chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Two weeks after the patient's sibling received varicella virus vaccine live, in approximately January 2001, the patient had a "classic presentation of chicken pox". The patient presented to the physician's assistant with 15 to 20 classic chicken pox type lesions and was diagnosed with chicken pox. On 01/10/2001 the patient had approximately 100 lesions. The patient had no contact with wild type varicella virus. In follow up the patient recovered completely and has no active lesions or scabs remaining. No additional information is expected.
1st vaccine 1/1/2021 1000 had  H/A initially   2nd vaccine 2/11/ 1000 cold shaking home with warm blanket , hot shower if can tolerate and tylenol.
Within 2 hours of receiving vaccination, arm and hand became swollen. Hand reddish/purple. Went to school nurse. Color has since resolved, current complaint includes pain from shoulder to fingers. She can move her fingers. 10/22/14 Mom states patient had hives last night that responded to BENADRYL. Today arm is still swollen and warm.
On January 28 around 9 am, I started feeling sick. About an hour later, I felt nauseated and then started vomiting. I vomited throughout the day, about 6 times. I assumed this was a fairly common reaction to the vaccine.  The following day (Jan. 29) I felt very weak and noticed that when I signed my name, my hand felt numb and I couldn't control it very well. On Saturday, my left leg began to feel abnormal.  I called a friend who is a retired doctor and he said that he had heard of some neurological reactions to the vaccine. By Sunday, I was having a difficult time walking so I called my GPs office and set up an appointment for Monday morning.  As soon as she saw my face without a mask, she said that I had had a stroke.  I had a slight droop on my left cheek and mouth which indicated to the doctor that a stroke had occurred. She scheduled me for a MRI the following morning, Feb. 3. As soon as the MRI was completed, my GP scheduled me with a neurosurgeon whom I was able to see the same afternoon. The diagnosis was a right medullary ischemic stroke. She ordered a number of tests to be run and scheduled me for March 9 to come back for the result of all the tests and blood work. Doctor referred me for physical therapy to help me regain the use of my left leg and hand.
Information has been received from a registered nurse concerning a patient who on an unspecified date was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient had a low antibody titer following two doses of varicella virus vaccine live (Oka/Merck). Unspecified medical attention was sought. Antibody titer determination studies were performed, and the results were low. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
9/11 12:40 pm mother called and reported that left thigh had 7-8 blisters filled with clear liquid where shots were given.  Some of the blisters burst.  Denies fever, redness, warmth to touch. Instructed mom to monitor  thigh and if drainage turns yellow or green  take child to ER.
Approximately three weeks after receiving the SHINGRIX vaccine, I started coughing up light yellow mucus a few times a day. At the time, I didn't attribute the issue to the shingles vaccine I initially thought that I was getting a cold. After about a month, it had not cleared up. I was not sick just coughing up the yellow mucus. On October 1, I went to my primary care physician NP, she said it was probably bronchitis and prescribed a ZPAK; didn't help. On October 28, I went to my lung doctor who ordered a chest Xray. He called several hours later and said there were two areas of infiltrates on my right lung. He said it was strange. He prescribed levofloxacin 500 mg that I took for 10 days; didn't help. He wanted me to wait six weeks to give it time to clear up. In mid December, another chest Xray showed that it had gotten slightly worse. The following week I had a chest CT scan and the first week of January 2019, I had a bronchoscopy. After getting the results, the doctor stated that a foreign substance had entered my lungs and asked about supplements I had been taking at the time. This is when I recalled that I had gotten the shingles vaccine about three weeks before the mucus started. What is strange is that I am not sick at all; just coughing up yellow mucus. As of mid January, the doctor ordered that I stop all vitamins, supplements, and any strange foods. I am scheduled to have another CT scan on Feb 19.
REDDENED AREA SIZE OF TENNIS BALL BEGAN FIRST AND THEN A SINGLE BLISTER CENTER STARTED AND CONTINUES AT PRESENT.  NO COMFORT MEASURES.  MOTHER ADVISED COOL COMPRESS, IBUPROFEN PRN, MD VISIT IF INCREASE IN REDNESS OR SWELLING NOTED.
Information has been received from a healthcare worker referring to unspecified amount of patients of unknown age and gender. The patients' medical history, concomitant therapy and drug reactions were not reported. From 24-NOV-2015 to 11-DEC-2015, the patients were vaccinated with doses of improperly stored PEDVAXHIB (lot # L030869, expiration date 08-JUN-2018, dose and route were not provided), which were exposed to 51.3 Fahrenheit (F) for 288.83 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter did not wish to be contacted.
Several red patches of skin, varying in size around the injection site.  Skin is swollen and warm to the touch.  Patches range in size from half dollar size to 2 inches in length and 1 inch in width.  There are no other symptoms or complaints at this point.
Redness and swelling around the site.  101.4 fever   Not sure if this is related but after the first injection my liver enzymes were elevated.
Information had been received on 10-MAR-2017 from a nurse who reported that improperly stored doses of ROTATEQ, GARDASIL 9, PEDVAXHIB and M-M-R II were administered to unspecified patients from 01-FEB-2017 to 28-FEB-2017. Temperature of vaccines ranged from 47 degrees Fahrenheit to 77 degrees Fahrenheit for a time frame of two hours. There was no previous temperature excursion. Call was because of a "data logger". No adverse effects. No further information to report. Names of vaccines involved: ROTATEQ (lot# M033337, expiration 13-APR-2018), (lot# M042822, expiration 19-JUN-2018), (lot# M042171, expiration 07-JUN-2018), (lot# M039067, expiration 18-APR-2018). PEDVAXHIB (lot# M036058, expiration 19-MAY-2019), (lot# M046133, expiration 26-SEP-2019), (lot# M046134, expiration 27-SEP-2019). GARDASIL 9 (lot# M028323, expiration 26-SEP-2018), (lot# M017983, expiration 30-MAY-2018), (lot# M041212, expiration 21-JUN-2019), (lot# M041990, expiration 28-JUN-2019). M-M-R II (lot# M029230, expiration 08-JUN-2018), (lot# M008588, expiration 16-FEB-2018), (lot# M035935, expiration 09-AUG-2018), (lot# M037096, expiration 23-AUG-2018). Additional information has been requested.
Treatment of COVID-19 - Sneezing and nasal congestion, runny nose; Lack of drug effect; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Treatment of COVID-19 - Sneezing and nasal congestion, runny nose) and DRUG INEFFECTIVE (Lack of drug effect) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 022C21A, 012M21A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included Allergy NOS (Name of Drug as Reported-No).   On 01-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021 at 1:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022 at 1:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Treatment of COVID-19 - Sneezing and nasal congestion, runny nose) and DRUG INEFFECTIVE (Lack of drug effect). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 10-May-2022 to 15-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Treatment of COVID-19 - Sneezing and nasal congestion, runny nose) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Company comment: This case concerns a 75-year-old male patient with no relevant medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown date after the second dose of mRNA-1273. The patient received treatment with NIRMATRELVIR, RITONAVIR. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This case concerns a 75-year-old male patient with no relevant medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown date after the second dose of mRNA-1273. The patient received treatment with NIRMATRELVIR, RITONAVIR. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
dizziness; felt terrible; fever; chills; really tired; Felt lousy; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Nov2021 00:20 (Lot number: FJ1620) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension. Vaccination history included: Bnt162b2 (Dose: 1, Lot: EM9810, Expiry: Unknown), administration date: 09Feb2021, for Covid-19 immunization; Bnt162b2 (Dose: 2, Lot: EM9810, Expiry: Unknown), administration date: 02Mar2021, for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt terrible"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown", described as "chills"; FATIGUE (non-serious) with onset 29Nov2021, outcome "recovering", described as "really tired"; MALAISE (non-serious) with onset 29Nov2021, outcome "recovering", described as "Felt lousy".  Additional information: No prior Vaccinations were taken (within 4 weeks). No AE(s) following prior vaccinations.   Follow-up attempts are completed. No further information is expected.
Pt has experienced bruising and several dark red rashy spots around the injection site. She did not report having a fever but has taken Ibuprofen around the clock since time of vaccine. She states her dr told her it was a skin infection from the vaccine. She did not tell whether or not her dr saw her in person
Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 14:15 as dose 5 (booster), single (Lot number: GH9694) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "history of bronchitis" (unspecified if ongoing). There were no concomitant medications. Known allergies: none.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". 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, the patient received paxlovid from Nov2022 to 22Nov2022.
Around 9/2/19 She started with quarter size welts on right arm and chest/breast,  central belly, inner thighs (started with right thigh now she says it's on both thighs) and excruciating pain in right arm. Internal pain in back, but but no breakouts on back. Breaking out on face. Broken out everywhere on scalp.  She saw lady about it and she said it was mosquito bites or spider bites.  Patient disagrees and thinks it's the vaccine.
Patient is 17 and 7 months years old. Mother signed and consented her daughter to be given the vaccine to her daughter
At the site of the injection for IPV, it was hard, red, swollen and blistered. Pt complained of itching at site. Dx'd at ER as allergic reaction to vaccine.
Patient had requested COVID 19; however; vaccine was incorrectly entered into computer system and pharmacist failed to notice the mistake.  Patient had already received a flu vaccine at this location on 9/19/22 and this was a second dose of same.  After discovering the mistake, the COVID 19 Pfizer Bivalent was given to the patient.  Pharmacist discussed implications of receiving a second flu shot and patient was satisfied with the discussion.
Patient received the Pfizer vaccine as her second dose 21 days after receiving  the Moderna vaccine as her first dose.
I received the 2nd dose at around 3pm.  About 12 hours later I woke up from my sleep and felt feverish, headachy, uncomfortable, and sick. I felt like I got hit by a truck. I had no energy. That feeling persisted all throughout the next day on 5/20/2021. I sat on my couch and didn't move that whole day. After that I was able to sleep better. I still felt achy and weak on 5/21/2021, but by 5/22/2021 I felt normal and back to myself.  2 days after getting the vaccine I was really knocked out. On 9/10-12/2021 I went on a backpacking trip in the wilderness. I had drank filtered surface water. On 9/19/2021 I began having intestinal issues. It started off with horrible diarrhea that lasted about 12 hours then the diarrhea had went away, but then I had constipation, bloating, and cramping that was uncomfortable but not severe. I was really uncomfortable for 2 days and moderately uncomfortable for 2 weeks. Just now I am starting to feel normal after a couple of months. I had went to the doctor's office and had tests did that were all negative. I started doing dietary changes, specifically with gluten. There seems to be some type of gluten sensitivity but I'm not for sure.
Redness, swelling, pain to Right upper arm, site of vaccination. Tylenol taken.
a potential exposure to COVID-19 while receiving the vaccine; just a little soreness at the site/small amount of discomfort at injection site; just a little soreness at the site/small amount of discomfort at injection site; fever/has a fever nine days after getting the vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A 85-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration on 07Feb2021 (at the age of 85-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  On 16Feb2021, the patient experienced fever/has a fever nine days after getting the vaccine, just a little soreness at the site/small amount of discomfort at injection site on an unspecified date. The reporter reported that the patient (her mother) had no reaction immediately after receiving the vaccine except "just a little soreness at the site, not much at all." Reporter would like to know if it is common to develop a reaction this far out after receiving the vaccine. She also reported that her mother may have had a potential exposure to COVID-19 while receiving the vaccine and was concerned about whether or not her mother could receive her second dose if she were to test positive for COVID-19. She would like to know if her mother tests positive for COVID-19, would she still be able to receive her second dose of the vaccine. She stated nine days later the patient developed fever. She asked if it was common. She also would like information about testing. Her mother went nine days ago to get the vaccine. She could have been exposed to Covid at that time. If after the first time she gets tested for Covid could she get a false positive result. She reported that her mother has not been tested. If she were to get tested and the results were positive would she get the second dose. Outcome of the events were unknown.   Follow up (16Feb2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported for patient (Reporter's mother) included additional event and clinical information.   Information on the lot/batch number has been requested.   Follow-up (11May2021): Follow-up attempts completed. No further information expected.
pt recv vax 14APR95 1005AM went home & around 3PM started running fever 102 & went into convuls; pt taken back to MD who realized shot should not have been given;pt adm to hosp;had ear infect, congestion, flu-like sx, daze, sore arm, rash;
Pt reports on 4/9/04 she developed extreeme HA, severe N/D, and itching in the morning.  By afternoon was dehydrated.  On 4/12/04 went to doctor, who admitted to hospital on 4/12/04.  By 4/12/04 states all symptoms persisting, "could hardly walk, but was coherent".  States received many IV fluids in hospital.  Liver enzymes apparently abnormal.  States did "every test" possible.  Discharged from hospital on 4/19/04.  On 4/23/04 ate barley soup and until 4/25/04 had diarrhea and nausea again.  Reports she continues to be weak all the time.  Seeing a GI specialist who has R/O most diagnosis but not Hepatitis A.  Not recovered but stable. Follow up 11/22/04: Patient states she is still weak and often has forgetfulness (states she did not have the problem before vaccination). States she received the Hep B disease from the vaccine. Unable to get patient to understand that she could not get the disease from the vaccine.
Contracted COVID four weeks after having our booster injection; Contracted COVID four weeks after having our booster injection; Contracted COVID four weeks after having our booster injection; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program.  A female patient (reporter's wife) received bnt162b2 (PFIZER COVID-19 VACCINE) (Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE) (Lot number: unknown) as single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Contracted COVID four weeks after having our booster injection". Clinical course: Patient contracted COVID four weeks after having our booster injection. Reporter thought the vaccine was effective, since patient only had moderate symptoms.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101590456 same reporter and drug, different patient and event
This case was reported by a physician and described the occurrence of exacerbation of elevated liver function tests in an adult female who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The pt's medical history included "elevated liver function tests (NOS)".  Her primary physician had confirmed that she could receive Engerix-B.  On 04/09/03, the pt received her first dose of Engerix-B (Lot # ENG5379A4).  At an unspecified time post-immunization, the pt went to her primary physician for a routine visit.  Laboratory evaluation revealed that her liver function tests had "risen higher".  The outcome of the event is unknown.  As per follow up report: this case was reported by a physician and described the occurrence of exacerbation of elevated alanine aminotransferase and aspartate aminotransferase in a 36 year old female patient. Alanine aminotransferase was elevated to 200 IU/L and aspartate aminotransferase was elevated to 115 IU/l. The immunization series with Engerix B was discontinued. On 08/29/2003, lab evaluation revealed that the events resolved. Alanine aminotransferase were normal at 32 IU/L and aspartate aminotransferase was normal at 15 IU/L. the physician considered the elevated liver enzymes to possibly be related to vaccination with Engerix B.
Received vaccines on 2-17-09 No bandaids applied & rash developed 3 days after. Mom stated that happened with 2 mo shots also.
She thought she was having a massive stroke; Severe left sided head pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. The patient previously took epinephrine, codeine, acetylsalicylic acid (ASPIRIN) and experienced anaphylactic reactions in the past. The patient stated that 45 minutes after her first vaccine, she experienced severe left sided head pain. She was driving down the road and had to go back because she thought she was having a massive stroke; it was that severe. She asked if she should still get the second dose or if she should reschedule it after she talks to her primary care provider. She is scheduled to get the second dose at the time of report but was nervous because she does not know if she should get it. The outcome of the events was unknown.   Information about lot/batch number has been requested.
1/17/21@ 2000: Pain-discomfort. 2/17/21@0400: Chills, fever, headache, joint pains, muscle pains, fatigue.  Narrative:   Other Relevant History:
Client was in post vaccination monitoring for 30 minutes and was preparing to be released from the area when she began to complain of her left arm burning, neck stiffness, difficulty swallowing and a faint red rash developing over her chest.  EMS crew was on site for post vaccine monitoring and responded- V/S reported at O2 sat of 99% on room air, Respiratory rate of 18, Heart rate of 61 and B/P of 155/81.  EMS staff reported lungs were clear to auscultation and no shortness of breath was noted.  EMS administered SQ epinephrine 0.3 mg and started an IV line with fluids. Ambulance transport was called for the client to be transported for a full assessment at the emergency room.
Vaccine was diluted incorrectly; subsequently, patient received 10 doses of mcg vaccine instead of one dose.  No adverse clinical signs or symptoms at this time; patient received immunization about one hour ago
Evening of shot-sore left arm. Next day-chills, fever up to 101.5, body aches and headache. Last 24 hours.