chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left eyelid twitches every once in a while,; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 12Apr2021 at 07:30 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN). On 12Apr2021, the patient experienced that left eyelid twitches every once in a while, which did not happen prior to vaccine. The patient did not receive any treatment for the event left eyelid twitches. The clinical outcome of the event left eyelid twitches every once in a while, was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment (30Aug2021): This follow-up report is being submitted to amend previously reported information that the patient had no known allergies to medications, food, or other products was added in narrative.
Pressure began to build behind and around my right ear. Resulting swelling, periods of hearing impairment, and tinnitus have resulted. Pressure in head and dizziness at times as well.
Extreme soreness site with swelling and redness and heat,elevated temp,lymph node swelling under arm,soreness joints,pleurisy type chest pain,fatigue.  In bed 1 day better today
Needle leaked (while administering SECOND dose); Not sure if the patient received even half the dose; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (Needle leaked (while administering SECOND dose)) and UNDERDOSE (Not sure if the patient received even half the dose) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced DEVICE CONNECTION ISSUE (Needle leaked (while administering SECOND dose)) and UNDERDOSE (Not sure if the patient received even half the dose). On 01-Apr-2021, DEVICE CONNECTION ISSUE (Needle leaked (while administering SECOND dose)) and UNDERDOSE (Not sure if the patient received even half the dose) had resolved. Not applicable      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment medications were reported Pharmacist reported that there was no adverse event that occurred after the vaccine was administered. Also reported that patient was administered full dose in the other arm.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Event update.
Onset on 21APR91 of fever 102.8 R, & on 22APR91 weakness lt arm; Subsequently went on over a 5 to 7 day period to develop a flaccid paralysis of anterior Horn cell type of lt arm;
Loss of normal leg function (flopping). Sensation of heat flowing down legs which eventually kept rising to the mid section. Incontinence. Constipation. Tingling of multiple body parts.
Vaccine was administered beyond use date after the thaw process; This spontaneous case was reported by an HCP and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use date after the thaw process) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 prophylaxis.     It was unknown if the patient had ever been diagnosed or tested positive for COVID-19. It was reported, acute illness at the time of vaccination and up to one month before and chronic or long-standing health conditions were unknown.     On 19-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's age was reported as 59 years 7 months.  No concomitant medications were provided by the reporter.  No adverse reactions were reported by the patient after the administration of vaccine. Vaccine Ndc code  was reported as 80777-0273-99.  No treatment medications were provided by the reporter.
The swelling at the point of injection was the size of about a half of a golf ball. It was also itchy at injection site. The pain progressed across my arm and back. I also experienced fatigue and chills.
patient complained of generally not feeling well and laid down in the hours after the injection.  When she awoke she had severe chest pain and felt as if the back of her throat was closing and was sore.  She went to emergency room and was admitted for observation. She spent 1.5 days in hospital.
Developed a headache 18 hrs after vaccine. Followed by bodyaches. Fever noted of 101.7 degrees F (oral) on 2/2/2021 @ 6pm. Fever lasted until 5am on 2/3/2021. On 2/3/2021 @ 4pm noticable redness and swelling in upper left arm. Arm is tender to touch and also warm. On 2/4/2021 redness has spread.
Case number PHEH2013US005084, is an initial spontaneous report received from a nurse on 27 Feb 2013, and with a follow up report received from physician on 15 Mar 2013: This case refers to a 12-years-old female patient. Her medical history included allergies to dairy products. She received only Men A lyophilized conjugated component of MENVEO vaccine (batch number: A11071, expiry date: Dec 2013) reconstituted with sterile diluent intramuscularly on 27 Feb 2013. No adverse reaction reported following this administration error. Follow up report received from physician on 15 March 2013. Patient initials, medical history and expiry date on vaccine updated.
This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 (lot#, expiry date, dosing details, anatomical location, route were unknown) for prophylaxis. Previous temperature excursion was reported. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010102: US-009507513-1708USA010099: US-009507513-1708USA010100: US-009507513-1708USA010102: US-009507513-1708USA010103: US-009507513-1708USA010101:
Night of  first injection my dad said he missed his bed and fell on the floor and laid in the floor and couldn?t move  for an hour. The day after second injection he almost passed out and we went to the ER. He was sent back home. Now he has been diagnosed with Parkinson?s disease. He has low Vitamin D. He is anemic and his iron is so low he is receiving 2 iron infusions. He has blood that has showed up in his stool and is having a colonoscopy on July 15th. He stays very dizzy and weak. He also has problems now with his eyesight.
Pt's mother stated pt's father contracted Ramsey Hunt Syndrome after pt recvd Varivax immunization. Pt's father was seen by another MD for diagnosis.
Vaccine expired on Friday 10/20/2023 and was given to patient Tuesday 10/24/2023.
Information has been received from a physician referring to multiple unspecified numbers of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. From January 2016, an unspecified number of patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (lot#, expiration date, dosage, frequency and route were not reported) for prophylaxis. No adverse effect reported. The vaccine was stored at unspecified high or low temperature excursions from January 2016. The reporter stated that one refrigerator experienced 2041 excursions and another experienced 230 excursions during this timeframe. There has previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA008490: US-009507513-1709USA004627: US-009507513-1709USA004633: US-009507513-1709USA004630: US-009507513-1709USA004632: US-009507513-1709USA004628: US-009507513-1709USA004629.
No further AE; 6 month old patient inadvertently received a first dose of ROTATEQ; This spontaneous report was received from a registered nurse and refers to a 6-month-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 24-FEB-2021 the patient was vaccinated, at inappropriate age, with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dosage form, orally (lot # and expiration date were unknown) for prophylaxis. The patient did not experienced any adverse events.
This spontaneous report was received from a nurse and refers to a 4 year old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 24-JUL-2015, the patient was vaccinated with a dose of PROQUAD (Merck) (dose, route and anatomical location were not reported) lot # K025766, expiration date 08-JUN-2016, which had been exposed to temperatures outside of the recommended range. No adverse experience was reported. Additional information has been requested.
A few hours after vaccine Pt. developed silant seizures 911 called and pt was taken to ED. Pt will F/U with neurologist
Injection site started swelling; Injection site started aching. She says that she can't lift her arm, can't move it, that it is very painful.; Major headache; A spontaneous report was received from a consumer concerning a 22-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273)and experienced injection site swelling, ache at the injection site, couldn't lift or move her arm, and headache.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 05-Jan-2021, approximately two hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L208) intramuscularly in her left arm for prophylaxis of COVID-19 infection.   On 05-Jan-2021, Patient received vaccine and approximately two hours later the patient began feeling an ache at the injection site.  She couldn't lift or move her arm and had a headache and injection site swelling. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events experienced injection site swelling, ache at the injection site, couldn't lift or move her arm, and headache were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Patient had throat discomfort several hours after receiving vaccines. Patient was given 1 dose of 25mg Benadryl at Pharmacy. Administering pharmacist followed up with patient on the following day; patient reported feeling better, but groggy from the Benadryl. Today, 2 days after vaccination, patient reports pain and whelps in the left arm (PPSV23) and flu-like symptoms with mild throat discomfort. Instructed patient to take ibuprofen and Benadryl and to follow up with physician in the morning. Instructed patient to go to ER if she feels throat closing or trouble breathing.
This spontaneous report was received from a pharmacist and refers to an elderly patient (over the age of 65 year old) of unknown gender. The patient's concurrent conditions, medical history, known allergies and concomitant therapy were not reported. On an unknown date, after reaching age 65, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route of administration, anatomical location, lot# and expiry date were not reported). The patient was scheduled to receive a dose of PREVNAR 13 in the near future, in the reverse order of established guidelines. No adverse effects were reported. No product quality complaint was involved. Additional information is not expected as there was no consent to contact the reporter.
Profound pancytopenia discovered on routine lab work: WBC 2300, absolute leukocyte count 400 (0.4), Hct 35, Hgb 11.8, platelets 110; no associated symptoms.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 05Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 27Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history included: "high ANA" (unspecified if ongoing); "immunocompromised" (unspecified if ongoing). Concomitant medication(s) included: NP THYROID. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Covid-19 treatment; (11Jun2022) positive, notes: Rebound/return of symptoms and 2 positive covid-19 rapid tests on day 8 after finishing treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course:  Patient received other medication in 2weeks: NP thyroid. Patient received COVID 19 Treatment (Paxlovid)  from 04Jun2022 to 09Jun2022 for the treatment of COVID-19. Rebound/return of symptoms and 2 positive covid-19 rapid tests on day 8 after finishing treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report has been received from a physician referring to a currently 79 year old female patient. There were no pertinent medical history or drug reactions/allergies. Concomitant therapies included CELEBREX and EVISTA. On an unspecified date, the patient was vaccinated with first dose in vaccination series of GARDASIL (intramuscular, dose, lot # and expiration date not reported) for prevention of skin cancer (product use in unapproved indication). On an unknown date, the patient developed lymphadenopathy within an unspecified time frame after receiving first dose in vaccination series. The patient sought medical attention via physician visit. No treatment was given for the event. No lab diagnostics were performed. The patient received second dose in vaccination series of GARDASIL (intramuscular, dose, lot # and expiration date not reported) for prevention of skin cancer on an unspecified date. At the time of the report, the outcome of the event was reported as not recovered. The causality between lymphadenopathy and GARDASIL was not reported.
A report has been received from a Pharmacist concerning a patient born on 29-SEP-1998, female subject, who had been receiving FLUMIST Quadrivalent. The patient's concurrent disease(s) include Viral hepatitis. FLUMIST Quadrivalent  started on an unknown date. It was reported that FLUMIST Quadrivalent was administered to a patient who they thought had viral hepatitis. The outcome of the event of gave FLUMIST Quadrivalent to patient with Viral hepatitis is unknown. The report was considered to be non-serious.
Left arm red, hot, swollen 4" X 3" wide and painful. Mother gave Motrin and cool compresses. Went to ER on 8/16/00 and was told to continue Motrin and compresses.
Fri night I already felt the body soreness, and by Sat midnight fever started that progress the whole day, can't even get up from bed, feels so bad. Tylenol taken for fever, and went to the nearest urgent care center.
This spontaneous report as received from a medical assistant refers to a 58 year old male patient with uncontrolled type II diabetes, hypertriglyceridemia and anemia. Patient had no history of drug allergies. On an unspecified date "before 04-JAN-2012", the patient received a dose of PNEUMOVAX23 (lot number, route unspecified), and developed throat tightness and difficulty swallowing. Outcome of throat tightness and difficulty swallowing were not reported. On 10-JUL-2013 the patient was vaccinated with another dose of PNEUMOVAX23 (lot number H021941, Exp. 11-JUL-2014) 0.5 ml intramuscularly. Concomitant therapies included gemfibrozil, losartan potassium (manufacturer unknown), TRADJENTA, glipizide, metformin, FLUTICASONE PROPIONATE and FLOVENT. On 10-JUL-2013 the patient developed flu-like symptoms with a fever, stomach pain and stomach upset. The patient had called physician's office for medical attention. No treatment was given and the patient's wife watched him carefully at home. No lab test was performed. At the time of reporting the patient was recovering from flu-like symptoms with a fever, stomach pain and stomach upset. Additional information has been requested.
Patient is 11 years old. Instead of boosting with the Pfizer 5-11 vaccine, nurse administered Pfizer bi-valent (12+). Patient's mom reports no adverse effects as of 48 hours post-administration.
After feeling nauseous and arm pain on 8/5 then I felt like I had a UTI infection but it went away after 2 days 8/9 having ear pain with blisters and left side facial paralysis,  I was diagnosed with having Ramsay Hunt Syndrome on 8/11/2021
Pt recvd 1st Engerix-B vax on 05JUN91 & next day had onset of rash (generalized); Seen in ER; given meds & rash resolved;
Approximately 10 minutes after receiving the second Pfizer COVID-19 vaccine patient became nauseated and vomited partially digested food.
Dose received at 10:00 am.  1/14/2021 Initially some pain at injection site,  Around 7 pm there were chills and fever (eventually spiking around 102.7 degrees),  There was a severe headache along with severe joint pain that made it difficult to even walk. These symptoms persisted until about 11:00 am the following day (1/15/2021) A low grade fever has continued throughout the day.
I felt very faint (after the first and second dose which does not usually happen with vaccines). My lymph nodes in my right armpit became swollen the next day. That following Saturday, I had a headache that medication did not help and felt weak. I checked my blood pressure throughout the day and noticed it continued to increase. I went to the ER and they concluded it was side effects from the vaccine because my blood work looked normal. On Sunday, I had no symptoms.
Recvd flu shot on 18OCT91; states 24OCT91 had sore throat; states next day started coughing; took med w/o relief; states coughed all night 28OCT91 (in morning) went to urgent care; states there the MD told pt may have a slight case flu;
The leg where her injections were given swelled to twice its normal size.  She screamed all night long, stopping only to vomit several times.  She had trouble standing, was clumsy and unresponsive at times. She woke the next morning thin, pale and lethargic. Afterword she had constant health issues (ear infections, colds, flu, staph - one following the next).  We worked with doctors, naturopaths, homeopaths and nutritionists to get her whole body healthy again.
Pt went to immediate care center a few days after receiving SHINGRIX due to the fact she could not move that arm. She had weakness in the arm not pain. There was also significant swelling and redness in the area from the shoulder to the elbow. The doctor treated for possible cellulitis with Clindamycin.
vaccine received 11/5/2021 ~545pm. Pt's wife stated  Okay over the weekend but Monday Pt's arm  became red & warm to the touch. States pt bruises easily. Pt does not complain of Pain. No issues with  hives. difficulty breathing. (No striation)
Starting in the evening on 1/6/21, night sweats and a severe headache that was not relieved with OTC meds. Signed off work on 1/7/21 due to symptoms.  Fever of 100.6 that has resolved. 1/8/21 chills and sweats alternating throughout the day along with body aches and swollen lymph nodes, making it difficult to swallow.
This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 01-JUN-2016 (reported as today), the patient was vaccinated with improperly stored dose of RECOMBIVAX HB (lot # L040458, expiration date 04-FEB-2018, exact dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of 49.8 degree Fahrenheit for 30 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Narrative: Patient received three doses of Pfizer COVID 19 vaccine Feb/Mar/Nov 2021. The patient tested positive for COVID 19 on 3 October 2022. Patient presented to ED at Medical Center with shortness of breath. The patient was admitted with COVID pneumonia, Acute Hypoxic Respiratory Failure, currently on 2L of O2. The patient was treated with remdesevir, ceftriaxone and Zithromax for possible bacterial pneumonia. The patient left against medical advice on 4 Oct 2022. The patient presented to the hospital on 8 October 2022 with shortness of breath and diarrhea. The patient was admitted with COVID pneumonia and hypoxia. The patient was treated with supportive treatment, dexamethasone and oxygen. The patient was discharged on 12 Oct 2022 on dexamethasone and oxygen. The patient was re-admitted on 21 October with respiratory depression and acute kidney injury. The patient was discharged on prednisone and oxygen on 29 October 2022. Reported per EUA.
erythemia and warm to touch, 3.5 in x 2 in oval. Marked with sharpe today to observe for changes.