chrisvoncsefalvay/vaers-outcomes huggingface dataset:
it hurt after first dose; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated, the patient reported that it hurt after she received her first dose of Shingrix. No further details were available from pharmacist regarding patient or product. The reporter consented to follow up. This case has been linked to US2021239194, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021239194:Same reporter
Pain; Burning; Exhaustion, tired; can't rest; lost all of Christmas this year; Have shingles, had the vaccination / Suspected vaccination failure; Still have shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In November 2022, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain, burning sensation, exhaustion, restlessness and activities of daily living impaired. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain, burning sensation, exhaustion, restlessness and activities of daily living impaired were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, burning sensation, exhaustion, restlessness and activities of daily living impaired to be related to Shingles vaccine.     Additional Information: GSK receipt date: 9 JAN 2023 Reporters comment: This case was reported by a patient via interactive digital media. The patient reported that had shingles which started 2 months ago from reporting. The patient had the vaccination, but it hit like a ton of bricks. The patient never experienced pain like this and the burning and the exhaustion. The patient could not rest and was tired. The patient lost all of Christmas this year and it was not over yet. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Patient fainted after Vaccs administration today, patient walked to nurse station and suddenly fell forward. Stiffness and convulsion were noted for about 7 seconds, patient was turned face up and ice pack was placed behind her head. Patient was responsive with the minute, we got her up and take her back to her room via WC. Dr was notified, and FNP also noted the situation. VSS 105/67, HR 83 O2Sat 100 percent. Parent stated that patient was fasting, peanut butter crackers and water were given after checking Blood sugar, BS: 88. Patient waited for 15 minutes and was released, no other symptoms noted. Patient was escorted to parent's vehicle per nursing staff. Patient will follow up with MD on Monday.
Arm unbelievably painful; Aches and pains; Very weak, no strength, No energy to do anything; Cannot eat or drink.; Head and ears ringing.; Cannot sleep; Splitting headache; A spontaneous report was received from a consumer who was also a 77-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who was very weak, no strength; no energy to do anything(asthenia), head and ears ringing( tinnitus), splitting headache( headache), cannot sleep(insomnia), cannot eat or drink(decreased appetite), arm unbelievably painful (vaccination site pain), and aches and pains (myalgia).  The patient's medical history was not provided. Relevant current conditions included asthma, chronic obstructive pulmonary disease, heart problems, and osteoarthritis. No relevant concomitant medications were reported.  On 5 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On 05 Mar 2021, patient had very weak, no strength, no energy to do anything, splitting headache, cannot eat or drink. The patient also had head and ears ringing, and cannot sleep. On an unknown date, the patient had arm unbelievably painful and aches and pains.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
12/11/12 pt seen by family practice MD for 15 cm x 15 cm area redness, warmth, swelling & tenderness at inj site Dx cellulitis KEFLEX 500mg QID x 10 days. 12/13/12 "getting better"
Severe headache; Nausea; Axillary Adenopathy; Fever; Malaise; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: HEADACHE (non-serious), outcome "unknown", described as "Severe headache"; NAUSEA (non-serious), outcome "unknown"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Axillary Adenopathy"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; MALAISE (non-serious), outcome "unknown".  Additional Information: It was reported that within 14 hours after administration of Pfizer COVID-19 vaccine, bivalent (and all previous Pfizer COVID-19-19 vaccines [Comirnaty]). Multiple, serial vaccine associated A.Es. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Approximately 3 minutes after receiving her first COVID-19 vaccination in her left deltoid developed a flat, non-priuritic, erythemic rash along both anterior arms. She denied any airway involvement; on examination her mouth was without edema or erythema. She was breathing comfortably and in no acute distress. She was provided with 50 mg of diphenhydramine at 11:28. She was rechecked 15 minutes and 30 minutes later, during which time her rash faded but did not resolve.  She was advised that the CDC's recommendations when an immediate reaction occurs is to not get her second dose, but that she can consider seeing an immunologist/allergist to discuss this more in depth. We discussed that should symptoms worsen, particularly if she develops airway symptoms, she should present to the ER for evaluation. She left the clinic at 12:04 pm accompanied by family in no apparent distress with no further concerns.
Erythema left arm with increased warmth after vaccination. Patient was sent to the emergency department and then discharged. Diagnosis was allergy  and she was prescribed ACETAMINOPHEN 325MG TAB  \ Sig: TAKE ONE TABLET BY MOUTH EVERY 8 HOURS AS NEEDED FOR PAIN/FEVER  DIPHENHYDRAMINE HCL 25MG CAP  \ Sig: TAKE ONE CAPSULE BY MOUTH EVERY 8 HOURS FOR ALLERGIES OR SLEEP  EPINEPHRINE (EQV-EPI-PEN) 0.3MG/0.3ML  \ Sig: INJECT 1 PEN (0.3MG) INTRAMUSCULARLY ONCE FOR ALLERGIC REACTION
EUA COVID VACCINE PFIZER WAS ADMINISTERED AFTER PATIENT KNOWINGLY PROVIDED FALSE INFOMRATION STATING THIS WAS HIS FIRST VACCINATION. PT WAS PREVIOUSLY VACCINATED WITH BOTH DOSES OF MODERNA. NO KNOWN ADVERSE REACTIONS HAVE BEEN REPORTED SINCE ADMINISTERING THE PFIZER VACCINE.
Post vaccination the pt developed swelling and redness from the elbow to shoulder. The pt sought unspecified medical attention.
Painful joints in limbs & digits (upper & lower); skin hurt; chills and shaking; frequent urination (six times over night); temperature of 100.6 degrees upon waking at 6 AM
This spontaneous report as received from a pharmacist refers to a 62 year old female patient with hypertension, depression, drug hypersensitivity and prophylaxis. On 17-AUG-2017 the patient was vaccinated with ZOSTAVAX lot # N009777, subcutaneous for prophylaxis. Other suspect therapies included sterile diluent (manufacturer unknown). Concomitant therapies included sertraline hydrochloride and hydrochlorothiazide. On 17-AUG-2017, the patient experienced headache. The outcome of headache was reported as not recovered/not resolved.
administered 12 expired vials to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 12 expired vials to patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     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 21-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 12 expired vials to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 12 expired vials to patients) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No Treatment was reported.
Fever, shaking, chills, pain and itching at site area 4" x 3" around site.
Presents with progressively worsening cough, HA, body aches, congestion, subjective fevers, N/V/D that started two days ago,recent COVID-positive contacts at home. Placed on steroid therapy with dexamethasone,received Covid-19 convalescent plasma and Remdesivir.Completed COVID vaccine 4/29/2021-Over several days the patient's respiratory status improved, and by the final hospital day the patient was stable and feeling well
This initial spontaneous report was received from a pharmacist referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concurrent conditions or drug allergies/drug reactions described. The reporter stated that on multiple unspecified dates, the patients were administered improperly stored doses of ZOSTAVAX injection (lot# L016283 with expiration date 16-AUG-2016 and lot# reported as L029482 with expiration date 06-NOV-2016; dose, route and frequency were not provided). No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. Additional information has been requested.
20 minutes after injection had itching and flushing all over body. No respiratory problems. Improved after Benadryl given to only intermittent itching. Never any facial/throat/tongue swelling or dyspnea.
This spontaneous report as received from a pharmacist refers to patients. On unspecified date, patients was vaccinated with ZOSTAVAX (strength, dose, frequency, route, lot # and indication were not provided). The pharmacist also reported that the pharmacy administers ZOSTAVAX to patients under the age of 50 years old if the patients have a prescription. Information on how many patients received ZOSTAVAX that were under the age of 50 years old is unknown. This is one of several reports received from the same source. Additional information has been requested.
Patient experienced little rash on her stomach from COVID-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Patient experienced little rash on her stomach from COVID-19 vaccine.) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease and Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis and Crohn's disease. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In 2021, the patient experienced RASH (Patient experienced little rash on her stomach from COVID-19 vaccine.). The patient was treated with FOLIC ACID at an unspecified dose and frequency and BIOTIN at an unspecified dose and frequency. At the time of the report, RASH (Patient experienced little rash on her stomach from COVID-19 vaccine.) had not resolved.            Patient reported a little rash on her stomach after taking COVID-19 Moderna vaccine. It has never gone away, fades sometimes and gets dark again.   This case was linked to MOD-2022-658237 (Patient Link).
Pain in the upper left thigh; Weird restless sensation; Tiredness; Had the sensation that the neck could not support the head. As if head was about to fall off the neck. No pain, just the weird sensation.; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 08:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol, high triglycerides, high testosterone, high insulin (not diabetic) and overweight; all from unknown date. The patient had no known allergies reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 22Apr2021, a couple of weeks after vaccination, the patient had tiredness and sensation that her neck could not support her head. The patient felt as if her head was about to fall off her neck. The patient had no pain and just had a weird sensation, which lasted about 2 weeks. On an unknown date in May2021, the patient had pain in her upper left thigh after four weeks or so. The pain ranged from her outer kneed up to mid buttocks and it lasted about 1 week. The pain and weird restless sensation would come and go throughout the day. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. 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 events tiredness and sensation that her neck could not support her head, as if her head was about to fall off her neck and pain in her upper left thigh were resolved on an unknown date in May2021. The clinical outcome of the event weird restless sensation was not resolved, at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Stomach issues / Stomach pain; Lots of blotting; Constipation; Sick; This case was reported by a consumer and described the occurrence of sickness in a 69-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th October 2019, the patient received Shingrix. On 30th October 2019, 1 days after receiving Shingrix, the patient experienced sickness. On an unknown date, the patient experienced stomach pain, abdominal bloating and constipation. On an unknown date, the outcome of the sickness was unknown and the outcome of the stomach pain, abdominal bloating and constipation were not recovered/not resolved.   It was unknown if the reporter considered the sickness, stomach pain, abdominal bloating and constipation to be related to Shingrix.  Additional case details were reported as follows: The patient had Shingrix shot 9 days ago from day of reporting and was sick the day after. Less than 2 weeks after vaccination, the patient had stomach issues that never had before. The patient asked could it still be from this vaccine. The patient had lots of blotting and constipation. The patient asked about the gastrointestinal does it last this long 9 days after the vaccine. The reporter requesting consent to follow up.
Patient was vaccinated in the morning. Came in the afternoon with her left arm swell but without pain. She complain of itching on her left arm. Was advised to use BENADRYL for the itching and cold compress for the swelling.
Monovalent vaccine given as a booster dose (not indicated). Communicated to patient that no harm will result, and patient may receive bivalent booster in 2 months. Patient was understanding.
Patient's reaction(s) noted during COVID vaccine observation period:  complains of itching on both forearms and small hives noted.  Actions Taken: Vital signs taken, BP 133/91, pulse 80 and RR 18.   Observation time extended, pt declined ED visit .
No adverse event; administered with 1st dose of Moderna COVID-19 Vaccine beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with 1st dose of Moderna COVID-19 Vaccine beyond use date) and NO ADVERSE EVENT (No adverse event) in a 6-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     The patient's past medical history included Gastroesophageal reflux (treatment Lansoprazole). Previously administered products included for Drug use for unknown indication: influenza tetravalent, Vaxelis and oral rotavirus (oral). Past adverse reactions to the above products included No adverse event with Vaxelis, influenza tetravalent and oral rotavirus.    On 03-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 03-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with 1st dose of Moderna COVID-19 Vaccine beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with 1st dose of Moderna COVID-19 Vaccine beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered with 1st dose of Moderna COVID-19 Vaccine beyond use date).    No concomitant medications were reported.  It was reported Caller mentioned patient number 1 did not experienced any AEs after getting the vaccine.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-708811 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-708811:Patient 2
Pt presented with fever & rash. Was referred to ER for further evaluation. Labs showed platelet count of 11. Was transported to medical facility for treatment.
103 fever; Chills; horrible headache; This is a spontaneous report from a contactable consumer (patient). A 20-year-old male patient received first single dose of BNT162B2 (Pfizer, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (vaccine location: left arm) on 30Jan2021 15:45 for Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: School or Student Health Clinic. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications received within 2 weeks of vaccination. On 31Jan2021, the patient experienced chills, horrible headache and 103 fever. The events were considered as non-serious by the reporter. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
45 y/o  male, ADSM, is referred to the  Transition Unit for several day h/o nausea and vomiting associated with his receipt of Flu Mist vaccine on 28 Oct 08. Symptoms : Nausea w/ vomiting abdominal pain, Dizziness, joint pain, isolated.
Patient had hive like rash within 2-3 hours of receiving vaccine. Also developed red swollen area on R lateral thigh (beneath shot sites). Increased fussiness over next 2 days, no fevers.
COVID breakthrough first vaccine 2/27/2021  Patient presented to ED from home with c/o SOB. Patient's daughter noticed patient c/o SOB, thought tracheostomy was potentially not functioning properly. Inner cannula was exchanged however patient continued to be SOB to which EMS was called. Per EMS report, patient had saturations in the 60s on RA and febrile at 102F on scene. Upon presentation to ED patient febrile 102.1F, tachycardia in low-100s, tachypneic with saturation of 63% on RA via tracheostomy.
Woke up at 2:15a with severe stomach cramps, by the time I woke up, vomited and severe diarrhea simultaneously. The next two hours was in a haze and unable to think clearly, and on my way to the bathroom from bed, I fell at the foot of my bed but cannot remember where I landed an if I hit my head.   I am bruised this morning and have concerns because I do have a history of strokes in the last 5 years.  When I woke up this morning, I did not have any full BM but noticed blood and mucus in my stool.   Looking into visiting the doctor after filling out this form.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 27-AUG-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot# reported as N032958 and expiration date 13-JUL-2020, or lot# N022583 and expiration date 20-JUN-2020 (strength, dose, dose number, site and route of administration were unspecified). Administered doses of vaccine were exposed to the temperature excursion below 32 degrees Fahrenheit (29.1 degrees Fahrenheit) for 16 days and the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit (57.9 degrees Fahrenheit) for 15 hours. Data logger was involved. There was no previous temperature excursions. There was no adverse effects reported. This is one of two reports received from the same reporter. Lot number N032958 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast). Sender's Comments: US-009507513-1808USA013371.