chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen eyelid; Itchy rash; Diarrhea; This spontaneous report received from a patient concerned a 60 year old female. 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, intramuscular, batch number was not reported) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis, and psoriatic arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced swollen eyelid, itchy rash, and diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itchy rash, diarrhea, and swollen eyelid. This report was non-serious. This case, involving the same patient is linked to 20220307008.
Developed multiple joint pain within 24-48 hours post injection.  The right shoulder, right hip, both knees, and thumbs were involved.  All pain resolved with Motrin within a week except for the right hip and shoulder pain.  The right hip pain resolved with Prednisone.  The right shoulder pain also resolved with this, but returned shortly after discontinuing the prednisone.
Tested positive for COVID/experiencing difficulty of breathing, disoriented a lot, feels horrible, 2 days ago experienced high fever, sore muscles, and headache/felt bad, 6 days after he felt pain and soreness; Breathing difficult; Disorientation; This is a spontaneous report from a Pfizer-sponsored program through a contactable consumers (one was patient), physician. A 67-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6201) via an unspecified route of administration on 16Feb2021 at single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. It was reported that patient got the 1st dose of the vaccine on 16Feb2021 and tested positive for COVID on 24Feb2021. He was experiencing difficulty of breathing, disoriented a lot, was suffering, and felt horrible in 2021. He says he was sorry he was so disoriented. He confirmed it was the Pfizer COVID 19 vaccine. patient stated 2 days ago he started experiencing high fever, sore muscles, and headache and 5 days later felt bad after vaccine shot. He says after 6 days from having the vaccine he felt pain and soreness and he called his administration health provider and they said for him to get a COVID test and on 24Feb2021 he tested positive for COVID. he was told to quarantine 10 days and take Tylenol, that was all they said. He was scheduled to get the second vaccine on 09Mar2021 at 12:30. The outcome for the events was unknown.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 09-NOV-2012 09:30, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Tongue swelling; flushed with rash right after vaccine; flushed with rash right after vaccine; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tongue swelling and flushed with rash right after vaccine. It was reported that the patient took PREGNAZON after the vaccine and everything calmed but the ER physician that she saw told her to take the it again in the morning and the swelling returned. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within 5 sec after giving shot, child started shaking, unresponsive for 15-30 sec then fainted.
Pt recv vax on 10/31/98; on 11/1/98 pt exp red rash on arms, legs & back w/itching; tx=Benadryl
pt recvd vax & devel t105.6 & sz activity for over 30 mins; pt was treated w/diazepam; blood & CSF cultures were pos for H. influenzae; pt was transported to another facility & died during transport from septic shock & brainstem infarction
fever 102 R 4 hr p/vax given lasted 2 days; high pitched cry for 1 hr; 4 hr p/vax given;
She states that 1 minutes after receiving the COVID vaccine in her right shoulder, she noticed increased pain, swelling, itching, redness at the site of the injection.  She also noticed that her right shoulder became numb and tingly which spread into her upper neck, distal right arm and right lower extremity.  She also endorses numbness of the right side of her face and mouth.  She denies any muscle fatigue or weakness.  She states that after receiving the vaccine she became dizzy and lightheaded upon standing but denies any loss of consciousness.
103 fever and every muscle and joint in my body hurt and I had a headache for 4 weeks. Regular MD said take Motrin. 2 weeks later headache was still there so I went to urgent care and they said my BP was at stroke level 206/165. At that time I was admitted in the ER for 6 hours and given 3 doses of amlodipine 2 5mg tabs and a 10 mg tab. It did not bring the BP down. I was sent home with amlodipine 5mg once a day. About a week later I woke up with no symptoms.  I have been taking it ever since. March 22nd of 2022 I will see my MD and she will tell me if I can come of the medication.
Swollen, red, and hot to touch below injection site. Pt given BENADRYL and using cold compresses area marked and being observed for growth of reaction area.
Nausea, Vomiting, Diarrhea, fatigue, muscle soreness, body aches, headache, small fever
Those weren't frozen; a large bump came up on my neck right side; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 16Aug2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE, lot number:UNKNOWN), dose 2 via an unspecified route of administration, administered in upper right arm on 15Apr2021 10:30 as a single dose for COVID-19 immunization. The patient had no medical history. Concomitant medication included ongoing metronidazole taken for rosacea on face every night. Past drug included BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6204)), dose 1 via an unspecified route of administration, administered in upper right arm on 18Mar2021 12:00 as a single dose for COVID-19 immunization. The patient had no prior vaccinations. A large lump or bubble came upon the patient's neck on the right side on 17Apr2021. She went to the emergency room. It lasted 2min but she was afraid it will come bad again and possibly burst, she was terrified. No treatment was given. She was afraid she would die. She knew this event happened because of vaccine, she had no issues with her heart or other things. She thought she might die that night if it ever happened again, it might burst, she guessed that would kill her. Relevant Tests include CAT scan and other (unspecified) on 19Apr2021 with result they found no blockage from the cat scan. The patient asked if the product really needs to be frozen. Those weren't frozen. While she was waiting in line, she had looked and said that those weren't frozen, they were just taken out, and the facility didn't have freezers. She wondered how they are doing it and were the vaccines still good if it was hot. The outcome of large lump or bubble on neck was unknown.  No follow-up attempts are needed. No further information is expected.
Since receiving the vaccine I have numbness on my side and down my right arm. The numbness goes all the way to my thumb and fingers; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   A 57-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 18Sep2021 at 14:15 (Lot number: Unknown) at the age of 57 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing) and "High blood pressure" (unspecified if ongoing), notes: HBP.  Concomitant medications included: COLCHICINE; INSULIN and LISINOPRIL. Vaccination history included:  Bnt162b2 (DOSE 1, SINGLE, Lot Number: UNKNOWN, Route of administration: Unspecified, Anatomical site: left arm, Administration Time: 14:15), administration date: 26Aug2021, when the patient was 57 years old, for COVID-19 immunisation.  The following information was reported: HYPOAESTHESIA (non-serious) with onset 01Oct2021, outcome "not recovered" and described as "Since receiving the vaccine the patient had numbness on side and down right arm. The numbness went all the way to the thumb and fingers". Therapeutic measures were not taken as a result of hypoaesthesia.  Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The lot number for BNT162b2 was not provided and will be requested during follow up.
approx 30 sec p/vax pt stiffened, rigid-like then arched backward in chair; pt woke up & cried mom states was wringing wet & sleepy afterward; slept on the way to MD;
It only takes 2 second for them to turn positive.; It only takes 2 second for them to turn positive.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: EP6955), on 16Apr2021 as dose 2, single (Lot number: ER8731) and on 03Dec2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "pneumonia" (unspecified if ongoing), notes: He had previous exposure to pneumonia and has weak lungs.; "headache" (unspecified if ongoing), notes: Advil for the headache. Concomitant medication(s) included: ADVIL [IBUPROFEN] taken for headache. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "It only takes 2 second for them to turn positive.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: He had all the vaccines, but had not gotten COVID until now. He lights up the test. It only takes 2 second for them to turn positive. Dose described as: 3 tablets at a time and it says 150 mg of the Nirmatrelvir and Ritonavir 100mg. It comes in a series of 3; 1 Ritonavir 100mg and 2 of the Nirmatrelvir 150 mg each time twice daily by mouth. Other medications provided as only Advil for the headache and he took a antihistamine because he originally thought it was an allergy attack. No further details provided. They were just over the counter ones.  No follow-up attempts are possible. No further information is expected.
This case was reported by a nurse via call center representative and described the occurrence of viral meningitis in a 55-year-old female patient who received SHINGRIX for prophylaxis. On 20th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In December 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, pain in arm and abdominal discomfort. On 26th December 2018, the patient experienced viral meningitis (serious criteria disability and GSK medically significant) and feeling unwell. In December 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the viral meningitis, feeling unwell and abdominal discomfort were not recovered/not resolved and the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the viral meningitis, injection site erythema, pain in arm, feeling unwell and abdominal discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient experienced redness at the injection site. Her arm was also sore for about 3 days. She said that she was expecting these type of side effects so she was not surprised about having them. However, the patient did not feel well and went to emergency room on 26th December 2018 and stayed about 4 to 5 hours at the emergency room and had in the Magnetic resonance imaging (MRI) machine for an hour. They did not know what she was having. The patient received a follow up from the neurologist and she was diagnosed with viral meningitis. The patient did not know if SHINGRIX caused the viral meningitis. However, she had a lot of belly activity and she was incapacitated for several days and she was at the time of reporting not back to herself and could not drive. The patient did not consent to follow-up. The patient did not have a primary care physician.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Nov2021 as dose number unknown, single (Lot number: FH8030) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Polycystic ovarian syndrome" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), all with latency 13 days after the suspect product(s) administration, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jun2022) COVID symptoms again on 02Jun2022, notes: COVID symptoms again on 02Jun2022, namely chills, nausea and dizziness. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient received vaccine. The patient did not receive other medication in 2weeks. Anti-viral details: The patient received Paxlovid for COVID 19 Treatment, treatment start date was 20May2022 and stop date was 24May2022. Adverse event: The patient completed Paxlovid course on 24May2022 and began experiencing COVID symptoms again on 02Jun2022, namely chills, nausea and dizziness. Adverse event start date was 02Jun2022. The patient had not recovered. The patient did not receive ae treatment and had no Known allergies.
States felts dizzy, warm to touch, decrease in LOC.  Ice pack to forehead.  Progressive worsening of LOC.  Epi 0.3 to R thigh.  EMS called @ 1328.  States Allergies of Seafood, Soy, PCN, Oysters, and Peanuts.
Temperature, chills, fatigue, muscle aches, Major Migrane.  I did not for to the emergency room. I went to bed and woke up at 7 am everything was normal expect a small headache and totally back to normal the following day
This spontaneous report as received from a medical assistant via company representative, refers to a 69 year old female patient. The reporter stated that the patient was allergic to latex, amoxicillin, and potassium. There was no information about the patient's medical history provided. On 25-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 dose reported as 1 rod inserted (site, route of administration, lot # and expiration date were not reported) for prevention of pneumococcal disease. Concomitant therapies included the flu shot. On 25-OCT-2017, the patient experienced injection site pain and redness from her left biceps down to her triceps. The patient sought no medical attention. No treatment was given for adverse events. The outcome of injection site pain and injection site erythema was unknown at the time of this report. The relatedness between the events and PNEUMOVAX 23 was unknown. No product quality complaint (PQC) was involved.
infanrix vaccine instead of the boostrix vaccine inadvertently; Inappropriate age at vaccine administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old patient who received DTPa (Infanrix) (batch number GG39D, expiry date 07-JUN-2025) for prophylaxis.   On 05-AUG-2023, the patient received the 5th dose of Infanrix. On 05-AUG-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: infanrix vaccine instead of the boostrix vaccine inadvertently) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-AUG-2023 The reporter was clinic manager. The reporter reported that a patient was administered an infanrix vaccine instead of the Boostrix vaccine inadvertently, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up.
Injected in the right arm.  Woke up this morning to the right underarm lymph node swollen and tender to the touch.  No redness, no rash, not warn to the touch.  Fatigue and body aches also accompany the adverse effects this morning.
pt recvd vax & did not devel a titer p/8wks;MD reported approx 14 patients;pts assigned WAES 95081597 & 95081815 through 95081827;
Day 2, my arm was sore to touch and move around. Day 3 I noticed my arm was starting to itch, and also had a large red blotch on my left arm around the injection spot. it is now day 5 and the red blotch is still there & itches more than before.
Pt called and spoke to me and explained that her arm had turned red and hard from the injection site down towards the elbow and was about 4 inches tall, She too said that it then wrapped around to the back side of her arm in that 4 inch strip to where it stopped about midarm.  She said it was warm to hot to the touch, somewhat itchy as well.  Pt said that she was taking Benedryl to try and counter the reaction.  She came in and saw me today and showed her arm to me.  She said it was looking somewhat better than it did yesterday.  She said it was still warm to the touch but not as red today.
Started with fever, body aches, fatigue and headache on 10/12 (all expected), fever broke 10/13, fever returned 10/15, everything returned body aches, fatigue, headache, arm soreness and new leg soreness getting worse, welts developing on body (raised red hard red spots), L eye swelling from a welt, mouth sores developing, finally went into urgent care on 10/18 as symptoms got worse from 10/15-10/18. Only took ibuprofen for medication during this whole time period.  Started taking Pepcid 20mg 2x a day and zyrtec 10mg 2x a day as prescribed by urgent care on 10/18. The fever broke 10/20/20, the eye swelling has decreased, and muscle soreness as decreased, welts are still painful and now itchy.
Bexsero exposed to RT 22 C (72 F) for 53 hrs, 12 min and administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number 5P2P7, expiry date 31-JAN-2026) for prophylaxis.   On 04-AUG-2023, the patient received the 1st dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Bexsero exposed to RT 22 C (72 F) for 53 hrs, 12 min and administered to a patient). The outcome of the incorrect storage of drug was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Receipt date: 10-Aug-2023 Clinical director assistant stated that Bexsero dose was exposed to room temperature 22 C (72 F) for 53 hours, 12 min and administered to a patient. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up via email. The patient received a dose of Bexsero after temperature excursion, which led to incorrect storage of drug.
Debilitating spine pain for the first 5 days and now into the second week debilitating headaches that come and  linger for hours.  Note: this is very concerning, he has never had headaches.
Pt recvd 3 doses of Engerix-B vax & 21NOV91 it was determined that pt did not respond to the vax series;
Patient  With numbness and tingling of her lips, tongue, palate.  Increased BP Clammy sweating
Swollen, red, painful to the touch, hot to the touch  muscle at injection site 8 days after injection. Being treated as cellulitis with antibiotics.
Client vaccinated and 7:15pm on 1/7/21. Symptoms began 06:00 on 1/8/21. Symptoms included severe chills, nausea, dry heaving, temp 102.4, severe joint pain, shortness of breath, headache, fatigue. Client alternated between Tylenol and ibuprofen.
Red, swollen left upper arm where injection was given.  Site is also warm, hardened and itchy/uncomfortable to touch.
Fellow employee called for client complained of dizziness, arm pain and feeling like she could pass out. Went to smoke cigarette - heart rate increased, nausea, and lightheadedness. Advised to call police to evaluate. Tylenol or Ibuprofen for sore arm. Suggest ER.
Awaken middle of night (3:10a.m.)  with pain at injection site.  Early morning (5 ish) started with aches in joints, progressed to serious pain across shoulder, neck, down arms, hands and back with chills and fever (100.3).  By later afternoon vomited.  Felt better by 7 a.m. the following morning.
He passed out while waiting 15min after receiving the vaccination. Pt. was pale and clammay.