chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vertigo; headache; This is a spontaneous report from a contactable consumer (patient). A 66-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9261, Expiry date: unknown, at the age of 66 years old), dose 1 via an unspecified route of administration, administered in Arm Left on 06Feb2021 09:30 as dose 1, single for covid-19 immunization. Medical history included peripheral neuropathy, hypertension and high blood cholesterol. Concomitant medication(s) included hydrochlorothiazide, losartan potassium, gabapentin, and simvastatin. The patient previously took neosporin topical and experienced drug hypersensitivity and reported allergy to adhesives. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Gabapentin300; Losartan-HCTZ100-25; Simvastatin10 within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The patient experienced exactly 7 days after the vaccination, woke up with vertigo/headache on 13Feb2021 07:00 which lasted 24 hrs. The patient did not receive any treatment for the events. The outcome of the events was recovered on an unspecified date in Feb2021.  Follow-up attempts completed. No further information expected.
I developed lichen planus all over my body starting in June 2021. Probably not vaccine related but I've been advised to complete this form anyway.
Exactly twelve hours after getting the second dose of the Pfizer vaccine, I experienced severe chills for three gruesome hours that rattles my teeth, plus fever, fatigue, & joint pain (especially in my elbows, fingers, shoulder, knees, and back) and headache.  My fever ranged from 100 degrees F to 102 degrees F for 36 hours.  After consultation with my doctor at the 16 hour mark past vaccination, I took Tylenol every 6 hours to reduce my fever, which helped tremendously.  These side effects lasted 36 hours almost to the minute then were gone.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19; This spontaneous report received from a patient concerned a 56 year old male. 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 not reported, batch number: 1808609 expiry: 04-FEB-2022) dose was not reported, 1 total, administered to right arm on 06-APR-2021 for prophylactic vaccination. Age at time of vaccination 55 years old. No concomitant medications were reported.  On 25-MAY-2022, the patient had a stuffy nose and a cough.  On 27-MAY-2022, tested positive for covid-19 with an antigen self test (suspected clinical vaccination failure and suspected covid-19) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint; Sender's Comments: V0.20220600585-covid-19 vaccine ad26.cov2.s -suspected clinical vaccination failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
received a dose of GARDASIL 9 on an unspecified date while pregnant.; This spontaneous prospective pregnancy report was received from a nurse referring to a female patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.      On an unknown date the patient was received a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, route, lot# and expiration date were not reported) for prophylaxis while pregnant (exposure during pregnancy). The last menstrual period (LMP) and estimated date of delivery (EDD) were unknown. The pregnancy outcome was outcome pending. The fetal outcome was unknown.
Pt developed clinical varicella with approximately 33 lesion on the back a few on the arms and a couple in the mouth.
patient states that she has had shoulder pain since the vaccine. She states that the pain is mostly at night, but sometimes occurs during the day
pt recv vax 17AUG95 & 9MAY97 pt devel an typical rash that consisted of numerous small vesicular lesions on an erythematous base;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with ZOSTAVAX at a Medical Group Practice, as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. In 2013, the patient was treated by the same Medical Group Practice for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.
Immediate allergic reaction.  Dizziness, light headed, nausea, numbness in lips, tongue, nose and lower part of face. Swelling in throat and feeling of pressure and heaviness in breathing.  Lasted for about an hour.
Resident had previously recieved two doses of the Pfizer COVID19 vaccine on 01/12/2021 and 02/02/2021. No side effects were reported following these immunizations. At 1445 on 10/15/2021, Patient recieved his third dose of the vaccine. At the time of administration the resident denied having any signs or symtoms of illness temperature was 98.1 F at the time of administration. No reactions were reported or observed from 1445 until 1700. At 1700, the resident was ambulating self from the dining room after dinner with an ataxic gait.He described to the nurse that he "can not see" but was unable to describe any other symptoms. The nurse noted confabulatory responses during assessment. Resident was alert only to self, unable to follow basic commans. Unable to follow neuro assessment. Resident was noted by the nurse to be profusely diaphoretic, drooling, restless, and without facial droop. Resident was transported via EMS to Hospital Emergency Department for evaluation. Vitals at the time of transfer to hospital BP 130/84, HR 88, Resp 16, Temp 98.3F, SpO2 98% on RA. The resident's first report of symptoms occured approximately two hours and 15 minutes after vaccine administration.  The time between reported symptoms and departure from the facility via EMS was 10 minutes. Resident was kept overnight in the emergency department for observation.   Hospital Update 10/15/21 at 0830, the hospital reported the resident to be in continued observation, CT scan negative for CVA, with only complaint of unilateral leg pain.   Hospital Update 10/15/21 at 1500: Admitted for acute mental status change, negative for flu, negative for COVID. Pending neurologist assessment with possible MRI to be completed. Lab results unremarkable. Resident eager to return to facility. All previously reported symptoms resolved at this time.
received Rotarix instead of receiving the 3rd dose of Rotateq.; This case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a 6-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 3T77H, expiry date 11th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis and ROTAVIRUS VACCINE (ROTATEQ) for prophylaxis.   On 10th June 2021, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, the patient received the 3rd dose of ROTATEQ. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details was reported as follows: The patient received Rotarix instead of 3rd dose of Rotateq which led to interchange of vaccine products. No other information was available. The reporter did not consent to follow up.
Pt called 9/20/09 and complained of being in pain from Friday (9/18/09). Ever since she received the flu vaccine she has been feeling "Pins and Needles" in her fingers and hand and numbness down her whole arm. She has been in so much pain it woke her up out of her sleep. As of 9/22/09 she is still in pain but feels 50% better: but still feels pins and needles.
Rotarix was reconstituted with sterile diluent and administered orally to patient. Pentacel was not reconstituted and patient only received Dtap IPV portion of the vaccine intramuscularly. No adverse reaction reported by patient's guardian. Patient is being brought back in clinic to be revaccinated for both rotarix and pentacel per manufacturer recommendations.
Patient states after receiving her first dose, she experienced chest tightness for approximately two weeks. Patient took cold medicine, which did not help symptoms. Patient did not consult with doctor. Patient states symptoms gradually resolved on their own after 2 weeks.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 15-SEP-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 1 injection, lot # S022584, expiration date: 31-OCT-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Dark spot on leg below knee; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 08Dec2021 at 10:45 (Lot number: FG3527) at the age of 49 Years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Allergic sinusitis" (unspecified if ongoing), notes: sinus and "Heart murmur" (unspecified if ongoing). Concomitant medications were not reported. The following information was reported: SKIN DISCOLOURATION (non-serious) with onset 09Dec2021, outcome "recovering", described as "Dark spot on leg below knee". Therapeutic measures were not taken as a result of skin discolouration.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
A 17 year old received a COVID-19 vaccination.  The patient proceeded through the normal vaccination process on 9 February 2021.  The vaccination team failed to identify him as medically ineligible due to age.  He had no complications.  The error was not discovered until he presented for his second dose on 9 March 2021.   The positive identification process requires ID card verification, which is documented with a scanner that feeds an excel spreadsheet.  This process is also used to verify the patient is in the appropriate vaccination tier.  The scan and spreadsheet were accomplished correctly, and the patient was verified as an employee in the appropriate tier.  The staff at the table failed to note the age of the patient. The medical screening process requires the staff to check the ID card and the DHA Form 207.  The DHA Form 207 was completed correctly.  Staff failed to note the age of the patient.  The vaccinator reviews the DHA Form 207 for completeness prior to the time-out and vaccination.  This step does not require documentation.  If this step was completed, staff failed to note the age of the patient.
THE WHOLE UPPER ARM  AROUND ARMPIT TO ELBOW. INJECTION SITE KNOT, HOT, RED, SWOLLEN AND SEVERE ITCHING  OCCURED ON FRIDAY
Area of induration, 3cm x 2cm, on R deltoid at presumed site of MENACTRA administration. Rx given for KEFLEX 500 mg 3 x daily x 7 days.
Woke up with severe dizziness and vertigo. The dizziness caused mild nausea.The vertigo has continued and continues now four days later with no change in severity.
This spontaneous report as received from a physician refers to a 17 year old, non-pregnant, female patient. The patient's pertinent medical history included seasonal allergies. She did not take any concomitant medications and had no drug reactions and/or allergies. On 22-JAN-2017, the patient was vaccinated with GARDASIL 9, lot # M023169, expiry date 13-JUN-2018 (dose, route and site of administration were not reported) for prophylaxis. On 08-FEB-2017, the patient called the physician's office to report redness, swelling, pain and a hard raised area at the injection site after receiving the vaccine. The patient was also unable to raise her arm above her shoulder due to pain. No treatment was given for the events. The events were reported as not recovered at the time of the report. The reporter requested lot check. This is one of two cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA004017.
6/23/09 BOOSTRIX given -> mild soreness/ swelling post injection Lt arm.  A "few days later" developed " electrical sensation" in arm -> Palm of hand.  8/4/09. Still with Lt. arm pain & numbness in Lt. arm.
The third injection really burned/hurt and I didn't get a good feeling about it.  My arm hurt immediately and I had to  sit in my car before driving home.  Shortly after, my knees and thighs hurt. We called both the clinic and our family doctor on Wednesday the 25th.   I saw our doctor on Thursday 1/26 since pain was unmanageable with ibupron.  I had blood work done that came back okay.  Friday my neck began to hurt and my vision got blurry.  Our family doctor was notified and prescribed Prednisone on Friday.  By Monday, I had to see doctor again as I still was in pain.  He changed me from Prednisone to Methylprednisolone hoping it would help my symptoms.  He also ordered an MRI and more lab work.  The MRI results came back normal as well as the lab work that has been received to date (1/31/12).
On 4/17/01, post vax, pt had 3 hours of inconsolable screaming.
Chronic fatigue, memory impairment, confusion, body aches, headache, aphasia starting a few days after last dose of vaccine and progressed over the 6 months until his death on 1/26/2022. He was perfectly healthy with no medical history or medications until he received his second dose of the vaccine. Possibly blood clots resulting in stroke like symptoms. We are requesting an autopsy.
Pain in left arm when I turn my arm to the side. Pain also travels from shoulder to elbow. Can't sleep on this arm. Sharp pain.
fever of 100.7 at 8:30 PM, lethargy, at 12:30 AM on 01/16/2010 vomiting
itching; swelling of her face; hives; her face got very red; she had an allergic reaction; This is a spontaneous report from a contactable consumer (patient) reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8727, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 22Mar2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 22Mar2021, about 30 minutes later, she had an allergic reaction and it was the line on her paper that said non-severe allergic reaction and she had itching, hives, swelling of her face, her face got very red and swollen and she had hives on her face and was very itchy. She had a HCP appointment that day and asked the HCP if she should go for the 2nd shot of the Pfizer COVID Vaccine or if next time for the 2nd dose she would have the same reaction or a worse reaction. The patient wanted to know if it was still safe for her to receive the 2nd dose. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Almost immediately after administration of FLUZONE, pt passed out for about 15 sec. He regained consciousness but had one jerky movement and rolled his eyes back for a couple of seconds. He was observed for 30 min offered Gatorade and pt was ok so he walked back with his dad.
7FEB91 lymph nodes under arms, neck & groin sore & swollen, tired, & achiness in knees; Persisted for about 10 days;
chills, joint pain, muscle aches, low-grade fever, fatigue starting at 4:00 pm 4/12/2021 through 2:00 am 4/14/2021 diarrhea 4/14/2021 6:00 am - 2:00 pm
Developed tachycardia, weakness in the lower extremities, followed by elevated blood pressure and left arm, chest, arm, neck, and back pain.  Pain and weakness continue today as well as elevated blood pressure.  I have been diagnosed with Brachial Neuritis as a result of receiving the flu shot.  I continue treatment at another facility. 7/21/08-records received for DOS 11/27/07-After flu vaccine on 11/7/07-C/O feeling bad, chest pain, back pain and left sided neck pain. Cramp like pain across chest. Dysphagia. Assessment:atypical chest pain. 12/3/07-C/O tremor and tic of temporal muscles eye, epididymitis.  Follow-up Information 12-JUN-2009: Numbness in the left leg and arm. Headaches daily. Upper left chest and back pain. Fatigue and weakness. Lacking stamina. A rise in blood pressure. I have been to specialists who have run test and determined that I have chronic polyneuropathy as a result of Guillain-Barre Syndrome from receiving flu shots.
About 8 hours after the first dose of the vaccines, my lympnodes became swollen and tender to the touch of te injection arm.  This tenderness grew increasingly more uncomfortable over the next 24 hours.  at About 16 hours after receiving the 1st dose of the vaccine, i developed a 100 degree fever, boody aches, chills and a sligght headache.  This subsided after about 6 hours.  owever, 72 hours later, i am still experiecing sore and tender lymphnodes in armpit area.
PATIENT CAME BACK TO THE PHARMACY THE NEXT DAY STATING SHE HAD A ADVERSE REACTION APPROXIMATELY 30 MINUTES AFTER RECIEVING THE SHOT. SHE WENT TO THE EMERGENCY ROOM FOR TREATMENT. SHE STATED THE SYMPTOMS  WERE DICCICULTLY BREATHING, BURNING IN THE THROAT, WELTS IN THE MOUTH AND SWELLING IN THE THROAT. SHE WAS GIVEN PRESCRIPTIONS FOR EPIPEN, BENEDRYL, PEPCID WHICH SHE REFUSED TO FILL. SHE SAID THE SYMPTOMS HAD IMPROVED. I CALLED HER ON THE FOLLOWING MONDAY AND SHE HAD GREATLY IMPROVED AND HAD A DOCTORS APPOINTMENT THE NEXT DAY.
This spontaneous report was received from a registered nurse and refers to a 4-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 21-DEC-2018, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB lot # R014261, expiration date 25-MAR-2021 or lot # R005118, expiration date 28-NOV-2020 (dose and route of administration were not reported).  Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient).; Sender's Comments: US-009507513-1901USA000071:
Caller states customer reported a 15 year old female patient developed hives after 3rd dose of GARDASIL 9; This spontaneous report was received from a consumer, referring to a 15-year-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, or allergies were not reported.  On an unknown date, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, frequency, anatomical site of injection, route of administration, lot number and expiration date were not reported) as prevention of human papillomavirus infection (HPV) (prophylaxis).  On an unknown date, the patient developed hives (urticaria) after the administration of the dose.  The outcome of urticaria and the causal relationship between the event and the suspect therapy were not reported.
10/10/02 immunizations given in am-pt OK at time. By evening developed T102.4 sent to ER dx'd with B/L OM put on amoxicillin x 10 days. (9/25/02 shorts were deferred due to URI).
Severe Shaking chills, severe myalgias and arthralgias; restlessness; joint stiffness; pain all over; mild nausea and orthostatic dizzyness; mild anorexia
body aches, headache, chills started the night of the shot (january14,2022) . approx 2 days later chest pain started and continued. cardiologist prescribed Colchicine 0.6 MG Oral Tablet  Dose: 1 Frequency: 2 times a day on February 07 , 2022. still currently taking the medication with a 3m follow up scheduled.
Patient 16 years old presented with facial and ear numbness/paralysis and received evaluation at facility. Physician  referred patient to Hospital where she was prescribed Barium MRI for brain/vascular evaluation. No known causes were determined aside from recent vaccination and Neurology follow-up determined no known existing conditions were determined.
Pt reported later that day feeling fever, chills joint pain, headache, nausea and fatigue. Pt called md and was advised to take benadryl and ibuprofen. she feels better today (2 days later) but not completely.