chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a male patient 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: Unk) dose 1 total was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAR-2021, the patient had antibody test which showed no antibodies. The test was negative. The patient suspected immunological vaccine failure. The patient might repeat the antibody test again on 02-Apr-2021, which would be 28 days after receiving the vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lack of antibodies was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210404388-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Suspected Immunological Vaccine Failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 19May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 13Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Naproxin, reaction(s): "Drug Allergy".  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. No other medication was received in 2weeks. Anti-viral details: Brand was Paxlovid, Treatment start date was 08Jun2022, Treatment stop date was 11Jun2022, Indication for Treatment of COVID-19.   The lot number for [BNT162b2], was not provided and will be requested during follow up.
AFTER RECEIVING THE VACCINE SHE STARTED HAVING CHEST PAIN AND RAPID SHALLOW BREATHING.  ONSTIE EMS AND PHYSICIAN RESPONDED. EKG  APPEARED NORMAL, VITALS WITHIN NORMAL LIMITS. RECOMMENDED TO GO TO ER AND SHE WAS TRANSPORTED BY EMS
vision loss; post-herpetic neuralgia; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for post-herpetic neuralgia and vision loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event post-herpetic neuralgia and vision loss was not recovered. The causality assessment was considered as related by the lawyer.  Upon internal review, vision loss was determined to be medically significant.
UNDER DOSE; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 15 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, intramuscular, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, the subject experienced under dose. On 30-JUL-2021, the subject experienced product administered to subject of inappropriate age. On 30-JUL-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product administered to patient of inappropriate age, off label use and under dose was not reported. This report was non-serious.
This spontaneous report was received from a nurse practitioner refers to multiple unspecified patients of unknown gender and age. Information regarding their medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unspecified dates in 2016(reported as between February 2016 and April 2016), the patients were vaccinated with improperly stored doses of VARIVAX (lot # K010437, expiry date: 22-JUL-2016). Nurse reported that the vaccine underwent a temperature excursion in a freezer at -3.2 degrees Celsius for 2 hours and 13 minutes, which came back to its temperature range. No adverse events were reported. This is one of the eight reports received from the same reporter. Additional information has been requested.
numbness of entire lt leg x 6 days 5wks p/inj of 2nd vaccine;
Patient received flu shot. Upon returning to her workplace she experienced hives and difficulty breathing due to throat swelling. Patient was taken to emergency department and was given BENADRYL, epinephrine, steroids, and ZANTAC. Patient was given discharge BENADRYL, steroids, and ZANTAC. This information was taken from the mother. Attempted to contact patient and there was no answer. I left a message.
sore left arm; This is a spontaneous report from a contactable consumer.This is report 2 of 2. This consumer (wife) reported for a 62-year-old male patient (husband) that: A 62-years-old male patient received bnt162b2 (Solution injection; Lot Number: EM9810), intramuscular, administered in Arm Left on 02Feb2021 at 10:00 am (at the age of 62-years-old) as dose number unknown, single for covid-19 immunisation. Medical history included follicular b cell lymphoma from 2006 to an unknown date and cancer from 2006 to an unknown date. Patient did not receive any other vaccine with 4 weeks prior to vaccination. The patient's concomitant medications were not reported. The patient experienced sore left arm on 02Feb2021. Caller stated that her husband did not have any side effects aside from a sore arm. He had a sore left arm but it was not bad and the soreness recovered two days later. He did really good. AE(s) did not require a visit to Emergency Room or Physician Office. The outcome of the event was recovered on unspecified date in Feb2021.  Follow-up attempts completed. No further information expected.
This spontaneous report as received from a pharmacist refers to a 49 years old female patient with codeine allergy, back pain and depression. Pharmacist reported that on 14-MAY-2010 a patient who had a history of ongoing shingles, was vaccinated with one dose of ZOSTAVAX (lot number not provided) 0.65 ml, subcutaneous. Concomitant therapies included MOTRIN and NEURONTIN. Pharmacist stated that a year later, in approximately May 2011, after receiving the ZOSTAVAX vaccination, the patient developed a recurrence of shingle-like symptoms, including blistering and muscle weakness. Pharmacist noted that at the moment of the report, the patient was experiencing more shingle-like symptom episodes that are more frequent and have become more intense. The patient was treated with acyclovir (unspecified). Patient contacted the physician. The outcome of blistering and muscle weakness was reported as recovering/resolving. The relationship between ZOSTAVAX and the events was not reported. Additional information has been requested.
COVID vaccine breakthrough case. Moderna 9/21/21 048B21A and Moderna bivalent 12/14/22 AS7148B
Had flu shot on Tuesday 11/11/08.  Missed next day of school on 11/12 with nausea and vomiting.
This is a spontaneous report from a contactable physician reporting for herself. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced flu-like symptoms, body aches, diarrhea and fatigue all on an unspecified date with outcome of unknown. She had a dose of BONIVA one day after receiving pneumococcal 13-val conj vac.
Large lympe node on my left under arm. Tender and sensitive to the touch. Extremely painful.
Loss of use of left arm/shoulder.  Able to bend at the elbow but severe pain throughout arm.  Unable to lift arm away from body, up in air in front of body or behind body. As the day progressed it got worse, and I have since had tingling and numbness in my hand and fingers.   I went to my primary doctor on Friday, have done 3 days of prednisone. Have gotten some mobility back.  Still unable to lift arm more than 12? away from body. Cannot lift any weight using the shoulder muscles and still have pain.  Shot was administered far up on arm. Did contact CVS shortly after onset of symptoms to see if they were normal or to see what I should do. They said they would document my symptoms, and suggested I maybe seek advice from a walk-in or er as they hadn't heard of it before.
Patient received 100 mcg of moderna vaccine instead of the booster dose of 50 mcg Patient was notified and advised to call our office if any adverse events occur
her arms were itchy; has a big lump on her arm; her arms got red; her arms got sore; arm was almost black; sores all over it; Initial information received on 17-Mar-2022 regarding an unsolicited valid serious case received from a consumer/non-health care professional.  This case involves an unknown age female patient who experienced her arms were itchy, has a big lump on her arm, her arms got red, her arms got sore, arm was almost black and sores all over it while receiving vaccine diphtheria, tetanus and acellular pertussis vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect diphtheria, tetanus and acellular pertussis vaccine Suspension for injection produced by unknown manufacturer (lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination. Information on batch number was requested.  On an unknown date, after an unknown latency, the patient received the vaccine and her arms were itchy (Pruritus) before she got in the house. Patient went to the hospital and her arms got red and sore (Erythema) (Pain in extremity). Patient's arm had a big lump (Limb mass) and her arm was almost black (Skin discolouration) with sores all over it (Blister). Patient went to the pharmacy afterwards and was told to put alcohol on it. Patient also saw her nurse practitioner. Patient went to hospital for 17 days, starting on 06-Sep-2019.   Action taken with diphtheria, tetanus and acellular pertussis vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the events (her arms were itchy, has a big lump on her arm, her arms got red, her arms got sore, arm was almost black, sores all over it).  At time of reporting, the outcome was unknown for all events.; Sender's Comments: Sanofi company comment dated 17-Mar-2022: This case concerns an unknown age female patient who experienced her arms were itchy, has a big lump on her arm, her arms got red, her arms got sore, arm was almost black and sores all over it after receiving vaccine diphtheria, tetanus and acellular pertussis vaccine. Time to onset of the event is unknown. Information regarding condition at the time of vaccination, Site of vaccination administration,  medical history, concomitant medication, would be needed to rule out the alternative etiology. Based on the reported information, the role of an individual vaccine cannot be assessed.
Information has been received from a licensed practical nurse concerning a female (approximately 4 years of age to 15 years of age) who on 01-AUG-2007 was vaccinated with Zostavax (Oka/Merck, lot # 657558/0461U) instead of Varivax (MSD).  Subsequently no adverse experiences have been reported.  Unspecified medical attention was sought.  This is one of several reports received from the same source.  Additional information has been requested. The nurse reported in follow-up that the packaging for the ZOSTAVAX and VARIVAX was similar and the 2 vaccines were stored in the same freezer. The VARIVAX had run and the ZOSTAVAX was picked up mistakenly. The nurse hoped to avoid this event in the event. There have been positive results noted from the parents of the vaccinated child. Additional information is not expected.
Patient was given the incorrect dose.  Patient should have received 5-11 yr age group of Covid but received the 12+ age group.  Patient waited 15 mins after vaccine with no reaction noted.
I was pregnant when I got my second shot (due date (1/2/2022). I subsequently had a pregnancy loss that started on 5/19/2021.
fatigue, nasal congestion and body aches/tested positive with infection; fatigue, nasal congestion and body aches/tested positive with infection; This is a spontaneous report from a contactable physician.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Dec2020 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. On 15Dec2020, the patient reported possible personal exposure (close contact / dinner with friend who tested positive on 18Dec2020, both unmasked) and received Covid vaccine on 16Dec2020. The patient reported fatigue on 17Dec2020, nasal congestion and body aches on 18Dec2020. He tested positive with infection control MD and had monoclonal Ab administered same day (18Dec2020). He wanted to know, what this means for his scheduled second vaccine and if needs to wait 90 days from positive Covid. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.; Sender's Comments: 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.
I had an abnormal headache, and I had excruciating pain in the left arm 24 hours after the injection.  BUT, I was more concerned with the "Covid Rash" or "Covid Arm" i had developed.  I noticed Friday morning after my injection a large red splotch under my injection site.  It didn't itch or hurt, but was abnormal.  We looked up vaccine reactions and found realized I had the covid rash.
Increased difficulty with feedings. Had initially subsided before visit, and then parents report significant increase in difficulty with feedings again.
Ive had canker sores all my life / I think you know about another thing it seems to work for! / It been 4 months now If this works for everybody you mightve come up something you accidentally didnt kn; This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic drug effect in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 4 months after receiving Shingrix, the patient experienced unexpected therapeutic drug effect. On an unknown date, the outcome of the unexpected therapeutic drug effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic drug effect to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had two shots to protect against shingles  The patient had canker sores all my life nothing seems to really work when was younger and went to for help when was in a service and then had gone to nothing worked since second shot of shingrix have not had one canker sore. The patient drink orange juice pop and take ibuprofen which it always make them worse and still have none The patient asked  If this works for everybody might have come up something accidentally did not know would work.
Mild rash at site of varicella vaccine 5-8 sl - raised pink papules -2mm in diameter, with surrounding pink skin, no warmth, no vesicles no signs of discomfort
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was unknown. Since 15-MAR-2015 doses of M-M-R II (lot #, strength, dosage, frequency and route unspecified), which were exposed to temperatures outside of the recommended range, had been administered to the patients (incorrect product storage). The reporter was not aware of any adverse experiences. This is one of several reports received from the same reporter. Additional information has been requested.
The patient has persistent pain in the left deltoid muscle region when she uses her upper arm. The pain is sharp and lasts seconds, but can happen multiple times per day. It has not improved since she received the vaccine. I am referring her to orthopedics for possible injury. I recommended ibuprofen and moist heat.
he has experienced tingling sensation in his fingertips and his nails; weakness in his arms; This is a spontaneous report from a Contactable consumer. A male consumer (patient) of an unspecified age received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247 and Expiry date: Unknown), via an unspecified route of administration from 27Jan2021 as a SINGLE DOSE for covid-19 immunisation.  Medical history included covid-19 from Nov2020.  By 02Dec2020 he was fine and back to work.  The patient's concomitant medications were not reported.  The patient experienced tingling sensation in his fingertips and his nails on 28Jan2021 with outcome of unknown and, weakness in his arms on 28Jan2021 with outcome of unknown.  He says it takes extra effort to move his arms.
15NOV91 tingling fingers & toes lt side numbness rt hand & foot; fatigue & muscular weakness; inc temp speech became more difficult; 19NOV91 placed on ventilator, only able to move lips shrug shoulder (tracheotomy); pneumonia;
Patient states he began to feel facial flushing  approximately 30 minutes after receiving injection. This was followed by a rash, spreading from torso down. He took 2 Benadryl tablets, fell asleep, and awoke after 2 hours. When he woke the  facial flushing and rash was resolved.  He also reports that on the morning of the following day, he was drinking coffee and noticed the facial flushing returning, then his arms started breaking out in the rash.  He took 1 Benadryl tablet and these symptoms resolved.
pt at home with c/o SOB; EMS called; pt went into cardiac arrest; CPR performed x7mins with ROSC; transferred to hospital; in ED pt lost pulse again; 3 mins of CPR with ROSC achieved; intubated; found to be positive for COVID; given ABX and methylprednisolone; pt without improvement; comfort measures; pt intubated and passed away in the hospital
Woke up on 11/29/2022 and felt heart fluttering, checked apple watch and it said I was experiencing an irregular heart beat. Called my doctor and went to his office for an Electrocardiogram the next day. Test showed I was in Afib. Having another Electrocardiogram and Stress test on 12/23/2022. Was prescribed ELIQUIS and metoprolol.
From initial information received on 28/Aug/2003 from a health care professional regarding an adverse event occurring the U.S.A., it was reported that a 15-year-old female patient received TD ADS adult, lot number U0839AA, administered intra-muscularly in the left deltoid on 07/Jul/2003. 49 days later, on 25/Aug/2003, the patient developed a 5 cm x 3.5cm hyperpigmented patch with skin induration at the injection site. The patient was scheduled for an appointment with a dermatologist. The patient's recovery status is unknown.
Nothing happened until days later when I got COVID-19, I was exposed the day before that I was golfing, I got tired, on October 1st, the next morning I felt very fatigue, tired and sore throat, I had a Home Test for COVID-19, and I tested Positive. I called the doctor, and he prescribed medication. I started taking it that evening, went to bed and that night it was really bad, a headache, body pain and overnight, the next morning I was very fatigue, a little caught and headache.