chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Broke her leg; Injection arm hurting; Headache; Felt very tired; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of FOOT FRACTURE (Broke her leg) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injection arm hurting), HEADACHE (Headache) and FATIGUE (Felt very tired). On 30-Mar-2021, the patient experienced FOOT FRACTURE (Broke her leg) (seriousness criterion hospitalization). The patient was treated with Surgery for Foot fracture. On 30-Mar-2021, FOOT FRACTURE (Broke her leg) had resolved. At the time of the report, VACCINATION SITE PAIN (Injection arm hurting), HEADACHE (Headache) and FATIGUE (Felt very tired) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment medications for the events included hydrocodone and acetylsalicylic acid.   No concomitant medications were reported.  Company Comment  Based on the current available information and the temporal association between the product use and the start date of the event a causal relationship cannot be excluded.   Reporter did not allow further contact
Injection site was LEFT arm.  Unable to lift LEFT arm for 24 hours then 24 hours PAIN and SORE.
1st & 2nd dose vaccines I received  were both with adverse reactions. The day after I received the vaccine, I had  Severe headache, generalised severe pain ,drowsiness  then 2nd day , still weak & dizzy  but lesser pain. I took Tylenol 500mg every 6hrs ATC for 2 days. These symptoms I felt the same when I had COVID
Numbness in arm and down to her hand; tingling in arm and down to her hand; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of numbness of upper extremities in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 29GB3, expiry date 16-SEP-2025) for prophylaxis.   On 19-SEP-2023 10:00, the patient received Shingrix (left deltoid). On 19-SEP-2023, immediately after receiving Shingrix, the patient experienced numbness of upper extremities (Verbatim: Numbness in arm and down to her hand) and tingling of extremity (Verbatim: tingling in arm and down to her hand).  The outcome of the numbness of upper extremities and tingling of extremity were not resolved.   It was unknown if the reporter considered the numbness of upper extremities and tingling of extremity to be related to Shingrix.     It was unknown if the company considered the numbness of upper extremities and tingling of extremity to be related to Shingrix.   Additional Information: GSK Receipt date: 19-SEP-2023  A pharmacist reported that Shingrix was administered to a patient this morning at 10 AM and the patient immediately stated that she was experiencing numbness and tingling in the injected arm.  The patient went home and called back around 1 PM stating that she was still experiencing the symptoms and that they had gone all the down to her hand.  The reporter consented to follow up via postal.
Approx 20 minutes after vax pts face, hands, feet became red, pt vomited. Pt returned to office and was given Benedryl. Pt continued with hive and therefore was admitted to hospital for observation of angina edema/urticaria. 1/13/06 Review of medical record. Admitting & D/C diagnosis confirmed as angioedema and urticaria.
Rash, burning, swelling, pain radiates from upper arm to elbow. Patient reported this on 12/11/14 approx 6:30 pm.
outbreak of herpes zoster; post herpetic neuralgia; vision loss; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of an unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route not specified) for the routine health maintenance and for its intended purpose: the prevention of singles (herpes zoster).  Subsequently on an unknown date, the patient suffered and was treated for outbreak of herpes zoster, post herpetic neuralgia and vision loss. As a direct and proximate result of the patient's receipt of zoster vaccine live (ZOSTAVAX), the patient´s symptoms have resulted in physical limitations, mental and emotional distress not present prior to vaccination. Further as a tragic consequence, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.   The outcome of herpes zoster, post herpetic neuralgia and vision loss was not recovered.   The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered all the events to be disabling.  Upon internal review, the event of visión loss was considered to be medically significant.
Notice today. No itch, c/o pain. No pain only touch. 5.5cm x 5cm. Redness slightly swollen.
approx. 8 hours after vaccine, pt experienced severe radiating pain in his L arm. swelling and redness over vaccine site. Symptoms lasted approx. 2 days. Treatment- Ice and Ibuprofen
pt recv vax SEP94 & 12 days p/vax pt devel fever 105, runny nose, cough & a few spot around ears; fever dec to 101 & entire body covered w/spots; 10 days p/vax pt reported to have t105 & rash;
Child started having very high fever at 6:30am on 10/15/17 of 104.8 degrees F. Stayed around this temperature most of the day and at about 8:30pm temperature spiked to 107 degrees F. This was followed by a febrile seizure. At 4:00pm 10/17/17 fever is still around 103.5.
A 12 year old patient was given a Pfizer bivalent 5-11.
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Called 911 and EMT completed an evaluation and released patient to go home
This is a spontaneous report from a contactable physician via a sales representative. A 2-year-old female patient received the third dose PREVNAR 13 at a single dose and the first dose of MMR at an unspecified dose; both via an unspecified route of administration on 10Sep2018 for immunization. The patient's medical history and concomitant medications were not reported. The patient received the first and second dose of PREVNAR 13 on an unspecified dates. The patient's mother reported that the patient's temperature was 105, they went to the ER to evaluate her temperature and was then documented as 102. Labs drawn in ER showed elevated WBC, so the second panel was ordered by primary physician which showed elevated monocytes, mono spot was currently pending at the time of report. Outcome of the events was unknown.
HIGH BLOOD PRESSURE; COULD NOT SLEEP AT NIGHT; RASH; ITCHINESS ON ONE SPOT AROUND THE HEART; This spontaneous report received from a patient concerned a 69 year old female The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, diabetes, no alcohol use, and non-smoker, and patient had no known allergies. Patient had no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: 23-AUG-2021) dose was not reported, 1 total, administered on 11-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported.  On 13-MAR-2021, the patient experienced rash and itchiness on one spot around the heart which resolved in 3 weeks. Three to four weeks after vaccination on 01-APR-2021, the patient experienced high blood pressure and could not sleep at night. Patient's daughter who was a nurse took her to the hospital. They tested her for brain bleed and stroke all negative. Patient also underwent Laboratory data included: Blood pressure (NR: not provided) high (250/150), Echocardiogram of the heart (NR: not provided) negative, and Eosinophils (NR: not provided) really elevated. They said that was because of the vaccine. They raised the dose of her blood pressure medication and added a second one and it took 2 weeks before her blood pressure came back to her normal. They released her the same day and sent her to a cardiologist which mentioned the same thing that it was because of the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high blood pressure on 15-APR-2021, itchiness in one spot around the heart, and rash on 01-APR-2021, and could not sleep at night. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211011824.; Sender's Comments: V0 20211012327-COVID-19 VACCINE AD26.COV2.S-high blood pressure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY.
Short Term Adverse Effect was that I got a strange chemical taste/smell in my mouth and nose on the second day .  Became very weak and ached all over for a few short days.  Injection site was very sore and swollen.  Long Term Effect so far has been continued swelling and pain at the injection site.  Find that exercise makes the area swell up.  Loss of energy continues to occur.
fever; symptoms of Covid-19 infection; difficulty breathing and sleeping; difficulty breathing and sleeping; an arm sore for a day; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the arm on 20Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included asthma. Concomitant medications were not reported. The patient previously tested negative Covid-19 on 18Mar2021 on a preoperative routine test. He had surgery on 24Mar2021. And on 27Mar2021, the patient came down with symptoms of COVID-19 infections. The patient has asthma and reported of having difficulty in breathing and sleeping since COVID. The patient also reported that he had a fever earlier today (01Apr2021). The patient informed that he didn't have any first dose reactions to vaccination, only for an arm sore for a day on an unspecified date in Mar2021, until a week later started having symptoms of COVID. The patient was due for his second dose on 10Apr2021 and asked if having contracted COVID-19 could affect getting his second dose. The outcome of the events was unknown.    No follow up attempts are possible; information about lot/batch cannot be obtained.
He got the vaccine, and didn't have any real reaction, anything unpleasant, he had a numb lip and 2 fingers were numb.  He called his doctor and she told him to go to the ER, which he did at  Hospital.  They did a CAT scan of his brain.  They tried to do an MRI and they pushed his head against the machine as his back is curved and he stopped breathing.  They had given him 2 narcotics for anxiety before the scan.   He was then transferred to   Hospital in .  He saw Cardiophysiologist/IM and he found that he had a blood clot (? where), and they inserted a pacemaker through his groin as his pulse dropped to 40 BPM.   He was hospitalized for 7 days, and discharged him with instructions on what he is able to do.  They started him on new blood pressure medicines for his kidney's.    On 3/26/21, lot# 028A21A.  He subsequently had the 2nd vaccine, and all liquids emptied from his body (vomiting and diarrhea), at the same time, and then he was fine once everything settled down which lasted for about 3-4 minutes and then he was fine.
vaccines that were exposed to highest temperature of 8.4 degrees C for 30 minutes with no reported adverse event; IPOL was used post excursion with no reported adverse event; Initial information received on 12-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 8 years old male patient who was administered ipol post excursion with no reported adverse event and vaccines that were exposed to highest temperature of 8.4 degrees c for 30 minutes with no reported adverse event, after receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Aug-2022, the patient received a  dose of suspect IPV (VERO)( lot TIE872M and expiration: 10-Oct-2022) at a dose of 0.5ml once via intramuscular route in the right deltoid for immunization.  On an unknown date,  the reporter stated that the vaccines that were exposed to highest temperature of 8.4 degrees c for 30 minutes with no reported adverse event (product storage error) .  On 10-Aug-2022(latency: same day), the patient administered ipol post excursion with no reported adverse event (poor quality product administered) following the administration of IPV (VERO).  Action taken: not applicable  It was not reported if the patient received a corrective treatment for the events.  Outcome: Unknown for both events   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 guidelines. 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 recvd vax & approx 1 1/2 hrs p/2nd inject tingling sensation in 1 hand that lasted 5 to 10 mins; pt did not receive treatment;
I tested positive for COVID-19 on 3/6/23. I had congestion, fever, headache, and body aches. This lasted for about 6 days total. I contacted my doctor and was prescribed Paxlovid. My doctor had me stop taking Atorvastatin and cut my Amlodipine dose in half while taking Paxlovid. I started getting some congestion again last night, so I am not sure if I am getting a rebound case or not.
Patient waited in the pharmacy for about 10 minutes. Left the pharmacy and husband was driving her home. She got dizzy in the car and husband thinks she may have passed out for about a minute or two.  Husband shook her and she woke right back up and he drove her back to the pharmacy. Patient reported that dizziness was getting better however she complained of headache. Legs were shaky and she was sweating. Clinic NP checked her blood pressure and blood sugar. Blood pressure was 100/60 and blood sugar was 110. NP told the patient to elevate her feet and to go to ER if symptoms are not improving. NP thinks patient's blood pressure may have dropped. Pharmacist has called her doctor's office and reported this reaction.
This spontaneous report was received from a patient of unknown age referring on his/herself. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported). No concomitant medications were reported. On an unknown date, reported as "right after receiving the vaccine", the patient experienced a rash on his/her back patient stated that it looked like it was shingles. The outcome of the event was unknown. Additional information is not expected.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L004014, expiration date 04-MAR-2017, dose and route unknown). The vaccine was stored under 1.8 degree Centigrade for 7 hours and 28 minutes. There was no previous temperature excursion. It was called because of a data logger. Additional information has been requested.
Redness and swollen right arm. AUGMENTIN 87mg one twice a day, BENADRYL 25 mg one every 6 hrs.
My arm, which had been painful after the vaccine, became swollen, red, and very itchy from my shoulder to my elbow. I went to the pharmacy and the pharmacist suggested benedryl.
This case was reported by a nurse via sales rep and described the occurrence of woozy in an unspecified number of patients who received MENVEO. On an unknown date, the patients received MENVEO at an unknown dose. On an unknown date, an unknown time after receiving MENVEO, the patients experienced woozy. On an unknown date, the outcome of the woozy was unknown. It was unknown if the reporter considered the woozy to be related to MENVEO. Additional details were provided as follows: The age at vaccination for the patients was not reported. The reporter said that few patients felt woozy after vaccination with MENVEO vaccine.
Caregiver reported possible HIVES , raised red itchy patches, on the left side of her body (arm, torso, and leg). No shortness of breath. No chest pains. The red areas reported began to present on 08/21/2019 sometime post Hep B vaccination. CG states she was experiencing "hot flashed on 08/21/2019 as well. This writing nurse did not physically assess this report.
Sore arm; Sore neck; Swollen lymphnode under my left arm; This is a spontaneous report from a contactable 44-year-old female consumer (patient). A 44-year-old female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date unknown), via unknown route of administration, on 14Jan2021 at 10:00 AM (at the age of 44 years old) as a single dose in the left arm for COVID-19 immunization. Relevant medical history included allergy to codeine, was diagnosed with COVID-19 prior to vaccination and had BNT162B2 vaccine dose 1 on unknown date, lot unknown. The patient was not pregnant at time of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications was not provided. The patient did not receive any other vaccines within 4 weeks or any medications within 2 weeks prior to the COVID vaccine. On 16Jan2021, at 08:00 AM, the patient experienced sore arm, sore neck and swollen lymph node under my left arm.  No treatment was received for the events sore arm, sore neck and swollen lymph node under my left arm. The outcome of the events sore arm, sore neck and swollen lymph node under my left arm was recovering. Since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Patient said she noticed increased hearing loss the morning after receiving 3rd dose (booster) on 10/15/21. Patient has previously had hearing loss but worsened after receiving vaccination.
Patient was very sick, running a high fever, so i took him to the doctors, and they wanted to give him his 9 months Vaccine. he had a temp. of 101.8. they gave him his shots and a few hours later his temp went up to 102.9. i called the doctor and she said to give him some medicine. i did. about 5 mins later he had a seziure. he went in to the hospital and had x-rays done and then we had to go back to the doctor with in 3days to follow up.
Fever starting 3 days after imms (6 mo) Tmax 103, persistent 3 days. TSs serious fluids and slightly thickened.
Information has been received from a physician concerning a female patient in her 20's who was vaccinated with a first and second dose of Gardasil. The physician reported that the patient had unusual soreness at the injection site after the first and second injection. He also reported that the patient had unusual stiffness and weakness with local mechanical trouble after she was given the third dose of Gardasil. The patient had not recovered as of this report day. The physician reported that this is one of the three patient who experienced similar experiences. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 9/17/2007. Initial and follow up information has been received from a physician concerning a 20 year old female student who was vaccinated with a first and second dose of GARDASIL vaccine. In follow up it was reported that on 27-JUL-2007, the patient had shoulder tendinitis and myositis. On 01-SEP-2007 patient recovered. The reporter indicated that the patient's adverse event left shoulder tendinitis and myositis was disabling. The physician reported that this is one of the three patient who expereinced similar experiences. Additional information is not expected.
Within 5-minutes of vaccination, the patient reported having diarrhea. EMS monitored the patient's condition on-site.
12/29/2020. 0430 I awoke with facial swelling including eyes/nose/lips. Slight wheezing, coughing & my skin felt like I had been sunburnt. I took Benadryl 25mg, Pepcid 20mg, Prednisone 10mg and I did an Albuterol Neb treatment. When I awoke at 0830, the swelling ,wheezing & burning had subsided. I was extremely fatigued & I had a 99 degree fever.  The fever subsided ,but I remain fatigued. (12/29/20 @ 1615) It's important to note my past severe allergic reactions have always been delayed by 8-14 days. I do carry an epi-pen.
The night that I got the shot I felt pressure in my left eye. One week after getting my shot my left eye was red and I was diagnosed with Scleritis. I was prescribed Prednisone and it seemed to help for a while. I get Avastin shots in my left eye to keep Retinal bleeding down. I was nervous about getting my shots I had one before the vaccine on 01/25/2021. The next time I got my Avastin shot on 04/19/2021 my vision took longer to get better. It usually takes a day or so to stop getting fuzzy and this time it took longer. I had Sceritis again in June and it was painful. The second time I got the Avastin shot on 07/29/2021 I was nervous and this time it felt different. When I got home it seemed Ok until the next day when my vision got black in that eye. I went to the doctor the next day and there was a substance in my eye. It got progressively worse and I ended up needing surgery on 07/29/2021 followed by a broad spectrum antibiotic. I missed two weeks of work. I have not had any more Avastin shots because my doctor can not get the pressure in my eye under control. Currently they think it might be Histoplasmosis.