chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a 72 year old female with a sulfa allergy and a history of hypertension and hypercholesterolemia who on 17 OCT 2001 was vaccinated in the right arm with a dose of pneumococcal vaccine 23 polyvalent (lot # 640576/0923L) at her well visit examination. Concomitant therapy included simvastatin, guanfacine hcl, aspirin, vitamins, calcium carbonate and naproxen 250 mg. On 17 OCT 2001, in the evening, the patient's arm was swollen and red from the shoulder to elbow. Her right arm had marked swelling with mild erythema and warmth. On 18 OCT 2001, she was rexamined and her right arm was swollen and red and no signs of infection were noted. It was reported that she was treated with loratadine and ice packs and she was instructed to call the physician's office if it worsened. No calls were received and the patient subsequently recovered. No further information is available.
The patient was given Tylenol before receiving vaccines and then 4 hours later the temperature began to rise and went up to 104F. The patient was taken to the ER and was told the reason for her fever was due to five shots being given at once.
suspected vaccination failure; had shingles twice; This case was reported by a consumer via media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 provided are as follows: The age at vaccination was not reported. The patient had shingles twice and have had the vaccine. The patient stated so much for that and vaccine did not help him/ her. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Bilateral optic neuritis with associated visual defects. 12/22/2008 MR received for 2 admission 10/28-31/08 and 11/12-14/08 with D/C DX: Optic Neuritis. Pt presented with 3 week hx of L eye pain, tearing, and blurry vision of the L eye, then blurry, darkened vision with visal field defects on the R. B/L disc edema, subnormal acuity, dyschromatopsia, pupillary defect, and inferior field defects noted on exam. Assumed to be 2' to Lyme's and tx with Doxycycline and steroids with improvement noted. Returned to hospital 11/12/08 with recurrent R eye visual loss now involving entire visual field. Malaise for weeks. Again tx with abx and sterois with improvement.
Injection site pain, sore arm, swelling (no fever reported). Pt iced arm, kept elevated - contacted Primary Care Physician who prescribed prednisone.
pt recv vax OCT97 & 1998 pt exp exacerbation of lupus;MD visit was required;
This case was reported by a consumer and described the occurrence of possible acute hepatitis in a female subject of unspecified age who was vaccinated with Hepatitis B vaccine recombinant (manufacturer unspecified), Hepatitis A inactivated and Hepatitis B  recombinant vaccine. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Hepatitis B vaccine (unknown) or an unspecified dose of Hepatitis a + b vaccine (unknown). Three weeks after vaccination with Hepatitis B vaccine or Hepatitis a + b vaccine, the subject's blood showed positive hepatitis b surface antigen. The consumer reported that the physician was not sure whether the subject is having acute hepatitis or if the blood test result is related to the vaccine three weeks prior. At the time of reporting the outcome of the event was unspecified.
11/20/09 approx. 11pm began to notice pain sensation in left upper arm, approx 12:45 began to have chills, sweating, nausea, headache, aching throughout body. All symptoms continued thru 11/21 & 11/22/09. 11/23/09 left upper arm swollen, red, hot to touch c/o pain into armpit area thru shoulder. Encouraged to seek medical attention.
administered with expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter stated that number of doses per vial was nine doses. The vials did not undergo any temperature excursions. The dates and number of doses which was administered are as follows: on 03-Jan-2022 4 doses was administered, on 04-Jan-2022 2 doses was administered, on 06-Jan-2022 2 doses was administered and on 11-Jan-2022 1 dose was administered. No concomitant and treatment drugs were reported.
Pt vesicles x 7 on her body, 12 days after receiving Varivax. Examined on 5/22/03. Diagnosed with mild chickenpox.
Information has been received from a health professional concerning a 6 year old white female with no medical history or allergies who on 17-OCT-2006 at 14:00 was vaccinated with a second dose of Varivax (lot # 654528/1044F). There was no concomitant medication. There was no illness at the time of vaccination. On 18-OCT-2006 the patient developed redness and swelling at injection site radiating to elbow. Unspecified medical attention was sought. No laboratory tests were performed. Subsequently, the patient recovered. The patient did not experience any adverse events following prior vaccination. There was no product quality complaint involved. No further information is available.
FLUZONE HD QIV was administered to a 20 month old infant with no reported adverse event; patient did not get the full 0.7mL so probably it was 0.5mL with no reported adverse event; Initial information received on 12-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 20 months old male patient who was administered Influenza Quadrival A-B High dose HV Vaccine [Fluzone High-dose Quadrivalent] with no reported adverse event and patient did not get the full 0.7ml so probably it was 0.5ml with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination and Chicken Pox vaccine.  On 12-Oct-2023, the patient of 20 months did not get the full 0.7ml so probably it was 0.5ml  dose of suspect Influenza Quadrival A-B High dose HV Vaccine (lot U8156DA, Expiry date: 30-Jun-2024 with unknown strength and form) via intramuscular route in the right thigh as prophylactic vaccination with no reported adverse event (incorrect dose administered) (product administered to patient of inappropriate age) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the 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.
27 days since the shot, and it feels as though I have had a severe case of shingles without the blisters/rash.  Arm on fire traveling on the radial nerve.  Skin so sensitive, at times i could not have anything touch on my arm or left shoulder.  This was WAAAYYY beyond site soreness which I expected.  I am still having pain, electric shocks down my arm.
Not feeling well for 24 hours after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well for 24 hours after 2nd dose) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MALAISE (Not feeling well for 24 hours after 2nd dose). In 2021, MALAISE (Not feeling well for 24 hours after 2nd dose) had resolved.            No concomitant medications was reported. No treatment drug details was reported.
This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. The pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ of lots M025565 with expiry date 06-NOV-2017, M019708 with expiry date 25-OCT-2017, L048854 with expiry date 31-AUG-2017, L033694 with expiry date 16-JUN-2017 (dose, strength, route, vaccination site unspecified). No adverse effects were reported. Product quality complaint (PQC)) was not involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Patient came into the clinic and stated he needed his second dose of Moderna. After completing questions Moderna vaccine was administered. When entering  it was noticed that his first dose was actually Pfizer. Patient notified and instructed to go to the ER if and adverse reactions occurred. No adverse reactions occurred in the clinic. Patient waited 15 minutes.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. In 2017 (reported as "on or after 05-JUL-2017"), the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # M040423 with expiration date 03-JUL-2019; an improperly stored dose of ROTATEQ per oral, lot # M044396 with expiration date 19-JUN-2018; or an improperly stored dose of VAQTA lot # N005274 with expiration date 03-APR-2018, for prophylaxis (dose and route of administration were not reported). It was stated that the vaccine was exposed to a temperature of 32 to 35 Fahrenheit degrees with a time frame of 1 hour. No previous temperature excursion was reported. The reporter did not know which vaccine was administered to the patient. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1710USA015406: US-009507513-1711USA008230: US-009507513-1711USA008231: US-009507513-1711USA008232: US-009507513-1711USA008233: US-009507513-1711USA008234:
diverticulitis; This is a spontaneous report from a contactable consumer reporting for herself. A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Feb2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient stated "I received the 1st dose of the Pfizer covid vaccine on 06Feb2021, I was hospitalized for diverticulitis (in 2021) a few weeks later and was unable to get the second dose. It has been exactly 60 days since the first shot. Can I still get the second shot or do I need to wait and start over?" The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
about 4 hrs p/vax pt devel high pitched crying for aobut 5 mins then immed following; collapse, white as sheet-look like dead;
Patient called clinic on 9/27/2018 to report that her arm where she had her chicken pox vaccine was swollen. She reports on 9/26/2018 she noticed a quarter size area of pinkness/redness and some swelling and the area did itch. Today 9/27/2018 she reports she noticed soreness and more swelling. Swelling of the area is described as tennis ball size. There is pinkness/redness and soreness when she touches the area. There is also some harness to the skin. She denies any fever or ill feeling. No other discomfort elsewhere in body. Clinic directed her apply cold compress on the area for 10 mins at a time. To take TYLENOL or ibuprofen which ever her health care provider allows her to take and to seek medical care. 9/27/2018 148pm clinic contacted client to see how her arm is doing and also if she seeked medical care. Reports she did not go to MD. She did apply cold compress to area and notes the swelling has actually gone down some. She does report it is still sore to touch and her arm does hurt. Clinic suggested she seek medical care. She report she has not taken anything for it as it is not a pain that she cannot deal with. She also plans on just applying cold compress to the area on and off until tomorrow. She reports it her arm does not look or feel any better tomorrow 9/28/2018 she will then seek medical care.
Lethargy; Low energy; Sore arm; Headache; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 23Apr2021 at 16:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies and known allergies to latex, coconut, mango, pineapple. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamin d nos (VIT D) and ethinylestradiol/ norgestimate (MILI) birth control pill, from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 02Apr2021 at 16:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 24Apr2021, the patient experienced lethargy, low energy, sore arm and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were not taken as a result of reported events. The clinical outcome of the events lethargy, low energy, sore arm and headache was recovered on unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Right off the back with fever and super tried. Started having swelling in my throat. Went to my cancer doctor an had a CAT SCAN and it came back abnormal with enlarged lump nose.  So, we understood with the cancer and went back the next month an did another CAT Scan and it came by with other things in my lungs. He don't know if it's from the vaccine. I go back to my cancer doctor on 06/09/2021. He also did a PET Scan on 06/04/2021 to see some other things. Hopefully, tomorrow's test will tell the outcome.  I had a total of three CAT Scan's and One PET Scan done. A lot of different things is starting to happen to my body since the vaccine. I will know more on tomorrow 06/09/2021 to be able to report more finding, if any by my PCP.
Left arm hot at injection site; Allergic reaction after booster dose; Left arm red at injection site; Left arm swollen at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Left arm hot at injection site), HYPERSENSITIVITY (Allergic reaction after booster dose), VACCINATION SITE ERYTHEMA (Left arm red at injection site) and VACCINATION SITE SWELLING (Left arm swollen at injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L21B, 047C21A and 014C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Cholesterol.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2022, the patient experienced INJECTION SITE WARMTH (Left arm hot at injection site), HYPERSENSITIVITY (Allergic reaction after booster dose), VACCINATION SITE ERYTHEMA (Left arm red at injection site) and VACCINATION SITE SWELLING (Left arm swollen at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in March 2022 at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) in March 2022 at an unspecified dose and frequency. In March 2022, INJECTION SITE WARMTH (Left arm hot at injection site), HYPERSENSITIVITY (Allergic reaction after booster dose), VACCINATION SITE ERYTHEMA (Left arm red at injection site) and VACCINATION SITE SWELLING (Left arm swollen at injection site) had resolved.            Patient reported that she takes concomitant medication for her cholesterol.  Patient reported that she is currently not experiencing any symptoms. She stated that she did not experience any symptoms with the previous two doses of the Moderna COVID-19 vaccine.   This case was linked to MOD-2022-525887 (Patient Link).   Reporter did not allow further contact
Chills; no fever; real bad headache; nausea. Headache and nausea it lasted all the way until the second vaccine  - January 19, 2021. I was taking Tylenol which didn't really help. The headache and nausea was pretty steady throughout the day and night - rough during the entire day and at night. Doctor's visit on January 25th, 2021 and another one on January 26, 2021.
Itchy at vaccination site on arm this morning and then slightly swollen red golf ball sized mark appeared this evening.
Information has been received from a registered nurse referring to 2 patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 28-AUG-2015, the patients were vaccinated with ZOSTAVAX (0.65 ml, Lot #L016284, expiration date: 07-AUG-2016), which were improperly stored for 15 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Patient developed hives around 9:30om the same day, on back, torso, groin area. Reoccurred the next day
numbness and pain (4 on pain scale) of left arm started in lower arm 20 minutes after receiving injection.
pt recv vax 27JUL98 & 28JUL98 pt c/o hives devel on backs of legs;recommended DPH & topical HC;pt returned to clinic w/gen urticarial rash;placed on pred x 3 days daily x 3 days;
12:30 patient reported difficulty breathing, elevated HR, legs feeling like jello, tongue feeling " bigger in the back" BP: 123/63. HR 106, SPO2 98 Lungs CTA, patient alert, oriented and conversing without difficulty 12:35 HR 97, SPO2 97 12:40 101/66, HR 97, SPO2 97 12:50 113/81, HR 94, SPO2 95, lungs CTA No visible airway swelling or edema  Patient feelings better, able to take deep breath, requesting to leave
COVID Breakthrough Dose 1: 03/26/2021, Moderna, 030A21A Dose 2: 03/30/2022, Moderna, 048L21A
Pt was given Daptacel instead of Adacel. Patient was called 8/31/07 and asked how her arm was after the injection. She said, "Fine, it wasn't sore at all." She was asked how she felt after the injection and she said she had no problems.
Fever on 7/14/00 X 2 days of 103F and a rash on 7/15/00 X 2 days and fussy.
Pt had L Upper chest pleuriti pain and DOE did not seek med attention 6 weeks later sought attention for R pleuriti pain and DOE - had pul infarct and LLE DVT
No additional AE information reported at this time; Nurse calling to report that a RECOMBIVAX HB pediatric dose was accidentally given to an adult patient.; This spontaneous report was received from a nurse and refers to an adult, female patient. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 09-MAY-2022, the patient was accidentally vaccinated with a pediatric dose (product administered to patient of inappropriate age) of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (exact dose, strength, lot #, expiration date, site and route of administration were not provided). The vaccine was stored properly and was not expired. There was no additional adverse event reported.
Within 5 seconds of 3rd injection, client fell over to side and passed out.  Seizure activity was noted twice which included eyes rolling back, facial drooping, and upper body tremors.  Pulse 60, weak, thready; blood pressure 80/50 and faint, pale, diaphoretic.  Ambulance transferred to emergency room.
Second shot appeared to have cleared their sinus; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Second shot appeared to have cleared their sinus) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sinusitis.   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 an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Second shot appeared to have cleared their sinus). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Second shot appeared to have cleared their sinus) had resolved.            No concomitant information was reported. No treatment information was reported. Reporter stated that second shot appears to have cleared sinus problem somewhat.
Moderna vaccine was administered outside of clinic- reported by patient ? NO LOT NUMBER WERE SUPPLIED ---------------------------------------------------------------------------------------------------------------------------- ACUTE NON ST ELEVATION MI 4/7/2023 SQUAMOUS CELL CARCINOMA LEFT LUNG, UNSPECIFIED PART ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/7/2023 SQUAMOUS CELL CARCINOMA LEFT LUNG, UNSPECIFIED PART ACUTE NON ST ELEVATION MI 4/7/2023 NAUSEA AND VOMITING ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/7/2023 NAUSEA AND VOMITING