chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Numbness and tingling on left side of mouth down to my neck on 04/22/22... Lasted a few days. It just happened again 05/23/21. Also, my eyeballs were very swollen and sore. Extremely painful to touch. My sister's lip started twitching after her 2nd dose of Pfizer.  I also had a headache for 2 weeks worse than a  migraine with fever and chills off and on fir a week. Lastly, tingling and numbness on top of right foot that just started as well.
Patient father and patient came to  pharmacy on August 7,2021  to receive 1st dose Pfizer - When pharmacist asked  Patient father and patient son- verified birthday as written on consent form.  After completion of vaccine, RPH processed paperwork and was a billing issue. Called insurance to verify discrepancy as to why bulling information stated "missing birthdate". Insurance verified on file birthdate for patient was in fact different then written on consent form. Tried to called patient multiple times to confirm and no response.
Pt reported nausea, feeling cold & clammy, and dizziness. Vitals: 97/56, 79, 20 -- > 109/57, 63, 100% O2 Sat Pt given water and biscuits.  Pt placed in T-Berg position x 30mins. Pt stable and released from the vaccination site.
Pain; This is a spontaneous report from contactable nurse through a Pfizer sales representative.   A male patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose, on an unspecified date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient experienced pain. Clinical outcome of the adverse event was unknown at time of this report.   No follow-up attempts are needed, information about lot number cannot be obtained.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 24Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 22Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 06Apr2022 at 19:00, outcome "recovered" (11Apr2022) and all described as "COVID 19 Treatment". Therapeutic measures were not taken as a result of covid-19, vaccination failure.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
1st in late 2021, early 2022. 2nd on 26NOV2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in late 2021 or early 2022).   On 26th November 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 26th November 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 07-FEB-2023 Reporter's Comment: The patient was self-reported this case. The patient reported that she received the first dose of Shingrix vaccine in late 2021 or in early 2022. The patient stated that after greater than six months, on 26th November 2022 she received her second dose. The patient reported that the second dose was delayed because she did not know it was a two dose series.  Nothing else was reported. The reporter did not consent to follow up. Additional supportive information: The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of vaccination schedule.
Patient got shingles vaccine on 8/3/2021 and appears the vaccine was injected into the subcutaneous tissu e, not the left deltoid muscle.  The area below the deltoid is now hot and red and patient reports she feels feverish. In addition, the vaccine was stored in the freezer upon its arrival to our clinic site on 7/20/21 until 8/10/21 when we learned that the vaccine should have been stored in the refrigerator at temperatures between 36-46 degrees farenheit.  Therefore, the vaccine has no efficacy.
Information has been received from a 24 year old female with no pertinent medical history and no allergies who on 02-FEB-2008 was vaccinated with the first dose of GARDASIL IM 0.5ml. On 07-MAR-2008 the patient was vaccinated with the second dose of GARDASIL IM 0.5ml. On 07-AUG-2008 (reported as 08/07/2007) the patient was vaccinated with the third dose of GARDASIL IM 0.5ml. There was no concomitant medication. On 25-APR-2008 the patient experienced severe joint pain after receiving her second dose. The patient's severe joint pain persisted. The patient sought medical attention. Additional information has been requested.  2/20/09 Received PCP medical records of 10/1/08-12/29/08. FINAL DX: none provided Records reveal patient experienced back pain, left paraspinal muscle spasms & bilateral hip pain.  Tx w/meds, PT & referred for MRI.
Pt rec'd immun on 14AUG90, 10CM swelling & redness noted @ site of inject; Seen in Er for allergic rxn; Tx DPH IM, APAP, EZOL & Pred;
Site became red, itchy and warm on 10/25/03 and remains warm and red on 10/27/03.
Nausea started at 03:15pm vitals taken all wthin normal. Observed for 15 more mins, pt continue to report symptoms, 8mg sublingual zofran given at 03:45pm, observed for 15 more minutes, symptoms slightly improved. Sent home with one more dose of 8 mg, zofran. Advised to go to ER if symptoms persist or worsened and other worrying side effects to watch for. Pt, spouse and son verbalized understanding.
Moderna on 2/18 and 3/19. Positive on 10/3
it was rpt fr HCP concerning pt who was vax 26aug96 & subsequently pt exp a varicella like rash. addl information requested.
Soreness, redness at inject site, area became quite red and swollen and require coritsone injection and IM antibiotic.
Impressive localized swelling and redness.  Improving.  +edema and mild erythema on exam.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (exact dose, route of administration, lot number and expiry date were not reported). There were no concomitant therapies reported. The administered doses of the vaccine were exposed to a temperature between 32 degrees Fahrenheit to 35 degrees Fahrenheit (33.9 degrees Fahrenheit) on an unspecified date, for a time frame of 40.5 hours. A digital data logger was involved. There were no previous temperature excursions recorded. No adverse experiences were reported. There was no product quality complaint involved. Sender's Comments: US-009507513-1707USA011460: US-009507513-1707USA012405: US-009507513-1707USA012403.
sore arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided   This case was linked to MOD-2021-010848 (Patient Link).; Sender's Comments: This case is under data review.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In March 2017, a healthcare provider administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In March 2017, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Site of injection is still sore and have a very limited range of motion almost a whole month later.
Pain in injected arm (left), spreading to the adjacent shoulder; also.  fever, chills, extreme fatigue, body aches.  All these symptoms started on the day of vaccination.  About 5 days post vaccination, swelling of clavicle on left side at the sternoclavicular joint.   The pain, fever, chills, fatigue, body aches resolved within one week.  However, the  clavicle swelling still persists 8 months later.  Some discomfort also present near the  clavicular swelling, with certain arm or neck movements.
hypedrthyroid,treated with methimezole for1 month waiting for  time to check resilts on july 24 had monoclonal amtibody  infusion 2 days after getting covid-19
Sick, went to hospital 3 times before passing; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 64-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included solitary kidney (the patient had an extensive medical history including having only one kidney).   On 9th October 2020, the patient received the 1st dose of FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. In October 2020, between 1 and 2 weeks after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced sickness (serious criteria death and hospitalization). On 15th April 2021, the outcome of the sickness was fatal. The patient died on 15th April 2021. The reported cause of death was sickness.   It was unknown if the reporter considered the sickness to be related to FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device.This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-APR-2022 Reporter's Comment: The case was reported by patient's husband.  The reporter did not provide specific details about the event or vaccine.  He stated that, the patient received the Flulaval Quadrivalent vaccine and about 1.5 weeks later she was sick and had to go to the hospital. The patient went to the hospital, she spent several days. The reporter could not describe patient's sickness or give a diagnosis.  He stated, she was in the hospital 2 more times before passing on 15th April 2021.  The reporter did not consent to follow-up. No further information was to report.; Reported Cause(s) of Death: Sickness
Sudden unstoppable nasal bleeding that needed emergent surgery to stop it.  In 12 hour time span I had to report to ER 3 times to try to stop the bleeding.  On the third visit ENT was called in and I had emergent surgery to stop the bleeding.  I spent the night in the hospital.  I lost about 4 or 5 units of blood. I have never had nose bleeds like this in the past.
Received first dose of Hepatitis B on 5/13/2013 and had a skin reaction lasting 3 days that she did not report. She receive 2nd dose on 7/15/2013 on had a rash lasting 1 month-requiring oral steroids.
3-4 days after injection patient reported pain at injection site. 5-6 days after injection patient reported swelling, redness, and hotness at injection site. Patient states swelling is the size of an egg underneath the skin. About a week after injection pain started to radiate down arm to the wrist and began affecting the middle finger of the left hand. Patient states swelling continues to worsen each day and does not appear to be subsiding. One doctor patient saw speculated patient may have sustained radial nerve damage.
This person is enrolled in a Covid-19 Vaccine study. He claimed in the inclusion/exclusion criteria portion of the informed consent interview that he had not received a Covid-19 vaccination. In the study, he received Dose #1 on 02 Aug 21 and Dose #2 on 30 Aug 2021. On 23 September 2021, an attempt was made to enter him into the Registry of Immunization and it was discovered that he had been vaccinated elsewhere in the state on 01 and 29 April 2021. The participant claimed that he thought the April vaccinations were flu shots.
OV today for shoulder pain. Says that he rec'd COVID vaccine in left shoulder. Says that the second day after the vaccine was lying on right side and couldn't lift his left arm to move the covers. The pain is in posterior arm. Can not extend arm. Can pull arm up in front of him. Not able to abduct arm.
Information has been received on 11-DEC-2018 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In November 2016, the patient's healthcare provider at a medical center administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 31-MAR-2017, the patient was treated by the patient's healthcare provider at a healthcare system for shingles and post herpetic neuralgia. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
4 minutes after the vaccine I got full body flush starting from core up through head/face. This was quickly followed by significant vertigo and light headedness as well as tachycardia and nausea. The most significant signs lasted approximately 3 minutes before improving  on their own that I was dissuaded from contacting pharmacist for treatment (vaccine administered at ).  However, the dizziness and nausea lasted another 30 minutes to a much lesser degree and then intermittently for another 3 hours following return home and self monitoring.
No further Adverse event details; they just found out they had another TE 1 week ago/-14°C up to-10°C (-12C) for 0 hours 50 minutes 0 seconds; This spontaneous report was received from a pharmacist regarding a patient of an unknown age and unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  Between 11-MAY-2022 and 24-MAY-2022, varicella virus vaccine live (oka/merck) (VARIVAX) lot #U039949, expiration date: 16-DEC-2023 (strength, and route of administration were not provided) was administered, following a temperature excursion (product storage error). The temperature was reported as -14 degree Celsius (C) up to-10 C for 2 hours 5 minutes 0 seconds; -10 C up to 8 C (-0.4 C) for 1 hour 25 minutes 0 seconds, there was a previous temperature excursion, reported as -14 C up to-10 C (-12 C) for 0 hours 50 minutes 0 seconds. No additional adverse events had been reported (no adverse event). No additional information was provided.
Vaccine was not given in correct location, supposed to be administered in deltoid, was given much lower in arm in back of arm.
Area of redness, extending from shoulder deltoid down to left elbow. Not especially warm or swollen but definitely red.
CHIEF COMPLAINT GI Bleed   HISTORY OF PRESENT ILLNESS Patient is a 80 y.o. male with a past medical history significant for dementia, Alzheimer's, atrial fibrillation, type 2 diabetes mellitus, peripheral artery disease and s/p TAVR (6/17/20) who was admitted with gastrointestinal bleeding.     Per records, the patient was hospitalized on 10/13/21 with acute hypoxia. He was discharged on 10/16/21 with a new supplemental oxygen requirement of 2L/day and 3L/night. In the interim following discharge, he developed confusion, weakness, hematuria, and hematochezia. His wife noted the latter this afternoon when she looked in the toilet bowl and found it to be full of blood. It was unclear to her whether this was from urine or stool. She called EMS and the patient was brought to the hospital.   On arrival to the ED, the patient was noted to be in renal failure with markedly elevated creatinine to 5.49 and potassium to 6.1. Calcium, insulin, and D50 were given. He had a CT abdomen/pelvis which was concerning for a pneumonia as the source of increased O2 demand. Ceftriaxone and doxycycline were initiated. The patient also complained of testicular pain with tenderness on examination. Urine contained >100 WBC with large leukocyte esterases. The specimen was reported to be bloody, however Foley was subsequently placed and no bleeding was appreciated. Testicular ultrasound not concerning for torsion The patient was also noted to have melenotic stools. His hemoglobin in the ED was 13.0 and he appeared hemodynamically stable. INR 2.5. Patient's wife reported increasing confusion over the past week so a CT head was done in the ED. This did not show any intracranial hemorrhage. Given his presentation and concern for bleeding, he was transferred to the ICU.   Of note, prior to transfer to the ICU, the patient was noted to be positive for COVID-19.
Hot, swollen, red, hard, splotchy, mildly itchy patch at injection site showed up around 1:30 pm on day 8 (April 23) after getting Moderna dose 1 on April 15. Spread to round patch the next day and faded after that. Googled and description matched known possible side effect known as ?covid arm.? It faded entirely by Monday April 26. I took an antihistamine (cetrizine) every day starting the day I noticed the patch and monitored myself for further issues possibly related. I?ve had a headache, but that could be for any number of reasons not related to the shot.
Rash started on bilateral anterior aspect of both thighs where previously vaccinated 6/17/17, on 6/18/17 noticed bumps in addition to rash, patient introduced to applesauce evening of 6/19/17.
Information has been received from a consumer concerning her son (age 5 at the time of this report) who at the age of 12 months, on 8/27/98, was vaccinated with a first dose of MMR II (623744/0506H). In September 2002, the pt was diagnosed with autism. The mother stated that her son had special needs and has been in special classes since age 3 but was not officially diagnosed with autism until September 2002. Unspecified medical attention was sought. It was also reported that the pt developed adverse experiences after vaccination with MMR II on 4/1/03 (WAES0304USA00745). Additional info received from the physician indicated that the pt had been born at 37.9 weeks gestation via cesarean section with a birth weight of 3.831kg. The pt ahd a dislocated hip secondary to the birth. The physician stated that she did not know if the pt was well when he received the first dose of MMR II as she was not his pediatrician until he was 3.5 years old. At 3.5 years old the pt was "experiencing delays and a sensory integration disorder." It was noted that the pt was in a developmental program and has made progress but that he still had a delay. Upon internal review, autism was determined to be an other important medical event (OMIC). Additional info has been requested.
This spontaneous report as received from a healthcare worker refers to a patients of unknown age and gender. On an unknown date the patients were vaccinated with doses of VARIVAX (Merck) (dose, frequency, route of administration and indication were not reported), which were exposed to temperatures outside of the recommended range. No adverse effect had been reported. This is one of several reports received from the same source. Additional information has been requested.
ErythemaMultiform post vaccine hs-1/7 low grade fever temp of 100.3. 1st day p vaccine developed red patches bilateral thighs and back. Resolved. Narrative: post vaccine hs-1/7 low grade fever temp of 100.3 1st day p vaccine developed red patches bilateral thighs and back. Resolved.
Myocarditis, presented with chest pain ,troponin peaked at 19, had left heart cath that showed normal coronaries
pt recv vax; got hives that covered most of body; scalp and hands itched and burned; took DPH; cont to have itchy scalp and palms of hands for 3-4 days p/ taking dph;
Client C/O generalized achiness next morning after injection. She took Tylenol that night prior to bed to alleviate the achiness. Second morning after inj., client experienced 6-7inch wide area of erythema,induration, and warmth surrounding inj. site (left deltoid muscle)Client also stated that right breast became tender surrounding nipple area that day. Client states that she was in a MVA April,2007, and sustained two fractured ribs right chest. no other symptoms reported.Client inst. to follow-up with Physician re: situation.