chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Vaccine was administered to patient after 1 day of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient after 1 day of expiry) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 prophylaxis.     It was reported that HCP did not describe medical history or condition.     On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient after 1 day of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient after 1 day of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient after 1 day of expiry).    Reported patients were both male and female, none of the patients reported being pregnant or breastfeeding. Concomitant product use was not provided by the reporter. Expiry date of the vaccine was 04-Apr-2022. All of the vaccine administered were boosters. Suspect vaccine dosage text was reported as unknown. Treatment information was not provided. This case contains information about patient 6th out of 8 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735621 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735621:Master case, patient 6 out of 8
9/2 at noon receive influenza, pneumococcal vaccine. 9/3 nauseated, achy. Thursday pm - redness (L) upper arm. 9/5 seen here large cellulitis.
During observation period, while walking around, patient started to feel  signs and symptoms of fainting (she stated she's had multiple incidents of fainting in her lifetime, due to various reasons), so she laid on the ground to prevent injuring herself in case she did faint. As associate got her a chair to sit on and I came to check up on her. She did not have any rash, swelling or difficulty breathing. She didn't want or need any type of treatment. I gave her a drink just in case, while we waited for her friend to come pick her up. I stayed with her then walked her out to the car. At this time, she was feeling better, and doesn't have the fainting feeling she had earlier. I asked the friend to contact us if anything else changes.
Out-of-sequence COVID-19 vaccination was given.  Person involved was a community member (non-affiliated healthcare provider) who showed up to a hospital based clinic that was administering first doses to 1A non-affiliated healthcare providers on 1/27/21.  Unknown to the clinic organizers this person had previously received one dose of the Pfizer vaccine 13 days earlier (1/14/21).  On 1/27/21 a dose of Moderna vaccine was administered and then after administration it was revealed that the person had previously received Pfizer and was not due for re-vaccination on 1/27/21.  Person was held for routine observation and no side effects resulted.  Person was provided with contact information for a hospital hotline to report any side effects that may result in the meantime.  As of 1/29 no effects have been reported.
Red water blister about 3 inches below navel and about the size of a quarter. No pain associated with blister yet.
foamy poops; This spontaneous report was received from a Medical Assistant, via Company Representative, and refers to a 3-month-old male patient (Also reported as "her grandson"). No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications.  On an unspecified date in 2023 (at 2 Months Old), the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), oral for prophylaxis (Strength, dose, frequency, lot number and expiration date were not reported).   On an unspecified date in 2023, 2 weeks after the patient received the rotavirus vaccine, live, oral, pentavalent (ROTATEQ), the patient experienced foamy poops (abnormal faeces). It was reported that the patient did not seek for medical attention and that no treatment was provided for the event. At the reporting time, the outcome of the event was not provided.   The causal relationship between the event and therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not reported.
Information has been received from a nurse practitioner concerning a female patient who was vaccinated with three dose of GARDASIL. Subsequently the patient "contracted HPV" after getting all three dose of GARDASIL. The patient underwent a Pap test. The patient's contracted HPV" persisted. Additional information has been requested.
Information has been received from a nurse practitioner concerning a "4-5 year old" male who in April 2003, was vaccinated SC with a 0.5mL dose of varicella virus vaccine live. Subsequently, in approximately June 2003, the pt developed over 30 lesions and a fever. Unspecified medical attention was sought. The pt was treated with diphenhydramine hydrochloride (Benadryl). A product quality complaint was not involved. Additional information has been requested.
pt recvd vax & exp induration, redness & pain @ inject site; the area was pruritic; these sx lasted for 1 wk; pt was seen in ER & treated w/DPH;
Pt was 17 years old, no adverse reaction has been reported. Pt wants to receive 2nd dose.
Patient was given Menveo vaccine in Left Deltoid & Bexsero vaccine in Right Deltoid IM at 2:30pm on 11/5/19 in our office by me (RN) Mom states she took her home after vaccines were given and was called by her husband around 5pm (same day) that she wasn't her usual self & was acting strangely. Mom came home from work and called after hrs number & was instructed to take her to UC for further evaluation. Mom states the UC physician felt her unusual mood, fever of 102.5 continuous body.
The night of Sunday, November 6th, 2022, I did not sleep well at all.  The effect knocked me on my ass and lasted two days. I had never had a reaction to anything my entire life! But this shot was very different. On Friday the 11th, I went in for a nuclear stress test, and my heart was beating a constant 135. They sent me to the ER, and my heart miraculously went back into normal rhythm. That issue put me on a heart monitor for 30 days, and it confirmed that I now suffer from afib when I did not suffer from anything before the shot on the 6th. Two weeks into the monitor, my heart started racing at about 200 bpm. I was sweating profusely, and I knew something was wrong. I went to the ER again and spent the night under observation. I am now on Eliquis and Flecanaid and am on a trial of Digoxin. I am scheduled for an ablation soon. I am not confident that it will do any good.
Information has been received from a physician concerning a 72-year-old retired male pediatrician with type 2 diabetes mellitus, hypertension, gout, chronic renal insufficiency, rhinitis allergic, allergies to salicylates and sulfonamide (which caused hives and rash) who on 25-JAN-2007 was vaccinated one time with a 0.5 mL dose of zoster vaccine live (Oka/Merck). Concomitant therapy included Amaryl, ezetimibe (+) simvastatin (MSD), losartan potassium (MSD), allopurinol, Plavix, Claritin and montelukast sodium (MSD). In July 2007, the patient experienced left back and subscapular pain and then went to see a dermatologist who diagnosed him with active shingles lesions. No laboratory or diagnostic tests were performed. He was prescribed Valtrex and the last of the lesions were seen in early August. The patient still has pain and was reported to be recovering at the time of this report. No product quality complaint was involved. Additional information has been requested.
a few minutes after receiving the vaccine, pt had SOB, trouble swallowing, itching.  50 Mg Benadryl given. symptoms continued and 911 was called.  8:40am BP 180/100 8:45am BP 190/102 8:50am BP 180/110 Rescue arrived and took over, administered epiPen and transported to hospital.  followup call, pt states had to call 911 again next day and they gave epi again, also precribed a prednisone dosepack.  Still has SOB, cough and has a follow up w/PCP for further trearment.
Patient mentioned that at the injection site on the arm had strong pain. Went to the doctor who examined it and prescribed Cataflam 50.  More tests will be done because the pain recurs sometimes. The patient said that he lifts weights in the gym.   Pt was offered for the report to be completed but he refused
arm as sore as dickens; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd June 2022, the patient received the 2nd dose of Shingrix. In June 2022, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-JUN-2022 Reporter's Comments:  The patient self-reported this case via interactive digital media. The patient said just got his/her Shingrix shot yesterday (day before reporting), insurance covers it 100 percent. The patient said it made arm as sore as the dickens for several days, but it beats getting shingles.
expired dose of Daptacel was given to a patient with no reported adverse event; Initial information received on 19-Jul-2021 regarding an unsolicited valid non-serious case from an other health professional via Media information (under reference 00688129).  This case involves a 24 months old female patient who received an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other vaccines/ concomitant medication(s) were given to the patient.  On 07-Jul-2021, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (total, lot C5624AA and expiration date: 10-Jun-2021) via intramuscular route in the left thigh for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  At time of reporting, the outcome was unknown for the reported 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. 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.
7 days after receiving first dose, experienced rash on right chest, subclavian area, spreading up along right side of neck to my ear, then extended down to right chest at bra line, spreading to the back side of ribs on right. On day 3 of this rash, it became painful. Day 4 erupted into pustules. Disappeared on day 6
Patient's parent brought patient in to receive a COVID-19 Pfizer vaccine on 08/26/2021.  The patient?s parent filled out a consent form on behalf of the patient and listed the date of birth as 05/16/2009 and signed and consented on the official Pfizer-BioNTech consent form.  The nurse verified the name and date of birth with the patient and the patient?s mother.guidelines were followed, and the parent received the up-to-date Pfizer-BioNTech EUA and the vaccine was administered.  In the patient?s 15-minute wait there were no adverse reactions. Upon entering the vaccine into the it was discovered that the patient's true DOB was 05/16/2010  and therefore this was an unauthorized vaccination.  The date of birth was then confirmed and verified. In addition, the patient's parents were notified per protocol.
8 days after vaccination the right arm at the spot of shot, I felt soreness. Red splotches, and warm to touch.  The site itches and throbs.
Monday night started feeling very achy which has continued to today yet (Thursday) - Tuesday  night around 10pm he threw up and then again at 12pm and 3am.  Wednesday and Today(Thursday) he has been nauseous, achy, no appetite, headaches, sleepy
On 2/19/21 veteran had Moderna Covid-19 vaccine #1, then 2 days later developed  a rash on the trunk, which spread to extremities. He also had seafood recently and so cause of rash unclear at the time. He subsequently had vaccine dose #2 in 3/2021 and developed pruritic maculopapular rash again  (no recent seafood or other changes) that manifested over the same time course,  symptoms appearance and pattern of spread - trunk -> extremities .
Chills/ Diarrhea/Throwing up/ aches  Very sick/  Head ache
On December 28, patient had a fever resulting in seizure. Taken to emergency room. Lab test for flu. Mom states A-B showed of flu. Transferred to hospital and kept overnight for observation. Siblings and parents also had flu at the time. The discharge summary received on 2/9/04 states decreased appetite, sore throat, otitis, and cough. The ER record received on 2/9/04 states incontinent, starting into space and biting.
Information has been received from a physician concerning a patient who was vaccinated with the first SC dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient developed outbreak of chickenpox. Unknown medical attention was sought. Unknown patient outcome status reported. No product quality complaint. Additional information has been requested.
numbness/ tingling in tongue after 5 minutes of vaccination. v/s 157/98, patient did not take blood pressure medication this morning.patient refused transport. s/s resolved after 2 minutes.
Sneezing; Nose started to run; Both of my lips were extremely swollen; underneath on my lips was extremely dry; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6203, Expiry date: Unknown), via an unspecified route of administration on 24Feb2021 (at the age of 63-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Patient previously received bnt162b2 on 03Feb2021 (at the age of 63-year-old) for COVID-19 immunization. Patient reported she took it on 03Feb2021 and again 24Feb2021. She stated treatment she was taking Histamine (clarification unknown). She stated did not have lab work. Patient stated, the reason I was calling you was this, to tell you about the side effects I experienced from it because I happened to heard from anybody else if they experienced the same side effects. She got her vaccine on the Wednesday and on the Sunday and Monday she started sneezing like eight to nine times like may be five to six times during the day. My nose started to run and on Tuesday morning my upper lips was swollen and Wednesday morning both of my upper lips were extremely swollen. Both of my lips were extremely swollen and underneath on my lips was extremely dry and like giddy feeling (2021). Therapeutic measures (Histamine, clarification unknown) were taken as a result of sneezing, nose started to run. The clinical outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Pt. was hear for husband's appt. Dr. came out to the nurses' station and provided orders for husband and requested that patient be added on for a nurse visit to get her bivalent booster with husband. RN requested that front desk add patient on. Chart labels were printed. RN obtained VIS, covid 19 screening questionnaire, and the vaccine.  RN presented to exam room and performed vaccine screening questionnaire.  Neither the husband nor the patient brought their vaccine cards in for this visit.  Both patients indicated that they received their primary series as well as a booster but that it had been greater than 2 months ago.  RN precharted NDC and Lot number on husband's vaccine and then administered the vaccine and finishing documenting it.  Husband, who utilizes a walker, needed to use the restroom so he was assisted to the bathroom and when RN returned, pt. had her arm out of   her shirt sleeve, ready for her immunization.  Pt. was inquiring about whether or not the anticipated snowstorm had started.  Sh was hoping to hurry up and get home before it started.  RN administered the vaccine without precharting.  Both husband and patient were observed for 15 minutes post administration without any adverse effects.  When RN went to chart patient's immunization, RN noticed patient had received the bivalent booster in 10/22.  Dr. notified immediately.  She was unaware that patient had received the bivalent booster as was RN.  Director of Primary Care Clinics was notified during the noon hour.  Incident report completed.  Contacted Pharmacy Director to notify him of the incident.  Submitting VAERs report per his request.  RN aware that MD and RN should have reviewed immunization record prior to administration. RN and provider will use this as a learning opportunity.  Spoke to patient.  She does not recall receiving her covid bivalent booster in 10/22.  Pt. will monitor for adverse events and will notify our office immediately should concerns arise.
slept for 1 1/2 days directly after the shot; slept the whole day; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140 and expiry date: unknown), intramuscular on the left arm, on 07Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications.  When she had the first dose she slept for 1 1/2 days directly after the shot on 07Jan2021. She got the shot in the morning and she slept until 10, so she was not really sure how long she slept. The next day she slept the whole day too. She had no pain and is better. Outcome of the event was unknown.
left leg DVT in two spots of her leg; This is a spontaneous report received from non-contactable reporter (Consumer or other non-HCP).   A 40-year-old female patient received bnt162b2 (BNT162B2 NOS), in 2022 as dose number unknown, single (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEEP VEIN THROMBOSIS (medically significant) with onset 2022, 48 hrs after the suspect product(s) administration, outcome "unknown" described as "left leg DVT in two spots of her leg." The Pfizer sales representative stated, "I just had somebody report today that 40 years old, she was not on a birth control a year ago after receiving the Pfizer Vaccine, about 48 hours later, left leg DVT in two spots of her leg." When asked if Vaccine name is Pfizer COVID-19 Vaccine, Pfizer sales representative stated, "I guess, I just know it was a COVID Vaccine. I was taking for granted, I guess she did not say it was the Pfizer just COVID Vaccine. I was thinking, it was Pfizer, I guess they are talking about the Pfizer." Reason for no lot number of COVID Vaccine: Caller does not have the product with them at the time of call.  No follow-up attempts are possible; information about the batch/lot number cannot be obtained. No further information is expected.
Vertigo starting 11/4  for 1-2 weeks,  mostly lightheadedness and feeling "off-balance".  Only one time did I feel it strongly in my head that I was unable to work.
developing a sore throat; got very nauseous / was sick with nausea for another week; was sick with nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Feb2021 (Lot number: EL9267) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing), notes: probably 2009 before that high blood pressure, don't know the exact; "breast cancer" (unspecified if ongoing), notes: had breast cancer but in Remission. Concomitant medication(s) included: GLIMEPIRIDE; GLIPIZIDE; AMLODIPINE BESYLATE; LISINOPRIL; LEVOXYL; SIMVASTATIN. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "recovered", described as "developing a sore throat"; NAUSEA (non-serious), outcome "unknown", described as "got very nauseous / was sick with nausea for another week"; ILLNESS (non-serious), outcome "unknown", described as "was sick with nausea". The event "developing a sore throat" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of oropharyngeal pain. Additional information: Clinical course: The patient took the first shot on 07Feb 2021, the patient developed a sore throat on second week and saw her doctor on 22Feb2021 and was given with a Zyrtec for sore throat. The patient got rid of the sore throat with antibiotics. On an unspecified date (reported as 2 days later), patient got very nauseous and was sick with nausea for another week. Ondansetron 4mg I can take 4-3 hours 1 tablet as needed was the treatment given for the event nausea. It was reported that the patient just changed her diabetic medication and she thought it was the time of the first shot she was still taking. The patient reported that she was taking "Amlokinda" but the insurance couldn't pay for it and they put her on "Fericita"; and reported that the insurance Insurance wanted her to take "Fericita" somewhere between first and second shot.  No follow-up attempts are possible. No further information is expected.
Patient had abnormal gait where he veered to the right when he walked.  His right shoulder was slumped and right arm lower than left and he veered to the right without being able to control it.  Mom called 911.  It resolved within a few minutes.
Information has been received from a Registered Nurse concerning a patient who in November 2009, was vaccinated with a first dose of RECOMBIVAX HB (Lot # unknown). Second dose of RECOMBIVAX HB (Lot #  unknown) was given on an unspecified date. Third dose of RECOMBIVAX HB (Lot # unknown) was given in April 2010. The nurse reported that the patient received all 3 doses of RECOMBIVAX HB and still had low titers. Titers were conducted "this week" on approximately 13-JUL-2010. The outcome of the patient was not reported. It was unknown if the patient sought medical attention. This is one of several reports from the same source. Follow-up information was received from the registered nurse who stated that the patient did not have exposure problems; she reported that the patient simply had series of shots and negative titers. There were no adverse reactions. No further information is available.
2nd COVID shot o 1/27 (Wednesday). Started having right sided lower back pain on Friday that continued to become worse each day. By Tuesday 2/2/21 the pain was significant. I went to ER.  During the time at the ER - lab work was completed and a abdominal CT. Then a chest CT and was diagnosed with a Pulmonary Embolism. I was then started on Eliquis 10 mg BID (eventually moved down to 5 mg BID).   I then followed up with my PCP. I was then referred to a Hematologist. I was on Eliquis for 3 months starting February 2, 2021 and was on light duty with both my work and with my teaching of karate.
Rash on hands, knees, extremely itchy skin on palms of hands and fingers, feet, elbows and legs.