chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After first shot I had difficulty swallowing along with blister like sores on my tongue. I took Benadryl allergy when I got home, but it didn't help. I ended up going to urgent care the next day because I wasn't feeling any better. The doctor felt it was more so a immune response then an allergic reaction.  So for my second shot my doctor prescribed 50mg of Prednisone 7 hours before and 1 hour before the injection. Also Benadryl 50mg 1 hour before the injection. The second shot I did not have the tongue and throat issues, just dry mouth and horrible taste in mouth right after vaccine.
Soreness in shoulder and then progressed to cervical region.  Started having "hypersensitivity" in shoulder, cervical, head, and into left arm.  The hypersensitivity progessed and got worse, on 1/13 blisters started developing on left  upper shoulder region and progressed to cervical region to occiput region and into left shoulder.  Went to clinic and have shingles.  1/19 the hypersensitivity in left arm has decreased but injection site has started to be "sore" again.  Still having shingle type symptoms in left shoulder/cervical region.
about 6 hours after injection I started to feel fatigued, weak- walking from room to room I have to stop and rest, shortness of breath resulting in taking inhaler, shivering, chills, and nausea , and arm pain
felt "horrible"; This case was reported by a consumer via call center representative and described the occurrence of feels awful in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced feels awful. On an unknown date, the outcome of the feels awful was unknown.   It was unknown if the reporter considered the feels awful to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient felt horrible after vaccination. The patient did not had fever after vaccination with 1st shot. This case has been linked to US2019AMR231241, reported by the same reporter.
Noted swelling right arm. (+) warmth on area.  Keflex, 28 hours ever day, motrin liquid arm elevation.
Janssen COVID-19 Vaccine EUA was given at 11am and symptoms began around 9pm. Mild fever, tiredness, achiness, nausea, and headache were the worst between 9pm and 11am the next day. Beyond the first 24 hours, mild nausea and tiredness have persisted for the first week after vaccine was administered.
contracted Covid 07Jan2021; contracted Covid 07Jan2021; This is a spontaneous report from a contactable other healthcare professional (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was unknown), via an unspecified route of administration on 02Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she received the first dose on 02Jan2021 and contracted Covid 07Jan2021. She was out of isolation since 17Jan2021 and currently have no symptoms. She is scheduled to receive the vaccine this coming Saturday (23Jan2021). The patient wanted to know if she can receive the second dose or should she postpone her appointment. The patient asked what would happen if she decided to get the second dose in 3 months after dose 1 and asked if she would need to start the vaccine series from the beginning. The outcome of the event was recovered on Jan2021.   Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE  due to temporal relationship.  There is limited information provided in this report.  This case will be reassessed once additional information is 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This spontaneous prospective pregnancy report was received from a physician and refers to a female patient of unknown age. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. On 11-SEP-2018, the patient was vaccinated with Oka/Merck VARIVAX lot # N035940 and expiration date 18-DEC-2019; and M-M-R II (lot# and expiration date unknown) both vaccines for prophylaxis (dose, strength, and route of administrations were unknown). It was reported that the patient was later found to be pregnant at the time of administration (maternal exposure during pregnancy), no adverse effects were reported. Last menstrual period, conception date, and estimated date of delivery were unknown. Outcome for maternal exposure during pregnancy was unknown.
(VERY HARD TO SEE)  Right had rash. Rash mildly pruritic.
I woke up the next morning with sore muscles and a low fever felt increasingly ill through the day. By noon I couldn't complete a sentence or understand what was being said to me. By the evening of 3/25/2021, I felt like I had the flu.  It lasted a week. The second week I was very tired, not hungry.  It another week before I had the stamina to do any chore for more than twenty minutes. The most common comment from family and friends was it sounded like I had the virus itself. (covid-19.
patient had received the full series of MMRlI already, (no dates given) but was given a 3rd dose by mistake on 05/24/2021 as they were supposed to have received VARIVAX; on 05/24/2021 as they were supposed to have received VARIVAX; This spontaneous report was received from a healthcare worker referring to a patient of unknown age (adult) and gender. The patient's concomitant medication, concurrent condition and drug reactions/allergies were not provided.  On 24-MAY-2021, the patient had already received the full series of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) but was vaccinated with the third dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, route, lot# and expiration date were not provided) for prophylaxis by mistake. The patient's another suspect therapy included varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route, lot# and expiration date were not provided) for prophylaxis which was supposed to be given on 24-MAY-2021.
Moderna COVID?19 Vaccine EUA. Within 24 hours, I had fatigue, headache, nauseous, lost appetite and red/swollen injection site. Within a few weeks my chronic nerve pain and post nasal drip went away! No I'm developing a rash on my stomach. Some of my ache in my stomach and low back is coming back. I notice it in the morning.
pt recv vax 3APR98 & the next day pt c/o swelling, the size of a tennis ball, mottling & redness @ the site of inj;
Left deltoid - collar bone to half way down arm - red, hard hot, swollen > 2 inches. Most of upper left arm.
Tremors and feeling of electric shocks all over body lasting more than 4 hours (1 AM to roughly 5 AM), chills and weakness lasting until current time, fever, muscle aches, weakness and dizziness (as of current time)
Approximately a few weeks after the second Pfizer COVID vaccination, I noted foamy urine.
Rash, itchy on right arm and next couple days get more and more on body and legs until present day. Taking Benadryl
approx 3-4 hrs p/vax pt became listless, cyanotic & apneic w/staring episodes; pt exp sz, still having sz & apnea; presently on Tegretol;
10/21  Pt to ED for complaints of increased coughing and shortness of breath with exertion. Diag w/ COVID-19 Pneumonia and  hospitalized for acute hypoxic respiratory failure.
headache; This case was reported by a other health professional via sales rep and described the occurrence of headache in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, less than a year after receiving Bexsero, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. Medical Assistant mentioned a patient had experienced headaches and contacted their office. The reporter had not given permission to follow up. This case has been linked with the case US2019AMR067915, reported by same reporter.
Within 30 minutes of immunization, eyes swelled up, headache, chills and temperature.
NAUSEA AND VOMITING STARTED AROUND MIDNIGHT AFTER GETTING VACCINE( RECEIVED 4/26 AT 11AM)-RESOLVED BY NOON NEXT DAY. FEVER ~100F AND FELT LIKE "SKIN WAS ON FIRE" STARTED AROUND MIDNIGHT AFTER GETTING VACCINE-RESOLVED BY WAKING TIME 9AM ON 4/28. RINGING IN EARS (MOST BOTHERSOME, CLAIMED EXTREME DIFFICULTY IN HEARING ANYTHING ELSE)STARTED AROUND 4AM 4/27-RESOLVED BY NOON 4/27.
Patient began complaining of shoulder pain and decreased range of motion the day after the vaccine. He was evaluated by a provider and unwilling to demonstrate range of motion and was guarding his arm. No evidence of infection. He  was told to move the arm regularly. He continued to complain of pain, stiffness and difficulty moving the arm on 10/21/22. On exam, the upper deltoid just below the acromion process was tender. No evidence of shoulder impingement. He was unable to abduct the left should to 90 degrees. On exam shoulder seemed frozen and could not be abducted beyond 90 degrees or arm reached behind back.  He was shown some exercises to do and referred to physical therapy.
Soreness in the arm; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (Soreness in the arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 22-Jun-2021 at 3:38 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness in the arm). At the time of the report, VACCINATION SITE PAIN (Soreness in the arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.  Treatment medications was not provided by the reporter   This case was linked to MOD-2021-264324 (Patient Link).
pt irritable for couple of wks p/receiving series 3 days p/inject lump are of DTP feels hard, not like a rock but like mashed silly putty; wierd per mom;
Pt received pneumococcal vaccine into left deltoid concurrently with acetaminophen 650mg PO on 3/27/06 at 20:00. No adverse reaction noted until morning of 3/29/06 when pt noticed several scattered red raised hive like wheals, approx 1/2 cm in diameter to upper left arm. Pt experienced no other symptoms and vital signs were stable and unchanged from baseline treated with Acetaminophen 650mg PO and warm compresses.
A physician reported that a 2 year old male received his fourth dose of Prevnar on an unspecified date. One day post immunization, he experienced a febrile seizure. He was hospitalized. He recovered. No further information was available at the date of this report.
Bleeding in the urine , vagina ,anus ,nose , gums red spots under skin  on breasts , abdomen and thighs . Brushing  I noticed it about the 23 of April . The spots, bruising  and bleeding in urine are constant. The bleeding from vagina and anus are sporadic.  I am concerned  this is something from the vaccine .  I am uneasy to take a booster shot .  I get pain in my abdomen but I am not sure that is related .
Vaginal bleeding like period day after vaccine and lingering headache since vaccine and currently. Some shortness of breath inconsistently
FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff)  This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267226; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193;   This case involves (an elderly) female patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the left deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No Concomitant vaccine given.  It was a case of actual medication error due to incorrect product storage.  At the time of report 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 holders 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.  Documents held by sender: none.
This spontaneous report was received from a registered nurse, via a company representative, referring to a 75 year old female patient. The patient's relevant medical history and drug reactions/allergies were not reported. On 02-OCT-2017, the patient was vaccinated with an unspecified dose of PNEUMOVAX 23 in the right arm (strength, route, dosage schedule and lot number were not reported) for prophylaxis. On the same day, the patient also received a dose of an unspecified flu vaccine at different site. On an unspecified day in October 2017, the patient experienced pain and after that, she went to the emergency room due to the inflammation of her right arm in which PNEUMOVAX 23 was administered. The patient was kept overnight for observation at the hospital and was discharged the following day. On 05-OCT-2017, the patient went back to the physician's office and was diagnosed with cellulitis at the vaccination site which was treated with a daily dose of CEFTIN. The outcome of cellulitis at the vaccination site and the relatedness between it and PNEUMOVAX 23 were not reported.
1st dose 2 years ago, does she have to start over?; This case was reported by a other health professional (Shingrix GSK Chatbot) via interactive digital media and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix approximately 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details provided were as follows: Age at vaccination was not applicable for this case. Till the time of reporting, the patient did not received the second dose of Shingrix, which led to incomplete course of vaccination. The patient received the first dose approximately 2 years ago and reporter enquired if she had to start the series over or she could get the second shot and be considered fully vaccinated. Follow-up would not be possible as no contact details available.
Pt. received 1st dose of Jynneos Monkeypox Vaccine, intramuscular, at 1542 on 08/26/22. Pt.  proceeded to observation area and began to feel lightheaded and dizzy at approximately 1555. Per  observation staff, pt. stated he needed to lie down, and began to lose consciousness at that time for up to 10 seconds. Eye rolling to back of head was noted. Observation staff performed sternal rub and pt. became responsive. PH nurses notified. VS taken: BP 90/54, Temp. 98.6. EMS notified; both Fire and EMS responded. Pt.s' VS stable upon 2nd set. Pt. declined ER treatment. Pt. remained in observation, drank water and juice, and ate a protein bar. Pt. able to depart without incident at approximately 1630. Observation staff provided contact number for pt. to call upon arriving home.
Memory fog, vision loss right eye, dry eyes, partial hearing loss in right ear. Multiple visits to eye center. Dr diagnosed me with Encephalopathy. Seen my Dr. an audiologist at Center. Dr. diagnosed with partial hearing loss in my right ear. I had the actual Covid 19 virus in August of 2020. At that time I lost my sense of taste and smell for approximately 2 weeks. I had no long term side effects related to the virus. I received my first COVID 19 vaccine in December 23 2020. I had no side effects from that vaccine. The day after receiving my second Covid 19 vaccine, I started having light sensitivity, right eye itching, and visual disturbance of the right eye.  Weeks later I started noticing changes in my ability to hear out of my right ear. Then people started noticing that I wasn?t hearing them appropriately. I?ve had multiple visits from specialist. I?ve had to buy new glasses, eye meds, contacts, take off work many times, and now I?m saving for a hearing aid.  I was told by both specialist that the outcome is unknown at this time because there is not enough information on the virus and the vaccine to make that judgement.
Pharmacist is reporting a dose of PROQUAD that was not fully dissolved being administered.; Pharmacist is reporting a dose of PROQUAD that was not fully dissolved being administered.; Pharmacist is reporting a dose of PROQUAD that was not fully dissolved being administered.; This spontaneous report was received from a pharmacist, referring to a 5-year-old male patient. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 21-OCT-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), at a dose of 0.5 milliliter (ml), as prophylaxis (formulation, strength, vaccination scheme, route of administration, anatomical site of vaccination, lot number and expiration date were not reported), however; during the administration the vaccine was not fully dissolved (product reconstitution quality issue, wrong technique in product usage process and product preparation issue). It was reported that, the health care professional wanted to revaccinated on 22-10-2020.
Headache; vomited in the toilet for 15 minutes; Woke up another couple times with soft urgent poop; Woke up another couple times with soft urgent poop; couldn't get comfortable or to sleep because of position and chills/hot flashes; nausea; cold flash; acid reflux; small dose of lower back pain; had arm and shoulder pain; had arm and shoulder pain; uncomfort on side of injection/shoulder joint uncomfort on left side (vaccination side); chills; hot flashes; This is a spontaneous report from a contactable consumer (patient).  The 22-year-old female patient received second dose BNT162B2(lot_number: EN 5318?, incomplete number), via an unspecified route of administration in left arm on 15Feb2021 15:30 at single dose for covid-19 immunization.  The patient medical history was not reported.  Concomitant medication included venlafaxine, ethinylestradiol, norgestimate (TRI-SPRINTEC), loratadine (ALLERCLEAR). The patient previously took z-pak for antibiotic therapy and experienced rash, sertraline hydrochloride(ZOLOFT) and experienced dizziness, first dose bnt162b2(lot: EN5318?) for covid-19 immunization on 26Jan2021 at 03:30 in left arm.  The patient experienced started on 15Feb2021 at 10 pm with acid reflux and a small dose of lower back pain, had arm and shoulder pain, uncomfort on side of injection, chills and hot flashes kept waking her up throughout the night, at 2:15 on 16Feb2021 she woke up went to bathroom and had a hot flash/nausea so laid on the floor until cold flash came. At 2:30 She got back up and vomited in the toilet for 15 minutes (total of 10 or so times within the 15 minutes first few were just dry heaving until anything came out.) She took acetaminophen before going back to bed. She woke up another couple times with soft urgent poop. She couldn't get comfortable or to sleep because of position and chills/hot flashes. At 6:30 I was feeling nauseous and still chills. At 11 am she woke up with just a headache and minimal chills. Headache lasted until 5pm or so she had taken meds again for the headache. On 16Feb2021 had acid reflux again. After finally getting to sleep she woke up 17Feb2021 morning with just shoulder joint uncomfort on left side (vaccination side). Therapeutic measures were taken as a result of vomited in the toilet for 15 minutes, headache. There was no treatment for other events. Events were assessed as non-serious. Outcome of events was recovered in Feb2021. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient had not been tested for COVID-19.   Information on the lot/batch number has been requested.
The flu shot was administered on Tuesday morning.  Upon waking on Friday morning, she was covered with welts (hives) that later turned into brillant red rashes.  She also passed-out within 5 minutes of getting out of bed.  She was taken to the hospital were they did bloodwork and an EKG.  They also administerd Benadyl.  The hives had lessened by the time we left the hospital 3hours later.  She was prescribe Benadyl, Loratidine, and Pednisolone.  The hives returned two more times- Friday evening/Saturday early am.  She has had no reoccurring hives since then.
This spontaneous report was received from a Pharmacist concerning a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 13-AUG-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ lot# N013992; expiration date 27-JAN-2019 orally (dose not reported) for prophylaxis, which had a temperature excursion of 47°F to 77°F (56F) for 15 days on unspecified dates. There were no previous temperature excursions and no digital data logger involved in recording the temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1808USA012996: US-009507513-1809USA006251: US-009507513-1809USA006252: US-009507513-1809USA006253: US-009507513-1809USA006254: US-009507513-1809USA006255: US-009507513-1809USA006256: US-009507513-1809USA006257: US-009507513-1809USA006258: US-009507513-1809USA006259: US-009507513-1809USA006260: US-009507513-1809USA006261: US-009507513-1809USA006262.
After I got vaccinated, I was fine for about five minutes. Then, my hands got all tingly and numb. My shoulders both got really hot and I sweated profusely despite being in the car driving home. When I got home, it hurt to the touch. The next day, nothing changed though the numbness disappeared. My arm had swollen up to a huge lump. It is still swollen today at the time of writing this (08/11/2021).