chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient developed a bulls eye appearance rash that is 3-4 inches in diameter, reddened circle at the injection site and a white circle surrounding the red circle. The rash is painful to the touch.; the patient also developed a fever; This spontaneous report was received from a pharmacist referring to a 53 years old female patient, with no concomitant medication, pertinent medical history or drug reactions/allergies. The patient's concurrent condition was not reported.  On 30-JUL-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R029518, expiration date reported as 14-OCT-2000, but upon internal validation established as 14-OCT-2020) (dose and frequency not reported), subcutaneously in the left arm for prophylaxis.  On 01-AUG-2019, the patient developed a bulls eye appearance rash that was 3-4 inches in diameter, reddened circle at the injection site and a white circle surrounding the red circle. The rash was painful to the touch. The patient also developed a fever. She sought medical attention. The pharmacist advised the patient to take acetaminophen (TYLENOL) for fever and to see her physician. No other lab diagnostics/studies were performed. At the reporting time, the outcome of the events were unknown.   The reporter did not provide the causality between the events and varicella virus vaccine live (oka/merck) (VARIVAX).
ITCHY RED PATCH ABOUT 1 INCH WIDE AND 3 INCHES LONG SHOWED UP 5/12/17 MORNING. PT WILL TAKE BENADRYL FOR ITCHINESS.
No adverse reaction to the vaccine. He had the normal reaction to the vaccine such as mild fever that resolved within 2 days.
Moderna Covid 19 vaccine given. Patient immediately appeared to be in respiratory distress.  Patient reports history of ASTHMA. Patient did not have rescue inhaler with her. Patient received 0.3mg IM epinephrine. 911 call was placed and patient was transferred to emergency dept. via Bangs ambulance for additional follow up.
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 29-APR-2013, the patient was vaccinated with a dose of GARDASIL (lot # H020002, expiry date 08-AUG-2015), with the same lot of improperly stored GARDASIL. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Information has been received from an RN concerning an 80 year old male pt who on approx. 9/21/00 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot 629633/1693H). By approx. 9/27/00, the pt's injection site arm was swollen from his shoulder to fingers, tender and red and he had a fever of 101F. The pt sought unspecified medical attention. It was reported that another pt (WAES 00100373) had a similar experience following exposure with pneumococcal vaccine 23 polyvalent (lot 629633/1693H). Additional information has been requested.
After the vaccine my arm was sore for a couple of hours. Then one day I was sick and I felt like I had a cold. I started throwing up a lot and shaking. I couldn't stand up on my own. My husband took me to the ER. I was out of it. When I came back to my senses they told me I had experienced diabetic ketoacidosis because I was diabetic without knowing it while being sick with covid so my blood sugar sky rocketed. They also said I had a mild case of pneumonia. I was hospitalized. I was put on Lantus insulin and antibiotics for pneumonia. Then I was put on gabapentin for neuropathy pain. I've had a lot of fatigue since then.
This is a spontaneous report from a contactable consumer reporting for a male patient (husband). An 89-year-old male patient received PREVNAR 13 at single dose in right arm for preventive for pneumonia, INFLUENZA VACCINE, both via an unspecified route of administration in Oct2016 at 12 O'clock for immunization, administered by a nurse at the responsible Physician. The patient medical history was not reported. Concomitant medication included levothyroxine (LEVOTHYROXINE) tablet 75 mcg, once a day approximately from 15 years and ongoing for thyroid. No other vaccines were given 4 weeks prior to the day of suspected vaccine. On an unspecified date, bronchitis about 2 weeks later weeks after getting his PCV13 shot. He started experiencing congestion in lungs probably about 2 to 3 weeks before this report and it was going on for 4 weeks. He thought it was bronchitis so he went to the doctor who gave him Prednisone and prescription for antibiotics: he was started on doxycycline (unknown manuf.) for treatment, but was allergic and broke out in big red splotches. His physician then switched him to a Z-PAK, albuterol and prednisolone. He still had the bad congestion in his lungs. Consumer asked that if there was something good that he could take for infection in his lungs that came from that pneumonia shot. On an unspecified date the patient also experienced infection in his lungs with outcome of not recovered, bad congestion in his lungs on an unspecified date with outcome of not recovered, bronchitis on an unspecified date with outcome of unknown, sick with outcome of not recovered, COPD (chronic obstructive pulmonary disease) with outcome of not recovered, patient received PREVNAR 13 and flu shot together with outcome of unknown. In response to other medication conditions, reporter stated that the patient had COPD and when the patient went to the doctor this Sunday (20Nov2016?) after the Lung infections, doctor told him that he had COPD. Reporter added that Sunday (20Nov2016?) was the first day when they knew about that the patient had COPD. The patient had blood work this past Sunday (20Nov2016?) but the reporter did not have the result of the blood work. The current status of infection in lungs and bad congestion in lungs was still in existence. Patient had bronchitis before, but the reporter had never known that if he would have bronchitis that long. It was four weeks now that the patient became sick. A product complaint was filed.
Pain at injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 54-year-old male patient received the first dose of bnt162b2 (lot number: EH9899), intramuscular on the left arm on 15Dec2020 09:00 at a single dose for immunization. There were no medical history and concomitant medications. The patient have no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 and had not been tested for COVID-19 since the vaccination. On 15Dec2020 18:00, the patient experienced pain at injection site. No treatment was received for the adverse event. Outcome of the event was recovering.
Lips swell up; This spontaneous case was reported by a pharmacist and describes the occurrence of LIP SWELLING (Lips swell up) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.  On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced LIP SWELLING (Lips swell up). On 20-Aug-2021, LIP SWELLING (Lips swell up) had resolved.      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 medications were reported.  No treatment information was provided.
Lip numbness and tingling.  Throat tightness.  Weakness.  Heart rate dropped to 42 bpm.  Facial and lip swelling.  No SOB, no chest pain.
Inflamed reddened area, size of baseball, under injection site.  This was slightly swollen and itchy.  8 days after receiving injection.  Have treated with Benadryl Cream and oral Claritin.  No further complicating factors at this time.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-395985 (Patient Link).
Dose 1. 5/3/2021 Dose 2.  5/26/2021
experienced a side effect; headache; ran fever for 10 days; lost of taste; lost sense of smell; severe body aches; dirreah for days and for no reason; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experienced a side effect), HEADACHE (headache), PYREXIA (ran fever for 10 days), AGEUSIA (lost of taste) and ANOSMIA (lost sense of smell) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (experienced a side effect), HEADACHE (headache), PYREXIA (ran fever for 10 days), AGEUSIA (lost of taste), ANOSMIA (lost sense of smell), PAIN (severe body aches) and DIARRHOEA (dirreah for days and for no reason ). At the time of the report, VACCINATION COMPLICATION (experienced a side effect), HEADACHE (headache), PYREXIA (ran fever for 10 days), AGEUSIA (lost of taste), ANOSMIA (lost sense of smell), PAIN (severe body aches) and DIARRHOEA (dirreah for days and for no reason ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter.  Treatment information was not reported.
Vaccine Site Reaction including Pain, Redness, Swelling. Size: Greatest Concentration 2.5 cm x 4 cm, Full Extent 8 cm x 20 cm. Injection Site in Upper Triceps Muscle.
Pt recvd vax in NOV92 & exp soreness in both elbows & fatigue in both upper arms; pt arms tired easily; sl inflammation; rheumatoid arthritis; hypothyroid condition;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 01-JAN-2008, the patient was inoculated with ZOSTAVAX at an Internal Medicine office for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. In or about February 2016, the patient was treated at the same Internal Medicine office for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
Difficulty sleeping, painful chills, headache.  Motrin 800 mg given.
Vesicular collarettes & budding red based papules in different stages on face/head/ arms torso.  Some with overlying eschar and more with yellow crusts esp right auricula.
Redness and swelling at site started 4-23-15 and symptoms lessening on 4-24-15 when reported.
This is a spontaneous report from a non-contactable consumer. A 21-years-old male patient of unspecified ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose. The patient medical history and concomitant medications were not reported. The patient experienced a lot of discomfort, numbness, tingling, feeling bad all over, and chills all on an unspecified date with outcome of not recovered. No follow up attempts possible. No further information expected.
Td booster given per protocol. Pt called on 11/29/00 with complaint of pain and swelling at injection site. Instructed to take Benadryl and ibuprofen per directions on bottle, apply ice pack to site. Called on 12/1/00. Had client come in to clinic. Irregular, red, raised patches on right deltoid, warm to touch. Arm on right 1" larger than left. States better "but still painful, itches and is swollen".
He experienced right leg rash; Mild headache; Body aches; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on unspecified date in 2021 as dose 1 single for COVID-19 immunization. Medical history and Concomitant medications were not reported. Patient mentioned that he had taken the shot 3 weeks ago and he was about to get his second dose but he experienced right leg rash and mild headache and body aches in 2021. The outcome of events was unknown.  Information about lot/batch number has been requested.
72 YO received pediatric dose; 72 YO received pediatric dose; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 72-year-old female patient who received HAV (Havrix 720) (batch number YG7YJ, expiry date 3rd February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th July 2022, the patient received the 1st dose of Havrix 720 and Havrix Pre-Filled Syringe Device. On 9th July 2022, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-JAN-2023 Reporter's Comments: Pharmacist reported a female patient was administered a dose of Havrix on 9th July 2022. The patient came back into the pharmacy to request second dose, the system rejected the dosing because of her age and at that time they realized she had received a pediatric dose for the first dose.   At the time of reporting, additional dosing had not been administered. Additional Supportive Information: The adult patient received pediatric formulation of Havrix, which led to accidental underdose and adult use of a child product.
According to mom approximately 5-6 hrs after recieving her Hep A and Varicella vaccines the pt. c/o her stomach hurting and she started throwing-up and that continued for about 6 hrs. and then just before bed that night she was finally able to hold down toast. She had no other symptoms and she was fine by the next day.
Menstrual period came 1 week early and was heavier than usual. Same thing happened after 2nd vaccine in 1/2021. Subsequent to that menstrual cycle has been highly irregular (more frequent and heavier lasting 7-10 days when previously had all been 27-29 day cycles with 5-7 day periods). STARTING in May, pt had 2 periods, one 14 day cycle followed by 6 days of no bleeding and then an 8 day cycle.  Had a cycle in June and since July 9 has not stopped bleeding at all.
I received the FLUZONE HIGH DOSE vaccine at around 1pm and at 5pm I had shortness of breath for five hours. Also I had some chills, and had to use my VENTOLIN inhaler about 8 times to breathe. It cleared up around 1 am.
This case was reported by a physician via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Previously administered products included ZOSTAVAX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injected limb mobility decreased was unknown. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of SHINGRIX on unknown arm. The patient had 2nd dose of SHINGRIX over two months ago and at the time of reporting experiencing pain in the arm she received the injection. The patient could not lift her arm over a 30 degree angle without pain.
This spontaneous report as received from a pharmacist refers to a 65 years old patient. The patient was vaccinated with lot # (669373/0130AA, expiration date 12-AUG-2012) PNEUMOVAX 23 on 25-SEP-2012, 0.5 ml single dose, by intramuscular injection. No other co-suspected were reported. No concomitant medications were reported. On 25-SEP-2012 the patient was administered an expired dose of PNEUMOVAX 23 (expiry date 12-AUG-2012). No treatment information was reported. No adverse effects reported. Additional information has been requested.
Patient called hospital call center to report side effects to Pfizer vaccine on 3/21/22. Patient reports lymph node pain and swelling (under the arm) on the same side as the injection site which started on 3/16/22. symptoms have "went down and is able to perform ADLS but still bothersome".  No emergency signs and symptoms were reported at the time of the call.  Patient advised to follow-up with patients external provider for further evaluation.
Patient became pale after receiving shot. She stood up and pitched forward and was caught by her dad and lower to the floor. She was responsive. Her pulse was strong and steady. After 10 minutes we helped her to the chair where she sat for another 5 minutes then said she was feeling woozy again so we laid her on the floor for another 20 minutes. After sitting for about 5 min she was ready to leave. I cautioned dad to hold on to her as they exited. He refused a call to 911.
pt recvd vax;devel n,fever,chills,SOB;localized tenderness to palpation Lt deltoid;no hives noted; sxs started approx 9 hrs a/ shot;
Pt vax; 8 hrs later exp rash on extremities: hands, arms, legs, hives & severe itching.  Tx w/ Benadryl.
This spontaneous report was received from a medical assistant and refers to a 1-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant drugs were not reported. On 11-FEB-2019, the patient was inadvertently vaccinated with LIQUID PEDVAXHIB lot# R013573, expiration date 22-MAR-2021 (exact dose, frequency, route and site of administration were not reported) instead of RECOMBIVAX HB for prophylaxis. No adverse effects were reported.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient pertinent medical history, concurrent medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, dose number, route of administration, lot# and expiration date were not provided). On 02-FEB-2018, the patient was re-vaccinated with a dose of GARDASIL 9 (dose, dose number, route of administration, lot # and expiration date were not provided). No adverse event was reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001550: US-009507513-1806USA001551: US-009507513-1806USA001552: US-009507513-1806USA001554: US-009507513-1806USA001555: US-009507513-1806USA001556: US-009507513-1806USA001557: US-009507513-1806USA001558: US-009507513-1806USA001559: US-009507513-1806USA001560: US-009507513-1806USA001561: US-009507513-1806USA001547: US-009507513-1806USA001548: US-009507513-1806USA001549: US-009507513-1710USA003103.
blood transfusion approx every 30 days; Four days after receiving the COVID vaccination my mother was diagnosed with a rare blood disorder; Her white blood cells, red cells, and platelets are were all messed up; Her white blood cells, red cells, and platelets are were all messed up; Her white blood cells, red cells, and platelets are were all messed up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRODUCT TRANSFUSION DEPENDENT (hospitalization), outcome "unknown", described as "blood transfusion approx every 30 days"; BLOOD DISORDER (medically significant), outcome "unknown", described as "Four days after receiving the COVID vaccination my mother was diagnosed with a rare blood disorder"; WHITE BLOOD CELL COUNT ABNORMAL (non-serious), RED BLOOD CELL COUNT ABNORMAL (non-serious), PLATELET DISORDER (non-serious), outcome "unknown" and all described as "Her white blood cells, red cells, and platelets are were all messed up". The patient underwent the following laboratory tests and procedures: Platelet count: all messed up; Red blood cell count: all messed up; White blood cell count: all messed up. Therapeutic measures were taken as a result of blood product transfusion dependent, blood disorder, white blood cell count abnormal, red blood cell count abnormal, platelet disorder.  Additional Information: Four days after receiving the COVID vaccination mother was diagnosed with a rare blood disorder. Her white blood cells, red cells, and platelets were all messed up. It had been a year and a half, and she received a blood transfusion approx every 30 days, in addition to now Promacta. The Promacta prescribed was 150mg daily. That was a retail value of very expensive a month. Prior to 2022 she was receiving a shot in her stomach once a week and billed lots of money per shot.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Suffered  a heart attack on 3/13/2021. Took medication. On 3/31/ 2021, had three separate heart attacks. Daughter took you to the hospital.  Given Nitros and aspirin.  Given  stint. Got very angry and agumentative. Cannot remember ever getting that way. Getting swollen legs and feet from sitting just a couple of hours. Previously, no swelling. Given clean bill of health just months ago prior to knee surgery. Currently on various medications (up to 13 pills and shots). Not on those medication previous. On B12. Experiencing extreme fatigue.  Vague memory, but could have had several trips. Cardiologist has advised against getting second dose. Half of heart damanged (right side) 99-100% blocked.