chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SKIN HURTS; CHILLS AND FEEL COLD; HEADACHE; FEELS LIKE THE VACCINE ESCALATED HER TUMOUR; VISION ISSUE; MUCUS FROM HER EYES; TEARING UP/ NOT ABLE TO READ; SITE OF INJECTION PAIN; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included anxiety, and tumour, and other pre-existing medical conditions included patient reported that had undergone 28 radiations because she was not able to do surgery. The patient had a tumour, which was located in the eyes/nose region.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, and expiry: unknown) dose was not reported, frequency one total, administered on the left deltoid on 23-JUL-2021 for prophylactic vaccination. She took anti-convulsion medication because she thought she was going to have convulsion. Patient took anti anxiety medicine for anxiety. For the headache she had been using cold compress.  On 23-JUL-2021, the patient experienced site of injection pain. On 24-JUL-2021, the patient experienced vision issue, mucus from her eyes, feels like the vaccine escalated her tumour, tearing up/ not able to read, feel cold, chills and headache. On an unspecified date, the patient experienced skin hurts. All the symptoms that started on the day of report occurred at 10:30 am when she woke up. The patient informed of not having any symptoms from her tumour prior to the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chills, site of injection pain, vision issue, and feel cold, and the outcome of skin hurts, mucus from her eyes, feels like the vaccine escalated her tumour and tearing up/ not able to read were not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210753058-covid-19 vaccine ad26.cov2.s-feels like the vaccine escalated her tumour. 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, UNDERLYING DISEASE
Soreness at site that evening. Next day,  weakness and soreness in arm. Three days later, 3/20,  General fatigue and weakness in arm returned. Awakened several times each night with sweating and feeling overly hot. Temperature normal. No medication taken for any symptoms.
Cellulitis after vaccine. Has a growing red spot 4-5", on the site of her zoster vaccine from 3 days ago. Bigger than last night. Red and warm. No fever - evaluation by doctor today - treated with: cephalexin 500mg 1 cap 4x/day for 10 days.
INJECTION SITE ITCHING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced injection site itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injection site itching was not reported. This report was non-serious.
After vaccination - redness for approximately 1 day which resolved  Then starting 12/9/20 - Redness, and warm to touch at injection site with borders about 5 inches
after 1 week itching around site occurred followed by swollen hard area on arm 12cm in diameter below injection site which also became itchy and then irritated.  2 weeks post injection single hive in center of left palm of hand appeared.
Fatigue, headache, diarrhea, extremely high blood sugar.  Started May 13, 2022 after air travel.
Patient was given undiluted dose (0.2 ml) of Pfizer pediatric Covid vaccine (PEDS), mother and doctor were notified. At the time of notification no adverse effects were observed. Patient's mother was instructed to call if any adverse events occurred.
Dizziness for 4 days vomiting body aches and severe diarrhea
very sore arm; This is a spontaneous report received from a non-contactable consumer from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "very sore arm".  Additional information: The patient's age was reported as 72 (unit unspecified).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Limited AE; Patient seeking 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (Limited AE) and PRODUCT ADMINISTRATION INTERRUPTED (Patient seeking 2nd dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The relevant medical history/conditions, allergy, concomitant diseases and risk factor was unknown.     On 21-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Limited AE) and PRODUCT ADMINISTRATION INTERRUPTED (Patient seeking 2nd dose). At the time of the report, VACCINATION COMPLICATION (Limited AE) and PRODUCT ADMINISTRATION INTERRUPTED (Patient seeking 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant Medication use information was not provided by reporter.  Patient received 1st dose of primary series of Moderna Covid-19 on 21Dec2021. Patient seeking 2nd dose.  Treatment Medication use information was not provided by reporter.   Reporter did not allow further contact
feeling like she had a mild hangover; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number=1), for COVID-19 immunisation. The following information was reported: HANGOVER (non-serious), outcome "unknown", described as "feeling like she had a mild hangover".  Additional information: The patient was generally in good health, very excited to have received this vaccine and event took place after use of product (2nd COVID shot).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PT said these symptoms happened 2 weeks ago.  Symptoms include: severe leg cramps, left hip pain/cramp, shoulder pain on the same side of injection.  She also felt very fatigue and sleepy since 8/15.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 01-DEC-2017, the patient was administered an improperly stored dose of GARDASIL 9 injection, lot # N015089 with expiration date on 20-OCT-2019 (dose and route of administration were not reported). The administered dose of vaccine underwent a temperature excursion of 47.6 degrees Fahrenheit, which lasted for an unspecified time. There was no previous temperature excursion. A digital data logger was not involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1712USA008157: US-009507513-1712USA008158: US-009507513-1712USA008159: US-009507513-1712USA008160: US-009507513-1712USA008161: US-009507513-1712USA008162:
My daughter received the GARDASIL shot in December of 2008 she received the first and second shot. About two weeks after receiving the shots she began having hives I took her to the doctor they could not find a reason for her hives she was tested for everything, that was 4 years ago she is still receiving treatments for hives no known cause. A little while later she started with muscle and joint pain took her to the doctor. Test were ran no known cause. She is still under doctors care at this time for that, a short while later the headaches started, test were run no known cause, she is still under doctors care for the headaches, next, heart problems, went to the doctor test were ran no known cause, she is still under doctors care for her heart, she is also seeing a Gyn doctor because her hormones are messed up, my daughter is currently on medicine for all of these problems, 5 pills a day, severe fatigue, never feels good. My daughter was a happy healthy girl that was active she also played sports, now she can't do any of it! My daughter was fine until she took the GARDASIL shot! No health problems are in our family, and patient was very healthy. I know this GARDASIL shot has changed my daughter's life. I hope they will find a way to prove that this shot is what's doing this to all these girls and stop the use of it! I really hate to see what is going to be next on the list of health problems for my daughter in the future!
Information has been received from a consumer via an internet newspaper concerning her daughter who an unspecified date was vaccinated with a dose of GARDASIL. It was reported that the patient had been horrifically injured (unspecified injuries) by the GARDASIL. At the time of the report the patient's outcome was unknown. It was unknown if the patient sought medical attention. This is one of several reports from the same source. Additional information is not expected.
Breakthrough case admission after 2 vaccines 3/23/21 Pfizer LOt# ER2613;  4/13/21 PfizerLot# EW0150
This case was reported by a nurse via call center representative and described the occurrence of cellulitis in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis was unknown. It was unknown if the reporter considered the cellulitis to be related to SHINGRIX.  Additional details were reported as follows: The reporting nurse was the concerned patient. The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The reporter did not have any additional details for this event. The reporter did not consent to follow-up.
Fever x  1 day, terrible headache x1day, minor headache x3 days, left arm pain x 2days, swollen injection site x 5days, minor arm pain x 5 days
Patient stated that the day after vaccine (over 24 hours later) he experienced chest tightness and difficulty breathing.  He is still having these issues. I did instruct him to go to the hospital, but he refused at this time.
This is a spontaneous report from a contactable consumer via Pfizer sales representative. This consumer reported similar events for two patients. This is second of two reports. An adolescent female patient (age group 15 and 16) of unspecified ethnicity received a single dose of TRUMENBA via an unspecified route of administration, on arm on unknown date. Relevant medical history and concomitant medications were not reported. The patient experienced hot to the touch at the point of injection on unknown date. The outcome of the event was unknown.
Woke up not being able to feel arms and legs. Fell. Fractured wrist and hit head. Left wrist in a soft case. Might need surgery.
Nasal congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Mar2021 (Batch/Lot number: unknown) at the age of 45 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NASAL CONGESTION (non-serious) with onset 21Apr2021, outcome "recovering", described as "Nasal congestion". Therapeutic measures were taken as a result of nasal congestion.  Additional information: The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Treatment for the event included acetylsalicylic acid [ASPIRIN] on 21Apr2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Employee received vaccine on 01/22 and second dose was 02/12. Employee became symptomatic on 04/20. And tested positive with COVID on 04/23
big red mark at the injection side; pain; hardness on the injection side; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (big red mark at the injection side), VACCINATION SITE PAIN (pain) and VACCINATION SITE INDURATION (hardness on the injection side) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (big red mark at the injection side), VACCINATION SITE PAIN (pain) and VACCINATION SITE INDURATION (hardness on the injection side). At the time of the report, VACCINATION SITE ERYTHEMA (big red mark at the injection side), VACCINATION SITE PAIN (pain) and VACCINATION SITE INDURATION (hardness on the injection side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided by the reporter no treatment information reported by the reporter   This case was linked to MOD-2021-175643 (Patient Link).   Reporter did not allow further contact
This spontaneous report was received from a registered nurse and refers to an  unspecified number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates beginning in December 2015, the patients were vaccinated with doses of improperly stored VAQTA (lot # L023232, expiration date: 25-FEB-2017 and lot # K018181, expiration date: 04-JUN-2017; dose and route were not provided). The vaccine was exposed to temperature of 32 degrees Fahrenheit for 30 days. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient had no issues  first couple days post administration of booster dose.  But 3rd day after immunization she noticed swelling of arm just above elbow that was large enough to move. Patient decided to go to walk in clinic to have it looked at. Although it was not at the injection site, provider there told her it was still likely to have been caused by immunization and was injection site type reaction.  Instructed patient to take benadryl and contact them again if symptom did not improve.   Follow up with patient today and she reports swelling has gone down and doing better.
Adult Pfizer Bivalent dose was given incorrectly to the patient. Patient was put under observation for approximately 45 minutes and no adverse event was reported. Patient was called approximately 3 hours later and mother reported patient had fever and Tylenol was given by the mother but she said her daughter was ok and sleeping.
Patient called the pharmacy on 10/03/2020, more than 5 weeks after getting immunized to speak to the pharmacist. According to the patient she was still experiencing pain on the injection site. She also stated that her left arm was getting numb and tingly at times. Patient did not report having any soreness, erythema, or swelling around the injection site but attributes her pain to the vaccination since she claims she wasn't feeling like that prior to getting vaccinated. Pharmacist recommended using OTC analgesics for pain and to follow up with her primary care provider to rule out other possible etiologies.
Patient was given pneumococcal vaccine in right deltoid. Within 5 minutes he developed sever itching and redness at the injection site. Redness spread to upper arm, neck and face. Denies SOB/tongue or throat swelling. Patient was given 50mg oral diphenhydramine and observed in clinic. Symptoms began to resolve in 30 minutes. Urticaria Pruritus and Erythema (redness)
Cough, fatigue, generalized muscle weakness, gait dysfunction. Patient is a previously healthy 16 y.o. 4 m.o. male who presents with 3 weeks of progressive limb weakness. This follows an illness consisting of a dry cough and low grade fever 3 weeks ago. On day 5 of that illness, he went to see his pediatrician, and was found to be Influenza and Pertussis negative; his urine was normal. During the course of his initial URI symptoms, he reported feeling like his arms and legs felt heavy. This feeling has continued until now. He now has difficulty with gross motor tasks such as walking up stairs, and his sister remarks that she has seen him holding onto the wall at school to help him walk. He has also struggled with fine motor skills like brushing his teeth, writing, and combing his hair. The difficulty is because even small things "feel like a work out". He states that his weakness is worse with exertion and improves following rest. However, they have not noticed a temporal association with symptoms. Anytime he uses his muscles, he feels physically tired and his muscles are sore--as if he has just exercised. It is mostly his proximal muscles, but also distal muscle groups. On 11/30/18, he endorsed neck pain to his pediatrician, but has not had this at any other time. Notably, in the last two weeks he has lost 7 lbs without trying. He has been eating and drinking normally. Patient and his mother think the weight loss has been mostly muscle. He has had no fever, chills, difficulty swallowing, nausea, vomiting, chest pain, SOB, numbness or tingling, cold or heat intolerance, joint pain, rash, dry skin/hair/nails, change in mental status, or rash. At baseline, patient swims 6 days a week and is a straight A student. He experiences normal school stresses, but has had no recent major life changes. He has only been able to swim twice since this started. He has also missed a lot of school. He denies smoking, drug, and alcohol use. Interestingly, he was at a swim meet three weeks ago, after which he developed his initial symptoms. He states that he has a friend who was at the same swim meet and developed similar, but less severe symptoms (including muscle weakness) that resolved in 1 week. Recommendations were provided and discussed with the consulting service. This consult was staffed with the Pediatric Neurology attending who agrees with the above assessment and recommendations. Patient attended for therapy evaluation on 12-05-18 for evaluation of Extreme Muscle Weakness in Arms/Legs. The patient has attended 11 treatment sessions since the evaluation.
pt recvd vax; arm & joint pain;began approx 1 mo p/ vax;PC to MD who advised ice & some cream; says this was 1st & last shot;
Patient came for second dose of Moderna vaccine and upon reviewing PQCF the patient indicated that for his first dose during the 30 mins observation period he experienced difficulty swallowing and dizziness. The patient has a history of anaphylaxis with sulfa drugs. Patient did not inform of adverse event to his PCP nor the staff of the pharmacy. He was very nervous. He was advised to consult with his PCP the risk vs benefit of receiving his second dose and to inform us of the final decision for documentation. Second dose of vaccine was not administered until further communication between patient and PCP.
WOKE UP THROUGHOUT THE NIGHT MULTIPLE TIMES WITH NIGHT SWEATS; WOKE UP WITH CHILLS; 101.4 FAHRENHEIT FEVER; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: UNKNOWN) dose was not reported, administered on 29-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-OCT-2021, the patient woke up with chills. On 29-OCT-2021, the patient experienced 101.4 fahrenheit fever. Laboratory data included: Body temperature (NR: not provided) 101.4 F. On 30-OCT-2021, the patient experienced woke up throughout the night multiple times with night sweats. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from woke up with chills, and 101.4 fahrenheit fever, and had not recovered from woke up throughout the night multiple times with night sweats. This report was non-serious.
On 6/1/99 and 7/9/99, the pt had his 1st and 2nd .5 cc dose of Lymerix. About 4 months later, in November 1999, he developed sore muscles and stiff joints which became progressively worse. He went to a physician who used "ultrasound" to dx "inflammation". The pt was treated with an unknown NSAID. By April, 2000, he could "hardly get out of bed". On 4/3/00, he was seen be a physician who did tests. He was dx'd with polymyalgia rheumatica. He was found to have a very stiff hip and shoulder. On 4/5/00, he started on prednisone and after the 1st dose, his symptoms resolved. The physician did not think that the dx was related to Lymerix. The most recent information, received on 6/16/00, reports the condition of the vaccinee as completely resolved.
the patient requested the updated bivalend  moderna vaccine this morning and I gave her the regular moderna , I spoke with the patient over the phone explained what happened  she will be coming back after 2 month for it
pt recv vax & became hypotonic, hyporesponsive & bradycardic, required IPPV w/100% 02;transported to hosp;
Hospitalization: 3/13/2023 - 3/16/2023 (3 days) Presentation to the ED: Shortness of breath and cough worsening for the last 6 days COVID + date: 3/13/23 Treatment: inhalers, Robitussin DM Discharge to: HOME. 013L20A 1/18/2021 031L20A 2/15/2021 046C21A 9/24/2021 001M21A 4/11/2022 MODERNA BIVALENT 049D22A 10/12/2022
large hard lump in arm, redness, swelling, inflammation, tender to touch, painful attempted Benadryl,  acetaminophen, cold/hot packs,  still unresolved from treatment seeking medical care