chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Experienced unusual tinnitus/whooshing sound in right ear which lasted an hour, about 2 months after second dose. My child experienced something similar 2 weeks after her second dose, and my mother has experienced hearing loss in one ear 2 months after her second dose.
Abnormal heavy menstrual period for 7 hours.  Changing soaked tampon 20 minutes.  In emergency room Platelet count 2K.  Hemoglobin 9.2 dropped from 12.9 in 1.5 hours. Diagnosed with thrombocytopenia.  Given immune globulin and platelet transfusion.
pt recvd vax;local rxn in deltoid that was red & hot;hand started to swell & redness devel in the antecubital area & was assoc w/ petechiae on arm;sed rate moderately elev;no inc in WBC;
SEVERE vomiting, diarrhea, low grade fever, aches, headache, cold sweats over 48 hours. Water & Tylenol - finally able to be taken after 30 hrs. Gatorade & saltine crackers - after 40 hrs.
Began to feel nauseated, feverish, diarrhea began until 04/18/12, fever broke 04/14/2012.
pt recv vax 15DEC95 & devel 3 to 4 very tiny vesicular type lesions on face, which disappeared w/in 24hrs;On 22DEC95 pt devel a gen vesicular rash around hip;area grew the size of a fifty cent piece & was filled w/100 tiny vesicles;
Less than 24 hours, post vax, had onset of painful aphthous oral ulcerations; punctuate, shallow erosions on inferior/lateral tongue (Seen on day #3 of symptoms). Similar reactions reported with 2 previous flu shots. (Wyatt Flu shot-lot 4008209 at age of 26 and Connaught Flu shot-lot U0135AA at the age of 25)
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jan2021 as dose 1, single (Lot number: EL9269), in left arm, on 26Jan2021 as dose 2, single (Lot number: EN6205) and on 03Oct2021 as dose 3 (booster), single (Lot number: FF2559), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Heart issues" (unspecified if ongoing). Concomitant medication(s) included: Eliquis; Torsemide; Olmesartan; Metoprolol. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: on 11th day after testing positive and taken the Paxlovid woke up with severe cold symptoms. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical course: patient age group was elderly (65+ years), and current age was 74, current age units was months. She was vaccinated with other medication in 2 weeks anti viral drug like Paxlovid for COVID-19 treatment, with start date 11Jun2022 and stop date 16Jun2022. other medication details are she took Eliquis, Torsemide, Olmesartan, Metoprolol. on 11th day after testing positive and taken the Paxlovid woke up with severe cold symptoms. Have persisted since then. Cough, congestion, lost taste and smell, fatigue, no energy, with adverse event start date 21Jun2022 patient was not recovered, and treatment was received for the AE's methylprednisolone and Azithromycin. No follow-up attempts are possible. No further information is expected.
08/24/04 evening: red, sore right arm, 08/25/04 Ice and Motrin; tired, 8/26/04 stayed at Dad's; unknown symptoms, 8/27/04 3"x4" red site, very warm, looks like "bulls eye" looks "hivey".
Patient complains of redness and heat from injection site lasting 48 hours since injection. Informed pt to apply cold compress and to take TYLENOL and BENADRYL and if symptoms get worse to contact a dr.
sore arm for 48 hours after vaccine however the 1:30 AM 12/27, spiked a fever to 101.7 oral with generalized aches, pains and GI of  diarrhea, loss of appetite.  fever persisted for 48 more hours reduced fever by taking 220 mg naproxen every 12 hours.  Had COVID nasal swab 12/27 and again on 12/30  BOTH NEGATIVE.  No real respiratory symptoms.  No contacts at home with COVID.  Was not working since 12/23, wears surgical mask or N95 with all patient interactions ( patient is an allergist immunologist with medical group)
Fever, Chills, Joint pains, Headache, Fatigue, Hugh red and swollen left arm that is bigger than my hand. Rest, Aleve, Benadryl.
This case was reported by a nurse via call center representative and described the occurrence of fainting in a patient who received HAVRIX. On an unknown date, the patient received HAVRIX at an unknown dose. On an unknown date, unknown after receiving HAVRIX, the patient experienced fainting and dizziness. On an unknown date, the outcome of the fainting and dizziness were unknown. It was unknown if the reporter considered the fainting and dizziness to be related to HAVRIX. Additional details were provided as follows: The age at vaccination was not reported. On day of reporting, the patient fainted following administration with HAVRIX. The health care professional refused to provide further information with was ok with information being sent via postal mail. This case has been linked with case US2017GSK177429, as reported by same reporter for same events.
Pt describes swelling from shoulder to elbow.  Seen in ER where she lives.  Resolved slowly over 2 weeks.  No sequelae.
RECEIVED AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 54 year old male. 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: 1805031, expiry: 24-AUG-2021) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-AUG-2021, the patient experienced received an expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of received an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210931844 and 20210931810.
Started with pain in the abdomen then spread upwards into chest. Serve pain around ribs making it hard to breathe. Vomited and symptoms went away for ten minutes. Pain came back gradually in same spots. This was cyclical occurance and then just stopped.
awakened @ 4AM 30AUg94 w/hives, rash, itchiness; seen @ hlth ctr 30AUg93 1050AM t97.8, BP 114/80, P70; DPH ordered;
Patient with 4 COVID vaccines who admitted with COVID complications and a detected COVID PCR.  Provider d/c note:  "78 YO-year-old male with PMHX of Afib on eliquis, COPD, HFrEF 35%, HX of CVA(9/2022) not on DAPT, HTN, BPH who presented via EMS to due to complaints of increased weakness, shortness of breath, and cough.  Patient reports he started experiencing a fever with chills on Monday which have progressively worsened since then to include body aches, cough productive for clear to light yellow sputum, and sore throat.  Patient is a poor historian as much of his speaking was hard to understand at the time which according to patient's niece is his baseline.  Patient is vaccinated and denied any hospitalization for COVID any history.  Patient did admit to having a sick contact with the past week which was reportedly his son who he resides with.  At baseline patient is fully independent.  Patient did have recent admission (9/22) for CVA of left temporal frontal lobes as well as left parietal lobe no longer on dapt.  Patient otherwise denied any dizziness, lightheadedness, chest pain, palpitations, abdominal pain or any diarrhea/constipation   ED vitals:  Febrile 101.1 F, Tachypneic RR 22, 148/100, 86% room air ED labs: Cr:  1.3 HGB 11.7 BNP 13.1K Trope 47-- >56 lactate:1.7-- >0.7 procal:0.12              CXR: B/L airspace disease R>L has developed since 9/13/2022              RVP: covid +              EKG: Normal Sinus Rhythm  ED Course: Given DuoNebs En-route to emergency department, Lasix 40, Solumedrol, Ofirmev, Zofran.   Upon admission, Patient completed 4 days of Remdesivir and decadron. He is to continue Dexamethasone 6mg daily through 12/10. His respiratory status greatly improved and cognition at baseline after discussion with patient's son.  A walk test performed indicative of hypoxia upon ambulation to 84% with improvement of 1L Nasal cannula.. Patient is set up with Oxygen prior to discharge. He is to continue his home medications and follow with PCP. "
Came to office 8-13-12 with c/o fatigue, cough, tactile fever, muscle aches (arms & legs) started reportedly 8-8-12 Flu test (Neg) CBC WNL; sister with similar sxs (got GARDASIL on 8-6-12 as well) - came back to office on 8-30-12 with continued weakness; difficulty walking; paraesthesia areflexia exam decreased muscle strength lower ext sent to hospital R/O Guillain Barre syndrome at that time. Just got records from hospital today 9-24-12.
Very ill day after first dose. Weak, vomiting, fever Not quite as I?ll after second dose.   Blood sugar had consistently been running about 15 points higher since receiving the vaccine. Diabetes is no longer in remission.
Pfizer BioNTech COVID-19 Vaccine EUA: Vaccine Administration Error - Pediatric Formulation Patient received 0.2 ml pediatric dose of Pfizer vaccine, was then provided 0.3 ml dose of Pfizer on same day.
Information has been received from a consumer concerning her 17 weeks old son with no previous medical history and no known allergies who on 21-JAN-2010 was vaccinated PO with the first 2 ml dose of ROTATEQ (lot number not reported). On 25-MAR-2010, the patient was vaccinated PO with the second 2 ml dose of ROTATEQ (lot number 665022/1613Y). Concomitant therapy included hepatitis B vaccine (manufacturer unspecified), PREVNAR and PENTACEL (unspecified). The patient choked a little bit on ROTATEQ after in was given which cause coughing. The patient has had no further adverse reaction from the vaccine. There was no lab study performed. On 25-MAR-2010, the patient had recovered. Follow-up information received from a registered nurse concerning the 17 weeks old male patient with no illness at time of vaccination who on 25-MAR-2010 at 13:58 PM was vaccinated PO with the second dose of ROTATEQ (lot number 665022/1613Y). The baby was administered the vaccine by the registered nurse. On 25-MAR-2010, at 14:00 PM, the baby apparently choked on vaccine. The registered nurse did not feel it was necessary to document event or get physician to assess the child. The mother stated she was concerned that the baby possibly aspirated 'live vaccine", so she called the Company. The patient recovered on 25-MAR-2010. There was no adverse reaction reported after the patient left the office. Additional information is not expected.
Very severe headache that would not go away.; Fever; Chills; All over body pain; Extremely inflamed lymph node; Extreme fatigue; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received third (BOOSTER) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 19Nov2021 at 08:00(at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's disease, high blood pressure, high cholesterol. The patient was allergic to scallops. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), rosuvastatin calcium (CRESTOR), estradiol (ESTROGEN), multivitamin (MANUFACTURER UNKNOWN) and homeopathics nos (ZICAM); all for an unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Mar2021 at 10:30(at the age of 48-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Apr2021 at 10:30(at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 19Nov2021 at 19:00 the patient experienced very severe headache that would not go away, fever, chills, all over body pain, extremely inflamed lymph node, extreme fatigue.  Severe symptoms lasted longer than 24 hours. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events very severe headache that would not go away, fever, chills, all over body pain, extremely inflamed lymph node, extreme fatigue was not resolved at the time of this report.  The batch/lot number for BNT162b2 was not provided and will be requested during follow up.
This spontaneous case reported by a physician, describes the occurrence of administered expired product (administration of vaccine past 30 days in the fridge) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 035C21A) for COVID-19 immunization. No medical history reported. On Sep 24, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 24, 2021, patient administered expired product (administration of vaccine past 30 days in the fridge). At the time of the report, administered expired product (administration of vaccine past 30 days in the fridge) resolved. The reporter did not provide any causality assessments, concomitant medications or treatment information. Most recent follow-up information incorporated: On Oct 1, 2021: Corrected/updated date of birth.
Initial and follow up information has been received from a physician concerning a 5 month old female who on 09-JAN-2006, at "likely 5 PM"(exact time not specified), was vaccinated into the left thigh with the second dose of PedvaxHIB (Lot#652226/0655R). It was reported that the patient had been vaccinated with a prior dose of PedvaxHIB (details of the first vaccination date and lot number number were not reported) and no reaction. There were no illness at the time of vaccination. It was reported that less than 24 hours after receiving the vaccine, the patient presented with "hysterical crying" and was "inconsolable to parents". It was reported that the patient developed a "fever to 10.1 rectally" (previously reported that on an unspecified date, the child developed an "unusually severe reaction" involving "high fever", "inconsolable crying" and "red lumps at the injection site"). The physician reported that she saw the patient on 14-MAR-2006 and she "looked perfect". It was reported that the patient was fully recovered. The physician checked with parents of other children vaccinated with this lot number and they were fine. A lot check of concern has been requested. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. In addition, a review of the Quality control Quarantine/Rejection System revealed that there were no open Quarantines registered against this lot/fill. No further information is available.
Left arm (injection site) became red, swollen, hard, warm to touch and itchy the day after the injection was given. In 24 hours was the size of an egg, 48 hours hard area size of large egg (5cm) and redness and warmth 10 cm. States one week later hard area was size of large marble. Encouraged to apply warm compress to promote healing. States was very tired 2-3 days after injection.
This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 51-year-old female patient who received SHINGRIX for prophylaxis. On 19th July 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). In July 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm, erythema of extremities and injection site swelling. On 19th July 2018, the patient experienced intramuscular formulation administered by other route, underdose and syringe leak. On an unknown date, the outcome of the pain in arm, erythema of extremities, injection site swelling, intramuscular formulation administered by other route, underdose and syringe leak were unknown. It was unknown if the reporter considered the pain in arm, erythema of extremities and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The health care professional received the SHINGRIX vaccine subcutaneously instead of intramuscularly, which led to incorrect route of drug administration. The health care professional stated that the arm had an egg shell appearance and was red and sore. The health care professional reported possibly some of the vaccine may have leaked when they received the injection. The health care professional thought she received more than 0.5ml of SHINGRIX when it was administered. She thought it was a 1ml injection. She would follow up with pharmacy. Update to case details post call escalation. Clarification had been requested for verbatim egg shell appearance, validity of undedose with reference to quantity and replacement dose, If this case was associated with Pharmaceutical product complaint and overdose.
Post vax, the patient experienced a local site reaction on the arm. Unspecified medical attention was sought. Additional information has been requested.
Treatment:  PIV placed for anticipation of access.  Reviewed treatment plan, pt expressing desire if possible to avoid iv steroids to "not negate the efficacy of the vaccine."  Pt with previous reaction to vaccine administration 3/21 and 11/21. Pt premedicated with IV benadryl 25 mg and Famotidine 2 mg iv push.  NS fluids started on pt.  Vaccine administered in R deltoid without problem.   10:28  About 5 minutes after vaccine injection, pt c/o tingling in lips/tongue and new onset headache 6/10.  Pt also describes chest pressure as "a bus slowly loading up and driving upward."  BP and O2 sats stable. Pt given additional Benadryl 25mg iv and Epi 0.3mg IM in L upper leg.      10:45 Pt reports chest pressure is lighter but still states she can feel tingling and possible swelling in her lips and tongue.  Second dose of Epi 0.3mg IM given.   10:55 Pt continues to endorse mild chest pressure and lip/tongue tingling.  Pt's main discomfort is restless legs "convulsing and kicking like a seizure, but the rest of my body is not."  Third dose of Epi 0.3 mg IM given.  VSS and pt requests to not receive iv steroids unless absolutely necessary.   11:05 Call made to provider's office regarding pt's reaction and need for additional medication orders. PA-C in touch with Dr for additional orders.   11:45 Pt continues to c/o restless legs and continuous motion of arms and legs.  Able to ambulate in unit with SBA.  Fourth dose of Epi 0.3mg IM given.  Pt reports decreased pressure in her chest.   12:20 Pt states symptoms of restless legs and arms resolved.  Ambulating independently in unit.  States chest pressure gone and no difficulty breathing.  VSS.  Reports 4/10 headache and mild tingling in lips/tongue. Pt requesting to go home so she can rest.  Pt discharged home in stable condition
In the arm got the shot, I felt painful. I applied cooling pad to release the pain. I felt tiredness, muscle pain, chills and had fevers. I took bed rest for one day and drank a lot of water. The adverse symptoms were less severe than the first dose. Side effects were gone within one and half days after the vaccination.
booster; her girlfriend may never walk again from this; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "her girlfriend may never walk again from this".  Additional information: Reporter wants to know when Pfizer is going to say that Pfizer shots are not wonderful. Mentioned that she knows people got paralyzed and blood clots as soon as they took a booster shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Neuropathy in feet and legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000002895 (Novavax).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "Neuropathy in feet and legs".  Clinical information: On 05Aug2022, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 vaccine with an unspecified dose/frequency and unspecified indication. It was reported the patient experienced Neuropathy in feet and legs.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
received full dose as booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (received full dose as booster dose) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination.     The patient's past medical history included Heart disorder and Hypertension since an unknown date.    On 27-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Sep-2021, the patient experienced ACCIDENTAL OVERDOSE (received full dose as booster dose). On 27-Sep-2021, ACCIDENTAL OVERDOSE (received full dose as booster dose) had resolved.            No concomitant and treatment information were reported by the reporter