chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine used; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.            No concomitant medications were reported. No treatment medications were reported. This is a case of Expired Product Administered concerning a 67-year-old female patient with no relevant medical history, who experienced the unexpected adverse event of Pain in Extremity. The event occurred approximately the same time after receiving the third dose of mRNA-1273 Vaccine. The rechallenge is positive for dose 2 and dose 3 since the event Pain Extremity happened on all 3 doses and resolving about 2-3 days however rechallenge for dose 1 and dose 2 is negative it was mentioned that in the first dose patient took treatment. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-392249, MOD-2021-392275 (Patient Link).; Sender's Comments: This is a case of Expired Product Administered concerning a 67-year-old female patient with no relevant medical history, who experienced the unexpected adverse event of Pain in Extremity. The event occurred approximately the same time after receiving the third dose of mRNA-1273 Vaccine. The rechallenge is positive for dose 2 and dose 3 since the event Pain Extremity happened on all 3 doses and resolving about 2-3 days however rechallenge for dose 1 and dose 2 is negative it was mentioned that in the first dose patient took treatment. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Patient presented to clinic 2/16/16 with bright red rash, fever, cough, runny nose, fussiness. Patient parent report treated for RSV at ER previously. Treated for bronchiolitis; and RSV admitted to Hospital. 2/16/16 - patient was "admitted" to hospital for rash, fever, cough, runny nose, fussiness.
intense pressure headache in forehead and face; Fever; Diarrhea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhea), HEADACHE (intense pressure headache in forehead and face) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 007B21A) for COVID-19 vaccination.     Medical history was not reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced DIARRHOEA (Diarrhea) and PYREXIA (Fever). On 26-Apr-2021, the patient experienced HEADACHE (intense pressure headache in forehead and face). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. At the time of the report, DIARRHOEA (Diarrhea) and PYREXIA (Fever) had resolved and HEADACHE (intense pressure headache in forehead and face) had not resolved.            No concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.
Swelling right eye; Conjunctivitis; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 73-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration in Arm Left on 03Mar2021 12:00 (at the time of 73-years-old) as first dose, single for covid-19 immunization. Medical history includes HBP (Blood pressure high), hypothyroid and depression. The patient did not receive any other vaccines in four weeks. Prior to vaccination, the patient had not Covid. The patient was not tested for COVID since the vaccination. Patient had no known allergies. facility country was US. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), ergocalciferol (VIT D) and melot within 2 weeks of vaccination, all for unspecified indication from an unknown date and unknown if ongoing. On 03mar2021 13:00 patient experienced swelling right eye and conjunctivitis. Treatment received for the events were unknown. Outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be requested.
This is a non-serious spontaneous case, initially received from other non-health professional on 30-Jan-2018, concerning a 63-year-old, adult, male patient. The patient's current conditions included diabetes, hypercholesterolemia and hypertension (from an unspecified date). The patient's concomitant medication included: ASA, metformin, TOPROL, REVATIO, ZOCOR and benazepril for an unknown indication. On 30-Jan-2018, the patient was administered with expired FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 185887 and expiry date: 30-Apr-2017). It was reported that, the patient did not experience any adverse event after the administration of vaccine.
Headache, body ache. Fever around 7:00 PM MST continues throughout the night
Severe Abdominal Pain; excruciating pain in neck; excruciating pain in arms .; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 45-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0173 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 07Jun2021 12:00 (at the age of 45 years) as single for covid-19 immunization. The patient concomitant medications were not reported. No other medical history reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0172 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 17May2021 12:00 (at the age of 45 years) as single for covid-19 immunization. Patient had no reported allergies. Patient did not receive any other vaccines within four weeks and other medications in two weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination. patient did not covid tested post vaccination. On 07Jun2021, the patient experienced severe abdominal Pain, excruciating pain in neck and arms. The patient did not receive any treatment for adverse events. The outcome the events was resolving at time of report.  Follow-up attempts are completed. No further information is expected.
Initially low fever, fatigue, soreness at injection site followed by severe rash on trunk and extremities; red, itching, fluid-filled blisters, skin peeling, bleeding then scabbing over. Larger raised sores appearing on rt upper thigh. 9/18 Prescribed valocyclovir 1gm 21,  methylprednisolone 4mg dosepak 21.  Rash and itching persists. 9/26 gabapentin 300mg 90, clindamycin 300mg 21. Rash and itching worsens. 10/01 urgent care visit. Dr., prescribes prednisone 10mg 60. 10/01 emergency dermatology appt. Dr. prescribed triamcinalone 0.1% 80gm, sulfameth/trimethoprim 800/160mg 20. 10/02 itching unbearable, Dr. prescribes hydroxyzine hcl 10mg. Rash and itching pesist. 10/21 methylpredisolone 4mg 60, hydroxyzine 25mg 30. Rash and itching persists. 10/23 betamethasone dipropionate 0.05 % cream. Itching and rash still persists at present time of report (10/25/19 4:43PM)
Pt received Moderna 12+ dose - MA did not scan the correct product and manually entered the 12+ dose.  Pt should have received the Moderna 6-11Yr dose.  VAERS report filed.
C/o extreme pain to arm states was better after 2 days past immunization then got worse again.
Left thigh with large pink swollen area around injection site. Occurred 1 day after vaccine given, redness did not spread.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 19-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (VIs 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) dose, route and anatomical location were not provided. There was no concomitant medication provided. On an unknown date, the PNEUMOVAX had a temperature excursion for1824 hours; the highest recorded temperature was 59.9 degrees Fahrenheit (15.5 Celsius). The vaccine status was reported as "in excursion" and was storage in a Refrigerator (R). There was no product quality complaint involved and no adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Pfizer  COVID Vaccine; ADR developed after 5 min. Patient became lightheaded and developed tunnel vision. Had a witnessed syncopal event in her car. Unconcious x1 min, had urinary incontinence, and vomited; Not postictal; developed episode of tunnel vision few hours after 1st dose as well
08-01-17, 1:00PM, VACCINES ADMINISTERED PER PARENTS REQUEST. IMMEDIATE REACTION NORMAL. PARENTS REPORTED WHILE WALKING OUT THE BLDG, CLIENT FELT WEAK, LIPS PALE. CLINIC NURSES TOOK VITALS, GLUCOSE, O2. BP (LA, SITTING)=92/62, RR=24, TEMP=97.8, P=56, O2=100, GLUCOSE=99. RESPONDING WHEN SPOKEN TO. DETAILS IN VAERS RPT. LIPS PINK, CLIENT REMAINS STABLE WHEN PARAMEDICS TOOK CLIENT TO ER FOR MORE OBSERVATION. 08-02-17, 5:00PM, MOM ON THE PHONE STATED ?ALL OK, HE'S LITTLE CRANKY?, YESTERDAY AT ER COUPLE HOURS FOR OBSERVATION, EVERYTHING OK.
Positive home pregnancy test 2 days after second dose of Pfizer covid vaccine, 8/19/21. Estimated due date based off last menstrual period was April 12, 2022. 12 days after second dose of Pfizer covid vaccine, patient experienced spontaneous miscarriage at 7 weeks 5 days. First pregnancy.
Sore arm at injection site.  Feeling tired, as if my body was fighting an infection.
Severe rotator cuff / muscular pain in right shoulder (opposite arm from injection) Burning . Painful to the touch.  Difficulty using right arm.  Restricted motion.
Shingles and she had all the vaccines/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID-19 VACCINE UNKNOWN) for prophylaxis.   The patient's past medical history included chickenpox (when the patient was young).   On an unknown date, the patient received Shingles vaccine and the 2nd dose of COVID-19 VACCINE UNKNOWN. On an unknown date, unknown after receiving Shingles vaccine and an unknown time after receiving COVID-19 VACCINE UNKNOWN, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had Shingles vaccine about 5 years ago from the date of reporting and 3rd day after 2nd COVID19 vaccine, the patient got a severe case of shingles on the same side of vaccine. The patient shingles was just awful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Patient described major swelling, and body aches. Also complains of major pain "in the ankles."  Body aches increased over the course of 2 days. When asked if patient has been using anything to help with the aches, did not mention taking any other medications. Patient was referred to Urgent Care to be seen by physician.
This case was reported by a nurse via call center representative and described the occurrence of erythema of extremities in a adult female patient who received SHINGRIX for prophylaxis. On 5th August 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous). On 5th August 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. In August 2018, the patient experienced erythema of extremities, swelling arm, tiredness, shivering, fever, extremities hot feeling of and feeling cold. On an unknown date, the outcome of the erythema of extremities, swelling arm, tiredness, shivering, fever, extremities hot feeling of, feeling cold and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the erythema of extremities, swelling arm, tiredness, shivering, fever, extremities hot feeling of and feeling cold to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On Sunday, the patient received SHINGRIX subcutaneously instead of intramuscularly, which led to inappropriate route of vaccine administration. 24 hours after receiving SHINGRIX, the patient experienced freezing shivering in bed then had a fever (the patient's body temperature was recorded as 101.6 F) and tiredness. Less than a week after receiving SHINGRIX, the patient entire upper arm was red hot and swollen and it was just starting to resolve after three days. The patient experienced tiredness and remained in bed for 48 hours. At the date of reporting on the third day, the patient was still tired. The patient called the pharmacist who administered the shot so that she would not continue to administer it incorrectly. The pharmacist read the pamphlet and apologized and said she would administer it intramuscularly from then onwards. The patient could not imagine this was just an isolated event since the original shingles shot was given subcutaneously. That route was what medical personnel were used to. The patient thought that there should be more education or something on the box to alert personnel to give the injection intramuscularly. The patient asked whether she would had adequate protection with the SHINGRIX booster that was given subcutaneously. The reporter believed that others might had received this product subcutaneously as well. This case has been linked with US2018144853, reported by the same reporter. For the inappropriate route of vaccination in unspecified number of patients refer linked case US2018GSK149636.
Hives and Singles. Shingles lasted about over a month on left eye and head. Excruciating pain all over! Hives on legs and arm. Still gets itchy at times
3hrs p/vax pt became very fussy, temp nl;pt remained very restless & fussy throughout the noc;t103.3 R;mom administered pediatric Advil q 4 hrs & temp returned to nl w/in 24hrs;extreme fussiness lasted 36hrs;MD advised no further pertussis
patient had bad shoulder pain he went to the doctor and was treated, the next few days patient was slowly starting to feel better
2 hours after I received the first vaccine,  I started experiencing, pounding heartbeat, palpitations, tachycardia,. As the night went on.. I had numb feeling in my face, tingling in my head, feeling of " head rushes", burning in both arms and chest. This lasted about 12 hours. I went to work the next morning,  did not feel well. To date I still am not feeling like myself.
At 3:40 am 4/8/21 my dog woke me to go outside. As I walked down the stairs, I was happy  I felt perfectly normal as I had heard so many side effects. My arm was sore but that was all. After a few minutes I went back upstairs and became incredibly nauseas and light headed. It was more overwhelming than any feeling like that in my life. I wasn?t sure if I was going to vomit or faint. I rushed in bed and was breathing very heavily in my nose and out of my mouth focusing on this awful feeling to pass. After a few minutes my right shoulder started to tingle and feel numb. The sensation started working its way down my right arm then began on the left side. The tingling/numb sensation went all the way to my fingertips and I lost movement in both of my hands. I could still feel touch but I had no movement in my fingers. After about five minutes I slowly regained movement in my fingers and the tingle/numb sensation moved slowly back up both my arms in the same manner it began. After roughly ten minutes this episode had entirely passed and I went back to sleep. When I woke around 7am I felt relatively normal, just minor tiredness and headache. Around 1:00pm I developed a fever of 100.7 and went to bed for the day about 6:00pm on 4/8/21. When I woke Friday 4/9/21 I felt entirely back to normal.  My husband said if I hadn?t regained movement of my fingers when I did, he was going to take me to the ER because it was so bizarre and scary. While the episode was at its peak, my husband gave me two Tylenol.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/5/2021 and 3/23/2021. Presented to ED on 9/18/2021 with reports decreased appetite over the last 3 days,  diarrhea and abdominal pain 2 days duration, shortness of breath, and fatigue. She was found to have pneumonia secondary to COVID-19.  She was hypoxic and admitted to the hospital.  She was started on dexamethasone and determined to not be a candidate for remdesivir.  She rapidly decompensated and required high-flow nasal cannula. By September 24th she had become relatively obtunded and stop taking all oral medications. On maximum high-flow she was only maintaining O2 saturations in the 86-89% range.  Palliative Care evaluated the patient on that evening and on the morning of the 26th she was transitioned to comfort care.  On September 26 at 3:16 a.m. the patient passed away.
Shortly after shot my left shoulder began to hurt and tingle. It was warm and sore to the touch. By bedtime it was starting to hurt to lift or move my left arm. I am only able to sleep on my left side but due to the pain I wasn't able to do so. This pain lasted for about 4-5 days. After that although it is not as painful I still have a constant ache in my shoulder and it is still difficult to raise or use my left arm without pain.
Painful muscle spasms reported in pt who recvd flu vax on 4OCT91 & on 5OCT91 devel painful muscle spasms involving anterior thigh muscle bilat; Pt seen by MD on 7OCT91 & found to have tender anterior & posterior thigh muscle;
Information has been received from a physician concerning an 11 or 12 year old female with a history of chronic bowel disease who was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown) on an unspecified date. it was reported that 11-14 days after the vaccination (also reported as 10 days post vaccination) she developed chronic inflammatory demyelinating polyneuropathy. Unspecified medical attention was sought and it was noted the prescription drug treatment was required. From this disease, she developed marked weakness of all muscles and became a quadriplegic (noted to be caused from the chronic inflammatory demyelinating polyneuropathy. The physician reported that the patient died two years later (date not specified) from death of bowel or bowel volvulus. The physician reported the bowel volvulus was related to the chronic inflammatory demyelinating polyneuropathy. No product quality complaint was involved. Additional information has been requested.
In the clinic, patient received second dose of Moderna vaccine at 1630. At 16:40 c/o difficulty breathing, feeling light headed, tingling lips, eyes puffy. BP 187/77, HR 84, O2 Sat=84. Rapid Response Team (RRT) activated, patient took Benadryl 25mg PO,symptoms not improving, transported to the ED via stretcher with the RRT.   In the ED, patient presented afebrile, hemodynamically stable, no acute distress. Physical exam overall unrevealing. No apparent hives, facial swelling, oropharyngeal swelling or wheeze. Patient stated the symptoms feel significantly better.   Patient given 25 mg Benadryl and 20 mg famotidine via IV. Observed in the emergency department for almost 3 hours. No resurgence of symptoms, no rash, no wheeze, no nausea or vomiting. Patient discharged home, advised to take another dose of Benadryl later at night, and reevaluate symptoms in the morning. Advised to follow-up promptly with primary care. Strict return precautions given.
Pt received vaccine in right deltoid muscle. The next morning the patient's arm was swollen upon awakening. By Saturday 9-18-10, the swelling moved down to the elbow. As of Friday 9-24-10, there was still some swelling in elbow. Pt would not go see doctor.
husband got his first ever shingles shot and than got shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: husband got his first ever shingles shot and than got shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 08-JUN-2023 The case was received from the patient's wife interactive digital media. The patient got his first ever Shingles shot and then got shingles. The reporter's mother had shingles, but reporter was not afraid of getting it because of her active healthy lifestyle. But that was not the case at all little did she know shingles varies from person to person. The reporter stated that for her it started with four days of neck pain. The pain kept getting worse.  Then a rash developed, and her physician diagnosed her with shingles.  The pain was so intense that she was not able to work for days. Even after the rash went away, she had pain that lasted for five months, and reporter wished that she would not have waited to learn more about shingles. The reporter stated that did not wait talk to a physician or pharmacist on the day of reporting, about shingles prevention for those over 50. The follow-up could not be possible as no contact details were available.
Information has been received from a health professional concerning a 7-year-old white male who on 24-JAN-2000 was vaccinated with a dose of Varivax. On 09-FEB-2006 the patient developed a rash illness and was sent home from school. This was noted to be vaccine failure. It was unknown if this was MD documented/evaluated. Follow up information indicated that there was no further information. Additional information is not expected.