chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm is sore; Arm is tender if she touches or bumps it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is sore) and TENDERNESS (Arm is tender if she touches or bumps it) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm is sore) and TENDERNESS (Arm is tender if she touches or bumps it). At the time of the report, PAIN IN EXTREMITY (arm is sore) and TENDERNESS (Arm is tender if she touches or bumps it) outcome was unknown.            No treatment information was provided. No relevant concomitant medications reported
Patient was given vaccine and about 5 minutes after felt faint. Patient passed out for a few seconds. Patient peed herself. Patient left pharmacy after 45 minutes and was fine
Lightheadedness/dizziness, pale, blurry sight that led to not being able to see, hot/sweats, vomiting, bit of confusion Applied ice pack to back of neck, patient removed jacket, had some sips of cold water EMS came to monitor patient and blood pressure was fine- patient refused further treatment at that time
received vaccines-11:30 , 2/1/02 in office MDPA, vomited in 1440 + 1505 2/1/02, no fever, seen 1810 MDFPA -exam normal, temperature 97 degrees F, took six oz of formula in office just prior to exam-no vomiting  2/2 phone follow up-doing fine, no fever or vomiting  Note :Patient received Hepatitis B which was 3rd hepatitis B per mom and MDPA records #1-9/17/01, #2-10/25/01
ADMINISTRATION ERROR / VACCINE ADMINISTERED TO 16 YEAR OLD PATIENT; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 16 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: 1822809, and expiry: 04-AUG-2022) dose was not reported, administered on 09-NOV-2021 for prophylactic vaccination. Age at time of vaccination 16 years old. No concomitant medications were reported. On 09-NOV-2021, the patient experienced administration error / vaccine administered to 16 year old patient, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration error / vaccine administered to 16 year old patient and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20220558451, 20220558511, 20220558598, 20220558439, 20220558390, 20220558638 and 20220558823.
Patient received second dose less than 24 days from 1st dose at 23 days.
aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches) and CHILLS (Chills) in a male patient of an unknown age 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 an unknown date, the patient experienced PAIN (aches) and CHILLS (Chills). At the time of the report, PAIN (aches) and CHILLS (Chills) outcome was unknown.            The reporter reported that his grandson received a second shot of vaccine and experienced aches and chills. No concomitant medications were provided by the reporter Treatment information was not provided by the reporter   Reporter did not allow further contact
Initial unsolicited report received from literature on 18 June 2015. This case is linked to 2015SA090249, 2015SA090258, 2015SA090257, 2015SA090260, 2015SA090261 and 2015SA090262 (same literature, reporter and event). Abstract: Background: In October 2012, the Committee recommended dose of Tdap during each pregnancy, irrespective of the woman's prior history of receiving Tdap. A retrospective cohort study to assess the safety of Tdap vaccination in pregnant women in two Vaccine Safety Datalink (VSD) sites during 2010-2012 found a small but statistically significant increased risk of chorioamnionitis. Objective: We conducted a review of the VAERS database to describe reports of chorioamnionitis following receipt of any vaccines. Methods: We searched the VAERS database for reports of chorioamnionitis after any vaccine during the period from July 1, 1990 through February 2, 2014. Results: VAERS received 31 reports of chorioamnionitis out of 3389 pregnancy reports in 24 years. The three most common vaccines in these reports were H1N1, quadrivalent human papillomavirus (HPV4), and Tdap vaccines in 32%, 29% and 26% of reports, respectively. Fifty-eight percent of reports had at least one reported risk factor for chorioamnionitis. Chorioamnionitis was identified in 3 reports of spontaneous abortions and 6 stillbirths, 6 reports of preterm birth (two of whom died) and 16 reports of term birth; maternal outcomes included two reports of postpartum hemorrhage and one report of maternal admission to the intensive care unit. No maternal deaths were reported. Conclusion: Chorioamnionitis was found to be uncommonly reported, representing 1% of pregnancy reports to VAERS. A majority of reports had at least one risk factor for chorioamnionitis. Two female patient, whose medical history and concomitant medications were not reported, had received a dose of IIV3 or Trivalent Inactivated Influenza Vaccine (batch number, route and site of administration were not reported) on unspecified date. On unspecified date, following vaccination, two patients experienced chorioamnionitis and was pregnant during vaccination. The last menstrual period and estimated date of delivery was not reported. Gestation period at exposure was unknown. Laboratory investigations and corrective treatments were not reported. At the time of this report, outcome of the event was unknown. Upon medical review, the case was considered as serious due to important medical event: chorioamnionitis and vaccine exposure during pregnancy. Documents held by sender: none.
Rec'd Varivax and Prevnar 4/2/07 in R thigh woke up week later with red, swelling. Seen in office 4/12/07 and diagnosed with cellulitis 20 immunizations.
Left arm swollen, warm to touch and red.  Patient denies any pain but states that her arm itches.  Patient given Ibuprofen and Benadryl by mother on 3/25/08 with no improvement of symptoms.  Temperature 97.2.  Patient very active with no other complaints.  Left arm 18-25cm, right arm 14-25cm.
7/9/04: phone call from mom: DTaP in left thigh on 7/9 now has bruise the size of an orange with small pinhead size water blisters around it no pain, waling fine. Doctor advised appointment to evaluate. Seen 7/10/04 by doctor. History, swelling , redness 2 days after shot at site, left thigh, 1 day later. Swollen, red (orange size) blisters on surface of skin. 7/10/04 blisters mostly gone, slightly red. 6.5cmx10.5cm area of erythema and induration.
COVID arm. A small ring started at the injection site nine days after receiving the vaccine. It has gotten a littler bigger and itchier each day since it appeared.
Information has been received from a physician for the pregnancy registry for VARIVAX, concerning a 33 year old female with hypertension and a poor obstetrical history with an abruption placenta and a child with cerebral palsy, who on 03-FEB-2007 was vaccinated with a first dose of VARIVAX.  Concomitant therapy included losartan potassium-HCTZ.  The patient received second dose of VARIVAX on 07-MAR-2007 and was subsequently determined to be pregnant with LMP date of 20-MAR-2007.  No problems were reported.  The patient underwent quantitative HCG and progesterone level diagnostic tests (results unknown).  On 07-NOV-2007 at 36 weeks 2 days, the patient delivered a healthy female infant (no defects) who weighed 6 pounds 12 ounces.  The infant's APGARs were 8 and 8.  The patient had a c-section due to pregnancy induced hypertension.  The patient did well post-op.  No other problems were noted during her pregnancy.  A product quality complaint was not involved.  Upon internal review, pregnancy induced hypertension was considered to be an other important medical event.  Additional information has been requested.
Information has been received from a physician concerning a 75 year old male with an allergy to dye who on 05-APR-2007 was vaccinated in the left deltoid with a 0.5 mL of Zostavax (Oka/Merck) (lot# 656609/0015U).  Concomitant therapy included vitamins (unspecified), glucosamine, ADVIL, simvastatin (MSD), PLAVIX, ALAVERT and TYLENOL PM EXTRA STRENGTH.  On 05-JUL-2007 the patient experienced a bad outbreak of shingles after receiving the vaccination on 05-APR-2007.  The patient went to the emergency room where he was diagnosed with shingles at dermatome T10.  Lab tests included cerebral spinal fluid results of protein was negative, glucose 98, RBC 4.29 and WBC 540.  Temperature 98.1.  Pain 6/10.  The patient contacted his physician the following week because he was experiencing tremendous pain.  He was treated with pain medication.  The physician also noted that this was the worst case of shingles that she had ever seen.  As of 20-AUG-2007 the patient was recovered.  Additional information is not expected.
Right upper arm: local redness, swelling , pain, itching, fever, treatment: Tylenol q 4 hours.
PATIENT RECEIVED 0.25 ML OF THE MODERNA BIVALENT 50 MCG/0.5 ML VACCINE ON 4/20/2023. PER CDC GUIDELINES FOR A PATIENT WHO WAS UNDERDOSED, THE PATIENT CAME BACK IN FOR A FULL DOSE (0.5 ML) OF THE MODERNA BIVALENT ON 04/24/2023
Low grade fever, vomiting, fussiness, and exhaustion. Did not give any medication for fever as it stayed under 100 degrees. Patient continued to vomit after every feeding as of this morning almost 2 days later.
Pt had sore arm on 8/10/19 and then on 8/11/19 had a less sore arm but notice rash on chest and back, pt was going to take some bendyrl and if symptoms get worse go see an MD
Patient began experiencing numbness immediately after injection and then neck stiffness and pain shortly after vaccination. All of this was on the left side of her arm and neck area. She had Gardasil 4 on 11/12/2014 but first Gardasil 9 injection.
Acute pericarditis (confirmed by ECG, Echocardiogram and cardiology consultation), 1 week after second dose. Patient was treated with Colchicine and Indomethacin and improved. She is fully recovered. No complications.
Patient may have received a YF-VAX dose using a diluent from Merck that contains 0.7ml sterile water instead of the diluent supplied with the YF-VAX with no reported adverse event; Initial information received on 24-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 41 years old female patient who may have received a yf-vax dose using a diluent from  merck that contains 0.7ml sterile water instead of the diluent supplied with the yf-vax with no reported adverse event while receiving vaccine yellow fever vaccine -  [YF-Vax].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included typhoid vaccine polysacch VI (Typhim VI).  On 23-Mar-2022, the patient received a dose of suspect yellow fever vaccine - , Solution for injection (lot UJ409AA; expiry date: 22-Oct-2022; strength: unknown) (frequency: once) total at a dose of 0.5 ml via subcutaneous route in the left arm  for Immunization.  On 23-MAR-2022, the patient may have received a yellow fever vaccine -  dose using a diluent from  merck that contains 0.7ml sterile water instead of the diluent supplied with the yellow fever vaccine -  with no reported adverse event (product preparation issue) (latency: same day).  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Pt. states that after receiving the 2nd dose of Moderna 05/08/2021, started experiencing irregular heart beat 08/04/2021, Primary visit ordered tests and referred to Cardio (diagnosed with A-Fib). No other symptoms noted. Scheduled for stress test 08/14/2021.
Pt developed severe headache 6 days after receiving flu vaccine (11/15). On 11/16 began to notice decreased vision in right eye. Went to ER. Over next several days, lost vision both eyes. Headache continued until 11/29. Hospitalized on 11/27. Treated with steroids. now beginning to regain some vision.
During the night I had a server upset stomach.  Felt like vomiting. I finally got up and did vomit.  My right leg and arm shook. I felt very cold. did not take my temperature. This lasted for about 30 minutes. I was able to get back to sleep.   Next day I felt fine.
FELT A BIT DOWN FOR ABOUT 12 HOURS; HEADACHE; This spontaneous report received from a patient via a company representative 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced headache, and felt a bit down for about 12 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and felt a bit down for about 12 hours. This report was non-serious.
Stomachache, pale face, mouth, and hand. I was losing hearing, cold sweat, desire to vomit, and chest discomfort.
Almost lost patient due to the flu vaccine; Initial information was received on 12-Feb-2021 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves a child male patient who was almost lost (unevaluable event), while he received vaccine INFLUENZA VACCINE.  Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was almost lost (died) (unevaluable event), (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory data was not reported.   It reporter said that there was no way their child will be getting the flu shot EVER again, they almost lost him due to the flu vaccine.  It was not reported if the patient received any corrective treatment or not.  The outcome for the event was unknown at the time of reporting.  There will be no information on the batch number for this case.
Patient came in and said she made an appointment for a Moderna shot and she was getting her second shot. She already noted that she received the first shot on 3/29/21 and put it on the consent form. She made no mention of getting Janssen vaccine. However, her insurance reported she got the Janssen vaccine back in March and not Moderna. She has no adverse events.
Recieved DaPT, IPV, Comvax, Prevnar and Rototeq at 11:30AM 11-01-2006. at 7:20PM had a episode of pallor. Parents called squad, arrived at 5 minutes into the episode. Was still pale. Transferred to hospital. Pallor had resolved by arrival, BP was 78/palp. Temp 38.1. Rule out sepsis work up initiated. CBC was negative, Cath U/A negative, CSF was clear(Cultures all pending). Patient admitted. Had another spell overnight (2 minutes per mother) DC Summary received for DOS 11/2/06-DC DX: Post immunization reaction. Became pale, episode of pallor and spike temp of 38.1. No vomiting, no diarrhea.
I was feeling bad with a stuffy head and congested sinuses. I was achy and chilly but didn't have a fever. I decided to do a COVID-19 test and it was positive. My husband had some dizziness and my brother had the same kind of symptoms as him back in December. We called our physician when we tested positive and we got Paxlovid. It was a 5 day regimen. We took the medication and I was feeling much better after about the 2nd day of taking Paxlovid. I got better quickly and we were told to quarantine for 10 days, and we did that for about 8 days. We got better quickly with that medication. We've been alright. We did more COVID-19 tests two days in a row by day 6 or 7 and had negative tests. We have seen the doctor since then because I had an appointment. We've been doing alright since then.
Within 30 minutes after getting the first dose of the vaccine I experienced feelings of dizziness and Vertigo. I was examined by a doctor, and I waited another 30 minutes. It resolved after that amount of time, and I have not had any more symptoms. I have a I got the second dose of the vaccine after consulting my doctor and I waited an hour. I had no symptoms on that occasion.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown ages and genders. No information about medical history, concomitant medications, concurrent conditions and drug reactions and allergies was reported for any of the patients. On unknown dates the patients were vaccinated with unspecified number of doses of ROTATEQ orally (dose not reported lot M007301 expiry date 19-NOV-2017 or lot M019691 expiry date 02-NOV-2017. No adverse events were reported. On an unknown date, the vaccines were stored in an inappropriate temperature of 34 degrees Fahrenheit for 8 hours (reported as "worst case"). The Digital Data Logger was not involved. No previous temperature excursions were reported. Additional information has been requested.
Woke up last night with a large swollen lymph node near my left collar bone (shot was in left arm).  I can't get in to see my health care provider until the 14th of April. I am under care of a Naturopath in the meantime--castor oil packs, warmth, and tomorrow, some lymphatic herbs. No history of breast cancer.  It's painful but not unbearable. Thought it important that this is recorded, though I expect to be fine--I wish I had heard about it before I went looking for it online as a possibility, though.
Had flu shot, huge bruise down 3/4 of inner aspect of upper Lt arm 10/13/10 Still present. Painful 10/3 - Had heart block -> cardiac arrest -> Life support -> Pacemaker -> life now changed forever with a pacemaker
slight fever; cough; This is spontaneous report received from a contactable clinician. A 71-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 16Apr2021 as single dose for covid-19 immunisation; and palbociclib (IBRANCE) 125mg, via oral route from 12Feb2021 (Batch/Lot number was not reported) and ongoing, at dose 15 mg, cyclic 21 days on, 7 off for breast cancer. Patient receivedbnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on unknown date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced slight fever and cough on Apr2021. with outcome of recovered. No other problems. primary md aware of vaccine issue and asked pt to notify oncologist. seeing md 26Mar2021. The action taken for palbociclib was unknown. The outcome of the event was resolved.  No Follow-up attempts are needed; information about lot/batch number cannot be obtained.
After recieving vaccines, client stood up, lost consciousness, fell to the floor, shook for 2-3 seconds while on his stomach. He began to roll over, assisted by nurses at this time. Client attempted to sit up. Nurses encouraged him to remain lying on floor. Ice applied to knot forming on his right forehead. He remained under 1st aid protocols until exiting the building, ambulatory, with his mother. Nurse talked to Mother at 1:00 pm. Client was wnl, per Mom.
PT A NON-RESPONDER TO RECOMBIVAX AND RECVD 1ST ADDITIONAL DOSE OF ENGERIX B ON 4-17-90. NEXT DAY PT WAS DIZZY, DEVELPD JOINT PAIN, MUSCLE ACHES, UPSET STOMACH. CURRENTLY IMPROVING. NO SUBSEQUENT INJECTS PLANNED
Pt called pharmacy 3 days after receiving the vaccine complaining of swelling in the arm.
slightly sore right arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (slightly sore right arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Patient did not had COVID positive test or diagnosis.  The patient's past medical history included Premature ventricular contractions (One episode lasted two weeks and resolved. Patient had a history of experiencing PVC's. Also it occurred long time ago. No change in condition after vaccination). Previously administered products included for Drug use for unknown indication: Shingles vaccine on 04-Apr-2021 and Klonopin (she withdrew from taking Klonopin two years ago and that caused a lot of withdrawal side effects). Past adverse reactions to the above products included No adverse event with Shingles vaccine; and Withdrawal symptom with Klonopin. Concurrent medical conditions included Allergy to antibiotic, Sulfonamide allergy, Pre-diabetic (No change in condition after vaccination) and Allergy to antibiotic (various antibiotics allergy).    On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (slightly sore right arm). At the time of the report, VACCINATION SITE PAIN (slightly sore right arm) outcome was unknown.            Concomitant medications were not reported.  It was stated that the patient was not immunocompromised.   Treatment medications were not provided.   This case was linked to MOD-2022-569840, MOD-2022-570092 (Patient Link).