chrisvoncsefalvay/vaers-outcomes huggingface dataset:
if_vaccine_received Yes/vaccine_brand=Pfizer / BioNTech/product=COVID 19 Treatment, brand=Paxlovid; if_vaccine_received Yes/vaccine_brand=Pfizer / BioNTech/product=COVID 19 Treatment, brand=Paxlovid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Cephalexin, reaction(s): "known allergies: Cephalexin", notes: known allergies: Cephalexin.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "if_vaccine_received Yes/vaccine_brand=Pfizer / BioNTech/product=COVID 19 Treatment, brand=Paxlovid". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical information:other medication in 2weeks: No.Covid-19 treatment =Paxlovid  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
itch near the injection site; hardness near the injection site; pain near injection site; swelling near the injection site; red near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itch near the injection site), VACCINATION SITE INDURATION (hardness near the injection site), VACCINATION SITE PAIN (pain near injection site), VACCINATION SITE SWELLING (swelling near the injection site) and VACCINATION SITE ERYTHEMA (red near the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itch near the injection site), VACCINATION SITE INDURATION (hardness near the injection site), VACCINATION SITE PAIN (pain near injection site), VACCINATION SITE SWELLING (swelling near the injection site) and VACCINATION SITE ERYTHEMA (red near the injection site). On 22-Feb-2021, VACCINATION SITE PRURITUS (itch near the injection site), VACCINATION SITE INDURATION (hardness near the injection site) and VACCINATION SITE PAIN (pain near injection site) had resolved. At the time of the report, VACCINATION SITE SWELLING (swelling near the injection site) had not resolved and VACCINATION SITE ERYTHEMA (red near the injection site) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator  Patient put rubbing alcohol on a white tissue and applied it to the area is the treatment medication reported.   This case was linked to MOD-2021-021920 (Patient Link).
Severe hives lasting several days over large portions of legs, trunk,arms,  feet.  Urgent care prescribed Prednisone.  Saw PCP.  Started Zyrtec 2x/day with Pepcid.  Have since weaned to 1 Zyrtec/day but unable to wean off due to intense itching when dose is not taken.
we both got COVID possitive PCRs results.; we both got COVID possitive PCRs results.; minor pain; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that: A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for Covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. The patient experienced We both got Covid positive Pcrs results., Minor pain on 2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date with we both got COVID positive PCRs results. The outcome for all the events was Unknown.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Roughly 48 hours after second dose I started to experience awful ringing in my ears. It was so bad that I was walking around the house looking for the source. Then, I realized it was internal ringing in both of my ears. It seemed to slightly dissipate over months but never truly went away.   I was given a three-day steroid course that had no effect to lessen the ringing. I also saw an audiologist and an ENT who were unhelpful in finding a solution to stop the ringing.   I had experienced pulsatile tinnitus, very infrequently, before the COVID vaccines. My thought is that the vaccines have worked to exacerbate my infrequent tinnitus.   I recently gathered up the courage to get the Pfizer booster (vaccine #3) and the ringing has become worse yet again. Being that the initial ringing, experienced back in March 2021 never fully went away, and now has  become worse, I fear that this could be a permanent side effect of the vaccine and do not believe I will allow any more boosters to be administered. I?m fearful this dreadful ringing will never go away and it was without question exacerbated by the vaccine. It is no coincidence.
Guillain-Barre syndrome - reported to my by his parents one year later when they came to our office to have travel vaccinations.  Patient treated at Hospital in 2011 (September).
PATIENT STATES THEY WERE HAVING AN ADVERSE REACTION IMMEDIATELY AFTER THE VACCINE WAS GIVEN. SHE STATES IT WELTED UP AND WAS VERY SORE AND TENDER TO THE TOUCH. SHE STATED IT FORMED  SCAB AT THE AREA AND STARTED TO PEEL. SHE ASSUMED IT WOULD GO AWAY. NOW, THE WELT HAS GOTTEN SMALLER AND THE SCAB IS SMALLER BUT STILL VISIBLE. THE AREA IS STILL TENDER/PAINFUL TO THE TOUCH.
REDNESS AT SITE AND FLU LIKE SYMPTOMS THAT EVENING AND NEXT DAY.
Patient/employee given the wrong vaccine - given Moderna series vaccine and not the booster as requested/scheduled. This was the patient's 4th round of the vaccine. The patient tolerated the vaccine well and there were no adverse reactions/events.
Strong muscle pain/strong muscle pain that moved around the body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 82 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 25Jan2021 (Lot number: EL9261, Expiration Date: May2021) at the age of 82 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MYALGIA (non-serious) with onset 27Jan2021, outcome "not recovered", described as "Strong muscle pain/strong muscle pain that moved around the body". The event "strong muscle pain/strong muscle pain that moved around the body" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of myalgia. Additional information: prior to Vaccination the patient did not receive any other vaccination within four weeks prior to vaccination. No follow-up attempts are possible. No further information is expected.
Shortly after my son's last set of shots, he had a fever, then after that, he lost all speech, eye contact and any social abilities. He has now been dx'd with autism.
Fever; fever keeps going; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 5 year-old female patient received bnt162b2 (BNT162B2), administration date 03Dec2021 (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: PYREXIA (non-serious) with onset 05Dec2021, outcome "not recovered", described as "Fever; fever keeps going"; HEADACHE (non-serious) with onset 04Dec2021, outcome "unknown", described as "headache". Therapeutic measures were taken as a result of pyrexia, headache.  Additional information: The last Friday, the patient's parent took her to get the vaccine, she was 5 years old and she was okay on that day, the next day she said she felt lot of 'headache' and on Sunday she got fever, they only used the Tylenol and today the fever kept going.  The patient did not have any known allergies.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Fever 102, whole body pain, malaise, dizziness, heart palpitations, rapid heart rate, swollen left arm, swollen left neck, swollen arm pit, lymphnode swelling, nausea, sweating, elevated Blood pressure, brain fog
Systemic: Nausea-Mild, Systemic: Tinnitus-Medium
HUSBAND AND I BOTH RECEIVED FLU AND PNEUMONIA SHOTS, AND THAT EVENING WE BOTH STARTED TO GET ILL.  CHILLS, FEVER, DRY HEAVES, RASH, REDNESS, I ALSO HAD BILLIONS OF PUSS FILLED BLISTERS AT THE INJECTION SITE.  THIS STARTED AFTER THE SHOTS ON 10-9.  WE WERE BOTH SEEM AT THE CLINIC ON SATURDAY, THE 11TH.  THEN I HAD TO BE SEEN AT THE EMERGENCY ROOM ON NEXT TUESDAY NIGHT, 10-14.  WE WERE TOLD WE HAD CELLULITIS, AND NEEDED TO BOTH GO ON ANTI-BIOTICS.  WE ARE STILL TAKING THEM.  WE WERE GIVING OUR SHOTS BOTH IN THE SAME ARM.  WE UNDERSTAND WE WERE NOT SUPPOST TO GET THEM IN THE SAME ARM.  MY ARM STILL HAS BLACK SCABS AT THE INJECTION SITE. MY HUSBAND ALSO NEEDED A BREATHING TREATMENT WHILE WE WERE IN THE CLINIC.
chills, body aches, headache, fever, fatigue, nasal congestion/sinus pressure.  Had dose-1 on 10/27/2020 and side effect symptoms that night and next day.  Has now happened 3 times about a month apart on 11/22/2020 and now 1/5/2021
Rising blood pressures starting overnight 10Feb2021; Persistent headache as well; This is a spontaneous report from a contactable physician, the patient. A 48-year-old female patient (non pregnant) received dose number 1 of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number: EL9264) via an unspecified route of administration on 09Feb2021 at 12:15 PM(at 48-year-old ) in left arm as a single dose for COVID-19 immunization. Medical history included Hypertension (well controlled prior) and glaucoma. Patient had known allergies of cephalosporins. Concomitant medications included Diovan, Biotin, Vitamin D, Magnesium and Glucosamine (within two weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 10Feb2021 at 03:00 AM, rising blood pressures started overnight that led to doubling of Diovan dose, then switch to a different agent, followed by ER visit on 13Feb2021 for BP 175/103 and another medication was added and experienced persistent headache as well. Both symptoms persist at this time. New medication for BP control were given, EKG and labs done. Outcome of the event was not recovered.; Sender's Comments: A contributory role of vaccine BNT162B2 to the event rising blood pressures cannot be fully excluded based on the close temporal relationship.  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.
Vaccinated with Menactra on 6/14/07, 6/15 can't lift arm due to pain, 6/16 redness/pruritus/pain. 6/18 seen by me, redness/pain decreased.
2/3/2021: Within the first 24 hours patient c/o fever, headache and rash to bilateral legs.  (Patient took Benadryl prior to receiving vaccine).  2/9/2021:  Patient states she has rash on bilateral legs with mottling that was worse then before. She states the rash spots blistered and are no longer painful, but still present, like little red dots at almost every hair follicle. 3/9/2021: Patient states the red bumps/rash is still present with mottling on bilateral lower legs; however, they are not painful and do not itch at this time.
Heplisav-B and Twinrix at the Same Time; Initial Report Received on 27-Dec-2022  A pharmacist reported that a 46-year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and was given Twinrix at the same time.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 27-Dec-2022, the patient received a dose of HEPLISAV-B (Lot # 940487, expiration date 14-Nov-2024 and NDC # 43528000301) intramuscularly in the right deltoid from a pharmacist. Concomitant vaccines administered included Twinrix (Lot #, route, and site not provided).   On 27-Dec-2022, on the same day he was vaccinated with HEPLISAV-B, the patient was given Twinrix at the same time. No additional adverse effects were reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
1755 Approx 10 minutes after receiving the J&J covid vaccine.  Patient leaned back in his chair and fainted.  Began to shake, eyes open and became diaphoretic.  Easily arroused but still diaphoretic and weak.     1805 Transferred to patient room on a exam table and head of bed elevated via w/c and assistance of urgent care nurse.  Vitals taken with bp of 138/90 Pulse 22 Temp 97.3 Patient is responsive.  Cold water, ice packs given.  Patient had a large emesis and never lost consciousness again.       18/23 Sitting up at bedsid.  Rechecked vitals and 114/76  Pulse 56.  Oxygen level 97-98. Patient is sitting up but still pale in color, diaphoretic has improved but still present.     1835  Patient states he is feeling better but still weak and dizzy. Recommend he have family member pick him up as he doesn't feel he is able to drive.  BP 125/85  Pulse 53.  Had smaller emesis.     1840 Patients wife is on her way to pick him up.  He is eating crackers and Ice water.  Still weak and somewhat dizzy. BP 128/80 pulse 58   1850  Patient still complains of dizziness and weakness.  Improved.  BP 133/86 pulse 57.   1900 patient sitting up and feels much improved.  Felt up to ambulation.  Ambulated in hall 150 feet and tolerated.  Color improved and no longer diaphoretic.  Dizziness subsided.     1910  Wife here and patient discharged.  Did not drive vehicle home.
diluent component of PENTACEL was administered to a patient; it was not reconstituted with the ACT-HIB component/no AE; diluent component of PENTACEL was administered to a patient; it was not reconstituted with the ACT-HIB component/no AE; Initial information received on 19-Oct-2021 regarding an unsolicited valid non-serious case received from a Physician and non-health care professional via Medical Information - 00818790.   This case involves a patient of unknown demographics who received only diluent component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] it was not reconstituted with the ACT-HIB component (Product preparation issue)(vaccine underdose).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was reported "Physician reports that the diluent component of PENTACEL was administered to a patient; it was not reconstituted with the ACTHIB component. Caller would like to know if the diluent counts as a valid dose of DTAP and can the ACTHIB component be diluted with sterile water. Caller would appreciate an email or call back from Customer Service regarding the purchase of 0.4 % saline solution to reconstitute the ACTHIB component of PENTACEL. Caller did not wish to be transferred to Customer Service as she was starting a webinar".  It was a case of an actual medication error due to Inappropriate reconstitution technique and vaccine underdose(latency was on same day).   At the time of report, no adverse event reported.   Outcome of event was unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Red and extremely sore at injection site beginning night of administration. Over next two days, redness moved to inside of upper arm, became itchy but pain subsided. Advised patient to monitor for 2 to 3 more days and seek medical attention in the meantime if it gets worse instead of better.
I had high dose flu vaccine (Unspecified flu vaccine) and after 48 hours later I had the Pfizer BioNTech Bivalent; I am getting tired fast; Achy joints; Shortness of breath; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 at 14:00 as dose number unknown (booster), single (Lot number: GH9694) at the age of 69 years, in left arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE), on 04Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, Unknown manufacturer), for Covid-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 06Oct2022, outcome "unknown", described as "I had high dose flu vaccine (Unspecified flu vaccine) and after 48 hours later I had the Pfizer BioNTech Bivalent"; ARTHRALGIA (non-serious) with onset Oct2022, outcome "unknown", described as "Achy joints"; CHILLS (non-serious) with onset Oct2022, outcome "unknown"; FATIGUE (non-serious) with onset Oct2022, outcome "unknown", described as "I am getting tired fast"; DYSPNOEA (non-serious) with onset Oct2022, outcome "unknown", described as "Shortness of breath". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fatigue, arthralgia, dyspnoea, chills. Additional information: Naproxen (treatment). No follow-up attempts are possible. No further information is expected.
Patient developed petechiae starting the morning after her typhoid vaccination.  Had a CBC done on 11/24 which showed a platelet count of 6,000 and has been presumptively diagnosed with ITP.
Patients Guardian was notified of incorrect dose and agreed to appointment to re-vaccinate  10/17/2023.
Patient waiting in waiting room after receiving Hep A injection. Came to counter to ask question and passed out falling back. 3:25 BP 130/64, P 72, 3:30 108/62 up to chair drinking OJ. 3:35 104/60 again 4:50 104/60.
I received the second dose in the afternoon and work up the next day feeling drained. Within the next couple of hours I had chills (did not check for fever), fatigue, headache and overall weakness.  Most of the symptoms subsided after 12ish hours later- the head ache lingered for an additional 24 hours.  I also experienced upper abdominal pain around30 hours after receiving the vaccine. I was seen by my healthcare provider and  they believe the abd pain was related to an ulcer separate from the other symptoms.
Patient with 2 Pfizer COVID vaccinations who admitted with positive COVID test.  Provider D/C note below:    "Hospital Course:  Patient, a covid positive 70-year-old male with history of traumatic brain injury, epilepsy with two recent 2 hospitalizations followed by Dr. at medical facility taking dilantin and zonisamide, and alcohol use disorder presented to the emergency department in status epilepticus. On arrival patient GCS of 3. He was given 8mg of ativan and a loading dose of fosphenytoin. Patient was intubated and started on propofol drip with concerns of his compromised airway. Stat EEG and neurology consult ordered.  CT imaging of the head unremarkable for acute pathology.  With initial concerns of sepsis, the patient was started on prophylactic antibiotics and blood cultures were obtained.   Stat EEG revealed encephalopathic changes without seizure activity seen. Per Neurology recommended to maintain 100 mg of IV Dilantin q8 hours after his initial fosphenytoin load.  They recommended to maintain on Depakote and zonisamide and change propofol to precedex at that time. Norepinephrine was given briefly on 7/9, central line was not needed.   In the ICU, patient has had episodes of hypotension along with agitation. On 07/10, became hypertensive tachycardic and tachypneic after nursing provides ETT suction. patient appeared slightly rigid particularly in the upper extremities bilaterally. Bilateral eyes did not show nystagmus and pupils PERRLA. Did not follow commands or show purposeful movement.  Neurology was consulted and no stat EEG was done. patient was stabilized by the end of the night. Last precedex and propofol use 7/10.   Patient extubated on 07/11. patient has remained relatively hemodynamically stable however has required hypertensive medications for elevated systolic pressures. Failed swallow study 7/12, NG tube was placed. Concerns for aspiration pneumonia on cxr and met SIRS criteria unasyn was started (7/12-). Bcx 7/9- NGTD. Vancomycin and Zosyn D/ced (7/9-7/10).   Pt however has had slow improvement in mentation with concerns for subclinical seizures. Neurology wanted an MRI done today (7/14), however was decided to transfer to Neuro-ICU under Dr. for further evaluation."
RN admistered Act HIB vaccine on 12/15/22 to patient, the vaccine had expired on 12/13/22. RN realized this error after administration. RN immediately notified doctor as well as patient mom. RN let pt. mom know that pt. may need another dose of vaccine depending on manufacturer protocol. Pt. mom expressed understanding. RN called manufacturer who clarified that another dose of Act HIB will need to be administered and can that can be done as soon as today. RN will call pt. mom to let her know. RN documented in pt. chart as well as followed facility protocol.
Arm became swollen and red, painful when touched, the following morning, swelling about four inches diameter, improving slowly over time.