chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had knot the size of grape on arm till 15th or 16 it went away till the 19th it came back. On the 16th i started to have swelling in my arm pit. Treated by pcp the 19th resolved by the 22nd. The month of january.
no further AE; GARDASIL 9 given during a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 07-AUG-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (lot# W029724, expiration date: 08-JAN-2025; strength, dose, and route were not provided) during a temperature excursion (TE) (product storage error). TEs were on 02-AUG-2023 and 04-AUG-2023. There was no further adverse event (AE).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2309USA002410: US-009507513-2309USA002283: US-009507513-2309USA002102: US-009507513-2309USA002460: US-009507513-2309USA002163:
received a 3rd dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number 4G942, expiry date 3rd February 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 21st October 2019 with Lot number: H5495, no expiration data provided) and Shingrix (2nd dose received on 16th January 2020, with Lot number: 252N2, expiry date: 8th March 2022).   On 25th October 2021, the patient received the 3rd dose of Shingrix. On 25th October 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided are as follows: The reporter reported that a patient at their clinic received 3rd dose of Shingrix, which led to extra dose administered. The patient's vaccine record was not up to date. The reporter consented to follow-up.
On 7/14/2021, while eating Lunch, blood pressue dropped and vomited, ER visit discovered colitis, across 6 weeks revisited ER 2 more time. Gastric pain comes and goes.
Patient is not currently reporting any symptoms. She recieved a Pfizer vaccine at Rite Aid and then came here for a second Pfizer vaccine.
LIGHT HEADEDNESS, DIZZY, SWEATING, INCREASED BLOOD PRESSURE, INCREASED HEART RATE, TINGLING IN ARM THAT VAC. WAS GIVEN.
3 year old with cochlear implants all other vaccines up to date with no history of reactions needed PNEUMOVAX 23 due to cochlear implants - seen 3-22-16 in good health and given vaccine. Reseen 3-29-16 with hx of red maculopapular rash since 3-25-16 on trunk and face - not itchy or painful. No other symptoms. Rash fading when seen.
Starting on October 17th, 4 days after vaccination: reddish circular, blotchy spots, about 3mm to 5mm in diameter, starting on chest and belly. Did not spread to arms or other parts of body.  Itchy, can tolerate.  Calamine lotion made it better.  Lasted for about 10 days. Still has some spots on her back today, November 2nd.
pt was diagnosed with a stroke which affected her speech only. Pt was admitted to the hospital for 24 hour observation and then discharged to home
Severe site pain, loss of range of motion within 8 hrs. Today on presentation pt has pain but o/w no site abnormalities & good range of motion.
Patient had a seizure that looked like an absence seizure that lasted about 2 minutes. After 2 minutes of absence, patient had a few myoclonic spasms and then returned to absence. Total seizure time was less than 4 minutes. Treatment consisted of sitting the patient in a chair and monitoring her breathing. Her husband was present and has dealt with her seizure disorder for some time. He was insistent that emergency services did not need to be contacted. After the seizure stopped, I sat with the patient and her husband for a few minutes and then patient said she felt well enough to go home. Patient left walking without assistance and appeared mentally unaltered.
Information has been received from a physician concerning a 32 year old female with no known drug allergies and a history of 4 pregnancies and one live birth who on 13 MAR 2001 was vaccinated with MMR. It was reported that the vaccination occurred 5 weeks prior to last menstrual period. Concomitant therapy included pre-natal vitamins. calcium supplement and multivitamin with folic acid. The physician reported that the patient had a positive pregnancy test on 23 APR 2001. The patient had a blood test scheduled for 23 APR 2001 with the OB/GYN. The physician reported she is no more than 4-6 weeks pregnancy. Estimated delivery date 26 DEC 2001. The patient had an ultrasound to date pregnancy and normal anatomy ultrasound at 23 weeks. The patient had a subchorionic hematoma in the first trimester. On 30 DEC 2001 the patient delivered a normal viable male infant weighing 8 pounds, 7 ounces via vaginal delivery. Apgar scores were normal (8,9). Additional information is not expected.
Administration after exposure to freezing temperature; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 1-year-old female patient who received DTPa (Infanrix) (batch number 9R2D7, expiry date 23-MAY-2025) for prophylaxis.   On 08-NOV-2023, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced incorrect storage of drug (Verbatim: Administration after exposure to freezing temperature). The outcome of the incorrect storage of drug was 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: 13-NOV-2023 An HCP contacted GSK via phone inquiring about Infanrix and what information was available about the administration of Infanrix after the vaccines were exposed to freezing temperatures and administered which led to incorrect storage of vaccine. They gave partial information about vaccines, patient and event. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
Approx 30 minutes after vax my lips started tingling and became numb.  Approx 45 minutes after vax my tongue became tingly and numb.  Two hours later the condition was the same.  I took an herbal antihistamine and it reduced a bit.  By approx 10:00am the next morning the tingling and numbness was gone.
approx 15min p/vax pt stated lips felt funny & speech sounded like had been to the dentist;bottom lip & neck area edematous;no localized rxn @ inj site;VS WNL & resp nl;epi & DPH given;pt taken to hosp
This spontaneous report as received from a physician via company representative refers to a female patient of 60 to 65 year old. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, dose number lot/batch number, expiration date and route were not reported). On an unknown date, reported as months after the administration, the patient experienced shingles. No product quality complaint was involved. The outcome of shingles was unknown. The related between the event and ZOSTAVAX was not reported. Additional information has been requested.
This spontaneous report was received from a healthcare worker refers to 9 patient of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of M-M-R II (lot # L001336, Expiry date: 13-JAN-2017). No adverse effect were reported. This is one of the several reports from the same reporter. Additional information has been requested.
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent condition, concomitant drug and drug reactions/allergies were not reported. On 05-JUN-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route was not reported) lot # r024023, expiration date of 22-AUG-2019 for prophylaxis (product storage error). Other suspect therapies included sterile diluent (strength, dose, route of administration, lot/batch# and expiry date were not reported). No adverse effects were reported. There was a previous temperature excursion and the time frame and temperature was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter.
Patient is a student and she came into the clinic on 5/18/18 at 8:45 AM to get her second dose of her Varicella vaccine for school. Patient was given screening checklist for contraindications to vaccines for Adults, consent form, and the VIS sheet. Patient signed VIS sheet as I had my back turned preparing to give injection. After vaccine was given and I was walking patient out the lobby, she then stated that she is pregnant. I told patient I will let the Doctor know what happened and let her know if there is anything that will need to be done. I told the doctor and he said that we have to let the supervisor and or Manager know of what happened. After sending an email to the supervisor I called patient to let her know that she should not have receive the varicella vaccine while pregnant. Patient stated that she is five months pregnant at this time. I told patient that we will be following up with her in regards to this matter.
Delayed onset of redness, lump over site were vaccine was given. tender to palpation indurated.
(IV immunoglobulin given). Diagnosis post-vaccination viral syndrome R/O Guillain Barre syndrome. Flu-like symptoms & neck pain; headaches; loss of ability to support myself & loss of ability to walk: loss of ability to protect airway - visited emergency dept at hospital 2-11-13, then hospitalized at hospital 2-14-13 to 2-21-13. Required intensive unit care, monitoring multiple systems, IV meds, lab, MRI of head.
soreness; fatigue; increased blood pressure; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from company (manufacturer control number: EC-2021-089016), for BNT162B2. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown) dose 2 via an unspecified route of administration in Dec2020 as dose 2, single for covid-19 immunisation. Co-suspect reported as Lenvima 05Dec2020 to 05Dec2020 at 20 mg, daily for an unspecified indication. The patient medical history included Endometrial Cancer, had mild food poisoning from eating some bad peanut butter on 27Feb2021. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown) via an unspecified route of administration as dose 1, single for covid-19 immunisation. Concomitant medication was not reported. The patient experienced soreness, fatigue and increased blood pressure. On unspecified dates patient underwent lab test and procedure blood pressure measurement: increased and then improved. The clinical outcome of events soreness, fatigue were unknown and outcome of the event increased blood pressure was resolving. After soreness, fatigue these symptoms patient was stopped taking Lenvima for about 4 days resulting blood pressure improved. The action taken for Lenvima was temporarily withdrawn on 05Dec2020.  Follow-up attempts are completed. No further information is expected.
Slight dizziness; a slight breathing difference; heart palpitations; soreness in arm and shoulders; soreness in arm and shoulders; tiredness; This is a spontaneous report from a non-contactable consumer (patient). A 51-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration: not reported), via an unspecified route of administration, administered in arm right on 06Mar2021 10:45 as single dose for covid-19 immunisation (at the age of 51-year-old). The patient's medical history was none. Concomitant medication(s) included nortriptyline (as other medications in two weeks) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks, no covid tested post vaccination, no covid prior vaccination and no known allergies. Previously, the patient received first dose of PFIZER-BIONTECH COVID-19 VACCINE (Batch/Lot number and expiration was not reported), via an unspecified route of administration, administered in arm right on 13Feb2021 10:45 as single dose for Covid-19 immunisation (at the age of 51-year-old). On 06Mar2021 11:30, the patient experienced slight dizziness, a slight breathing difference and heart palpitations, and soreness in arm and shoulders, with tiredness. Not major issues but the patient thought should report them. No treatment taken. The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Patient states that his arm immediately started to hurt after receiving the vaccine. He says his whole shoulder hurts, and it is hard for him to lift his arm to shoulder height. He says he wakes up at night, because he rolls onto his left arm and the pain wakes him up. The pain has not changed or subsided since the end of September. Patient was recently hospitalized for an undisclosed reason, and he forgot to ask about it in the hospital.
Edema, erythema, pain, itching. Tx: Benadryl/ Motrin prn.
A few minutes after receiving the vaccine, the patient let me know that he had a warm sensation  from the injection site up to the left side of his neck and tightness of the left side of his neck.  I asked if he felt like his throat was closing and he said no.  At this time, I gave the patient a diphenhydramine tablet 25 mg tablet and a bottle of water and observed him.  I took the patient's blood pressure about 10 minutes later and it was 170/75. I asked if this was a normal level for him and he said when he took it last week it was 180 over something.  I continued observing the patient and took his blood pressure again in 10 minutes. It was in the same range. The patient left approximately 45 minutes after receiving the vaccine. He said that he was feeling better.  I called the patient to follow up at 3 pm. I asked if he was feeling better. He said, "I think I'm ok." I asked if he was still experiencing the symptoms from earlier and he said, "No, I left those symptoms in Massillon."
heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient (no pregnant) received the first dose of bnt162b2 on 24Mar2021 at 08:45AM (lot number: ER 2613) (at the age of 58-years-old) via unknown route of administration in Right arm at single dose for COVID-19 immunization; the second dose of bnt162b2 on 14Apr2021 at 08:45AM (Lot Number: ER 8735) via unknown route of administration in Right arm at single dose for COVID-19 immunization. Medical history included COPD, Emphysema, Asthma, allergy to egg. The patient received some medications within 2 weeks of vaccination. Patient previously took Eurithimycin and experienced stomache. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient did not have been tested for COVID-19. Patient experienced heart palpitations on 24Mar2021 at 10:30 AM. This event resulted in Life threatening illness (immediate risk of death from the event). Patient did not receive any treatment. This event did not result in death, hospitalization, disability or Congenital anomaly. Starting with the 1st Covid shot patient experienced heart palpitations. The second shot after one hour of vaccine patient also experienced heart palpitations but much more serious. Her heart rate was jumping from 40 bpm to 150 on 25Mar2021 and higher back and fourth for over 45 minutes. She was on the interstate on her way home. She thought she was going to die. Since then she now experienced heart palpitations which she had never had before and now some other side effects she had never had either. She still occasionally had heart palpitations. She was going to report this to her physician. The outcome of the event was Recovered with Sequel in 2021.  Follow-up attempts are completed. No further information is expected.
Soreness and discoloration around injection site developed shortly after the injection.  Over the next day, soreness and discoloration spread from shoulder joint to half way down upper arm. Within several hours of injection, developed difficulty in lifting or preforming weight bearing activities with arm and restricted mobility of shoulder. Discoloration has diminished, but soreness and limited motion remain. Some ease of pain is received with Tylenol.
allergic reaction; This is a spontaneous report from a contactable physician.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced allergic reaction in Dec2020.  No further details were provided.  The outcome of allergic reaction was unknown.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event allergic reaction due to temporal association. However patient past medical history regarding allergy would have been helpful for a meaningful causality assessment. Case will be reevaluated upon further information
loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (loss of taste). At the time of the report, AGEUSIA (loss of taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pfizer vaccine was administered outside of Facility- reported by patient- ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------------- R09.02 HYPOXIA 4/16/2023 SICKLE CELL ANEMIA W ACUTE CHEST SYNDROME T78.40XA ALLERGIC REACTION, INIT 9/16/2022 SICKLE CELL ANEMIA W ACUTE CHEST SYNDROME R09.02 HYPOXIA 4/16/2023 SICKLE CELL ANEMIA T78.40XA ALLERGIC REACTION, INIT 9/16/2022 SICKLE CELL ANEMIA
Stomach pain; Aslight headache before the first dose/headache was still bad; Threw up a significant amount approximately 4 ounce cup of bright red blood; Still not feeling well; Just sleeping; Not active; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMATEMESIS (Threw up a significant amount approximately 4 ounce cup of bright red blood) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) 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 medical history was reported).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced HAEMATEMESIS (Threw up a significant amount approximately 4 ounce cup of bright red blood) (seriousness criterion medically significant), MALAISE (Still not feeling well), SOMNOLENCE (Just sleeping), SLUGGISHNESS (Not active) and HEADACHE (Aslight headache before the first dose/headache was still bad). On 20-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain). On 04-Apr-2021, SOMNOLENCE (Just sleeping) and SLUGGISHNESS (Not active) had resolved. On 21-Apr-2021, ABDOMINAL PAIN UPPER (Stomach pain) had resolved. At the time of the report, HAEMATEMESIS (Threw up a significant amount approximately 4 ounce cup of bright red blood) and HEADACHE (Aslight headache before the first dose/headache was still bad) outcome was unknown and MALAISE (Still not feeling well) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included acetaminophen, aspirin and caffeine, Excedrin and adult Pedialyte.   On 02 Apr 2021, the patient woke up and threw up approximately 4 ounces of bright red blood. The patient's spouse called the emergency room (ER) who informed the spouse that was not uncommon, to have the patient come and recommended the patient drink adult Pedialyte and rest. The patient continued to feel unwell throughout the night. At 9:00 pm that evening, the patient was able to get up and eat.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Information has been received from a nurse concerning a 8 month old patient who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (lot # not unspecified). The nurse mentioned that on 10-MAY-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. Additional information has been requested,
Fever on set w 24 hrs. after vaccine, Tmax 104F. Associated symptoms of headache, decreased appetite, fatigue, dizziness. Duration approximately 5 days, relieved with MOTRIN and/or TYLENOL. No rash, no reaction at injection site.
resting heart rate 140 bpm (slowly came down to normal range within 24 hrs by 2/13/20 6AM),  oral temperature 101.2 degrees F (normal 24 hours later), body aches (lasted less than 12 hours), soreness at injection site (continues), redness at injection site (continues)
PATIENT PRESENTED 3 DAYS POST VACCINE FOR LEFT SIDED FACIAL SWELLING. AFEBRILE. BELIEVED TO BE SUBMANDIBULAR EDEMA. TREATED WITH AUGMENTIN PO X 10 DAYS.
Throat tightness 1 min post vax.  Taken to ED from vax site. No meds, observation x 4 hours.