chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Lot number: ER26198) at the age of 32 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 20Mar2021, outcome "recovered" (22Mar2021), described as "a sore arm".  Additional information: The patient after her first vaccine literally had no issues, barely a sore arm.   No follow-up attempts are possible. No further information is expected.
Pt felt weak after vaccine and following day body was covered by rash. Patient tried BENADRYL & did not go away in the following day and then went to ER. Had high temp as well gave IV fluids.
6/23 pt started feeling tingling in her right arm. 6/24 at 3 AM pts heart started racing, nauseated, body aches, couldn't stand up. 6/25 pts symptoms were worsening and her family urged her to seek medical evaluation at the ED. At the ED on 6/25 at 10 AM pts BP was 269/169 and they gave her IV pain meds and anti nausea medication and fluids.  The ED discharged her at 4pm on 6/25. Pt couldn't keep food down at home, Pts BP readings ranged from very high to very low. Pt went back to the ED 6/28/21. Pt states ED didn't do anything at this visit. Then pt went back to ED 7/4/21. ED did EKG, ultrasound of legs and pt was discharged the same day.
After receiving both vaccines patient went to stand and wait her 15 minutes for observation. Within about 2- 3 minutes she reported not feeling well and sat back in the immunization chair. She reported feeling dizzy, stomach upset and chest tightness. She denied difficulty breathing, itching, swelling of lips or throat. Took the patients blood pressure and SBP was 125. Told patient to remain seated and we would continue to monitor. She reported that within about 5 minutes symptoms resolved. We monitored patient for about 1 hour and she said she felt back to normal and all symptoms resolved. She denied needing further medical care and was ok to go.
EPILEPSY, UNSPECIFIED 3/23/2023 ATHEROSCLEROSIS OF AORTA
The next morning after my 2nd vaccine, I had a hard lump, redness & soreness at injection site.; The next morning after my 2nd vaccine, I had a hard lump, redness & soreness at injection site.; The next morning after my 2nd vaccine, I had a hard lump, redness & soreness at injection site.; a headache began by noon; 2 short-lasting episodes of light dizziness w/o complications.; Also had all over muscle aches; This is a spontaneous report from a contactable other healthcare professional. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6200) via an unspecified route of administration in the right arm on 18Feb2021 at 17:30 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to adhesives. Concomitant medications included glucosamine sulfate (GLUCOSAMINE), ferropolichondrum (CHONDROITIN), herbal turmeric and vitamins, all from unspecified dates and  for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN5318) via an unspecified route of administration in the right arm in Jan2021 at 17:45 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. The patient also received previously erythromycin(MANUFACTURER UNKNOWN) on an unknown date and experienced allergy.  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 19Feb2021 at 07:00, the patient experienced a hard lump, redness and soreness at injection site(vaccination site). On 19Feb2021 in the noon, the patient had muscle aches all over, a headache and 2 short-lasting episodes of light dizziness without (w/o) complications. The patient did not receive any treatment for the reported events. The clinical outcome of the events hard lump, redness and soreness at injection site, muscle aches, headache and dizziness were recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Approx. 5 minutes after receiving MENVEO client began to feel light headed. She was then sat in a chair. Approx. 5 minutes after feeling light headed client began to convulse for 30 seconds. When she gained full consciousness, she said that she had experienced hearing loss. Her BP was 60/38 at 10:45 AM. We moved her to the bed and propped her feet up, at 10:55 we took her BP again and it was 118/83. She was picked up by her mother to be monitored.
Gradual onset of daily left arm band-like paresthesias; progressive over time from intermittant to constant, and from limited to generalized dermatomal distribution. Daily episodes of tingling paresthesias, same distributuion.  Motor involvement of elbow & wrist flexion/extension.  No improvement to the present time.
Pt recvd 3 dose series of Engerix-B; HBSAB test was negative; Pt given booster of Engerix-B on 01MAY91, but has not yet been drawn for titer p/booster;
Received flu vaccine and pneumonia vaccine on 11/3/00 in right deltoid. On 11/6/00, presented with localized redness encircling left arm and light generalized redness of upper body.
Extreme pain in body.  Left chest and arms.  Leg pain below knee in calf area.  Tingling and loss of feeling in hands. This started about 24 hours post injection and continued constantly for almost 72 hours.  Since 4 days post injection pain in arms and chest occur for about 30 minutes every 3 to 4 hours.  Tingling and numbness in hands and forearms is sporadic and comes and goes without any pattern.  At night the pain wakes me up from Sleep 2 to 3 times a night.
A report has been received from a Health Professional concerning a 1 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced ADMINISTRATION TO A 20 MONTH OLD which started on 15-Nov-2012. The outcome of the event of ADMINISTRATION TO A 20 MONTH OLD is unknown. The report was considered to be non-serious. Corrected report 29-Nov-2012: Key ingredient of FLUMIST corrected from influenza virus vaccine polyvalent to FLUMIST, coding of event 'administration to a 20 month old' corrected from intentional drug misuse to inappropriate age at vaccine administration, narrative updated.
2 hrs post vax developed fever, aches, pains, interm. altered mental status, diarrhea. Had brief resp arrest, was unconscious, intubated, & marked hyperthermia.Hospitalized & dxed w/ pneumonia; txed w/ IV Ancef.
Patient received the Pfizer COVID-19 vaccine on 1/19/21 and 2/9/21 so was fully vaccinated when they tested positive for COVID-19 on 9/3/21.
After receiving  J&J vaccine on Friday,  3 days later I developed severe lower back ache that spread across and covered my entire lower back and hip area also.  The muscle pain was so severe I had trouble sleeping and sitting but could stand pain free.  This lasted about 3 days. I took Tylenol to help with the pain and used a heating pad also. After day 3 it was all over and I've been fine ever since!
No additional adverse events.; on 20-JUL-2020 a patient was administered an improperly stored VARIVAX; This spontaneous report was received from an office manager, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 20-JUL-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, as prophylaxis (lot number S028925 which has been verified to be valid, expiration date reported and validated as 16-SEP-2021) (dosage, vaccination scheme, frequency, route of administration and anatomical site of injection were not reported). The vaccine was reconstituted with properly stored sterile diluent (DILUENT MRK).  The administered dose of the vaccine on 17-JUL-2020, was stored at a temperature of 6 degrees Fahrenheit (F) to 14 F (9.0 F), during a time frame of 1 hour, 15 F to 46 F (45.9 F), during a time frame of 10 hours and 30 minutes, and starting at 10:07 p.m. of -47 F to 77 F (77 F), during a time frame of 15 hours. On 18-JUL-2020, the vaccine was stored at a temperature starting at 2:52 p.m. of -78 F/26 degrees Celsius or warmer (79.5 F), during a time frame of 32 hours. There was no previous temperature excursion. No additional adverse events were reported in the patient.
giving the liquid component of the Pentacel to a child/lyophilized component wasn't mixed with the liquid component, with no reported adverse event; Initial information received on 30-Jun-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 2 years old male patient who was given the liquid component of the diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV(vero)/ HIB(PRP/T) vaccine [Pentacel (Vero)] / lyophilized component wasn't mixed with the liquid component, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 13V (CRM197) (Prevnar 13) for Prophylactic vaccination (immunization).  On 30-Jun-2023, the patient received 0.5 mL dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV (vero)/HIB(PRP/T) vaccine, suspension for injection (batch number: UJ678AA (Act-Hib); Expiry date: 09-sep- 2023; Batch number: U7311AA (DTAP-IPV), Expiry date: 09-sep- 2023) via intramuscular route in left leg for Immunization, only given the liquid component of the pentacel to a child/ lyophilized component wasn't mixed with the liquid component, with no reported adverse event (product preparation error) (same day latency).   Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event giving the liquid component of the pentacel to a child/ lyophilized component wasn't mixed with the liquid component, with no reported adverse event.  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 the 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.
Moderate-Extreme swelling in the left arm pit. Potential for lymph nodes submandillular  swollen also but to a much lesser extent
This spontaneous report was received from an office manager and refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 08-OCT-2018, the patient was vaccinated with an expired dose of VARIVAX subcutaneously, lot# M038859, expiration date: 14-SEP-2018 (exact dose, site and route of administration were not reported) for prophylaxis. No adverse effects were reported.
Arm soreness at injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Mar2021 11:00 (Lot number: EP7533) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Wheat allergy" (unspecified if ongoing), notes: Known allergies: Wheat allergy; "seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Past drug history included: Ibuprofen, reaction(s): "Drug allergy". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 07Mar2021, outcome "recovered" (09Mar2021), described as "Arm soreness at injection". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Reporter stated that, the patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Pt needed dose 2 of primary series Pfizer 5-11 and was given Pfizer 5-11 Bivalent as Dose 2 instead.
Patient received Hepatitis A vaccine 02/02/2005 at 9AM.  Went to ER at 9:30PM with confluent red rash on chest.  Given Benadryl.  Patient also started Zithromax and Tussinex Cough Syrup.
11 year-old boy received an ADACEL vaccine that was then noted to have expired with no reported adverse event; Initial information received on 21-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old male patient who experienced 11 year-old boy received an adacel vaccine that was then noted to have expired with no reported adverse event while receiving vaccine diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included meningococcal vaccine a/c/y/w conj (dip tox) (Menactra) for Prophylactic vaccination.  On 21-Mar-2022, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine (batch lot :U6612AA) (unknown strength and expiry date) via intramuscular route in the right deltoid for immunisation  On 21-Mar-2022 (latency: same day)the patient developed a non-serious event of 11 year-old boy received an adacel vaccine that was then noted to have expired with no reported adverse event (expired product administered) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event .  At time of reporting, the outcome was Unknown for the event .  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 the guidelines. 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.
Local allergic reaction started overnight after first dose on 1/7/21. Noticed on  morning of 1/8/21 that skin at injection site was itchy and a rash had broken out.  By the next day, 1/9/21, the rash had grown larger, extremely red, and was hot to the touch. Drew a circle around the rash to monitor growth, took a Benadryl. By afternoon of 1/10/21, rash appeared to have grown slightly larger, but significantly less red and temperature and swelling had reduced. Seemed to be gone by 1/11/21. Tonight, 1/14/21, around 6:30pm, I noticed that the skin was itchy at the injection site again, and that a rash had begun to break out once more. Will continue to monitor it.
Inability to use my arms, legs properly - incredible muscular stiffness throughout my body; dry cough; phelgm in my lungs, lost my voice  9/23/08 Reviewed PCP medical record of 9/22/08. FINAL DX: URI, doubt adverse effect of flu shot Record reveals patient experienced muscle stiffness & pain, tired, hoarse voice, wet cough, scratchy throat.  Sick contact at work w/similar symptoms. Symptomatic tx.
This patient presented with my ER on 16APR21 with headache, lightheadedness, nausea, every day since vaccination which was  on the 9th of April.  This may be a duplicate, but I was advised to place the report regardless as the symptoms are persisting.  The patients symptoms nearly resolved after Tylenol and IV fluids.
Hot feeling, weak, sore at site of injection previously red. Vomited 3 times within 3 hours today (9/17/13) T-98.8 orally.
Sister of patient could not provide lot# or vaccine site. My sister started to have convulsions the day after her Moderna dose 2 vaccine. My sister is in a senior living facility and she is in a wheel-chair. My sister has history of epilepsies, which were controlled for one year,  but since the Moderna vaccine, she has had four days straight of convulsiond. She has had 30 convulsions in the four day span along  with fever and she has also lost her sensation to her legs.
Constipation for 6 months now. Can't poop without mother's help. Nothing has helped her. And she is now receiving x rays because we have tried everything possible. This could be possible intussusception.
Headache, Myalgia, Fever, NauseaVomiting, chills, enlarged lymph nodes Narrative:
Patient seen by PCP at onset of symptoms and Opthamologist (rash - Zoster type) above right eye, Pt reports no pain; just itchy and sore to touch.
Information has been received from a physician concerning a 73 year old female with high blood pressure, history of cancer and no allergies who on 30-MAY-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (Lot # 657558/0461U).  Concomitant therapy included lisinopril, metoprolol and hydrochlorothiazide.  On 02-JUN-2007 the patient developed shingles like rash.  It was reported that rash was mostly on her chin but was spreading to her cheeks and was very itchy and sometime it burned.  Unspecified medical attention was sought.  No diagnostic laboratory tests were undertaken.  At the time of report, the patient was not recovered.  A product quality complaint was not involved.  Additional information has been requested.
the vaccine was given  as combination instead of mmr and varicella, we called the patient no side effect
Initial report received on 27 December 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 17-month-old female subject (initials not collected) was identified by the investigator based on review of data from the state Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3913AB received on 18 August 2011, lot number C3923AA received on 18 October 2011, and lot number C3980AB received on 09 January 2012. The subject developed a cough on 02 December 2012, approximately 10 months after the last dose, and a paroxysmal cough without a whoop on 06 December 2012. The subject also developed cold like symptoms on 23 November 2012, posttussive vomiting and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 10 December 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 11 December 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 18 December 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. Investigator causality assessment is not required as per protocol. This is one out a cumulative total of 180 cases solicited from the database during the surveillance period from 01 January 2010 to 27 December 2012. These 180 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
A nurse practitioner called to report an expired dose of GARDASIL 9 was administered to a patient.  No addiitonal AE's and PQC's were reported.; A nurse practitioner called to report an expired dose of GARDASIL 9 was administered to a patient.  No addiitonal AE's and PQC's were reported.; This spontaneous report has been received from a nurse practitioner and an office manager, regarding an identified patient of unknown age and gender.  Information regarding the patient's medical history, concurrent conditions, concomitant therapies, and past drug allergies or drug reactions were not provided.  On 08-FEB-2023, the patient was vaccinated with one expired dose (product quantity: 1) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringe injection, administered as directed to prevent human papilloma virus (lot #R025729 confirmed to be valid, expiration date reported and stablished as 18-JUN-2021; exact dose, vaccination scheme, strength, and route of administration were not provided). No additional adverse events (AE).
The shot area is hot; The shot area is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (The shot area is hot) and VACCINATION SITE ERYTHEMA (The shot area is red) in a female patient of an unknown age 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. On an unknown date, the patient experienced VACCINATION SITE WARMTH (The shot area is hot) and VACCINATION SITE ERYTHEMA (The shot area is red). At the time of the report, VACCINATION SITE WARMTH (The shot area is hot) and VACCINATION SITE ERYTHEMA (The shot area is red) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.
About 4 hours after flu shot I started having body aches. Shortly after that I felt weak and then very nauseous and dizzy. Then I began throwing up and had uncontrollable diarrhea. Shortly after it was over but I was still weak even the next day. It's been about 36 hours and I feel I am getting better. I was so  miserable I will never have another flu shot.
started feeling flushed; Started running a fever; This spontaneous case was reported by a nurse and describes the occurrence of FLUSHING (started feeling flushed) and PYREXIA (Started running a fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021 at 11:45 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced FLUSHING (started feeling flushed) and PYREXIA (Started running a fever). The patient was treated with NAPROXEN SODIUM on 02-Nov-2021 for Adverse event, at a dose of 2 Naproxen sodium. At the time of the report, FLUSHING (started feeling flushed) had not resolved and PYREXIA (Started running a fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided.   This case was linked to MOD-2021-022009 (Patient Link).