chrisvoncsefalvay/vaers-outcomes huggingface dataset:
on has been received from a licensed practical nurse concerning a 9 year old male with no known medical history who in 1996 was vaccinated with a dose of varicella virus vaccine live.  There was no concomitant medication.  On 07/16/2004 the patient was brought into the physician's office with a mild skin rash which started on 07/16/2004 and was reported to be chickenpox.  The patient was being treated with calamine lotion.  At the time of the report the patient had not recovered.  Additional information has been requested.
Vaccine given on 08/04/2021 on or about 08/21/2021 started with headaches, blurred vision, lethargic, stiff, painful hip and joint pains (unbearable pain).
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age or gender. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patients were vaccinated for GARDASIL 9 (dose, frequency, route of administration, injection anatomical location, lot# and expiry date were not reported), which were improperly stored. There were no concomitant or co-suspect therapies reported. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Intermediate Risk PE-diagnosed due to symptoms of pre-syncope, palpitations. Clinical history includes long car ride
7 days after vaccination he developed sensitivity to the right flank extending to the anterior chest and never crossing midline at dermatome distribution T6 and 7.
Significant fatigue 24 hours after injection. Brain fog, need to sleep. Next am felt better Left arm discomfort for week Day 4 after vaccine- nausea, mild congestion no fever Day 6 after vaccine mild congestion and significant headache
I experienced fever-like symptoms, tiredness, and soreness at the injection site after taking the 3rd dose. However around February 2022, my nose was stuffy. I experienced this severe pain in my neck, ear, & pain in my head. I went to my doctor and the ER. I was prescribed a muscle relaxer, Valium, and Toradol. The pain dissipated slightly.
Within minutes of receiving the 2nd dose of Pfizer vaccine the patient start to feel light headed, she saw stars, she vomited, she started to look pale and felt tightness in her chest. We called the EMTs and we advised the patient that syncope is something we have seen in children receiving the vaccine and the EMTs advised of the same thing. They took her vitals all normal and the patient began to see the symptoms disappear. The patient once better and cleared by EMTs went home per their advise.
This spontaneous report as received from a pharmacist refers to a 75 year old female patient with hypertension and no drug reactions/allergy. On 06-JUN-2013 the patient was vaccinated with a 0.5 ml dose of ZOSTAVAX (lot # J000495, EXP date 14-APR-2014) subcutaneously. Concomitant medication included unspecified anti-hypertensive agents. The patient experienced localized swelling at injection site after vaccination of ZOSTAVAX (on 06-JUN-2013). Pharmacist reported that seven days later (on 13-JUN-2013) the patient had a rash on both forearms made up of very tiny vesicles that did not itch or burn. Pharmacist stated that the patient reported that they went a few days later, and that now they are back. Patient sought medical attention by pharmacy visit. No treatment sought from physician at this time, no treatment used on rash. There were no labs performed. At the time of report, the localized swelling at the injection site remains unchanged. Patient had not recovered from events. Additional information has been requested.
5/3/10 11:00 am received MMR vaccination booster. Traveled to another state via air plane and back 5/13/10. Noted fever 102 degrees F and then a mild red dot rash on upper arms and trunk on 5/19/10. Notified doctor at hospital on 5/21/10 of symptoms.
Became extremely hot & went to check thermostat in house. Suddenly had no feeling in legs, i.e., felt like legs did not exist. Could not hold myself up. Fell down and landed on right side hip & knee.  After a minute or two, could get up on my own and feeling returned to legs.
No adverse event; HCP called to report an expired dose of VARIVAX was administered to Multiple patients. Patient Demographics provided for all patients, please see notes for additional case numbers. HCP gave permission to contact. No symptoms reported. No further AE d; Improper storage of product in use; This spontaneous report was received from a pharmacist refers to a 4-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-JUN-2023, the patient was vaccinated with one dose of expired and improper storage varicella virus vaccine live (oka/merck)(VARIVAX), lot#: W0252273, expiration date reported as: 02-JUN-2023, 0.5 milliliter (route of administration and anatomical location were not provided) for prophylaxis.  On 02-MAR-2023, administered dose of vaccine was exposed to the temperature excursion of 70 degrees Fahrenheit for 9 minutes. There were no additional adverse events reported (expired product administered, product storage error, no adverse event).  Lot number W0252273 has been verified to be non-valid lot number for varicella virus vaccine live (oka/merck) (VARIVAX) and does not match any Company product.  This is one of several reports received from the same reporter.
30 minutes after flu shot, she began to have itching on hands and soles of feet.  1% hydrocortisone cream applied to palms of hands and soles of feet, cold packs to feet - No shortness of breath - sent to be evaluated by physician.
Headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the COVID vaccine on Tuesday night (date unspecified) and experienced a headache on an unspecified date. Patient reported that within 5 minutes of receiving the vaccine, she took two Tylenol.  She would like to know if that lowers her immunity. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: ER8733), on 22Apr2021 as dose 2, single (Lot number: EW0175) and on 08Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 61 years for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 20Jul2022 as dose 4 (booster), single (Lot number: 055A22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; LOSARTAN; ATORVASTATIN, stop date: 20Oct2022; PALMETTO PLUS [EPILOBIUM PARVIFLORUM;SERENOA REPENS;URTICA DIOICA]. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: tested negative x2 done 48 hours apart; (2022) Negative, notes: tested negative x2 done 48 hours apart; (2022) Positive, notes: tested positive for COVID again on day 10. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient took Paxlovid and tested negative x2 done 48 hours apart then 9 days after last dose of Paxlovid, started coughing again and tested positive for COVID again on day 10.
48 hours post vax, the pt developed fever of 101 and irritability which lasted for 12-20 hours. Was seen in ER.
Patient began throwing up around 9:30 am. By 10:30 am she had thrown up twice and began showing signs of hives on her leg. By 11:30 the hives covered her body. She was taken to the emergency room where she was given a shot of epinephrine. When this happened her heart rate shot up, and she began to projectile vomit. After an hour the hives disappeared and then sent us home. Patient continued to throw-up at least once a day (at night) for one full week. After an allergy blood test it was determined that she now has a severe allergy to eggs which was not present at the time of the vaccination. She has been instructed to take Zyrtec, avoid egg foods, and carry an epi-pen.
Pain to touch, redness, pain to raise arm. We are now 2.5 days after immunization and symptoms persist. Have taken Advil. Arm still tender red, probably swollen and it hurts to raise arm.
The shot gave my mom shingles / Suspected vaccination failure; The shot gave my mom shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.     Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's comment: This case was reported by the Consumer via interactive digital media.  The reporter stated that, the shot gave his/her mom shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible, as no contact, details were available.
Information has been received from a licensed visiting nurse concerning a patient who on 17-SEP-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot # 658291/1100U) who experienced redness and induration at the injection site following vaccination. At the time of the report the patient's status was unknown. A product quality complaint was not involved. This is one of several reports from the same source. Additional information is not expected.
AREA AROUND INJECTION SITE BECAME VERY RED, SWOLLEN AND HOT TO THE TOUCH. THE AREA BEGAN TO SPREAD FROM THE SITE TO THE ELBOW. TREATED WITH KEFLEX, ATARAX AND TRIAMCINOLONE.
This is a 72y.o. female with PMH hypertension and arthritis with recent left knee replacement on 12/15/2021. She was recently admit at a HCF for CHF exacerbation. Had complete workup, Echo showed EF 40%, received IV lasix during hospitalization and discharged on 1/4. Tested positive on 12/30 for COVID. Again during this stay 1/10. Per patient, she is having worsen dyspnea. Daughter decided to bring her to facility for further veal and txt.  Up on exam this am, patient seems doing well. SOB is better.
Vaccine received 9-7-12. Incurred 102 degrees temp on 9-9-12, relieved by TYLENOL. Arm, at injection site, sore 9-10-12 no swelling.
No adverse reaction. Gave monovalent instead of bivalent. Patient will return in 2 months for the bivalent dose.
felt like I had covid starting 12 hrs after vaccine for about 20 hours.  I had previously had covid
Fever of 104, per mother started two days after vaccine-- swollen lips, red face, full body rash and hives. Was seen in local ED days later-- small rash, diagnosed with "viral exanthem", ED doctor did not feel it was related to vaccine. Given Prednisolone to treat.
Initial and follow up information has been received from a physician concerning a 22 month old white female with esophageal acid reflux and a history of bronchiolitis and incisional hernia repair, with no known food or drug allergies who on 02-OCT-2006 was vaccinated subcutaneously into the left arm with a first dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot # 655140/0832F).  Concomitant vaccine therapy that same day included a fourth dose intramuscularly into the right thigh of PREVNAR (Lot #B08683C), a first dose of HAVRIX (Lot #U2174DA) intramuscularly into the right thigh, and a first dose of FLUZONE (lot #U2174DA) administered intramuscularly into the left thigh.  Concomitant therapy included: PREVACID and ATARAX, (also reported to have been treatment).  On 21 AUG 2007 the patient, presented for a sick visit with a rash to the left anterior chest, left axilla, and scattered hives throughout body.  The mother noted that the patient had had a paradoxical reaction to BENADRYL the day before.  The rash was described as red, raised, blistery and had been spreading for the last 4-5 days, with an onset of approximately 16 SEP 2007.  It was reported that the sibling had a few red lesions on her neck 2 weeks ago.  The patient was afebrile, 97 degrees, (tympanic), healthy appearing, alert and interactive and in no acute distress.  The physical examination was essentially unremarkable.  Pin-point vesicles on a red base in small clusters were present on the left side of the chest, axilla, arm, and back.  A few isolated similar lesions were present on the right shoulder and leg.  No super infection was present.  Final assessment was Varicella without mention Comp, also reported as shingles.  A non-specific mild/resolving diaper dermatitis was also noted at the time of examination.  There was no illness at the time of vaccination.  The patient has no reported adverse events with previous vaccines.  Polysporin was prescribed to treat "the rash".  At the time of reporting the patient was considered recovered, date unknown.  Symptoms reportedly persisted until "Labor Day" 03 SEP 2007.  It was also confirmed that the patient had only one episode of shingles.  There was no product quality complaint.
For ten days since the second dose of Covid Pfizer: chills, loss of appetite, extreme malaise and fatigue, brain fog.
throat itching; lip swelling; tongue swelling; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (throat itching), LIP SWELLING (lip swelling) and SWOLLEN TONGUE (tongue swelling) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 004C21A) for COVID-19 vaccination.     No relevant medical history reported.  Concomitant products included HYDROCHLOROTHIAZIDE, AMLODIPINE, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), SIMVASTATIN, CLONAZEPAM, MELATONIN and HYDROXYCAMPTOTHECIN for an unknown indication.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced THROAT IRRITATION (throat itching), LIP SWELLING (lip swelling) and SWOLLEN TONGUE (tongue swelling). The patient was treated with LEVOCABASTINE HYDROCHLORIDE (ZYRTEC [LEVOCABASTINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, THROAT IRRITATION (throat itching), LIP SWELLING (lip swelling) and SWOLLEN TONGUE (tongue swelling) had resolved.            Concomitant medication includes multivitamin, Hepaguard
Information has been received from a certified medical assistant concerning a healthy 9-year-old female with no pertinent allergies, who on 23-FEB-2000 was vaccinated subcutaneously with a 0.5 milliliter dose of varicella virus vaccine live (Oka/Merck) (lot# 632276/1454J). There was no concomitant medication. On 23-OCT-2007, the patient developed chicken pox and was seen in the doctor's office on 25-OCT-2007 with about 50 scattered papular, crusted lesions. No laboratory or diagnostic tests were performed. The outcome was reported as recovering. No product quality complaint was involved. Follow-up information received indicates that the patient was vaccinated in the right arm with varicella virus vaccine live (Oka/Merck) (lot# "1126J"). On 23-Oct-2007, the patient developed 75-100 lesions all over. Culture of a lesion revealed a staph infection. The patient was given clindamycin and Bactroban was used on the lesions. On an unspecified date the patient recovered. Additional information is not expected.
Work up on Wednesday with sore throat, head fog, and fatigue. Could not work wed or thurs, worked Friday morning and felt better. Saturday experienced fatigue. Sunday woke up with larger swelling and redness near injection site. Took ibuprofen and allergy pills throughout. Used neosporin on injection site on Sunday morning.
Pt to clinic for immunizations. NKA. Immunizations given per PHN protocol. Pt and mother educated on need to remain in clinic for at least 15 minutes after immunizations. Pt and mother chose to wait in waiting room instead of exam room. Pt and mother walked to front of clinic, mother stopped at clerical window to check out, pt proceeded to restroom. Clerical staff heard pt bump against front window next to bathrooms and fall to floor. Clerical staff called for nurse, when I arrived pt was sitting in floor, pale in color but alert and oriented x 3. Two other clinic nurses and her mother arrived within 1 to 2 seconds of my arrival. Pt stood and was assisted to a chair and was rolled to an examination room. Pt was talking while being transferred to exam room. Approximately a minute after arriving in the exam room while speaking with mother pt began to pass out again. Pt lost muscle tone and eyes lost focus for 2 to 3 seconds then the patient regained facilities and was alert and oriented x 3. Pt drank 2 sips of apple juice then stood and was assisted to bed in exam room. 911 had been called and paramedics were in route. Cold, wet paper towels were applied to neck and chest, legs were elevated above head. VS were assessed. Paramedics arrived on scene and transported pt and mother to nearest ER.
9/9/09 - large local reaction - 29 inch area swelling, erythema at site of injection  -  Also ear pain on left - 9/10/09 - Swelling left face, arm, hand, leg, ankle treated with BENADRYL and Prednisone 50 mg for 3 days then tapered - 9/11/09 - Swelling improved - Urticaria began  - 9/12/09 Symptoms improved by 9/17/09 - Symptoms resolved.
Arrhythmia for 16 hours and unusual tiredness and 10 hours sleep; next day ok; following evening (10/11/2009) muscle tightness and extreme chills that lasted for about 4 hours; next day developed a headache in the afternoon followed by stomach cramps and diarrhea; the next copule of days these symptoms persisted but at much lesser intensity;
fever as high as 101.; I feel like a truck ran over me; felt like a truck was ran over; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 21st May 2020, the patient received Shingles vaccine. On 22nd May 2020, 1 days after receiving Shingles vaccine, the patient experienced fever, general body pain and feeling abnormal. On an unknown date, the outcome of the fever, general body pain and feeling abnormal were unknown.   It was unknown if the reporter considered the fever, general body pain and feeling abnormal to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. On 22nd May 2020, the patient felt like a truck was ran over the patient.  The patient's body temperature was recorded as 101 degree F and 99 degree F. the patient was asked was this unusual after vaccine nation.
I began to have a sharp pain under my right breast at about 1:00 pm 11/03/05 all across my chest and stomach felt sore. My thought was I got cold in my stomach. Then the pain worsened to the point that my breathing was causing the area around my stomach to just ache terrible. I called my family doctor 11/03/05 about 6:00pm I left a voice message. I tried to wait to hear from her but I became more agitated. Finally my daughter 11/04/05 11:00 am called a friend and took me to  the ER. I told the doctor I was having a lot of pain and it hurt to breathe. I also told him I had taken a Flu vaccine 11/01/05. The doctor ordered blood work a ultra sound a chest x ray and an EKG. I ask the doctor to give me something for pain so I could rest. I was given a shot for pain and something for my stomach. I started to feel better and there was no more pain. I stayed in the ER about six hours The doctor discharged me with two prescriptions 1 for Ranitidine 150 mg Ibuprofen 600 mg. I have a appointment to see my primary physician on  November 15 2005 at 3:00 pm.
Information has been received from a consumer concerning her son (a "43 year old" male) who "developed autism after receiving a dose of MMR II". Consumer also reported that "after the patient, who is her son received a dose of DTP he had a severe high fever and swelling." The consumer also reported that "after she received DTP she experienced swelling of the arm." Upon internal review, autism was determined to be an other important medical event. No further information is available.
Fever up to 102, headache, joint/body aches, nausea. Lasted for 28 hours
Hives all over the body; Sun burns/couldn't stay under sun for 5 min; Allergic reaction to any of the ingredients of Moderna COVID-19 vaccine; Bad skin rash all over the body; Itchy; Red spot around the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives all over the body), SUNBURN (Sun burns/couldn't stay under sun for 5 min), ALLERGY TO VACCINE (Allergic reaction to any of the ingredients of Moderna COVID-19 vaccine), RASH (Bad skin rash all over the body) and VACCINATION SITE PRURITUS (Itchy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. P38A21A and 0LYM20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE) for Hypothyroidism, CITALOPRAM HYDROBROMIDE (CELEXA [CITALOPRAM HYDROBROMIDE]) for Panic attacks, VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy). In April 2021, the patient experienced URTICARIA (Hives all over the body), SUNBURN (Sun burns/couldn't stay under sun for 5 min), ALLERGY TO VACCINE (Allergic reaction to any of the ingredients of Moderna COVID-19 vaccine) and RASH (Bad skin rash all over the body). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red spot around the injection site). On 03-Apr-2021, VACCINATION SITE PRURITUS (Itchy) had resolved. At the time of the report, URTICARIA (Hives all over the body), SUNBURN (Sun burns/couldn't stay under sun for 5 min), ALLERGY TO VACCINE (Allergic reaction to any of the ingredients of Moderna COVID-19 vaccine) and RASH (Bad skin rash all over the body) outcome was unknown and VACCINATION SITE ERYTHEMA (Red spot around the injection site) had resolved.            No treatment products were reported.
prior to MAR93 pt exp loss of fatty tissue of face, neck, upper arms, & upper trunk;MAR93 pt began to exp erythema nodosum;pt exp livedo vasculitis on both legs & vasculitis of the lt forearm;had swelling of both legs;lethargy;
ABOUT 10 MINUTES AFTER SHOT THERE WAS BURNING AND THAT EVENING IT WAS SWOLLEN AND VERY RED.