chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning of his son, a current 12 year old male patient. The patient was allergic to morphine. The patient had no pertinent medical history nor concomitant medications. In August 2017, the patient was vaccinated with the first dose of GARDASIL 9, route reported as "shot" (strength, anatomical location, lot number and expiration date not reported) to prevent human papilloma virus (HPV) prophylaxis. On an unknown date in 2017 (reported as "soon afterwards"), the patient complained of leg hurting and starting to lose weight. On an unknown date, the patient suffered from constipation, diarrhea, chronic inflammation and his weight went from 81 pounds to 69 pounds. On an unknown date, the patient visited a gastrointestinal specialist who gave unspecified treatment. Multiple tests were done included blood work, magnetic resonance imaging, "MRE", ultrasounds, colonoscopy and endoscopy; no results reported. In March 2018, the patient received dose 2 of GARDASIL 9, route reported as "shot" (lot number and expiration date not reported). About three weeks after the second dose, the patient was hospitalized as his condition worsened. On an unknown date, as his condition continued to get worse and the patient saw a vaccination specialist who was considering an autoimmune disease. At the time of the report, the patient had not recovered from the aforementioned events. The causal relationship between aforementioned adverse events and GARDASIL 9 was not reported. Upon internal review, the autoimmune disorder was considered as a medically significant event.
Patient came to pharmacy looking to get the COVID pfizer vaccine. The patient didn't express any previous problems with vaccines. Upon giving the patient the vaccine. The patient immediately went pale and started to sweat a lot. The patient stated that he was nauseous. I gave him water, the patient attempted to vomit while nothing came up. The emergency response team then showed up and assisted with checking his BP, O2, and pulse. His BP was low with 90/68 the first time and his BP raised after getting Apple juice and crackers to 120/78. His color in his face then returned and his father picked him up. He was in the pharmacy around one hour and 15 minutes.
Fever, tonic clonic seizure x 2 - time 10pm 3/10/10. Rx antipyretics. Shots given earlier in the day 3/10/10.
HIVES ALL OVER. RED BURNING RASH ON CHEST, NECK, SHOULDER, AND LEGS
pt exp poor balance, temp falling, low grade temp elevation 101;all sx began approx 72hr p/vax;sx lasted 7-8 days;pt was examined 7AUG97 nl exam;
Initial information received on 16-Nov-2018 regarding an unsolicited valid non-serious case received from a physician and nurse. This case involves a 10 years old male patient who experienced tingling and numbness from his elbow down to fingers. The 5th, 4th and 3rd fingers were particularly affected, pain, redness and swelling at the injection site, while he received vaccines ADACEL and FLUZONE QUADRIVALENT. The patients past medical history, concomitant medication and family history were not provided. It was also a case of an actual medication error due to Wrong injection technique as Patient received both ADACEL and FLUZONE QUADRIVALENT, both given in the left deltoid. On 15-Nov-2018, the patient received a 0.5ml dose of suspect FLUZONE QUADRIVALENT lot UJ034AD, expiry date 30-Jun-2019 via intramuscular route in the left deltoid. On 15-Nov-2018, the patient received injection of suspect ADACEL lot number, expiry date not reported via unknown route in the left deltoid. On 15-Nov-2018, the patient developed a non-serious tingling and numbness from his elbow down to fingers. The 5th, 4th and 3rd fingers were particularly affected (paraesthesia) Within 20 minutes following the administration of FLUZONE QUADRIVALENT and following the administration of ADACEL. On 15-Nov-2018, the patient developed a non-serious tingling and numbness from his elbow down to fingers. the 5th, 4th and 3rd fingers were particularly affected (hypoaesthesia) Within 20 minutes following the administration of FLUZONE QUADRIVALENT and following the administration of ADACEL. On unknown date, the patient developed a non-serious pain, redness and swelling at the injection site (vaccination site inflammation) with unknown latency following the administration of FLUZONE QUADRIVALENT and following the administration of ADACEL. On 16-Nov-2018the symptoms continued and patient was evaluated by a physician. Physician reports that his Strength is good and is able to squeeze hands equally. ROM fair. Final diagnosis was tingling and numbness from his elbow down to fingers. The 5th, 4th and 3rd fingers were particularly affected and pain, redness and swelling at the injection site. As a corrective treatment physician recommended ibuprofen and cool compress. Patient will be monitored by his HCP. The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for tingling and numbness from his elbow down to fingers. The 5th, 4th and 3rd fingers were particularly affected, as Unknown for pain, redness and swelling at the injection site. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Information has been received from a physician concerning a 16 year old female who on approximately 15-JUL-2008 was vaccinated with the second dose of GARDASIL vaccine (yeast), 0.5 mL, injection. On approximately 15-JUL-2008, the patient fainted after getting second dose of GARDASIL vaccine (yeast). It was unknown when patient was administered with first dose. The patient sought unspecified medical attention. On an unspecified date, the patient recovered from fainted. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2008.  Conflicting information was received in follow-up from the physician concerning a patient who only received one dose of GARDASIL and had no documented adverse reaction.  To date, the patient had not received a second dose.  No further information is available.
little warm  to touch; hives near the  injection site and describes the hives as, " one spot - 3 &1/4 of a   size, few small ones  which merged together and created  a big spot which is  2  inch  wide &  4  inch long.; slightly itching; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (little warm  to touch), INJECTION SITE URTICARIA (hives near the  injection site and describes the hives as, " one spot - 3&1/4 of a   size, few small ones  which merged together and created  a big spot which is  2  inch  wide &  4  inch long.) and INJECTION SITE PRURITUS (slightly itching) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy and Migraine. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced INJECTION SITE WARMTH (little warm  to touch), INJECTION SITE URTICARIA (hives near the  injection site and describes the hives as, " one spot - 3&1/4 of a   size, few small ones  which merged together and created  a big spot which is  2  inch  wide &  4  inch long.) and INJECTION SITE PRURITUS (slightly itching). The patient was treated with FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Adverse event, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, INJECTION SITE WARMTH (little warm  to touch), INJECTION SITE URTICARIA (hives near the  injection site and describes the hives as, " one spot - 3&1/4 of a   size, few small ones  which merged together and created  a big spot which is  2  inch  wide &  4  inch long.) and INJECTION SITE PRURITUS (slightly itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products also included a migraine medication as needed.  Treatment information included ice.
He saw his PCP on 08/15/2021 and was tested + for Covid, He has been on an albuterol inhaler and Decadron and mucinex at home with minimal relief. His oxygen saturation has been dropping slowly over the last the 2 days prior to his admission. The patient's oxygen saturation was 84% and he called EMS; however, when EMS arrived it was 75%. He was placed on a nonrebreather at 15 liters per minute. And in the ER admitted he was having to work hard to breath. He has also continued to have fever, chills, and bodyaches. The patient did state he completed the Moderna Vaccine in May 2021. After admission to the hospital. He was given Remdesivir and steroids and breathing treatments. He continued to deteriorate and required placement on BiPAP. And the patient was transferred to this facility due to no ICU beds in their facility. .
Information has been received from a health professional concerning a female who was vaccinated with the second dose of GARDASIL (lot# not reported).  Subsequently the patient experienced dizziness and nausea one month after receiving the second dose.  The patient sought unspecified medical attention.  The patient did not have any side effects after receiving the first dose.  Additional information received 28-MAR-2008.  The nurse called to state that the practice does not have any further information regarding the case and they do not want to receive any further letters.  Additional information is not expected. Additional information received from memo (01-APR-2008): Nurse states, "No further information." Additional information is not expected.
At 10:33 am Patient pushed her pendant for staff, staff arrived to her apartment and Patient was found unresponsive in her bathroom. Patient received her second COVID-19 Pfizer vaccine about 75 minuets prior to this, she had no adverse reaction's within the first hour of receiving the second dose. CPR was started until paramedics arrived, they took over and tried to resuscitate. Patient was pronounced dead at 11:33 am at scene.
Information has been received from a healthcare worker concerning three parents of unknown demographics. There were no medical history or drug reactions/allergies reported. On an unknown date in 2015, the patients were vaccinated with expired VARIVAX (Merck) (lot # J003218 with expiration date: 15-MAR-2015; dose, frequency and route were unspecified). No adverse events were reported. Additional information has been requested.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown gender and age. The patients' concurrent condition, medical history and concomitant therapy were not reported. On multiple unspecified dates multiple unspecified patients were vaccinated with improperly stored ZOSTAVAX (dose, route, lot# and expiration date unknown) which was reconstituted with properly stored sterile diluent for prophylaxis. The vaccine was improperly stored at 15 to 46 degrees Fahrenheit for 1 hour and 6 degrees Fahrenheit to 14 degrees Fahrenheit for 2 hours 30 minutes. The vaccine also had a previous temperature excursion at 15 to 46 degrees Fahrenheit for 1 hour. No adverse effects were reported. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1708USA010011: US-009507513-1708USA008431.
pain in the deltoid area of injection arm that "felt like needles"  soon after getting vaccine; pt thought the pain would go away after some time, and although the pain has gotten better, he still feels discomfort in the arm.  Pt is just reporting to pharmacy today because he was expecting the pain to resolve with time.
"Pfizer-BioNTech COVID-19 Vaccine "  I, the client sitting 5 minutes after receiving vaccine began to feel dizzy and drank the provided bottled water.   The dizziness lasted for 2 hours.  Within 10 minutues I also started having numbness and tingling from my right elbow to my hand, anterior and posterior.  This continued throughout the day.  After being observed by staff, after 30 minutes I was given Benadryl  tablet25 mg by mouth.  The adverse event has also been reported to my manager and employee health.
This spontaneous report as received from a healthcare professional who was a quality control representative of a company refers to an unspecified number of patients of unknown age and gender. Doses of PNEUMOVAX that were exposed to a temperature excursion on an unspecified date may had been administered to unspecified patients (lot#, dose, dose# and route not reported) on unspecified dates since the temperature excursion. He stated that some of the improperly doses were administered to some patients, but he was certain that the practices that administered the doses reported the administration to Merck to request revaccination information. He was not able to provide any healthcare provider information or case numbers, nor could he provide any additional information about these scenarios. He confirmed that the was aware that the administration of improperly-stored products to patients posted a safety risk to the patients. He did not know whether or not there had been any adverse effects. This is one of several reports received from the same source. Additional information is not expected as there was not consent for follow up contact.
Patient became lightheaded and profusely sweating after a couple minutes of the shot. After 5 minutes of sitting and water he became normal. He could breath fine and no other reaction.
Woke up in middle of night and noticed pain in arm, next AM it was swollen below the injection site, red, paniful, still painful on day she presented with symptoms on 9/13/17 but was improving. Had been using a cool compress but no other treatment.
This spontaneous report as received from a physician refers to a female patient of unknown age. The patient received her second dose of GARDASIL experienced "flu-like symptoms" and "a lump in her neck". The reporter indicated that the patient received her first dose at the office in "January" and that she did not know where or when the unspecified patient received the second dose of GARDASIL, she also did not specify if the AE was reported previously. The patient sought medical attention by notifying the physician. At the time of the report, the outcome was unknown. Additional information has been requested.
Patient here post vaccines with reaction on the left deltoid. Family reports that immediately after the vaccines, he started to have some redness. Over the next couple of days, the area started to swell and become warm to the touch. Patient told mother that it was tender to touch, but then denied that it was painful today. No V/D/rash/fever. Appetite and sleep normal. No ill contacts. Family told to do warm/cold compress, start ibuprofen, take antihistamines, and to FU if any s/sx of infection occur.  On exam: Patient has lesion on left deltoid that has 1cmx.5cm area of erythema and induration, no exudate and no warmth to touch. Area does not appear infected.
On August 6, 2021 I developed a severe headache.  The following 3 days I experienced a fever up to 100.4,  chills to the bones that were painful, hallucinations, profusely sweating and cold symptoms.  On Monday August 9, 2021 I tested negative for Covid.  On Thursday August 19th I developed profuse pain and swelling in my parotid gland on the right side.  I still took the 2nd vaccine on August 21, 2021 in the opposite arm from the 1st one.  The pain has subsided but the swelling is still there.  I see my PCP today at 4:00 regarding the swelling.  I have felt generalized fatigue since I took the 1st vaccine and honestly do not feel like my normal self since receiving it either.
On 6/11/08 about 4AM patient started complained of really bad headache, very tired, lethargic, fever over 101deg, and vomiting. Symptoms lasted all day. Mom says he slept most of the day. Next day he was much better. Rash showed on back of knees on 6/13/08. Doing fine 6/13/08 PM.
The patient received a dose that was diluted with 2.0mL dilutant instead of 1.8mL. We were notified by the nurse who administered it on 8/16/2021. We first called Pfizer to see what their recommended actions were. They recommended not administering the dose and said the CDC recommends not repeating the dose. Our Medical Director spoke to the patient's mother on 9/7/21 which is also when the child received their second dose of the Pfizer Covid-19 vaccine. She reported: Spoke with mother Provided more detail of the error She is frustrated because this is the second vaccine error that occured for this child in 2 months Was given an expired vaccine in June I apologized and advised that we are working hard to identify system errors and correct them.  I advised that we will be retraining everyone on vaccines She stated that her husband wants to pull kids out of the office.  She wants to keep them here as she likes the doctors but is frustrated on the mistakes.    I advised that I share in her frustration and again apologize.  We discussed that we checked with Pfizer and the CDC and no further action is needed at this time.  She is requesting that from now on, I visually oversee all vaccine administration for her family
Received dose #2 Moderna vaccine on Feb 3. On Feb 5 woke up with rash over body but not face. Rash more pronounced in bilat armpits. Rash was red and flat and somewhat itchy. Used antiitch cream for symptom relief. On the 9th started getting better and by the 10th it was gone.
husband has some bad reactions/ your vaccines do not work, they are useless; husband has some bad reactions/ your vaccines do not work, they are useless; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: Not reported) via an unspecified route of administration on an unspecified date, as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced has some bad reactions/your vaccines do not work, they are useless. The caller stated that, patient have some questions about your COVID-19 vaccines. Sadly patient's family and patient received it and her husband had some bad reactions, so no we will never, ever get another booster shot. Especially when they do not work. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Myalgia, NauseaVomiting, Rigors, chills, fatigue, skin sensitivity Narrative:
Large bruise developed along with a hive like patch that was raised below the bruise. Extreme pain when trying to lift arm above head or behind back. Began about 1 week after vaccination. Returned about 2 weeks after vaccine to show pharmacist. Swelling went down after about a month, bruising lasted 2 weeks.
Pneumonia; This spontaneous report was received from a lawyer referring to an elderly male patient (pt) of unknown age with high blood pressure (HBP) and neuropathy. The pt had been diagnosed with chicken pox in approximately 1950 at 2-5 years old, but did not receive the chicken pox vaccine. The pt had smoked or used tobacco products from 1960 to 2015 (3 packs a day). Concomitant therapy included losartan.  In 2015, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis which caused pneumonia in 2015. The patient was treated with steroids or corticosteroids. The outcome of pneumonia was unknown. The reporter considered pneumonia to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).     Upon internal review, event pneumonia was considered to be medically significant.  This case was split from a legal case regarding the same patient.; Sender's Comments:  US-009507513-2008USA002306:
Pt received pfizer today 3/23/2022 as her second dose, and had previously had her 1st Moderna dose on 2/1/2022.  Pt informed and monitored for 15 minutes. No adverse reactions observed.
Painful spots on her forehead and along hairline/contracted shingles; Painful spots on her forehead and along hairline; Painful spots on her forehead and along hairline; headache / intensified the next day; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd March 2021, the patient received the 1st dose of Shingrix. On 6th March 2021, 3 days after receiving Shingrix, the patient experienced headache. On 8th March 2021, the patient experienced shingles, spot-like rash and painful rash. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the shingles, headache, spot-like rash and painful rash were not recovered/not resolved.   The reporter considered the shingles to be related to Shingrix. It was unknown if the reporter considered the headache, spot-like rash and painful rash to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient had received the vaccine on her left arm and contracted shingles after vaccination. The patient experienced a headache and intensified the next day and had not resolved till the time of reporting. In the evening of 8th August 2021, the patient noticed painful spots on her forehead and along hairline and had not resolved till the time of reporting. The patient was prescribed anti-viral and started taking it on 9th March 2021. The reporter wanted that the patient's symptoms should be focused. The reporter did not know lot or expiration date. The reporter consented to follow-up and gave permission to follow-up with health care professional. This case has been linked to US2021009418 (husband's case), reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021009418:same reporter
Round red warm area to left upper arm with 7 cm in diameter. No antibiotics prescribed. Advised Benadryl and cool compresses.
21MAY92 devel fever of 103 & was listless; checked by MD & no evidence of infection present; fever stayed @ 101 x several days; had sz 29MAY92;
Narrative: Patient was not previously Covid positive and did not have any predisposing fators(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 86 and had at least one year history of progressive muscle weakness and dysphagia requiring tube feed dependency. On 3/22/21 he went to the ER with pneumonia which he eventually passed away from on 4/7/2021. Comorbidities include chronic afib, HTN, HLD, CKD, asthma/COPD.