chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Boostrix was given instead of Infanrix; 16 months old was given Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 16-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number GH32J, expiry date 29th November 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th November 2022, the patient received the 1st dose of Boostrix and Boostrix Pre-Filled Syringe Device. On 29th November 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-NOV-2022 Reporter's Comment: The reporter called in to report that Boostrix was given to a patient instead of Infanrix.  The reporter gave details with regards to patients and vaccine.  The vaccine administration facility was the same as primary reporter.  The reporter consented to follow up. Additional Supportive Information: The 16 months patient received Boostrix instead of Infanrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
slight itchiness, hot to touch, and half dollar size pink welt at injection site 9 days after injection
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored M-M-R II (lot # L001336, expiry date: 13-JAN-2017; lot # L012482, expiry date: 24-AUG-2017; lot # L032044, expiry date: 24-AUG-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. On an unknown date, the vaccine was exposed to temperature of 9 degree Celsius (C) for 1 hour 1 minute. No previous temperature excursion was reported. It was also reported that this case was reported because of a data logger. No product quality complaint (PQC) was reported. This case is linked to case number 1611USA004874 and 1611USA000386 via same reporter link. Additional information has been requested.
Severe vertigo with vomiting lasting several hours that occurred on the following dates: Shot was 4/7/21 Attack on 4/13/21 Attack on 4/15/21 Attack on 4/17/21 Attack on 4/24/21 Attack on 5/2/21
pt recv vax 3AUG95 & 18JUN97 pt devel chickenpox;another pt was reported w/the same exp (WAES97062012);
Went into ER with leg pain the night of 5/14. Admitted into ICU 5/15 for deep venous thrombosis in the leg and pulmonary embolisms in the lungs. Symptoms in leg started a few days prior to admittance. Was put on Heparin via shot and then IV. Clotting grew worse overnight with leg swelling, leading to an inability to walk. After increased elevation leg improved and was put on an oral dose of Eliquis. Was put on oxygen in the ICU and took portable oxygen home when discharged on 5/17.   Also tested positive for strep 4/11.  Was advised to file a report by my PCP.
Pfizer Covid19 vaccine was administered in error to 14 year old female with Down Syndrome. Patient was observed for routine 15 minute observation and had no signs/symptoms of adverse reaction.
Quarter-size reaction spreading to 3 x 3, red, raised hive-type rxn by 11:00 am. Put on Benadryl.
BODY ACHES; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and fever. This report was non-serious.
Heart became very discomfortable, there would be a series of events where it felt extremely discomfortable then went away. Then later that evening, Friday August 6 it came back and my heart was extremely discomfortable. On August 11th my breathing seems to not be normal either. For the August 6th event I was traveling out of state and was unable to visit my doctor, considered going to an emergency room but in the evening the pain went away so I did not go to one.
This spontaneous report was received from a medical assistant refers to a patient of unknown age. On an unknown date, the patient was vaccinated with improperly stored doses of (Oka/Merck) VARIVAX, lot # M000996, expiry date 07-JAN-2018. No adverse reactions were reported. Additional information has been requested.
Diffuse varicelliform (erythematous, papular) eruption, with irritability and fever, of onset seven days after Varivax & MMR were administered.
12/05/2021 presented to ED for vomiting, generalized fatigue, weakness and dehydration. PMHx of CKD stage 3, DM Type 2, HLD and HTN.
3days p/vax pt dx w/presumptive intussusception; to hosp & tx w/air contrast enema which relieved sx
Info has been received from a health professional concerning a 9 year old white female, with no medical history and no allergies, who on 9/17/96 was vaccinated with a 1st dose of varicella virus vaccine live. There was no illness at the time of vaccination and no adverse events following prior vaccination. It was reported that on 5/3/05, the pt experienced chickenpox breakthrough, during a middle school outbreak, described as a moderate outbreak with a mild generalized rash. It was noted that the pt was febrile via mother's palpation. It was reported that the pt recovered without hospitalization. There were no lab or diagnostic tests performed. Unspecified medical attention was sought. no product quality complaint was involved. No other info was provided. Additional info has been requested.
Swelling and soreness at injection site, fever and sweating, sore arm, itchiness and hives, flu like symptoms.
Pt devel swelling upper lip 1 day following vax. Seen by MD and treated with Benadryl. Swelling began to resolve on 10/09/1997
Information has been received from a consumer concerning her 19 year old daughter, for GARDASIL, a pregnancy Registry product, who with no pertinent medical history and drug reactions/allergies in November 2008, was vaccinated with the first dose of GARDASIL. In January 2009 the patient was vaccinated with the second dose of GARDASIL. There were no concomitant medication. The patient sought unspecified medical attention. In January 2009 (about 12 weeks ago), the patient performed a pregnancy test which showed pregnant. The patient's LMP (last menstrual period) was 05-JAN-2009 and her EDD was 12-OCT-2009. Follow-up information was received on 15-SEP-2010. The mother of the patient reported that her daughter's pregnancy was complicated only by "lots of nausea- she had hyperemesis". The patient was not hospitalized, but she was treated (not specified). She had a normal vaginal birth on 26-SEP-2009, 37 weeks from her last menstrual period, and delivered a boy who was healthy and normal. The boy was a year old and was "just fine" at the time of reporting. Additional information is not expected.
Information has been received from a 68 year old female patient with high blood pressure and no drug reaction/allergies who on 09-AUG-2011 was vaccinated with ZOSTAVAX (Merck) (lot # 669692/0615AA, EXP 02-JUL-2012) once. A month after injection received, on approximately 09-SEP-2011 the patient experienced light headedness, extreme fatigue and tingling in feet and legs. The patient believed that ZOSTAVAX (Merck) caused light headedness, extreme fatigue and tingling in feet and legs. Patient sought unspecified medical attention. Blood work was performed (result not provided). The outcome of light headedness, extreme fatigue and tingling in feet and legs were unknown at the time of the report. Follow-up information has been received from the patient concerning she was given her shingles injection at a pharmacy. On 09-AUG-2011 she was feeling fine. She had left the gym, stopped at the pharmacy, and had the shot. She had "now" (in approximately October, 2011) been diagnosed with Epstein Barr. She had been very ill for 2 months. She could not help feel that the injection caused this. They are too closely related. She was still not normal. This had been debilitating. 2-3 weeks after this hit. Not a good thing. She drove her car for the first time "yesterday" (16-OCT-2011). Follow-up information has been received from the patient stating that she continued to experience nerve complications (tingling, twitching and numbness) in her feet and legs which affected her ability to walk and her general quality of life (considered disabling). The patient reported that she had had numerous tests completed (numerous unspecified blood tests, magnetic resonance imaging (MRI's), unspecified tests for cancer, unspecified nerve and muscle test). The patient stated she believes ZOSTAVAX (Merck) caused her problems. The patient reported she experienced everything three weeks after receiving ZOSTAVAX (Merck). The patient stated she had "all extensive testing" yet they can not find a specific reason why she is experiencing her feet are numb and nerve damage. She stated she can walk but her legs are weak. The patient stated "This has completely changed my life. I have gone to five specialists and they all say the same thing, it was the shot. I do not have multiple sclerosis, I do not have cancer and have been doctoring since last September 2011. I had three heart stents March of the previous year (2010). I did not finish two sessions for rehabilitation because of extreme fatigue. I had to crawl to bathroom. I have this virus in my blood now." At the time of this report, the conditions were not recovered. Nerve complications (tingling, numbness and twitching in feet and legs) affect ability to walk and general quality of life, Epstein Barr, extreme fatigue, light headedness and very ill were considered disabling. Additional information has been requested.
It was documented to be COVID. I had a positive COVID test. Congestion, cough, headache, total loss of appetite, and a weird taste in my mouth. I guess the symptoms were mild, I'm fine but I couldn't work. The congestion lasted 14 days and I still have residue.
pt recv vax & then approx 1hr p/vax devel generalized urticarial eruption;no anaphylaxis;
Depression, crying for no reason since about 8am Fatigue since about 8am Sore arm muscles extending into chest since about 8am
This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients (reported as "1 or 2") of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patients received doses of improperly stored ROTATEQ (orally, lot# L033694, expiration date: 16-JUN-2017) (dose was not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Severe rash on hands, neck, arms (up to elbows) Upper inside of legs, face. Severe drying and itching. Hands severely swollen. Symptoms began noticeably the next day but I thought I'd gotten into soap or something as itching and dryness began. Saturday morning hands severely swollen and rash on neck and facial dryness, and neighbor took me to hospital for allergic reaction. Given a shot and instructions to use BENADRYL.
rash began around inj site-proceeded to travel down arm-across abd to rt arm;tiny pinprick rash spread over entire body bright red diffused w/litter separation;rapid breathing;fever, n, muscle aches, rapid pulse, loss appetite;
Developed flat, red rash at injection site - right arm. Also pain and warm to touch at injection site. Fever, lethargy, loss of appetite.
Optic neuritis and retinitis (right eye) resulting in retinal bleeding due to DVT. Five day course IV steroids starting day 13. Bromfenac ophthalmic BID starting (day 40). Intramuscular steroid injection (day 51).
Genital herpes type 2; This case was reported by a consumer via interactive digital media and described the occurrence of herpes simplex type ii in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th June 2022, the patient received the 1st dose of Shingrix. In August 2022, between 1 and 2 months after receiving Shingrix, the patient experienced herpes simplex type ii. On an unknown date, the outcome of the herpes simplex type ii was unknown.   It was unknown if the reporter considered the herpes simplex type ii to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-AUG-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient got the first dose of Shingrix vaccine and this month (reporting month) the patient developed Genital Herpes type 2 for the first time in his/her life. The patient did not had sexual intercourse anymore and was being married for 45 years, no sexually transmitted disease before. The patient was informed about research studies. Follow-up would not possible as no contact details were available.
ADMINISTERED DOSE OF THE VACCINE FROM A VIAL THAT HAD BEEN PUNCTURED  26 HOURS PRIOR; PRODUCT STORAGE ERROR; This spontaneous report received from a health care professional concerned a 52 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 07-AUG-2021) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-JUN-2021, the subject experienced administered dose of the vaccine from a vial that had been punctured 26 hours prior. On 09-JUN-2021, the subject experienced product storage error. The action taken with covid-19 vaccine was not applicable. The outcome of the administered dose of the vaccine from a vial that had been punctured 26 hours prior and product storage error was not reported. This report was non-serious. This report was associated with product quality complaint: 90000182689. The suspected product quality complaint has been confirmed to be the suspected product quality complaint has been confirmed to be it was reported that the consumer was vaccinated with an expired vial that was first punctured 26 hours earlier.product quality complaint has been confirmed to be voided (did not meet pqc criteria) based on the pqc evaluation/investigation performed. based on the PQC evaluation/investigation performed.
Patient said she had an allergic reaction to the vaccination which consisted of a rash that started on the lower body which spread to her chest area (NO breathing issues), mild flu like symptoms and local arm pain at the injection site. Patient went to a walk in clinic on 6-30-18 to be evaluated and the prescriber prescribed a course of keflex and for patient to take benadryl for a diagnosis of rash and other nonspecific skin eruption. On 6-31-18 I called patient to see how she was doing and she said she was doing much better.
Patient fainted, out about 15 sec. lowered to floor and raised legs and patient recovered. Called 911 and EMT checked vitals - all ok BP 116/70. Advised patient to have someone pick her up friend picked up.
Case number PHEH2015US026925 is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 45 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into left deltoid on 05 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Patient received her second COVID-19 vaccine. Rapid response called when patient returned to vaccine clinic and reported feeling "funny," itchy, and with a blotchy red rash around her neck. Heart rate noted to be 220/109, SpO2 100% on room air. Heart rate of 85. Emergency department PA notes questionable allergic reaction to the vaccine. Very mild erythema at the base of her beck. Given Benadryl, Solu-Medrrol and Pepcid. Heart rate of 183/95 trended down to 157/90 by the time of discharge.
At follow-up call, patient complained of swelling Lt severe enough she has to go to ER to get ring cut off (Sat. 2/23/08).  Also had hive like blister at/near injection site of YFVAX, itching, irritation all on Lt arm.
Information has been received from a health professional concerning  a 29 year old female who on 14-APR-2008 was IM vaccinated in her left arm with her first dose of GARDASIL (lot number 659964/1978U). Concomitant therapy included hormonal contraceptives (unspecified). On 21-APR-2008 the patient experienced a very painful ear ache. On 22-APR-2008 the patient experienced numbness in the lower left arm and tingling in the lower left arm. This numbness and tingling was not at time of injection site. Subsequently, the patient recovered from the very painful ear ache. The patient's numbness and tingling in the lower left arm persisted. The patient sought unspecified medical care with an office visit. Additional information has been requested.
Tested positive; tested positive; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient reported that she tested positive on 15Feb2021; wanted to know if it would be safe to have the second vaccine tomorrow after recovering for 10 days. No FAQ. Read ISI. Transferred to a facility due to being an AE/PCOM as well as to have clarification if the patient should receive the second covid vaccine. Outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Woke up on the morning of the 21st and my left ear felt clogged. Whenever I would speak or hear a loud noise, it would feel like someone running a metal spoon on a large metal bowl, resonating inside of my ear. This persisted for several days and I would also have occasional tinnitus that would come and go, so I went to the walk-in center on Saturday. The doctor prescribed prednisone and I took it for 1 day but had extremely adverse reaction so I stopped taking it. The loud resonance in my ear seems to have gone down somewhat over the last two days, but now I have tinnitus in both ears that is most prominent in the silence and is mostly steady now. I have been trying to get an ENT referral from the walk-in center for two days now and they keep saying they will get back to me and I keep calling but no one has gotten back to me with a referral. I have been taking lots of immune-boosting foods, supplements, and anti-inflammatory fruits and vegetables just trying to keep my immune system healthy. I am still recovering from the adverse effects from the prednisone.
Sharp headache - same day Muscular Pain around injection site - same day (lasted until 3/18/21) Joint pain - same day (lasted until 3/18/21) Nosebleed - 3/18/21 (8:13p - 8:37p) Mild cold symptoms (3/17/21 onward)
severe shaking/fever 102 degrees 6 hours after shot. Next day fever 103 degrees, head ache, body ache, took acetaminophen. Two days after felt better still taking acetaminophen. Three days later almost back to normal. Will the second dose be worse????
pt recv vax 7JUL98 & 28JUL98 pt was found to have positive hep A IgM antibody;pt was not treated for the event;
Dose 4 vaccination 04/01/2022, FL3197 Pfizer BioNTech. Normally have a temperature of 95.6 but had a increase of 97.8 significant change body temperature and I was having issues of feeling not being able to get warm all day, with aches and pains and temperature fluctuation not able to regulate the temperature. I also had the Hep A and B combo 04/12/2022 and MMR 04/12/2022. I also had positive COVID-19 diagnosis on March 15, 2022. I had a telehealth visits. I had exposure by family member who tested positive for COVID-19 and was confident with at home test. I used to be able to get 12,000 steps regularly still experience issue with fatigue no longer able to handle.
After waiting 15 minute observation, client left the facility and was transported by van to her facility. During the van ride, she started feeling sweaty, weak, and felt faint for about 5 minutes. She turned to administrator and said "I'm going to be sick". The van stopped and she vomited, it was" chunky" (she said it was her breakfast coming up).  She declined 911/EMS, she got back in the van and "felt better".  As she entered the facility, she also had an episode of diarrhea. The medical office came up to assess her, vitals were normal for her (bp 90/60) taken and she rested for the remainder of the day with no other instances of nausea/vomiting or diarrhea. Rested for the next day and did not participate in groups the next day. States today, Thursday, December 1, 2022, she feels fine.