit by truck), FATIGUE (She felt very tired), ASTHENIA (She felt weak), LETHARGY (lethargic), DIARRHOEA (She had diarrhea as well), PERIPHERAL SWELLING (Her right hand has not healed, it feels swollen and tight) and MUSCULOSKELETAL STIFFNESS (Her right hand has not healed, it feels swollen and tight). At the time of the report, PAIN (pain in her right hand/ pain in hips, hands, neck/ pain in back/ felt like she got hit by truck), FATIGUE (She felt very tired), ASTHENIA (She felt weak), LETHARGY (lethargic), DIARRHOEA (She had diarrhea as well), PERIPHERAL SWELLING (Her right hand has not healed, it feels swollen and tight) and MUSCULOSKELETAL STIFFNESS (Her right hand has not healed, it feels swollen and tight) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication details was reported. No treatment medication details was reported.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: Dizziness; Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Dizziness) and FATIGUE (Fatigue) in a 23-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness) and FATIGUE (Fatigue). At the time of the report, DIZZINESS (Dizziness) and FATIGUE (Fatigue) 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.   The concomitant medications were not provided.   This case was linked to MOD-2021-079477 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up information was received on 21-May-2021 contains information regarding the patient demographic details.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cough, Fatigue, Malaise
Clinical narrative: Hacking cough; Loss of taste; and smell; not like herself; felt tired; Nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Apr-2021 and was forwarded to Moderna on 16-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tired), NAUSEA (Nausea), COUGH (Hacking cough), AGEUSIA (Loss of taste) and ANOSMIA (and smell) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 30-Mar-2021, the patient experienced FATIGUE (felt tired), NAUSEA (Nausea) and MALAISE (not like herself). On 16-Apr-2021, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (and smell). On an unknown date, the patient experienced COUGH (Hacking cough). At the time of the report, FATIGUE (felt tired), NAUSEA (Nausea), COUGH (Hacking cough), AGEUSIA (Loss of taste), ANOSMIA (and smell) and MALAISE (not like herself) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tired), NAUSEA (Nausea), COUGH (Hacking cough), AGEUSIA (Loss of taste) and ANOSMIA (and smell) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 30-Mar-2021, the patient experienced FATIGUE (felt tired), NAUSEA (Nausea) and MALAISE (not like herself). On 16-Apr-2021, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (and smell). On an unknown date, the patient experienced COUGH (Hacking cough). At the time of the report, FATIGUE (felt tired), NAUSEA (Nausea), COUGH (Hacking cough), AGEUSIA (Loss of taste), ANOSMIA (and smell) and MALAISE (not like herself) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient did not take any medications.   Reporter did not allow further contact   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Hacking cough; Loss of taste; and smell; not like herself; felt tired; Nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Apr-2021 and was forwarded to Moderna on 16-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tired), NAUSEA (Nausea), COUGH (Hacking cough), AGEUSIA (Loss of taste) and ANOSMIA (and smell) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 30-Mar-2021, the patient experienced FATIGUE (felt tired), NAUSEA (Nausea) and MALAISE (not like herself). On 16-Apr-2021, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (and smell). On an unknown date, the patient experienced COUGH (Hacking cough). At the time of the report, FATIGUE (felt tired), NAUSEA (Nausea), COUGH (Hacking cough), AGEUSIA (Loss of taste), ANOSMIA (and smell) and MALAISE (not like herself) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tired), NAUSEA (Nausea), COUGH (Hacking cough), AGEUSIA (Loss of taste) and ANOSMIA (and smell) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 30-Mar-2021, the patient experienced FATIGUE (felt tired), NAUSEA (Nausea) and MALAISE (not like herself). On 16-Apr-2021, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (and smell). On an unknown date, the patient experienced COUGH (Hacking cough). At the time of the report, FATIGUE (felt tired), NAUSEA (Nausea), COUGH (Hacking cough), AGEUSIA (Loss of taste), ANOSMIA (and smell) and MALAISE (not like herself) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient did not take any medications.   Reporter did not allow further contact   Reporter did not allow further contact
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Below 18 years age female patient received 1st dose; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Below 18 years age female patient received 1st dose) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Below 18 years age female patient received 1st dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Below 18 years age female patient received 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.   The concomitant medications were not provided. The treatment medications were not provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site inflammation, Vaccination site mass, Vaccination site pain
Clinical narrative: Fatty lumps around the injection site; Inflamed; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Fatty lumps around the injection site), VACCINATION SITE INFLAMMATION (Inflamed) and VACCINATION SITE PAIN (Soreness) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 081B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE MASS (Fatty lumps around the injection site), VACCINATION SITE INFLAMMATION (Inflamed) and VACCINATION SITE PAIN (Soreness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Fatty lumps around the injection site), VACCINATION SITE INFLAMMATION (Inflamed) and VACCINATION SITE PAIN (Soreness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient applied ice on the injection site. Concomitant medications included unspecified blood pressure medications .
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: Patient has not come on menstrual cycle which was due 1Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (Patient has not come on menstrual cycle which was due 1Apr2021) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 01-Apr-2021, the patient experienced MENSTRUATION DELAYED (Patient has not come on menstrual cycle which was due 1Apr2021). At the time of the report, MENSTRUATION DELAYED (Patient has not come on menstrual cycle which was due 1Apr2021) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She had three negative pregnancy test .