chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 31-OCT-2013 the patient was vaccinated with a expired dose of ZOSTAVAX (lot # 672867/0241AE, expired on 26-APR-2013). No adverse effect reported. This is one of several reports received from same source. Additional information has been requested.
About 2 months after the fourth dose of my Pfizer COVID-19 vaccine I had a lot of gastrointestinal symptoms and I felt fatigued. I had a low-grade fever and I felt achy almost like a flu. I had no respiratory symptoms. I took PAXLOVID immediately and I felt better within 48 hours. I had a rebound of my symptoms about a week after I recovered. I just felt bad for 4-5 days, but the GI symptoms did not return. I was fully recovered about 5 days after the initial rebound.
Red, hot, itchy, slightly painful area at injection site.  Started 11 days post vaccination.  I put ice on it a few times the first and 2nd day.  The symptoms subsided about 3 days later, but the area remains slightly discolored at this time.
Headache occurring 2 hours after vaccine administration on 10/13. Morning of 10/15 had seizure. Found to have a right posterior temporal lobe hematoma.
Reaction was to the Shingrix shot I got on Friday morning. Noticed the reactions when I woke up the next morning. Right arm was very swollen, both at the injection site and the entire armpit area and below it. A lot of pain from neck to waist on right side of body. Rash appeared above injection site. Ran a fever with body aching all over the entire day (saturday). Sunday fever and rash was gone, still had a lot of pain, especially armpit area.  Today (tues) pain is mild and swelling has subsided a lot, still not back to normal.
After reporting symptoms of dizziness, Patient was monitored by RN at vaccination site. While monitoring, RN noticed patient exhibiting muscle tremors throughout his body that he reported not being able to control. Reaction intensified with patient advising that the was having sharp right sided chest pains that he rated on a pain scale of 0 to 10 as being an 8. In addition he stated that the felt as though his throat felt as though it was closing off. EMS were notified and while en route, RN continued to monitor patient. Patient remained able to speak with RN, pulse remained 70s bpm and respirations within normal range of 14 to 20. Patient did not display any symptoms of having trouble breathing. EMS arrived to evaluate patient; administered oxygen therapy and ran a 12-lead echocardiogram. Patient's parents opted to take patient local hospital to be evaluated, but declined to do so via the ambulance and transported patient via private vehicle.
Approx 3 cm x 4 cm area of redness, warmth and itching at the injection site that developed over a week after the injection
This spontaneous report as received from a Health care worker pharmacy technician refers to a unspecified number of patients of unknown age and gender. On an unknown dates the patients were vaccinated with GARDASIL lot # J008423 exp 21-JAN-2016 (dose and route not provided), GARDASIL lot # J009788 exp 17-MAR-2016 (dose and route not provided) and GARDASIL lot # J013324 exp 12-FEB-2016 (dose and route not provided). Health care worker (pharmacy technician) stated that an unspecified number of patients may have received vaccines (doses and dose in series unspecified) that were improperly stored on 28-FEB-2014 at 9.5C for 50 minutes. No adverse effects reported. The outcome of incorrect product storage was unknown. This is one of several reports from same source. Additional information has been requested.
Extreme muscle pain in injection site ( left arm), numbness in arm off and on ( left arm) and mild headache
Pt c/o chest tightness, SOB, which resolved within 10 min with reassurance and moving to a coder area
pt recv vax 9OCT97 pt had t100 instructed to take APAP;called back Monday AM to state was sick all weekend w/flu type sx but now rt arm pneumonia site is swollen & reddened from elbow to shoulder;
Chills Aches Headache Dizziness Frequent urination Severe sore arm
This spontaneous report was received from an unspecified employee refers to an approximately 77 year old female patient with no pertinent medical history reported. On 25-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot number and expiration date not reported) (dose and route not specified). No other suspect therapies or concomitant medications were reported. The reporter stated that the patient submitted a rebate for ZOSTAVAX and reported an adverse event, the patient circled itching, swelling and hard lump, and wrote a message that said "I had this". Outcome for itching, swelling and hard lump was not reported. No treatment information was reported. Additional information has been requested.
Mom states that pt had violent crying spell & turned blue 2 hrs p/vax 28APR92;
No pain after getting the shot. Within a couple of hours, upper arm started to get red and painful, felt like lightning bolts from upper arm down to elbow. Applied ice and waited it out. Called pharmacy about it. The pharmacist said he would send her something but she never received anything.
Swelling of intestines (leading to severe diverticulitis-never had before) Swelling of ovary (5x) Swellng of liver Swelling of mesentery Spleen pain Stomach pain Heart palpitations Continued stomach and intestine issues
arm was sore; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had arm was sore on an unspecified date with outcome of unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient concerned a 60 year old male of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose, start therapy date were not reported for covid-19 prophylaxis. On an unspecified date, the patient experienced osteoarthritis and upper extremity dysfunction (Dose number in series 1).The patient had not recovered from osteoarthritis, and upper extremity dysfunction. The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose was not reported, 1 total administered on 25-AUG-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. The drug was associated with Off label use (Dose number in series 2). Age at time of vaccination 60 years old. No concomitant medications were reported.  Non-company suspect drugs included: upadacitinib (oral, batch number: 1159488 expiry: UNKNOWN, form of admin was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis.  Treatment medications (dates unspecified) included: methotrexate, and celecoxib. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and action taken with upadacitinib was not reported. The outcome of off label dosing frequency was not reported. This report was non-serious. This case, involving the same patient is linked to 20220831989 and 20220853753.
SEVERE MUSCLE AND JOINT PAIN RADIATING FROM LOWER BACK TO BOTH GROIN AREAS WHICH RADIATED DOWN TO BOTH KNEES ANKLES AND FEET LASTING 24 HOURS.  MOOD SWINGS, ACUTE DEPRESSIVE SYMPTOMS LASTING 2 DAYS. FOGETFULLNESS .FATIGUE AND FOGGY THINKING LASTING TWO WEEKS. SEVERE INJECTION SITE PAIN LASTING SEVERAL DAYS (7) WITH REDNESS. TENDERNESS AND SWELLING AT INJECTION SITE . INTERMITTENT LIGHT HEADED EPISODES. HEADACHE LASTING ONE DAY.
Information has been received from a physician referring to a 60 year old patient of unspecified gender. The patient's medical history included chickenpox in childhood. The patient had no history of herpes zoster and herpes zoster ophthalmicus. The patient had no allergies or prior immunodeficiency. The patient's history drug included oral antivirals VALTREX (full treatment). On 28-DEC-2015 the patient was vaccinated with a dose of ZOSTAVAX (dose and route not reported) in left shoulder. There was no concomitant medication. On 29-DEC-2015 the patient experienced malaise, zoster like rash in penis, "scalene" and left medial thigh (25 lesions). The patient also experienced outbreak of shingles ( "L2-L3 middle left (L) dermatome") and had severe post-traumatic stress disorder (PTSD) from the shingles on 29-DEC-2015. The maximum temperature was reported as 99.6 (unit not provided). It was also reported that there was possible secondary transmission (onset date: 29-DEC-2015). It was mentioned that the specimen from healed rash in "SCAV" beyond vesicle was obtained. "14 days later", on 12-JAN-2016 the patient recovered from the above adverse events. The causality was not provided. Additional information has been requested.
Information has been received from a pharmacist concerning a male who was vaccinated with two 0.5 ml doses of PNEUMOVAX 23 (lot # not reported) subcutaneously. The patient received two doses total on the correct dosing schedule. Subsequently the patient developed chills and a fever from therapy on PNEUMOVAX 23. Therapy with PNEUMOVAX 23 was reported as discontinued. At the time of reporting, the outcome of the events was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Periodic chest pain since first vaccine, not better accounted for by anxiety or cardiac issues.  Significant weight gain - 10 lbs in first month after first vaccine; 10 lbs in the second month after 2nd vaccin; 20 lbs more gained since = 40 lbs in 8 months after vaccine.
Patient received adult dose of Engerix (1 mL) when they should have received 0.5 mL.
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (expired vaccine used) in a 29-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 038C21A) for COVID-19 immunization. No medical history reported. On Nov 8, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; .5mL. On Nov 8, 2021, patient administered expired product (expired vaccine used). On Nov 8, 2021, administered expired product (expired vaccine used) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reporter stated the box of vials was received on 10/14/2021. It was frozen/immediately placed in the clinic vaccine freezer (upon receipt). The vials remained frozen until the date of use and were thawed in the vaccine refrigerator prior to use. The vials remained in the refrigerator between uses and each vial discarded after the final appointment of the day. Only 1 vial was used per day between the hours of 8:00 am to 4:00 pm.
Experiencing pain in hands/wrists; Experiencing pain in hands/wrists; This is a spontaneous report received from a Pfizer-sponsored program, from a contactable other healthcare professional and consumer (patient). A thirty-eight-year-old female patient received BNT162b2 (BNT162B2), dose 1 via an unspecified route of administration on 31, Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 Immunizations. Medical history included depression, rheumatoid arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced pain in hands/wrists and trouble opening bottles due to the missed doses of tofacitinib citrate (XELJANZ) on an unspecified date in 2021 with outcome of unknown.  Follow-up (19Apr2021): New information included report type updated as spontaneous. This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Patient presented to emergency department on 11/5/2021 with cough, fever, diarrhea, shortness of breath, and passing out. She had tested positive for COVID-19 on 10/29/2021. She was admitted for management of COVID-19 infection due to acute hypoxic respiratory failure. She was treated with dexamethasone, remdesivir, barcitinib, and supplemental oxygen. Her condition gradually improved and she was discharged to inpatient rehab facility on 11/15/2021.
Swelling, erythema, induration, warmth to touch at injection site approximately 2.5 inches in length and 2 inches in width. Lasting from day of vaccination to full day after vaccination. Slight ecchymosis at bottom of reaction site/2 inches below injection site, day after injection.
pt recv vax 5/24/99 & 6/1/99 pt was found to have a fever & p/waking up from nap, had sz & was rushed to ER where was unable to be resuscitated;COD @ time of reporting was unk;
acute pancytopenia  She may be eligible for casirivimab and imdevimab COVID-19 antibody. WBC 1,100, platelet count 43,000 and hemoglobin 10.7
On Day 8 my injection site turned red, had a rash, and was extremely itchy.
Information has been received from a currently 76 year old male patient referring to himself. The patient medical history included joint problems from arthritis and "couple cancers" (unspecified) with no maintenance medications. The patient stated that he had no concomitant medications and that he had drug reactions/allergies to tetracycline and diazepam (VALIUM). On an unknown date (reported as more than ten years ago), the patient was vaccinated with ZOSTAVAX for prevention from shingles (dose, lot number and expiration date were not reported). In November 2015 (reported as about two years ago in November), the patient reported that he had an unspecified "post vaccination episode" on an unspecified arm. The episode "was minor, but annoying and lasted three weeks". The patient did not seek medical attention at the time. At a later unspecified time, the patient showed the affected area on his arm to an unspecified physician and the area was almost healed. The physician could not do a biopsy at that time because the arm was almost healed, therefore a case of shingles, nor any other source of the episode, could be confirmed. At the time of the reporting the patient status was "fine". The causal relationship between the event and therapy with ZOSTAVAX were not reported. Additional information has been requested.
04/29/2021Expand AllCollapse All    Number of Diagnoses or Management Options Acute non-recurrent maxillary sinusitis Close exposure to COVID-19 virus Diagnosis management comments: 68-year-old female no acute distress presents to urgent care with cough, sinus pain and congestion, postnasal drip, loss of taste and smell.  Patient states that 1 week ago she was mowing her grass and her seasonal allergies "flared up" she started having a cough, postnasal drip, sinus pain and pressure.  She reports that yesterday she lost her sense of taste and smell.  She states she has been fully vaccinated for COVID-19.  Due to patient's loss of taste and smell she was swabbed for COVID-19 PCR.  I also treated her for sinusitis with a Z-Pak.  Tessalon Perles were prescribed for cough.  Patient is aware to quarantine until results come back and are negative.  If she develops severe chest pain or shortness of breath she is to go to the emergency room.
SCAB AND SIGNIFICANT BRUSE AROUND INJECTION SITE 11 DAYS AFTER  BOOSTER  INJECTION.
Pt found dead in crib am 31Jan91, pt asymptomatic prior to death.
So I was out walking and I felt something rubbing against my sports bra and when I got home i checked and I saw this big lump un der my armpit. So I was very concerned, I looked on the internet and saw that it was a side effect from the vaccine and I made an appt with my Dr, which was a day or two later, went to the Dr.  and she took pictures of it and stated that there was nothing to be really concerned about and suggested that I wait 6 months before I get a mammogram. Dr. stated it should go down but it is still slightly enlarged under my armpit.
pt recv vax & began jerky movements of legs, arms (sz) episode last approx 30 seconds; confused, disoriented, frightened; MMR was given approx 5 mins a/exam; MD observed in ofc then referred to another MD
A non-serious spontaneous report of patient received expired FLUMIST was received from a health professional concerning a five-year-old female. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 20-Feb-2011. The patient received the expired FLUMIST on 25-Feb-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Lip swelling bottom > top lip began evening after receiving HPV vaccine. No lip swelling. No resp breathing difficulty. Patient presented to MD office 2nd day - exam showing mild swelling lower lip only. No wheeze/resp distress.
Developed flu like symptoms.  Lasted 4 days.  No nausea.  Dizziness, headache diarrhea.  I had a positive test reported to Florida health department.  In January on the 11th.  You can call me if you need additional info!
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history was provided. On 27-FEB-2013 the patient was vaccinated with dose 1 of GARDASIL. On 13-JUN-2013 the patient received the second dose which was reported to be late. No dosing information or route of administration was provided. No concomitant medication was reported. No symptoms were reported. Additional information has been requested.
On Saturday, January 29, 2022, the patient presented to the clinic to receive a Moderna vaccine. She told administrative assistant "I'm here for my booster vaccine". The administrative assistant retrieved the patient's vaccination record where she saw the patient's 1st dose logged. The administrative assistant applied a green sticker - which we use indicating a Moderna Booster dose - to the recipient's intake form and wrote a "2" on the sticker. The administrative assistant also applied a green sticker to the patient's vaccination card indicating she was receiving her booster dose even though the recipient never received a 2nd dose of Moderna. Register nurse (RN)vaccinated the patient with a booster dose of Moderna 0.25 ml. Later, the RN realized that the patient should have received a 2nd full dose and that she gave the recipient the booster dose - half of the recommended dose of 0.5 mL Moderna. Observation staff caught the error and brought it to the attention of the draw team lead. Usual practice is that vaccinators present the intake form with the sticker indicating the desired vaccine and dose to the draw team which distributes the appropriate vaccine syringe to the vaccine applicator. Regional Lead was notified. He phoned and spoke with the patient at about 3:30 pm inviting her to return to receive the remainder of her vaccine regimen and told her that our clinic would close at 6 pm. The patient did not return that day. The regional lead again attempted to contact and left a voicemail with the patient's phone on Tuesday, Feb 1st, 2022,  which was the next day the clinic was open. As of today, February 9th, the patient still has not returned to the clinic for the additional half-dose and the registry does not indicate she has received the remainder elsewhere. The incident was reviewed with above staff. Today, February 9th, the patient's account in the Registry still incorrectly states that she received the 0.5 mL dose of Moderna instead of 0.25 mL. Assistant Site Lead.
fever; chills; This is a spontaneous report from a non-contactable other health professional (patient). This report was received via a sales representative.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on an unspecified date he had fever, chills, and had to stay home from work "for a couple of days." The patient has since completed the two-dose series with the Pfizer COVID-19 mRNA vaccine (BNT162) (date unspecified). The outcome of events was unknown.  No follow-up attempts are possible. Information on Lot/batch number cannot be obtained.
Pain in arm that has resulted in limited use of arm; arm seems to be getting better, but I still have trouble with certain movement like taking off my shirt, scratching my back, raising my hand. With past flu shots, my arm would hurt for a day or two. This time, the pain was more intense, resulted in limited use of arm, and is taking longer to go away.
He received the vaccine and had a heart attack on May 3, 2021 and passed away on May 4th. They did an full autopsy
Knot , swollen tissue at injection site the size of a silver dollar.  Accompanying  rash located 2 inches below injection site with a diameter of about 3 inches. Extreme soreness and pain.
Pt inadvertently received inadequate dose of Moderna vaccine, no signs or symptoms of adverse reaction noted
left thigh with mild erythema, 3cm with slight induration, non-tender.
Initial misuse report received from a healthcare professional on 21 February 2014. The cases were received on 21 March 2014. A 62-years-old patient, received FLUZONE HD (no other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Dizziness, hallucinations, fever, hot and cold sweats, ringing in ears
VACCINE WAS GIVEN OUT OF VIAL THAT HAD BEEN OUT FROM THE DAY BEFORE
Caused me to have heavy menstural bleeding for 2 weeks. I do not typically have a cycle due to birth control (nexplanon). Also, I was fatigued, weak, with leg, back and overall bodyaches.
Received only the adjuvant; Received only the adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number FB2BH, expiry date 26th January 2024) for prophylaxis.   On 30th January 2023, the patient received the 1st dose of Shingrix. On 30th January 2023, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 30-Jan-2023 Reporter's comment: The medical letter was read. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient was inadvertently given the adjuvant portion of Shingrix without reconstituting the lyophilized component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Stated he noted red areas on back Sat after receiving Imm's on Thursday. No c/o itching, burning or pain. Was instructed by Dr to come to the Health Dept. Areas measured on his back at their broadest are 10" from one side of back to the other. There are 11 individual areas, some are edged some are more solid. Individually the are 3/4" wide from under scapulas to waistline. Almost look like bruising in color. No swelling or tenderness, pain noted on palpation. No temp or other sx from injection other than discomfort at site bil. deltoids. States he has had no injuries. Picture included.