chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A couple of weeks after booster I started experiencing rapid heart rate, exhaustion, and dizziness. When I would get up to take a bath I couldn't take it. I have been so exhausted because my heart is beating so fast that it tires me out because of the dizziness and rapid heart rate. I was referred to a Dr. and was given several scans on my heart and I had to wear a heart monitor twice and both times the monitor came back and heart was 220 BPM and I was put on heart medication. I went to ER locally and they released me on the same day but they told me to up dosages on heart medicine. I also have tightness in chest and my heart hurts. This is still ongoing. I can't distinguish how it happened or when it happened and I still have issues and I have never had issues with my heart.
Patient falsified DOB when registering for vaccination, stating the minor was. Guardian, consented to the vaccination.  Department of Health verified with statistical records that the patients actual DOB is  which made the vaccine a contraindication.  No known adverse reactions noted.
Approximately 6- 7 days  after I received my 1 dosage my left arm began to hurt where I had received my vaccine. I noticed a very large area on my arm (about 7-8 inch circular area) that was very red, raised and extremely hot. My arm hurts pretty bad and have also had a headache for about a week. I do not feel well (tired and stomach issues)
Patient began to cough and indicates that the cough began after being immunized. The patient's forehead area was visualized reddish.
Dizziness; Weakness; Fatigue; Headache; Muscle pain; Joint pain; Fever; Chills; A spontaneous report was received from a Consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Fatigue, Headache, Myalgia, Arthralgia, Pyrexia, Chills, Asthenia and Dizziness.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 11 Jan 2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Jan 2021, The patient experienced Fatigue, Headache, Muscle pain, Joint pain, Fever, Chills, Weakness and Dizziness.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   On 13 Jan 2021, the outcome of the event(s) Fatigue, Headache, Myalgia, Arthralgia, Pyrexia, Chills, Asthenia and Dizziness were resolved.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
patient received Tdap vaccine at her primary care (not this location). Started having apparent arthus reaction at side within the day of recieving vaccine. Came to clinic day 8 after vaccine. Swelling on arm still present but lessened, still warm to touch. Also now having swelling and inflammation of many of her joints. Worst in clinic 2/10 were wrist (L) and bilat elbows.
This spontaneous report as received from a 67 year old female patient with arthritis. The patient cannot take morphine and codeine. The patient reported that she had received the ZOSTAVAX (lot#, dose, frequency, route, indication not reported) vaccination from her physician approximately three and half weeks ago (approximately on an unknown date in beginning of September). Concomitant therapy included ibuprofen (also reported as no concomitant medications used). Approximately three and half weeks ago, on an unknown date in beginning of September after receiving the vaccination she had a headache and joint pains in her body. The patient did not seek medical attention. There was no product quality complaint. No treatment was given for the event. No lab diagnostics studies were performed. The events improved and the outcome was reported as recovered. Causality was not reported. Additional information has been requested.
pain to his right arm by the shoulder. "Feels like pins and needles Right arm pain is really bad unable to sleep at night" states pt. "This started in the evening of 1/14/10 and I went to the emergency on the 17th of January" states pt I got pain meds nothing else then I called you on 1/21/10 when nothing was helping me. I sent him to his private MD and they began treatment
This case was reported by a nurse via sales rep and described the occurrence of shingles in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced shingles and scab. On an unknown date, the outcome of the shingles and scab were unknown. It was unknown if the reporter considered the shingles and scab to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient presented with shingles within 3 days of receiving the vaccine. The patient came in with scabs on her ankles that were already crusted. It was not clear that which patient out of 3 has not received vaccine in reported pharmacy, the pharmacy name is not coded. This case has been linked with US2018GSK173217 and US2018GSK173216, reported by the same reporter.
Information has been received from a physician concerning a 21 year old female who was vaccinated intramuscularly (date and site not reported) with a dose of the GARDASIL (lot# not reported). On the same day, the patient was concomitantly intramuscularly vaccinated with diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown). Subsequently the patient fainted the next day. The patient received unspecified medical attention and recovered on an unknown date. Additional information has been requested.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 14-DEC-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 "10PK 0.5mL SD-PFS LLokwTip 10Pk" and  lot # L014876 with expiration date 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 32F (0 Celsius) for 104 hours; also there were reported temperatures of 48F (8.8 degrees C). The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
9 year old male  received Flublok Quadrivalent/no AE; Initial information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA284749 same reporter.  This case involves a 10 years old male patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1917, expiry date-30-06-2020 via intramuscular route in the left deltoid on 09-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Body pain and aches at onset with extreme pain at and around vaccination site (unable to move arm at all without pain). Starting at 2:00 PM, fever and weakness began to develop. Fever grew to 105F in cyclic spurts with accompanying delirium and vomiting at the peak. All symptoms resolved by 9AM 04/08/2016.
Patient is complaining of upper arm pain that had not resolved since she received immunization 7 days prior.
After 3 hours: headache, fatigue, pain at injection site.  Next day (3/17): extreme fatigue, dizziness, temperature of 100 F, chills, headache, pain at injection site, red and holt welt at injection site 3/18: Temperature of 99.1, dizziness, extreme fatigue, chills, pain at injection site, red and holt welt at injection site 3/19: fatigue, mild pain and redness at injection site, itchiness at injection site
No additional AE reported; Gardasil 9 was improperly stored and administered.; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported.  On 06-JAN-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1637642, expiration date 28-MAY-22) at a dose of  0.5 milliliter for prophylaxis (strength, vaccination schedule, route and anatomical site of administration were not provided); which had a temperature excursion of 64.36 F for 3 hours on 14-OCT-2020, 35.7 F for 1 hour and 30 minutes on 27-OCT-2020 and 30.20 F for 1 hour and 30 minutes on 28-OCT-2020. The temperature excursion were detected by a data logger. No additional adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637642; expirationdate: 28-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 01-DEC-2015, the patient was inadvertently vaccinated with an expired dose of PROQUAD (Merck) (lot number K006771 and expiration date 07-NOV-2015, albumin status therapy type, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects had been reported. Additional information has been requested.
Patient received a routine blood draw (fasting) and immunization with MMR at aprox 0940 on date of incident. Patient described feeling  nauseous, sat down, and doesn't remember anything until being woken up by medical staff asking how he was doing. No difficulty breathing, normal heart rate, lungs clear to auscultation. Vitals steadily increased over time. Pt had not eaten breakfast. Pt was given water and banana, oxygen via nasal cannula. Discharged after 20 minutes to place of work, with improved symptoms.   Vitals at 0948: Pulse 59,, weak; 16 breaths per minute, shallow, BP: 98/78; Vitals at 1008: Pulse 72, Breaths 14 per minute; BP: 122/90, Temp: 97.7
Rt shoulder burning, aching and tender. Area warm and firm to touch, approx. 2x3 inch area. Sent to Occ Med for treatment. No treatment given. Told shot given "too high". Advised by provider will resolve in 7-10 days. Using Ibuprofen still on 10/16/17 and area of redness, aching and swelling improving.
Headache and body aches were mild. Then, began to have burning in eyelids and down side of nose started and continues until now. It decreased after dermatologist perscribed medication. On 3/13 went to hospital with severe chest pain. They determined it was muscular-sceletal. While in the hospital and to this day has burning in bottoms of feet. Has weakness and numbness in both legs and feet. The weakness decreases ability for activity- very uncomforatable and making her unsteady when up. She also has some weakness in her arms.
A consumer reported that her 77 year old mother received Pnu-Imune 23 vaccine on 10/30/01. On 10/30/01, the pt developed an injection site reaction characterized by swelling, soreness and itching. The injection site swelling and soreness resolved on 11/1/01. The injection site itching resolved on 10/31/01. No additional information was available as of the date of this report. Follow-up information received on 1/4/02 from physician. Physician confirmed consumer information reported previously.
Information has been received from a certified medical assistant (CMA) /healthcare student concerning a female with no pertinent medical history and no prior drug reactions who on 06-SEP-2007 was vaccinated subcutaneously in the right upper arm with a first dose of GARDASIL. There was no concomitant medication. The CMA reported that the patient was recently vaccinated with GARDASIL via subcutaneous (SQ) route. The patient also developed mild redness and warmth at injection site. The patient sought medical attention in the form of an office visit. No other symptoms were noted. Subsequently, the patient recovered from mild redness and warmth at injection site. Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/12/2007. Initial and follow-up information has been received from a certified medical assistant (CMA)/healthcare student concerning a 23 year old female registered nurse with no pertinent medical history and no prior drug reactions, who on 06-SEP-2007 at 11:00, was vaccinated subcutaneously in the right upper arm with a first dose of GARDASIL vaccine (Lot # 1061). There was no concomitant medication. There were no inllnesses at the time of the vaccination. On 06-SEP-2007 the patient developed redness, warmth, and swelling at the injection site. The patient sought medical attention in the form of an office visit. No other symptoms were noted. The patient recovered on an unspecified date a few days later (also reported as recovered immediately). Additional information has been requested.
This spontaneous report was received from a nurse practitioner via a company representative, referring to an 11 years old male patient. The patient's medical history, concurrent condition, drug and allergy history was not reported. There were not concomitant medications reported. On an unknown date, the patient was vaccinated intramuscularly with GARDASIL 9, solution for injection (dose, frequency, lot number and the expiration date were not reported), for vaccination (prophylaxis). Other suspect non-Merck therapies included, MENACTRA and DIPHTHERIA TOXOID (+) PERTUSSIS ACELLULAR VACCINE (UNSPECIFIED) (+) TE) (dose, frequency, administration route, lot number, expiration date and indication were not reported). On an unspecified date (reported as very recent), the patient experienced syncopal episode immediately following the administration of GARDASIL 9. In addition, it was reported that an orange juice was given to the patient after the episode. The reporter was not certain which of the vaccines caused the adverse event. The patient's outcome was reported as recovered. The causality assessment between GARDASIL 9 and syncope was unknown at the time of reporting. Additional information has been requested.
Frozen shoulder, severe shoulder pain, redness, chills, insomnia, arm swelling. Pt was in severe pain that they would not wish on anybody for at least 24 hours after the reaction started which was about 6 hours after the shot was given.
12hr p/vax pt devel nausea, vomiting x 1 & diarrhea;sx lasted about 12hr;
After getting the vaccine I was taking some medication for the UTI. I was taking like 4 medications. Then I went to see a urologist  and they an endoscopy. They gave me a lot of medications. I was on that for like 4 or 5 months.  I still have gas and burning in my stomach. I am having issues to control my Diabetes. I don?t know if it because of the vaccine or because I had Covid on 10/31/2020. But I cannot get my Diabetes under control, even though I am following a strict diet, I am exercising, and taking medications.  I went to the doctor about a month ago because I was starting to get Covid like symptoms again. I had a headache, body aches, flu like symptoms. I got a test and it came back negative.  They gave me more medication and something for allergy, which helped relieve the symptoms.
The concern was the gi symptoms,,,severe cramping nausea, vomiting and bloody stool
pt recv vax 19FEB97 & on 6MAR97 pt devel vesicular eruptions @ the site of inj, & on the face, back, & trunk;pt devel 8 or 9 lesions total;
Since the vaccine, I have had occasional heart flutters, chest pain when running, and also had recived an abnormal TPO antibody results which will be retestedbin December.
Positive Covid test; Positive Covid test; Congestion; Exposure last Tuesday to someone that tested positive Thursday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6 year-old female patient received bnt162b2 (BNT162B2), administration date 30Nov2021 (Batch/Lot number: unknown) at the age of 6 years as dose 2, single and (Batch/Lot number: unknown) 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 DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Dec2021, outcome unknown; EXPOSURE TO SARS-COV-2 (non-serious) with onset 15Dec2021, outcome unknown; NASAL CONGESTION (non-serious) with onset 19Dec2021, outcome unknown. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Dec2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
"Client lost consciousness and fell to the ground while trying to scan the bar code for 2nd dose scheduling after injection. Her head bumped into the wall while falling. Two EMTs carried her to the post vac area. She regained her consciousness a few moments later. She looks very pale. After lying down for about 15 minutes, she tries to sir up and had syncope again for about one minutes but wake up later. She was transported to the hospital." "Once she regains consciousness, she states that she always passes out at the sight of needle. The area where she had the head bumped did not have any visible bruise or skin tear or blood. She had another period of brief syncope while sitting up in EMS Areas. She is alert and oriented to time, place and people. Her citals were stabvvle. She was transferred to the hospital."  Supervisor Report.  Dose #2 due 5/15/2021
Day after the vaccine, arm was sore and remained sore for a few days. I was feeling like I caught the flu.
Pt had nausea with diarrhea 3 hours after receiving vaccine. Pt states that it lasted about 4 hours then stopped. She called the office the following week to report.
1420: patient approached vaccinator and c/o heart racing and temporal HA 1421 patient HR117 pO2 100%. c/o pain moving to top of heat seated in chair 1442: HR114 BO 116/86 pO2 100% HA pain level 5-6 and described as "heavy" 1443 HR 99, drank sips of water and no new complaints 1445: HR 104, pO2 100% 1450 HR 95 head still the same no change or new symptoms 1451 HR 89-90 no change in symptoms 1455 c/o mouth dry but sips of water without c/o 1500 HR 92, pO2 99% no  new symptoms head pain slightly improved 1515 States head pain is resolved States feels ready to leave clinic. 1530 left clinic without c/o. escorted ambulatory to meet friends for ride home.
Information has been received from a registered nurse concerning a 10 year old male with no pertinent medical history or drug allergies who on 01-OCT-1998 was vaccinated with his first 0.5ml SC dose of varicella virus vaccine live (Oka/Merck) (lot# 626966/1054H) in the left arm. There was no illness at the time of vaccination. There was no concomitant medication. On 04-SEP-2007 the patient experienced an "insect bite-like rash" consisting of 28 lesions on his face, neck, chest, back, and buttocks. Medical attention was sought via physician exam in office. No labs or diagnostic studies were performed. The patient was treated with hydrocortisone (SARNA) lotion, diphenhydramine HCl (BENADRYL) and oatmeal baths. On 10-SEP-2007 the patient recovered. There was no product quality complaint. Additional information has been requested.
PT RECVD 1ST ENGERIX-B DOSE (DELT) 3-29-90 AM. SAME DAY EXPER RED AREA AT SOI, NAUSEA. FOLLOWING DAY ACHES SUBSIDING 4-1-90;NAUSEA CONTINUED.3-31-90 FLU-LIKE SYMPTOMS. 4-4-90 RASH AT LF AXILLARY AREA NOT AT SOI.TREATMENT TYLENOL BENADRYL.
One month following senior flu shot, I woke with severe pain in left arm.  My range of motion was severely limited.   The pain lasted over 24 hours, into the next day.  While in pain, I took 1 extra strength Tylenol every 4 hours.  Did not notify my doctor.
Myopericarditis treated with colchicine, pantoprazole and aspirin for 90 days
Fast heart beat; Vivid dreams; Can't sleep; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heart beat), ABNORMAL DREAMS (Vivid dreams) and INSOMNIA (Can't sleep) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Fast heart beat), ABNORMAL DREAMS (Vivid dreams) and INSOMNIA (Can't sleep). At the time of the report, HEART RATE INCREASED (Fast heart beat), ABNORMAL DREAMS (Vivid dreams) and INSOMNIA (Can't sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
Intense arm pain, starting at bicep all the way to the hand. Symptoms lasted 7 days.
Patient had circular erythema around the injection site measuring approximately 5cm in diameteter with erythematous maculopapular lesions and erythematous papules on an erythematous base that started near the injection site and spread down the left arm, across the torso, up the neck and face, over the arm, and to the waistline within hours. Rash described as pruritic.  Patient denied any anaphylactic symptoms. There was no fever, SOB, chest pain. The patient denied any history of skin conditions, recent infections, chronic health issues. Pulse was 63 beats per minute, no tachypnea. Normal heart sounds and lung sounds on exam. No purulent discharge or ulceration at the injection site. No open lesions, vesicles, or ulcers on the skin other than expected scab at small pox vaccine injection site. There were no enlarged axillary or cervical lymph nodes. Rash thought to be consistent with generalized allergic reaction vs generalized vaccinia. Patient treated with antihistamine and given return precautions for any signs of anaphylaxis. Will follow up within 24 hours.
Patient with nasal Flu was given on 10/27/09. I had intended to have an Influenza B screen done in this patient with rheumatoid arthritis. My RN gave Flumist 24 hours stated she had a 10 minute nose bleed. The next day and thereafter she was fine.
About 2 days after vaccine - itching/swelling at injection site. Redness. Itching around midsection. Symptoms less severe 1 week later.