chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He had normal site pain and swelling which was no big deal. It wasn't as bad as the second time.; He had normal site pain and swelling which was no big deal. It wasn't as bad as the second time.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 23Apr2021 (Lot number: EN5318) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "knee issues" (unspecified if ongoing); "degeneration in her joints" (unspecified if ongoing); "torn rotator cuff" (unspecified if ongoing). Concomitant medication(s) included: DULOXETINE (ongoing). Vaccination history included: Bnt162b2 (First Dose, Lot number: ER8734.), administration date: 02Apr2021, when the patient was 42 years old, for COVID-19 Immunization, reaction(s): "Pain in arm ". The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 2021, outcome "unknown" and all described as "He had normal site pain and swelling which was no big deal. It wasn't as bad as the second time.".  Additional information: The report was not related to a study or programme. She got Pfizer BioNTech for the first two in the series six months ago. She had normal site pain and swelling which was no big deal. It wasn't as bad as the second time. She got her six-month booster on 29Nov2021 in the left arm muscle of shoulder. The first times it was given, and she had the same nurse both times. Caller thought it was done in the right arm, but she was not 100 percent positive. She knew they notate it in their system. The first was six months ago, so she is not 100 percent sure which arm it was given in. The difference between the first two times was caller didn't ice the arm. This time she iced the arm.
don't feel very good either; have a headache but not throwing up; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (don't feel very good either) and HEADACHE (have a headache but not throwing up) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 05-Jun-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Jun-2023, the patient experienced FEELING ABNORMAL (don't feel very good either) and HEADACHE (have a headache but not throwing up). At the time of the report, FEELING ABNORMAL (don't feel very good either) and HEADACHE (have a headache but not throwing up) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.   Reporter did not allow further contact
Information has been received from a nurse concerning an unidentified patient who was vaccinated with a dose of PNEUMOVAX. It was reported that the patient has had swelling and redness at the injection site after PNEUMOVAX was given. It was also reported that the patient developed a "local reaction". No further information was reported from the caller. This is one of two reports from the same source. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of hive in a 9-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 21 February 2011 the subject received unspecified dose of HAVRIX (unknown). That same month, at an unspecified time after vaccination with HAVRIX, the subject experienced hives. At the time of reporting the hives were worse. Follow-up information was received on 09 March 2011 via healthcare professional who reported on 21 February 2011 the subject received 1st dose of HAVRIX pediatric (.5 ml, intramuscular, left deltoid). The nurse reported the hives experienced by the subject was an allergic reaction. The immunization series was discontinued. The nurse reported the allergic reaction resolved on "29" February 2011.
Small dime size red itchy spot on 1/23, increasing in size to approximately 3 inches by 2 inches until 1/27, faded on 1/28
Information has been received from a consumer who reported she knew of two people whose kids on an unspecified date were vaccinated with MMR II. Subsequently, the patients became autistic. No further information provided. Upon internal review, became autistic was determined to be an other important medical event. This is a hearsay report. Attempts to verify the existence of an identifiable patient have been unsuccessful. This is one of several reports received from the same source. Additional information is not expected.
Temperature; cold chills; headache; tired; sore arm; nausea; vomiting.
This spontaneous report has been received from a Licensed Vocational Nurse (LVN) referring to unspecified number of patients. On unknown dates the patients were vaccinated with an improperly stored dose of MMRII (dose and route not reported, lot# K001231, expiration date 27-JAN-2016, lot # L012479, expiration date: 10-APR-2017, lot# K024035, expiration date 26-NOV-2016). No adverse event. This is one of several reports from the same reporter. Additional information has been requested.
Pt describes immediate right arm numbness and inability to move entire right arm "feels heavy". Right arm movement resolved after 20 minutes.
couldn't even get a blood pressure reading because it was so low; got very weak and sick; got very weak and sick; could catch her breath her body was shutting down; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received BNT162B2, via an unspecified route of administration on 11May2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 21May2021 (ten days to the day of taking the shot), the patient got very weak and sick. Her fiance had to call emergency medical service (EMS), because she could catch her breath her body was shutting down and the EMS couldn't even get a blood pressure reading because it was so low. The doctors trying to tell her it wasn't the shot, she took a total parenteral nutrition (TPN) 12 hours a day and hadn't changed anything. The patient was trying to figure out why the doctors were trying to lie about these shots and pushing everyone to get it. What she would like to know was they getting a kick back from all this and just didn't care what happened to the patients and could less if patients die or get deathly sick like her. The outcome of all events was unknown.  Information on the lot/batch number has been requested.
Contacted by this patient that she had received her first dose of Moderna. On day two post vaccination red rash started at elbow and then began to work its way up her arm and across her chest. Rash was itchy. She notified her Oncologist when the rash began. No urgent medical treatment given.
p/vax pt noted sharp shooting pain from site of inj; (lt tricep area) to lt shoulder; also noted some subjective weakness in lt arm & shoulder
Within 5 minutes of injection, seated for 15 minute watch period, I felt nauseous, followed by lightheadedness, racing heart, felt like I couldn't get enough air, and slight tightness in my chest, and was concerned I was going to pass out / fall off of my chair. I was double masked, and removed one mask to get more air. No medications were administered to treat the adverse event. After about 7 minutes, symptoms started to subside. Within 20 minutes was mostly back to normal, but was nauseous the remainder of the day.  Stayed for a 30 minute watch period.   Upon returning home, within 1 hour of receiving vaccine, first I felt like I was getting the flu, and took a Sudafed. Then I was exhausted and could not keep my eyes open, and slept for 3 hours. No recurring symptoms that evening or the following day.   Injection site became very sore about 24 hours after injection, with minimal heat emanating from skin. Soreness changed to tenderness in 2-3 days, and completely subsided within 4-5 days. Took Tylenol and Alleve for soreness.
suspected vaccination failure/both shots and he has shingles; shingles on his head and forehead and around his eye; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details provided were as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient took both shots and he had shingles on his head and forehead and around his eye.  On 25th October 2021, the patient was taken to the doctor and they gave him medication to help dry it up. Follow-up would not be possible as not contact details available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
pt recvd vax; pt devel sore throat, watery eyes &sneezing; pt devel a rash on both arms;
After about 10 days and airy about 4 inches in diameter started itching and felt hard. No real pain just irritation and heat.
IT HAS BEEN NOTHING BUT PROBLEMS; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced it has been nothing but problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of it has been nothing but problems was not reported. This report was non-serious.
Within 24 hour period, arm hard around injection site and warm to touch. Swollen too. Advised to go see doctor. Patient called today on 9/19/14.
Patient reported waking up with arm soreness at 2:30am.  She got out of bed to get a pain reliever, felt lightheaded and passed out. She woke up and passed out again, but feels fine now.
This spontaneous report was received from a male patient of unspecified age reporting on himself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23, injection (dose number, exact dose, route of administration, administration site, lot # and expiration date were not provided) for prophylaxis. It was reported that the patient had an unspecified extreme reaction to PNEUMOVAX 23 and almost died. The outcome of the event was not provided. The reporter considered the event to be related to the suspect therapy.
felt fever sl dizziness w/in 30 mins of inject lt arm stiffness & soreness 2 hrs p/inject; small bumps pin size in shape in various locations; sl reddness to bumps, itching;
vial was first punctured on 11Feb 2023 and administration of vaccine on 14Feb2023; No adverse event; Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), PRODUCT STORAGE ERROR (vial was first punctured on 11Feb 2023 and administration of vaccine on 14Feb2023) and NO ADVERSE EVENT (No adverse event) in a 45-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     Patient's health history was unknown. It was reported that there was no diagnosis. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 14-Feb-2023 at 5:15 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 14-Feb-2023 at 5:15 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was first punctured on 11Feb 2023 and administration of vaccine on 14Feb2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), PRODUCT STORAGE ERROR (vial was first punctured on 11Feb 2023 and administration of vaccine on 14Feb2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (vial was first punctured on 11Feb 2023 and administration of vaccine on 14Feb2023).    No concomitant medication were reported.  Facility administered a vaccine more than 12 hours post puncture to a patient. The vaccine was punctured on 11-Feb-2023 and was in refrigerated storage. Bivalent vaccine 6yrs and older. Individual vial of 5.5 mL. The vial was initially stored in the refrigerator on 11-Feb-2023. The vial was first punctured on 11-Feb-2023 at 9:06 PM. The vial was stored in fridge post puncture. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range for more than 12 hours. No treatment information was provided by the reporter.
A physician reported a pt received vaccine on 7/11/00 and subsequently developed induration at the injection site. The child's previous dose of Tetanus toxoid was administered when the child was two years of age. Additional info received on 03/01/2001 from the reporter provided the pt's date of birth, county of administration, recovery status, product lot number, concurrent illness, and concomitant medication. The reporter noted that at the time of immunization the child received Tetanus and Diphtheria toxoids adsorbed, Ultrafined,a nd that he was suffering from allergic rhinitis for which he was prescribed Dimetapp. The child recovered from the event.
Patient completed 2-dose Pfizer series on 1/31/21 and passed away on 2/13/21.  Pt presented to ER on 2/11/21 with SOB, weakness, diffuse abdominal pain and diarrhea that started that day.  Pt tested positive for COVID and was transferred out to a higher level of care.  1st dose: 1/5/21, 2nd dose: 1/31/21
There were not any adverse effects. Patient received a second bivalent booster of pfizer after receiving one at her doctors office back in september. Per guidelines, you are only to received one bivalent booster. At the time of injection, mom didn't realize her daughter received the booster already and gave consent for us to inject.
rash generalized on head, face, hands, trunk & feet 11 days post vax; bilat conjunctivitis;
This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced pain in extremity (sore arm), onset 2021, with outcome of recovered (2021). No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-202101031523 same reporter/drug/event, different patient. US-PFIZER INC-202101031524 same reporter/drug/event, different patient. US-PFIZER INC-202101029522 same reporter/drug/event, different patient.
hand numbness Narrative:  Employee reports experiencing "mild numbness of my left hand" within minutes after receiving second dose of COVID-19 vaccine. Reports has fully recovered without use of medications.
cried repeatedly for 10 hrs did not want to be moved or touched swelling & redness on & off; taken to ER no treatment given x/APAP;
Pain at injection site immediately. Went to library - 12 in library felt shaky, crying, ht racing, lightheaded and hyperventilating upon arrival. Rested 1/2 hour - given Gatorade and felt better.
Body aches, nausea, dizziness, weakness lasting, pain at injection site, stomach upset lasting about 36 hours.
Breakthrough case COVID-19 after fully vaccinated with 2  doses of Pfizer.
Right ankle was itchy and round, red patch and grew larger. In the following week a second patch appeared with the same itchy feeling.
Patient is an incomplete quadriplegic due to a spinal cord injury over 16 years prior.  After the first injection on 07/18/2021, patient noticed increased sensation of numbness and tingling in the outer half of the left hand (including the two fingers farthest from the thumb).  The sensation seemed to lessen after a few days; but, did not completely dissipate.  After the second dosage, the sensation returned and patient experienced additional loss of muscle strength and control in all fingers of the left hand.  To date, patient's strength and muscle control remains lessened causing increased quality of life impairment.  This includes a further diminishment in typing ability which is affecting work quality.
Death.  My father-in-law was found unexpectedly deceased in his home Saturday morning.  He worked the previous day.
Chills, fever, body aches, headache started about 12 hours after injection. About 24 hours after injection I developed a rash and swollen lymph nodes on the arm the shot was given to me
Patient received first dose of Modera Covid vaccination and was not eligible. Patient returned to receive second dose vaccine and upon assessment , it was acknowledged that the first dose vaccine should not have been administered. Mother of the patient informed and made aware of the eligibility criteria and that based on that criteria, we would need to deny the second vaccine administration. Mother instructed to discuss with patients pediatrician.
Chill; Low fever; My heart started to race and felt dizzy within 5 min. of the vaccine on 28Feb; blood pressure 190 over 100; My heart started to race and felt dizzy within 5 min. of the vaccine on Feb 28; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: lot/batch number: unknown) on 28Feb2021 at 12:00 pm in the right arm as a single dose for COVID-19 immunization. The patient's medical history included breast cancer 1999, lung cancer 2012, allergies to fire ant bites, penicillin, sensitive to EPI. The patient's concomitant medications were not reported. Patient's other medications four weeks prior vaccination was none. Other medications in two weeks prior vaccination included: alendronate70, levothyroxine88, rosuvastatin5. The patient stated that her heart started to race and she felt dizzy within 5 minutes of the vaccine on 28Feb2021 at 12:00 pm, blood pressure was 190 over 100 (came down to 140 after about 20 minutes). The patient stated that on 04Mar2021, around 3:30am the same happened again. The patient stated that her heart was pounding faster than 1st time and blood pressure went up to 200 over 115. The patient stated that she went to ER and her blood pressure came down to 140 after 2 hours. The patient also stated that she had a similar episode on the evening of 04Mar around 10:30, 170 over 97, accompanied by chill and low fever. The patient confirmed that she had not prior history of high blood pressure. The patient did not receive any treatment for the events. The outcome of the events was resolving.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
cough, wheezing, worsening SOB, hospitalized next day at a local HCF/ passed away
Developed a large increase in joint pain that has now continued for 4 weeks. This has never happened with previous flu shots over the past 5 years. Reported this to my primary care physician.
Nurse administered COVID Vaccine #2 @ 14 days after dose #1.  EDD: 10/18/21
Tiredness; painful swollen lymph nodes/lymph nodes on base of her neck started to become swollen and tender; injection site soreness; painful swollen lymph nodes/Lymph nodes on base of my neck started to become swollen and tender; kind of a side effect it was worst; my right deltoid is really very sore and my neck has really become sore.; my right deltoid is really very sore and my neck has really become sore.; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Brand=Pfizer; lot number: EL3248) via an unspecified route of administration at right arm on 13Jan2021 at 09:15 AM at a single dose for COVID-19 immunization. Medical history included hypertension. No known allergies. No other vaccine in four weeks. Other medications in two weeks included hydrochlorothiazide/losartan potassium (LOSARTAN/HYDROCHLOROTHIAZIDE), pantoprazole sodium sesquihydrate (PROTONIX), multivitamins/plain (reported as MVI), biotin, docusate sodium (COLACE), Adde (to be clarified). The patient was not pregnant. Facility type vaccine was at Hospital. No COVID prior vaccination. No COVID tested post vaccination. The patient experienced adverse events included tiredness, painful swollen lymph nodes, injection site soreness; all with start date on 13Jan2021 and with outcome of not resolved. No treatment received for events. It was also reported right deltoid had been sore, lymph nodes on base of her neck started to become swollen and tender; kind of a side effect it was worst, and neck had really become sore; all on 13Jan2021 and with outcome of unknown. The patient stated she had the vaccine on 13th and her right deltoid had been sore. Yesterday (15Jan2021) her lymph nodes on base of my neck started to become swollen and tender, she knew it's a kind of a side effect but it was worst today than it was yesterday and she just wanted to know how long those side effect last because her right deltoid was really very sore and her neck had really become sore.
Child screamed and cried for two full days without sleep and then slept for two full days. When doctor was contacted and said as long he isn't seizing there is nothing to worry about.
On 5/5/2019, five days after receiving the 1st injection of Gardasil 9, and lasting several months, patient had several bouts of feeling faint, heart racing, light-headedness, brain fog, nausea, numbness in hands and feet, hot & cold flashes, dizziness, abdominal pain.  Saw Pediatrician several times.  She did EKG, bloodwork, stool.  Saw cardiologist at hospital.  She did EKG, etc. and diagnosed vasovagal syncope.  Saw ER doctor at hospital.  She did EKG, etc. and diagnosed POTS.  ER doctor also said Gardasil could very well be the reason patient has been experiencing these symptoms.