chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This Non valid spontaneous report was received from a registered nurse and refers to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On dates on or after 21-SEP-2017, the patients were vaccinated with improperly stored dose of PEDVAXHIB for prophylaxis, lot# N000238 with expiration date of 25-OCT-2019, lot# N003701 with expiration date of 01-NOV-2019, lot# N008079 with expiration date of 02-DEC-2019, lot# N012920 with expiration date of 07-FEB-2020 (strength, dose, route and frequency were not reported); or with improperly stored dose of RECOMBIVAX HB for prophylaxis, lot# N020613 with expiration date of 05-MAY-2020, lot# N002202 with expiration date of 04-NOV-2019, lot# N011851 with expiration date of 19-DEC-2019; or with improperly stored dose of ROTATEQ orally, for prophylaxis, lot# N000175 with expiration date of 20-SEP-2018, lot# N005618 with expiration date of 04-OCT-2018, lot# N005078 with expiration date of 22-NOV-2018; or with improperly stored dose of VAQTA for prophylaxis, reported lot# M019924 with expiration date of 02-SEP-2018, lot# N008823 with expiration date of 26-MAY-2018. No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32°F (degrees Fahrenheit) to 35°F for 40 minutes; No previous temperature excursion was done. The call was because of a "data logger". This is a non-valid case due to lack of patient identifier. Follow up information was received from the registered nurse 30-APR-2018. The nurse stated the temperature excursion was stable and they had two refrigerators that held the related vaccines. The nurse was not able to provide patients' names or initials, or ages, but was able to provide number of patients, gender information, and vaccination dates. This report referred to a female patient vaccinated with improperly stored ROTATEQ (oral; lot# N005078 with expiration date 22-NOV-2018) on 25-SEP-2017. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. This is one of several reports received form the same reporter(link reports: 1710USA004069, 1805USA001661, 1805USA004617, 1805USA004618, 1805USA004590, 1805USA004591, 1805USA004592, 1805USA004593, 1805USA004674, 1805USA004675, 1805USA004676, 1805USA004678, 1805USA004679, 1805USA004680, 1805USA004681, 1805USA004682, 1805USA004683, 1805USA004967, 1805USA004968, 1805USA004969, 1805USA004970, 1805USA004971, 1805USA004972, 1805USA004973, 1805USA004974, 1805USA004975, 1805USA004976, 1805USA004977, 1805USA004978, 1805USA004979, 1805USA004980, 1805USA004981, 1805USA004982).
pt recvd vax 15MAY95 & that evening pt devel a fever of 103 & a large localized rxn @ inj site;16MAY fever was 105 & throat red;pt was taken to pediatrician;strep test neg;fever resolved 17MAY;22MAY pt devel itchy rash on face & upper arm;
Tachycardia 160-170bpm, anxious, carpal pedal spasm. States she took Zyrtec and inhaler this morning (for asthma). Transferred  to outpatient clinic for assessment.
VACCINE ADMINISTRATION ERROR. PFIZER (5-11 YEAR) DOSE WAS GIVEN TO 12 YEAR 2 MONTH PATIENT. ADMINISTRATION WAS DUE TO CDC CARD HAVING 1ST DOSE WRITTEN WITH PFIZER (5-11 YEAR) LOT NUMBER INSTEAD OF PFIZER (12+ YEAR) LOT NUMBER. LATER CONFIRMED 1ST DOSE WAS APPROPRIATE PFIZER (12+ YEAR) DOSE BUT HAD THE PFIZER (5-11 YEAR) LOT NUMBER INCORRECTLY WRITTEN ON IT AND SECOND DOSE GIVEN 12/23 WAS INCORRECTLY GIVEN AS PFIZER(5-11 YEAR).
allergic reaction; Eyelid swelling/ swelling of my eyelids; This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a adult female patient who received Flu Seasonal TIV Dresden (Flu trivalent vaccine) for prophylaxis.   On an unknown date, the patient received Flu trivalent vaccine at an unknown dose. On an unknown date, unknown after receiving Flu trivalent vaccine, the patient experienced allergic reaction and swelling of eyelid. On an unknown date, the outcome of the allergic reaction and swelling of eyelid were unknown.   It was unknown if the reporter considered the allergic reaction and swelling of eyelid to be related to Flu trivalent vaccine.  Additional details were provided as follows: The age at vaccination was not reported. A pharmacist reported that she had an allergic reaction to the flu vaccine which included swelling of my eyelids. The reaction occurred 10 to 12 years ago and she was unsure of the name of the vaccine, but she mentioned it may have been FluLaval. No additional details were provided at time of reporting.
Patient developed a red rash from his knees up to his neck. Patient followed up with Medical two days following his vaccination.
Information has been received from a registered nurse concerning a 67 year old female patient who "3 months ago" in approximately December 2008, was vaccinated with ZOSTAVAX (Merck). "1 week after vaccination", the patient had a scab that "look like a dried pustule" at the injection site. The patient was given ZOSTAVAX (Merck) by her physician and it was unknown if the physician was contacted. The patient's a scab that "look like a dried pustule" at the injection site persisted. Additional information has been requested.
Dizziness and tingling legs 4 days after receiving immunization - progressive symptoms muscle weakness, fatigue resolution paresthesias continues with increased tiredness, proximal muscle weakness (insists seen at ER and specialists - PT). Headaches.
Severe joint inflammation & Pain, lasting over 3 months (so far) despite treatment with Diclofenac nsaid & Methylprednisolone Dosepack (2 weeks post-vaccine April 14-19). Severe Daily Vaccine Headache and Migraines (different symptoms & treatments). Daily migraines continuing over 3 months later. Vaccine Headaches Occasionally still. Migraines include sensitivities to light, Sound, Touch, Smell & taste. Frequency of Nurtec ODT & Sumatriptan is rendering them less effective. I have appt with clinic in July 20th after managing chronic migraines for over 12 years. Botox, Aimovig, Bio-identical HRT, Dietary restrictions, Supplements are no longer enough to keep migraines down to moderate levels, JOINT PAIN started next day after vaccine, was not "arthritic achiness", but "joints of FIRE! Waking me out of a Deep Sleep!" pain that some days made it difficult to even walk in the house. (I used to walk a mile several days per week.) Norco resorted to occasionally in order to sleep or function. Steroids decreased severity somewhat, but pain persists. Relief creams used frequently. VACCINE HEADACHES starting day of vaccine, did not have sensory sensitivities (as with Migraine), but were severe. Migraine meds ineffective. Discovered that Cambia (diclofenac powder) did reduce. This is the only nsaid I am able to tolerate. I now take diclofenac tabs (Voltaren) occasionally when HA & joint pain get intolerable. STEROID pack did greatly reduce the severity & frequency of the vaccine headaches, migraines & even the severity of the joint pain. But the moderate joint pain & daily migraines persist. My fear is that the vaccine was a trigger for a lifetime problem that may be disabling. (Note that before my over-reactions, I was a strong promoter for Vaccine, & as Medical Technologist, was quite excited for the new mRNA possibilities.) These are the longer-term effects that have me worried. I also experienced short-term symptoms. Within 5 minutes (no wait in clinic after #2), my entire shot arm had tingling & numbness all the way down, including my hand. Severe arm pain started an hour later & continued for a week. For 2-3 days, fever, chills, extreme fatigue, indicating the vaccine had triggered immune response. Also extreme body weakness; climbing stairs was like climbing a mountain. Joint pain started in previously injured joints (ankles, 1 knee, back) then spread to other joints, including my hands. Knees & ankles remain the worst, sometimes debilitating, along with my lower back. Migraines nearly Daily with meds becoming less effective. Seeking more expert help for this at clinic.
The patient received a total of 2 shots since the first visti/the patient case back to the office and brought her medical records which showed two prior injectiosn of Gardasil 9; No additional AE reported; This spontaneous report as received from a nurse via company representative, concerning to female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant medications were not provided.  On an unknown date (discrepant information reported as on 20-JUL-2020 and also reported as date unknown), the patient was vaccinated with an extra dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (frequency, route, lot number and expiration date were not provided) for prophylaxis with no adverse event. The reporter stated that the patient came approximately in 2019 (reported as about a year ago), and did not have her records of whether the patient had been previously had hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) or not; the nurse went ahead and began the series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The patient received a total of 2 shots since the first visit on an unknown date. The patient came back to the office and brought her medical records which showed two prior injections of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).
Heart pounding first, about an hour after injection.  Extremely uncomfortable Chest tightness about 5 hours afterward - sill experiencing at 7:30
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 as dose 1, single (Lot number: HG4633) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), no known allergies. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:1), for COVID-19 Immunization; Covid-19 vaccine (Dose:2), for COVID-19 Immunization; Covid-19 vaccine (Dose:3), for COVID-19 Immunization; Covid-19 vaccine (Dose:4), for COVID-19 Immunization; Covid-19 vaccine (Dose:5), for COVID-19 Immunization; Covid-19 vaccine (Dose:6), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 21Oct2023 to 26Oct2023.  No follow-up attempts are possible. No further information is expected.
Hives approximately 2.5 HRS after receiving vaccines; when she got up from her nap
Dermatomyositis. Rash on face, chest, neck, hands. Generalized muscle aches and weakness (head to toe).
Lg red spot oval shape. Knott, hot to touch. Itchy, achy pain from shoulder down to hand. Still have pain two wks later. Still have red spot.
Terrible knee pain where I could not even walk.   It came on me overnight..  Extreme pain in knee and legs
covid pneumonia; covid pneumonia; covid pneumonia; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1, via an unspecified route of administration, on 05Aug2021 (age at vaccination of 54 years; Batch/Lot Number: FC3180) as single dose for COVID-19 immunization. Medical history included was diabetic and had obesity. The patient's concomitant medications were not reported. It was unknown if patient had received any other vaccine in four weeks. Patient had no COVID prior to vaccination. She developed COVID pneumonia on unspecified date in 2021. COVID was tested post vaccination on unspecified date with unspecified results. COVID pneumonia resulted in hospitalization and patient died. Patient was hospitalized for 5 days and passed away 04Sep2021. No autopsy was performed and cause of death was provided as COVID pneumonia.; Reported Cause(s) of Death: covid pneumonia; covid pneumonia; covid pneumonia
Hypoglycemia; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm on 16Mar2021 at 14:15 (at the age of 68-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as blood pressure. The patient was allergic to unspecified medications, food or other products. The patient received unspecified medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021, the patient experienced hypoglycemia. Therapeutic measures were taken as a result of hypoglycemia which included treatment with sugar-chocolate. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event hypoglycemia was recovered with sequelae on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2008, the patient was inoculated with ZOSTAVAX by a physician 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. On an unknown date in 2010, the patient was treated by the same physician for the onset of a 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 and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Outcome of the events was unknown. Causality assessment was related. Additional information has been requested
father states 7PM pt became pale & non responsive, flaccid;taken to ER by the time they arrived  skin nl;t100 in ER;tx by ER md w/Ibuprofen;parents observed pt through the noc w/no further problems;dad reports pt has fully recovered;
Employee states after 1st Hep B vaccine 5/20/11 - symp. naus, vomiting, headache, dizziness. 2nd Hep B given 8/1/2011 same symptoms 2 hrs. after vaccine given.
Information has been received from a physician concerning a 13 month old male who on 9/17/04 was vaccinated SC in his left anterior thigh with a 0.5ml first dose of varicella virus vaccine live (lot # 648080/0079P). Concomitant vaccinations that day included an SC first dose of MMR (lot # 04169) in his right anterior thigh, a third dose of hepatitis B virus vaccine (+) HIB conjugate vaccine (lot # 648530/0129P) in his right anterior thigh and a third dose of pneumococcal 4 6B 9V 14 18C 19F 23 F conjugate vaccine (lot # A74404A) in his left anterior thigh. There was no illness at the time of vaccination. On 10/27/04, the patient developed a rash. On 10/28/04, the patient developed vesicles in T9 T10 dermatome on his right abdomen that were consistent with shingles. The patient was subsequently diagnosed with shingles. It was reported that the patient had no history of chicken pox and there was no recent exposure to chicken pox or herpes zoster. Neither a direct fluorescent antibody nor a PCR were done. Unspecified medical attention was sought. On approximately 11/15/04, the patient recovered. There was no product quality complaint involved. No further information is available.
patient was at pharmacy picking up her normal monthly medications and mentioned she had to go to urgent care for redness and a lump on the back of her shoulder from receiving the shingles vaccine. patient was placed on antibiotics
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number and expiry date not provided). Other suspect therapies included VARIVAX (Merck) and PROQUAD (Merck). On an unkonwn date, temperature excursion to ZOSTAVAX, VARIVAX (Merck) and PROQUAD (Merck) which was supported and no product was administered. However, the healthcare worker then stated that the freezer has had episodes of cycling after which the practice had administered all three products. ZOSTAVAX, VARIVAX (Merck) and PROQUAD (Merck) all supported post cycling events described. The healthcare worker had no knowledge of adverse effects note by any patient post administration. The outcome of temperature excursion and ZOSTAVAX, VARIVAX and PROQUAD all supported post cycling events described were unknown. This case is 1 of 3. This case is related to case 1405USA004770 and 1405USA004771 (same reporter link). Additional information has been requested.
SUSPECTED CLINICAL VACCINATION FAILURE; METALLIC TASTE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and the patient have no other health history.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, Frequency: 1 total, batch number: 1808978 expiry: Unknown) dose was not reported, administered at left arm on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-APR-2021, the patient experienced suspected covid-19. On 01-MAY-2021, On the same day the patient underwent rapid swab test and tested positive for COVID-19 (suspected clinical vaccination failure, Stuffiness, Runny nose, Drainage, Congestion, Anosmia, Ageusia). It was reported that, the symptoms started about 4 days prior, but it was hard to discern due to allergies. On the same day, the patient went to gym for about 45 minutes and felt okay except for slight metallic taste in mouth. Later, he went home and tried smelling whiskey and realized he had lost his sense of smell and experienced loss of taste. The patient did not present with typical symptoms and had felt okay because he had been working out prior. It was reported that, the patient could smell firewood burning but nothing else. Later, all vitals checked at urgent care and all was normal. The patient's laboratory data revealed blood pressure was normal, Oxygen level on Oximeter 99%, Smell and Taste was 90-95% gone. At the time of this report, the patient had a tiny amount of fatigue and was in quarantine for the next ten days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from metallic taste, had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210504165-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. 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
This initial case was received from a healthcare professional on 03 March 2014, and is one of a cluster of three employees at the same facility who experienced similar events after vaccination with FLUZONE ID. The events for the other two patients are captured in cases 2013SA136389 and 2013SA136392. An adult female patient, with no reported concomitant medications or relevant medical history, received an intradermal injection of FLUZONE ID (lot number not reported) in November 2013. On 24 December 2013, the patient developed "suspected flu", described as 103 degree fever, achiness, and weakness. Outcome was not reported. According to the reporter, the patient was no longer an employee of the facility, and was considered lost to follow-up. Additional documents held by sender: None.
slight headache; extremely dizzy; joints ached; nauseated; felt really weak; This is a spontaneous report from a contactable nurse (patient). This non-pregnant 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6202) via an unspecified route of administration in the left arm on 23Feb2021 at 07:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, COVID-19, tape allergy, and osteoarthritis all from unknown dates and unknown if ongoing. The patient reported taking concomitant medications. The patient previously received nubain for an unknown indication and experienced allergy, codeine for an unknown indication and experienced allergy, oseltamivir phosphate (TAMIFLU) for an unknown indication and experienced allergy, and amoxicillin sodium; clavulanate potassium (AUGMENTIN) for an unknown indication and experienced allergy.The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 23Feb2021 after receiving her injection, she went home and in a little while she had a slight headache. She took a muscle relaxer and went to bed around 11:30. When the patient got up to go to the bathroom, she was extremely dizzy, her joints ached, she was nauseated and felt really weak. The events were reported as non-serious and did not require hospitalization. The clinical outcomes of slight headache, extremely dizzy, joints ached, nauseated and felt really weak were recovering. It was also reported that since vaccination the patient had not been tested for COVID-19.
Teardrop-shaped induration 4 inch X 3 inch which was red, swollen and hot, followed by hives over entire neck, trunk and limbs.
Information has been received from a doctor of pharmacy concerning a patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX. Subsequently, the patient had a local injection site reaction that was "the size of a silver dollar". It was unknown if the patient sought medical attention. At the time of reporting, the patient 's outcome was unknown. This is one of several cases received from the same source. Additional information has been requested.
Severe sore throat, extreme red eyes, body aches, temp of 101.1, headache, chills, dry cough, hoarseness. Took holistic cold?flu medication and went to bed
Very bad headache, problem urinating, muscle pain, high fever, chills, nerve pain in back.
Upon leaving observation room after 15 minute wait period lost feeling from knee down on both legs. Unable to ambulate safely. Patient initially refused to go to ER, so RN observered patient outside for 30 minutes, where same symptoms persisted. RN insisted patient go to ER. Patient escorted to ER while in wheelchair. Accompanied by daughter.
Appetite change, fatigue, pain, visual disturbance, dizziness, weakness, and headaches.