chrisvoncsefalvay/vaers-outcomes huggingface dataset:
18 hours after the first dose started to feel the ache; Fever; Site where I was injected it also swelled up, got red and itchy; Site where I was injected it also swelled up, got red and itchy; Right armpit swelling; that is gone; Little bit of a lump; she started to feel the ache and the flu and a fever; This is a spontaneous report from Pfizer-sponsored program. A contactable  female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730) at single dose for COVID-19 immunization on 22Dec2020 (reported as 18 days ago). Relevant history and concomitant drugs were unknown. The patient stated 18 hours after the first dose, she started to feel the ache and the flu and a fever. So, she was saying that before she received the vaccine 18 days ago, she was tested positive with COVID back in the last week of Oct2020 up to the first week of Nov2020. But she received the vaccine 18 days ago. The patient did not feel like she had the flu. The patient was scheduled to take her second dose on 09Jan2021 but she also want to mention that the site where she was injected it also swelled up, got red and itchy and she still had a little bit of a lump there. And she did not know if that was normal. She wanted to know if it was okay to go and get her second vaccine today (09Jan2021) with all of those symptoms.  The patient also had right armpit swelling but that was gone.  The outcome of event right armpit swelling was recovered, the outcome of other events was unknown.
This spontaneous report was received from a physician and office manager and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (dose, route of administration, lot# and expiration date were not reported). The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot# and expiration dte were not reported). No adverse effect reported.  Administered doses of vaccines experienced the temperature excursion between 47 and 77 degrees Fahrenheit for 2 hours. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA011670: US-009507513-1706USA011669: US-009507513-1706USA011671: US-009507513-1706USA011307:
Initial report received from a health care professional on 10 Feb 2011: This patient was vaccinated with MENVEO (batch number M10030) on 08 Feb 2011. The patient received only MenCYW-135 liquid conjugate component and did not receive MenA lyophilized component of MENVEO. No adverse event had occurred.
Patient told her mom that she thought she was losing her hearing and vision. Mom reports that the patient started to faint. Mom caught her and eased her down to the ground and held her. Patient regained consciousness immediately.
At 12:30 just prior to check out, Attendee voiced complaints of dizziness which had start 2 minutes after shot, but didn't say anything. Thought she could just wait it out'. Attendee requested Vital signs just before end of observation period.  Attendee's skin was warm and dry.  Attendee's respirations were not tachypneic or dyspneic. Attendee declined offer to cot and lie down, just sat and was getting sleepy like last time. Previously felt fatigue with first shot. Accepted juice box, water Vital signs stable 12:40- Attendee stated she felt better, no skin signs noted. Departed at 1pm
Patient was given COVID 19 vaccine that was 1 day past the 10 weeks refrigerator  expiration date.
Patient received accidental 3rd dose of vaccine 12-2022. (dose 1 and 2 of series completed 2020). Patient presented today (9-20-2023) to complete series when it was identified he actually received an extra dose last december. He states no adverse effects or issues from having had extra dose last december.
Heplisav-B Has Been Out of Temperature Range; Initial Report Received on 11-May-2022  An office front desk clerk reported that 5-10 patients (age, gender, race or ethnicity of patients were unknown) received HEPLISAV-B (hepatitis B vaccine) that was out of temperature range.  On an unspecified date, patient 5 received a dose of HEPLISAV-B.  Details of administration was not provided.   On 11-May-2022, an office front desk clerk reported that the HEPLISAV-B vaccine (Lot # 935845 and NDC # 4352-8003-05) has been out of temperature range since Dec-2021, with an average temperature of 11-12°C. This affected 5-10 patients, but they had no information on them at time of report.   No further information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
injection site pain; chills; flushing; tired; unable to sleep; It felt like I had a fever but my temperature did not go above 98.6.; This is a spontaneous report from a contactable Other HCP. A 30-years-old female patient (Other HCP) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL1283) via an unspecified route of administration on 26Jan2021 at single dose for Covid-19 immunization. Medical history included panic attack from an unknown date and unknown if ongoing and not known drug allergies (NKDA). The past drug included received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EJ1685) via an unspecified route of administration on 05Jan2021 10:30 AM at single dose for Covid-19 immunization. The patient's concomitant medications included multivitamins (Smartypants) and birth control. As per adverse event description, 14 hours after the injection on 27Jan2021 at 03:00 AM, she began to have injection site pain, chills, flushing, tired/unable to sleep. It felt like she had a fever but the temperature did not go above 98.6. The outcome of events was not recovered.  No follow-up attempts are possible. No further information was provided.
The child received Pentacel vaccine instead Prevnar 13/ no adverse event; Initial information received on 11-Apr-2019 regarding an unsolicited valid non-serious case received from a Nurse. (case was Forwarded by Pfizer).   This case involves a eight months old male patient (70 cm and 8.16 kg) who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (formulation Suspension for injection) (lot: C5517AA, expiry date: 15-Sep-2019) via intramuscular route in the left thigh instead of PREVNAR 13 (formulation: unknown) on 09 Jan 2019.  The patient's had no past medical history and had no family history and did not receive any concomitant therapy.   It was an actual medication error due to wrong vaccine administered.  It was unable to clarify if Pentacel was included in the temperature excursion with Prevnar 13.  The patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mild, Additional Details: Patient experienced reaction with 1-2 minutes after administration. Patient was given water and she started feeling fine after
Slight chills and some body aches, mild headache, all starting at night. Sore arm at injection site reaction. Vaccine was administered around 10am. Went to sleep and woke up with more severe headache, took Naprosyn, headache resolved. Chills and body aches were gone after sleeping. Some fatigue also present after waking up.
NURSE ADMINISTERING VACCINE ADMINISTERED SOME DOSES AS INSTEAD OF FOR BOOSTER. WHEN ERROR WAS REALIZED SHE WAS UNSURE WHICH PATIENT RECEIVED THE WRONG DOSE. THIS PATIENT MAY HAVE RECEIVED WRONG DOSAGE.
Patient presented with chest pain that started the day after his Covid booster vaccine. He was found to have elevated troponin (EKG non-ischemic, no arrhythmia; BP and HR normal) and was diagnosed with myocarditis. No other possible cause of myocarditis was found. Specifically, he had no illness or sick contacts in the preceding weeks,  a viral RNA PCR panel was negative (including Covid, Influenza A H1, Influenza A H3, Influenza B, RSV A, RSVB, Parainfluenza 1, Parainfluenza 2, Parainfluenza 3, Rhinovirus, Metapneumovirus, Adenovirus), HIV was negative, and he had no signs/symptoms/history of rheumatologic disease. His pain is improving without treatment. He has no s/sx of heart failure.  A TTE was completed, result pending.
Seconds after both vaccines had been given patient turned pale, felt dizzy, and her eyes rolled back. She never lost consciousness, but was pale and lethargic for about 15 minutes. She also complained of headache which we treated with Tylenol once she was alert and interactive. On further history, she had not eaten much lunch or drank much fluids throughout the day. She was monitored for about 45 minutes following vaccination. During that time she drank 2 juice boxes and a bottle of water, ate an ice pop and a few cookies. She slowly improved and was back to baseline and able to walk out of our office without assistance by 4:13pm. I spoke with her mother at 5:30pm that evening and she reported patient active, back to her usual self.
8DEC93 pt started running fever; day p/vax had vomiting p/meals & drinking fluids for the wole day; also had jerking of legs, arms & eyes twitching;
Two weeks after vaccination he developed pruritic itchy papules on the elbows and sore pink macules on the lateral digits.
Patient's right under arm was swollen and tender to the touch. Patient went to ER and was told that is was a normal side effect to this year's flu vaccination.  Patient was advised to take Benadryl as needed.
This spontaneous report was received from a nurse refers to a patient of unknown age who one year after received the first dose of MMR II, on an unknown date, was vaccinated with the second dose of MMR II before he reached age of 4-6 as per prescribing information. No adverse effects were reported. Additional information has been requested.
pain; This case was reported by a consumer via call center representative and described the occurrence of pain in a 56-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season (intramuscular). On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR224679:same reporter US-GLAXOSMITHKLINE-US2020222182:same reporter
Information has been received from a pharmacist concerning an approximately 50 years old female registered nurse with history of chickenpox as a child and allergies and takes diphenhydramine hydrochloride (Benadryl) as and when needed who administered a dose of Zostavax.  It was reported that on 25-Aug-2007 the patient experienced lower abdominal pain for 2 days.  On the third day the patient developed blisters on her lower abdomen.  The patient was seen at office and was diagnosed with shingles.  The patient was treated with acyclovir tablets and cream for 10 days and pregabalin (Lyrica) for pain.  It was reported that the patient's lesions had healed but they were still discovered and she still had pain in the lower abdominal area.  At the time of report the patient had recovered from shingles but not from lower abdominal pain.  A product quality complaint was not involved.  This is one of several reports received from the same source.  Additional information has been requested.
Anaphylaxis swelling of tongue enlarging mass left angle of mandible > right angle of  mandible almost like parotitis acute both sides Narrative:  6 days after 2nd dose of Pfizer covid 19 vaccine, fullness on both  ears, 10days started to see swelling and a huge round mass at the angle of  mandible Left >right. Tongue swollen, back of throat swollen->called 911 arrived  at Hospital and given cocktail of Solu-medrol iV push, Famotidine iv  AND Diphenhydramine drip. CT with contrast neck and sinuses normal . Benadryl  25 mg q 6 ohours, Medrol dose pack, Famotidine tab for 6-7 days . F/up with ENT  2/5/2021
Client complained of being "dizzy and lightheaded after vaccine administration while sitting in observation. B/P 140/80 and 138/88. Skin warm and dry to touch.  No other complaints. Client given orange juice and crackers and was discharged home accompanied by family member.
nose bleeds; darkening in the stools; extra dose administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EPISTAXIS (nose bleeds), FAECES DISCOLOURED (darkening in the stools) and EXTRA DOSE ADMINISTERED (extra dose administered) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced EXTRA DOSE ADMINISTERED (extra dose administered). On 18-Sep-2021, the patient experienced EPISTAXIS (nose bleeds) and FAECES DISCOLOURED (darkening in the stools). On 17-Sep-2021, EXTRA DOSE ADMINISTERED (extra dose administered) had resolved. At the time of the report, EPISTAXIS (nose bleeds) and FAECES DISCOLOURED (darkening in the stools) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment drug was reported No concomitant product reported  It was reported that patient received the 1st dose in 20 Mar 2021 with lot 044a21a, 2nd dose 23 Apr 2021 with lot 037b21a. The symptoms were ongoing but they were getting better.  Company Comment : This case concerns a 54-year-old, male patient with no previous relevant medical history reported, who experienced the unexpected events of epistaxis and Faeces discoloured. The events occurred 1 day after the third dose of mRNA-1273. The rechallenge was not applicable. The reporter assessed the events as possible. The benefit-risk relationship of mRNA-1273 is not affected by this report.  Events seriousness were downgrade due there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.; Sender's Comments: This case concerns a 54-year-old, male patient with no previous relevant medical history reported, who experienced the unexpected events of epistaxis and Faeces discoloured. The events occurred 1 day after the third dose of mRNA-1273. The rechallenge was not applicable. The reporter assessed the events as possible. The benefit-risk relationship of mRNA-1273 is not affected by this report.  Events seriousness were downgrade due there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.
this spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient was vaccinated with RECOMIVAX HB (lot # was reported as 0384AE and expiry date was 02-NOV-2014, route and dose were not reported) that was exposed to 25 Fahrenheit for an unknown period of time on 13-NOV-2012. No concomitant medications were reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Follow up information was received from the licensed practical nurse who confirmed that none of the patients complained of any adverse experiences after receiving the above vaccines that had been stored incorrectly. Additional information is not expected.
the patient got a partial dose as most of the vaccine leaked out; most of the vaccine leaked out and ran down her arm from the injection; Initial and follow-up information received on 23-Sep-2020 regarding an unsolicited valid non-serious case from a health care professional.   This case involves a 72-year-old female patient who experienced that the injection site was different like the skin was harder and the patient got a partial dose as during administration, most of the vaccine leaking and running down her arm from the injection (exposure via skin contact and underdose) while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment, past vaccination and family history were not provided. Concomitant medication were not reported.   On 23-Sep-2020, the patient received a partial dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ478AA, expiry date: 30-Jun-2021) via intramuscular route in right arm as prophylactic vaccination.  It was reported that, the patient got partial dose (vaccine underdose) and that most of the vaccine leaked out. The patient's blouse was wet and her fingers were wet. The patient thought that it ran down her arm from the injection site (exposure via skin contact) (latency same day). Reporter was unaware as to how it leaked.  Reporter was requesting a time frame as to when the injection could be repeated safely. She stated in the past she was told to wait 30 days before re-injecting.  Laboratory details were not reported.  It was not reported if the patient received any corrective treatment.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Approximately 10 minutes post vax, mother brought child back into clinic area and stated that child was talking, holding onto her arm when she went "limp, eyes rolled back" and she hit her head on pavement. She was not moving. Pt immediately placed on exam table and immediately began crying, was alert and talking. Her color was pink and she was noted to have a slight scrape on right knee. There were no bumps or abrasions noted on head. Parents instructed to phone MD re: incident. At 5:15 PM, pt walked out without problems. Phone call at 6:30 PM revealed mother took pt to MD as she became "pale" on ride home. Nothing was found. Pt did have emesis but was playing without problems. Phone call on 8/17/01 revealed pt had decreased appetite, was complaining of stomach ache but was playing at child care with some fussiness.
Over the course of 2 months, I experienced stabbing pain in my head. I slowly loss my sense of awareness. 2 weeks after receiving the COVID vaccine, I experienced a sharp pain in my center brain/ forehead region. After this, I experienced decrease in cognition for approximately three days. I experienced ring in the ears for 3 months. Continued stabbing pain in the center of the forehead. Looks of cognition and consciousness. Headache/ migraines, feeling of being detached from reality/ no emotion. Pressure in the center of the forehead. Hallucinations (images), voice in the subconscious mind and confusion. The side effects were triggered approximately 2 weeks after taking the vaccine and last 3 months. Some of the symptoms were come and go, some maintained over the course of 3 months, The hallucinations and confusions, brain fog lasted approximately  3 weeks.
20 minutes after injection shoulder area started to become number at the injection site. 35 minutes after the injection my neck and face started to become numb.  As the numbness traveled from the injection site (left to right) across my neck and face, the numb areas became a "tingling" feeling on face, lips, chin and below the eye.  Again traveling from left to right (the injection was in the left arm). Day two the above symptoms have lessened but have not gone away.  Starting the same evening of the injection I experienced a progressively worse headache.  As of 4/13/2021 I still have some numbness and tingling on the left side of my lower face between my cheek and chin.  Headache is going away slowly.
Fever 104 f, 2-3 minute seizure, turned blue, Ar ER chest x-ray done blood work and urine samples.  Nurse follow up on 07/02/04 states: "ADD: febrile seizure."
This spontaneous report as received from a medical assistant refers to a female patient of unknown age. The patient was vaccinated with the first dose of RECOMBIVAX HB (lot# not provided) 1 ml intramuscular on 01-FEB-2012. No other co-suspects were reported. No concomitant medications were reported. On 02-AUG-2012 the patient received the second dose of RECOMBIVAX HB (lot# not provided) 1 ml intramuscular. No adverse event reported. It was unknown if the patient sought medical attention. Additional information is not expected.
Numbness both upper extremities, Nausea, Dizziness, Headaches, Face numbness right side
Two hours post typhoid administration, patient developed chest pain, (L) arm pain, swollen hands and diaphoresis. BP 240/110. R 76 P Ox 96%. Eval in local ER determined reaction to the typhoid injection. F/U with PCP/rheumatologist suggested.
Turned cold, with chills continuously shaking in 15-20 minute intervals like convulsions. Vomited violently all over, can't move, very weak, sweaty, wet.
chills; fever / fever varied between 100.2 and 100.9; diarrhea; muscle aches are located in the patient's back; night sweats; This case was reported by a consumer and described the occurrence of chills in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th April 2021, the patient received the 1st dose of Shingrix (intramuscular). On 15th April 2021, 8 days after receiving Shingrix, the patient experienced chills, fever and diarrhea. In April 2021, the patient experienced night sweat and muscular back pain. In April 2021, the outcome of the chills, fever and diarrhea were recovered/resolved. On an unknown date, the outcome of the night sweat and muscular back pain were recovering/resolving.   It was unknown if the reporter considered the chills, fever, night sweat, diarrhea and muscular back pain to be related to Shingrix.  Additional details were provided as follows: The fever varied between 100.2 and 100.9 degree celsius. The patient experienced night sweats and muscle aches a couple of nights before the date of reporting. The muscle aches were located in the patient's back.  The reporter consented to follow up.