chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a licensed practical nurse referring to a 15 year old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported. In April 2018, the patient was vaccinated with improperly stored vaccine of GARDASIL 9 lot # N025428 with expiration date of 19-JUN-2020 (strength, dose, route, and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature excursion below 32 degree Fahrenheit (31.1 degree F) for 8 hours and 27 minutes, also between 32 degree F to 35 degree F (32.5 degree F) for 4 hours and 33 minutes, which were called by a data logger. No adverse events were reported. Product quality control issue was not involved. This is one of the 46 reports from the reporter.
Hair loss; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious) with onset 2021, outcome "unknown", described as "Hair loss". The event "hair loss" required physician office visit.  Additional information: Caller states that she had her first dose of the Pfizer-BioNTech COVID-19 Vaccine back in Sep2021 or Oct2021 but she hasn't received the second booster dose because after getting the first dose of the primary series she began experiencing some hair loss. she got COVID in July. she went to see dermatologist to treat her hair loss and her dermatologist said that COVID and pneumonia are stressors that may cause hair loss too. She said the hair loss started around the first time with the first vaccine and she said she did have COVID. She said dermatologist told her there are a lot of people with that happening and she said was around 3 months after and from Jul and then she got pneumonia. She said lasted for 11 weeks. She said the hair loss stopped and is now coming back and she is due for a booster and asking should she be reluctant or should she wait. She is not sure if the vaccine could cause hair loss or could COVID cause hair loss. She is going through menopause. She said hair loss is the only thing that happened and she is not sure if from that. The dermatologist though the hair loss was from COVID. She said was around the 3 months timeframe. Caller declined to complete report since on her lunch hour. Unable to obtain full details. Caller confirmed Pfizer COVID-19 vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 3/25/21, he went to Hospital because of a high fever. One 3/28/21, he had a moderate stroke in his frontal lobe and can no longer talk, understand basic things or take care of himself.
This spontaneous report as received from an other health professional refers to a female patient of unknown age. The patient was vaccinated with 0.65 ml ZOSTAVAX in 2008. No other co-suspects were reported. Concomitant medications included: PREDNISONE and inhaled corticosteroids (not otherwise specified). The nurse reported that she administered ZOSTAVAX to a patient that had completed a MEDROL Dosepak. The patient completed the MEDROL Dosepak a month prior to the administration of the ZOSTAVAX (administration of the ZOSTAVAX was believed to be in 2008, but nurse was not sure). The nurse reported that the patient had no adverse reaction associated with the administration of the ZOSTAVAX, but then stated that the patient has since died at age 93. On an unknown date the patient experienced death (death). No treatment information was reported. The outcome of death was reported as fatal. The date of death is not known. Nurse did not feel death was associated with ZOSTAVAX vaccination. The nurse asked about using ZOSTAVAX in a patient that is on 10 mg of Prednisone and inhaled corticosteroids. The nurse did not wish to provide additional information at the time of the call and did not wish follow up. Additional information is not expected. It has been determined that case 1210USA013797 is a duplicate of case 1210USA013349. Therefore, case 1210USA013797 is being deleted from our files and the cases consolidated into case 1210USA013349. No new information was reported.
This spontaneous report was received from a registered nurse referring to a 16 months old patient of an unknown gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was not provided. On 04-APR-2017, an improperly stored dose of VARIVAX injection (lot # L050561 with expiration date of 14-DEC-2017 or lot # M019841 with expiration date of 20-APR-2018; dose and route of administration were not reported) reconstituted with properly stored sterile diluent (manufacturer unknown), was administered to the patient. No adverse effects were reported. Administered vaccine was exposed to temperatures between 6 and 14 degrees Fahrenheit for 30 minutes. No previous temperature excursion was reported. Data logger was involved  in recording the excursion. This was one of several reports received from the same reporter. Additional information is not expected as all scheduled correspondence was received.; Sender's Comments: US-009507513-1704USA009837: US-009507513-1704USA010916:
Pt received a HD flu shot in left arm and Shingrix in right arm on 9/24. Pt came in to pharmacy on 9/27 to show her right arm had an injection site reaction.  There was an area about the size of a 2 inch square that was pink/red in color.  Pt said it was tender and warm to the touch/ swollen.  The reaction happened a day or two after getting the vaccine and she stated that it was a lot worse before she came in on 9/27.  Pharmacist explained that this looks like an injection site reaction from Shingrix and that patient should ice the area for about 15 min three times daily until better and to also take tylenol for the pain.. Patient was fully recovered after following up with her 2 days later.
Pt got redness and swollen in the injection area the next day. It got worse and the area was warm to the touch and also hard. Pt went to see doctor 5/23/16 after consulting with pharmacy. Pt was treated for cellulitis in injection area.
Took two doses of Vivotif in a row; A spontaneous report was received from the pharmacist on 09SEP2022. It described a 24-year-old adult male patient who "took two doses of Vivotif in a row" (PT: Inappropriate schedule of product administration). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient administered the first 2 doses of Vivotif on 08SEP2022 and 09SEP2022 mistakenly. Additionally, the patient did not experience any side effects. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a patient took two doses of Vivotif in a row (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a patient took two doses of Vivotif in a row (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non-serious as per medical assessment.
rash at the injection site; 4 month old patient received a dose of Kinrix; Received  Kinrix instead of Pediarix; This case was reported by a nurse via call center representative and described the occurrence of injection site rash in a 4-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced injection site rash, inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the injection site rash, inappropriate age at vaccine administration and wrong vaccine administered were unknown.   It was unknown if the reporter considered the injection site rash to be related to Kinrix and Kinrix Pre-Filled Syringe Device.   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: 02-MAR-2023 and 06-MAR-2023 Reporter's comment: The nurse asked further questions and mentioned that the patient developed rash at the injection site after the administration of Kinrix. The vaccine was administered at unknown place.  The reporter received the call from a parent and did not had patient details, other than age, or any vaccination details (date, lot, expiry date, etc). The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow up. Additional supportive information: The patient received a dose of Kinrix instead of Pediarix at an inappropriate age, which led to inappropriate age at vaccine administration and wrong vaccine administered.; Sender's Comments:  US-GSK-US2023035536: - same reporter
This spontaneous report as received from a physician via company representative refers to an 81 year male patient with heart disease. The patient's medical history and drug reactions or allergies were unknown by the reporter. On an unknown date, "4 or 5 years ago", the patient was vaccinated with ZOSTAVAX (dose, route, anatomical location, lot number and expiration date were not provided). The patient's concomitant medications were unknown by the reporter. On an unknown date the patient developed a "severe case of Herpes zoster after receiving ZOSTAVAX". The physician also reported that the Herpes zoster caused post Herpetic neuralgia. No product quality complaint was involved. The outcome of the Herpes zoster and post Herpetic neuralgia was reported as not recovered/not resolved. The causality between the events and the therapy with ZOSTAVAX was unknown. Additional information has been requested.
Pt started feeling adverse effects on 04-17-2021 (Saturday) but they got really worsened on 04-18-2021 (Sunday) when she reported to the pharmacist.  She had severe nausea and vomiting , diarrhea, loss of appetite and vertigo.  She is being treated by her physician who per patient prescribed her Ondansetron. She generally described her condition very sick.
A 16 year old patient received a VAXELIS vaccination in the office on 08SEP2021; This non-serious spontaneous safety report was received by a partner on 15-SEP-2021 and forwarded to Agency on 16-SEP-2021 from a nurse.  The causal relationship between Vaxelis and the reported event: A 16-year-old patient received a VAXELIS vaccination in the office on 08-SEP-2021 is assessed as not applicable due to the nature of the event.  No further information is expected
Pt vaccinated with MMR developed easy bruising and petechiae. Dx'd with ITP hospitalized 2 days for treatment w/IV Gammaglobulin
Beginning afternoon of 2/9/21, began realizing my heart was sore and that leaning forward was most comfortable. Was teleworking and so was busy but by evening realized symptoms were exact symptoms of 5 years prior, when I was dx. with pericarditis after a virus. Reached out to OMS as well as my cardiologist and primary. Cardiologist office told me they had not heard of vaccine causing this and would not evaluate. Primary, allergist and new cardiologist all evaluated but unfortunately episode resolved before they we could schedule an Echo. Episode lasted total of 10 days, subsiding to chest/hear soreness and SOB only w/activity by day 5. By the time new cardiologist was able to fully evaluate, all symptoms had resolved and test results were WNL. Initial bout of pericarditis in 2016 had lasted several months before resolving and had been more painful, so relieved it was total of only 10 days. I would like to further note that while at the 1 year anniversary of vaccines, I feel completely well and did not receive a booster due to an infection with COVID, week of December 21st and am waiting full 90 days, however this past year I maintained a list as I realized that throughout the year my body was in an increased inflammatory response mode, where my body continually overresponded to any injury with overwhelming inflammation. I actually required a weekly hospitalization for a spider bite in July! My body finally seems to have quieted down at 1yr and I am very concerned about what the booster might do!
Shingles; This case was reported by a physician via call center representative and described the occurrence of shingles in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was in her late 60s or early 70s. About a month ago, the patient received 1st dose of Shingrix . The next day, the patient presented in the office with active shingles.  The patient had no signs of shingles at the time of vaccination.  Limited details available at the time of reporting, as physician was unable to access patient data in the system and the vaccination was not administered at the office.
Body aches, low grade temp. 99.9°f,  right shoulder pain and hand weakness.
Initial report received from a health care professional on 22 December 2010. A 15 year-old female patient had received on an unknown day in 2006 a right deltoid dose of ADACEL (lot number C2384AA, expiration date 04 May 2008, route not reported), and subsequently received a first intramuscular right deltoid injection of MENACTRA (lot number U2230AA) on 04 May 2007; and on 02 November 2007 she received an intramuscular right deltoid injection of FLUZONE (lot number U2436AA), and an intramuscular left arm (also documented as right arm in patient's chart) injection of GARDASIL (manufacturer Merck, lot number unknown). The patient was in the physician's office around 22 December 2010 and during her physical examination it was noted she had a 6 x 6.5 cm lump under the skin at the right deltoid. It was reported by the patient's mother that the lump had been there since the patient's last vaccinations 3-4 years ago. The event had not been reported to the physician prior to that time. Relevant medical history was unknown. Per the reporter, no relevant diagnostic tests/laboratory data were performed. Documents held by sender: None.
Stomach cramps; Low grade fever; Nausea; Chills; Fatigue; Sore left arm; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (Stomach cramps), PYREXIA (Low grade fever), NAUSEA (Nausea) and CHILLS (Chills) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced DIZZINESS (Dizziness), PYREXIA (Low grade fever), NAUSEA (Nausea), CHILLS (Chills), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Sore left arm). On 12-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramps). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 14-Mar-2021, DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (Stomach cramps), PYREXIA (Low grade fever), NAUSEA (Nausea), CHILLS (Chills), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Sore left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Received first shot on 1/27/2021 and noticed a different feeling right away, my arm was very tender and the pain has never gone away.  1/30/2021 is when I started feeling really ill. My symptoms were equilibrium was off, heart palpitations, brain fog, very sick to my stomach, low grade fever, and sore throat, which lasted for days, maybe a week or so. The heart palpitations, and balance cleared up in about 2 weeks. I  was so sick during that time period that I can not remember when I zoomed my doctor but at about 3 weeks out I got a Covid test which was negative.  The symptoms still pop up every now and then, but the brain fog is the worst. After my second shot, my Oxygen was very low and I was given an oxygen monitor because my SPO2 was dipping to around 72.  I ended up using one of my daughters inhalers because my breathing was so bad. I was frightened to get my second shot but did it anyway.  I feel that I am not the same person I was before having the vaccine.
Tinnitus & partial hearing loss in right ear; Tinnitus & partial hearing loss in right ear; This is a spontaneous report from a contactable consumer (the patient). A 44-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unspecified route on 31Mar2021 as single dose for covid-19 immunization. Medical history included supplementation therapy. The patient's concomitant medications include escitalopram oxalate (LEXAPRO), Iron supplements and Vitamin D. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Reportedly, patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. On 05Apr2021, the patient experience tinnitus and partial hearing loss in right ear. Started 5 days after vaccine. The patient did not receive any treatment for the adverse events. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
I had a fever, headache, tickle cough without production and loose stools. I tested positive for COVID-19 on 07/29/2022.  I began taking Paxlovid and felt better. I tested negative for COVID-19 by 08/01/2022.
late in receiving second dose of gardasil 9; no adverse effect; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/ allergies and concomitant medications were not reported. On an unknown date in February 2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, exact dose, route of administration, anatomical location, lot number and expiry date were not reported). It was reported that the patient was late in receiving the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine series as noted in the prescribing information (inappropriate schedule of product administration). No adverse events were reported. No product quality complaint (PQC) was reported.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from Regulatory Authority (159558). The reporter is the patient. A 79-year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 25Jan2021 (Lot number: EK4176) at the age of 79 years as dose 1, 30 ug single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (non-serious) with onset 05Feb2021, outcome "unknown", described as "Tested positive for the covid virus". Relevant laboratory tests and procedures are available in the appropriate section. Additional information-Patient was hospitalized for a procedure, which was unrelated to this event, and they couldn't do it and said because he has covid not to get the second shot. Patient was asking whether to take second dose or not.
Information has been received from a medical assistant referring to unspecified number of patients of unknown age and gender. On unspecified dates, the patients were administered improperly stored GARDASIL 9 lot # M032650 with expiration date of 31-MAR-2019; strength, dosage, frequency and route unspecified for prophylaxis which was reconstituted with sterile diluent. Sterile diluent was not involved in the temperature excursion. No adverse effects were reported. Temperature was from 9 to 25 degree C (11.3 degree C) for 2 hours (refrigerated vaccine). On 14-APR-2017, there was a previous excursion with temperature from 9 to 25 degree (9.7 degree C) for 30 minutes. This is one of 4 cases received from the same reporter. Sender's Comments: US-009507513-1708USA003787: US-009507513-1709USA001896: US-009507513-1709USA001898.
34 year old scheduled and arrived in flu clinic with husband and 3 children for routine annual flu vaccine. Screening questions were asked and patient was sitting on exam table and vaccine was given. Shortly after flu vaccine was given patient stated that she needed to sit down and then that she felt like she was going to pass out. Myself and the other MA that were working together in the flu clinic immediately layed the patient down on the exam table and put her feet up, got her a wet cold towel to place on forehead.  patient then passed out. I left the room to go and call for help while the other MA stayed with the patient. I proceeded to call the cisco number for on-site emergencies and asked another MA that was not involved to place the page for me for on-site emergency. A pediatric physician happened to be sitting close as well and stepped into the room with the patient to check on her. Patient came back around and alert before I could get ahold of anyone to come evaluate and assist. Patient was given juice and crackers and kept in the clinic for about a half an hour. Patient had a small amount of vomit after drinking the juice and was given water. Patient recovered and felt much better and left clinic with husband and 3 children. LPN and RN arrived after patient was gone - LPN did not start in clinic until 8:30 and RN stated that pager was malfunctioning. I called to follow up with patient the following Tuesday and she said that that day she had a headache and went home and took a nap but she was doing fine and stated that we were great and that she appreciated the follow up call. Patient was notified to always mention that she has the tendency to pass out so that precautions can be taken ahead of time. Patient mentioned after the fact that she had passed out with all 3 of her children but she had the flu shot sitting up the last couple years and did not have a problem and that is why she did not mention it.
Developed hives on Left arm about 4 days after injection. They are mostly upper arm, but as of today may have spread to lower arm as well. Have not subsided.
Difficulty breathing the day after dose 2 in series, complains of cough, struggling to breath at night, returned to on 8/17 and admit to hospital the same day. Currently admitted