chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Evening after immunization, 45 yo woman developed fever 101 102 malaise, swelling 2-3' around at injection site (triceps area), erythema and pain, with discomfort extending into hand. Still present 2 days later.
body aches, chills, nausea, headache, fatigue, took Tylenol
9-10-13 Patient received MENVEO on right arm. 2-23-14 Parent presented with patient with the complaint of right arm pain since Monday the 17th.
Atraumatic 2x3 cm non-blanching ecchymosis chin without other active sources of hemorrhage or allergic rxn.
Pt was asymptomatic day of injection, but site became red and sore the following evening. It formed a raised rash about 5" in diameter which was itchy and warm. She called her PCP on Monday and was instructed to apply cold compresses which gave some relief and improvement.
Raised Red rash area at site of injection with surroning redness.  Some soreness. Does NOT itch.
Pt intended to receive influenza, but receive TDaP (BOOSTRIX) and experienced itchiness to site of injection - LA injection site.
Post vax, the pt had swelling and redness of the upper arm. Treated with Benadryl, ibuprofen, and cool compresses.
she tested positive for COVID-19 after receiving the first dose of the Pfizer-Biontech COVID-19 vaccine.; she tested positive for COVID-19 after receiving the first dose of the Pfizer-Biontech COVID-19 vaccine.; This is a spontaneous report from a contactable physician. A 41-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899) intramuscular in left arm on 26Dec2020 14:30 at a single dose for COVID-19 immunization.The patient's medical history and concomitant medications were not reported. The physician received her first dose of the COVID vaccine on 26Dec2020 and on 02Jan2021, tested positive for COVID. She actually tested negative 2 days before testing positive (26Dec2020). The outcome of the event was recovered on an unknown date. According to the physician, the event was unrelated to the vaccine as her nanny and her son was also tested positive.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported tested positive for COVID, which is considered ineffective of BNT162B2, and the administration of BNT162B2.
Severe lymphatic swelling under both armpits approx the size of a grapefruit; mild lymphatic swelling along collarbone and under jaw
Left arm: deltoid area. Large red area, swollen. Treated with Benadryl (Children's) and Tylenol.
Pt c/o pain in L delt (site of admin) also tenderness, redness - onset eve of injection.
Injection site redness, itching, pain and warmth started day following injection and continued for 4 days.
Fever, pain in arm, red hot area around arm, puss open hold where vaccine was administered stinging sensation.
Patient caregiver came by the pharmacy and said the injection site (left arm) was a little red, itchy and sore. I told her to use a cold compress and take some MOTRIN or TYLENOL and use BENADRYL if it was itching. I told her that if it got worse to let us know and to call the doctor. I called tonight and the left arm was better. The patient went to the hospital to get it checked out. Everything is better now.
no adverse event reported; the patient was inadvertently administered a third dose of MMR-ll; This spontaneous report was received from a nurse concerning to a patient of unknown age and gender.      The patient's concurrent conditions, medical history, past drug reactions/ allergies and concomitant therapies were not provided.   On 24-APR-2012, and 31-JUL-2015, the patient was vaccinated with the first and second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) respectively, as prophylaxis (strengths, doses, routes of administration, lot numbers and dates of expiration were not provided). On 15-APR-2019 the patient was inadvertently administered a third dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)(rHA) lot # reported as R010474, date of expiration: 10-APR-2020, as prophylaxis (overdose)(strength, dose, and route of administration were not provided). No adverse event reported. No further information was provided. No product quality complaint (PQC) was filed.
Headache for 36 Hours and Chills. Patch and itch developed which lasted until 03/26/21
Flu/fever-like symptoms (but temperature at 96.9), moderate to severe body aches, moderate to severe headache, fatigue. This started 12 hours after injection, and ended 24 hours after symptoms first appeared.
Rash on left thigh, faint spots appearing on forehead and buttock, fever or 101 degrees - 102 degrees last night
Pt recvd vax & devel a t101, nausea, diarrhea & dizziness; No further details were provided;
pt received a 2nd high dose flu shot (2 weeks apart)-no adverse reaction reported at the time or next day
10 days p/vax parents heard pt gasping/choking air (same sound as last time w/febrile sz) & then saw pt shaking & +fever given APAP & resolved;
This spontaneous report as received from a other refers to a patient of unknown age. On 14-JUL-2017 the patient was vaccinated with VAQTA lot # L031196 for prophylaxis. On 14-JUL-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to VAQTA.
I was exp. left really bad cramps especially in right leg. I did go to the doctor for blood clots (tests showed none). I have also exp. hair loss and 10 fingernails started to crush off like eggshells. Behind both ears I've exp. rash coming and going since vaccine.
Initial misuse report received from a healthcare professional on 12 June 2013. An expired dose of MENACTRA was administered (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
I had itching in the rectal pelvic region without a rash, that I noticed the day after receiving my vaccination. I called my doctor on April 25, 2023, she suggested I used Triamcinolone Acetate on the affected area to try and help alleviate the itching. I also had a follow up visit so she could exam the area and find out if I was getting any relief from the cream. I am still using the cream. My doctor and I have noticed that with each vaccine I have had this occur and it will last 15 to 20 days this goes away. Then it goes away for good.
Systemic: Fainting / Unresponsive-Mild, Additional Details: patient felt lightheaded & dizzy ~15 min after receiving the Pfizer vaccine.  She was asked to have a seat & fainted.  Patient was responsive when spoken to & was kept under observation. She was given water, an ice pack, & snack while her feet was kept elevated while she was seated.
Persistent and continuing coughing for over a  month,fatigue, some  sore  throat, muscle aches, some stuffy nose, some difficulty breathing, and could not sleep well due to the continuous coughs.
Information regarding Prevnar was received from a healthcare professional via a regulatory authority regarding an 8 month old male patient who experienced vasculitis. The patient received the first dose on 21 Nov 2006. The patient experienced vasculitis starting 22 Nov 2006. he was hospitalized. On 29 Nov 2006 the event was abating.
This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender.  No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX lot # m030138 with expiry date: 15-JUN-2018 (dosing details, route unknown) for prophylaxis. The sterile diluent (unknown lot, unknown expiration) used for reconstitution did not undergo a temperature excursion. There was no previous temperature excursion. It was reported that the vaccine was exposed to a temperature range of 6 F to 14 F for a duration of 96 Hours 25 Minutes. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of the two reported from the same reporter.; Sender's Comments: US-009507513-1708USA009347:
She breast feeds; Tested positive for Covid19; Tested positive for Covid19; She breast feeds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (medically significant), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "She breast feeds"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for Covid19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The reporter and his wife tested positive for Covid19 just a few days ago and the reporter had two daughters. Eldest 9-year-old had first dose while our youngest 1-year-old daughter doesn't have any. However, she breast feed and has had two doses of Pfizer vaccine. There was youngest also got sick but got better into two days. The reporter believed she developed some natural immunity through breastfeeding. This could a breakthrough for 4 and under Pfizer vaccines.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200132906 baby case
Chills, body aches, headache, cough, low grade fever, sore left arm.
I started feeling poorly on Saturday. I wasn't sure whether it was just a virus, such as the flu or whether it was COVID-19. My wife had been exposed to COVID-19 recently. We began to feel worse over the weekend. I didn't do the COVID-19 test until 1/30/2023, and the result was positive. I felt extremely fatigued, achy, listless. I developed a sinus infection. I had a fever on Monday that lasted a short while, and it was 101.4, and that was the highest that it got. I continued to feel bad. On Monday, I had a sort of tickle in the chest, but I didn't have a cough or any real signs of congestion. On Tuesday, the tickle in my chest began to develop into mild congestion. I began coughing. My sinus congestion worsened considerably. The mucus changed color from yellow to green. I sent information to my doctor through the online portal, and she prescribed me PAXLOVID. I went to urgent care on Thursday morning and was examined by the physician there. I was diagnosed with a severe sinus infection, for which I was prescribed a ten-day supply of AUGMENTIN. I also developed bronchitis. By Thursday evening, my chest congestion was significantly worse. I coughed up significant amounts of phlegm. I contacted my PCP's office and informed them of my condition. I was advised to go on an albuterol nebulizer, which I wasn't able to start until the following Monday. When I started using the albuterol nebulizer and saline solution, the relief was pretty quick. I continued using the nebulizer for over a week until the congestion and the like began to subside. The sinusitis finally resolved on the eighth day of the AUGMENTIN supply. The cough continued for at least another five days after I finished the AUGMENTIN. At the time of this writing, I continue to struggle with fatigue, occasional headache, muscle aches, and joint aches. However, I no longer have respiratory symptoms. On 2/4/2023 and 2/5/2023, I tested negative for COVID-19. This was my fourth bout of COVID-19 since January 2022. I was able to recover from the first three bouts pretty quickly, but the fourth bout took my surprise because of the severity of the symptoms.
Diffuse 10cm induration/erythema in deltoid area (appears as delayed type III reaction) (?DTAP).
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient' concurrent conditions, medical histories and concomitant medications were not reported. On 23-FEB-2016, the patient received improperly store VARIVAX lot # L035128, expiration date: 14-SEP-2017 (exact dose, route of administration and anatomical location were not provided). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Fahrenheit for 1 hour. There was no previous temperature excursion. This is one of the several reports from the same reporter. Additional information has been requested.
Patient was given the second dose past the 12 hour pierced vial time; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given the second dose past the 12 hour pierced vial time) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given the second dose past the 12 hour pierced vial time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was given the second dose past the 12 hour pierced vial time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant medications were not provided.  Treatment medication was not provided.
Arthralgia pain, swelling and redness at site, chills, fatigue and body aches for 3 days Narrative:
Time of injection 2:30 PM on 9/8/21   At 1:30 AM  on 9/9/2021 painful cramps and spasm woke me from my sleep - spasms of feet and hand - cramps on outer side of both calves lasting se real minutes each and recurring until 6:00 AM then joints in hands, feet, knees, shoulders and generalized achínese.  After that, very bad head ache and fever ranging from 100.6 to 101 until the present time. Along with fever and headache I have chills, body ache, loss of appetite and severe fatigue.
Headache, Myalgia, Arthralgia, chills, left arm soreness at injection site, fatigue
This spontaneous report as received via Poison and Drug Center from a pharmacist refers to a female patient of unknown age. The patient's relevant medical history and past drug history were unknown. The pharmacist reported that on 01-JAN-2015, she administered an expired dose of M-M-R II subcutaneously at a dose of 0.5 ml "because she needed a 2nd dose a couple of months ahead of time for work" (expiry date: 01-AUG-2014; strength, frequency and lot# unspecified). It was unknown if the patient took any concomitant medications, neither if the patient had any relevant lab work performed. As of 01-JAN-2015, the patient would not continue on the M-M-R II vaccine and the outcome of receiving an expired vaccine was unknown. The pharmacist did not have a lot number or other information for the report as she did not have that information with her. The event occurred at the pharmacy. The address provided by the caller was her own home address and not for the pharmacy. She did not wish to provide the address for the pharmacy because she did not work there on a regular basis. The reporter considered the event as non-serious. Additional information has been requested.
Received booster 5 months after second vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received booster 5 months after second vaccine) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received booster 5 months after second vaccine). On 18-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received booster 5 months after second vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported. Patient had a booster dose.
On 8/18/2021 Patient was out with friends. He was noted to be short of breath and then collapsed with PEA arrest. ROSC wasn't obtained for over 15 minutes. He received 3 mg of epi in total. At the hospital, patient tested positive for meth, methadone, and COVID-19. His pupils were fixed and dilated. One dose of Narcan was administered and his pupils were reactive again. There was concern for seizure activity and ativan was given. He was intubated with a GCS of 3. Targeted temperature management was started. His pH was noted to be less than 6.9 and CO2 of 100. He had a lactate of 15. Patient arrived at hospital intubated, sedated, and non-responsive.  Patient is currently in Critical Care (admission date 8/18/2021) and prognosis is uncertain.   Active diagnosis include: Acute respiratory failure with hypoxia and hypercapnia (*) Yes  ? Post Cardiac arrest (*) Unknown ? COVID-19 virus infection Unknown ? Anoxic encephalopathy (*) Yes ? Lactic acid acidosis
Started 24-36 hours after vaccine (R) deltoid.  Swelling at injection site according to mother- 3 1/2 in high 2 1/2 in wide.  Described red firm- like 2 golf balls one on top of other No blister, No seepage cleared 36 hours after topical ice- gone by office visit.
Patient's 15 min observation period completed, she got up to leave and c/o feeling dizzy while waiting for the elevator. Had patient sit down and assessed her VS.  2:10p BP 106/70 , HR 70,   O2 sat 96% 2:25p BP 101/62, HR 74, O2 sat 96% 2:37p BP122/81, HR 82, O2 sat 96%  Patient reported dizziness subsided and was DC'd home at 2:38p
I woke up in the morning at 8:30 on 07/22 with bile stomach feeling nauseous. 2 hours later I broke out in hives on my stomach, groin area, thighs, eyes. I took something for my stomach which helped a little bit. My throat started feeling itchy. I went to urgent care and was given prednisone 3 day course and PEPCID. The hives weren't totally gone for several days and I didn't have much of an appetite at all.
Information has been received from a physician concerning a child who was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. The physician reported that the patient subsequently experienced an adverse event. It was unknown if medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
Dizzy, lightheaded, shortness of breath, tachycardic Vaccine given at approximately 1612 Benadryl given at 1614. 1615 Epi in L thigh. Pt transported to ED by wheelchair
Report 2001022498-1 describes headache in a pt who rec'd hepatitis B vaccine (brand unknown). The pt's allergies, medical history, and concomitant medications were not specified. In 8/01, the pt rec'd her third intra-muscular dose of hepatitis B vaccine (brand unknown). Three weeks later, she experienced hair loss, fatigue, and headache. As of 9/14/01, the adverse events had not resolved.
nurse gave a patient 0.1 ML of IPOL instead of Tubersol; redness and induration at the injection site; redness and induration at the injection site; Initial information received on 19-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA234226 (same reporter).  This case involves a 18 years old male patient who experienced redness and induration at the injection site, while he received vaccine IPV (VERO) [IPOL] and instead of TUBERCULIN TEST [TUBERSOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Aug-2019, the patient received a 0.1 ml dose of suspect IPV (VERO) (lot number: P1E701M, expiry date: 09-Nov-2020) via intradermal route in the left forearm instead being tested with Tuberculin test  On an unknown date, the patient had redness and induration at the injection site (vaccination site erythema) and (vaccination site induration) (unknown latency) following the administration of IPV (VERO).  It was an also a case of actual medication error due to wrong product administered (nurse gave a patient 0.1 ml of IPOL instead of TUBERSOL).  Lab data was not reported.  Final diagnosis was vaccination site erythema and vaccination site induration.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of document held by sender: none.
Information has been received on 04-JAN-2018 regarding a case in litigation from a lawyer and an estate administrator regarding a male patient of unknown age. The patient's prior concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 05-MAR-2014, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 09-JUL-2015, the patient was treated at a medical center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed VALTREX for management of his painful and persistent symptoms. On 24-FEB-2016, the patient succumbed to death with post-herpetic neuralgia listed a significant factor causing his death. Post-herpetic neuralgia is a chronic condition of intense pain and nerve damage secondary to herpes zoster infections. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment, with monetary damages. As a further proximate result, the patient has suffered and suffered significant medical expenses, and pain and suffering, and other damages, including his eventual death due to complications of his injuries. Additional information has been requested. Reported Cause(s) of Death: post-herpetic neuralgia.
approximately 2.5? x 3? red rash at injection site ( upper left arm),  slightly warm to touch, mildly hard, slightly itchy, first noticed this morning and has increased a little in size over the last 5-6 hours, no treatment
ADULT OBSTRUCTIVE SLEEP APNEA ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA
Developed itchy rash across stomach and abdomen starting about 5 hours after the injection and beginning to dissipate about 12 hours later
ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPERCAPNIC RESPIRATORY FAILURE
Eyes almost swollen shut. Very itchy. Headache. One week later headache is severe and muscle pains.
Tested positive for COVID, May 18th Chills, fever, runny nose, dry cough, tremendous fatigue, stomach ache