chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed a "lump" three or four days after receiving the first dose of the GARDASIL 9 vaccine in the injection site of her left arm; burning sensation; This spontaneous report has been received from a 43-year-old female patient referring to herself. The patient's concurrent conditions, pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 20-JAN-2023, the patient received her first dose of hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, lot#, expiration date and route were unknown) in her left arm for prevention of human papillomavirus (HPV).  It was reported when the vaccination provider plunged the vaccine in the patient's arm, it "burned like crazy" (burning sensation) which lasted a minute or two, after then the patient was fine. When the patient questioned the nurse pertaining to the burning sensation, the nurse told the patient "this one stings". On 23-JAN-2023 (reported as three or four days after receiving the first dose of the hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccine), the patient developed a lump in the injection site of her left arm (vaccination site mass), and it went away after a couple of days.  On 17-MAR-2023, the patient received the second dose of hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, lot#, expiration date and route were unknown) in her right arm.  The reporter reported it "didn't burn". The patient questioned the nurse why the first dose of hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) "burned like crazy" but the second dose did not, the nurse responded with "it didn't burn because it came straight out of the fridge". The patient also reported that she looked up the hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) dosing schedule to ensure she was on schedule when she read the hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccine needed to be shaken before administered. Per the patient, she was not paying attention during the second dose of hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and was unsure if the nurse shook the vile before administration, making the patient question if it was properly administered and would still be effective. The patient reported the difference between getting the first dose of hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the second dose made her question if the second dose was administered properly.  The patient did not seek for any medical attention. It was not reported if patient received treatment, or any lab diagnostic/studies were performed. Action taken with hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for the events was not applicable. The outcome of the events burning sensation and vaccination site mass was reported as recovered.   The causality assessment between the suspect vaccine and events burning sensation and vaccination site mass was not provided.
It was the evening of the 17th, she had a cough that sounded worse. She started day care a year ago and had developed an on and off cough. It sounded worse than before. She was a bit more fussy. She had some clear runny nose discharge that seemed to go away and come back. We got her tested for COVID-19 on Wednesday the 20th and that was negative. We had her ears checked and she had fluid in the middle ears but no infection. Her cough did persist and get worse over 2 days. Friday we got her checked again and she was diagnosed with a bilateral ear infection and she was given Amoxicillin that day.
p/receiving immun, mom noticed pt was not as active then laid down, was limp; began running fever inc 103; heavy breathing noted; mom was told to bring pt to ER;
The patient stated that her arm became red and swollen. Then she reported 1/17/13 that on her opposite hand, her knuckle became bright red and her hand was swelling.
Onset of anxiety and sleeplessness within weeks which became chronic and continued to present.  Significant relief eventually achieved through chelation of toxic metals including aluminum in 2019.
Slight cough and hives all over body.  Hives started in the evening the day after and she woke up with many more that next morning.  Hives and cough resolved by 11am that day very quickly and almost all at once (within a 1 hour time frame).   I called and spoke to the doctors office where she received vaccine they gave me different answers stating it may be from vaccine and then later called back and said it wasn?t.  I know that it was as I keep her allergies very under check as she has severe ones.  We never change food, detergents or anything as we don?t want to disrupt her allergies.
Information has been received from a pediatric office concerning an 8 year old female who on 18-AUG-1999 was vaccinated in the left arm with a first dose of Varivax (lot # 631168/0710J). Subsequently the patient developed about 15-16 spots of macular papular vesicular lesions over the body. All lesions were in different stages; 5-6 over the face, 4-5 over right arm, 1-2 over left arm and 2 over medial thighs. At the time of the report, the "disease was in progress". Additional information included the following adverse experiences: diabetes 02-FEB-2006. The patient's immunization history was provided and included: first, second and third doses of ACEL-IMUNE and first, second and third doses of HIBTITER on 24-SEP-1998, 23-APR-1999 and 04-JUN-1999, respectively; first and second doses of poliovirus vaccine inactivated (unspecified) on 24-SEP-1998 and 23-APR-1999 and a first dose of hepatitis B virus vaccine (manufacturer unknown) on 15-JUL-1998 and a second and third dose of hepatitis B virus vaccine on 19-AUG-1998 (lot #624815/1221E) and 04-JUN-1999 (lot #630470/0213J), respectively. Additional information has been requested.
This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 4-year-old female patient who received BOOSTRIX (batch number EA2GE, expiry date 24th January 2016). On 24th September 2013, the patient received BOOSTRIX .5 ml. On 24th September 2013, an unknown time after receiving BOOSTRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration to be related to BOOSTRIX.
Pain on arm and fever stating  later in the same day of taking the shot.  It last over a day and fever reducer was taken.
Patient received booster dose from vial which had exceed the 12 hour expiration but remained within the recommended temperature setting.
Menstrual cycle disruption. Period came 14 days after previous period. It was at least 10 days earlier than expected. Bleeding was heavier than usual, for days. My menstrual cycle timing and length has shifted since then.
I am sick today; it wiped me out; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of malaise (1st dose received on an unknown date, refer case US2022AMR140180).   On 27th September 2022, the patient received the 2nd dose of Shingles vaccine. On 28th September 2022, 1 days after receiving Shingles vaccine, the patient experienced sickness and malaise. On an unknown date, the outcome of the sickness and malaise were unknown.   It was unknown if the reporter considered the sickness and malaise to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR140180   Additional Information: GSK receipt date: 28-SEP-2022 Reporters comment: This case was reported by the patient via interactive digital media. The patient stated that he/she received the second dose of vaccine and experienced sickness and it wiped out both the times. Additional supportive information: Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR140180:Same reporter  1st  dose
The child c/o of sore right arm in pm of 02-21-02. In the am of -2-02-02, mom examined arm. Red, hot and swollen from just below shoulder to elbow. Called MD told use cold compresses and Tylenol 02-25-02-Resolving
p/vax pt exp anaphylactic react including raised rash on chest; abdominal pain/bowel problems; inflammation of throat, eyes & nose; projectile vomit & diarrhea; also gagging, choking cough; problems sleeping; pt is currently doing better
PMH:  ESRD, CHF, seizure disorder; hypothyroidism; hypercoagulable state, on chronic Coumadin; to ED due to altered mental state; AFR and positive for COVID; placed on BiPAP; condition worsened; to ICU; COVID protocols followed; metabolic encephalopathy; DNR; sepsis and shock; pt died in the hosp
Information has been received from a nurse practitioner concerning a 23 year old female with no medical history and no allergies, who on 21-MAY-2008 was vaccinated in the left deltoid with third dose of GARDASIL vaccine (yeast) (lot # reported as "17574"). Dates and lot #s of previous two doses were not reported was no concomitant medication. It was reported that on 22-MAY-2008 at 10 am, the patient called the office with complaints of migraine. She was advised to take ibuprofen (ADVIL) and go to ER if headache get worse. It was reported that at 11:30 am on the same day, the patient felt better and subsequently recovered from the migraine. It has been determined that WAES No. 0806USA03218 is a duplicate of WAES No. 0805USA04997. Therefore, WAES No. 0806USA03218 is being deleted from our files and the reports consolidated into WAES No. 0805USA04997. No additional information is expected.
purple eyelids, low level sz; sleepy, limp, fever 103; APAP given for fever;
Fever swelling of arm Narrative: Per supervisor report: "received 2nd COVID injection on 3/25/2021. C/o elevate temp, arm swelling."
left arm is tingling; swelling, redness at old BCG site with tenderness; swelling, redness at old BCG site with tenderness; itching below injection site/itching in the injection area; pain in the injection site right away/myalgia local pain; A spontaneous report was received from a physician, who was also the patient, that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine injection site itching, tingling, vaccine injection site swelling, vaccine injection site redness and vaccine injection site pain.   The patient's medical history was not provided.  No concomitant medications were reported.  On 23-Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 23-Dec-2020, the patient experienced injection site pain that resolved right away. On 31-Dec-2020, the patient experienced itching and redness where she previously received a vaccine many years ago.  She took Tylenol for those symptoms.  On 01-Jan-2021, the patient experienced swelling at the injection site that went away.  She also experienced random itching in the left arm area.  On 04-Jan-2021, the patient's left upper arm was tingling.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, injection site itching, tingling and injection site redness was not recovered/resolved.  The outcome of the events, injection site pain and injection site swelling, was recovered/resolved.; 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.
Right arm numbness that radiated to right side of the neck.  Weakness headache and shortness of breath, difficulty swallowing.
Breakthrough covid-19 infection; Breakthrough covid-19 infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 14Jan2021 at 13:00 as dose 1, single (Lot number: EL3247), in right arm, on 04Feb2021 at 13:15 as dose 2, single (Lot number: EL3247), in right arm and on 06Oct2021 at 13:00 as dose 3 (booster), single (Lot number: EW0217) at the age of 43 years, in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Apr2022, outcome "recovered" and all described as "Breakthrough covid-19 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Apr2022) Positive, notes. Therapeutic measures were not taken as a result of the event. The patient experienced the following symptoms: mild headache, significant cough, fever, chills and general fatigue. Most symptoms lasted about 3 days. Fatigue and cough have persisted for approximately 1 week with some lingering coughing.
medication error; received 1st dose of the Moderna COVID-19 vaccine from a vial that had been first punctured on 07Jul2021 @ 3:42p with the syringe having been at room temperature approximately 24 hours when administered.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received 1st dose of the Moderna COVID-19 vaccine from a vial that had been first punctured on 07Jul2021 @ 3:42p with the syringe having been at room temperature approximately 24 hours when administered.) and MEDICATION ERROR (medication error) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received 1st dose of the Moderna COVID-19 vaccine from a vial that had been first punctured on 07Jul2021 @ 3:42p with the syringe having been at room temperature approximately 24 hours when administered.). On an unknown date, the patient experienced MEDICATION ERROR (medication error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received 1st dose of the Moderna COVID-19 vaccine from a vial that had been first punctured on 07Jul2021 @ 3:42p with the syringe having been at room temperature approximately 24 hours when administered.) and MEDICATION ERROR (medication error) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. Treatment medication was not provided.
Itchy red rash on left and center of neck. Patient states she started BENADRYL Tues 9/23 and hydrocortisone. On 9/26 urgent care doctor told patient to use cetirizine, prednisone and famotidine.
For every Anthrax shot received after patient's 3rd dose and on. He has had a series of similar reactions lasting for a period of 2-5 weeks.  Primary symptoms are pain and aching in major joints (knees, hips, lower back, elbows) and an inability to sleep for the same 2-5 week period. Pt has had a total of 5 anthrax vaccinations.
swelling of the face; swelling of the throat; dry mouth; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medication history reported).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant information provided. No treatment information provided.
Pt called 7/31 to report that area that she received a pneumo shot. She explained that area was red and painful and getting a bit larger than day before. I explained that this is a normal reaction - but since pt was leaving for trip - out of country - maybe should consult with MD.
received 10mcg each and the 7 y/o and 11 y/o received 20 mcg each; "she bled a lot", had a lot of cramping pain and vomited x2.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the parent.  A 11 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OVERDOSE (non-serious), outcome "unknown", described as "received 10mcg each and the 7 y/o and 11 y/o received 20 mcg each"; HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown", described as ""she bled a lot", had a lot of cramping pain and vomited x2.".  No follow-up attempts are possible. No further information is expected.
at 1600 patient c/o  scratchy throat; administered at 1620 Benadryl 25mg/10 ml p.o.; patient states he did fine with for covid19 shot, and that since then he had his 3rd dose of Nucala for asthma. Patient looks good and bp a little elevated (1620-148/108, pulse 90; at discharge bp- 148/82). At 1640 patient stated feeling better and stated he was going straight home.
Patient is still complaining of arm pain and soreness, got the second vaccine today 4-27-21
Resident was admitted  to the hospital with diagnoses of toxic metabolic encephalopathy likely related to hypovolemia which was resolved after fluid resuscitation. A brain Ct was done and showed chronic occipital infarct with chronic meningioma. A follow up MRI done which did not show any hemorrhage. There was also left occipital lobe acute infarction measuring 3.2 cm in dimension from the CT scan. A new medication Eliquis 2.5 mg twice a day was started in the hospital per Neurologist recommendations and to discontinue ASA 81mg. She also has supraventricular tachycardia with A-fib, cardiologist recommended Lopressor 25 mg twice a day. She was also found to have UTI on admission.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 21-OCT-2015, the patient was vaccinated with improperly stored GARDASIL 9 (strength, dose and route of administration were not reported, lot # L007560, expiration date: 15-JUN-2017). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
multiple outbreaks of herpes zoster; osteoporosis; vasculitis; This spontaneous report was received from a lawyer, regarding a case in litigation and refers to a patient (pt) of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, site of administration, lot #, and expiry date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the pt suffered multiple outbreaks of herpes zoster, osteoporosis and vasculitis. As a result of these symptoms, pt was seen and treated by medical providers and was still under their care at the time of reporting. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not resolved. The reporter determined the events to be related to zoster vaccine live (ZOSTAVAX).  The events of multiple outbreaks of herpes zoster, osteoporosis and vasculitis were considered to be disabling by the reporter.
Symptoms:  severe muscle spasms, fever, ached all over,  extremely tired and weak. Began 4:30 a.m. March 3rd (14.5 hrs. after vaccine)  and ended by 8:00 a.m.  March 4th. Seems to be gone now. These were basically the ame symptons he had with Covid 19.
Pt received 1st dose of vax onset of sore throat, upper respiratory symptoms, back aches. Events resolved
This spontaneous report was received from a registered pharmacist and refers to an 80 year old patient of unknown gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 11-JUL-2017, the patient was vaccinated with an improperly stored ZOSTAVAX, lot number M041087 with expiration date 03-JAN-2018 (dosage schedule, anatomical location and route of administration not provided) for prophylaxis, reconstituted with properly stored diluent (MRK INJ). The administered vaccine was exposed to a temperature of 6 degree Fahrenheit to 14 degree Fahrenheit for 1 hour. Previous temperature excursion was reported as 6 degree Fahrenheit to 14 degree Fahrenheit for 45 minutes. The call was because of a data logger. No adverse effects were reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010696: US-009507513-1708USA010732: US-009507513-1709USA014569: US-009507513-1709USA014570: US-009507513-1709USA014571: US-009507513-1709USA014573: US-009507513-1709USA014574: US-009507513-1709USA014575: US-009507513-1709USA014576: US-009507513-1709USA014577.
Narrative:  Patient was previously COVID-19 positive in December 2020, but did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was admitted to the ED on 3/1/21 for a new onset heart failure diagnosis presenting with shortness of breath and bilateral lower leg edema. Patient was discharged on 3/3/21 with a request to received palliative care. He passed away on 3/21/21 with details surrounding his passing unclear and not documented in his chart. Comorbidities included COPD, smoker, chronic pain syndrome on chronic opioids with benzodiazepines, obesity, HTN
History of controlled HTN for 13 years. Received second Covid 19 vaccine on 1/28/21 and on 2/1/21 blood pressure was registering in the 180's over 90's and even after an increase in blood pressure medication, Losartan, blood pressure continues to increase. Took Losartan 25mg once a day for 13 years and on 2/23/21 increased to Losartan 50mg twice per day. Blood pressure today 2/25/21 is 187/11.
Accelerated heart rate (104 BPM Resting) Fever climbing above 103 (8/29/10@11:30am) Soreness of joints and temp. paralysis of left arm Fatigued and lightheadedness