chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via call center representative and described the occurrence of induration in a patient who received FLUARIX QUADRIVALENT (batch number 5C2L4, expiry date 18th June 2016). On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced induration, injection site induration and neck swelling. On an unknown date, the outcome of the induration, injection site induration and neck swelling were unknown. It was unknown if the reporter considered the induration, injection site induration and neck swelling to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: The reporter stated that, 700 patients received FLUARIX QUADRIVALENT and 5 patients developed localized reaction. The patients experienced quarter sized induration to a full arm and neck swelling. The reported batch number (5C2LA) for FLUARIX QIV did not exist and was updated to be 5C2L4 as per sales database. No patient information available at the time of reporting. This case was one of the 5 cases reported by same reporter.
Nausea; Body aches; Fever, it is at 104 and it kind of went down but it is going back up; Lower back pain; This is a spontaneous report from Pfizer-sponsored program. A contactable consumer (parent) reported that a 16-year-old male patient received bnt162b2 (COMIRNATY) via an unspecified route of administration on 11Oct2021 as DOSE 1, SINGLE for covid-19 immunisation at the age of 16 years old.  The patient medical history and concomitant medications were not reported.  The patient experienced nausea on 11Oct2021 with outcome of unknown and fever, it is at 104 and it kind of went down but it is going back up, lower back pain and body aches, above on Oct2021 with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 104 on Oct2021.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Information has been received from a pharmacist concerning several female patients experienced burning sensations while receiving GARDASIL with lot number 660620/0571X. No further information is available. The patients were seen by a nurse.
Information has been received from a registered nurse who on unspecified date developed shingles like blisters from giving ZOSTAVAX to patients. She had little blisters on her hands. As of 17-Dec-2008 the outcome was unknown. No further information is available.
Pregnancy; Initial Report Received on 05-Aug-2019  This report was received from the HEPLISAV-B Pregnancy Registry.  A women's clinic reported to a representative that "a couple" of pregnant female patients were administered HEPLISAV-B (hepatitis B vaccine) likely within the last month.    The pregnancies were reported to the registry by the representative.    At the time of the report, no adverse events were reported.   The action taken with HEPLISAV-B was unknown.   Additional information is pending.   Company comment: The company assessed the event of pregnancy as non-serious. The event of pregnancy is unlisted per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of pregnancy as non-serious. The event of pregnancy is unlisted per HEPLISAV-B USPI.
Hemolytic flares; This is a literature report.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "classic PNH" (ongoing). Concomitant medication(s) included: RAVULIZUMAB taken for paroxysmal nocturnal haemoglobinuria. The following information was reported: HAEMOLYSIS (medically significant), outcome "recovered", described as "Hemolytic flares". Therapeutic measures were taken as a result of haemolysis.; Sender's Comments: Based on the temporal association, a possible contributory role of BT162B2 to the event Hemolysis cannot be 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.  ,Linked Report(s) : US-PFIZER INC-202101854207 same article, different patients/events
Teammate had vaccine 9/19/23. On 9/20/23 had general achiness in joints, neck and shoulders. On 9/21/23 woke up with redness, swelling, and tender to touch site just below injection site.  Area measures approximately 3x4 inches.  Teammate does not feel needs to seek medical care at this time.
pt recvd 1st dose of Hep B vax on 29JAN92 & w/in 10 mins exp dizziness, nausea, & was noted to have a staggering gait; sx lasted 1 hr & resolved spontaneously;
Headache, Nausea due to dizziness, whole head, cheek bones and ears like sinus infection Narrative:
Information has been received from a physician concerning a 57 year old white female with no known drug allergies or medical history who on 10/15/03 at 10:00 Am was vaccinated in the right deltoid with a second dose of hepatitis A virus vaccine inactivated (lot # 643456/0701M). There was no illness at the time of vaccination. The reporter indicated that the patient has since developed pain and redness at the injection site. No other symptoms were reported. Unspecified medical attention was sought and on treatment was required. A product quality complaint was not involved. Follow up information was received from the physician which indicated that on 10/16/03 the patient developed local swelling and induration. No diagnostic tests were performed. The patient recovered on 10/23/03. It was also noted that the patient had no adverse events following prior vaccination. No further information is expected.
HIGH BLOOD PRESSURE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: low blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced high blood pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of high blood pressure was not reported. This report was non-serious. This case, from the same reporter is linked to 20211012327 and 20211011386.
Case number PHEH2014US022834, is a combined initial and follow up spontaneous report received from a nurse on 11 Nov 2014 and on 14 Nov 2014, with a follow up received from a nurse on 22 Dec 2014. This report refers to a patient of unknown demographics. Past medical history and concomitant medication were not reported. On an unknown date between Aug 2014 and 10 Nov 2014, the patient was vaccinated only with the liquid component (MenCYW) of MENVEO (batch number: A14025) without being reconstituted with MenA powder via intramuscular route into the deltoid. No adverse reaction was reported following this administration error. Follow up received form a nurse on 22 Dec 2014: updated site of vaccination and reporter comments.
Husband also tested positive and he has received the Pfizer booster; Husband also tested positive and he has received the Pfizer booster; He received Pfizer's two boosters and he got first two dose with Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 52-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in arm and as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), in arm and as dose 2, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Husband also tested positive and he has received the Pfizer booster"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "He received Pfizer's two boosters and he got first two dose with Moderna". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
shortness of breath; chest discomfort; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A child 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: DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "chest discomfort".  Additional Information: It was reported that, Patient #2 was not vaccinated by this office but child reported shortness of breath and chest discomfort following vaccination for Covid. Country of Occurrence: PRIVATE, Event took place after use of product.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
HEART STOPPED; This spontaneous report received from a consumer concerned a 33 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient had history of obesity, enlarged heart, and heart issue. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered 1 in total on 23-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 05-APR-2021 (13 days after vaccination), the patient's heart stopped. Patient's mother also received the shot on same day. She was told that his son's heart stopped. She wanted to know if vaccine was not safe for obese persons or people with heart issues. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died as his heart stopped on 05-Apr-2021. This report was serious (Death).; Sender's Comments: V0:20220139574-COVID-19 VACCINE AD26.COV2.S- Heart stopped This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
After 2nd dose of the vaccine presented swelling of the Rt hand that still continues and also persistent pain on both knees.
Expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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 concerns a patient, unknown age and gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after unspecified dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient, unknown age and gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after unspecified dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
This spontaneous case was reported by a health care professional and describes the occurrence of PALPITATIONS (Heart started racing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PALPITATIONS (Heart started racing). At the time of the report, PALPITATIONS (Heart started racing) 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.
I had a breakthrough of COVID-19, I couldn't breathe, horrible dry cough, fatigue, high fever, turning colors. I had to go the hospital and also received breathing treatment, steroid injections and antibody infusion.
Seen at approximately 3:30pm for PE. DTaP, HIb and Prevnar given at 8:30pm he had twitching of body and lips, eyelid, eyes rolled up, "gagging" (no vomiting," "staring" lasted five minutes then better for 5, then another 3 min episode. Color always normal. At ER sepsis was negative, T102, sent home PE today 07/03/02 normal. Left thigh seems to hurt.
24 hours after injection site sore and warm  this is 4 days later still feel it
severe aches and pains in muscles and joints; severe aches and pains in muscles and joints; it hurt to pee; in tears from the pain; throwing up; This is a spontaneous report from a contactable consumer (patient). A 15-year-old non pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0168, Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 25Jun2021 at 10:00 (at the age of 15-year-old) as a single dose for covid-19 immunisation at Center. The patient had no medical history and no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included Colecalciferol (VITAMIN D), birth control and anti-depressant medications received within 2 weeks of vaccination. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8736, Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 04Jun2021 at 10:00 (at the age of 15-year-old) as a single dose for covid-19 immunisation. The patient was fine at first from the day of vaccination, on 30Jun2021 at 07:00, (after 5 days of vaccination) she started having severe aches and pains in muscles and joints. No one could touch her. She thought it was the vaccine and then she mentioned that it hurt to pee. Patient was taken to urgent care to rule out UTI infections, which they did and then referred her to the E.R (emergency room) because no one could touch her. She was in tears from the pain, and she was also throwing up. Patient received pain medications through an IV (intravenous) and anti-nausea medication as a treatment. The events resulted in emergency room/department or urgent care. The reporter assessed the events as non serious. The outcome of the events was not recovered.  Follow up needed, further information has been requested.
Patient experienced localized redness that spread distally from the injection site on patients right deltoid.  Patient also experienced minor localized pain at injection site.
A male consumer reported that he contracted the most severe case of flu virus that he has ever experienced after being inoculated with the vax. This time the malady was not only the most painful, it affected his eye sight and lasted 17 days. Within hours of the onset of the virus, his eye sight was reduced to the point where he could not see any features of his face in the mirror. His eye sight gradually improved, but not to the condition which it was prior to the onset of the virus. He now finds it very difficult to read, write, drive, watch television and/or perform other functions which were not a problem before this incident.
Pt reports she noted area itchy, red and warm day after injection. Area very painful.  Examination by provider notes this to be an allergic reaction.
Complaint of cough, elevated temperature, sore/scratchy throat, headache, runny nose/congestion, and nausea/vomiting.
Received Wed 8/26/09 fever next day. Friday - rash, splotches 3-4" across, worse, chills spreading.  Saturday & Sunday - hives upset stomach Saturday.
Pt developed fever, "funny breathing", and was seen in ER the following day, post vax. Pt was given Rocephin 500mg and dx'd as viral syndrome.
Pt had concern of reactions to vaccines Pt. called office at 5:00pm 3/18/21. Pt stated feeling dizzy, weakness, chills, and diarrhea. Pt stated symptoms started at 2:00pm. Pt stated he was feeling better now. Pt stated he had 3 eps. of diarrhea. Last med was at 11:00am. And he only drank 2 bottles of water. Pt temp was 97.4. Pt. was advised to drink plenty of fluids. Consulted w/ provider. I followed up w/ pt 3/22/21 @ 12:49 pm Mom stated pt is doing just fine and stated, my son told me the next day (3/19/21) mom I am feeling much better. No fever, no more diarrhea. Mom was advised to call w/ any questions or concerns
UNABLE TO LIFT WITH LEFT ARM; BODY ACHES; MUSCLE SPASM; DIFFICULTY CONCENTRATING; SEVERE LEFT ARM PAIN; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included ptsd, and concurrent conditions included osteoporosis, gluten allergy, non-smoker, and abstains from alcohol, and other pre-existing medical conditions included no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and expiry: 25/MAY/2021) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: cannabidiol, and paracetamol. On 17-MAR-2021, the subject experienced unable to lift with left arm. On 17-MAR-2021, the subject experienced body aches. On 17-MAR-2021, the subject experienced muscle spasm. On 17-MAR-2021, the subject experienced difficulty concentrating. On 17-MAR-2021, the subject experienced severe left arm pain. On 17-MAR-2021, the subject experienced chills. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021, the subject experienced fever. Laboratory data included: Pain scale (NR: not provided) Described pain 12/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 22-MAR-2021, and headache on 26-MAR-2021, was recovering from body aches, muscle spasm, and difficulty concentrating, had not recovered from severe left arm pain, and the outcome of unable to lift with left arm was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious
Pt. developed area of red, hard area on the underside of the same arm that recieved Flu and Shingles vaccine.  Needed to be treated for cellulitis.  Improved over 3 days of treatment.
Pt states hand hurts 3 days after administration, just reported today 10/5/23, patient states taking an OTC pain reliever for the pain, she is not sure if immunization was given near a nerve
Information has been received from a nurse who reported that she received an email from a former employee of theirs, who stated in the email that "a high school student received one or more doses of GARDASIL and after vaccination the patient experienced severe migraines/headaches and then had to hospitalized because the patient also had to have a venous port put in her because her veins kept collapsing". The email did not mention how long the patient was in the hospital or any of the hospital information. Attempts are being made to verify the existence of an identifiable patient. Additional information is not expected.
First vaccine increased asthma symptoms saw PCP. Second vaccine, chest tightness, productive cough, chills, fatigue, congestion
I experienced itching at injection site; I experienced redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (I experienced itching at injection site) and VACCINATION SITE PRURITUS (I experienced redness at injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (I experienced itching at injection site) and VACCINATION SITE PRURITUS (I experienced redness at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (I experienced itching at injection site) and VACCINATION SITE PRURITUS (I experienced redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The relevant concomitant medications were also not provided.  No treatment information was provided.
10:30 PM Saturday OCT 9, I woke up with extreme pain and pearlized on the left side, leg, knee, hip. At 2:30 AM Sunday OCT. 10 I awoke again with Massive Pain, completely pearlized on left side.  A few days later the massive pearlized condition lessened but my low back hurt constantly and I could no longer stand up straight. I saw 5 doctors over the next month or so. I can no longer walk more than a couple hundred feet, I can not stand for more than a minute or so without horrible pain.  The first doctor I saw was a knee doctor.
This spontaneous report as received from a newspaper via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot#, dose, frequency and indication not reported). The representative reported that there was an article on the front page of the newspaper "today"(07-NOV-2013). She reported that the article talked about how GARDASIL caused two sisters to have premature ovarian failure. The outcome of the event was unknown. The case captured one of the two sisters, the other sister was captured in the case(1311USA003897). This is one of several reports received from the same source. Additional information has been requested.
Knot in arm at site of injection; size of small fist, no fever, no redness c/o soreness at site. Client went to school 12/01/08 still swollen 4 days post Imm. Client reports it feels better today. This information was collected in a series of phone calls today;We have not actually seen the client. Mother was to bring him after school but they didn't come today.