chrisvoncsefalvay/vaers-outcomes huggingface dataset:
having a stroke; had a seizure; increase of BP./My BP was 185/ 95; I felt dizzy at a meeting; felt fuzzy; a pressure behing my eyes; This is a spontaneous report from a contactable consumer (reported for herself). A 66-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown), via an unspecified route of administration on 26Mar2021 (age at vaccination was 66-year-old) as dose 2, single for covid-19 immunisation in pharmacy or drug store. The patient medical history was not reported. The patient's concomitant medications were not reported. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 17Feb2021 as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient had no known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. On 09Apr2021 16:00, the patient started to increase of blood pressure. The patient attends a clinic. BP was taken. Always 120/ 80 or slightly lower. The patient doctor appointments show the same. The patient was felt fuzzy and a pressure behind her eyes. The pharmacist took the patient BP and called for an ambulance. The patient BP was 185/95 and it gradually went done. The patient's doctor saw her the next week and the patient BP was fine. After a few weeks, the patient felt dizzy at a meeting. One lady thought patient was "having a stroke" and called 911 again. The patient had a seizure, and her BP was high again. For 4 months it was like this. The events resulted in doctor or other healthcare professional office and clinic visit, emergency room/department or urgent care. The patient lab tests blood pressure measurement was blood pressure increased 185/95, Cat (computerised tomogram) scan of the brain was unknown results, heart tests (various heart tests) unknown results on 09Apr2021. The patient sought treatment with a cardio specialist and various tests ordered. So far nothing had showed. The patient current on a third BP medication. They all had affected her blood levels and the mysterious fluctuations continue. The patient was supposed to have a hip replacement in 2 weeks. The outcome of the events was unknown.  The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.
After exposure to two Covid-positive individuals, I had a dry racking cough initially. Later a fever developed, about day 2. I was exhausted and short of breath, both of which continued long past the other symptoms, which cleared up in about a week. The brain fog I remember from my previous infection (pre-vaccination), the balance and vestibular issues, and the lack of fine motor control were all back during the illness.
Child was inconsolably crying and lethargic all day after receiving the vaccine. Child also refused to eat.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Mild, Additional Details: Patient went to observation area after receiving Pfizer Covid-19 Vaccine. Patient became lightheaded and faint and fell to floor. Patient was unconscious for aproximately 30 sec. After being repositioned, patient did regain consciousness; however was a little confused as to what had happened. Patient did injure his lip during fall. Vitals were all within normal limits with a slightly low blood pressure reading. 911 was called immediately. Stated had not eaten today/slept night before either.
Mom brought child to office 4 days after 1 z given child L thigh was pale red over entire upper area (5"x5") stated  wasn't hard but mom stated that been over weekend.  Localized response resolving.
Pt reports onset on metallic taste in mouth after first vaccination, pt also reports urine and stool both have stool. Pt reports smell is most noticeable after eating any protein (eggs, meat, fish). Pt described immediately after first vaccine was strong enough to make him avoid eating; pt reported to primary care provider 5 wks later reporting symptoms are less severe now.  Pt still notices smell with eating proteins, but now is less noticeable.  Pt received second Moderna vaccine 4/27/21 regardless of smell he has been experiencing since first vaccine dose.
9-3-14 pt call to report body rash (chest, abdomen, lower neck, groin) started after taking last VIVOTIF (oral typhoid) pill aprox 8-12-14. Traveled to another country on 8/18/14. Saw pharmacist who gave her creams to apply. Creams were not helpful. No itching. Denied respiratory issues. Rash is fading on 9/3/14 day of this call. Advised to see PCP or same day sick clinic for evaluation of rash.
Headache, nausea on 1/25 progressed to SOB 1/26 and death 1/27
Acute facial and oral pharyngeal swelling left side. 25ml Benadryl IM.
fever up to 102, vomiting, profuse diarrhea, diffuse macular papular rash which did not involve the face, palms of hands or feet;impression is that this is viral in nature;blood test results: WBC 12.3 w/67 sed, 28 lymphs, 5momos, platelets;
Case number PHEH2014US018222 is an initial spontaneous report from the health care professional (medical assistant) received on 09 Sep 2014. This report refers to a 11 year old female patient. She was vaccinated with MENVEO (batch number: not reported) at a dose of 0.5 ml intramuscularly on 02 Sep 2014. It was reported that the vaccine received by the patient had been stored at 47 F for 10 minutes before administration to the patient. No adverse event reported following this medication error (incorrect storage of drug).
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a elderly female patient who received HAVRIX (batch number 3C7ZG, expiry date 29th January 2022) for prophylaxis. On an unknown date, the patient received the 2nd dose of HAVRIX. On an unknown date, immediately after receiving HAVRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to HAVRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that, the patient experienced pain during administration of HAVRIX. Pain spreads down the hand and then subsided. The patient did not experience same symptoms during the 1st dose. The reporter gave consent to follow up. This case was 1 of the 3 linked cases, reported by same reporter.
TINGLING AND NUMBNESS TO RIGHT SIDE OF FACE, PROGRESSED TO MOUTH DROOP. BY THIRD DAY HAD TWITCHING, QUIVERING OF LIPS AND FOREHEAD. Some mouth droop and the twitching and quivering of mouth/lips remains to date.
I had redness and itching about an inch below the injection site that developed 8 days after receiving my vaccine. It was red and extremely itchy on the 10th day after injection.  I applied hydrocortisone cream to the site to help with the itching.  On the 11th day there was no itching or redness remaining.  It was not painful, only very itchy.
High, prolonged fever. My daughter received the shot Friday late afternoon. She was exhausted Saturday, exhausted Sunday (2 naps) and later on Sunday had a low fever. On Monday spiked a 105.3 fever. On Tuesday she also reached 105 again. She was quite feverish from Monday dinnertime until Tuesday EOD, which we treated with rotating Tylenol and Ibuprofen--her fever kept spiking if the medication wore off. On Wednesday she awoke at 100.5, and now seems to be on the mend. But overall, she was feverish from Sun-thru-Weds, severely so on Monday and Tuesday.  We called the pediatrician's office for guidance on Monday, Tuesday and Wednedsay.
pt recv vax 29MAY97 & 12SEP97 pt devel a rash that consisted of 10-15 lesions;
Patient received first Pfizer COVID vaccine and in observation area started complaining of scratchy throat.  Exam was normal.  Calm patient, clear lungs, strong pulse.  No rash.  Gave positive answers to all questions, such as do you itch 'a little,' do you have trouble breathing 'a little.'  I suspect anxiety.  Given Benadryl and continued monitoring.  All symptoms resolved.  Observed total of 45 minutes and discharged home.  Ok for next vaccine.
Initial unsolicited case received from a consumer (patient mother) on 11 Oct 2016. This case involves a 4 year old female patient who was vaccinated with a dose of FLUZONE QIV (Batch number, expiry date, and dose was not reported) in left thigh on 03 Oct 2016. The patient Pre-existing physician diagnosed allergies, birth defects, medical conditions were not provided, and illness at the time of vaccination and any other vaccinations within 4 weeks of vaccinations were reported as none. The patient concomitant medications were unknown. On 04 Oct 206, one day after vaccination the patient left thigh was red, hot it had a baseball size lump at the injection site with pain. The patient Required doctor visit and went to the physician on an unknown date. The patient lab tests were reported as none. The patient was taken a first dose of antibiotics prescribed by the physician. The patient recovered from the events on an unspecified date. List of documents held by sender: none.
Information has been received on 18-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a physician's office as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, the patient was treated by a physician at a physician's office 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 and/or despite receiving the 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 has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Tic disorder began with 3 days of fever 102 - 103 and headache.
I HAD A BLACK SPOT WHERE THE SHOT WAS GIVEN, HAD PAIN IN MY RIGHT SHOULDER AND UNABLE TO SLEEP, RED RASH ON RIGHT SHOULDER.
a patient that had their vaccination 8 days and was now testing positive; a patient that had their vaccination 8 days and was now testing positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from medical information team.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "a patient that had their vaccination 8 days and was now testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  Clinical course was as follows: a nurse called to say that she had a patient who had their vaccination 8 days and was now testing positive.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
3 deaths after the second dose of the Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (3 deaths after the second dose of the Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant products were not provided.    Treatment medication were not reported.  Further information has been requested.  This case concerns a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected serious event of death (reported as 3 deaths after the second dose of the Moderna vaccine). The event occurred at an unknown day after the second dose of Spikevax. The rechallenge was not applicable as the events happened after the second dose and no additional dosing will be given (due to the outcome). The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-334634, MOD-2021-334640 (Patient Link).; Sender's Comments: This case concerns a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected serious event of death (reported as 3 deaths after the second dose of the Moderna vaccine). The event occurred at an unknown day after the second dose of Spikevax. The rechallenge was not applicable as the events happened after the second dose and no additional dosing will be given (due to the outcome). The benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Started inconsolable crying, decreased appetite and projectile vomiting x 2. Cried for 12 hours started 6 hours after Vax.
fatigue; missed work; Couldn't get out of bed; severe low back pain; light headed; altered mental status/ making mistakes; Wobbly legs/ bilateral leg weekness; Head feels funny; numbness/Numbness in the face; This case was reported by a nurse via call center representative and described the occurrence of weird feeling in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis.   On 19th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 19th March 2019, less than a day after receiving Shingrix, the patient experienced weird feeling, numbness generalized, lower extremities weakness of and mental status changes. On 20th March 2019, the patient experienced light headedness. On 21st March 2019, the patient experienced low back pain, bedridden and impaired work ability. On an unknown date, the patient experienced fatigue. The patient was treated with muscle relaxants (Muscle Relaxant). Shingrix was discontinued. On an unknown date, the outcome of the weird feeling, numbness generalized, low back pain, lower extremities weakness of, bedridden, light headedness, mental status changes, fatigue and impaired work ability were unknown.   It was unknown if the reporter considered the weird feeling, numbness generalized, low back pain, lower extremities weakness of, bedridden, light headedness, mental status changes, fatigue and impaired work ability to be related to Shingrix.  Additional details were provided as follows: Less than a year after vaccination, the patient experienced fatigue. After vaccination with Shingrix, the numbness persisted 1 day and then reoccurring. As the patient did not feel right in the head or Altered Mental Status, led to emergency room visit. The patient was not admitted in the hopital. On 22nd March 2019, the patient was diagnosed with alerted mental status and severe lower back pain. The patient prescribed with muscle relaxant, relaxer in the emergency room but back pain improved but not resolved. The patient reported symptoms intermittently over 6 weeks after vaccination. The nurse will provide the report with more details to safety when they receive correspondence in the mail. This was intentional medication error with associated adverse reaction.      Lab Comments: On 22nd March 2019, the patient was evaluated for alerted mental status and severe lower back pain.
Administered Havrix and Infanrix after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 6-year-old female patient who received HAV (Havrix) (batch number 2K57N, expiry date 11th December 2022) for prophylaxis.   Co-suspect products included DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th April 2022, the patient received Havrix and Infanrix. On an unknown date, the patient started Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 Information: GSK Receipt Date: 15-Jun-2022 Reporter's comments: Medical assistant reported that the patient was administered with the Havrix in right arm and Infanrix in left arm after a temperature excursion. The consent to follow up was given. Additional Supportive Information: The patient was administered with the Havrix and Infanrix after a temperature excursion, which led to incorrect storage of drug. This was 1 of the 10 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093637:Same reporter US-GLAXOSMITHKLINE-US2022093638:Same reporter. US-GLAXOSMITHKLINE-US2022093643:Same reporter. US-GLAXOSMITHKLINE-US2022093600:Same reporter. US-GLAXOSMITHKLINE-US2022093640:Same reporter. US-GLAXOSMITHKLINE-US2022093647:Same reporter. US-GLAXOSMITHKLINE-US2022093602:Same reporter. US-GLAXOSMITHKLINE-US2022093597:Same reporter. US-GLAXOSMITHKLINE-US2022093644:Same reporter. US-GLAXOSMITHKLINE-US2022093648:Same reporter. FU1 deleted.
Pronounced swelling in arm at injection site 8 days after receiving the vaccine.  Looks slightly bruised, bluish color. Sore to touch. Sore to move arm.
Following first dose - sore arm only; This is a spontaneous report from a contactable other hcp. A 25-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via intramuscular route, administered on Arm Left on 19Dec2020 at 11:30(age at vaccination: 25 years) at single dose for covid-19 immunization at hospital. The patient medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There was no allergies reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient has not received other medications in two weeks. On an unspecified date, the patient experienced Following first dose - sore arm only. The patient did not receive any other treatment. The outcome of the event recovered on an Unspecified date.  Information on the lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Rash on hands, feet, shoulders, and collarbone. Swelling in eyes, lips, and bra line. Incident stared 3 hours after receiving injection.
2 days after vaccines Child presented hives on her legs.  3 days after she had hives on her legs, arms, butt, and back.  Was taken back to the doctors on the 3rd day after and was told to administer Claritin Redi Tabs 1 tab bid. 4 days after she had hives on her chest, back, legs, feet, hands, face, back of neck, and butt. There were alot more of them on the 4th day after having had 3 doses of Claritin.  They are still there and not fading.
pt started crying around 130PM pt would cry uncontrollably for long periods, stop for a few minutes then start again; this happened till 5-530pm;
Dtap and HIB given on 3/28/07. On 3/29/07 Left thigh (Dtap) had 9 cm Red, Raised warm area with tenderness. Right thigh (HIB) had 4 cm Red, Raised warm area. Prescription of Cephalex in 250 mg given
Big rash with mild pain; the skin is raised, warm, and tender to the touch. Rash is about 6 inches.
Congestion; Nostrils are really like dry inside; back was hurting; Body ache; Muscle ache; Sweats; Body fatigue; Sore in arm; This is a spontaneous report from a contactable nurse.  A 28-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. Medical history included antidepressant therapy. Concomitant medication included sertraline hydrochloride (ZOLOFT) as an antidepressant therapy. On 28Dec2020, patient was sore in her arm. On 29Dec2020, the next day patient woke up, she had body fatigue and muscle aches and had the sweats and was fine the next day. On 30Dec2020, Wednesday, the patient's back was hurting and has a body ache. And on 01Jan2021, patient stated she was like super congested. There was no back ache or anything but just has a really bad congestion and stated her nostrils were like really dry inside. Therapeutic measures were taken as a result of congestion, nostrils were like dry inside with spray nose with normal saline and the use of a humidifier. The patient recovered from the event, back pain; has not recovered from the events, congested and nostrils were like really dry; and outcome of all other events was unknown.
Injection site swollen, red and hot. Injection was in the deltoid, swelling went down to forearm.
NO ADVERSE EVENT; 2 month old baby spit out ROTATEQ; This spontaneous report was received from an other health professional and refers to a 2-month-old patient. The patient's concurrent condition, medical history, concomitant medications, drugs reactions or allergies were not provided.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ), orally for prophylaxis (dose, lot # and expiration date were not provided). The reporter stated that a 2 month old baby spit out rotavirus vaccine, live, oral, pentavalent(ROTATEQ). There was no adverse event reported. The outcome of underdose was unknown.
redspot; pain and soreness; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH MACULAR (redspot) and PAIN (pain and soreness) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 016M20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date. Concurrent medical conditions included Vitamin D low (She does have low Vitamin D as of 09-2020) in September 2020. Concomitant products included LISINOPRIL for Hypertension, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for Vitamin D low.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced RASH MACULAR (redspot) and PAIN (pain and soreness). On 13-Jan-2021, RASH MACULAR (redspot) and PAIN (pain and soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.