chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain at the injection site; fatigue; spacey; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), via an unspecified route of administration on 22Dec2020 at 15:00 at a single dose in the left arm to prevent Covid. The patient's medical history included ongoing blood pressure high, ongoing cholesterol, ongoing anxiety, and ongoing sleep disorder. Concomitant medications included pravastatin for cholesterol, amlodipine besylate for blood pressure high, lisinopril for blood pressure high, zolpidem tartrate (AMBIEN CR) for sleep, olanzapine for anxiety, all ongoing. On 10Jan2021, the patient noticed feeling fatigue and spacey. On an unspecified date, the patient stated that she did get some pain at the injection site and took Aleve 2 capsules as needed. The patient considered the events fatigue and spacey as non-serious. The outcome of the events fatigue and spacey was recovered on 10Jan2021, while unknown for the other event.
3:41 PM: Client reported dizziness and vomited. 3:42 PM: With assistance from client's father, client lowered to floor, feet raised, cold compress given. 3:52 PM Client had juice and reported feeling "better", client assisted to seated position in chair. 3:54 PM Client vomited again and asked to return to lying position on floor. Client reported feeling dizzy. 3:56 PM EMS called. 4:04 PM EMS arrived and assessed client. 4:13 PM EMS transported client to hospital for assessment.
she is losing weight from something else that was detected, pancreatitis-like, they located a mass on the pancreas on 16Mar2021; she is losing weight from something else that was detected, pancreatitis-like, they located a mass on the pancreas on 16Mar2021; they saw something like an ulcer on the pancreas head, with cancer cells, it is localized, it is serious; they saw something like an ulcer on the pancreas head, with cancer cells, it is localized, it is serious; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 54-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 12Mar2021 as SINGLE DOSE for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included vitamin D3, multivitamins, and some other supplements. It was reported that the patient was in a delicate health situation that was discovered, she was losing weight from something else that was detected, pancreatitis-like, they located a mass on the pancreas on 16Mar2021, they saw something like an ulcer on the pancreas head, with cancer cells, it was localized, it was serious, and she received chemo after the first dose. This came up from an accident she had in Jan, the airbag opened and hit her stomach. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
NO ADVERSE EVENT.  PATIENT WAS GIVEN BIVALENT DOSE, WHEN DUE FOR MONOVALENT DOSE.
Tenderness; Hurting after Shingrix administration.; Ocular migraine; skull cap headache; headache; Chills; Not feeling well; Feeling horrible; Pain in arm; Nausea; Profuse sweating; yelling in her sleep; Redness / of arm at injection site; harness of arm at injection site; Itching; This case was reported by a nurse and described the occurrence of chills in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ophthalmic migraine.   On 16th September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In September 2020, 24 hrs after receiving Shingrix, the patient experienced chills, feeling unwell, feels awful, pain in arm, nausea, sweating, sleep talking, injection site erythema, injection site induration, pruritus and headache. On an unknown date, the patient experienced tenderness, pain, ophthalmic migraine and migraine. The patient was treated with naproxen (Aleve) and paracetamol (Tylenol). On 23rd September 2020, the outcome of the chills, feeling unwell, feels awful, pain in arm, nausea, sweating, sleep talking, injection site induration and pruritus were recovered/resolved. On 27th September 2020, the outcome of the ophthalmic migraine was recovered/resolved. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the tenderness, pain and migraine were unknown and the outcome of the headache was recovered/resolved.   The reporter considered the chills, feeling unwell, feels awful, pain in arm, nausea, sweating, sleep talking, injection site erythema, injection site induration and pruritus to be related to Shingrix. It was unknown if the reporter considered the tenderness, pain, headache, ophthalmic migraine and migraine to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that a little over 24 hours later after received Shingrix she began to experience multiple symptoms including chills, not feeling well, feeling horrible, pain in arm, nausea, profuse sweating, yelling in her sleep, redness and harness of arm at injection site and itching. Lot and Expiry date were unknown. Nurse stated that the patient also experienced tenderness, hurting after Shingrix administration.  She also experienced headache 24 hours after receiving Shingrix and that it was intermittent and resolved by Monday.  Headache was relieved by Aleve and Tylenol. She also experienced an ocular migraine that started Thursday and was gone by Sunday.  It was like a skull cap headache.  She's experienced Ocular migraines in the past but never had a severe migraine. The reporter consented to follow up. The case had been linked with US2020190562 same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020190557:same reporter US-GLAXOSMITHKLINE-US2020190562:same reporter
Information has been received from a male pharmacist of unknown age referring to himself. The patient had no pertinent medical history or drug reactions/allergies. On 25-JUL-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route were not reported) as a vaccination. There was no concomitant medication. On the same day the patient developed redness, swelling, and itching at the injection site after administration of ZOSTAVAX. No lab diagnostics studies were performed. The patient did not seek medical attention. The injection site reactions resolved in 1 week without requiring medical treatment (in 2014). The causality was not provided. Additional information has been requested.
Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 20-APR-2015, the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Patient given Moderna in 21 days instead of 28 days or more. He has not had any symptoms.
PAIN STARTED IN THE AFTERNOON, FOLLOWED BY DIFFICULTY MOVING HIS ARM. PAIN AND DECREASED RANGE OF MOTION CONTINUED ON 10/10/2013. ICE, IBUPROFEN, BAYER ASPIRIN. IBUPROFEN 600 MG AND CYCLOBENZAPRINE 10 MG RX'D BY PROVIDER ON 10/10/13. ALTERNATE ICE WITH HEAT, ENCOURAGE SMALL RANGE OF MOTION EXERCISES.
patient developed leg pains bilaterally. went to emergency room and diagnosed with DVT in right leg
Pt received Twinrix #1, 1cc, IM, in left deltoid and Typhium VI, 0.5cc, IM, in right deltoid at 09:20. He felt dizzy for several minutes after injections. Returned at 11:30 with complaints of bilateral buttocks and thigh achiness. Given Tylenol and told to rest. Symptoms resolved. At 21:30, went to ER with a temperature of 102F and feeling poorly. Evaluation done by doctor.
Fever above 100.4. Vomiting - mulitple times, diarrhea, lethargic, difficulty breathing - tongue/lips turned blue, decrease in appetite, extreme tiredness.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 38-year-old male. Neither medical history nor concomitant medications were reported. On an unspecified date in Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.
heart rate increased to 104-108 beats; didn't sleep well; felt tired; This is a spontaneous report from a contactable other-health care professional (Patient). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP6955 and expiration date was not reported), second dose via an unspecified route of administration, administered in arm left on 27Mar2021 10:15 (at the age of 60 years) as single for COVID-19 immunization. Medical history included HTN, GERD followed by known allergies (as yes) from an unknown date and unknown if ongoing. Patient Concomitants were not reported. Patient did not receive any other vaccines within 2 or 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN5318 and expiration date was not reported), first dose via an unspecified route of administration, administered in arm left on 06Mar2021 11:15 (at the age of 59 years) as single for covid-19 immunisation caused insomnia, patient couldn't fall asleep until 4am that night. On 27Mar2021 21:00 the patient experienced heart rate increased to 104-108 beats which started 9pm the day of vaccine 2 and lasted until the next day about 2pm, didn't sleep well, felt tired. The patient underwent lab tests and procedures which included heart rate found to be 104-108/returned to my normal resting rate on 27Mar2021 (increased beats per minute) and Nasal Swab test found to be negative on 05Apr2021. The outcome of the events was found be recovered on unspecified date of 2021.   No follow-up attempts are possible. No further information is expected
Tested positive for Covid-19 on 8/2/2021.  Acute hypoxic respiratory failure due to Covid-19
16cm red & warm surrounding injection site of her mid upper arm on exterior surface. Dx: cellulitis. Dr. prescribed antibiotic & Dicloxacillin 500 mg 1 qid #40, no refill. Following 8/11/11 mom called back & left message - patient doing better.
Two days after shot got runny (dripping) nose. When standing or sitting nose would drip onto food, book, floor or shirt sleeve. No problem when laying down to sleep. Problem went away after 2 1/2 months. Note In Dec. 2017 was found to have Glaucoma and prescribed eye drops for daily use. These may or may not have contributed to longevity of my nose problem. Note Regular dose flue shots received in previous years did not cause any problems. Patient comment High Dose flu shots may not be suitable for all seniors. Because of my problem, I have since refused to have flu shots. I've learned to live with this as well as other side effects of "preventative" medicine which "might" contribute to longer life.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 57-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. In October 2018, the patient received the 1st dose of SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. In October 2018, less than a week after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced fever, muscle pain, feeling cold and headache. On an unknown date, the outcome of the fever, muscle pain, feeling cold and headache were not recovered/not resolved. It was unknown if the reporter considered the fever, muscle pain, feeling cold and headache to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows. The reporter was the son of the patient. He did not know for sure if his dad (patient) had the a dose of SHINGRIX 2 or 3 days before the time of reporting. The patient started experiencing symptoms and had not recovered till the time of reporting. The patient did not know when the symptoms started. The patient also received the flu vaccine on the same day as having the dose of SHINGRIX. The reporter did not know the brand of the flu vaccine.
Patient was given the immunization and as I was talking to him after the immunization he told me his palms were sweaty and he wasn't feeling well. His pupils got large and he then passed out. Code white was called, 911 was called, we got an ice pack and placed on his chest and a cold rag on his head. After about 10 seconds, he regained alertness. EMT arrived and accessed the patient. His blood pressure was normal and pulse was normal. He was given a cold drink and sat in the chair until he felt better.
Erythematous indurated rash (nodular) over L thigh, no leg, R lower extremity L.
On 3/28/06, patient complains of soreness, edema and erythema on left upper arm extending from deltoid to elbow. States inflammation has not increased over past 24  hrs. Advised to take antihist6amine and use ice 5-10 min as necessary, pain reliever and go to urgent care if s/s worsen.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Shakiness-Mild, Additional Details: EMS was called, pt said she was feeling fine and didn't want to go with EMS.
Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder pain) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced ARTHRALGIA (Shoulder pain). The patient was treated with PARACETAMOL (TYLENOL) for Shoulder pain, at a dose of 1 dosage form. At the time of the report, ARTHRALGIA (Shoulder pain) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided.   This case was linked to INC.-MOD-2021-081263, INC.-MOD-2021-082203 (E2B Linked Report).
got severe case, hospital 4x; had shot and got severe case/suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had them at 14 year of age), bedridden (was in bed 2 months) and sickness (was very sick).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had shot and got severe case/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got severe case, hospital 4x) (serious criteria hospitalization). The outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved (duration 8 months).   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 16-Mar-2023 The case was received from the patient via  interactive digital media. The patient asked that what was shingles. The patient had the shot and contacted a severe case and under he/she hospital 4 times took 8 months to get over. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
A report has been received from a Health Professional concerning a 50 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 26-Oct-2014. 50 year old patient received FLUMIST QUADRIVALENT. The outcome of the event of 50 year old patient received FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
No additional AE reported.; Nurse reports improperly stored PROQUAD was administered.; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, and drug reactions or allergies were not reported. Concomitant medication included sterile diluent.   On 13-NOV-2022, the vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (PROQUAD) lot #W012730 with expiration date 16-OCT-2023 had an excursion of temperature -14 degree Celsius up to -10 degree Celsius (-13.7 degree Celsius) at a time frame of 5 hours 15 minutes 0 seconds, with no previous temperature excursion. On 10-JAN-2023, the patient was vaccinated with the improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (PROQUAD) administered for prophylaxis (strength, dosage, route of administration and anatomical location were not provided) (product storage error). No additional adverse event (AE) reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2301USA008920: US-009507513-2301USA008846: US-009507513-2301USA008948:
1st dose Aug2020, 2nd 12Nov2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 49EL9, expiry date 7th February 2024) for prophylaxis.   Previously administered products included Shingrix (1st dose received in August 2020).   On 12th November 2022, the patient received the 2nd dose of Shingrix. On 12th November 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 15-NOV-2022 Reporter's comment: Pharmacist reported that the patient got a late second dose of Shingrix on 12th November 2022 after the first dose was in August 2020 (no specific day information available). The reporter did not consent to follow-up. Additional supportive information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule.
information has been received concerning a pt who was vaccinated on 09/19/98 with his first varicella vaccine. On 05/15/00 the pt developed a maculopapular rash consistent with varicella. At the time of the report 06/20/00 the pt was still being treated for the experience. The pt's brother also experienced a similar event. Follow up information received on 08/24/00 that the pt had recovered by 06/30/00.
On my 12th minute in the waiting area, I started having itchiness on my legs then it spread to my arms and face. I felt lightheaded and started having difficulty breathing. I approached the paramedic nearby. By then, the itchiness was all over my body from head to toe. They alerted 911 and monitored my vital signs. My 02 sat was 100% and BP was 140/90 mmHg. I asked if I can take Benadryl. They said wait for the ambulance. I declined to go to the hospital unless my symptoms get worse. I then took 25 mg of Benadryl. Shortness of breath and lightheaded ness was slightly relieved but the itchiness was still there. I waited for 30 more minutes in the waiting area. When the itchiness subsided a little bit, I went home. After 3 hours, the itchiness and SOB returned so I called my PCP and I was informed to take Benadryl q4 hrs until symptoms are resolved. As of today, 1/12/21 at 7:18pm, I still have itchiness but not as bad as yesterday.
no additional AEs; inadvertently administered to a 19 year old female; inadvertently administered instead of the MMR II; This spontaneous report was received from a medical assistant referring to a 19 years old female patient. The patient's concomitant medication, pertinent medical history and drug reaction/allergies were not reported.  On 11-MAY-2021, the patient was inadvertently administered with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (strength and route were not reported, 0.5 ml injection, lot # T027114, expiration date 07-FEB-2022) for prophylaxis instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). No additional adverse events and no further information were provided
Patient is 16 but she received her 1st dose of Moderna 4/15/21 at health dept site. she was advised that Moderna is not approved for under 18. she received her 2nd dose of Moderna.
Attendee received dose of the Johnson & Johnson vaccine at 12:40 in the left arm.  Lot# 205A21A. Attendee was directed to observation area.   At 12:45 the attendee started to fall out of his chair, but was kept from falling by 2 nurses and another attendee, who was his brother.  He was assisted to the cot after vital signs were taken and his legs were elevated. Cold packs applied.  Attendee's skin was cool and clammy. Stated that he felt really hot.  Eyes were open during the event and attendee stated that he remembers everything. HR:  50   BP:  110/60   RR:   12   O2Sat%: 99 12:57 -  Laying down on the cot. Gave him some water. He reported that he had not had anything to eat or drink prior to the vaccination.  Stated that he was feeling better.  No longer cold, clammy, or feeling hot. HR:  67   BP:  120/80   RR:   Not obtained   O2Sat%:  99   Temp:  96.5  13:08  Sitting up in a chair. Asymptomatic. Attendee's mother had come into site from her car. HR:  58   BP:  110/60   RR:   16   O2Sat%:  100  13:12  Attendee wanted to go home, so the Care Practitioner educated him and his family on home discharge/adverse reaction instructions and attendee was discharged to home with his brother and mother.  Recommended to call medical provider to advise that he had this reaction.  Attendee did not have any reported escalation of symptoms and was able to walk out of clinic independently.
patient informed prior to vaccine that she has vasovagal syncope & will know if she is going to pass out. after administering the vaccine, patient stated she was going to pass out. asked for a bag to vomit if necessary. patient regained conciousness quickly. vomited no food only small amount of salivia. provided patient with water & stayed with patient until she was fine. patient sat for 20 minutes, felt better, and left the store.
Injection site reaction of a red, hot, very sore rash extending down from injection site to inner elbow. Rash appeared 24 hours after injection and continued to resolve over 2 days.
Right arm swollen and 4x4 inches diameter of redness. Area warm to touch.