chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Uveitis; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 10:00 (Lot number: Ep7534) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "NA" (unspecified if ongoing), notes: NA. The patient's concomitant medications were not reported. Past drug history included: Tetanus, reaction(s): "Known allergies Tetanus", notes: Known allergies Tetanus. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: En6205, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 26Feb2021, when the patient was 41 years old, for COVID-19 immunization. The following information was reported: UVEITIS (disability, medically significant) with onset 06Jun2021 09:00, outcome "not recovered", described as "Uveitis". The event "uveitis" was evaluated at the physician office visit. Therapeutic measures were taken as a result of uveitis. Clinical course- Treatment received for the adverse event was Eye drops. Facility where the most recent COVID-19 vaccine was administered was unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. It was reported Hospitalization was not prolonged. Device Date was 26Dec2021. Dose details: Bnt162b2 (Dose Number: 3, Batch/Lot No: Fe3590, Location of injection: Arm Left, on 01Nov2021 10:00 AM, for COVID-19 immunization.; Sender's Comments: Based on the available reported information, the causal association between the event uveitis and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
A little pain; A little fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (A little pain) and FATIGUE (A little fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (A little pain) and FATIGUE (A little fatigue). At the time of the report, PAIN (A little pain) and FATIGUE (A little fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Crosslinked cases MOD21-089411 and MOD21-089413 Limited report.   This case was linked to INC.-MOD-2021-117969, MOD21-089413, INC.-MOD-2021-118966 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: INC.-MOD-2021-117969: MOD21-089413: INC.-MOD-2021-118966:Husband case.
I have been monitored for years.  My blood glucose was fine.  Four months after the second Moderna vaccine I was diagnosed as being diabetic.  The only thing that changed this year was being vaccinated and now I am a diabetic for life thanks to Moderna and the mrna vaccine.
RECOMBIVAX 40mcg was given instead of RECOMBIVAX 10mcg.  No reaction at that time reported. When error was discovered on 4/5/2017 patient was contacted  and he stated he has no reaction or discomfort.
right side  between neck and clavicle appears to be swollen lymph node, tender to palpate, fatigue will monitor and report to PCP if needed
Patient previously received two doses of Moderna COVID vaccine 1/12/21 & 2/9/21. Patient was given Pfizer COVID vaccine in error as the 3rd dose instead of Moderna.
Client reported feeling "anxious and dizzy" approx. 15 mins. after receiving vaccine. Client was led to zero-gravity chair and V/S taken. V/S @ 10:42am: BP 116/56, HR 65, RR 12. V/S @ 10:50 BP 105/58, HR 66, RR 20. V/S @ 10:57 BP 111/70, HR 60, RR 16. V/S @ 11:04am BP 108/70, HR 52, RR 16. V/S @ 11:10am BP 115/68, HR 60, RR 20. Client reported "feeling better" at 11:15am and left site unassisted and with a steady gait, accompanied by her mom. Mom reported she was driving them home.
Information has been received from a pharmacist concerning a male patient of unknown age. The patient had no concomitant medications, pertinent medical history or drug reactions/allergies. On 09-NOV-2016, the patient was vaccinated with one dose of PNEUMOVAX 23 (lot # M026317, expiration date 11-JAN-2018) intramuscularly. "After withdrawing needle, some blood ran down the arm about 4-5 inches. It did not look like vaccine was mixed in the blood". No treatment was given for the event. No lab diagnostics studies were performed. At the time of the reporting, the outcome of the event was unknown. Additional information has been requested.
Injection site was itchy; Injection site was red; Had discomfort first few days; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Had discomfort first few days), VACCINATION SITE PRURITUS (Injection site was itchy) and VACCINATION SITE ERYTHEMA (Injection site was red) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included Crohn's disease. Concurrent medical conditions included Blood pressure high.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced DISCOMFORT (Had discomfort first few days). On 31-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site was itchy) and VACCINATION SITE ERYTHEMA (Injection site was red). At the time of the report, DISCOMFORT (Had discomfort first few days), VACCINATION SITE PRURITUS (Injection site was itchy) and VACCINATION SITE ERYTHEMA (Injection site was red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
This spontaneous prospective pregnancy report was received from a healthcare worker refers to a 34 year old female patient with autoimmune urticaria. No drug reactions were reported. On 09-AUG-2013, the pregnant patient was inadvertently vaccinated with a dose of GARDASIL (lot #, expiry not reported), 0.5 ml, intramuscularly. The patient became pregnant with LMP of 12-JAN-2013 and EDD of 19-OCT-2013. Concomitant therapies included ALLEGRA and PLAQUENIL. Initial exposure to GARDASIL was at 30 weeks. The pregnancy outcome was pending. The healthcare worker reported that this patient was intended to receive TDaP vaccine manufactured by GlaxoSmithKline. The caller stated that she picked up the wrong vaccine vial due to the similarities in the color of the labels between the 2 vaccine vials. No laboratory tests were performed. Additional information is not expected.
Information has been received from a physician concerning a 6-7 year old male with asthma, eczema and unspecified allergies who in approximately 2000, at 12 months of age, was vaccinated with a dose of Varivax. Concomitant therapy included montelukast sodium (MSD) and inhaled corticosteroids (unspecified). On 28-MAR-2006 the patient presented with a chickenpox rash. There were greater than 50 lesions, but the areas of the body were not specified. There was no fever. The physician prescribed a topical antiviral and BENADRYL. There were no labs done. At the time of this report the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Immediately after the proquad and hep A vaccines, his appetite severley decreased. Less than a week later, he had a fever of 102 to 105 for three days, completely lost appetite and lost all speech. Prior to the shot he was speaking a few words. In fact, previously his speech and vocalizations appeared to be a bit advanced for his age. A few weeks later, he started to try and speak again. He had great difficulty saying words previously he had said with ease. He was evalute by the state run program early intervention and recommended for speech therapy.  I was told he had premotor speech problem. He also seem to be having memory problem which I never noticed before.  I was told there was not a diagnotic test for children his age.  Also after a few weeks of his shots his appetite only improved slightly.  Prior to the shots he ate a varied diet and a substantial amount. For a long time after the shot he would only eat certain fruits and meats and not as much.  3/27/09 Received vaccine records & PCP medical records of 11/20/07-11/10/2008. FINAL DX: speech & language regression Records reveal patient experienced good health on 11/20/07.  RTC 11/28 w/fever, dx w/viral illness.  RTC 2/29/08 w/speech loss, had already been evaluated by early intervention, ST & peds neuro.  Had respiratory congestion.  Dx w/serous OM, mild conductive hearing loss.  Parent dizzy & feeling unwell.  Carbon monoxide, sulfure dioxide & nitrogen found in home.  Seen in ER & labs slightly abnormal at that time.  RTC 4/08 Slowly regaining speech, dx w/recurrent serous otitis media.  RTC 9/08 much improved speech, ears clear.
Left arm very painful for over 1 week.  Tender.  No rash. Mild warmth.
Labored breathing, starting early in morning... erratic, on and off throughout the day...  Sometimes with "fluttery" chest - like "frantic" when very hungry. Persisted for about 10 days. Note:  When outside, visiting doctor, or having dinner with friends had ABSOLUTELY no labored breathing.   Steps taken to mitigate/or explain: - tested Pulse-ox frequently - always within 94 to 98 (normal for me) - Used Albuterol occasionally, to no effect.   - Visited PCP and Pulmonologist.  - Had Chest X-ray and CBC  (both within normal limits, no changes from previous tests) - temperature 97.x  (normal for me) - BP 129/72  (normal for me) - PCP and resident at office visit  said not related to COPD (not a flare)  -  Pulmonologist agreed -  Tried decaf coffee (no change) -  Changed Stiolto medication (new on same day as vaccine) BACK to Anoro (no change) -  Turned off ionizer in apartment (part of an air filter) - no change -  Opened doors and windows in apartment to freshen air - no change  Symptom disappeared at about 10 days after onset. Flew to state (no breathing problem on plane) - six days there, no problem.  Returned home 4/20, still no problem.    Note:  had three previous Covid vaccines with only sore arm on third (August 2021), when done with Flu vaccine (other arm) No other Covid vaccine reactions.
DVT's in both of my upper arms; Hysterectomy; infection; This is a spontaneous report received from a contactable reporter (Nurse). The reporter is the patient. A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: EL1284), in left arm for covid-19 immunisation.  The patient's relevant medical history and concomitant medications were not reported.  Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL 9262, Location of injection: Arm Right), for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: F63527, Location of injection: Arm Left), for COVID-19 immunization. The following information was reported: HYSTERECTOMY (medically significant) with onset 06Jun2022, outcome "unknown"; INFECTION (medically significant) with onset 06Jun2022, outcome "unknown"; DEEP VEIN THROMBOSIS (hospitalization, life threatening) with onset 10Jun2022, outcome "not recovered", described as "DVT's in both of my upper arms". The patient was hospitalized for deep vein thrombosis (hospitalization duration: 13 day(s)).  The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jan2022) Positive, notes: Nasal Swab.  Therapeutic measures were taken as a result of deep vein thrombosis includes Lovenox injections; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
noted erysipelas to right arm during bath on 6th day after vaccine, 10x5cm  area below  2cm target area of incision site, warm to touch with clear borders, no systemic symptoms
At roughly 2:30pm, started with nausea and chills,  went home went to bed.   Severe muscles cramping and soreness.  Went to ER for this was perscribed naproxen for inflammation.   Still nothing helped.  Went back to ER with elevated heart rate and BP due to the discomfort was accused of being a pill seeker.   I just want the pain and muscle cramps to stop.  I hurt from head to toe.
No pain at injection site, but "horrible muscle aches" which began 36 hours after the shot, which have worsened.  No other symptoms.  Muscle aches so bad "I have to drag myself in and out of the car".  Patient is Pediatrician.
4/14/2021 MODERNA SECOND R09.02 HYPOXEMIA 5/19/2021 LYMPHANGIOMA 4/14/2021 MODERNA SECOND R09.02 HYPOXEMIA 5/19/2021 CKD STAGE 4 (GFR 15-29) 4/14/2021 MODERNA SECOND R09.02 HYPOXEMIA 5/19/2021 ELEVATED TROPONIN I
Patient reported the COVID arm. Itchy, welts and red spot on the arm where injection was given.
lip tingling/swelling Narrative: Employee reports experiencing "lower lip tingling, swelling, numbness" within minutes after receiving second dose of vaccine. No medications were taken, per employee report and denies seeking medical attention for symptoms. Unclear how long symptoms lasted.
erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd flu vax; above sx occurred 12 hrs p/flu vax & fesolved w/in 48 hrs;
pt tested positive for COVID at home; family unable to care for her and brought her to the hospital; minimal COVID symptoms, symptoms primarily related to Parkinson's progression; minimally responsive, dysphagic, failed several swallow tests, NPO; family opted for comfort care with hospice; pt was in hospice facility only hours before she passed away in the facility
Severe headache, flu like symptoms, loss of taste and smell. Still today 1/08/2022 taste and smell are not completely back.
No adverse event; improperly stored vaccine was administered to a patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 27-SEP-2022, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHa (PROQUAD) subcutaneous injection, lot #W019623, expiration date: 19-DEC-2023, administered for prophylaxis (strength, and route of administration were not provided) (product storage error). Administered dose of vaccine experienced the temperature excursion of -11.8 Celsius degree for 1 hour 45 minutes. No previous temperature excursion was reported. No additional details were provided. No additional adverse event or product quality complaint was reported.
I began to feel the typical side effects of the flu vaccine however 6 days later I continue to feel the symptoms and feel they are getting worse.
Oscillopsia, dizziness 10 hours later. Gradually subsided over 8 days, but still persists as if this report.
I woke up and my armpits were swollen and very sore. I also had right groin/upper leg swelling and my lymph nodes in my neck were swollen.  I became achy during the day and have been taking ibuprofen and tylenol as needed.  Yesterday, 3/9 the backs of my knees were swollen and achy also.
3 Days after my 1st vaccination  injection on March 06, 2021;  it felt like my shoulder was broken from the inside out. I  have taken  2 to 3 Advil just to be able to sleep, today I have taken my 2nd vaccination injection and I am worried, because I still have soreness and pain in the shoulder from the 1st vaccination injection. I immediately started feeling lightheaded from the 2nd dose today; which I expected some maybe cold like symptoms. I do know why I still have pain and soreness in my shoulder, but I am worried, because I should not feel any pain whatsoever anymore at least I thought.  I tried to register with the CDC to have someone contact me my email, I have given multiple ways to check with to help me. Respectfully yours,
Fatigue  Muscle aches over back, arms, legs Red area on arm Day6. Jan 28-Hip pain and difficulty walking:  ongoing feb 2 given cortisone  I hip for bursitis of hip. By feb 2 fatigue and generalized muscle pain and arm redness gone. Feb 3 arm redness recurs, swollen, red, itchy and scaly. 3  and 1/2 inches by 4 inches
PT LOSING VISION. SEEN SEVERAL SPECIALISTS WHO HAVE TOLD HER POSSIBLY FROM VACCIENE
no additional AE's; a pediatric patient was inadvertently administered GARDASIL 9 instead of another scheduled vaccine.; This spontaneous report has been received from a medical assistant concerning to a 12-month-old of an unknown gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not provided.  On 15-FEB-2023, the pediatric patient was administered inadvertently with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, scheme vaccination frequency, lot number, expiration date, and route of administration were not provided)  for prophylaxis instead of another schedule vaccine (wrong product administered). The reporter did not know other vaccine the patient was supposed to received and did not have other details.   No additional adverse event were reported.
Initial reaction was hives noticed about 1.5 hours later. Then red patches began spreading first along arm. Saw Dr  and was given a steroid shot at visit told to continue using Benadryl and skin lotions for itching. Then was given a round of oral steroids a couple day later as symptoms had not resolved. Then was treated in ER for anaphylactic reaction. Then was diagnosed as having Uticaria and given more steroids and increased allergy medication to 2 Allegra and 2-3 Zyrtec plus added an additional dose of Pepsid. Then saw PCP who decided I had been diagnosed incorrectly and sent me to dermatology who diagnosed me with Guttate Psoriasis brought on by being given the flu shot when I had strep throat.  The additional autoimmune disorder has resulted in extremely fragile immunity, and increased worsening of asthma symptoms.   I also continue to get flare ups of the Guttate Psoriasis.
Slight swelling of inoculation site with ?? long lymphadenopathy in that arm only.
immed fever p/immun; pt woke up screaming 3PM-6PM 102.6 fever by 6PM; couldn't move arms; redness noted on lt arm; 12MAY94 teacher noticed swollen lt fingers; c/o being stiff; rash in PM 12MAY94 under lt arm;
This spontaneous report was received from a patient's daughter concerning to an 81 years old male patient. On 04-DEC-2012, the patient was vaccinated with a subcutaneous dose of 0.65 ml ZOSTAVAX (lot not reported). No other co-suspects were reported. Since 05-DEC-2012, he had been having intermittent muscle spasms in the ZOSTAVAX injection arm. The patient's daughter stated that her father received the shot subcutaneously in the deltoid, but spasms were from his wrist to elbow. The patient also received an unspecified flu shot the same day in the opposite arm. The outcome of the event was unknown. The relatedness the event was unknown for ZOSTAVAX. Additional information has been requested.
Patient felt funny. EMS was called vitals were taken BP 132/92  100% O2 room air HR 88. General Malaise unknown cause patient refused evaluation/care. Left aginst medical advice.
This case was reported by a nurse via call center representative and described the occurrence of regurgitation of medication in a infant patient who received ROTARIX. On an unknown date, the patient received ROTARIX (oral). On an unknown date, less than a day after receiving ROTARIX, the patient experienced regurgitation of medication and accidental underdose. On an unknown date, the outcome of the regurgitation of medication and accidental underdose were unknown. It was unknown if the reporter considered the regurgitation of medication to be related to ROTARIX. Additional details were provided as follows: The age at vaccination was not reported. The patient regurgitated a dose of ROTARIX when given, which led to accidental underdose. The health care professional asked if replacement dose of ROTARIX should be given. No further information was provided.
almost fainted; This is a spontaneous report from a contactable consumer or other non hcp   A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number was not reported), via an unspecified route of administration on unspecified date as dose 1, single dose for covid-19 immunization. The patient medical history and concomitant medication was not reported. On an unknown date, the patient was almost fainted.The reporter stated that his half-sister had a strange side effect after Pfizer, don't know when she got the Pfizer vaccine, when she got the first dose, she almost fainted and she was taken to the hospital and her boyfriend (patient) had same effects. The outcome of the event was unknown.
Pt recvd 1st dose of Engerix-B 20SEP91 & reporter indicated during that wk of administration pt exp flu-like sx; sx fever & h/a;
Breasts have been itching since vaccination intently at times.  My menstrual cycle has changed.  I have cramping throughout my cycle and it has become less regular.  The spacing varies.  It is now unpredictable with both timing and flow.  Extremely heavy some times.