chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The 1st dose the only adverse was a red and swollen arm, slight temp. Arm swollen/red about 1 week. The 2nd dose about 10 hrs later my entire body all my bones hurt, horrible pain where I had to wrap my body with a warm/hot blanket, it help some and this was through the night, not like flu symptoms. The next morning it a little better but the bones in my hand still hurt and the 3rd finger(right hand)ended up getting stuck while I went to sleep that night had to lift the finger. Waiting and use a splint for about 4-5 weeks and it did not go away, saw on orthopeditic dr who shot of courtesone but it has not helped and now he wants to do surgery. I use a splint at this was never ever a problem
Swollen at red covering forearm.  hot to touch and fever of 100 normal temp for client is reported at 96
Approximately 2 weeks post vax the pt developed two spots at the injection site. Each spot was the size of two pencil erasers put together. The physician felt that the spots at the injection site were related to therapy with varicella virus vaccine live.
This report was received from Pfizer and was assigned manufacturer report number 2015335437 for HUMIRA. This was originally reported by a consumer. This spontaneous report refers to a 61 year old female patient reporting on herself. The patient's concurrent conditions included high blood pressure and angina, both started over ten years ago. Rheumatoid arthritis which was diagnosed in 2006 or 2007 and she started taking ENBREL right away (unspecified date). The patient's medical history included sinus disorder. In approximately 2011 or 2012 (referred as "about three to four years ago"), the patient received a dose of pneumococcal vaccine (manufacturer unknown). The vaccine was purchased with the insurance, and a copay and was given at the doctor's office. Other suspect therapies included methotrexate (manufacturer unknown) which was given to take alone with ENBREL in 2011 (referred as "about four years ago"). Concomitant therapies included prednisone (manufacturer unknown), cortisone (manufacturer unknown) and ENBREL. In approximately 2011 (referred as "about 4 years ago"), the patient experienced bronchitis. Then in approximately 2012 (referred as "about 3 years ago"), she developed asthma because of her "sinuses". In approximately 2013 (referred as "about 2 years ago"), the patient experienced pneumonia. She was in the intensive care unit for two days, and was hospitalized for a total of five days. She completely recovered from the pneumonia on unknown date. A year and a half to 2 years after vaccination (2013 or 2014), her doctor said that she was probably developing rheumatoid arthritis lungs. Since on an unknown date, the patient could not tolerate the methotrexate (manufacturer unknown). It was described as the drug was tearing up her stomach, also described as "building up in her stomach". In approximately 2013, after taking methotrexate (manufacturer unknown) for about two years, the therapy was discontinued and replaced with XELJANZ which worked well for the patient. The patient did not have any pain. On 14-SEP-2015, blood test Hepatitis C: everything was fine. At the time of this report, the outcome of pneumonia and abdominal discomfort was reported as recovered. The outcome of drug intolerance, vaccination failure and rheumatoid arthritis was unknown. The outcome of asthma and bronchitis was reported as ongoing (not recovered). The reporter considered drug intolerance to be related to methotrexate (manufacturer unknown). The responsible physician considered that the events were not related to pneumococcal vaccine (manufacturer unknown). Additional information has been requested.
Started with low grade fever the same day as immunizations. Approx 3 days later pt was transported to facility and then transported by ambulance to hospital where he was dx with complex febrile seizure and viral infection.
mom reports red blotches on body p/vax; pt had red raised areas on feet & hands c/o itching & pain; seen by PA 26JUN given DPH told to get eval by MD; pt seen 5JUL93 by MD then rest of body had bright red rash; MD reported swollen glands;
hair loss started again; completely bald; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 78 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Feb2021 10:00 (Lot number: EL9269) at the age of 77 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Right shoulder reverse rotator", start date: 12May2020 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, Lot Number: EL9261, Left Arm, Onset Date: 06Feb2021 (Hair loss), Onset Time: AM, AE outcome: Not recovered , Treatment:, Dis the event require the initiation of new medication/ Other treatment/ procedure: Yes, If yes, Details:, See Dermatologist OCD), administration date: 20Jan2021, when the patient was 77 years old, for Covid-19 immunization, reaction(s): "hair loss". The following information was reported: ALOPECIA (non-serious) with onset Jul2021, outcome "not recovered", described as "hair loss started again"; ALOPECIA (non-serious) with onset 2021, outcome "not recovered", described as "completely bald". Therapeutic measures were taken as a result of alopecia, alopecia.  Additional information: The patient suffered hair loss after receiving the Pfizer covid vaccine, but her hair grew back some, but then lost it again, and is now completely bald.Her hair loss started again in Jul2021, the Dermatologist have prescribed Vitamin supplements, Rogaine, and scalp massagers twice a day, but none of is doing anything. One of the dermatologist told that the Pfizer Covid vaccine may not cause the hair loss, it may contribute to it.   No follow-up attempts are possible. No further information is expected.
3 minutes seizure. Stiffening and eyes rolled back.  No incontinence.  No measured fever.  Was back to normal in 2-3 minutes. No recurrence.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated for a severe vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Information has been received from a physician concerning two females (age was not reported) who were recently vaccinated intramuscularly with the 3rd 0.5mL dose of Gardasil vaccine. Both patients reported experiencing injection site pain, general body aches and pain that lasted several days after the injection. Patient's received unspecified medical attention. Outcome is not known on either patient at the time of this report. In follow-up it was reported through Merck's Pregnancy Registry and the physician that one of the two patients reported previously was complaining daily of general body aches, nausea and vomiting. It was reported that "they performed blood-work and it turned out the patient was pregnant." The physician reported that he thought the patient's reaction was related to the Gardasil vaccine. The physician also reported that another patient after third dose of Gardasil vaccine had injection pain for 1-2 days (WAES # 0710USA05320). Additional information has been requested.
01/12/22 presents to ED for "Shortness of Breath". PMHx of "T2DM, ESRD s/p renal transplant in 2013"
Child had autoimmune hemolytic anemia 6 weeks after her 6 mos old shots and had no previous illness.  07/11/2008 MR received for DOS 3/17-20/2008 with D/C DX:  Acquired autoimmune hemolytic anemia. Infant presented to ER from PCP's office with anemia and splenomegaly for eval and tx. Pt had decreased eating x several days now listless, pale and with mild jaundice. (+) fussiness and decreased activity. 1 episode of vomiting. PE (+) for pallor, jaundice, tachycardia with a flow murmur. Abdomen firm with organomegaly. Tx with steroids and PRBC transfusions x 5. D/c home for outpt f/u.
Patient was in chair waiting  her 15 minutes after IMZ, when she begin to slid down and slump in her chair.  She could not keep her  eyes open.  After calling her name she began to come to and the main complaint she had was that she had a sweet taste in her mouth.   She continued to complain with sweet taste and then became hoarse.   She denied being a diabetic and was not having trouble with her breathing or throat closing,   Fire Department and Ambulance arrived and she wanted to go to hospital.  She stood up to get on the stretcher.
Immediately after giving vaccines - VARIVAX, in right arm subcutaneously deltoid area, patient developed urticaria at injection site, had itching.  Benadryl 25 mg PO given.  Urticarial rash resolved within 20 min.
I was referred to see RA doctor and I did on March 14, 2022; I was having the same issue joint and muscle pain burning all over but no inflammation. She orders bloodwork like a bunch but she still prescribed medication. Because all tests came back normal. Prednisone for three wks. which caused an adverse event so she gave me Hydroxychloroquine Sulfate; I also went to see the bone Dr. and they ran an x-ray which came back fine and they prescribed physical therapy but I am very active so I declined to go.
Moderna Covid-19 Vaccine EUA symptoms (other than discomfort at injection site) began about 8- 10 hours after injection. headache, overall body ache, joint pain, feeling of cold (not chills) restlessness. *most significant is body parts with previous injuries were the most painful. also I have had a previous injury to my foot with loss of sensation. this area has been recovering for a year however nearly all sensation recovered was lost at the time the symptoms began. it is now about 24 hours post injection. sensation seems to be returning.
Information has been received from a physician concerning a female who in October 2007, was vaccinated with Gardasil.  After the vaccination the patient developed a local reaction at the injection site.  The area was red, swollen, and hot.  Medical attention was sought.  The patient did not respond to antihistamines but symptoms did respond after an antibiotic was started.  At an unknown date the patient was recovered.  No product quality compliant was involved.  Additional information has been requested.
Headache, Myalgia, BILATERAL ARM WEAKNESS, PHOTOSENSITIVITY Narrative:
pt running low grade temp since immun 28JUN94 despite APAP-pt stays w/grandmother during the day & had a shaking spell 1min on 30JUN94 poss sz; then had another light sz on 1JUL94;
High fever 105 first 4 hours then between 100 To 104 for three days. Headache, sweats, chills, vomiting, dry heaves, body fatigue, no taste or smell, It took five to start felling better after 7 days all was good.
I missed my period entirely.  I?m not sure why but I was very worried and I took several pregnancy tests all negative. I also had very tender breasts and other symptoms of pregnancy such as nausea and early morning sickness.  I document my period religiously and I?m always regular.  I did have some spotting on the 12 of April 2021 but I also had that same symptom during actual pregnancy.    I hope this side effect is studied.  I talked to my PA about it and she suggested I complete this form.
No adverse reaction noted. On January 20th, 2022 around 9am the patient was scheduled for a second Covid vaccine. MA lead realized the patient was given the wrong covid vaccine on 12/29. Patient is 13 years old and he was administered by MA lead the 5-11 covid Pfizer vaccine (0.2 ml) instead of the 12 years and up Covid vaccine. Ma lead notified PM immediately . Chart was reviewed and staff was also notified and she did admit mistake. Patient did received incorrect vaccine. Dr. was informed and mother of patient, she was informed of the incident as well. Parent was told pt. received 0.2 ml of the 5-11 Pfizer Covid vaccine. Parent understand and was ok since dose was lower. Parent is bringing back patient tomorrow Friday  1/21/22 for him to get correct Covid Pfizer vaccine.
Headache, Fever, chills, fatigue Narrative:  Fever 99.5, chills, severe headache, fatigue; took advil; resolved 36 hours.
lower back pain, very slow walking, tylenol had no effect, exercises in 2nd week seemed to help and the back pain was negligible after 2 weeks. i had had a history of lower back lumbar sacral muscle spasm, but it had been years ago and more responsive to treatment back then. this was different.
mom stated took pt to MD p/shots recv on 8JUL96;mom states pt had a fever of 103.5 & was covered in a light pink rash, & suffered from projectile vomiting;states MD told mom it was an allerg rxn to vax;pt has since completely recovered;
I was the Emergency Department physician providing care for the patient. Meningococcal vaccine in R deltoid and Tetanus in L deltoid at 11:20.  Patient then developed numbness in the right hand that progressed across the fingers and extended up the arm.  Right side facial numbness and slurred speech followed.  Symptoms resolved in 20 min.  2 hours later at 14:30 again with numbness of in the right hand with extension up the right arm.  This time with facial droop in addition to slurred speech and facial tingling.  The patient had an intense headache at this time.  The patient reported nausea and was found to have slowed mentation and slowed speech.  The symptoms lasted 30 minutes.  No further symptoms after these two episodes.
Symptoms from 4/10 to 4/6: Fatigue  late morning and afternoon of 4/10; slept four hours; Pain at injection site, left arm; Pain and inflammation  along left leg and  knee.  Difficulty walking. Hives over front and back of torso.
Inappropriate Schedule of Vaccine; Body aches; Significant Malaise; This case was reported by a physician via sales rep and described the occurrence of general body pain in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (1st dose received on November 2018, refer case US2019175365).   On 12th September 2019, the patient received the 2nd dose of Shingrix. On 12th September 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In September 2019, the patient experienced general body pain and malaise. On an unknown date, the outcome of the general body pain and malaise were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the general body pain and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix approximately two weeks ago from the date of reporting, which led to lengthening of vaccination schedule. After vaccination with dose of Shingrix, the patient experienced symptoms but were milder. The symptoms were resolved within 2 days. The sales representative indicated that, the reporter provided this information to her during a Congress she was attending and was unable to provide any additional details. This case is one of 5 cases, reported by the same reporter.
Rt upper thigh, noticed redness on Fri 10/8/10. Mother called office on 10/18/10, requesting an appt., mother outlined redness and come into office for appointment. Pt was wearing sweat pants & pulled scab off on 10-17-10. Pt given Rx for KEFLEX.
immediately after vaccination noticed bruising and knot at site of injection. Day after vaccine had cough, flu-like symptoms and sinus infection (dx by MD. On 10/22/06 noted numbness sensation on hands, feet and part of mouth.  1/16/07 Received medical records from neurologist which reveal initial eval done 10/30/06 for progressive weakness & tingling of extremities.  Patient had viral illness of fever, malaise, arthralgias & nausea s/p flu shot 2 weeks prior.  Then developed tingling  of bilateral toes which progressed up & into her hands with weakness of all extremities along with significant imbalance.  Patient reported going to ER on 10/26. Exam revealed absent reflexes, finger to nose & heel to shin were ataxic, gait was wide based & unstable.  Patient seen on 10/31 with some improvement & dx unchanged.  Next seen on 11/13 with significant improvement.  Continued to have left facial palsy & was treated with ointment & taping at night.   FINAL DX: Miller-Fisher variant of GBS based on clinical s/s of prominent ataxia, double vision, areflexia & retained power.  Complete seventh nerve palsy.  It was felt that all of her symptoms were secondary to the flu shot & that patient would continue to improve over time. 2/1/07 Received medical records from hospital ER & Employee health which reveal patient seen in ER on 10/26/06 with tingling of fingers, feet, mouth & tongue with nausea.  Ambulation noted to be unsteady & hand grips were equal but weak. FINAL DX: Anxiety r/o hyperventilation.
Patient was vaccinated at 04:25 PM and at 04:35 PM began to feel dizzy. She reported feeling warm, flushed, heart palpitations,  dizzy, itchy, and felt as if her legs were heavy. She reported symptoms to nursing staff at 05:00 PM. She stated she did not feel she could stand but was able to pivot herself to a wheel chair. She was taken to the triage area and was also able to stand and move herself to the cot to lay down. She did report dizziness increased with movement. Vitals at 5 PM were BP 140/72, HR 125, O2 96% on room air. She denied any breathing difficulty or swelling. She was lethargic in appearance and slow to answer questions. She felt "foggy". She was oriented to person place and time. She had bilateral pedal pulses and was able to feel light touch in her feet an calves and able to lift feet up. Stroke assessment done.  No facial droop. She was able to smile equally. She was able to lift both arms equally. Her speech was not slurred but it was slow. Her baseline is unknown.  BP was taken again at 05:30 PM and was 160/90 with pulse of 120. She continued to feel dizzy and did not report any improvement in her symptoms. She was given the option for paramedics to be called which she was agreeable to. Paramedics arrived and patient reported no improvement in her symptoms. She was able to walk slowly from cot to stretcher and was transported to hospital.  She initially did not report any adverse reactions to her first COVID vaccine but upon further questioning she did say she felt palpitations and dizziness after her first vaccine but it went away so she did not report it to anyone.
Herpes zoster reoccurance; 6 of 6 rpts from same provider; 9DEC93 No response to f/u request;
12/31 vaccination Bunch of people sick at work with COVID. I was Asymptomatic.  1/11 COVID; + *4/19/2021 2nd vaccination
The FLUZONE vaccine has cause severe pain in my left shoulder, and it goes all the way down my left leg, sometimes can't hardly walk or move my arm and leg for full use. Discussed with my doctor when I went in for check up.
Horrible for him; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Horrible for him) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Horrible for him). At the time of the report, FEELING ABNORMAL (Horrible for him) outcome was unknown.            No information regarding concomitant nor treatment medication was provided.
Muscle and joint paint (arms, legs, knees, hips, ankles) from 12:30pm on 6/18/2020 until bedtime 9:30pm and during sleep Headache- woke with headache on 6/19/2020 Weakness / Feeling faint - upon awakening on 6/19/2020
Rash; lots of itching; hives; welting, in several parts of her body such as her left wrist, under her chin on her neck,underneath her arm on her right side, under her right breast, and stomach; A spontaneous report was reported by consumer, a 58-year-old female patient, who received Moderna COVID-19 Vaccine (mRNA-1273) and experienced the occurrence of rash, lots of itching/pruritus, hives/urticaria and welting in several parts of her body such as her left wrist, under her chin, on her neck, underneath her arm on her right side, under her right breast and stomach/urticaria.  The patient's medical history was not provided. Concomitant product was not provided by the reporter  On 10-Feb-2021, the patient received the first dose of mRNA-1273 (lot/batch number: 011M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 21-Feb-2021, the patient developed a rash and wasn't sure if it was due to a change in laundry detergent or dry skin from turning the heat on. Then she had lots of itching, rash, hives, welting, in several parts of her body such as her left wrist, under her chin, on her neck, underneath her arm on her right side, under her right breast and stomach. Treatment for the events included hydrocortisone ointment which helped.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events rash, lots of itching, hives, welting, in several parts of her body such as her left wrist, under her chin, on her neck, underneath her arm on her right side, under her right breast and stomach was not reported.
pt became confused a few days after receiving the vaccination. he began having hallucinations. family took him to ER on 1/19/21