chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very sore upper arm; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 19May2021 at 14:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included zolpidem tartrate (AMBIEN), fluoxetine hydrochloride (PROZAC), cefdinir (MANUFACTURER UNKNOWN) and colecalciferol (5000International Units) (VITAMIN D3), all from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20May2021 at 04:30, the patient experienced very sore upper arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event very sore upper arm was resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
pt recvd measles vax on 23MAY91 & on 21OCT91 lab eval showed no immunity; No further details were provided;
Patient reported that he has not had any swelling in the shoulder that has been visible. He stated that he had pain on the day of the injection that has persisted. He described the pain as a "toothache in your arm". Patient notified the pharmacy about discomfort on 5/3/2012.
Patient began with substernal chest pain 8 out of 10. Patient was taken to emergency room.  At the outside hospital patient was given Motrin with improvement of pain.  Patient's troponin at outside was 34.5.  CK-MB was 41.6.  CK was 523.  CBC was unremarkable.  Sed rate was 15.  CRP 1.46.  Patient had chest x-ray that showed no acute process.  EKG at outside hospital shows sinus rhythm with occasional PVC. Mild diffuse settle ST elevation and no PR depression.  Upon arrival to the floor patient had no significant pain.  On telemetry patient was found to have an episode of nonsustained ventricular tachycardia.  Patient denies recent cough, congestion or fevers.  Patient does have 2 parents and a dog at home. Of note patient got first dose of pfizer Sars-Covid-19 vaccine on April 14.  Second dose of Pfizer vaccine was given on May 14. Initial troponin i-STAT presentation was 11.03.  Patient also experiencing nausea and vomiting on 5/20.
Severe headache for 5 days, neck and shoulder pain, injection site pain. No treatment received; took meds already prescribed to me to deal with pain.
Rashes all over the body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes all over the body) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rashes all over the body). At the time of the report, RASH (Rashes all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were reported.   This case was linked to MOD-2022-456445 (Patient Link).
Patient reports cough and feeling like her throat was thickening and mucousy.  Progressed to a wheezy cough, then wheezes, then chills.  Says she took her temperature and it was 94.  She the said she developed hives on her neck. She said she took 2 Benadryl about 12:50 pm and called her physician.
Patient returned to inform us he was having non-specific pain from the wrist up around his shoulder and to his chest in the same arm in which he received his flu shot. His Left arm to be specific.
Employee health flu shot clinic. No privacy area set up. Asked to pull shirt down over my shoulder. Concerned that I could not pull it far enough down. RN administering vaccine stated "it should be good enough" and injected me quickly, at the top of my shoulder. Did not use landmarks. Felt buzz/shock feeling with administration of medication. Arm ached immediately and continued to hurt. Progressed over the next couple of days to where I could not lift arm more than 45 degrees or cross it over my chest without pain. Diagnosed with bursitis at the ER (09/22/2017) and impingement syndrome at the Orthopedic office(09/29/2017).  Currently taking Naproxen, applying heat and doing two arm stretch exercises daily.
No additional adverse events reported; The patient was administered with improperly stored vaccine; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Information about the patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies was not reported.   On 04-JAN-2022, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (lot# T033815, expiration date 05-OCT-2022; strength, dose and route were not reported) for prophylaxis (product storage error).  The administered vaccine experienced a temperature excursion in 49.6 Fahrenheit degrees (F) for 35 hours 9 minutes. The previous temperature excursions included 32.9 F for 53 hours 16 minutes, 49.1 F for 5 hours 9 minutes, and 56.3 F for 14 hours 7 minutes. No additional adverse events reported.   This is one of multiple cases received from the same reporter.; Sender's Comments:  US-009507513-2202USA003592: US-009507513-2203USA003311: US-009507513-2203USA003313: US-009507513-2203USA003314: US-009507513-2203USA003315: US-009507513-2203USA003316: US-009507513-2203USA003317: US-009507513-2203USA003318: US-009507513-2203USA003319: US-009507513-2203USA003320: US-009507513-2203USA003335: US-009507513-2203USA003322: US-009507513-2203USA003323: US-009507513-2203USA003324: US-009507513-2203USA003325: US-009507513-2203USA003326: US-009507513-2203USA003327: US-009507513-2203USA003328: US-009507513-2203USA003329: US-009507513-2203USA003330: US-009507513-2203USA003331: US-009507513-2203USA003332: US-009507513-2203USA003333: US-009507513-2203USA003334: US-009507513-2203USA003310: US-009507513-2203USA003321:
Chills (severe for an hour) Fever (100.0), all day relieved briefly with tylenol Body aches, over 16 hours Dizziness, on and off  Weakness, all day Headache, all day Arm pain around injection site
Patient is complaining that the site of injection has gotten swollen and redness is moving toward the armpit. She said the spread looks like it stopped on 8/31/19
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in an adult female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.
Information has been received from a physician concerning an 18 month old male who in approx June 1985, was vaccinated SC with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. In approx June 1985, the pt experienced an arthritic reaction. Subsequently, the pt recovered from arthritic reaction, however it was unk how long it took before the arthritic reaction went away. No further information was available. There was no product quality complaint. Arthritic reaction was considered to be disabling by the physician. Additional information has been requested.
Runny nose, fast spike in temperature to 103 by 10:30pm day of vaccination, vomiting, wracking chills, body aches.
Chest pain, shortness of breath, leg cramps, tachycardia (baseline 50-60, increased post vaccine to 130?s-150s at random occurrences ex standing up), increased BP (140-150/90s, baseline BP 100s/50-60), dizzy/lightheaded (feels like my head is floating).
vomiting a lot; This is a spontaneous report from a Pfizer sponsored program . A non-contactable consumer (patient's partner) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Dec2020 at single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. Caller's partner received the vaccine yesterday morning and drank a lot of alcohol in the evening. In Dec2020, her partner (patient) was vomiting a lot. She was worried if this was due to the vaccine and wanted to know what else could happen. Outcome of event was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Headache starting about three hours after vaccinated; Muscle soreness/pain starting about 6 hours after vaccinated, fever (101.1~102.2 F) starting about 14 hours after vaccinated. Symptoms disappeared about 42 hours after vaccinated.
Developed redness at right deltoid site 24 hours after injection. Low grade temp. Erythema & induration (R) deltoid.
21M caucasian who received 2nd dose of Pfizer vaccine on 4/11/21 and started having fever chills and headache next day. The following day he started having substernal chest pain which was non exertional. He presented to hospital where he was found to have normal vital signs.
The day after vaccination, patient's arm was very sore and she was "achy all over". Symptoms resolved within 2 days.
Dizziness & Headache Narrative: my menstrual cycle. I noticed I am delayed on my current cycle and I haven't been active so I doubt it can be anything pregnancy related. I also have had some slight pinching/sharp pain In my lower left pelvic area as well.
No additional AE information provided.; a patient was administered an improperly stored dose of PROQUAD which was also expired; a patient was administered an improperly stored dose of PROQUAD which was also expired; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about pertinent medical history, drug reactions or allergies was not provided.           On 17-DEC-2019, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R015740, expiration date 02-DEC-2019; dosage detail, strength and route were not reported) for prophylaxis (product storage error and expired product administered). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was reconstituted with properly stored sterile diluent.  Administered doses of vaccine experienced temperature excursion from -14 degrees Celsius (C) to -10 C for 1 hour and 30 minutes. There was previous temperature excursion from -14 C to -10 C for 15 minutes. Digital data logger was involved. No adverse effects were reported.
Patient called the pharmacy the day after the immunization was given and stated that the night after the immunization was given she had severe pain in her arm where the injection was given. Patient stated that the area was red at first, however, redness has resolved. Patient stated the area was warm to the touch. Patient stated she took OTC anti- inflammatory meds but area is still really swollen. Patient also stated that she had a previous reaction to a flu shot that required her to call out of work the injection site was so swollen and sore, however, patient did not disclose prior incident to immunizer at time of immunization.
Post vax two to three minutes pt developed small hives on his legs and lower trunk. The pt was treated with diphenhydramine elixir and recovered.
patient mistakenly got adult dose of Engerix B instead of the pediatric; patient mistakenly got adult dose of Engerix B instead of the pediatric; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental overdose in a 9-month-old female patient who received HBV (Engerix B adult) for prophylaxis.   On 03-JUL-2023, the patient received Engerix B adult. On 03-JUL-2023, an unknown time after receiving Engerix B adult, the patient experienced accidental overdose (Verbatim: patient mistakenly got adult dose of Engerix B instead of the pediatric) and inappropriate age at vaccine administration (Verbatim: patient mistakenly got adult dose of Engerix B instead of the pediatric). The outcome of the accidental overdose and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 03-JUL-2023 The pharmacist stated that a 9 month old patient mistakenly got the adult dose of Engerix B instead of the pediatric dose which led to inappropriate age at vaccine administration and accidental overdose. The reporter consented to follow up via postal.
WHITE CLOTS COMING OUT AFTER GOING TO THE BATHROOM (FROM VAGINA) AND ONE CLOT WAS HALF AN INCH IN DIAMETER AND  A LOT OF OTHER SCATTERED SMALLER ONES SITTING IN THE BOWL.; CRAMPING IN THE STOMACH SIMILAR TO FIRST DAY OF PERIOD; SPOTTING (IN THE UNDERWEAR) 10 DAYS AFTER GETTING THE VACCINE.; STRANGE BOWEL MOVEMENTS WITH HARD TEXTURE AND CLUMPY FOR ABOUT 2 WEEKS; PERIOD CAME 1 WEEK EARLIER THAN IT SHOULD HAVE; This spontaneous report received from a patient concerned a 50 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, intramuscular, and batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 08-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-OCT-2021, the patient experienced period came 1 week earlier than it should have. On 15-OCT-2021, the patient experienced strange bowel movements with hard texture and clumpy for about 2 weeks. On 18-OCT-2021, the patient experienced spotting (in the underwear) 10 days after getting the vaccine. On 01-NOV-2021, the patient experienced cramping in the stomach similar to first day of period. On 02-NOV-2021, the patient experienced white clots coming out after going to the bathroom (from vagina) and one clot was half an inch in diameter and a lot of other scattered smaller ones sitting in the bowl. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from period came 1 week earlier than it should have, and spotting (in the underwear) 10 days after getting the vaccine. on 20-OCT-2021, had not recovered from cramping in the stomach similar to first day of period, and strange bowel movements with hard texture and clumpy for about 2 weeks, and the outcome of white clots coming out after going to the bathroom (from vagina) and one clot was half an inch in diameter and a lot of other scattered smaller ones sitting in the bowl. was not reported. This report was non-serious.
Noted to have red rash annular and expanding at injection site  Was warm to touch and painful with some swelling
This case was reported by a pharmacist via call center representative and described the occurrence of injected limb mobility decreased in a 77-year-old female patient who received BOOSTRIX (batch number 54B74, expiry date 14th September 2020) for prophylaxis. On 26th June 2018, the patient received BOOSTRIX (intramuscular) .5 ml. On an unknown date, less than a week after receiving BOOSTRIX, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the injected limb mobility decreased was not recovered/not resolved. It was unknown if the reporter considered the injected limb mobility decreased to be related to BOOSTRIX. Additional details were provided as follows: The patient received the vaccine in the left deltoid. The patient called the pharmacist on the day of reporting and said she could not raise the arm in which she received the vaccination. The reporter's call was transferred to Medical Information (MI) for additional assistance. The reported batch number 58B74 for BOOSTRIX did not exist and was updated to 54B74 as per the sales database.
Left anterior thigh slight raised erythema patch- pain (4 x 5 cm)
Palpitations & Tachycardia Narrative: at approx 0920 employee c/o of heart palpitations Pt states that she walked into the observation area and saw her colleague have chest pain and she then began to have increase heart rate. Denies any chest pain, shortness of breath or difficulty breathing. Vitals assessed BP 128/78, HR 120, RR-20, O2-100% via room air . Employee placed in recliner for 30 mins given water and orange juice. At the end of 30 mins HR 75 O2-100% via room air. Pt report feeling better. Pt ambulated back work section on own in stable condition.
I received a Pfizer booster on 12/29/21 at 6pm. My symptoms started the next day in the morning and became progressively worse from 2pm until around 10pm. I experienced all of the side effects that are listed (headache, fatigue, fever, chills, nausea, body aches all over) but at an intensified level. Around 6pm on 12/30/21, I was considering going to the hospital, because I felt that my head was going to explode and I was very hardly able to move out of bed to use the bathroom.  I was not able to get out of bed without assistance, and it was difficult. I was winded just from getting out of the bed and taking a few steps. I felt like I was going to pass out and I experienced the worst discomfort that I had ever felt in my life. I would rate my discomfort at about a 9.5 out of 10.   10 being I need to go to the hospital, because I felt very weak and almost incapable of walking to the bathroom.   I feel that these side effects were extreme compared to other acquaintances my age who received the booster.  A suspicion may be that I still had some flu virus in my system while I had the booster, but I had been symptom free from that at least 72 hours prior to my booster injection.  I took Tylenol throughout the day of symptoms and it did help relieve my symptoms temporarily. The Pfizer booster vaccine left me unable to do anything during at least 24 hours. On the 2nd day after vaccination, I felt a lot better, but still fairly winded and a then moderate headache persistent from the previous day.  In total, I experienced symptoms during 48 hours, with the most severity in a window of about 8 hours.
Information has been received from a physician concerning a 9 yr old female child with no medical history or allergies who was vaccinated on 11Nov97 at another practice with the first dose of varicella virus vaccine live (lot unavailable). There was no illness at the time of vaccination. The physician reported that on 06May05 the pt developed cases of mild breakthrough varicella (with few vesicles). The physician described it as clinical varicella. The pt's present status was reported as recovered. The physician also noted that the pt's unvaccinated father also developed varicella. No product quality complaint was involved. The physician also reported that the pt's sister also developed varicella (associated WAES0505USA02237). Additional information is not expected.
I instructed patient to wait 20 minutes in the office after vaccines are administered. He wanted to wait in the waiting area. He stopped at check out first before going to the waiting room at 4:50 p.m. He passed out while standing. He started falling and staff held him up and helped him sit down. We then laid him down in a room and observed him for 30 minutes and monitored his blood pressure and heart rate. He felt much better. Denied lightheadedness or dizziness.
Shortness of breath, coughing on inhalation, tightness /pressure in chest,  pressure/tightness in chest worse when leaning forward
Patient got Fluvirin vaccine on 09/24/14. She reported about one week after shot she is having a problem with vaccine site. Symptoms include red and peeling around the area. After 3 weeks site has large mark with peeling, darkening, and yellowing.
I got hives on my arms, trunk and legs. I went to urgent care and they did blood work. There was no treatment provided as it self resolved within 3 hours.
Chills, body aches, fever (102), cough, migraine, fatigue, sore arm. I couldn?t get off the couch and was sitting in the dark and crying from how I felt. Was about to go to ED but fell asleep and started feeling better next day.
Numbness and paralyzed waist down. Hospital ER admission July 3. The hospital discharged me July 3 and I came back July 6 worse. Guillane barre syndrome and lymphoma is the case healthcare reported to patient.
Patient reported that his heart rate has increased to 150 pm since the shot, also had shaking chills and 103 fever, severe headache for 3 days
thought he was going to die.  Weak, general malaise,  feeling like he was going to pass out.   developed lump under L arm- painful.