chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient, - came into the pharmacy on 10/2/19 at 1:25 pm and reported that her right arm is very red and swollen from her immunizations. The patient reported that the arm "feels warm to the touch." The patient stated that the arm does not itch. The patient also reports that she is not experiencing any breathing problems, and no other systemic reactions reported. The patient showed me her arm, and I observed the arm to be very bright red and swollen from the top of the arm up near the shoulder down to the elbow. It was a fairly large area affected on the outside of the right arm. Due to the severity of the reaction, I advised the patient to seek medical care. Recommended the patient see a physician to rule out reactions suchas cellulitis/infection versus an allergic reaction. The reaction is severe enough that it should not be treated OTC. The patient was going into her doctor office about this today per my recommendation to follow up with physician about this. I looked up the patient's recent immunization history in our computer: on 9/30/2019, this pharmacy gave the patient 3 immunizations ... Fluzone Quad and Pneumovax 23 were administered in the right arm, and Shingrix was administered in the left arm. The patient did not experience any reactions in the left arm where the Shingrix was administered. This IMZ reaction in the right arm would be from either the Fluzone Quad and/or the Pneumovax 23.  CALLED THE PT. TO CHECK UP ON HER 10/2/19 8:55 PM - PT. SAID SHE WENT TO HER DR. AND THEY GAVE HER AN ORAL ANTIBIOTIC BECAUSE DR. THOUGHT IT MIGHT BE INFECTED DUE TO "RED STREAKS" - HER DR. TOLD HER THAT IF SHE DOES NOT GET BETTER, TO GO TO THE ER.
Debilitating headache; body ache; vomiting; nausea; chills; This is a spontaneous report from a contactable consumer (patient) and the consumer's spouse. A 38-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EZ3246) via an unspecified route of administration on 20Jan2021 (at the age of 38-years-old) as a single dose for COVID-19 vaccination. Medical history was reported as "no" and concomitant medications ("other products") were reported as "no". The patient experienced "debilitating headache", "body ache", "vomiting", "nausea" and "chills", all on unspecified dates. It was reported that the patient went to the emergency room for the adverse events and was hospitalized on 26Jan2021 for the events "debilitating headache", "body ache" and "vomiting". The consumer called to report "a debilitating headache afterward (after the first dose of the vaccine) that persisted for 3 days and was still present, but diminished, for a total of 3.5 days. He also reported nausea, vomiting, chills, body ache, no fever.  He went to the ER (emergency room) and was treated with fluids and other meds." The patient wanted to know whether the symptoms would be worse with the second shot and if they were more commonly reported after the second shot? The patient's spouse also called and reported that her husband "received the COVID Pfizer Vaccination (COVID-19 Vaccine) last Wednesday and had a really bad experience with that afterwards." She stated that he received the vaccine at a hospital. When asked about the start date of the adverse reaction the reporter stated "Saturday 23rd." When clarification was requested regarding the adverse reaction, the reporter stated, "He had an extremely bad reaction to it. His head was hurting so bad that it was more than a migraine and he was vomiting, body ache but way worse than anyone that he has ever talked to, that has had it. He had to go to the hospital for it, it was bad." The reporter stated that the date of hospitalization was "yesterday 26Jan2021." The reason for hospitalization was not confirmed further. When asked about the outcome of the events the reporter stated, "A little bit better but not much". The reporter wanted to know whether "this was a common thing, are you seeing this happening?" The clinical outcome of the events "debilitating headache", "body ache", "vomiting", "nausea" and "chills" were all not recovered/not resolved.
Dark bruise. About 1 1/4 inch in diameter with smaller dark spots in the circular site. I reported this before and tried to send a photo but it evidently did not go . The bruise is finally going away but has lasted almost three weeks. There were no other symptoms that I noticed except some soreness  at the injection site. When I received the injection it seemed to be lower down on my arm than. I had thought it would be and there was some bleeding, along with unusual pain during the injection.
Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Joint Pain-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium
I was vaccinated on December 1  at a medical center and received the J&J Vaccine in my right arm.  On December 13th I began experiencing shooting pain across my chest and in my left breast that got progressively worse each day  On December 21st I saw my gynecologist for this pain and was sent for an ultrasound of my left breast.  January 3rd I got my ultrasound.  January 13th I found  a lump in my left breast.  January 14th I went back to my gynecologist who recommended I see a breast surgeon.  January 27th I saw a breast surgeon who said my symptoms are an inflammatory response and possible signs of an auto immune disease. She suggested I  may need to see a rheumatologist. She has sent me to go get further testing. I am  scheduled for a mammogram and ultrasound on February 18th as well as bloodwork per her request.
The arm is red, swollen, tender, and the injection sites are scabbed and red.
Three days after vaccine I experienced severe stabbing pain in left chest. A burning sharp pain. Several times throughout the day. This increased over the next 2 days and radiated into left arm and left jaw.  I went to the hospital march 2nd as the pain became more constant and severe
3rd shot of Shingrix; This case was reported by a consumer via Shingrix GSK and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The reporter was the patient. The patient received 3rd dose of Shingrix, which led to extra dose administered.
After about 45 minutes from the initial injection he completely blacked out while driving us home on the freeway. I had to grab the wheel to keep from running off the road or into a semi truck. He said she had tingling in the shoulder and felt nauseous. He blacked out before we could switch drivers. Terrifying
PATIENT RECEIVED PFIZER MONOVALENT INSTEAD OF PFIZER BIVALENT.       PATIENT ALSO HAD ALLERGIC REACTION THIS TIME.   REPORTS SWOLLEN EYE AND ARMPITS AND REDNESS ON FOREHEAD WHICH BEGAN AN HOUR AFTER VACCINE
Patient presented to the ED by EMS on 12/30/22. She was a known COVID-19 positive patient with increasing cough and shortness of breath that was requiring oxygen. Patient tested positive at her living facility, and repeat COVID-19 PCR test performed in the ED also resulted positive. She was admitted to the hospital from 12/30/22 - 1/5/23. Problems addressed in the hospital include acute hypoxemic respiratory failure in the setting of COVID-19 pneumonia and complete right upper lobe atelectasis/collapse. Patient was initially started on supplemental O2, but was able to be weaned off oxygen. She was given Decadron, and was satting well on room air prior to discharge. Other problems were also addressed during her admission, including asthma, permanent atrial fibrillation, and dementia. Notably, patient has received the primary COVID vaccine series and one booster.
On September 30th I experience very fast heart rate even at resting and feeling very nervous. Called 911 paramedics check my heart rate at 140 BPM. Went directly to the emergency room for care.
A rash started Fri 6/21 and has risen and faded all over for a week and 1/2. Experienced muscle pain in arches of feet, palm of hand and back of hem strings. Treatment with prednisone 60mg for 4 days, 40mg for 2 days, 20mg for 2 days. Persistent intermittent urticaria thru 7/17, given 3rd Rabavert.
Patient fainted momentarily after flu shot administered; stated he felt a little dizzy prior to fainting.  His blood pressure  reading was normal afterwards 126/80.  He recovered quickly, no injury reported.  He left the pharmacy and continued grocery shopping.  I checked on him as he was leaving the store about 5:20.  He was fine
This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ACCIDENTAL UNDERDOSE (Lower first dose. One drop of the vaccine fell from the needle.) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. No Medical History information was reported. On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced ACCIDENTAL UNDERDOSE (Lower first dose. One drop of the vaccine fell from the needle.). At the time of the report, ACCIDENTAL UNDERDOSE (Lower first dose. One drop of the vaccine fell from the needle.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient takes concomitant medication, but Pharmacist didn't tell which ones and what are they for.  Treatment information was not provided.
pt recvd vax & 22 days later lt deltoid was swollen, painful, & warm;
Within a month or so of getting the second dose, I began noticing occasional soreness in my shoulders - specifically the area where I got the injection. The soreness is not enough to be debilitating and it does not usually last more than half a day. I experience the soreness when moving my shoulder muscles (particularly when carrying things) but not when putting external pressure on that part of my body.
Suspected vaccination failure; Shingles; Rash; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and rash (Verbatim: Rash). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the rash was not reported.   The reporter considered the vaccination failure, shingles and rash to be possibly related to Shingles vaccine.     The company considered the vaccination failure, shingles and rash to be possibly related to Shingles vaccine.   Additional Information: GSK receipt date: 21-Mar-2023 This case was reported by a patient via interactive digital media. The patient developed shingles a year after having the shot and did even know that she had shingles until the physician notice the rash. The patient reported that the shingles shot was one of the best shots to get no matter what the cost.  The reporter think that the event might have been related to the Product/Device. The follow up would not possible, as no contact, details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
reporting a missed dose of VARIVAX.; No additional AEs; This spontaneous report was received from a nurse and refers to a male patient of unknown age. The patient's medical history, concurrent conditions were not reported. The patient did not receive varicella virus vaccine live (oka/merck) (VARIVAX) at 12 months of age. On an unknown date (at 4-year-old), the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection subcutaneously for prophylaxis.  He had not received a second dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection for prophylaxis as of 14-MAR-2023 (missed dose) (product dose omission issue). No additional adverse events were reported (no adverse event).
patient is currently pregnant at this time and received the GARDASIL 9 vaccine inadvertently today; no additional adverse events have been reported; This spontaneous prospective pregnancy report as received from a registered nurse concerning a 28-year-old female patient. There was no information about the patient's medical history, concurrent conditions or concomitant medication. On 14-JUN-2021,  the patient was vaccinated with a first dose reported as single dose of of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) prefilled syringe,  lot # T026168, expiration date reported : 04-DEC-2022,  dose:0 .5 milliliter, intramuscularly,  for prophylaxis (anatomical location was not reported), inadvertently.  On an unknown date, the patient became pregnant. At the time of vaccination the patient was currently pregnant and no additional adverse events had been reported by the patient as a result of receiving the vaccine. The mother's last menstrual period, estimated due date, prenatal tests and results were not reported.The trimester of exposure was unspecified. The pregnancy outcome was outcome pending. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026168; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
4/20/2022 I had cold symptoms, cough and runny nose. I took a COVID-19 home test, and it was positive. I reported it to a  Dr., and he prescribed Paxlovid. That night, after the first dose, I felt worse. My breathing was constricted. I slept on my stomach and that relieved it a little bit. It was unpleasant enough and scary enough that I did not take another dose. I still have a runny nose, but the cough is better. I have a lot of fatigue with normal activities.
Did not hurt at time of injection, but it got sore that evening.  It got better but not gone, around Nov 1, 2, 3 then severity of symptoms returned. It never hurt to touch the arm at injection site, it hurt inside. Now unable to sleep due to pain described as burning and aching.
10/19/2021 Exposure to Covid Fever or Chills  Headache  Sore throat loss of smell
Pain, swelling, redness at injection site (thigh).  Swollen knee on same leg, diagnosed as cellulitis.
Spitting up blood. Spontaneous. Started 2 days after. has continued to this day on perhaps 15-20 days during that time, maybe more. Accompanied. by giant hives and rashes. Thick hives. Bizarre shapes and sizes. All over my body. Had CT scan of chest and Sinus - normal. ENT normal. Blood tests including many for sed rate and other blood or infectious related things, all normal. Urine normal. Phlegm and sputum cultures normal. Going to see pulmonary on April 19. Going for second opinion ENT April 7. Chest pains and general body aches and pains and straining pains in mornings four times including this morning. Dermatologist says he has seen hives from vaccine because there is no other cause when so many patients show up with it; however mine are the most extensive, large and thick he has seen. Suggested Claritin and Benadryl and hoped it would go away in time. I am a physical mess and had zero problems before the vaccines. Please contact me immediately I should have come too sooner.
Pt presented to our office today with a round red rash on trunk, behind ears and in genital area. Dx'd by our physician as "chickenpox". History of step-sister having same.
- Fever, prob seizure 8/17/1995 8/17/1995; seen in ER (ambulance) dxom - Lack of understanding or responsiveness to oral language
1 day after administration patient developed left arm pain, swelling, redness affecting entire arm, without dyspnea, hives, dysphagia. Saw in clinic 2 days after vaccine, swelling improving, no treatment required.
Profound weakness, burning sensation in chest, fuzzy-headed, nausea, headaches, feeling like his muscles were tightening from the inside.  .  Began the night of his vaccine and have gradually decreased but still 50% present 3 weeks out.
Information has been received from a pharmacist concerning a patient of unknown age and gender. No current or historical conditions were reported. On 20-APR-2015 the patient was vaccinated with M-M-R II (strength, dose, route and lot# unknown, expiration date is 22-MAR-2015) after the expiration date. No adverse effects were reported. Additional information has been requested.
Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 20-month-old female patient who received HAV (Havrix) (batch number EP47E, expiry date 6th February 2023) for prophylaxis.   On 27th February 2023, the patient received Havrix. On 27th February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 28-Feb-2023 Reporter's Comments:  Nurse Practitioner (NP) reports administration of Havrix following after expiration date. The reporter consented to follow up. Additional Supportive Information: The patient received Havrix after expiration date, which led to expired vaccine used.
Some reaction, feeling euphoric; High amount of energy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of euphoric in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 5YR3P, expiry date 07-JUN-2024) for prophylaxis.  On 07-FEB-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced euphoric (Verbatim: Some reaction, feeling euphoric) and energy increased (Verbatim: High amount of energy). The outcome of the euphoric and energy increased were unknown.  It was unknown if the reporter considered the euphoric and energy increased to be related to Shingrix.  It was unknown if the company considered the euphoric and energy increased to be related to Shingrix.  Linked case(s) involving the same patient: US2023063913  Additional Information: GSK Receipt Date: 02-MAY-2023 A pharmacist reported that the patient experienced some reaction after the 1st dose of Shingrix. According to the pharmacist, the patient was feeling euphoric and with high amount of energy after the vaccination. The reporter had consented to follow-up. For tolerance of second dose, refer case US2023063913, reported by same reporter.; Sender's Comments:  US-GSK-US2023063913:Same reporter
Fine the day of the shot. Almost exactly 24 hours later, I had malause severe muscle and joint aches that led me to be nearly unable to walk. I had to take 4 days off work.
12 hours after admin I had onset of 5 hours of shaking chills in bed. I had trouble getting up to urinate, walking straight and selecting some TYLENOL with codeine and CELEBREX from the medicine cabinet as my hands shook so badly. Now in the AM I have a mild HA addressed with more TYLENOL 1000 mg. I am a physician. I will get my second vaccination in two months but will be sure to get it on a weekend. Fever but not chills were listed on my handout so I though it well to report this side effect for possible inclusion in the patient handout if this turns up more in the future. I informed the pharmacist to lookout for this when I called to get the lot number.
Patient fainted immediately after vaccination. He was on the floor for roughly 15-20 seconds before regaining consciousness. Once he regained consciousness, we gave him some water and he felt better. He was observed for about 30 minutes post vaccination and he left with his mother.
2 days p/vax pt exp lower eyelids "jumpy" & eye strain.
FEVER AND HEADACHE STARTED 10/12/2103 PT HOSPITALIZED 10/17/2013. AS OF 10/23/2013 PT CONTINUES TO BE IN INTENSIVE CARE AND HAVE FEVER UP TO 102.8 WITH ENCEPHALOPATHY FROM PROLONGED FEVER.
Darkening and dark marking on her arch on the side of her left foot; This is a spontaneous report from a contactable consumer (the patient). A 55-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0172), via an unspecified route of administration, administered in right arm on 26Apr2021 (at the age of 55-years-old) at pharmacy as a single dose for COVID-19 immunisation (reported as advised and being she was at high risk do not want to die and it would cut severity). Medical history included the patient was diabetic since 20 years. There were no concomitant medications. No history of previous immunisation with the other vaccines. No prior vaccinations within 4 weeks. On 26Apr2021, immediately that evening (after first dose), the patient experienced darkening and dark marking on her arch on the side of her left foot. Caller stated she went to the doctor the next day to report that since she was a diabetic and she always notices her feet and thought it was strange. No pain or anything just darkening that she thought was strange. The outcome of event was not recovered.  Information on the lot/ batch number has been requested.
Described it as "kicking his butt"; Sore at the injection site; Second day his arm hurt more; He felt flu like for a day; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site pain, pain in arm, influenza-like symptoms and feels awful. On an unknown date, the outcome of the injection site pain, pain in arm, influenza-like symptoms and feels awful were recovered/resolved.   It was unknown if the reporter considered the injection site pain, pain in arm, influenza-like symptoms and feels awful to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for himself. The age at vaccination was not reported. The patient received 1st dose of Shingrix prior to the pandemic and was sore at the injection site and the 2nd day his arm hurt more, and it took 3 to 4 days to resolve. The patient also reported that he felt flu like for a day and he described it as kicking his butt.    The patient mentioned that he had received the flu short for over 65 patients within 3 to 4 weeks of the Shingrix vaccine, however, he could not confirm which vaccine he received first. The reporter did not consent to follow-up. For tolerance of 2nd dose and Flu vaccine, refer case US2021AMR080315 and US2021AMR080271, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR080271:Same reporter. US-GLAXOSMITHKLINE-US2021AMR080315:Same reporter.