chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a health care student concerning a patient of unknown age. On 01-JAN-2013, the patient was vaccinated with ZOSTAVAX (dose, frequency, lot number and expiry date unspecified), subcutaneously. On 10-JUN-2016, the patient was inadvertently vaccinated with a second dose of ZOSTAVAX lot # L034726, expiry date: 09-DEC-2016. No adverse effects reported. No further details provided. Additional information has been requested.
Information has been received from a nurse practitioner concerning a 16 year old female with no pre-existing allergies, birth defects, or medical conditions, who on 02/27/1990 and 04/03/1992 was vaccinated with a first and second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. There was no illness at the time of vaccination. Subsequently, it was noted that the patient had a negative rubella titer. No other information was available. The outcome was reported as not recovered. Unspecified medical attention was sought. There was no product quality complaint. Follow up information indicated that the third dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live was given 09/16/2005. It was noted the titers were done by gynecology. the outcome was reported as recovered. No additional information is expected.
Left eye was swollen; Arm was red; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (first dose received on unknown date without any issues).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced erythema of extremities, pain in arm and eye swelling. On an unknown date, the outcome of the erythema of extremities and pain in arm were recovered/resolved and the outcome of the eye swelling was not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities, pain in arm and eye swelling to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-Jul-2022 Reporter's comment: The patient arm was red and sore for 3 days afterwards, when patient had received the second dose. Then, on day 5 patient left eye was swollen. Till day 8, patient had not got better. The patient saw the doctor yesterday (from the date of reporting), and they disagreed it was from the vaccine. The patient requested consent to follow-up.
injection site pain; This case was reported by a consumer and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that he/she understood there was pain at the injection site and aked the reason for this. The reporter also asked how long should pain last.
The patients mom came to consultation area and stated that patient is recovering from her immunization at a hospital. She stated that she has arm pain, weakness, and elevated liver function tests. She wanted to know if I ever seen anything like that before. She was not specific in the timeline but stated that her arm started hurting around 5 hours after the immunization. I went over side effects, answered her questions, and told her I would report the adverse event. She stated that patient is starting to get better.
got COIVID; got COIVID; 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 76-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got COIVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: he was to get his second booster but got COIVID.  Clinical course: Caller states he just finished his regime of Paxlovid and had to stop taking his Crestor, Tamsulosin, Fenofibrate and hydrochlorothiazide. Caller states he has received the Pfizer COID-19 vaccine and one Pfizer booster he was to get his second booster but got COIVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Case number PHEH2015US025437 is an initial spontaneous report received from a nurse on 04 Dec 2015. This report refers to an adult female patient. Past medical history and concomitant medications were not reported. She was vaccinated with 1 ml of FLUVIRIN (batch number: 1411302) intramuscularly on an unknown date. No adverse event was reported following the maladministration. Case was lost to additional follow up.
I almost got fainted or black out; My blood pressure and heart rate dropped to 76/55/42 respectively; My blood pressure and heart rate dropped to 76/55/42 respectively; Sweaty; Clammy; This is a spontaneous report from a contactable consumer. This 45-year-old male consumer (patient) received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration administered in arm right on 27May2021 12:26 (Batch/Lot Number: EW0180) as single dose for covid-19 immunisation. There was no medical history or concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received first Pfizer dose in his right arm at 12:26 PM on 27May2021.  even minutes after vaccination, at 12:33 PM, he almost got fainted or black out. His blood pressure and heart rate dropped to 76/55/42 respectively. The patient was sweaty and clammy for about 3 minutes. At 12:40 PM, his blood pressure and heart rate elevated to 103/69/65. At 1:05PM, his blood pressure and heart rate came back to normal 120/84/67. The patient drove home afterwards without further reaction. He was a heathy male with no underline health condition. The patient have been testing  for COVID-19 once a week since 07May2021 and all test results came back negatives (on 28May2021). The events result Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The outcome of blood pressure and heart rate dropped was recovered on 27May2021 1:05PM, of other events was recovered in May2021. No treatment was received for the events.
pt recvd vax;demonstrated irritability & poor sleep 3dec in eve;cried on & off 6-8 hrs;not high pitched;seemed to have tenderness at rt thigh where DTP given(per mom);mom reported inject site warm & red;appetite gone & devel cold by 6dec94;
I started having these light grey spots in my vision and so I went to my eye doctor. They ran lab work and did lap tests and found a blood clot in my retina which is called a branch retinal artery occlusion. The first round of the testing most of the numbers were normal other than one and then we tested again 12 weeks apart and that number was high both times and slightly higher the second. I have been put on a low dose aspirin to monitor this but have not been put on a blood thinner as it is not needed at this point per the hematologist.
Medical assistant inadvertently gave an undiluted dose of the COVID-19 vaccine. Parent notified. At this time, no adverse events reported.
Vaccine was under diluted by 50% therefore patient received dose of almost 200% normal recommended dose. Patient remained in pharmacy for 15 minute wait time post vaccination and when error was discovered, pt was then later notified of error. Pt was not experiencing any adverse side effects and was counseled on potential adverse effects.  Will follow-up with pt within 24-48 hrs for update.
Severe flu symptoms; feeling incapacitated; Gagging; Feeling like humming and buzzing (motor-like); Throat constriction/contraction; Eye/vision distorted and were constricted; Felt like head would explode; forehead and headache; Forehead/head constriction; Constriction/contraction of chest; A spontaneous report was received from a consumer, a 74-year-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced, feeling like humming and buzzing (motor-like), throat constriction/contraction, eye/vision distorted and were constricted, felt like head would explode, forehead/head constriction, constriction/contraction of chest, severe flu symptoms, feeling incapacitated, and gagging.  The patient's medical history was not reported. No concomitant medications were reported.  On 10 Feb 2021, prior to the onset of events, the patient received their second planned doses of mRNA-1273 (batch number: 030M20A), intramuscular for the prophylaxis of COVID-19 infection.  The patient reported that she had adverse reactions after administering the vaccine around 2:00 on 10 Feb 2021. Later, the patient went to bed. On 11 Feb 2021, at midnight, the patient started feeling like that she was humming and buzzing from the waist up; throat was constricted and contracted; gagged a few times; vision/eyes were constricted and vision was distorted; forehead, and head ache felt constricted and felt like it was going to take off and was so tight. Later, it moved to chest, the constriction/contraction was so tight that and felt like someone was standing on it. The patient stated that these feelings were all above the waist and lasted for about an hour and ten minutes and just stopped on the same day. The next day on 12 Feb 2021, about six hours later, the patient had regular side effects which started about 10 hours after the shot. The patient was fine for about six hours then had severe flu symptoms and was feeling just incapacitated. The patient just got rid of these flu symptoms around 1 pm on the same day. The patient wanted to know if these were allergy symptoms. No treatment medication information was provided  Action taken with second dose of mRNA-1273 in response to the events was not applicable.   The outcome of the events, feeling like humming and buzzing (motor-like), throat constriction/contraction, eye/vision distorted and were constricted, felt like head would explode, forehead/head constriction, constriction/contraction of chest, and gagging were recovered on 11 Feb 2021 and that of event severe flu symptoms was recovered on 12 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Had breakthrough bleeding  and cramps after both vaccines  despite being on birth control pill that persisted over a span of 2 months. These varied from spotting to heavy bleeding. I was so concerned that I spoke with my OBGYN listed in the chart and had an ultrasound performed and almost changed my birth control pill to a stronger one.
Took second dose COVID vaccine on 1/18/21, had fever, fatigue, headache that lasted through the day of 1/19, only took 1g dose of Tylenol that evening mostly due to headache. I woke up feeling fine on 1/20 but then developed some shakiness that evening. On 1/21, I had fatigue/tiredness, and other than food/bathroom, stayed in bed resting. On 1/22 continued to feel fatigued and dizzy, finally checked my BP, the readings were 93/67 (did not write down HR - heart rate) and 89/68, HR87. I videoconferenced the Methodist urgent line, spoke to NP, recommended continued check BP and increase fluid intake. Still feeling slightly dizzy and tired, but better overall, just feel slightly "off", especially with exertion.  BP: 1/23 - 98/76 HR84 , 104/83, HR77; 1/24 - 102/82, HR87; 1/25 - 109/75, HR68, 104/67, HR58, 98/79,HR104, 96/74, HR93; 1/26 - 94/69, HR81, 95/72, HR74, 98/64, HR80; 1/27 - 121/84, HR81 (during MD video visit), 114/80, HR75, 96/74, HR82. Spoke to my doctor today.  She asked if I'd filled out this form so decided to fill out.  She recommended I continue to monitor BP, increase fluid intake, restart vitamins, add electrolyte drink, add caffeinated drink (for intermittent headache) and follow-up next week if not resolved.
Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 26-JAN-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
2 weeks post vaccine, anthrax, wrists (some swelling), then uticaria (seen) by examiner.
STORAGE IN REFRIGERATOR (2 grade C - 8 grade C) upt to 30 days.  (Vaccine used after 10/16/2021)
Swelling in joints - including  ankles ( worst- pitting edema), knees, wrists, hands, hips,. Unable to get up day after vaccine, slowly resolved and then came back stronger and still having symptoms months later.
Patient reported significant muscle pain in the left arm after receiving the first dose of Shingrix.  Over time she says the pain has lessened somewhat, but still bothers her.  She has subsequently received the second dose, also in the left arm, which did not affect the pain whatsoever.  At rest she reports no pain, however, when extending her left arm she feels a pain level of 6 out of 10.
The PT's mother noticed reaction this morning at 7:30 a.m. When she was getting her dressed, noticed a pinkish lump about the diameter of orange. Slight pain - it was worse yesterday, the injection was given in left arm.
swollen lymph node in left underarm approximately size of tennis ball.  pain in left underarm lymph node like muscle tear
Information has been received from a woman in a pediatrician's office concerning a 13 year old white male with Down's syndrome and "acquired hypothyroid" who on 08JAN1998 was vaccinated with a first dose of varicella virus vaccine live, in the right arm and a second dose of measles virus vaccine live + mumps virus vaccine live+ rubella virus vaccine live, in the left arm. There was no illness at the time of vaccination. On 18NOV2003 the patient developed a "diffuse vesicular rash on arms, legs and trunk." There were no relevant diagnostic tests or laboratory data. The patient recovered on 26NOV2003. No further information is expected.
Stiffness, soreness in neck that started 8/30/00 at night. 3 days prior.
it gave me that reaction with the 2nd dose, injection is painful but it's worth it; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 06-Nov-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient said thank god, as he/she had already been vaccinated, that injection was painful but it was worth it. It gave the patient that reaction with the 2nd dose. Additional supportive information: The follow-up could not be possible as no contact detail were available.
1) Itching on extremities, mouth (side where vaccine was given 2) Fingers numb (on injection arm side) Feet numb 3) Excruciating pain (In injection arm)
before administering forgot to add dilute. So gave patient Pfizer vaccine with out diluten. Patient did not experience any symptoms and did not have signs of any other reactions. Informed our primary Doctor in the office and she told me to just make sure patient is feeling ok.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On an unknown dates, the patients were vaccinated with doses of ROTATEQ  orally (dose, dose number and lot number were not reported), which were exposed to temperatures outside of range. No adverse effects were reported. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information is not expected, because the permission to contact was not given.
PER PT. REPORT: ONSET OF SWELLING ABOUT THE INJECTION SITE, DEVELOPMENT OF HAND, WRIST, ELBOW, SHOULDER PAIN ON VACCINE ARM (LEFT ARM), THEN SUBSEQUENT DEVELOPMENT OF SIMILAR SYMPTOMS ON THE RIGHT ARM. THERE WERE NO ANAPHYLACTOID SYMPTOMS PER REPORT. THE PATIENT WAS NOT GIVEN THE Tdap VACCINE BY THIS AUTHOR OR EVEN BY THIS CLINIC. THE PATIENT WAS MADE AN APPOINTMENT FOR EVAL OF HER SYMPTOMS. THE CLINIC THAT GAVE THE PATIENT IN THE INJECTION WAS NOTIFIED OF THE ADVERSE EVENT AND WAS ADVISED TO F/U WITH THE PATIENT.
Graves hyperthyroidism confirmed by bloodwork 21 days after first Pfizer vaccine
hemorrhoid; inflammation; anaphylaxis; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4409243-00 (Agency).  A 63-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant) with onset Mar2021, outcome "recovered", described as "anaphylaxis"; HAEMORRHOIDS (medically significant), outcome "unknown", described as "hemorrhoid"; INFLAMMATION (medically significant), outcome "recovering". The action taken for adalimumab was unknown.  The reporter considered "anaphylaxis" related to BNT162b2. The reporter's assessment of the causal relationship of "hemorrhoid" and "inflammation" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Mom came in on Friday 6/3/2022 with three children as an appt. 2 appts. were for Pediatric Pfizer and 1 appt. for Adult Pfizer. One of the children turned 12 after getting his first dose of Pediatric dose on 3/4/2022. RN was the technician that took them in at the check in window and did not notice that the child was 12 yrs old now. The RPH who gave the shot gave it incorrectly by not double checking the DOB with the child. RPH said she spoke with the Mom and verified that 2 shots were pediatric dosing and 1 shot was adult dosing. RPH did not verify the DOB with the Mom to make sure the child was under 12 years old. The RPH verifying and that he noticed that the child was 12 years old and should have been given the adulting dosing. He informed me today of the error. I left a message with the Mom to call me back.
Sore arm, redness at injection site, bright red blood in urine for  2 days
Unstable gait (Ataxia) and tremors started 10/10/04...About 6 Days after vaccine (Flu Vaccine) Given. Seen by pediatric neurologist and diagnosed with post vaccination Cerebellisis. Medical records state Otitis, cerebellitis.
Back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Myeloma (Multiple Myeloma was reported).   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced BACK PAIN (Back pain). At the time of the report, BACK PAIN (Back pain) outcome was unknown.            patient took chemo pills 3 weeks No treatment medication were reported.
20DEC96 pt recv vax & 1-2 hr p/vax had a high fever (parents didn't know temp);resp distress;did not notify clinic until came in for 4mo check up;
This case was reported by a pharmacist and described the occurrence of nonspecific reaction in a male subject of unspecified age who was vaccinated with hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified). On unspecified dates over a decade ago, the subject received 2 doses of Hepatitis B vaccine (unknown). At an unspecified time after vaccination with the Hepatitis B vaccine, the subject experienced nonspecific reaction. At the time of reporting the outcome of the event was unspecified.
Next day shoulder was hurting, vaccination area hurt, couldn't lift arm, could even put shirt on. Called the hospital the next day and was waiting for doctor to call back on Monday. Went to doctor's office on Monday given a prescription for pain; it did not help. Was referred to specialist in the same facility after a week. Doctor questioned whether there was an on injury, surgery in that area but patient denies any. Doctor prescribed medicine and couldn't take them for too long since got bad side effects. Referred for neck MRI, referred to physical therapy for neck and shoulder. Referred to shoulder MRI. Referred to another doctor, around late May, referred to continue to physical therapy for about a year. Doctor confirmed that it was related to vaccine and no surgery was necessary. Today, has some improvement but still has a lot of pain. In the beginning, after vaccine, couldn't do anything with right arm couldn't do anything at old. Pain from right shoulder to your neck. Couldn't move head backwards or forward; can move forward better. Still has a lot of pain even thought doing better than before and taking painkillers.
Covid symptoms (H/A, muscle ache, fatigue, fever, stomach ache, chills). Positive home antigen test for Covid on Saturday, Oct 8. Positive PCR Sunday, Oct 9. Started pavlovid Monday Oct 10. most symptoms improved except fatigue Oct 11