chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received vaccine for shingles on 11/19/12. Developed a small rash on face on 12/16/12. Dermatologist Dx w/ shingles.
The patient is a healthy 32 yo female with a history of continued left shoulder pain s/p IIV. She received Afluria (SEQ P100136349) on 12 NOV 2019. She recalls her arm being unusually sore. She states placement was OK, and still has a bluish discoloration at the site. She was sitting and the vaccinator was standing. She states she had a PT test 2 or three days after receipt. She had practiced pushups the day before and then performed her test. She states the day after her test she awoke with severe shoulder pain, 9/10, burning, sharp, worse motion (which was severely limited) radiating to her fingertips, with numbness, but no paresis . She had difficulty dressing, reaching. She denies any previous or new specific injury. She did self care with ROM, home PT and NSAIDS. She saw PCP day 14 and requested acupuncture and again on 30 JAN with minimal improvement. COVID disrupted followup. She was in school and is now. She currently has 85-90% of function, most of her ROM. She did not pursue a profile and her subsequent PT tests have been delayed, but thinks she could pass.  PCP note 26 NOV states w/ onset following immunizations though increased shoulder muscle use in prep for and doing PRT more likely the precipitating cause. Has mixed picture of findings. Several findings suggest rotator cuff impingement,  also w/ + scarf but no AC joint tenderness. Accupuncture  note 27 NOV 20  Exam shows tenderness on the distal biceps tendon and worsening pain with resisted biceps action, suggesting a distal biceps tendinopathy.  Follow up late January stated  Minimally improved over the last few months. Suspect pain is isolated to the anterior deltoid based on physical exam.
The patient explained the he received "one of his Gardasil 9 vaccine doses without it being agitated properly beforehand"; This spontaneous report was received from a male patient of unknown age, referring to himself. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant medications were not provided.      On an unknown date, the patient was vaccinated with one of his vaccine dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number, and expiration date were not reported) without it being agitated properly beforehand (product preparation issue).
Pt. complains of pain, unable to lift arm, redness swelling warm to the touch.  Started later that day and last 3 days.  No treatment given.
chills, fever, sweats, body aches, headache, injection site soreness - lasted about 24 hours
Medical assistant calling to check and see if there is any information on extend expiration for VARIVAX that was expired and was administered today.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patients' pertinent medical history, current condition, previous drug reactions or allergies, and concomitant medications were not reported.   On 22-SEP-2020, the patient received an expire dose of varicella virus vaccine live (oka/merck) (VARIVAX), administered at a dose of 0.5 milliliters (ml) (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number R026548, which has been verified to be valid, expiration date reported and validated as 17-SEP-2020) as prophylaxis. It was reported that no temperature excursion occurred.
Starting about 12 hours after my vaccine, I started to feel fatigue and body aches.  An hour after that I experienced intense chills and a sense of dread. I put a heater on myself with two layers of thick blankets, but it didn't help. My fingers and parts of my face started to tingle and go numb and I couldn't fall asleep in spite of me doing breathing exercises and lying down. Eventually the chills turned into a fever and my body temperature suddenly shot up. I didn't have a thermometer, but it was certainly over 100 degrees Fahrenheit. Despite my relief from the chills, I still couldn't sleep.  I wasn't remarkably stressed/anxious, I just couldn't get to sleep. I'm not typically an insomniac, and upon speaking to others who received the same vaccine, they've also reported intense chills and an inability to fall asleep.
Started losing hair on his legs and a short time later he began losing the hair on his head / He now is bald; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Jul2023 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "Started losing hair on his legs and a short time later he began losing the hair on his head / He now is bald".  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Mycocarditis.  The patient was hospitalized for severe chest pain on the evening of May 26.  His chest pain resolved in 12 hours without specific treatment and he was discharged on May 27th.  Follow up (by phone) 1 week later (June 3), he reports doing well with no residual symptoms.  He is back at work.
Almost immediately (remember noticing the next day after my vaccine shot), a very hard big lump started forming about an inch lower than where the injection needle went in (it was definitely about an inch down from where my band-aid was).  The lump got bigger and harder over the last week and seemed to spread out into like a sideways egg shape.  My skin there almost looked like a light purple bruise in the shape of a sideways egg.  It has gone down now in the last couple of days, but there is still a hard nugget of lump there.  It has me concerned like it could be a blood clot or something.
patient was given pediatric Pfizer dose of 10mcg. Patient requires 30mcg dose of Pfizer
booster; Positive Covid diagnosis; Positive Covid diagnosis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from regulatory authority. The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 03Nov2021 (Lot number: EW0217) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: CLARITIN-D; FEBUXOSTAT; ALBUTEROL HFA. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 15Feb2021, when the patient was 38 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 25Jan2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jan2022, outcome "recovering" and all described as "Positive Covid diagnosis"; IMMUNISATION (medically significant) with onset 11Jan2022, outcome "recovering", described as "booster". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, immunisation.  Clinical course: No any other vaccine in four weeks. Patient had no Covid prior vaccination. Covid tested positive post vaccination. Patient had no known allergies.
This spontaneous retrospective pregnancy report was received from the nurse practitioner via a company representative and refers to a female patient of unknown age. There was no information regarding the patient's concomitant medications, drug reactions and allergies provided. On an unknown date (reported as "when she was young"), the patient was vaccinated with a dose of GARDASIL for prophylaxis (route of administration, lot number and expiration date were not provided). On an unknown date after administration, the patient believed she experienced Guillain-Barre syndrome. It was reported that the patient was a mother at the reporting time, however the representative was not able to clarify if the patient became pregnant after receiving GARDASIL or if she was ever pregnant. The outcome of the Guillain-Barre syndrome was unknown. The relatedness between the event and GARDASIL was not provided. Upon internal review, the event of Guillain-Barre syndrome was considered to be medically significant.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The reporter said there was only an 85 percent chance that a person would not get shingles again after having both shots. The patient had them twice after getting both shots. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
received a dose of Hep B vaccine in 2015 and never had administered a second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 81-year-old female patient who received Hepatitis B vaccine for prophylaxis.   Previously administered products included Hepatitis B vaccine (received 1st dose on 30th December 2015).   On an unknown date, the patient did not receive the 2nd dose of Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced incomplete course of vaccination (Verbatim: received a dose of Hep B vaccine in 2015 and never had administered a second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 17-JUL-2023 The reporter reported that a patient received a dose of Hepatitis B vaccine in 2015 and never had administered a second dose. The reporter mentioned was not sure if vaccine given in first dose was Engerix-B no lot number available. The reporter consented to follow up via email. Till the time of reporting, the patient did not receive the 2nd dose of Hepatitis B vaccine, which led to incomplete course of vaccination.
Mild fever (100.1) and crankyness began. I controled with minimal tylenol. In the morning she had a seizure.
Patient reported flu-like symptoms that began the night following vaccination. These included: fatigue, headache, body aches and fever.  On 10/2/23, patient developed a rash near the injection site. Initially started with a red spot at the injection site which then spread to the lower arm. Area is painful to touch, swelling present, mild itching.
This case was reported by a other health professional via sales rep and described the occurrence of hives in a patient who received MENVEO. On an unknown date, the patient received MENVEO at an unknown dose. On an unknown date, 1 day after receiving MENVEO, the patient experienced hives. On an unknown date, the outcome of the hives was unknown. It was unknown if the reporter considered the hives to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. 24 hours after receiving MENVEO the patient experienced hives on arms and face. The GSK sales representative called to report adverse event reported by a health care professional . The reporter had no product or patient information and requested to be contacted by e-mail.
Patient had dizziness, head felt heavy but no pain. Feeling better, patient stable, released from vaccination site.
Lightheaded,vertigo, severe shaking, cold extremeties, Increased respirations from 16 to 34 within minutes of having the vaccine. Nausea, Increased blood pressure and pulse rate. EKG was normal sinus rhythm. Tounge felt heavy and thick.
Case number PHEH2014US001217 is an initial spontaneous report received from a health care professional on 13 JAN 2014. This case refers to a 14-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX (batch number: 004031A) intramuscularly on 11 JAN 2014. No adverse event was reported following this administration error.  Following an internal review on 18 AUG 2014, a significant correction wad done for the information received on 13 JAN 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Tinnitus and diminished hearing onset 12/27/2020.  Symptoms less evident, but still persisting as of the date of report.
Evidence of cellulitis of the arm requiring antibiotics. 7 x 4 inches of erythema, warmth and tenderness.
Individual received Pfizer dose one, immediately experienced localized reaction of erythema and edema at injection site, followed quickly by generalized flushing, dizziness and hot flashes,   denied breathing issues, give 50mg IM diphenhydramine.  vital signs stable.  symptoms began improving about 5 minutes after diphenhydramine injection.  Pt monitored in clinic, then discharged home when recovered.
allergic reaction; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient received Shingrix vaccine and asked that could someone get an allergic reaction the day after or two days or usually happened right away any, after the shingles vaccine. The patient could call to talk about this from company. The call center representative did not get a chance to ask if the question was hypothetical or real
Few red spots on face, back, abdomen and diaper area (papules). No fever or itching.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In 2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided), as prescribed and/or administered by a pharmacist for the long-term prevention of shingles and/or zoster-related conditions. Subsequently, the patient was treated by healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient suffered and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the shingles was unknown. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
PATIENT FAINTED SHORTLY AFTER DOSE ADMINISTERED. PATIENTS FATHER WAS PRESENT WHO WAS ALSO A FIRST RESPONDER. PATIENT WOKE SHORTLY AFTER EPISODE, WAS ALLOWED TO REST FOR A FEW MINUTES BEFORE GETTING UP. BROUGHT PATIENT TO A CHAIR WITH WATER AND JUICE AND LET HER SIT UNTIL SHE FELT BETTER. SHE WAS ALERT AND IN GOOD SPIRITS RIGHT AFTER, AND WENT HOME WITH FATHER. CALLED PATIENT'S FATHER LATER ON TO CHECK ON STATUS AND WAS NOTIFIED SHE WAS DOING JUST FINE. SHE WAS NERVOUS COMING IN TO GET THE SHOT TO BEGIN WITH WHICH PROBABLY CAUSED THE EPISODE
Baseball size knot on arm; Swollen lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the left arm on 25Jun2021 at 10:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included COVID-19. The patient had a known allergy to peppers. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included XYZAL, Multivitamin, and Melatonin, all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0187), via an unspecified route of administration in the right arm on 04Jun2021 at 14:45 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 27Jun2021 at 04:15, the patient experienced baseball size knot on arm and swollen lymph nodes. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event baseball size knot on arm and swollen lymph nodes was not resolved at the time of this report.
ER HPI: 78 y.o. female who presents with respiratory distress.  Patient is transported to the emergency room via emergency medical services from local long-term care facility.  Patient is unable to give any history due to acuity and severity of current condition.  On arrival to the emergency room patient is in obvious distress she is hypertensive with a blood pressure of 74/51 she is tachycardic with a rate of about 140 she is tachypneic with a rate of the 29th at 30 her oxygen saturation on a non-rebreather are 82% and her temperature is 102.9°. FINAL IMPRESSION     ICD-10-CM ICD-9-CM 1. Septic shock (HCC)  A41.9 038.9   R65.21 785.52     995.92 2. Aspiration pneumonia of right lower lobe due to gastric secretions (HCC)  J69.0 507.0 3. Acute hypoxemic respiratory failure (HCC)  J96.01 518.81
Hospitalized for acute new DVT, hypertensive urgency. Patient states had COVID before admission. Treated with vitamin D, vancomycin IV, doxycycline PO, cefepime IV. DVT treated with Eliquis.
Had mild myalgias for 3 days then started with SOB, fatigue, sweating and lightheadedness w/ activity which is still occurring as of today 5/11/21.  No hypoxia, normal EKG. Recent cholecystectomy 4/29/21.
Moderna COVID-19 Vaccine Joint pain, muscle pain, headache, fever, chills
Pt experienced pain at right side, left chest and shoulder pain. Generalized fatigue and malaise.
The Moderna vaccine taken out of the freezer and placed in the refrigerator on 9/8/2021. The vaccine administered beyond the 30 days of which the vaccine is recommended to be kept in the refrigerator. No adverse reaction occurred during the 15 minute waiting period or reported after the clinic date.
Patient received expired dose of Fluarix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 3-year-old patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number HS75G, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th September 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 20th September 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: Medical assistant reported that a patient received an expired dose of Fluarix, which led to expired vaccine used. The reporter did not consented to follow-up. This case was 1 of 8 linked cases reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021232194:Same reporter US-GLAXOSMITHKLINE-US2021232193:Same reporter US-GLAXOSMITHKLINE-US2021232200:Same reporter US-GLAXOSMITHKLINE-US2021232197:Same reporter US-GLAXOSMITHKLINE-US2021232198:Same reporter US-GLAXOSMITHKLINE-US2021232202:Same reporter US-GLAXOSMITHKLINE-US2021232206:Same reporter
Mom reports fever 104.5F, extreme lethargy, increased irritability and fussiness, at appointment time fever 102F via tympanic thermometer. Tired but cooperative. Dx likely DTaP reaction vs early flu sx. No evidence of encephalitis.
Sinus infection; Ear infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection) and EAR INFECTION (Ear infection) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced SINUSITIS (Sinus infection) and EAR INFECTION (Ear infection). At the time of the report, SINUSITIS (Sinus infection) and EAR INFECTION (Ear infection) had resolved.            It was unknown if patient was enrolled in a covid-19 vaccine trial. Concomitant medications were not reported.  No treatment information was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Patient stated that she woke up a knot on her arm near the injection site. Arm is harm to move if she moves her neck to the right she gets a sharp pain.