chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 34 year old female who on 27-Dec-2006 was vaccinated with a dose of Zostavax vaccine (lot#654603/1405F). The patient was supposed to received a dose of varicella virus vaccine live. The physician stated that she attributed this to "carelessness" and because "they were in a hurry". Unspecified medical attention was sought. The patient has not had any adverse events. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
pt recvd vax & exp no immediate sx's or resp distress; felt tired & slept 5 hrs; same evening didn't exp pain, stiffness & swelling of arm; 9AM next day pt observed a red, raised, circular welt the size of a 1/2 dollar @ site of inject;
Head and body aches - very severe on the first day.  Second day some headache and extreme fatigue Rested most of the time, took tylenol and once took an advil Continued to get better over the next few days through Friday Nov 12
A REALLY GOOD SIDE EFFECT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced a really good side effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a really good side effect was not reported. This report was non-serious.
Simple febrile seizure for less then 5 min, onset 1/30/19 at 6:02AM.
Treatment of COVID-19; Treatment of COVID-19; DOSE 5 (BOOSTER); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known Allergies: Penicillin" (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"; IMMUNISATION (medically significant), outcome "unknown", described as "DOSE 5 (BOOSTER)". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Employee reported feeling of itching and thought at first she caught lice from her daughter and later looked at vaccinated arm and noticed it was red and itchy. Took photos of red lacy rash beginning at injection site and extending to fingertips. Reported 12/28/2015 and again 3/16/2016. Was seen by walk-in clinic in 12/2015 and continues to have rash that is slowly improving.
stomach upset; fever; cold; chills; Muscle stiffness; vomiting; diarrhea; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches), PYREXIA (fever), NASOPHARYNGITIS (cold), CHILLS (chills) and MUSCULOSKELETAL STIFFNESS (Muscle stiffness) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Allergy (Allergic to Amoxicillin, Sodium-penicillin, oxycodone, and outside things.). Concomitant products included LORATADINE for Allergy, METOPROLOL for Hypertension, AMLODIPINE BESILATE (PRODIPINE).    On 24-Jan-2021 at 1:15 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced HEADACHE (Headaches), NASOPHARYNGITIS (cold), CHILLS (chills), MUSCULOSKELETAL STIFFNESS (Muscle stiffness), VOMITING (vomiting) and DIARRHOEA (diarrhea). On 25-Jan-2021, the patient experienced PYREXIA (fever). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach upset). On 24-Jan-2021, HEADACHE (Headaches) outcome was unknown, MUSCULOSKELETAL STIFFNESS (Muscle stiffness) had resolved. At the time of the report, PYREXIA (fever), NASOPHARYNGITIS (cold), CHILLS (chills), ABDOMINAL DISCOMFORT (stomach upset) and VOMITING (vomiting) had resolved and DIARRHOEA (diarrhea) outcome was unknown. For Callers mother and husband this symptom appeared after taking Moderna's COVID 19 vaccine.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Body temperature increased: 101 degree f.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       As treatment for the events she has also taken Tylenol.   This case was linked to MOD-2021-017362, MOD-2021-018532 (Patient Link).
Vasovagal response: nausea, diaphoresis, pale, "feeling faint" about 5 min. after injection. Tx: ammonia inhalant, body position, breathing technique.
Flu Vaccine was given from Private Stock and not VFC stock. Pt tolerated injection well with no known reaction.
Chest pain, Chest Tightness, Extremely rapid heartbeat, short of breath, clammy felling, cold sweat, nausea, back pain. Went to ER Hospital approximately 7:30 PM 8/11/2021.
Diarrhea beginning 4 hours after receiving vaccine.  Has been continuing daily shortly after meals ever since.  Patient reported symptoms 6-1-22.
Patient was noted to have a red lump at injection site immediately following injection. Ice was applied within 2 minutes. He was given Benadryl elixir 2 tsp po 15 minutes after injection.
Allergic reaction, redness rash over abdomen, neck, face and down the legs. Benadryl did not work. Rash lasted for a week.
This year had thimerosal free vaccine. Within 30 min had fainting spell, sweating, blurred vision, ringing in ears, nausea, dizzy, couldn't stand up. Finally drove home and slept 12 hours.
Had a headache/fatigue following vaccine, but improved 24-48 hours afterwards. Pt woke up Sunday and felt jittery, lightheaded, sweating, numbness/tingling in both hands, feeling strange
expired Bexsero was administered; administered to patient; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a adult male patient who received Men B NVS (Bexsero) (batch number ABXA69CB, expiry date 20th October 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at the vaccination was reported. The reporter reported that an expired Bexsero was administered to patient, which led to expired vaccine used and inappropriate age at vaccine administration. The vaccine was administered in late October-early November 2021. The reported had not reported any reactions. The reporter consented to follow up as email was preferred.
Initial unsolicited misuse report received from a consumer (patient herself) via other company Pfizer (manufacturer reference Number: 2017094549) on 13-MAR-2017. This case involves a 67 years old male patient who was vaccinated with dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (TDAP) (batch number, expiry date, dose and dose in series for both the vaccines were not reported) and a dose of PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL POLYSACCHARIDE 23 VALENT) (batch number, expiry date, dose and dose in series for both the vaccines were not reported) in the right upper deltoid instead of PNEUMOCOCCAL CONJUGATE VACCINE (PNEUMOCOCCAL CONJUGATE 13) on 03-OCT-2016. Illness at the time of vaccination was reported none and the patients mother past away in sleep at 95 years old. Concomitant medications were reported as the patient had Vitamin one a day, Astaxanthin 4 mg gel oil and Super Green capsule every other day. It was a case of Wrong vaccine administered where the patient was supposed to get pneumococcal conjugate 13 first but accidently vaccinated with pneumococcal polysaccharide 23 valent. On 03-OCT-2016, shortly after vaccination, the patient had developed pain in right arm which got worse shortly after receiving the TDap. Patient's medical history was reported as the patient was previously vaccinated with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (TETANUS, reported as TETANUS/TDap) (batch number, expiry date, dose and dose in series for both the vaccines were not reported) in the left upper deltoid on 12-SEP-2016 and also received another vaccine within two months of the first vaccine also the patient had hip operation an unknown date (reported as 27 Oct 2016). Laboratory investigations were reported none. The patient received Naproxen sodium and Aleve as corrective treatment. The patient had no emergency visit. The outcome of event was reported as recovered on an unknown date. List of documents held by sender: none.
Infanrix /administered to an 11YO; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received DTPa (Infanrix) (batch number 4L9E4, expiry date 7th February 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd July 2021, the patient received the 1st dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 22nd July 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional case details were reported as follows: A dose of Infanrix was accidentally administered to an 11 Years old patient which led to inappropriate age at vaccine administration. The patient received Infanrix in right deltoid. At the time of the report the patient had not reported any issues. The reporter consented to follow up.
Pericarditis. Chest pain. Fatigue. Shortness of breath. Headache. Nausea.
3rd box opened on 09Nov had tag alert alarm read #2; This case was reported by a other health professional via other and described the occurrence of intercepted product storage error in a patient who received Flu Seasonal TIV Dresden (Fluarix) (batch number 997A5, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Fluarix. On an unknown date, unknown after receiving Fluarix, the patient experienced intercepted product storage error. On an unknown date, the outcome of the intercepted product storage error was unknown.   Additional Information: GSK receipt date: 11-Nov-2022 Reporter's comment: As per management, the reporter reported this intercepted medication error.  There was an order placed for a 98 packs/980 doses of Fluarix that shipped in 3 packages via parcel service. When the order arrived on 6th October 2022, the customer only opened and checked the tag alert for 2 of the 3 boxes, and did not check/open the last box of 42 packs/420 doses.  All 3 boxes were delivered next day by parcel service.  When they finally opened the 3rd box on 9th November 2022, the tag alert alarm read 2.  The tag alert was ok when they received the other two boxes. On there end, they were handling a request from the customer to return the 3rd box of 42 packs, but wanted to report this to them as they could not confirm viability of the vaccines. Additional supportive information: The reporter could not confirm viability of the Fluarix vaccines, which led to intercepted product storage error.
Arm warm to touch; Hard arm; Swollen arm; Red arm; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm warm to touch), VACCINATION SITE INDURATION (Hard arm), VACCINATION SITE SWELLING (Swollen arm), VACCINATION SITE ERYTHEMA (Red arm) and VACCINATION SITE PAIN (Sore arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Arm warm to touch), VACCINATION SITE INDURATION (Hard arm), VACCINATION SITE SWELLING (Swollen arm), VACCINATION SITE ERYTHEMA (Red arm) and VACCINATION SITE PAIN (Sore arm). On 13-Jan-2021, VACCINATION SITE WARMTH (Arm warm to touch), VACCINATION SITE INDURATION (Hard arm), VACCINATION SITE ERYTHEMA (Red arm) and VACCINATION SITE PAIN (Sore arm) had resolved. At the time of the report, VACCINATION SITE SWELLING (Swollen arm) had not 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.   Treatment for the event included paracetamol.  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.; 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.
"Burning" rash in straight line R side of abdomen. DX: Shingles
Received vaccine on 2/14/07. Saw patient 3/12 had varicella lesions approx 20-30 some inflamed.
The only chemical change to my father in 2021 were the 2 injections.   He had had seizures of unknown origin 4 times in  the prior 18 months.  A little over 2 weeks later he had a seizure.  It was thought to be dehydration or lack of food.  He was given a water bottle and we started watching his food intake.  He had 4 seizures in 2 weeks.  He had another 4 the week after, then they came everyday.  More often, longer durations, and more powerful.  He passed away on June 8, 2021 cause of death ruled to be parkinsons.
Pt states that she developed right forearm pain and swelling the day after. She was seen by me on 4/29/21 and diagnosed with DVT radial and cephalic veins. Also with SVT of the fore arm.
I miscarried at 6 weeks and 4 days.  It was right after the vaccine I miscarried.
pt devel T103 day p/vax;seen in ER & was told by MD that was having rxn to immun;PE findings were WNL;T103 x 18hr then temp dec to 101 w/APAP & motrin;rt arm sore, red, swelling;
Bulls eye allergic reaction around injection site about 4-5? wide. Area site burning hot and itchy.
Patient developed pain, swelling and area of erythema at the placement site, starting a few hours after administration of vaccine. Pain does radiate to back of neck.
Bell's palsy stage 4/partial face paralysis; A spontaneous report was received from a female consumer who received Moderna's COVID-19 vaccine and diagnosed with Bell's palsy stage 4.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 25 Dec 2020, after receiving the vaccine the patient was diagnosed with stage 4 Bell's palsy. She has a partial face paralysis. Treatment for the event was not provided.   Action taken with the mRNA-1273 in response to the event was not reported.   The outcome for the event was Not recovered/Not resolved.; Reporter's Comments: This case concerns a female patient of unknown age. The medical history is not provided. The patient experienced a medically significant and unexpected event of Facial paralysis approximately two days after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Very limited information regarding this event has been provided at this time. However, based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
Moderna COVID?19 Vaccine EUA  Patient received COVID-19 vaccine booster dose on 4/7/2022. No symptoms or adverse events noted during administration and observation.  No adverse events reported by the patient to date.  On 5/4/2022 discovered that dose administered is past the expiration or beyond-use date.  Manufacturer contacted to report event and  to obtain re-vaccination guidance.
Case number PHHY2011DE87332 is an initial combined spontaneous report received from pharmacist via center on 27 Sep 2011 on 05 Oct 2011. This case refers to an adult male patient. He was suffering from lupus erythematosus which was affecting the kidney, therefore he was treated with corticosteroids. He was vaccinated in past with influenza INN and developed epididymitis two weeks later (see case PHHY2011DE87329). He was vaccinated with influenza INN vaccine (manufacturer and batch number unknown) on unspecified date. Two weeks after vaccination, he developed an epididymitis. In the subsequent three to four years, he received influenza INN and developed epididymitis (see related cases PHHY2011DE86252, PHHY2011DE87333 and PHHY2011DE87334). The causality and event outcome were not reported. 'It was reported that 'it would not be possible to receive more information'.
lightheaded - 110/60 - 60 - 18 rested, ate additional food
HIGH BLOOD PRESSURE AND HEADACHES.  SLOWLY WORSENING OVER THE LAST 3 MONTHS
Pt had bilateral itching of ears and scalp and described sensation of 'heavy tongue'. Gave 2 oral doses of benadryl 25mg each for a total of 50mg. Vitals stable.
SLURRED/STUTTERED SPEECH (ON-AND-OFF); COLD SWEATS; WEAKNESS; SEVERE HEADACHE; This spontaneous report received from a consumer concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, iodine contrast dye allergy, alcohol non-user, and smoking, and other pre-existing medical conditions included the patient had known drug allergies. the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced slurred/stuttered speech (on-and-off). On 24-MAY-2021, the subject experienced cold sweats. On 24-MAY-2021, the subject experienced weakness. On 24-MAY-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from slurred/stuttered speech (on-and-off), severe headache, weakness, and cold sweats. This report was non-serious.
c/o fever, feeling tired and headaches since after immunizations yesterday.    reports that he got it after he got his two meningitis shots yesterday, reports malaise, fever, chills, body aches and headaches; denies any sore throat, no abdominal pain, no diarrhea, no dysuria. OF NOTE: Per immunization registry, pt had received Menveo as his first Meningitis ACWY vaccine.
7MAR97 started w/cough & fever;saw MD Saturday 8MAR97;probably flu placed on ATB;
Face burning; Poor sleep; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Face burning) and POOR QUALITY SLEEP (Poor sleep) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 02-Apr-2021, the patient experienced BURNING SENSATION (Face burning) and POOR QUALITY SLEEP (Poor sleep). At the time of the report, BURNING SENSATION (Face burning) and POOR QUALITY SLEEP (Poor sleep) had resolved.            No concomitant products were reported.  No treatment information was provided.
Possible administration error. Unable to verify if 0.5 or 0.3 ml was drawn up and administered to the patient. Alerted patient to possible error and filled out VAERS report to record incident. Verified that correct vaccination was given but when drawing up vaccine, did not recall properly verifying dosage before administering vaccination. Patient showed no signs of adverse reactions during time of event.
On 12/27/99, the pt developed chicken pox. It was reported that the pt has 15 marks which are located on his back, chest, face, and soft palate. The physician described the varicella as mild. Subsequently, the pt recovered.
Patient's whole body got warm right after the second dose as she was getting home. Caregiver gave her tylenol day flu as preventative care and continued with Tylenol extra strength for the next day twice.
About 12 hours after the two shots, I got very cold and shivering. Once I warmed up, my face got very hot. My entire body felt terrible; my back ached, I felt dizzy upon standing, and my head would throb and ache whenever I moved my neck. Some of the time, I felt like throwing up. I slept restlessly for 11.5 hours, feeling immense pain every time I moved. The next morning, I felt pain behind my ears when I turned my head and my head throbbed when bending down. I was also sensitive to loud noises and bright lights.
After  9 days, I had a delay response  in the injection site. Redness, firmness and warm ness in the area. This lasted  a day and went away. However, today after 15 days , the redness in the injection site is back . The area is red and warm not form though.
Pt became lightheaded after receiving COVID vaccine. He was provided 2 bottles of cold water and monitored vital signs. pt felt better.