chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Develop Tinnitus. Saw doctor. No solution. On meds now.  Hopefully it will stop over a period of time. Not being able to sleep due to ringing in my ears especially left side.
Arm soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US243524.  A 59 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm soreness".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Continued, persistent shoulder pain at site of vaccine administration - currently being treated with NSAID's.
Pt. fainted after given HPV and MENVEO vaccinations. Pt walked to waiting room accompanied by MDA. Felt faint--occurred at lunch time (his lunch not eaten yet-was in his car) when attempted to get pt up in W/C to take to treatment room pt fainted again--eyes rolled back-arms flailing. Sent to ER to R/O seizure. Will be following with neurologist.
Soreness in Right Shoulder at site of vaccine.  Soreness all over body.  Fatigue and very tired after 8 hours of sleep.
Hard lump, red, swollen, itchy. Upset stomach. Symptoms peaked on 9/7/14.
At time of vaccination, sore arm.and headache One week later - itchy, soreness and rash
Redness/swelling/pain at injection site, severe  left shoulder joint pain limiting range of motion, and left axillary lymphadenopathy.  NSAIDS, Benadryl, and ice  for treatment. Condition ongoing.
'Pt rec'd vaccine lying down on cot. pt stayed 3 min lying down talking to vaccinator. Pt Sat up on cot for  2 more min, gave water for hydration Pt Alert and orientated. Pt stated "I did better than I thought I would."  moved to recovery chair. Pt AAO after sitting another minute stated" I think I need to lie down. " 5:35pm  pt started to have syncoble  episode. + LOC - SOB. Several people came to pt side.  Caught pt to help to floor. pt regained consciousness after 10 sec,  with verbal and sternal rub. Mother at side stated" this happens every time he gets a shot. "  Pt immediately became pale, diaphoretic, warm and alert.  Ice packs to back and front of neck. Elevated feet on chair. Medical MD responded. stated Vasovagal episode occurred.  VS taken  5:37 pm 102/60, HR 48 weak, thready, resp 12 reg non labored SpO2 97%. After 15 min sat pt up on floor. Check head for any bumps. denied hitting head and denied any pain.  No further episide of syncoble.2nd set VS taken 114/72, HR 78 reg, strong, resps 12 reg non labored. SpO2 97%.  Paleness and diaphoresis subsided. pt stated I feel back to normal . Suggested to go to hospital to be checked out. Pt refused hospital. stated this happens all the time.   Ok'd to exit after 30 min.
wife found pt down in the home and started CPR; EMS contacted; EMS also performed CPR, gave O2, Epinephrine, Bicarbonate, intubated; preceding sx was SOB; pt had been recently admitted to the hosp with COVID pneumonia (positive COVID test on 12/27/21) and was dc'd to home; wife requested CPR be stopped and pt passed away in the ED; DC and med records sent per VAERS request
This is the eighth of eight spontaneous reports as received from a physician refers a female patient between 14-15 years old who throughout this year "in 2012", was vaccinated IM with a dose of GARDASIL (lot # not provided). No other co-suspects were reported. No concomitant medications were reported. The physician stated that the patient suffered from syncope after having GARDASIL vaccination. The syncope was also more prevalent with the first dose given than with subsequent doses. Orange juice was given as treatment. The patient did not seek medical attention. The patient improved before leaving the office. The patient's outcome was recovered. The relatedness for syncope was unknown for GARDASIL. This is one of several reports from the same source. Additional information has been requested.
Vomiting x 3 this AM and fever (undocumented) - hot to touch.
Fever @ 102 degrees F Systemic Shivering Systemic Chills Systemic Muscle Aches Headache Lightheadedness
Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: arm
Information has been received from a medical assistant concerning a female who was inadvertently vaccinated with a dose of GARDASIL, instead of the hepatitis vaccine (manufacturer unknown).  The medical assistant reported that it was staff error only, and that the patient was at the appropriate age for GARDASIL.  The patient sought medical attention at the physician's office.  No further information is available.
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 04-JUN-2013, the patient was vaccinated with a dose of GARDASIL, (lot # H021608, expiry date 13-AUG-2015), which was exposed to 31 Fahrenheit for 1 hour. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Vomiting- since 12 July; fever- 12 July to 1 Aug; burning in feet- 15 July to present; teeth hurting-15 July to present, headache- on and off since 12 July, nose bleeds- on and off since July 12; diarrhea -since July 12.
1st and 2nd dose in 2021, shingles recently/ took shingle shot, got shingles/Suspected vaccination failure; shingles on back; left arm is still sore; 4-5 little bumps; it hurt/very painful; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (one outbreak when he was around 55 or 60 years old).   On 2nd June 2021, the patient received the 2nd dose of Shingrix (intramuscular) 50 ug. On 2nd April 2021, the patient received the 1st dose of Shingrix (intramuscular) 50 ug. On an unknown date, between 1 and 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain in arm, papular rash and pain. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure, papular rash and pain were unknown and the outcome of the shingles was recovered/resolved and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, papular rash and pain to be related to Shingrix and Shingrix. The reporter considered the pain in arm to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 02-MAR-2023 Reporter's Comment: The patient self-reported this case. The patient received two doses of Shingrix vaccine in left arm. The patient did not had the lot number of the administered vaccines but he provide the phone number of the pharmacy where the shots were administered. The pharmacy should have a record of the lot numbers used.  The patient stated the vaccine being be injected into the muscle, but he wonders if it was injected into a tendon because his left arm was still sore today and it was almost 2 years later. The patient reported that recently he experienced a case of shingles. He stated that he had just gotten over the shingles.  The patient was prescribed acyclovir pills as a treatment which was cleared shingles up in the past couple weeks.  The patient stated the shingles outbreak was on the left side of his back and it was only 4 to 5 little bumps, but it hurts very painful. The patient wanted to know the Shingrix vaccine did not work for him should he had to take it again. The reporter did not want to share his physician contact information. The reporter did not consent to follow up. Additional supportive information: This case was considered as suspected vaccination failure as detail regarding laboratory confirmation regarding shingles was unknown at the time of reporting.
Immediately after varicella injection given, pt had swelling below the injection site.  Patient was back in our office on 3-5-2007 and had acute localized eruption (blisters) at site of varicella injection.
Patient received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 62-year-old female patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   On 30th January 2023, the patient received Havrix. On 30th January 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: 30-Jan-2023 Reporter's comment: No symptoms were reported. The reporter consented to follow-up via postal mail. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Information has been received from a physician concerning a male pt who on approximately 2/13/02 was vaccinated with a dose of MMR II apparently "via the intradermal route of administration." Unspecified medical attention was sought. Follow-up info received from the physician indicated that there was no adverse effect from the MMR II, but rather that when it was administered, a wheal formed immediately at the injection site indicating that it had actually been delivered intradermally or subcutaneously. No further info is available.
Called health system call ceneter to report feeling tired, chills and slight fever but did not check temp since 5/4/2021 after got 2nd dose covid vaccine Pfizer on 5/3/2021.Pt denies any emergency sx at this time. Pt took tylenol on 5/4 and 5/5 with relief. Home management pt education given, pt assure understanding. Pt requested MD consult appt for today, Scheduled telephone visit with urgent care MD 5/7/21
pt recv vax; swelling/erythema w/ 24-48 hr of adm of vax; 20x 8cm lt upper arm;
12/07/2022 I felt like I had a cold coming on with post nasal drip, runny nose and feeling a little out of it. At 5:00PM, I took a home COVID test and it was positive. The next day my prominent symptom was a bad headache throughout the day. As the day progressed my nasal drip became more mucous. I called my doctor and she prescribed PAXLOVID and I began it on 12/9/2022. On 12/09/22, I continued to have congestion in my sinus, my headache was gone. I felt better with a little bit of a cough and congestion. I took another home COVID test on 12/13/22 and it was negative. I have recovered.
Approximately 10 minutes after receiving the vaccination the patient began complaining of dizziness and "not feeling right".  Vital signs indicated the patient to be hypertensive, vital signs otherwise within normal limits.  Patient denies rash, itching, shortness of breath, chest.  Patient transported to the ER for evaluation within 15 minutes.
unilateral pulsatile tinnitus that started 3 days after her first pfizer vaccine
Patient became lightheaded 3 min after shot given. Had patient sit down. Passed out 3 times. Called 911, pt taken to hospital and released.
Immediate arm pain, so bad I had difficulty driving within a hour of injection.   Cough with subsequent feeling of  irritation of airways, like a feather duster rubbing down the center of my chest,  I then developed a feeling of having a rock in my throat around the area of the Adam?s apple , which continued to worsen.   I went to Hospital at around 415 pm but they could not see any swelling, however, the area of concern was lower than could be visualized by looking inside my mouth.  The arm pain began to lessen, due to having taken a Tylenol at around  2 pm.  I went home around 5:30.  Eyes were extremely bloodshot, I had extreme fatigue.  I awoke at 11:14 with chilling and shaking, had low grade temp, nasal congestion, severe headache.  On Thursday I was extremely fatigued and felt very unwell and had also developed a rash all over my torso and upper arms.  I had stomach cramping and diarrhea.  The rash lasted for 3 days and I did not feel well for the remainder of the week.
She was experiencing an injection site reaction, redness and inflammation around the injection site. I advised her to take Tylenol for any pain and to ice the area. It has been occurring for the last 3 days, Friday through Sunday.
Deep Vein Thrombosis; second blood clot on lower right leg; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the first dose of BNT162B2 (Pfizer COVID 19) via an unspecified route of administration on the right arm on 07Sep2021 at 10:30 AM (Lot Number: FD8448) as single dose for COVID-19 immunization. Medical history included melanoma (x3), hiatal hernia, bone tumor (left talus), asthmatic bronchitis (COPD) and childhood bacterial immunity deficiencies. The patient didn't received other vaccine in four weeks. COVID prior vaccination was none. COVID tested post vaccination was none. Known allergy was none. Concomitant medication included ergocalciferol (VIT D [ERGOCALCIFEROL]) and multivitamin/VitD Gummies. The patient received the second dose of BNT162B2 via an unspecified route of administration on the right arm on 28Sep2021 at 10:30 AM (Lot Number: 30130824) as single dose for COVID-19 immunization. On 21Sep2021 at 18:30, the patient experienced deep vein thrombosis and second blood clot on lower right leg. Presented 8 hours after shot. Admitted to hospital 32 hours after shot. The patient performed catscan and ultrasound. The events resulted in emergency room/department or urgent care and hospitalization. Treatment was received included eliquis (ultrasound/CATSCAN/bloodwork). The outcome of events was recovering.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 12:26 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 12:26 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 27.52.  Concomitant products were not provided.  On 13-Feb-2021, Excursion time was 09 AM, temperature was 32, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Feb-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
I WAS DIAGNOSED WITH A BREAKTHROUGH CASE OF COVID-19 ON JULY 29, 2021. I HAD ALREADY RECEIVED MY TWO INITIAL DOSES OF THE PFIZER VACCINE
sounded like she had shingles; severe pain up her back that goes to her upper torso, left side only; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 01Mar2021 (Batch/Lot Number: Unknown) as 1ST DOSE, SINGLE for covid-19 immunisation (Age at vaccination: 78 years). Medical history included ongoing diabetes mellitus, ongoing degenerative joint disease, ongoing osteoarthritis and ongoing heart disorder. Concomitant medications included tramadol; pregabalin (LYRICA); gabapentin (GABAPENTIN "PCD").  The patient experienced severe pain up her back that goes to her upper torso, left side only on 03Mar2021. The patient also stated that she had sounded like she had shingles on an unspecified date. They felt that the vaccine was trying to fight the shingles virus that stays in her body. She has no bumps, fever or breakout. She went to the Emergency Room once to get pain medicine. She went to her doctor (physician office visit), she doesn't know if he reported this. The events were assessed as medically significant. The patient underwent lab tests and procedures which included MRI, scan and x-ray: unknown results on an unspecified date. Therapeutic measures were taken as a result of pain and shingles. Outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
VACCINE WAS STORED FOR FREEZER TEMPERATURE FOR TOO LONG.  WE HAVE RECOMMENDED TO THE PATIENT TO GET REVACCINATED.
Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 35-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Jan-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  No treatment information was provided.  The number was reported.
positive for COVID; positive for COVID; This is a spontaneous report received from a contactable Nurse. This Nurse reported similar events for 3 patients. This is 1st of 3 reports. An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3302), via an unspecified route of administration, administered in Arm on 20Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The contactable nurse calling about COVID vaccine. She was director at an Assisted Living, and pharmacy administered vaccines to residents on 20Jan2021, and they just had 3 residents, who were positive for COVID, so she wanted to report it in case there was data to look at, to see if they got a bad batch, or was this something that was happening frequently. The patient experienced positive for COVID on 03Feb2021. The outcome of the events was reported as not recovered.  The information on the Lot/Batch number has been requested.; Sender's Comments: Based on immunization history,patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 at single dose for covid-19 immunization.patient experienced positive for covid on 03Feb2021, which is the 14nth day from dose 1.Resulting in lack of efficacy of given vaccination.The patient becoming COVID positive is most likely an intercurrent condition. However, based on the temporal association, the association between the event Covid positive and the vaccination cannot be completely ruled out.,Linked Report(s) : US-PFIZER INC-2021162196 same drug and event, different patients;US-PFIZER INC-2021162159 same drug and event, different patients
Histamine Rx at 2 1/2 diameter 2 days post injection.
Fever 103 degrees. Diarrhea. Vomiting. Rash / red / swollen right arm. Antibiotics by PCP.
Pain in arm; Headache; Chills; Tiredness; Heavy eyes feeling; Muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20May2021 09:45 (Batch/Lot number: unknown) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety disorder" (unspecified if ongoing), notes: Anxiety Syndrome; "Cardiovascular disease" (unspecified if ongoing), notes: Cardiovascular disease. Concomitant medication(s) included: MELEX. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE LOT NUMBER: UNKNOWN ANATOMICAL SITE: ARM LEFT, time of administration: 09:45 AM.), administration date: 29Apr2021, when the patient was 40 years old, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 20May2021 12:00, outcome "not recovered", described as "Pain in arm"; HEADACHE (non-serious) with onset 20May2021 12:00, outcome "not recovered", described as "Headache"; CHILLS (non-serious) with onset 20May2021 12:00, outcome "not recovered", described as "Chills"; FATIGUE (non-serious) with onset 20May2021 12:00, outcome "not recovered", described as "Tiredness"; ASTHENOPIA (non-serious) with onset 20May2021 12:00, outcome "not recovered", described as "Heavy eyes feeling"; MYALGIA (non-serious) with onset 20May2021 12:00, outcome "not recovered", described as "Muscle pain".  Additional information: Other medication in two weeks included mexazolam (MELEX), anxiety and cardiovascular medications (UNSPECIFIED) from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.