chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a 9-year old white female child with no medical history and no allergies who on 22-Aug-1995 was vaccinated with one 0.5 ml dose of varicella virus vaccine live. There was no illness at the time of vaccination. It was reported that the patients' sibling had no adverse events following prior vaccination. On 19-May-2003 the patient developed a breakthrough rash with cluster of 5-10 scattered vesicular lesions on the right side of her chest below the right nipple. Unspecified medical attention was sought and it was reported that no treatment was required. No diagnostic tests were performed. On approximately 02-Jun-2003, two weeks later, the patient recovered. No product quality complaint was involved. It was also noted that the patient's 8 year old sister was vaccinated with a dose of varicella virus vaccine live and developed a breakthrough rash with 10-20 lesions on her trunk and upper extremities (WAES #0304USA02917). No further information is expected.
Exactly 1  week after my 1st dose of Covid 19 vaccine (Moderna), my left arm felt so itchy, that night I saw redness and swelling. Next day, I went back to the site in my workplace where I got the vaccine, they said it looks like cellulitis and to go directly to the doctor. Doctor prescribed antibiotics. The redness became bigger even if I am already taking antibiotics although swelling subsided, but it is still itchy.  There is also a throbbing pain near my elbow. My Primary Care Doctor confirmed that it is cellulitis.
Redness, Swelling, Heat, Patient told to apply ice pack to area and take ibuprofen.
On Wednesday 7/6/2022, around 7am we noticed that his entire front torso area was covered in hives. We made an appointment the same day with pediatrics around 8-9am. By that point, it went down a little bit, and he was prescribed Benadryl and calamine lotion. By the time we got home, the chest area cleared, and his entire back area was covered along with his face. At the time we gave him Benadryl and he took a nap right after. It began fading a little bit, and then when he had woken up, it spread down to his legs. Again, followed the calamine lotion. In the evening we did an additional Benadryl. On 7/7/2022, he still had some spots left on his arms, and face. They would fade and come up in different areas. This morning, he had some spots on his legs and neck area, but they come and go.
After shot he had a fever. It started @ 12 hours after the shot. It got fairly high and was associated with some twitching. He was seen in ER. His physical examination was unrevealing and so he was treated with a fever reducer and felt fine the next day.
WITHIN 24 HRS., RAPID HEART RATE, REDNESS & FEVER AT SITE, MALAISE, POOR APPETITE. ARM HAS PROGRESSIVELY GOTTEN WORSE OVER THE LAST 3 DAYS, NOW REQUIRING AN E.R. VISIT. I WAS NOT TOLD BY THE HEALTH DEPT. THAT GBS CAN OCCUR, OR THAT AN ADVISORY IS OUT. I AM AN ANGRY R.N. MY CHILD IS ON TYLENOL AND BENADRYL FOR THIS.
05/10/21: Six hours after injection pain and swelling at injection site along with fatigue. Twelve hours after injection severe pain in joints and muscles along with chills. A few hours after nausea. 05/11/21: slept off and on all day. I did not take any medication due to nausea. Arm itched but no rash 05/12/21: Fever broke at 1:20AM slept until 7:00AM-pain and nausea subsiding-had toast and slept remainder of day 05/13/21 Brain fog all day
R shoulder swelling: warm/calor; armpit swelling R side. Local warmth in R arm has subsided. R shoulder and armpit swelling for 6 days, since administration of vaccine.
Case number PHEH2015US000685, is an initial spontaneous report received from a pharmacist on 05 Jan 2015. This report refers to a 62 year old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 145205) intramuscularly at a dose of 0.5 ml on 01 Nov 2014. It was reported that the patient received FLUVIRIN which reached temperature below 36 degree F for 3.5 non-consecutive days and 33.1 degree F for less than 12 hours. Reporter did not believe that the vaccine was frozen. She thought that it could be due to thermometer malfunction. But she was not sure. No adverse event was reported following this medication error.
I had a reaction about 10 hours after the vaccination. At midnight I awoke with a full body bright red burning painful rash that lasted for about 25 minutes. I also had the same experience on 3/13 and 3/15 during the day when I was on the train. I have never experienced anything like this before the vaccination.
Roughly 15 hours after I got the shot my fever spiked over 100 and began sweating and chills. The second day fever spiked at 101.3. Body aches all over and symptoms lasted till this morning Saturday 4/10
From report provided by event staff: "At 2:35pm a second dose vaccine for COVID-19 (Moderna) was attempted to be given to the recipient, , but the syringe came apart when the person who was injecting, student nurse, , pushed on the plunger of the syringe. It appeared that probably most of the dose was lost, not injected. The dose splattered down the recipient's arm and sprayed on the facial visor of the student nurse giving the injection.  Time of Evaluation of incident by MD on-site for clinic: At approximately 2:37pm  was brought to  the MD on-site. At 2:42 pm  administered the 2nd dose of the Moderna vaccine for COVID-19 to  in the deltoid area of her left arm. She was observed for 15 minutes and did not have any signs or symptoms of reaction"
Fever, chills, nausea, abdominal pain,  BECAME DELUSIONAL, GI bleed, fatigue Came on within hours of vaccine (except GI bleed which occurred in September 2022.  Believes that a group of people tried to murder him and that he got married (neither of which is true)
Onset of redness & swelling of L/upper extremity, 7.5 x 12 cm.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 69-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. Date the vial was initially stored in the refrigerator reported as unknown and the vial did not undergo any temperature excursions. The treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: follow up received contains non significant information.
Fever; Chills / Lots of chills; Abdominal pain; This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma. Concomitant products included salbutamol sulphate (Albuterol).   In March 2020, the patient received Shingrix. In March 2020, 7 days after receiving Shingrix and an unknown time after starting Albuterol, the patient experienced fever, chills and abdominal pain. On an unknown date, the outcome of the fever, chills and abdominal pain were unknown.   It was unknown if the reporter considered the fever, chills and abdominal pain to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient's wife. The patient was on inhaled steroids due to asthma. The patient received vaccine 7 days prior to the date of reporting. The reporter enquired if Shingrix reaction of fever and chills could develop a week post vaccination. She also enquired if these reactions should be considered as Shingrix reaction or medical care need to be sought.
Pfizer Dose 1 3/8/21 (EN6199) Pfizer Dose 2 3/31/21 (EN6207) Pfizer Dose 3 10/6/21 (NA) COVID Positive 1/26/22  1/26/22: -Patient is an 82 yo female with medical history of Autoimmune hemolytic anemia/ Iron deficiency anemia  f/u Dr,  DM,HTN,  Hypothyroidism,GERD, HLD, Rheumatoid arthritis, BPPV  -She is presenting with progressively worsening left eye lid swelling , pain and redness which started on monday . She also has generalised facial swelling  -She does not recall history of trauma. Has left eyelid pain but denies chemosis , decreased vision , pain on moving the left eyeball , fevers, chills . She does have clear secretions from her left eye and jaw and cheek pain. Left eyelid now very swollen that she is unable to open her eyes.  -She has been on steroids for the past 2 week for AIHA. The dose was decreased from 60mg daily to 40 mg daily by Dr today because of concerns for orbiltal cellulitis. She was referred to the ER for further evaluation of her eye and face.  -In the ER her BP was borderline low, afebrile , mildly tachycardic 90-100 with normal saturation on room air  -Imaging showed left periorbital and preseptal soft tissue edema without retrobulbar abnormality or significant sinus abnormality and questionable scleral enhancement on the left.Right maxillary and left anterior ethmoid sinus disease was also seen.  -CT soft issue neck showed Multiple bilateral pulmonary nodules, not significantly changed.  Additional follow-up recommended in approximately 12 months.Enlarged paratracheal predominant mediastinal lymph nodes which have not significantly changed. Interval increase in size in pericardial lymph nodes nearby the right atrium.  -Labwork significant for mild pseudo hyponatremia, glucose 297, AKI Cr 1.16, T bili 2 with normal LFTs , lactate 6.6> 4.9, wbc 30, Hb 9 ( at baseline) , elevated ESR and CRP.  -ER provider consulted opthalmology ( Dr ) and they will evaluate patient  -Patient received Unasyn and Clindamycin in the ER. Received 2.5L fluids  2/10/22: Patient is 82-year-old female with past medical history chronic anemia due to autoimmune hemolytic anemia on prednisone following up with Dr., rheumatoid arthritis, hypertension, hypothyroidism, and type 2 diabetes mellitus.  Admitted to hospital for acute hypoxic respiratory failure due to COVID-19 pneumonia, hospitalization was complicated by left preseptal cellulitis, herpes simplex keratitis of left eye, acute on chronic anemia requiring blood transfusion and strep to coccus pyogenes, under the guidance of Pulmonary Medicine, Infectious Disease and Ophthalmology patient was treated with appropriate medical therapy and supplemental oxygen. As time progressed patient clinically improved, prior to discharge patient completed IV antibiotics, repeat blood cultures are negative to date.  Per Ophthalmology recommendation, patient will be discharged home with erythromycin ointment, and valacyclovir for total course of 7 day.  Patient recommended follow-up with Pulmonary Medicine in 2-4 weeks, PCP within 1 week, ophthalmology within 1-2 days after discharge.  Patient has also been referred for VNA including RN, PT and OT
(L) deltoid where Tdap given @ 48 hours - swelling & redness. No fever. Length at exam of affected site is 8cm.
abrupt, severe uncontrolled movements-flailing arms & legs, head shaking, rash, low pulse;hosp ICU & dx acute encephalopathy;hosp again 2 wk later for another 4-5 days dx w/tourette synd;on med & in therapy  but unable to return to school;
pt broke out with a bad case of shingles on her right leg 2 days post 2nd vaccination
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). A 28 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "Patient developed myocarditis after receiving COVID-19 vaccine he was 28 years old". Event took place after use of product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
redness around the site of the injection with heat in it and itching.  The redness was about the size of a baseball in area.  Drew around the area to make sure did not keep getting bigger.  Told her to use ice for the heat and she already takes Aleve every morning but also to take Benadryl for the itching.
Case number PHEH2014US012908 is an initial spontaneous report received from a nurse via sales representative on 25 Jun 2014. This report refers to a male patient of unknown age. Past medical history and concomitant medications were not reported. On 24 Jun 2014, he was vaccinated intramuscularly with only MenCYW-135, the liquid component of MENVEO (batch number: M14021) and did not receive Men A lyophilized conjugate (powder form). No adverse event was reported following this administration error (inappropriate preparation of medication).
Bruise on left forearm approx 3x5" head pad 10 days, swelling of lower lip 2 weeks, activation of numbness in fingers in both hands still 12/31/2004 (CT syndrome)
Flucelvax was injected in left arm 1st.  The Shingrix was injected 1 inch below the Flucelvax in the left arm.  After the Shingrix the patient said his arm hurt and became white and started sweating.  The patient's wife and myself (pharmacist) asked if he was ok and he became limp and passed out briefly.  Patient's wife asked me (pharmacist) to call 911 and I directed my staff to do so. In the meantime I grabbed a wet paper towel and returned to patient and his wife. At this time patient was gaining coherence and didn't know he had passed out.  I put cool paper towel on his neck and noticed patient had also wet his pants. Patient and wife were able to leave with no help and I told staff to tell 911 that he was ok.
Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient received the booster dose. It was reported that two vials were administered from same lot number. 1st vial was administered on 05-Nov-2021 and 2nd vial was administered on 12-Nov-2021. On 04-Nov-2021, the vials was initially stored in the refrigerator. The vial did not undergo any temperature excursions. There was no adverse event as a result of this misadministration, patients were monitored.  No treatment information was provided.
Lump on arm about 2 inches below the injection site. The area was very red and had a couple of blisters. This showed up the day after the vaccine and stayed there for several days. It went away, then came back 10 days later.
pt recv vax 22APR98 & had sz 1MAY98 taken to pediatrician then 5 more sz from 1MAY98-11MAY98;seen by neurologist;EEG gone & dx of epilepsy;
pt recv vax JAN & FEB97 then in JUL97 lab eval revealed a lack of seroconversion;
I was so cold, not enough blankets; BP jumped to 191/91 and pretty high the rest of the night; This serious case was reported by a consumer via interactive digital media and described the occurrence of hypothermia in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced hypothermia (Verbatim: I was so cold, not enough blankets) (serious criteria GSK medically significant) and blood pressure high (Verbatim: BP jumped to 191/91 and pretty high the rest of the night). The outcome of the hypothermia and blood pressure high were not reported.   It was unknown if the reporter considered the hypothermia and blood pressure high to be related to Shingles vaccine.     It was unknown if the company considered the hypothermia and blood pressure high to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-Mar-2023 The case was received from the patient via interactive digital media. The patient stated that shots would be covered next year by medicare and the patient found out the day after, he or she got his or her second. The patient also had a terrible reaction and was so cold, not enough blankets and his or her blood pressure jumped to 191/91 twice during the evening and was pretty high the rest of the night. The patient stated so be careful. The follow-up could not be possible as no contact details were available.
Injection site started to bleed, and then began to swelling immediately. Injection site knotted up. Patient was held for monitoring. Approximately 5 min. after injection patient had complaints of nausea and hot sweats. 25mg IM Benadryl was administered and ice applied to injection site. Patient began to feel better and left approx. 45 min. after injection.
3? x 3? red, swollen, warm itchy patch at injection site. No treatment.
Since July of 2021, second vaccine date in May, my blood pressure has been hypertension stage 1, or elevated, or normal.  I was looking at my blood pressure history on my phone and the first case of hypertension was 133/69 on July 23rd. A value as high as 149/87 on February the 6th. I am continuing to monitor. I reported this to my doctor in December they advised I come in however I lost my job and benefits.  I did not become worried about my circulation until December when I felt lightheaded after a meal in the evening. I did contact my doctor however I did not make an appointment because I had lost my health insurance.  Presently I'm monitoring my blood pressure daily and it fluctuates.
flare of  RA; This is a spontaneous report from a contactable physician.   A 75 year old female patient received both doses of BNT162b2 (COMIRNATY, Solution for injection, Lot number: unknown) intramuscular on an unknown date at single dose for COVID-19 immunization. Past drug history included Methotrexate 20 mg SC weekly and Xeljanz XR 11 mg and experienced infection, shingles in Apr2018 and a flare of RA in Nov2018. The patient did have bronchitis in Mar2020, hospitalization but COVID- 19 test was negative, patient has 4-6 swollen joints. The patient received COVID 19 vaccine, on an unknown date, held Methotrexate two weeks after both shots but had some flare of RA. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of flare of RA . The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
soreness in L arm-2 days,  back pain 1/2 day,  chills 1/4 day
Within 30-60 minutes of injection the patient developed severe headache, body aches, chills, fever to 103F, nausea, vomiting.
Pt noticed raised area on R upper arm, itchy at approx 7 PM while at dance class. Mother noted 4-5 1" areas with depth approx 1/4"-1/2" on both upper arms and one 2" raised area on R upper arm. Mother administered BENADRYL which was effective. All of this happened on 11-19-09. The morning of 11-20-09 pt had no raised areas but the spot on the right arm that had been the worst had residual bruise.
Employee received COVID vaccine on 1/6/2020 and developed bilateral hip pain that night and then developed numbness and tingling in her buttocks and both legs on 1/7/2020. Employee was sent into Emergency Room.
The patient reports adverse reaction to the influenza vaccine that she received on 10/16/2013. She reports that she had left arm pain that was severe and weakness that lasted approximately 2 weeks. The patient did not report this until following visit Nov. 6, 2013.
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 ZOSTAVAX at a community health center for routine adult health maintenance and the intended purpose for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. In 2014, the patient was treated at a medical center for a 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 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.
Within two weeks of vaccination out break of cellulitis occurred in lower leg along with issues of nephropathy.  Exact same events occurred after first shot, but I am more educated on all the unadvertised side effects of the Covid vaccine.