chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was administered Menactra that was expired by one day/No AE; Initial information was received on 10-Aug-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient (unknown age and gender) who was vaccinated with expired dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination (expired product administered)  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   It was an actual medication error case due to expired vaccine used. Vaccine was expired by one day.  Reporter stated that patient was set to come in and get re-administered but delayed.   At a time of reporting no adverse event 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.  There will be no information available on the batch number for this case.
This spontaneous report was received from an office manager regarding a 25 years old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-AUG-2018, the patient was vaccinated with the first dose of GARDASIL 9 lot number N020139 and 14-FEB-2020 expiration date for prophylaxis (dose, strength, frequency and route of administration was not reported), on 29-AUG-2018, was vaccinated with the second dose of GARDASIL 9 lot number N019104 and 03-FEB-2020 expiration date for prophylaxis (dose, strength, frequency and route of administration was not reported) and on 05-MAR-2019 was vaccinated with the third dose of GARDASIL 9 lot number R017249 and 04-MAY-2021 expiration date for prophylaxis (dose, strength, frequency and route of administration was not reported). No adverse effect reported.
weird reaction to my booster; itching bump forming on my wrist; received the vaccine on wrist; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (weird reaction to my booster), PRURITUS (itching bump forming on my wrist) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (received the vaccine on wrist) 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.    In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced VACCINATION COMPLICATION (weird reaction to my booster), PRURITUS (itching bump forming on my wrist) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (received the vaccine on wrist). In January 2022, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (received the vaccine on wrist) had resolved. At the time of the report, VACCINATION COMPLICATION (weird reaction to my booster) and PRURITUS (itching bump forming on my wrist) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.
Uncontrollable shaking/shivering after going to bed. happened several times until falling asleep. No further reactions, no soreness.
Horrible headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Horrible headache) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Horrible headache). At the time of the report, HEADACHE (Horrible headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
PMH  Vaccine 1/11/21 1/14/21 edema, pain, 6/10, more severe if laying on left side,l lymphadenopathy  Left axilla area with one node the size of a tangerine. When Motrin was taken for pain, Size of lymph node edema would somewhat decrease,  and then increase hours later. Symptoms have continued for 7 days . No other complaints
Currently experiencing brain fog. When I go to talk the words come out as jibbersh. My head feels like it's  in a cloud. This is after my first pfizer shot.
A report has been received from a Health Professional concerning a patient, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on an unknown date.  The patient was administered expired FLUMIST QUADRIVALENT. The outcome of the event of administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
The pt experienced redness and swelling which was fairly small at first, about the size of a silver dollar. After sleeping all night, the redness had grown considerably, almost whole bicep, and experienced flu-like symptoms.
Patient became unresponsive and difficult to rouse immediately after administration of vaccination. Patient was hypotensive (see flowsheet), diaphoretic, and required sternal rub to rouse. Upon arousal, patient oriented but lethargic. Followed commands. Nausea with emesis x3 between 10:00 and 10:40. Patient reports she hadn't eaten anything this AM prior to vaccination; patient's father also present and stated that patient has been stressed with school and likely didn't eat last night either. Patient tolerated approx 5 oz of apple juice with intermittent nausea. Reports stress from having two exams due this evening in chemistry and biology.  Patient given 4 mg Zofran in clinic at 10:15 with some relief. Patient advised to continue drinking fluids as tolerated throughout the day and eating small bites as tolerable. Encouraged to rest today. RN spoke with preceptor on site who deemed patient safe to return home. Patient felt comfortable ambulating to fathers vehicle and declined assistance of nursing staff or wheelchair.
Heart palpitations, leg cramps, alopecia, muscle weakness, joint pain, vivid nightmares, amenorrhea, thyroid stimulating hormone overproduction.
Information has been received from a RN concerning a 6 yr old male who was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt experienced breakthrough. Unspecified medical attention was sought. There was no product quality complaint. The reporter also indicated that the pt's brother developed breakthrough after vaccination with varicella virus vaccine live (WAES0504USA00025).  Additional information has been requested.
knot; painful (knot); red (knot; warm to the touch at the site of injection; headache; sore arm; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INJECTION SITE MASS (knot), PAIN IN EXTREMITY (painful (knot)), ERYTHEMA (red (knot), INJECTION SITE WARMTH (warm to the touch at the site of injection) and HEADACHE (headache) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 13-Jan-2021, the patient experienced HEADACHE (headache) and INJECTION SITE PAIN (sore arm). On 20-Jan-2021, the patient experienced INJECTION SITE MASS (knot), PAIN IN EXTREMITY (painful (knot)), ERYTHEMA (red (knot) and INJECTION SITE WARMTH (warm to the touch at the site of injection). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of UNK dosage form; ANTIBIOTICS ongoing since an unknown date for Adverse event, at a dose of UNK dosage form and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) ongoing since an unknown date for Adverse event, at a dose of UNK dosage form. At the time of the report, INJECTION SITE MASS (knot), PAIN IN EXTREMITY (painful (knot)), ERYTHEMA (red (knot), INJECTION SITE WARMTH (warm to the touch at the site of injection), HEADACHE (headache) and INJECTION SITE PAIN (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took acetaminophen(Tylenol), antibiotics and diphenhydramine ( Benadryl).
Pt received the PFizer COVID-19 vaccination and then three days later she developed general malaise, body aches, nausea, followed by a rash to her abdomen at the T6 dermatome on the Left side on 3/27/21.  I saw her on 4/4/21 and diagnosed her with shingles.  She reports a previous shingles event several years ago.  She continues to get new lesions and therefore was treated today with Valacyclovir and a prednisone taper.  Awaiting the outcome.
Redness, soreness, and swelling at injection site. 10/25 1:19 PM: Pt's mother called stating the night after she received her shots, Pt had a rash on her thigh around the injection site, and mother was concerned and took Pt to the ER around 9:00 PM. Physician said it was probably from the band-aid. Mother stated the rash has gone away but Pt has a red, warm, lump about the size of a 50 cent piece at the injection site. Mother has tried to cool wet wash cloth and hydrocortisone cream, but they have not helped. CR informed of  mothers reported and Pt received MMRV vaccine in that thigh. Per CR, give Pt ibuprofen per size and weight and apply ice with clothe in-between, if the area does not start to get better or gets worse to come in tomorrow for Saturday Clinic. Mother verbalized understanding and agreed to call with any further questions.
Local itching at injection site within 12 hours with duration of 7 days, for JEV #1 and JEV #2. Reports worsening of osteoarthritis in May and June following these vaccines. He has a prior history of osteoarthritis and asks if these vaccines could exacerbate this condition.
5 weeks daily: Sweats, Nausea, Light headed, Light sensitivity, headache, joint pain, myalgias
11 y/o male who developed cellulitis on the right arm following Meningococcal vaccine administration on June 8th, 2016. Lesion is warm, nodular and tender to touch. Patient's mother gave him BENADRYL that evening but the redness progressed so they came to the hospital the next morning. Patient was treated with Clindamycin 150mg 2 caps QID x7 days.
Thursday woke up with body aches, headaches, fever of 100 through Friday Saturday was better - But did have the COVID infection  earlier in the year.
Patient walked outside after waiting 15 minutes and felt like throat was closing and re-entered the building and went to paramedic.
Red bumps on hands and knuckles, few on the member's heels. Itchy, less red when under cold water. Onset was approx 2 weeks after vaccination. Member still has the bumps.
Patient administered vaccine and then felt lightheaded. patient laid on floor, did not fall. emergency responders checking vital signs with blood pressure low. patient stabilizing with level of consciousness returning to normal and blood pressure coming up within normal perfusion levels. Emergency transport is on site patient is electing to go to the hospital with them. Intravenous fluids have been started bolus administered. Patient transported via ambulance to hospital
I started swelling up in my legs while at work with chest pain and SOB. I took Nitro to help with chest pain. After awhile the chest pain continued even after third nitro pill. I called the doctor and went in the following day. While at the doctor I had blood work at the lab beside the hospital. I was also ordered to get an ultrasound. They were thinking the amlodipine could be a possibly so took me off and added Lasix and potassium. I took that for 3-5 days. I stopped taking Lasix and potassium in 5 days. Then I started swelling again with edema, high blood pressure 170/90, chest pain, and SOB. I called my doctor and told them what was happening. The doctor wanted to increase one of my meds. I called 2 days later stating that I was not feeling better so they advised me to go to the ER. While at ER, they checked my enzymes which came out negative. While at the ER, the ultrasound results showed that the bottom ventricles were hardened and not strong enough to push into the next chamber. I received IV Lasix while at ER and was discharged. I got back in touch with my cardiologist the next day which explained my issues with my heart. I have to take more Lasix 40 mg and potassium. I was also put on a fluid restriction of 2 liters a day. If I do have to go back with more issues, I would need a heart catherization.
9 sz for 45 mins - DIAZEPAM rectally and midazolam intranasally. 1st sz lasted for 5 mins - had 9 sz total over the course of 4 hrs. Was kept overnight.
feet were swollen up/legs were swollen up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PERIPHERAL SWELLING (medically significant), outcome "unknown", described as "feet were swollen up/legs were swollen up". The event "feet were swollen up/legs were swollen up" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: unknown results; coagulation time: unknown results; echocardiogram: unknown results; x-ray: unknown results. Clinical course: Call in January went in for a wellness check. Caller told doctor it had been more than 10 years and her doctor told her she had to get the pneumonia shot. A couple of days after the pneumonia shot caller's feet were swollen up, within 4 days her legs were swollen up.  She went back to doctor, sent for a blood clots in the leg test for both legs because both legs are swollen up. Can't get shoes on. Tests: Caller has had an echocardiogram, x-rays, orthopedic surgeons, more blood tests and no one can help, doctors can't help. Caller has spoken to people and no one can help. She has been up and down since January and no one can help. Caller is 80 years old, pissed, frustrated, could be dead.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
no additional AEs were reported; a patient received improperly stored vaccine.; This spontaneous report was received from a medical assistant, referring to a 12 months old patient of unknown gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On 14-DEC-2021 the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U024221 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck), expiration date reported as 04-OCT -2023, but upon internal validation established as 04-AUG-2023; 1 dose, route and expiration date were unknown) for prophylaxis (product storage error). No additional AEs were reported, no further information provided  Administered dose of varicella virus vaccine live (oka/merck)(VARIVAX) experienced the temperature excursion below 39.55 Fahrenheit degrees for 10 hours. There was no previous temperature excursions reported.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown date the patient was vaccinated with M-M-R II, via intramuscular route (incorrect route of product administration)(strength, dose, frequency, route, lot#  and expiry were not reported) for prophylaxis and no adverse symptoms reported. Product quality control issue was not involved.
TOOK 2 NAPS; SLOW MOTION; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 2021, the subject experienced took 2 naps. On 2021, the subject experienced slow motion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the took 2 naps and slow motion was not reported. This report was non-serious. This case, from the same reporter is linked to 20210432557.
I have developed severe Tinnitus since receiving the vaccine.  I have a constant, loud hum in both ears.  It is extremely irritating in normal and quiet environments.  Loud noise drowns it out.  The sound is high pitched like circadia bugs.
Patient called 05/21/2018 with a red rash to cheeks. No other s/s. Family will continue to monitor will call back if worsens.
fainted / was found unresponsive / reaction to vaccine; vomited; fever of 104; sweating; chills; nausea; diarrhea; abdominal pain; back pain; This case was reported by a consumer and described the occurrence of faint in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th November 2019, the patient received the 2nd dose of Shingrix. In November 2019, 12 hrs after receiving Shingrix, the patient experienced faint (serious criteria GSK medically significant), vomiting, fever, sweating, chills, nausea, diarrhea, abdominal pain and back pain. On an unknown date, the outcome of the faint, vomiting, fever, sweating, chills, nausea, diarrhea, abdominal pain and back pain were not recovered/not resolved.   It was unknown if the reporter considered the faint, vomiting, fever, sweating, chills, nausea, diarrhea, abdominal pain and back pain to be related to Shingrix.     Additional Information: GSK receipt date: 17-Nov-2022 Reporter's comment:  The patient received the second dose of Shingrix vaccine. About 12 hours post injection, the patient was fainted and vomited. The patient was found unresponsive in a restaurant bathroom. The patient was taken at home and having fever of 104 and symptoms of sweating, chills, nausea, diarrhea, abdominal pain and back pain through the night. The patients one of friend had recently reported the same adverse reaction following Shingrix dosing. The reporter did not agrees to follow up from GlaxoSmithKline. Less than a day, the patient experienced fever, sweating, chills, nausea, diarrhea, abdominal pain and back pain. Additional supportive information: This case had been linked with US2022AMR171802 same reporter, different patient.; Sender's Comments:  US-GSK-US2022AMR171802:same reporter, different patient
Pt. schedule incorrectly to return for 2nd dose of flu. 2nd dose was administered 1.5 week earlier that minimum of 30 days.
Got shot three days later got shingles; No relief from pain; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles was unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.  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, he/she got the Shingle shot and three days later the patient got shingles.  The patient said, bad stuff, no relief from pain, never should had gotten the shot. The follow up would not be possible as no contact details were available.
HAIR STARTED SHEDDING/ DRAMATIC HAIR LOSS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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) dose was not reported, administered on SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On OCT-2021, the patient experienced hair started shedding/ dramatic hair loss. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hair started shedding/ dramatic hair loss. This report was non-serious.
my blood pressure shot up to 191/112; heart rate of 178 bpm; Vision got blurry; skin got clammy; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ew6206), via an unspecified route in the left arm on 19Mar2021 (age at vaccination: 63-year-old), as a single dose for covid-19 immunization. Medical history included high Blood pressure (BP), hemochromatosis, acid reflux, cholesterol and known allergies: codeine. The patient concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: E19267), via an unspecified route in the left arm on 26Feb2021 at 15:45 (age at vaccination: 63-year-old), as a single dose for covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received unknown medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 26Mar2021 at 12:00 am, eight hours after receiving second dose, patient blood pressure shot up to 191/112, with a heart rate of 178 bpm, vision got blurry, and skin got clammy. Patient did not receive any treatment for the events. The patient underwent lab test and procedure on 26Mar2021 which included blood pressure shot up to 191/112 and heart rate of 178 bpm. The clinical outcome of the events was recovered unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
18 month female was given Proquad and varivax, at this time child is not showing any symptoms or signs of an adverse reaction to the vaccines given. Mother and patient were offered to come in this morning to speak to Pediatrician in regards to incident and mother choose to come in tomorrow since she has an appointment her self close by the office .