chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hep A and Hep B for dose two of the series; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a patient who received Hepatitis A vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis.   Previously administered products included Twinrix.   On an unknown date, the patient received Hepatitis A vaccine and Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis A vaccine and Hepatitis B vaccine, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Twinrix for dose one and monovalent Hepatitis A and monovalent Hepatitis B for dose two of the series, which led to wrong vaccine administered. The health care professional did not have patient demographics, lot numbers and expiration dates. Discrepancy- Twinrix coded as historical vaccine though reported as suspect on source document because the patient received latest suspect vaccine as Hepatitis A and Hepatitis B which was considered event as wrong vaccine administered.
No side effects experienced; Once every 3-4 years/once a year since 2011; This spontaneous report was received from a 69-year-old female patient referring to herself. No information about the patient's concurrent conditions, drug allergies and reactions were reported. The patient had a history of shingles rash while on prior vaccination with zoster vaccine live (ZOSTAVAX) (case #1805USA011374)  In 2011, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not reported) once a year (also reported as once every 3-4 years) (inappropriate schedule of product administration), without adverse reactions/side effects.; Sender's Comments:  US-009507513-1805USA011374:
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and unknown gender. On 29-MAY-2015, the patient was vaccinated with 0.5 ml of improperly stored VARIVAX (Merck) (lot# L001334 and expiry date: 13-JAN-2017) once subcutaneously. No adverse effects were reported. No product quality complaint was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Inflammation, swelling, tenderness of upper arm - deltoid and biceps area, fever 99.8. Physician treated as a cellulitis with Keflex and is resolving
Pain at base of left thumb inflammation.; Pain at base of left thumb inflammation.; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number- EN6199), via an unspecified route of administration in right arm on 18Feb2021 at 10:30 AM (at the age of 61-year-old) at a single dose, for COVID-19 immunization. Medical history included high blood pressure, hypothyroidism and psoriasis. The patient had no allergies to medications, food or other products. Concomitant medications included levothyroxine sodium (SYNTHROID) and hydrochlorothiazide, triamterene (TRIAMTERENE & HCTZ). The patient was not pregnant. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient experienced pain at base of left thumb inflammation on 22Feb2021 at 12:00 PM. The events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if treatment was received for the events. The outcome of the events was not recovered. The second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6199) was administered, via an unspecified route of administration, in left arm on 11Mar2021 at 11:00 AM at a single dose for COVID-19 immunization.  No follow up attempts are possible. No further information is expected.
Red eyes; Swollen eyes; Itchy eyes; Rash on body; This case was reported by a other health professional via sales rep and described the occurrence of eye red in a 3-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number XM9TB, expiry date 30th June 2020) for prophylaxis.   Previously administered products included Flu vaccine (received the flu shot the past couple of years without any reactions).   On 1st October 2019, the patient received the 1st dose of Fluarix Quadrivalent 2019-2020 season (intramuscular) .5 ml. On 1st October 2019, immediately after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced eye red, eye swelling, eye pruritus and generalized rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the eye red, eye swelling, eye pruritus and generalized rash were unknown.   It was unknown if the reporter considered the eye red, eye swelling, eye pruritus and generalized rash to be related to Fluarix Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The patient received vaccine in anterolateral left thigh. The patient received Fluarix vaccine and left the office, but was returned shortly with red, swollen itchy eyes and a rash on her body. The patient received 9cc of Benadryl oral suspension ( 12.5mg per 5ml) and responded well. The patient  had received the flu shot the past couple of years without any reactions. No other vaccine or medication was given prior to the reaction. The patient did not have any difficulty in breathing. The reporter consent to follow up.
she has slept pretty much all day; feels awful; achy; pain at the injection site; fatigue; fever of 102 F; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Dec2021 (Lot number: 330308D) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01, Lot Number: EN6203, Route, Anatomical Location: right arm), administration date: 22Feb2021, when the patient was 74 years old, for Covid-19 immunization; Bnt162b2 (Dose: 02, Lot Number: EN6203, Route, Anatomical Location: right arm), administration date: 15Mar2021, when the patient was 75 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021, outcome "unknown", described as "Booster"; SOMNOLENCE (non-serious) with onset 16Dec2021, outcome "not recovered", described as "she has slept pretty much all day"; FEELING ABNORMAL (non-serious) with onset 16Dec2021, outcome "not recovered", described as "feels awful"; PAIN (non-serious) with onset 16Dec2021, outcome "not recovered", described as "achy"; VACCINATION SITE PAIN (non-serious) with onset 16Dec2021, outcome "unknown", described as "pain at the injection site"; FATIGUE (non-serious) with onset 16Dec2021, outcome "unknown", described as "fatigue"; PYREXIA (non-serious) with onset 16Dec2021, outcome "not recovered", described as "fever of 102 F". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of somnolence, feeling abnormal, pain, vaccination site pain, fatigue, pyrexia.  Additional information: The patient received the booster dose yesterday, 15Dec2021. Today, 16Dec2021, she relayed that she has slept pretty much all day and been in bed all day, feels awful, achy, pain at the injection site, fatigue, and a fever of 102 F. She reported having taken 2 Tylenol. She would like to know if these symptoms have been reported. The patient took her temperature and she had a 102 fever, so she was checking to see if these were normal. She wasn't feeling bad yesterday after she got the booster dose and she went to lunch. When she woke up this morning she felt awful. Her son told her to take 2 pills, but she can't think of what they were called, for the fever. She took Tylenol but she wanted the other one that she could not think of the name. The patient took a lot of pills but the first two vaccines did not bother her and she was taking them then.   Follow-up: Follow-up attempts are completed. No further information is expected.
Felt great at first and cleaned the house, scrubbing the bathroom with only right arm. About 6 hours after left arm vaccine, bedridden for 1 day; except quick bathroom breaks. Fever, chills, clammy, severe malaise for about 12 hours with hands and feet ice cold feeling like my circulation was shutting down. Minor aching in muscles and joints. Wondered if I should go to ER and afraid I might die that night 10/29/19, but felt too sick to go anywhere and lie freezing cold in an ER, so risked it. Too sick to get a thermometer. Interrupted sleep. Felt the same when I had H1N1 flu a few years back, although no vomiting or nausea or cough.  Moderate malaise for remaining 12 hours. Lost As quick as it came on, it went away. Disability: Lost one day of work. No claim of loss, just want you to know you need to warn people it could take them out of work/activities for a day or so. I had no idea. Thought it would be similar to previous vaccines, which were no problem other than sore arm. Didn't research ahead of time and was not warned.
Muscle aches from Lt shoulder to Right shoulder. Hair falling out. All eyebrows fell out. Lost  some eye lashes. Hyper-sensitivity on face & head
Ongoing Metallic taste in mouth after vaccine Feeling of chest flutters after second vaccination Burning sensation to left sternum few months after vaccine
On the morning of 02/02/2023, I went to the urologist who diagnosed me with a urinary tract infection. They gave me an injection of an antibiotic. By that afternoon, I was basically incoherent. My wife took me to the emergency room. I was admitted to the hospital. The infection had gone septic in a matter of hours. I was in the hospital for five days. I don't remember what all they did, but I was mainly treated with antibiotics and was released after five days.
chills; headache; facial itching; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of chills in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included cetirizine hydrochloride (Zyrtec).   On 15-OCT-2023, the patient received the 1st dose of Shingrix (left arm). On 15-OCT-2023, less than a day after receiving Shingrix, the patient experienced chills (Verbatim: chills), headache (Verbatim: headache) and pruritus facial (Verbatim: facial itching). The patient was treated with fexofenadine hydrochloride (Allegra) and ibuprofen. The outcome of the chills and headache were not resolved and the outcome of the pruritus facial was resolved.   The reporter considered the chills, headache and pruritus facial to be related to Shingrix.     The company considered the chills, headache and pruritus facial to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-OCT-2023 The reporter reported that after receiving Shingrix vaccine patient had chills, headache and facial itching. The reporter reported that the patient used Zyrtec, OTC vitamins. The reporter reported that the facial itching was resolved after taking Allegra. Patient also took ibuprofen as per need for headache and chills. The reporter consented to follow up.
Localized reaction to PREVNAR 13 (R) upper thigh 4 x 5 cm pinkness/warmth at inj site non tender, no induration, swelling or fever.
This case was reported by a other health professional via sales rep and described the occurrence of hives in a male patient who received FLULAVAL. In 2013, the patient received FLULAVAL. On an unknown date, Unknown after receiving FLULAVAL, the patient experienced hives (serious criteria disability and clinically significant/intervention required). On an unknown date, the outcome of the hives was recovered/resolved. It was not reported if the reporter considered the hives to be related to FLULAVAL. Additional details: The patient's previous vaccination went always uncomplicated. No other details were known. This was one of the 3 reports sent by the same reporter.
Headache, Myalgia & Fever Narrative: Felt feverish day after injection, bad headache, and sore arm. Took Tylenol.
I've been getting bloody noses a lot (at least every three days, and sometimes 3 or 4 times a day). The bleeding also lasts much longer than I've had before, and will sometimes soak entirely through a tissue or two before stopping.
Caller received the first dose of the Pfizer COVID-19 vaccine and has experienced stinging and burning sensation that was not attributed to the needle; Caller received the first dose of the Pfizer COVID-19 vaccine and has experienced stinging and burning sensation that was not attributed to the needle; Arm was sore; This is a spontaneous report received from a contactable consumer or other non hcp (patient). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration in Arm Left on 20Jan2021 11:50 (at the age of 59-years-old) (Batch/Lot Number: EK9231) as single dose for covid-19 immunisation. Medical history included myocardial infarction from an unknown date and unknown if ongoing Heart attack 6-7 years ago, anxiety, anticoagulant therapy from an unknown date and unknown if ongoing. Concomitant medication(s) included carvedilol 6.25 mg twice daily taken for myocardial infarction, clopidogrel 75mg once daily taken for anticoagulant therapy, rosuvastatin 20mg once daily taken for hypercholesterolaemia, escitalopram 10mg once daily taken for anxiety start and stop date were not reported. There was no AE(s) following prior vaccinations that sometimes when she gets the flu shot, she gets the feeling of the flu after, but it's minor. None other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). The patient experienced stinging and burning sensation that was not attributed to the needle and arm was sore on 20Jan2021. The patient received her 1st dose about 2 weeks ago and had no issues, but as she had spoken with other people that have gotten it, it left her thinking.  She asked when you get a shot and sometimes you feel the pinch, and sometimes it burns. Further stated that everyone she talked to said it was nothing for them; they didn't have that burning. But for her it burned during the injection and for 10 minutes after. Also states that her arm was sore the next day, which she expected. And everyone else said they had the arm soreness to, but no one had said that it burned during the injection. She just wanted to make sure that she was getting the right thing and was getting the protection. Caller clarified and stated that the burning lasted about 20 minutes after the injection. When asked what time she got her injection, caller stated that her memory was so bad, but she thought it was around 11:50am. The AE did not require a visit to emergency room or physician office. List other relevant diagnostic and confirmatory test results for event(s) was none. Outcome of the event (Caller received the first dose of the Pfizer COVID-19 vaccine and has experienced stinging and burning sensation that was not attributed to the needle) was recovered on 20Jan2021 while event (Arm was sore) was recovered on 22Jan2021.  Follow-up attempts are completed. No further information is expected.
Localized swelling of right thigh in duration warmth 2-3 inches in diameter.
a temperature excursion for VARlVAX, were administered to patients; This spontaneous report was received from a Licensed Practical Nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 12-JAN-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection, 0.5 milliliter (ml) (dose described as 0.5 mL SQ x 1 dose), lot # S038698, expiration date: 01-DEC-2021 (dose number, route of administration and anatomical location were not reported) for prophylaxis.  It was reported that the dose of the product administered to the patient was not stored properly for the time frame of 4 hours in the temperature 32.4 degrees Fahrenheit (F). There was no previous temperature excursion. Digital Data Logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2101USA010369: US-009507513-2101USA010348: US-009507513-2101USA010358: US-009507513-2101USA009977:
Initial report received on 21 May 2009 from a health care professional.  A 63 year old female patient received ADACEL (lot number C3005) on 09 April 2009 in the left deltoid.  The patient later experienced severe cellulitis of the arm, noted as a probable vaccine reaction.  The patient made a full recovery.  No additional information was provided.  The reporter of this case is the same as case number 2009-02083.
I HAD NO ISSUES WITH THE FIRST DOSE BUT WITH THE 2ND     I HAD THE TYPICAL PAIN AT THE INJECTION SITE AND AS THE DAY PROGRESSED i STARTED TO GET EXTREMELY TIRED SO I WENT TO BED.  ABOUT 16 HOURS AFTER RECEIVING THE SHOT I STARTED TO EXPERENCE EXTREME SHAKING ALMOST HAVE IF I WAS HAVE A SEIZUR.  I WAS ALSO EXPERIENCING A RACING HEART.  THIS ATTACK LASTED ABOUT 5- 10 MINUTES THEN SLOWLY SUBSIDED.  I THEN FEEL IN  A DEEP SLEEP. IN THE MORNING  I NOTICED PAIN IN MY JOINTS (ESPECIALLY MY NECK NEAR THE SITE OF INJECTION AND MY HIPS JOINTS) AND HAD DEVELOPED A FEVER OF 100.2.  TOOK 2 TYLENOL.   THE FEVER LASTED ONLY ABOUT 1 HOUR THEN SUBSIDED. THEN NOTICED ALL THE SIDE EFFECTS DISAPPEARED.
slightly sore arm where the needle went in; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A male patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration in the arm on 07Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the Pfizer COVID vaccine 8 days ago and had no side effects other than a slightly sore arm where the needle went in on 07Jan2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Painful lump in my arm pit that came on the morning of 3/25/21.
Pain in left groin, left thigh and into left buttocks starting on 10/22/21 Friday pm after cutting toe nails. Pain continues to interfere with movements especially getting into and out of bed, car, chairs, going up and down steps. Unable to go to work on Monday 10/25, went to medical facility where I was evaluated. X-Rays were taken of my left hip and leg.   Sick also on Tuesday 10/26.   Had a previously planned day off Wednesday 10/27. Worked Thursday 6 hours, left 2 hours early due to discomfort.  Worked Friday 7 hours.   Also limited in my work capacity unable to take stairs and walk without the use of a cane.
After receiving each COVID vaccine, had a couple of irregular periods. Became pregnant about 1 month after receiving 2nd dose of vaccine. At 8.5 week ultrasound, was told baby was only 6.5 weeks judging by size and heart rate. At 10.5 weeks, went in for another ultrasound and there was no heartbeat - baby measured about 6 weeks. Miscarriage.
got our flu shots in september and here we are with the flu; Initial information received on 28-Nov-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who experienced got our flu shots in september and here we are with the flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot Unknown at this time via unknown route in unknown administration site for Immunisation.  On an unknown date the patient developed a serious got our flu shots in september and here we are with the flu (vaccination failure) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (got our flu shots in september and here we are with the flu).  At time of reporting, the outcome was Unknown for the event got our flu shots in september and here we are with the flu.; Sender's Comments: Sanofi company comment dated 30-Nov-2022: This case involves an unknown age female patient who experienced got our flu shots in september and here we are with the flu while receiving vaccine INFLUENZA VACCINE. Case will be re-evaluated post further update on information regarding underlying disease, risk precipitating factor, other concomitant medication, past medical history and patient lifestyle which will preclude a comprehensive assessment of this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Pt with rash to all area. No fever. No redness or induration injection sites. Dr diagnosing erythema multiforme vesicular hives after vaccination.
PFIZER COVID VACCINE #3 DOSE GIVEN 8/3/21, LOT #FA7485. PFIZER COVID VACCINE #4 DOSE GIVEN 8/24/21, LOT #FC3183. PFIZER, COMIRNATY, COVID VACCINE #5 DOSE GIVEN 5/7/22, LOT #FM9992. pt transferred from a local Medical Center; received ABX and IVFs while there; pt with increasing SOB, generalized weakness, abdominal cramps, nausea, vomiting, fever, chills; given Azithromycin, O2 supplementation, received blood; pt's respiratory status worsened and was placed in ICU; on 7/3/22, pt had a positive COVID test; given Decadron and eventually weaned to Room Air; continued to have severe anemia and thrombocytopenia, requiring transfusion; became more SOB; given O2 via NC; code blue on 7/13/22; ACLS protocol followed without recovery of pulse or heart activity; pt passed away in the hospital
She woke on 01/28/2021, she felt very achy, sinus felt like they were burning, headache.  After day one symptoms progressed, started having diarrhea that lasted approximately 6 days, legs were very painful, and very swollen- gained 11 pounds in fluid weight in one day.  Around day 10 started to become confused and very foggy.  Report getting "lost" in her home, she couldn't figure out where the bathroom was and had an incontinence episode.  She was in so much pain she stopped eating and drinking.  On February 8th contacted her primary care physician, who prescribed Doxycycline. She reported after that she slowly started getting better, swelling started to dissipate around the 17th she was beginning to feel better.  She reports she was off work from February 1- 18th.  She reports during that time her skin bright red and stools were yellow in color.