chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She has not slept since she got shingles; it is too painful for her to turn from side to side.; she has a rash on her back that was painful; Shingles; her skin was sensitive; headache; fever; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received second dose of bnt162b2 (Pfizer Covid vaccine, Solution for injection, Batch/lot number: EN6200, Expiration date: Unknown), via an intramuscular route in the upper right arm on 03Mar2021 at 13:30 (age at vaccination: 70-year-old), as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer Covid vaccine, Solution for injection, Batch/Lot number: Unknown, Expiration date: Unknown), via an intramuscular route in the right arm on 10Feb2021 at 13:30 (age at vaccination: 70-year-old), as a single dose for covid-19 immunization. She did not take any prescription medication and was healthy before the second dose of her Covid vaccine. On 03Mar2021, patient experienced fever which started on the same evening of receiving the second dose of the covid vaccine. Her fever resolved, and it stayed resolved. But then she had a fever of 100 like two days ago. She writes in a diary every day. She noticed headache either the day she received the second dose of the Covid vaccine 03Mar2021, or the next day 04Mar2021. She thinks that she only had a headache on 03Mar2021 and 04Mar2021. She did not worry about having a headache, because people told her that she can expect that. She wrote down in her diary on 04Mar2021, that she has a headache, and her skin was sensitive. She believes that she noticed the beginning of a rash on 05Mar2021. On 05Mar2021, she wrote down that she has a rash on her back that was painful, and she thinks it could be shingles. On 06Mar2021, she knew she had shingles and went to the urgent care on 06Mar2021, because she was in so much pain. She believes that the Covid vaccine was what caused her shingles. This has been going on for 2 weeks. She has not slept since she got shingles, it was too painful for her to turn from side to side. Her skin was so sensitive, and it hurts so bad that she wants to cry every day. Her doctor from home prescribed her a nerve pain killer that people took for shingles, but she doesn't think it has helped at all. She was also on an anti-viral drug. Her fever may be related to the drug she is having to take for her shingles. She had a fever but today she does not. The patient underwent lab test and procedure which included body temperature of 100. The clinical outcome of headache was resolved, shingles has gotten worse; and fever, skin was sensitive, rash on her back, she has not slept since she got shingles, it was too painful for her to turn from side to side was unknown.  No follow-up attempts are possible. No further information is expected.
This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 43-year-old, adult, female patient. The patient had no relevant medical history. The patient was not taking any medication at the time of vaccination. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 1.5 ml instead of 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252235, expiry date: 30-Jun-2019]. At the time of this report, no adverse events were reported. This case: 201804672 was cross-linked to the source case: 201804657 reported by the same reporter.
Sore arm. Pt. feels like he can't lift his arm. He saw his doctor today about it and the dr gave him a muscle relaxer.
Warm, red, wollen, patient could not lift or move left arm, Right arm very warm, had 5 red dots.
Decreased appetite and activity. Sleeping more. Injection area on Left thigh slightly swollen.
Rash that covered her whole right side of her thigh and the back of that leg.  She noticed this rash in the evening when getting ready for bed. This rash did not itch, was not warm, or bother her in any other way. She called me on Monday 9/6 and let me know. She also said that it was almost gone at that point
Headache  Muscle pain Chills Fever 100.8 Fever 103.4 Nausea Swollen lymph nodes  Night sweats  Took Tylenol which helped some
Per patient report via email: fever, wheezing, headaches, eye twitches, severe joint pain, tingling in feet, dizzy, nauseated.
Fever,  body aches,  sight auras,  early unscheduled menstrual cycle - heavy bleeding
PT REPORTED REDNESS AROUND THE INJECTION SITE THE MORNING AFTER VACCINE RECEIVED. IT BECAME TENDER AND WARM TO THE TOUCH. SHE BELIEVES IT IS GETTING WORSE. ADVISED HER TO TAKE SOME BENADRYL AND IF IT DOES NOT IMPROVE OR BECOMES WORSE TO CONTACT HER PCP.
DTaP given in (L) upper arm on 8/15 - within x1 days area for (L) elbow to shoulder was red, warm, tender to touch/swollen. By day 3 arm looking better - area 2-3 in diameter redness and 8/20 quarter size area. By 8/22 area resolved. Rx'ed with Ibuprofen and cool compresses.
Pt. states that after receiving the 3rd dose of Moderna 01/12/2022, started experiencing symptoms 01/19/2022 of rash developing throughout the torso and back. Urgent Care visit 01/29/2022, diagnosed with Shingles. Follow-Up with Prednisone and Primary visit 02/01/2022. Shingles rash with nerve pain still remain.
Patient complained of severe swelling and bruising on arm of injection site. Pain. fever & nausea & vomiting for first 2 days. Improving slowly after 3 days. Still has swelling.
Headache, Myalgia & Fever Narrative: low-grade fever (most recently 99.9), alternating chills and sweats, fatigue and headache. significant pain at the injection site limiting movement of left arm.
Had the normal side effects 24 hrs of chills and flu like symptoms. Alarming is a 3 weeks later, I am experiencing horrible chest pains, crushing chest etc.. have been in the emergency room twice.
Rash on buttocks and trunk, runny nose/sinus congestion, conjunctivitis in left eye, fever, irritability, lack of appetite.
About 10 minutes after I took my shot I began to feel light headed. I decided to go get some breakfast since it was close and I felt I may have needed food on my stomach. In the line waiting on my food I began to cough uncontrollably. That was about 15 minutes after the shot. Even though I looked pale in line after the shot.  I was let go before the full time to wait.  I went home and could not eat as I did try to bite into a chicken biscuit. I laid down. In about an hour after shot I was very cold and still coughing. I had on a weighted blanket and a heated blanket on top of that. Still cold. Around 11 am I tried to get up and go to the bathroom. I began to coughing even more as I sat up. At  that point I felt as it was very hard for me to breathe.  I coughed even more and began to throw up. At that point I was taken to the hospital.
Rapid, pounding heart rate with onset around 10 pm the day of vaccination that recurred nightly thereafter, and intermittently during the day. Chest pressure and mild discomfort with occasional pangs of sharp pain. Increased fatigue and slight dizziness that was intermittent. Went to ER on Saturday following Tuesday vaccination since the symptoms were persisting, though not necessarily worsening. Abnormal blood tests that suggested mild, acute pericarditis. Doctor discharged me same night with a prescription for aspirin, colchicine, and pantoprazole and referral for follow-up with cardiologist.
First day - debilitating chills, fever, sweats, weakness Day 7 started experiencing light sensitvity, loss of central vision, dizzyness, headache Note: I have never had anything like this happen before (not prone to migraines etc.)  Now in Day 13 and still have headaches light headedness and sensitivity to heat and light
Pt. developed red, papular, urticarial-like lesions to L thigh.  Benadryl administered and pt. monitored for 20 mins. - no other adverse effects noted.  Left office in NAD.
Waited the required 15 minutes. got to my car and drove one block.  suddenly confused so stopped  vehicle along a side street (I believe I had a TIA.) and didn't know my way home for only a couple of minutes. Within minutes recovered and drove on home.  Not sure if this vaccine was the cause ( I have  had a couple of TIAs many years ago)   Not sure if I should get a second shot, it it is safe for me
flutters; palpitations; heartrate accelerated which was alarming and startling; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ATRIAL FLUTTER (flutters), PALPITATIONS (palpitations) and HEART RATE INCREASED (heartrate accelerated which was alarming and startling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot #010M20A) for COVID-19 vaccination.     Concomitant products included ATENOLOL for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 31-Jan-2021, the patient experienced ATRIAL FLUTTER (flutters), PALPITATIONS (palpitations) and HEART RATE INCREASED (heartrate accelerated which was alarming and startling). At the time of the report, PAIN IN EXTREMITY (sore arm), ATRIAL FLUTTER (flutters), PALPITATIONS (palpitations) and HEART RATE INCREASED (heartrate accelerated which was alarming and startling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by reporter.   Reporter did not allow further contact
Headache, fatigue, heart/chest pressure is most disturbing. Took Tylenol for headache at 1:00p
18 year old patient was given a 5-11 year old dose of Pfizer as their second vaccine in the series. Looked up on the FDA website of what to do, and states to give an additional dose of the age appropriate vaccine immediately. The patient above received the correct dose of Pfizer at 0.3mL to complete the series. No adverse effects happened.
This literature marketed report was received from the authors of the literature article. The authors conducted a retrospective cohort study among the patients of unknown age (reported as "older"), with autoimmune or inflammatory (AI) diseases, including rheumatoid arthritis (RA), ankylosing spondylitis (AS), inflammatory bowel disease (IBD), psoriasis, and psoriatic arthritis (PsA), using 2006-2013 insurance data. The aim of the study was to evaluate the duration of herpes zoster (HZ) vaccine (manufacturer unknown) effectiveness. The vaccinated cohort consisted of 59627 patients. 53.1% of the patients had RA, 1.4% had AS, 20.9% had IBD, 31.6% had psoriasis and 4.7% had PsA. 11.0% of the patients used biological drugs prior to index date, 46.1% used disease-modifying antirheumatic drugs (DMARD). 14.0% used unspecified glucocorticoids at the dose lower than 7.5 mg/day, 2.5% used them at the dose higher or equal to 7.5 mg/day and 83.5% of the patients did not use them at all. Upon evaluation of potential confounders, 26.7% of the patients had diabetes, 24.9% had chronic obstructive pulmonary disease (COPD), 10.4% had renal disease, 11.3% and heart failure, 44.8% had outpatient infection during baseline, 50.7% used narcotics, 27.7% used unspecified antidepressants and 21.8% used unspecified nonsteroidal antiinflammatory drugs (NSAID). On unknown dates, the patients were vaccinated with a dose of  zoster vaccine live (manufacturer unknown) (dose, route of administration, lot # and expiry date were not reported) for prophylaxis. To understand long term effectiveness and avoid misclassification related to healthcare associated with vaccine administration, follow-up started from 30 days after the vaccination date or corresponding calendar date in the matched cohort, and ended at the earliest of first HZ, death, loss of coverage, or 31-DEC-2013. Matched patients were censored if they were subsequently vaccinated, and then included in the vaccination group and re-matched. The maximum follow up time was 7 years post-vaccination. HZ was diagnosed using an International Classification of Diseases, 9th (ICD-9) inpatient diagnosis code alone or an outpatient diagnosis code plus antiviral medication (famciclovir, acyclovir, valacyclovir) within 7 days of HZ diagnosis. This report refers to 225 patients who, on unknown dates, developed HZ in the 3rd year after the vaccination (considered as lack of efficacy). The authors concluded that the duration of HZ vaccine (manufacturer unknown) effectiveness waned over about 5 years among older patients with AI conditions, many of whom were treated with immunosuppressive and immunomodulatory agents. This is one of several reports from the same literature article (cross-referenced with MARRS # 1703USA010321, 1703USA010592, 1703USA010594, 1703USA010595, 1703USA010596, 1703USA010597). Additional information has been requested. Sender's Comments:  US-009507513-1703USA010321.
MOP reports 4 yo son received routine vaccines on 5/29/2018. KINRIX IM to left thigh and MMRV (PROQUAD) to right thigh. That evening his left thigh began to turn red about vaccine site and increased to quarter size. By Wednesday (5/30) it site had a 1-2 inch red circle, Thursday 5/31 there was about a 4 inch circle about vaccine site. She contacted Immunization Clinic who recommended she take her son to ER where HCP dx cellulitis vs normal site reaction. As a precaution, they began Keflex x 10 days. Mom follow up with HCP on 6/1/2018 and reports marked improvement of site reaction. Mom advised today 6/4 the redness has resolved with a red spot at vaccine site that appears to be scabbing over (child scratching site). She states he did not have any fever or any other systemic reactions and had full use of both legs. No site reaction reported to right thigh MMRV vaccine site.
3/4/21 - day after shot, golf ball size knot, soreness in right arm 3/12/21 - red, itchy injection site, swelling  and warm
Multiple hives all over body approximately 9 hours after injection - diphenhydramine 25mg taken with resolution by following morning
had a rash appear at the bends of both of my arms.; The rash started out as small red dots and then turned into a pink/red blotch; This is a spontaneous report received from contactable reporter (Consumer or other non-HCP). The reporter is the patient reporting for herself.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 (Lot number: EW0182) as dose 1, single and administered in arm left, administration date 12May2021 (Lot number: EW0172) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Prilosec, reaction(s): "known allergies: Prilosec"; Zantac, reaction(s): "known allergies: Zantac". The following information was reported: RASH (non-serious) with onset 23Apr2021, outcome "not recovered", described as "had a rash appear at the bends of both of my arms."; RASH MACULAR (non-serious) with onset 23Apr2021, outcome "not recovered", described as "The rash started out as small red dots and then turned into a pink/red blotch". The events "had a rash appear at the bends of both of my arms." and "the rash started out as small red dots and then turned into a pink/red blotch" were evaluated at the physician office visit. Therapeutic measures were taken as a result of rash, rash macular.  Additional information: Facility type vaccine was Hospital. Other vaccine in four weeks was None. Other medications in two weeks were None. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. Adverse event: A couple days after receiving her 1st vaccine, she had a rash appear at the bends of both of her arms. The rash started out as small red dots and then turned into a pink/red blotch. She was still dealing with this rash and have never had anything like this before. Adverse event start date: 07Nov2021. Adverse event start date: 23Apr2021. The patient received treatment for adverse events with OTC anti-fungal cream.  Follow-up attempts completed. No further information expected.
NauseaVomiting & HYPERtension Narrative:  Nausea, resolved quickly BP 141/91 P 72 R 18 O2 SAT 97% RA, after 10 min in recliner resolved BP 127/82 P 77 R 18 O2 SAT 97% RA  Other Relevant History:
On Sunday 1/3 noted a few spots on the left arm, some by the sit other not, that had a hive appearance and itched.  These went away and on Monday noted a few more spots on the right arm resolved the next day
Patient came to pharmacy.  Her left arm was inflamed, red, painful (according to patient) and has blisters.
Hive like rash on neck. No treatment. Rash persistent for 7 days now. Seems to be spreading.
Double vision,can no longer see with both eyes open- I realize this will be written off as a diabetic thing but no, this has never happened before
A report was received from a healthcare professional on 3 November 2003 concerning a vaccinee of unspecified demography who experienced severe headache, malaise and bodyache an unspecified length of time after receiving Fluvirin on an unspecified date. On an unspecified date the vaccinee experienced severe headache, malaise and bodyache.  The vaccinee was negative for influenza virus in serum.  The symptoms were relieved with naproxen sodium and ibuprofen.  The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
I fainted around 6:35 am on 4/10/21. This was about 10 mins after I had taken Tylenol because my fever was at 101 and I had a bad headache. My heart was racing and I felt very weak. I was crawling on the floor to try to get my husband because I felt like I couldn't stand. I passed out in the hallway and came to probably 30 seconds later (I'm not sure how long it was, but I think it was only a little while) and was very disoriented. I then got my husband who told me to lay in bed but I felt so weak that I couldn't get off the floor for about a minute. Finally I was able to lay down in bed and I was very sweaty. I slept/laid there for a couple of hours and felt a little better after but had a bad headache until mid afternoon that day.
Information has been received from a physician concerning a 4 year old male with a history of rhinorrhea, drooling, watering eyes, pain in roof of mouth, cough and redness of face after vaccination with Varivax (WAES Report 0703USA03084)  who in approximately 2006 was vaccinated with MMR. Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and poliovirus vaccine. In approximately 2006, the patient sneezed three times and experienced rhinorrhea, drooling and red face with red eyes. The patient was given an injection of diphenhydramine HCl, and his symptoms resolved without further treatment. Subsequently, the patient recovered from sneezed three times, rhinorrhea, drooling, red face and red eyes. The physician thought patient was allergic to gelatin. On an unspecified date, serum IgG to porcine gelatin was elevated, at 2.10 kU/L (class 2). As of 24-JAN-2007, at the age of five years old, the patient has been able to eat beef-derived gelatin for the past year, but has avoided porcine gelatin. Recently, a RAST test to porcine gelatin had fallen to 0.38 (class 1) kU/L. Egg, pork and beef have not demonstrated IgE, either by RAST testing, or by skin testing. As of 13-MAR-2007, the patient's outcome was not reported. Additional information has been requested.
Dark rash appeared on the left side of my face near my lips.  Rash spread to my upper lips, my lips and some spots on my forehead. I treated it as if it was a simple rash with vitamin E and Aleo Vera Gel.  The rash was itchy, flaky and irritating. The rash is still very visible even though I have been using the above items.
Redness; Swelling; Itching; Pain in arm; Heat in arm; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of   in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-003300, US-MODERNATX, INC.-MOD-2021-003306 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021:  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-2021-003300: US-MODERNATX, INC.-MOD-2021-003306:
It started with itching at the injection site 8 days after the injection. The following morning the site was red, inflamed, and hard.
On 6/15/99, the infant developed a low-grade fever and vomiting. That evening, her temperature was 102.4. On 6/18/99, the infant developed loose stools. The infant was seen by a physician and unspecified blood tests were performed. The physician reportedly dx a virus. Tylenol was prescribed.
Administration Error: Pt sated he had not received a covid vaccination prior. He received Pfizer on 6/22 and received an incentive. When data was entered, it was discovered he received a Janssen Vacccine on 3/27/21.
Lightheadedness, dizziness, at first, then joint and muscle pain, fatigue, low fever, nausea, diarrhea. I am a week out and have had previous two days asymptotic, but today, back to dizziness, fatigue, and fever.
This spontaneous report was received from a registered nurse (R.N.) concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 24-SEP-2014, the patient was vaccinated with an improperly stored dose of VAQTA (Lot No. K 001792 Expiration date: 22-OCT-2015) (dose, route, and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.