chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax; devel 11 pox on 20jun95;pt had been exposed to chicken pox at school 2 wks prior;25jun95 pt exposed again to chicken pox;3aug95 devel over 100 pox lesions which was verified by pt's md to be varicella;
This spontaneous report as received from a nurse practitioner and refers to a multiple unspecified patient's unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies and medical history provided. On an unknown dates the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB lot # M003658 with an expiration date 02-JUN-2018, lot# M036153 with an expiration date 31-MAY-2018 and lot# L016959 with an expiration date 12-MAR-2018 for prophylaxis. No adverse effects were reported. Administered doses of RECOMBIVAX HB experienced the temperature excursion between 32 degrees Fahrenheit and 35 degrees Fahrenheit for 4 days. There was no previous temperature excursion. A digital data logger was not involved.   This is one of several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1706USA004379: US-009507513-1706USA004378: US-009507513-1706USA004376: US-009507513-1706USA002585:
nausea; Vomiting; fatigue; loose stools12 hours following the vaccine, hadloose stools; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: ER8730) via an unspecified route of administration in the arm right on 27Mar2021 at 09:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and drug allergy ( allergic to sulfa drugs) . Concomitant medications included levothyroxine, liothyronine (NP THYROID). The patient previously took Chlorhexidine and experienced drug 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 27Mar2021, the patient experienced loose stools 12 hours following the vaccine and again had loose stools after 24 hours. On 28Mar2021 at 09:30, the patient experienced nausea, vomiting  and fatigue. The patient reported that, she had more diarrhea followed by extreme nausea and then vomiting and felt nausea all morning with extreme fatigue. Slept a great portion of the day and woke up the next morning feeling fine (48-hours later). The clinical outcome of the event loose stools 12 hours following the vaccine was resolved on an unknown date in 2021. The clinical outcome of the event nausea, vomiting and fatigue was resolved on 30Mar2021 at 09:30.  No follow-up attempts are needed. No further information is expected.,
Day of the shot my arm hurt a lot. The next day when I got up for breakfast I kept feeling like I was going to pass out. I laid on the floor of the kitchen several times to get blood to my head. I think I passed out once while on the kitchen floor. I lost control of my bowels. Once I was a bit ok I got up and went to the bathroom to try to clean up. Next thing I knew I was laying on my face on the floor of the bathroom covered with fecal matter. I eventually got up and was fatigued and sore for the rest of the day. The next day, other than the pain I still had at the site of the injection, I was fine.
4-6 cm redness left deltoid & soft tissue swelling - onset 48 hrs after vaccinations. T-97.5 PO.
Fever 104.2 p/DTP, occurred w/in 24 hrs of shot, very irritable;
BLOOD IN EYE; DO NOT HAVE TOTAL VISION IN LEFT EYE; This spontaneous report received from a patient concerned a female of unspecified age. Initial information was processed along with the additional information received on 06-MAY-2021. 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, batch number: unknown) dose was not reported, 1 total, administered on 05-MAR-2021 for prophylactic vaccination. Batch number was not reported. Per procedure, no follow-up would be requested for this case. No concomitant medications were reported. On 22-MAR-2021, the patient experienced blood in eye. On an unspecified date, the patient experienced losing vision in left eye and reports she has not yet got back complete vision in the eye. It was reported that, the patient would love to get compensated for all the physician visits, blood test, prescriptions, and time out of work. He also said that he knew when he signed for the vaccination that they are not responsible. He also mentioned that he would never get another shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from don't have total vision in left eye, and the outcome of blood in eye was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210504249 -COVID-19 VACCINE AD26.COV2.S- Do not have total vision in left eye, Blood in eye. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
arm hurt, swelled & red-temp terrible pain several days;pain resolved but redness persists;
MMR and Varicella ordred. PROQUAD and Varicella given.
Vaccinated 4/7/2021, 3/10/2021. Hospitalized with COVID 1/3/22.
Arm hurt; This case was reported by a consumer and described the occurrence of pain in arm in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received second dose of Shingrix and reported arm hurt.
This is a spontaneous report from a non-contactable consumer reported for his/her son. A male patient of an unknown age, gender and race received the second dose of Meningococcal Group B Rlp2086 at single dose for immunization on unknown date. Medical history and concomitant medication were not reported. The patient had received the first dose of the same vaccine on unknown date and he had a sore arm. On unknown date the patient experienced arm pain, swelling redness and fever  at 102. The patient received ibuprofen (ADVIL) and paracetamol (TYLENOL). The outcome of the events was unknown. No follow-up attempts are possible. No further information expected. Pfizer is Marketing Authorization Holder of Meningococcal Group B Rlp2086 in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of Meningococcal Group B Rlp2086 has submitted the same report to the regulatory authorities.
Orbital edema on the left eye; This case was reported by a nurse and described the occurrence of orbital edema in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On 25th October 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On 25th October 2019, less than a day after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced orbital edema (serious criteria GSK medically significant). The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the orbital edema was unknown.   It was unknown if the reporter considered the orbital edema to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient demographicdetails were not provided. The age at vaccination was not reported. On friday, the patient received Flu vaccine. On friday in the evening, the patient started to notice some orbital edema on the left eye, which increased in nature through the weekend. The patint received steroids as a treatment medication for orbital edema on the left eye. The patient was seen by provider in the afternoon of the day of reporting. No other visible symptoms.
approx 3yrs p/vax pt exp breakthrough chickenpox w/ more than 100 lesions noted. addl info requested
swollen injection site, tender,sore for 4 days, redness, rash on arm, headaches
All of the virus symptoms with the exception of blurred vision n couldn?t see for about ten to fifteen minutes. Temp. 100. Headache
Diagnosed with gout; having pain in right leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (having pain in right leg) and GOUT (Diagnosed with gout) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination.     Concurrent medical conditions included Gout (The patient was diagnosed with gout.).    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (having pain in right leg). On an unknown date, the patient experienced GOUT (Diagnosed with gout). At the time of the report, PAIN IN EXTREMITY (having pain in right leg) and GOUT (Diagnosed with gout) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications was provided. No treatment information was provided.   Reporter did not allow further contact
Pt experienced syncope after vaccine administration. Pt was altered for approx 1-2 min. Given water and laid with legs elevated. Refused juice or crackers. Vital signs stable.
I had just finished giving patient the last vaccine which was the Varivax heard then patient say "wow" and once I turned around he had fell. Patient stated he felt dizzy.
Pt has 2-3 raised spots on each ankle-says they itch and is treating with OTC BENADRYL cream and hydrocortisone cream.
Eye swelling, face swelling, inside right mouth swelling, high fever about 16 hours following injection
This case was reported by a physician via a sales representative and described the occurrence of not responding to therapy in a male subject aged between 40 and 49 years old who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  On unspecified dates the subject received 3rd dose, 2nd dose and 1st dose of Engerix B.  Approximately five months after completing the series of three vaccinations with Engerix B, the subject had a titer for hepatitis B surface antibodies drawn and was found to have not responded to vaccination; the specific titer levels were not known by the reporter.  At the time of reporting, the physician was still determining whether he would give additional doses of the vaccine and the event was unresolved.  No further information available per the subject's physician.
Health concern: Patient came in for his second covid vaccine around 9:35 AM.  Patient was roomed by Medical Assitant (MA). The MA  was administering the vaccine in the deltoid muscle in the left arm when the MA noticed that the vaccine was leaking from the syringe.The MA noticed that more than half of the vaccine was leaking down the patient's arm.  He immediatel reported incident to MA Supervisor. MA supervisor reported incident to the provider NP. The Provider found the guideline on the CDC for this particular incident.  She also called Moderna the manufacturer and they concurred with CDC's the guidelines. The MA's supervisor found that the needle that was used had a manufacturer defect. The needle did not tighten when screwed on the syringe.  The rest of the syringes from that box were examained and found to have a totel of 4 defective syringes.  The needles and syringes are provided by the state Department of Health Services. A new shipment arrives everytime the vaccines are ordered.    After receiving guidance from Moderna and reviewing the CDC guidelines, the patient received a second dose in the deltoid muscle of right arm, administered by a different MA. The lot number and  expiration are the following respecively 021C21A,  10/21/2021. Patient was observed in lobby for 15 minutes with no side effects noticed.
Severe pain in shoulder, involving tendons and possibly the joint,  Decreased range in motion.  Cannot lay on it, hard to get clothing on and off.
During the 15 min. observation period post vaccination this individual reported tingling in the back of her tongue and feeling hot. Reported no difficulty swallowing, and no difficulty breathing. Observed for 30 minutes and released following report if decreased symptoms.
INCREASED PAIN AND REDDNESS APPROXIMATELY 2 INCHES BELOW INJECTION SITE
Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (148871). The reporter is the patient.  A 72 year-old female 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: FATIGUE (non-serious), outcome "unknown", described as "Fatigue". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
micro colitis; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS MICROSCOPIC (micro colitis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COLITIS MICROSCOPIC (micro colitis) (seriousness criterion medically significant) and DIARRHOEA (Diarrhea). At the time of the report, COLITIS MICROSCOPIC (micro colitis) and DIARRHOEA (Diarrhea) had not resolved.            Concomitant Drugs Not Reported. 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.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a female patient of unknown age, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Colitis microscopic, which occurred after vaccination with mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed or treatments received. At the time of the report the event had not resolved. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a female patient of unknown age, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Colitis microscopic, which occurred after vaccination with mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed or treatments received. At the time of the report the event had not resolved. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
This is a 24 year old left handed male. After receiving his initial Moderna COVID-19 vaccination on 24 Jun of this year he noted some twitching around the left eye a few days to a week later. It became gradually worse and was interfering with the operation of a motor vehicle, then he noted tightness and muscle spasm of the left facial muscles and the left eye began closing involuntarily. No other neurologic symptoms were noted at the tim. There is no history of any toxic exposures prior to the onset of symptoms. He denies any significant headaches or cognitive issues. No history of viral illness, health issues, traumatic injury to the head or neck  prior to the onset of these symptoms. There is no family history of any movement disorders or other neurologic diseases. The symptoms have improved and nearly resolved recently. He was given a week of Sinemet treatment which he believes may have been beneficial. He had one concussion as a teenager from wrestling without any residual symptoms. He denies any mental health history, his mood has returned to normal at this point and he is not depressed, suicidal or homicidal at the present time.
A report has been received from a physician concerning a 1 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. It was reported by physician that a patient under 2 years given FLUMIST QUADRIVALNET which started on 24-Sep2014. The outcome of the event of Patient under 2 years given FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
03/05/2021 The day after my vaccine, in the morning I woke up with terrible joint pain and a slight fever. Overall, did not feel well. After sitting in the chair, I fell asleep quickly and everything felt extremely heavy. I had severe fatigue. These symptoms lasted for about two weeks long. I took Tylenol and Advil to see if it would help however they did not do much for the symptoms I experienced. I still am experiencing great fatigue in my day to day activities. I do not suffer from any fevers anymore. Just within the last 6 months which I have also had my other vaccinations, I have started to develop abscesses in my armpits that the doctor has given me doxycycline before. The abscesses have been going going away slightly however they are still present.
This spontaneous report was received from a physician via a company representative referring to a 12 year old male patient. The patient did not have a history of fainting (was stated by physician). Information about concurrent condition and concomitant medication were not provided. On an unknown date, the patient was vaccinated with the first dose (was reported as company representative believed) of GARDASIL 9 for prophylaxis (strength, frequency, route, lot# and expiration date were not reported). When the patient was administered GARDASIL 9, he was sitting and leaning forward, he fainted and fell to the floor and chipped his tooth. The outcome of events and causality were not provided.
Patient was given an expired Menactra , with no adverse event; Initial information received on 19-Apr-2021 regarding an unsolicited valid  non-serious case from a other health professionals   This case involves a 22 years old female patient who received an expired dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (0.5 ml, lot U6346AA and expiration date: 30-Aug-2020, frequency: once) via intramuscular route in the right deltoid for prophylactic vaccination on 19-Apr-2021 (expired product administered).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No concomitants were administered to the patient.  It was an actual medication error due to expired vaccine used (latency: same day).  Reported that caller asked what to do if an expired Menactra was given to a patient.  At the time of reporting, it was unknown whether the patient had any 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.
Burning, tingling, patastesia in arm, legs, feet, back...Inflammation of heart, fast heartbeat, arrithymia, insomnia, deep depression and anxiety, no urge to urinate, joint aces and pains, unable to function
Patient received vaccine and has had a red rash around the area starting the day after the vaccine. She said it has been itchy and hot to the touch.
Auditory and visual hallucinations, confusion, headache.  Symptoms waxed and waned for approximately 15 hours and were preceded by chills, mild fever, myalgias, malaise and anorexia.
p/ pt recv vax approx 8 hrs later pt exp 4 red bumps across body. 24 hrs later devel 4 more bumps at diff sites.
Patient developed generalized macular-papular rash on and off, high fever.  10 days after MMR, Varicella, Comvax and PCV no achiness.  Hospitalized at clinic. The discharge summary received on 4/5/04 states decreased appetite, cough, wheeze and otitis media.
Information has been received concerning a 10 year old male with allergic rhinitis, asthma and allergy to peanut butter who on 22-MAR-2001 was vaccinated with a dose of VARIVAX (Oka/Merck), lot Number # 635463/1147K). On 13-MAR-2005 the patient developed rash (1) side underarm. He was treated with Acyclovir 200 mg per 5cc. On 24-Mar-08, the adverse event was resolving. No further information is expected.
Patient became lightheaded and queasy. She laid down on the floor and her feet were elevated. She became more comfortable so she returned to a seated position and was given water to drink. After 30 minutes of observation the patient felt comfortable and left under the supervision of her mother (who attended the vaccination clinic with her).
emesis x1 after pushing away bottle and coughing, decreased feeds after that, fussy, slight increase in nasal congestion
Approximately 6 hours after the vaccine injection, symptoms began and then progressed over the next 24 hours: extreme fatigue, headache, body pain (muscles/joints), specifically aching/uncomfortable feelings in my left breast, left arm pit, left side of abdomen and left buttocks, cough (dry/tight), nausea and abdominal cramps, poor appetite, heart palpitations, dizziness, poor balance, achiness behind sternum. 8 days later some symptoms have lessened the following continues: Fatigue is still present, cough (dry/tight), left breast/chest achiness, dull ache behind sternum, mild heart palpitations, occasional nausea and occasional headache.