chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow-up information has been received from a physician concerning his 13 year old daughter who on approximately 05-FEB-2008, "two weeks ago on a Tuesday", was vaccinated intramuscularly "in the arm with her second dose" (originally reported as "first dose") of GARDASIL (lot # not reported).  Concomitant therapy included MENACTRA, "administered in the other arm at the same visit".  "On Thursday, 07-FEB-2008", originally reported as "08-FEB-2008", the patient presented to the office with petechiae around the hip and buttocks.  At the time of follow-up, 20-FEB-2008, it was reported that "the spotting was going away already".  No other symptoms such as pain were reported.  The patient was not sick at all.  Additional information has been requested.
Pneumonia; A spontaneous report was received from a consumer concerning reporter's husband a 79-year-old, male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and who developed pneumonia.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 02 Mar 2021, approximately 13 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 001A21A) via an unknown route for prophylaxis of COVID-19 infection.  On 14 Mar 2021 the patient was hospitalized for pneumonia and was discharged on 16 Mar 2021. The reporter stated that her husband has "previously been prone to pneumonia".  Treatment information included unspecified antibiotics.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event pneumonia was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
Flumist nasal vaccine administered.  Pt. had an allergic reaction - allergic conjunctivitis.  10/21/08 Reviewed PCP office notes of 8/13 & 9/26/08. FINAL DX: none provided Records reveal patient experienced fever, HA decreased appetite, irritability, runny nose, tonsils enlarged & red on 8/13.  Dx w/pharyngitis & HA.  When RTC on 9/26, was doing well when flumist given.  No further records available.
fever; Diarrhea; headache; chills; feeling unwell; Joint pain; injection site pain; tiredness; This is a spontaneous report from a contactable consumer. A 53-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot EK5730), intramuscular (Dose number 1, Arm left) on 23Dec2020, 13:45 at single dose for COVID-19 immunization. Medical history included diabetic, thyroidectomy, hysterectomy, tonsillectomy, and Known allergies: Sulfa. Concomitant medication included zolpidem, levothyroxine, and pantoprazole from unspecified dates for an unspecified indication. The patient experienced fever, diarrhea, headache, chills, feeling unwell, joint pain, injection site pain, and tiredness on 23Dec2020 13:45. No treatment for AE was given. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 since vaccination. Outcome of the events was not recovered. Events were reported as non-serious.
left arm began itching for two days then became red/warm hard and swollen down just past the elbow for at least the days days following that (still having issues today)
This spontaneous report was received from a nurse practitioner, and refers to an unspecified number of patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were administered an unspecified number of improperly stored doses of PNEUMOVAX 23, lot number M035104, expiration date 06-MAY-2018, for prophylaxis (routes of administration were not provided). On unknown dates, the doses of PNEUMOVAX 23 underwent temperature excursions of 47 degrees Fahrenheit (°F) to 77°F for a time frame of 12 hours and 47°F to 77°F for 9 hours, which were detected by the data logger. No adverse effects were reported. This is one of two cases received from the same reporter. Sender's Comments: US-009507513-1709USA009358.
redness 4-1/2 inches in diameter surrounding the injection site. Puffiness of the eyes.  Both lasting three days.
COVID 19 Treatment; COVID 19 Treatment; 1st dose, 2nd dose, 3rd dose: BNT162B2, 4th dose: Moderna; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown), on 22Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 26Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient has no known allergies. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03Sep2022, outcome "unknown", described as "1st dose, 2nd dose, 3rd dose: BNT162B2, 4th dose: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19 which included Paxlovid treatment from 22Jun2023 to 27Jun2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
At day 10 post booster, I developed a rash that appears to be Dermatographia. Red lines, very itchy that first appeared mostly on my back and torso, under arms and palms of hands. The rash disappears within 20-30 min. I have been taking 1x 24hr Allegra each day and that helps. So does lotion. Hot water makes it worse. It is much better now but I still occasionally am getting the rash on various parts of my body. Never on my face.
Shingles; right eye; 2 1/2 years after vaccine. Left eye pain; photophobia; lethargy and increased sleeping. Started with intense pain and photophobia of right eye followed 48 hours later with vesicular rash (forehead and scalp to just below lower lid).
Blood clots after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots after the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clots after the vaccine) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clots after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter. Treatment information was not provided.  Very limited information regarding this event has been provided at this time and a causal relationship cannot be excluded.   This case was linked to MOD-2021-233535 (Patient Link).; Sender's Comments: Very limited information regarding this event has been provided at this time and a causal relationship cannot be excluded.
8/11/04 came for anual evaluation for birth control. LMP 7/13/04. Requested MMR, Hep A/Hep B and Td. No missed periods: used condoms every time (immunizaiton for school). 9/16/04: got second Hep A/Hep B. No menses in August. 9/22/04 came to start Depoproveral period started 9/18/04 . Pregnancy test postive. Received MMR 8/11/04
ran low grade fevers a few days ago noted last pm to have some small bumps on his back-Today 4-5 small blistered bumps on back, 2 on abd. and 2 on legs
Information has been received from a health professional concerning a 26 year old female with no medical history or allergies, who in June 2007, was vaccinated with a dose of Gardasil. There was no concomitant medication. In June 2007, the patient experienced severe pain in her arm, fainted, facial weakness, Bells Palsy, and facial pain after being vaccinated with Gardasil. The patient did go to the ER however, was not admitted to the hospital. At the time if this report, the patient had not recovered. No product quality complaint was involved. Severe pain in arm, fainted, facial weakness, Bells Palsy, and facial pain were considered to be disabling. Additional information is not expected.
Swollen, feels like a big ball, and it?s red in the area where I received the shot.
This case was reported by a pharmacist and described the occurrence of a medication error in a 18-day-old female subject who was vaccinated with Engerix B for prophylaxis.  Previous vaccination included Engerix B, given on 27 July 2007.  Concurrent medications included Nystatin (Nystatin cream), Paracetamol (Tylenol) and Iron supplements (Iron supplement).  On 28 July 2007 the subject inadvertently received 2nd dose of Engerix B at 10 mcg, unknown).  This was considered to be a medication error as the subject had already received an injection of Engerix B the day before, on 27 July 2007.  The same day of the 2nd injection of Engerix B, 28 July 2007, the subject developed increased heart rate (200 - 230 bpm) and increased fussiness.  The events were unresolved at the time of reporting.
I had a low grade fever, muscle and joint aches and a cough. I was very tired as well. I experienced flu like symptoms. This lasted about 3 days. I took Tylenol and naproxen sodium. That was effective at bringing the fever down. The highest the fever ever got was 100.2. This only lasted a couple days.
Patient said that she got a flu shot around 4pm and when she went to bed (10pm) she felt very itchy all over her body.  This symptoms lasted about two days and it was gone.
Patient complained that injection hurt more than usual when received it on 11/18/05. Stated when woke up next morning, 11/19/05, arm hurt to move it certain way or to lift anything. Stated continues to have this same sore muscle ache now when moves deltoid muscle or lifts anything. Has been taking Advil for pain. Stated no fever nor other symptoms noted; just the pain at injection site for 3.5 weeks. States area does not hurt when pushed on. Plans to follow up with physician for evaluation.
This spontaneous report was received from a Nurse Practitioner and refers to a 15 year old male patient. The patient did not suffer from any illnesses at the time of the vaccination and did not have any preexisting allergies, birth defects or medical conditions. On 07-MAR-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L013429, expiration date 21-JUL-2017, intramuscularly in the left arm (dose not reported). The vaccine administered to the patient was improperly stored as it underwent temperature excursion for an unspecified cumulative period of time since January 2016 at 0.5 degrees Celsius. There had been no previous temperature excursion and the aforementioned one was identified due to a data logger. No adverse symptoms or reactions occurred. This is one of several reports received from the same source. Additional information is not expected as all scheduled correspondence has been received.
Pain, slight swelling & warmth at inject site next day. Nausea & generalized myalgia/arthralgia lasting a couple of days.
4 patients was administered only the diluent of Arexvy; 4 patients was administered only the diluent of Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: 4 patients was administered only the diluent of Arexvy) and inappropriate dose of vaccine administered (Verbatim: 4 patients was administered only the diluent of Arexvy). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-NOV-2023 Pharmacist reported that patient was administered only the diluent of Arexvy which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  Asked to revaccinate. The Hcp mentioned that details will be provided later. The reporter consented to follow up. This case is 1 out of 4 cases reported by the same reporter.
Patient tested positive for COVID-19; Patient tested positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Oct2021 09:00 (Lot number: EW0217) at the age of 24 years as dose 3(booster), single, administered in arm left, administration date 04May2021 09:00 (Lot number: EL3247) as dose 2, single and administered in arm left, administration date 13Apr2021 13:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) (Batch/Lot number: unknown). Relevant medical history included: "chronic Urticaria" (unspecified if ongoing), notes: other medical history: Chronic urticaria; "known allergies: Penicilin" (unspecified if ongoing), notes: known allergies: Penicilin. The patient did not have COVID-19 prior vaccination. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Dec2021 18:00, outcome "recovered" and all described as "Patient tested positive for COVID-19". The event "patient tested positive for covid-19" and "patient tested positive for covid-19" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (14Dec2021) positive, notes: Nasal Swab; (15Dec2021) positive, notes: Nasal Swab. The action taken for cetirizine hydrochloride was unknown. Therapeutic measures were taken as a result of vaccination failure, covid-19 and included symptom management using OTC medications.  The lot number for bnt162b2 was not provided and will be requested during follow up.
POC of site gave patients covid vaccine cards to staff and informed them all residents had cards. Patient went to check in for covid vaccine appointment. Patient told check in staff that he had never received a vaccine in the past. Staff registered patient for 1st dose of Moderna. After patient was given vaccine, POC informed staff that patient has dementia and was supposed to receive his booster vaccine. Patient felt fine and still proceeded to observation. Clinical lead verified through Immunization Information System patient received 2nd dose of Moderna on 2/22/2021. Clinical lead reported incident via phone and incident form.
Information has been received from a 27 year old female patient referring to herself. The patient was vaccinated with her first dose, second dose and third dose of GARDASIL (dose, lot # and router were unknown) on 06-JAN-2010, 29-JUL-2011 and in 2012, respectively. Additional information has been requested.
Information has been received from a 26 year old female registered nurse, for GARDASIL, a Pregnancy Registry product, concerning herself with a family history of cervical cancer and no drug reactions/allergies who was vaccinated with the first dose of GARDASIL (lot number not provided) in 2009, and the final dose (lot number not provided) on 19-OCT-2010. Concomitant therapy included methotrexate. On 22-NOV-2010 the patient later discovered she was 1 week pregnant with an ectopic pregnancy. She required surgery to remove her right fallopian tube. The patient sought medical attention by calling physician. Diagnostic laboratory test sonogram performed, no results provided. Pregnancy test was positive (unspecified for which time of pregnancy). On an unspecified date, the patient was hospitalized. At the time of this report, the patient's outcome was unknown. On 10-DEC-2010 the patient discovered she was pregnant again with another ectopic pregnancy, this time on the left side and had been on methotrexate, (WAES #1101USA01251). Follow-up information has been received from a licensed practical nurse reporting that GARDASIL were not administered by their office; vaccine dates and lot #s not known. No information available regarding any concurrent conditions or personal medical history. No LMP data available. The patient was seen from January 2009 to March 2010 for abnormal Papanicolaou (PAP) smears (pre cancerous cells). On 22-NOV-2010, the patient admitted to hospital; and emergency surgery performed. The patient was last seen on 03-JAN-2011. Methotrexate started with doses given on 07-JAN-2011 and 14-JAN-2011. The health care professional contacted during telephone follow-up could not supply the following information: dates of vaccination and lot numbers. Follow-up information has been received from the patient reporting that she got her GARDASIL vaccines through a planned parenthood center. The patient's last normal period was on 23-SEP-2010. The first dose of methotrexate was "not successful in dissolving the ectopic pregnancy" on the left side. She was to see doctor for more blood work on 21-JAN-2011 to see if the second dose of methotrexate was successful. The patient's status was not recovered. Additional information has been requested.
No other adverse event reported; the patient received this vaccine following the excursions; This spontaneous report has been received from an office manager, referring to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies was not provided.  Between 11-MAY-2022 and 28-JUN-2022, there were reported temperature excursions registered for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) total excursion time was 96 minutes. On 11-MAY-2022, a temperature of 5.7 Fahrenheit degrees (F) for 7 minutes, on 27-MAY-2022 a temperature of 5.7 F for 5 minutes, on 06-JUN-2022, a temperature of 5.9  F for 6 minutes, on 09-JUN-2022 a temperature of 5.4  F for 4 minutes, on 14-JUN-2022  a temperature of 5.7  F for 7 minutes, on 17-JUN-2022 a temperature of 29.1 F for 39 minutes, on 20-JUN-2022  a temperature of 7.2 F for 10 minutes, on 22-JUN-2022 a temperature of 8.4 F for 15 minutes, and on 28-JUN-2022 a temperature of 5.2 F for 3 minutes.   On 20-JUL-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) at a dose of 0.5ml once, lot number W006583, expiration date: 23-AUG-2023 (route of administration, and anatomical location were not provided) administered for prophylaxis following a temperature excursion for total time of 96 minutes (product storage error). Additionally, the patient was administered sterile diluent, solution for injection/infusion, (strength, dose, lot #, expiry date, route of administration, and indication were not provided). The patient had no adverse effect or other symptoms as a result of the vaccine administration (no adverse event).  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2207USA007832: US-009507513-2207USA007867: US-009507513-2207USA007985: US-009507513-2207USA007729: US-009507513-2207USA007826: US-009507513-2207USA008018: US-009507513-2207USA008097: US-009507513-2207USA007975: US-009507513-2207USA007928: US-009507513-2207USA007867:
Shoulder pain - more than from an injection. Trouble moving her arm. Follow up with MD who ordered blood work and MRI and an antibiotic - referral to ortho who ordered PT - as of May 22, 2017 no resolution of pain.
1.  mild Asthma lasted 2 weeks,  had not had any occurrences since childhood. 2.   had mild headaches in the right top of head on and off periodically. 3.   fatigue which lasted up to 6 weeks weekness in legs. 4.   scars from previous surgeries began to itch and hurt again which had not happened in past year.  5.  lower back pain and sciatica, lasted a few weeks.  overall I think the vaccine caused inflammation causing these problems.
Dizziness, vomiting, weakness, nausea, pale and moist, blood pressure low.
7-10 days after my vaccine, my left side had felt tight and just off. I was getting ready to work in my home office. I realized that the pain was just getting worse. So I tried over the counter Aleve. That night I couldn't sleep and the next day it got worse. After a meeting, I stood up and there was a shooting pain in my left leg that was excruciating. I went to see a chiropractor who thought I had a rotator cuff issue and treated me for that. The heat he applied made the pain feel worse. I called my doctor and was able to get an appointment. My doctor stated that he thought it could be shingles despite the fact that I did not have a rash. He prescribed pain medication. He stated that it was not normal for shingles though to occur across three nerves in my back so he wanted to get me in for an MRI. My insurance company denied the MRI since it was not recommended by a neurologist. Since then, I have been dealing with inflammation in these three nerves in my back. The pain has gotten better, but it continues to flare up and whatever is causing these nerves to be inflamed, has not calmed back down.
11/08/2003: Received DTAP, IPV left deltoid.  11/19/2003: Mom noted area red, hard, swollen.  Seen 11/20/2003- noted 7x2 area of rubor, color, induration, edema.  Prescribed Keflex and Benadryl.
After receiving IM shot for flu c/o pain going up left side. Tenderness at site. Spoke with pt on 2/5/03 arm fine, no adverse relations. Case closed.
1-2 days after DTaP, Left arm eryth lacy, blanching rash, warm to touch on upper arm.  Reactive tissue at injection site.  No tenderness.  Area of eryth 12cm x 11cm.