chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (parent) reported two reports for herself and her son. This is one of the two reports. An 18-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 28Apr2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the 2nd dose of the Pfizer covid vaccine yesterday on 28Apr2021. He had a fever in Apr2021. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient), via a Pfizer-sponsored program (159558). A 69-year-old female patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), at the age of 69, single dose, for COVID-19 immunisation. The patient's medical history not reported. There were no concomitant medications. The patient developed chills/felt chills after 1st dose, with outcome of unknown. Additional information: 2nd dose scheduled on Friday, Mar 12, 2021. She felt chills after 1st dose. She stated she went to the doctor and needs an echocardiogram. She will be getting this done today. She stated they don't inject anything and are only scanning her heart. She is also getting a stress test done next week, after the second dose of the vaccine. She asked if it is a problem to get the echocardiogram and get the vaccine on Friday. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
My feet are cold as well feeling of left foot tingling when sitting or laying down.; Chest pains; Lightheadedness; My feet are cold as well feeling of left foot tingling when sitting or laying down.; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EM9810, Expiration date was not reported), via an unspecified route of administration, in left arm on 19Feb2021 12:45 as single dose for covid-19 immunisation. Medical history included gout. Concomitant medication included allopurinol taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced Known allergy. Patient did not receive other vaccine in four weeks. Patient did not have COVID prior vaccination. Patient did not test COVID post vaccination. Patient experienced chest pains lasting 2 hours with light headedness, slow talking as well. Patient went to ER for this and when inlaid down the chest pain went away. ECG was normal as well as all blood work. Still feeling slight light headedness, the following day sporadically and my feet are cold as well feeling of left foot tingling when sitting or laying down on 23Feb2021 08:00 AM. Patient did not receive treatment for adverse events. The outcome of the events was recovering.
Out of breath; Arm soreness; Headache; Felt tired; Got COVID-19 after 2 doses of Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got COVID-19 after 2 doses of Moderna COVID-19 vaccine), DYSPNOEA (Out of breath), INJECTION SITE PAIN (Arm soreness), HEADACHE (Headache) and FATIGUE (Felt tired) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Hypercholesterolemia and Prostate infection.   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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced COVID-19 (Got COVID-19 after 2 doses of Moderna COVID-19 vaccine). On an unknown date, the patient experienced DYSPNOEA (Out of breath), INJECTION SITE PAIN (Arm soreness), HEADACHE (Headache) and FATIGUE (Felt tired). In October 2021, COVID-19 (Got COVID-19 after 2 doses of Moderna COVID-19 vaccine) had resolved. At the time of the report, DYSPNOEA (Out of breath), INJECTION SITE PAIN (Arm soreness), HEADACHE (Headache) and FATIGUE (Felt tired) had resolved.            Concomitant medications include diabetic, cholesterol medicines, sugar pill, water pill, prostate medicine. All conditions are controlled. No treatment medications provided by the reporter.  Caller gotten both Moderna shots but his wife did not. Wife just got 1st Moderna shot on 10-Nov-2021. Mentioned that he got the shot about 8 months ago. Did not provide any information on the 2 shots he gotten (including the exact dates of vaccination, lot number and expiry date). Patient was quarantined for 10 days after diagnosed with COVID-19.  This spontaneous case concerns a 72-year-old male patient with no relevant medical history reported, who experienced non-serious unexpected event of special interest  COVID-19. The event occurred unspecified time after the second dose of the Moderna COVID-19 Vaccine (mRNA-1273). Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.; Sender's Comments: This spontaneous case concerns a 72-year-old male patient with no relevant medical history reported, who experienced non-serious unexpected event of special interest  COVID-19. The event occurred unspecified time after the second dose of the Moderna COVID-19 Vaccine (mRNA-1273). Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.
PATIENT C/O GENERALIZED ITCHING ALL OVER BODY.  ALSO REPORTED TINGLING(PINS AND NEEDLES FEELING) ON BACK, UPPER ARMS, AND KNEES.  KNEES ARE STILL TINGLING AS OF 9/1/2021, SHOT GIVEN 8/12/21.  PATIENT ALSO REPORTS HAVING AN OUTBREAK OF GENITAL HERPES.  AND REPORTS HAVING INCREASED DIFFICULTY SLEEPING.  ALL SYMPTOMS HAVE RESOLVED EXCEPT FOR SOME MILD ITCHING, STILL HAVING INSOMNIA ALTHOUGH SHE STATES SHE SUFFERS FROM THIS REGULARLY AND STILL EXPERIENCING NUMBNESS/TINGLING IN KNEES
I had soreness in my arm after receiving the vaccine for about a day.  I have trouble with fatigue with muscle and joint soreness.  I try to rest as much as I can and need to help with the symptoms. For a short time, I had hair loss but that has stopped. If I start with a good day and overdo it my symptoms are worse.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with PEDVAXHIB (dose, lot and route were not reported) which was improperly stored outside the temperature stated in the prescribing information. No adverse reactions reported. This is one of multiple cases from the same reporter. Additional information is not expected.
Patient described a red knot the size of a baseball at the injection site that started itching approximately 2 hours after the administration and noticed the knot the next morning while taking a shower. Patient was referred to primary care provider for treatment if needed.
Major headaches | Migraines for 3 days Fever for 2 days day 2-3 Fatigue for 4 days starting about 4.5 hours after administration of injection lasting for 4 days with days 2-3 being the worst On day 3-5 dizzy spells On day 2-3 harder to take deep breaths pulse ox was measuring normal
DEATH; This spontaneous report received from a consumer by a company representative via social media   and concerned a male of unspecified age, race and ethnicity. 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, and batch number were not reported, expiry: unknown) dose was not reported, 1 total (first dose), start therapy date was not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. Reporter reported that " Ummm, no. You dirty rats killed my uncle with your clot shot". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20221052157- covid-19 vaccine ad26.cov2.s- Death. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
passing out- great pain,= caused gout...not in 2022 & 2023 auto immune compromised, acerbated arthritis...now has caused Thyroid issues...enlarged thyroid and nodules
Ongoing Hives, itchy/rashy skin.  Administered hydroxyzine, loratadine, Allegra, cetirizine, famotidine and a steroid.  None effective at relieving symptoms.
Red, hot, swollen area around 3 inches across at injection site appeared the morning after the injection. Chills, low grade fever, nausea, headache, fatigue, body aches developed later the same day. The day after the injection was the most severe for side effects. Some remained on the following day.  By day 3, most symptoms had resolved except for some redness and itching at injection site. I notified the clinic of my reaction.
p/vax pt exp tender skin; T101.4; nausea; severe abdominal pain; elevated sed rate & elevated platelets; symptoms lasted 6 days; 25day later pt exp T100.7 & severe stomach ache;
No other adverse effects were reported in the patient; received a dose of GARDASIL-9 in March 2020 (exact date not specified) and is currently at the pharmacy to get the second dose in the 3-dose series; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. In March, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) at a dose of  0.5 milliliter for prophylaxis(strength, frequency, lot # and expiration date were not provided) for prophylaxis.  It was reported that on 14-JUL-2020, the patient was at the pharmacy to get the second dose in the 3-dose series. No other adverse effects were reported in the patient.
Initial report received from a health care professional on 15 August 2011. A 2-year-old female patient with no pre-existing medical history, was seen for well child visit on 13 August 2011 and received a 4th left thigh dose of DAPTACEL (lot number C3618AA, route not reported) and 2 days later was found to have cellulitis with abscess, unspecified erythema, swelling, and it was reported the patient was "allergic to drug (unclassified)". The site of the events were not reported. The patient required a physician visit and was prescribed OMNICEF. It was not reported whether any diagnostic tests/laboratory data were performed. It was noted the patient had received a dose of PEDVAXHIB (Merck) with no reported adverse event on 02 July 2011. At the time of this report, it was unknown if the patient had recovered. Documents held by sender: None.
PASSED OUT 3 MINUTES AFTER RECEIVING THE VACCINE; This spontaneous report received from a consumer concerned a male of unspecified age. 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: unknown) dose was not reported, 1 total, administered on 01-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-SEP-2021, the patient passed out 3 minutes after receiving the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of passed out 3 minutes after receiving the vaccine was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210923877.; Sender's Comments: V0: 20210923780- Covid-19 vaccine ad26.cov2.s-passed out 3 minutes after receiving the vaccine. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Very weak, all joints ache, pain, woke up during sleep, pain brought tears, pain radiate shoulders to fingertips. Swollen fingers, very sore buttocks after 15 minutes sitting. Except knee its (artificial).
Had shot 10:30. Felt bad in afternoon. Was sick by 8:00. Went to hospital. Stayed 5 days. Was hospitalized all week. Couldn't walk without help. Was sent to nursing home for rehab. I'm still on walker. I am permanently/disabled. I was allergic to something in shot. I saw a story about VAERS and flu shots in newspaper. I decided to tell you about myself.
extreme sleepiness (for 2 days), stomach pain (for 5 days), leg pain (1 day); scan on injection site (still present on 4/21/21 - 13 days post vaccine).
Soreness, redness at injection site.  Next day: circle of redness about 4" diameter and tired.  Next swelling, hot feeling and rash down arm from injection site almost to elbow
Information has been received from a registered nurse concerning a 65 year old female, weight 147 pounds height 61 inches, with a history of oral cold sores who on 29-MAY-2008 at 13:30 was vaccinated with the first dose of ZOSTAVAX (Oka/Merck) subcutaneously (lot#: 659614/0161X). There was no concomitant medication. Within an hour after vaccination, the patient stated she had a "cold sore" on her lip. The patient had a history of cold sore on lips, but she stated it had not occurred in awhile. The patient felt strongly it was related to the vaccine. She was unable to take her anti-viral medication due to the vaccine. After 2-3 days, the patient recovered from cold sore on lip. It was unspecified if the patient sought medical attention. Additional information is not expected.
pt recv vax & pt devel approx 20 lesions which were treated w/DPH & calamine lotion;pt was afeb;
RHEUMATOID ARTHRITIS/INFLAMMATION IN THE JOINTS; INFLAMMATION LOCALIZED; DEVELOPED A COUPLE OF PATCHES OF PSORIASIS; This spontaneous report received from a patient via a company representative concerned an adult female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis, and other pre-existing medical conditions included: There was no medical history reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry date were not reported) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number and expiry date were not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced rheumatoid arthritis/inflammation in the joints, pain/ pain aggravated/increased achiness, inflammation localized (in rib area), developed a couple of patches of psoriasis, and fatigue. Treatment medications (dates unspecified) included: etanercept. The events were resistant to topical with humira. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with adalimumab was withdrawn. The outcome of the rheumatoid arthritis/inflammation in the joints, inflammation localized and developed a couple of patches of psoriasis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220351371-covid-19 vaccine ad26.cov2.s -Rheumatoid arthritis/inflammation in the joints The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. Therefore, this event(s) is considered not related.
Information has been received from a physician concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 01-MAY-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 12-NOV-2012 the patient was vaccinated with ZOSTAVAX, 1 DF, (lot# and route unknown) for the prevention of shingles. Within the week, the patent began to exhibit symptoms of shingles, including pain and rash on the right side of her body within three days of the vaccination. The painful rash continued to spread until the patient visited her physician, and was diagnosed with shingles on 21-JAN-2013. The pain and symptoms spread to the patient's head, including decreased eyesight in her right eye, pain in her jaw and lip, and headaches. The patient was subsequently diagnosed with trigeminal neuralgia, which required neurosurgery. The patient's injuries continue to this day. As a direct and proximate result defective ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using this product, including cognitive issues, poor memory, drooping eye and vision loss, inability to drive, physical pain, inability to work on a routine basis, and migraines. The patient also experiences mental and emotional distress due to resulting physical limitations from, and seriousness of her condition. The patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX.  The events of herpes zoster, trigeminal neuralgia, cognitive issues, poor memory, drooping eye, vision loss, inability to drive, physical pain, inability to work on a routine basis, migraines and mental and emotional distress were considered disabling.   Upon internal reviewtrigeminal neuralgia, which required neurosurgery and vision loss were considered medically significant events.  Additional information has been requested.
This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9 (lot # M036059 with expiration date of 03-JUN-2019; strength, dose, route and anatomical location were not provided), for prophylaxis. The vaccine was exposed from 47 degrees Fahrenheit to 77 degrees Fahrenheit for 12 hours. There was no previous temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA008817: US-009507513-1707USA008818: US-009507513-1707USA008819: US-009507513-1707USA008862: US-009507513-1707USA008863: US-009507513-1707USA008793: US-009507513-1707USA008820: US-009507513-1707USA008821: US-009507513-1707USA008839: US-009507513-1707USA008864: US-009507513-1707USA008865: US-009507513-1707USA008794: US-009507513-1707USA008822: US-009507513-1707USA008823: US-009507513-1707USA008840: US-009507513-1707USA008866: US-009507513-1707USA008867: US-009507513-1707USA008795: US-009507513-1707USA008824: US-009507513-1707USA008825: US-009507513-1707USA008841: US-009507513-1707USA008868: US-009507513-1707USA008869: US-009507513-1707USA008796: US-009507513-1707USA008826: US-009507513-1707USA008827: US-009507513-1707USA008828: US-009507513-1707USA008842: US-009507513-1707USA008870: US-009507513-1707USA008797: US-009507513-1707USA008829: US-009507513-1707USA008830: US-009507513-1707USA008843: US-009507513-1707USA006643: US-009507513-1707USA008799: US-009507513-1707USA008831: US-009507513-1707USA008832: US-009507513-1707USA008844: US-009507513-1707USA008845: US-009507513-1707USA008800: US-009507513-1707USA008833: US-009507513-1707USA008801: US-009507513-1707USA008802: US-009507513-1707USA008834:US-009507513-1707USA008846: US-009507513-1707USA008803: US-009507513-1707USA008804: US-009507513-1707USA008835: US-009507513-1707USA008847: US-009507513-1707USA008848: US-009507513-1707USA008805: US-009507513-1707USA008806: US-009507513-1707USA008849: US-009507513-1707USA008850: US-009507513-1707USA008807: US-009507513-1707USA008808: US-009507513-1707USA008851: US-009507513-1707USA008852: US-009507513-1707USA008853: US-009507513-1707USA008789: US-009507513-1707USA008809: US-009507513-1707USA008810: US-009507513-1707USA008854: US-009507513-1707USA008855: US-009507513-1707USA008790: US-009507513-1707USA008811: US-009507513-1707USA008812: US-009507513-1707USA008836: US-009507513-1707USA00885.
After the second shot, she has had ongoing headaches and painful swelling in her extremities that comes and goes.  For instance, one day her entire palm of her hand, the next day her fingers, the next day the sole of her foot, a few days later it will be just one finger. It is very odd, but she has never had this issue. Also, she has never suffered from headaches until after this second shot. This has been going on for almost a month. We don't know what to do about it.
No Adverse event. Error in giving vaccine.  Vaccine was given after 6 hours of puncture of vial and had expired for over 30 minutes.  Spoke with Janssen manufacturer and also CDC guidelines no data available for vaccine stability and will revaccinate patient asap.  Patient was contacted and explained situation, appt. was made for patient to return for revaccination.
About 4 hrs post immunization, parents checked on their child to determine temp; Temp 100.6(R) given APAP; Child picked up then turned white;