chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hard to lift arm-continued for 3-4 days and then started to get better. Last few days worse again, pain 8 out of 10. Fever and vomiting 3-4 days after shot. Applying ice, heat and taking Tylenol.
sick; lost her smell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; ANOSMIA (non-serious), outcome "unknown", described as "lost her smell". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up attempts completed. No further information is expected.  Follow-up (28Feb2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
I woke up middle of night and I have a weaker numb right leg, but I couldn't move it was  paralyzed.  In the morning I still could not move my right leg.  It eventually slowly came back so I could walk but has left it weaker then before I had the shot to this date.  I spent 4 days in our condo before I felt I could walk.
rash started 18JUL96 on rt arm spread to chest, lt arm & body had itching went to MD was treated w/DPH & pred;phone call to pt today pt said was much improved;no other c/o noted;
pt recvd vax & had high pitched unusual screaming for approx 30 min; fever to 104;
My brother died 8 days after the vaccine due to a blood clot in his heart.  Death Certificate indicates blood clot in heart.
began having very bad diarrhea about 7 days after first dose of the Pfizer vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 02Apr2021 at 10:00 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included escitalopram oxalate (LEXAPRO) and quetiapine fumarate (SEROQUEL); both for unspecified indication from unknown date and unknown if still ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food or other products. The clinical course was reported as follows: on 08Apr2021 at 08:00, about 7 days after first dose of the Pfizer vaccine, the patient experienced very bad diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event very bad diarrhea was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
No additional AE; Nurse reporting AE for improperly stored PROQUAD administered; This spontaneous report was received from a nurse and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-AUG-2022, the patient was vaccinated with an improper storage dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, live recombinant Human Albumin (rHA) (PROQUAD) lot # W002783, expiration date: 24-JUL-2023 (strength, dose frequency, anatomical location and route of administration were not provided) administered as prophylaxis (Product storage error).   The improper storage lot # underwent a temperature excursion of -14.5 degrees Celsius (C) for 10 minutes without previous excursions. No adverse events were reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA003994:Case # 02220598 US-009507513-2208USA004112:Case # 02220597
Customer does not report any symptoms or issues at this time; Customer reports that she is 31 years old and received PROQUAD 4 weeks; This spontaneous report has been received from the consumer, referring about herself, a 31-year-old female patient. Information about her pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions and allergies were not provided.  On 06-OCT-2021 (reported also as "4 weeks ago"), the patient was vaccinated at a clinic with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (strength, dose, frequency, route of information, anatomical injection site, lot number, and expiration date were not provided) (product administered to patient of inappropriate age).   She also received on 01-NOV-2021 ("Monday"), varicella virus vaccine live (Oka/Merck) (VARIVAX), from pharmacy. Customer did not report any symptoms or issues at the time. No adverse event reported.
Just a few hours after receiving the flu shot in my left arm, it began to ache. I noticed by that evening it was very sore from the shoulder all the way down to the elbow. It became difficult for me to cross my arm across to the right side of my body and raise it above my head. When I did try to move my arm in this way, a sharp pain ran from my shoulder to my elbow. It has gotten worse since that initial day and I am now plagued with sharp pains, muscle weakness, tingling in my fingers and a throbbing pain all day, everyday. It also aches all night! I have difficulty sleeping because my left arm hurts to sleep on and hurts terribly to move! It has been 3 weeks now and I have seen a chiropractor twice thinking that might ease the pain. I have also tried sleeping with a heating pad on my shoulder (on the injection site) but that seems to make it worse. I am finding no relief at this point! I have a doctor appointment on Monday, October 5, 2015 to see if they can help me or have any suggestions/solutions.
I developed a numbness in my tongue and left hand fingers that night of injection and I still have it even after my second vaccine.
Significant swelling, erythema, wasting and induration developed 48 hours after receiving TDaP. Also significant arm pain.
There was a delayed reaction starting 7 days after first dose. Symptoms included redness and soreness at the site of injection and swollen lymph nodes in the armpit of the arm where the shot was injected. 12 hours after receiving the second dose I was shaking, nauseated, dizzy, sweating one minute and freezing the next, pain all over the body, my breathing slowed down and lastly there was a loud deafening ringing in my ears. These symptoms lasted a frightening 10 or so minutes leaving behind the bodily aches.
25 minutes after receiving injection, complained of swollen tongue, difficulty swallowing. Given epinephrine. EMTs called.  Refused transport.  Advised to go home, take Benadryl and rest.  Hot flashes.
pt recv vax 5JUN96 & 10NOV96 pt devel less than 40 lesions;no further details were provided;
Pt given 1st dose of vax 3days later developed muscle weakenss, numbness & a burning sensation in her lt arm; Also dec ROM in her lt shoulder;
Mild Nausea; severe chills; fever; moderate headache; moderate fatigue; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the right arm on 26Mar2021 at15:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food, or other products. Concomitant medications included ascorbic acid (VITAMIN C), vitamin D (MANUFACTURER UNKNOWN), vitamin E (MANUFACTURER UNKNOWN), vitamin B12(MANUFACTURER UNKNOWN) fish oil (MANUFACTURER UNKNOWN), emtricitabine, tenofovir disoproxil fumarate (TRUVADA) and cetirizine hydrochloride (ZYRTEC) received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Mar2021 at 10:00, the patient experienced mild nausea, severe chills, fever (which topped at 100.2), moderate headache and moderate fatigue. Therapeutic measures were taken as a result of the events which included Tylenol. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events mild nausea, severe chills, fever, moderate headache and moderate fatigue were not resolved.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Colitis ulcerative aggravated; COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4331384-00.  A 41 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 23Nov2021 (Batch/Lot number: unknown) at the age of 40 years as dose 3 (booster), single, intramuscular, administration date 20Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 30Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "COVID-19"; COLITIS ULCERATIVE (medically significant), outcome "not recovered", described as "Colitis ulcerative aggravated". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive. The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira (adalimumab): The reporter causality for the event(s) of Ulcerative Colitis Flare Up and Covid was not provided. Causality: 1) Colitis ulcerative aggravated (Colitis ulcerative): Causality as per reporter (Drug/Vaccine): Not reported, 2) COVID-19 (COVID-19): Causality as per reporter (Drug/Vaccine): Not reported. Causality: 1) Colitis ulcerative aggravated (Colitis ulcerative): Causality as per reporter (Drug/Vaccine): Probable, 2) COVID-19 (COVID-19): Causality as per reporter (Drug/Vaccine): Probable.  The reporter considered "covid-19" and "colitis ulcerative aggravated" related to bnt162b2.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the Limited information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event. The case will be reassessed once new information is available
3/17/21 Pfizer Covid 4/7/21 Pfizer Covid 8/12-8/14/21 family gathering 8/13 exposure to family member 8/14 "allergy symptoms" 8/17 + Covid PCR 8/28/21 potential to RTW
administration of expired dose of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA714A, expiry date 30-JUN-2023) for prophylaxis.   On 06-JUL-2023, the patient received Menveo. On 06-JUL-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: administration of expired dose of Menveo). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 06-JUL-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patient received a dose of Menveo which was already expired on 30th June 2023, which led to expired vaccine used.
This is a cluster case of four patients (same reporter, same product and same batch number) and is linked with the cases 2012-11094, 2012-11095 and 2012-11083. Initial report received from a health care professional on 19 November 2012. A 50-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose FLUZONE (Lot number UH728AA, dose number and site of vaccination were not reported) intramuscularly on 10 November 2012. It was reported that, the patient was not able to raise her arm for several days after the injection. On 11 November 2012, the patient was unable to lift her arm over her head because of site soreness. The patient had been applying heat to the site as a corrective treatment. Laboratory data were reported as unknown. The outcome of the event was reported as unknown. Follow up information received from a healthcare professional on 09 April 2013. The patient concomitant medications included vitamin B12 and multiple vitamins. The patient had no illness at time of vaccination and had no adverse event after previous administration of vaccine. The patient had allergy to penicillin and LEVAQUIN. The patient had received FLUZONE in right deltoid on 10 November 2012 at 0700. The patient had recovered from the events on an unspecified date. List of documents held by sender: none.
Muscle twitching and spasms all over body and not resolving. Did not get second dose due to this.
Information was received from a PharmD on 18-AUG-2010. A female, in her 60's, received the flu vaccine (manufacturer unknown) on an unknown date. She had a medical history of fibromyalgia. Post-vaccination, the female experienced 3 days of pain at the injection site. The patient sought medical attention. No further information is expected. Information was initially received to Merck & Co., Inc. (case# 1008USA01983). The company considered the events to be possible in relation to the suspect drug. Information derived from this AE report does not change the current safety profile of the product.
Information has been received on 22-FEB-2019 regarding a case in litigation from a lawyer concerning a patient of unknown age and gender. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 05-DEC-2014, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a physician at a physician's office. On an unknown date, the patient was treated by a healthcare provider for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self and economic losses. The outcome of the event was unknown. The causality of the event was considered to be related. Additional information has been requested.
immed hives & itching @ site; exactly 10 hr later erythematous rash & difficulty breathing; tx @ MD ofc EPi & DPH;
Started earlier in the evening with Body aches in the hips, back and lower rib areas and fatigue.  At midnight unstoppable shivering started where teeth were chattering; no fever (temp was 96.8 which has been fairly normal) Heart rate steady at 84 - 92 bpm. At approximately 2:30 am nausea and light vomiting.   Shivering subsided at 2am and stopped at 3am; nausea was done at 5:30 am Fatigue lasted until 11am Sunday morning. Took two advil at noon and another two advil at 7pm on Sunday Back to normal by 5pm on Sunday.
Bell's Palsy like symptoms.  Initially post dose soreness at injection site and arm muscle as expected.  Gradually arm soreness continued down the length of the arm and up the neck into the face and head.  Left side (injection side) facial pain in the jaw accompanied with feeling of numbness in lips and headache on left side.  Symptoms progressed thru 5:30 that evening when shortness of breath developed and heart palpitations.  Symptoms gradually subsided.  Facial feeling returned to normal.  Headache, shortness of breath, palpitations, neck and arm soreness subsided by 9:00 PM.  All symptoms except expected injection site soreness and a small bruise at injection site subsided by 9:00PM
Child came to office for Hepatitis A vaccine and influenza vaccine. She was given Hepatitis B vaccine by mistake.
After about 8 min customer passed out sitting in chair, easily awoke, all sweatty, lightheaded, tingling in hands, little nausea.
The nurse did not write down the lot # or date on my card. I tested positive  for Covid 19 yesterday due to an exposure incident 1 week ago. I used the home test.  My only symptoms are sinus pressure, drainage and a headache. I cannot taste food but can smell ok. I have no fever.
Moderna COVID-19 Vaccine EUA Fever and leg aches in the middle of the night.  Fever has been as high as 101.3 and as low as 99.9.  Taking Advil and Tylenol to treat the fever and aches.
out breaks since I got vaccine / suspected vaccination failure; out breaks, shingles; so painful; looks like a bad burn; peels; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, burning skin and peeling. On an unknown date, the outcome of the vaccination failure, shingles, pain, burning skin and peeling were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain, burning skin and peeling to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had out breaks since he or she got the vaccine. It was so painful and nothing helps, after it looks like a bad burn and peels. The reporter mentioned that he or she never had vaccine. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
This case was reported by a physician via sales representative and described the occurrence of arms feel weak in a 36-year-old female subject who was vaccinated with FLULAVAL TETRA (GlaxoSmithKline). On 11 November 2013 at 16:30 the subject received 1st dose of FLULAVAL TETRA (.5 ml, unknown, unknown arm). On 11 November 2013 at 17:20, 50 minutes after vaccination with FLULAVAL TETRA, the subject experienced arm felt weak side unknown, itchy throat and strange feeling. The sales representative stated that the physician reported that the subject went to urgent care, was referred to the emergency room, was treated with BENADRYL and written prescriptions for prednisone and ZYRTEC. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting the events were improved. The physician considered the events were probably related to vaccination with FLULAVAL TETRA.
Patient received her first dose of Pfizer vaccine on 1.12.2021. Patient reports that she woke up at 0230 on 1.13.21 with extreme dizziness. Patient says at 0530 she woke up again, still dizzy, but improved. Once she came to work at 0800, she felt normal again. Patient will call back again with any changes.
Pt received Varicella vaccine in the back of the right arm. Immediately developed rash around site, diffuse hives all over and face swelling over several minutes.  Given 25mg of Benedryl with no significant improvement Transferred to ER via ambulance, given Famotidine. Discharged after 4 hours observation and improvement.
This spontaneous report as received from a nurse practitioner via a company representative refers to a 61 year old male patient. No medical history, concomitant medication, drug reactions or allergies were reported. On 21-DEC-2016, the patient was vaccinated with ZOSTAVAX (lot #, expiration date were not reported), one unspecified dose, for shingles. On 24-DEC-2016, the patient experienced pain. On 25-DEC-2016, the patient experienced red spots on chest and left arm. On an unspecified date in late January 2017, the patient had heart surgery. No treatment was given for the adverse events. The outcome of heart surgery, pain and red spots on patient's chest and left arm was not reported. The relatedness between the events and the ZOSTAVAX  was not reported. Upon internal review, the event of heart surgery was considered medically significant. Additional information has been requested.
Information has been received from a nurse referring to a 11 months old patient of unknown gender. Concomitant therapies included MERCK STERILE DILUENT. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 16-AUG-2006, the patient received a dose of PROQUAD (strength, lot # and expiration date were not reported) subcutaneously for prophylaxis at an unspecified facility (inappropriate age at vaccine administration). No adverse effect was reported.
Legs quit 2 days after 2nd vaccination, could not stand up alone. Eyesight became worse and worse til now legally blind.
30min p/immun began vomiting became pallid, listless; was seen back in the office about 4 hrs p/immun was given; pt had stopped vomiting but was still pale & listless;