chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered an expired ACT-HIB to a 6-month-old patient with no reported adverse event; Initial information received on 07-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 months old male patient whom had was administered with an expired haemophilus type B (HIB) Vaccine [ACT-HIB] to a 6-month-old patient 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 Ipol polio vaccine [Polio vaccine inact 3v (vero)]  On 27-Oct-2022, the patient received a  dose of suspect haemophilus type B (HIB) Vaccine Powder and solvent for solution for injection dose 0.5 ml lot UJ600AAB, expiry date: 20-Oct-2022 via intramuscular route in the right thigh for immunization, the patient had administered an expired act-hib to a 6-month-old patient with no reported adverse event (expired product administered) on the same day  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event administered an expired act-hib to a 6-month-old patient 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 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.
Patient was fully vaccinated. He was vaccinated on 12/18/20 with Pfizer BioNTech lot EJ1685 and on 1/6/21 with Pfizer BioNTech lot EJ1685. Patient tested positive for covid-19 on 3/23/21. Another collection for covid was sent to lab for testing. Pending results if variant. Patient's wife and two kids had covid as well but weren't vaccinated.
swollen throat and tongue; swollen throat and tongue; itching; This is a spontaneous report from a non-contactable pharmacist. A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the left arm, on 07Apr2021 (lot number: ew0151), at age 27 years old, as dose number unknown, single, for COVID-19 immunisation, at a hospital. Relevant medical history and concomitant medications were not reported. Relevant medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination, and it was unknown if he has been tested for COVID-19 post vaccination. The patient had no other medications in four weeks. On an unspecified date in 2021, the patient experienced swollen throat and tongue, and itching. Treatment for the events included Benadryl. The patient recovered from the events on an unspecified date in 2021. The reporting pharmacist assessed this report as non-serious.  No follow-up attempts are possible. No further information is expected.
Syncope episode resolved within 10-20 seconds.  She slumped and was caught, never falling or striking her head.  She was observed supine for 1/2 hr then sitting for another 15 min by NP and had no complains except localized arm pain after that.  MOC was present and informed throughout the event.
Guardian states after received shots and walked to the vehicle patients (rt) nostril began to bleed and bought patient back inside clinic. Per guardian states filled up one tissue with blood. Had patient sit for 15 min. Pt denied any other symptoms.
BODY ACHE; COLD; SLIGHT WEAKNESS; HEADACHE; TEMPERATURE SOMETIMES RAISED UP TO 38.5 C AND DROPS DOWN; This spontaneous report received from a consumer concerned a 37 year old male. 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: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 15-JUN-2021 19:00 for prophylactic vaccination. No concomitant medications were reported.  On 16-JUN-2021, the subject experienced body ache. On 16-JUN-2021, the subject experienced cold. On 16-JUN-2021, the subject experienced slight weakness. On 16-JUN-2021, the subject experienced headache. On 16-JUN-2021, the subject experienced temperature sometimes raised up to 38.5 c and drops down. Laboratory data included: Body temperature (NR: not provided) 38.5 C. On 17-JUN-2021, Laboratory data included: Body temperature (NR: not provided) 36.6 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from temperature sometimes raised up to 38.5 c and drops down on 17-JUN-2021, and had not recovered from slight weakness, headache, body ache, and cold. This report was non-serious.
Patient received vaccinations on 12/10 and when she woke up on 12/13 she had a blotchy/splotchy rash on both arms. The rash was up and down both arms but was not itchy or painful.
pt recvd vax in AM by afternoon had high pitched, loud cry lasting few minutes followed by sleep for +-30 mins; then repeat crying; rash near site of DTP spreading up leg to trunk-welt like bumps;
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 29-JUL-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX lot # L000454, expiry date 06-JAN-2017 (dose and route were not reported). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recvd vax; mom states pt cried uncontrolable x 3-4 days; mom did not bring pt in a call until next appt; was fine; refused further immun;
Information has been received from a pharmacist concerning an approximately 63 year old female with a history of five different cases of the shingles who was vaccinated with single dose of ZOSTAVAX (Oka/Merck). Subsequently the patient broke out with a case of the shingles "one week later". The patient was treating herself with VALTREX. The patient sought unspecified medical attention. The patient did not have any diagnostic studies or lab work done. At time of the report the patient was recovered. No further information is available.
Around 5/16/2003 pt stated " I felt Flu like symptoms."   Around 5/19/2003  pt stated "I  felt chest pains."    on 5/21/2003 pt was transfered to institute for Cardiac Catheterization.
from neck to feet; it is still itching; Allergy/Hypersensitivity; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (from neck to feet), PRURITUS (it is still itching) and HYPERSENSITIVITY (Allergy/Hypersensitivity) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A, 002B21A and 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy. Concomitant products included METFORMIN, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), LISINOPRIL, SITAGLIPTIN PHOSPHATE (JANUVIA), EZETIMIBE (ZETIA), ARIPIPRAZOLE, NIFEDIPINE, ESCITALOPRAM, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (WIXELA INHUB), SALBUTAMOL SULFATE (ALBUTEROL SULFATE), TESTOSTERONE and MIRABEGRON (MYRBETRIQ) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced RASH PRURITIC (from neck to feet), PRURITUS (it is still itching) and HYPERSENSITIVITY (Allergy/Hypersensitivity). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Adverse event, at an unspecified dose and frequency; HYDROXYZINE for Adverse event, at an unspecified dose and frequency; PREDNISONE for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; AMMONIUM LACTATE at an unspecified dose and frequency and LEVOCETIRIZINE for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (from neck to feet), PRURITUS (it is still itching) and HYPERSENSITIVITY (Allergy/Hypersensitivity) outcome was unknown.            The patient went to several doctors (primary, kidney doctor, dermatologist and allergist) and none could solve the problem. About 3 weeks ago, patient had a biopsy and it returned that he had allergies to a medication. Caregiver said that the only thing that changed was the vaccination.Kidney doctor said to stop almost all the regular medications  Other treatment included Eucerin
Child's dose of hepatitis A given to an adult. No event-misadministration. No adverse event.  Misadministration of vaccine.  Pediatric vaccine given to adult.
Date and time adverse event started: pt was vaccinated on 3/11/21, she felt fatigued from 3/12-3/17, on later developed nausea and dizziness on 3/19 until today. recommended to call pmd in am for possible evaluation. symptoms could be from other medical conditions.
Pt was vaccinated in facility with a 15 min observation done. Pt ambulated to car with mother at side.  Pt and mother left site to go home when pt told mother "my lips feel numb". Mother drove pt back to facility and came in to tell us that her daughter was in the car and c/o mouth feeling numb. Myself, Site Leader and charge nurse went outside to car. Pt was sitting on passenger side of car A/Ox3.  Denies feeling sob,  headache and chest pain.  V/s obtained with inital v/s b/p 118/84, HR 83 O2 98% on RA. Advice pt that we could call EMS for further evaluation. Pt refused.  Wanted to go home and take benadryl if numbness presist. Verbalized understanding of risk and outcomes of monitoring  any other adverse symptoms.
Given Thursday, 11/17/05. On Friday and Saturday, 11/18/05 and 11/19/05, area size of silver dollar on left deltoid, reddened, hard and hot to touch as reported by patient. States she applied warm soaks - no medical care sought. Not observed by nurse. Area checked on 11/23/05; appears normal, left deltoid area flat, soft with normal skin tones - no marks.
Rash on arm around injection site, in the hour post site. Then fever, 100 degrees for 4 days & vomited, myalgia for 3 days.
Allergy to vaccine; Psoriasis; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergy to vaccine) and PSORIASIS (Psoriasis) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced ALLERGY TO VACCINE (Allergy to vaccine) and PSORIASIS (Psoriasis). At the time of the report, ALLERGY TO VACCINE (Allergy to vaccine) and PSORIASIS (Psoriasis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Patient reported non-serious events Allergic reaction to moderna shot and Psoriasis with HUMIRA 40MG/0.4ML (ADALIMUMAB).   On unknown dates, the patient experienced Allergic reaction to moderna shot and Psoriasis.  COVID-19 VACCINE MODERNA (COVID-19 VACCINE MRNA (MRNA 1273)) was also considered suspect.  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.
fever; chills; fatigue; pain at injection site; booster; nausea; Lay down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 01Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01), for Covid-19 immunization; Bnt162b2 (Dose:02), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Nov2021, outcome "unknown", described as "booster"; PYREXIA (non-serious) with onset 02Nov2021, outcome "unknown", described as "fever"; CHILLS (non-serious) with onset 02Nov2021, outcome "not recovered", described as "chills"; FATIGUE (non-serious) with onset 02Nov2021, outcome "unknown", described as "fatigue"; VACCINATION SITE PAIN (non-serious) with onset 02Nov2021, outcome "unknown", described as "pain at injection site"; NAUSEA (non-serious) with onset Nov2021, outcome "not recovered", described as "nausea"; BEDRIDDEN (non-serious) with onset Nov2021, outcome "not recovered", described as "Lay down".  Additional information: Patient reported being shivering despite cashmere sweater, puffy jacket and blanket. On 03Nov2021 patient was still experiencing chills and severe nausea causing him to lay down.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
He got his vaccine, and on Saturday 3/27/21 started having a slight fever, head cold/foggy head, slightly runny nose, loss of appetite.   Had a COVID test yesterday which was negative, but he still continues to run low grade fevers which was 100.  He has taken Ibuprofen for the symptoms.  His temperature today 4/1/21 at 8:58 AM is 99.5, his blood oxygen has been between 95-97%, his pulse and BP have been a little high as well, and his pulse is 90, his BP  was 141/99 yesterday at the store BP machine.  He has not called his doctor to report his reactions.
3-4 inch red, swollen, hot, painful induration on left posterior upper arm.
She got her vaccine, started getting really itchy and started to scratch and looked like her hives on the inside her left forearm.  She would scratch and it would come up again.  Then it started on the other forearm in the same place, and then on her back.  She then saw her doctor as she had at the wasteline of her underwear really bad, and on the lower stomach and looked like hives when she would scratch them.  When they went down they looked more like pimples.  Her doctor and thought that it was scabies as she had it in the top part of her buttocks, and then it went everywhere.  She was then sent to a dermatologist who said it was eczema, and she saw him 3-4 times, and it wasn't going away.  He put her on a cream, which did not help, and started using it twice a day.  She went back to see him again about 2 weeks later and it was not going away.  He continued her on the same medication and told her not to scratch it.  She was getting frustrated and said that he was too old, and saw another dermatologist.  She felt that it possibly could be eczema and she put her on another cream, and she did not know what it was.  The cream was a steroid cream which did not work, she wasn't any better.  She then wanted to do a lot of testing and when she went to get the blood work and Medicare was not going to pay for it, which she could not afford it.  She could not get the allergy testing done, and went to an allergist.  He did not know what it was, and was put on different creams, and then put on Prednisone as she could not take the itch anymore, which stopped.  She was on a short course of that, tapering dose and when she was finished with that the itch started again.  She continued with the rash.  The last time she saw the allergist he told her to do a chest x-ray to see if she has a tumor which causes an itch, which she is going for tomorrow.  The itch is really bad, and went to see her dermatologist and wanted to send her to another state, which she could not afford, and increased the steroid cream which takes the itching away for about 4 hours.  The cream gets her through the day and takes a shower, and then breaks out more.  She is considering to go to away as she is at the end of her rope, and does not know what else to do.  She is supposed to do a scraping of her skin to see what it is, and doing that this afternoon.  She is going to try and get some blood work tomorrow.    She says that the rash looks like chicken pox, and she scratches in the night during her sleep and has sores due to it.  The itching is driving her crazy.   She also has pimples in her hairline at the bottom and said it was not psoriasis.  She never had this type of reaction in her life prior to the vaccine.
upset stomach; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach) and DIARRHOEA (diarrhea) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach) and DIARRHOEA (diarrhea). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach) and DIARRHOEA (diarrhea) outcome was unknown.            No concomitant medications reported by reporter. No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Additional information received and Reporter details updated. On 14-Jul-2021: Follow up information received on 14 Jul 2021 and patient's demographics were updated,Dose 1 batch number 029L20A was added.
13:45 Patient stated feeling a little dizzy. Blood pressure 170/83 and Pulse Ox 97 and Pulse 66. Patient stated did not eat breakfast and did not take medicine. States he takes Larsten 125mg 1/2 tab once daily.  Patient given PB crackers and bottle of water. After a few minutes states feeling better.  Patient took medication and remained in Post observation area for 30 mins. V/S taken B/p 157/81 and pulse 67. Patient ambulated to car without and problems noted.
while giving a VARIVAX to a young child, they moved and a very small amount of VARIVAX dripped out instead of going in the patient.; No additional AE information; This spontaneous report was received from a nurse and refers to a young child patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. There was no information regarding the patient's allergies or drug reactions.   On an unknown date while a varicella virus vaccine live (oka/merck) (VARIVAX) (strength, exact dose, dose number, route and site of administration , lot# and expiration date were not reported) was giving to the patient for prophylaxis, they moved and a very small amount of varicella virus vaccine live (oka/merck) (VARIVAX) dripped out instead of going in the patient (incorrect dose administered). The nurse stated that she was knew it was not enough to matter but the parent was concerned. No additional adverse event was reported (no adverse event).
Vaccine given outside of schedule. Dose 1 administered on 12/21/2020. Dose 2 Administered on 1/7/2021 (Day 16)
patient states that his arm became very sore the day after receiving his shot, including difficulty raising his arm. It has persisted for at least a month so far with no resolve. He does state it is getting slightly better.  I did recommend he go see his doctor if the pain persists.
Patient was given SHINGRIX vaccine via subcutaneous route (incorrect) instead of IM route.  Patient has since suffered worsening redness, swelling, and pain at site of injection. Two days after vaccination, patient went to urgent care and was prescribed AUGMENTIN 875/125mg twice daily for 10 days. Patient also went to see PCP and size of reaction was measured and was told to use warm compress to affected area.
This spontaneous report as received from a consumer refers to a 66 year old female patient with Parkinson's, migraines, penicillin allergy, codeine allergy, darvon allergy and shingles. On an unknown patient had drug allergy or drug reaction with penicillin, codeine, darvon. The patient's medical history included cracked vertebrae from a fall. On 31-DEC-2013 at 9:00 AM, the patient was vaccinated with ZOSTAVAX (dose number, dose units, route, lot number and expiry date unknown) to prevent shingles. It was reported patient was on many unspecified medications. On 31-DEC-2013 by 10:00 AM, the patient experienced headache and it got worse by 2:00pm. She took a hydrocodone bitartrate and acetaminophen (manufacturer not specified). It was also reported that patient did not sought medical attention no treatment was given for adverse event. She feels that it was getting better now, but she still has a headache. The outcome of headache and headache got worse by 2:00pm was reported as not recovered/not resolved. No further information was reported. Additional information has been requested.
Neck in severe pain and stiffness  No particular side 20% movement  Unable to life head up or down or un rotation without severe pain.
Mid Sept 2008 rec'd smallpox vaccine, never scabbed but healed with large 2-in diam scar over the month and a half.  Early Dec with papular rash on arms, intense itchiness for 2 weeks.  Has had some soap changes and may be unrelated to vaccine.  Given antihistamine for itching.  No other symptoms
This is a spontaneous report from a contactable consumer, the patient. A 40-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8737) via an unspecified route of administration on 30Apr2021 at 15:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. It was unknown if the patient was pregnant at the time of vaccination. Concomitant medications were not reported. The patient previously received penicillin (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01May2021 at 07:00, the patient experienced headache, backache, chest pain (sharp pain in chest), and difficulty breathing deeply. The clinical outcome of the events headache, backache, chest pain (sharp pain in chest), and difficulty breathing deeply were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
high fever (102.8F).  Swealing and redness around injection site.  symptoms lasted for 3 days.  Patient was administered motrin and tylenol to reduce fever.
Patient states that after the 2nd dose she began to feel dizzy and the dizziness has not gotten better despite treatment from her primary care and physical therapy.
Extreme muscular pain starting in both arms and moving to both legs after 7 weeks.  After being very active before vaccine, now pain is so bad I can barely walk.