chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Upon onset of other typical effects (sore/swollen arm, fever, fatigue) experience instantaneous and intense panic attack, which included tightness in the chest, feeling of fear and danger, sobbing, and paranoia. I had no anxiety surrounding the receiving of the vaccine nor anxiety about potential side effects. I was standing still and upright at the time of the attack and it lasted appx 30-40 min, subsiding to feelings of heightened anxiety through the remainder of the night. While anxiety and panic attacks have occurred in the past, it is not on a regular basis, nor has either occurred in over 6 months.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Myalgia, Pyrexia
Clinical narrative: DIZZINESS; WEAKNESS; FEVER; HEADACHE; MUSCLE ACHE; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hepatitis b, non smoker, and no alcohol use, and other pre-existing medical conditions included the patient have no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-MAR-2021, the subject experienced dizziness. On 17-MAR-2021, the subject experienced weakness. On 17-MAR-2021, the subject experienced fever. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021, the subject experienced muscle ache. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, weakness, fever, headache, and muscle ache on 20-MAR-2021. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Hypoaesthesia oral, Swelling
Clinical narrative: Had swelling of that and numbness in lips and stomach started hurting and only took 10 mins after shot.Then the people admitted ephi into my leg..03mg.And then fire department got called and got 50 cc of liqard benadryl into me and iv and it was off to the hospital and got some prednisone and and was in hospital for 8 hrs
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Hypoaesthesia, Hypoaesthesia oral, Throat tightness
Clinical narrative: Had swelling of that and numbness in lips and stomach started hurting and only took 10 mins after shot.Then the people admitted ephi into my leg..03mg.And then fire department got called and got 50 cc of liqard benadryl into me and iv and it was off to the hospital and got some prednisone and and was in hospital for 8 hrs
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Hypoaesthesia oral, Swelling
Clinical narrative: IMMUNIZATION GIVEN AROUND 10:15AM, APRIL 22, 2021.  AROUND 10:30AM SAME DAY, PT COMPLAINED OF NUMBNESS OF LIPS AND SURROUNDING AREAS,  TIGHTENING OF THROAT AND ABDOMINAL PAIN.  i BROUGHT PATIENT INTO IMMUNIZATION ROOM.  HE WAS AMBULATORY WITHOUT ANY ISSUES OR DIFFICULTY.  ADMINISTERED 1 DOSE EPI-PEN.  CALLED 911.  FIRE DEPT AND EMS ARRIVED BEFORE 10 MINUTE WINDOW FOR SECOND EPI-PEN SHOT.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Hypoaesthesia, Hypoaesthesia oral, Throat tightness
Clinical narrative: IMMUNIZATION GIVEN AROUND 10:15AM, APRIL 22, 2021.  AROUND 10:30AM SAME DAY, PT COMPLAINED OF NUMBNESS OF LIPS AND SURROUNDING AREAS,  TIGHTENING OF THROAT AND ABDOMINAL PAIN.  i BROUGHT PATIENT INTO IMMUNIZATION ROOM.  HE WAS AMBULATORY WITHOUT ANY ISSUES OR DIFFICULTY.  ADMINISTERED 1 DOSE EPI-PEN.  CALLED 911.  FIRE DEPT AND EMS ARRIVED BEFORE 10 MINUTE WINDOW FOR SECOND EPI-PEN SHOT.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Rash, Rash morbilliform
Clinical narrative: Started developing morbiliform exanthem that spread to the whole body, sparing palms and soles of feet 4 days after Vaccination, Worsened into day 8 in spite of Prednisone 20mg Daily  2 doses. Also developed Temp up to 102 day 7-8.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: I got the JNJ vaccine on Wed 4/7/21 (a wk before FDA paused that covid vaccine).  Initial response was Extreme Fatigue, but starting 11:45 pm on 4/18/21, I suffered headache, chest pain, short of breath. I could not sleep at all till 4/19/21 PM after asking my kids to pray for me. In case it's just heartburn, I took TUMS at 8:15 pm  on 4/19/21 . Headache, short of breath comes and goes, but the chest pain persists, and I develop a hot flash.  I never took birth control pills, but my OB/GYN prescribed daily Estrogen (to prevent osteoporosis) and every 3 month, Progesterone for 10 days (to prevent breast cancer). Estrogen & Progesterone happen to be the birth control pills' composition.  On 4/17/21, I finished my 10 days Progesterone regime. I discontinued the Estrogen supplement on 4/19/21 or 4/20/21, now (4/23/21 1:20 am) no more chest pain, but still feel fatigue, feverish with a hazy/foggy head (not really a headache).   I have a suggestion for JNJ, FDA, CDC on JNJ vaccine warning label.   If indeed those 6 women are all on birth control pills which are composed of synthetic estrogen and progesterone, then the warning label should also warn people who take these hormone supplements, instead of just an age range.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Insomnia, Pyrexia
Clinical narrative: I got the JNJ vaccine on Wed 4/7/21 (a wk before FDA paused that covid vaccine).  Initial response was Extreme Fatigue, but starting 11:45 pm on 4/18/21, I suffered headache, chest pain, short of breath. I could not sleep at all till 4/19/21 PM after asking my kids to pray for me. In case it's just heartburn, I took TUMS at 8:15 pm  on 4/19/21 . Headache, short of breath comes and goes, but the chest pain persists, and I develop a hot flash.  I never took birth control pills, but my OB/GYN prescribed daily Estrogen (to prevent osteoporosis) and every 3 month, Progesterone for 10 days (to prevent breast cancer). Estrogen & Progesterone happen to be the birth control pills' composition.  On 4/17/21, I finished my 10 days Progesterone regime. I discontinued the Estrogen supplement on 4/19/21 or 4/20/21, now (4/23/21 1:20 am) no more chest pain, but still feel fatigue, feverish with a hazy/foggy head (not really a headache).   I have a suggestion for JNJ, FDA, CDC on JNJ vaccine warning label.   If indeed those 6 women are all on birth control pills which are composed of synthetic estrogen and progesterone, then the warning label should also warn people who take these hormone supplements, instead of just an age range.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Approx. 24 hours after 2nd shot, a very large swollen lump appeared at injection site. It is more than 3? in diameter, very hot to the touch, and very itchy.  A rash has also appeared around the edges of the soles of my feet.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient concerned a 52 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 19-MAR-2021. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Lymph node pain
Clinical narrative: One week after vaccination my arm started to itch. When I looked at it it was pink, about an inch around. Also at the same time the lymph node under my arm, on the same side as the vaccine site, started hurting. Over the next 24 hours the spot on my arm grew to about four inches around and got brighter red. It alternated between itching and burning, much of the time feeling like a sunburn. One day after it started I did an online doctor visit. She said it was most likely "Covid arm" and after reading about it online I agree.  Now almost 48 hours after symptoms started there is improvement, it has gone back to a dark pink. Lymph node still hurts but it has also improved.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Period came 8 days early on the day after the 2nd vaccine shot. This is rare for me.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Malaise, Sleep disorder
Clinical narrative: Normally I take a Coreg CR 20 mg @9am, and another one @9pm; blood pressure (BP) was well controlled for the last 5 years. The day of the 2nd COVID dose I started feeling malaise/weakness around 7-8pm. My BP was 188/106 (3 measurements average). Took the 9pm Coreg at 8pm; didn't feel improvement, my BP increased to 220/118. I took a Labetalol 100mg; in about 2-3 hrs my PB came down to 170/105 and I fell asleep. I woke up several times feeling sick. The next day my BP was higher than usual around 170/112 (in the morning I felt a bit better; but started to feel very sick again in the afternoon; it continued in the evening & during the night). I felt as if my heart was giving up. The only reason I did not go to Emergency was the fear I can get the COVID in the hospital.   THIS WAS A VERY SERIOUS, LIFE THREATENING EVENT; if I didn't have Labetalol in the house I believe I would be dead now.   Note: I did not panic, my pulse was around 66 the first day. The second day it was around 72.   There should be an investigation covering the side effects in people with a high BP history after the 2nd vaccine dose, to make sure their problems were not blamed on their health history. During the side effects/time frame I described, it seemed my BP medication did not have the effect it usually has on me.  I found it unacceptable that the only site reporting the spikes in BP as a COVID vaccine side effect was a hospital in another country; if there were such side effects reported by the date of my vaccine, they were not readily available for the public.   These heart problems could have been made much better if people like me knew of an increase in BP as adverse reaction to the vaccine's 2nd dose, so we could have been prepared, i.e. take the BP medication BEFORE the BP spikes up so much, so it doesn't reach critical values (especially in the conditions of malaise and general sickness given by the vaccine.)
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Tremor
Clinical narrative: EXTREME NAUSEA AND SEVERE FATIGUE AS WELL AS SHAKINESS
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Heart rate increased, Pyrexia
Clinical narrative: Flush and feverish (low grade), racing heart. Headache onset at say 6 and continuing.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy symptoms within 4 hours of shot.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: A LITTLE BIT OF ACHES AND PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and 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) dose was not reported, administered on 20-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On 20-APR-2021, the patient experienced a little bit of aches and pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a little bit of aches and pain was not reported. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Chills, Confusional state, Cough, Fatigue
Clinical narrative: Uncontrollable shivering Chills Body aches Mild fever(99.2F) Cough HEADACHE Fatigue Confusion Nausea Shivering and chills resolved within 7 hours All other AES ongoing at 5 days
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Nausea, Pain, SARS-CoV-2 test negative
Clinical narrative: Uncontrollable shivering Chills Body aches Mild fever(99.2F) Cough HEADACHE Fatigue Confusion Nausea Shivering and chills resolved within 7 hours All other AES ongoing at 5 days
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Cough, Hypersensitivity, Urticaria
Clinical narrative: Severe allergic reaction with hives that started on my face and moved down to my neck and body also with a cough. Went to Er bc my face felt like it was on fire and they gave me meds and a steroid shot and I know have to take steroids for 3 days along with Benadryl every 6 hours as well.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain lower, Blood test normal, Computerised tomogram normal, Gait disturbance, Lymphadenopathy
Clinical narrative: I just spent 14 hrs in the ER trying to treat, what I was sure to be, an ovarian cyst. The pain had been building over the past mo. I procrastinated going to the ER, because I wanted my 2nd dose b4 going, which was yesterday.    I had exams, pelvic, ultrasounds, Cat scans, labs, etc & they found nothing. I can barely walk without doubling over.  4 wks ago I had an L-5 block & trigger point injections with steroids, due to inflamed nerve roots, & inflamed L thigh. 1 wk later, I had my 1st shot, L arm. Within days my abdomen began hurting mildly, but I thot it'd subside. It never occurred to me that it could be related to the vaccine. 2 wks later, it was unbearable & I thot it an ovarian cyst. I waited for my 2nd shot appt, b4 going to ER, in case I was hospitalized. I didn't want to ruin my 2nd dose, as I have lung issues.   ER Dr said, I had "undetermined inguinal pain". Then, I found a study about women, hormonal changes & the vaccine. I saw that lymph nodes can get inflamed after a vaccine.   Now, I think I had a vulnerable area on my L side, then rec'd steroids L side, which lowered my immune system. Next, I rec'd my 1st shot L side, & my "inguinal lymph node" on L side became inflamed. It got progressively worse, & now my 2nd dose was yesterday, also on my L side, & has aggrivated it even more.   Tomorrow I see my pcp.  It feels exactly like my ovary's swollen, & the inguinal lymph node's located right in the same place, so after all tests have been negative, I suspect a connection & I'll discuss with pcp for more testing & treatment.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Ultrasound scan normal, Urine analysis normal
Clinical narrative: I just spent 14 hrs in the ER trying to treat, what I was sure to be, an ovarian cyst. The pain had been building over the past mo. I procrastinated going to the ER, because I wanted my 2nd dose b4 going, which was yesterday.    I had exams, pelvic, ultrasounds, Cat scans, labs, etc & they found nothing. I can barely walk without doubling over.  4 wks ago I had an L-5 block & trigger point injections with steroids, due to inflamed nerve roots, & inflamed L thigh. 1 wk later, I had my 1st shot, L arm. Within days my abdomen began hurting mildly, but I thot it'd subside. It never occurred to me that it could be related to the vaccine. 2 wks later, it was unbearable & I thot it an ovarian cyst. I waited for my 2nd shot appt, b4 going to ER, in case I was hospitalized. I didn't want to ruin my 2nd dose, as I have lung issues.   ER Dr said, I had "undetermined inguinal pain". Then, I found a study about women, hormonal changes & the vaccine. I saw that lymph nodes can get inflamed after a vaccine.   Now, I think I had a vulnerable area on my L side, then rec'd steroids L side, which lowered my immune system. Next, I rec'd my 1st shot L side, & my "inguinal lymph node" on L side became inflamed. It got progressively worse, & now my 2nd dose was yesterday, also on my L side, & has aggrivated it even more.   Tomorrow I see my pcp.  It feels exactly like my ovary's swollen, & the inguinal lymph node's located right in the same place, so after all tests have been negative, I suspect a connection & I'll discuss with pcp for more testing & treatment.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis
Clinical narrative: I received the first dose of Pfizer vaccination #1 on April 8 at 9:15am.  Almost immediately the hearing in my right ear started to shut down/muffle.  Today is April 22 and the problem persists.  After researching online I will not take the second dose, scheduled for April 29 at 12:30pm, for fear of worsened and/or permanent damage.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Tinnitus, tried Claritin  for a month, been ongoing for a month
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Abdomen scan, Asthenia, Chest X-ray normal, Diarrhoea, Fatigue
Clinical narrative: Extreme weakness, inability to sit upright for extended period of time, extreme fatigue with walking short distances, diarrhea/loss of bowel control, extremely pail skin, cold extremities, low blood pressure.  Started approximately 27 hours after vaccine and continued to get worse.  Dr. was consulted and diagnosed Shy-Dragers Syndrome related to Dementia as a possibility.  We were to increase salt intake and observe for worsening.  Patient began showing improvement after about 5 days.  Was taken to hospital ER for UTI evaluation per Dr.; no UTI present but bloodwork showed the need for a two-unit blood transfusion.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin decreased, Hypotension, Multiple system atrophy, Pallor, Peripheral coldness
Clinical narrative: Extreme weakness, inability to sit upright for extended period of time, extreme fatigue with walking short distances, diarrhea/loss of bowel control, extremely pail skin, cold extremities, low blood pressure.  Started approximately 27 hours after vaccine and continued to get worse.  Dr. was consulted and diagnosed Shy-Dragers Syndrome related to Dementia as a possibility.  We were to increase salt intake and observe for worsening.  Patient began showing improvement after about 5 days.  Was taken to hospital ER for UTI evaluation per Dr.; no UTI present but bloodwork showed the need for a two-unit blood transfusion.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count decreased, Scan abnormal, Sitting disability, Transfusion, Urine analysis normal
Clinical narrative: Extreme weakness, inability to sit upright for extended period of time, extreme fatigue with walking short distances, diarrhea/loss of bowel control, extremely pail skin, cold extremities, low blood pressure.  Started approximately 27 hours after vaccine and continued to get worse.  Dr. was consulted and diagnosed Shy-Dragers Syndrome related to Dementia as a possibility.  We were to increase salt intake and observe for worsening.  Patient began showing improvement after about 5 days.  Was taken to hospital ER for UTI evaluation per Dr.; no UTI present but bloodwork showed the need for a two-unit blood transfusion.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia, Rash
Clinical narrative: MUSCLE ACHES; FEVER; RASH; HEADACHE; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included latex allergy, and ciprofloxacin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 11:00 for prophylactic vaccination. Concomitant medications included levothyroxine sodium. On APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced rash. On 10-APR-2021, the subject experienced muscle aches. On 10-APR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash on 11-APR-2021, and muscle aches, and fever on APR-2021, and had not recovered from headache. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Big welp little bigger than a silver dollar ( I have a photograph).
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever 24 hours after vaccine Local redness, tenderness, swelling 48 hours after vaccine, localized to injection site
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Feeling abnormal, Headache, Palpitations
Clinical narrative: Delayed onset (day 4): headache, dizziness and vertigo, brain fog, chest pressure, increased heart palpitations, tinnitus
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vertigo
Clinical narrative: Delayed onset (day 4): headache, dizziness and vertigo, brain fog, chest pressure, increased heart palpitations, tinnitus
Age: 50.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Burning sensation, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Fever, muscle pain, pain at the injection side, burning sensention from head to fingers at the injection side.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Pain  in both arms and shoulders, stiff neck, and back Exhaustion
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Musculoskeletal discomfort, Oropharyngeal pain, Pharyngeal swelling
Clinical narrative: I took the FIRST dose of the Moderna vaccine this Tuesday on the  20th of April at 11:30 AM. Around 10:00 PM Wednesday I have been feeling short of breath. This feeling has persisted throughout the entire day of Thursday and I continue to feel the same way (I think it has slightly worsened). I can breath, but I am completely unable to take a full, deep breath. I sometimes can achieve a full deep breath but it's completely at random. I find myself trying to forcefully take a deep breath but can't seem to fully fill my lungs how I normally am able to.  Additionally, my throat feels mildly swollen/sore, starting from the back of my mouth and down my esophagus. The lowest point of my esophagus at which I feel the soreness/mild swelling is near the center of my chest.  I think my shortness of breath is progressively, and slowly worsening, but its hard to tell for certain. Some of the muscles around my back are beginning to feel uncomfortable due to me constantly trying to forcefully achieve a full and deep breath.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Full blood count normal, Metabolic function test, Nausea, Seizure
Clinical narrative: pt began having n/v in the evening and then seizures at night. pt does have seizure history but does not usually have breakthrough seizures.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: pt began having n/v in the evening and then seizures at night. pt does have seizure history but does not usually have breakthrough seizures.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Muscle spasms, Pain, Pain in extremity
Clinical narrative: RIGHT LEG CRAMPING; TINGLING OF ARM AND HAND; NUMBNESS OF ARM AND HAND; PAIN IN ARM; FATIGUE; GENERALISED ACHING; SPIDER VEINS HURTING; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included spider veins. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced spider veins hurting. On 12-APR-2021, the subject experienced generalised aching. On 12-APR-2021, the subject experienced pain in arm. On 12-APR-2021, the subject experienced fatigue. On 13-APR-2021, the subject experienced right leg cramping. On 13-APR-2021, the subject experienced tingling of arm and hand. On 13-APR-2021, the subject experienced numbness of arm and hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the generalized aching, fatigue, pain in arm, right leg cramping, tingling of arm and hand, numbness of arm and hand and spider veins hurting was not reported. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Spider vein
Clinical narrative: RIGHT LEG CRAMPING; TINGLING OF ARM AND HAND; NUMBNESS OF ARM AND HAND; PAIN IN ARM; FATIGUE; GENERALISED ACHING; SPIDER VEINS HURTING; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included spider veins. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced spider veins hurting. On 12-APR-2021, the subject experienced generalised aching. On 12-APR-2021, the subject experienced pain in arm. On 12-APR-2021, the subject experienced fatigue. On 13-APR-2021, the subject experienced right leg cramping. On 13-APR-2021, the subject experienced tingling of arm and hand. On 13-APR-2021, the subject experienced numbness of arm and hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the generalized aching, fatigue, pain in arm, right leg cramping, tingling of arm and hand, numbness of arm and hand and spider veins hurting was not reported. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: This resident is a new resident to the facility, admitted on 03/09/2021 according to the patient chat.  Staff member are not aware the patient already received 2 doses of Pfizer ( on 01/19 and 02/09) at the facility she previously lived in.  Staff filled out the consent and answered "No" to the question she has ever received COVID vaccine.  I have no way of knowing or verifying with the patient because she is nonverbal.  So, I gave her a dose of Moderna. I only found out after getting an insurance reject and looked up immunization registry.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain, Pyrexia
Clinical narrative: MIGRAINE / HEADACHE; FEVER; BODY ACHES; This spontaneous report received from a parent concerned an 18 year old female. 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: 042a21a, and expiry: UNKOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced fever. On 16-APR-2021, the subject experienced migraine / headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and fever on 09-APR-2021, and the outcome of migraine / headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: LIGHT HEADEDNESS; SWEAT; POSSIBLE VOMITING; NAUSEA; This spontaneous report received from a health care professional concerned a patient of unspecified age and 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced light headedness. On 2021, the subject experienced sweat. On 2021, the subject experienced possible vomiting. On 2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the light headedness, sweat, nausea and possible vomiting was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Rash
Clinical narrative: PINPRICK RASH TO ELBOWS; SWEATING; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa drugs allergy, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-JUN-2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced sweating. On 17-APR-2021, the subject experienced pinprick rash to elbows. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating on 09-APR-2021, and had not recovered from pinprick rash to elbows. This report was non-serious.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Tremor
Clinical narrative: SHAKING; BODY ACHE; CHILLS; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included aspergers. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021 17:00, the subject experienced shaking. On 25-MAR-2021 17:00, the subject experienced body ache. On 25-MAR-2021 17:00, the subject experienced chills. On 25-MAR-2021 17:00, the subject experienced fever. On 25-MAR-2021 17:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, body ache, chills, fever, and headache on 27-MAR-2021. This report was non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Blood pressure increased, Cerebrovascular accident, Hypertension
Clinical narrative: Suspected stroke; Bell's palsy; High BP; A spontaneous report was received from a healthcare professional concerning a 48-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bell's palsy, suspected stroke, and high blood pressure.    The patient's medical history, as provided by the reporter, included hypertension.  The patient stopped taking hypertension medications since Aug-2020.The concomitant product use was not provided/unknown by the reporter.      On 16 Feb 2021, approximately 9 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 004M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 16 Feb 2021, approximately 9 hours of receiving vaccine, the patient developed left ear fullness/pain/pressure. On 17 Feb 2021, the patient developed left eye watery and pain behind left ear. On 18 Feb 2021, the patient dribbled when drinking water when working overnight shift. On 19 Feb 2021, upon awakening in the afternoon, patient's speech was "off" and noted left side of face drooped and unable to close left eye. The patient went to Urgent care and referred to ED for suspected stroke due to High blood pressure. The patient was diagnosed with bell's palsy. Treatment for the vent included steroids, eye ointment and metoprolol.  Action taken with the drug in response to the event was not provided  The outcome of the events, bell's palsy, suspected stroke, and high blood pressure, were not resolved.; 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.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-026086:Same reporter
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Facial pain, Feeling abnormal, Hypoaesthesia, Neck pain
Clinical narrative: Feel tingling feeling on left nose; Continued pain at site of injection; arm numb; ears numb; Bell's Palsy; Left arm (injection arm) went numb; "Charley" horse like pain in left neck; Charley" horse like pain in left face; Tingling feeling on left ear; Tingling feeling on left face; Felt exhausted; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Bell's Palsy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hormone replacement therapy. Concurrent medical conditions included Asthma.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced HYPOAESTHESIA (Left arm (injection arm) went numb), NECK PAIN ("Charley" horse like pain in left neck), FACIAL PAIN (Charley" horse like pain in left face), PARAESTHESIA EAR (Tingling feeling on left ear), PARAESTHESIA (Tingling feeling on left face), FEELING ABNORMAL (Felt exhausted), HYPOAESTHESIA (arm numb) and PARAESTHESIA EAR (ears numb). On 13-Mar-2021, the patient experienced VACCINATION SITE PAIN (Continued pain at site of injection). On 14-Mar-2021, the patient experienced PARAESTHESIA MUCOSAL (Feel tingling feeling on left nose). On an unknown date, the patient experienced FACIAL PARALYSIS (Bell's Palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Bell's Palsy), HYPOAESTHESIA (Left arm (injection arm) went numb), NECK PAIN ("Charley" horse like pain in left neck), PARAESTHESIA EAR (Tingling feeling on left ear), PARAESTHESIA (Tingling feeling on left face), FEELING ABNORMAL (Felt exhausted), PARAESTHESIA MUCOSAL (Feel tingling feeling on left nose), HYPOAESTHESIA (arm numb), PARAESTHESIA EAR (ears numb) and VACCINATION SITE PAIN (Continued pain at site of injection) outcome was unknown and FACIAL PAIN (Charley" horse like pain in left face) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment included Tylenol, Benadryl and Prednisone.  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.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Event Bell's Palsy was diagnosed.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia ear, Paraesthesia mucosal, Vaccination site pain
Clinical narrative: Feel tingling feeling on left nose; Continued pain at site of injection; arm numb; ears numb; Bell's Palsy; Left arm (injection arm) went numb; "Charley" horse like pain in left neck; Charley" horse like pain in left face; Tingling feeling on left ear; Tingling feeling on left face; Felt exhausted; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Bell's Palsy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hormone replacement therapy. Concurrent medical conditions included Asthma.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced HYPOAESTHESIA (Left arm (injection arm) went numb), NECK PAIN ("Charley" horse like pain in left neck), FACIAL PAIN (Charley" horse like pain in left face), PARAESTHESIA EAR (Tingling feeling on left ear), PARAESTHESIA (Tingling feeling on left face), FEELING ABNORMAL (Felt exhausted), HYPOAESTHESIA (arm numb) and PARAESTHESIA EAR (ears numb). On 13-Mar-2021, the patient experienced VACCINATION SITE PAIN (Continued pain at site of injection). On 14-Mar-2021, the patient experienced PARAESTHESIA MUCOSAL (Feel tingling feeling on left nose). On an unknown date, the patient experienced FACIAL PARALYSIS (Bell's Palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Bell's Palsy), HYPOAESTHESIA (Left arm (injection arm) went numb), NECK PAIN ("Charley" horse like pain in left neck), PARAESTHESIA EAR (Tingling feeling on left ear), PARAESTHESIA (Tingling feeling on left face), FEELING ABNORMAL (Felt exhausted), PARAESTHESIA MUCOSAL (Feel tingling feeling on left nose), HYPOAESTHESIA (arm numb), PARAESTHESIA EAR (ears numb) and VACCINATION SITE PAIN (Continued pain at site of injection) outcome was unknown and FACIAL PAIN (Charley" horse like pain in left face) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment included Tylenol, Benadryl and Prednisone.  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.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Event Bell's Palsy was diagnosed.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Pyrexia, Seizure
Clinical narrative: passed out; seizure; fever; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) and SEIZURE (seizure) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No relevant medical history provided.).   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), SEIZURE (seizure) (seriousness criterion medically significant) and PYREXIA (fever). On 10-Mar-2021, LOSS OF CONSCIOUSNESS (passed out) and SEIZURE (seizure) had resolved. At the time of the report, PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  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   This case was linked to US-MODERNATX, INC.-MOD-2021-072687 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested US-MODERNATX, INC.-MOD-2021-072687:1st dose vaccine
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: bell's palsy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (bell's palsy) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced FACIAL PARALYSIS (bell's palsy) (seriousness criteria medically significant and intervention required). At the time of the report, FACIAL PARALYSIS (bell's palsy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Products known to have been used by patient, within two weeks prior to the event, included cholesterol and blood pressure medications. Patient received his 1st dose of Moderna on 18Mar2021 and on 22Mar2021 he started having bell's palsy. He went to ER. Treatment included steroids.  Patient was concerned regarding his second shot of Moderna vaccine which is due on 14Apr2021.  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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Syncope, Vomiting
Clinical narrative: Fainted; Vomiting; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No Reported Medical event).    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), VOMITING (Vomiting) and NAUSEA (Nausea). At the time of the report, SYNCOPE (Fainted), VOMITING (Vomiting) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.; Sender's Comments: This case concerns a 22-year-old female with a serious unexpected event of syncope and nonserious expected nausea and vomiting. Event onset 3 days after 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: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Measles, Rash
Clinical narrative: his wife says it's like measles; everything the doctors gave him made it worse; a rash that spread to all over his body/around his back/around his neck/around his head; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MEASLES (his wife says it's like measles) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included TAMSULOSIN for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MEASLES (his wife says it's like measles) (seriousness criterion medically significant), CONDITION AGGRAVATED (everything the doctors gave him made it worse) and RASH (a rash that spread to all over his body/around his back/around his neck/around his head). At the time of the report, MEASLES (his wife says it's like measles), CONDITION AGGRAVATED (everything the doctors gave him made it worse) and RASH (a rash that spread to all over his body/around his back/around his neck/around his head) outcome was unknown.            The patient received the 1st dose of vaccine 3 weeks before 2nd dose and 2nd dose a few weeks ago. Treatment included unspecified antibiotics and steroid creams.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Hypersomnia, Pyrexia, Syncope
Clinical narrative: Patient fainted / 3 episodes of fainting attack; Feeling bad; Headache; High fever; Vomiting episodes; slept for more than 3 hours after the fainting attack; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Patient fainted / 3 episodes of fainting attack) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 57A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced SYNCOPE (Patient fainted / 3 episodes of fainting attack) (seriousness criterion medically significant), FEELING ABNORMAL (Feeling bad), HEADACHE (Headache), PYREXIA (High fever), VOMITING (Vomiting episodes) and HYPERSOMNIA (slept for more than 3 hours after the fainting attack). At the time of the report, SYNCOPE (Patient fainted / 3 episodes of fainting attack), FEELING ABNORMAL (Feeling bad), HEADACHE (Headache), PYREXIA (High fever), VOMITING (Vomiting episodes) and HYPERSOMNIA (slept for more than 3 hours after the fainting attack) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   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.   This case was linked to US-MODERNATX, INC.-MOD-2021-073768 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-073768:linked case