chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 07-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional by phone. This case involves a 6 months old male patient who was vaccinated with a 0.5 ml dose of ACT-HIB (Batch number: UI987AAA and expiry date: 01-Apr-2020) via subcutaneous route in the left thigh on 04-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVENAR and POLIO VACCINE on the same day of vaccination. It was a case of actual medication error due to inappropriate route of vaccination. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none.
This spontaneous report as received from a Registered Nurse refers to multiple unspecified patients of unknown age and gender. On an unspecified date the multiple unspecified patients were administered VAQTA (Lot# unspecified) dose, frequency, route and location unspecified was stored improperly (first exposed to 9C for 30 minutes and then exposed to 8.3C for 1 hour). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
10 x 12 cm area of induration , erythema, and warmth at site of injectino of IPV and Daptacel (left arm). No fever.
Left lymph node in jaw swollen and couldn't bite or chew on left side; Left lymph node in jaw swollen and couldn't bite or chew on left side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Mar2021 15:00 (Lot number: EN6207) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Acid Reflux" (unspecified if ongoing); "Blood thinner" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS taken for blood disorder, start date: 15Apr2020 (ongoing); ATORVASTATIN taken for blood cholesterol, start date: 15Apr2020 (ongoing); LISINOPRIL taken for blood pressure measurement, start date: 2018 (ongoing); OMEPRAZOLE taken for gastrooesophageal reflux disease, start date: 12Dec2020 (ongoing). The following information was reported: LYMPHADENOPATHY (non-serious), JOINT STIFFNESS (non-serious) all with onset 16Mar2021 07:00, outcome "recovering" and all described as "Left lymph node in jaw swollen and couldn't bite or chew on left side". Therapeutic measures were taken as a result of lymphadenopathy, joint stiffness.  Additional information: The treatment for events lymphadenopathy, joint stiffness with tylenol and cold compression. No prior vaccination within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Mother did not report any adverse effect so far as this was admisnitered today. I encouraged the mother to monitor closely for any major adverse events
This spontaneous report was received from a nurse regarding a currently 1 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 23-APR-2018, the patient was vaccinated with a dose of the following vaccine that was improperly stored: VARIVAX lot # N027000 and expiration date 28-SEP-2019, per unknown route (frequency and anatomical location were not reported) for prophylaxis. The dose of VARIVAX vaccine was exposed to a temperature excursion at or above 6° Fahrenheit (°F) up to 14 ° Fahrenheit (°F) with a time frame of 15 hours. There was a previous temperature excursion of the same temperatures for 48 hours. A digital data logger was involved. Furthermore, no product quality complaint (PQC) was involved.
This spontaneous report as received from a register nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 07-JAN-2014, the patient was vaccinated with GARDASIL intramuscular (dose, strength, lot number and expiration date were not reported). Secondary and concomitant therapies were not reported. Nurse reported that a patient was administered dose two of GARDASIL on 10-NOV-2013 and dose three of GARDASIL on 07-JAN-2014, which was only six weeks interval. No adverse effects reported. Additional information has been requested.
spots & rash it was shingles, hospitalized for colon cancer surgery; pimples on back; itched like crazy; felt like sand; does not remember anything, was not alert; spots and rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included colon cancer (had colon cancer prior to shingrix vaccination).   On 03-OCT-2022, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: spots & rash it was shingles, hospitalized for colon cancer surgery), pimples (Verbatim: pimples on back), pruritus (Verbatim: itched like crazy), feeling abnormal (Verbatim: felt like sand), disturbance in attention (Verbatim: does not remember anything, was not alert) and spot-like rash (Verbatim: spots and rash). The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). The outcome of the shingles, pimples, pruritus and feeling abnormal were not reported and the outcome of the disturbance in attention was unknown and the outcome of the spot-like rash was recovering/resolving.   It was unknown if the reporter considered the shingles, pimples, pruritus, feeling abnormal, disturbance in attention and spot-like rash to be related to Shingrix.     It was unknown if the company considered the shingles, pimples, pruritus, feeling abnormal, disturbance in attention and spot-like rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-Mar-2023 Reporter was a female patient and reports that she received the 1st dose of Shingrix on 3rd October 2022.  She was admitted to the hospital for a week 29th November 2022 for colon cancer surgery to have part of her colon taken out.  Her cardiologist and pulmonologist both had to be aware of what was going on with her prior to performing the colon cancer surgery, and were checking her all over, and the pulmonologist saw spots and a rash on the patient's back, on her left shoulder beyond where her underarm was on her left side, and a few at her waist on her right side.  The pulmonologist told the patient these spots and rash were shingles. 29th November 2022, while she was preparing for the colon surgery, and the patient was put on an antiviral (unknown product) for about a week.  The patient did not remember anything about the week she was in the hospital as the surgery took 11 hours, and she was not alert for the entire week after. The patient did say a couple of the places (spots and rash) took a long time to heal over, and a couple of the places on her back were like pimples, and the areas involved felt like sand and itched like crazy. Did not consent to follow-up.
This subject is a female with the date of birth of 11/4/2003, who expired while enrolled in a comparative post marketing safety study of Daptacel (Diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed) administered with other recommended vaccines according to the standard of care at 2, 4, and 6 months of age in infants and as a booster to toddlers. The subject received two dosed of the study vaccine. The last dose prior to the event was given on 3/4/2004. Other vaccines administered on that day included a dose of ActHib lot number UE210AA (manufacturer lot number X0411-3). this subject, with a congenital anomaly, suffered from Lissencephaly and hypotonia and required g tube feedings. She expired 25 days post immunization. Autopsy was not requested. The event of a congenital anomaly was reported by the investigator as unrelated to the study vaccine. no additional information is pending at this time. Death Summary received which revealed lissencephaly, failure to thrive, Pierre-Robin syndrome and global hypotonia w/recent URI & dyspnea.
Severe Chills for 5hours, fever at 101.7 for 19 hours, rash on trunk of body and left arm near injection site, some wheezing.  Rash still has not gone away
Patient received vaccine on Monday 9/17/18. Started on Thursday night 9/20/18, patient had a rash on chest. Site is itchy and red. Patient was at doctor's office on 9/21/18 and the nurse reported the reaction to pharmacy.
Patient was in office for 11-year-old well child check. HPV, Tdap, Menveo, and Covid vaccine was ordered for patient. In error MA gave patient a Trumenba.
Patient had received flu shots in past with no adverse reaction. All questions answered no on form. Patient received flu shot in left deltoid at approximately 1150am. At 1210 patient's mother came running in saying her daughter had passed out in her father's arms. When I arrived in the waiting room, the patient was conscious, normal heart and lung sounds, no rash noted. Patient was hot, pale and appeared as though she was still a little out of it. Recommended patient be seen. Parents did not want an ambulance called. Pediatricians office called by mother. Both mother and father traveled with patient in their own car.
Almost 11 hours I began to have controllable body tremors. I could not keep my hands steady. Entire body was in this state of shaking jitters. Then severe pain in all joints for duration on 24 hour period. Ankles, toes, fingers wrists. Felt like burning deep pain. All subsided by taking both Tylenol and Advil within 24 hours.
Blood Clot in my left kidney.  8am on May 9th I started to feel pain in my lower back which quickly moved to my left lower abdominal area and intensified in pain.
took 1st capsule Sunday & ok; took 2nd capsule 29SEP 430AM & 15 mins later felt hipper & later on irritable & chest tightness & both of ears felt warm;
Red 3 inch x 4 inch rash at injection site.  So far I?ve had it for 3 days. It continues to get redder and itchier
rash on upper back area, behind ears and itching down left arm; rash on upper back area, behind ears and itching down left arm; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 02Mar2021 at 15:30 (Batch/Lot number was not reported; at the age of 54 years old) as dose 1, single for COVID-19 immunisation.  Medical history included asthma, prediabetes, and Penicillin allergy. Concomitant medications included fluticasone propionate (FLOVENT HFA) and hydrochlorothiazide. No other vaccine in four weeks. The patient experienced rash on upper back area, behind ears and itching down left arm on 04Mar2021 at 06:30 AM. The patient did not receive treatment for the events. No history of COVID prior to vaccination and has not been tested for COVID post vaccination. The patient is recovering from the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient experienced severe adverse reaction to PENTACEL given 7-17-09 left arm.  Had swelling, pain, huge bullae which when pressed caused vesicles to enlarge - skin was leathery, orange peel texture.  Prescribed KEFLEX by ER doctor. Note:  Mother failed to mention adverse reaction to DTAP at previous pediatrician's office in 5 of '06.
My tongue started going numb and tingly after 3 hours. Took Benadryl thinking it was an allergic reaction. Later I noticed I lost the sense of taste for sweet items. My tongue and gums were sore and painful. About a week or so later, I developed blisters under my tongue and gums.  I went to the dentist and he confirmed it was an autoimmune response to the shot. He advised to continue with a peroxide rinse. Blisters are slowly going away and pain is gone.
had a lot of heart palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "had a lot of heart palpitations". The event "had a lot of heart palpitations" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Consumer stated she was calling about the Pfizer vaccine for coronavirus and stated for her 2nd dose that she had, she had a lot of heart palpitations and did not report this and called the doctor office and they had her come in the following day and she did an EKG and she assumed the doctor's office reported this and she finally saw the doctor and the doctor told her that the vaccine pushes the immune system and affects the body all over and she does not believe the doctor's office reported this about her.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
TOOK VIVOTIF 1 HOUR AFTER EATING FOUR PIECES OF PIZZA; This spontaneous case report (PVX2019-1787) report was received from a healthcare professional on 11-Jul-2019. It describes a 26-year-old adult male consumer who "took Vivotif 1 hour after eating four pieces of pizza", (PT: Product administration error) while being on oral Vivotif (one dose every other day) for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif 1 hour after eating four pieces of pizza. The first dose was taken on 09-Jul-2019 and the second dose was taken on 11-Jul-2019 (without food).  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took Vivotif 1 hour after eating four pieces of pizza" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif 1 hour after eating four pieces of pizza" was considered as not applicable.
1 day after vaccination, patient developed itching around vaccination site. Then the next day, swelling in the vaccination site developed; this resolved. 8 days after vaccination, she developed a rash around the vaccination site that has increased in size over time and is itchy at times. Zyrtec controls her itching.
Administered to pregnant patient; This spontaneous prospective pregnancy report was received from an immunization coordinator via company representative concerning a female patient of an unknown age.  The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported.  On an unspecified date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) (dosage regimen, route of administration, lot number and expiry date were not reported) for prophylaxis. It was reported the patient notified she was pregnant. Last menstrual period (LMP) or date of conception were not provided. No product quality complaint was involved. At the time of reporting, the outcome of exposure during pregnancy was unknown.
Fever 103, fussy, crying, decreased sleep, went to ER 9/1/07, dx with UTI and given Bactrim. Came to doctor office 9/3/07. Dx: Drug reaction vs. Early Stevens Johnson vs. Kawasaki Disease. Pt admitted to hospital x 7 days. Diagnosed with Kawasaki, peeling hand, feet, nail bed.   10/1/07 Received vax record which confirms RO dose & lot # as reported.  10/2/07 Reviewed hospital medical records which reveal patient experienced rash, fever, runny nose, diarrhea, conjunctival injection, oral erythema, cracked lips, swollen hands & feet & fussiness.  Admitted 9/3-9/8/2007.  Seen in ER for UTI & given IM & oral antibiotic on 8/30 & developed rash & fussiness on 9/1.  Returned to ER for tx w/antibiotic, steroids & antihistamine.  D/C to home.  No response to treatment & seen by pcp 9/3 who direct admitted.  Continued fever x 5 days.  Dermatology & cardiology consults done.  Tx w/IVIG & ASA & improved.  D/C to home on continued ASA & w/cardiac f/u.   FINAL DX: Kawasaki Disease.
Flu like symptoms (aches, chills, headache, mild fever) for one-two days. Longterm: increase in existing heart palpitations to frequently during the day no longer connected to exercise or anxiety
Not sleeping well; "how do I report a side effect"; Full body muscle aches; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Full body muscle aches), POOR QUALITY SLEEP (Not sleeping well) and VACCINATION COMPLICATION ("how do I report a side effect") in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Nerve pain and Fibromyalgia. Concomitant products included PREGABALIN (LYRICA) for nerve pain and Fibromyalgia.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Full body muscle aches), POOR QUALITY SLEEP (Not sleeping well) and VACCINATION COMPLICATION ("how do I report a side effect"). At the time of the report, MYALGIA (Full body muscle aches) had resolved and POOR QUALITY SLEEP (Not sleeping well) and VACCINATION COMPLICATION ("how do I report a side effect") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment medication  was not provided .   This case was linked to MOD-2021-320061 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Significant follow up appended- vaccination site complication added as an event
Redness approx. 4 inches in diam. on Lt. upper arm. Sl. swelling.
weakness; left eye twitching/main twitching was on the eye & on the left side; left finger twitching then left arm twitching on the top all over/ random twitching on the stomach on the arm and on her leg; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), BLEPHAROSPASM (left eye twitching/main twitching was on the eye & on the left side), MUSCLE TWITCHING (left finger twitching then left arm twitching on the top all over/ random twitching on the stomach on the arm and on her leg) and FATIGUE (fatigue) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058e21a) for COVID-19 vaccination.     The medical history information was not provided by the reporter.  Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR), GABAPENTIN and CLONAZEPAM for an unknown indication.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced ASTHENIA (weakness), BLEPHAROSPASM (left eye twitching/main twitching was on the eye & on the left side), MUSCLE TWITCHING (left finger twitching then left arm twitching on the top all over/ random twitching on the stomach on the arm and on her leg) and FATIGUE (fatigue). At the time of the report, ASTHENIA (weakness), BLEPHAROSPASM (left eye twitching/main twitching was on the eye & on the left side), MUSCLE TWITCHING (left finger twitching then left arm twitching on the top all over/ random twitching on the stomach on the arm and on her leg) and FATIGUE (fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The symptoms were ongoing, since every other minute.
dose #1 of Engerix-B given 17JAn95 24JAN95 urticaria for 3-4 days on face; 17FEB95 urticaria for 2-3 days on face; 5MAR95 urticaria again on face;
Frozen Shoulder Syndrome -  I complained with a call to the Pharmacy immediately following injection. I had two shots prior and this felt very different with muscle pain and immobility.  I also felt and reported the injection was up on the shoulder joint vs. the deltoid muscle.  I continued my daily exercise routine that included 40-50 morning pushups until the mobilization and pain became so severe I sought out medical attention.  No amount of over the counter medications or prescription muscle relaxers or rest/immobilization of shoulder relieved the pain.
Pt developed pruritis, erythema 8 min post vaccination. Symptoms initially started on neck then involved chest, face and arms. No uticaria, wheezing, cough, diaphoresis, chest or abd pain, no angioedema. Given 0.3mg IM of epinephrine in R lateral thigh. Erythema, itching improved after 2 min with residual itching on L forehead only.  VS remained stable bp 120-127/70-84; pulse 109-130; RR 19; pulse Ox 98%; Lungs-clear. EMS activated and pt transported to ER at 10:45am. She remained alert, oriented at all times.
Sever local reaction right upper arm and temp 103.0 about 24 hours after vaccine administration.  Treated with ice, NSAID, antihistamine.
Appendicitis with resulting appendectomy on 2/2/2021.. Started on 1/31/2021 with upper right quadrant abdominal pain and then progressed to fever. Appendix was found to be in upper right quadrant behind my liver and was removed via laproscope.. The CAT scan revealed a blockage of the appendix. Specifically it was said that I had an appendix stone.
My shot was at 3:30p last Wednesday;  I started feeling sick (nausea & generally cold) around 11:30 am on Thursday.  By 1pm on Thursday my fever was ratcheting up & I couldn?t control the chills (had on thermals & in bed under 3 blankets)?.that lasted until about 7-8 pm and then my fever shot up to 101.5 (but chills went away) and stayed there until Friday morning around 6am.   By 1 pm on Friday, I was 100% better.
Information has been received from a receptionist at a physician's office concerning an 8 month old male who on 27 Apr 2006, 20 Jun 2006 and 29 Aug 2006 was vaccinated PO with the first, second, and third 2.0mL doses, respectively, of Rotateq (human bovine) (Lot #65366/0138F). The receptionist reported that on 27 Sep 2006, the patient was diagnosed with rotavirus. Unspecified medical attention was sought.  No laboratory/dianostic tests were performed. At the time of this report, the patient was recovering. Additional information has been requested. Additional information is not expected.
Lymph nodes under injection arm swelled up significantly and lasted 1 or 2 weeks.
First COVID vaccine (Pfizer EL1284) received 1/5/2021. No Reaction.  Second COVID vaccine (Pfizer EL9264) received 2/2/2021. No reaction  3/15/2021 had a sore throat and thought it was allergies but since I work in home health I decided to get a COVID and strep test. Strep test came back negative. 3/16/2021 COVID test came back positive. A family friend that is a PCP told me to fill this out so you knew. I am symptomatic and have informed my work and everyone I have been in contact with they are being tested this week.