chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This report refers to a 26 years old female patient enrolled in a not blinded other studies. The patient's current condition includes Crohns disease, drug allergy ALEVE, PNEUMOVAX allergy manifests as swelling, non-smoker and alcohol use:socially. The patient's medical history included spinal fusion. The patient was vaccinated (route not provided) with PNEUMOVAX23 (lotnumber and expiry date not provided) on AUG-2012. Other suspect therapies included HUMIRA with dosage information as (40 mg, 1 in 2 wk) on SEP-2011. Concomitant medications included: PENTASA. On AUG-2012 the patient experienced swollen arm. On SEP-2012 the patient experienced pain with injections and red circle at injection site. On an unknown date the patient experienced bumps with injection, the solution dispensed with HUMIRA, pulled pen off to soon, feels like knife when needle goes in, sore to touch after injection, red rash with injection and bruising with injection. No treatment information was reported. The outcome of bumps with injection, the solution dispensed with HUMIRA, pulled pen off to soon, swollen arm, feels like knife when needle goes in, sore to touch after injection, red rash with injection, bruising with injection, red circle at injection site and pain with injection is unknown. The relatedness for bumps with injection, the solution dispensed with HUMIRA, pulled pen off to soon, swollen arm, feels like knife when needle goes in, sore to touch after injection, red rash with injection, bruising with injection, red circle at injection site and pain with injections is unknown for PNEUMOVAX23. Additional information has been requested.
Vertigo, dizziness, nausea, diarrhea, headache started night 4 after vaccine. Also triggered migraine on first day of vaccine.
Muscle pain; Chills; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Body temperature: 102 (High) 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided   This case was linked to MOD21-052063, MOD21-052109 (E2B Linked Report). This case was linked to MOD-2021-042708 (Patient Link).; Sender's Comments:  MOD21-052063:Crosslink MOD21-052109:Crosslink
The same day of injection, the pt experienced vomiting,nausea and dry heaves for a total of 4 days. The pt also reported that it felt like her arm would fall off. In the evening the left arm was so sore she had to lift it with her right hand.
Patient came to clinic for pfizer booster.  Pfizer vial was diluted with .018ml of diluent instead of 1.8ml.  Patient was informed by Dr. that vaccine was mixed with too little diluent, and patient reported only having headaches the day after vaccine, which resolved the day after.  Patient reported to provider having no other symptoms, and reported symptoms have resolved at time of call on 01/18/2022.
condition aggravated; Headache; Pressure on brain; Brain fog; Bit confused; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBRAL DISORDER (Pressure on brain), FEELING ABNORMAL (Brain fog), CONFUSIONAL STATE (Bit confused), CONDITION AGGRAVATED (condition aggravated) and HEADACHE (Headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergy to composine), Allergic reaction to analgesics (allergy to acetaminophen), Food allergy (allergy to parsley), Food allergy (allergy to MSG), Vegetable allergy (allergy to cabbage) and Hypothyroidism. Concomitant products included THYROID (ARMOUR THYROID) from 15-Nov-2006 to an unknown date for Hypothyroidism.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced CEREBRAL DISORDER (Pressure on brain), FEELING ABNORMAL (Brain fog), CONFUSIONAL STATE (Bit confused) and HEADACHE (Headache). On an unknown date, the patient experienced CONDITION AGGRAVATED (condition aggravated). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Head pain, at an unspecified dose and frequency. At the time of the report, CEREBRAL DISORDER (Pressure on brain), FEELING ABNORMAL (Brain fog), CONFUSIONAL STATE (Bit confused) and HEADACHE (Headache) had not resolved and CONDITION AGGRAVATED (condition aggravated) 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.   Lab testes included - MRI was done and result was not provided, ordered an MRV.  Patient was set up with an infusion that was used to treat migraine. Infusion had helped the patient slightly to get out of pain and the pressure.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received: Patient demographics, race, ethnicity, medical history were added. Anatomical location of first dose, concomitant and treatment medication were added. Events outcome was updated from unknown to Not recovered.
The following day my throat was swollen making it hard to speak, breath, and eat.  My speech was a little slurred and I felt sick to my stomach.  I threw up twice.  I still feel sick.
Patient received second dose too early.  It was administered at day 14 instead of day 21. Patients arm is stiff today.
Patient came in for a shingles shot and was mistakenly given a Pfizer covid vaccine. this is patients 3rd dose
Pt started with pox of scalp, then to back, arms and legs about 7-10 a day.
This spontaneous report as received from a pharmacy technician refers to a patient of unknown age. On 17-JUN-2014, the patient was vaccinated with GARDASIL (dose, route and lot # not provided) that was improperly stored. The product was supported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, since the reporter does not want to be contacted.
Mom noticed a quarter size bump on the child's leg. The bump was hard to touch. Mom noticed the bump 10/29/21. No treatment done at this time.
Change in Taste & Smell; Change in Taste & Smell; Hot & Cold Flashes; This is a spontaneous report from a contactable consumer (Patient) or other non hcp.  A 28-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EW0161) as dose 2, via an unspecified route of administration, administered in Arm Left on 15Apr2021 12:45 (Age at vaccination 27 year) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient past drug include known allergies - Imodium. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8730), via an unknown route of administration on 22Mar2021 at 11:00 (Age at vaccination 27 year) in arm left as dose 1, single for covid-19 immunisation and experienced left arm ache, weakness from fingertip to shoulder blade, Pins and Needles, tingling, Began experiencing changes in cognitive ability, acute onset psychosis, debilitating OCD, schizophrenia like symptoms, visions, delusions, hallucinations, paranoia, intrusive thoughts, anxiety, panic attacks, short term memory loss and depression. Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. On 15Apr2021, the patient experienced Change in Taste and Smell and Hot and Cold Flashes. The patient underwent lab tests and procedures which included sars-cov-2 test NAT was negative on 28May2021 Nasal Swab. Patient was received treatment for events. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. Patient was not received other medications within 2 weeks of vaccination. Patient was visited to emergency room and physician office. Physical Testing, Mental Therapy, Medication was performed as treatment. The outcome for all the event was unknown.  Follow-up attempts are completed. No further information is expected.
Left shoulder upper arm pain in area the shots were given after taking both shots in Oct 2022. Not its May 2023 and she still has pain in her Lt arm/shoulder.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-JUL-2022; No adverse event; Administered the vaccine to patient after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-JUL-2022) and NO ADVERSE EVENT (No adverse event) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 20-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-JUL-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-JUL-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-JUL-2022).    No concomitant medications were reported. The vial was initially stored in the refrigerator on 04-Jun-2022. The date of vaccine administration was from 4-Jun-2022 until 26-Jul-2022. Patient received full dose. The vial did not undergo any temperature excursions. No treatment medications were reported.
Blood pressure immediately went up to 200/116 chest pressure and metallic taste . Pressure was elevated until the next day . Diarrhea and upset stomach.
Itchy hands, swollen fingers, hives first day increasing. Itchy hands and feet, larger hives second day. Swollen eyes, larger hives and itchy hands and feet third day. First day 20 mg of prednisone was given along with Benadryl taken every 6 hours. Third day went back to stat health and they increased the dose of prednisone to 60mg and continue taking Benadryl. Instructed to go to hospital if breathing problems arise.
Woke up on 1/21/21 with itching, redness, and mild localized swelling to vaccine site on L arm
About a week and a half after vaccinations, patient reported an allergic type reaction across her body.  She had itchy hives.  She wasn't sure if it was from vaccines or something else.  Patient recieved hydroxyzine and medrol dp for her symptoms.
? Sinus Problem     pain, pressure, congestion, PND, chest congestion ? Cough     deep productive cough SXS  EDC 07/08/2021
This spontaneous report as received from a registered nurse refers to two patients of unknown ages and genders. Pertinent medical history and drug reactions/allergies were not reported. On 24-MAR-2014, the patients received improperly stored, GARDASIL (lot # J006850, expiration date 31-MAR-2016) 0.5 ml, intramuscular; exposed to 31F for 84 hours. No adverse effect was reported. Additional information has been requested.
This spontaneous report was received from a healthcare worker and refers to unspecified number of patients of unkonwn age and gender. Concurrent conditions, medical history, concomitant therapies and known allergies were not reported. On unspecified dates since 30-JUN-2015, the patients were vaccinated with unknown number of doses of RECOMBIVAX HB (lot # reported as K020218, an expiration date 24-OCT-2016; dose, route of administration and anatomical location were not reported), which were improperly stored. No adverse effects were reported. This is one of the several reports received from the same reporter. Lot number K020218 has been verified to be a valid lot number for the RECOMBIVAX HB. Additional information has been requested.
2 cases of shingles; 2 cases of shingles; This spontaneous report as received from a pharmacist, who was informed by her aunt, refers to an unspecified female patient of an unknown age. No information regarding patient's pertinent medical history, drug reactions or allergies and concomitant medications was reported.  On an unknown date, reported as "years ago", the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot# and expiration date were not provided) for prophylaxis.  On an unknown dates, the patient experienced 2 cases of shingles after receiving the zoster vaccine live (ZOSTAVAX). The outcome of the events was reported as recovered on an unspecified dates.  The relatedness between the events and the suspect vaccine was not provided.
Covid-19 vaccine (Pfizer-Biotech) first dose (Lot # EW0161) was administered into the left deltoid on 4/19/2021 at 5:04 PM. The second dose was administered on 5/5/2021 at 5:15 PM or day 16.  The second dose was not administered with in the 4 day window and considered an "Administration Error."  Determination of how the error occurred and corrective strategies to prevent it from happening again were reinforced and implemented.  Patient came early as she thought she saw a pop-up window when she had registered for first dose stating that her second dose was May 5 and this is the date she put on her calendar. Patient received her first dose and second dose at a vaccination Center.  The actual e-mail she showed the staff and her CDC card both stated the correct date of May 10th. Thus, both registration and the vaccine floor did not correctly identify the date the second dose was to be administered.  Patient did not realize until after the second shot had been administered that her card actually said she was due May 10th.  She brought it to attention of the staff, post facto.    Corrective action included reminding registration, nursing, and data entry staff leads the following morning to be certain that each person verifies the vaccine is occurring within the 4-day window of the due date and not earlier.   Patient was discharged home following an uneventful observation.
COVID 19 Treatment; COVID 19 Treatment; Dose Number: 4:Moderna / Dose Number: 3:Pfizer / Dose Number: 2:Pfizer / Dose Number 1:Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 80-year-old male patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: en9581), in left arm, on 25Feb2021 as dose 2, single (Lot number: en6203), in right arm and on 31Dec2021 as dose 3 (booster), single (Lot number: 701-021) at the age of 79 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Apr2022 as dose 4 (booster), single (Lot number: 59267-1000-02), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Semvistatin, start date: 05Mar2015. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Dose Number: 4:Moderna / Dose Number: 3:Pfizer / Dose Number: 2:Pfizer / Dose Number 1:Pfizer". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Positive, notes: rebound. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient had received other medication in 2weeks. Patient had not known allergies.
I received 3 vaccines. Hep A first dose, Yellow Fever, and typhoid. Within the hour of receiving the vaccinations I had waves of nausea and head aches as well as tenderness in my left ear. These symptoms lasted from Thursday - Sunday. On Sunday I had a migraine from the moment I woke up at 7:30am - 9:30pm when I dozed off to sleep. I slept for less than 30 minutes only to be awaken by pain and a severe itching in my eyes only to realize that both eyes were swelling and red. My eyes continued to swell and deepen In Color  over the course of an hour almost to the point of shutting. I took two Benadryl although there was no immediate relief. I thought it best to be driven to the Emergency room, I was checked in but by then the Benadryl had slowly started working and alleviating some of the swelling and welts around my eye.   The swelling and red color in my eye stayed for 20 hours even after more Benadryl and Zyrtec has been taken by me.
Information hs been received from a physician concerning a 15 year old female who was vaccinated with GARDASIL. The patient developed genital warts after completing the GARDASIL series. The outcome of the patient was unknown. The patient sought unspecified medical attention and was seen by the physician. Additional information has been requested.
23JAN recv vax & cried for 2 days, leg swelled & fever 101 x 4 days
pain in arm like something had punched me there real hard.  sick with a fever and lost muscle  and weight.  the real actual onset started on 10/31/2022 and has lasted ever since.
Awoke 2/4/2021 with flushing to cheeks and swelling from my eyes down to my cheeks.  Rapid pulse (>120 bpm), and my normal benign tremor was significantly worse.
Dizziness-for about 1 hour; extreme fatigue for about 5 hours.  Periods of chills for several hours.  Rested/slept during the day to aid in the recovery.
1/4/21- First dose: general symptoms: headaches, muscle pains, fatigue. Second dose: 1/26/21- general symptoms: diarrhea, joint pains, fatigue, headache, fever Narrative:
Shortly after giving meningococcal vaccine U2643AA 11/09; Patient turned pale become limp and fell to the floor; BP was 86/40 - O2 was administered
The mother reported that the patient has had 3 diagnosed cases of chicken pox. The first case was in approximately September 1998. The patient had 3 or 4 lesions on his arm but he had no fever. Then in March 2000, he presented with 20 lesions and a fever. On 12/22/2000, he presented again wtih 90 lesions and no fever. It was reported the patient recovered early January 2001. The physician's office did not have documentation on the breakthrough rash occurring in the Fall of 1998, or March 2000 that the mother reported. No additional information is expected.
He received shots PROQUAD and KINRIX (L) thigh on 6-15-18, the next day there was swelling and redness at the injection site, gradually increased and limping in the afternoon. Mom applied ice pack and gave MORTIN the next day (48H) he woke up w/whole (L) thigh swollen more rash and painful, itching. Seen at urgent care, given BENADRYL.
Got hot Blood pressure went to 150/110 Full blown vertigo attack 3 hours after vaccine.  Limbs were limp Lethargic
This spontaneous report as received from a physician refers to an unknown number of patient of unknown age and gender. The patients' pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with VARIVAX (lot # N026070, expiry date: 20-SEP-2019; lot # N019822, expiry date: 13-JUL-2019; lot # M023380, expiry date: 11-MAY-2018) subcutaneously for prophylaxis following temperature excursion (product storage error). The temperature excursion ranged between -14 degrees Celsius (C) to -10 C for 11 hours and 35 minutes on an unknown date. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. Product quality complaint (PQC) was not involved.
This spontaneous report as received from a physician refers to a 13-year-old female patient. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 09-JAN-2017, the patient was vaccinated with properly-stored GARDASIL 9 injection (dose, route of administration, lot # and expiry date were not reported) for prophylaxis. On an unknown date in 2017 (reported as "shortly after receiving the GARDASIL 9 injection"), the patient began experiencing symptoms of depression, further described as feeling tired, not feeling well, not eating well and feeling depressed. The physician reported also that the patient used to be outgoing and on an unknown date in 2017 (reported as "now"), she was not going out, was sleeping all the time, felt depressed and was missing days at school. The physician reported that due to missing days at school, the patient "got a D in math at school for the first time in her life". On an unknown date in approximately 2017, the physician did the Columbia Depression Scale with the patient and she scored a 9. On an unknown date, the patient had a thyroid-stimulating hormone laboratory test performed, which result was normal. The outcome of the events was unknown. The relatedness between the events and GARDASIL 9 was not reported. Additional information is not expected because there was no consent to contact the physician.