chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered, reconstituted with non approved diluent; Administered, reconstituted with non approved diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 27-APR-2022 Reporter's Comment: The reporter stated that, the patient was administered Shingrix reconstituted with a non approved diluent .  They were trying to figure out which patients received an incomplete dose of Shingrix. The reporter consented to follow up. Additional Supportive Information: The reporter stated that, the patient was administered Shingrix reconstituted with a non approved diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This was 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022070806:Same reporter US-GLAXOSMITHKLINE-US2022070807:Same reporter US-GLAXOSMITHKLINE-US2022072616:Same reporter
No additional AE; MMRII with a labeled expiry of 5/29/2022 was administered; This spontaneous report was received from an office manager via a Company representative referring to a patient of unspecified age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 27-JUN-2022, the patient was administered an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) 0.5 milliliters as prophylaxis (route of administration and anatomical site of vaccination were not provided; lot number T018669 has been verified to be valid, expiration date reported and established as 29-MAY-2022) (expired product administered). No additional adverse event reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA007052: US-009507513-2207USA006816: US-009507513-2207USA007188: US-009507513-2207USA007049: US-009507513-2207USA007041:
Sore arm at injection site lasted three days. On Friday I got a mild headache by Saturday evening it was VERY severe mostly all night I took (1) Advil, next morning tried (1)Tylenol. From pain of headache I felt nauseous. Felt slightly better Sunday afternoon (slightly)....still am having mild symptoms today. Tired, headache (not as severe) and general not feeling 100%. Thinking I may not get the second dose. Worried my reaction may be worse the second time around?   ** My husband had one too same time, same lot number...he only had mild sore arm. No other symptoms.
7 days after injection, injection site swollen, red, hot, itchy, began as a few red dots, grew larger and swelled together into a big red blob 8 days after injection, fatigue, runny nose
12 hours: painful injection site left arm. 24 hours: severe myalgias, arthralgias, fatigue, redness and severe pain inferior to injection site left side. 48 hours: severe myalgias, arthralgias, fatigue, redness and severe pain inferior to injection site left side 7 x 4 cm, fever 101.9 F. 72 hours: residual myalgias, arthralgias, fatigue; worsening redness and severe pain inferior to injection site left side 10 x 7 cm with 4 x 4 cm induration in the middle of the erythema. 96 hours: myalgias, arthralgias gone; mild fatigue; improving redness and induration left side.
Headache, Myalgia, Arthralgia, Fever,  Fatigue, Chills Narrative:
Flu like symptoms; fever; body aches; headache; Arm pain to the point when it hurt to move my arm at all for 36 hours; Dose Number 3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 10:00 (Lot number: EW0196) at the age of 30years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Left Arm, Vaccine Administration Time: 10:00), administration date: 23Feb2021, when the patient was 29 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 10:00), administration date: 16Mar2021, when the patient was 29 years old, for COVID-19 Immunization, reaction(s): "Flu like symptoms", "Fever", "body aches", "headache", "Arm pain". The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021 10:00, outcome "unknown", described as "Dose Number 3"; INFLUENZA LIKE ILLNESS (non-serious) with onset 22Nov2021 18:00, outcome "recovered" (Nov2021), described as "Flu like symptoms"; PYREXIA (non-serious) with onset 22Nov2021 18:00, outcome "recovered" (Nov2021), described as "fever"; PAIN (non-serious) with onset 22Nov2021 18:00, outcome "recovered" (Nov2021), described as "body aches"; HEADACHE (non-serious) with onset 22Nov2021 18:00, outcome "recovered" (Nov2021), described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 22Nov2021 18:00, outcome "recovered" (Nov2021), described as "Arm pain to the point when it hurt to move my arm at all for 36 hours". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of influenza like illness, pyrexia, pain, headache, pain in extremity.  No follow-up attempts are possible. No further information is expected.
Throat itching, tightness progressing to stridor and wheezing. Initial P 61. Pulse Ox 100%  BP 138/70 0.3 cc epi  given x 2 with improvement. Transported by EMS to local Hospital.
SERVICE MEMBER DEVELOPED A 7 INCH NODULE ON HIS LEFT DELTOID 2 DAYS AFTER VACCINATION. LUMP WAS SELF LIMITED TO THE LEFT DELTOID, AND IT SELF RESOLVED WITHIN 4 WEEKS AFTER VACCINATION.
Redness, swelling at injection site 4x3 inches x 5 days.
Pt recvd vax & immed afterward, presented w/chest pain & fever; 17MAR93 was hospitalized w/pleural effusion; approx 1 wk later devel polyarthritis; started on Pred 2APR93;
4/12/21 HZV (herpes zoster virus) post herpetic trigeminal neuralgia, s/p cornea transplant due to ocular varicella zoster 4/2021 dx'd with Sjogren syndrome, rheumatoid arthritis 6/2021 atypical pneumonia, elevated d-dimer, abnormal echocardiogram, hyperthyroidism 8/2021 hypoxemia 2nd to acute covid 19 infection, elevated troponin, NSTEMI 11/2021 pneumonia, parainfluenza infection, sepsis, acute encephalopathy
This spontaneous report was received from a nurse, referring to 40 unspecified patients of unknown gender and age. No information regarding the patients' concomitant medications, pertinent medical histories and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M042170, expiration date: 22-JUN-2018 and lot #M044397, expiration date: June 2018 (dose was not reported). No adverse effects were reported. It was reported that the vaccines were exposed to the temperature of 12.2 Celsius degrees for a time frame of 37 minutes. The temperature excursion was recorded by a digital data logger and the previous excursion was reported as 9.3 Celsius degrees for 16 minutes for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA007367: US-009507513-1708USA008138: US-009507513-1708USA008139: US-009507513-1708USA008141.
While I was given the shot a pain went down into my shoulder unlike any shot that I had before. My shoulder hurt to move and could not life. The entire 5-6 days following my shot I could not move my arm without my shoulder hurting,  popping and grinding painfully. Arm is still weak.
Hives; Swelling in throat; Treated in ER for 4-5 hours then released; Given Benadryl and Solumedrol in ER, released with Medrol Dose Pak.
On July 9 I went for my general check up and my platelets were down to 67,  My GP recommended me to see a hematologist, Dr., who took some blood work ups and also recommended a bone marrow biopsy to rule out any chance of Leukemia.  The biopsy showed everything was normal with the bone marrow.  However after more blood tests my platelets this past Tuesday went down to 28 and she put me on 40mg Dexamethasome for 4 days and will take more blood this coming Monday.  I am showing no signs at all for ITP and the only thing that could've brought this on is the Covid  vaccine.  There is a possibility this could be the second occurrence for me since in March I did have bronchitis and was given prednisone for 2 weeks, so that might have made an increase in platelets without me knowing I ever had a problem until I went for my yearly checkup.  As I stated I am showing no other signs of ITP at all.  My son in law works at Facility, a local health care provider in the region and he spoke to the head hematologist there and they are also finding many cases of ITP with no underlying causes besides having the COvid vaccine.
About 5 hours after the shot my joints were extremely painful and I had a sever headache.   With Aleve and about 48 hours later felt better.   Since then my joints have progressively become painful again and  are swollen.   I never had this prior to the vaccine.  I have not seen a doctor about it.   I am looking for direction on what I should do.
Information has been received from a registered nurse concerning multiple unspecified patients who "during the past two years" was vaccinated with dose of RECOMBIVAX HB (route, dose and lot number not reported) for the treatment for liver disease. Nurse reported that the multiple unspecified patient being treated for liver disease and failed to seroconvert after being vaccinated. Nurse reported that patients who failed to seroconvert were administered a second series of hepatitis B vaccine, it was unknown whether all affected patients received the second series with RECOMBIVAX HB or with another hepatitis B vaccine. Nurse stated she did not have any patient specified information available. Patients had sought unspecified medical attention and at the time of reporting, outcome of the events were unknown. All telephone attempts to obtain follow-up information have been unsuccessful. This is an amended report. Upon internal review, the low level term of adverse event has been changed from "Anti-Hbs antibody negative" to "Hepatitis B antibody negative", the preferred term has been changed from "Hepatitis B surface antibody negative" to "Hepatitis b antibody negative". The lab test term has been changed from "serum hepatitis B surface antibody screen" to "serum hepatitis B antibody test". Additional information has been requested.
12/6 moist cough, temp 99.3.  Zithromax started.  12/8 continues with loose cough and more responsive.
About 5 minutes after the vaccine I felt really hot all over and my tongue started tingling. This lasted about 2 minutes. After this, for the next hour and a half, my tongue felt numb and I had intermittent hot flashes and increased heart rate until I took 25mg of Benadryl at home. The symptoms then resolved.
4/28- Pain at the injection site in the left arm hours after vaccines 4/29- Pain /redness/swelling at injections site (left arm), chills, body aches  4/30-  Pain /redness/swelling at injections site (left arm) becomes larger, softball size area 5/1- Patient reports to the clinic. Swelling and redness have spread dependently from the previous day. Patient c/o pruritus in the swollen area. Area is warm to touch.
pt states he started getting numbness and tremors within his muscles in his hands, arms and face.  He developed shortness of breath and cardiac palpitations.  He had chest pains that would come and go. He would get abnormal headaches sometimes.  He had no fever but had chills and joint pains that would experience everyday.  He also had optical migraine headaches a couple of time per week.  He had shaking of his muscles in his arms and legs that would come and go.  He had intermittent bleeding within the layers of his skin that would appear in one place, disappear and then reappear in different places.  Some of his non varicose veins turned to varicose veins.   He had intermittent neck pain.  He went to the Hospital ER.  they did blood work and scans.  It was  recommended he go to another Hospital to have another scan.  The doctor has ordered him  more testing to be completed that he has not had done at this time.   His symptoms are unresolved and his is still seeking treatment.  He provided this information to his PCP.
A non-serious spontaneous report of we gave 14 doses of expired FLUMIST of was received from a health professional concerning a four-year-old child. Neither the patient's medical history nor the concomitant medications were reported. The product expired on 22-Jan-2012. On 26-Jan-2012, the patient received expired product. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 14-APR-2015, the patient was vaccinated with improperly stored PNEUMOVAX (lot # K024976 exp date 09-JUN-2016) (dose and route not reported). The temperature and time of excursion was 1.11 degrees C for 64 hours. The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
14 year old female was mistakenly administered a boost dose of Pfizer COVID-19 vaccine (Comirnaty).  Pt did not experience any adverse effects while in clinic and had no complaints of discomfort.  Pt's parents were advised of mistake and advised to monitor Pt in case of any severe side effects and to seek medical attention should it become necessary.  Both parents verbalized understanding.  Pt and parents left clinic without incident.
02/13/2003 Red 2 1/2 inches x 2 1/2 inches. Fever, hard knot
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer (patient's wife) concerned a 69 year old male. The patient's weight, height, and medical history were not reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, 1 total, administered on 10-MAR-2021 in left arm for covid-19 prophylaxis.  The patient did not mentioned any side effects after covid-19 vaccine ad26. cov2. s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, 1 total, administered on 30-OCT-2021 in left arm for covid-19 prophylaxis. Age at time of vaccination 69 years old. No concomitant medications were reported.  On 14-AUG-2022, the patient experienced covid-19 symptoms, he had fever, coughing, and body aching (dose number in series 2) (confirmed clinical vaccination failure, and confirmed covid-19 infection). On 17-AUG-2022, around 3 to 4 pm Laboratory data included: COVID-19 virus test Positive at home test. Patient's wife reported that she has contacted the doctor and he was supposed to prescribe something to help them feel better (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number: 90000247158 and 90000247157.; Sender's Comments: V0: 20220841198-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Two weeks after my 2nd dose I had loose stool frequently. The doctor decreased my Metformin medication. Then my doctor took me off  of Metformin. I have lost almost 25 pounds since the last of January. COVID- 19 test was negative a year ago. I had a little fever 101.0. My symptoms are a lot worse now. I was referred to the GI doctor. They have tested my stool sample and it came back fine. At the GI doctor they did blood work and it came back negative. They also did a CAT scan and it came back normal.
Pt went to ER with nasal drainage, headache, sinus congestion, facial pain.  Onset 3 days ago.
Moderna COVID-19 Vaccine EUA, developed sciatic nerve pain on my right side that began on Day 2 or 1/1/21, developed red streaking on my right arm that was warm to the touch at injection site that started on Day 8 or 1/7/21.
pt recv vax 23JUL96 & 1AUG96 pt devel fever & coryza & on 1AUG96 devel florid moribilliform rash which cont to spread;4 days now of illness w/fever to 104.8 R;
pt reported pain @ rt deltoid w/swelling, dec mobility extending to fingers & scapula, pruritus surrounding inj site & ant chest, lungs in throat;transported by amb to hosp & tx w/epi & ice compresses;dx anaphylaxis;
Patient has pink rash on trunk, arms, and face (no localized reaction at injection site).
tingly, itchy, prickly feeling hands; tingly, itchy, prickly feeling hands; red blotches on her hands; This is a spontaneous report from a contactable nurse. A 62-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249), intramuscular on 21Jan2021 16:30 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 30 minutes after vaccination was administered, client stated she started tingly, itchy, prickly feeling hands. She did have red blotches on her hands. Public Health Nurse offered Benadryl which she accepted and was ok a half hour later. The outcome of the events was recovered on 21Jan2021 17:30.
Patient developed dyspnea 1 week after vaccination and thought he was developing asthma at the age of 70.  This progressed to frank orthopnea where patient could not sleep more than 30 minutes even upright due to dyspnea.  He was admitted and found to have EF 10-15% and was treated for florid heart failure.  Cardiology notes they do not expect an ischemic etiology.
Pt called clinic 8/16/07 reporting immediately pain in Tdap injection site resulting in persistent pain/swelling (5x7 in)/black-hard spot x 3-4 wks. Now resolved. Denies fever. Did not state allergy to latex prior to injection.
Missed day 3 dose of vaccine imovax rabies and back to day for the next dose, No Ae; Initial information received on 06-May-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 66 year old male patient who missed day 3 dose of vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] and back to day for the next dose (inappropriate schedule of product administration) which was started on 29-Apr-2020 for post exposure immunization.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a actual medication error due to inappropriate schedule of product administration.   At the time of report no adverse event was reported.   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.  There will be no information on the batch number for this case.
I received the SHINGRIX vaccine a few months ago and since then have had 2 herpes outbreaks while suppressive therapy with acyclovir. I typically have about one outbreak a year that is mild. These have both been very painful outbreaks. I found numerous people on an internet thread that have had the same experience.
This case was reported by a consumer via call center representative and described the occurrence of fainting in a 60-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of fatigue (1st dose received on 26th October 2018, refer case: US2019GSK016718). On 22nd January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 23rd January 2019, 1 days after receiving SHINGRIX, the patient experienced fainting (serious criteria GSK medically significant), feeling unwell, chills, low blood pressure, pulse rapid and sweating. On an unknown date, the outcome of the fainting was recovered/resolved and the outcome of the feeling unwell, chills, low blood pressure, pulse rapid and sweating were recovering/resolving. It was unknown if the reporter considered the fainting, feeling unwell, chills, low blood pressure, pulse rapid and sweating to be related to SHINGRIX. Additional details were received as follows: The case was reported by the patient's husband. At the time of reporting, in the morning patient woke up with not feeling good and she presented with chills as well.  The patient got up and tried to do some stuff, but she ended up fainting 3 times. The patient's blood pressure was very low, which was showed to be 20 points lower than normal range. The patient's pulse was up and sweaty. The patient was laying down helped and went back to sleep. At the time of reporting, the patient was not awake again and was feeling better.
Patient presented for a COVID and influenza vaccine on 10/27/2023.  Upon entering the Moderna Spikevax vaccination into the state immunization registry it was discovered that she had received Comirnaty on 9/27/23 at another vaccination site.
Experienced severe shaking chills, necessitating I leave work. Also experienced mild myalgias, headache. Treated with acetaminophen 1000mg and ibuprofen 400mg.
Patient had Johnson and Johnson vaccination in April 2020- single dose. 2 weeks prior to presentation, he was recommended to receive a Pfizer booster shot. On presentation, he had rapidly progressive ascending weakness/paralysis with respiratory compromise over ~48 hours leading to respiratory failure and need for intubation. He also lost his reflexes while in the hospital. His diagnosis is consistent with Guillain-Barre Syndrome. He received 2gm/kg IVIG over 5 days. He is improving and yesterday was extubated but is still profoundly weak and remains in the ICU currently.