chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lymphocytes were low/lymphocyte percentage was low, 0.81 units; monocytes were high/monocytes were 11.8%; This is a spontaneous report from a contactable consumer (patient). A 74-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7533), dose 2 via an unspecified route of administration, administered in arm left on 06Apr2021 (between 10:00-12:00) (at the age of 74-years-old) as single for COVID-19 immunization. Medical history included diabetes from on an unspecified date in Jan2017 and ongoing (last diabetes checkup was on 29Apr2021) and AFib (atrial fibrillation) from on an unspecified date in Jan2016 and ongoing. The family history included diabetes. The patient's concomitant medications included flu vaccine. The patient's previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6198), dose 1 via an unspecified route of administration, administered in arm left on 16Mar2021 (around 11:00) as single for COVID-19 immunization. There was no history of any previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive any additional vaccines on same date of the Pfizer suspect or within four weeks prior to the first administration date of the suspect vaccine. The patient reported that he received flu vaccine every year. There was no adverse event following prior vaccinations and reported that he had a bunch, working overseas. On 29Apr2021 at 09:53, the patient experienced lymphocytes were low/lymphocyte percentage was low, 0.81 units and monocytes were high/monocytes were 11.8%. The events did not require a visit to emergency room or physician office. On 29Apr2021, the patient underwent lab tests and procedures which included Bloodwork showed lymphocyte count: 0.81 /10^3/uL (normal range: 0.9-3.40), lymphocyte count: 15.9% (normal range: 16.2-45.9) and monocyte count: 11.8 % (normal range: 4.2-11.6). The patient reported that this was abnormally high according to the report. The patient wanted to know if the Pfizer COVID vaccine had anything to do with lymphocytes being low or his monocytes being high and what were the repercussions. The patient asked whether this was related to the vaccine and what were the ramifications. He asked whether he was more susceptible to diseases. The patient further reported that he has not had anymore blood work done so he was not sure if it was ongoing. The outcome of all the events was unknown.  Follow-up attempts have been made. Case will be update upon receipt of further information.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of currently 77 years old. No information was provided regarding concomitant medications, concurrent conditions or medical history.  On or about 2011, the pt was vaccinated by a healthcare provider with a dose of zoster vaccine live(ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, dosage schedule, route, lot number and expiration date were not provided).  On an unknown date, the pt developed shingles, therefore was treated by a healthcare provider. The outcome of shingles was unknown and the reporter considered the event to be related to Zoster Vaccine Live(ZOSTAVAX).
administered a dose of Engerix-B that had expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 26-day-old female patient who received HBV (Engerix B pediatric) (batch number LR537, expiry date 3rd January 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th January 2022, the patient received Engerix B pediatric 10 mcg/mg and Engerix B Pre-Filled Syringe Device. On 4th January 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 were provided as follows: The reporter administered a dose of Engerix-B 10 mcg to the patient on 4th January 2022 that had expired on 3rd January 2022, which led to expired vaccine used. The reporter  consented to follow up with Email.
Spotting 7 days in advance of start of menstrual cycle. Light cramping too. I called my OBGYN to report it and they recommended that I report it. Advil to treat cramping. No other symptoms other than soreness at site of injection.
ARM WAS HOT, AND HAD A BIG LUMP. SHE WAS NAUSEOUS AND VOMITED.
headache (low grade burn, 7/23/21), muscle spasms (began 08/21), burning pain(8/21), joint pain (9/21), progressive muscle weakness (9/21), diffuse electric buzzing (10/21), zapping in head (10/21), pins and needles (10/21), muscle atrophy (11/21)
2/10 first dose, on 4/12 after 2nd dose that evening my eyes went completely into prisms and I could see 3 or 4 of everything and I was disoriented and it lasted about 5 minutes, then it went away then there was a change where I felt something in my eye and my right eye is extremely blurry and now there's a fog over my eye and it seems to be depleting.
Generalized itching and SOB after receiving seasonal and H1N1 Influenza vaccines. Epi administrated and O2 started at 100% 15L/min. Transp to local ER by ambulance personnel.
She got her vaccine, at first she started with a generalized headache within 2 hours of getting the vaccine.  It then progressed to stomach issues, nausea, gurgling and then widespread joint pains to fingers and tops of her feet.  Then had ear pain what feeling like inflammation in both ears.  She has pretty much been off of work since then.  She did not go to sleep until Tuesday morning at 5:00 AM.  Said it feels like the flu on steroids.  It is better now, still has joint pain and a dull headache, but no longer has the intense stomach issues that she did have.   She has not taken anything for her reactions due to her intense reactions to medications.  She wrapped herself in an electric blanket and opted for a liquid diet.    She states that she had the same symptom body part with all vaccinations, body aches and headache, body chills but not fever and had the stomach issues with the last one, and also with the first one.  She just waited out the course and she knew it was related to the vaccine.   She feels better, able to get up off the couch today and will probably go back to work tomorrow.
Patient was inadvertently given a COVID19 vaccine as the second dose after receiving a COVID19 vaccine.  Patient was given one manufacturer on 3/28/21 at another pharmacy and incorrectly thought he had missed his second dose.  He came to our pharmacy to get the second dose, and it was not realized he had already received different manufacturer just 12 days before.  Patient is not experiencing any unusual adverse effects, just a sore arm and drowsiness as would be expected after theCOVID19 vaccine.
pt recv vax 1SEP98 & 8SEP98 pt exp pain & paresthesia on chest & back;the reporter expressed a concern w/the specific lot of the vaccine;
No adverse event as of yet. IMZ was given outside of the 12 hour Window?. IMZ was expired?. Will be following up with patient in 7 days.
Diarrhea; feeling very weak; chills; fever; whole body aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ASTHENIA (feeling very weak), CHILLS (chills), PYREXIA (fever) and MYALGIA (whole body aches) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), ASTHENIA (feeling very weak), CHILLS (chills), PYREXIA (fever), MYALGIA (whole body aches) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), ASTHENIA (feeling very weak), CHILLS (chills), PYREXIA (fever), MYALGIA (whole body aches) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.
Within one to two minutes after receiving the vaccination her face flushed extremely red quickly followed by severe dizziness. She was shaking and having a difficult time breathing. She was provided a place to sit and a bottle of water.  Her blood pressure was 140/85.  The flushing started to fade and breathing became less difficult. Within 45 minutes she was feeling well enough to head home.
Extreme pain to right upper arm...like being hit with a baseball bat.  Chills and fatigue.  I put on three long sleeve shirts, a sweatshirt and had the electric blanket on High!!!
A couple red spots going to bed on Friday night. Woke up Saturday morning with red spot rash covering most of body. No signs of discomfort from the spots. Emergency care could not confirm as chicken pox or measles rash or other allergic reaction. Worsened through Saturday and then began to abate Sunday afternoon. Almost cleared by Tuesday evening. Wednesday follow up with primary physician suspected chicken pox vaccine reaction.
Diarrhea, low fever (100.1 degrees F), swelling at vaccination site, ache in arm.
Swelling & redness rt deltoid; Keflex & pred given & instructed to have cool compresses to arm;
Presented with erythema, tenderness, and warm to touch. On right arm from knee to upper thigh.
Patient received 2nd covid booster and does not meet the eligibility requirements (50 years or older, immunocompromised, etc.)
Loss of taste (50%); This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male 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 30Mar2021 at 14:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient was allergic to airborne allergies. The patient did not receive any other medications within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 09Mar2021 at 14:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021at 16:00, two hours after vaccination, the patient experienced fifty percent loss of taste. The patient did not receive any treatment for the reported adverse event. The adverse events neither resulted in doctor or other healthcare professional office/clinic visit nor emergency room/department or urgent care. On 31Mar2021, in the morning, the event fifty percent loss of taste was resolved.   No follow-up attempts are needed. No further information is expected.
Large, circular red spot on arm near the injection site. Swelling, itching, warm to the touch, tender.
No other AE and no PQC; Pharmacist calling to report the administration of an expired dose of a PNEUMOVAX 23 SYRINGE to a patient on 08/30/2023; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant therapies.  On 30-AUG-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, unk, lot #W004863, expiration date: 21-AUG-2023 (expired vaccine administered), administered for prophylaxis (strength, and route of administration were not provided).  No adverse symptoms were reported.
This spontaneous report as received from a doctor of pharmacy refers to a 89 years old female patient. The patient's medical history included cancer survivor of 2 years. The patient was vaccinated with subcutaneously with 0.65 ml dose of ZOSTAVAX (lot # H016765; exp date 12-OCT-2013) on 13-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that immediately after injection, the patient reported burning at the injection site and an area of redness and induration that measured about the size of a quarter. On 14-DEC-2012, the patient stated that her injection site was much improved. No treatment information was reported. The relatedness for the reported events was not provided for ZOSTAVAX. This is one of several reports received from the same source. Additional information has been requested.
Seizure 44 hours after 2 month shots. Suspected cause found other than vaccine. At 4 months shots (pertussis withheld), patient developed fever and had several seizures about 10 hours after shots. Patient has apparently had a head injury as then is evidence of an old subdural hematoma. Seizures have a temporal relationship to vaccines. Medical Records received on 2/18/2005 states fever.  Follow-up: On medication still to reduce seizures.
Tightness in chest 15-20 minutes following vaccination.  She was given benadryl 50mg around 11:30am and 911 was called.  When paramedics arrived they monitored her breathing and blood pressure.  She did not worsen and was allowed to go home about 30 mins later.
Headache and fever for 7 days. Eczema flare up on day 4 of fever on elbows and knees (large red oozing swollen bumps). On day 6 of fever, rash (small raised bumps) spread all over her legs and a few on her trunk. Appear to look like measles. We have pictures of the rashes. Four pound weight loss in one week. Weight on 8/4/12: 96 pounds. Weight on 8/20/12: 92 pounds.
his case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events was unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756549A, A0756551A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA 320AA and on the basis that there were 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA 320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Patient experienced significant fluctuations on his Blood pressure readings- the blood pressure spikes up - not a regular one as per mentioned by the patient. He is currently on blood pressure medicines. He will be consulting his doctor  as soon as he get a chance.
Not sure if it has to do with the COVID vaccine but her caregiver reported to me today (1/27/20201) that she passed away on 01/16/2021 from a pulmonary embolism  that was 18 days after vaccine
She woke up this morning complaining of a severe headache, left sided neck pain.  She reported she could not see out of both eyes and then vomited. This episodes lasted~10 min and then resolved with residual neck pain.
Mild to moderate pain at the injection site; limitation of arm movement; This is a spontaneous report from a contactable pharmacist via Pfizer sales representative.  A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration at single dose in the arm on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced mild to moderate pain at the injection site, limitation of arm movement. The outcome of the events was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
At 12:05am ( about 12 hours after vaccination) I developed severe (worst ever) chills and rigors. Temp was 101.7. I also had moderate nausea for which I took ondansetron. After taking 1000mg Tylenol my temp dropped to 98.4 but then peaked to 100.8 after  6 hours and taking 1000mg Tylenol  followed by another fever 6 hours later and a fever of 100.9. I continue to be febrile after 3g Tylenol. I also continue to have dizziness, joint pain, myalgias, and  headache.
1 week after the vaccine, right upper arm swelling and warmth and pain. Then splotchy red rash on upper arm.
Pt had no symptoms until November 5, 2016 and at 3:30 PM when you walking and felt burning pain in left breast which was intermittent.  Since that time it has become more regular, and daily, not constant, tenderness especially with moving her left arm.  The pain is isolated to the breast.
Chill, Headache. Body Aches, Fatigue, Fever- 101.  Treated with Acetaminphen 1000 mg oral every 8 hours x3 doses, Ibuprofen 800 mg oral every 8 hours x 3 doses starting 0600 on 02/06/2021. On 02/07/2021, Right upper arm at and around injection site was red, swollen, very warm to touch and had a hard bump area. on 02/08/2021, The reddened site was approxiately 2"x4" and was still very warm to touch and sore. No fever noted since 02/07/2021 AM.
Fever of 102 degree fahrenheit; Chills; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 40-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 40 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CHILLS (non-serious) with onset 08Nov2023 at 03:00, outcome "recovering"; FATIGUE (non-serious) with onset 08Nov2023 at 03:00, outcome "recovering"; PYREXIA (non-serious) with onset 08Nov2023 at 03:00, outcome "recovering", described as "Fever of 102 degree fahrenheit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, fatigue.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Information has been received from a consumer, who is also the mother of a four year old son who was vaccinated with measles vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live and then developed "PPD, mild autism with a high IQ" after being vaccinated. The mother did not provide any further information regarding the event, because she didn't feel that her son's experience is related to vaccination with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. There was no product quality complaint reported. The patient sought unspecified medical attention. Upon internal review PPD, mild autism has been determined to be another important medical event (OMIC). Additional information has been requested.
He was going to be discharged from Hospice on Monday 2/15/2021. The patient was in Hospice due to a stroke.   The nurse indicates after the vaccine she started with stomach pain and vomiting. Hospice evaluated her, she was given Pedialyte and then she died on 2/19/2021
Pt recvd 1st 2 doses of Recombivax & 3rd dose of Engerix-B & was determined to be a non-responder;
COMITTING SUICIDE BECAUSE THEY COULD NOT HANDLE THE PAIN AND SYMPTOMS; ADVERSE EFFECTS; PAIN; This spontaneous report received from a consumer via a company representative via media concerned multiple patients (unspecified) of an unspecified age, sex, race and ethnicity.   The patient's weight, height, and medical histories were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry dates were not reported) dose, start therapy dates were not reported, 1 total administered 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 patients experienced adverse effects, pain and the patients were comitting suicide because they could not handle the pain and symptoms. The cause of death was suicide. It was unspecified if an autopsy was performed. As per reporter, "I know plenty of people who received your vaccine with the same adverse effects I have. People are committing suicide because they can not handle the pain and symptoms and the manufacturers do nothing to help us".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse effects and pain was not reported.  This report was serious (Death).; Sender's Comments: V0:20221225746- Committing suicide-  Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable; Reported Cause(s) of Death: SUICIDE
She got her vaccine, first started with pain and in the middle of January her BP had problems.  It went so high, her pulse was high, she had no energy, hair was falling out, asthma was out of control.  Her doctor did blood work, her thyroid was out of control and put on medication.  She was put on Metimizol, Amlodipine and Telmasartan.  She is feeling better with these medicines.  She had no problems prior to the vaccine of this condition.  Her endocrinologist is reported.
Thyroid got real big in her neck; Chills off and on; This spontaneous case was reported by a consumer and describes the occurrence of GOITRE (Thyroid got real big in her neck) and CHILLS (Chills off and on) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GOITRE (Thyroid got real big in her neck) and CHILLS (Chills off and on). At the time of the report, GOITRE (Thyroid got real big in her neck) and CHILLS (Chills off and on) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
pt recvd vax 14JAN93 & exp extreme somnolence w/chest tightness; sx resolved w/in 24 hrs; 15JAN93 pt felt jumpy;
Felt chills, tired, not feeling good at all. Saw MD said I had bronchitis. Lost my taste and smell. Went back to Dr. Said I have asthma and allergies. Worse now. I have a sinus infection. Still don't feel well. Dr. visits from Nov 12, 2105-Dec 22, 2015.