chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Seizure
Clinical narrative: SEIZURE; This spontaneous report received from a consumer concerned a 94 year old female. The patient's weight was 135 pounds, and height was 60 inches. The patient's past medical history included heart rate, oxalate and polysorbate sensitivity, and other pre-existing medical conditions included the patient had no known drug allergies.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination on the left arm. No concomitant medications were reported.  On 23-MAR-2021, the patient experienced seizure,  had to be taken by ambulance to hospital and was hospitalized for 5 days. She was in ICU for 3 days. On 26-MAR-2021, Laboratory data included: MRI (NR: not provided) MRI showed no damage Mitral Valve Regurgitation. The Patient was discharged on 27-Mar-2021.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from seizure. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210400319- JANSSEN COVID-19 VACCINE Ad26.COV2. S- Seizure. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder, Viral test
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 38-year-old not Hispanic or Latino, of unspecified sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) once a total dose was not reported, administered on 23-MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was reported by patient that on 30-MAR-2021, the patient had no antibodies found in bloodstream (suspected immunological vaccine failure). On 30-MAR-2021, Laboratory data included: SARS-CoV-2 IgM antibody test negative, no antibodies found in bloodstream, and Viral PCR test negative means no virus found. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210401325-COVID-19 VACCINE AD26.COV2.S-Suspected Immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: vasovagal syncope; This spontaneous report received from a health care professional concerned a 46 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies and no significant past medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 31-MAR-2021, a couple minutes later of vaccination, patient experienced vasovagal syncope for which a Code Blue was called by clinic staff. 911 was also called. Patient was evaluated by ED physician on scene at the clinic, where patient had regained consciousness and responded to questions. The patient was then transported to emergency department next door by the  emergency department staff where patient was monitored and ultimately discharged home. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vasovagal syncope on 2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210401417 -COVID-19 VACCINE AD26.COV2.S-VASOVAGAL SYNCOPE. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: Cellulitis flare up; A spontaneous report was received from a Pharmacist concerning a 78 year  old female patient, who received second dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced Cellulitis flared up.  The patient's medical history included Cellulitis for 15 Years. No relevant concomitant medications were provided.  On 07 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 027L20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.   On an unspecified date, the patient experienced cellulitis that was aggravated after vaccination. The event cellulitis was considered medically significant.  No Laboratory details were provided.   The Treatment medication included Cephalexin 500 mg twice a day.  Action taken with mRNA-1273 in response to the other events was unknown.  At the time of this report, the outcome of the event, Cellulitis aggravated was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Corneal reflex decreased, Ear pain, Eye movement disorder, Facial paralysis
Clinical narrative: Left eye was not closing; Left face drooping; Extreme pain behind his left ear; Can't blink; A spontaneous report was received from a consumer concerning a 65-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events left side of his face was drooping/facial paralysis, extreme pain behind his left ear/ear pain, can't blink/corneal reflex decreased, and his left eye was not closing/eye movement disorder.   The patient's medical history included COPD, congestive heart disease and chronic problems with his back. No relevant concomitant medications were reported.  On 4 Jan 2021, 17 days prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 21 Jan 2021 the patient had an unexpected reaction. He got up that morning and felt fine, but as the day went on, he noticed that when he spoke, the left side of his mouth was not moving, then he noticed his left eye was not closing and that side of his face was drooping. He was not in any pain at that point. He made an appointment to see his general doctor the next day, 22 Jan 2021, after the exam he was diagnosed him with Bell's Palsy (BP) and referred him to a neurologist and ophthalmologist. The earliest he could see the ophthalmologist back was next week and he could not get the neuro to call him back. His doctor prescribed him prednisone which he completed after 7 days but said the BP symptoms have not improved. Then on Saturday, 30 Jan 2021, he started feeling extreme pain behind his left ear. Everyday the pain got worse. His pain medications were not helping the pain behind his left ear. He could not see out of his left eye and he could not blink. The event left side of his face was drooping was considered as medically significant.  Action taken with mRNA-1273 in response to the events left side of his face was drooping, extreme pain behind his left ear, can't blink, and his left eye was not closing was not provided.   The events left side of his face was drooping, extreme pain behind his left ear, can't blink, and his left eye was not closing was not reported.; Reporter'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. Further information has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Heart rate increased, Hypersensitivity
Clinical narrative: Swollen lip; Rash over their body (it itches bad); Heartbeat fast; Difficulty breathing; Had all of the symptoms of an allergic reaction; Dizziness; Weakness; Swelliness of their face, hand and feet; A spontaneous report was received from a healthcare professional concerning a 66-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events had all of the symptoms of an allergic reaction, rash over their body, it itches bad (hypersensivity), dizziness, weakness (asthemia), swelliness of their face, difficulty breathing (dyspnea), heart beat fast (heartbeats increased), swollen lip, feet and hand swolle up.  The patient's medical history was not provided. Concomitant medications reported were metformin, carvedilol, atorvastatin, aspirin, citalopram.  On 4 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011M20A) via unknown route for prophylaxis of COVID-19 infection.  On 5 Feb 2021, the patient experienced the event(s) had all of the symptoms of an allergic reaction, rash over their body (it itches bad), dizziness, weakness, swelliness of their face, difficulty breathing, heart beat fast. On 19 Feb 2021, the patient experienced the event(s) swollen lip, feet and hand swolle up.  Treatment details included Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), had all of the symptoms of an allergic reaction, rash over their body (it itches bad), dizziness, weakness, swelliness of their face, difficulty breathing, heart beat fast, swollen lip, feet and hand swolle up was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Rash, Swelling
Clinical narrative: Swollen lip; Rash over their body (it itches bad); Heartbeat fast; Difficulty breathing; Had all of the symptoms of an allergic reaction; Dizziness; Weakness; Swelliness of their face, hand and feet; A spontaneous report was received from a healthcare professional concerning a 66-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events had all of the symptoms of an allergic reaction, rash over their body, it itches bad (hypersensivity), dizziness, weakness (asthemia), swelliness of their face, difficulty breathing (dyspnea), heart beat fast (heartbeats increased), swollen lip, feet and hand swolle up.  The patient's medical history was not provided. Concomitant medications reported were metformin, carvedilol, atorvastatin, aspirin, citalopram.  On 4 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011M20A) via unknown route for prophylaxis of COVID-19 infection.  On 5 Feb 2021, the patient experienced the event(s) had all of the symptoms of an allergic reaction, rash over their body (it itches bad), dizziness, weakness, swelliness of their face, difficulty breathing, heart beat fast. On 19 Feb 2021, the patient experienced the event(s) swollen lip, feet and hand swolle up.  Treatment details included Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), had all of the symptoms of an allergic reaction, rash over their body (it itches bad), dizziness, weakness, swelliness of their face, difficulty breathing, heart beat fast, swollen lip, feet and hand swolle up was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Disorientation, Dizziness, Fall
Clinical narrative: Dizzy; Disorientated; Can't balance, fell several times; fell several times; A spontaneous report was received from a consumer and confirmed by a healthcare provided concerning a 73-year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dizziness, disorientation and balance issues falling several times.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 03-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly on unknown arm for prophylaxis of COVID-19 infection.  On 16-FEB-2021, it was reported that the patient was dizzy, disorientated, couldn't balance and fell several times. On 17-FEB-2021, the patient was admitted to the hospital.    Laboratory reports were not provided. Treatment information was not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was unknown.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Decreased appetite, Delirium, Gait disturbance, Pain in extremity
Clinical narrative: Unsteady/had to hold onto the wall to keep upright; Forever to write a simple email/weired things; No appetite but able to eat after 10 pm; Slept and woke up delirious; Woke up with 101.6 degrees fever; Tremendous itching; Soreness/pain; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (Slept and woke up delirious) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 18-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 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness/pain) and SWELLING (Swelling). On 25-Jan-2021, the patient experienced PRURITUS (Tremendous itching). On 19-Feb-2021, the patient experienced DELIRIUM (Slept and woke up delirious) (seriousness criterion medically significant), GAIT DISTURBANCE (Unsteady/had to hold onto the wall to keep upright), ABNORMAL BEHAVIOUR (Forever to write a simple email/weired things), DECREASED APPETITE (No appetite but able to eat after 10 pm) and PYREXIA (Woke up with 101.6 degrees fever). On 19-Feb-2021, DELIRIUM (Slept and woke up delirious), GAIT DISTURBANCE (Unsteady/had to hold onto the wall to keep upright), ABNORMAL BEHAVIOUR (Forever to write a simple email/weired things), DECREASED APPETITE (No appetite but able to eat after 10 pm) and PYREXIA (Woke up with 101.6 degrees fever) had resolved. At the time of the report, PAIN IN EXTREMITY (Soreness/pain) and SWELLING (Swelling) outcome was unknown and PRURITUS (Tremendous itching) was resolving.            No relevant concomitant medications were reported.  Treatment for events included 3 paracetamol.; Reporter's Comments: This case concerns a 66 Y/O F with a serious unexpected event of delirium, and nonserious unexpected abnormal behavior, pain in extremity, pruritus, and expected swelling and pyrexia.  Serious event onset was 2 days after second dose mRNA-1273. Delirium resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Swelling
Clinical narrative: Unsteady/had to hold onto the wall to keep upright; Forever to write a simple email/weired things; No appetite but able to eat after 10 pm; Slept and woke up delirious; Woke up with 101.6 degrees fever; Tremendous itching; Soreness/pain; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (Slept and woke up delirious) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 18-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 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness/pain) and SWELLING (Swelling). On 25-Jan-2021, the patient experienced PRURITUS (Tremendous itching). On 19-Feb-2021, the patient experienced DELIRIUM (Slept and woke up delirious) (seriousness criterion medically significant), GAIT DISTURBANCE (Unsteady/had to hold onto the wall to keep upright), ABNORMAL BEHAVIOUR (Forever to write a simple email/weired things), DECREASED APPETITE (No appetite but able to eat after 10 pm) and PYREXIA (Woke up with 101.6 degrees fever). On 19-Feb-2021, DELIRIUM (Slept and woke up delirious), GAIT DISTURBANCE (Unsteady/had to hold onto the wall to keep upright), ABNORMAL BEHAVIOUR (Forever to write a simple email/weired things), DECREASED APPETITE (No appetite but able to eat after 10 pm) and PYREXIA (Woke up with 101.6 degrees fever) had resolved. At the time of the report, PAIN IN EXTREMITY (Soreness/pain) and SWELLING (Swelling) outcome was unknown and PRURITUS (Tremendous itching) was resolving.            No relevant concomitant medications were reported.  Treatment for events included 3 paracetamol.; Reporter's Comments: This case concerns a 66 Y/O F with a serious unexpected event of delirium, and nonserious unexpected abnormal behavior, pain in extremity, pruritus, and expected swelling and pyrexia.  Serious event onset was 2 days after second dose mRNA-1273. Delirium resolved. Based on 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.
Sex: F
Vaccine: COVID19
Symptoms: Lower respiratory tract infection, Nasal congestion
Clinical narrative: Chest congestion; Nose congestion; A spontaneous report was received from a consumer concerning a female (age not provided) who received Moderna's COVID-19 (mRNA-1273) vaccine and experienced nose congestion (nasal congestion) and chest congestion (lower respiratory tract infection).  The patient's medical history was not provided. Concomitant medication was not provided by the reporter.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (lot number: unknown) via intramuscular route for COVID-19 infection prophylaxis.  After receiving the first dose, the patient reported experiencing nose and chest congestion.  No treatment information was provided.  No additional details were reported.  Action taken with mRNA-1273 in response to the events was unknown.    The outcome of the events, nose and chest congestion, was unknown..; Reporter's Comments: This case concerns a female of unknown age with a serious unexpected event of Lower respiratory tract infection and nonserious unexpected Nasal congestion.  Event onset with unknown latency after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Limb discomfort, Musculoskeletal discomfort, Pain in extremity, Polymyalgia rheumatica
Clinical narrative: autoimmune disorder which is Poly myalgia Rheumatica; having discomfort in my shoulders/started started noticing discomfort in hips and thighs; mostly about discomfort in lower extremities; Could not even get out of my bed at one point a; Joint pain; A spontaneous report was received from a physician concerning himself, a 65-years-old, male patient who experienced joint pain, having discomfort in my shoulders, started noticing discomfort in hips and thighs, mostly about discomfort in lower extremities, autoimmune disorder which is poly myalgia rheumatica and could not even get out of my bed at one point.   The patient's medical history included neurological issues. Concomitant product use was not provided by the reporter.  On 12 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 lot number 012L20A for prophylaxis of COVID-19 infection.  On 12 Jan 2021, the patient reported discomfort in his shoulder and discomfort in his hips and thighs. Patient found out that it was an autoimmune disorder which was polymyalgia rheumatica.  Treatment for the event included high dose steroid.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of all the events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Neuropathy peripheral, Pruritus, Vaccination site pruritus
Clinical narrative: Not sure if the vaccine stirred up the neuropathy in arms; Still getting outbreaks of itching various sites on her body; Redness on the arm and redness proceeded to go down arm; Intense itching at the injection site and it moved down to her forearm; A spontaneous report was received from a consumer concerning a 86-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events patient reported intense itching at the injection site and it moved down to her forearm .  The patient's medical included diabetes. Concomitant medications reported were dulaglutide for diabetes.  On 9 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031LZOA) intramuscularly in the left upper arm for prophylaxis of COVID-19 infection.   on unknown date, Patient reported intense itching at the injection site and it moved down to her forearm and now 2.  Treatment details included steroid cream  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, patient reported intense itching at the injection site and it moved down to her forearm  was not reported.  Follow-up was obtained on 23 Mar 2021.  Patient had history of neuropathy in feet because of diabetes.  The patient experienced redness on the arm and redness proceeded to go down arm/erythema and not sure if the vaccine stirred up the neuropathy in arms/neuropathy peripheral. It was medically significant event.  Treatment included cortisone 10 over the counter (OTC) medication.   The events still getting outbreaks of itching various sites on her body, intense itching at the injection site and it moved down to her forearm, redness on the arm and redness proceeded to go down arm were recovered with the medication on unknown date.  The outcome of the event not sure if the vaccine stirred up the neuropathy in arms was unknown.  Practitioner said to not get 2nd dose because could be much worse, so she was afraid to get the second dose.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events pruritus, erythema, and vaccination site pruritus, a causal relationship cannot be excluded.The peripheral neuropathy aggravated event is related to the patient's comorbidities.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; A spontaneous report was received from a pharmacist concerning a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine on an unknown date and experienced Bell's palsy.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unspecified date, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.   On an unspecified date, after first dose of vaccine, the patient experienced Bell's palsy. The event is  Bell's palsy was considered as medically significant.  No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event development of Bell's palsy was not resolved at the time of report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Pyrexia, Rheumatoid arthritis, Vaccination site erythema, Vaccination site pain
Clinical narrative: injected arm started getting very hot; The shot hurt; Hot fever; Red area around the shot; RA flare gotten worse; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (RA flare gotten worse) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis and Allergic reaction NOS (patient had history of allergic reactions.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE WARMTH (injected arm started getting very hot). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (RA flare gotten worse) (seriousness criterion medically significant), DIZZINESS (dizzy), VACCINATION SITE PAIN (The shot hurt), PYREXIA (Hot fever) and VACCINATION SITE ERYTHEMA (Red area around the shot). At the time of the report, RHEUMATOID ARTHRITIS (RA flare gotten worse), DIZZINESS (dizzy), VACCINATION SITE WARMTH (injected arm started getting very hot), VACCINATION SITE PAIN (The shot hurt), PYREXIA (Hot fever) and VACCINATION SITE ERYTHEMA (Red area around the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: This case concerns an elderly patient of unknown age with a serious unexpected event of rheumatoid arthritis, and nonserious unexpected dizziness, vaccination site warmth and expected pyrexia, vaccination site pain, vaccination site erythema.  Event onset the same day as first dose mRNA-1273. Event outcomes unknown. Based on 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.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: injected arm started getting very hot; The shot hurt; Hot fever; Red area around the shot; RA flare gotten worse; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (RA flare gotten worse) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis and Allergic reaction NOS (patient had history of allergic reactions.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE WARMTH (injected arm started getting very hot). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (RA flare gotten worse) (seriousness criterion medically significant), DIZZINESS (dizzy), VACCINATION SITE PAIN (The shot hurt), PYREXIA (Hot fever) and VACCINATION SITE ERYTHEMA (Red area around the shot). At the time of the report, RHEUMATOID ARTHRITIS (RA flare gotten worse), DIZZINESS (dizzy), VACCINATION SITE WARMTH (injected arm started getting very hot), VACCINATION SITE PAIN (The shot hurt), PYREXIA (Hot fever) and VACCINATION SITE ERYTHEMA (Red area around the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: This case concerns an elderly patient of unknown age with a serious unexpected event of rheumatoid arthritis, and nonserious unexpected dizziness, vaccination site warmth and expected pyrexia, vaccination site pain, vaccination site erythema.  Event onset the same day as first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Choking, Cough, Fatigue, Haemoptysis, Injection site erythema
Clinical narrative: I feel tired; Arm is still swollen; Spitted and saw blood; Choking; Coughing; Red arm; A spontaneous report was received from a consumer concerning a 66-year-old, female patient, who experienced choking, coughing, spitted blood/hemoptysis, fatigue, arm redness/injection site erythema and swelling of arm/injection site swelling.    The patient's medical history was not provided. Concomitant products known to have been used by the patient, within two weeks prior to the events were atorvastatin, aspirin, Lipitor, water pills and vitamin D3.  On 26 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 028L20A) in the left non-dominant arm for prophylaxis of COVID-19 infection. On 23 Feb 2021, the patient received their second of two planned doses of Mrna-1273 (Lot number: 012M20A) in the left non- dominant arm for prophylaxis of COVID-19 infection.   After the second dose, the patient experienced arm redness. On 25 Feb 2021, the patient experienced choking, coughing and spitted out blood, which was experienced on 26 Feb 2021 morning as well. Later, on 26 Feb 2021 the patient developed swollen and reddish arm and fatigue. No such symptoms were experienced after first dose.   Treatment  for the event was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events, choking, cough, hemoptysis, fatigue, injection site erythema and injection site swelling were unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: I feel tired; Arm is still swollen; Spitted and saw blood; Choking; Coughing; Red arm; A spontaneous report was received from a consumer concerning a 66-year-old, female patient, who experienced choking, coughing, spitted blood/hemoptysis, fatigue, arm redness/injection site erythema and swelling of arm/injection site swelling.    The patient's medical history was not provided. Concomitant products known to have been used by the patient, within two weeks prior to the events were atorvastatin, aspirin, Lipitor, water pills and vitamin D3.  On 26 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 028L20A) in the left non-dominant arm for prophylaxis of COVID-19 infection. On 23 Feb 2021, the patient received their second of two planned doses of Mrna-1273 (Lot number: 012M20A) in the left non- dominant arm for prophylaxis of COVID-19 infection.   After the second dose, the patient experienced arm redness. On 25 Feb 2021, the patient experienced choking, coughing and spitted out blood, which was experienced on 26 Feb 2021 morning as well. Later, on 26 Feb 2021 the patient developed swollen and reddish arm and fatigue. No such symptoms were experienced after first dose.   Treatment  for the event was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events, choking, cough, hemoptysis, fatigue, injection site erythema and injection site swelling were unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Chills, Fatigue, Headache, Nausea
Clinical narrative: Cellulitis; Nausea; Fatigue; Fever; chills; Headache; A spontaneous report  was received from a consumer concerning a 68-years-old , female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nausea, fatigue, fever, chills and headache. Sometime after that, the patient was diagnosed with a Cellulitis infection.   The patient's medical history was not  provided by the reporter. Products known to have been used by patient with in past two weeks included, metformin, levothyroxine and refasten.   On 28-JAN-2021 , prior to the onset of the events, the patient received the first of two dose of mRNA-1273 (Lot number: 039K20A) through Intramuscular route for prophylaxis of COVID-19 infection.    On an unspecified date, 2 weeks after vaccination patient experienced nausea, fatigue, fever, chills and headache. Sometime after that, the patient was diagnosed with a Cellulitis infection. Treatment included antibiotics.   Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the event, nausea, fatigue,fever, chills and headache and cellulitis infection was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Cellulitis; Nausea; Fatigue; Fever; chills; Headache; A spontaneous report  was received from a consumer concerning a 68-years-old , female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nausea, fatigue, fever, chills and headache. Sometime after that, the patient was diagnosed with a Cellulitis infection.   The patient's medical history was not  provided by the reporter. Products known to have been used by patient with in past two weeks included, metformin, levothyroxine and refasten.   On 28-JAN-2021 , prior to the onset of the events, the patient received the first of two dose of mRNA-1273 (Lot number: 039K20A) through Intramuscular route for prophylaxis of COVID-19 infection.    On an unspecified date, 2 weeks after vaccination patient experienced nausea, fatigue, fever, chills and headache. Sometime after that, the patient was diagnosed with a Cellulitis infection. Treatment included antibiotics.   Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the event, nausea, fatigue,fever, chills and headache and cellulitis infection was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Blister, Skin exfoliation, Swelling, Urticaria
Clinical narrative: angioedema; blistering on arms; swelling; arms continues to have flaking; arms continues to have blistering; welts on arms; A spontaneous report was received from a Health care professional, concerning a female patient of 37 year age, who received Moderna's COVID-19 vaccine and experienced angioedema, welts on arms, blistering on arms, swelling, arms continues to have flaking, arms continues to have blistering.  The patient's medical history includes chronic idiopathic angioedema, paroxysmal atrial fibrillation is noted. Patient has known allergy to benzyl peroxide. Concomitant product use includes cetirizine, famotidine metoprolol, epinephrine were provided by the reporter.  On 28 DEC 2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) via intramuscular route for COVID-19 infection prophylaxis. The treatment given were Cetirizine 10mg BID for angioedema, Famotidine 20mg BID for angioedema,2 doses of epinephrine 2 hours apart with no relief for angioedema, triamcinolone for welts and blistering, Benadryl (Diphenhydramine) 25mg-50mg for angioedema noted.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events such as angioedema, welts on arms, blistering on arms, arms continues to have flaking, arms continues to have blistering was considered to be not unknown at the time of this report.  The outcome of event swelling considered to be resolved at the time of report.; Reporter'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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Malaise, Movement disorder, Myalgia
Clinical narrative: neuropathy; couldn't walk or coudn't move; felt sick; nauseous; severe throbbing headache; muscle pain; joint pain; A spontaneous report was received from a consumer concerning a 57 years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced neuropathy (medically significant), couldn't walk and couldn't move, felt sick, nauseous, severe throbbing headache, muscle pain, and joint pain.  The patient's medical history included brittle diabetes, thyroid issues and neuropathy. Concomitant medications included clonazepam and melatonin.   The patient received their first of two planned doses of mRNA-1273 (lot/batch 038K20A) on 25 Jan 2021.  On 22 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch 007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 22-Feb-2021, post vaccination, the patient felt sick all night which lasted until  25 Feb 2021.  The patient described feeling nauseous, had a severe throbbing headache, muscle pain, joint pain, and neuropathy. Patient reported past neuropathy but not like this where patient couldn't walk and couldn't move.   Treatment details included 500 mg of paracetamol.   The patient received both planned doses of mRNA-1273; therefore action taken with mRNA-1273 in response to the events was not applicable.  The events neuropathy, couldn't walk and couldn't move, felt sick, nauseous, severe throbbing headache, muscle pain and joint pain were considered recovered / resolved on 25 Feb 2021.; Reporter'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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neuropathy peripheral
Clinical narrative: neuropathy; couldn't walk or coudn't move; felt sick; nauseous; severe throbbing headache; muscle pain; joint pain; A spontaneous report was received from a consumer concerning a 57 years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced neuropathy (medically significant), couldn't walk and couldn't move, felt sick, nauseous, severe throbbing headache, muscle pain, and joint pain.  The patient's medical history included brittle diabetes, thyroid issues and neuropathy. Concomitant medications included clonazepam and melatonin.   The patient received their first of two planned doses of mRNA-1273 (lot/batch 038K20A) on 25 Jan 2021.  On 22 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch 007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 22-Feb-2021, post vaccination, the patient felt sick all night which lasted until  25 Feb 2021.  The patient described feeling nauseous, had a severe throbbing headache, muscle pain, joint pain, and neuropathy. Patient reported past neuropathy but not like this where patient couldn't walk and couldn't move.   Treatment details included 500 mg of paracetamol.   The patient received both planned doses of mRNA-1273; therefore action taken with mRNA-1273 in response to the events was not applicable.  The events neuropathy, couldn't walk and couldn't move, felt sick, nauseous, severe throbbing headache, muscle pain and joint pain were considered recovered / resolved on 25 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Muscle twitching, Seizure
Clinical narrative: Convulsions that did not let up, shaking and tremors; severe twitching; Shortened time interval between first and second dose; A spontaneous report was received from a family member  concerning a 72-years old, female patient who experienced convulsions that did not let up, shaking and tremors (seizure), twitching (muscle twitching) and shortened time interval between first and second dose (inappropriate schedule of product administration).  The patient's relevant medical history included essential tremor. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly on 29-Jan-2021. On 26-Feb-2021, prior to the event onset, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   On 27-Feb-2021, 25 hours after vaccination, the patient experienced very severe twitching, shaking, tremors and convulsions that did not let up. Reportedly, it lasted 12 hours until she fell asleep and remained ongoing. 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.  The outcome of the events, convulsions that did not let up, shaking and tremors and twitching, were not provided. The event,  shortened time interval between first and second dose, was resolved on 26 Feb 2021.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with an associated convulsions reported. Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Mobility decreased, Myalgia, Nausea, Polymyalgia rheumatica
Clinical narrative: doesn't feel tremendous; similar to his other disease, polymyalgia rheumatica; couldn't move; bones and muscles were aching and he couldn't move; fever; nausea; arm was just sore; A spontaneous report was received from a consumer concerning a 68-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm was just sore (vaccination site pain), similar to his other disease, polymyalgia rheumatica (polymyalgia rheumatica aggravated), bones bone pain and muscles were aching (myalgia) and he couldn't move (mobility decreased), fever and nausea and couldn't get out of bed (mobility decreased) and doesn't feel tremendous (malaise).   The patient's medical history was not provided.  No relevant concomitant medications were reported.  On 25 Feb 2021, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: 10A21A) intramuscularly for prophylaxis of COVID-19 infection.    On 25 Feb 2021, the patient's arm was just sore.   On 26 Feb 2021 in the middle of the night patient woke up and symptoms he experienced were similar to his other disease, polymyalgia rheumatica. The patient's bones and muscles were aching and he could not move. He had a fever and nausea and could not get out of bed. At the time of reporting, the patient did not feel tremendous, but felt a little better.   Treatment for the event included acetaminophen and ibuprofen.  Action taken with mRNA-1273 in response to the events was unknown.  The events, arm was just sore, bones and muscles were aching, he couldn't move, fever, nausea and couldn't get out of bed were considered resolved on 28 Feb 2021. The event, doesn't feel tremendous, was considered resolving. The outcome of the event, similar to his other disease, polymyalgia rheumatica, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: doesn't feel tremendous; similar to his other disease, polymyalgia rheumatica; couldn't move; bones and muscles were aching and he couldn't move; fever; nausea; arm was just sore; A spontaneous report was received from a consumer concerning a 68-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm was just sore (vaccination site pain), similar to his other disease, polymyalgia rheumatica (polymyalgia rheumatica aggravated), bones bone pain and muscles were aching (myalgia) and he couldn't move (mobility decreased), fever and nausea and couldn't get out of bed (mobility decreased) and doesn't feel tremendous (malaise).   The patient's medical history was not provided.  No relevant concomitant medications were reported.  On 25 Feb 2021, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: 10A21A) intramuscularly for prophylaxis of COVID-19 infection.    On 25 Feb 2021, the patient's arm was just sore.   On 26 Feb 2021 in the middle of the night patient woke up and symptoms he experienced were similar to his other disease, polymyalgia rheumatica. The patient's bones and muscles were aching and he could not move. He had a fever and nausea and could not get out of bed. At the time of reporting, the patient did not feel tremendous, but felt a little better.   Treatment for the event included acetaminophen and ibuprofen.  Action taken with mRNA-1273 in response to the events was unknown.  The events, arm was just sore, bones and muscles were aching, he couldn't move, fever, nausea and couldn't get out of bed were considered resolved on 28 Feb 2021. The event, doesn't feel tremendous, was considered resolving. The outcome of the event, similar to his other disease, polymyalgia rheumatica, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.