chrisvoncsefalvay/vaers-outcomes huggingface dataset:
when he got his vaccine he got very ill from both shots; This is a spontaneous report from a contactable consumer (patients mother) reporting for A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single dose, dose 2 via an unspecified route of administration on an unspecified date as 2nd dose, single dose for covid-19 immunization. The patient's medical history included Reporter stated that son (patient) had Covid, his wife and his son. He was very, very bad but he was quarantined and in the house, that had been a while back. and concomitant medications were not reported. On an unspecified date, the patient was very ill from both shots. When he got his vaccine he got very ill from both shots. The outcome of event was unknown. Patient relevant information added to the narrative and rest of the information was in cross linked case for the respective patient. Information on the lot/batch number has been requested.
Constant headache above eyes and occasional nausea since shot. started with 400 mg ibuprofen/ 8 hrs to no avail. Tried adding 625 mg tylenol/ 6 hours. headache would dull but never disappeared. Also took a generic daytime allergy pill in the mornings. Ibprofen would dull the pain but as soon as it wore off, head would start throbbing - to the point that it would wake me up. 3/10 had phone appointment and was prescribed imitrol 50 mg and 800 mg of ibuprofen. No relief provided. 3/11 went to urgent care. Was given fioricet with no relief. Then given zofran and percocet. again headache was dulled, but still there.
Patient is a local physician who came to facility for H1N1 vaccination. States he has been getting "ophthalmic migraines" per report since shortly after receiving injection. Reported to this office on 11/25/09 (a.m). Stated migraines were beginning to subside.
received april 5 2021 second pfizer shot in left arm and within 10 days acquired a hissing/ringing noise in my left ear. subsequently i went to ENT/audiologist and was told no hearing loss and almost normal . when i press on my temple or around my head the sound increases. ive had to take anti anxiety and see a therapist to deal with problem
got the flu; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via agency through social media on 01-Dec-2020  This case involves a adult patient who got the flu (influenza) , while the patient was treated with  INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, past vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiry date not reported) at an unknown dose via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date (latency unknown) after starting the suspect vaccine therapy, the patient got the flu (influenza).  It was reported that the patient get the vaccine every year in the month of October and she did not have the flu that bad that she would have it if she did not get the flu shot and the patient was glad that she get it every year.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of the reporting , event outcome was unknown .  There will be no information available on batch number for this case .
Hives rash, transient over the entire body. Treatment cetirizine 20mg daily, famotidine 40mg daily.  As of 11/24/2021- the rash is improving but not completely gone.
Sudden severe vertigo upon waking up on 4/14,   Had to lay on back and was ok, took 2hrs to go away.   Have similar but much less severity every morning for short time.  Throughout day still feel "off" and not perfect.  Also noticed tinnitus seems worse since all day long.   Blood Pressure, O2 level and pulse all seemed normal during vertigo spells.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: EL9265), in right arm, on 03Mar2021 as dose 2, single (Lot number: EN6206), in right arm and on 08Oct2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Alopecia" (unspecified if ongoing), notes: other medical history: alopecia. Concomitant medication(s) included: TYLENOL, start date: 27Apr2022, stop date: 29Apr2022; FINASTERIDE, start date: 01Sep2021. Past drug history included: Prednisone, reaction(s): "Known allergies: prednisone", notes: known allergies: prednisone. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) Positive; (2022) Negative, notes: I tested negative about 10 days after my first positive test; (2022) Positive, notes: I tested negative about 10 days after my first positive test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Paxlovid antiviral treatment for COVID 19 were started from 28Apr2022 to 03MAy2022, Lot number NDC:0069-1085-30, the patient taking other medications/products within 2 weeks of starting COVID-19 treatment of multivitamins. Patient tested negative about 10 days after her first positive test and about 5 days after her last Plaxovid then tested positive 2 days later on 09May2022 at 08:00 AM.  No follow-up attempts are possible. No further information is expected.
injection site discomforts pain, redness, inflammation, swelling and warmth to the injection site
Client complaining of lower abdominal pain, emesis. Hospitalized from 9/17/00 to 9/22/00. Had surgical consult. Afebrile, no pain or swelling at injection sites. MD told pt it could be shot related.
Patient reports an increase in her hemiplegic migraine following the first dose of covid-19 vaccine. On 11/1/21 had hemiplegic migraine for about 8-10 hrs which involved intense head pain, losing her vision, vomiting and Rt side paralysis (cheek, tongue, arm and leg all on Rt side). Then for 2-3 days after the start of the migraine she will then have debilitating symptoms. Treatment: 3 tab tylenol 500 mg, 1 zofran 4 mg sublingual,  And 1 tab prochlorperazine (compazine) 5mg tab.  Patient reports an increase in her hemiplegic migraine following the first dose of covid-19 vaccine on the following dates:  11/1/21, 11/3/21,  11/4/21, 11/8/21, 11/12/21,  11/15/21, 11/18/21.  Prior to vaccine hemiplegic migraine occurring 1-2 times per year.
Case number PHEH2015US009845 is an initial spontaneous report received from a consumer on 19 May 2015 with a follow up information received from the consumer on 20 May 2015. This report refers to a 60 year old male patient. His medical history and concomitant medications were not reported. His vaccination history included complete post exposure series with RABAVERT, (batch number: not reported) 5 years ago after a bat attack and he experienced headache, feeling of heaviness in arms, weakness and soreness all over the body and tingling (see related case number: PHEH2015US010209). He had a bat exposure and was vaccinated with first dose of post exposure RABAVERT, (batch number: 556011A) intramuscularly on 12 May 2015 at 10:40 AM. On the same day, within hours after the administration of first dose, he felt weakness, headaches, feeling of heaviness in arms and soreness all over the body (not only limited to injection site). The consumer did not seek medical care or informed physician about the event. The events outcome, seriousness and causality were not reported. He was further vaccinated with second dose of post exposure (batch number: 556011A) intramuscularly on 19 May 2015 and experienced tingling (see related case numbers PHEH2015US010210 and PHEH2015US010211 (for schedule deviation)). No further information was provided.
Patient received second dose of the moderna Covid-19 vaccine 7days early. Patient was observed for 15 minutes  after receiving the dose. No adverse reactions occurred during that time.
receive an expired dose of Menveo; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA260A, expiry date 31st March 2021) for prophylaxis.   On 2nd June 2021, the patient received Menveo (intramuscular). On 2nd June 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional case details were reported as follows: The age at vaccination was not reported. The patient inadvertently received an expired dose of Menveo in the left deltoid. As per sales data sheet reported batch number was changed from AMAA260A to AMVA260A. The reporter consented to follow up.
auto-immune encephalopathy; acute respiratory failure; refractory status epilepticus; dose 2: 26Jul2021, dose 1: 05Jun2021; This is a spontaneous report from a contactable nurse. A 40-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 26Jul2021 11:15 (lot number: EW0217) at the age of 40 years as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 intramuscular on 05Jun2021 (lot number: EW0191) at the age of 39 years as single dose for covid-19 immunisation. Adverse event concerned for auto-immune encephalopathy, acute respiratory failure, refractory status epilepticus. Adverse event start date was 30Jul2021. AE resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Treatment was received. AE treatment plex for autoimmune encephalitis. Covid tested post vaccination, test type post vaccination=Nasal Swab on 07Aug2021, negative. Outcome of events were not recovered.; Sender's Comments: Based on the available information in the case, the causal association between the events autoimmune encephalitis, acute respiratory failure, status epilepticus and the suspect drug BNT162B2 cannot be excluded. 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.
8/4 RECEIVED PHONE CALL FROM MOM REPORTING A QUARTER SIZE AREA ON BACK OF LEFT ARM. DENIES WARMTH, BLISTERING, PEELING. ADVISED TO USE OTC MOTRIN AND COLD COMPRESSES AND IF NO IMPROVEMENT TO TAKE TO FAMILY DOCTOR SINCE OUR CLINIC WAS CLOSED 8/5. ASKED MOTHER IF SHE NEEDS TO TAKE CHILD TO DOCTOR TO LET CLINIC KNOW. 2ND PHONE CALL FROM MOM ON 8/11 REPORTED SHE TOOK CHILD TO FAMILY DOCTOR BECAUSE AREA ON ARM INCREASED TO BASEBALL SIZE, HOT TO TOUCH, PAINFUL. DENIES ANY OTHER SYMPTOMS. REPORTED WAS GIVEN CEPHALEXIN FOR 10 DAYS AND BENADRYL. REPORTS STILL TAKING MEDICINE AS ORDERED BUT SX GONE.
Patient presented to pediatric urgent care on 9/10 with increasing difficulty walking x 8 days. Patient described crampy leg pain, paresthesias and decreased sensation beginning in his lower extremities on 8/30/07 at which time he call urgent care and was told it was muscle pain and would resolve on it's own. It progressed to involve upper extremities as well as a facial droop. On presentation on 9/10/07 barely able to walk with crutches, currently unable to ambulate for more that 3 steps with out assistance. Heart Rate 130, BP 157/80 and afebrile. No history of previous infection or diarrhea. Diagnosed with Guillain-Barren and started on IVIG 48mg IV Daily x 5 days after LP. Currently on 3/5 of inpatient treatment.    10/16/07 Reviewed hospital medical records of 9/10-9/17/2007. FINAL DX: Guillain Barre syndrom in context of recent Menactra immunization; obesity; paresthesias; weakness.   Records reveal patient experienced pain in his legs & difficulty walking, weakness of arms, numbness of lips, tearing of right eye, facial droop.  Symptoms progressed from onset 8/30/07 until admitted.  Exam revealed HA, dark urine, weakness.  Neuro & endocrinology consults done.  Tx w/IVIG x 11 doses.  LP done under fluoroscopy.
pt recvd vax;3 days later exp erythematous rash on inner thighs especially on lt side;rash was tender to touch;exp muscle pain in both legs; seen in er; tx w/ dph,zinc oxide ointment & cephalexin;
Sore upper arm developed late afternoon/evening on 1/13/13. I went to bed around 11 pm & woke up around 2:30 am super cold with teeth chattering. I could not get enough blankets on me to warm up. I fell back asleep. I woke up again around 4 am & when I got up I was dizzy, had headache & was nauseous. I went to the bathroom then to the kitchen to take a Tylenol. While at the sink taking Tylenol I developed very strong heart racing/pounding like my heart was coming out of my chest. I then felt like I was going to faint but made it to a couch and after laying down the heart racing & fainting feeling  went away. After about 10 minutes, I returned to bed. When I woke up the next morning around 8 am I was dizzy & light headed when I got out of bed. I felt better when I laid back down. The same thing happened when I got up again later in the morning. I decided to look at my iWatch to check out my sleep & heart &  then realized that every time I stood up after reclining my heart beat would increase 30-50 beats. This has continued since 1/14/23 although I have been able to manage it somewhat by drinking huge amounts of water with Liquid IV and a lot of salty food. Yesterday my heart rate increased to 165 & I've called my doctor. I visited him about a week after all this started and he said to contact him again if in two weeks my symptoms persisted. He was hopeful my apparent reaction to the vaccine would just go away.
Patient is complaining of painful arm which she is unable to lift and keeps her awake at night.
experienced difficulty breathing; This non-serious case was reported by a physician via sales rep and described the occurrence of difficulty breathing in a adolescent female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced difficulty breathing (Verbatim: experienced difficulty breathing). The outcome of the difficulty breathing was resolved.   It was unknown if the reporter considered the difficulty breathing to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the difficulty breathing to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 26-JUL-2023 A physician reported that a patient received Bexsero and then later experienced difficulty breathing that required a visit to the emergency Department.  The reporter consented to follow up.
Typical injection site pain and mild swelling in right arm on day of injection.  Also reported pain at site of COVID 19 (Johnson & Johnson) vaccine administered on 3/16/21 in left arm and severe hip pain.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was reported. On an unknown date, the patient was vaccinated with the second dose of PNEUMOVAX 23 (strength, route of administration, anatomical location, lot# and expiration date were not provided). It was reported that the first dose of PNEUMOVAX 23 was administered at "age 61 years" and the second dose "4 years 11 months after the first dose".  No adverse effects were reported.
Patient has h/o essential thrombocythemia. Following vaccination, he developed immature white blood cells with signs of progression to myelofibrosis.
had a reaction to the product and the product has gluten in it; Initial information received on 02-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves patient with unknown demographics who experienced reaction to the product and the product has gluten in it (reaction nonspecific), while patient received vaccines MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and MENINGOCOCCAL VACCINE B RFHBPA/FHBPB [TRUMENBA].  Medical history, medical treatment, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number and other dosing details were not reported) via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect TRUMENBA (not produced by Sanofi Pasteur) (lot number and other dosing details were not reported) via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious had a reaction to the product and the product has gluten in it (reaction nonspecific) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and TRUMENBA.  It was unknown TRUMENBA has been prescribed to the patient who had a reaction to a product with gluten in it  Details of laboratory data not reported.  Final diagnosis was reaction nonspecific.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as Unknown for reaction nonspecific.  Information on the batch number was requested.
Having difficulty raising arm over my head, off to the side and behind my back. Had an X-Ray  of left shoulder on June 17,2022. No results as of yet. Will be getting physical therapy. Not sure how long it will take to heal.
Fever to 104.4 about 24 hours after vaccines. Seen in ER - no labs or treatments given, recommended fever tx.
Patient had low grade fever beginning 8/27/07 of uncertain origin.  Was treated with Amoxicillin for uncertain reason with no response.  On 9/3/07 he had several seizures with clonic movements and some perioral cyanosis.  Taken to ER and given Ativan.  Hospitalized for one day and then released.  /8/2008 MR received for DOS 9/3-6/2007 with D/C DX:  Complex Febrile Seizures. Child presented to ER in status epilepticus and respiratory distress following a 2 day hx of fever. At home pt had a 5 miute seizure consisting of mouth twitching, drooling, and eye blinking with R arm and leg clonic movements and perioral cyanosis. IN ER another seizure lasting >20 minutes.  Pt was intubated. Rash and posturing noted. Pt weaned to RA 9/4/07 and back to baseling prior to d/c.
Covid19 breakthrough.  1st vaccine on 01/14/2021.  Pt states had booster on 10/10/2021 but lot # not available.  80 y/o presents to ED with 4 day history of shaking, incoherent speech, increased confusion, hallucinations, decreased oral intake and sleeping more than usual.  T-101.5 and Urine/Blood cultures + for Staph Lugdunensis.  CXR no acute and Room air sat 98%.  Started IV ABX/Steroids.
Redness, swelling at injection site. 10 hours post injection, headache, shivering, stomach pain, vomiting, bowel movements for 4-5 hours. (1st injection in Feb 2023 only had redness, swelling at site)
My daughter received the Moderna vaccine in error.  The vaccine she was intended to receive was the Pfizer vaccine due to her age <18
dec in muscle tone, persistent unconsolable crying was very faint; did not move, would sleep alot; sometimes fever; slowly lost weight, would not move, pale, neck skinny & wrinkled; pt would cry all day; faint & hoarse;
This spontaneous report as received from a patient's friend refers to the 67 year old female patient with osteoporosis. The patient's medical history included thyroid disorder and thyroid surgery. "About four years ago", in approximately August 2009 the patient was vaccinated with ZOSTAVAX (lot # not reported) (strength and total daily dose not reported). Concomitant medication included unspecified "osteoporosis shot". "Sometime in June, 2013", the patient developed shingles after receiving ZOSTAVAX. It was unspecified whether the patient sought for medical attention. Unspecified "anti-viral medication" was given as treatment. The outcome of shingles was unknown. Additional information has been requested.
Arthritis of left ankle with effusion.  Admitted to hospital.  Tap of joint negative for infection.  Started on anti-inflammatory medication.  Arthritis thought to be post-viral and not related to vaccines.
At 10:00 am the Patient complained of burning in the chest (esophagus area) and reported 3 out of 10 on the pain scale. Vital signs: O2 96%, HR 95 bpm, Temp 97.1 degree F, BP 104/71. Patient does not have underlying diseases nor does the patient take medications.  10:12 am patient states they are feeling better and was released 10:16 am.
Headache, Myalgia, Arthralgia & Fever Narrative: Pt reported "Chill, shakes, tremors, and increased temp (highest noted 101.8), extremely sore/ sensitive arm, and headache. I took two doses of Tylenol to control the fever/ headache."
MILD HEADACHES IN THE BACK OF HEAD; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-JUN-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On NOV-2021, the patient experienced mild headaches in the back of head. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from mild headaches in the back of head. This report was non-serious.
20 minutes s/p vaccine administration client stated that she felt pain in her arm, shellfish, corn, wheat, strawberries, oranges, pet dander, grass.  Client initial BP hypotensive and recovered on second BP to baseline.
Redness, itchiness, slight swelling and tenderness at injection site that ended up covering my entire upper arm.
Patient  was due to receive Moderna Vaccine, but was given Pfizer vaccine instead. Mistake was recognized about 15 minutes after dose was given.  This was supposed to be the second dose of the moderna Series. Counseled patient that they should still receive an immune response