chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chest pain; Heart palpitation; This is a spontaneous report from a contactable consumer. A 16-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 10May2021 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication taken within two weeks of vaccination was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 18Apr2021 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. On 10May2021, the patient experienced chest pain and heart palpitation. The events resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chest pain and heart palpitation was resolved on an unknown date in May2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Rash to mostly trunk front and back, with mildly to thighs, hands, breast area up to neck and genitalia.
Information has been received from a physician concerning a 16 year old female who on an unspecified date in March 2008, was vaccinated with VAQTA.  Concomitant therapy included MENACTRA and DTAP (unspecified) ("1 dose only").  The patient's sister was reported to have MS.  On an unspecified date in March 2008 "within 24 hours after the vaccines were given", the patient became paralyzed in half of her body, and that same night, she developed chest pains and facial edema.  The patient sought medical attention and was hospitalized.  Diagnostic lab studies were performed, but unspecified.  At the time of this report, the patient was hospitalized and recovering, but was still experiencing problems with her right foot and was undergoing physical therapy.  The reporter considered the events of paralyzed in half of her body, chest pains and facial edema to be also disabling.  Additional information has been requested.
Information has been received from a healthcare worker concerning a 12 year old male with seasonal allergies and no other medical history who in February 2000, was vaccinated with a dose of varicella virus vaccine live (lot # 635461/1246K). Concomitant therapy included loratadine. In 2004, the patient had a varicella titer through another physician which was 0.03. It was noted that the lab stated that it was not the proper test for vaccine seroconversion. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested. The healthcare worker also reported that the patient had a titer that showed no mumps seroconversion after therapy with MMR (WAES0409USA02400).
After getting the vaccine I have been diagnosed with COVID-19 October 25, 2021.
Neurological reaction; Drug allergy; This spontaneous report was received from a physician via Pfizer refers to a patient of unknown age and gender. Information on the patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dosing details, lot# and expiry date not reported). On an unknown date, the patient experienced neurological symptom and drug hypersensitivity. Outcome of neurological symptom and drug hypersensitivity was unknown. The reporter considered neurological symptom and drug hypersensitivity to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).  Follow-up information was received from a physician via Pfizer (2019169966) refers to a female patient of currently 69 year old. Upon follow up this case was considered as valid due to availability of patient identifier.
Seizure activity, low grade fever, starting approximately 24 hours after administration of immunizations. Approximately 25-30 minutes of seizure activity; 6-7 discrete episodes, all generalized. No treatment; patient evaluated and observed.  Nurse follow up on 09/28/04 states: "Final diagnosis was fever, possible seizure.  Additional symptoms noted were vomiting described as spitting up after feeds, runny nose, and dyspnea."
joint problem; muscle soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHROPATHY (non-serious) with onset 2021, outcome "unknown", described as "joint problem"; MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "muscle soreness".  Additional information: The patient was wondering if she will still get the second shot of the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown). The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (22May2022) Positive, notes: Tested positive for COVID again on 22May2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The Other medication in 2weeks: Yes. The patient did not had any known allergies. The patient did not received any treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a registered nurse concerning a 31 year old female who on 1/16/04 was vaccinated SC with a first dose of varicella virus vaccine life (lot # 643597/0895M) 0.5ml. On 1/30/04, the patient presented to the doctors office with a left arm 4 by 4 cm lump described as red and hard, with a small spot underneath. There was no fever, no rash, no treatment provided and no prescription required. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Mild/moderate loss of bladder control Off balance Injection site pain Headache/ stabbing pain in left temple area,a little in the right temple/"spacey" feeling Lower back pain/General muscle weakness Chills/ low grade fever Nausea Congestion/cough Lasted 24-48 hours
3 of my friends that got shot got COVID again; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (3 of my friends that got shot got COVID again) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (3 of my friends that got shot got COVID again). At the time of the report, COVID-19 (3 of my friends that got shot got COVID again) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment information was reported.   This spontaneous case is concerning a patient of unknown age and gender with no medical history reported, who received mRNA-1273 vaccine on an unknown date, experienced the unexpected, AESI of COVID-19. The event occurred on an unknown date after the unknown dose of mRNA-1273 vaccine.   Re challenge is not applicable as the event occurred after the unknown dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case is concerning a patient of unknown age and gender with no medical history reported, who received mRNA-1273 vaccine on an unknown date, experienced the unexpected, AESI of COVID-19. The event occurred on an unknown date after the unknown dose of mRNA-1273 vaccine.   Re challenge is not applicable as the event occurred after the unknown dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
pt recvd & exp numbness & tingling p/1st & 2nd doses; tx APAP, Pepto-Bismol, Emetrol;
Patient was given HPV vaccine and within 30 seconds had a syncopal episode lasting 30 secinds. Her arms and legs became rigid and eyed dilated. Recovered quickly. Treatment was application of cool compresses to forehead and neck. Patient had not eaten much that day. B/P was 94/66 prior to administration.
Vaccination site through a Health Center. Day of shot, only sore arm. Woke up to large (1/2 lemon size) knot  on right arm at injection site.  Very warm to touch, red and itichy!   Cold compresses used.  Just started taking Benadryl.
Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 69 years old patient who was vaccinated with 0.5 ml dose of vaccine FLUZONE HIGH DOSE (batch number: UJ042AB and expiry date: 19-May-2019) via intramuscular route in the deltoid on an unknown date (reported as today). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List concomitant or no other vaccines- none. It was a case of actual medication error due to wrong technique in product usage process and vaccine under dose. It was reported as she did not screw on needle tight enough and it leaked. The patent may only have gotten a very little or not any FLUZONE at all. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Developed GI symptoms approximately 24 hrs after the second Moderna vaccine consisting of severe nausea and dirreaha-no vomiting. The following day the nausea was gone, but not the dirreaha. The dirreaha continues. Until I received the shot, I had never had any GI problems what so ever.
Flushing, rash, dizziness, lightheadedness, slightly elevated BP and heart rate
Loss of strength/movement below the waist.  Admitted to hospital.  Physical and occupational therapy administered.  Normal strength/movement fully restored.
After  Does 1, I broke out into hives, I was given prednisone and the swelling and itching did go down. After dose 2, The hives returned and I developed plaque psoriasis all over my body in perhaps 20 locations. I was given prednisone again, the itching stopped  but The psoriasis remains and is getting worse. As a note, I have had psoriasis for most of my life on my hands and feet, but after this experience I have psoriasis all over my body.
Swelling of vycross fillers; This is a spontaneous report received from a non-contactable other HCP.   A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Six days after receiving the vaccination, patient developed swelling of vycross fillers on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Severe diffuse muscle pain and stiffness same vaccine without prior c/o these SX. NSAIDs and physical therapy.
4/6 night of i had night sweats all night 4/7 woke up horrible headache and body aches 4/8 really really bad headaches and body aches 4/9 weakness, nausea, dizzy tiredness 4/10 weakness, nausea, dizzy slept all day 4/11 started a period.  I have already gone through menapause and haven't had a period in over 3 yrs.
the patient passed out about 3 seconds after the injection of GARDASIL 9/as soon as the immunization was administered, she fainted immediately; This spontaneous report was received from a office manager in a physician's office via company representative and refers to a 14-year-old female patient. The patient's pertinent medical history, concomitant medications and drug reaction/allergies were not reported.  On 11-NOV-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot # 1621934, expiration date 29-JAN-2020, intramuscularly in the left arm for prevention of human papilloma virus (HPV) related cancer (exact dose was not reported). As soon as the immunization was administered, the patient fainted immediately. She passed out about 3 seconds after the injection of the vaccine and she had little headache and dizziness. Her blood pressure was 92/64 and heart rate 64 (units not provided). There was no treatment given for the event, the patient was just observed by the physician. The patient left the physician's office feeling fine. She had a little headache, however was walking fine (outcome reported as recovered). The relatedness between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  Upon internal review, the event was determined to be medically significant.
Initiation of an irregular menstrual cycle exactly 24 hours after receiving the vaccine; This is a spontaneous report from a non-contactable physician, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 29Jul2021 at 14:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 30Jul2021 at 14:00, exactly 24 hours after receiving the vaccine, the patient experienced initiation of an irregular menstrual cycle. The patient took birth control and did not have natural periods but started an irregular bleeding cycle after the first shot. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event initiation of an irregular menstrual cycle exactly 24 hours after receiving the vaccine was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Irregular vaginal bleeding after 3 months (April, May, June) of no period.  Sept.--hemorrhaging and hormone taper.  Oct.--benign results from cyst and endometrial biopsies.  Dec.--uterine polyp detected.  No period since November.  Hormone levels are postmenopausal.
A nurse reported that a 20 year old female received an injection of Cholera on 12/2/98. The next day, she developed an injection site reaction characterized by a 6 cm area of swelling, redness, warmth, and pain. She recovered within 48 hours.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages and genders. On an unknown date, the patients were vaccinated with GARDASIL (dose, route and lot number were not reported), vaccine had been exposed to multiple excursions with highest temperature reaching 57F for total time of 206 hours and these vaccines' stability could not be supported. No adverse effects reported. This is one of several reports from the same source. Follow up information was received with patient identifiers. This case reported that GARDASIL (dose and route not reported, lot# J006850,expired date:31-MAR-2015(reported as 10-JUN-2015)) was administered to a 11 year old patient on 28-FEB-2014. This case was linked to 1405USA001165, 1405USA00164, 1405USA001161, 1405USA1162, 1405USA001166 and 1403USA007265. Additional information has been requested.
After the first injection I got a major headache and I?ve had it ever since. After the second shot my body broke out in a red measles like rash.
Product storage error; Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported. The vial was placed in refrigerator on 18-Oct-2021. It was reported that the expired lots were administered due to the confusion with expiry date printed in the carton and the expiration date when the QR code was scanned. The vials did not undergo temperature excursion. The patient did not experience any adverse event. No Treatment medication reported.
This spontaneous report was received from a certified medical assistant and refers to six patients of unknown demography. The patients' concurrent conditions, medical history and concomitant medications were not reported. The reporter stated that on unspecified dates from February 2016 to May 2016, six unspecified patients were vaccinated with improperly stored RECOMBIVAX HB (dose, frequency, route, therapy type, lot # and expiration date unknown). No doses of VARIVAX were administered. No adverse effects were reported. This is one of two reports from the same reporter. Additional has been requested.
Post vax, on 4/1/01 at 06:00, had severe frontal headache and was started on Zithromax. On 4/2/01, had onset of severe bilateral tinnitus. On 4/3/01, saw an ENT doctor. No ear infection but dx'd with cholear nerve infection. Steroids and Augmentin were prescribed for possible sinusitis. On 4/8/01, steroids stopped. On 4/11/01, had onset of extreme lethargy, unable to work. On 4/14/01, had onset of acute CNS changes (confused, disoriented, slurred and thick speech, balance problems, intractable hiccups, headaches, lethargy continues). From 4/14/01 to 4/16/01, had extreme somnolence, difficult to awaken and irritable. On 4/16/01, saw a neurologist, and was dx'd with acute encephalopathy and hospitalized. On 4/18/01, discharged with CNS changes improved. On 4/23/01, balance, disorientation and hiccup problems resolved but still unable to work. San ENT/Tinnitus specialist who felt tinnitus was secondary to an acute bilateral hearing loss, probably would not go away. Prescribed another steroid course and Elavil. On 5/3/01 through 5/12/01, confined to bed secondary to fatigue and lethargy. From 5/12/01 to 5/24/01, fatigue starting to resolve. Current problems: severe, unremitting, bilateral tinnitus; insomnia secondary to tinnitus and fatigue continue to be problems, other CNS problems seem to have returned to baseline. Still unable to work.
neuropathy in my feet; psoriasis breakout; This case was reported by a consumer via interactive digital media and described the occurrence of peripheral neuropathy in a 64-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In January 2023, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced peripheral neuropathy (serious criteria GSK medically significant) and psoriasis. On an unknown date, the outcome of the peripheral neuropathy and psoriasis were not recovered/not resolved.   It was unknown if the reporter considered the peripheral neuropathy and psoriasis to be related to Shingles vaccine.     Additional Information: GSK receipt date: 28-Feb-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the first shot last month and thought the shots were to prevent it. The patient did not need shingles. The patient was trying to get rid of a first-time psoriasis breakout right now. The patient did not need anything else right now. The patient had neuropathy in his/her feet was bad enough and trying not to get covid either. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Allergy symptoms started March 28, 2021. Fever and aches on April 3rd,2021.
Patient states 3 days post vaccination lethargic, neck pain, right arm sore.
Next morning, felt so fatigued & out of it, went back to bed. By the next evening, had extreme flu-like symptoms - vomiting, diarrhea, fever, chills, headache, body aches. Was in bed until the next evening, when I got up realized I had very blurry vision, couldn't read or focus, still had headache and nausea and was very dizzy. Felt like I was drunk. Was sent to the ER because of the blurry vision. Two days later, I developed a painful sore on my lower buttock, and about 4" of  red patches on my right arm. I looked at the one on my butt with a mirror & saw that it looked like it had lots of little blisters on it, so I was concerned I had shingles or herpes or something. So I went and had a doctor look at it.
lt upper arm to top of shoulder is red, warm & swollen there is no pain;there is full ROM;tx w/augmentin, use cool compresses;
Prolonged abnormal involuntary movements that started 3 days after receiving his first influenza vaccine. The episode lasted several hours, he was fussy/aware the whole time. Mom had a video of it, limbs/head were jerking/twitching randomly - almost chorea like movements.  Taken to local ER for observation. At recheck appointment in office on 1/15/21 pt was back to baseline.