chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed a constellation of generalized itching, mild skin rash, injection site soreness, throat and chest tightness. Episodes 24 to 48 hours after a Td injection at her primary care clinic. Pruritus started 07/08/2006 and ended 07/13/2006, it was generalized and started about 24 hours after shot. Rash, focal, started 07/08/2006 and ended 07/13/2006, it was a few itchy papules on the forearm. Chest tightness started 07/09/2006 and ended 07/09/2006, episodes staring 48 hours after shot and resolved by the following day.
Feeling extremely cold, shivering, fever of 99.3, feeling nauseas time 11:30 p.m. Fever of 99.9 at 12:15 a.m.. One tablet Tylenol, 500 mg at 12:20 a.m. Temperature at 1:45a.m. 98.4
Chest pain, difficulty swallowing, choking sensation, stomach and abdominal pain.  Heart stent Oct 5, 2022. Heart stent April 26, 2023. Medication for esophageal spasms. I continue to have constant stomach and abdominal pain and cramping, causing difficulty sleeping and ruining normal life. I had never had GI problems of any kind my entire life until September, 2022. The two heart stents seem to have been effective, though test show it is likely that I had irreversible heart damage between October and April.
From correspondence received on 11/14/01, it was reported that a 65 year old male patient received a Fluzone SV '01 -'01 vaccination on 10/29/01. Approximately 3 days post vaccination, the patient experienced severe myalgia in neck, shoulder and pelvic region ,mainly in proximal muscles of the body. Had difficult getting up in morning due to stiffness. After he got up and moved around an hour or two later would be more functional but some discomfort was still present. Symptoms persisting until the present with little improvement in the neck muscles at this time.
DEATH; BLOOD CLOT; This spontaneous report received from a consumer news/social media platform concerned a 5 decade old female. 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, 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. No concomitant medications were reported.  On an unspecified date, the patient developed a rare blood clot and died within two weeks of getting the Janssen covid vaccine. On an unspecified date, the patient died from unknown cause of death. It was unknown whether autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to.; Sender's Comments: V0-covid-19 vaccine ad26.cov2.s-This case concerns with 5 decade old female. Death, Blood clot. This event(s) is considered unassessable. The event(s) 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(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Patient says she has chronic shoulder pain which started about 3 days after vaccination. Pt states she is 108 lbs and we suspect SIRVA resulting from using a needle too long for injection
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 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jul2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The patient did not receive other medication in two weeks. Past drug history included: Erythromycin, reaction(s): "known allergies: Erythromycin", notes: known allergies: Erythromycin; Levaquin, reaction(s): "known allergies: Levaquin", notes: known allergies: Levaquin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid from 11Jul2022 to 16Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Initial reaction after first vaccine shot was awful headaches--worst I ever had. This lasted for a couple days. The most bothersome adverse event happened and continues to happen since the second vaccine shot. I will more frequently get lesions on my face. What may look like "acne" outbreaks are not what I remember from my youth. If a pimple pops, it doesn't look like a normal pimple and just heal. It looks like a lesion and it begins to "weep" clear fluid for a few days and takes about two weeks or more weeks to heal. This has been on going and persistent. Doctors and specialists did not think the vaccine had anything to do with it. Dermatologist just prescribed creams to treat the symptoms. It wasn't until I started doing more research that I tried taking different supplements and settled on something that mitigates these effects where it now takes about a week to fully heal and the area of the outbreak is not as large. Before I took supplements and would get outbreaks, it would be bad to the point that I would have to go to urgent care to get seen or schedule emergency dermatology visits.
This spontaneous report was received from a medical assistant referring to an 18 year old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 20-MAR-2018, the patient was administered an improperly stored GARDASIL 9 (lot reported as: N026814; Expiry date: 15-JUL-2020 and lot reported as: N021572; Expiry date: 01-MAY-2020) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 47 °F to 77°F (67.3°F) for 10 hours, 30 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several cases received from the same reporter.
Dose administered from a vial that was more than 30 days on the fridge; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Dose administered from a vial that was more than 30 days on the fridge) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT STORAGE ERROR (Dose administered from a vial that was more than 30 days on the fridge). On 20-Sep-2021, PRODUCT STORAGE ERROR (Dose administered from a vial that was more than 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Vaccine Facility type was health clinic.  No Concomitant medication was reported. No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Updated patient initials. Added patient demographic include Updated Gender, Race information, Ethnic group. Updated Vaccine Facility Information.
46 y.o. male RN hospitalized with elevated BP, chest pressure and severe headache on 25 February following vaccination on 24 February, about 10:15 hours. Recipient states that about 45 minutes after vaccination he developed arthralgias/myalgias. By the evening he was felt fatigued as well, and had to lie down during his night work shift. He woke up at ~1300 hours on  2/25, post-vaccination day 1, with the worst headache of his life, which was somewhat remittent or intermittent over the next few hours. He went back to bed, and when he arose at 1500h he felt chest pressure. His BP was found to be 230/120's. He was transported by ambulance to the ER, and subsequently admitted. The headache was apparently attributed to the elevated BP, and he received IV beta blockers beginning in the ER after Nitroglycerine in the field. Chest pressure resolved, patient undergoing cardiology evaluation. Headache apparently persists, ? improved.  Recipient has a history of "borderline HTN" for which he intermittently takes Lasix and KCl, according to his BP monitoring. Runs 120's-150's systolic. Denies other cardiac risk factors.   Had been in usual state of good health. Was getting over a cold which started about a week before. No organ-system specific symptoms suggestive of incipient infection. Was seen by ID physician as well as cardiology because of history of recent vaccination (came in as "possible smallpox vaccine reaction".   Patient denies other medical problems. Allergy to Naprosyn. Reports fever and unusual arm pain after influenza vaccination last autumn. One previous smallpox vaccination, infancy or early childhood.  Patient in hospital and doing well.
Swelling, redness, warmth, area of firm lump, pain, itching continued to increase over four days despite elevation of arm, Benadryl and application of ice.  Seen by physician on 4th day, who prescribed Keflex 500mg four times daily.  Day 6, lump remains though smaller, warmth and erythema remains.
Pt recvd vax & exp swollen & sore elbow & forearm 1 wk p/3rd shot;
Rash between 3 to 6 inches reported by patient around injection site about two days after shot. Called to check with patient Sunday 4-1-18 and she said rash is slowly getting better. She did report chills and possible headache as a possible side effect as well. Patient contacted dr office on 3-30-18 and they told her to take BENADRYL and will see her this week sometime according to patient.
1st Adverse reaction after 2nd shot: On April 7th, 8th day, after the second vaccine, I experienced starting with  nausea, intense headache, abdominal discomfort, vomiting and chills.  My head was spinning and had to lay down for my headache became a migraine. 2nd Adverse reaction after 2nd shot: On April 13th, 14th day after the second vaccine, I experienced a feeling of not well-being and fatigue.  That afternoon I had to crash and slept for 4 straight hours in the afternoon.
Pt reported tightness in throat the night of vaccine administration, redness, pain, and warm to the touch at injection site for all vaccines administered except the skin test site.  Pt was seen by provider today with instructions to follow up in one week.  Pt was discharged
LOSS OFBLADDER CONTROL; IRREGULAR HEARTBEAT; This is a spontaneous report from a contactable other hcp. A 56-year-old female patient started to receive bnt162b2 (BNT162B2, Solution for injection, Lot # EL9261), via an unspecified route of administration from 29Jan2021 to 29Jan2021 at SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On Jan2021, the patient experienced loss of bladder control, irregular heartbeat. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was not recovered.
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 27-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No medical history provided by Reporter.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 22-Aug-2020 and the estimated date of delivery was 28-May-2021. On 24-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirtieth week of the pregnancy.  On 24-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. Not Provided      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 drugs were not provided
I had my vaccination on 09/07/2022. On 05/08/2023 I had a sore throat and not like one I have ever had before. It hurt around the circumference of my inner throat and I had a stuffy nose. On 05/09/2023 I was weak fatigued and called my doctor. I tested COVID-19 Positive on 05/09/2023. I was prescribed Paxlovid. I presently feel fine on 05/16/2023.
12 year Patient received Td when he should have received Tdap vaccine. Physician was consulted. The Td was appropriate for the age of the Patient, but the Tdap was required.  Patient did receive the Tdap vaccine, as directed per Physician. There were no Adverse outcomes from the vaccines administered,  other than the Patient received the wrong vaccine.  As soon as the error was discovered, the Parents, the Nursing supervisor and the Physician on call was notified.
About 24 hours after vaccine administration I broke out in severe hives on my arms and legs.  It appeared to be a rash all over the extremities with large red raised blotches that itched and burned severely.
severe inflammation in the mouth; severe inflammation in the  eyelids; rash on head; body ache; torso with itchiness; This is a spontaneous report from a contactable consumer (Patient).   A 74 year-elderly-male received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: ER2613,) via an unspecified route of administration into arm left (at the age of 74 Years) on 20Mar2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history included Type -2Diabetes and hypertension. The patient concomitant medication included Losartan, Fish oil (OMEGA 3 EPA), Bezafibrate and Atorvastatin. It was reported that patient had no known allergies and did not take any vaccination within four weeks of vaccination. The patient underwent with covid test after vaccination. The patient previously took bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: EN6198) via an unspecified route of administration into left arm on 27FEB2021at 09:45 AM as DOSE 1, SINGLE for covid-19 immunization and experienced that I followed the recommended protocol by the responsible staff of vaccinations, applied first dose I waited 15 minutes, no secondary effects were manifested or allergic reactions; after 8 days, I noticed severe inflammation in the mouth, eyelids and rash on the head and torso with itchiness, body ache; she didn't consider a reaction to the vaccine, but an allergy for having eaten almonds although there was no background (it was a mistake having considered it an allergy);she told a known doctor about the problem, who prescribed "Loratadine" and diet without fats, strawberries, eggs, dairy and chocolates; there was improvement and symptoms disappeared. After the administration of second dose on 28 mar2021 at 14:00 pm the patient had experienced severe inflammation in the mouth, eyelids and rash on the head and torso with itchiness, body ache. On 29 mar2021, the patient underwent lab test and procedures which included SARS-CoV-2 test via Nasal swab and diagnosed with negative results. Therapeutic measures were taken for the AE and treatment included with Loratadine" and diet without fats, strawberries, eggs, dairy and chocolates. The outcome of the events was recovered.  No follow-up attempts are needed. No further information is expected.
Four days after vaccination, patient began vomiting, had bloody stools, diagnosed with intussusception, patient required surgery.
Pt came into office. Patient got flu/pneumonia vaccines. 15 min after administration she went into an anaphylactic reaction. The nurse was called in where she was given epi/ and BENDARYL. O2 was applied. Ambulance was called and patient was taken to the hospital.
39 patients administered with the Moderna COVID 19 vaccine that have past the expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (39 patients administered with the Moderna COVID 19 vaccine that have past the expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (39 patients administered with the Moderna COVID 19 vaccine that have past the expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (39 patients administered with the Moderna COVID 19 vaccine that have past the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   Number of doses/vials: As per reporter if it was 14 doses per vial, there would be 3 vials impacted. Date(s) of administration of vaccine: 01-Sep-2021 and 08-Sep-2021. There was no prior excursion episode that the reporter was aware of.  No treatment information was provided by the reporter.
This spontaneous case, initially received on 13-Sep-2016, was reported by a health professional and concerns a 74-year-old female patient. Weight: not provided; Height: not provided. The patient's medical history is unknown. It is unknown if the suspect product (AFLURIA) was tolerated in the past. Administration of company suspect drug(s): The patient received AFLURIA from 13-SEP-2016 to 13-SEP-2016. Dose regimen: 0.5 ml once, Route of administration: Intramuscular, Batch number: 13049221A. The product was stored correctly. No additional suspect drugs. On 13-Sep-2016, AFLURIA vaccine with particles and cloudiness floating in vaccine was administered to a patient / received the vaccine with altered appearance - no specific AE (adverse event) is reported for the patient at this time. The outcome is reported as unknown. Reporter comments: The reporter considered the event as non-serious (quality defect).
Redness, induration at site, warm to touch came back to office 2 days later use Benadryl, compresses.
Information has been received from a health care professional regarding a female who was vaccinated with GARDASIL (lot number 672547/1745AA, expiration 13-SEP-2012, dose 1 on 07-JUN-2012; dose 2 on 09-AUG-2012 and dose 3 on 13-SEP-2012 (inappropriate schedule of drug administration). The health care professional reported no adverse effect has been observed or reported. No additional information currently available. Additional information is not expected.
Patient arrived in our office on 10/3/17 at 3:35 PM complaining of (R) sided facial paralysis. She reports (L) arm/foot weakness and numbness which begin that morning. Vision exam revealed RT 20/13, LT 20/40. Exam show's facial paralysis, no weakness, denies tick exposure. Pt. can blink and move both eyes. No weakness noted of extremities. Ordered Lyme test. Began prednisone 20 mg (3) QD x 5 days, 2 tabs day 6 and 7, 1 tab days 8, 9, 10. Pt was reassesed at 8:00A 10/4/17. No change in facial paralysis. Vision - RT 20/13, LT 20/50. Pt. states it is more difficult to move eyes up and down and left to right. Referral to opthamologist today. Pt. appears stable at this time. Further monitoring ongoing. Pt. had endoscopy/colonoscopy approximately 2 weeks ago. Pt. received sedation.
Per the client on the day after receiving her Meningococcal vaccine (MENVEO) around 1 pm she developed a headache that has not gone away. She also felt hot to the touch but felt cold inside of her body. She did not take her temperature. Injection site left deltoid area became red, swollen, sore with red bumps that are going away. The injection site is getting better. The client was advised to see her primary care provider. She does not have one. She is in college and was advised to go to the health center. If her symptoms get worse to go to the ER or call 911.
pt recv vax 18SEP96 & 27JUN97 pt devel varicella consisting of forty pustules, little blisters over face, head & a body & itching;pt tx w/APAP & DPH;pt recovered;
5 days after my vaccine. I had muscles spasm up my spine that was 5 inches long and an inch wide. Then I started getting muscle spasms in my feet, hands, and arms which I still suffer from today. I went to the doctor almost right away because I didn't know what was going on and I could hardly move. She recommended a prescription but I prefer not to take medications and tried to use an over the counter medication. That did not work, so I ended up having to get muscle relaxers for the pain.
Patient started to complain of not feeling well on 03/18/2021 and went to the ER and was found to be in Complete Heart Block and was transferred to ICU with EP and Cardiology consults pending> He was found to be covid and Flu negative but strep positive.
headache; severe joint pain; fatigue; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Jan2021 10:30 (Lot number: EL3247) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HUMIRA taken for crohn's disease, start date: 2010 (ongoing); LEXAPRO taken for depression, anxiety, start date: 2013 (ongoing); ALLEGRA taken for hypersensitivity, start date: 2015 (ongoing); QUESTRAN taken for crohn's disease, start date: 2009 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1st, Date/time:, Date: 31Dec2020, Time: 11:00, Site and route of injection:, Anatomical site of injection:  Left arm, Route of administration: Intramuscular, Batch/Lot number: EL0142), administration date: 31Dec2020, when the patient was 39 years old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 18Jan2021 18:00, outcome "recovered" (2021), described as "fatigue"; HEADACHE (non-serious) with onset 19Jan2021, outcome "recovered" (2021), described as "headache"; ARTHRALGIA (non-serious) with onset 19Jan2021, outcome "recovered" (2021), described as "severe joint pain". Therapeutic measures were not taken as a result of fatigue, headache, arthralgia.  Additional information: It was reported that all side effects were experienced more severely with each subsequent dose. The reporter consider the Pfizer product had a causal effect to the adverse event. No prior vaccination within 4 weeks.  Follow-up attempts are completed. No further information is expected.