chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients were administered with vaccines after they experienced an above temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unknown number of patients who received DTPa (Reduced antigen) (Boostrix) (batch number 31A745, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-May-2022 Reporter's comments: The health care provided reported that some patients were administered with Boostrix vaccines after they experienced an above temperature excursion of 12 degree Celsius for 6 months since 8th December  2021. When asked about patient or vaccine details, the healthcare professional stated she did not have any data available. Only batch number was provided. The consent to follow up was given. Additional Supportive Information: The patients received Boostrix that was exposed to temperature excursion of 12 degree Celsius, which led to incorrect storage of drug.
BEE STING ON RIGHT WRIST AROUND 4PM (NO KNOWN ALLERGY); SWELLING ON THE HAND FELT LIKE 3 BRICKS, SWELLING GOING TO FOREARM AND REACHED ELBOW; DIARRHEA; UNEXPECTED THERAPEUTIC EFFECT (EXACTLY 72 HOURS AFTER THE VACCINATION, FELT NO MORE PAIN FROM PAST INJURIES AND HAD BEST SLEEP EVER); This spontaneous report received from a patient concerned a 47 year old female. The patient's weight was 158 pounds, and height was 66 inches. The patient's past medical history included: pre-vaccine broken injuries, wrist brace, and pre-vaccine pain, and concurrent conditions included: seafood allergy, non-alcohol user, and cigarette smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-APR-2021, the patient experienced unexpected therapeutic effect (exactly 72 hours after the vaccination, felt no more pain from past injuries and had best sleep ever). On 26-AUG-2021, the patient experienced bee sting on right wrist around 4pm (no known allergy). On 26-AUG-2021, the patient experienced swelling on the hand felt like 3 bricks, swelling going to forearm and reached elbow. On 26-AUG-2021, the patient experienced diarrhea. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unexpected therapeutic effect (exactly 72 hours after the vaccination, felt no more pain from past injuries and had best sleep ever), had not recovered from bee sting on right wrist around 4pm (no known allergy), and swelling on the hand felt like 3 bricks, swelling going to forearm and reached elbow, and the outcome of diarrhea was not reported. This report was non-serious.
Right after receiving the vaccine patient complained of arm pain then back pain.  She said she "felt off" and was very sweaty.  Paramedics believe anxiety attack.  BP + HR normal.
20APR98 devel h/a;21APR98 fever & severe h/a, swollen glands neck; fever, noc sweats, h/a w/eye pain, diff swallowing, achy joints, tactile pain, loss of appetite, nausea, dizziness;
Previously reported increase in muscle spasms.; This is a spontaneous report from a non-contactable consumer (patient). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) from unspecified date at single dose for COVID-19 immunisation. Medical history included irritable bowel and quadriplegia. Concomitant medication included take multiple meds in two weeks. Previously reported increase in muscle spasms. AE resulted in Hospitalization. No COVID prior vaccination. COVID tested post vaccination with covid test result of Negative. Outcome of the event was unknown.   No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained. No further information is expected.
No additional adverse effects were reported; patient received an expired dose of M-M-R II; This spontaneous report was received from a nurse prescriber referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On 14-JAN-2020, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (0.5ml, once, lot# R00556, expiration date 08-JAN-2020; route of administration were not reported) for prophylaxis (expired product administered). The vaccine was reconstituted with sterile diluent (STERILE DILUENT) (lot# S024968, expiration date 28-FEB-2022). No additional adverse effects were reported.
Per pt's manager-pt developed hives 2 days post injection-self tx with Prednisone did not seek tx at Ed. Recovered per manager.
SYMPTOMS STARTED 4 DAYS AFTER SHOTS, HE DEVELOPED BODY ACHES, FEVER, CHILLS, SWEAT, HEADACHE, DIZZINESS, NO APPETITE AND COUGH; MD TOLD HIM TO GET PLENTY OF REST AND STAY HYDRATED
This spontaneous report as received from administrator (other) refers to a patient of unknown age. Pertinent medical histories and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL or GARDASIL 9 (lot number and expiration date unspecified) (unspecified dosages) for prophylaxis and then received second unspecified dose of GARDASIL or GARDASIL 9 (lot number and expiration date unspecified) six months later (inappropriate schedule of drug administration). The products could not be clarified, and patient age could not be obtained before the call was disconnected. No additional information is available. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: Several minutes after receiving the vaccine, the patient passed out and fell out of chair. He appeared to be shaking on the floor similar to a seizure but cannot confirm. He reports no history of seizures. When patient regained consciousness, he reported feeling light headed and dizzy. Patient looked pale and was sweating. He was given water and remained laying on the floor and sitting in chair for about 15 minutes until leaving with mother.
rash or bumps on arm; rash or bumps on arm; my inners legs swells like little bumps; other arm which feels like a shot; I had an allergic reaction, symptoms occurred the following day they progressively grown and it's behind my arm on the arm that I got the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101021874.  A 31 year-old male patient received bnt162b2 (BNT162B2), administration date 29Jul2021 (Lot number: EW0179) at the age of 31 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 30Jul2021, outcome "unknown", described as "my inners legs swells like little bumps"; PAIN IN EXTREMITY (non-serious) with onset 30Jul2021, outcome "unknown", described as "other arm which feels like a shot"; HYPERSENSITIVITY (non-serious) with onset 30Jul2021, outcome "unknown", described as "I had an allergic reaction, symptoms occurred the following day they progressively grown and it's behind my arm on the arm that I got the shot"; SKIN DISORDER (non-serious), RASH (non-serious), outcome "unknown" and all described as "rash or bumps on arm".  Additional information: There nothing is changing and it's been 9 days afterwards. I took Claritin put like lotion on and I don't know what to do." It all came at once, the only thing I've taken is Claritin twice, but it brings it down to smaller bumps, but the bigger ones won't be as itchy.   Follow-up attempts are completed. No further information is expected
Pain in left ear, swelling in left ear with growths in the ear, neck, chest, heart and groin area.
NAUSEA, WEAKNESS, NO APPETITE,  THIS STARTED ON 2/26.  ON 2/23 2 HOURS AFTER INJECTION SHE HAD ITCHING AND RED DOWN TO ELBOW.
My COVID-19 infection started on 12/28/2022 at night I had a sore throat. I had extreme body aches, fatigue, chills, fever of 101.00, cough, runny nose, and nausea. I had a shortness of breath in the morning at 11:00AM. On 12/29/2022 I tested positive. I was sick with COVID-19 for 3 weeks. I went to the urgent care and told them my symptoms and my positive test result. They prescribed me with an antiviral (LAGEVRIO) for 5 day. I also took benzonatate for cough and I also used albuterol nebulizer. I took TYLENOL 4-6 hours.
This case was reported by a consumer via other manufacturer and described the occurrence of broken blood vessel in eye in a 60-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden for prophylaxis. On 17th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) and Influenza vaccine Quadrivalent 2018-2019 season. In October 2018, less than a week after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced pain in arm. On 17th October 2018, the patient experienced chills, fever and insomnia. On 19th October 2018, the patient experienced broken blood vessel in eye (serious criteria GSK medically significant). The patient was treated with paracetamol. On 18th October 2018, the outcome of the chills, fever and insomnia were recovered/resolved. On an unknown date, the outcome of the broken blood vessel in eye was unknown and the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the broken blood vessel in eye, chills, fever, insomnia and pain in arm to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional information received as follows: The patient did like to report possible side effects to the SHINGRIX vaccine. The patient was in good health. The patient received SHINGRIX in the left upper arm muscle and at the same time, she also received a seasonal flu vaccine in the right arm. That same night of vaccination she experienced severe chills, mild fever and insomnia that lasted all night. The next morning to vaccination day, she took some Acetaminophen and felt better by midmorning. On reporting day, she woke up with a burst blood vessel in her left eye with no known trauma to the orbit. There was no pain nor loss of vision, and she felt fine other than some lingering soreness in the left arm where she received the vaccination.
Rash, grows to the size of about 2.5 inches in diameter. No itchiness, just red and painful.  Patient was treated in urgent care with antibiotic and topical steroid cream.
Information has been received from a nurse practitioner concerning a 21 female who on 13-MAR-2008 was vaccinated with her first dose of 0.5 ml GARDASIL (Lot #659962/1740U) intramuscularly in the deltoid.  The nurse practitioner reported that the patient had pain at the injection site for 2 days (onset date not specified).  The pain began improving but on 24-MAR-2008 the patient reported tightness in the shoulder where the GARDASIL vaccine was given, inflammation, and was tender to the touch.  The patient sought medical attention by speaking with the nurse practitioner on an unspecified date.  The patient was treated with ibuprofen (MOTRIN) and hot/warm compresses.  At the time of reporting the patient's outcome was unknown.  No other information was available from the nurse practitioner.  Additional information has been requested.
I had a mild heart attack on Sunday 5-30-2021. Because I have had the covid vaccine i was told I should report having the heart attack.
Day after receiving booster, I developed a large, painful, swollen "bump" at injection site, then that was followed by 2 inch diameter red circle around bump and injection site. Some what itchy. Treating with tylenol, ibuprofen,  heat/ice rotation.
arm is still killing them a month after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm is still killing them a month after getting the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (arm is still killing them a month after getting the vaccine). At the time of the report, VACCINATION SITE PAIN (arm is still killing them a month after getting the vaccine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were not reported.   This case was linked to MOD-2021-418640, MOD-2021-419667 (Patient Link).
nausea; This is a spontaneous report from a contactable other HCP (patient). A 60-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included (BNT162B2, covid vaccine) via unspecified route and unspecified date for covid-19 immunisation and experienced fatigue. Patient states that she is having occasional fatigue. Patient did have a Covid vaccine and the first injection she took during her on week and just had fatigue. The second dose was during her off week and she states she slept for three days and had nausea on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch no. cannot be obtained.
Generalized fatigue and muscle weakness. Neck ache and diffuse headache. Started in the evening, a few hours after receiving the vaccination. The next morning, all symptoms were much worse. Came into the clinic that afternoon concerned about new onset of symptoms so closely related to vaccination administration.
Hospitalized 10/8/2021; COVID-19 positive 10/8/2021; fully vaccinated  BRIEF OVERVIEW:  Admission Date: 10/8/2021 Discharge Date: 10/18/2021 DETAILS OF HOSPITAL STAY:     HOSPITAL COURSE: The patient is 65-year-old gentleman presented to the hospital with chief complaint of having syncopal episodes x2 while on dialysis.  He has a past medical history significant for morbid obesity, chronic obstructive pulmonary disease, coronary artery disease status post cardiac stents, ESRD on hemodialysis, type 2 diabetes mellitus, dyslipidemia, hypothyroidism. He was evaluated in the emergency department where he was noted to have bilateral lung infiltrates on the x-ray chest.  COVID test was done which was found to be positive.    On presenting at the emergency department was found to have a blood pressure of 99/59.  This improved after 500 mL of bolus of saline.  The patient continued to seem fatigued with some hypoxia.  Was started on dexamethasone however remdesivir was held due to renal failure.   The patient's respiratory status improved requiring minimal oxygen.  Tolerated dialysis without further episodes of hypotension or syncope.  Completed 10 days of Decadron.  Unable to return back to his long-term care home until completing isolation.  Afebrile and hemodynamically stable.  Eager to go home at time of discharge.
Patient needed Shingrix vaccination and received Menveo by mistake, no ill effects were noted from this vaccination.  Shingrix will be given ASAP.
presented with acute pancreatitis and went to hospital; This spontaneous report has been received from a physician via a company representative referring to a 14 years old female patient. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On an unknown date (reported as recently, the exact date was unknown), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, route and dose details were unknown) for prophylaxis.         On an unknown date (4 days after the dose), the patient presented with acute pancreatitis and went to hospital. The patient sought medical attention and received treatment.      The patient recovered in 2 days. At the time of this report, the patient was fine. The causality assessment between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, acute pancreatitis was determined to be medically significant.
11:00am, 15 minutes after Vaccination, pt states she was feeling tingling in her tongue, ?like throat was closing? and dizziness, but it subsided. The Observation person notified me right away and I immediately went to pt. with Crash Kit. I assessed her and she denied any complaints at that time and that they had subsided. She denied any pain, tingling, oral or airway issues. Pt. report when asked that she has chronic Fibromyalgia, and immune system issues. Otherwise no allergies to medication or food. I gave her Benadryl 50 mg PO once. She stated she had a ride waiting, so she would not drive. I asked pt. to stay an additional 30 minutes, then I would reassess and walk her out. I also updated the Dept.  Supervisor in the event we needed to give Epi and provide higher level of care. After 30 minutes,  I reassessed and pt denied any c/ o pain, tingling oral/ airway issues, but stated she had ? sinus like pressure ? in her forehead. I advised her to contact her physician and update with what occurred and if she has any continued side affects, headache pain, or other s/sx.
ROTATEQ that experienced a temperature excursion and was administered.; No side effects reported; This spontaneous report was received from a healthcare professional referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) which experienced a temperature excursion and was administered orally for prophylaxis (lot# W0291190 with an expiration date on 28-JAN-2024) (strength, dose, and anatomical location were not provided).  The dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was exposed to a temperature excursion of 9.3 Celsius degrees (C°) during a time frame of 11 minutes (poduct storage error). There was prior temperature excursion of 18.8°C for 2 hours 55 minutes and 0 seconds.  No side effects reported.
This case was reported by a consumer via call center representative and described the occurrence of sickness in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The reporter stated that there were some people who might not be the candidates of receiving SHINGRIX, and he found that their friend was getting sick from the SHINGRIX vaccine.
Chills Headache Insomnia Muscle Aches (Arm and Both Legs) Nausea Vomiting
Flu-like:  Fever up to 100.1, swollen lymph nodes in neck, painful arm with milder pain radiating outward to neck, lower arm, and right shoulder.  Second days saw all symptoms get better but not gone.
excessive swelling of lt leg from thigh to ankle area; cried cont (high-pitched) x 3-4 hrs; was taken to ER by mom; while @ hosp had 2 episodes of sz activity; kept in hosp overnoc; fever never over 100;
Systemic: Bell's Palsy-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patietn recived the shot within 5 minutes blacked out not able to see by was still alert. Resolved with in 10min but emergency was call for further evaluation. Patient also reported issues with hearing and hot flashed.  Was no signs of anaphylaxis.
Bilateral eye redness and swelling X 2 hours after vaccine.  Now resolved.  Per pt report.
Administered dose past 12-hour mark; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered dose past 12-hour mark) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered dose past 12-hour mark). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered dose past 12-hour mark) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-365212, MOD-2021-365214 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Added reporter email address.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: patient felt a little dizzy and light head. we assisted him to floor, and call rescue. He began to feel better and left on his on
The pt experienced a fever on 9/27/00 and the left arm deltoid area had cellulitis and hives.
Pinpoint erythema with 1cm pink area non tender. No tx pt to f/u 10/25/10. Pt to RTC if s/s worsen.
Naseasu, headache, sore injection site, pain in hip and clavicle.  Malaise,
This 83   year old   black male received the Covid shot on    03/22/2021  and went to the ED on  4/5/21      and was admitted  on   4/8/21     with  CHF, bilateral lower extremity edema, chronic kidney disease  and died on    5/1/21    .  Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.