chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEAVY BLISTER ON THROAT; HEAVY BLISTER ON MOUTH; HEAVY BLISTER ON SKIN; CRAMPS; SHAKES; FATIGUE; ALLERGIC REACTION; This spontaneous report received from a patient via a company representative concerning himself, a 75 year white old male patient. Initial information was received on 10-APR-2021 and processed with additional information received on 12-APR-2021 from the patient's son in law. The patient's weight, height, and medical history were not reported.  The patient received JANSSEN COVID-19 VACCINE (covid-19 vaccine ad26.cov2.s) (suspension for injection, route of admin not reported, batch number: 041A21A,  expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 between 1130am and 2.30pm for prophylactic vaccination. Vaccination site was not reported. No concomitant medications were reported.  On 09-APR-2021, the patient was admitted to the ER for an allergic reaction and variety of symptoms included fatigue, cramps, shakes, heavy blisters on skin, inside mouth, and throat. ER doctor mentioned that the appearance of symptoms were similar to Steven Johnson's syndrome but patient was not formerly diagnosed. Patient was discharged on 10-APR-2021 with steroids for the blisters.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of events heavy blister on throat, mouth, and skin, cramps, shakes, fatigue, and allergic reaction was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0-20210422654- Covid-19 vaccine ad26.cov2.s-Throat Blister, Blistering in mouth, Blister, cramps, shakes. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20210422654-covid-19 vaccine ad26.cov2.s Fatigue and Allergic reaction. These events are labeled per RSI and are therefore considered potentially related.
reported that he had a red bump on his right arm; the red bump was approximately 2" in diameter and is warm to the touch; This spontaneous report was received from a pharmacist refers to a 57 year old male patient. The patient's drug allergies were none. Patient's medical history and concurrent conditions were unknown.  Concomitant therapies included lamotrigine, pravastatin, lurasidone hydrochloride(LATUDA), albuterol sulfate(PROAIR HFA), metformin, zoster rge vaccine (mammalian)(SHINGRIX), montelukast sodium(SINGULAIR), gemfibrozil, latanoprost, tiotropium bromide(SPIRIVA), fluticasone furoate, vilanterol trifenatate(BREO ELLIPTA), prazosin and gabapentin. On 20-APR-2019, the patient was received 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # R028002 and expiry date 01-OCT-2020, route via subcutaneous in the right arm for prophylaxis.  Other suspect therapies included sterile diluent(1 dose, Lot number S003325 and expiry date 03-NOV-2019).  On 13-MAY-2019, after the therapy the patient reported that he had a red bump on his right arm which was also the same arm that he was administered the vaccine. The pharmacist noted that the red bump was approximately 2 in diameter and was warm to the touch(vaccination site erythema and vaccination site warmth). The pharmacist reported that the patient would be going to his physician today to seek medical treatment for the red bump. The outcome of vaccination site erythema and vaccination site warmth was reported as not recovered. Causality assessment was not provided. No additional information was provided.
On 09/07/2022 I received my 5th dose. On 12/10/2022 around 5:00PM. I felt feverish, fatigue, and cough. I called my doctor on 12/12/2022 but, they couldn't get me in till Tuesday. They did PCR test for COVID-19, flu, and RSV. It came out positive for flu. It was too late for TAMIFLU. I took TYLENOL, albuterol was prescribed by my doctor and cough medication. I took TYLENOL continuously till Saturday and other medication as per needed.
lung disease; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient. A 76-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, single; manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (dose 2, single; manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (dose 3 (BOOSTER), single; manufacturer unknown), for Covid-19 immunization. The following information was reported: LUNG DISORDER (medically significant), outcome "unknown", described as "lung disease". Therapeutic measures were taken as a result of lung disorder. Clinical information: the reporter considered the case as non-serious. She is concerned as she has a lung disease, has to wear oxygen all day, and other health issues. She mentioned that she had her 4th booster of the covid vaccine months ago but added that, it does not cover this particular variant.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
She went to ER due to one sided numbness/tingling, one arm became flaccid, half of face was numb, and she could not get her thoughts out.
Patient's leg (where shot was administered) doubled in size (for two weeks), the injection site was red, about 3" in diameter along with pink streaks radiating outward, large amounts of pain (causing the child to cry consistently), fever. Called the Clinic and talked to their on-call nurse since after hours (around 8pm). She said to give the child Motrin and we only needed to take her to the ER if she developed breathing issues; there was nothing that they could do and the swelling should dissipate in 2-3 days.
No adverse reaction. Patient previously received Janssen vaccine on 3/30/2021 and requesting Pfizer. Discussed pros/cons, recommendations, and potential outcomes. Patient expressed understanding and had first dose of Pfizer on 9/2/21. Well tolerated.
Injected with H1N1 vaccine. Developed redness at vac site and around neck and chest. Feel light headed, symptoms lasted about 1 hr. Headache developed later. TYLENOL 500 mg 1 PO with relief of H/A.
This patient received the Covid shot and has a primary coded discharge of U07.1 Covid-19.  Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation. Other diagnoses include: J18.9 - Pneumonia R77.8 - Elevated troponin
Information has been received from a medical assistant, referring to unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the unspecified patients were vaccinated with an improperly stored doses of ZOSTAVAX lot # M018453 expiration date 28-JUN-2017 (strength, dose, administration route and anatomical location were not provided) for prophylaxis. No adverse effects were reported. It was reported, that the vaccines had a temperature excursion of 9.0 Fahrenheit (F) with a time frame of 70 minutes, also, it was reported that no previously excursions occurred and a digital data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected because the reporter did not want to be contacted.; Sender's Comments:  US-009507513-1701USA013126: US-009507513-1701USA008029:
pt recv vax;09nov94 flu vax adm, on 15dec94, pt donated blood; Red Cross informed pt that blood tested pos for HTLV-1;
patient received an incomplete dose of Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 77-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 9994M, expiry date 21-MAR-2025) for prophylaxis.   On 24-OCT-2023, the patient received Arexvy. On 24-OCT-2023, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: patient received an incomplete dose of Arexvy). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 24-OCT-2023 A pharmacist reported that a patient received an incomplete dose of Arexvy which led to incomplete dose administered. The patient was still in the clinic. The reporter asked for guidance on this situation. The reporter did not consent to follow up.
tested positive in covid-19; tested positive in covid-19; This is a spontaneous report from a Pfizer-sponsored program  from a contactable Pharmacist. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. It was reported that the patient (the reporter don't know the name) got the 1st dose already and tested positive in covid-19. The patient asking if when he/she can take the 2nd dose. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Started with the inside of the left wrist as itching then became what looked like poison ivy; Started with the inside of the left wrist as itching then became what looked like poison ivy; Also had a severe headache a few days later.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Sep2021 11:00 (Lot number: 301358A) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Compounded PTSD" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "High funtioning autistic" (unspecified if ongoing); "fatty liver" (unspecified if ongoing); "kidney stones" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Leaky gut" (unspecified if ongoing); "concussion" (unspecified if ongoing); "Cerebral vascular disease" (unspecified if ongoing); "degenerative disc" (unspecified if ongoing); "restless limb" (unspecified if ongoing); "tremors" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes; "known allergies: Yes- topical iodine" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Dicyclomine, reaction(s): "known allergies: Yes-Dicyclomine". The following information was reported: PRURITUS (non-serious), DERMATITIS CONTACT (non-serious) all with onset 15Sep2021, outcome "recovered" (2021) and all described as "Started with the inside of the left wrist as itching then became what looked like poison ivy"; HEADACHE (non-serious) with onset 15Sep2021, outcome "recovered" (2021), described as "Also had a severe headache a few days later.". Therapeutic measures were not taken as a result of pruritus, dermatitis contact, headache.  Additional information: The patient not tested COVID post vaccination and not had other vaccine in four weeks.  Follow-up attempts are completed. No further information is expected.
Initial report was received on 12 July 2013 from a consumer, who is also the patient's parent. A male patient had received a pertussis vaccine (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later, (verbatim from the report) "had toxic levels of heavy metal in his brain and irritable, digestive issues and after he was five months old and he had a metal detox he got better a month after the first pertussis vaccinations his major outbreak was after his second vaccination." No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
PATIENT RECEIVED 2ND DOSE OF MODERNA VACCINE ON 3/29/2021. PATIENT EXPERIENCED SHORTNESS OF BREATH ON THE EVENING OF VACCINATION. ON 4/1/2021, PATIENT CALLED TO INFORM THE PHARMACY ABOUT SHORTNESS OF BREATH. PHARMACY INSTRUCTED THE PATIENT TO CONTACT HER PRIMARY CARE PHYSICIAN. PATIENT RECEIVED ANTIBIOTIC AND RESCUE INHALER FROM DOCTOR'S OFFICE ON 4/1/2021. PHARMACY COUNSELED ON THE CORRECT USE OF THE INHALER AND WILL CONTINUE TO FOLLOW-UP. AS OF 5:45 PM OF 4/1/2021, PATIENT STILL EXPERIENCES SHORTNESS OF BREATH.
2 days after receiving MMR, VARIVAX, Hep A (10/4/12) developed "red bumps "(L) armpit. Note: VARIVAX given (L) deltoid. Rash spread over next week to (L) upper arm, (L) upper chest. No fever. Not fussy. Office visit 10/15/12 - well appearing, afebrile with vesicular lesions on erythematous base (L) axilla, (L) medial upper arm, (L) upper anterior chest extending just to (L) sternal border. Not painful. Not pruritic. Dx - Herpes zoster. No meds indicated.
hx of migraine rare in life recent headaches no photophobia, not severe, no n/v states light, not to point of taking tylenol but had similar with covid also states a/w with lightheadedness on standing that might have been associated with blood donation that has since improved also intermittent right arm "heaviness" denies paresthesias or true weakness or dyspraxia states these sx are exactly what she experienced with covid dz and had them again following covid vaccine over last 10 days. initially not concerned as had head others with similar and states drank wine over weekend so attributed to this. neuro exam fully normal so less likely more serious issues such as mass, myelitis, but discussed our understanding of this disease and the vaccine are still emerging and she is the second patient I have met with headache and dizziness beyond day after the vaccine who had the virus priorly engaged in shared decision making about getting second shot given that this has effected her life and functioning and given there is some evidence in those who had the virus that one mRNA vaccine dose may result in levels commensurate to two doses in those who are virus-naive.  Pt to consider this.  discussed to be in close touch if symptoms evolve especially if focal weakness or increasing severity of headache. Offered meds such as migraine ppx for headache and pt deferred given headache is not terribly severe, more so she is seeking explanation offered covid testing as pt requested given sx so similar and when she had virus no clear chain of infection. advised isolation until test result available
tested positive; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (tested positive) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive). At the time of the report, COVID-19 (tested positive) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
Bump on shoulder where given, swelling, some facial numbness,  overall unwell feeling for 2 days +  second dose of shingrix. No rxn; were experienced during first immunization.
On 9/13/2006 patient went to emergency room at hospital after having a seizure.  She had a second seizure in th emergency room witnessed by emergency room doctor.  She was started on Cerebyx and had MRI.  She was slightly anemic she will have a follow up MRI prolactin level and TSH (thyroid stimulating hormone) done on follow up visits.  She was placed on DILANTIN 100 mg three times a day with follow up in three weeks.  Dismissed 9-14-06. 10/06/06-records received for DOS 09/13-09/14/2006 DC DX: Seizure activity related to meningitis vaccine. HX of Present Illness: presented to ER after having a possible seizure, received immunization day before ER visit. Began feeling funny this morning. Her roommate said she looked to the left and then collapsed to floor with a grand mal seizure that lasted less than two minutes. States she want non incontinent and did not bite her tongue, denies any trauma. Review of Systems: WNL. PE: WNL During ER visit while talking to physician she tells physician that she feels funny and gazes off to the left, she then begins a focal seizure on the left side of her body with complete loss of consciousness, she then has a generalized tonic clonic movement over the rest of her body. It lasted about 2 minutes. Treated with 1mg of Ativan, she had a normal post ictal phase. Suctions, placed on oxygen and loaded with Cerebyx 1 gram IV.
Information has been received from a licensed practical nurse concerning a patient of the parents of a 21 week old female who was vaccinated with a first and second oral dose of rotavirus vaccine (human-bovine) on 20-DEC-2006 (lot # 655174/0848F) and 21-FEB-2007 (lot # 656188/1238F), respectively. Subsequently the parents developed rotavirus (date unspecified). The parents outcome were unknown. There was no product quality complaint involved. Additional information has been requested.
Tiredness, severe insomnia, irregular menstrual cycle (6 days late and it's never late), sore arm for 2 days,  headaches; Tiredness; Severe insomnia; Irregular menstrual cycle; Sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the arm left on 25Mar2021 at 16:30 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history included latex allergy. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN) for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 at 17:30, the patient experienced tiredness, severe insomnia, irregular menstrual cycle (6 days late and it's never late), sore arm for 2 days and headache .The patient did not receive any treatment for the event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event tiredness, severe insomnia, irregular menstrual cycle, sore arm and headaches  was not recovered at the time of this report   No follow-up attempts are needed. No further information is expected.
Nausea, vomiting with meals x 3, low-grade fever 99 degrees oral, severe headache. Had n/v with flu vaccine in 2009 also. School nurse gave anti-nausea medication.
I woke up the next day (01/03/2021) with extremely swollen lips (3-4x normal size). I took Benadryl and eventually they went down overall several hours. 30 minutes after taking the Benadryl, I took a picture of them and sent it to Dr. When I went to work, Dr. consulted with Dr. (an allergist) who looked into it. She advised me to not get the second dose or booster of Pfizer or Moderna. Rather, to get the J&J vaccine. Initially I didn't get a J&J vaccine because the single dose of Moderna seemed equivalent to the J&J vaccine. So, when the boosters came out, I started looking for the J&J vaccine, but have not been able to find it in stock.
Information has been received from a physician concerning a 8 year old female who on 02-JAN-2009 was vaccinated subsequently with a 0.5ml dose of VARIVAX (Oka/Merck) (lot # 662455/1329X). There was no concomitant medication. On the same day of the vaccination, 02-JAN-2009, the patient experienced dizziness along with pain and swelling at the injection site after vaccination. The patient called the physician for medical attention. Subsequently, the patient recovered on an unspecified date. Follow-up information was received on 13-JAN-2009. It was reported the patient was 6 year old. Reporter was not sure if the patient recovered but noted that the patient had not called for a follow-up visit. This is one of several reports received from the same source. Additional information has been requested.
Chills; Bone aches; Minor HA; Diarrhea; Violent vomiting; A jaundice color of skin; This is a spontaneous report from a non-contactable pharmacist. A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3246), intramuscular on 12Jan2021 at a single dose for COVID-19 immunization in a hospital. The patient's medical history and concomitant medications were not reported. On 12Jan2021, the evening after the vaccine was administered, the patient experienced chills, bone aches, and minor HA that then worsened to explosive diarrhea and violent vomiting with a jaundice color of skin. The events resulted in a doctor or other healthcare professional office/clinic visit. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Child has approx 50 red lesions, mainly over the trunk & a few on the extremities.
instant arm pain followed by anaphylactic shock.  Shot given by nurse but Dr. called immediately. administered 'anti tetanus' shots, tourniquet on left arm, shots in both arms, crash cart,  3 hrs later, left facility with warning to NEVER get another tetanus shot.  I hope this becomes a place where Dr. and EMT, hospitals and etc. will use this facility to 'check before inject'  facility.
Fever of 102°F, headaches, fatigue, painful enlarged lymph nodes in left armpit.
covid positive 06/13/2022 june 28, 2022 Chief Complaint   Covid positive 3 weeks ago. coughing and bilateral ear pain continues  Subjective  Patient presents with complaints of bilateral ear pain and cough.  Endorses COVID positive 3 weeks ago, symptoms had improved but then over the weekend they came back.  Endorses right ear pain along with pain in right side of head, sinus pressure, non-productive cough.  Denies fever, sore throat, any sputum or nasal drainage.  Endorses she has been using Mucinex max with relief of cough and achiness, however ears remain sore and pruritic.  Physical Exam/Objective   Notes continued body pains with 'burning feeling' in her lower torso.  Face numbness when waking up in the morning.  History of Present Illness/Subjective      here today with above concerns.   Has had intermittent facial and body pain, numbness, tingling x's over 1 year.
Per Mother the child woke up this morning 8/5 with an red knot and inflamed area in the thigh where the vaccine was given.  The knot is extremely hard and inflamed.  The child was examined by the Doctor and Mom was instructed on how to handle the inflammation and what to do if it worsened.
Approximately 2 hours after receiving 1st covid vaccine I experienced chest pain, rapid heart rate, high blood pressure, chills, shakes, body aches.  I thought the symptoms would go away but they did not . I decided to seek evaluation at an urgent care facility the following day (11/20/21).   EKG performed showed Sinus Tachycardia with no acute ST. Blood pressure was 198/124, 197/134, 188/112. Resting heart rate was 112. Oxygen saturation was 99.  I have continued to have mild chest pain 2 weeks after 1st dose.
Vaccine admin error:  Administered expired Proquad vaccine  (had expired within a week before) making the dose invalid,  Patient/parent notified and will return to revaccinate with an appropriate dose in 3 months.