chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state
Clinical narrative: Brainfogged, he did not know where he was.; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Brainfogged, he did not know where he was.) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Anticoagulant therapy since an unknown date. Concurrent medical conditions included Blood pressure inadequately controlled, Gout, Restless leg syndrome and Ulcer.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced CONFUSIONAL STATE (Brainfogged, he did not know where he was.). At the time of the report, CONFUSIONAL STATE (Brainfogged, he did not know where he was.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       as per reporter patient uses concomitantly medications for Blood Pressure, anticoagulants, pain, gout, restless leg syndrome, ulcer and hypnotics. No treatment medications were reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination complication
Clinical narrative: Had another event; Patches of red all over her body; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Patches of red all over her body) and VACCINATION COMPLICATION (Had another event) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to antibiotics.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced RASH ERYTHEMATOUS (Patches of red all over her body). On an unknown date, the patient experienced VACCINATION COMPLICATION (Had another event). At the time of the report, RASH ERYTHEMATOUS (Patches of red all over her body) and VACCINATION COMPLICATION (Had another event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided reporter. Treatment medications were not provided by reporter.   This case was linked to MOD-2021-236619 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2021: Follow-up information received on 04 Feb 2021. Added new adverse event vaccination adverse reaction. On 22-Apr-2021: Follow-up information received on 22 Apr 2021.Updated reporter's contact details. On 24-Jun-2021: Follow-up information received on 24 Jun 2021 included re-challenge details of the suspect vaccine.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (fever) in a 43-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and PYREXIA (fever). At the time of the report, CHILLS (chills) and PYREXIA (fever) outcome was unknown.            No relevant concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: reaction to the vaccine shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction to the vaccine shot) 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) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction to the vaccine shot). At the time of the report, VACCINATION COMPLICATION (reaction to the vaccine shot) 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.; Reporter's Comments: Unspecified adverse event
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness In Injection Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness In Injection Arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O12M2OA) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness In Injection Arm). At the time of the report, VACCINATION SITE PAIN (Soreness In Injection Arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: heart felt like was coming out of my chest, and recorded heart rate of 150ppm; overwhelmed and out of breath, started getting worse; This spontaneous case was reported by a patient and describes the occurrence of HEART RATE INCREASED (heart felt like was coming out of my chest, and recorded heart rate of 150ppm) and DYSPNOEA (overwhelmed and out of breath, started getting worse) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concomitant products included HYDROXYCHLOROQUINE for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced HEART RATE INCREASED (heart felt like was coming out of my chest, and recorded heart rate of 150ppm) and DYSPNOEA (overwhelmed and out of breath, started getting worse). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event following immunisation, at an unspecified dose and frequency. On 07-Feb-2021, HEART RATE INCREASED (heart felt like was coming out of my chest, and recorded heart rate of 150ppm) had resolved. At the time of the report, DYSPNOEA (overwhelmed and out of breath, started getting worse) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, Heart rate: 150 (High) ppm. heart felt like was coming out of my chest. On 20-Jan-2021, Heart rate: 130-140 (High) heart was still racing at about 130-140 beats per minute. On 01-Feb-2021, Heart rate: 112-113 (High) heart rate was still 112-113 beat per minute at rest.. On 07-Feb-2021, Heart rate: normal (normal) heart rate normalized on Sunday072021.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included Irritable bowel syndrome. Concurrent medical conditions included Salicylate, Caffeine and Food allergy (Coffee).    On 22-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 DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.  Treatment medication included daily vitamins.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up information received on 12-Jul-2021 Contact details and email ID are provided.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Nausea
Clinical narrative: extremely dizzy; Can't get up and walk/ can barely walk; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extremely dizzy), GAIT DISTURBANCE (Can't get up and walk/ can barely walk) and NAUSEA (Nausea) in a female 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 reported medical history).    On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced DIZZINESS (extremely dizzy), GAIT DISTURBANCE (Can't get up and walk/ can barely walk) and NAUSEA (Nausea). At the time of the report, DIZZINESS (extremely dizzy), GAIT DISTURBANCE (Can't get up and walk/ can barely walk) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Vertigo
Clinical narrative: vertigo; hardly walk; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), GAIT DISTURBANCE (hardly walk) and DIZZINESS (dizziness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Patient is taking allergy pill) and Depression (Patient is on antidepressant drug).   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced VERTIGO (vertigo), GAIT DISTURBANCE (hardly walk) and DIZZINESS (dizziness). At the time of the report, VERTIGO (vertigo), GAIT DISTURBANCE (hardly walk) and DIZZINESS (dizziness) outcome was unknown.            Treatment included Neosporin for the rash, Valium for vertigo and a pill for nausea. Also cold medicine for cough. Upon internal review on 04-Aug-2021, the age was corrected to 76 years.
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Bone pain, Headache, Influenza like illness, Joint injury
Clinical narrative: Intermittent fever; Headaches; Aches in bones; Flu-like symptoms; Balance issues; Injured my knee; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Intermittent fever), HEADACHE (Headaches), BONE PAIN (Aches in bones), INFLUENZA LIKE ILLNESS (Flu-like symptoms) and BALANCE DISORDER (Balance issues) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No adverse event reported.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) unknown. On an unknown date, the patient experienced PYREXIA (Intermittent fever), HEADACHE (Headaches), BONE PAIN (Aches in bones), INFLUENZA LIKE ILLNESS (Flu-like symptoms), BALANCE DISORDER (Balance issues) and JOINT INJURY (Injured my knee). At the time of the report, PYREXIA (Intermittent fever), HEADACHE (Headaches), BONE PAIN (Aches in bones), INFLUENZA LIKE ILLNESS (Flu-like symptoms), BALANCE DISORDER (Balance issues) and JOINT INJURY (Injured my knee) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Intermittent fever; Headaches; Aches in bones; Flu-like symptoms; Balance issues; Injured my knee; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Intermittent fever), HEADACHE (Headaches), BONE PAIN (Aches in bones), INFLUENZA LIKE ILLNESS (Flu-like symptoms) and BALANCE DISORDER (Balance issues) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No adverse event reported.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) unknown. On an unknown date, the patient experienced PYREXIA (Intermittent fever), HEADACHE (Headaches), BONE PAIN (Aches in bones), INFLUENZA LIKE ILLNESS (Flu-like symptoms), BALANCE DISORDER (Balance issues) and JOINT INJURY (Injured my knee). At the time of the report, PYREXIA (Intermittent fever), HEADACHE (Headaches), BONE PAIN (Aches in bones), INFLUENZA LIKE ILLNESS (Flu-like symptoms), BALANCE DISORDER (Balance issues) and JOINT INJURY (Injured my knee) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: side of her arm is pretty red; arm swollen; arm itchy; injection site warm; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE ERYTHEMA (side of her arm is pretty red), VACCINATION SITE SWELLING (arm swollen), VACCINATION SITE PRURITUS (arm itchy) and VACCINATION SITE WARMTH (injection site warm) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included OMEPRAZOLE, LINACLOTIDE (LINZESS) and ESTRADIOL, NORETHISTERONE ACETATE (MIMVEY) for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (side of her arm is pretty red), VACCINATION SITE SWELLING (arm swollen), VACCINATION SITE PRURITUS (arm itchy) and VACCINATION SITE WARMTH (injection site warm). At the time of the report, VACCINATION SITE ERYTHEMA (side of her arm is pretty red), VACCINATION SITE SWELLING (arm swollen), VACCINATION SITE PRURITUS (arm itchy) and VACCINATION SITE WARMTH (injection site warm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment included Advil on the night of the vaccination
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: pain on their left thumb, and they could not grab anything, could not touch their other fingers with their thumb because if the pain; They feel their thumb joint very stiff; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN (pain on their left thumb, and they could not grab anything, could not touch their other fingers with their thumb because if the pain) and MUSCULOSKELETAL STIFFNESS (They feel their thumb joint very stiff) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain on their left thumb, and they could not grab anything, could not touch their other fingers with their thumb because if the pain) and MUSCULOSKELETAL STIFFNESS (They feel their thumb joint very stiff). At the time of the report, VACCINATION SITE PAIN (pain on their left thumb, and they could not grab anything, could not touch their other fingers with their thumb because if the pain) and MUSCULOSKELETAL STIFFNESS (They feel their thumb joint very stiff) 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.   Treatment included ibuprofen arthritis cream "Voltaren" Support for the hand and thumb
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Vaccination site pain
Clinical narrative: arm pain; headache; body ache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm pain), HEADACHE (headache), MYALGIA (body ache) and NAUSEA (nausea) in a 72-year-old female 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 (No reported medical history). Concomitant products included METOPROLOL, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and SIMVASTATIN (ZOCOR) for an unknown indication.    On 28-Jan-2021 at 12:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm pain), HEADACHE (headache), MYALGIA (body ache) and NAUSEA (nausea). At the time of the report, VACCINATION SITE PAIN (arm pain), HEADACHE (headache), MYALGIA (body ache) and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that headache was worst out of all symptoms. No treatment information was provided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Pharyngeal swelling, Rash, Vaccination site pain
Clinical narrative: Congested (Can not breath through the nose); Swelling in the throat (Difficulty Swallowing); Rash behind both ears; Little pain in the vaccinated arm; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Congested (Can not breath through the nose)), PHARYNGEAL SWELLING (Swelling in the throat (Difficulty Swallowing)), RASH (Rash behind both ears) and VACCINATION SITE PAIN (Little pain in the vaccinated arm) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (Little pain in the vaccinated arm). On 27-Jan-2021, the patient experienced NASAL CONGESTION (Congested (Can not breath through the nose)) and PHARYNGEAL SWELLING (Swelling in the throat (Difficulty Swallowing)). 27-Jan-2021, the patient experienced RASH (Rash behind both ears). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 18-Jan-2021 for Pain in arm, at an unspecified dose and frequency. On 20-Jan-2021, VACCINATION SITE PAIN (Little pain in the vaccinated arm) had resolved. At the time of the report, NASAL CONGESTION (Congested (Can not breath through the nose)), PHARYNGEAL SWELLING (Swelling in the throat (Difficulty Swallowing)) and RASH (Rash behind both ears) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient reported that he was doing good.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow up document was received on 12 Jul 2021. Age and event outcomes updated to recovered.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Heart rate increased, Myalgia, Nausea
Clinical narrative: felt like her heart was pounding out of her chest/High heart rate; tenderness underarm; redness at the injections site; had intense pain in head, body/ body aches, aches from the shot/felt like somebody beat her up; severe headache/m intense pain in head and body; 102.6 fever; chills; some nausea; a lot of swelling; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (felt like her heart was pounding out of her chest/High heart rate), TENDERNESS (tenderness underarm), VACCINATION SITE ERYTHEMA (redness at the injections site), MYALGIA (had intense pain in head, body/ body aches, aches from the shot/felt like somebody beat her up) and HEADACHE (severe headache/m intense pain in head and body) in a 59-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.     The patient's past medical history included COVID-19 in April 2020. Concomitant products included LISINOPRIL and LEVOTHYROXINE SODIUM (LEVOXYL) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced HEART RATE INCREASED (felt like her heart was pounding out of her chest/High heart rate), TENDERNESS (tenderness underarm), VACCINATION SITE ERYTHEMA (redness at the injections site), MYALGIA (had intense pain in head, body/ body aches, aches from the shot/felt like somebody beat her up), HEADACHE (severe headache/m intense pain in head and body), PYREXIA (102.6 fever), CHILLS (chills), NAUSEA (some nausea) and VACCINATION SITE SWELLING (a lot of swelling). At the time of the report, HEART RATE INCREASED (felt like her heart was pounding out of her chest/High heart rate), TENDERNESS (tenderness underarm), VACCINATION SITE ERYTHEMA (redness at the injections site), MYALGIA (had intense pain in head, body/ body aches, aches from the shot/felt like somebody beat her up), HEADACHE (severe headache/m intense pain in head and body), PYREXIA (102.6 fever), CHILLS (chills), NAUSEA (some nausea) and VACCINATION SITE SWELLING (a lot of swelling) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was reported.    Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: NNI (non-significant follow up is added)
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tenderness, Vaccination site erythema, Vaccination site swelling
Clinical narrative: felt like her heart was pounding out of her chest/High heart rate; tenderness underarm; redness at the injections site; had intense pain in head, body/ body aches, aches from the shot/felt like somebody beat her up; severe headache/m intense pain in head and body; 102.6 fever; chills; some nausea; a lot of swelling; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (felt like her heart was pounding out of her chest/High heart rate), TENDERNESS (tenderness underarm), VACCINATION SITE ERYTHEMA (redness at the injections site), MYALGIA (had intense pain in head, body/ body aches, aches from the shot/felt like somebody beat her up) and HEADACHE (severe headache/m intense pain in head and body) in a 59-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.     The patient's past medical history included COVID-19 in April 2020. Concomitant products included LISINOPRIL and LEVOTHYROXINE SODIUM (LEVOXYL) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced HEART RATE INCREASED (felt like her heart was pounding out of her chest/High heart rate), TENDERNESS (tenderness underarm), VACCINATION SITE ERYTHEMA (redness at the injections site), MYALGIA (had intense pain in head, body/ body aches, aches from the shot/felt like somebody beat her up), HEADACHE (severe headache/m intense pain in head and body), PYREXIA (102.6 fever), CHILLS (chills), NAUSEA (some nausea) and VACCINATION SITE SWELLING (a lot of swelling). At the time of the report, HEART RATE INCREASED (felt like her heart was pounding out of her chest/High heart rate), TENDERNESS (tenderness underarm), VACCINATION SITE ERYTHEMA (redness at the injections site), MYALGIA (had intense pain in head, body/ body aches, aches from the shot/felt like somebody beat her up), HEADACHE (severe headache/m intense pain in head and body), PYREXIA (102.6 fever), CHILLS (chills), NAUSEA (some nausea) and VACCINATION SITE SWELLING (a lot of swelling) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was reported.    Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: NNI (non-significant follow up is added)
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site haemorrhage
Clinical narrative: took off the band aid it was soaked in blood; the site of injection was black; A spontaneous report (United States) was received from a consumer concerning herself, who is a 61-years-old female patient received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events when she took off the band aid it was soaked in blood, the site of injection was black .  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 025J20A) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Jan 2021, the patient experienced the events when she took off the band aid it was soaked in blood and the site of injection was black. The site of injection has remained black since then. She has not used anything to alleviate the symptoms. The black spot is gradually fading.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events when she took off the band aid it was soaked in blood, the site of injection was black was resolving.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itchy at injection site; Rash at injection site; Red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE ERYTHEMA (Red at injection site) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE ERYTHEMA (Red at injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE ERYTHEMA (Red at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Very bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Very bad headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced HEADACHE (Very bad headache). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, HEADACHE (Very bad headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No relevant concomitant medications were reported. 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 HEADACHE (Very bad headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced HEADACHE (Very bad headache). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, HEADACHE (Very bad headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at injection site; A spontaneous report was received from a healthcare professional concerning a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain at injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 004M20A) intramuscularly for prophylaxis of COVID-19 infection. On unknown date, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: UNK) intramuscularly for prophylaxis of COVID-19 infection.  On 3 Jan 2021, the patient experienced the event(s) pain at injection site.  Treatment details included Aleve BID self administered.  Action taken with mRNA-1273 in response to the events was not reported.   On 4 Jan 2021 the outcome of event(s), pain at injection site was resolved.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Arm was all swelled up; Red arm; Sore red swollen arm; Arm started to itch; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Sore red swollen arm), VACCINATION SITE PRURITUS (Arm started to itch), VACCINATION SITE PAIN (Sore arm), VACCINATION SITE SWELLING (Arm was all swelled up) and VACCINATION SITE ERYTHEMA (Red arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 022M20A) for COVID-19 vaccination.     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 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 27-Jan-2021, the patient experienced PERIPHERAL SWELLING (Sore red swollen arm) and VACCINATION SITE PRURITUS (Arm started to itch). On 28-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Arm was all swelled up) and VACCINATION SITE ERYTHEMA (Red arm). On 22-Jan-2021, VACCINATION SITE PAIN (Sore arm) had resolved. On 01-Feb-2021, PERIPHERAL SWELLING (Sore red swollen arm) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Arm started to itch), VACCINATION SITE SWELLING (Arm was all swelled up) and VACCINATION SITE ERYTHEMA (Red arm) outcome was unknown.            Concomitant product use was not provided  by the reporter.  Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Follow up information was received on 07 Apr 2021 had more details about patient, suspect drug and events.; 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical reported history).    On 09-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). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 27-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 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    No treatment information was provided.    This case was linked to MOD-2021-025089 (Patient Link). 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 09-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 27-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 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    No treatment information was provided.    This case was linked to MOD-2021-025089 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Feels warm at site of injection), VACCINATION SITE PRURITUS (Site of injection is itchy) and VACCINATION SITE ERYTHEMA (Site of injection is red) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Feels warm at site of injection), VACCINATION SITE PRURITUS (Site of injection is itchy) and VACCINATION SITE ERYTHEMA (Site of injection is red). At the time of the report, VACCINATION SITE WARMTH (Feels warm at site of injection), VACCINATION SITE PRURITUS (Site of injection is itchy) and VACCINATION SITE ERYTHEMA (Site of injection is red) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment details included Tylenol. No relevant concomitant medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Ear pain, Neck pain, Oropharyngeal pain, Pain in extremity
Clinical narrative: Left ear hurt; Neck hurt; Left arm hurt; Left fingers hurt; Sore throat; Burning sensation from her shoulder to her finger tips; Itchiness; Soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), BURNING SENSATION (Burning sensation from her shoulder to her finger tips), EAR PAIN (Left ear hurt), NECK PAIN (Neck hurt) and PAIN IN EXTREMITY (Left arm hurt; Left fingers hurt) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness) and VACCINATION SITE PAIN (Soreness of arm). On 07-Feb-2021, the patient experienced BURNING SENSATION (Burning sensation from her shoulder to her finger tips). On 08-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), EAR PAIN (Left ear hurt), NECK PAIN (Neck hurt) and PAIN IN EXTREMITY (Left arm hurt; Left fingers hurt). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), BURNING SENSATION (Burning sensation from her shoulder to her finger tips), EAR PAIN (Left ear hurt), NECK PAIN (Neck hurt), PAIN IN EXTREMITY (Left arm hurt; Left fingers hurt), VACCINATION SITE PRURITUS (Itchiness) and VACCINATION SITE PAIN (Soreness of arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Tylenol. No relevant concomitant medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: Left ear hurt; Neck hurt; Left arm hurt; Left fingers hurt; Sore throat; Burning sensation from her shoulder to her finger tips; Itchiness; Soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), BURNING SENSATION (Burning sensation from her shoulder to her finger tips), EAR PAIN (Left ear hurt), NECK PAIN (Neck hurt) and PAIN IN EXTREMITY (Left arm hurt; Left fingers hurt) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness) and VACCINATION SITE PAIN (Soreness of arm). On 07-Feb-2021, the patient experienced BURNING SENSATION (Burning sensation from her shoulder to her finger tips). On 08-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), EAR PAIN (Left ear hurt), NECK PAIN (Neck hurt) and PAIN IN EXTREMITY (Left arm hurt; Left fingers hurt). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), BURNING SENSATION (Burning sensation from her shoulder to her finger tips), EAR PAIN (Left ear hurt), NECK PAIN (Neck hurt), PAIN IN EXTREMITY (Left arm hurt; Left fingers hurt), VACCINATION SITE PRURITUS (Itchiness) and VACCINATION SITE PAIN (Soreness of arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Tylenol. No relevant concomitant medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Nausea, Pruritus
Clinical narrative: Itchiness; Acid reflux; Severe nausea; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) and NAUSEA (Severe nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced PRURITUS (Itchiness), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) and NAUSEA (Severe nausea). At the time of the report, PRURITUS (Itchiness), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) and NAUSEA (Severe nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment details included Pepto Bismol.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site irritation, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: irritation at injection site; itchiness at injection site; pain at injection site; swelling at injection site; nausea; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), the first episode of VACCINATION SITE PAIN (pain at injection site), VACCINATION SITE IRRITATION (irritation at injection site), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE PRURITUS (itchiness at injection site) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced NAUSEA (nausea), the first episode of VACCINATION SITE PAIN (pain at injection site) and VACCINATION SITE SWELLING (swelling at injection site). On 06-Feb-2021, the patient experienced VACCINATION SITE IRRITATION (irritation at injection site), VACCINATION SITE PRURITUS (itchiness at injection site) and the second episode of VACCINATION SITE PAIN (pain at injection site). On 02-Feb-2021, NAUSEA (nausea) and VACCINATION SITE SWELLING (swelling at injection site) had resolved. At the time of the report, VACCINATION SITE IRRITATION (irritation at injection site), VACCINATION SITE PRURITUS (itchiness at injection site) and the last episode of VACCINATION SITE PAIN (pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Concomitant medications reported were low dose diuretic. Treatment details included Tylenol, ice.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Visual impairment, White blood cell count increased
Clinical narrative: change in vision; significant knot in arm, real red; delayed hypersensitivity; excess white blood cells in aqueous fluid; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VISUAL IMPAIRMENT (change in vision), WHITE BLOOD CELL COUNT INCREASED (excess white blood cells in aqueous fluid), ERYTHEMA (significant knot in arm, real red) and HYPERSENSITIVITY (delayed hypersensitivity) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-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 WHITE BLOOD CELL COUNT INCREASED (excess white blood cells in aqueous fluid). On 23-Jan-2021, the patient experienced ERYTHEMA (significant knot in arm, real red) and HYPERSENSITIVITY (delayed hypersensitivity). On an unknown date, the patient experienced VISUAL IMPAIRMENT (change in vision). The patient was treated with PREDNISOLONE ACETATE (ophthalmic) ongoing since an unknown date for Eye inflammation, at a dose of 1 dosage form and CYCLOPENTOLATE (ophthalmic) ongoing since an unknown date for Eye inflammation, at a dose of 1 dosage form. At the time of the report, VISUAL IMPAIRMENT (change in vision), WHITE BLOOD CELL COUNT INCREASED (excess white blood cells in aqueous fluid), ERYTHEMA (significant knot in arm, real red) and HYPERSENSITIVITY (delayed hypersensitivity) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: my arm has started to react with a large erythema and red patch; My arm is hurting; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (my arm has started to react with a large erythema and red patch) and PAIN IN EXTREMITY (My arm is hurting) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (my arm has started to react with a large erythema and red patch) and PAIN IN EXTREMITY (My arm is hurting). At the time of the report, ERYTHEMA (my arm has started to react with a large erythema and red patch) and PAIN IN EXTREMITY (My arm is hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not provided.   This case was linked to MOD-2021-072148 (E2B Linked Report). This case was linked to MOD-2021-072130 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. MOD-2021-072148:Husband's Second Vaccine