chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case received from a healthcare professional on 13 and 14-Sep-05 (MIS/VIS reference numbers # 05-0447 and 05-0450). A 39-year-old female patient, with no relevant medical history, had received and injection an injection of DECAVAC (lot # U1215AA, on left deltoid) on 26 Jul 05 and later on the same day, she complained of headache, arm edema, sore arm, rash on arm (no description) and low grade fever. It was reported that the vaccine was given with a 5/8" needle. She required a doctor visit. The patient did not received any corrective treatment. The patient recovered on 29-Jul-05. Follow up information received on 17/Nov/2005. As per responsible physician there is no further information for this case.
Caller states he is an allergist and seeing "arms swell up" looking for more specific information; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Caller states he is an allergist and seeing "arms swell up" looking for more specific information".  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Started  having worsening shortness of breath, exertional dyspnea, paroxysmal nocturnal dyspnea 3 days after 2nd dose of COVID 19 modern a vaccine.  transthoracic echocardiogram showed heart failure with reduced EF of 20-25%.
The night after receiving the vaccine (3/31/22), his left thigh was warm to the touch, swollen and tender and began to have a knot under the skin. On 4/4/22 morning, a rash was noted on child's chest. On 4/5/22, child was fussy and clammy (fever was checked and no fever noted), owlet monitor alerted red, O2 sat was 76%. Child was picked up from crib and after picking him up, he stiffened his arms and legs and then went limp. Child turned blue around his mouth and would not respond for about 10 minutes. All of the sudden, he appeared to "snap out of it" and, even though he appeared weaker than usual, he was back to normal self.  Knot and discoloration of skin still noted on left thigh on 4/19/22.
Itching, coughing, within 1 min broke out in hives and started wheezing. 0.3 epi given then 30 min later 0.3 epi given again. 3 tsp of Benedryl elixir given. 15mg of Prelone.
Received 0.5ml for 3rd doses instead of .025ml. Patient experienced headache and fatigue the following day and then returned back to normal.
broke out in a bad case of them / Suspect vaccination failure; broke out in a bad case of them last week; This serious 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 JUN-2023, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: broke out in a bad case of them / Suspect vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: broke out in a bad case of them last week). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-JUN-2023 This case was reported by the patient via interactive digital media The patient got the Shingles shots three years ago from reporting. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.
Pt received Meningitis injection and fainted following administration. Pt stated hadn't eaten since night before and is afraid of shots. Pt had dry mucous membranes. Pt was laid on floor, pt awoke. Juice and crackers given. Pt was sat up and then stood without difficulty. Vital signs were stable. Pt ate sandwich and stated he was feeling much better. Pt ambulated without difficulty under care of mother.  4/17/13: Spoke with Dad, stated pt took nap yesterday afternoon and then felt better. Pt attended baseball practice last night. Pt attended school this morning and stated he was feeling fine. No further treatment needed.
Information has been received from a registered nurse concerning a 23 year old female patient with no pertinent medical history, no drug reactions/allergies, who on 04-FEB-2009 was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL (Lot # 661952/1129X).  There was no concomitant medication.  On 09-FEB-2009 the patient experienced hives.  The presentation of the hives limited to the GARDASIL vaccine injection site.  The patient called the practice.  There were no laboratory or diagnostic tests performed.  On 10-FEB-2009, the patient had recovered.  Additional information has been requested.
This spontaneous report as received from a physician via company representative refers to a male patient of unknown age. On an unknown date the patient was vaccinated with the first dose of PNEUMOVAX 23 (dose and route of administartion were not reported). The second dose was administered after 5 years, 0.5 ml administered to prevent of pneumococcal disease. On an unknown date, after receiving the second dose, the patient's the injection site, was hot to touch, painful and it almost looked like cellulitis. The outcome of the event was reported as recovered/resolved on an unknown date. Causality assessment was not reported. Additional information has been requested.
At 9pm 10hrs after the shot was given I got the chills. A headache began forming as well. All night I was overheating then freezing and I had a high temperature of 105. The headache was the worst I've ever experienced. I took Tylenol every 6 hrs but it didn't do much. I continued to have chills throughout the next day. My whole body ached and my knee caps really hurt. Now it is two days after the shot and my very sluggish and I have a pain in my left armpit, I received the shot in my left arm. My eyes are also sore when i move them left to right and i keep my head in one spot.
STATED SHE RECEIVED THE BOOSTER DOSE AROUND 820AM AND BY 0900 WAS HAVING SEVERE HEADACHE, NO TASTE, VERY SORE ARM. AROUND 1200PM ON 11/8/21 SHE STATED THAT SHE HAD SEVERE LEFT SIDED PAIN (PAIN DOWN THE WHOLE SIDE OF THE BODY AND WAS SORE TO TOUCH, DESCRIBED AS THE PAIN AT INJECTION SITE BUT  THAT IT WAS HER WHOLE LT SIDE) SHE ALSO STATED THAT SHE BEGAN VOMITTING. THIS LASTED TILL APPROXIMATELY 0200 ON 11/10/2021. TODAY 11/10/2021 @ 545PM SHE STATES SHE IS FEELING BACK TO NORMAL WITH A SLIGHT SORE ARM.
This spontaneous report was received from a nurse via a company representative and refers to a 55 year old female patient. No information regarding her pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On approximately 06-FEB-2018, reported as "approximately a month ago", the patient was vaccinated with a dose of PNEUMOVAX 23 injection, intramuscular route of administration (exact dose, lot # and expiration date were not reported). On the same date, "immediately" after vaccination, she developed "extreme induration at the injection site" to the point she "could not move her arm". The patient sought medical attention by contacting her "primary physician" (unspecified), who prescribed her an "extended prednisone treatment" to take as a treatment for the event. No product quality complaint (PQC) was involved. The outcome of the events was reported as recovered. The relatedness between the events and PNEUMOVAX 23 was not reported.
Pt. had dyspnea, red eyes 3 hours after Flu shot. Went to hospital, and pt. rec'd increased platelets and treated w/BENADRYL.
Suspected vaccination failure; shingles; post herpetic neuralgia; 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) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure, shingles and post herpetic neuralgia were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had both doses of the Shingrix series completed. The patient experienced post herpetic neuralgia. The patient did not exhibit any rash or visible indication of shingles. The patient noted that, the patient must have had shingles based on the post herpetic neuralgia. The patient did not wish to participate in a safety report and provide to her demographics. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting. The reporter did not consent to follow up.
Arthritis like rxn to left arm- deltoid, erythematous, swollen area from shoulder to elbow, positive for itch. No pain, occurred approx 3-4 hours past injection. 3x3.5 inches.
Approximately 10 days following my 2nd Pfizer vaccination I developed a whelp (like a large mosquito bite) at the injection site.  It itched very much.  I applied anti-itch salve for several days and after 3-4 days, the whelp began to shrink, and the itching stopped.
Twenty minutes after receiving the flu shot the patient got hives all over her body, itched, her lips and tongue were swollen and she was very shaky. She did not have any shortness of breath or wheezing.
Case number PHEH2013US012005 is an initial spontaneous report received from an office manager on 30 May 2013. This report refers to an 11-year-old female child. She was vaccinated with MENVEO (batch number: A11082) subcutaneously on 29 May 2013 and her arm became swollen at the injection site. No further information about outcome, seriousness and causality was reported.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Apr-2021 at 10:54 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 10:54 AM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant product use was reported. The age of patient was provided as 57.03. It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. On 03-Apr-2021, At excursion time 09:00 AM temperature was 34, total doses given for the day was 210, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were moved to clinic. Vaccine BUD date was 29-Apr-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The temperature recordings were taken by using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided.
I was supposed to be shadowing floater RPh but due to busy work conditions I tried to help process and administer a Pediatric COVID vaccine.  Due to my inexperience with vaccine processing and administration, i was flustered and did not dilute vaccine before administering to the patient.
Because the very 1st dose she received was a bi-valent,; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Because the very 1st dose she received was a bi-valent,) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Because the very 1st dose she received was a bi-valent,) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Because the very 1st dose she received was a bi-valent,) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Because the very 1st dose she received was a bi-valent,).    No concomitant medications were reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment medications were reported.
Received vaccine on Friday 09/21/2007. Reported feeling dizzy, HA, and passing out on Saturday 09/22/07.
Extremely itchy patch/rash around injection site. Red,  raised lump at injection site.  Swollen and hot to touch.
Information has been received from a physician concerning a 65 year old male patient "about a year ago", in approximately 2009, was vaccinated subcutaneously with one dose of ZOSTAVAX (Merck). The physician reported that the patient got a breakthrough case of the shingles "about 6 months ago", in approximately January 2010. At the time of the report, the patient had not recovered from the event. The patient sought unspecified medical attention. Additional information has been requested.
Did not receive the 2nd dose because of fear; Weakness and aching on her leg; Aching on her leg; Shortness of breath; Leg cramps; Her legs wouldn't support her; A rash in the injection site that had spread to her upper arm; Arash in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness and aching on her leg), PAIN IN EXTREMITY (Aching on her leg), DYSPNOEA (Shortness of breath), MUSCLE SPASMS (Leg cramps) and LIMB DISCOMFORT (Her legs wouldn't support her) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter.  Concomitant products included LISINOPRIL, OMEPRAZOLE, LEVOTHYROXINE SODIUM (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]), FENOFIBRATE, VITAMIN E [VITAMIN E NOS], PROBIOTICS NOS, ASPIRIN [ACETYLSALICYLIC ACID], COLECALCIFEROL (VIT D3), ASCORBIC ACID (VIT C), CYANOCOBALAMIN (VIT B12) and CALCIUM for an unknown indication.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced MUSCULAR WEAKNESS (Weakness and aching on her leg), PAIN IN EXTREMITY (Aching on her leg), DYSPNOEA (Shortness of breath), MUSCLE SPASMS (Leg cramps), LIMB DISCOMFORT (Her legs wouldn't support her), RASH (A rash in the injection site that had spread to her upper arm) and VACCINATION SITE RASH (Arash in the injection site). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not receive the 2nd dose because of fear). At the time of the report, MUSCULAR WEAKNESS (Weakness and aching on her leg), PAIN IN EXTREMITY (Aching on her leg) and DYSPNOEA (Shortness of breath) had not resolved, MUSCLE SPASMS (Leg cramps), LIMB DISCOMFORT (Her legs wouldn't support her), RASH (A rash in the injection site that had spread to her upper arm) and VACCINATION SITE RASH (Arash in the injection site) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Did not receive the 2nd dose because of fear) had resolved.        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.   Concomitant medications include calcium + bone strengthening and Others No treatment medications were reported.
1/24/21 morning, 10 days after getting 1st dose of vaccination, broke out in hives in several places on both feet.  The next day more hives appeared on knees and the ones on feet got worse.  The day after that hives also appeared on hips and elbows.  On 1/27 went to Doctor's office and received steroid shot to stop the allergic reaction. Took 5-7 days for all the hives to disappear. Based on the allergic reaction to the first dose, doctor recommended not taking the second dose as reaction could be more severe and/or have an asthma attack.
patient received moderna ndc 80777-0273-10 booster, patient received half of the adult dose
Vaccine was administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use date after the thaw process) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown if patient had chronic or long lasting health conditions.     On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient's age was 34 years 10 months.  It was reported that the patient had no adverse reactions after the administration of the vaccine. It was unknown if patient had acute illness at the time of vaccination and up to one month before. It was unknown if patient had been diagnosed with or tested positive for COVID-19. The vaccine was administered beyond use date after the thaw process. No treatment information was provided.   This case was linked to MOD-2022-542869 (Patient Link).
tickle in the nose; Sneezing; This spontaneous case was reported by a consumer and describes the occurrence of NASAL DISCOMFORT (tickle in the nose) and SNEEZING (Sneezing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASAL DISCOMFORT (tickle in the nose) and SNEEZING (Sneezing). At the time of the report, NASAL DISCOMFORT (tickle in the nose) and SNEEZING (Sneezing) outcome was unknown.            No concomitant medication were reported. No treatment information was provided by the reporter.
Baby was really fussy. Was seen twice before being admitted. 1) Fever & possible teething on 7-13-11. 2) Rash on 7-15-11 then admitted to hospital on 7-19-11 because of intussusception with manual reduction.
Partial loss of vision in both eyes. Treatment at  Hospital Treated with steroids nothing seemed to help.  Was admitted to hospital November 10 - 22 they did  several tests. It has been determined that the loss of sight was caused by lose of oxygen to the eyes.  Started this journey on Nov. 10th and last visit with Dr. was on April 8, 2022.
Caller reports multiple doses of VAXELIS administered since temperature excursion; This non-serious spontaneous report was received by partner (reference number 02197725) on 05-JUL-2022 and forwarded on 06-JUL-2022 from a consumer.    The causal relationship between Vaxelis and the reported event "multiple doses of VAXELIS administered since temperature excursion" was assessed as not applicable due to the nature of the event.    Further information is expected.
Patient received the Moderna Covid-19 vaccine. He reports symptoms of feeling faint; patient appeared very pale and diaphoretic.   Vital signs 5 minutes post-vaccination: HR 39, BP  103/43, SpO2 96% on room air.     Patient given water and candy in case of hypoglycemic episode.  Patient remained pale and diaphoretic -- 911 called for further assistance at 1440.  Patient denied shortness of breath, difficulty breathing, itching, rash, nausea/vomiting, or other signs and symptoms of anaphylactic reaction.   EMS arrived at 1445 and assessed patient -- care taken over at that time.   Vital signs improved after water and candy, patient refused hospital transfer.  Wife beside patient at this time.
At approximately 1530, RN 1 reviewed the Moderna 0.5 ml full dose POD participant form. RN 1 noted a discrepancy. The Moderna 0.5 ml full dose POD form was mislabeled with a Moderna 0.25 ml booster dose label. The POD form indicated patient  received a Moderna 0.25 ml booster dose (LOT# 070H21A). RN 1 reviewed the Moderna 0.5 mL full doses drawn into syringes. RN 1  noted the Moderna 0.5 ml full doses were mislabeled with Moderna 0.25 ml booster dose labels. At 1327, patient  received a Moderna 0.5 ml dose in left deltoid. RN 2 notified and educated vaccinator to inspect vaccine dosage before administration. RN 2 reminded RN 1 to confirm vaccine labels before usage. Vaccinator verbalized understanding.