chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving the first dose of the Pfizer vaccine, my face immediately went all red and got hot.  I stayed at the pharmacy for 30 minutes to ensure I didn't have an allergic reaction like a breathing issue.  I had my epi pen with me just in case.  It was loud in the pharmacy so I didn't notice it at first but once I got outside and was in the car, my ears were ringing.  When we got to the restaurant to eat, we were the only family in there and it was pretty quiet.  The ringing was really high pitched and loud.  For the following two weeks it did not stop, day and night.  I contacted my primary and had a telehealth appt and also went physically in to my ENT's office.  I also tried acupuncture to see if that would take away the ringing.  The acupuncture seemed to lower the pitch in my ear but it was still present.  2 hours after I left the office the pitch was back to a high pitch ring again.  I cancelled my appointment today for 3/18 for the second dose because no one can assure me that this ear ringing will go away and the doctor's are unsure of whether the second dose will trigger a worse condition.  I had a hearing test on 3/16 at my ENT's office and I couldn't hear some of the sounds because of the ear ringing but I did pass the test at the very line of baseline normal.  My ENT is unsure if I will lose hearing due to this vaccine.
About 12 hours after the vaccine , headache and super tired; joint pain and body aches and a little nausea. And that kept going for a few days. Chest started getting tight - hard to breathe and fatigue got worse and worse. The weekend after the injection - the tiredness increased and I went to go get COVID tested - negative result .  February 6th - Went to Immediate Care for fatigue  and breathing issues. They put me on prednisone for the breathing issues - three week course and held off on getting second dose. I have been having problems with the breathing - it was inflamed though by the vaccine - could still be a Sarcoidosis issue. Had follow up visit with Primary Care doctor. Had the 2nd vaccine of Feb 6 - this did not have any AE for me. Maybe because I was on Prednisone prior.
Suspected vaccination failure; Shingles twice, diagnosed with a 3rd bout; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced suspected vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the suspected vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the suspected vaccination failure and shingles to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient stated that the patient's shingles came back worse after the vaccine Shingrix.  The patient had shingrix vaccine and had shingles twice and was diagnosed with a 3rd bout on 8th February 2022. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Consent to follow up was not possible as no contact details were available.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 59 year old male. Initial information processed along with additional information received on 25-MAR-2022. 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, intramuscular, batch number was not reported) dose, start therapy date were not reported 1 total for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis.  On an unspecified date, the patient felt fog in throat (throat discomfort) which was recovering.  In FEB-2022, the patient experienced had suspected covid-19 infection (lab test data not specified) and had suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint number 90000223498.; Sender's Comments: V0:20220354463- COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered not related.
Within 10 minutes post vax the pt stood up and fainted and fell on the floor on his back and hit his head and sustained a small abrasion. The pt was pale and not responding within a few seconds only. The pt's blood pressure was 100/62. The pt began responding after a few seconds. The pt was place with his feet elevated. No additional complaints were noted.
A report has been received from consumer concerning a female patient  of unknown age. The relevant history and concomitant drugs of patient were not reported. The patient had been receiving nasal FLUMIST which started on an unknown date. The patient's mother reported that the patient experienced multiple episodes of flu. She also reported that every time someone comes in her house within 234 hours of receiving it, her daughter gets the flu. This had happened every year since she was born. At the end of 2012 her friend with FLUMIST came into their home and was only here for about 30 minutes, she was diagnosed with the flu once again in that weekend. The outcome of the reported event was unknown. The reporter considered the event  of multiple episodes of flu to be non-serious.
Had Tdap, Menactra, Varicella-both arms with red welts warm to touch- increase in redness, increased swelling- low grade fever- increased on Augmentin PO
within about one hour after getting vaccine she started having severe nausea and vomiting and it would not stop.  Daughter called me after 20 minutes after vomting started.  I told her to take her mom to the emergency room.  When there, the ER gave her IV fluids, zofran, and told her to take benadryl.  She said she was a little confused as well.  She said she does not know if they gave her anything else by IV.  She was feeling much better about 7pm after I called her.  I checked on her the next morning and she was doing good.
9/4/03 called - arm sore, red, swollen. Advised to see private MD. She was seen in regional medical center either 9/4 or 9/5. Wound drain, drain inserted, drain inserted, put on antibiotics. Rechecked on 9/9/. Injection given 8/26/03.
Very red around injection site, swollen and warm to touch around injection site.  The guest also stated she had swollen lymph nodes on the side of vaccine admin.  The guest saw her doctor and was told to come back if the lymph node swelling continued.
The patient presented for her 2nd dose Pfizer vaccine. She received her 1st dose on December 4th, 2021. She was given her 2nd dose without incident.  Several days later, the staff noticed that the dosing interval was not concordant with recommended CDC EUA. The Father was notified by me and claimed that he thought two weeks was when he was told to schedule her follow up dose.
Almost immediately to maybe 3 minutes after I received the vaccine my tongue started tingling and the sides of my tongue began to burn. I also had a slight red rash on my chest that began to burn and itch. These are similar to the reaction I have after I eat cinnamon. It wasn?t severe like my shellfish allergy where I go into anaphylactic, but it was definitely a reaction. My tongue was then slightly swollen that day into the next day. Very slightly swollen. Just enough that I noticed it because I kept biting my tongue. The burning and tingling lasted for maybe an hour after. I was slightly dizzy as well, but nothing too bad.  I was seen by the ER team to make sure I didn?t go into anaphylactic and then I was allowed to return home. Others I walked by stated my face was bright red and I got very hot.   Following that I had extreme exhaustion. I couldn?t even make it home without having to pull my car over to try and wake myself up. I am feeling fine now, but just wanted to make this known for study purposes. I plan on getting the second shot on 1-19-21.
One hour after injection this infant started vomiting 8 times in 1 hour, stopped after approximately 3 hours, no fever.
Pt reports hives covering chest, back and neck. Painful swelling in arm where administered.
Emotional agitation, sobbing for unknown reasons - very emotions for 2-3 hours.
pt had a positive COVID test on 2/20/22; pt was found by EMS DOA at the pt's home
2 days p/receivng #1st set of vax pt states shrill screaming which lasted for hrs @ a time for 3 days; had t101; would be rigid & bowing back;
On the day after my 2nd dose, I had the typical low grade fever, chills, and aches. But on the 2nd day, I woke up with a red rash all around my torso and down both arms. It did not itch and was gone by the 3rd day.
Swelling and induration L thigh from groin to just above the knee occurred post injection. Hives x 3 at time of injection then progressed to multiple all over his body, no fever at any time. Swelling of leg resolved by 9/28 now knot at site of injection was resolved by 9/30.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6198) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The consumer started Paxlovid on 05Feb2021 for Treatment of COVID-19 (lot number: el9265). The patient previously received a COVID-19 Vaccine. Device Date: 01Jun2022.
WITHIN 10 MINUTES Patient developed swelling of had , face and throat. and some chest tightness  She took 30 mg prednisone and benedryl an Pepcid.   the symptoms stabilized ove an hour observation but did not totally resolve.   She continued to have throat swelling and loss of voice till today.  Still having extreme fatigue and shortness of breath
This spontaneous report was received from the mother of the consumer, referring to her daughter, an approximately 16 year-old female patient. The patient's had not  historical conditions, concurrent conditions and not concomitant medications ; however, it was reported that the patient is possibly allergic to morphine. On an unspecified date, the patient started the vaccination series with GARDASIL for routine vaccine (dosage, route of administration anatomical location, lot number and expiration date were not reported) which was completed in February 2009. On approximately 2009, within one week of completing the series, the patient had a high fever, headaches, light sensitivity and fatigue. It was reported that tests for Lyme and meningitis were negative and within "to three to four days these symptoms were resolved. In approximately 2010, reported as "one year later", the patient began experiencing pain through her body and spread to all four limbs in 2011. She was diagnosed with Complex Regional Pain Syndrome (although she never had an injury), and needed assistance with crutches for mobility, and at the reporting time, she was confined to a wheelchair for many years (disability). On an unspecified date, the patient sought for medical attention. It was reported that the patient has been to many rehabilitation facilities, on an unspecified dates. At the time of this report, the outcome of high fever, headaches, light sensitivity and fatigue was resolved and for the Complex Regional Pain Syndrome and mobility decreased was ongoing. The reporter did not provide the causality assessment for the events. This is one of two case from the same reporter.; Sender's Comments: US-009507513-1902USA002071:
Booster/3rd dose of Moderna vaccine caused dermographic urticaria that the first two doses did not cause. Symptoms developed on 1/15/2022 with itchy scalp.
devel itchy rash 5 days p/receipt of vax; also devel sore arm which was achy & throbbing;
Information has been received from an approximately 80 year old male oral surgeon with no known drug allergies and a history of chickenpox (age 10) and having been vaccinated with ZOSTAVAX (Merck) (2007). On 13-SEP-2012, the physician reported he received an unspecified flu vaccine. The physician stated he received prostaglandin for his macular degeneration (no date reported). On 15-SEP-2012, the physician reported he had a painful rash which was mid stomach and went up into his back. He was treated with an unspecified antiviral medication, prednisone and topical medication (unspecified). The physician reported he was recovering. Additional information has been requested.
pt recv vax 8JUL97 & mom states 24hr later pt devel swelling of rt upper arm & redness, swelling extended to neck on rt side & then to lt side of neck including facial swelling & redness;
On January 1, 2018 I observed him falling flat on his face, six falls were observed. He's still toe walking, and now is having involuntary movements of his arms/torso and arm flapping. I was able to get the arm flapping on video. I called the health department and was told by the nurse these behaviors weren't caused by the vaccine.
PATIENT PRESENTED TO CLINIC FOR ANNUAL WELLNESS VISIT ON 4/12/2021 AND RECEIVED THE JANSSEN COVID-19 VACCINE FOLLOWING HIS VISIT.  ON 4/14/2021 PATIENT CALLED EMS FOR C/O CHEST TIGHTNESS. DISCOMFORT HAD RESOLVED BY THE TIME EMS ARRIVED. PATIENT WAS TAKEN TO ER FOR FURTHER EVALUATION. PATIENT REMIANED FREE OF CHEST TIGHTNESS/DISCOMFORT THROUGHOUT THE VISIT AND  CARDIAC WORK-UP AT THE ER WAS ESSENTIALLY NORMAL. PATIENT WAS DISCHARGED HOME WITH F/U INSTRUCTIONS.  ON 4/15/21 RN RECEIVED A CALL FROM THE COUNTY MEDICAL EXAMINER STATING THAT PATIENT WAS FOUND DECEASED IN HIS DRIVEWAY THIS MORNING AT AROUND 09:41 AM.  THERE WERE NO SIGNS OF FOUL PLAY AT THE SCENE.  PATIENT'S RECENT PHYSICAL AND LAB WORK WITH HIS PROVIDER ON 4/12/2021 SHOWED NO FINDINGS OF CONCERN.  PATIENT HAD NO CHRONIC ILLNESSES, WAS ACTIVE, AND OFFERED NO MEDICAL CONCERNS AT HIS VISIT ON 4/12/2021.
Hospitalized on 10/27/2022. Died on 11/03/2022.
Sore throat; Congestion; Chills; Fevers; Lost my taste and smell; Lost my taste and smell; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Congestion), AGEUSIA (Lost my taste and smell), ANOSMIA (Lost my taste and smell) and CHILLS (Chills) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Aug-2021, the patient experienced AGEUSIA (Lost my taste and smell). 28-Aug-2021, the patient experienced ANOSMIA (Lost my taste and smell). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Congestion), CHILLS (Chills) and PYREXIA (Fevers). The patient was treated with PARACETAMOL (TYLENOL) for Adverse drug reaction, at an unspecified dose and frequency and IBUPROFEN for Adverse drug reaction, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Congestion), CHILLS (Chills) and PYREXIA (Fevers) outcome was unknown and AGEUSIA (Lost my taste and smell) and ANOSMIA (Lost my taste and smell) had not resolved.        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.   No concomitant medication information was provided. Patient has adipose disease.
On or around December 22, I noticed pain in my left forehead as though someone had hit me with a baseball. The next week around the 29th, it got very noticeable - pain to the touch but no swelling. It continued.  Between the first dose and second dose I didn't recover, it just stayed.
One of five pt's, immunized from same vial of DTP, who devel high fever (103-104) & irritability w/in 12 hrs p/immun; tx APAP & tepid bath; Pt's also recvd HIB-TITER/OPV;
By 5:15 symptoms of itching, runny nose, hoarseness, painful itchy eyes began and by 8:30 I experienced a racing heart, inability to sleep, excessive sweating and unusually sharp vision. These symptoms continued for 48 hours. It was 4 days before I felt my body had returned to feeling normal.
17DEC91 recvd DTP/HIB  @ 215PM & @ 6PM tired, refusing to walk; 1130PM high fever 104 ax; tepid bath 102.5; finally asleep 830AM 18DEC91; refused food, still feverish 104.5; body vibrating;
Vaccines given 1/14/04. Pt developed fever 1/17/04. Decreased appetite. Increased sleeping. Rash on abdomen and back 1/21/04. Seen office 1/21/04. Diffuse papular rash abdomen and back high febrile, nontoxic approving possible OM. Tx: symptomatic.
Soreness and swelling with redness and warmth that is growing in size at both injection sites; worse on right (MMR). Afebrile. No SOB, or angioedema. Reviewed with Pediatrician. Concerned about developing cellulitis, esp on right. Started on AUGMENTIN 500mg BID x7 days. Use OTC pain relievers. To see PCP tomorrow morning. Margins of erythema marked with skin marker.
Shot hurt tremendously, arm felt very lethargic, pain continued to increase during the day and night. Have had difficulty lifting arm in certain directions.  Range of motion severely diminished.
Information has been received from a physician concerning a 13 year old female who on 18-DEC-2006 was vaccinated with a first dose of Gardasil (lot #654389/0961F). There was no concomitant medication. Subsequently, the patient experienced hip, knee and ankle pain. In January 2007, the patient began to experience occasional episodes of blurry vision. On 02-FEB-2007, the patient was vaccinated with a second dose of Gardasil. It was reported that the patient's symptoms "severely worsened" following the second dose of Gardasil and the patient also experienced lightheadedness and increase in headaches. The patient was seen by an orthopedic physician on 02-FEB-2007. Unspecified laboratory and diagnostic tests were performed (results not reported). On 07-FEB-2007 the patient experienced "one episode of blacking out." The patient saw a neurologist on 20-MAR-2007. At the time of the report, the patient had not recovered. The reporting physician considered the events to be disabling as the patient was unable to participate in ballet or dancing classes. Additional information has been requested.
first dose 13-JAN-2022, second 5-AUG-2022; flu-like symptoms; pain in the arm; inflammation of the arm; pain of the right shoulder; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGRIX with an associated reaction of influenza like illness (for tolerance to the 1st dose refer case US2022118618).   On 5th August 2022, the patient received the 2nd dose of Shingrix. On 5th August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In August 2022, the patient experienced influenza-like symptoms, pain in arm, inflammation localized and shoulder pain. The patient was treated with ibuprofen. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms, pain in arm, inflammation localized, shoulder pain and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the influenza-like symptoms, pain in arm, inflammation localized and shoulder pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022118618   Additional Information: GSK receipt date: 12-Aug-2022 Reporter's comments: The patient self reported this case for herself.  The patient's doctor recommended that she wait 3 months before she get her second Shingrix dose. The patient received her second dose of Shingrix. After her second dose, she experienced pain in the arm, inflammation of the arm, pain of the right shoulder and flu-like symptoms. The patient stated that she took ibuprofen to help with the pain. The reporter consented to follow up. Additional supportive information: The patient received 2nd dose delayed than the recommended vaccination schedule, which led to lengthening of the vaccination schedule.; Sender's Comments:  US-GSK-US2022118618:Same reporter
Information has been received from a physician concerning a 7 year old white male who on 03/04/1998 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck) (Lot#624643/1328E).  There was no illness at the time of vaccination.  On 05/03/2004, the patient presented to the office with chickenpox.  There was no prescription drug treatment required.  There was no relevant diagnostic laboratory tests performed.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  No further information has been requested.
Fever, significant left arm pain, redness & swelling at injection site (3 distinct erythematous patches)
PATIENT ARRIVED  FOR HIS 2ND DOSE OF PFIZER. (1ST DOSE GIVEN 4/6/21, WITHOUT ANY REACTIONS NOTED). NURSE  SCREENED PATIENT AND FORM COMPLETED WITHOUT ANY NOTED REACTIONS OR REASONS NOTED TO HOLD VACCINE. INTERVIEW WITH PT WHO SAID HIS LEFT ARM STARTED TO CRAMP BEFORE THE SHOT WHEN HE WAS REMOVING HIS SHIRT. PT RECEIVED HIS PFIZER VACCINE AT 1205PM, THEN TO 15MIN WAITING. HE SAID HE FELT FLUSHED, AND SEEN SPOTS. ASSISTED BY EMERGENCY PERSONEL WITH VS TAKEN. EP SAID THE PT WAS DIAPHORETIC AND PALE WHEN HE MADE IT TO THE CAR AT 1215 AND CALLED THE AMBULANCE MONITORED EKG BY EP AND ASSESSED BY THE AMBULANCE PERSONEL. PT REFUSED TO GO TO THE ER, SAID WOULD GO TO HIS PRIMARY PHYSICIAN WITH HIS WIFE, WHO WAS PRESENT AND DRIVING THE CAR. LEFT WITHOUT ANY ACUTE SYMPTOMS AND SAID WAS FEELING BETTER.
Received a Flu shot on 10/19/2018. After flu shot was administered, I experienced common arm/shoulder pain, however, the pain never went away; it progressively got worse. The pain got worse as time went on which led to "frozen shoulder".