chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Fatigue; Shortness of breath; Chest pain; Dizziness; Arm soreness; This is a spontaneous report from a non-contactable healthcare professional.  This 24-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, on an unspecified date (at the age of 24 years-old, as a single dose for COVID-19 immunization. Medical history and concomitant medications were 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. There were also no other medications taken in the last two weeks. On 24Dec2020, the patient experienced  fever, fatigue, chest pain, shortness of breath, arm soreness, and dizziness. The patient was not hospitalized for the events but received treatment with acetaminophen (TYLENOL). The clinical outcome of the events of fever, fatigue, chest pain, shortness of breath, arm soreness, dizziness was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient requested for his pfizer booster on the 12/29/21 and administered as per his request. Pt denies any medical condition or allergies.  Accompanied by his older sister, 12:04 pm vaccine administered, 12:18 pm patient lost his vision with dilated eyes, lost of hearing , skin was pale, clammy and profusely sweating . Oxygen stat 97% , 63BPM. Ambulance called and responded around 12:23pm. Patient's vision and hearing  in right ear returned. Left ear still affected. Patient left in ambulance still pale and mildly disoriented. Sister accompanied patient to hospital.
his platelet count had dropped significantly; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021073856_NC .  A 77 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PLATELET COUNT DECREASED (non-serious), outcome "unknown", described as "his platelet count had dropped significantly". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt claim that she developed a  staph. infection due to the vaccines that was given to her on the right arm.  She's currently on antibiotics prescribed by her doctor.  She stated that her arm was swollen, throbbing and in pain.
liver failure; now have non-alcoholic cirrhosis of the liver; sick; 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 26 year-old female patient received bnt162b2 (BNT162B2), administration date Sep2021 (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: HEPATIC FAILURE (hospitalization, medically significant) with onset Sep2021, outcome "unknown", described as "liver failure"; HEPATIC CIRRHOSIS (hospitalization, medically significant) with onset Sep2021, outcome "unknown", described as "now have non-alcoholic cirrhosis of the liver"; ILLNESS (non-serious) with onset Sep2021, outcome "unknown", described as "sick".Event details reported as follow: A healthy patient received the first dose of the vaccine in Sep2021, two weeks after receiving the vaccine and with no change in her day to day lifestyle she was hospitalized due to liver failure. She now had non-alcoholic cirrhosis of the liver. She had been sick ever since. She was also not the only person to have this problem after taking the vaccine. She had been to many specialists that believe it was the vaccine that did this to her. The lot number for bnt162b2 was not provided and will be requested during follow up.
NauseaVomiting EXTREME FATIGUE, TIRED, CHILLS Narrative:
Extreme soreness to arm, vesicles on arm injected, redness, swelling, nausea, myalgia, fatigue, decreased (none) appetite, bronchitis
This case was reported by a consumer via call center representative and described the occurrence of rash in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day 6 hrs after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. 30 hours following dose of SHINGRIX, the patient experienced a skin rash on her stomach and sides. The reporter wanted to know was this a common side effect or one that warrants medical attention and should prompt her to reconsider the second dose. The GlaxoSmithKline information does not seem to reference skin rash in any context, only hives or allergic reaction.
Unusual pain in arm immediately upon vaccine administration; arm pain continued to gradually worsen each day; pt reporting can hardly use arm 11/8/2014.
prescribing Adacel administration 1 year after previous vaccine, no adverse event; Initial information was received on 21-May-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a pregnant female patient who had a been prescribed DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] 1 year after previous Tdap vaccine (Product prescribing error). Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known and this event occurred at unknown gestation period. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient previous pregnancy not reported.  The patient had received a dose of Boostrix in past.   On an unknown date, the patient was prescribed a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to Product prescribing error. It was reported that the patient that came in and got tetanus and diphtheria toxoids with acellular pertussis (TDAP) from her primary care doctor a year ago. The patient was going to have a new baby and her obstetrician/gynecologist (OBGYN) wanted a guidance on administering Tdap within a year of receiving the vaccine previously  It was product prescribing error and it was not confirmed if vaccine was administered or not.  Pregnancy outcome was unknown at the time of report.  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.
Focal Seizure 6/6/2021 around 0800 witnessed by husband. Drooling, Starring into space, tremors. Awake but non responsive, non verbal. c/o headache and sleepy for 90 minutes after.
Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nauseous). At the time of the report, NAUSEA (Nauseous) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported by the reporter. No treatment medications were reported by the reporter.   This case was linked to MOD-2021-254074 (Patient Link).
Bright red rash, raised up, very hot to touch, swollen. Took her to the emergency room and they started her on antibiotics.
20 y/o male received primary SPV + AVA (2) 6/12/2007. Felt well before vaccinations. Had no atypical problems related to vaccine site; About a week later, 6/19/07, he noticed a slight headache associated with feeling 'feverish', chills, and fatigue. Two days after that, 6/21/07 (10 days post SPV), while sitting in truck, he noted his heart beating 'hard and fast' and had acute onset of midsternal chest chest pain, described as "like a screw-driver in my chest'. Pain intensity 9/10, intermittent in nature, with episodes lasting up to a minute, pain radiating into jaws, worse, with lying down or deep breathing, and slightly better with standing straight up. Pain present with activity or rest. Seen at ER - after labs, CXR, ECG, transferred to hospital. Hospitalized 6/23-6/28/2007. Fatigue, Malaise <60 Days: 06/19/2007. Fever:06/19/2007: subjective. Chills: 06/19/2007. Headache: 06/19/2007. Chest pain, sub-sternal: 06/21/2007 sharp, 9/10, worse lying, better standing, intermittent. Dyspnea: 06/21/2007. Palpitations: 06/21/2007 heart pounding hard and fast. 8/15/07-records received from receiving facility for DOS 6/23-6/28/07-DC DX: Persistent chest pain, Myocardial infarction ruled out. Admitted with chest pain. Substernal knife like soreness to touch, pleuritic and positional and constant. effusion Transferred to another facility for cardiac catheterization.  8/23/07-records received for DOS 08/08/07-6/12/07-received small pox vaccine. Admitted to hospital 6/21-6/28 for chest pain. Negative cardiac cath on 6/29. Small pox induced myocarditis. As of 8/8/07-continues to have chest pains that last approximately 3 mintues relieved with ibuprofen or mobic. Get SOB easily. Secondary problem: GERD. 1/1/10 - follow up - patient being followed by military cardiologist; he remains deployed;re-evaluate 6 months from event which will be dec-jan.
Seizures noticed 3 weeks after vaccination, diagnosed as infantile spasms, developed into refractory subclinical seizures resulting in (R) frontal lobe resection in 2009. She is still on medications and suffers from learning disabilities.
2 patients received an expired dose; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 14-NOV-2022 Reporters comment: Doctor reported that the patient received a dose of Havrix that expired 5 weeks earlier. The health care professional did not provide patient identifiers, lot number or exact expiration date of product. The reporter consented to follow-up. Additional Supportive information: The patient received a dose of Havrix that expired 5 weeks earlier, which led to expired vaccine used. This case had been linked to the case US2022AMR171880 reported by the same reporter. This case was linked to the cases US2022AMR163515, US2022AMR163547, US2022163626 and US2022AMR164695.; Sender's Comments:  US-GSK-US2022AMR171880:Same reporter. Patient 2 of 2 US-GSK-US2022AMR163515:Same reporter US-GSK-US2022AMR163547:Same reporter US-GSK-US2022163626:Same reporter US-GSK-US2022AMR164695:Same reporter
This spontaneous report has been received from a nurse referring to multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored M-M-R II (dose and route were not reported) lot# M029230 with expiration date 08-JUN-2018, lot# M035389 with expiration date 02-AUG-2018, lot# M036544 with expiration date 15-AUG-2018, lot# M039914 with expiration date 26-SEP-2018, for prophylaxis. The vaccines were exposed to temperature excursion of 9 degrees Celsius to 25 degrees Celsius for 2 hours. Data logger was involved. There was no previous temperature excursion. No adverse effects reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA000379: US-009507513-1708USA000378.
pt had flu vax 6OCT93 in the lt deltoid area; following evening noticed an area of redness & edema below & inside the area where the inject was given; pt states was bruised;
Received Moderna 1st dose on Tue 6/29 @0933am. Very mild soreness in left arm Tue and Wed. Otherwise, felt fine until Thu 7/1 around 530pm with the onset of mild lower back pain, hip joint pain, and nausea. Friday and Saturday morning, the pain was severe and eased throughout the days to a dull ache. Hurt to inhale. Saturday afternoon, mild muscle pain in neck and shoulders. General feeling of weakness and fatigue.
BURN PAIN IN BETWEEN BREAST; PAINFUL BUMP ON LEFT ARM; ITCHY; RASH; NAUSEA; FEVER; REDNESS LEFT ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced rash. On 01-APR-2021, the subject experienced nausea. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced redness left arm. Treatment medications included: ibuprofen, and paracetamol. On 02-APR-2021, the subject experienced burn pain in between breast. On 02-APR-2021, the subject experienced painful bump on left arm. On 02-APR-2021, the subject experienced itchy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burn pain in between breast, rash, nausea, and fever on 02-APR-2021, and had not recovered from redness left arm, painful bump on left arm, and itchy. This report was non-serious.
Rash below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash below the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ). Concomitant products included LEVOTHYROXINE for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash below the injection site). At the time of the report, VACCINATION SITE RASH (Rash below the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a pharmacist refers to a 69  year old male patient. There was no pertinent medical history or drug reactions. On 17-SEP-2014 the patient was vaccinated with the second dose of PNEUMOVAX23 (strength was not reported), lot # J009833, expiration date: 25-JAN-2014, 0.5 ml, intramuscularly in right deltoid muscle. There was no concomitant therapy. On 18-SEP-2014, the patient experienced redness, soreness, and swelling of the right biceps muscle. The injection site was not affected. No treatment was given. No labs were performed. The patient sought medical attention by pharmacy visit.  The outcome of the adverse events was reported as not recovered/not resolved. Additional information has been requested.
Two patients whose medical history and concomitant medications were not reported, received a dose of FLUZONE (lot number: UH899AD, expiry date: 30 Jun 2014) intramuscularly on deltoid on 01 October 2013. On 01 October 2013, patients had red raised welts like an itchy rash 1 hour after the vaccine that lasted 1 hour then went away. The events were resolved. Listed of documents held by sender: none.
Felt hungover / Hangover; Achiness; This spontaneous case was reported by a consumer and describes the occurrence of HANGOVER (Felt hungover / Hangover) and PAIN (Achiness) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis (Moderate to severe ulcerative colitis).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced HANGOVER (Felt hungover / Hangover) and PAIN (Achiness). At the time of the report, HANGOVER (Felt hungover / Hangover) and PAIN (Achiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This case was reported by a nurse via call center representative and described the occurrence of sickness in a 64-year-old female patient who received SHINGRIX (batch number T5242, expiry date unknown) for prophylaxis. On 4th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, unknown after receiving SHINGRIX, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of SHINGRIX on left deltoid. Initially the patient did not get the second dose due to the product stock issue, however an appointment was scheduled when the product was in stock and the patient cancelled the appointment due to being sick. The nurse does not have further details available regarding the statement sick, as the patient had spoken to the receptionist at the time. Till the time of reporting, the patient did not receive the second dose of SHINGRIX.
never went back for my second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (never went back for my second dose) 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 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (never went back for my second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (never went back for my second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were provided by the reporter.
Went into anaphylactic shock from second Moderna Covid-19 vaccination shot. Am now being denied second booster shot because of that reaction even though my primary care physician has found an acceptable alternative. Had first booster shot (Janssen) on 12/6/21 without any reaction. I did not have a reaction to this booster shot, although speaking with another woman who was also there for a booster shot, she, too, went into anaphylactic shot after receiving her Covid-19 vaccination. Since then, I have been unable to obtain a second booster shot for the following reasons: 1. The only booster shot deemed acceptable for me is the NoraVax. This was determined by my primary care physician and a pharmaceutical specialist with whom she consulted. That pharmacist reviewed the ingredients used in the NoraVax and said that I would not have an adverse reaction to them. 2. My doctor instructed me to obtain this booster shot at one of the pharmacies. None of these pharmacies carried the NoraVax booster shot. They only carry the Pfizer or Moderna booster shots. I reported this information to my doctor. 3. My doctor then found a pharmacy that had the NoraVax booster shot. 4. Upon walking into the pharmacy to receive the booster shot, I was told that I could only receive the booster shot after making an appointment online. 5. I left the pharmacy and later attempted to make an appointment online. There were no appointments available for NoraVax. They were only showing the Pfizer and Moderna Covid-19 vaccinations. 6. I returned to the pharmacy to ask when they would be getting the NoraVax in stock. The pharmacist informed me that having it stock is not the issue; they have it in stock. The issue was the health department would not permit them to administer the booster shot except on certain designated days. I would have to go online to find out when those days were. The pharmacy said that they could not tell me when the NoraVax booster shot would be administered. 7. I replied that my primary care physician had faxed over a prescription for me to receive the booster shot. I was informed that a doctor's prescription didn't matter; they could only give the booster shot on the days designated by the health department. I would need to keep checking their website to determine which days those would be. 8. The pharmacy lists the availability of the Covid-19 vaccines for two-week periods. I have yet to see the NoraVax available. 9. On the pharmacy's website, there is a warning that if an individual has previously suffered an adverse reaction to a Covid vaccine, that individual would not be permitted to receive that booster shot at the pharmacy. This means that regardless if I finally found a day when the pharmacy was offering the NoraVax, I would be denied it because I went into anaphylactic shock from the second Moderna shot. I cannot find a way to receive a booster shot. The area hospitals do not carry it. The only pharmacy that does have it in stock is not permitted to administer it except on the days designated by the health department. Even
3days post vax pt exp swollen, tenderness, redness @ inj site;noted on f/u visit
Left arm swollen, red, and warm to the touch. Fingers on left had are tingling slightly. No Dr. Seen