chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist concerning a 52 year old female patient with an allergy to eggs, hypertension and chronic asthma with frequent exacerbations, who on 10/01/03 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot number not available). Concomitant therapy included losartan potassium-HCTZ, pravastatin Na, fluticasone propionate (+) salmeterol xinafoate and albuterol. The patient complained of shortness of breath and had developed uncontrollable hypertension at the time of admission to the hospital. The pharmacist reported the patient was admitted to the hospital on either 10/1/03 or 10/2/03 in the evening. It was noted that treatment was required for the adverse event. The pharmacist reported that the patient has since responded to corticosteroids and is stabilized at the present. The patient was only hospitalized for a couple of days. She recovered and was discharged from the hospital on 10/4/03. Additional information was received via a follow up telephone conversation with the pharmacist who reported that the patient's experience sounded like anaphylaxis, however she truly did not think it was an adverse drug reaction because the patient's experience occurred more than 24 hours post vaccination. The pharmacist reported that because of the patient's egg allergy she has never and will never receive the flu vaccine. The pharmacist indicated that she had notified the patient's health care provided that she was reporting the patient's experience, and she indicated the lot number was unavailable because the vaccine was given in the physician's office. The pharmacist was unable to provide any additional information. There was no product quality complaint reported. Additional information is expected.
no additional AE'S; improperly Stored; Administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medication were not provided.  The previous temperature excursion of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was reported as 30.28 Fahrenheit degrees (F) for 19 minutes and 34.81 F for 35 minutes. On 12-MAR-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T020616,expiration date 16-MAR-2023, dose was reported as 1 (unit unknown); strength and route were not provided) for prophylaxis (product storage error). Administered dose of vaccine was stored in the temperature of 28.34 F for 1 hour and 2 minutes. No additional adverse event was reported. Data logger was involved.  This is one of several reports received from same reporter.; Sender's Comments:  US-009507513-2104USA002996: US-009507513-2104USA002997: US-009507513-2104USA002998: US-009507513-2104USA002999: US-009507513-2104USA003000: US-009507513-2104USA003001: US-009507513-2104USA003002: US-009507513-2104USA003003: US-009507513-2104USA003004: US-009507513-2104USA003005: US-009507513-2104USA003006: US-009507513-2104USA003007: US-009507513-2104USA003008: US-009507513-2104USA003009: US-009507513-2104USA003010: US-009507513-2104USA003011: US-009507513-2104USA003012: US-009507513-2104USA003013:
Scab at the injection site; Itchinh/wanted to "tear her arm apart" from the itching; Swelling; Redness; Burning; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SCAB (Scab at the injection site), VACCINATION SITE PRURITUS (Itchinh/wanted to "tear her arm apart" from the itching), VACCINATION SITE SWELLING (Swelling), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PAIN (Burning) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (50 years ago), Drug hypersensitivity (Lidocaine), Dry skin, Asthma since 1988, Arthritis (Osteoarthritis) since 1982, Gastrointestinal disorder NOS (IBS) since 2015, Anxiety since 1960 and Heart disease, unspecified since 2004. Concomitant products included ISOSORBIDE, MACROGOL 3350 (PURELAX), ACETYLSALICYLIC ACID (BABY ASPIRIN) and ALPRAZOLAM for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 23-Feb-2021, the patient experienced VACCINATION SITE SCAB (Scab at the injection site), VACCINATION SITE PRURITUS (Itchinh/wanted to "tear her arm apart" from the itching), VACCINATION SITE SWELLING (Swelling), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PAIN (Burning). On 24-Feb-2021, VACCINATION SITE SCAB (Scab at the injection site), VACCINATION SITE PRURITUS (Itchinh/wanted to "tear her arm apart" from the itching), VACCINATION SITE SWELLING (Swelling), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PAIN (Burning) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up received information about ethnicity and Previous allergy history, Vaccine facility information and Concomitant medications details were updated.
Initial report received from a health care professional on 28 October 2010. It involves a case of misuse, i.e. wrong vaccine administered. A 30-year-old female patient received an intradermal injection of ADACEL (lot number C3488BA) instead of TUBERSOL on 26 October 2010. The patient also received an intradermal injection of TUBERSOL (lot not reported) the same day. The patient was not taking any concomitant medications, was not ill at the time of vaccination, and had no pre-existing medical conditions. One day post-vaccination, the patient complained that the ADACEL injection site was warm, red, and hard. Treatment included ice and ibuprofen. The patient returned to her physician on 28 October 2010 to have her skin test read, and at that time the ADACEL site remained warm with a large reddened area. Per the reporter, the physician was planning to prescribe antibiotics to treat the event. At the time of the report, the event was still ongoing.
About 2 weeks after the vaccines were administered, we started noticing a head jerking almost seizure like movement. It was most noticeable when he was tired (nap or night time) and it was scary because he had never done that before to ?self sooth? to get to sleep before his 4 month vaccines.
Patient rec'd Pfizer COVID vaccine at 1438. Reported he felt "slight discomfort at the back of his throat" at 1451. VS WNL. Denied dyspnea. Water given. Denied difficulty swallowing. AT 1457, patient stated his "throat felt tight".  Denied allergies to any medications and stated he has taken benadryl in the past. 50 mg PO Benadryl given. VS remained WNL. Stated throat "felt better" shortly after. Then c/o SOB and "feeling like he had to cough, but couldn't". Discussed treatment options and need for evaluation. States understanding. Consents to EMS being called. EMS called and patient monitored while waiting. C/o continued s/s and feeling "jaw tremble and chills, as well as back pain".
Varicella - Information has been received from a health care professional concerning a male patient who 1- to 2 years ago was vaccinated with one dose of varicella virus vaccine live.  In March 2000 the patient was exposed to wild type virus .   Approximately 20 day later, he developed a mild case of varicella consisiting of bumps and a slight fever.  He sought unspecified medical attention.  No further information is available.
Severe Tinnitus getting louder; fluid in ears; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 02Mar2021 at 16:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) in the right arm on 26Mar2021 at 10:15 (at the age of 68-years-old) for COVID-19 immunisation. Medical history included asthma and hypertension. The patient previously took tetracycline (MANUFACTURER UNKNOWN) and duloxetine hydrochloride(CYMBALTA) on an unspecified date, for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other unspecified medication (Prescribed) within two weeks of vaccination. The patient did not receive any other vaccines within four weeks, prior to the vaccination. On an unknown date in Mar2021 the patient experienced severe tinnitus getting louder and fluid in ears. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the reported events that included referral to ENT. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe tinnitus getting louder and fluid in ears was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Fluzone, reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no reported adverse event; Product was administered to patients post excursion with no reported adverse event; Initial information received  on 14-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves Adult patient of unknown gender where vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV]. , reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes with no reported adverse event and product was administered to patients post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza quadrival a-b vaccine Suspension for injection (strength, lot number and expiry date was unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient had a non-serious event of fluzone, reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes with no reported adverse event (product storage error) (onset date: unknown) involving influenza quadrival a-b vaccine.  On an unknown date the patient had a non-serious event of product was administered to patients post excursion with no reported adverse event (poor quality product administered) (latency: same day) following the administration of influenza quadrival a-b vaccine.  Action taken : not applicable.  Outcome: Unknown  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.   Additional information was received on 16-Feb-2023 from other health care professional: case was updated from non-case to Non-valid.  Based on information previously received, the following information [Classification updated from Non-Valid Case to Valid with no AE, as a single adult patient is involved , accordingly age group will be captured as adult.] have been amended.; Sender's Comments:  US-SA-2023SA069591:
Patient said she felt hot and "bad" approximately 30 seconds after receiving the vaccine. Patient did break out into a sweat. Gave patient an icepack to place on her neck to help cool her down. Remained with patient until she felt better.
No adverse event; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 29-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medications were reported. The patients age was reported as 29 year 10 month. Treatment information was not provided. The reporter informed that the patient received this Moderna vaccine between 8-Apr-2022 and 15-Dec-2022.
Patient fainted briefly within 5 minutes of receiving BOOSTRIX and MENACTRA, cool clammy and sweaty skin, pale color, low blood pressure, no other injury made sure patient stayed hydrated with water and monitored blood pressure for the next half hour in store, monitored how patient felt and symptoms as they improved.
Swallowing difficult-(subsided). Swollen glands-(subsided) (Thyroid med). Metal taste in mouth (still). Tongue tingly (still).
delay in second dose. More than 36 after first dose without receiving second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delay in second dose. More than 36 after first dose without receiving second dose) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delay in second dose. More than 36 after first dose without receiving second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delay in second dose. More than 36 after first dose without receiving second dose) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Patient admitted for Procedure(s): Right - EXCISIONAL DEBRIDEMENT AND IRRIGATION RIGHT ANKLE WITH HARDWARE REMOVAL. The hospitalization was necessary for pain control, therapy, medical care and discharge placement. Ultimately, the patient was discharged to home under satisfactory medical and post-operative condition. ED visit 4 days later for occlusion of peripherally inserted central catheter. Treated and released. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
sore at injection site lasting longer than 2 days.  Hurts when pressure is put on site, especially when sleeping.  Redness at injection site lasted greater than 2 days
104-degree fever; very tired; chills; very sore arm at site; headache; This is a spontaneous report from a contactable consumer(patient). A 74-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Medical history included covid-19 immediately prior to getting the vaccine. Patient had just recovered from the actual COVID virus days prior to getting the vaccine. The concomitant medications were not reported. The patient experienced 104-degree fever, very tired, chills, very sore arm at site, headache. on an unspecified date. The patient underwent lab tests and procedures which included body temperature: 104-degree on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt had 2nd vaccine, went home and started having "cramping" in all of her muscles.  It became bad enough that she was taken to local ED where she then started coughing up blood, required intubation and about 6 hrs later, died.
I had strange pain in my shot site, it's not pain its mostly like a something running through my arm pulling on my arms; I had strange pain in my shot site, it's not pain its mostly like a something running through my arm pulling on my arms; This is a spontaneous report from a contactable consumer or other non-HCP (patient himself). A 77-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- E252267) via an unspecified route of administration in left arm on 10Aug2021 11:00 as dose 2, single (at the age of 77-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- UNKNOWN) via an unspecified route of administration in left arm on 20Jul2021 as dose 1, single for COVID-19 immunization. On 10Aug2021 11:00, it was reported that patient experienced some strange side effects from his most recent second Covid shot vaccine shot, he just had it yesterday on the 10Aug2021 at 11 in the morning and everything fine but he had strange pain in his shot site, it was not pain it was mostly like something running through his arm pulling on my arms. Patient was wondering, if this was going away or it was going to be better or if he should go to the doctor or emergency room. Patient took some 2 Tylenol within a period of day 5 hours apart as a treatment for the adverse events. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Pain in area of administration beginning in  late November 2021; somewhat  mild. After  acquiring Booster, pain became constant,  traveling down left arm, into hand and fingers, on occasion as well as left shoulder and neck.   Pain can be constant and continue during sleep and sometimes continue for days at a time. No topical  nor oral meds taken to date for this issue.
This spontaneous report as received from a medical assistant refers to 18 unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored VARIVAX lot # L045993, expiry date: 17-NOV-2017, (dose#, route, and site of administration not reported). Concomitant medication was not mentioned. No adverse effects were reported. No further information was provided. Product quality complaint was not filed. Additional information has been requested. This is one of the six reports received from the same reporter.
This spontaneous report as received from a physician refers to a 66 years old female patient. The patient's medical history included hypertension, migraine, goiter and high cholesterol. The patient was vaccinated with PNEUMOVAX23 on 02-SEP-2012. No other co-suspects were reported. Concomitant medications included ALDACTAZIDE and potassium chloride. On 29-OCT-2012 the patient experienced myalgia, 58 days after onset of therapy, sweats, fever, injection site redness, tenderness at injection site and swelling. No treatment information was reported. The outcome of myalgia, sweats, fever, injection site redness, tenderness at injection site and swelling was reported as recovering/resolving. The relatedness for myalgia, sweats, fever, injection site redness, tenderness at injection site and swelling is unknown for PNEUMOVAX23. {Additional information has been requested./Additional information is not expected.}
Scratchy throat ("feels like something sharp stuck in my throat"), vomiting (2/2 throat sensation), lightheadedness 1g Tylenol PO and 12 hours of sleep lead to resolution of symptoms
No symptoms or adverse effects reported; patient received unspecified dose ofVARIVAX that was improperly stored; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent  On 07-OCT-2019, the patient was vaccinated an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S003447, expiration date 04-FEB-2021; strength, dose, route were not provided) for prophylaxis (product storage error).  Temperature excursion of this vaccine was -12.8 degree Celsius for 2 hours and 38 minutes. There was previous temperature excursion and the worst previous temperature excursion was -9.8 degree Celsius for about 112 minutes. No symptoms or adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA000010:
SEEN IN OFFICE 8-27-07,AFEBRILE, RASH ON TRUNK, FACE, 8-27-07;  PARENT REPORTS FEVER ON 8-25-07
Nov. 7, 2013 she was treated for bronchitis with a Z-PAK and also given her 2nd dose of the HPV vaccine. She was running a fever when she received the vaccine. The evening of Nov. 8, 2013 she developed a rash. This rash lasted less than 24 hours. She got better from the bronchitis with the Z-PAK and then began new symptoms on Nov. 22, 2013 20:00. She ran a fever and told me she just felt awful. November 28, 2013 she was taken to urgent care. We were told both ears were bulging. She was prescribed AUGMENTIN. That evening she began having trouble urinating and it hurt her neck to look down. Nov. 29, 2013 she was taken to the ER. She was given fluids, checked for a bladder infection, and blood work was done. We were told it looked like something viral, and it should be fine for her to go on vacation. We had a flight a few hours after the ER visit. The evening of Nov. 30, 2013 she began vomiting and was so lethargic that she couldn't even walk. She was still complaining of her neck hurting and this was day 10 or 11 with a fever. Many test were run during her 11 day stay in the hospital. MRI's (brain and lumbar), x-rays, bladder scans, blood work, spinal tap, urinary catheterization, test that had to do with her vision problems. On December 5th or 6h a spinal tab was done and she was diagnosed with viral meningitis. They were never able to figure out the virus that was the cause. She was triple checked for EBV. She was also checked for CMV. She had a neurogenic bladder. The urologist that took care of her told me that I should report the HPV vaccine. At the time, things were busy around our house and time passed without me reporting the vaccine. It has been on my mind to report this vaccine for the past two years. I feel she should have never gotten this vaccine or any vaccine while sick. She was not able to return to school until January 2014.
Information has been received from a consumer concerning her granddaughter who on 01-JUL-2010 was vaccinated with a first dose of GARDASIL (route and lot number unspecified). The consumer stated that her granddaughter had not had a menstrual cycle since she was given the first dose of GARDASIL (approximately in July 2010). She stated that the patient had had normal cycles for 1 year until the vaccine was given. It was reported that the patient also had been experiencing knee and back pain since the GARDASIL was given (approximately in July 2010). At the time of the report the patient was not recovered. The patient did not seek medical attention. Additional information is expected.