chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Side effects; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (Side effects) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
patient inadvertently administered expired Tenivac vaccine/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a other healthcare professional via Agency (Reference number- 00610121) and transmitted to Sanofi on 20-May-2021.  This case involves a patient (unknown demographics) who received inadvertently administered expired vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (batch number: U6265AA and expiry date: 19-Apr-2021 via unknown route at an unknown administration site) (expired product administered) on 18-May-2021 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to expired vaccine used (latency: same day).  Reporter want to know what need to know and which actions to take for the affected donors  At the time of reporting, no adverse event was 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.
She has MCV4 on Tuesday 6-25-19. Developed Redness & swelling that evening on left Deltoid. Today seen in office 6-27-19. Fainter redness, Puffy. Not tender. Will Take Claritin. Area 6x9cm.
She felts sleepy for app. 10 min. after vaccination . By a wheelchair to the waiting area , lightheaded, no  N or V, , no medication. BP 100/64 126/78 130/86 She had a ride and went home
This literature marketed report as received from authors of the literature article refers to 4 children of unknown gender (exact age was not provided). It was assumed, that the patients were immunologically naive to mumps antigens, and that the children did not have circulating maternal IgG antibodies. In relation to first dose of M-M-R II, sera used to analysis were collected from these children at four visits resulting in the following overlapping time frames: 0.5 to 6 months, 3 to 8 months, 5 to 10 months, 1.7 to 2.7 years, and 4.0 to 5.3 years post-vaccination. On unknown dates (when the patients were at age 14 to 18 months), the patients were vaccinated with the first dose of M-M-R II (dose, route of administration, lot # and expiration date were not provided). The second dose of the vaccine was given 5 to 6 months later. On unknown dates, serum analysis revealed low avidity results after the second dose of M-M-R II. The authors stated, that it was unlikely that these 4 low-avidity results were due to mumps virus infections in individuals with two-dose primary vaccine failure, due to the low mumps virus circulation at the time. The outcome of vaccination failure and low-avidity results after vaccination was not provided. The authors considered the events to be related to M-M-R II.
Lots of bloating; Not feeling good; Arm got really sore; Afib; Lots of chills; Redness itching at the injection site; Itching at the injection site; A spontaneous report was received from a consumer who is a 71-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed atrial fibrillation, arm got really sore, redness itching at the injection site, lots of bloating, lots of chills and just not feeling good,  The patient's medical history included tachycardia, COVID-19, atrial fibrillation, asthma and lung inflammation. Products known to have been used by the patient, within two weeks prior to the event, included diltiazem, flecainide and rivaroxaban.  On 10 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) in the left arm intramuscularly for prophylaxis of COVID-19 infection.   On 10 Feb 2021, at noon, post vaccination, the patient reported she had atrial fibrillation. She was able to get it under control until it started back again at approximately 4 pm the same day. At 6 pm that evening, the patient reported her arm was really sore, there was redness and itching at the injection site. She had lots of bloating, chills and overall, not feeling good. The patient stated it felt like having COVID again.   Treatment for the event included hydrocortisone cream.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, afib/atrial fibrillation, was considered not resolved.   The outcome of the events arm got really sore, redness itching at the injection site, lots of bloating, lots of chills, just not feeling good, and feeling like having COVID all over again were considered unknown.  Follow-up received on 16 Feb 2021 included date of when patient had COVID-19, treatment information and added redness and itching at the injection site to the events.; Reporter's Comments: Based on the current available information, which includes a strong temporal association with onset of the reported events and the use of the product, a causal association cannot be excluded.
Headache; sore arm; A spontaneous report was received from a consumer himself, a 48-year-old, male who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache and sore arm.   There were no medical history and concomitant medications reported.  On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot 011J02A) intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 2020, patient experienced a headache and sore arm. There was no treatment information provided.   Action taken with mRNA-1273 in response to the events headache and sore arm was not reported.   The outcome of the events headache and sore arm was unknown.; Reporter's Comments: This case concerns a 48 year old male who received their first of two planned doses of mRNA-1273 (Lot 011J02A) intramuscularly for prophylaxis of COVID-19 infection and experienced non serious listed event of headache and non-serious unlisted event of sore arm. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded and the events are possibly related.
she said that her arm has been sore since the shot but that the redness she just noticed today
FELT ACHY; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. 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 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced felt achy, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt achy, and headache. This report was non-serious.
Vaccines that expired on 6/16 at 10:30pm were left out overnight and administered the following day on 6/17. The floating pharmacist assumed that the technicians had drawn up the vaccines and the immunizing technicians assumed that the floating pharmacist drew them up- neither of them looked at the USE BY label on the vial containing the vaccines.
Fever over 102.6, spots on legs and arms with pimple like protrusions, vomiting, diarrhea.  Bad diaper rash (probably related to diarrhea).
Client was administered Janssen vaccine at a clinic. Client was not of the required age of 18 and older.
Muscle aches all over, muscle cramps in left leg, left arm still having difficulty in lifting. can more in daytime, pain all over at nite. Has been almost a month. taking hot baths helps. also Advil. mostly now, left arm issues, and pain all over in evenings.
Left arm where shot given was red and swollen/raised, feeling flushed, feeling feverish, general malaise.
CHIEF COMPLAINT:   Family called d/t SOB and weakness. RA sat 86%, improved with NC 4LPM. Increased urination   HISTORY OF PRESENT ILLNESS:     80-year-old female with history of DVT, currently on Coumadin, lives at home with her daughter, uses a walker to get around, comes to the ER by ambulance for evaluation of shortness of breath and low oxygen saturation.  Patient does not use oxygen at home.  Patient knows that she is at the hospital but she does not know why she is here.  Apparently the daughter was concerned for some respiratory issues.  Patient is currently on nasal cannula she says that she feels completely fine.  Patient has no complaints at this time.
Within a couple of weeks after the vaccine, I started experiencing hear palpitations. They would happen through most of the day on and off at different times. They started a few at a time during a sitting and then started to last for longer periods of the day. Once it grew to the point of scaring me, I booked a Cardiology visit. By the time the doctors were able to examine me, they saw the issue on the EKG and booked a number of follow up tests. I had never had these before nor any heart issue. Since the offices were so busy there was a number of weeks that passed before I could get the first test, a Holter Monitor. At that point since it had been over 3 weeks, the very bad sessions had died down a bit but I still had sporadic hear palpitations. I recorded over 12 instances of what feels like a fluttering or drop in beats in my chest. Following the results which were "within normal parameters" 2 weeks went by until my next appointment. I then had a stress test which showed I did not have any blockages or blood flow issues. Another week or more went by and I had an echocardiogram. While taking the test, I did report and the tester confirmed that they saw skipped beats during the test 2 times. By this point the issue was subsiding and the results reported were not outside of normal parameters for a person my age. At the final meeting, the doctor adamantly claimed that the vaccine had no part in this problem stating that there are no reported cases of this issue due to the vaccine, but to me, timing of this issue and the fact that I never had any of these problems before the vaccine was administered seem to indicate otherwise. That said it should be documented and doctors should know about it. I want people to know I had it post vaccine, and that now the issue seems to be gone. This gave me and my family great anxiety, discomfort and more. I am unsure if these symptoms could be worse for people with heart issues or weaker hearts as well, so I am reporting it.
fever to 104 x 2 days; pain & sl redness 94-5cm) @ site of inject;
posterior vitreous detachment; This is a spontaneous report from a contactable physician. A 50-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EL-3302), intramuscular, administered in Arm Right on 18Dec2020 08:00 (at 50-years-old) as single dose for COVID-19 immunization. Medical history included HTN (hypertension). Patient had no known allergies. Facility type vaccine was Hospital. Patient did not have covid prior vaccination. Patient was not tested for covid post vaccination. Concomitant medications included amlodipine; chlorthalidone. The patient experienced posterior vitreous detachment on 20Dec2020 with outcome of not recovered. Ae resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of posterior vitreous detachment (also reported that "treatment: exam, there is no treatment", pending confirmation).; Sender's Comments: Based on the information provided, the event "Posterior vitreous detachment" is likely to be an intercurrent event unrelated to the use of suspect product bnt162b2 in this 50-year-old male patient. This case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Reports she felt flushed about 10 minutes after she received the vaccine.  Also states she felt a little "spacy".  States she was talking with the RN who gave her the shot and states "I felt like she had to concentrate more to have a conversation".  She reports the flushing subsided while she was in the observation area, but still left a little spacy that night.  She was feeling back to normal this morning and able to work.   She states she was nervous going in to the appointment.  Had ate a good lunch.  Hydrated well before injection.
Headache, chills, left arm pit swollen and painful lymph nodes, muscle pain, and tiredness.
Site: Swelling at Injection Site-Severe, Additional Details: Patient called to state that about 24 hours after immunization she experiencef swelling in lymph nodes in arm pit area along with stabbing pain. Patient is going to follow up with PCP
NO ADVERSE.  Reporting administration error only.  Pfizer Bivalent formula booster given 5 days too early.
This spontaneous report was received from a nurse refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy was not provided. On an unknown date, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # L029073, expiry date: 19-APR-2017). Nurse stated that VAQTA, RECOMBIVAX HB, GARDASIL, MMR II and sterile diluent (Manufacture unknown) appeared on the product list because temperature stability questions were asked, however, no doses of these improperly stored vaccines were administered to the patient. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Patient had the DTaP shot on 1/31/03.  His Left leg was so swollen and really hot.  The leg was swollen from his pelvis to the bottom of his knee.  Lasting 2 1/2 days. We called the Dr. on Sat. and she advised us to monitor him for any other signs.  None seen other then the swelling.
This is a spontaneous report from a Pfizer-sponsored program from a contactable Health Care Professional (HCP). This HCP reported similar events for 3 patients. This is the 2nd of 3 reports. A patient of an unspecified age, race/ethnicity and gender received TRUMENBA, via an unspecified route of administration, on an unknown date, at single dose, for immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient became ill and experienced pretty bad fatigue, fever and was feeling crummy. Clinical outcome of the adverse events was unknown at time of this report. No follow-up attempts possible. No further information expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017503288 Same reporter, different patient;US-PFIZER INC-2017503280 Same reporter, different patient
PATIENT REPORTED HIVES AND LIP SWELLING ON 7/23/21. PATIENT IS FOLLOWING UP WITH PRIMARY CARE PROVIDER FOR TREATMENT.
Pt was given 1 single dose of varicella vaccine and 1 single dose of proquad on the same day.  3/16/18 As of 3/19/18 there have been no report of side effects from patient.
Infant had extreme fussiness and abdominal pain 2 hours after infant go dose of vaccines for 4 hours. She wanted to stay curled in the fetal position with knees to chest and mother couldn't straighten her out. She was completely inconsolable during that time. Mother gave her Tylenol initially and then finally laid a warm compress on her abdomen and this relaxed her. She never had any blood in her stool. She hasn't had this problem again. She was not reevaluated that day.
Started with feeling chilled (though no fever initially). Very slight fever recorded at 11:00pm (99.6 F) and continued with fever all night until taking ADVIL at 5am. Muscle aches and nausea also present starting around 11pm. Symptoms resolved by noon next day. Another 36 hours of fatigue and now mostly back to normal.
Severe swelling at injection site approx 3in x 5in, followed within 8 hours by severe fatigue, fever (required medication), deep muscle aches, headache for both shots
Red and hot left arm. Swelling started 24-36 hours after vaccine 6x12 cm patch of
It was reported that a patient (3 of 6) received a Fluzone SV 01'02 vaccination. Lot number U0590AA administered IM on 09/26/2001. Reportedly, the patient developed a local reaction consisting of pain, redness and warmth at the injection site. Patient was treated symptomatically and the symptoms resolved. Linked cases: U2001-01025, U2001-01195, U2001-01197 & U2001-01199.
pt recv vax 20AUG96 & noticed lt arm red swollen p/vax;21AUG noticed 2 quarter size raised area;pt was warm to touch;by morning pt had large baseball size reddened area on arm w/2cm raised area;mom states pt is sensitive to bug bites;
8 days after getting the shot my arm started to itch and a rash formed in a rectangle patch around the spot I received the vaccine.  It hurts most where I actually received the injection.
Pfizer-BioNTech COVID- 19 Vaccine EUA: After the vaccine recipient was administered the vaccine, the vaccinator had a needlestick injury while engaging the safety mechanism. The need was DPS, 23 g 1/2 inch , medical appliance
This spontaneous report as received from a medical assistant refers to a 6 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 10-SEP-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # N022015, expiry date: 10-MAR-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1809USA002868: Original Case : 1809USA002868 US-009507513-1902USA009324: Original Case : 1902USA009323 US-009507513-1902USA009323: Original Case : 1902USA009323 US-009507513-1902USA009326: Original Case : 1902USA009323.
arm pain, redness and swelling 2-3hrs later then severe headache, chills, fatigue + body aches - started 4-6 hrs later + lasted 24 hrs
Pt states left thumb, 1st and 2nd finger are numb upon awaking the day after receiving the vaccine.
Extended interval between doses; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Extended interval between doses) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3001647) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Extended interval between doses). On 29-Jun-2021, PRODUCT DOSE OMISSION ISSUE (Extended interval between doses) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing was delayed on an unknown date.       Concomitant product use was not provided. Treatment information was not provided.  It was reported that the patient scheduled her second dose on 03-Aug-2021.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
sick all day; did it knock me on my butt; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In April 2022, the patient received the 2nd dose of Shingles vaccine. On 23rd April 2022, less than a month after receiving Shingles vaccine, the patient experienced sickness and malaise. On an unknown date, the outcome of the sickness and malaise were unknown.   It was unknown if the reporter considered the sickness and malaise to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-APR-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient just received the second shot and did it knock on patients butt patient was sick all day the day prior to the reporting. Additional supportive information: Follow-up would not possible as no contact details were available.
#2 MMR administered left arm on 05/20/2003.  Mother brought child to health department 05/22 with concerns regarding left arm redness.  Left arm high with area of erythema approximately 1 1/4 x 2 1/2 inches, warm to touch.  Mother denies fever, no behavoiral change's.  Instructed application of cool compresses to keep swelling down.  Reviewed possible reactions to look for and report if occurs.
COUGHING; BUZZ TO THE LEFT EAR; FEVER; SCRATCHY THROAT; This spontaneous report received from a patient concerned a 59 year old female. 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: 211A21A expiry: 14-DEC-2021) dose was not reported, administered on 14-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-DEC-2021, the patient experienced scratchy throat. On 22-DEC-2021, the patient experienced coughing, buzz to the left ear, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the scratchy throat, coughing, buzz to the left ear and fever was not reported. This report was non-serious.
Difficult breathing, elevated heart rate, swollen and hard arm, pinkish, itchy at injection site, headache.
I started having a headache, sore arms, and fatigue, and it kept getting worse and then I got the chills and ran a low grade fever I think it was 101, I had terrible beyond terrible body aches, I couldn't left my head off the pillow and it felt like I had covid all over again and I also had diherra and that lasted for 3 days and it took me 5 days in total before I felt normal. the fever broke after the 3 day and went back down to normal. I am finding I have shortness of breathe walking up a hill or walking up the steps to fast.