chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT HAD A FAINTING SPELL SECONDS AFTER THE SHOT GIVEN.  HE FELL OUT OF THE CHAIR, APPEARED CONFUSED, DIAPHORESIS,  MYDRIASIS, LOW PULSE RATE 30 SECONDS PER MINUTE, THAT LASTED MAYBE A MINUTE OR 2 MINUTES AT MOST.  AFTER THE PATIENT CAME THROUGH FROM THE SPELL, HE CONTINUED TO TELL ME THAT THIS HAPPENS WHENEVER HE GIVES BLOOD OR OTHER VACCINES.  PRIOR TO THE SHOT, ALL HE SAID IS THAT HE IS AFRAID OF NEEDLES.   DUE TO THE CONFUSION AND THE BRIEF MOMENTS WHERE HE WAS NOT WITH IT, I HAD MY TECHNICIAN CALL 911 OUT OF ABUNDANCE OF CAUTION.   WHEN EMS ARRIVED, HE WAS COMPLETELY FINE AND DRINKING WATER AND CONVERSING FULLY.
multiple tense bullae on left anterior forearm (site of injection is left deltoid), scattered smaller bullae on anterior lower legs and left forearm
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, fatigue, headache and myalgia. On an unknown date, the outcome of the injection site pain, fatigue, headache and myalgia were recovered/resolved. It was unknown if the reporter considered the injection site pain, fatigue, headache and myalgia to be related to SHINGRIX. Additional details reported as follows: The caller was GlaxoSmithKline employee from R and D that was made aware of two individuals who received SHINGRIX. The events began the evening of the injections. This case has been linked with US2018144841 and US2018144839, reported by same reporter and linked with case  US2018GSK150475 (reported for same patient for 2nd dose).
This spontaneous report as received from a pharmacist refers to a 56 year old female patient. The patient's medical history included history of chicken pox, itching and unknown skin condition with red spots which is not eczema and it's not psoriasis, history of itching using an antihistamine for it. On 14-OCT-2013, the patient was vaccinated with ZOSTAVAX, (lot number, expiry date was unknown). Concomitant therapies included Atarax. On an unknown date in Oct-2013, the patient had little bumps around the injections site and the pharmacist believed it to be a shingles rash. Lab test were unknown. It was unknown if she would ever have ZOSTAVAX again. The outcome of the reported event was not recovered. Additional information is not expected.
Fever of 104, migraine, chills, body aches, sore throat, dizziness, weakness, fast heartbeat
Pt recvd 3 doses of Engerix-B & 2OCT91 found to be a non-seroconverter;
Chills, sweats, fever of 101.5, body aches, nausea, and fatigue
About 24 hours after the shot, the soreness began to reach around to my shoulder blade, with in a few hours of that I started to get pain in both the front of my chest and back pains.
Redness, induration, itching and pain in the arm. Itching started within hours and rest of symptoms developed overnight.
Red, inflamed, size of silver dollar, with swelling size of small apple; area tender, warm with upset stomach
Itching in multi areas of the body, swelling inside throat, painful swallowing, it felt as though an obstruction had swelled in the back of the throat.
A 67 year old female patient was treated with a  cycle of OncoTICE instillations for bladder cancer from 17 March until 22 April 2005.  On 1 April 2005, during her second instillation, some of the medication accidentally spilled onto her legs with the removal of the bladder catheter.  There were no open wounds to her legs and she washed it off with soap and water due to exposure.  On 11 August 2005, she had liver function test done and found the levels to be increased.  Patient has an appointment scheduled to follow up with her physician.
Patient states that about 45 minutes after her vaccine, she states that her chest felt very "heavy" and that it was hard to breathe. She did not feel that her throat was closing and denies any swelling. She did not feel any constriction. She did report a rapid heartbeat. No other symptoms reported.
Narrative:  ADR reported initially in 2007 as "rash" at hospital. No documentation that patient has received a vaccine in the facility. Taking immunosupressants and is unable to receive vaccines. No documentation of recent allergy for "anaphylaxis." Immunization reminders are active for this patient and has no documentation or receiving a recent influenza vaccine. Unsure where "anaphylaxis" occurred and if it is true anaphylaxis. Reported as a historical allergy in 2021. Also reported as historical in 2007 (the earliest known documentation of the allergy). Without supporting documentation. Unsure of true origin.
Chills; Shaking; Body joint ache; Sore arm; Slight dizziness; Fatigue; Nausea; This is a spontaneous report from a contactable other healthcare professional, the patient. A 22-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the left arm on 20Mar2021 at 11:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient did not receive any concomitant medication in two weeks prior to the COVID-19 vaccine. The patient was not allergic medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 19:30, the patient experienced chills, shaking, body joint ache, sore arm, slight dizziness, fatigue, and nausea. The treatment received for the adverse events included ibuprofen. The clinical outcome of chills, shaking, body joint ache, sore arm, slight dizziness, fatigue, and nausea was recovered on an unspecified date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Nine minutes after receiving the vaccine, I began to feel "weird", then hot.  I asked the nurse to take my temperature, but it was normal.  I was thirsty, then extremely weak and light-headed.  While sitting, I started tilting over to the side and thought I would pass out.  They called EMTs who took my blood pressure -it was 166 over about 82.  They gave me oxygen and took me to the hospital.  I was incredibly thirsty and drank a huge glass of ice water.   After being monitored and released within about  2 hours, I felt brain fog.  The brain fog worsened the next day and significantly worsened on the second day after the vaccine.  It was so bad that it felt like having a concussion:  I had trouble word-finding and was stumbling all over my words.  The night of the vaccine, I had hot flashes all night long.  Eight days after the vaccine, I developed "COVID-arm".
Patient vaccinated with Pfizer COVID vaccine on 2/18/21 and 3/11/21. Presented to regional hospital 10/16, transferred to reporting hospital on 10/26 with nstemi and COVID symptoms. COVID PCR collected via NP on 10/26 resulted positive 10/27. Discharged home in good condition on 10/30. INFORMATION, INCLUDING LENGTH OF HOSPITAL STAY ONLY RELATE TO REPORTING HOSPITAL AS TRANSFERRING HOSPITAL RECORDS ARE INCOMPLETE/UNAVAILABLE VIA EMR.
Pt has vascular neuropathy controlled by medications. 12 hours post vaccine pt states her neuropathy flared in legs and arms. It diminished every morning and increased every evening over last 4 days. Decreased severity every day.
patient was given PENTACEL without reconstitution with no reported adverse event; Initial information received on 10-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was given diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] without reconstitution with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection strength, dose, expiry date, lot number not reported via unknown route in unknown administration site for immunization and patient was given pentacel without reconstitution with no reported adverse event (product preparation error) on the same day.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event patient was given pentacel without reconstitution with no reported 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 the 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.
He has bilateral leg soreness, with the right being more sore than the left this morning but overall he is improving. Mom did report that he has a little swelling at the site on the right leg. There is no swelling on the left. Patient received his immunizations on 5/3/2017, and mom reported that night, at about 9 PM, he became really pale and cold. They provided him some blankets to warm him up. Mom stated that this episode lasted a couple of hours. He has not had a recurrent episode, and is not running any fevers.
FEELING COLD; NAUSEA; HEADACHE; FEVER; CHILLS; This spontaneous report received from a patient concerned a 62 year old white (Not Hispanic/Latino) female. The patient's height, and weight were not reported. The patient's past medical history included COPD, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 08-MAR-2021, the patient experienced chills. On 08-MAR-2021 11:00, the patient experienced fever. On 09-MAR-2021, the patient experienced nausea. On 09-MAR-2021, the patient experienced headache. On an unspecified date, the patient experienced feeling cold. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, nausea, headache, and feeling cold. This report was non-serious.
Acute pericarditis, onset 4/25/21 (2 days after vaccination).
Presented w/ respiratory distress , shortness of breath and productive cough; found to be hypoxic requiring oxygen by nasal cannula; tested positive for COVID-19 w/ left basilar pneumonia. Tx w/ O2 and steroids; weaned to RA, discharged home.
Swollen left eye, 5 minutes after vaccines. Mother gave child BENADRYL. Mother called 9/9/14 informing us that her left eye was swollen shut. Appt made for evaluation.
tenderness in shoulder; Arthritis; redness in arm; severe excruciating pain/soreness in arm; arm limp; unable to dress herself; could not raise arm; This case was reported by a consumer via call center representative and described the occurrence of arthritis in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th June 2019, the patient received the 2nd dose of Shingrix. On 25th June 2019, less than a day after receiving Shingrix, the patient experienced arthritis, erythema of extremities, pain in arm, flaccidity, activities of daily living impaired and injected limb mobility decreased. On an unknown date, the patient experienced shoulder pain. The patient was treated with steroids nos (Steroid Pack (Nos)) and paracetamol (Tylenol). On 30th June 2019, the outcome of the erythema of extremities was recovered/resolved. On 1st July 2019, the outcome of the activities of daily living impaired was recovered/resolved. On 2nd July 2019, the outcome of the flaccidity was recovered/resolved. On an unknown date, the outcome of the arthritis and injected limb mobility decreased were unknown and the outcome of the pain in arm was recovered/resolved and the outcome of the shoulder pain was not recovered/not resolved.   It was unknown if the reporter considered the arthritis, erythema of extremities, pain in arm, flaccidity, activities of daily living impaired, injected limb mobility decreased and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced a tiny bit of redness, after receiving 1st dose in March 2019. The patient received a dose of Shingrix in the left arm. After vaccination with 2nd dose of Shingrix, the patient had severe excruciating pain, her arm went limp, could not raise it. The pharmacist advised ibuprofen or Tylenol to the patient, but the patient used Tylenol, and still had a lot of pain. On 26th June 2019, the patient went to doctor, and doctor gave her a steroid dosepak (name unknown). By Sunday, the patient was able to use her arm again. On 1st July 2019, the patient reported that, she still had soreness in the arm. The redness was gone and soreness was mostly gone. On 1st July 2019, The patient had x ray of shoulder with mild arthritis. The patient reported that, she did not have any problem with any shot. The patient reported that tenderness in shoulder gone partway down her arm. The reporter consented to follow up. For the tollerence of 1st dose refer case US2019AMR124429.      Lab Comments: The patient had mild arthritis on x ray test.
Pneumonia after first shot. Second shot caused unexplained swelling in various parts of body to include neck, hands and feet.
Mom called to say that after patient's shot yesterday, he is c/o leg pain and can barely walk. Also c/o hurting to breath. Mom gave patient Tylenol for the pain. Encourage mom to take patient to the ER if he is having a hard time breathing. Mom refused the ER stating that ER is not equip for pediatric patients.  Mom stated that patient is actually not having a hard time breathing. He is only breathing heavy due to the pain.
Patient appeared in clinic for headache,  brain fog, fatigue, fever that has been since after second dose of vaccine. Stated had similar with first dose but only lasted 3 days and not as bad. This time symptoms have persisted for 8 days and patient was unsure of something else was going on. feverish in for a few days after vaccine but has since subsided. Still has Headache  - describes as  band around head with  photophobia, , brain fog still there and caused her to mess up some tasks at work, feels fatigued and had to take a few days off of work. Encouraged rest, hydrate, ibuprofen or Tylenol as needed for headache, quiet dark room for headache, come back to clinic if not better in 3 days.
Nausea, migraine, mild convulsing for a short period of time, feeling shaky without shaking.
Baseball size swelling to Left upper arm after vaccines given, swelling has gone but tenderness is till there.
Information has been received from a licensed practical nurse concerning a 12 year old female patient with no previous medical history who on 06-AUG-2009 was vaccinated with the first dose of GARDASIL (Lot number 661841/0653X). There was no concomitant medication. About one month after vaccination, approximately on 06-SEP-2009, the patient had hair loss. The patient's hair loss persisted. The patient sought medical attention, was seen in the office. Additional information has been requested.
fever 104 @ 930PM; had grand mal seizure was seen in ER; treated for fever; ran fever for 2 days;
This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 09-MAY-2016, the patient was vaccinated with VAQTA "10Pk 25U/0.5 ml SD LLok w Cap Ped", lot # L030442 with expiration date 19-DEC-2016, which was stored at 1.11 Celsius Degrees for 384 hours and at -0.5 Celsius Degrees for 72 hours. The type of excursion was refrigerator and the vaccine status was reported as "in excursion". There were no concomitant medications and adverse effects reported. No product quality complain was involved. This is one of several cases from the same reporter. Additional information has been requested.
Pt. was given Dtap too early. Age of patient at time of event: 1 years.
3:45 pm Patient c/o feeling dizzy at 3:45 pm. Daughter and son in law present and requested water. Patient took a few sips of water and soon after became cool and clammy. Patient became incoherent and was not responding to myself or her daughter. Became lethargic and couldn't hold her head up. Diaphoretic and skin remained cool and clammy. Client is not diabetic. Patient is on meds for B/P and did have cardiac bypass surgery 2 years ago. Daughter and I decided to call an ambulance. B/P 80/40 (L) and rechecked 5 min later and was 90/50. No SOB or trouble breathing. Lung sounds were clear and WNL. No respiratory distress noted. O2 sat 94%. Pulse 55. Ambulance arrived and took over care. Patient did get transferred to ER  via ambulance per the daughter's request
did not fully attach the needle to the FLUZONE HIGH DOSE QUADRIVALENT syringe/ during injection, about half of the vaccine squirted out/ did not receive the full dose with no reported adverse event; Initial information received  on 23-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a patient of an unknown age and gender and reported  immunizer did not fully attach the needle to the fluzone high dose quadrivalent syringe/ during injection, about half of the vaccine squirted out/ did not receive the full dose with no reported adverse event , and it involved vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE , with an unknown formulation and strength, (lot number and expiry date: not reported) via unknown route in unknown administration site for immunization.  It was reported that there was an administration issue when they administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE  to a patient. The reporter stated that the immunizer did not fully attach the needle to the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE syringe, and during injection, about half of the vaccine squirted out between the needle and the syringe/the patient did not receive the full dose with no reported adverse event (accidental exposure to product) (latency: unknown)  Action taken : not applicable.  Outcome: unknown   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 the 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.
I received the SHINGRIX vaccine at my pharmacy. The injection was in my left upper arm. Within 3 hours I developed a very painful area under that arm, between my armpit and chest. I also developed chills and a fever of 101.5 F, which lasted for 24 hours. The day following the injection, the area near my armpit/chest was very swollen and painful. Two days later it had not improved. I went to my primary care doctor. He was perplexed but decided it must have been related to my lymphatic system and a response to the vaccine. The swelling went away after a week. The area was then bruised for another week. I want to emphasize that this was not the injection site.
Patient presented to clinic for a booster following receipt of J&J for primary series, a full-dose Moderna was administered by mistake.  Unable to reach patient via phone to notify of dosing error. RN left voice message.
sick; This is a spontaneous report from a contactable consumer or other non-HCP (patient wife) via Pfizer-sponsored program. A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 28Jan2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced sick (reported as he has to go to the hospital) on an unspecified date. He got his 1st dose on 28Jan2021. She wants to know if he will now have to revaccinate since he was going to miss the 2nd dose. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Day 1 - major fatigue Day 2 - major fatigue, mild headache, general malaise; 400mg ibuprofen and 500mg acetaminophen every 6 hours; symptoms controlled but no improvement Day 3 - minor fatigue, headache turned into a severe headache; 800mg ibuprofen, 1000mg acetaminophen, and 200 mg caffeine every 6 hours; headache got worse, had to leave work early Day 4 - severe headache; 800mg ibuprofen, 1000mg acetaminophen, and 200 mg caffeine every 6 hours; no improvement, missed work, went to clinic for treatment - IV Toradol, Phenergan, and Benadryl Day 5 - headache or "headache hangover"; 400mg ibuprofen, 500mg acetaminophen, and 200mg caffeine every 6 hours PRN; pain decreased, still somewhat fatigued Day 6 - general malaise, minor headache; 400mg ibuprofen, 500mg acetaminophen, and 200mg caffeine every 6 hours PRN; pain decreased, still somewhat fatigued Day 7 - pretty much normal - no meds
Started in the morning  as feeling dizzy, light-headed.  As the day  went on, developed severe headache, body aches, naseous, fever (100.4), extreme fatigue and chills By the next morning all symptoms were gone
Pt came to ER c/o worsening mental status for the past few days.  Febrile.  Family concerned pt has UTI.
Headache, fatigue starting approximately 60 hours after 2nd dose of vaccination. Patient also had some bruising of the tongue starting at approximately 60 hours from 2nd dose that has improved from initial onset based on history/pictures and today's clinic visit.
Swelling, redness, heat, induration, soreness at injection site radiating down entire upper arm.
tested positive for covid 19 infection recently (after the first shot); tested positive for covid 19 infection recently (after the first shot); This is a spontaneous report from a contactable consumer reporting for himself. A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 46 years old on 05Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had his first shot of pfizer covid vaccine on april 5th and was due for his 2nd shot this coming Monday. Stated he tested positive for covid 19 infection recently (after the first shot in Apr2021). Asking should he wait to get his second shot? wanting recommendations. The outcome of the event was unknown. Information on the lot/batch number has been requested.
received injection on 3/23/2021. C/O Tired, sore all over.
Two days after receiving my second dose, I awoke to the most intense dizziness and spinning I have ever experienced,  accompanied by nausea. The rapid spinning subsided, but I am unable to remain upright without dizziness and nausea returning. I have thrown up a little, but mostly have just heaved. I have a headache as well. Other side effects have been soreness at injection site and heavy fatigue the day after the second dose. I