chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This prospective pregnancy case was reported by a healthcare professional and described the occurrence of hospitalization in a male neonate exposed to FLUARIX (GlaxoSmithKline) transplacentally when his mother was treated during pregnancy. On 10 October 2012 the 32 year old mother of the subject received unspecified dose of FLUARIX (unknown) and experienced maternal vaccine exposure. The mother's last menstrual period was on 27 July 2012 and estimated date of delivery was 16 April 2013. The neonate was exposed to FLUARIX at approximately 10 weeks gestation during the first trimester. On 14 February 2013, at 31 weeks gestation, the neonate was delivered prematurely by normal vaginal delivery and weighed 4.75 pounds. The neonate had no apparent congenital anomaly. The neonate experienced hospitalization since the nurse reported that a "(illegible) team here for delivery and assumed care for the infant at the time of birth" and the neonate was transferred to another location "due to being 31 weeks." The nurse did not attribute any problems to the suspect vaccine. The nurse requested that GSK not "send anymore correspondence on this case"; therefore, this case was closed. Please see report A0998075A for details regarding the mother case.
good sized drop / running down my wife's shoulder when she got her shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCHARGE (good sized drop / running down my wife's shoulder when she got her shot) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028D21A, 031MZ0H and 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE DISCHARGE (good sized drop / running down my wife's shoulder when she got her shot). At the time of the report, VACCINATION SITE DISCHARGE (good sized drop / running down my wife's shoulder when she got her shot) outcome was unknown.            No Concomitant medications were provided by the reporter. No Treatment information was reported.
G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SUBSEQ 1/7/2023 UNSPECIFIED ANXIETY DISORDER G62.9 NEUROPATHY 12/30/2022 UNSPECIFIED ANXIETY DISORDER I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 1/7/2023 UNSPECIFIED ANXIETY DISORDER G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SUBSEQ 1/7/2023 ANEMIA G62.9 NEUROPATHY 12/30/2022 ANEMIA I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 1/7/2023 ANEMIA G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SUBSEQ 1/7/2023 PANCYTOPENIA DUE TO ANTINEOPLASTIC CHEMOTHERAPY G62.9 NEUROPATHY 12/30/2022 PANCYTOPENIA DUE TO ANTINEOPLASTIC CHEMOTHERAPY I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 1/7/2023 PANCYTOPENIA DUE TO ANTINEOPLASTIC CHEMOTHERAPY G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SUBSEQ 1/7/2023 PANCYTOPENIA G62.9 NEUROPATHY 12/30/2022 PANCYTOPENIA I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 1/7/2023 PANCYTOPENIA
Extreme bone and muscle soreness next two days. Fever, chills. Exhaustion. Splotchy rash showed up all over body. Is still here 4 days later. Extreme headache next day.
Pt tested positive for Covid 19 on 9/18/21 when Patient presented to the emergency department by EMS for evaluation of generalized weakness and fatigue.  He reported onset of symptoms was 2 weeks ago however on that day he became febrile and diaphoretic. He was tachycardic  122 and febrile at 102.7. He was not hypoxic.  Chest x ray revealed R sided ground glass opacities c/w covid 19 pneumonia. He was discharged home. He then returned to the ER on  9/21/21 c/o fatigue, dry cough and dark stools. No repeat chest x ray was done. He arrived with low hemoglobin of 6.2 and was transfused 2 units of blood. He was seen by GI and due to covid 19 positive state intervention was not done . He was discharged 9/22/21 home and asked to closely monitor for any worsening respiratory symptoms or shortness of breath. He did complain of a dry cough and fatigue and weakness.
Herpes simplex virus reactivation with every dose. Reactivation with in hours and up to 3 days following each dose. Upper lip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2021 as dose 2, single (Lot number: EP6955) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EP6955), administration date: 17Mar2021, when the patient was 57-year-old, for COVID-19 Immunization, reaction(s): "Herpes simplex virus reactivation with every dose. Reactivation within hours and up to 3 days following each dose. Upper lip". The following information was reported: ORAL HERPES (non-serious) with onset 07Apr2021, outcome "recovered" (09Apr2021), described as "Herpes simplex virus reactivation with every dose. Reactivation within hours and up to 3 days following each dose. Upper lip". Therapeutic measures were not taken as a result of oral herpes.  Additional information: It was reported that herpes simplex virus reactivation with every dose. Reactivation within hours and up to 3 days following each dose in upper lip. If other vaccine in four weeks: No. Other medications in two weeks: No. If Covid prior vaccination: No. If Covid tested post vaccination: No. The patient had no known allergies and none other medical history.
Immediately after receiving vaccinations, she sat down next to her mom and began to feel dizzy.  She laid her head on her mom's shoulder and fainted.  Her mother and two clinic nurses laid her on the floor.  Her arms and legs tightened and raised for five seconds - seizure. She then opened her eyes. Pupils were dilated.  She laid on floor for five minutes, then sat up and moved to chair.  reminaed htere for ten minutes, then felt stronger and went home with her mother.  No further problems noted.
Fever, chills, body aches, headache until early morning 3/31 sore arm, itchy red rash on arm continuing still on 4/1
Ramsey Hunt Syndrom  7/28/21 Tongue painful and tingling 8/1/21 Headache, fatigue 8/02/21 Headache, fatigue, nausea Video visit with Doctor P.  8/03/21 Covid test negative 8/04/21 ER visit for Bells Palsy, vertigo sent home with Valtrex and Prednesone 8/06/21 Taken by ambulance to ER for extreme vertigo, nausea, weakness, headache and admitted to Hospital  8/06/21-8/8/21 In-Patient at Hospital diagnosed Ramsey Hunt 8/31/21 Complete hearing loss continues as does the facial paralysis.
Bruise like mark quarter-sized at site of injection that persisted over 10 days after injection. On Sunday 12/10/17 pt claimed to start having an achy pain in the whole upper arm of the injection site that worsened. Was reported today to the pharmacy @ 5:00pm. Pt claimed it aches like a "bad toothache" and the ache includes the whole upper part of the arm including joints and bruise is still apparent at injection site.
Rhinorrhea, already taking Zyrtec for environmental allergies for about 1 year consistently with no allergy symptoms noted during that period.  Recieved seasonal flu vaccine IM on Oct 27, 2009 at 1300 hrs with no noted side effects.  On Nov 3, 2009 at 1200 hrs, recieved H1N1 flu vaccine IM.  In the PM on Nov 3, started feeling a "burning" feeling in upper nairs.  On Nov 5, 2009, woke up with a severe runny nose that will not go away.  Up to date on all vaccinations to include being on Active Duty for 8 years and having recieved all standard vaccines for deployment, to include all Anthrax vaccine shots.  No other symptoms presently noted.
Shingles right upper torso. Mild/moderate itching beginning 1/31/21, followed by single small vesicle 1 week later, then scattered mild scabbing over the dermatome pattern 2/12/21. Patient was given  Zoster vaccine 12/1/16.
G40.909 EPILEPSY, UNSPECIFIED 11/2/2021 HEMIPLEGIA & HEMIPARESIS, LEFT NONDOMINANT SIDE, LATE EFFECT OF HEMORRHAGIC STROKE I82.4Z2 ACUTE DVT OF LEFT CALF, UNSPECIFIED VEIN 11/19/2021 HEMIPLEGIA & HEMIPARESIS, LEFT NONDOMINANT SIDE, LATE EFFECT OF HEMORRHAGIC STROKE G40.909 EPILEPSY, UNSPECIFIED 11/2/2021 INTRACEREBRAL HEMORRHAGE, CORTICAL HEMISPHERE I82.4Z2 ACUTE DVT OF LEFT CALF, UNSPECIFIED VEIN 11/19/2021 INTRACEREBRAL HEMORRHAGE, CORTICAL HEMISPHERE
Adverse allergic reaction to Pfizer Booster shot was noted on the evening of Nov. 17, 2022, with Hives appearing on neckline and armpit areas.  Then had pain on poke area for two days.  By Nov. 18, have experienced loose stools and sometimes watery discharge.  Color was normal but consistency was soft.  Hives disappeared by Nov. 19.  Also Gastric Reflux experienced from Nov. 17 until today, Nov. 26 2022.  Too much gas being emitted via mouth and anus areas during the day and nighttime.  Diarrhea also occurs sometimes but only once per day.  Have taken Diphenhydramamine for Hives and Imodium for Diarrhea and watery stools.
1 2/3yr p/initial series completed employee found to be neg to Anti HBs testing waning immunity; Given 5 doses 5OCT88, 2NOV88, 21APR89, DEC90, 22MAR91 from lots# 1893P, G629A4-(Engerix), 1238S respectively.1st & 2nd dose Lot# not recorded;
Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 15-OCT-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # L008031 with expiration date of 03-AUG-2015, strength, dosage and frequency unspecified (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter.  Additional information has been requested.
Pt was 15 at the time of vaccination, which is below the recommend age of 16 for the EUA.
This spontaneous report as received from a healthcare professional refers to 2 unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of MMR II injection (lot # K024036, expiration date 26-NOV-2016, therapy type, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
little soreness on left arm; stomach pain; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little soreness on left arm), ABDOMINAL PAIN UPPER (stomach pain) and DIZZINESS (dizziness) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ALFUZOSIN for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain) and DIZZINESS (dizziness). On an unknown date, the patient experienced VACCINATION SITE PAIN (little soreness on left arm). At the time of the report, VACCINATION SITE PAIN (little soreness on left arm), ABDOMINAL PAIN UPPER (stomach pain) and DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information provided.
He got his vaccine, didn't really have any reaction other than the arm soreness the next day.  8 days later he woke up one morning and he felt like he had an appendicitis, pain in his lower abdomen.  He went to work and eventually went away after 4-5 hours.  Then he had a pain all across his stomach that lasted the remainder of the day, perhaps 12 hours.  The next day it was completely gone.  Then he was fine the day after that, but after that he went to work and he felt like he was having trouble breathing, heavy chested feeling.  He was almost ready to drive himself to the ER and was short of breath.  This lasted for about 3 hours and went away and was then fine.  The next day after that they went out to get a pizza and his daughter asked if he was feeling okay, had an uneasy feeling in his stomach and she informed him that his lips were purple, which when he checked they were bluish purple and lasted the entire evening.  The next day that was gone and never came back again.  The following day while sitting at his desk in his home office both arms got clammy, hot and sweaty.  This lasted maybe 3-5 minutes and went away, never happened again.  He went to work the following day and he came home and it was a real hot sunny day, was outside the entire day.  He noticed the right side of his head felt like he had sunburn/sensitive.  He was mowing his lawn and brush against a pine tree and that felt like needles against his head.  He asked if he had a sunburn on his head to his wife, right side only divided down the middle.  This went on for a couple of days and on Monday he decided to call a nurse hotline and ask some questions and see what they felt it could be.  They told him to go to the ER as they felt it was serious.  Said it was a red flag, and he did not go to the ER.  He called his doctor and made an appointment, and by then he had a rash on his forehead, and she looked at him and said that it sounded like it was the beginning of shingles, which got worse and that was indeed what he had.  It went into his eye and had to go to an eye doctor, but not into his optic nerve.  It has since all cleared up which took about 3 weeks for it to go away, still has some sensitivity in that area, but pretty much gone.    Since having the shingles he has not had anything additional.  While he was being diagnosed with that he had the shingles he did not mention his other symptoms.  They asked him if he had recently gotten the vaccine and told them that he did 3 weeks prior and was supposed to get the vaccine the following week and then told them about the reactions he had, and told him to think about getting the 2nd vaccine.   While having the shingles he was put on an antiviral and he had back pain, severe pain that felt like somebody beat him with a baseball bat which lasted for about 2 days, and then kind of went down into his hips, legs, and knee caps that felt like they were going to explode.  He has never felt anything that has felt like that that possibly be related to the 1st vaccine, and did not get the 2nd one due to the reactions that he has had.  He is scared to get the 2nd vaccine.
During the middle of the night after receiving the vaccine, woke with chills and other flu-like symptoms such as fatigue and body aches into the next day. Had some chest congestion into the next day. Advil tylenol and allegra to get through the symptoms. Slept for most of the day the following day.
I had congestion, runny nose, fever, I was fatigued. This started out on the 18th went to bed and woke up the next day and felt the same, so I decided to take a home a COVID-19 test that came back positive. I called the doctor's office and had a telehealth visit. They prescribed the PAXLOVID that I started taking on the 20th for the five days. I was getting better but then I started feeling worse for 12/12/22 and found out that I have bronchitis. I have now on prednisone and an inhaler. The cough is a little better, but I am still trying to get over the lingering cough.
Information has been received from a nurse, for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female patient with asthma, migraines, depression, irregular heartbeat, high blood pressure, penicillin allergy and diphenhydramine allergy and a childhood history of anemia who on 29-SEP-2009 was vaccinated IM with her first dose of GARDASIL (lot # 663452/0671Y, expiration date 18-SEP-2011). On 07-DEC-2009, the patient was vaccinated IM with her second dose of GARDASIL (lot # 661952/1129X, expiration date 12-MAR-2011). On 22-FEB-2012, the patient was vaccinated IM with her third dose of 0.5 ml GARDASIL (lot # 670049/1261AA, expiration date 11-NOV-2013). There was no concomitant medication. A pregnancy test was done on 22-FEB-2012 before the patient received dose 3 and it was negative. On 06-MAR-2012, the patient had a positive urine pregnancy test. Her last menstrual period (LMP) was on 03-FEB-2012, and delivery date (EDD) was on 09-NOV-2012. The patient had sought medical attention by office visit. No treatment was given to the patient. A phone call was placed to the registered nurse who indicated the baby was born at 40 weeks gestational age. No complications during pregnancy. On 11-FEB-2014, the baby was seen at a facility and was diagnosed with flu (MARRS case no 1403USA004648). The R.N. also noted in the baby's chart that the baby was experiencing behavior problems and was scheduled for an autism review once the baby reaches 18 months of age. Significant information. This case is related to MARRS case no 1403USA004648 (parent-child link). Additional information has been requested.
After the 2nd shot on Saturday morning. On that evening, I expected what was expected, fever, headache and chills and I slept for the day. On Sunday evening, I felt like I had a medicine head and headache. On Monday, I had trouble thinking and figuring out daily task. I could not concentrate and think regularly. I had a interview and couldn't remember the day of the week, and I had trouble processing questions and pronouncing my words and speaking and completing a sentence. I had to ask other to repeat things. It lasted about 4 to 5 days. I finally felt it started to wear off. I did not have to call my doctor, I started more like I could focus and make decisions. I still had the headache, but the next weekend and next week I was back to myself.
Fatigue and malaise began less than 12 hours after injection. Around 3 am, I awoke with body aches, chills headache, and 102 fever. I took 800 mg of ibuprofen when permitted and temp only came down to 101. 5. Fever got up to 102.5 and was over 102 for about 36 hours. Severe headache, body aches, "fogginess", dizziness for several days as well.
Approximately 2 weeks post vax the pt developed a rash and was diagnosed with chickenpox.
my son (consumer) needs "new Heart and Lung"; my son (consumer) needs "new Heart and Lung"; This is a spontaneous report from a contactable consumer (mother) reported for a male patient that: A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter stated, "We both (mother and son) got our Pfizer (first dose) shots and we did really good but for my son (patient) needs "new Heart and Lung" (further not clarified) we had (first dose) received in the Hospital about 3 weeks ago (Covid vaccination). Now we just had Vaccine second dose yesterday. Asking if there anything you can tell me about any help (treatment)". The outcome of both the events was unknown.  Follow-up attempts are completed. No further information is expected.
Information was received on 07-JUN-2017 from a nurse who reported that on 05-JUN-2017 a four year old male patient was administered PROQUAD (lot# reported as M044719, expiration 07-MAY-2018; dose not reported) subcutaneous, reconstituted with sterile water diluent, and patient received less than recommended dose due to syringe leaking. No adverse reactions reported. No further information provided.  Additional information has been requested.
5IN BY 3.5IN SWELLING IN UPPER LEFT THIGH/PINK/ WARM TO TOUCH/ SURROUNED BY PALE BORDER/NEEDLE MARK IN THE MIDDLE/MINIMAL TENDERNESS TO DEEP PALPATION/NO INGUINAL LYMPH NODES TO PALPITATION
sick to his stomach; chills; now experiencing fever, chills, and is sick to his stomach; This non-serious case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced upset stomach (Verbatim: sick to his stomach), chills (Verbatim: chills) and fever (Verbatim: now experiencing fever, chills, and is sick to his stomach). The outcome of the upset stomach, chills and fever were not resolved.   It was unknown if the reporter considered the upset stomach, chills and fever to be related to Shingrix.     It was unknown if the company considered the upset stomach, chills and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-OCT-2023  The reporter was a patient. Patient received the Shingrix and at the reporting time experiencing fever, chills and was sick to his stomach. No further information was known. The reporter consented to follow up.
No additional AEs/PQCs reported; all lots of GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This spontaneous report has been received from an office manager regarding an 11-year-old patient of unknown gender. The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions, and concomitant therapies were not reported.  On 09-SEP-2022 and 16-SEP-2022, it was reported that some hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine had suffered a temperature excursion. On 01-JAN-2023, the vaccines suffered another temperature excursion and on 24-MAR-2023, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe injection (product storage error), administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023, lot #1775827, expiration date: 27-JUN-2024, lot #U032681, expiration date: 26-OCT-2023, lot #1780876, expiration date: 09-NOV-2023, and lot #W009829, expiration date: 19-OCT-2024; however, it was not specified which one was received by the patient), (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). All temperature excursions had a total time of 25 minutes (lasting for 8, 5 and 12 minutes, respectively). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (The temperature excursion occurred as a result of a reading from a Digital Data Logger).  This is one of several reports received from the same reporter.
On 11/9 the pt experienced dizziness and the pt was sent to the ER. Treated for high blood pressure. Stated fluid behind ear. On 11/10 began medication for elevated blood pressure. On 11/16 and 17. went to ER, blood pressure still elevated. Sent to the ER for a 3rd time treated by neurology for "viral infection".