chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received form an unknown reporter referring to unknown number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On unknown dates, unknown number of patients were probably vaccinated with improperly stored doses of VARIVAX (lot# and expiration date not specified; dose, route, site of administration unknown) for prophylaxis. It was reported that VARIVAX lot # K016129 (expiration date 23-SEP-2016), K021484 (expiration date 03-NOV-2016), K026385 (expiration date 15-DEC-2016), L002868 (expiration date 27-JAN-2017), L012036 (expiration date 17-APR-2017), lot # L023593 (expiration date 26-JUN-2017) and L029466 (expiration date 06-AUG-2017) underwent a temperature excursion in 2015. In October, November and December of 2015, the minimal/maximal temperature of the freezer was -2/6, -2/6 and -2/6 (units not provided) respectively.  The lot number L029466 (expiration date 06-AUG-2017), L035126 (expiration date 14-SEP-2017), L040419 (expiration date 14-OCT-2017), L049532 (expiration date 08-DEC-2017), M005974 (expiration date 02-FEB-2018), M009765 (expiration date 23-FEB-2018), M025864 (expiration date 24-MAY-2018), lot # reported as M0228553 (expiration date 07-JUN-2018), lot # reported as M03138 (expiration date not provided), and M034586 (expiration date 28-JUL-2018) underwent a temperature excursion in 2016. In January to March, May, July to October, and December of 2016, the minimal/maximal temperature of the freezer was -2/10, -7/15, -7/ 9, -4/8, -15/19, -6/7, -5/12, -5/10 and -10/10 (units not provided) respectively. There was no VARIVAX lot number reported in 2017 temperature excursions. This is one of several reports received from the same source. Lot number M0228553 and M03138 are invalid lot numbers for VARIVAX. Additional information has been requested.; Sender's Comments: US-009507513-1705USA007740: US-009507513-1705USA007741: US-009507513-1705USA004287: Original Case : 1705USA004287 US-009507513-1706USA001287: US-009507513-1706USA001288: US-009507513-1706USA001289: US-009507513-1706USA001290: US-009507513-1706USA001292:
syncope; POTS; orthostatic intolerance; autonomic dysfunction; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an 18-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) for prophylaxis. On an unspecified date in 2009 (reported date of injury), the patient experienced Postural orthostatic tachycardia syndrome (POTS), orthostatic intolerance, syncope and autonomic dysfunction. At the time of the report, the patient's outcome was unknown. According to reporter, the events were related to the suspect therapy.   Upon internal review, the event of syncope was considered medically significant.
Dry cough, 5 days of fever of 102-104 F, diff breathing.
Arm was very sore and difficult to remove. She also had a fever and diarrhea.
Patient was vaccinated with Pfizer #1 on 4/02/2021 . She received a second dose of Pfizer 4/15/2021, which is a week early. Her parent or guardian did not make an appointment for this vaccine.  No adverse outcomes or symptoms reported. Troubleshooting: This was missed in screening two times; the scribe and vaccinator did not ask birth date. Parent also did not follow the instructions regarding return time (written on the back of the card).
Intense body aches, chills, fever, headache, upset stomach on Saturday, less intense on Sunday, milder on Monday.  Now dealing with lack of energy and still no appetite.
I do not have the lot # as I am not the facility that administered it. "Last Thursday she got SHINGRIX vaccine at around 4pm at store. She reports that the injection was extremely painful (left deltoid). Within a few hours, she felt that she was falling asleep in the middle of working- "I would just wake up. It happened a few times. I started to feel a flu-like illness. Fevers but chills. No ST. Full body ache. I went to bed. That night I kept waking myself and my husband" groaning loudly. "I couldn't get out of bed" due to pain in her back. At 12:30pm Friday she forced herself to get up to urinate and to let the dogs out. Then went back to bed and got up again at 6pm to let the dogs out but then went back to bed. Today got up this morning for the first time since Friday (today is Monday) other than to let the dogs out and use the restroom Today is the first time that she has left the house since she got the vaccine last Thursday. Total loss of appetite other than some soup on Saturday and "I don't remember what I ate last night." Thought her appetite might be returning last night. "I still have chills. Those aren't going away."
Patient received vaccine mid-morning (around 10:30 am). By 4pm that day, he began to feel ill. The next morning, he experienced chills, sweating and general malaise. By the morning after that, he had no remaining symptoms.
temp 100.2-100.6/fever/chills, body aches, injection site L.arm very sore/heavy/painful
Patient felt dizzy, shortness of breath and chest pain around 10minutes after receiving the vaccine.
Nausea, lethargy, headache. Warm rash appx 1 inch below injection site, in a horizontal line appx 1 in tall and 3 inches wide
Pt started to notice redness and bruise at injection site and it is itchy after a day of injection. He said he didn't have that the first two doses of Moderna.
Tolosa-Hunt syndrome; This literature-non-study case was reported in a literature article and describes the occurrence of TOLOSA-HUNT SYNDROME (Tolosa-Hunt syndrome) in a 45-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE: Tolosa-Hunt syndrome presenting after COVID-19 vaccination. Cureus;13(7):e16791     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Spikevax), the patient experienced TOLOSA-HUNT SYNDROME (Tolosa-Hunt syndrome) (seriousness criterion medically significant). At the time of the report, TOLOSA-HUNT SYNDROME (Tolosa-Hunt syndrome) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered TOLOSA-HUNT SYNDROME (Tolosa-Hunt syndrome) to be related.    Concomitant and treatment medications were not reported.  Patient had Tolosa-Hunt syndrome (THS), a granulomatous inflammatory process of the cavernous sinus, occurring in a patient one week after getting COVID-19 vaccination. Reported that this rare diagnosis of exclusion must be considered in patients presenting with painful ophthalmoplegia.  Company Comment: This is a literature-non-study case concerning  a  45-year-old, male patient with no reported medical history, who experienced the unexpected serious (medically significant) event of Tolosa-Hunt Syndrome. The event occurred on an unknown day after the unspecified dose of mRNA-1273  Vaccine which was administered on an unknown date. No further details on clinical course, lab test results and treatment received were reported. Outcome of the events was unknown, at the time of report. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: This is a literature-non-study case concerning  a  45-year-old, male patient with no reported medical history, who experienced the unexpected serious (medically significant) event of Tolosa-Hunt Syndrome. The event occurred on an unknown day after the unspecified dose of mRNA-1273  Vaccine which was administered on an unknown date. No further details on clinical course, lab test results and treatment received were reported. Outcome of the events was unknown, at the time of report. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Patient came in today picking up ATARAX and triamcinolone, complained after vaccination experiencing itching, swollen glands and redness upper extremity.
Within five minutes I suffered an adverse reaction to the vaccine.  I experienced heart palpitations, high blood pressure, dizziness, shortness of breath, and tingling sensation in my hands.  Lasted approximately 2 hours.
This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-JUL-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N001528 with expiry date: 13-JAN-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.
Anaphylactic reaction; she felt weird like her throat was itchy; She got blotches above her bra line up to her neck and face; scalp was hot; felt wonky/ felt weird; swelling of the face and throat; swelling of the face and throat; difficulty of breathing; This is a spontaneous report from a contactable consumer. A 52-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left at the age of 52 years old on 01Mar2021 (Batch/Lot Number: EN6203) as dose 1, single for covid-19 immunisation. Medical history included type 2 diabetes mellitus (diagnosed in early 20's and reports that diabetes is under control), hypertension (reports that hypertension is under control), early ventricular heart beat (considered benign), menopause, had gall bladder out a few years ago, and hysterectomy last summer. Concomitant medications included metformin (METFORMIN) taken for diabetes mellitus from an unspecified start date and ongoing; diltiazem hydrochloride (DILTIAZEM XR) taken for hypertension from an unspecified start date and ongoing; estradiol (ESTRA [ESTRADIOL]) taken for menopause from Aug2020 and ongoing; calcium (CALCIUM) taken for an unspecified indication, start and stop date were not reported; vitamin d [vitamin d nos] (VIT D [VITAMIN D NOS]) taken for an unspecified indication, start and stop date were not reported; methylcellulose (CITRUCEL) taken for supplementation therapy from an unspecified start date and ongoing. The patient previously took flu shot. On 01Mar2021, the patient had an anaphylactic reaction including difficulty breathing and swelling of the face and throat. Within 4 to 5 minutes after she received the shot, she felt weird like her throat was itchy. She got blotches above her bra line up to her neck and face. Her scalp was hot. She did not have any trouble breathing. She felt wonky. She beeped the horn. The person who came over to her car, told her that it was just a like a little reaction and to sit there until she felt better. The patient stated that she sat there for close to an hour. The blotches went away but she still felt strange and her throat was still itchy. She went home and called her sister who told her that it sounded like she had had an anaphylactic reaction. The patient stated that she is not allergic to anything. She took a couple of Benadryl and went to sleep. When she woke up late that night, she felt fine clarified as she has completely recovered from all of her symptoms. The outcome of the events was recovered on 2021.
Severe headache on the night of the shot. Woke up at 5:30am with a headache and fatigue after sleeping all night. Fever, body aches and chills started at around noon on 12/19/2019. Took ibuprofen at noon and slept during part of the afternoon. Feeling somewhat better by late afternoon.
Shingles; This is a spontaneous report from a contactable consumer (Patient). A 60-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Lot Number: EP7533) via an unspecified route of administration in the left arm on 01Apr2021 (age at the time 60-year-old) as dose 2, single for covid-19 immunisation. The patient's medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously took first dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Lot Number: FN6205) via an unspecified route of administration in the left arm on 09Mar2021 (age at the time 60-year-old) as dose 1, single for covid-19 immunisation. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. List of any other medications the patient received within 2 weeks of vaccination reported as some. On 14Apr2021, the patient experienced shingles. The patient visited the doctor or other healthcare professional office/clinic visit for the adverse event. Therapeutic measures were taken as a result of shingles. The outcome of the event was not recovered.  Follow-up (30Jun2021): Follow-up attempts are completed. No further information is expected.
Feeling fatigued, dizziness; approximately 2 hours later started having severe chills, shaking alternately with fever 103 degrees...went to sleep and woke up at 11:00 pm with 165/ 107 BP; took BP meds and aspirin and went back to sleep....4:00 am woke up with severe headache, took Hydroco/apap 5-325M Tab Amne went back to sleep. Woke up at 7:30 am (10/17/2015) feeling weak but much better.  At 11:54 am I am improving.  When this event got to the fever/chills/high BP stage, I considered going to the ER but was too sick to go. I do not know if this event was life threatening but I felt like it was at the time.
2cm elongated erythematous papular lesion on left thigh, non-painful at injection site. Sister with same response, occurred 15 days, post vax. No systemic symptoms although pox lesion also noted on face and arm, several days later.
Vomitedx1. Pt was fine afterwards. Asked to stay another 15 minutes for observation. Dad stated that there was a ?bug going around and his friend also had similar symptoms this week?
Narrative: COVID infection following COVID vaccine series 01/16, Pfizer, dose #1 02/06, Pfizer, dose #2 08/22 chills, cough, diarrhea, fatigue, fever, headache exposure; school , as security guard 08/24 COVID swab, result: detected
This case was reported by a consumer via call center representative and described the occurrence of ministroke in a male patient who received SHINGRIX for prophylaxis. On 1st December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced ministroke (serious criteria GSK medically significant). On an unknown date, the outcome of the ministroke was unknown. It was unknown if the reporter considered the ministroke to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient did not experience any harm to his system. The reporter wanted to know, if it was okay to take the 2nd dose on 17th December 2018.
The pt experienced soreness, swelling, redness, axilla of left arm. Symptoms persisted then worsened on the breast, neck and ear. Saw MD on 7/30. Prescribed antibiotics.
I received the shot and came home. I started feeling different later that night. The next morning my arm was swollen really bad. It looked like I had half a football in my arm. I then started getting sick. I had an upset stomach and diarrhea. The diarrhea was horrendous. I was going 12-20 times. On the 3rd day, I was still having diarrhea and severe abdominal pain. It was horrible. I went to the doctor and had a colonoscopy done. The doctor did detect a diverticulosis but nothing else. A diagnosis was never found. The diarrhea lasted about 3 months. I took Pepto-Bismol, OTC anti diarrheal medication. I was prescribed hyoscyamine .125mg tabs by the doctor. to prevent the spasming from happening. It did help some with the pain. I was also put on antibiotics. Nothing seemed to help the diarrhea.
Patient received the DTaP vaccine...within a couple she began uncontrollable crying non-stop. She also began a fever. About 1 1/2 days later she collapse and had a hypotonic hypo-responsive episode and a seizure. She was rushed to the hospital where it was confirmed of her seizure episode. I followed up with her pediatrician and the county health dept. and they both agreed it was due to an allergic reaction from the Pertussis from the DTaP vaccine. Since the incident she had 3 more febrile seizures in a 6 month period. Then on October 31, 2006 she had 6 seizures (non-febrile) and was taken to the hospital and had multiple test done. She is 17 months old now and has been diagnosed with epilepsy. There is no history on either side of her family of any seizures (febrile or non-febrile). Note on 6/29/05-diarrhea times 8 days. 3/29/06-fever on day of shot at health dept 102. On amoxillin now for OM for 5 days. Seizures 2 days after vaccine, eyes rolled, fell on her side, facial grimace lasted 2-3 minutes. Seizure in ER. Assessment: history of seizures related to dTap.  6/22/06-rash, fever 1 month ago. No family HX of seizures. Assessment: seizure disorder. DDST.  Referred to neurologist. 6/29/06-has not seen neurologist. Recommend that child not have dTap.  11/15/06-Dr. did not see patient records received from hospital for DOS 3/24/06 DC DX: Febrile Convulsions Otitis Media NOS Fever Febrile seizure 1-2 minutes 30 minutes prior to ER visit. Became limp, "strange eye movment" Temp in ER 101.9 PE Right TM erythematous. remainder WNL. ER visit 5/11/06-DX: Febrile convuslions after DTAP vaccine.  3/31/2010 Follow up: Still has seizures mostly at night, was given medication to present the seizures and had an adverse reaction to it, doctor had us stop medication.
First dose 21-Sep-2021, has not received dose two.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 46-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 21 September 2021).   On an unknown date, the patient did not receive 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.   Additional Information: GSK Receipt Date: 03-OCT-2022 Reporter's Comment: The reporter was a pharmacist. The reporter reported that the patient had not received second dose of Shingrix vaccine. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter did consent to follow up.
pt was anxious about getting the shot, stated she's diabetic with heart condition pre vaccine. dose approx 1:20, at 1:28 said her arm was going numb and declined water and food. 1:33 continued tingling numbness of left arm and jawline, she again declined food and water. 1:43 hot, sweaty, ache in chest and rapid pulse feeling. called ems, gave water and crackers, 1:48 bp between 103/80 Pulse 94 to 127/79 pulse 86. 1:55 bp 156/113 pulse 88. said her arm was tingly and face going numb, feeling her heart flutter. when EMS arrived she said her blood glucose was 286 this am and she took Humalog then. normal bp 130s/80s pulse in 90s. Tx to hospital, FU 3/12&3/14 said she had throat closing and vax site numb and swollen
This spontaneous report was received from a Nurse practitioner via a company representative refers to a 12 year old female patient. On 05-AUG-2013, the patient was vaccinated with GARDASIL dose 2. Concomitant therapy included TDAP. On 05-AUG-2013 (after the second dose), the patient experienced swelling and warmness at the injection site and swelling and warmness at the injection site. As a result of this adverse event, the parents of this patient did not allow the patient to complete the series of GARDASIL and the patient did not receive the 3rd shot of GARDASIL. The representative stated that, the patient received the 1st shot of GARDASIL on 28-MAY-2013. The representative then reported, the patient received the TDAP vaccine the same day as receiving the 2nd shot of GARDASIL. No intervention was initiated to prevent serious criteria as there was no seriousness criteria reported. No product quality complaint (PQC) was filed. On 05-AUG-2013, therapy with GARDASIL was discontinued. The outcome of swelling and warmness at the injection site and causality were not reported. Additional information has been requested.
Congestion, Aches, Fatigue, low fever, sinus headache, Nausea.
Exhausted/tired; Headaches; Have not been able to get warm; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received unspecified dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 25Mar2021 at 13:00 as a single dose for COVID-19 immunisation. Medical history included fertilization issues. The patient did not have any known allergies. Concomitant medications included metformin (MANUFACTURER UNKNOWN) for fertility reasons but not diabetic, topiramate (MANUFACTURER UNKNOWN), sertraline (MANUFACTURER UNKNOWN), lisdexamfetamine mesilate (VYVANSE) and omeprazole (MANUFACTURER UNKNOWN). 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 COVID-19 vaccination. On 26Mar2021, the patient was not able to get warm. On 27Mar2021, the patient had headaches and from 28Mar2021, the patient felt exhausted and did not remember being so tired for so many days in a row after the vaccination. Therapeutic measures taken included treatment with alternated TYLENOL and ibuprofen. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events exhausted, not able to get warm and headaches were recovered with sequelae on an unknown date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
WHOLE-BODY ARTHRALGIA AND INJECTION SITE PAIN. STARTED 6 HOURS POST-VAX .  LASTED 48 HOURS. TREATED WITH TYLENOL AND EDIBLE THC