chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 2 weeks (mid January) after the first shot, I started experiencing transient diplopia on awakening in the morning that would resolve in 5 minutes. 2 weeks after the second shot (2/16/21) I started having pain in my left orbit.  I received an MRI brain/orbits on 2/26/21 showing inflammation of my inferior and lateral rectus eye muscles. Labs on 2/26/21 showed normal TSH, free T4, free T3. ANA was positive (without titer). TSI (thyroid stimulating immunoglobulin) was positive at 1.75, 3x the upper limit of labs were normal (0.5). On 3/3/21, I noticed left suborbital swelling and eye restriction on upward gaze. 3/15/21, restriction in upward and lateral gaze. I was diagnosed with thyroid eye disease. I attempted treatment with a methylprednisone dose pack for 6 days on 3/26/21 without improvement. Then a 20 day high dose prednisone (1mg/kg) on 5/8/21 with rapid taper also without symptom improvement. I am starting authorization now for a monoclonal antibody for thyroid eye disease.
Muscle twitching primarily in feet and calves. Also in thighs, gluteal muscles and fingers at times.
I was given a tetanus shot on Wed. 04/20/05 at approximately 2PM. There were no marks or pain. Friday morning at approximately 2:30 AM (36 hours after receiving shot) I woke up to chills, sweating, headache, and terrible thirst and had big red rash on my arm where vaccine was given. Felt sick all day Friday. Rash was getting bigger and arm was swelling up but I thought this was normal reaction to the shot. By Saturday Morning 04/23. Rash looked like a big square beet red, painful, and hot to the touch. It also measured 4"x4". I then went to store to see a Pharamacist and was told to see an MD ASAP. However being a saturday there wee no MD's available in my MD office. The NP did call me backa nd told me to come in to the office and she would look at it. After seeing  the rash I was told it looked like cellulitis and prescribed an antibiotic. On Sunday morning i started breaking out with a big red itchy rash all around the square rash. No rash anywhere else on body. By Monday morning rash was not swollen, and itchy and measured 6"x6". Saw MD in afternoon and was told  it was not cellulitis but a severe allergic reaction to the tetanus shot and to  be sure I never get another one. I was put on prednisone which I am still taking and it seems to be getting better.
LEGS PAIN, FEVER 100,  ARM PAIN ,  DIARRHEA  NAUSEA
Initial overdose report received from a healthcare professional on 01 May 2013. A 4-month-old patient received PENTACEL and DAPTACEL vaccine both on 01 May 2013. No adverse event was reported. List of documents held by sender: none.
Pt was inadvertently given adult Td (0.25ml) rather than a ? vaccine. Broke out in hives at 11am 10/23/01.malaise - mild - afebrile R thigh swollen & red started 10/23/01pm.
didn't feel anything on the first one, just very lightly; a lot of fatigue; developed a rash in the neck; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Medical history included ongoing cellulitis. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced didn't feel anything on the first one, just very lightly, a lot of fatigue, developed a rash in the neck. Consumer stated that she had ongoing cellulitis and was taking antibiotics. She was received her 1st dose of the vaccine. About the 1st dose, she said she didn't feel anything on the first one, just very lightly. Caller declined her age. Caller stated she was scheduled to get the second dose of the Pfizer Covid 19 vaccine. She was taking antibiotics for treatment of a wound, Doxycycline mono twice a day. She noticed she developed a rash in the neck after taking the antibiotic. Can she still get the second dose? Caller stated she felt a lot of fatigue after the first dose. Outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Mom stated patient was vomiting the day after her COVID shot was administered. Mom believes it was due to the COVID shot
Got shot at work @1145. By 1245 noted right shoulder hot and itchy. Visual assessment shows erythema and one hive. Within five minutes head (scalp/hairline) was hot and itchy. Took 25 mg BENADRYL oral and took ride to Emergency Room immediately where was treated for several hours. 3 days later and still having intermittent flushing and wheezing requiring ongoing use of anthistamines and albuterol (in addition to prednisone presecibed by ER).
5 year old was administered Bexsero; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-year-old female patient who received Men B NVS (Bexsero) (batch number R42C, expiry date 30th June 2024) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 18th August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-AUG-2022 Reporter's Comments: The nurse reported that patient was inadvertently administered a dose of Bexsero. The reporter was consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter. Additional Supportive Information: The 5 years old patient received bexsero inadvertently, which led to inappropriate age at vaccine administration.
pt recv vax; rt thigh red & hard; fever inc to 103; to er & dx of cellulitis; atbs adm; f/u call on 22jun, pt better, will visit ofc 23jun95;
-ringing in ears, has not gone away.  -vomiting for about 3 hours  -diarrhea for an hour  -fever of 101.7 that lasted for 10+ hours  -cold chills -heavy feeling on chest  -dizziness -intense fatigue -full body aches
Pt recvd vax 20FEB91 & on 21FEB91 pt exp itchiness on back w/clusters of red, raised areas & mild achiness; second day following vax, devel n,v,d & coughing; 3rd day, sx worsened w/chest pain, upper resp sx, laryingitis; spots, shingles;
Patient started to have redness and swelling at the injection site on day 8 after the injection. Getting worse today.   Immediately after the injection, patient only experienced minimum discomfort at the injection site, including very mild pain and minimum swelling. Those symptoms resolved 3 days after the injection. No systemic adverse reactions.
9/24/2021 Ringing in both ears. Right side of chest developed 5 nodules size of a quarter, under the skin, could be felt by touch. Large bruise appeared over all the nodules. There was no injury or trauma to that area. 9/28/2021 My family physician suspects that these are adverse reaction to the covid vaccine. 9/29/2021 rigging in both ears has increased, body chills and sweats, blurry vision.
I can't smell or taste today; Sniffles lots of mucus in throat; couldn't catch my breath; fever; Sore arm at the injection site; sore throat, felt like pins in throat; burning eyes; cough; achy; tired; chills; This is a spontaneous report from a contactable consumer (patient). This 65-year-old non pregnant female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on left arm on 11Feb2021 10:30 (Batch/Lot Number: EL 9269) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient not received other vaccine in four weeks. patient had Sore arm at the injection site the following 2 days in 20Feb2021. 18Feb2021 achy, tired, chills. 19Feb2021 burning eyes, achy, chills, cough. 20Feb2021 aches in lower back mild cough sniffles, chills, sore throat, felt like pins in throat, tired. At 20Feb2021 16:30 fever of 100.9. 21Feb2021 sore throat felt like pins poking them and also in ears. Sniffles lots of mucus in throat. Felt like I couldn't catch my breath to clear it. It's was a drowning feeling. 22Feb2021 sore throat sore ears, lots of mucus, chills. Temp of 100.1. Still stuffed up the pain in the throat and ears were better but no energy. 23Feb2021 still a lot of mucus, stuffy nose, Slight chills. 2.24 still stuffed up but better. Now I can't smell or taste today. Please get back with me as I want to know if this is just vaccine symptoms. Because if this is the case people need to know. The patient not received any treatment. patient not having covid prior vaccination; patient not tested covid post vaccination; The outcome of the events was recovering.
This spontaneous report as received from a registered nurse refers to a dialysis patient of unknown age and gender. The patient's medical history was not reported. On 12-FEB-2014, the patient was vaccinated with the first dose of dialysis formulation of RECOMBIVAX HB 40 mg/ml (route, lot number and expiration date were not provided). On 21-MAR-2014, the patient received the second dose of ENGERIX B 20 mcg but the patient should had received 2 doses of ENGERIX-B. No adverse effect reported. Additional information has been requested.
Immediate (within 15 minutes) dizziness and flushing across chest, neck and face. Given 10 mg Zyrtec and paged Allergist. Symptoms resolved within 20 minutes.  24 hours later nausea, diarrhea, body aches, sweats and chills, dizziness, headache symptoms hit. Reported to occupational health, treated with Tylenol 1000 mg BID and Naproxen 500mg BID, and pushed hydration. Patient tested negative for COVID-19 x3 over two and a half weeks of persisting diarrhea, headaches, dizziness, and nausea. She saw PCP virtually (02/24/21) and recommended an in- person visit. From this visit, she was transferred to the Emergency department (02/26/21)for workup. Normal EKG, normal blood labs, normal neurological exam. Treated with headache cocktail x2 (including 1L saline, Tylenol 1000mg, Magnesium 500mg, Zofran 5mg) and discharged with referrals to neurology and gastroenterology. Allergist virtual consult (03/01/21) recommended PEG testing. Received nerve block injections weekly from April 1 through June 24. During this time PCP recommended short-term disability from work (03/12/21).  Center treated  patient with meclizine, doxycycline, Zofran, Tylenol 1000 BID, Naproxen 500mg BID, Benadryl 10 mg BID, Zyrtec 10 mg BID, Singulair 10 mg BID with little change in symptoms. Finally met with a Neurologist (06/01/21) and Gastroenterologist (05/28/21). Discontinued all other meds while increasing nightly nortriptyline dose to 40 mg, Magnesium 500 mg, add colace, add hydrocortisone suppository rectally. Initiated vestibular physcial therapy (06/09/21) for dizziness and awaiting otoneurology consultation (10/01/21). Negative PEG testing followed by Immunology consultation July 20, 2021.
24 yo presents himself to facility for a F/U with the ER after another break out of hives around 1900. Medics gave pt three pills, pt only knows that one of them was diphenhydramine. Upon arrival ER could not evaluate pt due to the fact that the hives were no longer present. Pt was sent back home and around 2030, pt broke out in more hives around his neck and thighs. Pt returned to ER and was given a prescription of diphenhydramine. Pt has taken x1 capsule around 1200 today, 7/6/17. Pt has only taken x1 Zyrtec yesterday and has not repeated. Pt states that he was told to come in to get tested for Allergies. Pt states only having one runny.
Pt had "heaviness" in his arm. Stated very difficult to lift arm for 2-3 hrs after vaccine.
Pt developed rash to left thigh.  Also developed cough with fever up to 103 2/3/10.
Patient received vaccine on 10/23/14 and started noticing soreness and warmth on 10/28/14 and a few small dots. On 10/29/14 the patient's arm is hurting and there is a big raised whelp on her arm and the area is hot.
RabaVert was administered after temperature excursion; Case reference number US-BN-2021-000243 is a spontaneous case report initially received from a health care professional on 17-Mar-2021, and concerns a 9 years-old female patient.  The patient's medical history was not provided.  The patient's concomitant medication details were not provided.  On 03-Nov-2020, RabAvert vial was affected by temperature excursion (Product storage error).  On 04-Nov-2020, the patient received dose of RabaVert (Inactivated Rabies Virus Vaccine, Batch no. ARBA731A) at an unknown dosage regimen for post-exposure prophylaxis, from the vial that was affected by the temperature excursion.  At the time of this report it was not known whether the patient developed any adverse event.  This case is linked whit cases US-BN-2020-019887 and US-BN-2021-000244 (same reporter).  Further information was not provided.; Reporter's Comments: Product storage error is listed by convention. Reportedly, the patient received RabAvert that was affected due to temperature excursion which is considered to be product storage error. No adverse events were reported. Product storage error is not related to the suspect product but to human action.; Sender's Comments: Product storage error is listed by convention. Reportedly, the patient received RabAvert that was affected due to temperature excursion which is considered to be product storage error. No adverse events were reported. Product storage error is not related to the suspect product but to human action.
first singrex last October, had shingles in December; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number ae2j4, expiry date 30th March 2023) for prophylaxis.   On 25th October 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In December 2021, between 1 and 3 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Linked case(s) involving the same patient:  US2022132048, US2022AMR136275   Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's comment: The patient self-reported this case. The patient received first dose of Shingrix last October and had a shingles in December. The patient got second dose today(on the day of reporting). The patient asked did he/she need another dose. Additional supportive information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule.   Follow-up information received on 13th SEP 2022. This follow-up was considered significant. Reporter's comment: The patient stated that she got shingles in December 2021 after she was getting the first Shingrix vaccine. Summary of Changes: The patient's demographics details, vaccination start date, patient route of administration, anatomical location, batch number and expiration date TTO details for shingles and narrative details were updated. The 2nd dose suspect with its events was deleted.; Sender's Comments:  US-GSK-US2022132048:Same reporter US-GSK-US2022AMR136275:Same patient- FU 1
First pregnancy, no complications. Estimated date of delivery: 12/14/2022. Stillbirth, no heartbeat detected. Induced labor on 10/18 3 lb 6 oz. No source or reason found for fetal demise.
Tachycardia.    I was injected on 4-3-21 at 2:15 pm in the left arm.  I was instructed to wait 30 minutes due to my given history of anaphylactic events.  I took one 25 mg Benadryl  and one 180 mg of Allegra one hour prior to the shot due to this history.  I was released at 2:45 pm and felt fine.  I went home and sat on the sofa to watch tv.  I sat there a couple of hours and thought I would take a nap since it was Saturday.  At 5:50 pm I felt my heart begin to race and could see the veins on the back of my hands pulsing and my jacket I still had on moving/jumping to my heart beat. I could hear and feel my heart beating too fast.  I got the pulse-ox meter that my husband has since he is an EMT and measured my resting heart rate to be 161 bpm.  It frightened me as the only other time my heart raced like that was during two other anaphylactic events.   I took 50 mg of Benadryl, got my epipens from my pocketbook and tried to breathe slowly and calmly.  After about 40 minutes my heart rate slowed to 125 bpm.  It took about two hours to reach a normal rate around 79 bpm.  I had it fluctuate all evening but not as high as 161 bpm.  I took more Benadryl as I went to bed.  The next morning my resting heart rate was between 90-115 bpm off and on through lunch time.
Patient has a long-standing history of cardiac issues (pulmonary hypertension and rheumatic mitral stenosis). He presented for follow-up in CT surgery clinic 4/5/2021.  At that time referred to ED for new onset atrial flutter, hypoxia, and hypotension. Admitted to ICU.    Platelet counts normal on admission. Patient started on heparin.    4/10/2021 platelet count dropped to low 60K and remained in this range. Differential diagnosis is heparin induced thrombocytopenia versus vaccine adverse event.
The evening following the shot - chills, sweating, muscle achiness, headache, fatigue   approximately  the week prior to March 27 I was very very very fatigued.   the following week still fatigued.  I felt a weird sensation near my heart that was only momentarily - like a bubble or something about 1/4 inch in length move through a vein near my heart - I think I felt it again near my stomach a few days later - weird.  and then my face felt like I was losing sensation - like it was tingling .  that lasted a little longer, like a sagging.  I thought maybe I put on weight.  i was concerned and went to pharmacy to get my blood pressure taken - which I have never done in my life.  I am 56!  They no longer do that bc of COVID - so I asked a nurse friend to take it. She measured 124 over 60 something.  that is high for me.  I am typically 106/62.  I checked my records.  I started running then - in case I have put on weight.  I am 155 (high).  But now I started getting a constant headache about a week ago.  I am in a new job - so have thought it was due to stress or I reactivated a concussion  headache.   i started taking  Ecotrim 2 everyday now.  I am NOT an aspirin taker and I do not get headaches.  I try not to take ibuprofen for the headache.  I am not sleeping.  I have slept well ALL my life up to now.  I go to bed late now like 11;30 and I don't sleep.  I have a lot on my mind.  so it could be that.  Under a lot of stress.  this just started the last week.  A very new pattern.  I started a new job 3/15/21.  I was drinking coffee for the first 2 -3 weeks and now am not drinking it.  I don't drink much alcohol but I have had 1 glass of wine on the weekend or beer.   I run about 3 miles 2-3 times a week.
reacted severely to the pneumococcal 23 and felt he/she was dying, whole body reaction; This spontaneous report was received from a physician via Pfizer (2019507561), and refers to a 66 year old patient of unknown gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.      On an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), for prophylaxis (strength, dose, frequency, route, lot number and expiration date were not provided).         On an unknown date, the patient reacted severely to the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) described as a whole body reaction and felt like dying (vaccination complication).      At the time of reporting, the outcome of vaccination complication was unknown.  Causality assessment was not provided.
10/19/06 late afternoon patient calls complained of very sore arm. 10/20/06 complained of fever and pain in arm. Patient to be seen. In office no fever, Left arm red, swollen, sweats and tender. Patient told to ice down and Benadryl every 4-6 hours. 10/23/06 followup in office visit. Left arm normal limits, increased redness, but resolving. No fever.
burning sensation in feet, neuropathy in feet and legs to calf muscle, neuropathy in hands and some occasional tremor
3/16/22 pt to ED via EMS; pt unresponsive; hypoxic with O2 saturation in 80s%; intubated; pt had a positive COVID test 1/23/22 per family and had been treated; pt became bradycardic and hypotensive; resuscitated; CT of head showed no acute abnormalities; CXR showed bilateral infiltrates; given IV ABX; Atrial Fibrillation treated with medication;  pt suffered another PEA arrest; ROSC achieved after 8 mins of CPR; pt then hypertensive and tachycardic; family decided no more CPR; pt expired in the hospital
arm was a little sore; experienced a sharp shooting pain on his lower right back at 3am; shoulder was a little sore; This is a spontaneous report from a contactable consumer (Patient) reported for himself. A 75-Year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date: unknown), via an unspecified route of administration, in left arm, on 11Feb2021 at 15:00, as a single dose for COVID-19 immunization at hospital. Patient's medical history included blood pressure and allergy. Patient's family history included stroke and high blood pressure. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) which was taking for at least 5 years and for severe allergies, cetirizine hydrochloride (ZYRTEC) which was taking for at least 5 years and for allergy, and Lisinopril for blood pressure. It was reported that on 12Feb2021, the patient experienced a little soreness on his left shoulder, but no more than having a flu shot. On Monday, patient mentioned that he awoke and experienced a sharp shooting pain on his lower right back on 14Feb2021 at 3 AM. Patient also described the pain as if someone has stabbed him and recall having a dream of being held at knifepoint. It "hurt like crazy" and he was unable to go back to sleep after he woke up with the pain. It was extremely painful that he could not sleep until 5:30 AM when his wife woke up and gave him Ibuprofen and Aspercreme. Patient wife applied an anti-inflammatory cream to his back and wrapped it. Patient said that he rested in bed and slept very heavily until late afternoon at 6 PM. After he awoke, he felt better, and the pain was gone. The pain returned again at Tuesday 1:30 AM but it was less and like "half or a third of what he experienced before". He took Ibuprofen and Aspercreme again. The pain was gone. He was unable state if the extreme back pain has resolved. It came back but was reduced. He was asking if this was a common side effect of the vaccine as he mentioned that he seems couldn't see the correlation with the vaccine, but this was so far out of the regular pains he was experienced. Patient's blood pressure was sliding in the upper 120's. The patient did not require physician office and emergency room visit. The patient did not receive any vaccine within four weeks. Outcome of the event shoulder was a little sore was recovered on 12Feb2021 and for all other events, it was unknown.   Follow-up attempts are completed. Information on the Lot/Batch number has been requested.
Had flu vaccine admin - First time receiving vaccine. Developed chills, increased temp, aches & tight feeling approximately 2000 11/1/10 - 6 hrs after receiving injection. Rt arm sore.