chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of sores mouth in a 77-year-old female patient who received SHINGRIX for prophylaxis. On 3rd October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In October 2018, immediately after receiving SHINGRIX, the patient experienced sores mouth and blistering of mouth. On an unknown date, the outcome of the sores mouth and blistering of mouth were not recovered/not resolved. It was unknown if the reporter considered the sores mouth and blistering of mouth to be related to SHINGRIX. Additional details were provided as follows: The patient reported that shortly after receiving 1st dose, she had been experienced sores or blisters in her mouth. The reporter did not consent to follow up. For tolerance with 2nd dose of SHINGRIX, refer linked case US2019GSK036841.
Butterfly rash on face. As of a month later, I still have this symptom. I plan on getting blood tested for lupus.
Severe itching throughout my entire body most notably armpits, back, feet/ankles, head that started a week or so after receiving the Covid19  booster.    Manageable during the day worsening in the evening to the point that all attention is spent scratching the affected area.  This happens every night now.
I had continuing shapes in my left arm ever since I got my vaccine. These symptoms are ongoing as of today. I can not lay on my left arm. I went to my doctor several times about this. They did x-ray of my arm but that did not show anything.
This spontaneous report as received from a pharmacist refers to a 66 years old female patient. The patient was vaccinated with single dose 0.65 ml ZOSTAVAX. Route of administration, vaccination date, and lot number were not provided. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient developed shingles two weeks post vaccine. It was reported that the patient sought medical attention by an office visit. No additional treatment information was reported. The outcome of patient developed shingles two weeks post vaccine is unknown. The relatedness for patient developed shingles two weeks post vaccine was not reported for ZOSTAVAX. Additional information has been requested.
no adverse event, patient received 2nd booster of moderna at age 23 yrs , has asthma, not on steroids
Pain when he stands up; Dizzy; Pain where his bones join; Pain in his back; Pain in his arm; Feels hot inside; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), BONE PAIN (Pain where his bones join), BACK PAIN (Pain in his back), VACCINATION SITE PAIN (Pain in his arm) and FEELING HOT (Feels hot inside) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052C21A and 008D2VA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jul-2021, the patient experienced DIZZINESS (Dizzy), BONE PAIN (Pain where his bones join), BACK PAIN (Pain in his back), VACCINATION SITE PAIN (Pain in his arm) and FEELING HOT (Feels hot inside). On an unknown date, the patient experienced BONE PAIN (Pain when he stands up). At the time of the report, DIZZINESS (Dizzy), BONE PAIN (Pain where his bones join), BACK PAIN (Pain in his back), VACCINATION SITE PAIN (Pain in his arm), FEELING HOT (Feels hot inside) and BONE PAIN (Pain when he stands up) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.
about 6 hours later, sharp pain in shoulder of injection site.  over the course of the night, pain increased.  next day, pain was debilitating if the arm was moved in any way that involved the shoulder.  on 2nd day (40-48 hours later), the pain decreased almost as dramatically.  it is currently 75 hours later, and the pain is still present when moving arm, but far less severe.
(1) 10/9/07-Parent called at 12:30 pm to report that pt had fever of 100.1 F. Normal temps post vaccinations and Tylenol doses given to parent by office RN. (2) 10/13/07-Parent brought pt for office visit at 11:00 am for s/sx of vomiting x one episode, inconsolable crying x 6 days, arching when nursing, pulling his legs up and screaming, no bowel movement x 2 days, insomnia 10/18/07-constipation.  1/16/08 Received vax record which confirms dose & lot #s as reported.  Also received hospital medical records from 12/27/2007-1/12/2008 admission for inability to gain weight.  Diarrhea 2 mos prior to admit & milk protein allergy dx.  Diarrhea improved w/formula change but unable to gain weight.  Peds GI, ID, ST eval for swallowing, & Nutrition consults done.  EGD/colonoscopy & colon biopsy done which was WNL w/self limiting colitis.  D/C to home on continued tube feedings  FINAL DX: Failure to thrive; c. diff colitis, resolved.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications and no treatment medications were reported.   This case was linked to MOD-2021-395985 (Patient Link).
Pt rec'd shots 2/27/03; approximately 24 hrs later noted to be staring, eyes deviating to right side for 3 min. then very drowsy, hard to arouse for approximately 30 min. No fever.
Pt recvd Engerix-B & 8JUL92 exp flu-like sx; pt is self-medicating w/an Ampicillin prescription;
After the second dose on my right arm, it became sore.  However, it has gotten progressively worse over the year.  When I got my booster I asked the person administrating it why it would continue to cause pain, as well as my movement, which has now been limited in my right arm ( the rotator cuff hurts as well as surrounding muscles with  I have limited movement in my arm). .  She asked wherein the arm they had administered it at and I did not recall.  After that appointment, I looked up issues with vaccines and found additional information on issues on pain, etc. that can be caused due to where it was administered.
pt exp papulo-vesicular rash over trunk/extremities compatible w/chicken pox about 2 wk p/vax; pt's sibling devel similar rash about 2 wk p/pt devel rash-there is no other known exposure; pt showed a pos low antibody titer for varicella;
3/26/04- Redness noted at injection site, left arm warm to touch. Redness increased by next day. Seen in ER on 3/27/04. Diagnosed cellulitis. Cettriaxone given.
5/21/2021  lump at a previous COVID vaccine site. His second dose of Pfizer vaccine was administered on March 5, 2021. Few weeks after the injection there was a significant swelling pyramidal in shape. It appeared like an overgrown folliculitis. It gradually shrunk to the current size. there is a 5 mm nodule projecting outward from the injections site at the left deltoid region, it is mildly tender. No signs of infection. Assessments: Injection site granuloma Plans: We agreed on trial of steroid instillation using Kenalog .5ml sterile technique . Patient tolerated well. 6/18/2021 On his left deltoid region is a nodular lesions approximately about 8 mm injecting outward.  No sign of infection. The nodular lesion is best addressed by using shave biopsy.  There is no guarantee that further steroid instillation is going to decrease the size.
SCABS; ABSCESSES ON SKIN CLOSED (UNEXPECTED THERAPEUTIC EFFECT); This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 160 pounds, and height was 64 inches. The patient's past medical history included insect bite, and concurrent conditions included high blood pressure, and skin abscesses, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced scabs. On 09-MAR-2021, the subject experienced abscesses on skin closed (unexpected therapeutic effect). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the scabs and abscesses on skin closed (unexpected therapeutic effect) was not reported. This report was non-serious.
Red Dots; Burning; Shingles; Pain / Soreness; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 13th August 2019, less than a day after receiving Shingrix, the patient experienced pain. On 1st September 2019, the patient experienced shingles. On an unknown date, the patient experienced erythromacular rash and burning sensation. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the shingles, pain and erythromacular rash were recovering/resolving and the outcome of the burning sensation was not recovered/not resolved.   The reporter considered the shingles, pain, erythromacular rash and burning sensation to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in left deltoid. The patient developed an area about 2 inches in diameter on the back inside of her right leg. The patient asked her neighbor who was a nurse practitioner to look at the area and she thought it appeared to be shingles.  The patient then went to the doctor on 3rd September 2019 and her physician thought it appeared to be shingles and prescribed Valacyclovir. Emergency room visit required The reporter consented to follow up.
Red, Indurated, Warm 24 hours after administered  Ibuprofen, Ice packs, Heat Packs
Body aches, feeling feverish with no temperature, headache, dizziness, hives all over body, sore arm at injection site
Shingles returned same area, very painful, left rear thigh upper, below the cheek.
About one week after the first vaccine injection, I got was appears to be Covid Arm: red, swollen, hard rash around injection site on arm. About 3 inches by 1 inch.  The area is sensitive to the touch.
Was flying on 2 Apr 21 at cruise about 1 hour into flight, experienced loss of color in vision, went from full color to red and gray, somewhat washed out, experienced lightheadedness and a bit of disorientation but not dizziness. Needed to use the bathroom and try to move to improve circulation and had to think about moving my body. I was not uncoordinated but my steps and balance were deliberate vs. unconscious and automatic. I was able to walk down the aisle to the lavatory without any problem but my vision did not immediately improve as I had hoped.  I went into the lavatory and leaned against the side (I'm 6'4" and it was the rear lavatory on a 737). I was not dizzy and my lightheadedness began to clear up slowly as I urinated. The color was also coming back slowly as I finished up and walked back to my seat, again, I had to think about each step and my balance, although I was okay walking back. As soon as I sat down, I began sweating profusely. It lasted about two minutes or less, not long at all and I didn't get wet from the sweat. As suddenly as the sweat came, it went. My eyesight went back to normal and I felt nothing had happened. I am sure I was awake, aware and lucid the entire time, although it felt like what I imagine a psychedelic episode would be like (I've never used any form of hallucinogen, however). I was back to normal when I disembarked the aircraft, felt no adverse or lingering effects either. Nothing to report since.
Flu like tiredness, no energy--I have had and still have all of these symptoms Headache Dizziness Ringing in ears
frog in throat like a tickle; pain and tenderness at injection site; pain and tenderness at injection site; Swollen glands; Muscle pain in back; Tired; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (frog in throat like a tickle), the first episode of VACCINATION SITE PAIN (pain and tenderness at injection site), the second episode of VACCINATION SITE PAIN (pain and tenderness at injection site), LYMPHADENOPATHY (Swollen glands) and MYALGIA (Muscle pain in back) in a 61-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.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROAT IRRITATION (frog in throat like a tickle), the first episode of VACCINATION SITE PAIN (pain and tenderness at injection site), the second episode of VACCINATION SITE PAIN (pain and tenderness at injection site), LYMPHADENOPATHY (Swollen glands), MYALGIA (Muscle pain in back) and FATIGUE (Tired). At the time of the report, THROAT IRRITATION (frog in throat like a tickle), the last episode of VACCINATION SITE PAIN (pain and tenderness at injection site), LYMPHADENOPATHY (Swollen glands), MYALGIA (Muscle pain in back) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported
This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 02-Aug-2018 by Seqirus from VAERS (VAERS ID: 744961), concerning a 24-year-old, adult, female patient. The patient's vaccination history included unspecified influenza vaccines in the past (on an unspecified date in 2009, 2010, 2011 and 2013). It was reported that, 2 weeks after vaccination every year, the patient developed non-immunoglobulin E [IgE] mediated reactions with same severity which included fever with a temperature 101-104, body aches, upper and lower respiratory tract congestion, and cough which persisted for several weeks. The patient's medical history included allergic rhinitis and had no known current illness. The patient was allergic to sulpha drugs (since an unspecified date). On an unspecified date in 2014, the patient was administered influenza vaccine (dose: unknown, route of administration, anatomical site, trade name, manufacturer, batch number and expiry date: not reported). On an unspecified date in 2014, 2 weeks after vaccination [as reported], the patient experienced fever with a temperature 101-104, body aches, upper and lower respiratory tract congestion, and cough which persisted for several weeks. The outcome of the events was not reported. The reporter assessed this case as non-serious. This case was linked to the case 201803106 due to the same patient and reporter.
Child was sleepy after immunization & took nap. Upon arising child seemed less alert per mother. During diaper change, child became unresponsive, lips turned blue, & developed hand tremor. Mother noted she was not breathing & called EMS. Episode lasted 1-3 minutes. Upon arrival of EMS child was breathing & started to regain consciousness. Temp 101.9 ax EMS contacted primary care physician; child was not seen by physician or taken to ER. Dx - likely febrile seizure. Child recovered without further incident.
Narrative: 50 yr old woman on HRT 11 days after moderna dose 2 had onset severe HA and blurry vision. also states incoordination. Sent her to ER for MRI and CBC 4/29/2021
product preparation error with no adverse event; Initial information received on 12-Jan-2023 regarding an unsolicited valid non-serious case received from a health professional.  This case involves a 16 months old male patient who experienced product preparation error, with no adverse event after receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot: UJ678AAA, Expiry date: 09-Sep-2023) via unknown route in unknown administration site (form, Strength: unknown) for Childhood vaccination.  On an unknown date the patient had a product preparation error with no adverse event (product preparation error) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. In April 2015, the patient was vaccinated with unspecified dose of ZOSTAVAX (lot#, expiration date and route of administration were not reported) and then received another dose on 19-JUN-2015 (0.65 ml, subcutaneously; lot#, expiration date and anatomical location were not reported). The patient did not experience any adverse events. Additional information has been requested.
?COVID Arm? where the site of injection became super swollen and painful. The swollen area is slightly red and rounded, tender to the touch. It?s still lasting past 48 hours but has deflated about 25%
Dizziness. I felt slightly dizzy about 15/20 minutes after I got the vaccine. The dizziness was on and off, that day. It got worse the next two days, but waned about the third day.  It has been sporadic, and somewhat persistent since then.  I have felt slightly dizzy at various times, on most days.  I'm not sure how long this is supposed to last before it goes away.
I woke up at 12:45 am from sleep to find my throat uncomfortably tight. I could not breathe or  swallow. I took 2 OTC Benadryl and within 45 minutes I felt my throat less tight. I was more comfortable. I went back to sleep and awoke at 3:00 am. My throat felt much better. I took 2 more Benadryl at 7:45 am because my throat felt a little tight.
Fine? I've never felt fine after antiviral inoculations.; This is a spontaneous report from a Pfizer-sponsored program Corporate (Pfizer) Social Media Platforms via a non-contactable consumer. A patient of unspecified age and gender started to receive BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient reported "fine? I've never felt fine after antiviral inoculations". Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pregnancy marked off on consent form, newly pregnant. I gave the shot as I always do, make a "C" on the arm from the shoulder bone and place needle in middle of "C" in the muscle. When I removed the needle there was a stream of blood that came out of injection site. So I immediately applied pressure with cotton ball and held til it stopped in about 10 seconds. I applied a bandaid and wiped patient's arm with cotton ball from blood that ran down arm. I apologized immensely and asked her if she was light headed, she said no. I asked her if I could get her a drink or something to eat. I asked her if she wanted to stay seated to relax she could. I asked if she had been working out or active before her flu shot bc I know that could get blood flowing but she said no. There was a slight inflammation and and bruise at the injection sight after I put the bandaid on. Patient was upset and crying and again I apologized many times.  I advised her to put ice on it when she got home that it would be sore.  An hour later her mother called saying I never apologized saying I gave the flu shot wrong and I shouldnt be giving flu shots. I tried to explain how I handled the situation and the mom hung up on me saying I will take this to the highest level.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021 at 5:05 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Nov-2021 at 5:05 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided. Patients were given doses from vials that were stored in an ultracold freezer which is colder than they should have been. The vial undergone temperature excursions for one month. The vial was in frozen state at the time of the excursion. The vials moved from freezer to refrigerator on  23 NOV 2021. The maximum and minimum reached temperatures was negative 82 degrees Fahrenheit. The vials were returned to the freezer or refrigerator or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursion issues had happened.   This case was linked to MOD-2021-402935 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2022: Follow up contains Non-significant follow up.