chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles on head, face and neck; This case was reported by a consumer via (Shingrix ) interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included COVID-19 VACCINE (COVID-19 VACCINE UNKNOWN).   In April 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months 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 reported as follows: The case was reported by the patient. The age at vaccination was not reported The patient had the Shingrix vaccine in early April.  45 days after second COVID shot, the patient reacted to the vaccine and got shingles in 3 places on head face and neck.  The reporter asked what should he/she do regarding the second dose. No contact details were reported.
Vomited day of vaccine. Dizziness, tingling in hands & feet, SOB, sweating intermittently. 10/18-10/24/11.
Patient developed hives/rash under skin on upper extremities and face about 2 days after vaccine hives resolved after 7 days. Pt reports being fine.
pt was given a shot that was outside of the 6 hour puncture expiration date. No ADR's reported. Administering another 2nd dose since this dose is considered invalid per CDC guidance.
Information has been received from a physician concerning a 17 year old female with no known medical history and no known drug reactions/allergies who on 24-AUG-2010 was vaccinated with GARDASIL. There was no concomitant medication. On 25-AUG-2010, the patient stated that her heart was racing. No laboratory tests were performed to the patient. The patient did not seek medical attention. At the time of this report, the outcome of the patient was unknown. Follow up information was received from the physician, who reported that further questioning the patient, she admitted that the symptoms began before the dose of GARDASIL. She had been unclear regarding chronology. No further information is available.
Severe migraine headache with visual changes, aura, right sided numbness of face and arm, followed by pain.  never had this before. lasted over 24 hours and necessitated trip to urgent care; CT scan was considered, but symptoms resolved with sumitriptan; recovered completely and no further symptoms
has first dose over one year ago, do patient / need 2nd dose"; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 8th January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.2  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting ,the patient did not received the 2nd dose of shingrix, which led to incomplete course of vaccination. The reporter also inquired that, if the patient need to repeat 2 doses again or only 2nd dose would enough. During the chat,the reporter did not have information regarding batch number and expiry date. The reporter consented to follow up via email.
Headache, chills, fever & blister at vaccination area. A large red rash 8m x 10m around vaccinated area
sick after second covid-19 vaccine/it put patient down; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4410114-00 (AbbVie).  A 63-year-old female patient received BNT162b2 (BNT162B2), on 17Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (dose:1), administration date: 27Mar2021, when the patient was 62-year-old, for Covid-19 immunization, reaction(s): "Epilepsy"; BNT162b2 (dose:1), administration date: 27Mar2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "Sickness", "Sleep excessive", "Bronchitis asthmatic", "Tinnitus on both ears". The following information was reported: ILLNESS (medically significant) with onset Apr2021, outcome "recovered" (Apr2021), described as "sick after second covid-19 vaccine/it put patient down".  The reporter's assessment of the causal relationship of "sick after second covid-19 vaccine/it put patient down" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Clinical course: Causality for event Sickness (Illness): Action(s) taken with drug: Unknown; Causality as per reporter (Drug/Vaccine): Possible; Dechallenge: N/A. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event illness and the use of suspect product BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
PFIZER COVID VACCINE #3 GIVEN 11/29/21, LOT # FD0809; pt had a previous hospitalization from 12/1-12/3/21 for a positive COVID test on 12/1/21 and COVID pneumonia; dc'd to home on 12/3/21; 12/4/21 pt brought back to ED after being found unresponsive in home; testing showed large left brain stroke due to carotid artery occlusion; in extremis with status epilepticus; treated with medication but continued to have seizures; admitted to hospital with end of life care; transitioned to comfort care and passed away in the hospital
pt recv vax;devel rash approx 1-2 wk following vax;
Have had many issues with Hsv outbreaks and symptoms of pain, tingling, itch even with being on anti virals. Outbreaks prior were almost non existent and as soon as I got my first shot everything flared up making life very hard to deal with.  I am a year out and things have not gotten better with being on 1 to 1.5 gram valtrex daily for 8 months.
No additional AE details; A patient was administered a dose of VAQTA past it's expiration date; This spontaneous report was received from a health business professional referring to a 13-month-old (reported as 1 year and 1 month) patient of unspecified gender. Information regarding the patient's medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On 15-NOV-2022, the patient was vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) as prophylaxis (dose, route of administration, and anatomical site of vaccination were not reported; lot number U031911 has been verified to be valid, expiration date reported and established as 11-NOV-2022) (expired product administered).  No additional adverse event reported (no adverse event).
Incredibly high fever, blurred vision, full body ache to the point I can hardly move, headache, chills, vomiting, cough, poor balance, unable to sleep and no appetite.
Report body aches, HA an flu-like symptoms day 1 post vaccination. Treatment: Tylenol. Outcome: Symptoms are improving. Does not interfere with ADLs.
I felt terribly achy and sick for the 2 days following each injection, but that's not why I'm concerned. I always keep track of my periods, and they are usually 6-8 days in length and 25-28 days apart. However, I have been bleeding almost nonstop since receiving the vaccine. My periods have been at least 2 weeks long and up to a month in length, with only a day or a few days in between. This has severely affected my mood, and I am constantly exhausted and lightheaded, due to my already anemic nature and the constant loss of blood (the bleeding is generally medium to heavy).
p/recv vax pt exp inj site pain; pt took advil & 24hr later exp swelling & pain of entire arm to fingers w/fluid in enlarged bursae at the lt elbow; pt sought unspecified medical attention & 10/12 recovered from exp
Tongue swelling; could not process his breath; Could not swallow his saliva; headache; Nausea; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer(manufacturer control number: US-AMGEN-USASL2021053617), license party for etanercept (ENBREL).  This non-serious solicited report (USASL2021053617) was reported on 07/APR/2021 by a consumer from a commercial program (PSP00046b) and involves a 61 year old male patient who had headache [PT: headache], nausea [PT: nausea], tongue swelling [PT: swollen tongue], could not process his breath [PT: dyspnoea] and could not swallow his saliva [PT: dysphagia] while receiving Enbrel with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included psoriatic arthritis. The patient's concomitant medications included methotrexate. The patient's co-suspect medication included covid-19 vaccine. The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date. It was reported that the patient was using Enbrel for about five to six years. On an unknown date in MAR/2021, the patient received a recent injection of Enbrel. On 27/MAR/2021 at 10:00 AM, the patient received covid-19 vaccine. On the same day, the patient had nausea and headache but then it went away. On the same day at 05:30 PM, the patient had tongue swelling. The patient could not swallow his saliva and could not process his breath. Subsequently, the patient went to ER (Emergency room) and was started on Benadryl (diphenhydramine hydrochloride), prednisone and ranitidine. The patient was instructed by the physician not to receive a second dose of covid vaccine. The outcome of the events headache and nausea was reported as recovered/resolved. The outcome of the events swollen tongue, dyspnoea and dysphagia was reported as unknown. The events headache, nausea were resolved on 27/MAR/2021. Action taken with Enbrel with Single Dose Prefilled Autoinjector was reported as unknown for the events headache, nausea, swollen tongue, dyspnoea and dysphagia. The causal relationship between the events headache, nausea, swollen tongue, dyspnoea, dysphagia and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up has been requested for lot number.  Causality Assessment: Events Swallowing difficult, Breathing difficult, Swelling of tongue and Nausea were assessed to be not related to etanercept.; Sender's Comments: Based on a temporal association and the known safety profile, the reported events are considered possibly related to BNT162B2. The events were unrelated to etanercept.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
5/19/21 received my first dose. I noticed problems with my vision within the first week. I saw eye doctors and specialists who took photos and tried steroid treatment. I did not realize that this could be caused by the vaccine because there were ZERO side effects listed beyond a sore arm for a day or two or being tired for a few days. I was not informed there could be any other issues unless allergic. I received my second dose 06/24/2021 and immediately my vision almost completely was destroyed. They took photos again to show how aggressive my body was reacting to the poison unleashed inside me. I was told my body was attacking itself.  I had to see a neurologist. Receive an MRI and a horrific spinal tap. I had spinal surgery at a young age so this was very traumatic and painful.  During all of this time i noticed i had lost some hearing. I saw an audiologist who confirmed that i have lost half my hearing in BOTH ears.  The neurologist sent me to Clinic where i had multiple days of testing, MRI's, IV's, more spinal taps, blood draws etc.   Additionally i developed constant shoulder pain in the arm that I had the injection in. I also developed high blood pressure which i never had in my life. Debilitating headaches and fainting or passing out during blood draws which has never ever been an issue for me. I am still fighting to keep my vision, hearing and to keep swelling in my brain down every day. I have been offered no treatment options as there is no treatment for this untested, ineffective toxin that was fraudulently labeled a safe and effective vaccine. it is none of those things
pain lt arm x 2wk;no tx;clavicle node enlarge x 1-1cm size;supraclavicular node;
rapid heart beat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heart beat) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (rapid heart beat). At the time of the report, HEART RATE INCREASED (rapid heart beat) outcome was unknown.            No concomitant medication were reported. No treatment medication was provided.
Had vaccine on 9/17 in right upper arm. Reaction noticed on 7/20 described as enlarging area of induration, erythema and warm and tenderness especially to the tricep area.
Case number PHHY2015US171359, is an initial literature report received on 30 Dec 2015. The authors discuss about T-follicular helper (Tfh) cell expansion during pregnancy. This report refers to a 36 female pregnant patients. Their last menstrual period (LMP) was not reported. These patients were vaccinated inactivated influenza vaccine (manufacturer and batch number: not reported). The influenza specific T-follicular cell response varied based on trimester or pregnancy in which the vaccine was given. There was a significant expansion of Tfh cells after vaccination among women in the firs trimester )p=0.036) but there was not a significant expansion after vaccination in either the second or third trimesters (p=0.091 and 0.347 respectively). No adverse event was reported.
Fever lasting 36 hours, highest of 102.5 degrees. fatigue starting at 12pm after receiving  shot at 9am. Soreness to touch, redness and slight itching throughout left upper arm also starting around 12pm day of the shot with increasing redness since. Redness is irregular and not in single spot, moving throughout upper arm. Armpit pain and swollen lymph nodes.  After first shot had redness in an oval shape at injection site along with swollen lymph nodes in left armpit
Employee developed genralized rash, fast heartbeat, elevated blood pressure, and dizziness. She was given Epinephrine via pen 0.3mg to left outer thigh and 911 arrived to evaluate. Patient was taking to Hospital for evaluation and treatment.
Initial report received from a healthcare professional on 11 November 2013.  A 66-year-old female patient who medical history of Anemia, Hereditary peripheral neuropathy and muscles flinch and concomitant medication were not reported, but received an intramuscular dose of FLUZONE (lot number: UH920AC3, expiry date: 30 June 2014, dose number not reported) in the right deltoid and received a dose of Pneumococcal 23 Vaccine (manufacturer: MSD, lot number, dose number and route of administration were not reported) in the right arm, both on 16 October 2013. On 17 October 2013, the patient had sore arm and was sick after vaccination of flu shot. Laboratory investigations and corrective medications were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none.
Patient had a massive stroke on 5/30/2022. The surgeon removed a 10 INCH bloodclot from the mid-cerebral artery. She was found after she had collapsed on the living room floor by a friend and may have been laying there for 12 hours. Outcome is poor.  She is left side paralyzed  in the arm and left side weak in left leg. She lacks balance and coordination. She is unable to walk and meets the definition of lneeds consistent with long term care.  She is currently being cared for by family.
Please note the site of injection is not documented  presents to the ED with wrist swelling. Pt documents swelling of the right wrist following a TAVR at health center on 7/18. Pt documents she experienced pain throughout the right arm which improved after and ultrasound procedure 1 week ago. Pt admits she was seen at facility today for a mitral valve ultrasound where she was informed to present to the ED. Pt also c/o nausea, general fatigue, and generalized joint pain. Patient positive for malaise/fatigue, positive for cough, positive for bloating and nausea, positive for weakness.   Hospital course:  #COVID19 Patient presented with nausea, generalized weakness, and fatigue. She was initially on 1L NC. COVID nasal swab positive. She received IV diuresis (Bumex 2 mg). She received 2 doses of dexamethasone 6 mg and Remdesivir 200 mg x1 and 100 mg x1. She was able to be weaned to room air. Her nausea and generalized weakness had resolved. On the day of discharge she stated she felt "wonderful", her energy had improved, she was tolerating PO intake, and she was requesting discharge.  Discharge Disposition/Condition Disposition: Home Condition: Stable (s/sx potential problems absent or manageable)
Fever, dehydration, severe tremours, shiver/chills, headache, muscle aches, interrupted sleep
About two days after injection I could not stop vomiting for about 48 hours and on day 3 I had a severe migraine. Had hot and cold chills as well.
Nausea, upset stomach, feeling the need to make bowel movements that aren't there.
got sick; Initial information was received on 01-Dec-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional (patient) via social media.  This case involves patient (age and gender unspecified) who got sick (illness), while patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, family history and concomitant medication were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, the patient got sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Case Summary:  Author/Reporter:   Product Name: Product name was not provided. Since this is a public post on the Sanofi Site we are assuming the consumer is referring to the Sanofi flu vaccine.  Author/Reporter Comment: So why did I get so sick after getting it.   Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported for event.  There will be no information available on the batch number for this case.
pt recvd vax & cried alot; face turned red then turned pale for 1/2 minutes; p/that color was better but seemed tired & has nausea; pt was transferred to ER;
Redness, swelling, some induration and warmth. Pneumococcal vaccine is worse than the shingles reaction.
sore arm/pain in arm that is going away; red blotches that feels warm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm/pain in arm that is going away) and RASH MACULAR (red blotches that feels warm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (pill). Concomitant products included VITAMINS NOS for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm/pain in arm that is going away) and RASH MACULAR (red blotches that feels warm). At the time of the report, PAIN IN EXTREMITY (sore arm/pain in arm that is going away) was resolving and RASH MACULAR (red blotches that feels warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included Blood pressure pills. Treatment medications were not provided by reporter.
Itching within 1 hour of vaccine. Has appointment with allergy to evaluate if she should get 2nd.
Initial report received on 03 March 2008 from another manufacturer, report number MCN54683. The initial reporter to this manufacturer was a health care professional. "This spontaneous case was received via a company representative, reported by a physician and concerns a 46 year old male patient who had an unexplained death after taking Peg-Interferon Alfa 2A (Pegasys), Ribavirin (manufacturer unknown) for hepatitis C and tetanus vaccine as a prophylaxis. On an unknown date, the patient commenced treatment with Peg-Interferon Alfa 2A and Ribavirin. About a week back, the patient cut himself and went to the hospital. He was administered a tetanus vaccine. The patient died shortly after that due to unknown reason. No further information was available. "
Information has been received from a physician concerning an 8 yr old Hispanic male who on 20Jan98 was vaccinated with a dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 22Oct05 the pt experienced a breakthrough case of chickenpox. There was attenuated varicella with papulo macules and pruritis, approx 15 lesions, without vesicles. He had no complications and recovered on 02Nov05. The physician noted that the pt did not have an adverse reaction and no titers were ordered. No medical attention was sought. Additional information is not expected.
Father brought daughter into pharmacy and forged date of birth and age to make his 4 year old appear to be 5 years old. Vaccine was given to the presumed 5 year old and error was discovered upon entry into Agency database. When attempting to reach parent to confirm date of birth, no response.  Insurance company confirmed patient is indeed 4 years old and was not eligible to receive the pediatric Pfizer vaccine.
Swollen right arm red, hot all the way to the elbow 1xN to DTaP.