chrisvoncsefalvay/vaers-outcomes huggingface dataset:
second dose on 15-Jun-2022 and a third dose on 25-Aug-2022.; first dose on 23-Mar-2022, second dose on 15-Jun-2022; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received HBV (Engerix B) (batch number 98X5P, expiry date unknown) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number 98X5P, expiry date unknown) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On 25th August 2022, the patient received the 3rd dose of Engerix B. On 15th June 2022, the patient received the 2nd dose of Engerix B. On 15th June 2022, not applicable after receiving Engerix B and unknown after receiving Engerix B, the patient experienced drug dose administration interval too long. On 25th August 2022, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too long and drug dose administration interval too short were unknown.       Additional Information: GSK receipt date: 07-SEP--2022 Reporters comment:  The reporter reported that the adult patients received the Engerix-B vaccination series, first dose on 23rd March 2022. As per the reporter, all doses were from lot 98X5P. The reporter consent to follow-up. As no other patient identifiers were reported, as per the reporter, patients received the same product on the same dates, same lot number Additional Supportive information: On 25th August 2022, the patient received the 3rd dose of Engerix B, which led to shortening of vaccinations schedule. 15th June 2022, the patient received the 2nd dose of Engerix B which led to lengthening of vaccination schedule.  This case has been linked to the US2022129657 case reported by the same reporter.; Sender's Comments:  US-GSK-US2022129657:Same reporter
Patient unexpectedly died on o1/6/2020.  No known signs or symptoms.
Initial and follow-up information has been received from a medical assistant, for the Pregnancy Registry for GARDASIL, concerning a 21 year old female with no known drug allergies and a history of chickenpox and depression in past who on 12-OCT-2007 was vaccinated with the first dose of GARDASIL (lot no. 658556/1060U). On 12-DEC-2007 the patient was vaccinated with the second dose of GARDASIL (lot no. 659435/1265U). On 12-JUN-2008 the patient was vaccinated with the third dose of GARDASIL (lot no. 659964/1978U). The patient is now pregnant. As of 22-JUL-2008, it was reported that the pregnancy was normal to date. The patient was seen in the office to seek unspecified medical attention. Follow-up information was received which reported in September 2004 the patient had one previous pregnancy and delivered a baby boy at 39 week gestation. The previous live born child was healthy and well. On 05-AUG-08, the initial physical examination was performed. The pregnancy was essentially unremarkable. On 02-SEP-2008, the follow-up physical examination was performed. No fetal heart tones were detected. On the same day, ultrasound confirmed the intrauterine fetal demise. On 08-SEP-2008 the baby was delivered in the evening at approximately 18:00. The mother denied use of tobacco and alcohol in excess during the pregnancy. Her only medications include prenatal vitamins, some Omega-3 fatty acids over-the-counter and acetaminophen over-the-counter. On 08-SEP-2008, the parents reported the baby was active until approximately a week ago. The physical examination of the baby was performed. The infant weighted 85 grams. Cranium was intact. Ears were normally formed and positioned for a 17 week gestation. Palpebral opening were horizontal with very slight fusion still present. Nose, cheeks and philtrum appeared to be normal. Palate is intact. Tongue appeared to be normal. Mandible is only slightly recessed. Cervical area was unremarkable. Thorax was normally developed. Abdomen was negative palpably. There was a very small narrowing at the umbilicus. Umbilical cord measured 18.5 cm in length. External genitalia were normal male with testes undescended, consistent with gestational age. Anus appeared to be patent. Overall skin was gray with some early maceration consistent with the demise over a week ago. No anomalies of the skin were detected. No contractures were evident in the extremities. Fingers, toes, hands and feet all appeared to be normally formed. No evidence of polydactyly or syndactyly. The impression was 17 week male intrauterine fetal demise, mild cord stenosis and no significant dysmorphia. Upon internal review, intrauterine fetal demise was considered to be other important medical events. Additional information is not expected.
Fever (2 days now), extreme muscle pain/joint pain.  Headache.  Two large (quarter size) welts near injection site.  Fatigue.
pt recvd vax 17OCT95 & exp rash near the site of inj to rt armpit manifested 18OCT, lympahtic swelling & tenderness in the rt armpit & radiating pain to the rt elbow manifested 19OCT;overnoc muscular aches & tiredness on 19OCT;face numb
Receive shot at 12 PM. By 6 PM started to feel achy and had a 101 fever. Had chills and bodyaches through the night and through the following day. Following day had fever until about eight or 9 PM. By 10:30 PM the fever had gone. Waking up on May 6, Felt much better.
Woke up in middle of night with very sore, red arm.  Continued to get worse red and swollen all to way around the arm.  Saw doctor on Wed Nov 4th who determined it to be cellulitis and started tx with abx.  Pt still recovering and taking abx as of Nov 16.
mother calls to report that child has "red spots" on face, forehead and up into beyond hairline." Also on stomach
Got 2nd dose beyond 35 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got 2nd dose beyond 35 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got 2nd dose beyond 35 days). On 08-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got 2nd dose beyond 35 days) had resolved.            Concomitant medications was not provided by the reporter Treatment information was not provided
pt recvd vax 11DEC92 & pt devel welts & hives on trunk & exp a burning sensation over trunk; sx persisted for 1 day;3 days later,exp nausea,vomiting&transient numbness on the lt side of face & lips which persisted @ the time of the report;
Early menstrual spotting/bleeding and cramping. I am on the 3 month birth control pill and have never experienced spotting this early into a pack.
COVI D 19 positive on 8/30/2021 nasal congestion, diarrhea, H/A, bodyaches, runny nose, cough
sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (the patient had shingles on back when he/she was 15 year old and very unusual but the patient vividly remember the pain. Had not had it since).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR095003   Additional Information: GSK Receipt Date: 16-June-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient had the shingles shots recently, because he/she never want shingles again. The patient received 2 shots. The first one was fine, just a sore arm for a couple of days. Additional supportive information:  For tolerance of 2nd dose of Shingles vaccine, refer case US2022AMR095003 reported by same reporter. The follow-up would not possible, as no contact, details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR095003:same report, 2nd dose
Patient transferred to Hospital on 02/02/2022 from Health System for encephalopathy and failure to wan off the vent.  Patient received a positive Covid-19 test on 01/12/2022.  He had worsening confusion requiring frequent reorientation.  On 01/22/2022 wife brought him to ED, he was initially on room air but decompensated and was intubated on 01/24/2022.  He received Decadron and finished treatment on 01/31/2022.  Patient failed to wean off the vent d/t issues with severe agitation and tachycardia and tachypnea.  He was placed on broad spectrum antibiotics.  MRI obtained on 01/25/2022 without acute abnormality.  He continued to have fevers and worsening respiratory distress.  Doppler revealed a DVT, and placed on Eliquis.  On 02/7/2022 patient developed Afib with RVR.  Patient developed worsening kidney failure.  Continued to deteriorate and required nor epi and vasopressin.  Palliative consulted and extubated on 02/15/2022.
Hoarse and raspy voice three days after vaccine; sore throat for only a few hours after voice changeoccurred.; Soreness in the injected arm muscle the evening ofthe injection; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in the left arm on 06Mar2021 at 09:30 as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN) and ascorbic acid, biotin, calcium, calcium phosphate dibasic, chromic chloride, cupric oxide, cyanocobalamin, ferrous fumarate, folic acid, magnesium oxide, manganese sulfate, nickel sulfate, nicotinamide, pantothenic acid, phytomenadione, potassium chloride, potassium iodide, pyridoxine hydrochloride, retinol, riboflavin, sodium metasilicate, sodium molybdate, sodium selenate, thiamine mononitrate, tocopheryl acetate, vitamin d not otherwise specified, zinc oxide (CENTRUM SILVER) both for an unknown indication from an unknown dates and unknown if ongoing. On 09Mar2021 at 10:00, the patient experienced  hoarse and raspy voice three days after vaccine, sore throat for only a few hours after voice change occurred. The patient felt fine; temperature was normal. The patient received vaccination in the morning and got soreness in the injected arm muscle the same evening of the injection. Fourth day after vaccine voice was still hoarse and raspy, no fever, felt fine. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hoarse and raspy voice, sore throat and muscle soreness at injected arm was not recovered at the time of this report  No follow-up attempts are needed. No further information is expected.
Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Joint pain). At the time of the report, ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt administered COVID-19 Moderna Vaccine at ~10am in left arm. A few minutes after administration pt reported feeling dizzy, was given juice. Vitals at 10:32am include: BP 110/80 mmHg; HR 80 bpm; O2Sat 98%. At 10:37am pt reported developing red hives along right mid arm & left hand but reported no airway closing or difficulty breathing. Pt given 50mg Benadryl liquid PO. BG finger stick 119 mg/dL. Pt reported still feeling lightheaded though no oral swelling or wheezing & clear lung sounds ~10 mins after Benadryl given.  11:07am Pt reported developing tingling of the lips & shortness of breathe. Pt given 20mg Pepcid PO. Vitals included: BP 110/70mmHg; HR 87bpm; O2Sat 97%.  11:21am Redness along both arms significantly decreased in both arms. Pt reported no wheezing/SOB and no oral tingling. Pt released to her husband to be seen at ED. Pt also instructed to contact her allergist and make a plan prior to next dose.
First few days there was a bubble at injection site. A week later the bubble started to go away. The site is red, painful, warm to touch. My eyelids were swollen this morning.  I have had a sore throat for days. Not sure if it's related.
Moderna COVID 19 Vaccine EUA  Fever 103, for 3 days, swollen left lymph nodes, nausea, vomiting, diarrhea, headache, chills, serve joint pain and pain at the injection site. All lasting for 4 days.
Information has been received from an attorney on behalf of a representative of the estate of a patient who, on 7/1/98, was vaccinated with a dose of hepatitis B virus vaccine. Subsequently, the patient experienced an unspecified injury. Additional information will be provided when it becomes available. (OMIC)
Information was received 13-OCT-2016 via telephone call from a registered nurse who reported that an improperly stored dose of GARDASIL 9 was administered to a 22 year old patient on 10-OCT-2016. (Lot # L036301, expiration date 20-DEC-2017 and Lot # M018810, expiration date 28-MAY-2018). It was not specified which lot # was administered to this patient. No adverse effects reported. This report was due to data logger. This is one of several reports from the same source. Additional information was requested.
No adverse reactions noted. Patient came in for her second dose of the Moderna vaccine.  Vial was punctured 1:55PM on 06/03/2021. Vaccine was administered from the same vial at 08:55AM 06/04/2021
In September 2015, patient took the HPV virus vaccination and the changes began. Please read the story and Pray for patient!  Patient is my granddaughter and her Mother feels it is now time for everyone to see and know what has been happening to her daughter - patient has now had 5 of these episodes since February 2016 and has been to family doctors, hospitals, ER's, Neurologist, NeuroSurgeons, had MRI's, Cat Scans, Brain Wave test, etc with no conclusive answer. At first the doctors said she could possibly be faking, then it's epilepsy, then it's migraines, now it's Chiari Malformation. The doctors cleared patient to do anything she felt like doing with adult supervision. So, on Sunday July 31, 2016 she was running in a track meet with her Mom, coaches, medical staff, etc in attendance, when one of these episodes happened. Up until this time the doctors had not been able to see what was happening to patient when one of the episodes came on - her coach told her Mom on Sunday get this on video!! I have patient - take the videos!!!! Patient was taken to the ER and they found nothing wrong except her potassium was low but should not have caused anything like what you see on this video!! All her vitals were NORMAL - no heat exhaustion, no heat stroke, Nothing!!! Videos have been sent to her doctors and we are waiting on appointments to become available!!  Her mother has done hours of investigation into all aspects of possible causes and truly believes that patient is having a reaction to taking the HPV virus vaccination. That is the only answer left!!! Now she waits and watches for any sign from patient that it is happening again!! Please pray for patient and her family!!!
After receiving the shot on 22May, around 12pm he started becoming lethargic and started to develop a fever. On the 23rd, the injection site was red and swollen. He flinched when I would touch the site. There was also a ring around the site. On the 24th his fever had reached 103F. I gave him MOTRIN to lower his fever. On the 25th, in the morning his fever was down to 100F but by 12pm it had spiked to 103.7F. On the 26th, his fever finally broke but he was now covered in a rash. On the 29th, we went to his doctor and ER because the night before I woke up to him not breathing and his lips were dark. After we finally woke him up, he took a deep breath. At the ER he was diagnosed with an ear infection and an Apneic episode. As of today, (11Feb2019) he is still having episodes where he will stop breathing but not as a severe as the one that happened on the 28/29 May.
2-3min p/vax began walking toward waiting room then began to feel nauseated & like had shut down;suddenly fell to floor, striking head hard on a metal scale;had few sz-like twitches;face felt numb on one side x 1/2hr;had vasovagal syncope;
Information has been received from a nurse concerning a patient who was vaccinated po with a dose of ROTATEQ (date and number of dose unspecified). The nurse reported that the patient developed rotavirus. It was reported that the patient sought medical attention, unspecified. The outcome was not reported. This is one of several reports from the same source. Additional information has been requested.
It has been just over 2 weeks now and I have continued pain in my arm around the injection site. I had no other effects from the vaccination except for some fatigue the following 6 hours after vaccination. I had severe arm pain for 5 days after injection where I could not move my arm. Today I still feel pain lifting it over my head.
6/22/2023 - 7/1/2023 (9 days) presented to the emergency department status post fall at home asx 7/27/2021 EW0161 8/17/2021 EW0173 1/27/2022 33036BD
Patient received her booster dose to the Moderna vaccine. About 5 minutes after administration, reported nausea, dizziness, feeling hot, and sweating. This had not occurred before with other vaccines, or the first 2 doses to the Moderna Vaccine. Patient was sat down, given a cold bottle of water to drink, and a snack due to the patient not eating breakfast or lunch. Blood pressure, heart rate and blood sugars were checked and within normal limits. After about 15 more minutes, the patient felt better and visually looked better. A significant other arrived to take the patient home, and they were advised to follow-up with a doctor if additional symptoms/side effects occur.
pt recvd vax & devel immediately redness, swelling over LA w/ 1 cm  wheal at sites of immunization;
I had been in remission from Graves? disease for 3 years. About a week after my second Moderna dose, I started having tremors and high/unstable heart rate. I had blood tests done for my thyroid two weeks after my second vaccination. They showed that I was hyperthyroid again and no longer in remission. Since my previous blood test two months before had shown that I was stable, we determined that the vaccine caused a relapse.
FEVER 102  DIZZINESS WHEN STANDING MOVING ( SENSATION OF WOBBLING)
This case was reported by a other health professional via call center representative and described the occurrence of rheumatoid arthritis aggravated in a 53-year-old female patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis. The patient's past medical history included cancer. Concurrent medical conditions included rheumatoid arthritis. On 13th March 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 14th March 2019, 1 days after receiving SHINGRIX, the patient experienced rheumatoid arthritis aggravated (serious criteria GSK medically significant), fatigue, heart rate increased, arthritis, sleepiness, weakness and blistering of mouth. On an unknown date, the outcome of the rheumatoid arthritis aggravated, fatigue, heart rate increased, arthritis, sleepiness, weakness and blistering of mouth were unknown. It was unknown if the reporter considered the rheumatoid arthritis aggravated, fatigue, heart rate increased, arthritis, sleepiness, weakness and blistering of mouth to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left deltoid. The patient called and reported that, she was experiencing fatigue, weakness, increased heart rate, rheumatoid arthritis symptoms, painful arthritis, blisters in her mouth and sleepiness. The patient also stated that, she had cancer and rheumatoid arthritis in the past and has never felt like this before. No further details were provided.
On 9/24/08 pt's mother reported that after receiving her second GARDASIL vaccine pt experienced a migraine type headache with nausea and photophobia which lasted x 3 days. Pt also experienced a heaviness in both arms and leg cramps. This was not reported at the time the symptoms occurred. Mother called our office 7/24/08 with concerns about medic reports regarding deaths after pt received GARDASIL. Child's mother refused 3rd vaccine.
pt recv vax; mom reports to immun clinic that pt has inc T; did not sleep at noc p/ 2nd dtp;
Unusual heart beat. Felt as if my heart was skipping beats. Was diagnosed with premature beats by a cardiologist, caused by the vaccine.