chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received 31 JUL 2020 / Received 26 NOV 2020 / developed shingles/ suspected vaccination failure; developed shingles and still has outbreaks on her face and chin; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a adult female patient who received Herpes zoster (Shingrix) (batch number 5KM49, expiry date 26th November 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number XG52X, expiry date 28th November 2021) for prophylaxis and COVID 19 VACCINE MODERNA for prophylaxis.   The patient's past medical history included shingles (in February 2020), shingles (in March 2020) and shingles (in June 2020).   On 26th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 31st July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 28th February 2021, the patient received the 1st dose of COVID 19 VACCINE MODERNA. On 22nd March 2021, 116 days after receiving Shingrix and 234 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. On Monday 22nd March 2021, the patient developed shingles and still had outbreaks on her face and chin. This shingles outbreak has prevented her from getting her second Moderna COVID-19 dose. The patient was upset and concerned about the shingles vaccine failure and its interference with her COVID series. It was unknown if the reporter considered the shingles to be related to Moderna COVID-19 vaccine. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown. The reporter consented to follow up.
temporary numbness in the deltoid region of her arm on an unspecified date which resolved "within a month"; third dose of GARDASIL 9 was administered by subcutaneous injection; This spontaneous report was received from a physician and refers to a 34-year-old female patient. The patient did not have pertinent medical history and drug reactions or allergies. The patient did not take any concomitant medications.  On an unknown dates, the patient was vaccinated intramuscularly with two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, lot number and expiration date were not reported) for prophylaxis.   On an unknown date, after the patient's second hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, she experienced temporary numbness in the deltoid region of her arm which resolved within a month. There was no lab diagnostic performed and no treatment given for the adverse event.  On an unknown date in 2018 (reported as "sometime late last year"), the patient's third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered by subcutaneous injection (incorrect route of product administration) (exact dose, lot number and expiration date were not reported). No adverse effects were reported after the third injection of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  The relatedness between temporary numbness in the deltoid region of patient's arm and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) was not reported.
About 18hrs p/inject father noted pt's arm was reddened & swollen distal to site of inject - pt afebrile & otherwise normal except for increased sleepness- pt tx w/antibiotics & diphenhydramine.
Patient has still been experiencing pain in arm near injection site since he got the shot over 2 months ago.
Patinent was under the age of 18 at time of vaccination. No adverse results were reported by patient.
BLOOD CLOT IN THIGH; This spontaneous report received from a consumer via social media through a company representative concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration not reported , batch number: Unknown and expiry date: Unknown) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced mysterious blood clot in his thigh. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in thigh. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211245900 and 20211245964.; Sender's Comments: V0: 20211245023- COVID-19 VACCINE AD26.COV2.S- blood clot in thigh. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
This spontaneous report was received from Physician Assistant via company representative referring to an adolescent female patient of unknown age (reported as "14 or 15"). The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date, the patient was vaccinated with GARDASIL, intramuscular (dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis.  On the other hand, it was also reported other suspect therapy, an unspecified birth control that was given to the patient at the same time she received the vaccine. On an unknown date, (reported as "within a few weeks"),  the patient experienced headaches, syncope, muscle weakness, incontinence, and was unable to control her bladder, so she was treated at a hospital. At the time of the report, the outcome of muscular weakness, headache, syncope and urinary incontinence was reported as not recovered. Muscular weakness, headache, syncope and urinary incontinence were determined as disabling by the reporter.
That night and next day:  Chills. Aches Overall weakness Soreness at injection site Redness at injection site  2 days later: Soreness and swollen at injection site. Pain to the touch, even while getting dressed.  Redness 4inch radius around it.
Case previously recorded as MA2009-4579. Case report received from a physician, via Novartis Medical Communication, on 17 NOV 2009. Patient (gender unknown) under 3 year-old was vaccinated with S-OIV FLUVIRIN (batch no. unknown) i.m., on 13 NOV 2009. No adverse event was reported. MedCom reference no.: NA09-008308.
This non serious case was received on 24 February 2009 from VAERS (reference number 331469) via a search of the agency database. A 58 year old female received an intramuscular injection of ADACEL (lot number not reported, FLUZONE (lot number U2744AA, and PNEUMOVAX (manufacturer Merck, lot number not reported) on 23 October 2008. On that day, the patient complained of a cough, chills, her throat closing up, eye drainage, blood shot eyes, and a possible fever. She took TYLENOL for her symptoms. A local site reaction was not reported. The patient was reported as recovered. List of Documents held By Sender: None.
This spontaneous report was received form a medical assistant and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 21-MAR-2017, the patient inadvertently was vaccinated with 2 doses of PEDVAXHIB lot number reported as M034189 with expiration date 23-MAY-2018 (dose, route and anatomical location were not reported) for prophylaxis. Additional information has been requested.
In my left knee, I know that I have arthritis but it has never bothered me until 3 days or two days after that vaccine; I could hardly walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 as dose 1, single (Lot number: HGL629) at the age of 78 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing); "Arthritis/In left knee" (ongoing). Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol abnormal. The following information was reported: GAIT DISTURBANCE (non-serious) with onset Sep2023, outcome "unknown", described as "I could hardly walk"; ARTHRITIS (non-serious) with onset Sep2023, outcome "unknown", described as "In my left knee, I know that I have arthritis but it has never bothered me until 3 days or two days after that vaccine". The events "in my left knee, I know that I have arthritis but it has never bothered me until 3 days or two days after that vaccine" and "I could hardly walk" required physician office visit. Therapeutic measures were taken as a result of arthritis, gait disturbance. Additional information: The consumer stated, "In my left knee, I know that I have arthritis, but it has never bothered me until 3 days or two days after that vaccine. I went to the orthopedic plus doctor and he said that they have been studies that shows the COVID 19 vaccine can erupt an arthritic response. I could hardly walk so, I am going on a trip on airplane this coming Saturday 07Oct2023 and I have to get a cortisone shot in that knee so, I can walk, now the problem is I am supposed to wait two weeks after that vaccine to get the Cortisone shot but I do not have enough time because not enough days so, I am going to hope give it to me tomorrow because I can hardly walk. Now I did the research on my own and doctor said, there have been studies that show that the vaccines erupted arthritic response". The consumer further stated, "I think it was little longer that I had the flu shot, Flu vaccination I think it was about a month". The patient was using over the counter Aleve as treatment.
Shooting pains (pain level 2 out of 10) along sides of abdomen from below ribs to upper pelvis occurred the evening after the 2nd injection. About 3 weeks after that I got "covid arm," at the injection site on my left arm and was itchy along my arm, abdomen and back. Was easily controlled with Benadryl and subsided about 24-36 hours after covid arm was noticed. The approximate diameter of the arm rash at the injection site was 3.5 inches. About a month after the Covid Arm subsided, I developed a rash along both sides of my abdomen, with more concentrated on the right side. The same rash also developed from above my coxic bone up my spine, feathering out a few inches in either direction and ending about mid-shoulder blade area. This rash started approximately March 15th and has not gone away since then. Sometimes it lessens to barely noticeable, and then it comes back bright red and itchy, always in the same exact spots, and then fades slowly and as it fades turns the color of a bruise.
0.25ml influenza vaccine was administered as the first dose of the 2017-2018 flu season. 0.5ml is the recommended dose for this vaccine. No adverse reaction was observed or reported. Parents have been notified to bring child to clinic for revaccination at no cost.
1/9/21 woke up with fever, body aches and fatigue. 1/10/21 developed right lower back pain radiating to right side and right lower quadrant without any known injury. Presented to ER on 1/11/21 and was found to have elevated liver enzymes. 1/12/21 woke up with right thigh numbness and was referred to spine specialist by PCP. Saw spine specialist on 1/14/21 and was referred to physical therapy and given medrol dose pack taper. Repeated liver enzymes after 1 week resulted with abnormal results and referred to GI doctor. 1/28/21 Developed worsening right thigh numbness with decreased strength to right leg and following up with spine specialist on 02/01/21.
Patient came for the 2nd dose on 06/07/2021 and reported she has had pain in the lower left arm and can't sleep her on her left side after 2-3 days from her 1 st dose. Her range of motion is not affected.
One day post vax, the pt experienced diarrhea, high fever, and abdominal cramps. ON 9/20/99, the pt was seen by a physician and received treatment for abdominal cramps, nausea, and vomiting. The pt did not improve and on 9/24/99 went to the ER. The pt reported to the ER MD that she had lost 10 lbs in 2 weeks. All of the pt's lab results were normal. The pt was dx with anacute viral syndrome. The pt was sent home on trimethobenzamide hydrochloride for the nausea and dicyclomine for the cramping. The pt recovered.
pt brought to ED via EMS with SOB; DNR/DNI; in respiratory distress, fever, Atrial Fibrillation, anemia, AKI; positive for COVID; COVID pneumonia; family decided to transition pt in ED to comfort measures; pt passed away in the ED at Medical Center.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 08-OCT-2014, a pharmacist administered the ZOSTAVAX (dose, route, and lot # not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. On or about 30-NOV-2016, the patient was treated by a physician assistant for shingles. 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 had and would continue 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 event was not recovered/not resolved. Causality assessments were related.
RIGHT ARM SWELLING AROUND INJECTION SITE; RIGHT ARM PAIN; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, and non smoker, and other pre-existing medical conditions included: Patient does not have any known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, treatment medications included: paracetamol. On 27-AUG-2021, the patient experienced right arm pain. On 28-AUG-2021, the patient experienced right arm swelling around injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm pain, and right arm swelling around injection site. This report was non-serious.
This spontaneous report was received from a 24 year old female patient refers to herself. In 2007 the patient was vaccinated with 2 doses of GARDASIL, intramuscular for prevention of HIV. The patient stated that she had never completed the series. No adverse effect was reported. Additional information has been requested.
They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. The vials were frozen, shipped in refrigerated temperature and then refroze for storage once arrive at facility. No treatment medication details was reported.
This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 21-NOV-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M014544 with expiry date: 27-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705.
After 3 days, my baby began to sleep for abnormal amounts of time, waking just to eat and low grade fever. Around the 7th day he had a high fever for his age. 101.9 and was unconsolable. We brought him to the ER where they questioned meningitis, he was poked over 4 times to get blood samples. Straight cathed for urine sample. All of which came back negative.
After receiving the Pfizer Covid-19 Vaccine patient during 15 minute observation started to say he wasn't feeling very well and was feeling dizzy. After stating this he started to lean in his chair and starting making sounds with  his throat..gargling sounds like he couldn't breathe and then began to lose consciousness. He was brought down to the floor from the chair and an Epi-pen was administered and shortly after he came through. Paramedics arrived afterwards and they took him to the local hospital.
Red area on left arm about 1 1/2 inches below injection site. Red area is 6.5 cm x 7 cm. Warm to the touch.
Mom reports "temperature of 100.6, responsive to Tylenol at 3AM, started crying 24 hours post shots (08/01) and cried for 14 hour straight. Took child to ER and sent home due to no significant findings, Baby cried again again the following day for 6 hours and mom visited ER with the same results. Mom reports "baby cried until Sunday, (08/04).
Soon after vaccination, patient started complaining of lightheadedness, dizziness and tongue tingling along with swelling.  On exam, patent airway, no stridor BP 118/86. Pulse 60, O2: 97%.. Patient was observed for a few more minutes, had not eaten that morning, gave orange juice.  She was able to drink without difficulty. Then, symptoms remain the same expect discomfort of the throat, more on the left side. Throat re-evaluated, remain non edematous. Given Benadryl 50 mg PO, tolerated well. Observed for 30 minutes. Symptoms remained the same. No progression to throat swelling, hives or SOB. Patient discharged home, stable with spouse. Called around 13:30 pm and symptoms had subsided.  No further intervention.
Redness, swelling, and itching of the injection site. Redness spread 2-3 inches from site, swelling was localized to injection site. Treated with 50mg of BENADRYL by mouth.
Cellulitis left upper arm area  Body aches, headaches, nausea, fever, fatigue
there was not an actual adverse reaction that occurred but am reporting that this dose was given from a vial stored beyond the recommended 31 days.
night sweats; fatigue; chills/fever; terrible headaches; chills; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced night sweats, fatigue chills, fever and terrible headaches. 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.
Painful injection site for 3 days. Can't sleep. Going to doctor today. Doctor told her that shot probably hit a tendon or ligament and gave her some pain pills to use at night.
Swelling, redness, warmth (R) upper arm "14 cm diam area erythema" w/ central vaccine mark per Dr.
1st Day - 15 Apr 2021: Scratchy throat, sneezing  2nd Day - 16 Apr 2021: Sore throat (difficult to swallow), post-nasal drainage, nausea, fatigue, body aches, hard to get out of bed. 3rd Day - 17 Apr 2021: Same as day 2 plus chills, periods of sweating, stayed in bed most of day. 4th Day - 18 Apr 2021: Fatigue, nausea, slight cough, body aches.