chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came down with a rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Patient came down with a rash) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     The medical history was unknown.     On 04-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 13-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced RASH (Patient came down with a rash). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH (Patient came down with a rash) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications was reported.  Dose of suspect Moderna Bivalent was reported as Booster. Patient went to the doctor and was prescribed antihistamine Zyrtec but currently rash was still persistent. Patient mentioned appointment was scheduled to see a doctor on 17-MAR-2023.   Reporter did not allow further contact
patient was inadvertently administered an expired Twinrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 30-year-old female patient who received HAB (Twinrix) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   On 05-OCT-2023, the patient received Twinrix. On 05-OCT-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: patient was inadvertently administered an expired Twinrix).The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-OCT-2023 The reporter called to inquire if this dose was valid. The reporter reported that a patient was inadvertently administered an expired Twinrix, which led to expired vaccine used. The reporter did not consent to follow-up.
Moderna COVID-19 Vaccine EUA Full body aches, head aches, fever over 100 degrees, sweats and chills, nausea
I accidentally gave a five-year-old the 6m-4y first dose of the Pfizer. There was no adverse reaction or harm to the patient.
on 4/1/21 5 hours after 2nd vaccine, pt experienced rash on his arm discomfort in the arms, back and legs.  on 4/2/21 The following day he reported temp 101.7 and tachycardia prompting ER eval.  ER believed to be related to anxiety.  on 4/5/21 he described "out of body experience" on 4/9/21 went to ER for fever, CXR showed possible pneumonia, treated with Zpak on 4/12/21 tunnel  vision on the left.  numbness of the L eyebrow, forehead and superior orbit Admitted 4/15/21-4/22/21 for cranial nerve palsy, blurred vision L eye, afferent pupillary defect on 4/20/21 lumbar puncture performed, 2 oligoclonal bands seen, otherwise normal.  Treated with high dose methylprednisolone x 3days without improvement.   4/22/21 visual evoked potential test second trial showed abnormal pattern on the left MRV, CT, MRI brain no abnormality 4/24/-5/4/21 admitted for L vision loss, severe neck, back pain, weakness, difficulty walking.  OCT ellipsoid zone loss possible autoimmune process, decreased corneal sensation on the left.  OS 20/50.    pt continues to have L vision loss, R bells palsy, difficulty ambulating. Now reports trouble swallowing.
less appetite; eye pain; changes in taste a little bit; discomfort in his eyes/dry eyes; discomfort in his eyes/dry eyes; has an inconsistent bad taste in his mouth and describes as tasting like gasoline.; slept for 11 hours; really tired; have some sensory issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the parent.  A 9 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) at the age of 9 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DECREASED APPETITE (non-serious) with onset Nov2021, outcome "unknown", described as "less appetite"; EYE PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "eye pain"; TASTE DISORDER (non-serious) with onset Nov2021, outcome "unknown", described as "changes in taste a little bit"; OCULAR DISCOMFORT (non-serious), DRY EYE (non-serious) all with onset Nov2021, outcome "unknown" and all described as "discomfort in his eyes/dry eyes"; DYSGEUSIA (non-serious) with onset Nov2021, outcome "unknown", described as "has an inconsistent bad taste in his mouth and describes as tasting like gasoline."; HYPERSOMNIA (non-serious) with onset Nov2021, outcome "unknown", described as "slept for 11 hours"; FATIGUE (non-serious) with onset Nov2021, outcome "unknown", described as "really tired"; SENSORY DISTURBANCE (non-serious) with onset Nov2021, outcome "unknown", described as "have some sensory issues".  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Her daughter called and stated that she "had a baseball sized lump in her arm" and it was warm to the touch and extremely red. She also stated that "she was having trouble moving the arm at all."
Fever, seizure, admitted to hospital. H&P:questionable seizure with episode of eye movement up/down/side/side, limp body, lasting 1-1.5 minutes followed by approximately 20 minutes of somulence. Per parents since birth infant has had episodes of "blank staring" more prominent within last month as patient achieved milestones, will stop and stare. More prominent around the time of sleep/wake. Usual frequency daily or every other day. Prior to ER visit scheduled for outpatient EEG. Family HX of cousin with epilepsy. H&P:questionable seizure with episode of eye movement up/down/side/side, limp body, lasting 1-1.5 minutes followed by approximately 20 minutes of somulence. Per parents since birth infant has had episodes of "blank staring" more prominent within last month as patient achieved milestones, will stop and stare. More prominent around the time of sleep/wake. Usual frequency daily or every other day. Prior to ER visit scheduled for outpatient EEG. Family HX of cousin with epilepsy. DC DX: Spell, unclear etiology, unlikely seizures.
Extremely heavy period  bleeding started on February 20th out of no where. Bleeding contained big clots and was very heavy. Went to my GYN on March 15th who prescribed a five day supply of Tranexamic acid. On March 20th, my bleeding finally stopped.
pain; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain) and PYREXIA (fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN (pain) and PYREXIA (fever). At the time of the report, PAIN (pain) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided. The reporter did not provide an assessment for the events, fever and pain.
Right arm where vaccine was given was swollen and red and slightly warm to the touch. Pt said it was sore and difficult to move. She could also feel the soreness up her right neck.
I was at work and my arm started feeling very sore. It started hurting. By the time I got home from work, my body was starting to ache. It progressively got worse to where I couldn't do anything. It was like everything hurt and I was like that for 3 days. I was a little bit better for about 3 weeks and it started all over again. It was to the point that I would go to work, come home, sleep, get up in the morning, get dressed, go back to bed, and then finally go to work. My legs, feet, ankles, knees all hurt. I could barely walk. I have a high pain tolerance. I was putting something in the refrigerator and got on my knees and starting sobbing because it hurt so much. I went to the doctor and they had me take some Tylenol and Aleve. It didn't help. Then my feet were swelling so bad that they were huge. I went back to the doctor and they ended up doing some blood work. They ended up testing me for rheumatoid arthritis and my numbers were very high. Now I have to see a rheumatoid arthritis doctor and he has me on some medicine. They had to put me on steroids to bring all the swelling down. It is somewhat manageable now, but it still hurts. I was in so much pain that I almost went to the ER, but I never did.
Shortly after my first dose of Moderna on 3/13, I experienced a constant ringing in both ears, very noticeable during the daytime and when trying to sleep. I also experienced some dizziness / mild vertigo that still comes and goes. After my second dose on 4/13, the ringing has become much louder, so I did research and learned this is a common side effect. I also have pulsating / throbbing in both ears. I had no other side effects with dose #1, but experienced extreme chills, aches and fever (101.3) for two days following dose #2. Both my husband and son had two doses of the Pfizer vaccine and had none of these side effects (good for them, unlucky for me!).
Redness and swelling to left arm around site of injection starting the evening after vaccine received. Fevers, and pain associated
sore throat; waist pain; fever up to 101.4F; fatigue; started feeling bad; headache; pain in the arm of the injection and under her arm: ¨it was hard to raise my hand¨; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (started feeling bad), OROPHARYNGEAL PAIN (sore throat), PAIN (waist pain), HEADACHE (headache) and VACCINATION SITE PAIN (pain in the arm of the injection and under her arm: ¨it was hard to raise my hand¨) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid cancer. Concurrent medical conditions included Breast cyst. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced FEELING ABNORMAL (started feeling bad), HEADACHE (headache) and VACCINATION SITE PAIN (pain in the arm of the injection and under her arm: ¨it was hard to raise my hand¨). On 10-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), PAIN (waist pain), PYREXIA (fever up to 101.4F) and FATIGUE (fatigue). At the time of the report, FEELING ABNORMAL (started feeling bad), OROPHARYNGEAL PAIN (sore throat), PAIN (waist pain), HEADACHE (headache), VACCINATION SITE PAIN (pain in the arm of the injection and under her arm: ¨it was hard to raise my hand¨), PYREXIA (fever up to 101.4F) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Body temperature: 101.4 (High) Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took Tylenol from 12-Apr-2021. Second dose is scheduled for 30-Apr-2021.
A child who did not recv vax but was exposed to children who were vaccinated w/varicella devel zoster;
After the first vaccine next day at 9:00am I have shooting headache,severe pounding in my ear. I told my wife (physician) what happened she recommended me to go toER. I went to ER they thought I had a stroke,CT scan diagnosed with subarachnoid bleeding. I was transferred to another hospital  1 day had another CT scan, MRI Scan and was seen by a Neurosurgeon. I was told I have a revolving bleeding in my brain,  loss sensation right side and  double vision. I'm scheduled for Cerebral Angiogram in Feb.
COVID vaccine breakthrough case. Moderna 3/24/21 047A21A, 4/21/21 040B21A and boosted Pfizer 2/11/22 FD2718, 11/4/22 GJ3275
I woke up with chills, very cold that day, I could not breath, my lungs were very painful, pain on all my joints, my eyes were sensitive to the sun. No fever or any other symptoms coughing (no cough, no running nose).  On the 2nd day the chills were gone, but I still had a lot of trouble in breathing, joints still hurt, and the lung hurt. On the 4th day I went to the doctor, and they took chest Xray, the Xray did not showed anything, I thought it was a virus and not a bacteria, they took a nose swab and throat swab, and they did a culture for bacteria and not for a virus. One week later the pain on my joints were gone, I still had difficulty breathing, but it was getting better, after 2 weeks the pain on the lungs were gone. They did not give me any prescription.
Itchy, red, swollen circular bump at injection site appeared almost 7 days following the vaccine.
The pt developed right leg numbness (knee to the foot) that progressed to muscle spasms, twitches and abnormal movements within 24-48 hours after the first dose of the Pfizer COVID-19 vaccine.
Pfizer booster, 3rd shot; Pfizer booster, 3rd shot; a blood pressure of above 200/it was from 150 to 180 to 190; heart palpitation; This is a spontaneous report from contactable consumer (patient). A 76-year-old female patient received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on 02Oct2021 (Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation at age of 76-year-old. The patient's medical history and concomitant medications were not reported. The patient had her first dose of bnt162b2 and experienced sore arm and had second dose of bnt162b2 and was fine. The patient had COVID 19 vaccine on 02Oct2021 (Saturday) and on Sunday (03Oct2021), she needed to go to the Emergency Room (ER) for heart palpitation and a blood pressure of above 200. Her 1st and 2nd were fine so she assumed her 3rd would be. Patient stated that yesterday (03Oct2021) when she got up, she was laying there and got up for decaf coffee and went back to bed. Patient stated she had a little thumping, palpitations and what not and she said this was very strange and she had a blood pressure machine they gave her husband and she checked her blood pressure. Patient stated her blood pressure was high and higher and she called the nurse line on the card and they advised her to go to the ER as it was from 150 to 180 to 190 whatever. Patient relayed at the hospital it was 200 and she was getting palpitations and they did all kinds of tests. Patient stated she knows it's the vaccine and she doesn't take medication for blood pressure and her blood pressure is fine until the shot and now it's not. Patient stated they couldn't confirm it was or wasn't and they checked her with EKG, chest x-ray, bloodwork and blood pressure. Patient stated that today (04Oct2021) it was 129 which was a normal blood pressure. Patient stated she knew it was the vaccine she just knew it; she had had nothing like that in her entire life. Outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Very sore arm; rash from shoulder to elbow around injection site; slightly raised and very warm
Headache, Myalgia, NauseaVomiting & Angina Narrative:  N/A
2-3cm area of erythema - right deltoid, warm to touch, tender, vomiting, diarrhea, headache, ice and Benadryl for treatment.
Itchy hot skin at sight of injection and on both arms, hands and left shoulder  turning into  itchy spots with a scab in the middle.  Started early morning after two days.  Less itchy but still apparent.  Also top of head itchy.
11SEP93 fatigue, vomiting; 12SEP-16SEP photophobia-noc sweats, swollen glands; all joints stiff exp spine; extreme fatigue sl cough; sx improved sl each day; personal MD prescribed Advil & PDH;
Almost 4 weeks from the day of vaccination my left knee swollen up, warm hot to the touch, no fever, but unable to do daily activities.
During summer of 2008, patient had many episodes of anxiety which she never had before, she also is more easily confused;                   9/30/08 Dr visit for side pains, and sore neck, 2nd dose of gardasil given at this visit; 10/28/08 Dr visit for dizziness, headaches and stomach pain, Dr attributed to gas, and rec increase fluids, and tylenol; 11/11/08 Dr visit for muscle pain, near inability to walk, inability to raise arms, stomach pain, back pain, tingling, vibrating sensation of extremities, Dr rec continue Ibuprofen or aleve daily; symptoms slightly resolved for a short time; 3/26/09 Dr visit with another doctor in practice- gained 10 lbs in fluids, severe ankle swelling numbness and tingling of feet, had been having nightly fevers for 10 days prior, legs and arms go numb when "crossed" for a few seconds, these symptoms have gotten better for now, she does still have headaches, dizziness and lightheadedness.  5/4/09 Received PCP medical records of 10/19/07-3/26/2009. FINAL DX: polymyositis Records reveal patient experienced usual state of good health on 10/19/07 when received HPV & Menactra. RTC 2/9/08 w/sore throat x 2 days, fever x 1 day, nasal congestion & fatigue.  Dx w/strep throat & tx w/IM antibiotics.  RTC 4/18/08 w/fever & sore throat x 2 days.  Dx w/laryngitis/croup.  RTC 10/28/08 w/dizziness, HA, stomach pains, low grade fever, hoarseness & cough x 2-3 days.  Dx viral laryngitis & URI.  RTC 11/11 w/muscle pain & tingling x 2-3 wks.  Dx w/myalgias & paresthesias.  Referred to Neuro.  RTC 1/14/09 w/resolved polymyositis. RTC 3/16/09 w/pharyngitis.  RTC w/ bilateral ankle swelling, possible facial edema, malaise, tonsillitis.  Labs done but were unrevealing.
subjective fever (tm 99.5), body aches, nausea, chills, headache, listless - lasted two days - slept 14 hours evening of vaccine (usually sleep 6 hours)
sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm).   On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was on  regular blood pressure medications (unspecified).   This case was linked to US-MODERNATX, INC.-MOD-2021-081481 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081481:
CLIENT RECEIVED (PEDS) PEDIATRIC PFIZER DOSE OF 0.2ML AT 12YO. CLIENT SHOULD'VE RECEIVED THE GRAY CAP FORMULATION OF 0.3ML.
5th DTaP-developed swelling, erythema, warmth, firmness and tenderness a day after immunization. Swelling and erythema to.
This spontaneous report was received from a Medical Assistant referring to an unspecified number of patients of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not provided. On an unknown date, since 26-OCT-2015, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # L016427 expiration date: 13-APR-2017 and lot# "K022265" expiration date: 22-OCT-2016  (administration route was not provided). No concomitant therapies were reported, neither was any adverse effect. This is one of several reports from the same reporter. Additional information has been requested.
Hospitalized 7/6/22-7/12/22 Foot pain,  cough, bronchitis, afib, diarrhea, tachycardia, UTI, abdominal wound
little soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little soreness in her arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 042B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (little soreness in her arm). At the time of the report, PAIN IN EXTREMITY (little soreness in her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and 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.   No concomitant medication details were provided. No treatment medication details were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-078301 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078301:second dose case
Saturation down to 84%; Temperature of 101.3; Rapid pulse having some difficulty; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) via an unspecified route of administration, on 30Dec2020, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The reporter is working in long term in Nursing care facility. It was reported that they have a resident who recovered from COVID. They are having some questions following the guidelines stuff, just kind of asking some more questions. Just one of their resident had temperature of 101.3, saturation down to 84%, 'frustration' at 24% and rapid pulse having some difficulty. The patient was put in her bed. The reporter contacted the doctor in house. 'The reporter wanted to see if any of the recommendation were for (incomplete sentence). The long term care facilities recovered COVID, the reporter wanted to know any of the lasting short term and any guideline for treating. They were all recovered COVID, all of two of the resident two weeks or more out and we (Further clarification was unknown) just had the vaccine yesterday' (as reported, pending clarification). Outcome of the events was unknown.  Information on the batch number has been requested.
Had a stroke due to blood clot on 12/7/22. Was treated at Hospital then transferred to Hospital for observation.