chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (on an unknown date) and SHINGRIX (1st dose received on 6th November 2018). Concurrent medical conditions included shingles. On 1st April 2019, the patient received SHINGRIX (intramuscular). On 1st April 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm, headache, tiredness, generalized aching, chills and flushing. In April 2019, the outcome of the pain in arm and headache were recovered/resolved. On an unknown date, the outcome of the tiredness, generalized aching, chills and flushing were unknown. It was unknown if the reporter considered the pain in arm, headache, tiredness, generalized aching, chills and flushing to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient for herself. The patient experienced sore arm, headache, tiredness, felt achy all over, chills, developed red flushing on front and back of her torso and her face. The reporter provided the consent to follow up.
C/o Headache and dizziness, still c/o headache and dizziness when called HD on Monday 4/19/2010.
I received covid vacine in left arm, now 2-3 times a day my left hand/wrist is momentarily hard to move (like making a fist) and is painful for 10-15  seconds and then goes back to normal.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 15Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not receive any other medication in 2 weeks. The patient was treated with paxlovid from 12Jun2022 for the events. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I'm a neurologic ICU physician and I'm taking care of patient in my ICU.  He's got a severe case of Guillain-Barre, so I'm filling this out for him. Patient got a piece of metal in his leg while working on a motorcycle on 2/12. He went to an urgent care clinic the following day and got a TDaP (I can't find if it was ADACEL or BOOSTRIX, sorry!). A few weeks later, he started developing back and lower extremity pain and went to an ED twice on 3/2. He got an urgent referral to a neurosurgery outpatient clinic on 3/4 due to back pain, and the neurosurgeon quickly realized he had GBS. He was referred to medical center and was hospitalized on 3/4. IVIg was started and the patient finished the standard dosing on 3/9. Unfortunately, he continued to progress and required intubation. He was trialed for extubation on 3/16 and 3/27, but ultimately failed and received a tracheostomy 3/28. We've started plasma exchange on 3/23 and he's set to get his 5th session today. His GBS was consistent with his lumbar puncture and an EMG/NCS study. He remains in the ICU and has just now regained barely antigravity strength in his left arm.
This nurse was informed patient was experiencing dizziness approx. 5 minutes after vaccination around 11:25am. The patient's vitals were taken and were stable, though systolic BP was slightly elevated and pt with hx of HTN. Patient was given water and after a few more minutes states she felt better. Pt observed for 30 minutes.
suspected Vaccination failure; had it twice, but was lessened by the shot; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving 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.  Additional details were provided as follows: The reporter was patient's wife. The age at vaccination was not reported. The reporter stated that the patient had shingles twice, but was lessened by the shingles shot. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Patient received expired dose of the J&J Covid Vaccine. Vial expired on 5/6/21 at 4:46pm. Pharmacy Technician went to the ED to refill the vaccine and noticed the vial did not have an expiration date on it, just a time. This was sent up to pharmacy management. A report was run and the vial was opened on 5/6/21 at 10:46am. Therefore it expired on 5/6/21 at 4:46pm. The other vial in the ED fridge was closed. Therefore, the dose must have come from the expired vial. The dose was given on 5/7 at 0327am. ED Director and ED Manager notified. Per CDC instructions, Janssen contacted for direction on whether to revaccinate. No information available. leadership offered antibody testing to patient in a few weeks, with further direction based on results.
Bodyaches, fever, fatique, ChillS, Nausea Headache, muscle pain, lymph node Swelling, Hives, dizziness.
normal arm pain; This case was reported by a consumer and described the occurrence of pain in arm in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th February 2022, the patient received Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022035993, US2022AMR045957   Additional information was provided as follows: The patient experienced normal arm pain for 2 days after receiving Shingrix vaccine. No other information was provided. This case linked with US2022AMR045957, US2022035993, reported for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022035993:Same patient US-GLAXOSMITHKLINE-US2022AMR045957:Same patient
This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not reported. On 10-DEC-2018, the patient was inadvertently vaccinated with an expired dose of VAQTA 25/0.5 (unit unspecified) (lot # N020689 and expiry date: 22-OCT-2018) via intramuscular route for prophylaxis. No adverse effect was reported. There was no product quality complaint (PQC) reported. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1812USA011184.
This spontaneous report was received from a healthcare professional referring to a patient of unknown age and gender who on an unknown date, was vaccinated with a dose of PNEUMOVAX23, (lot #, series and route of administration not reported). On an unknown date, the patient experienced hypersensitivity to PNEUMOVAX23. The outcome of hypersensitivity was unknown. The patient then after, on an unknown date was vaccinated with a dose of PREVNAR 13. The healthcare professional inquired if the patient could receive PREVNAR13 even if the patient has the hypersensitivity history with PNEUMOVAX23. Additional information has been requested.
Vaccine greater than 12 hours in refrigerator; Expired vaccine administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (Vaccine greater than 12 hours in refrigerator) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine greater than 12 hours in refrigerator). On 24-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Vaccine greater than 12 hours in refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   1 punctured vial of Moderna COVID-19 vaccine, which was first opened on 23-AUG-2021 around 8-10AM, in the refrigerator for more than 12 hours. On 24-AUG-2021, They Injected the expired Moderna COVID-19 vaccine to 7 patients between 8AM -11:30AM.  No concomitant medication was provided.  No treatment medications was provided.
Employee was given her second dose of her HEP B vaccine.  She shows redness, swelling, and sensitivity at the injection sites.  No current fevers or illnesses.
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 concurrent conditions, medical history, or concomitant medications. In 2012, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). In 2014, the patient was treated by a physician at a hospital for shingles (not specified whether admitted; considered Emergency Room visit until follow-up is received). The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of 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 including 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 was not recovered.  Causality assessment was related. Additional information has been requested.
Left medial and high swelling with slight erythema to twice the size of opposite leg. Pt presented to clinic 2 days after. Administration of vaccinations. No fever. Pt refusing to walk.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that, on an unspecified date, and unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information from the registered nurse who provided patients details. This report refers to a 6 month old infant patient. On 12-JUN-2014, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because follow has been obtained.
Hospitalized on 8/4/2021 with sepsis, multisystem organ dysfunction, cardiac arrest, found COVID-19 Antigen +  In CCU on ventilator.   Appears Sepsis is the primary factor
what would happen if a patient mistakenly received only the liquid component of the Shingrix vaccine; what would happen if a patient mistakenly received only the liquid component of the Shingrix vaccine; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The case was reported by the consumer for herself or himself. The age at vaccination was not reported. The reporter stated that, he or she was wondering what would happen if a patient mistakenly received only the liquid component of the Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Redness in area of injection around 4 inches in diameter. Just uncomfortably to the touch
Nausea  Fatigue Fever Stomach  Pain Soreness at Injection Site Diarrhea
Outbreak of Pityriasis Rosea / still spreading today. Spread over torso, thighs, back, arms, legs, neck; BOOSTER; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 (Lot number: FH8028) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: EW0169, prev dose lot unknown: False, prev dose administration date: 16Apr2021, prev dose number: 2, prev dose vaccine location: Left arm), administration date: 16Apr2021, when the patient was 46 years old, for Covid-19 immunization, reaction(s): "Pityriasis Rosea"; Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: ER8732, prev dose lot unknown: False, prev dose administration date: 26Mar2021, prev dose number: 1, prev dose vaccine location: Left arm), administration date: 26Mar2021, when the patient was 46 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 11Nov2021, outcome "unknown", described as "BOOSTER"; PITYRIASIS ROSEA (non-serious), outcome "unknown", described as "Outbreak of Pityriasis Rosea / still spreading today. Spread over torso, thighs, back, arms, legs, neck".  Additional information: The reporter was reported administered in facility type vaccine: Doctor's office/urgent care visited. The patient was in facility country: private.  The patient did not had  other vaccine in four weeks and  received other medications in two weeks. The adverse event was described in   Outbreak of Pityriasis Rosea after 2nd shot, waned slightly before 3rd shot, still spreading today. Spread over torso, thighs, back, arms, legs, neck. The details for Dose 2 in Linked case 202200143794 adverse event start date 23Apr2021. The AE resulted was  Doctor or other healthcare professional office/clinic visit and no treatment and patient Not recovered. The patient did not covid prior vaccination and no tested post vaccination and no known allergies. There was no other medical history for significant.  Follow-up (02Feb2022): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Pt A&O x4. Communicates verbally. At 11:45AM pt stated she felt "tinging at the back of tongue and pressure on head" right after she received pfizer booster vaccine. Denies SOB. Denies pain. No emotional distress noted. VS taken at 11:48AM. BP 122/84, HR 72, RR 18, SpO2 98% RA. Crackers and water given. Pt recovered w/o difficulties. ER precautions given. Pt acknowledge understanding. Observed pt for another 15 min. Pt left at 11:53AM without assistance.
Participant was dizzy and unable to move after receiving vaccine/ no epi administered/ rested and put ice pack on back of neck.
suspected vaccination failure/had both shots , still had shingles; shingles; 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 1st dose of Shingles vaccine and the 2nd 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 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 Shingles vaccine and Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. The patient received both the doses of Shingles vaccine and still experienced shingles. The patient stated that shingles would hang on for months. Follow-up would not be possible as no contact details available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Local reaction, red, swollen and hot.  Vaccine given on 07/01/2003: Talked with patients father on 07/08/2003 @ 16:30-he stated patients leg was much better.
I was having a stuffy nose and was blowing my nose and it had a lot of mucus in it. I do have allergies, so this mucus was different than my allergies. I ended up taking a COVID-19 Home Test and it was positive. I called my doctor, and we did not have me take anything during this and I really only had those bad cold symptoms with a bad headache.
About 6 days my other RPH said patient needs to talk to me. 2 days later I saw the patient's arm and it had a slight inflammation in a 4 in circle. Later (1 week) he talked about muscle weakness.
Patient reported injection site soreness for 2 days and red, swelling, rash for 7 days from shoulder to the elbow on the injection arm. patient contacted doctor and was instructed to use cortisone carem to relief the symptoms. All the symptoms are gone and recovered reported by patient on 05/13/2023.
Patient came in pharmacy Oct 28, 2018 asking fro topical preparation for infected boil on left upper arm. Advised patient to go to urgent care. Patient prescribed cephalexin for treatment-patient states boil resulted from vaccine.
Weakening/paralysis of one side of the face, onset the morning of 4.27.2021.
Pt developed a red & tender site reaction initially. About 1 month later he developed pain, redness, swelling in axilla, bicep area some lymphadenopathy.
Hard time lifting up arm; Soreness on arm above injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Hard time lifting up arm) and VACCINATION SITE PAIN (Soreness on arm above injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025620A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 26-Jan-2021 at 5:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Hard time lifting up arm) and VACCINATION SITE PAIN (Soreness on arm above injection site). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Hard time lifting up arm) and VACCINATION SITE PAIN (Soreness on arm above injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported included blood pressure medication NOS. Treatment included acetaminophen.
No additional AE reported; a patient received her first dose of GARDASIL 9 in 2019 when she was 23 years old, received her second dose in 2020 and came in today (23MAR2022) to complete the series; This spontaneous report was received from an office manager and refers to a 26-year-old female patient. The patient's concurrent conditions, concomitant medications, medical history and drug allergies were not reported.  On an unknown date in 2019, the patient was was vaccinated with first dose of HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis. On an unknown date in 2020, she received her second dose of the same vaccine, and on 23-MAR-2022, she was vaccinated with third dose (inappropriate schedule of product administration). For all vaccines dose, formulation, route of administration and injection site were not reported. No adverse events were reported.
Persistent  sore throat since roughly 4 days post vaccine through today, menstrual cycle initiated a week earlier than normal schedule
hives on her left arm from the top of her shoulder to the crease of her elbow; itching; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on her left arm from the top of her shoulder to the crease of her elbow) and PRURITUS (itching) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced URTICARIA (hives on her left arm from the top of her shoulder to the crease of her elbow) and PRURITUS (itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itch, at a dose of 1 dosage form. On 30-Mar-2021, URTICARIA (hives on her left arm from the top of her shoulder to the crease of her elbow) and PRURITUS (itching) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable. No concomitant treatment was provided. She is scheduled for a Humira injection on 31Mar2021.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Followup received;