chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vaccination was administered subcutaneously rather than intramuscularly.  There was no immediate reaction noted.  The patient was consulted to contact the pharmacy if any reactions did occur and the prescriber was notified of the error.
Hep B #3 given but not ordered. Discovered this date 6/6/03. MD will repeat Hep B #3. No adverse event (injectin given 1/30/02). (Given too early at 4 months of age- Hep B #1 12/5/01). The follow up received on 7/2/03 states there was no adverse affect. On 6/6/03 it was discovered that MMR #1 had not been given or had been given but not charted correctly. It was also discovered that hep B #3 had been given too early. Repeat hep B #3 was then repeated.
they have reconstituted acthib with a sterile diluent that comes with the live vaccines, and administered it to a patient with no reported adverse event; Initial information received on 27-Sep-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age and unknown gender patient and the reporter stated they have reconstituted HIB (PRP/T) vaccine [ACT-HIB] with a sterile diluent that comes with the live vaccines, and administered it to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On an unknown date, the patient received an unknown (total) dose of suspect HIB (PRP/T) vaccine,  Powder and solvent for solution for injection (strength, lot number, expiry date: unknown) not reported via unknown route in unknown administration site for immunization and they have reconstituted acthib with a sterile diluent that comes with the live vaccines, and administered it to a patient with no reported adverse event (product preparation error) (unknown latency).  Action taken with haemophilus type B (HIB) vaccine (ACT-HIB) was not applicable.  Outcome: Unknown.    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 and Regulatory Authority 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.
Waking up in the middle of night with terrible fiver (feeling extremely cold while in reality burning up). Headaches. Fatigue.
Pt devel intermittent paresthesias in both arms, hands, & fingers p/recvd flu vax; pt also exp soreness, achiness, & a heavy feeling in both arms as well as the shaking of 1 hand from time to time;
It started with the body aching on Friday (12/24/21)and on Saturday my lower back was hurting so bad I couldn?t sit, stand or do anything and then on Sunday it was my upper back by my right shoulder, like a baseball had grown there and then Sunday night I started getting dizzy so dizzy I was nauseous and then Monday very sick to my stomach and no appetite.  Today Wednesday 12/29/21, I still am dizzy and have an upset stomach and no appetite.
had my second shot 3 days ago and my headache is just getting worse; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (had my second shot 3 days ago and my headache is just getting worse) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced HEADACHE (had my second shot 3 days ago and my headache is just getting worse). At the time of the report, HEADACHE (had my second shot 3 days ago and my headache is just getting worse) outcome was unknown.            No concomitant medications were provided.  No treatment information was provided.
lots of nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "heart disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "lots of nausea".  Additional Information: The patient was due for second dose on 26Mar2021 and she pretty much have decided not to get the second shot. The patient was 72 (unit: unknown) and anyone she have talked to have had significant side effects and that scared her. It's her fear. The patient was asking if she will have the same event after the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Bilateral injection sites red, burning, itching and swollen superficial scratches right arm. Immunization records were not provided at time of visit. Monitor sites.
Patient did not understand until after administration of Tdap that it included pertussis vaccine. No adverse effect observed, but Patient VERY upset about additional components.
I started having swelling and discomfort in my right arm pit area; Discomfort in right arm pit area; Discomfort at the injection site; Booster; This is a spontaneous report from a non-contactable nurse regarding a patient. A 45-year-old non-pregnant female patient booster dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: EW0180, Expiry date: unknown) (age at the time of vaccination was 45 years, patient was non-pregnant at the time of vaccination), via intramuscular administered in Arm Right on 01Oct2021 at 10:30 as dose 3 (booster), single for COVID-19 immunization. The patient's medical history included blood pressure abnormal treated with unspecified blood pressure medication, penicillin allergy. The patient's concomitant medication included unspecified medication for blood pressure. 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. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EH9899), via intramuscular administered in Arm Right on 07Jan2021 at 08:00 as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EL3302), via intramuscular administered in Arm Right on 29Jan2021 at 08:00 as dose 2, single for COVID-19 immunization. On 02Oct2021 at 13:00, the patient started having swelling and discomfort in her right arm pit area. The patient had the usually discomfort at injection site but the swelling and discomfort in her right arm pit was a side effect that she didn't experience with her first or second dose. The patient had notified her employee health department as well. The events didn't result in physician or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swelling and discomfort in right arm pit area, discomfort at the injection site was resolving at the time of this report.   No follow-up attempts were possible. No further information was expected.
Approx. 3 hrs after injection: vomiting, chills/fever 101.2 F, headache, hives on face and neck. Denied photophobia, dizziness, tinnitus, paresthesia, or shortness of breath. Symptoms continued x 24 hrs. Seen by PCP next day 9/18/02. Rx: Benadryl. Pain and redness at injection site.
This spontaneous report was received from a physician via a company representative refers to a male patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL intramuscular (dose and lot # were not reported). On an unknown date the patient experienced postural orthostatic tachycardia syndrome after receiving GARDASIL. The outcome of this event was reported as recovered/resolved. This is ine of several reports received from the same reporter. Additional information has been requested.
Received Flu shot in upper back side of left arm involving the ulnar nerve on 11/21/00. By morning of 11/23/00, there was severe pain in my left arm and hand with partial paralysis of both and is continuing to present. The pain in my arm had progressed to the point of not being able to sleep. The MD prescribed steroids and ibuprofen but did not help even with wearing a sling. All the various doctors I have been shuffled to, agree that I have ulnar nerve damage but don't seem to have a clue as to how to treat me. The original doctor stated he had never had this happen and had no idea how to treat me. I've had Flu shots for 15 years without even have flu symptoms as a result of the shot! The MRI, I had approx. 2 1/2 weeks ago, dispelled the theory of my ruptured disc that I had done in 1983! When I walked into that clinic on 11/21/00, there was not one thing wrong with me. I was working and didn't even take an aspirin unless my head was falling off. Needless to say, I lost my job and most of the use of my left hand and arm. I have been to more doctors in the last 7 months than I have in my whole life. I was also prescribed Neurontin and finished this medicine even though it kept me light-headed and dizzy until it was finished. It did nothing for the pain nor bring us any closer to a solution. Then he prescribed more Neurontin and Vioxx but taking Neurontin 3 X a day, kept me feeling as if I was walking in the clouds, continually. Then he stopped the Neurontin and prescribed amitriptyline to be taken at bedtime, as it makes you tired. I was referred to an infectious control doctor. Then my regular doctor prescribed Carbamazepine and he wants to do blood work to see if any of these medications have affected my liver or kidneys. My doctor has now put me on Celexa Citalopram Hbr for the next month and he also gave me a prescription for Valium to take before the MRI to calm me down but I did not take this. The other medication made me sick to the point of hanging over the commode several times. Cancelled all my appointments with this doctor because nothing seemed to be doing any good. Follow up: received flu shot in upper back side of left arm involving the ulnar nerve on 11/21/2000. By morning of 11/23/00, there was severe pain in left arm and hand with partial paralysis of both continuing to present.
Initial symptoms (within 24 hours)- itchy, pain around area around vaccination site. Delayed symptoms (7-10 days after shot)- itchy, mild discomfort/pain, redness, warm to the touch, and Large welt/swelling around vaccination site.
shingles after 1st dose; This case was reported by a consumer via interactive digital media SHINGRIX and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In August 2021, between 3 and 4 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient reported that, had received one of the two part Shingrix shot in 2021, it's been about three months since first dose. At the time of reporting, the patient have shingles.  The patient asked when or if should he/she take second shot.
Chills started 9/14/10 - same day as vaccine R arm welted from shoulder to elbow headache, off-balance. Broke out in a sweat later in evening - next day exhausted but felt better.
Pt came in 3 days (11/4/13) after getting vaccination with complaint of severe soreness. When looking at injection site - area is swollen, red and warm to the touch - advised pt to see MD.
Dose administered past the 12 hr mark, vial was exposed to room temperature range for 15 hrs; No adverse event; A staff member gave 2 Moderna Covid-19 Vaccine, Bivalent booster shots past the 12 hr mark.; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (A staff member gave 2 Moderna Covid-19 Vaccine, Bivalent booster shots past the 12 hr mark.), PRODUCT STORAGE ERROR (Dose administered past the 12 hr mark, vial was exposed to room temperature range for 15 hrs) and NO ADVERSE EVENT (No adverse event) in a 58-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (A staff member gave 2 Moderna Covid-19 Vaccine, Bivalent booster shots past the 12 hr mark.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered past the 12 hr mark, vial was exposed to room temperature range for 15 hrs) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (A staff member gave 2 Moderna Covid-19 Vaccine, Bivalent booster shots past the 12 hr mark.), PRODUCT STORAGE ERROR (Dose administered past the 12 hr mark, vial was exposed to room temperature range for 15 hrs) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (A staff member gave 2 Moderna Covid-19 Vaccine, Bivalent booster shots past the 12 hr mark.) and PRODUCT STORAGE ERROR (Dose administered past the 12 hr mark, vial was exposed to room temperature range for 15 hrs).    No concomitant medication were reported.   The vial was initially stored in the refrigerator on 22-Sep-2022 at 5:15p and vial was opened for use on 22-Sep-2022 at 5:30p. The vial was first punctured on 22-Sep-2022 at 5:30p. The vial was stored post puncture at Room temperature. The vial did not undergo any temperature excursions. The vial was exposed to room temperature range for 15 hrs.  No treatment information was provided.
Patient arrived to ED with c/o breathing difficulty and SOB.  Symptoms also include coughing and fever.  Patient expired on 01/31/2022 d/t Respiratory Cardia cessation secondary to Covid.
Near syncopal episode approximately 2.5 hours after vaccination. Sudden onset of dizziness, nausea, and diaphoresis. Was admitted to ED and observed overnight. Full cardiac work up was done and shown to be within normal limits. I have no pre-existing conditions and considered to be a healthy adult.
Second dose given to an unknown patient at 21 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given to an unknown patient at 21 days) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given to an unknown patient at 21 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given to an unknown patient at 21 days) outcome was unknown. Not Provided      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.
Jan 8 vaccine night: left arm pain that resolved next day Day 6 post-vaccine: severe left arm and left axillary pain  Day 8: arm swelling, injection site localized erythema < 1 inch. Arm firm with significant pain  Day 9: injection site urticaria like rash spreading approximately 3 inches wide, persistent arm swelling and firmness with significant axillary pain and tenderness  Day 10: cutaneous patch of erythema observed on left upper chest near axilla with warmth and persistent arm and axillary symptoms  Day 11: coalesced cutaneous discoloration upper left chest and axillary region with persistent arm and axillary pain  Day 12-13: cutaneous changes very slowly fading and arm pain improving, axillary pain persistent
Information has been received from a physician and a registered nurse (RN) concerning a 32-month-old white male with no medical history who on 22-Oct-2001, was vaccinated SC in the right thigh with the first dose of varicella virus vaccine live (Lot #639128/0567L). There was no illness at the time of vaccination. The physician reported that on 05-Jun-2003, the patient had a moderate outbreak. The RN clarified that the moderate outbreak was a pruritic rash that started on the patient's arms and was eventually all over. The patient was seen by the physician on the same day. On 12-Jun-2003, the patient's pruritic rash resolved. The patient's brother also developed a papular rash and pruritis after being vaccinated with the first dose of varicella virus vaccine live (WAES #0306USA01066). Additional information is not expected.
I tested positive for COVID-19 on 11/22/22. I went in to be checked for AFIB and they did a COVID-19 test and I ended up testing positive. The only symptom I had was a sore throat. My heartrate was very high, so they hospitalized me for four days. They prescribed ELIQUIS, metoprolol, and amiodarone.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old child patient and unknown gender. On 22-JUL-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot H020901, expiration date 05-JUL-2015) (dose, route, were not reported). No adverse effect was reported. The outcome of events reproted was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Redness & swelling in (R) arm within hours of shot - Temp 102, chills, tremors, fatigue, diarrhea redness and swelling from (R) axilla to mid forearm treated with KEFLEX and antihistamine.
I received the shot on Friday and the next day on Saturday I started getting a headache and every day since then I have had a headache that is constant 24 hours a day. It is now 5 days in a row, It just won't go away
Left breast hurts; Underneath the nipple its been sore; Breast tender to touch or if  move arm; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 03Aug2021 at 14:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid disorder. The patient had no known allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included thyroid (ARMOUR THYROID) from an unknown date for thyroid disorder and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 04Aug2021 at 05:00, the patient experienced left breast hurts. Underneath the nipple it been sore and tender to touch or if she moved her arm. It was started the very next day and had not gotten better. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of event left breast hurt, underneath the nipple it been sore and breast tender to touch or if move arm was not resolved at the time of this report.
w/in 4 hrs of vax mom noted pt pale, hot to touch, t105 R tonic/clonic sz; pos incontinent of urine/stool; neg cyanotic, pos post-ictal x 1-2 hrs; no MD assistance sought;
Reported feeling faint during observation period.  Placed on cart and provided ice pak.  Reported feeling fine after 5 minutes.
itching/burning from neck down to chest; rash is not red or bumpy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching/burning from neck down to chest) and RASH (rash is not red or bumpy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.    Co-suspect products included non-company products DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL N) for an unknown indication and CORTISONE for an unknown indication.    The patient's past medical history included No adverse event.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL N) (unknown route) at an unspecified dose and CORTISONE (unknown route) at an unspecified dose. On 17-Feb-2021, the patient experienced PRURITUS (itching/burning from neck down to chest) and RASH (rash is not red or bumpy). At the time of the report, PRURITUS (itching/burning from neck down to chest) and RASH (rash is not red or bumpy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.