chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness, inflammation, tender to touch (Rt arm).  Warm to touch.  Treated with TYLENOL, BENADRYL.
having problems with sleep-flying; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sleep disorder in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sleep disorder (Verbatim: having problems with sleep-flying). The outcome of the sleep disorder was not recovered/not resolved.   It was not reported if the reporter considered the sleep disorder to be related to Shingles vaccine.     It was not reported if the company considered the sleep disorder 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 shingles vaccination and now had problem with sleep flying. The follow up would not possible, as no contact, details were available.
Patient's mother called and asked us if she needed to come in and have her son checked. he had been running a fever of 104.1 rectally and he had just had his vaccinations the day before. We had him come in and he was checked by PAC; he saw this to be a vaccine reaction. He suggested that she keep on on tylenol or ibuprofen to keep the fever down.
I got a few blood spots in my inner elbow region soon after and I wasn't sure if it was related.  Also, I normally don't bruise easily but I got a bruise on my right top part of thigh 2 days after.
Ulnar neuropathy - pain and tingling in left elbow to pinky and ring finger   Prednisone Ortho appointment scheduled
pt c/o loose stool w/orange tinted mucoid component 24hr p/vax ongoing for 1wk;lower abd cramping noted;
Patient was given Afluria influenza injection. As bandaid was being applied to injection site patient slouched over in chair and lost consciousness for approximately 10-15 seconds. Patient was given water to drink and cold compresses were applied to forehead and both wrists. Patient appeared pale after event with some perspiration on forehead. Prior to immunization patient reported no reaction in past to immunizations. After adverse event patient reported that he had passed out before during a blood draw and thought he had experienced a seizure during that episode. Patient was held in immunization area and supervised for 20 minutes and then walked off on his own after he confirmed that he was doing fine.
flu-like symptoms:  chills, fever, etc. Soreness at injection site; extreme fatigue
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 21-SEP-2012, patient received improperly stored VARIVAX dose 2, from lot # 0610AE (dose and expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax & 2-3min p/vax became pale & passed out p/vax;skin remained dry-BP & pulse ok;responded to stimuli immed;
At 7pm I started to get very tired. I had been running some errands at the local stores. When I got home, I felt very tired. I had a smoke and my lungs started hurting. This is unusual. I laid down for about an hour and when I got back up to get a glass of water, I was short of breath. My lungs feel about a 3 on the pain scale. Planning to just lie down for the night and reassess in the morning how I feel.
An attorney reported that a male child who was healthy at birth received series of DTaP, Hib, hepatitis B, and IPOl vaccines as well as Orimune, MMRII , Influenza virus, and Varivax vaccines from birth through 14 months of age. It is alleged that the child now 5 years of age, subsequently developed Thimerosal-induced mercury poisoning. No further information was available at the date of this report. Theimersol induced mercury poisoning was considered medically important. The follow up states the child, now five years of age, developed "toxic neurological effects of mercury poisoning including injuries, illnesses, and disabilities." According to the legal complaints, the child's injuries are "severe," and he has "been permanently injured."
8cm x 7cm erythematous, warm area at site of injection - also firm - tender to touch - Ibuprofen, cold compresses and antibiotic given.
Client received 2 immunizations. Was walking back out to waiting room with his mother and fainted. Nurse helped him to floor. Legs were elevated. Client came to and was offered water. Sat in clinic for 15-20 minutes and then went home with his mother. Nurse called and checked in later and mother reported client was fine.
Approx. 5 min after vaccination, client fell in clinic hallway, hitting her head on the wall on the way down. Presumed syncopal episode - HA, nausea, and visual changes.
Child was given VARIVAX and MMRV together. No symptoms at present. Merck called to observe for local reaction or any symptoms.
I felt sick like the flu and it lasted for about four days; It was like headache and aching like I had the flu; It was like headache and aching like I had the flu; This is a spontaneous report received from a contactable Consumer (Patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and batch no/lot number: EL9263) via an unspecified route of administration on 29Jan2021 04:00 in the morning (at the age of 77-years-old) as single dose for COVID-19 immunization. The patient medical history was reported as hypothyroid. Concomitant medications included levothyroxine. Patient experienced I felt sick like the flu and it lasted for about four days and It was like headache and aching like I had the flu in 2021. It was reported that, Consumer stated I had vaccination, I thought I was supposed to call and just report any adverse effects from the vaccination. I had the vaccination on the Friday night of 29Jan (not clarified) and about 4:00 in the morning, I felt sick like the flu and it lasted for about four days. That's pretty much it, it was like headache and aching like I had the flu. Treatment: Consumer stated, No, once I got out, I felt like it has got better and it felt just like flu and I thought, well at least it doesn't feel as bad as the real thing is (not clarified further). No, I didn't, I think I might have taken some Tylenol. The outcome of the event I felt sick like the flu and it lasted for about four days was recovered on an unspecified date in 2021.while other was unknown.   Follow-up (12May2021): Follow-up attempts completed. No further information expected.
administered expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Patient with history of 4 COVID vaccines who admitted with complications from COVID and detected PCR.  Provider d/c note:  "Patient is a 61-year-old male with a history of end-stage chronic obstructive pulmonary disease, hypertension, obesity, chronic anemia who presented to the emergency department with difficulty breathing.  He recently was treated for community-acquired pneumonia, had just gotten home and then started feeling sick again and presented back to the emergency department.  Found to have COVID infection, placed in quarantine and given remdesivir, IV steroids.   Patient continues to require increased oxygen from his home baseline 2 L (previous that was only using oxygen at home and he was ambulating or working hard, using here continuously).  He continued to improve during his hospital stay, eventually saturating in the high 90s at rest while on oxygen, did not desaturate when he took the oxygen off at rest; did desaturate when he took the oxygen off while he was shaving in the bathroom"
Approx 10min p/receiving the inject pt developed painful, blotchy, warm, local rxn 3in diameter @ inject site; Sx subsequently resolved;
After 48 hours, I was experiencing mild chills and body aches off and on for 2 days.
This spontaneous report as received from a pharmacist refers to a 72 year old female patient. The patient's medical history included shingles which affected her left eye (on an unspecified date) and psychosis. None drug reactions/allergies were reported. Concomitant therapies included DEPAKOTE and risperidone. On 12-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX (subcutaneous, lot # K020187, expiration date 27-JAN-2016, dose was not reported). On an unknown date in May 2015 (reported as shortly after receiving ZOSTAVAX the patient complained of feeling groggy and her left eyelid has been sticking (which was similar to what she experienced when she originally had the shingles). The patient saw an eye physician who suggested surgery, but the patient declined. No treatment was given for the adverse events. The outcome of the adverse events and the vaccination with ZOSTAVAX was not reported. Additional information has been requested.
extreme hives on body; first night hard woke up with a hard time breathing; This is a spontaneous report from a contactable consumer (Patient). A 17-years-old (non pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EN5318), via an unspecified route of administration, administered in arm left on 16Feb2021 (at the age of 17-years-old) as single dose for covid-19 immunisation at workplace clinic. Medical history included anxiety. Patient had known allergies as she got a rash from Sulfa drugs. Concomitant medication included (other medication in two weeks) fluoxetine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Solution for injection) on an unknown date (at the age of 17-years-old) for COVID-19 immunisation. Patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient did not have COVID-19 and the patient not been tested for COVID-19 post vaccination. On 16Feb2021, patient experienced first night hard woke up with a hard time breathing and extreme hives on body on 20Feb2021. Therapeutic measures were taken as a result of the events included Benadryl. The outcome of events was recovered on an unknown date in 2021.  Follow-up (13May2021): Follow-up attempts are completed. No further information is expected.
Second dose given 6 days early (22 days instead of 28 days). No adverse event reported.
Information has been received from an investigator concerning a 15 month old who received vaccines on 9/2/00 as part of a post-marketing safety surveillance trial. On 9/25/00, he presented for otitis media where the physician noted that the subject had possible bruising on the chest. The physician speculated that this may have been secondary to trauma. On 9/29/00, he had more bruising and was brought in by his parents. He was hospitalized and treated with IV immune globulin. He was discharged on 10/2/00. The next day, he was seen and his platelet count was 295,000 cells/mm3. Both the investigator and the medical monitor agree that idiopathic thrombocytopenic purpura (not expected) was 'possibly related' to either Prevnar or other vaccines administered.
This spontaneous report was received from a medical assistant and refers to multiple unknown patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA, (dosing details and route of administration unknown) (lot # M036459 with expiry date 18-JAN-2018 (also reported as 08-JAN-2018); lot # M039202 with expiry date 11-MAR-2018; lot # M018767 with expiry date 01-FEB-2018) for prophylaxis. Medical assistant did not know which of the vaccine lot numbers were administered. The administered doses of VAQTA experienced a temperature excursion of 47 degree Fahrenheit (F) to 77 degree Fahrenheit (F) for a time frame of 50 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no Product Quality Complaint (PQC) involved. No additional information was provided. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA001442: Original Case: 1706USA001442.
Episodic right hand, ring finger itchy and swelled and will turn purple at times if she over uses it. Sometimes if feels like it gets hard and swells. Noted to occur 30-45 minutes post receipt of vaccine
Narrative:  80yo male patient's son called facility to report that pt was found down around 0300 on 6/18/2021 unresponsive. Pt was taken to Hospital. Son reports he was diagnosed as having a massive stroke. Pt then died on 6/21/21 at same hospital. Pt had received two covid19 vaccines on 2/10/2021 & 3/12/2021. Death unrelated to covid19 vaccinations.
expired dose Fluzone HD administered, no AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA268361, 2019SA268346, 2019SA268355, 2019SA268356, 2019SA268357, 2019SA268358, 2019SA268359 and 2019SA268360 (same reporter).  This case involves a 74 years old male patient who received 0.5 ml dose of expired vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UI994AA, Exp. Date 09-Apr-2019) via intramuscular route in the left deltoid, on 13-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse reactions were reported.  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.  List of documents held by sender: none.
102.1 fever, vomiting, nausea, chills, sweating, joint pain, headache
Nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 23Mar2021 12:00 (Lot number: EN6206) at the age of 58 years as dose 1, single and intramuscular, administered in arm left, administration date 13Apr2021 11:30 (Lot number: EW0161) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; FENOFIBRATE; VITAMIN E AND VITAMIN C; VITAMIN D3; ASPRIN; COQ 10; GARLIC & PARSLEY [ALLIUM SATIVUM OIL;PETROSELINUM CRISPUM OIL]. The following information was reported: NAUSEA (non-serious) with onset 24Mar2021 04:00, outcome "recovered" (2021), described as "Nausea". Therapeutic measures were not taken as a result of nausea. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient had not been tested for COVID-19. The patient had no known allergies.   No follow-up attempts are possible. No further information is expected.
warm to the touch; Itchy arm; hard lump on arm; red 4-5 inches in diameter; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE SWELLING (hard lump on arm) and VACCINATION SITE ERYTHEMA (red 4-5 inches in diameter) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for Covid-19 Vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included LISINOPRIL, AMLODIPINE and ALENDRONATE SODIUM (ALENDRONATE).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE SWELLING (hard lump on arm) and VACCINATION SITE ERYTHEMA (red 4-5 inches in diameter). At the time of the report, VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE ERYTHEMA (red 4-5 inches in diameter) outcome was unknown and VACCINATION SITE SWELLING (hard lump on arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Consumer states the discomfort wasn't unbearable but she did take a Zyrtec and iced it to relieve the feeling.
Recipient had a prior history of the feeling of a lump in his throat, narrowing of his throat and dry throat with his first dose of Pfizer COVID-19 vaccine. This resolved with oral Benadryl at home.  Prior medical history included COVID disease in January, 2021. Due to his history, he was vaccinated next to our ambulance with physician and EMS team in attendance. Approximately 5 minutes after vaccination, recipient began complaining of dryness of the throat and feeling a lump in his throat without any compromise in breathing. Approximately 9 minutes post vaccination, he complained of a progression of his swallowing symptoms, swelling and pressure feeling (periorbital and in the malar area) of the face. He did not complain of dyspnea. Due to his symptoms, he was administered 0.3 mL of epinephrine IM at 10:39, followed by diphenhydramine 50 mg IM approximately 1-2 minutes later. Symptoms seemed to remain static, with treatment, with the exception of post-epinephrine shakiness and complaints of tingling of his feet. Initial vital signs were: Pulse 90, Respirations 20, BP 148/84 and SaO2 of 99. Vital signs and SaO2 remained stable.  A transport ambulance was notified and recipient was transferred to the care of EMS for further treatment and observation.
fully vaccinated (pfizer, 2/16/21, 3/15/21); symptom onset 8/4/21
CLOTS WERE 4 INCHES LONG/BIG; PROFUSE NOSE BLEED; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and Expiry: Unknown) dose was not reported, frequency 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced profuse nose bleed a couple days after receiving the vaccine. The nosebleed lasted for 1 and 1/2 hours and had to go to the emergency department due to the amount of blood and length of time the patient nose was bleeding. At the emergency department cauterize was done in order to stop the bleed. The patient reported that clots were 4 inches long/big. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from profuse nose bleed, and the outcome of clots were 4 inches long/big was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210913219-covid-19 vaccine ad26.cov2.s-clots were 4 inches long/big, profuse nose bleed. 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).
Patient entered lobby after 1st Moderna vaccine accommodated by daughter for monitoring. This nurse asked patient three times during monitoring if she felt fine. Patient responds yes each time. Once 15 minutes patient was released with daughter and walked to car with walker. At 1410 this nurse was called out to car to assess patient due to n/v. Vitals were obtained T-99.0, B/P 148/96, R-18 regular and at ease, P- 96, O2-96 at room air. Dr. consulted and this nurse was instructed to patient into office to be evaluated by provider. With stand by assist from 3 LPN's patient walked into building with walker. Once entering lobby patient fainted and was assisted slowly to ground with one nurse behind her and one on each side. Patient awoke 30 seconds later. Physician came to scene of accident, vitals were obtained B/P- 140/88, O2-97% at 3 L of oxygen, P-92, no Temp obtained, squad called and in route. On scene approx. 1420 squad arrived. Paramedics took over care at that point. This has been reported to CDC
Patient has had severe muscle and joint pain since her second vaccination.  The pain started in her legs and knees and then moved to her shoulder then her wrist, then her back and back to the wrist and then shoulder.  The pain was so severe that Motrin wouldn't even help.  She ended up having to get on steroids starting July 4th.  The prednisone helped quite a bit, but as soon as she ended her steroids the pain came back.  We are now over 5 weeks from the injection and she is still in pain.
Acute Vertigo- dizziness, vomiting , could not walk unassisted- had to crawl down the stairs. Lasted approximately 24 hours
Signs redness itching, swollen hurts. time course 1/26/07 time 11:00am. Treatment Hydrocortisone cream USP 1%. Diphenhydramine (Benadryl) 25mg. Naproxen (Naprosyn) 500 mg.
Got vaccine #1 in left arm and a week later, got a red splotch on arm enclosed with a darker red raised rim.  Lesion lasted a week.  Got vaccine #2 in rt arm and got a faint pink area that I might have missed had I not looked for it.  Six months later got the half dose booster in left arm as right arm has a significant shoulder situation that I did not want to add to. As with previous vaccines, there was soreness and arm was swollen. With the booster,felt a little under the weather and ran a low grade 99 fever.  (Did not happen with previous shots.) Was in shower on day 2, and left arm  itched when I washed it. There is an irregular red splotchy area-- on large hive- like irregular lesion and several smaller similar lesions that itch.
Arm pain: onset 7/26/23 PM resolving at time of report Headache: onset 7/27/23 AM worsening at time of report Sore throat/lymph node pain/neck stiffness: 7/27/23 PM and worsening at time of report. Reporting as considered rare side effect.