chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling; redness; warmth; tenderness; itching; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number Y5X93, expiry date 30th June 2020) for prophylaxis.   On 3rd October 2019, the patient received FluLaval Tetra 2019-2020 season. In October 2019, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site erythema, injection site warmth, injection site tenderness and injection site itching. On an unknown date, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site warmth, injection site tenderness and injection site itching were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site warmth, injection site tenderness and injection site itching to be related to FluLaval Tetra 2019-2020 season.  Additional details provided as follows: The patient's demographic details were not provided. The reporter did not consent to follow up. This was 1 of 5 linked cases reported by same reporter.
Prior to the injection, nurse commented that she would give the shot higher than I thought she would, then there was unusually intense pain at time of injection--I screamed. Over the next few to several weeks, pain worsened, mobility decreased, could barely move it. Four months later mobility is much better, but still have a lot of pain.
Day after - headache and sore arm. Almost one month after began noticing taste changes with Certain foods, which then began to be smells of favorite things, and now more and more foods are tasting like detergent and things that I once loved smell like burning plastic.
She became sick with tired and weak symptoms along with some sinus type issues by early December. Then early January she had a headache (first ever in her life). Initially it was missed on a CT scan, but several MRIs later there proved to be a dilated perivascular space in her brain, neuroinflammation in her brain, Encephalopathy and Encephalitis. All presumed due to the vaccine, because she was fine before it. The treatment has been antibiotics (which don't work), Occupational therapy, therapy. The adverse event has caused weakness, dizziness, headaches, neck pain, tingling sensations, fatigue, school regression, OCD, anxiety, worry, fear, PTSD, anger and of course as listed above -  dilated perivascular space in her brain, neuroinflammation in her brain, Encephalopathy and Encephalitis.
2 month vaccines given 5/7/15 1P at 3:20 pm woke from nap screaming inconsolably calmed down at 4P, seen in our office 4:10 pm, noted 3cm swelling on (L) thigh at PENTACEL site. Per dr consistent with local reaction will observe for increased swelling.
This spontaneous report was received from a 62 year old female patient, who is also a physician, reporting on herself. Medical history was not reported. On 18-JUN-2014 the patient was vaccinated with ZOSTAVAX, intradermal, in the proximal region of her upper arm, dosage, lot number, expiration date were not reported. Concomitant therapy was not reported. The reporter informed that she believed that the ZOSTAVAX received on 18-JUN-2014 may have been administered intradermally. She also reported that could feel fluid entering a small space at time of injection and it was painful. Beginning on 20-JUN-2014 she developed wheal measuring 3 inches by 2 inches along with thickening to the injection site, the events remains ongoing. The patient's outcome with the event was not recovered. Additional information has been requested.
Patient was waiting in designated waiting are following vaccine administration. About 5 minutes after vaccine I heard wife calling for help. When I went out to assess patient I found him laying back in chair with his head back, shaking, eyes open, and making fists with his hands. I asked him if he wanted me to call 911. He was able to respnd through clenched teeth that he felt very strange and to call 911. He remained conscious and knew his name. We contacted 911 and I supported pt from opposite side of wife. After a few minutes he calmed down and asked for water, he appeared to be sweating around head area. He took a few sips of water until operator on phone asked us to withhold further liquid until EMTS arrived. He was completely back to normal status within 5 minutes, EMTS came and assessed pt and allowed him to leave of his own accord. After the incident her relayed that similar reactions including full fainting spells have occurred to him in the past when receiving vaccines. this was not indicated on his intake form
Numbness in injected arm up, on side of neck and face; Fear; very lethargic feeling; Weakness; Increase fatigue; Headaches; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 64-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration, administered in Arm Left on 23May2021 14:45 (at the age of 64-years-old) as single dose for covid-19 immunisation. Medical history included chronic whole-body pain associated with fibromyalgia, had a stroke 11 years ago, irritable bowel syndrome (IBS), gastroesophageal reflux disease (GERD), temporomandibular joint disorder (TMJ), arthritis, degenerative disc disease, fainting problems, fatigue and depression, chronic cough, many other health issues, environmental allergy, allergy to dogs, latex allergy and drug allergy (many medications). The patient's concomitant medications were not reported. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. On 23May2021 14:45, the patient experienced numbness in injected arm up, on side of neck and face, fear, very lethargic feeling, weakness, increase fatigue, headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events. The outcome of all the events was not recovered.  The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up.
inappropriate schedule of vaccine; shivering; feeling unwell; This case was reported by a consumer via call center representative and described the occurrence of shivering in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 3rd October 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shivering, feeling bad and incomplete course of vaccination. On an unknown date, the outcome of the shivering and feeling bad were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shivering and feeling bad to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient experienced shivering and feeling bad for 2 days. The patient had missed the 6 month window for the second dose which led to incomplete course of vaccination. The reporter did not consent to follow-up. The reporter declined to provide any demographics and declined any follow up. This case been linked with the case US2019115941, reported by same reporter. There is a discrepancy between the outcome reported in the structured field "resolved with sequel" and the outcome reported in the sender's comment " shivering and feeling bad for 2 days".
cellulitis; warm sensation; pain; red blotches; arm was swollen; This is a spontaneous report based on the information received by Pfizer from Sanofi (Manufacture Report No: 2020SA066748). A contactable consumer reported that a female patient of unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on 13Oct2020 at single dose for immunisation. Medical history and concomitant medications were not reported. Patient had 13-val conj vac (dipht crm197 protein) injection on 13Oct2020 and severe reaction. In 2020, she was diagnosed with cellulitis. She had warm sensation, pain, red blotches and whole arm was swollen. Outcome of events was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Extreme fatigue, nausea, headache, joint and muscle pain, tightness in chest   I am still experiencing fatigue, joint/muscle pain, tightness in chest (breathing) brain fog, swelling in feet/hands
tested positive greater than 14 days after fully vacinated Narrative: tested positive greater than 14 days after fully vacinated
Patient's family called staff approximately 10 minutes after vaccine administration due to her becoming pale and feeling lightheaded.  EMS was called to the scene and the patient was evaluated after having a near syncopal episode just prior to their arrival.  EMS stayed on scene for approximately 30 minutes and evaluated the patient in the ambulance.  Staff was advised that the patient ended up feeling better after evaluation and refused care from EMS, leaving with her family.  No further information was obtained.
COVID-LIKE SYMPTOMS ONE WEEK AFTER VACCINATION; BLOOD THICKENING; DEVELOPED AN ENZYME IN LIVER; HEART PALPITATIONS THAT WERE PERSISTENT AND GOT WORSE; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and concurrent conditions included: allergies and stuff, and other pre-existing medical conditions included: The patient had no heart issues and had great health and wellness. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On AUG-2021, the patient experienced heart palpitations that were persistent and got worse. Laboratory data included: Investigation (NR: not provided) not available. On an unspecified date, the patient experienced covid-like symptoms one week after vaccination, blood thickening, and developed an enzyme in liver. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart palpitations that were persistent and got worse, and the outcome of covid-like symptoms one week after vaccination, blood thickening and developed an enzyme in liver was not reported. This report was non-serious.
PATIENT ADMINISTERED VACCINE 1 DAY AFTER THE BEYOND USE DATE OF 03/27/2022.
arm swollen size of orange-red & hard, t100.5; mom stated pt recvd vax records show pt recvd Td; pt was given Antihistamines by MD; pt was told had allergic reaction to pertussis;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 01-AUG-2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
sore arm; This is a spontaneous report from a Pfizer-sponsored program Support, from a contactable consumer (patient). A 73 (unit: unknown) male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose number unknown, single, for Covid-19 immunisation. Medical history included multiple sclerosis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced sore arm on an unspecified date. Patient also stated that he felt better than he has in the past year after receiving the vaccine. Outcome of the event was unknown.No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt exp nausea & vomiting, rectal bleeding, BUN inc & creatinine inc are reported in pt who recvd fluogen on 12NOV86; pt devel abdo pain; some rectal bleeding; partial paralytic ileus was noted;
This spontaneous report as received from medical assistant refers to a patient of unknown age and gender, who on 18-SEP-2013 was vaccinated with an expired dose of M-M-R II (lot # 1120AA, expiration date 12-JUL-2013) (dose and route were not reported). Concomitant medications were not reported. No adverse effects reported. Additional information has been requested.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's medical history, drug reactions/allergies and concomitant medications were not reported. On 29-AUG-2016, the patient was vaccinated with improperly stored PROQUAD, lot # M019232, expiry date 17-OCT-2017, rHA, 0.5 ml. Vaccine was exposed to a maximum of 9F and a minimum of 6.8F or a cumulative time frame out of recommended storage range for 23 hours. Data logger in use yes. No adverse effects reported. The outcome of the events was unknown. No product complaint (PQC) was involved. No further information provided. This is one of several reports received from the same reporter Additional information has been requested.
NO APPETITE, HEADACHE, HANDS HURT WHILE EXPOSED TO HOT WATER, DARK PURPLE OVAL BRUISE-LIKE MARKS ON BOTH ELBOWS, REDNESS AROUND BOTH FEET, PAIN IN LEFT ARM AND IN FEET WHEN STANDING UP.  I TOOK MY DAUGHTER TO URGENT CARE AND PRIMARY DOCTOR WITHIN DAYS OF EACH OTHER.  REFERRED TO DERMATOLOGY AND AWAITED BLOOD TEST RESULTS.  A WEEK OR TWO AFTER THESE SYSTEMS, THE SKIN ON HANDS AND ELBOWS BEGAN TO PEEL OFF JUST SHREDD OFF AND ABOUT TWO WEEKS LATER THE SKIN ON THE FEET BEGAN TO PEEL OFF, JUST SHREDDING OFF AND PURPLE BRUISE-LIKE MARKS APPEARED ON BACK, ANKLES, BUTTOCK AREA.  DERMOTOLOGIST TOOK BLOOD TESTS AND A BIOPSY.  A STERIOD OINTMENT WAS GIVEN AND USED ON PEELING/PURPLE AREAS OF SKIN FOR 14 DAYS.  MANY BLOOD TESTS WERE DONE, CHEST X-RAY, BIOPSY OF ELBOW AND FOOT AREA.  REFERRED TO HOSPITAL. ANOTHER OINTMENT WAS ISSUED.  11/14/08 MR received for dematology consult dated 10/15/2008. Pt presented for eval of rash which began on the elbows, gluteal cleft, hands and feet.   Itchy at first, now improved. Burning sensation noted in hot water. Tx with steroids with some improvement. Pt also reports elbow pain. PE (+) for diffuse, slighly waxy exfoliation on the bilateral plantar surfaces of the feet, mild erythema w/o scale on elbows, hyperpigmented scaly plaques on the posterior and medial ankles, scaling and exfoliation on palms, follicular hyperkeratosis on knees and pustule and papules (acne) on the face.  Assessment:  Localized variant of pityriasis rubra pilaris vs psoriasis.
VARIVAX that had undergone temperature excursion was administered to a patient; No additional AE reported.; This spontaneous report was received from medical assistant and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, lot #W020540, expiration date: 28-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided). Administered dose of vaccine experienced unknown temperature excursion.  There was no adverse event reported.
This case was reported by a consumer via call center representative and described the occurrence of swollen thumb in a 55-year-old female patient who received Shingrix for prophylaxis. On 6th September 2018, the patient received the 1st dose of Shingrix .5 ml. On 9th September 2018, 3 days after receiving Shingrix, the patient experienced swollen thumb, pain in thumb, injection site pain and injection site swelling. On an unknown date, the outcome of the swollen thumb, pain in thumb, injection site pain and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the swollen thumb, pain in thumb, injection site pain and injection site swelling to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in the right deltoid. The patient's soreness was little around the injection site and but mostly at the base of her right thumb. The patient said that it felt swollen more than it looks swollen (not specified if around the injection site or thumb).
arm is sore; Fatigue; eyes are still heavy; a metallic taste in her mouth; sleepy/eyes are still heavy/she is yawning a lot more; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on 06Jan2021 at single dose in her left arm for covid-19 immunization. The patient had no medical history. There were no concomitant medications. The patient had no investigation assessment. It was reported that it had been 24 hours, she received her first bnt162b2 (reported as Pfizer COVID vaccine), yesterday (on 06Jan2021), and she was wondering, her arm was sore on 07Jan2021, which she thought was normal and fatigue on 06Jan2021, she got right away, she didn't know if that was normal, but she got a metallic taste in her mouth on 06Jan2021. It felt like a metallic taste when she swallows, a little metallic taste, yesterday (on 06Jan2021) was more than today, it was after the vaccine, about 7 hours after. She thought in her head, like the aluminum chewing gum, when kids chew it, it had a metallic taste, like the (company name withheld) wrapper she used to chew on it. Provides she was shrinking. Provide she was wearing stretch pants when providing weight. She Googled and didn't see the metallic taste, the only thing she saw with metallic taste is if you have the actual virus, she didn't have it, she was fine. Maybe it was all in her head. Arm was sore not right away, it built up, like when you stretch like with the flu shot, she lifted and it's sore, and she felt sleepy. It was like with the flu shot, it took a few days to go away. Last night on 06Jan2021, she was very sleepy, she was kind of sleepy, but it could be watching the Capitol and insanity, but she was yawning a lot more, her eyes felt heavy, she was ok, she had an appetite and is fine, she would drink (company name withheld) now. Thought she was peaking with it, she would go to sleep early today (07Jan2021), her eyes were still heavy, she wanted to close them and took a nap, but couldn't. It was like her saliva has a metallic taste in her mouth, it may be in her head, she googled to see side effects and when they start, it may be going soon, who knows, she was just wondering. The taste was worse yesterday (06Jan2021), and it wasn't IV or anything like that, the patient wanted to know how can that be. She had to go back on the 27th for her second dose. She had been tested and retested on an unspecified date, and it was offered for those 65 and over, and she was lucky to get an appointment. The outcome of the event metallic taste was recovering; the events fatigue and eyes heavy was not recovered; the outcome of the rest events was unknown.
This spontaneous report was received from a consumer via social media regarding her kids of unknown age and gender. The kid's were sexually abused by their farther who had genital warts surgically removed resulting in other infections of STD (Sexually transmitted infection) in one of them. On an unknown date, the patient was vaccinated with unspecified quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (Manufacturer unknown) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (Manufacturer unknown) (dosing details, route of administration and lot# unknown) for infections of STD (product use issue) for use other than indicated (treatment of existing HPV infection or prior HPV exposure). There was no product quality complaint (PQC) involved. Additional information is not expected as there was no contact details.
Patient developed left eye inward turning consistent with 6th nerve palsy 12 days after receiving immunizations for her 15 mos health maintenance visit. Pt. received MMR #1 and HIB #4 (HIBEREX). 11/23/2009 MR and DC summary for 11/4-11/5/2009. Dc Dx 6th nerve palsy Patient with c/o's lt eye gaze palsy. Tx: IVVF,  MRI brain neg,  f/up with opthalmologist Labs: CBC and CMP normal Dx studies: MRI Brain normal
The vaccinee was not immunocompromised. On an unspecified date, the vaccinee received the 3rd dose of Engerix-B (lot ENG5213A2; expiry 11/23/02). At that time, the vaccinee received 2 injections of the 10 mcg pediatric formulation to provide the adult dose of 20 mcg. Subsequently, the vaccinee's antibody titer against Hep-B surface antigen (HBsAg) was found to be "too low". As of 4/4/02, the outcome of the event was unknown.