chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: DIARRHEA; HEADACHE; MUSCLE ACHES; FEVER; PERIOD CYCLE  STARTED 3 HOURS AFTER GETTING THE SHOT; DROWSINESS; BODY CHILLS; This spontaneous report received from a patient concerned a 25 year old female. The patient's weight was not reported and height was 67 inches. The patient's concurrent conditions included: penicillin allergy, non smoker, and non alcoholic, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 15-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 15-OCT-2021, the patient experienced period cycle started 3 hours after getting the shot. On 15-OCT-2021, the patient experienced drowsiness. On 15-OCT-2021, the patient experienced body chills. On 15-OCT-2021, the patient experienced headache. On 15-OCT-2021, the patient experienced muscle aches. On 15-OCT-2021, the patient experienced fever. On 22-OCT-2021, the patient experienced diarrhea. Treatment medications (dates unspecified) included: bismuth subsalicylate, and loperamide hydrochloride. The action taken with covid-19 vaccine  was not applicable. The patient recovered from drowsiness, body chills, headache, muscle aches, and fever on 19-OCT-2021, had not recovered from diarrhea, and the outcome of period cycle started 3 hours after getting the shot was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: She received both doses of the Moderna vaccine and had an allergic reaction immediately following both doses; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (She received both doses of the Moderna vaccine and had an allergic reaction immediately following both doses) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Allergic to yeast).    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 HYPERSENSITIVITY (She received both doses of the Moderna vaccine and had an allergic reaction immediately following both doses). At the time of the report, HYPERSENSITIVITY (She received both doses of the Moderna vaccine and had an allergic reaction immediately following both doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was given.  No treatment medication was given.   This case was linked to MOD-2021-386595 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received expired vaccine of Moderna COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired vaccine of Moderna COVID-19) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired vaccine of Moderna COVID-19). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (received expired vaccine of Moderna COVID-19) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported No treatment medications were reported No adverse event for the patient.   Most recent FOLLOW-UP information incorporated above includes: On 11-Nov-2021: Follow up received and updated the I narrative supplement.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Myalgia, Pain in extremity
Clinical narrative: Myalgia bilateral arms (Left greater than right); Administered expired vaccine; Sore arms/aches; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Sore arms/aches), MYALGIA (Myalgia bilateral arms (Left greater than right)) and EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Nov-2021, the patient experienced PAIN IN EXTREMITY (Sore arms/aches) and EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On an unknown date, the patient experienced MYALGIA (Myalgia bilateral arms (Left greater than right)). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arms/aches) outcome was unknown and MYALGIA (Myalgia bilateral arms (Left greater than right)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment medications were not reported.  The patient experienced mild to moderate (3 or 4 out of 10) on scale myalgia bilateral arm (left greater than right), lasting less than 24 hours, resolved at the time of reporting.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow-up contains significant information. Case became valid, patient details, suspect drug information, vaccine facility information, new event were added.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Had a temperature of 101.6F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Had a temperature of 101.6F) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 016B21A and 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension since 1985 and Atrial flutter since 2017. Concomitant products included FLECAINIDE from August 2017 to an unknown date and APIXABAN (ELIQUIS) from January 2017 to an unknown date for Atrial flutter, LISINOPRIL from 1987 to an unknown date and AMLODIPINE MALEATE (AMLODIPINE A) from 2010 to an unknown date for Blood pressure high.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Had a temperature of 101.6F). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. On 10-Nov-2021, PYREXIA (Had a temperature of 101.6F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2021, Body temperature: 101.6 (High) fever of 101.6 F.         This case was linked to MOD-2021-382261 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow-up includes patients demographics, current conditions, concomitant drugs and Reporters causality.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 46 Patients received expired Moderna Covid-19 vaccine on 10NOV2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (46 Patients received expired Moderna Covid-19 vaccine on 10NOV2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (46 Patients received expired Moderna Covid-19 vaccine on 10NOV2021). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (46 Patients received expired Moderna Covid-19 vaccine on 10NOV2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter No treatment information was provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Follow up received contains no new information On 12-Nov-2021: Follow up received on 12-Nov-2021 reported no Known Adverse events. On 13-Nov-2021: Follow-up information received on 15-Nov-2021:  On 16-Nov-2021: Non-significant Follow Up appended
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: HCP calling to report 12 patients received expired doses of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP calling to report 12 patients received expired doses of the Moderna COVID-19 vaccine) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A, 043L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP calling to report 12 patients received expired doses of the Moderna COVID-19 vaccine). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (HCP calling to report 12 patients received expired doses of the Moderna COVID-19 vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No treatment medications were reported.     Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: FollowUp received include No new information
Age: 6.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product preparation issue
Clinical narrative: Grandparent states the patient received adult dose of vaccine instead of childrens' dose. ADMINISTRATION ERROR!
Age: 6.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Grandparent states the patient received adult dose of vaccine instead of childrens' dose. ADMINISTRATION ERROR!
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness/tingling  in upper extremities lasting for short period of time, chills and rigors following
Sex: U
Vaccine: COVID19
Symptoms: Panniculitis, Pyrexia
Clinical narrative: blood vessel of my legs and ankle were inflammated painfully/In another sense, I got diagnosed by pennicolitis; Associated fever; This spontaneous case was reported by a consumer and describes the occurrence of PANNICULITIS (blood vessel of my legs and ankle were inflammated painfully/In another sense, I got diagnosed by pennicolitis) 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.     Previously administered products included for COVID-19 vaccination: J and J (Patient vaccinated with J and J first). Past adverse reactions to the above products included No adverse event with J and J.    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 PANNICULITIS (blood vessel of my legs and ankle were inflammated painfully/In another sense, I got diagnosed by pennicolitis) (seriousness criterion medically significant) and PYREXIA (Associated fever). At the time of the report, PANNICULITIS (blood vessel of my legs and ankle were inflammated painfully/In another sense, I got diagnosed by pennicolitis) was resolving and PYREXIA (Associated fever) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No concomitant medications reported by reporter.  No treatment medications provided by the reporter.   Patient got vaccinated with J and J first and after 4 months we were asked to have a one-shot MODERNA. Patient got diagnosed by pennicolitis. After ten days It got really better but patient suffered a lot.  Company Comment - This case concerns a patient of unknown age and gender with a history of Johnson& Johnson vaccination for COVID-19 who experienced the unexpected serious event of panniculitis. The event occurred on an unknown date after vaccination with mRNA-1273 vaccine on an unknown date. The rechallenge was unknown as information about the date of dosing was not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender with a history of Johnson& Johnson vaccination for COVID-19 who experienced the unexpected serious event of panniculitis. The event occurred on an unknown date after vaccination with mRNA-1273 vaccine on an unknown date. The rechallenge was unknown as information about the date of dosing was not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Illness, Nausea
Clinical narrative: I was sick for 3 days but no fever but nausea is really bad. nobody is giving me any answers I have no stomach ache or flu just bad nausea. please help me I never thought booster will do this to me.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Lymph node pain, Lymphadenopathy
Clinical narrative: swollen and sore lyphnodes in the armpit of the arm i got the vaccine, left. mild painf closing arm completely pressing armpit against itself, raising my arm above my head. mild discomfort  with arm at rest.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper storage (temperature).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Urticaria
Clinical narrative: Generalized transient blanchable hives
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: I randomly get itchy ever since I got the vaccine when I first got it I noticed it at night I decided to ignore it but it?s happening at work and when I?m at home I?m just icing my skin so it stops but regardless I?m still itchy it?s my arms that itchy my neck and face behind my head and stomach
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymph node pain, Lymphadenopathy, Pain in extremity, Pruritus
Clinical narrative: Dose 3 - booster shot:  initially tired and sore arm the evening of; the next day (Sunday), swollen glands under my neck - not super large but noticeable and very tired. Today (Monday- day 3) ... upon waking lymph node in right underarm swollen and painful, but soft, not hard.  Has been like this all day. Also, in the morning very itchy right forearm and thumb. I had to take claritin to stop the itching. So right now, as I type this, my underarm hurts and I am tired, but all else is okay.  I wanted to call the doctor today but thought I would wait to see it it gets better. I will call tomorrow, if it is not.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose given after vials stored in dry ice box ran out of batteries, thus deemed compromised by CDC.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution-
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: Injection site pain and soreness lasting over a week, huge bruise that lasted two weeks, and a huge rock hard nodule near but not at the actual injection site (this nodule has decreased significantly but is still there two weeks later).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper storage (temperature).
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Chills, Decreased appetite, Dizziness
Clinical narrative: Fever of 103 (highest recorded temp thus far as of 11/23 0038- still having sx; rigors; piloerection;  muscle spasms; arthralgia / myalgia; Headache, dizziness, insomnia, stuffy and runny nose, nausea, anorexia; stomach pain; flank pain;
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Flank pain, Headache, Insomnia, Muscle spasms, Myalgia
Clinical narrative: Fever of 103 (highest recorded temp thus far as of 11/23 0038- still having sx; rigors; piloerection;  muscle spasms; arthralgia / myalgia; Headache, dizziness, insomnia, stuffy and runny nose, nausea, anorexia; stomach pain; flank pain;
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nausea, Piloerection, Pyrexia, Rhinorrhoea
Clinical narrative: Fever of 103 (highest recorded temp thus far as of 11/23 0038- still having sx; rigors; piloerection;  muscle spasms; arthralgia / myalgia; Headache, dizziness, insomnia, stuffy and runny nose, nausea, anorexia; stomach pain; flank pain;
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Client reports a red, itchy rash on face, 2 days post vaccination.  Client took Bendaryl  and the rash resolved that same day.  Client denies any shortness of breath, no throat tightening or trouble swallowing.  Client did not follow up with primary doctor.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discharge, Headache, Myalgia, Pyrexia
Clinical narrative: there was a body fluid coming under her arm, on the left side of her chest, it was flapping around; Chills; body aches; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DISCHARGE (there was a body fluid coming under her arm, on the left side of her chest, it was flapping around), CHILLS (Chills), MYALGIA (body aches), PYREXIA (Fever) and HEADACHE (Headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISCHARGE (there was a body fluid coming under her arm, on the left side of her chest, it was flapping around), CHILLS (Chills), MYALGIA (body aches), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, DISCHARGE (there was a body fluid coming under her arm, on the left side of her chest, it was flapping around), CHILLS (Chills), MYALGIA (body aches), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.            NO Concomitant medication was reported NO treatment medication was reported   This case was linked to MOD-2021-385672 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: dose given after vials stored in dry ice box ran out of batteries, thus deemed compromised by CDC
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper storage (temperature).
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: dose given after vials stored in dry ice box ran out of batteries, thus deemed compromised by CDC
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Headache, Pain in extremity, Peripheral swelling
Clinical narrative: Fever, headache,  sore feet, dizziness, swelling in left armpit,  coughing, wheezing
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Wheezing
Clinical narrative: Fever, headache,  sore feet, dizziness, swelling in left armpit,  coughing, wheezing
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: dose given after vials stored in dry ice box ran out of batteries, thus deemed compromised by CDC
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)-
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: dose given after vials stored in dry ice box ran out of batteries, thus deemed compromised by CDC
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: Same day tunnel vision and light headed, muscle weakness.  24h after, body aches and headache, low energy. Swollen lymph nodes in left armpit to size of grapefruit hemisphere and right armpit to lesser degree day 2-5 after injection, tender to pressure and weight of arm against armpit.  Swollen mid jawline at submandibular glands, bilateral, equal size, tender to touch day 4-5.  Left more pronounced.  Tender pain and stiffness  at base of skull uppermost vertebrae of neck.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Musculoskeletal stiffness, Neck pain, Pain, Tenderness
Clinical narrative: Same day tunnel vision and light headed, muscle weakness.  24h after, body aches and headache, low energy. Swollen lymph nodes in left armpit to size of grapefruit hemisphere and right armpit to lesser degree day 2-5 after injection, tender to pressure and weight of arm against armpit.  Swollen mid jawline at submandibular glands, bilateral, equal size, tender to touch day 4-5.  Left more pronounced.  Tender pain and stiffness  at base of skull uppermost vertebrae of neck.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Tunnel vision
Clinical narrative: Same day tunnel vision and light headed, muscle weakness.  24h after, body aches and headache, low energy. Swollen lymph nodes in left armpit to size of grapefruit hemisphere and right armpit to lesser degree day 2-5 after injection, tender to pressure and weight of arm against armpit.  Swollen mid jawline at submandibular glands, bilateral, equal size, tender to touch day 4-5.  Left more pronounced.  Tender pain and stiffness  at base of skull uppermost vertebrae of neck.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: dose given after vials stored in dry ice box ran out of batteries, thus deemed compromised by CDC
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: dose given after vials stored in dry ice box ran out of batteries.temperature therefore unable to be monitored, thus deemed compromised by CDC
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: enlarged lymph node; body aches; Chills; Milld Fever; slight Headache; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (enlarged lymph node), MYALGIA (body aches), CHILLS (Chills), PYREXIA (Milld Fever) and HEADACHE (slight Headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 046821A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (enlarged lymph node), MYALGIA (body aches), CHILLS (Chills), PYREXIA (Milld Fever) and HEADACHE (slight Headache). At the time of the report, LYMPHADENOPATHY (enlarged lymph node), MYALGIA (body aches), CHILLS (Chills), PYREXIA (Milld Fever) and HEADACHE (slight Headache) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-385661 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Injection site bruising, Muscle spasms, Pain
Clinical narrative: Moderate to severe diarrhea (liquid stool with cramping 4 times the first day, 5 times the second day) beginning several hours after vaccination, and ongoing more than 54 hours later. Additionally, a 1 inch diameter purple-blue bruise at the injection site. (Additional reactions I experienced are listed as common, including low grade fever 12 hours after vaccine lasting 20 hours, chills, body aches).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Moderate to severe diarrhea (liquid stool with cramping 4 times the first day, 5 times the second day) beginning several hours after vaccination, and ongoing more than 54 hours later. Additionally, a 1 inch diameter purple-blue bruise at the injection site. (Additional reactions I experienced are listed as common, including low grade fever 12 hours after vaccine lasting 20 hours, chills, body aches).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: right arm tingling
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: ose given after vials stored in dry ice box ran out of batteries.temperature therefore unable to be monitored, thus deemed compromised by CDC
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: dose given after vials stored in dry ice box ran out of batteries.temperature therefore unable to be monitored, thus deemed compromised by CDC
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Chills, Malaise, Mobility decreased
Clinical narrative: Malaise, chills, and sore arm by 5pm, Nov 19 Fever of 102 by 9pm, Nov 19 continuing to morning of Nov 21. Right arm became nearly impossible to move. Could not raise it or lift anything. Painful in armpit and around shoulder joint. Fever returned 7pm Nov 21 but stayed at 100.5. Fever returned 7pm Nov 22 but stayed at 100.5
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Malaise, chills, and sore arm by 5pm, Nov 19 Fever of 102 by 9pm, Nov 19 continuing to morning of Nov 21. Right arm became nearly impossible to move. Could not raise it or lift anything. Painful in armpit and around shoulder joint. Fever returned 7pm Nov 21 but stayed at 100.5. Fever returned 7pm Nov 22 but stayed at 100.5
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Hyperhidrosis, Loss of consciousness, Mydriasis, Nausea
Clinical narrative: Vasovagal syncope- dilated pupils, sweating, passed out, tonic posturing, lasted about 1 minute. Felt weak and nauseous afterword and didn?t feel strong enough to walk out of clinic (took wheelchair). Vomited about 45 mins later. Did not eat dinner. Fell asleep at 8:00, which is unusual for my 16yo.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Presyncope, Tonic posturing, Vomiting
Clinical narrative: Vasovagal syncope- dilated pupils, sweating, passed out, tonic posturing, lasted about 1 minute. Felt weak and nauseous afterword and didn?t feel strong enough to walk out of clinic (took wheelchair). Vomited about 45 mins later. Did not eat dinner. Fell asleep at 8:00, which is unusual for my 16yo.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Amblyopia, Dizziness, Dysphagia, Hypoaesthesia, Nausea
Clinical narrative: Left arm numbness, lazy right eye, difficulty swallowing, dizziness, nausea and vomiting.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Left arm numbness, lazy right eye, difficulty swallowing, dizziness, nausea and vomiting.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: dose given after vials stored in dry ice box ran out of batteries.temperature therefore unable to be monitored, thus deemed compromised by CDC
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: dose given after vials stored in dry ice box ran out of batteries.temperature therefore unable to be monitored, thus deemed compromised by CDC
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Arm is sore; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is sore) and PYREXIA (Fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 025A21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, the patient experienced PAIN IN EXTREMITY (Arm is sore) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Arm is sore) and PYREXIA (Fever) outcome was unknown.            No relevant concomitant medications were reported. No treatment was received.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow-up information included no new information
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper storage (temperature).
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: dose given after vials stored in dry ice box ran out of batteries.temperature therefore unable to be monitored, thus deemed compromised
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: dose given after vials stored in dry ice box ran out of batteries.temperature therefore unable to be monitored, thus deemed compromised by Agency.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose given after vials stored in dry ice box ran out of batteries. Temperature therefore unable to be monitored, thus deemed compromised.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: dose given after vials stored in dry ice box ran out of batteries.temperature therefore unable to be monitored, thus deemed compromised by Agency
Age: 24.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Hypersensitivity, Mechanical urticaria, Peripheral swelling, Rash, Swelling face
Clinical narrative: The morning of 11/10 I developed an allergic reaction, possibly in response to a shampoo I used, but the reaction was full body. I developed widespread hives, rash, and swelling in my hands and face. On 11/11 I saw a virtual urgent care provider and started a course of prednisone along with antihistamines. The reaction continued until 11/23, and now I?ve developed dermatographia, which I did not have before the reaction.  I?m concerned that the sensitization of my immune system and mast cells in particular could have been related to the my moderna booster about 10 days prior.
Age: 24.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Urticaria
Clinical narrative: The morning of 11/10 I developed an allergic reaction, possibly in response to a shampoo I used, but the reaction was full body. I developed widespread hives, rash, and swelling in my hands and face. On 11/11 I saw a virtual urgent care provider and started a course of prednisone along with antihistamines. The reaction continued until 11/23, and now I?ve developed dermatographia, which I did not have before the reaction.  I?m concerned that the sensitization of my immune system and mast cells in particular could have been related to the my moderna booster about 10 days prior.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itching, rash on arm, forehead and neck
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Tremor
Clinical narrative: had chills again today; chills and shaking for 3-5mins yesterday; chills and shaking for 3-5mins yesterday; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (chills and shaking for 3-5mins yesterday), CHILLS (chills and shaking for 3-5mins yesterday) and CHILLS (had chills again today) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A, 030A21A and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, the patient experienced TREMOR (chills and shaking for 3-5mins yesterday) and CHILLS (chills and shaking for 3-5mins yesterday). On 14-Nov-2021, the patient experienced CHILLS (had chills again today). On 13-Nov-2021, TREMOR (chills and shaking for 3-5mins yesterday) and CHILLS (chills and shaking for 3-5mins yesterday) had resolved. At the time of the report, CHILLS (had chills again today) outcome was unknown.            Concomitant medication use was unknown Treatment information was unknown
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper storage (temperature).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: dose given after vials stored in dry ice box ran out of batteries.temperature therefore unable to be monitored, thus deemed compromised by Agency
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: I began a very heavy ?period? that lasted 2 weeks 8/8-8/23, it began 2 days after the 1st shot. Then after the 2nd shot I began to bleed very heavy again. The bleeding lasted  5 days 9/12-9/17. I have not had a period since then.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: dose given after vials stored in dry ice box ran out of batteries.temperature therefore unable to be monitored, thus deemed compromised by CDC
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: dose given after vials stored in dry ice box ran out of batteries.temperature therefore unable to be monitored, thus deemed compromised by CDC
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: received his first dose of the Moderna covid19 on the 22Sept2021 is not well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (received his first dose of the Moderna covid19 on the 22Sept2021 is not well) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (received his first dose of the Moderna covid19 on the 22Sept2021 is not well). At the time of the report, MALAISE (received his first dose of the Moderna covid19 on the 22Sept2021 is not well) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment information was provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Periarthritis
Clinical narrative: Painful shoulder, shoulder frozen for about 12 hours, then continued to be sore for a couple days before full function returned.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea
Clinical narrative: PT STATES THAT AFTER RECEIVING HER FIRST PFIZER VACCINE, HER MENSTRAL CYCLE HAS BEEN VERY PAINFUL.  PT STATES THAT THE PAIN FEELS LIKE SHE WAS IN LABOR.  PT RECEIVED FIRST VACCINE 16 SEP AND STATES THAT THE PAIN HAS LESSEN BUT DID RECEIVE SECOND PFIZER VACCINE 23 NOV AT 0953
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: dose given after vials stored in dry ice box ran out of batteries.temperature therefore unable to be monitored, thus deemed compromised by CDC
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood urine present, Fatigue, Headache, Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Myalgia, Product preparation issue, Pyrexia, Renal pain
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urine analysis
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pharmacy called on 11/22 to indicate they failed to dilute the vaccine resulting in a double dose being administered.  Confirmed 60mcg was administered instead of the 30mcg.  Severe flu like symptoms started at 12:30am on 11/21 and lasted through 11/22 including severe head ache, fatigue, muscle and joint pain, side (kidney pain), low grade fever (99.9), and blood in urine.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood urine present, Fatigue, Headache, Incorrect dose administered
Clinical narrative: Pharmacy called on 11/22 to indicate they failed to dilute the vaccine resulting in a double dose being administered.  Confirmed 60mcg was administered instead of the 30mcg.  Severe flu like symptoms started at 12:30am on 11/21 and lasted through 11/22 including severe head ache, fatigue, muscle and joint pain, side (kidney pain), low grade fever (99.9), and blood in urine.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Myalgia, Product preparation issue, Pyrexia, Renal pain
Clinical narrative: Pharmacy called on 11/22 to indicate they failed to dilute the vaccine resulting in a double dose being administered.  Confirmed 60mcg was administered instead of the 30mcg.  Severe flu like symptoms started at 12:30am on 11/21 and lasted through 11/22 including severe head ache, fatigue, muscle and joint pain, side (kidney pain), low grade fever (99.9), and blood in urine.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urine analysis
Clinical narrative: Pharmacy called on 11/22 to indicate they failed to dilute the vaccine resulting in a double dose being administered.  Confirmed 60mcg was administered instead of the 30mcg.  Severe flu like symptoms started at 12:30am on 11/21 and lasted through 11/22 including severe head ache, fatigue, muscle and joint pain, side (kidney pain), low grade fever (99.9), and blood in urine.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: dose given after vials stored in dry ice box ran out of batteries. Temperature therefore unable to be monitored, thus deemed compromised by CDC
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: dose given after vials stored in dry ice box ran out of batteries.temperature therefore unable to be monitored, thus deemed compromised by CDC
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Throat tightness
Clinical narrative: throat tightness and heartburn
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and PYREXIA (fever) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 025J2D-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-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 HEADACHE (headache) and PYREXIA (fever). At the time of the report, HEADACHE (headache) and PYREXIA (fever) outcome was unknown.            No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-385680, MOD-2021-385701 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Dyspnoea, Syncope
Clinical narrative: shortness of breath, followed by syncope and collapse and subsequently death
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: felt sleepy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (felt sleepy) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J2D-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (felt sleepy). At the time of the report, SOMNOLENCE (felt sleepy) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  Treatment information was not provided.    This case was linked to MOD-2021-385695, MOD-2021-385680 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Extra dose administered, Fatigue, Feeling abnormal, Pain
Clinical narrative: Usual fever, fatigue, aches hit after 24 hour mark and then by  30 hour mark, chest pain, racing heart , brain fog (trouble  problem solving clearly).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: Usual fever, fatigue, aches hit after 24 hour mark and then by  30 hour mark, chest pain, racing heart , brain fog (trouble  problem solving clearly).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Face injury, Hypotension, Injection site pain, Nausea
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Additional Details: pt insisted to get up to go to bathroom and got dizzy and fell on her way to bathroom hit the chin face down on the floor
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Additional Details: pt insisted to get up to go to bathroom and got dizzy and fell on her way to bathroom hit the chin face down on the floor
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: arm swelling with paresthesia
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Got ringing of the ears or tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Got ringing of the ears or tinnitus) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 037K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Thyroid disorder. Concomitant products included LOPERAMIDE HYDROCHLORIDE (IMODIUM) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced TINNITUS (Got ringing of the ears or tinnitus). At the time of the report, TINNITUS (Got ringing of the ears or tinnitus) had not resolved.            Concomitant medications included thyroid medication.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: heart problems; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (heart problems) 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 CARDIAC DISORDER (heart problems). At the time of the report, CARDIAC DISORDER (heart problems) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the patient stated that she saw people who had experienced heart problems after taking Moderna vaccine, Blood clots after taking Pfizer vaccine and Johnson & Johnson vaccine, happened with women's of age 20-20, she linked it with taking birth control medications.  No concomitant medications were reported No treatment medications were reported.
Age: 99.0
Sex: F
Vaccine: COVID19
Symptoms: Gastric disorder
Clinical narrative: gastric effects; This spontaneous case was reported by an other health care professional and describes the occurrence of GASTRIC DISORDER (gastric effects) in a 99-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-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 GASTRIC DISORDER (gastric effects). At the time of the report, GASTRIC DISORDER (gastric effects) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.    This case was linked to MOD-2021-009966 (Patient Link).