chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received Quadracel instead of Pediarix, no AE; Initial information received on 03-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 10 months old male patient who received 0.5 mL DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5635AA and expiry date: 18-Jun-2021) via an intramuscular route in right lateral thigh on 27-Jan-2020 for prophylactic vaccination, instead of DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX), as the office did not have PEDIARIX.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX-B) for Immunisation.  It was actual medication error due to wrong vaccine administered.   It was reported that 10 month old male patient had a medication error by receiving Quadracel and not the Pediarix. The nurse reported that the vaccine was given due to the office did not have the Pediarix; that the administrator of the vaccine was a medical asssitant who decided to administer the Quadracel and a sperate dose of ENGERIX-B (Hepatitis B).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Mom called on 3/5/19 stating the following: After the first Men B. vaccine, patient's upper arm swelled and was black, blue and red. She had red patches of hives all the way down her arm. Not itchy. Hot to the touch. This occurred about 2-3 days after the vaccine was given. It lasted for 2-3 weeks. She went to the nurse at college but nothing was done. She was achy all over.
First 24 hours fever up to 101.5 nausea headache chills fatigue general body pains and aches. Then about 36 hours after injection dizziness and off balance, feeling like falling.  Fever has resolved but mild headache persists.
Left upper leg with large warm erythematous area tender small rash macular to same leg lateral side, two days after vaccine. Treated with KEFLEX 187.5mg tid x 10 days.
Information has been received from a 21 year old female consumer who on 07-SEP-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast). Subsequently the patient experienced body rash, head swollen and headache. Unknown medical attention was sought. The patient was recovering. No product quality complaint was involved. Additional information has been requested.
temp to 104 w/APAP; had brief episode of screaming & very restless sleep;
Developed a rash that has progressed started 8 days after 2nd vaccination. Bilateral arm to elbow to wrist redness. states did take steroid PO/Cream. got better but didn't go completely away. gradually getting worse by the day. rash all over body now, redness, itchy skin and bleeding from scratching.
Initial information received on 26 October 2007 from a health care professional.  A 28-year-old female patient, with a history of panic attacks and who was pregnant (33 weeks gestation), had received a left deltoid, intramuscular injection of Fluzone SV 2007-2008, lot number U2469AA on 24 October 2007. Fifteen minutes post-vaccination the patient experienced an anxiety attack with hyperventilation, anxiety and trembling. She refused transport to an emergency room. The patient was contacted one hour later following the event and "was fine." The patient recovered from the event. Follow-up informaion was received from a health care professional on 16 January 2008. The reporter stated that the vaccine had been administered in a retail pharmacy setting and indicated that they have no access to the patient's medical records or information. According to the consent form completed by the patient prior to immunization, the patient had no egg allergies and no prior reactions to any vaccines in the past requiring medical care. The reporter provided a copy of the patient's consent form which contained contact information for the patient's physician. No futher information was provided.
This spontaneous report was received from a Medical Assistant, referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 02-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L042265; expiration date: 26-OCT-2017 (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. The vaccine underwent a temperature excursion (10F) for a time frame of 3 hours and 16 minutes. No previous temperature excursions were reported. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a pharmacist concerning a 53 year old female who on 12-DEC-2005 had a pre-vaccination titer performed. On 10-JAN-2006, the patient was vaccinated with Pneumovax 23 (lot # not reported). On 19-MAR-2007, the patient had a post vaccination titer performed that revealed low titer. Medical attention was sought. No symptoms have been reported. No further information was available at the time of reporting. Additional information has been requested. Follow-up information was received froma pharmacist. The patient was reported as immune deficient. No other information was provided. No additional information is expected.
Information has been received from a licensed practical nurse concerning a 16 year old female patient with no medical history or drug allergies who on 25-JUN-2007, was vaccinated IM with a first 0.5ml dose of GARDASIL (Lot# 658094/0524U). Concomitant therapy included Alesse. On 28-JUN-2007, the patient developed hives. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 7/16/2007. Subsequently, the patient recovered. Additional information is not expected.
For 3 weeks after receiving vaccinations mom reports patient with high pitched cry, "jumpy", vomited a few times, slept poorly during the day but fine at night, quit vocalizing and then gradually normalized to normal vocalizations.  After 3 weeks the symptoms spontaneously resolved.  No intercurrent viral symptoms, fevers, disruption of gross motor development or eye contact.
I have intense shoulder pain. I cannot lift my arm. This is way more extreme than any other vaccine arm pain I've ever experienced. I have to lift my affected arm using my "good arm."
Pain, swelling, fever at injection site persisting 72 hours after vaccine administration. Generalized malaise & aches persisting 72 hours after vaccination.
PREVNAR vaccine given in left arm, night of vaccination patient had "shakes", the following day patient's left arm red and tender at site, around six inches around site, also hot to touch.
No adverse event; Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 12-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster).    Concomitant medication details was not reported. Treatment details was not reported.  The reporter reported that they called the CDC and were instructed to go ahead and administer the other half of the dose (0.25ml) on the same day.  This case contains information for the second adult patient out of 15 adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-658139, US-MODERNATX, INC.-MOD-2022-658150, US-MODERNATX, INC.-MOD-2022-658152, US-MODERNATX, INC.-MOD-2022-658154, US-MODERNATX, INC.-MOD-2022-658155, US-MODERNATX, INC.-MOD-2022-658156, US-MODERNATX, INC.-MOD-2022-658157, US-MODERNATX, INC.-MOD-2022-658158, US-MODERNATX, INC.-MOD-2022-658159, US-MODERNATX, INC.-MOD-2022-658160, US-MODERNATX, INC.-MOD-2022-658162, US-MODERNATX, INC.-MOD-2022-658168, US-MODERNATX, INC.-MOD-2022-658173 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658139:Adult patient 1, same reporter US-MODERNATX, INC.-MOD-2022-658150:Adult patient 3, same reporter US-MODERNATX, INC.-MOD-2022-658152:Adult patient 4, same reporter US-MODERNATX, INC.-MOD-2022-658154:Adult patient 5, same reporter US-MODERNATX, INC.-MOD-2022-658155:Adult patient 6, same reporter US-MODERNATX, INC.-MOD-2022-658156:Adult patient 7, same reporter US-MODERNATX, INC.-MOD-2022-658157:Adult patient 8, same reporter US-MODERNATX, INC.-MOD-2022-658158:Adult patient 9, same reporter US-MODERNATX, INC.-MOD-2022-658159:Adult patient 10, same reporter US-MODERNATX, INC.-MOD-2022-658160:Adult patient 11, same reporter US-MODERNATX, INC.-MOD-2022-658162:Adult patient 13, same reporter US-MODERNATX, INC.-MOD-2022-658168:Adult patient 14, same reporter US-MODERNATX, INC.-MOD-2022-658173:Adult patient 15, same reporter
Hives, elevated b.p., elevated blood sugar. Took oral 25 mg Benadryl and a cool shower then took another 25 mg Benadryl and was comfortable enough to go to sleep.
Patient received flu vaccine plus Remicade injections at same time. She woke the next morning with loss of strength and feeling in legs and heaviness in arms. Information from discharge summary sttes pain, difficulty urinating. msv
Mild/Moderate - Chills/shivering 11 hours after Moderate -feverish feeling 21 hours after (98.7 F) Moderate  throbbing headache 21- 25 hours after Moderate  fatigue/body aches 21 hours after
her spot on chest is now hives on chest, back, arms, and at injection site.; her spot on chest is now hives on chest, back, arms, and at injection site.; her chest had a red spot; vivid dreams; restlessness; This is a spontaneous report from a contactable Nurse.    A 36-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot# EK9231) vaccine , intramuscular in the left arm  on 11Jan2021 08:00 at single dose for Covid-19 immunisation .  Medical history included drug hypersensitivity to azithromycin, morphine and sulfa.  Concomitant medication included levothyroxine (LEVOTHYROXINE), liothyronine (LIOTHYRONINE), abaloparatide (TYMLOS).  The patient received the first dose of bnt162b2 vaccine on 21Dec2020 .  The patient experienced her chest had a red spot  on 11Jan2021 10:00 with outcome of unknown , vivid dreams on 11Jan2021 with outcome of unknown , restlessness on 11Jan2021 with outcome of unknown , her spot on chest is now hives on chest, back, arms, and at injection site on 12Jan2021 14:00 with outcome of unknown.  The patient received cetirizine (ZYRTEC) and acetaminophen (TYLENOL) as treatment of rash. Further information has been requested.
Exposed, below freezing, administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 20-Oct-2022 Reporter's comment: The pharmacy resident reported that Flulaval which was exposed to temperature below freezing (24.4 Fahrenheit) was administered to 5 employees. The vaccine administration facility was the same as primary reporter. The reporter did not had any other details but agreed to follow-up via email only. The reporter consented to follow-up. This is one of five linked cases reported by same reporter for different patients. Additional supportive information: The patient received Flulaval after temperature excursions, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022AMR152068:Same reporter US-GSK-US2022AMR152067:Same reporter US-GSK-US2022AMR152066:Same reporter US-GSK-US2022AMR152065:Same reporter
Pt reported (1/13/21) -Sunday ~4p received 2nd shingrix vaccine -Monday night- hives/rash on opposite arm of shot (left arm had reaction). Pt reported using CBD oil here for 1 month with no reaction similar to this but stopped in case maybe it was a reaction from the CBD oil. -Tuesday hives/rash spread to upper body on the left and neck (asked if shortness of breath but denied) -3am Wednesday took Benadryl, called pharmacy ~10am  -11:30 I contacted prescriber to let them know I'm reporting to VAERS and pt was coming in today for an appointment and pcp stated they would address situation at appointment at noon today
received Adjuvant  (Without the Lyophilized Antigen Component); received Adjuvant  (Without the Lyophilized Antigen Component); This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 4N2AB, expiry date 10th February 2023) for prophylaxis.   In August 2021, the patient received Shingrix. In August 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The clinical coordinator reported that, the patient received the AS01B Adjuvant of Shingrix without lyophilized antigen component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that, 1 patient received only adjuvant of shingrix vaccine. The reporter consented to follow up.
Head fell backwards, arched back, eyes rolled back in head, right hand clenched and arms jerked several times. Then appeared somewhat lethargic (arousable).
temperature of 101 °F; body aches; headache; nausea; chills; This is a spontaneous report from a contactable Other HCP (patient).  A 26-year-old female patient started to receive BNT162B2 (Batch/lot number: EK9231) at right deltoid via an unspecified route of administration on 03Jan2021 12:20 at single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient experienced temperature of 101 °F, chills, body aches, headache and nausea on 04Jan2021 02:00. Patient stated for the second one, she was hoping for the best, but she got the vaccine yesterday (03Jan2021), at 12:20, and today (04Jan2021), at 2 AM, she had a temperature of 101, and chills, body aches, headaches, and nausea. She was out of it today, she was not feeling good, and was told to do this. Caller got the vaccine at Employee Health. After 4 hours of Tylenol (expiry is May2021, lot is P115252), her temperature went right back up. It was about 99 when she had Tylenol. Chills started late this morning (04Jan2021) and were ongoing when she was not on Tylenol, but her body aches were ongoing. 9AM was when her headache started, and she was intermittently on Tylenol, but if past the 4 hour mark, they were as bad as they were this morning, but with Tylenol they were better. Nausea was mostly this morning, and had gotten better. Patient stated that due to her current symptoms her employer had required her to be tested for COVID-19. She had not yet received the results of that test. Seriousness for events temperature of 101 °F, chills, body aches, headache and nausea was Medically significant. Lab data included COVID test on 23Dec2020 was negative. The outcome of temperature of 101 °F, headache and nausea was recovering; of body aches was not recovered; of chills was unknown.  Primary Source Reporter (Method of assessment was Global Introspection) considered the events were related to BNT162B2.; Sender's Comments: There is a reasonable possibility that the events reported were related to BNT162b2 based on known drug safety profile and close temporal relationship.  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.
the injection site and its still there it's like a 1 and a half inch almost oval it's red; the injection site and its still there it's like a 1 and a half inch almost oval it's red, it's warm to the touch and it's swollen.; the injection site and its still there it's like a 1 and a half inch almost oval it's red, it's warm to the touch and it's swollen.; I had a low grade temperature; Chills; body ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 at 10:45 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: Dec2021, when the patient was 76 years old, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 18Oct2022, outcome "unknown"; PYREXIA (non-serious) with onset 18Oct2022, outcome "recovered", described as "I had a low grade temperature"; PAIN (non-serious) with onset 18Oct2022, outcome "unknown", described as "body ache"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 18Oct2022, outcome "unknown" and all described as "the injection site and its still there it's like a 1 and a half inch almost oval it's red, it's warm to the touch and it's swollen."; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "the injection site and its still there it's like a 1 and a half inch almost oval it's red". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated, "It all started on Tuesday she got the vaccine on Monday the 17 and all the other reaction except the redness that came right away the other reaction all came on Tuesday." "she did, it came the next day she had a low grade temperature, chills, body ache, the injection site and its still there it's like a 1 and a half inch almost oval it's red, it's warm to the touch and it's swollen. But the low grade temperature doesn't last long, it only lasted a few hours." Consumer stated, "she don't see there is an expiration, it says GH9702, no (Consumer was not sure). Well it says (Pharmacy name) but she can't read what the writing is underneath (Pharmacy name) is a Pharmacy where she got it from." No prior vaccination (Within 4 weeks).  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.
Experienced upper respiratory congestion, cough, and fatigue so took a PCR home test and it was positive. Went to the urgent care and tested positive for COVID-19 as well. Dr. persuaded me not to take PAXLOVID. On 08/01/2022 tested negative for COVID-19.
Chest pain developed on 5/7- after getting covid vaccine 5/5 - sent to ED for further work up
Tinnitus and vertigo starte07/01/2021 and lasted 4 weeks
Nose bleed, mainly from the left nostril but also some coming from the right side.  I had been taking a nap in the afternoon.  I was asleep for approximately an hour on my left side, and woke up with blood dripping out of my nose.  I sat up and leaned my head forward while squeezing my nostrils together.  It took over an hour, and the blood was still coming any time I would lift my head.  My husband drove me to the nearest hospital.  By the time I arrived, the bleeding had stopped on its own. By then it had been approximately 90 minutes that my nose was bleeding.  I went into the Emergency Room and the physician assistant cleaned my nose, but she said she didn't think the nose bleed could be from the vaccine.  She didn't say why it couldn't be from the vaccine.  She suspected that my nose bleed could be from allergies and/or a mixture of sudden changes in temperature we have been having lately.  I reminded her I haven't had a nosebleed since I was a child.  However, she said that if it keeps happening then to see an Ear, Nose and Throat doctor.
No additional adverse effects reported; a patient was administered improperly stored VARIVAX; This spontaneous report was received from an medical assistant and refers to a 4-year-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 19-JUN-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)( VARIVAX) injection lot # S028924, expiration date 16-SEP-2021 (strength, dose and route of administration were not provided) for prophylaxis, which was reconstituted with properly stored sterile diluent. Administered doses of vaccines experienced the temperature excursion between 15 and 46 (reported also as 29.5 F) degrees Fahrenheit (F) for 67 hours. Data logger was involved. There were no previous excursions reported. No additional adverse effects reported.
Case  is a vaccine breakthrough case of interest who died of COVID-19 pneumonia on 6/2/2021 after an approximately 2 week hospitalization. Whole genome sequencing resulted in identification of B.1.1.7.
pt recv vax;upper arm soreness, swelling; had fever; periodic pain on upper arm ;