chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 66 year old male patient. The patient concurrent condition included allergy to quinolones. On 31-OCT-2014, the patient was subcutaneously vaccinated with ZOSTAVAX 19400 plaque-forming unit (PFU) lot # K010732, expiration date 31-OCT-2015, (dose was not reported) to prevent shingles. Concomitant therapies included FLUZONE. The reporting pharmacist mentioned the patient received ZOSTAVAX and FLUZONE on the same day 31-OCT-2014 and the vaccines were administered in opposite arms. On 02-NOV-2014, the patient experienced itchy rash on his back that was sensitive to heat. The patient was not given any treatment. There were no lab diagnostics studies performed. The outcome of the event was reported as not recovered. The patient sought medical attention by contacting his pharmacist. The relatedness between the vaccination with ZOSTAVAX and the event was not provided. Additional information has been requested.
On 2/22/2021 caller c/o of a rash that was warm, raised and "itchy" at injection site. Reports talking Tylenol and using Benadryl cream which provided relief, symptoms resolved after a few days.
Fever of 102 for 2 days, intense joint and muscle pain, on 2nd day after shot woke up with right eye swollen.  Was unable to do anything but lay in bed for 2 days. This is day 4 after shot and finally can move around better. Just a little soreness in joints and muscles but not to bad. Eye is still swollen. No pain in it though.  Took tylenol for first couple of days, then also tried benadryl on 3 day to see if that would help with the eye swelling. It had not effect on it.
This spontaneous report as received from a pharmacist refers to a 66 year old female patient who in March or April 2014 was vaccinated with a first dose of ZOSTAVAX (dose, route, lot # and expiration date were not provided). Then on 29-JUN-2015, the patient was vaccinated with a second dose of ZOSTAVAX 19400 PFU, lot # L006381 (route was not provided), (extra dose administered). The extra dose was not intended to be a second dose; the patient did not remember that she had previously received ZOSTAVAX until she went home. The patient had not reported any adverse effects. Additional information has been requested.
Patient started with a mild urticarial rash behind knees and back 24 hrs after covid vaccine. No respiratory symptoms described. Rx was started in Benadryl for symptoms.
This spontaneous report as received from a healthcare student (pharmacy student) refers to 22 patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unspecified dates between 01-APR-2015 and 28-MAY-2015, the 22 patients were vaccinated each with ZOSTAVAX (lot # L006379 expiry date of 25-MAY-2015 and also reported with expiry date of 24-MAY-2015 subcutaneous, which were improperly exposed to 8 Fahrenheit (F) for 28 days since an unspecified time. Concomitant medications were not reported. No known adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
This is a spontaneous report from a contactable physician and non-contactable consumer via a Pfizer sales representative who reported similar events for two different patients. This is the first of two reports. A 16-year-old male patient (race: other) received TRUMENBA (NDC number 0005-0100-10) first dose on 21Apr2016 at 16:15 in the left thigh (lot M95612, expiry date 22Jul2017), second dose on 21Jun2016 at 11:23 in the right thigh (lot M95612, expiry date 22Jul2017), third dose on 24Oct2016 at 16:03 in the right thigh (lot N11903, expiry date 01Jul2017), each one intramuscular, at 0.5 ml single, for immunization. The patient received also human papilloma vaccine (HPV 9; Manufacturer Merck, NDC number 0006-4119-03) first dose on 21Apr2016 in the right thigh (lot L037339, expiry date Feb2018), second dose on 21Jun2016 in the left thigh (lot M00916, expiry date Jun2018), third dose on 24Oct2016 in the left thigh (lot M023169, expiry date Jun2018), each one intramuscular, for immunisation. Prior vaccinations within 4 weeks before: none. The patient medical history was not reported. Illness at time of vaccination: none. The patient's concomitant medications were not reported. The patient experienced fatigue and had a dramatic decrease in speed and endurance, both since an unspecified date in 2016, right after the first doses of both vaccines. The coach noticed the boy on the high school running team had a dramatic decrease in speed and endurance and also had fatigue. The boys run 60 miles a week. He was an athlete and could not perform. His pulse was monitored every day. The events did not require an emergency room or physician visit. The events resolved on an unspecified date and the patient resumed being able to run again. The physician did not know about the events until after all 3 doses of vaccines had been given. The physician thought the event could be related to TRUMENBA but the patient also got HPV 9 on the same days for all 3 doses. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017056828 same reporter/events, similar suspect drugs, different patient.
This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of Oka/Merck VARIVAX (lot # N017698; expiration date: 09-JUN-2019) or (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of MERCK STERILE DILUENT. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1801USA005992.
Based on information received on 28-MAR-2019, the report previously considered as non-valid became valid: the patient identifier reported. Initial information received on 12-Mar-2019 regarding an unsolicited non-valid non-serious case received from a physician. This case involves a 55 years old patient who experienced local skin erythema at injection site, while he/she received vaccine IPOL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 12-Mar-2019, the patient received a 0.1 mL dose of suspect IPV (VERO) lot number N1V451M via subdermal route in unknown administration site. On an unknown date, the patient developed a non-serious local skin erythema at injection site (vaccination site erythema) following the administration of IPV (VERO). It was a case of actual medication error due to Inappropriate route of vaccination and vaccine underdose. Final diagnosis was local skin erythema at injection site. It was not reported if the patient received a corrective treatment. The outcome of the event not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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. Follow-up information was received on 28-MAR-2019 and additional information was received on same date 28-MAR-2019 from a physician. Based on information received, the report previously considered as non-valid became valid: the patient identifier reported. Patient demographics, date of vaccination, dose, lot number and event updated in field and narrative. Documents held by the sender: none.
Child had abrupt onset of hives on face and legs. Mother went to doctor's office (child's physician). Benadryl 12.5mg IM in office. Prescription Prediapred 1tsp tid x 2 days then bid x 2 days.
dizziness; headache; nausea; This is a spontaneous report from a non-contactable consumer (patient). A 37-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 09Feb2021 00:45 (reported as "12:45 AM") (Batch/Lot number was not reported) at the age of 37 years old as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (Pfizer) in left arm on 19Jan2021 for COVID-19 immunization. The facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. The patient experienced headache, dizziness, nausea on 10Feb2021 06:00 (AM). No treatment received for the events. No covid prior vaccination. No covid tested post vaccination. The outcome of the events was recovered in Feb2021.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
On 07/07/2021, a 2019 Coronavirus SARS-CoV-2 Rapid~2019 Coronavirus SARS-CoV-2 Rapid test was ordered and came back positive for the patient. Case investigation interview with patient has not been conducted at the time of this note.
Severe headache, moderate nausea and vomiting, moderate to severe  body aches/muscle pain throughout body, moderate to severe fatigue. Treating with APAP, warm baths, rest, clear fluids.
Severe illness, weakness, extreme fatigue, muscle spasms, pain in muscles, pain in joints, complete insomnia, tinnitus, head ache
vomiting; dizziness; severe headache; very tired; chest pain; achy everywhere; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer reported for a 24-year-adult female consumer (daughter, patient). A 24-year-old female patient received first dose of bnt162b2 (Pfizer Covid-19 Vaccine, Solution for injection), via an unspecified route on 04Apr2021, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient experienced vomiting, dizziness, severe headache, very tired, chest pain and achy everywhere. The clinical outcome of the events was unknown.   Information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021393498 Same drug , different patient and AE
My face swelled I treated with Benadryl. After 2 days stomach started swelling had to see a GI doctor in August 202. My creatinine was 1.47 had to get a Kidney biopsy in August 2021. I also had Covid in August 2021.
This is a prospective pregnancy case. This 31-year-old female subject was enrolled in an open label study: a prospective, exploratory, cohort study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with BOOSTRIX during pregnancy or within 28 days preceding. The subject received the 1st dose of BOOSTRIX (intramuscular) .5 ml on 26th November 2014. The subject's last menstrual period was on 18th April 2014 and estimated date of delivery was 23rd January 2015. The subject received BOOSTRIX at week 32 of the pregnancy and during the third trimester of pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was going. Additional information received on 26 November 2014: It was unknown if the patient was using contraceptive method. The patient had one previous pregnancy with normal birth. It was also unknown if the child born with defect, if there was any maternal history which may have an impact on the outcome of this pregnancy and if the father had a relevant medical or family history. The last menstrual period was not reported but was calculated with the due date.
This spontaneous report was received from a pharmacist referred to an unspecified patient of an unknown age. The patient's past medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, frequency route, lot # and expiry date were unknown) for prophylaxis. On an unknown date about 10 months later the patient received a second dose of PNEUMOVAX 23 (lot and expiration unspecified) (extra dose administered). No adverse effects reported. Additional information is not expected as no consent to follow up.
Pt. states that after receiving the 1st dose of J&J 09/01/2021, immediately started experiencing symptoms of sharp pain in the chest pain and heaviness in the chest. Urgent Care visit 09/01/2021 @ 5:00pm Chest X-Ray, examined with no known explanation. Continuing to experience symptoms.
7/22/15 "suspect chicken pox after varicella vaccine administered 7/15/15." "Patient looks well-ok to return to day care. 24 hours after rash has scabbed over" "or to get 2nd vaccine in future as per CDC."
Vaccination failure; Hepatitis B titer drawn which showed that he was not immune; This spontaneous report has been receive from a nurse regarding to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unspecified date, the patient was vaccinated with a dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (dosage regimen were not reported) for vaccination when he was a child.   On an unspecified date, the patient now as an adult, the patient presented hepatitis b titer drawn which showed that he was not immune. At the reporting time, the outcome of the events was unknown.   The causality assessment between the events and dose of hepatitis b vaccine (recombinant) (manufacturer unknown) was not reported.
Felt arthritis pains in her shoulder joints. Right knee joints are swollen and cracking.
Inappropriate Schedule of Vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 25-year-old female patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX-B).   On 26-MAY-2023, the patient received the 2nd dose of Engerix B. On 26-MAY-2023, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too short (Verbatim: Inappropriate Schedule of Vaccine). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 08-Jun-2023 The pharmacist reported that the patient was going to start nursing school and need to receive hepatitis series. At the time of reporting, the third dose has not been received. The vaccine administration facility was the same as primary reporter. Inadvertently did not obtain permission for follow-up. The patient received the second dose of Engerix-B earlier than the recommended interval, which led to shortening of vaccine schedule.
The symptoms lasted 2 weeks and were extreme congestion, a little sore throat, bad fatigue, cough, intermittent loss of taste and smell. A few days of low grade fever. After 3 days I went to the clinic and gave me PAXLOVID which I took the full course. I still have lingering sinus congestion and intermittently more fatigued than I normally would be.
Patient all of a sudden went from smiling and laughing in her father's arms to very uncontrollably upset. She began crying harder than she ever does and it took us about 15-20 minutes to get her to calm down. This kind of behavior never happens with her, ever.   The next day (Thursday) she did not have a bowel movement at all. The following day (Friday) she had two tiny BM's and then a very liquidy, green and bloody stool at about 5:00 pm. We went to the after hours pediatrician and they sent the stool to labs for testing. The next week she only had one BM every OTHER day which is not usual for her as she is exclusively breastfed and typically has 4-5 BMs each day.   It has now been 8 days (Thursday 1/13/11) and she just had a second BM today (her first time to do this in a week) and I was thrilled until I noticed there was blood in it again. She has also had shorter breaths every once in a while and last night became congested which has not gone away. She also coughs every once in a while whether awake or asleep. My pediatrician is supposed to be calling me back to tell me what I should do next.
Information has been received from a physician concerning a patient of unknown gender and age. On 22-APR-2011, the patient vaccinated with a dose of GARDASIL, intramuscular, (dose and lot number were not provided). On 17-AUG-2012, the patient was vaccinated with a dose of GARDASIL. No known adverse effects. Additional information has been requested.
Patient reported that about an hour after receiving vaccine, her tongue started to feel swollen and her face was swelling. She went to the ER where she said they administered an epi-pen. She then picked up a script for a 3-day course of prednisone 20mg once daily. She reported 1/20/22 that she is still feeling like her tongue is fat and starting to swell again. I recommended she go back to the ER.
At 1710 - 08/28/12 - Mother reported "pea & golf ball sized bumps" on back of (R) arm; No fever; Child "felt fine"; red area on back of (R) arm; stated ice "makes it swell more"; instructed to see a healthcare provider; stated would "go tomorrow if worse" 8/29/12 at 1115 - mother states son "felt fine" & "sent to school"; states redness & swelling "from his shoulder to elbow"; states going to see doctor after school 8/29/12 at 1645 - in hospital ER; red area triangular in shape on back of (R) arm warm to touch, measures 10cm x 10cm at widest areas; no fever; no pain or discomfort; given antibiotics & told to take BENADRYL to use ice packs by ER healthcare provider.
PATIENT STATES HAS HAD A SORE ARM FOR 3 WEEKS WILL BE SEEING DR IN A COUPLE WEEKS WILL DISCUSS WITH HIM IF STILL HURTING
26 y.o. male with spastic quadriplegic cerebral palsy, previously high-functioning and self-sufficient prior to decline in 2022, that 6 weeks after covid vaccination, developed global weakness, dysphagia (to point that required new PEG tube), with secondary weight loss of 100lbs, pressure ulcers complicated by infection, and overall failure to thrive.
Initial unsolicited misuse report received from the literature on 16-MAR-2017. This case involves a 46-year-old female patient who was vaccinated with a dose of TETANUS TOXOID injection (manufacturer: unknown, batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced left shoulder pain/ left shoulder arthroscopy for continued pain and weakness, severe pain during an injection of tetanus toxoid in her left deltoid, partial-thickness tear of the supraspinatus tendon/ delaminated rotator cuff tear and significant glenohumeral synovitis and subacromial bursitis. It was reported that patient's shoulder was immobilized in an abduction brace for 4 weeks. It was also a case of wrong route of administration as Rotator cuff tear resulting from intratendinous injection during attempted deltoid intramuscular vaccination. On an unspecified date, other lab data included MRI examination with intraarticular contrast was performed. The patient elected to undergo left shoulder arthroscopy for continued pain and weakness, and arthroscopic subacromial decompression and transtendinous rotator cuff repair with a double-row, suture-bridge construct was performed. The patient received corrective treatment with 6 weeks of physical therapy. Physical therapy was started the day after surgery for passive range of motion, and the patient progressed through the rehabilitation protocol. On an unspecified date, the patient recovered from the events. The case was reported serious by the reporter due to Disability. List of documents held by sender: none. Sender's Comments: Patient was vaccinated with tetanus and given by intratendious route which lead to Rotator cuff tear with associated symptoms and vaccination site pain. Time to onset is compatible, as the event occurred due to wrong route of vaccination, but additional information regarding patient medical history, any trauma history are needed to further assess the case. Based on available information the role of vaccine cannot be excluded.
1st injection: sore upper arm for 3 days; 2nd injection: sore upper arm, chills and body aches beginning 3am, 100deg fever by 5am, headache--took x2 ibuprofen in the AM, fever returned by 4pm, took another x1 ibuprofen; no fever since 6pm on the 11th, feeling better today with some fatigue
Minutes after patient had walked away after receiving vaccines, patient came back skin and eyes very red, he stated he did not feel well, sat on a bench and then stated his low back hurt to the point he could not move. EMS/911 was contacted, paramedics arrived; at that point the patient stated he felt that the pain had moved down from his back to his legs but was well enough to not go in the ambulance.
*vaccine received @ 11a 040721 12:00p 040721- severe dizziness and nausea lasting about 1-2 hours 2p- 7p 040721- completely asymptomatic 7p- 8p 040721- fatigue, chills, temp 101 8p 040721- 7a 040821- fatigue, chills, temp 101-102, headache, nausea, body aches 7a 040821- 2p 040821- fatigue, nausea, chills, headache, body aches, temp 98-99 2p 040821- 5p 040921- nausea, headache, sweating, fatigue completely asymptomatic by 5p 040921
Patient's arm began to swell and redden outward from the injection site. Patient presented to her PCP who said it was an allergic reaction and patient should take Benadryl to help alleviate the symptoms. Patient reported back to vaccination site on 10/7 to report allergic reaction and to report that the reaction was getting better/resolving.
shortly p/vax pt exp migrating urticaria, erythema, w/edematous centers 4-5cm; comes & goes pruritic; No SOB; DPH
With in 100 minutes after getting the vaccine, reactions were body rash on chest, arms, face welt like rash , and fast heart rate along with high blood pressure.