chrisvoncsefalvay/vaers-outcomes huggingface dataset:
OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned a 36 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient have no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 expiry: UNKNOWN) .5 ml, administered on 22-MAR-2021 at left deltoid for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of out of specification product use was not reported. This report was non-serious.  Additional information was received from physician on 29 /mar/2021 following information was updated and incorporated into case narrative: patinets date of birth, age group, age, unit dose, reporters details.
This is a spontaneous report from a non-contactable nurse via a Pfizer sales representative. A 19-year-old male patient received TRUMENBA (lot number and expiration date not reported), via an unspecified route of administration on 25Jul2018 03:00 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On 26Jul2018 at 07:00, the patient experienced stomach pain which increased every-time he bent over, accompanied by diarrhea, nausea, and severe chills. It was reported that the house was not air-conditioned except for one room, patient laid on floor covered with 3 blankets from chills but temperature showed no fever. Also on the same day, 26Jul2018, the patient had pain at the injection site and stomach bug. Nurse believed that the patient had stomach bug and it's just coincidental he received meningococcal group b rlp2086 dose day before. The patient has shown improvement since the morning and was feeling better. Outcome of all the events was recovering. No follow up attempts are possible. No further information is expected.
Deathly ill; Initial information received on 05-Feb-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp (non health care professional).  This case involves an unknown age and unknown gender patient who experienced deathly ill while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine (strength and dose: unknown) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed a serious "deathly ill (critical illness)" (unknown latency) following the administration of Influenza Vaccine. This event was assessed as medically significant.  It was reported that "Flu shots make me deathly ill. Never more".   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (Deathly ill).  At time of reporting, the outcome was Unknown for the event deathly ill.; Sender's Comments: Sanofi Company Comment dated on 10-Feb-2022: This case involves an unknown age and unknown gender patient who experienced deathly ill while receiving vaccine Influenza Vaccine. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. A significant temporal relationship cannot be established due to lack of information on event onset date and product start date and hence, causal role of suspect vaccine cannot be excluded in occurrence of the event. However, lack of information of past and concomitant medication/vaccination, any family history and any relevant medical history of patient, any concurrent conditions, lab data to exclude other etiologies, precludes comprehensive case assessment. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Mild/Moderate Fever ranging 99.8-100.8, full body aches, headache, chills. Began midnight after vaccine injection, and escaladed throughout the first night unable to sleep for long amounts of time, night sweats and aches. The next day, Wednesday, the fever broke around 11a and came back stronger around 4p. Full joint aches and headache the entire day. My fever subsided around 11p and was able to get 6 hrs of sleep. In the morning on Thursday, the fever was gone but full-body aches and headache were present. Symptoms subsided around 1p.
vaccinated, about a year, with only one dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received about a year ago from the date of reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 17-MAY-2022 Reporter's Comment: The patient's wife reported this case via. The patient already vaccinated (about a year) with Shingrix but only one dose by skipping the 2nd dose. The reporter asked that the patient would need to start with the 2 doses again. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow-up would not possible, as no contact, details were available.
Soon after the vaccine (approx. 5 minutes), he was pale, weak and complained headache and dizziness, was breathing okay and conscious. HR - 40 gave oxygen right away and his pallor and HR improved 53 ---> 59 ---> 68 --->. Pulse ox 98-100% with oxygen, BP 46/64. Called ambulance. He then started complaining throat irritation and difficulty of swallowing, transferred to ER. 05/23/07-records received-DX Mild Dehydration. Vasovagal episode. Syncope after vaccine, with few minutes of loss of consciousness. No SOB, no rash. C/O tenderness left clavicle line.
This spontaneous report as received from a healthcare worker refers to a 62 year old male patient. On an unknown date, the patient was inadvertently administered a dose of VARIVAX (dose, lot # and expiration date were not provided) instead of ZOSTAVAX. No adverse effects reported. Additional information has been requested.
chills at night; muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergy to penicillin" (unspecified if ongoing), notes: allergy to penicillin; "anesthesia" (unspecified if ongoing), notes: gives her tachycardia when she receives very strong anesthesia.; "gives her tachycardia when she receives very strong anesthesia" (unspecified if ongoing), notes: gives her tachycardia when she receives very strong anesthesia. The patient's concomitant medications were not reported. Past drug history included: Iron, reaction(s): "allergy to iron", notes: allergy to penicillin, iron. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "chills at night", "muscle pain". The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills at night"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was exhibiting shaking hands for 2-3 minutes; alert & oriented with no color change; able to verbalize; no SOB; vaccine given at 1:37 and exhibited s/s 5-10 minutes later; Vital signs BP 140-78, HR-90, O2 94%, no medication given; monitored for 30 minutes then released home.
h/a, felt cold, weakness & tiredness, upset stomach 24 hrs p/3rd capsule;
Beginning 1/4/11 am, increased feeling of malaise, increased fatigue.  Went to bed at 6:00 pm -- slept til 8:00 am.  Went to work at 11:00 am, increasing feeling of nausea, chills, diarrhea, fatigue.  Left work at 4:30, to bed at 5:00, increasing chills, temp 102, and continued feeling of weakness and malaise.  1/6/11  woke up at 7 am, continued feeling of weakness, malaise and chills, low grade temp of 100.
Initial information received on 21-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA323313, 2018SA323312 and 2018SA323310 (same reporter). This case involves a 16 years old female patient who was vaccinated with 0.25ml FLUZONE QUADRIVALENT instead of 0.5 ml, on 21-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due vaccine underdose. It was unknown whether the patient had any 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 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. List of documents held by sender: none.
fully vaccinated and they still got sick/COVID vaccine inefficacy; fully vaccinated and they still got sick/COVID vaccine inefficacy; This is a spontaneous report from a contactable other HCP. A 62-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation.  The patient medical history was not reported.   The patient's concomitant medications were not reported.  The patient was fully vaccinated and still got sick/COVID vaccine inefficacy (medically significant) on 04May2021 with outcome of unknown. Causality was reported as Related.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE.    There is limited information provided in this report.  This case will be reassessed once additional 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.
Patient experienced mild reaction to Influenza vaccine. Had redness on neck and back of arms with itching.
Swelling on arm at injection site. Started Jan 23 10pm still swollen right now Jan 24 @12pm.
Breakthrough case admission after three doses Moderna 1/29/21 Lot# 027L20A Moderna 2/26/21 Lot# 043L20A Moderna 12/1/21 Lot# 027
This employee/fire fighter calls asking if he can get his second vaccine. He reports he received first Pfizer COVID 19 vaccine on 12/24/2020. 4 hours later he noted a flat blotchy red rash to his neck that itched. He awoke the next day with same blotchy red itchy rash to bilateral anticubes/inner arms and behind both knees. He self-treated with oral Benadryl and topical steroid creams for itching. At time of this call rash has resolved but redness seen when in a hot shower.  he denies contact/ingestion of any  new foods, detergents, deodorants, clothing, contacts. No contact with plants, animals, etc. Admits to relocation to new fire station to replace coworker who was COVID positive. Slept in new bed but ha
Site: Swelling at Injection Site-Mild, Systemic: anxiety-Mild, Additional Details: patient caregiver (mother) for > 20 y patient w/ DS reported that the pt was experiencing swelling at injection site. Observed and no swelling detected. Pt appeared anxious, was given water to drink and ice pack for arm. Patient stayed for 20+ minutes. Pt and caregiver reported that they were OK, and no longer anxious.
Patient had a lump at injection site. She put ice on it for few hours and stated the lump flattened to a 4 inch by 4 inch section.  I warned her about calling 911 if having any reaction associated with breathing or swelling of face tongue or throat over night. Patient is taking Benadryl and Tylenol and will call in morning.
c/o chest "felt a little tight", denies pain, SOB ,. Feels better after 10 min.
Immediately following injection:  warm flushing feeling to right side of my neck and face. One hour after: fatigue, dizziness and nausea 12 hours: fatigue (slept for 19 hrs post injection) , dizziness, nausea 24 hours: fatigue, dizziness 48 hours: dizziness Present day: dizziness
shingles like rashes; shaking; sweating; felt hot and cold; diarrhea; loss of appetite; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash vesicular (Received 1st dose on October 2020 for tolerance of 1st dose, refer case US2022166275).   On an unknown date, the patient received the 2nd dose of Shingrix. On 9th November 2022, less than 2 years after receiving Shingrix, the patient experienced tremor, sweating, feeling hot and cold, diarrhea and appetite lost. On an unknown date, the patient experienced vesicular rash. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vesicular rash was not recovered/not resolved and the outcome of the tremor, sweating, feeling hot and cold, diarrhea and appetite lost were unknown.   It was unknown if the reporter considered the vesicular rash, tremor, sweating, feeling hot and cold, diarrhea and appetite lost to be related to Shingrix.     Linked case(s) involving the same patient:  US2022166275   Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's Comment: The case was reported by the patient. The reporter stated that, after receiving Shingrix, he had continued outbreaks of the same shingles like rashes.  The reporter stated that, the day before reporting, he was shaking, sweating, felt hot and cold, had diarrhea and a loss of appetite.  The reporter consented to follow up.; Sender's Comments:  US-GSK-US2022166275:Same reporter
FEVER; VOMITING; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-MAR-2021, the patient experienced fever, and vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and vomiting was not reported. This report was non-serious.
Until 03/20/2021 I had fever, chills, nausea, cramps, fatigue, body aches, sore arm, and felt shaky;  until 03/23/2021 I had all the previous except fever, chills and sore arm.
4 hours after vaccine, head rolled back, pupils pinpoint, body became limp. Went to emergency room. Received IVF fluids, supplemental O2 for transient respiratory distress. It took approximately 5 hours for pupils to return to normal. Patient began to return to baseline about 2 hours after episode .
Started getting severe chills which I could not stop. Fever of 101.1 about two hours later. Fever and chills which made me shake uncontrollably until after midnight when I fell asleep. Awoke about 4:25 AM with horrible headache and a continuing fever. Slept on and off all day 10/26/2016 until son arrived that evening. Fever did drop to 99.9 before I went back to sleep. When I got up in morning, my son felt I was not acting normally and after checking with other family members, they decided I might be having a stroke. Went to Hospital and was admitted. CAT Scan, Ultrasound, MRI, EEG, and blood drawn. Tests were negative.
Pt to ED 6/24 by EMS with c/o weakness for past 3 days and urinating blood. COVID+ 6/24, not a candidate for any antiviral therapy for COVID-19 infection, given  IV cefepime. 6/26 pt pulled out IV arm bleeding , patient is heparin drip. 6/27 pt is A&O x 4 with periods of confusion, VSS, no S/S of acute distress noted, denies any SOB/chest pain. 6/29 pt in no respiratory distress, denies coughing, denies pain. Pt resting comfortably in bed, aox4, on RA, denies pain or sob, with ongoing Cardizem drip at 10mg/hr. 7/1 pt ao x 4 with o c/o pain no shortness of breath.  Patient on room air. 7/1 patient disharged.
Approx 1d after vaccine, begin with pruritis & erythematous macular rash spredding from b/l thighs & forearms to entire trunk (front & back), extremities x4   .  Rash was pruritic but non-tender.  Symptoms well controlled with benadryl.  As this body rash resolved over 4-5d, developed lichenoid drug rash on b/l hands (L>R) (this lichenoid rash present (x2d) at time of this report)
Patient was given an MMR immunization that he wasn't required to have.  There was serological testing already done for the immunizations he was given.
BODY ACHES; CHILLS; LOW GRADE FEVER; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, low grade fever, and body aches. This report was non-serious.
Left upper lobectomy, thoracic lymph node sampling and left back lipectomy. Hospital admission within 6 weeks of receiving the COVID-19 vaccine.
STATED SYMPTOMS STARTE ON THE FRIDAY THE 20TH AT 11PM, HAD SWOLLEN THROAT, CHEST PAIN, LIGHT HEADED, FATIGUE, DIZINESS.
Flu like symptoms both times - I had two shots within the six months and got very sick both times.
Client received two previous COVID vaccines at other sites.  Pt gave false information regarding previous vaccinations.  When questioned, pt stated he was here for first dose.  Stated he did not have a vaccination card. First dose 3/25 Pfizer, Second dose 4/9 Moderna, Third dose 4/15 Moderna.
Mother called to report patient developed fever 101.1.  Messages left by pediatric nurse to obtain more information..
became allergic to shell fish, grass, some spices, dust mites, environmental allergies, hives everyday
Chills and fever,  beginning at app.15 hours later,  around 9AM,  intensifying over the course of the day,  with severe aching,  especially  over the torso.   Soreness at the injection site.  Fever reaching peak of 101.8  by late evening.    I took two Tylenol before retiring.   I woke  ,  self and gown  drenched in sweat at  3AM on 3/6.      Slight chills upon rising  for about 3-4 more hours on 3/6.      Upper injection arm itching continues  to this  day,    3/9 ,   which is relieved with cold compresses and a 25 mg  Benadryl tab.
Fever, muscle pain, fatigue, redness in face, metallic taste in mouth, soreness
Woke up with my arm itching.  The injection site was swollen, red, warm, and tingly. It is the size of a  2 inch circle.  I took 2 zyrtec and went to work.  Called pharmacy and they said to report to VAERs.
High heart rate, hands turned purple, high fever, dizziness,chills, body aches, orthostatic intolerance. All within 1 day of dose. Diagnosed with POTS thereafter. Medications have helped tachycardia but continue to have brain fog, fatigue, exercise intolerance, heat/humidity intolerance.
no adverse event; Healthcare provider reports administration of an expired dose of VAQTA to a patient on 02NOV2022; This spontaneous report was received from a health provider referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 02-NOV-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot #U026792, expiration date: 28-OCT-2022, administered for prophylaxis (dose, strength, and route of administration were not provided) (expired product administered). The vaccine was not involved in a temperature excursion and was stored per the recommended storage range until date of administration. There was no adverse event (no adverse event).  The follow-up information received from the health provider on 22-DEC-2022. This was a 12 months old female patient. The anatomical location for hepatitis a vaccine, inactivated (VAQTA) was thigh. There was no reaction at all. The device was not available for evaluation. Because the expired vaccine was injected into the patient's thigh. This adverse event had reported to doctor previously. The provider and patient's parents were notified. The vaccinated at private doctor's office/hospital. The vaccine/vaccine device purchased with private funds. There was no temperature excursion occur as a result of a reading from a digital data logger. The hepatitis a vaccine, inactivated (VAQTA) was pulled from stock. It was given to patient and while be entered into system was realized to be expired as soon as noticing the expiration date. It was reported to provider and parents were contacted.
Swollen red rash at injection site and running down the interior arm to elbow.  Itching with spreading over 2-3 days.  Needed to take Benadryl at night for past 3 nights.