chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4528096-00 (Agency).  A 27-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (cf), subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 14Aug2022, outcome "unknown" and all described as "COVID-19". The action taken for adalimumab was unknown.  The reporter considered "covid-19" related to BNT162b2.  Clinical course: On 14Aug2022, the patient experienced COVID-19. Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 vaccine trial. Primary reporter contact for lot number information was not available. Causality for Humira (Adalimumab) The reporter's causality for the event(s) of COVID-19 was not provided. Causality as per reporter (Drug/Vaccine) was not reported. Causality as per reporter (Drug/Vaccine) was possible. Did reaction abate after stopping drug was N/A.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events  Drug ineffective and suspected Covid 19 cannot be completely excluded.
Onset of Autism about 5 weeks after MMR shot was given on 10/5/99.  60 day follow up on 07/28/03: "Patient did not recover from adverse event.  'Patient is still severly autistic!'"
patient fainted after varicella vaccine.  Fell off chair and received a quarter sized abrasion.  BP 100/50 pulse 60.  After settled and up in a chair fainted again.  Sent to physician's office for observation.
3 - 4 days post vax, pt experienced Bell's palsy. The second dose was not administered. No further information is available.
Blisters; Scabs; Unbearable pain chest; Unbearable pain back; Nerve pain; Slept a lot; Had the shot broke out from the middle of chest all the way around back; broke out from the middle of chest all the way around back; This serious 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 (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On 07-JAN-2023, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the shot broke out from the middle of chest all the way around back) (serious criteria GSK medically significant) and shingles (Verbatim: broke out from the middle of chest all the way around back). On an unknown date, the patient experienced blister (Verbatim: Blisters), scab (Verbatim: Scabs), chest pain (Verbatim: Unbearable pain chest), back pain (Verbatim: Unbearable pain back), post herpetic neuralgia (Verbatim: Nerve pain) and sleep excessive (Verbatim: Slept a lot). The patient was treated with gabapentin and paracetamol (Tylenol). The outcome of the vaccination failure was unknown and the outcome of the shingles and sleep excessive were not reported and the outcome of the blister and scab were recovered/resolved and the outcome of the chest pain, back pain and post herpetic neuralgia were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, blister, scab, chest pain, back pain, post herpetic neuralgia and sleep excessive to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, blister, scab, chest pain, back pain, post herpetic neuralgia and sleep excessive to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-Mar-2023 The reporter reported the case via interactive digital media. The patient had the shot in 2017 and broke out on 7th January 2023 from the middle of his/her chest all the way around to his/her back.  The reporter mentioned not in left side front and back. Finally, all blisters and scabs gone but he/ she still had unbearable pain in chest and back.  It was the nerve pain.  On gabapentin 600mg for 3 day plus Tylenol.  It did not kill the pain, he/she still feels.  Almost the middle of March, 3 months he/she had slept a lot. The reporter did not wish this on anyone and just want it to go away. The follow-up would not possible as no contact details were available This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting.
One day after 2nd dose, (Apr 13) pt woke up with symptoms resembling a sinus infection. On Apr 14, pt woke up with sore tooth and thought she'd been grinding her teeth through the night. Apr 15, pt had a severe tooth ache in tooth 4 involving gum tissue and into bone. Apr 16, she went to an endodontist and was diagnosed with a severe infection on a tooth with a prior root canal. Dr put her on antibiotics for a week. Pain and swelling reduced somewhat during antibiotic course. On Apr 26 pt had an apicoectomy.  Apr 27 Pt started having pain in tooth 19 (that also had a prior root canal.)  Apr 29 pt had the sutures of first surgery removed, and pt had dr take an xray of tooth 19, which showed an infection in tooth 19, despite the ongoing antibiotics course.  May 7 pt had a root canal on tooth 19. May 19 tooth 21 started hurting . May 27, pt went to an new endodontist. He said pt need an apicoectomy on tooth 21 or simply pull the tooth. Summary: after years of no problems with root canals (or even decay), within 1 day of 2nd Pfizer dose and over the next 7 weeks, 3 prior root canal teeth became problematic.
Case number PHEH2015US026901, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a female patient of an unknown age. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 28 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The nurse stated that, the reason was unknown for the refrigerator to be out of temperature range. There was not any further problem since the temperature excursion problem. No further information provided. No adverse event was reported following this medication errors (incorrect storage of drug). Follow up information received from nurse on 26 Jan 2016: Updated reporters comments.
PFIZER COVID VACCINE ADMINISTERED AT 1:38PM. AT 1:53PM SHE HAD A HARD TIME KEEPING HER BALANCE WHILE WALKING TO THE PHARMACY COUNTER FOR HER VACCINATION CARD. SHE WAS ASKED TO SIT DOWN TO BE MONITOR FOR ANOTHER 30 MINUTES. ABOUT 5 MINUTES LATER I CAME OUT TO CHECK ON HER. SHE WAS TRYING TO DRINK SOME WATER BUT SEEM TO BE CHOKING. SHE WAS GRABBING HER NECK AND LEANING TO HER LEFT. I ASKED IF SHE IS HAVING A HARD TIME BREATHING. SHE REPLIED YES AND SHE I AM IN PAIN. I ASKED MY TECH TO CALL 911. AT 2:06PM I GAVE HER ONE DOSE OF EPIPEN 0.3MG. AT THIS POINT SHE DID NOT COMPLAINT ABOUT HER BRATHING. I ASKED IF SHE STILL HAS A HARD TIME BREATHING SHE JUST COMPLAINT ABOUT THE PAIN.  HER SKIN WAS COLD AND CLAMMY. SHE WAS HAVING A HARD TIME SITTING IN THE CHAIR. EMT SHOWED UP AT 2:13PM.
This spontaneous report was received from a Registered Nurse via company representative referring to a child of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with the first dose of M-M-R II (route, lot number and expiration date were not provided). Concomitant therapies were not provided. On an unknown date, the patient experienced allergic reaction with hives (drug hypersensitivity). The case did not involve cancer or overdose, the patient did not die and there was no intervention to prevent serious criteria. There was no  PQC involved. The outcome of drug hypersensitivity was unknown. The reporter considered drug hypersensitivity to be related to M-M-R II. Additional information has been requested.
I noticed on about day 10 an erythema on my arm at injection site.  I had no prior adverse reactions to this vaccine.  At day 14, the erythema is dissipated and almost gone.
Headache, Myalgia, Fever, fatigue, swelling of bilat neck & bilat groin lymph nodes, with left groin lymph node more noticeable than right
Pt developed groin nodal enlargements.  Obtained ID consult.  Negative w/u.  Hematology/oncology consult suggest possible vaccine related.  Now, it is resolved.
STILL DEALING WITH THE AFTER EFFECTS OF VACCINE; This spontaneous report received from a patient via social media via company representative concerned a patient of unspecified age and sex. 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, route of admin, and batch number, expiry date were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced still dealing with the after effects of vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from still dealing with the after effects of vaccine. This report was non-serious.
I have been diagnosed with Type 1 Diabetes.  I have never had trouble with blood sugars until now.; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female (pregnant: No) patient received 2nd dose of BNT162B2, Lot Number: EL3249 on 12Jan2021 01:15PM on Left arm at single dose for Covid-19 immunisation. Medical history was Hypothyroidism, High cholesterol. Concomitant drugs included Atorvastatin, sertraline hydrochloride (ZOLOFT), ergocalciferol (Vit D), Levothyroxine. Known allergies to Erythromycin previously. Historical Vaccine was 1st dose of BNT162B2 (Lot Number: EJ1685) on 21Dec2020 01:15PM on Left arm for Covid-19 immunisation. She had been diagnosed with Type 1 Diabetes from 01Apr2021 01:15PM. She had never had trouble with blood sugars until now. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. AE treatment: Many lab tests, Bicarbonate drip, Insulin. Patient recovered with lasting effects. No COVID prior vaccination. No COVID tested post vaccination.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: There is not a reasonable possibility that event type 1 diabetes mellitus is related to BNT162B2.  This is an intercurrent medical condition. 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.
This spontaneous report was received from a nurse refers to a 3 patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (dose, route of administration and lot # were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
The day after the shot, I woke up with extreme burning pain in both arms and hands, a fever, and a mild headache; Fever; Mild headache; I have since developed tingling; Numbness; Weakness; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 02Apr2021 at 17:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis, hypothyroid (non-autoimmune type), generalized joint hypermobility and scoliosis. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included low estrogen (MANUFACTURER UNKNOWN) for birth control and levothyroxine (MANUFACTURER UNKNOWN) taken for an unknown indication on an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 10Mar2021 at 15:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. On 03Apr2021 at 06:00, the day after the shot, the patient woke up with extreme burning pain in both arms and hands, a fever, and a mild headache. All resolved within 2 days, but since then on an unknown date in Apr2021 the patient developed tingling, numbness, and weakness, particularly in her right (dominant) hand. At first it was most intense in the morning, but then came and gone. It was further reported that if patient did anything very physical with her hands (such as pull weeds), the burning returned. The patient had no prior history of this and it developed suddenly after the shot. The patient had not seen her PCP (primary care physician), but since it has been getting more debilitating, the patient planned to see her by the end of this month. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events the patient woke up with extreme burning pain in both arms and hands, tingling, numbness and weakness were not resolved while the events a fever, and a mild headache were resolved on 05Apr2021 at the time of this report.
Pt received HPV 9. Reported same night of administrations, had chest pain. Resolved without treatment. Reported to provider during flu visit two months later. Evaluated by pediatrician.
This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine, Formulation: solution for injection, Batch/Lot Number: EK5730, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on Dec 19, 2020 as dose 1, single dose, dose 2 via an unspecified route of administration, administered in left arm on Jan 9, 2021 08:45 (Batch/Lot Number: EJ16B6) as dose 2, single dose for COVID-19 immunization at hospital. Medical history included tennis elbow in both arms. Concomitant medications included fluoxetine hydrochloride (Prozac) taken for antidepressant, start and stop date were not reported; glyceryl trinitrate (Nitroglycerine) taken for an unspecified indication, start and stop date were not reported and clonazepam (Klonopin). When probed for dose of clonazepam, consumer stated, 0.5 mg. Consumer provided both Klonopin and clonazepam, it was not clarified if consumer was on generic or brand. The patient did not receive any other vaccines 4 weeks prior to COVID Vaccine. On an unspecified date, had a side effect she believed was COVID. Indentations in fingernails (on every finger and her thumbs). She stated it's a pretty deep indentation; the nails, the nail beds (the indentations are mid-nail until they grow out), tinnitus and carpal tunnel. She stated, where it is at on her finger would take her back to the timeline of something having happened when she got her COVID vaccine. Regarding lab tests, she stated, it was just blood test. He took it for routine and then for Gram staph (not clarified). When probed about the date and result of the tests, she doesn't know. It's been since January (this particular one) with no staph (not clarified further). She was (from what she can remember) just evaluated for her kidney (not clarified further). It had been a while back. When probed if she was still experiencing adverse events, she did not think so. She still has tinnitus and carpal tunnel, which was why she was given Prednisone (treatment for event). But Prozac was kind of like an extended thing. Klonopin goes with the antidepressant, so she did not take medications for them, and she did not have symptoms. Patient stated, once she starts taking medication it was better but that was from her mental (not clarified). She did not think it had anything to do with Pfizer. The patient underwent lab tests and procedures which included blood test: Gram staph on an unspecified date and no staph on an unspecified date. Therapeutic measures were taken as a result of tinnitus and carpal tunnel with prednisone 10 mg. The outcome of the events was unknown. Follow-up attempts are possible; further information is expected.
I had mucus and bloody discharge from the rectum. Cramping and nausea and bowel urgency with no diarrhea. I also experienced general malaise. I have had IBS flare ups before but none of the treatments that I have used before to treat it did not work so it was not a IBS flare. Once I got in to see the doctor it was confirmed that it was not an IBS flare. It was found that I had Enterotoxigenic e coli. and inflammation in cecum and rectum.
Pain in right arm lasting two days, headache lasting two days, dizziness lasting two days, and fatigue lasting three days
Moderna COVID-19 Vaccine EUA (First 24 hours)   right away- brain fog, dry mouth  A few hours later- pain at the injection site, pain continued to move down arm, hard to move arm. Upon waking at 7 am- body aches, congestion, fatigue, constipation, brain fog
12FEB sz @ 1545 grand mal x 2min w/short post ictal state;
ON 06-04-08 PT. DEVELOPED A FEVER OF 101-102. SEEN BY DOCTOR ON 06-04-08. PER PT.'S MOM DR. UNABLE TO DETERMINE IF FEVER WAS FROM VACCINE OR JUST A VIRUS. PT REMAIN LISTLESS AND FEBRILE TIL FEVER BROKE LATE 06-05-08. MOTHE STATES HE IS FEELING MUCH BETTER TODAY, 06-06-08.
Fever, chills, arm and leg numbness, pain radiating from the neck to the arms. Patient reported a rash under the injection site.
Patient's husband showed me a picture of his wife's arm today, 03/27/21.  It is red from the deltoid muscle going almost all the way down her arm.  I called the patient.  She said it started around Monday, 03/22/21 and vaccine given 03/12/21.  She said it itches slightly and has a little soreness.  Her rash is still present.
EXASPERATED DORMANT LUPUS; This spontaneous report received from a patient via a company representative through social media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: dormant lupus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total administered, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient's dormant lupus exasperated. Reporter reported that, "1 j and j vac exasperated my dormant lupus. Never will vac again" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of exasperated dormant lupus was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221246304-exasperated dormant lupus. 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. Specifically: UNDERLYING DISEASE. Therefore, this event is considered inconsistent with vaccine administration.
27Jan98 Pt recv 1dose vax. 1 hr. post vax Pt devel rash on cheeks w/urticaria. Rash on trunk & legs. Rash cont next day. Pt tx w/Benadryl. 4 days later rash only on legs.
Severe swelling and fluid behind ear drums along with high blood pressure; Severe swelling and fluid behind ear drums along with high blood pressure; Severe swelling and fluid behind ear drums along with high blood pressure; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 52-years-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: UH-WON), via an unspecified route of administration, administered in Arm Left on 20Feb2021 09:30 (Age at vaccination: 52-years-old) as single dose for covid-19 immunization. (Vaccination facility: Other). Medical history included Sjogrens, Hypothyroidism, allergies to Shellfish all from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (TIROSINT) taken for an unspecified indication, start and stop date were not reported. patient did not receive any other vaccine in four weeks. On 21Feb2021 20:00 patient experienced Severe swelling and fluid behind ear drums along with high blood pressure. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events with Antihistamines and decongestants. patient underwent lab tests and procedures which included blood pressure measurement: high. The outcome for the events was reported as not resolved a the time of this report.  No follow-up attempts are needed. No further information is expected.
Symptoms noticed at 630-700am on 6/27/06. Cheeks were red on lower cheek bone on left cheek, red whelps noticed. Gave child Motrin at 1030-1100pm. Fever went down but whelps cont. Rash is moving down from face to arms and trunk/chest area. No problems with respiratory process. Declined eating at times but having adequate wet diapers. Mother is BF but denies any diet change.
Pruritic eruption of left upper arm. Treated with topical cortisone cream.
Painful; This case was reported by a consumer and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as the case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient stated that the 2nd shot of Shingles vaccine was painful as after effects.