chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No other adverse events reported.; An expired dose of GARDASIL 9 was administered to a patient yesterday.; This spontaneous report was received from pharmacist and refers to a patient of unknown gender and age.  The patient's medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 16-JUN-2022, the patient was vaccinated with an expired HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)  (GARDASIL 9) injection, one dose, administered as prophylaxis (lot number 1621926 which has been verified to be valid, expiration date reported and validated as 28-NOV-2021) (strength, dosage, route of administration and anatomical site of injection were not reported) (expired product administered).   Also, the reporter mentioned that the dose was properly stored up through the time of administration. No other adverse events were reported in the patient.
Got shot about 6 pm Friday (19 Oct). Arm sore and stiffness started 2 hours later and got worse all evening. I made a point of moving the arm around. Saturday morning (12 hours after injection) woke up with painful arm, fever and lethargy. Took aspirin for the pain, applied a heating pad for the arm, and stayed in bed/on sofa for the lethargy. Injection site was slightly swollen and red, No rash. No nausea, but little appetite. By Saturday evening (24 hours), arm pain was diminishing. Sunday morning, (36 hours), arm was sore, no fever, more energy, underarm was sore. Monday morning (2.5 days) arm still slightly sore, no other symptoms. Resumed normal activities. Injection site continued to be sore until Wednesday (5 days).
soreness @ inj site, rash redness (erythema) itching near site;
A pediatricians office assistant reported that an infant rec'd her first dose of Prevnar and a dose of hepatitis B (manufacturer unknown) vaccine on 9/17/01. the following evening, the infant developed a fever of 100.8F (axillary temperature) and experienced irritability. She was treated with tylenol (paracetamol) and seemed better the next morning. On 09/19/01, she developed slight swelling at the injection site. On 09/20/02, her temperature was 100.2 F
Persistent muscular pain with abduction and external rotation of arm. Now going on 3 weeks. No site reaction, however.
ACUTE STROKE OF BRAINSTEM, UNSPECIFIED TYPE AND ARTERY ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS
don't feel well today; nauseous; vomiting; fatigue; sore arm; This is a spontaneous report from a contactable consumer.  A (Age: 65, Unit: Unknown) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot number: unknown), dose 1 via an unspecified route of administration on 23Mar2021 (Tuesday) at 14:30 as 1st dose, single for COVID-19 immunization. No medical and concomitant medication history were reported. On 24Mar2021, the patient experienced a little bit of fatigue and a pretty sore arm. On 26Mar2021, the patient was feeling nauseous and vomiting. Caller stated that he was not really up to filing a report as he was not feeling well and he just wanted to know if this was normal and if it may be related to the vaccine. Caller stated that would be three days or 72 hours since he got the vaccine at 14:30. The outcome of the events were unknown.    No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
stroke like symptoms; similar to migraines; mini-strokes; Passing Out; Blind spots in her vision; Nausea; Believes it effected her memory; stroke like symptoms; similar to migraines; mini-strokes; This is a spontaneous report received from a contactable consumer. A 59-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 16Apr2021 (Lot Number: EW0153; Expiration Date: 31Jul2021) as 1ST DOSE, SINGLE for covid-19 immunisation (Age at vaccination: 59 years).  Medical history included ongoing strokes, ongoing third and fourth Nerve Palsy. Concomitant medications included dabigatran etexilate mesilate (PRADAXA) taken for blood thinner; metoprolol for Stroke, Heart regulation; lovastatin taken for Stroke, Heart regulation. The patient states that she went to the Emergency Room on 17Apr2021 and then went again on either 18Apr2021 or 19Apr2021. The patient states she does not know if she was admitted or not. States that she thinks she just was in the emergency room the time that she was there. Says that after the Covid Vaccine she was having stroke like symptoms; similar to migraines; mini-strokes. She was passing out, had nausea, blind spots in her vision, and she believes it effected her memory. The events occurred on 17Apr2021. Also, she said on her first emergency room visit they did a CT Scan and on her second emergency room visit they did a MRI and both was not reported. States they told her there was no issues. The patient underwent lab tests and procedures which included CT Scan: and MRI: not reported on Apr2021. Outcome of the event vision impairment was not recovered while outcome of the event nausea was recovered on Apr2021. Outcome of the event memory impairment was recovering while outcome of the remaining events was unknown.   No follow-up attempts are needed. No further information is expected.
I had swollen face and lips. I also had body rashes, hives, and welts. I took Benadryl at the time for the symptoms. I fell asleep after that. I didn't take any medication after that for the swollen face and lips because I had to wear mask I knew that would cover it. Symptoms have been reoccurring so throughout the months so I've been seeking medical attention to rule out the point besides the shot.
On approximately 12/19/2022, I went into AFIB, and stayed in AFIB for 4 or 5 days. I came out of it and have been fine since. I told my doctor, because I noticed it on my smart watch.
Received vaccine at 2:30 PM.  By 8:30 PM was beginning to develop these side effects which lasted around 24 hours:                 Headache, body aches (joint, muscles), generally tired and hard to focus. By second morning after vaccine, was back to normal.  No treatment required.
Pt. experienced fever increased to 102 degrees, nausea, syncope, achy joints. Pt. also fainted while showering next day.
Bilateral Rash and itching / burning sensation on hands (reported 20 minutes ago, no treatment / outcome determined yet)
Initial misuse report received from a health care professional (nurse) on 23 October 2013 and the case was received on 21 March 2014 at GPV. A 67-year-old patient (gender was not provided) had received a dose of FLUZONE ID on an unspecified date. No adverse event was reported. List of documents held by sender: none
Fever, chills, muscle aches, lethargy, swollen left supraclavicular lymph node
suspected vaccination failure; diagnosed as shingles on my left arm (underside); blisters that  are very small; bright red patch/spread in a rash; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an 80-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister and red rash. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, blister and red rash were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, blister and red rash to be related to Shingrix.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingrix, the patient's doctor diagnosed with shingles on his/her left arm underside.  The patient reported that, he/she did not have blisters, or if he/she did, they were very small. The patient asked, had a bright red patch on his/her upper under that had spread in a rash. This case was considered as suspected vaccination failure since the details regarding the completion of the primary immunization, time to onset and laboratory test confirming shingles were not provided.
Chest pain; pleuritis; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0158), via an unspecified route administered in right arm on 09Apr2021 at 13:30 (at the age of 55 years) as a single dose for covid-19 immunisation. Medical history included high blood pressure, melanoma stage 2, right lung segmentectomy, and known allergies with penicillin, and latex, were from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. 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. Since the vaccination, the patient has not been tested for COVID-19. The patient received other medications within 2 weeks of vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8727), via an unspecified route administered in right arm on 19Mar2021 at 11:30 (at the age of 55 years) as a single dose for covid-19 immunisation. On 09Apr2021 at 21:00, the patient experienced chest pain and pleuritis. Treatment was not received for the adverse event. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab, PCR/NAAT): negative on 13Apr2021. The outcome of events was recovering.   No follow-up attempts are possible. No further information is expected.
Within 30 mins and possibly prior as I was pre occupied cooking and not paying attention.  Shot received at 12:15pm and I felt heat and itching along with normal vaccine swelling then once in front of a mirror at 1pm I noticed hive above the injection site. on 9/3 the hive was finally dissipating!  Hesitant on 2nd shot as I have other allergies along with fact that I am on hormone therapy for menopause following hysterectomy's
Back pain / Feels like kidney pain; Radiating leg pain; kidney pain; This case was reported by a nurse via call center representative and described the occurrence of back pain in a 58-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 97S5T, expiry date 30th June 2020) for prophylaxis.   On 8th October 2019, the patient received FluLaval Tetra 2019-2020 season. On 9th October 2019, 1 days after receiving FluLaval Tetra 2019-2020 season, the patient experienced back pain, pain in extremity and renal pain. On an unknown date, the outcome of the back pain, pain in extremity and renal pain were not recovered/not resolved.   It was unknown if the reporter considered the back pain, pain in extremity and renal pain to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: This case was reported by the Registered Nurse (RN). The patient experienced low back pain with radiating leg pain. The patient felt like kidney pain. The reporter consented to follow up. This is 1 of the 4 cases reported by the same reporter.
Pt experience injection site soreness, redness and inflammation. Pt also devel swelling around the injection site all the way to the hand.
I went home with the usual pain at the sight of the injection, but stronger than usual.  About 4:00pm a sharp pain flew all the way down my left arm which has not gone away.  I have been taking pain relievers, some aspirin when eating and Acetaminophen at night,  So many movements hurt me furiously that I have changed my choice of clothes to keep from making certain movements.  There are many movements I try not to make anymore.  By doing this I am able to enjoy most days without much pain, but night time is difficult because there is not really a comfortable position to get a lot of rest.
Got flu shot yesterday morning, this morning arm was sore noticed red place larger than a quarter called it to attention of case worker who called the clinic red swollen warm area 5 1/2cm x 5cm at site of flu shot on L arm.
chills; fever; headache; Patient received first dose of vaccine on 12Jan2021 and received second dose of vaccine on 24Feb2021; The initial case was missing the following minimum criteria: [No specific adverse event reported on second dose of vaccine]. Upon receipt of follow-up information on [02Mar2021], this case now contains all required information to be considered valid.   This is a spontaneous report from a contactable consumer or other non hcp (patient). A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via intramuscular, administered in Arm Left on 24Feb2021 at 12:30 (Batch/Lot Number: EN5318; Expiration Date: May2021) as dose 2, single for covid-19 immunization (at the age of 58-years-old). Medical history included ongoing hypertension, ongoing Vitamin B12 deficiency, Vitamin D3 deficiency and herpes zoster from 31Jan2021 to 15Feb2021. Concomitant medication(s) included metoprolol and hydrochlorothiazide both were taken for hypertension from 2018 and ongoing and cyanocobalamin (B12 [CYANOCOBALAMIN]) taken for Vitamin B12 deficiency and colecalciferol (D3) taken for Vitamin D3 deficiency both from an unspecified start date and ongoing. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via intramuscular, administered in Arm Left on 12Jan2021 at 13:30 (Batch/Lot Number: EL0140) as single dose for covid-19 immunization (at the age of 58-years-old) and experienced shingles and soreness at site. It was reported that the patient received first dose of vaccine on 12jan2021 and received second dose of vaccine on 24feb2021 and experienced headache on 24Feb2021 and chills and fever on 25Feb2021. The patient had not received any treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test which was negative on an unspecified date (bi-weekly at Nurshing home always negative). The patient was recovering from the event headache and was recovered from the events of chills and fever in Feb2021.  No follow-up attempts are possible. No further information is expected.
BLOOD CLOTS AND DEVELOPED A FIBER; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethic origin. 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 s (dose number in series: 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The patient stated that "I got J and J covid shot. Ended up in ICU for 8 days with blood clots and developed a fiber which is now an on going issue," (Dose number in series: 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots and developed a fiber. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211258481-COVID-19 VACCINE AD26.COV2.S-blood clots and developed a fiber . 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).
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (moderate to severe).   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. In February 2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.    Concomitant medication of the patient was not reported.  Formulation of Humira (adalimumab) was reported as solution for injection in pre-filled pen.  On 11-Nov-2021, the patient received the booster dose (1 in 1 once) of Moderna COVID-19 vaccine via intramuscular route. It was unknown if the patient was enrolled in COVID-19 Vaccine trial. No treatment information was provided by the reporter. Causality for Humira (adalimumab): The reporter's causality for the event(s) of headache was not provided.
Information has been received from a pharmacist concerning a female patient who "not recently" was vaccinated with a first dose of Pneumovax 23.  Subsequently the patient "got a little sick".  Unspecified medical attention was sought.  It was reported that the patient recently received another dose of Pneumovax 23, and had no problems.  No further information is available.
The patient did not experience any symptoms; one dose of pediatric V AQTA was inadvertently administered to a 5-week old infant; This spontaneous report was received from a medical assistant and refers to a 5-week-old infant of unknown gender. No information regarding the patient's pertinent medical history, drug reactions, allergies, or concomitant therapies was provided. On 23-JAN-2020, the patient was inadvertently vaccinated with pediatric hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (unit not reported; lot # S007769, expiration date 24-JUL-2020) 1 dose, intramuscularly for prophylaxis. The patient did not experience any symptoms.
Tips of all 10 fingers were numb - pins and needles.  Continued balance of day/night. Next day the bottoms of both feet were partially numb.  By 10/23/09 weakness was spreading into my feet.  At approx. 9:00 PM I began to feel a pain across my back at bra-level in addition to 2" +/- on either side of my bra.  Pain/numbness continued on Saturday and was progressively worse.  My daughter took me to the ER for the 1st of 4 trips before they would finally admit me, still without a diagnosis. I was finally admitted to hospital on the 4th trip to the ER, where they didn't know what to do with me or what was wrong with me.  They finally admitted me with a diagnosis of a UTI for want of a better diagnosis.  I was "housed" on the indigent care floor in mortal pain and being unable to move anything from my toes to my neck.  Luckily, a  PA from the Neurology Dept. happened onto my file and knew instantly what was wrong with me and took the file and later, me to the NIU where I stayed until Nov. 9, 2009.  While in the NIU, a 5-day regimen of IVIG was given to me and slowly my recovery began.  Was moved upstairs to Rehab where I had to learn to walk, stand, write, do household chores, etc.   The paralysis began to subside and after much therapy I was released from the hospital on Dec. 14, 2009.
I was supposed to get a tetanus vaccine, but instead was accidentally given tuberculin (PPD) intramuscularly because my health practitioner was distracted. She did not even notice that she had given me the wrong product. I noticed the bottle and alerted her. I do not know if I will be having any effects because of this. All she could do was apologize. This is malpractice, and so I am reporting it. How can a health professional be injecting a patient without paying attention to what is being injected? I have not been able to get any information on possible effects of the tuberculin.
This case was reported by a healthcare professional and described the occurrence of elevated blood pressure in a female subject aged between 20 and 29 years old who was vaccinated with Twinrix (GlaxoSmithKline). Concurrent medications included low dose MACRODANTIN. On 27 March 2008 at 10:10 the subject received 2nd dose of Twinrix at 1.0 ml in the left arm. On 27 March 2008, 30 minutes after vaccination with Twinrix, the subject experienced elevated blood pressure, facial flushing, hypertonic sensations (defined as shaking and tremors) and tremor. This was considered to be a systemic reaction. The healthcare professional considered the events were disabling and clinically significant (or requiring intervention). The subject did not experience rash or respiratory symptoms. The subject had received her 1st dose of Twinrix 7 days earlier and did not experience any symptoms. The subject denied any nausea or fatigue. The events were indicated as unresolved and probably related to treatment with Twinrix.
Pt. states that after receiving the 2nd dose of Moderna 08/28/2021, started experiencing symptoms 08/29/2021 of severely swollen shoulder from shoulder down to hands. Next day (Herpes) bump back of the left calf still continuing to swell. Also fatigued. Still continuing to experience symptoms.
I lose some weight; I did not know where I was, I was like in a 'twilight thing' / felt like she was in another world; Couldn't hardly walk / could not walk; Couldn't get in and out of bed, couldn't sit in a chair; Wet the bed; Sore arm; I was very sick; Very tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Feb2021 17:00 (Lot number: EL9263) at the age of 82 years as dose 1, single and administered in arm right, administration date 13Mar2021 11:00 (Lot number: EL9264) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Ehlers-Danlos syndrome" (ongoing), notes: has had all her life; "Fall" (unspecified if ongoing); "Fractured left collar bone" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D2 (ongoing). Vaccination history included: Flu shots, reaction(s): "hurts a little where they give the shot". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 19Feb2021, outcome "recovered" (20Feb2021), described as "Sore arm"; DISSOCIATION (non-serious) with onset 20Feb2021, outcome "recovering", described as "I did not know where I was, I was like in a 'twilight thing' / felt like she was in another world"; GAIT INABILITY (non-serious) with onset 20Feb2021, outcome "recovering", described as "Couldn't hardly walk / could not walk"; MOBILITY DECREASED (non-serious) with onset 20Feb2021, outcome "recovering", described as "Couldn't get in and out of bed, couldn't sit in a chair"; ENURESIS (non-serious) with onset 20Feb2021, outcome "recovered", described as "Wet the bed"; ILLNESS (non-serious) with onset Feb2021, outcome "recovering", described as "I was very sick"; FATIGUE (non-serious) with onset Feb2021, outcome "not recovered", described as "Very tired"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "I lose some weight".  Additional information: The patient reported same events happened after both doses. The patient had no additional vaccines administered on same date of BNT162B2. The patient denied any testing, labs, treatments, emergency room, or physician office visits related to the events. The patient had not received any other vaccines within 4 weeks prior vaccination. The patient had sore arm with the second dose of vaccine on 13Mar2021 and recovered on 17Mar2021 and experienced wet the bed after the second dose of vaccine on 20Mar2021.   No follow-up attempts are possible. No further information is expected.