chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Oral pain, Vaccination site pain
Clinical narrative: Pain in the mouth; Pain on the arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of ORAL PAIN (Pain in the mouth) and VACCINATION SITE PAIN (Pain on the arm of injection) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included Oral lichen planus in 2016. Concurrent medical conditions included Pre-diabetic, Thyroid disorder, Panic attacks, Glaucoma and Dyslipidemia. Concomitant products included PREDNISONA, LEVOTHYROXINE, LISINOPRIL, PROPRANOLOL, METFORMIN, METHENAMINE, RETINOL (VITAMINE A), OMEPRAZOLE, FISH OIL (OMEGA 3 FISH OIL [FISH OIL]), MULTIVITAMINS;MINERALS, CYANOCOBALAMIN (VITAMINA B 12), CALCIUM, PROBIOTICS NOS, ZINC, ASCORBIC ACID (VITAMIN C ACID), IBUPROFEN, TRAMADOL and CURCUMA DOMESTICA for an unknown indication, GENTIAN VIOLET.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced ORAL PAIN (Pain in the mouth) and VACCINATION SITE PAIN (Pain on the arm of injection). At the time of the report, ORAL PAIN (Pain in the mouth) and VACCINATION SITE PAIN (Pain on the arm of injection) outcome was unknown.            Action taken with mRNA-1273 is not applicable.  No treatment information was provided.  Concomitant medication also include ginfisona.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Rapid acceleration in pulse rate at high of 104; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (Rapid acceleration in pulse rate at high of 104) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included METOPROLOL for an unknown indication.    On 26-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced HEART RATE INCREASED (Rapid acceleration in pulse rate at high of 104). At the time of the report, HEART RATE INCREASED (Rapid acceleration in pulse rate at high of 104) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Heart rate: 104 (High) experienced rapid acceleration in pulse rate at high of 104.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patients HCP advised him to monitor(pulse rate), and drink lots of fluid.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature decreased, Dizziness, Headache, Heart rate increased, Injection site swelling
Clinical narrative: low-grade fever; aching; terrible headache; swollen lymph nodes; injection site swelling; Couldn't get warm; Increased heart rate; Felt really dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt really dizzy), PYREXIA (low-grade fever), PAIN (aching), HEADACHE (terrible headache) and LYMPHADENOPATHY (swollen lymph nodes) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (on Nov2020. No hospitalization was required.) and Unspecified disorder of knee joint (Unknown knee condition.).    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced DIZZINESS (Felt really dizzy). On an unknown date, the patient experienced PYREXIA (low-grade fever), PAIN (aching), HEADACHE (terrible headache), LYMPHADENOPATHY (swollen lymph nodes), INJECTION SITE SWELLING (injection site swelling), BODY TEMPERATURE DECREASED (Couldn't get warm) and HEART RATE INCREASED (Increased heart rate). At the time of the report, DIZZINESS (Felt really dizzy), PAIN (aching), HEADACHE (terrible headache) and BODY TEMPERATURE DECREASED (Couldn't get warm) outcome was unknown, PYREXIA (low-grade fever) had not resolved and LYMPHADENOPATHY (swollen lymph nodes), INJECTION SITE SWELLING (injection site swelling) and HEART RATE INCREASED (Increased heart rate) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included acetaminophen and ibuprofen.  Past medications received include "cortisone shot". Concomitant medications were not provided.  Her second dose in the series of Moderna's COVID-19 vaccine is scheduled for 10Feb2021.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pyrexia
Clinical narrative: low-grade fever; aching; terrible headache; swollen lymph nodes; injection site swelling; Couldn't get warm; Increased heart rate; Felt really dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt really dizzy), PYREXIA (low-grade fever), PAIN (aching), HEADACHE (terrible headache) and LYMPHADENOPATHY (swollen lymph nodes) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (on Nov2020. No hospitalization was required.) and Unspecified disorder of knee joint (Unknown knee condition.).    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced DIZZINESS (Felt really dizzy). On an unknown date, the patient experienced PYREXIA (low-grade fever), PAIN (aching), HEADACHE (terrible headache), LYMPHADENOPATHY (swollen lymph nodes), INJECTION SITE SWELLING (injection site swelling), BODY TEMPERATURE DECREASED (Couldn't get warm) and HEART RATE INCREASED (Increased heart rate). At the time of the report, DIZZINESS (Felt really dizzy), PAIN (aching), HEADACHE (terrible headache) and BODY TEMPERATURE DECREASED (Couldn't get warm) outcome was unknown, PYREXIA (low-grade fever) had not resolved and LYMPHADENOPATHY (swollen lymph nodes), INJECTION SITE SWELLING (injection site swelling) and HEART RATE INCREASED (Increased heart rate) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included acetaminophen and ibuprofen.  Past medications received include "cortisone shot". Concomitant medications were not provided.  Her second dose in the series of Moderna's COVID-19 vaccine is scheduled for 10Feb2021.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Hyperhidrosis, Pyrexia
Clinical narrative: Felt dizzy; Wakes up sweating; Fever of 101.2, little low grade fevers; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt dizzy), HYPERHIDROSIS (Wakes up sweating), PYREXIA (Fever of 101.2, little low grade fevers) and CHILLS (Chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced DIZZINESS (Felt dizzy), HYPERHIDROSIS (Wakes up sweating), PYREXIA (Fever of 101.2, little low grade fevers) and CHILLS (Chills). At the time of the report, DIZZINESS (Felt dizzy), HYPERHIDROSIS (Wakes up sweating) and CHILLS (Chills) outcome was unknown and PYREXIA (Fever of 101.2, little low grade fevers) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Pyrexia: 101.2 High.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication included unknown heart medication. Treatment information were not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Patient administered 2nd dose hence action taken was changed to "No change".
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Fever of 99.7°F; Body aches; Headache; Pain on her legs; Very tired; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on her legs), FATIGUE (Very tired), CHILLS (Chills), PYREXIA (Fever of 99.7°F) and MYALGIA (Body aches) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 02-Dec-2020. Concomitant products included ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE (PREMPRO) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain on her legs), FATIGUE (Very tired) and CHILLS (Chills). On 29-Jan-2021, the patient experienced PYREXIA (Fever of 99.7°F), MYALGIA (Body aches) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Pain on her legs), FATIGUE (Very tired), CHILLS (Chills), PYREXIA (Fever of 99.7°F), MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Body temperature: 99.7°f Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever of 99.7°F; Body aches; Headache; Pain on her legs; Very tired; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on her legs), FATIGUE (Very tired), CHILLS (Chills), PYREXIA (Fever of 99.7°F) and MYALGIA (Body aches) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 02-Dec-2020. Concomitant products included ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE (PREMPRO) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain on her legs), FATIGUE (Very tired) and CHILLS (Chills). On 29-Jan-2021, the patient experienced PYREXIA (Fever of 99.7°F), MYALGIA (Body aches) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Pain on her legs), FATIGUE (Very tired), CHILLS (Chills), PYREXIA (Fever of 99.7°F), MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Body temperature: 99.7°f Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site was raised about 3 inches in diameter; Red (injection site); Hot to touch (injection site); A spontaneous report was received from an other HCP concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  vaccination site swelling, vaccination site erythema, Vaccine administered at inappropriate site and vaccination site warmth.  The patient's medical history was not provided. No relevant concomitant medications were reported.     On an unknown date, the patient received their first of two planned doses of mRNA-1273 (lot :unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced the Injection site erythema (redness) and Injection site warmth (hot to touch), Vaccine administered at inappropriate site (Received the vaccine 2 or 3 inches below of where it should have been given: Was given halfway) and Vaccination site swelling (injection site was raised about 3 inches in diameter).  No Laboratory details was provided.   Treatment included as Tylenol, Advil and Ice.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event was unknwon.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  The causality for the event of vaccine administered at inappropriate site is assessed as not applicable.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site pain, Injection site warmth
Clinical narrative: Injection site warm; Injection site sensitive; Injection site hurting; Injection site pretty red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site warm), INJECTION SITE HYPERSENSITIVITY (Injection site sensitive), INJECTION SITE PAIN (Injection site hurting) and INJECTION SITE ERYTHEMA (Injection site pretty red) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Lyme disease. Concurrent medical conditions included Allergy (Allergic to sulpha drugs.).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced INJECTION SITE PAIN (Injection site hurting) and INJECTION SITE ERYTHEMA (Injection site pretty red). On 27-Jan-2021, the patient experienced INJECTION SITE WARMTH (Injection site warm) and INJECTION SITE HYPERSENSITIVITY (Injection site sensitive). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 16-Jan-2021, INJECTION SITE ERYTHEMA (Injection site pretty red) had resolved. At the time of the report, INJECTION SITE WARMTH (Injection site warm) and INJECTION SITE HYPERSENSITIVITY (Injection site sensitive) outcome was unknown and INJECTION SITE PAIN (Injection site hurting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications include Cholesterol pill, medications for anxiety and medications for nerves pain.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pruritus, Rash
Clinical narrative: Itches; Little dizzy; Rash on legs and arms; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itches), DIZZINESS (Little dizzy) and RASH (Rash on legs and arms) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029120A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced PRURITUS (Itches), DIZZINESS (Little dizzy) and RASH (Rash on legs and arms). At the time of the report, PRURITUS (Itches), DIZZINESS (Little dizzy) and RASH (Rash on legs and arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site warmth, Pruritus, Swelling, Vaccination site pain
Clinical narrative: itchiness; Redness; warm to touch; Swelling; COVID arm; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness), ERYTHEMA (Redness), INJECTION SITE WARMTH (warm to touch), SWELLING (Swelling) and VACCINATION SITE REACTION (COVID arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02AL20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension since an unknown date and Osteoporosis since an unknown date. Concurrent medical conditions included Drug allergy (cipro allergy) and Drug allergy (Levaquin). Concomitant products included OLMESARTAN from 15-Aug-2018 to an unknown date for Blood pressure high, DENOSUMAB (PROLIA) from 01-Jun-2018 to an unknown date and CALCIUM for Osteoporosis.   On 17-Jan-2021 at 12:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021 at 12:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at injection site). On 24-Jan-2021, the patient experienced PRURITUS (itchiness), ERYTHEMA (Redness) and INJECTION SITE WARMTH (warm to touch). 24-Jan-2021, the patient experienced SWELLING (Swelling) and VACCINATION SITE REACTION (COVID arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 01-Feb-2021, PRURITUS (itchiness), ERYTHEMA (Redness), INJECTION SITE WARMTH (warm to touch), SWELLING (Swelling), VACCINATION SITE REACTION (COVID arm) and VACCINATION SITE PAIN (Soreness at injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Medical history includes hypertension and osteoporosis.   This case was linked to MOD-2021-080783 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Added in patient tab: Levaquin drug allergy.Added information product tab: Batch number and anatomical site.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: itchiness; Redness; warm to touch; Swelling; COVID arm; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness), ERYTHEMA (Redness), INJECTION SITE WARMTH (warm to touch), SWELLING (Swelling) and VACCINATION SITE REACTION (COVID arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02AL20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension since an unknown date and Osteoporosis since an unknown date. Concurrent medical conditions included Drug allergy (cipro allergy) and Drug allergy (Levaquin). Concomitant products included OLMESARTAN from 15-Aug-2018 to an unknown date for Blood pressure high, DENOSUMAB (PROLIA) from 01-Jun-2018 to an unknown date and CALCIUM for Osteoporosis.   On 17-Jan-2021 at 12:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021 at 12:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at injection site). On 24-Jan-2021, the patient experienced PRURITUS (itchiness), ERYTHEMA (Redness) and INJECTION SITE WARMTH (warm to touch). 24-Jan-2021, the patient experienced SWELLING (Swelling) and VACCINATION SITE REACTION (COVID arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 01-Feb-2021, PRURITUS (itchiness), ERYTHEMA (Redness), INJECTION SITE WARMTH (warm to touch), SWELLING (Swelling), VACCINATION SITE REACTION (COVID arm) and VACCINATION SITE PAIN (Soreness at injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Medical history includes hypertension and osteoporosis.   This case was linked to MOD-2021-080783 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Added in patient tab: Levaquin drug allergy.Added information product tab: Batch number and anatomical site.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; A spontaneous report was received from a consumer concerning, a male patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, prior to the onset of the event, the patient received their dose of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced the fatigue.   No laboratory details were provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event fatigue was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: adverse event that occurred 8-10 days after receiving vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (adverse event that occurred 8-10 days after receiving vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ADVERSE EVENT (adverse event that occurred 8-10 days after receiving vaccine). At the time of the report, ADVERSE EVENT (adverse event that occurred 8-10 days after receiving vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: NNI , patient wants to cooperate but not comfortable releasing her medical health records to unknown third party, seeking advice from Moderna; Reporter's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate increased, Hypertension, Tachycardia
Clinical narrative: accelerated heart beat; blood pressure also went up; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (accelerated heart beat) and HYPERTENSION (blood pressure also went up) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included DILTIAZEM HYDROCHLORIDE (CARDIZEM CD), DULAGLUTIDE (TRULICITY), EMPAGLIFLOZIN (JARDIANCE), METFORMIN, LOSARTAN and ROSUVASTATIN for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced HEART RATE INCREASED (accelerated heart beat) and HYPERTENSION (blood pressure also went up). At the time of the report, HEART RATE INCREASED (accelerated heart beat) and HYPERTENSION (blood pressure also went up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Blood pressure measurement: 130/80 (High) Normal 117/80. On 26-Jan-2021, Tachycardia: 99/120 (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects after first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects after first shot) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pain on 06-Feb-2021.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 06-Feb-2021, the patient experienced VACCINATION COMPLICATION (side effects after first shot). At the time of the report, VACCINATION COMPLICATION (side effects after first shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment medications was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: really really bad itching at the injection site; injection site was itchy; injection site was; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PRURITUS (really really bad itching at the injection site), VACCINATION SITE PRURITUS (injection site was itchy) and VACCINATION SITE ERYTHEMA (injection site was) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     no medical history reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and LISINOPRIL for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (injection site was itchy) and VACCINATION SITE ERYTHEMA (injection site was). On 17-Feb-2021, the patient experienced INJECTION SITE PRURITUS (really really bad itching at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PRURITUS (really really bad itching at the injection site), VACCINATION SITE PRURITUS (injection site was itchy) and VACCINATION SITE ERYTHEMA (injection site was) 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.   OTC vitamins were also  used as concomitant medications .  Treatment medication include Benadryl.   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2021: Treatment information, event updated
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Runny nose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Feb-2021 and was forwarded to Moderna on 08-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 06-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced RHINORRHOEA (Runny nose). At the time of the report, RHINORRHOEA (Runny nose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Heart rate, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscles and joints hurt), ARTHRALGIA (Muscles and joints hurt) and FATIGUE (Exhausted and went to bed early) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 036A21A) for COVID-19 vaccination. Concurrent medical conditions included Diverticulitis. Concomitant products included CLINDAMYCIN for Dental treatment NOS, METRONIDAZOLE (FLAGYL [METRONIDAZOLE]) and SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for Diverticulitis, FAMOTIDINE, LORAZEPAM and ALLOPURINOL (ELAVIL [ALLOPURINOL]) for an unknown indication. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced MYALGIA (Muscles and joints hurt), ARTHRALGIA (Muscles and joints hurt) and FATIGUE (Exhausted and went to bed early). At the time of the report, MYALGIA (Muscles and joints hurt), ARTHRALGIA (Muscles and joints hurt) and FATIGUE (Exhausted and went to bed early) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Heart rate: (Inconclusive) fast heart rate. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information not provided. This case was linked to MOD-2021-041007 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for covid-19 after receiving 1st dose of vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (tested positive for covid-19 after receiving 1st dose of vaccine) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) 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) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced COVID-19 (tested positive for covid-19 after receiving 1st dose of vaccine). At the time of the report, COVID-19 (tested positive for covid-19 after receiving 1st dose of vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: Correction of patient initials. On 19-Apr-2021: Follow-up received on 19-Apr-2021 included no new information. On 26-Jul-2021: Follow-up received 26-Jul-2021 included no new information.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Adverse reaction; This spontaneous case was reported by a patient and describes the occurrence of ADVERSE REACTION (Adverse reaction) 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-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ADVERSE REACTION (Adverse reaction). At the time of the report, ADVERSE REACTION (Adverse reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: Reporter contact information
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site is all red) and VACCINATION SITE SWELLING (inflamed) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D30LZ0P) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included SIMVASTATIN, ANASTROZOLE (ANASTRAZOLE DENK), TEMAZEPAM and GABAPENTIN. On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site is all red) and VACCINATION SITE SWELLING (inflamed). The patient was treated with METHYLPREDNISOLONE (MEDROL DOSEPAK) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (injection site is all red) and VACCINATION SITE SWELLING (inflamed) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Lip swelling, Mouth swelling, Swollen tongue
Clinical narrative: whole lip, lips were swollen; swollen tongue; swollen mouth; couldn't swallow; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (swollen tongue), MOUTH SWELLING (swollen mouth), DYSPHAGIA (couldn't swallow) and LIP SWELLING (whole lip, lips were swollen) 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 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced SWOLLEN TONGUE (swollen tongue), MOUTH SWELLING (swollen mouth) and DYSPHAGIA (couldn't swallow). On 24-Jan-2021, the patient experienced LIP SWELLING (whole lip, lips were swollen). At the time of the report, SWOLLEN TONGUE (swollen tongue), MOUTH SWELLING (swollen mouth) and DYSPHAGIA (couldn't swallow) was resolving and LIP SWELLING (whole lip, lips were swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not provided  It was reported that on 23-Jan-2021, the symptoms went down after a while.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Headache, Pain in extremity
Clinical narrative: Feels arm full/arm hurts; Diarrhea; Upset stomach; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Feels arm full/arm hurts), DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Upset stomach) and HEADACHE (Headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M2UA) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Feels arm full/arm hurts), DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Upset stomach) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Feels arm full/arm hurts), DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Upset stomach) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Treatment details included Pain medications.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Influenza like illness
Clinical narrative: Feeling cold in the eye like a flu; Felt dizziness; Severe throbbing headache; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (Feeling cold in the eye like a flu), DIZZINESS (Felt dizziness), HEADACHE (Severe throbbing headache) and FATIGUE (Fatigue) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Feeling cold in the eye like a flu), DIZZINESS (Felt dizziness), HEADACHE (Severe throbbing headache) and FATIGUE (Fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (Feeling cold in the eye like a flu), DIZZINESS (Felt dizziness), HEADACHE (Severe throbbing headache) and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was unknown by the reporter. Treatment medication include BC packet, oxycodone (7.5-325 mg) 1 tablet every 6 hours, Meloxicam 15 mg 1 tablet once daily for 3 days; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Full body rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Full body rash) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced RASH (Full body rash). At the time of the report, RASH (Full body rash) outcome was unknown. Not Provided          Concomitant medication was not reported. Treatment medication was not reported.  As reported the only spot on her body without the rash was her 1 foot.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Fatigue, Headache, Myalgia
Clinical narrative: Coughing; Cold-like symptoms; When she blows her nose there is a lot of mucus coming out (not green, clear); Headache; Arm sore; Muscle pain; Joint pain; Nausea  had to force herself to eat; Her energy level is kind of low (fatigued); This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), NASOPHARYNGITIS (Cold-like symptoms), RHINORRHOEA (When she blows her nose there is a lot of mucus coming out (not green, clear)), HEADACHE (Headache) and VACCINATION SITE PAIN (Arm sore) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced COUGH (Coughing), NASOPHARYNGITIS (Cold-like symptoms), RHINORRHOEA (When she blows her nose there is a lot of mucus coming out (not green, clear)), HEADACHE (Headache), VACCINATION SITE PAIN (Arm sore), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), NAUSEA (Nausea  had to force herself to eat) and FATIGUE (Her energy level is kind of low (fatigued)). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, COUGH (Coughing), NASOPHARYNGITIS (Cold-like symptoms), RHINORRHOEA (When she blows her nose there is a lot of mucus coming out (not green, clear)), HEADACHE (Headache), VACCINATION SITE PAIN (Arm sore), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), NAUSEA (Nausea  had to force herself to eat) and FATIGUE (Her energy level is kind of low (fatigued)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  The patient's son was tested positive for COVID 0n 22-Jan-2021; however, the patient could smell and taste everything.   This case was linked to MOD-2021-184566 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: TCR with F/U information: Event outcome updated . patient states she feeling great.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Nausea, Rhinorrhoea, Vaccination site pain
Clinical narrative: Coughing; Cold-like symptoms; When she blows her nose there is a lot of mucus coming out (not green, clear); Headache; Arm sore; Muscle pain; Joint pain; Nausea  had to force herself to eat; Her energy level is kind of low (fatigued); This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), NASOPHARYNGITIS (Cold-like symptoms), RHINORRHOEA (When she blows her nose there is a lot of mucus coming out (not green, clear)), HEADACHE (Headache) and VACCINATION SITE PAIN (Arm sore) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced COUGH (Coughing), NASOPHARYNGITIS (Cold-like symptoms), RHINORRHOEA (When she blows her nose there is a lot of mucus coming out (not green, clear)), HEADACHE (Headache), VACCINATION SITE PAIN (Arm sore), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), NAUSEA (Nausea  had to force herself to eat) and FATIGUE (Her energy level is kind of low (fatigued)). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, COUGH (Coughing), NASOPHARYNGITIS (Cold-like symptoms), RHINORRHOEA (When she blows her nose there is a lot of mucus coming out (not green, clear)), HEADACHE (Headache), VACCINATION SITE PAIN (Arm sore), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), NAUSEA (Nausea  had to force herself to eat) and FATIGUE (Her energy level is kind of low (fatigued)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  The patient's son was tested positive for COVID 0n 22-Jan-2021; however, the patient could smell and taste everything.   This case was linked to MOD-2021-184566 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: TCR with F/U information: Event outcome updated . patient states she feeling great.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Dysgeusia, Headache
Clinical narrative: Headache; Has no taste; Bitter metallic taste on her lips and fingers; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), AGEUSIA (Has no taste) and DYSGEUSIA (Bitter metallic taste on her lips and fingers) 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 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), AGEUSIA (Has no taste) and DYSGEUSIA (Bitter metallic taste on her lips and fingers). At the time of the report, HEADACHE (Headache), AGEUSIA (Has no taste) and DYSGEUSIA (Bitter metallic taste on her lips and fingers) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment medications were not reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Eating disorder, Eczema, Gastritis
Clinical narrative: Eczema reaction than a rash on her face, primarily on her cheeks; Severe digestive issues, kind of like gastritis; Severe tenderness; She couldn't eat much of anything; Her stomach hurt when she was standing up or walking; Flu-like symptoms; Intestinal pain; Fever around 99 to just under 101F; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema reaction than a rash on her face, primarily on her cheeks), GASTRITIS (Severe digestive issues, kind of like gastritis), TENDERNESS (Severe tenderness), EATING DISORDER (She couldn't eat much of anything) and ABDOMINAL PAIN UPPER (Her stomach hurt when she was standing up or walking) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 ECZEMA (Eczema reaction than a rash on her face, primarily on her cheeks), GASTRITIS (Severe digestive issues, kind of like gastritis), TENDERNESS (Severe tenderness), EATING DISORDER (She couldn't eat much of anything), ABDOMINAL PAIN UPPER (Her stomach hurt when she was standing up or walking), INFLUENZA LIKE ILLNESS (Flu-like symptoms), ABDOMINAL PAIN (Intestinal pain) and PYREXIA (Fever around 99 to just under 101F). The patient was treated with PANTOPRAZOLE at an unspecified dose and frequency and IBUPROFEN (MOTRIN IB) at an unspecified dose and frequency. On 28-Jan-2021, ECZEMA (Eczema reaction than a rash on her face, primarily on her cheeks), GASTRITIS (Severe digestive issues, kind of like gastritis), TENDERNESS (Severe tenderness), EATING DISORDER (She couldn't eat much of anything), ABDOMINAL PAIN UPPER (Her stomach hurt when she was standing up or walking), INFLUENZA LIKE ILLNESS (Flu-like symptoms), ABDOMINAL PAIN (Intestinal pain) and PYREXIA (Fever around 99 to just under 101F) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Follow up received on 06-Apr-2021 reported minimal side effects from the second shot as well, not otherwise specified. On 08-Jun-2021: FU NNI : Reporter said: No need for additional follow up she is fine.; 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.