chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was given on 5/14/07 @ 10am. Pt. reports she noticed a blister inside her mouth @8:30pm. Today, 5/15/07, she reports blisters on her lips and the inside of her mouth feels "burned", she states she has never had fever blister before now.
Anaphylactic reaction; Lightheadedness; Sensation of throat closure; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Latex allergy (Had a reaction to latex in the past). Concurrent medical conditions included Environmental allergy (dust mites).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). an unknown date, the patient experienced DIZZINESS (Lightheadedness) and THROAT TIGHTNESS (Sensation of throat closure). At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction), DIZZINESS (Lightheadedness) and THROAT TIGHTNESS (Sensation of throat closure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Tryptase: elevated (High) Elevated.         Concomitant medications reported include ibuprofen and loratadine.  Treatment for the event included epinephrine injection and intravenous diphenhydramine.  Company Comment: 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.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow-up received on 20 Apr 2021 included non-significant information.; Sender'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.
sick; Initial information received on 02-Feb-2021 regarding an unsolicited valid non-serious case received from a lawyer in the.  This case involves patient (unknown demographics) who experienced sick (illness), while he/she received vaccine INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that patient got one flu shot around seven years ago, never been that sick in life. Have not got a flu shot since and have not got that sick so.  It is unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information available on the batch number for this case.
PATIENT'S WIFE CALLED AND SAID HE EXPERIENCED FLU-LIKE SYMPTOMS (CHILLS & BODY ACHES). HE WENT FOR A WALK AND CAME BACK FEELING EXTREMELY WEAK, DIZZY AND NAUSEATED.  EMS WAS CALLED AND THEY TOOK HIS BLOOD PRESSURE AND IT WAS VERY LOW. THEY ATTRIBUTED HIS SYMPTOMS TO BE RELATED TO DEHYDRATION. HE WAS NOT TAKEN TO THE HOSPITAL BUT WAS TOLD TO REHYDRATE.  I ADVISED THAT THE PATIENT MAY HAVE AN ELECTROLYTE IMBALANCE AND TO REHYDRATE WITH AN ELECTROLYTE SOLUTION INSTEAD OF JUST WATER AND TO CALL THE PHARMACY OR HIS PRIMARY CARE PHYSICIAN IF HIS CONDITION WORSENS.
I woke up with sever stomach pain and nausea. I could not lay down or else it would hurt worse. By the afternoon this turned into chest pain, shortness of breath, headache, sweating, back and muscle pain, and a fever of 101.4.
Patient develop big  bruises and red spots in the left arm where the vaccine was administer, also she develop bruises all over her legs, front of the legs and back of the legs.  Patient is not taking any blood thinner.
8 days post-vaccine I developed a large red rash near the injection site. I'm now 12 days post- vax and it has continued to grow. It's now a large blotch covering my entire inner arm from shoulder to elbow- red, itchy, and warm to the touch.
Needle flexed and did not penetrate the skin when nurse went to administer vaccine. Skin only minorly broken, needle was properly exchanged and full dose of vaccine administered properly. Band-Aid applied over site. Patient had no complaints, no adverse reactions noted.
Patient immediately reported the shot hurt more than usual shot and that he was feeling dizzy (he described it as "the spins").  He stated getting warm to the touch and started sweating profusely. About 4-5 minutes after the shot he said he was nauseous. About a minute later he threw up.  He said that throwing up helped a little. RPh asked if he wanted some orange juice. He said he did and he took a few sips. He continued to feel warm to the touch and was sweating quite a bit. He also was quite pale.  RPh continued to monitor him, providing cool compresses to forehead and back of neck and continued to have him sip on orange juice (drank about 20 ounces aver 30 minutes).  He reported feeling better at 10:45am (about 30  minutes after shot.) RPh kept him for observation for another 15 minutes at which time he felt good enough to go home. Girlfriend drove him home. RPh called to check on patient at 6pm. Girlfriend reported he was doing ok and hadn't had any other reactions. He had just been sleeping all day.
Discussed that pt is prone to allergies and that I would monitor her 30 mins after her vaccine.  1310 pt received the vaccine.  1324 Pt c/o itching to upper extremities, chest, head and torso.  No c/o breathing issues or a feeling of her throat ?closing?.  No other symptoms reported.  25mg liquid Benadryl administered PO.  BP 160/95, Pulse 92; 1329 Itching improving, administered another 25mg liquid Benadryl PO.  No c/o breathing issues or feeling of throat thickness.  Discussed treatment options with EpiPen and calling 911.  Pt. felt comfortable to the treatment of Benadryl since it was helping her symptoms of itching.  1334 BP 141/97, Pulse 98.  Assisted her to recline in the lounge chair she was sitting in.  Observed her closely.  No other complaints of symptoms, itching improving.  Instructed her to call her primary physician.  She called and described her symptoms to the person that answered the phone.  They will discuss with her physician and call her back. 1405 Pt feeling much better. States she feels comfortable to leave.  I gave her the bottle of Benadryl and let her know when she could take it again if needed.  She is going back to her orthodontics office and will be around several people to assist her is needed.  1815 Called pt., she heard from her physician.  He told her to continue the Benadryl if needed and that she could add Zyrtec.  No other recommendations given.  She has slight itching.
Flu shot given at 11:13 AM. Within 30 mins hives began appearing on chest, arms and abdomen. Went to emergency room.
Approximately 1 month post vax pt developed 100 varicella like maculopapular lesions on an erythematous base on the pinnas of both ears, along the left jaw, on the dorsal aspect of the hands extending to the lower forearms and along the right leg.  Pt also developed a pruritus and a cough. Pt was afebrile and there were no oral lesions. Pt was treated with calamine, pramoxine and zinc acetate.
Heart flutters. Doctor had me wear a heart monitor for a week and determined that the flutters were not an issue.
Patient was administered Monovalent Moderna COVID19 vaccine after FDA unauthorized the use of this vaccine on 04/18/2023.
Nausea, headache, fever, shaking chills, body aches - it lasted about 24 hrs
About a few after receiving you notice a soreness and swelling in my armpit. It got to this size of half a softball. This lasted for about a couple weeks. It pain throughout.
Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult 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 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 Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. Eight family members of patient received Shingrix vaccine. After receiving Shingrix vaccine, the patient experienced shingles.  This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown. This case was 1 of the 4 linked cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063288:Same reporter US-GLAXOSMITHKLINE-US2021AMR063309:Same reporter US-GLAXOSMITHKLINE-US2021AMR063310:Same reporter
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: constipation (severe)-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: Shakiness-Mild, Additional Details: patient presented with complaints of constipation that per patient increased in severitiy post vaccine and warrented an er trip. patient also stated she experienced shaking, muscle rigidity, headache, sob red raised skin areas and gait changes, patient went through vaers form which will be physically faxed to vaers.
Patient is 3 years old.   Patient was give Pfizer COVID vaccine 5-11 year old.   Patient did not have any adverse outcome.
Pt received Influenza and Pneumovax 23 vaccine 10/3/23. Pt developed symptoms of rash on abdomen, chest, arms, hands and leg on 10/3/23 after vaccines administered. Described as raised, red, burning and itchy. No identified specific triggers or remedies for symptoms. Worse at night. Severity of rash and itching stated to be severe. Over-the-counter medications tried without relief. No changes in soaps, detergents, lotions or medications. Solu-medrol IM injection administered 10/9/2023. Prescribed oral prednisone and Triamcinolone cream on 10/9/2023.
Malaise and severe joint pain, nausea, frequency in bowels, stomach pain, dizziness, headache that started about 12 hours post injection in the night. Arm pain radiating into axilla and down arm from injection site. A bit disoriented upon waking, pushed fluids and OTC meds with some relief of pain but GI symptoms persisted.
This spontaneous report was received from a Registered nurse regarding a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Had vaccines in the late afternoon, then played soccer with her team. On the drive home, she felt nauseous and fainted. She was able to pull over before fainting. Continued to feel nauseous with low grade fever the next day. Rested and felt better the next day.
No further AE details; HCP called to report an expired dose of VARIVAX was administered; Product storage error; This spontaneous report was received from a pharmacist and refers to an 11-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 02-MAR-2023, varicella virus vaccine live (oka/merck) (VARIVAX) underwent temperature excursion for 9 minutes in 70 Fahrenheit (F) (Product storage error). On 08-JUN-2023, the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Expired product administered). No additional events were reported.  Lot number #W0252273 has been verified to be a non valid number for varicella virus vaccine live (oka/merck).; Sender's Comments:  US-009507513-2306USA007917: US-009507513-2306USA007830: US-009507513-2306USA007844: US-009507513-2306USA007881:
administered expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patient, after the manufacture date of expiration) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. The vial did not undergo any temperature excursions. Date vial was initially stored in the refrigerator was unknown. Total of 102 doses were given from LOT 026C21A with expiration date 24-Oct-2021. Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non-significant follow up received.
ingredients in flu vaccine from 2009 / that year she got it and was allergic; gradual swelling; itching; redness; hives; face swelling; This case was reported by a nurse via call center representative and described the occurrence of allergic reaction in a 36-year-old female patient who received Flu Seasonal TIV Dresden (Influenza vaccine unspecified 2009-10 season) (batch number AFLUA456AA, expiry date unknown) for prophylaxis.   Concurrent medical conditions included drug allergy.   On an unknown date, the patient received Influenza vaccine unspecified 2009-10 season (intramuscular). On an unknown date, less than a month after receiving Influenza vaccine unspecified 2009-10 season, the patient experienced allergic reaction, swelling, pruritus, erythema, hives and facial swelling. On an unknown date, the outcome of the allergic reaction, swelling, pruritus, erythema, hives and facial swelling were recovered/resolved.   It was unknown if the reporter considered the allergic reaction, swelling, pruritus, erythema, hives and facial swelling to be related to Influenza vaccine unspecified 2009-10 season.  Additional details were provided as follows: The age at vaccination was not reported, but could be 35 or 36 years. The reporter called asking for full list of ingredients in flu vaccine from 2009 with lot number AFLUA456AA. She did not knew the name of the flu vaccine, only lot number. The reporter stated that she always used to get a flu vaccine but that year she got it and was allergic. The reporter stated that she was allergic to thimerosal but that did not mean she was not allergic to rest of the ingredients. Upon follow up received on 5th November 2010, it was confirmed that the vaccine received was Fluarix from 2009. The reporter believed the vaccine was given intramuscular. The patient experienced gradual swelling, itching, redness and hives following vaccination that was generalized. The reporter remembered face swelling.  She is unsure how long it lasted but stated a handful of days as she went to see her doctor of medicine and then allergist so at least a week. The reporter gave permission to contact again for further information.
No additional AE reported; HCP reported that VARIVAX with an expiration date of 4/10/2022 was administered to a patient today (4/21/2022). HCP requested information on re-vaccination of VARIVAX; This spontaneous report was received from a nurse and concerns 17-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 21-APR-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) in dose of 0.5 ml, lot number T012551, expiration date 10-APR-2022 (formulation was not reported) for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event).
Systemic: Allergic: Rash (specify: facial area, extremities)-Severe, Systemic: Flushed / Sweating-Mild, Additional Details: Red Rash all over trunks and arms
Hospitalization: 12/23/2022 - 12/26/2022  Presentation to the ED: fell & hit head. No LOC.  Shoulder pain.  COVID + date: 12/23/2022 Treatment: no indication for remdisivir or steroid.  Discharge to: Home.   002A21A 2/24/2021 017B21A 3/29/2021 014C21A  9/11/2021 006M21A  8/14/2022
Treatment of COVID-19; Treatment of 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 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 12Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "medically obese" (unspecified if ongoing), notes: Other medical history: medically obese; "BMI high" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Body mass index: High. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Allergic reaction.; Rash; Itching all over body; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the arm left on 19Aug2021 at 09:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive concomitant medication. On 26Aug2021 at 18:00, the patient experienced an allergic reaction, rash and itching all over his body. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of events included treatment with cortisone cream (MANUFACTURER UNKNOWN) from an unknown date. Since the vaccination, the patient had been tested for COVID-19. On 14Sep2021, the patient underwent polymerase chain reaction (PCR) test (nasal swab) and the result was negative. The clinical outcome of the events allergic reaction, rash and itching all over body was not resolved at the time of this report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the arm left on an unspecified date in 2021 (at the age of 42-year-old) as a single dose for COVID-19 immunisation.
Swollen, blotchy, red, itchy face, eyelids, ears.   General feeling of being warm and itchy all over.
Vaccine site had extreme swelling (grapefruit size). Rash bumps got larger and had hives. Received antibiotics. Patient also had respiratory symptoms.
No additional adverse events reported; Temperature -7.9 for 53 minutes and -10.5C for 52 minutes; Information has been received from the vaccine coordinator and a nurse, referring to a 11 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 29-JAN-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1637651, expiration date on 09-JUN-2022 (also reported on 09-SEP-2022) (anatomical location and administration route were not reported) as prophylaxis. No adverse effects were reported.  The reporting vaccine coordinator was unsure about the lot number used, however the nurse confirmed the lot number administered to the patient. The vaccine had two temperature excursions of -7.9 Celsius degrees (C) during 53 minutes and -10.5 C during 52 minutes. It was confirmed that no previous temperature excursions occurred and no digital data logger was involved. This is one of several reports received from the same source. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA001188: US-009507513-2102USA001280: US-009507513-2102USA001367:
Tender, sore, swelling, erythema and pruritis of skin surrounding injection site. Improving