chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via a company representative refers to a 4 year old male patient. On 23-APR-2014 the patient was vaccinated with PROQUAD (lot number J013857; valid). Other suspect therapies included KINRIX administered at the same time. On 24-APR-2014 the patient was sent to the hospital (ER) with a 102.7 fever and a 10 minute long febrile seizure, but he was not admitted. After (unspecified) tests were run while the patient was at the ER, the physician said that the patient had an urinary tract infection and pneumonia. "The patient also experienced a febrile seizure some time ago when he was sick, this was not the first time". The outcome of the events was reported as recovering/resolving. The relatedness was not provided. Additional information has been requested.
Severe allergic reaction(assuming it's allergic reaction) Itchy HOT rashes from neck to waist. And now arms, going to the fingers by a few. Groin area has been occupied by the 5th day, now going down to the legs. Fever ranging to 38~39°C, sometimes it goes down to 37.5°C. None of the hospitals I asked help, including ER would entertain me, not unless I have PCR test result. Which I have made appointment for a home service ASAP.
pt became faint, fell backward, eyes wide & staring into space;face became pale, lips purple, approx 1min p/vax; began taking deep breaths approx 1min later;pt observed for 10-15min;pt ambulated out of clinic;
Had mild symptoms of headache, fatigue, nausea, light headedness for starting about 3 hrs. after shot given and lasting into evening of next nigh; No fever or shortness of breath experienced.  Except for fatigue was generally OK for next 6 days.  Then eyes started blurring down my vision, and started seeing double/triple vision... symptoms are intermittent; worse in evening when eyes are fatigued. Called medical center for info and course of action and was advised to report to medical center emergency Room. Will see what eyes are like in morning
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient asked can she take Tylenol with it PAXLOVID as she can not find the answer in the paper that was in the PAXLOVID box, the print was tiny on the paper. Her fever was up again, and she can't find the answer. She has been 3 times vaccinated by Pfizer and she could not get the 4th dose. The patient had COVID-19. Report: 2GKIZXSP.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Covid arm.  Yesterday evening I noticed that my injection site was firm, warm, and a little tender. I looked in the mirror and saw large red patch where I was injected. I took Benadryl and put some hydracortisone cream on. It doesn't itch anymore, but it is still red, a little swollen, warm, and tender.
pt recv vax 10APR96 & 12APR96 pt devel severe chicken pox, felt to be a wild type;mom called MD & stated pt exp great pain in back & shoulders;could hardly walk or bend over;pt made clonic movements w/legs & jerking movements;encephalitis;
Expected reaction to the 2nd, nothing out of the ordinary, which lasted less than 24 hours.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Expected reaction to the 2nd, nothing out of the ordinary, which lasted less than 24 hours.) in a male patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Expected reaction to the 2nd, nothing out of the ordinary, which lasted less than 24 hours.). At the time of the report, VACCINATION COMPLICATION (Expected reaction to the 2nd, nothing out of the ordinary, which lasted less than 24 hours.) had resolved. Not Provided          No concomitant medication information was provided. No treatment medication were provided.   This case was linked to MOD-2022-454742 (Patient Link).
ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 38 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient didn't experience any adverse event after the vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: 21-SEP-2021) dose was not reported, administered on 04-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-OCT-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious.
White pustules on red spots; Diarrhea; red spots on the back of his throat; Sore throat; Coughing; Swelling in throat; Wheezing; tightness in throat; Trouble breathing; Hoarseness; Shivering; Ringing of the ears; Deep sleep; This case was reported by a consumer via call center representative and described the occurrence of sleep disorder in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 7th February 2020, 1 days after receiving Shingrix, the patient experienced sore throat, cough, throat swelling, wheezing, throat tightness, difficulty breathing, hoarseness and shivering. On 8th February 2020, the patient experienced red throat. On 10th February 2020, the patient experienced pustule and diarrhea. In February 2020, the patient experienced sleep disorder and ringing in ears. The patient was treated with prednisone and ambiguous medication nos (Cortisone (Nos)). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the sleep disorder, sore throat, cough, throat swelling, red throat, pustule, wheezing, throat tightness, difficulty breathing, hoarseness, diarrhea, shivering and ringing in ears were unknown.   It was unknown if the reporter considered the sleep disorder, sore throat, cough, throat swelling, pustule, wheezing, throat tightness, difficulty breathing, hoarseness, diarrhea, shivering and ringing in ears to be related to Shingrix. The reporter considered the red throat to be related to Shingrix.  Additional details were provided as follows: The patient Shingrix vaccine and came home sat in a chair and was in deep sleep in such a deep sleep that he did not even wake up to vacuum cleaner noise.  The patient experienced sore throat, coughing, and swelling in his throat it got worse.He experienced red spots in his throat on Saturday evening. The patient called his united health care nurse but she was of no help to him. The patient reached out to his pulmonologist via text about his adverse reaction. The patient also noticed the red spots on the back of his throat had white pustules. His doctor mentioned to him that the red spots on his throat are due to Shingrix vaccine. The patient started on prednisone and would be tapered down in the next few days.The patient was scheduled to get a cortisone shot once he was done with prednisone.  After starting the prednisone, his throat swelling and red spots are present but better. He also experienced wheezing, tightness in throat, trouble breathing, and hoarseness that are still present. He was making loud noises due to his wheezing and coughing at night. The patient had diarrhea and shivering. He has also been experiencing ringing in his ears, but he did not know when that started.  The reporter did not consent to follow up. No further details were provided.
It started with hives all over his trunk and back. Treated with Benadryl and disappeared the next day. Symptoms returned a couple of days later with smaller random patches of hives in different body parts. Took Benadryl, disappeared, then small patches of hives came back in different body parts, eyes, neck, sculp. Stopped using Benadryl, some random hives pop up every other day or so and disappeared on their own. The hives cleared for a few days, then they came back on his face and chin one night. Took him to the doctor's, prescribed 5-day course of Prednisone and Claritin. Symptom was gone during this period, but bounced back two days after he completed the treatment. Now, hives pop up every day. I give Claritin when there are larger patches.
Subsequent to receiving vax, the pts screamed intensely and their lower extremities developed hivey, swollen, hot to touch, bright red rashy phenomenon. Once the pts were calmed down, all symptoms resolved. An additional pt had a similar experience following exposure to haemophilus b conjugate vaccine + hepatitis b vaccine recombinant (yeast). Additional information has been requested.
Starting on 14Aug, my arm was very sore. Migraines kicked in, hot body flashes and severe, extreme fatigue. Arm pain has stopped, migraines, hot body flashes and extreme fatigue continue to this; Starting on 14Aug, my arm was very sore. Migraines kicked in, hot body flashes and severe, extreme fatigue. Arm pain has stopped, migraines, hot body flashes and extreme fatigue continue to this; Starting on 14Aug, my arm was very sore. Migraines kicked in, hot body flashes and severe, extreme fatigue. Arm pain has stopped, migraines, hot body flashes and extreme fatigue continue to this; Starting on 14Aug, my arm was very sore. Migraines kicked in, hot body flashes and severe, extreme fatigue. Arm pain has stopped, migraines, hot body flashes and extreme fatigue continue to this; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Aug2021 22:30 (Lot number: EW0168) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimotos disease" (unspecified if ongoing); "food and skin allergies" (unspecified if ongoing), notes: food and skin allergies; "skin allergies" (unspecified if ongoing), notes: skin allergies. Concomitant medication(s) included: LEVOXYL; IBUPROFEN; TYLENOL; TENSION HEADACHE RELIEVERS. Past drug history included: Morphine, reaction(s): "known allergies:Morphine", notes: Morphine, Z-pack, food and skin allergies. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer,, lot number=EW0217,, lot unknown=False,, administration date=23Jul2021,, administration time=11:00 PM,, dose number=1,, vaccine location=Left arm), administration date: 23Jul2021, when the patient was 51 years old, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), MIGRAINE (non-serious), HOT FLUSH (non-serious), FATIGUE (non-serious) all with onset 14Aug2021, outcome "not recovered" and all described as "Starting on 14Aug, my arm was very sore. Migraines kicked in, hot body flashes and severe, extreme fatigue. Arm pain has stopped, migraines, hot body flashes and extreme fatigue continue to this". Therapeutic measures were not taken as a result of pain in extremity, migraine, hot flush,  fatigue.  Additional information: Starting on 14Aug, my arm was very sore. Migraines kicked in, hot body flashes and severe, extreme fatigue. Arm pain has stopped, migraines, hot body flashes and extreme fatigue continue to this day. No Covid prior vaccination.No Covid tested post vaccination.No other vaccine in four weeks.  Follow-up attempts are completed. No further information is expected.
pt recvd vax; fever, muscle, body pains, weakness the eve of inject; tx w/ apap;
10 hours after vaccination experience severe shaking, fever of 102.6 Took 2 (500 mg) Tylenol. Fever kept climbing to 104.5 Took 25 mg of Benadryl for red color of face and small rash on abdomen. Placed call to Dr. Advised every 8 hours Tylenol (1000mg)  and cycle with Ibprofen- 2 (200mg). Fever remained at 104 till morning, then 103.1. Fever down for 2 hours and spikes to 104. Took cold bath, reduced fever to 102. Chills, violent shaking a headache behind eyes, very dehydrated. Drank Gatorade and with fatigue slept off and on for 48 hours. Fever finally down by 03/10/2021 to 98.9 with mild headache. Did not have any body or muscle aches during this event.
On 5/12/17 patient accidently received MMRV and Hep A vaccines (usually given at 12 months). Mistake was made by nurse. Eight days later more crabby, lethargic and T 99.9 Axillary. Developed cough, not sleeping well, irritable. Ten days after the vaccines, fever resolved. Developed conjunctivitis and nasal congestion. Had a couple red swollen spots on her body. Still irritable. Sx's improved by 5/24/17.
L shoulder pain started at time of the injection and has persisted to this date, approximately 3 weeks later. Pain with shoulder motion, lifting objects, and laying on left arm. I have been taking 2 tabs OTC ALEVE twice/day and/or 1000 mg acetaminophen twice/day, massaging, heat packs. Just got a physical therapy referral today, 1/16/18.
Nausea and lethargy which then developed into being light headed. Awoke on 10/19/2021 with fever and chills at 4am. Muscle soreness and lethargy throughout the day/evening on 10/19/2021.*Not resolved as of 5pm eastern standard time 10/19/2021.
Sore throat, back pain and general fatigue on the 3rd and 4th day post second vaccine dose.  Took Ibuprofen 400 mg 3 times daily x 2 days
Patient developed a febrile illness starting approximately 2 days after receipt of the vaccination.  7 days after the vaccination the fever seemed to subside and a rash appeared. However family reports fevers reoccurred on day 9 and continued for another 5 days by which time the rash had resolved. Patient was fussy and listless per the parents report.
sleepy, lifeless, stated mom told take pt to nearest ER; mom to notify clinic of dx; 28APR95 # 335PM called home-no answer-no answering machine;dx shock collapse from DTP-sx limp, staring, pale, t104
Hives all over legs when out walking 24hours later. Spread to feet. Has happened again with vigorous activity since the booster.
Within days of my first vaccination, two large rashes appeared on my right thigh and  right abdomen.  Rashes were itchy and warm to the touch.   The largest rash is 9 1/2" x 5".  A biopsy confirmed my dermatologist's diagnosis of granuloma annulare.  She has treated it topically (Halog, Clobetasol propionate) and with injections to the site, but the granuloma has in no way diminished.  In the past few days I have acquired 3 new sites of what appears to be granuloma (left groin, thigh, and ankle).  I am concerned that the granuloma is generalized and is a side effect of the Pfizer Covid-19 vaccine.
FORGOT TO TAKE THIRD AND FOURTH DOSE OF VIVOTIF ON TIME; A spontaneous case report was received from a pharmacist on 17-May-2019 for two consumers.  Based on the information obtained from the pharmacist, two individual case safety reports PVX201905-000389 (PVX2019-1238; wife) and PVX201905-000390 (PVX2019-1239, husband) were created and cross-linked in the database.  This case describes a female consumer who "forgot to take third and fourth dose of Vivotif on time". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took two doses of Vivotif on 10-May-2019 and 12-May-2019, respectively. Then, she forgot to take the remaining doses.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "forgot to take third and fourth dose of Vivotif on time" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "forgot to take third and fourth dose of Vivotif on time" was considered as not applicable. US-PaxVax Berna GmbH-PVX201905-000390:
This spontaneous case was initially received on 03-Dec-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received Influenza vaccine for indication not reported on unknown dates, Batch no: not provided, Route of administration: Unknown, Dose: no information provided. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: On an unknown date, after starting /treatment with Influenza vaccine the patient missed work for 2 days (non serious, outcome: unknown), experienced headache (non serious, outcome: unknown) and was sick (non serious, outcome: unknown).
10/14/2022 I first started PAXLOVID after testing positive with COVID-19. The symptoms that I experienced were fatigue, brain fog, I feel much better throughout the day and towards the evening. I still have congestion throughout the day. I do feel that I have had some additional symptoms like anxiety and depression as well. Since taking PAXLOVID I have still been feeling the same with similar symptoms.
Information has been received on 04-JAN-2018 regarding a case in litigation from a lawyer and a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapy are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 20-AUG-2013, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster in addition to herpes zoster of the eyelid and Bell's palsy. On or about 14-AUG-2015, the patient was treated at an urgent care clinic for a blistering vesicular outbreak that was diagnosed as severe herpes zoster, or shingles. On or about 18-AUG-2015, the patient was treated at the urgent care clinic for an outbreak that was diagnosed as herpes zoster of the eyelid with lag opthalmos and was ordered to continue antiviral treatments. On or about 25-AUG-2015, the patient received subsequent treatment at the urgent care clinic for ongoing and worsening symptoms, which were diagnosed as "exposure keratitis OS d/t lag opthalmos", 7th nerve palsy related to herpes zoster, and herpes zoster of the eyelid. Bell's palsy is a condition involving permanent contraction of facial muscles, resulting in drooping of the face and lack of muscle function. The patient had consistent treatments at the urgent clinic with an ongoing diagnosis of severe herpes infection, neuralgia of the 7th cranial nerve and herpes zoster of the eyelid. On or about 02-NOV-2015, the patient underwent an operative procedure for repair brow ptosis, canthoplasty and correction eyelid with implant which was performed by a physician at clinic. The patient sought continued treatment at the clinic for his chronic herpes zoster condition. Throughout his extensive treatment, the patient has been prescribed acyclovir in increasing dosages, mineral oil, petrolatum, white (PURALUBE OINTMENT) and latanoprost for management of his painful and bothersome symptoms. As a direct and proximate result of these malfunctions, 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, pain and suffering and other damages. Bell's palsy/7th nerve palsy/repair brow ptosis/canthoplasty/correction eyelid with implant was considered to be disabling. Upon internal review, Bell's palsy/7th nerve palsy/repair brow ptosis/canthoplasty/correction eyelid with implant and herpes zoster of the eyelid were considered to be medically significant. Additional information has been requested.
Information has been received from a nurse practitioner concerning a 20 year old female with a prednisolone allergy, asthma and a history of pneumonia who on 13-NOV-2006 was vaccinated IM into the left arm with a dose of Pneumovax 23. Concomitant therapy included Lexapro. That evening at 19:00, the patient presented to the physician office and complained of achiness in her left arm. On 15-NOV-2007, the patient began to experience prodromal symptoms including: generalised body aches, fever of 102 F, low back pain, headaches, inability to extend her arm without pain, cellulitis and erythema of the left arm. The patient was treated with IV Rocephin. It was reported that they were not sure if the patient experienced an allergic reaction or cellulitis. On 15-NOV-2006, a CBC was performed and WBC was 20,000 and a chem panel was performed (results not provided). On 16-NOV-2006, a CBC and blood cultures were performed (results not provided), and a WBC of 15,0000. On 18-NOV-2006 the patient was seen with minimal erythema. On 20-NOV-2006, the patient recovered. No product quality complaint was involved. Achiness in arm, body aches, fever of 102 F, back pain, headaches, cellulitis, inability to extend arm and erythema of the left arm were considered to be other important medical events. Additional information has been requested.
Patient self palpated a right breast mass, ended up being breast cancer.  Needing chemo and surgery
I experienced many of the expected symptoms such as headache, chills, fatigue, and injection site pain. The unexpected symptoms were palpitations and chest pain. The palpitations and tachcyardia developed approximately 1 hour after receiving the vaccine and continued for over 24 hours.  My resting heart rate was in the 120s and up to 147 bpm just walking across my bedroom to the bathroom. The chest pain developed about 26 hours after receiving the vaccine. This was intermittent, stabbing pain in my right chest.
Initial misuse report received from a healthcare professional on 10 June 2013. It was reported that post exposure dose 3 and dose 4 of IMOVAX rabies were given early. Dose 3 will not be considered as valid. Dose 4 would count as dose 3 and patient will receive dose 4 and dose 5 as per schedule. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
I experienced stroke like symptoms on Saturday, April 10th, 15 days after receiving my first dose of the Pfizer vaccine. I experienced these symptoms starting around 1:30pm. First, my eyesight had been affected, I was seeing a black straight line aura in both of my eyes, I could not focus on any objects or people. I walked around my house and splashed some water on my face because I was feeling faint, I walked into the kitchen and said I?m going to pass out, I need to sit down, I sat on the floor... my partner was cooking me food and I asked him to get me water, but what came out was ?get me watermelon? from that point on, several of my sentences were not making sense and I was experiencing aphasia.  I was starting to freak out and my right thumb began to tingle and feel numb. My partner gave me .05 mg of Xanax because I was shaking uncontrollably. I became very cold. It took about 20-25 minutes to calm down. In that time, I tried to read words off of his phone and I could not verbalize out loud what specific words actually said, it made sense in my mind, but when I would try to read it out loud, it was wrong. My episode ended in about 25 minutes, while I was eating and then I went to the urgent care.