chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was observed for 30 min after her second dose of covid-19 vaccine (note patient decided to take diphenhydramine immediately after receiving this dose of vaccine because she experienced a spike in her blood pressure with her first covid-19 vaccine). Patient felt fine and left the vaccine clinic. But about 2 hours after receiving the second dose, patient developed numbness, right upper and lower extremity weakness and headache. Upon presentation to the ED, patient developed right sided facial droop and ongoing right upper and lower extremity weakness and headache. Stroke protocols were initiated including offering tPA for clinical stroke, but patient declined it.   At workup, her EKG showed a sinus rhythm, she had not reported recent illness.  A CT angiogram showed no significant flow limiting stenosis either in the neck or head and there was no perfusion deficit.  However, incidental bilateral aneurysms were discovered at the anterior cerebral arteries at the junction of the A3 segments and pericallosal arteries.  There was no evidence that they had hemorrhage and they are small, less than 5 mm in diameter and neurosurgery has evaluated the patient and is not recommending any urgent intervention.   The next day the patient was doing well, presenting symptoms/deficits resolved except for ongoing mild headache. An MRI examination of the brain has shown no acute infarct and normal brain morphology was described.  She had an echocardiogram, which showed grossly normal left ventricular size and systolic function with an estimated ejection fraction of 65%.  Amlodipine was started for elevated blood pressure. Note: patient had a history of hypertension but was not on medications for this prior to admission.   Neurology consult = ?This is a peculiar event.  It is unclear if the patient had a TIA or COVID reaction to a COVID vaccination or a reaction to headache.  She does not exhibit a completed stroke on MRI scan.  She has recovered completely except for mild headache.  Incidental aneurysms were discovered and at some point she should have follow up for that. She should have a follow up with the stroke service.  In the meantime, I think it is reasonable to continue with daily aspirin on this patient.  Note that she had a cryptogenic TIA.?
Information has been received on 02-NOV-2017 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported), subcutaneous on or about 26-MAR-2008, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of ophthalmic herpes zoster. On or about 12-MAY-2015, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as ophthalmic herpes zoster, or shingles with interference into the eyes. The patient has been prescribed valacyclovir to attempt to manage and relieve her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Upon internal review, persistent and chronic strain of ophthalmic herpes zoster/shingles was considered to be medically significant. Additional information has been requested.
Swelling of thighs, crying for hours before Tylenol was give , loss of appetite, fever, rash on back, whimpering a little and death crying before Tylenol,  each time Tylenol was given and then it wore off the temperature was higher each time. I believe the doctors down there have no idea what they are doing when it comes to vaccines. They keep pushing Tylenol and it?s not helping. I made a detox bath after another appointment, bath given at 8:10pm today. Tylenol was give at 5:46 pm when fever of 100.4. Then again at 101 at 1/2am on 4/30/19 and then the last dose was when temp was 101.7 on 4/30/19 at 11:29pm.
"I" was tired on day of the shot and slept a lot on the second day; Some brain fog; "My" arm was also very warm and somewhat red on 2nd day; "My" arm was also very warm and somewhat red on 2nd day; Just generally felt nauseated for and three days; Pain in left arm starting the evening of the 22nd and 2nd day was the worst pain pain was less on 3rd day and finally had no pain by 5th day; "I" was tired on day of the shot and slept a lot on the second day; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 22Apr2021 at 11:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included mild asthma, obesity and known seasonal allergy; on unknown dates and unknown if ongoing and suspected COVID-19 in Dec2020. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications included paroxetine (MANUFACTURER UNKNOWN), trazodone (MANUFACTURER UNKNOWN), hydrochlorothiazide (HCTZ) and naproxen sodium (ALEVE); all for unspecified indications, from an unknown date and unknown if ongoing. The patient previously received codeine (MANUFACTURER UNKNOWN) for unknown indication on unknown date, and experienced drug allergy. On an unknown date in Dec2020, the patient underwent SARS-CoV-2 test and the result was negative. On 22Apr2021 at 18:00 starting in the evening, the patient experienced pain in left arm, second day was the worst pain (hard to lift left arm out from the body laterally). Then the pain was less on third day and finally had no pain by fifth day and also was tired on day of the shot. On 23Apr2021 (reported as on the second day), the patient was slept a lot and had some brain fog (was not as bad as when patient was sick with COVID-19 on an unknown date in Dec2020 - though test came back negative, but had most symptoms, but was not hospital needed). On same day patient felt, arm was also very warm and somewhat red, and just generally felt nauseated for three days. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event felt nauseated for three days was resolved on 26Apr2021; whereas the event pain in left arm starting the evening was resolved on 27Apr2021; thereof the events she was tired on day of the shot and slept a lot on the second day, some brain fog, her arm was also very warm and somewhat red on second day were resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Information has been received from a 43 year old female consumer, who was enrolled in a market research, referring to some female patient of unknown age. The patients' concurrent conditions, medical history and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (manufacturer unknown) (dose and route were unknown). Other suspect therapy included hpv rl1 6 11 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) (dose and route were unknown). The consumer had heard from friends that some girls had fainted when they received vaccination. She spoke with her doctor about it and he said that it was because the girls were afraid of shots. The outcome of the events were unknown. The causality was not provided. Additional information has been requested.
ABOUT 5 PM ON THE NIGHT THE VACCINE WAS GIVEN THE CHILD BECAME IRRITABLE AND DID NOT SLEEP THROUGH THE NIGHT. THE NEXT DAY HE SCREAMED INCONSOLABLY FOR THE NEXT 24 HOURS AND HAD A LOSE OF APPETITE. THE NEXT DAY ON 1/6 HE WAS EXTREMELY IRRITABLE, RUNNING A FEVER, STILL NOT EATING WELL AND STILL CRYING INCONSOLABLY. THIS WAS NOT LIKE THE CHILDS NORMAL DEMEANOR.
spoke with PUI's son. He is her and answered for her. PUI is still in the hospital. The only symptoms her son was aware of was coughing and fatigue. She was exposed by her husband. PUI had a stroke a few years ago and is still recovering. She has some trouble speaking so her son has been authorized to speak for her. She is fully vaccinated. According to the son her only close contact was her husband. Current symptom status unknown.
Menveo administered after freezing exposure; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA690A, expiry date 31st October 2022) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 04-AUG-2022 Reporter's Comment: The reporter reported that, patient received Menveo that had been stored in the freezer. The reporter did not want MI to store information in MI database. The reporter consented to follow up. Additional Supportive Information: The patient received Menveo that had been stored in the freezer, which led to incorrect storage of drug. This was 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR115730:Same reporter. Patient 3 US-GSK-US2022115428:Same reporter. Patient 1
15 hours - very tired, chills, slept for 12 hours. 36 hours - fever, headache, body aches, chills. Rested. 46 hours - symptoms diminishing a bit but injection site is hard, red and swollen. Applied heat, took Advil and antihistamine. 60 hours - headache and swollen arm remain. Took Advil and antihistamine.
while receiving the injection it felt weird; as soon as the pharmacist put the needle in.....it started hurting.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-02005, U1076693.  A female patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Batch/Lot number: unknown), on 01Apr2021 as dose 2, single (Lot number: ER8733) and on 03Dec2021 as dose 3 (booster), single (Lot number: 330308D) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Jul2022 as dose 4 (booster), single (Lot number: 011B22A) for covid-19 immunisation. The patient's relevant medical history included: "several allergies: Latex" (unspecified if ongoing); "several allergies: Penicillin" (unspecified if ongoing); "COVID", start date: 23Nov2020 (unspecified if ongoing), notes: she had COVID during the early pandemic. The patient's concomitant medications were not reported. Past drug history included: Lexapro, reaction(s): "several allergies: Lexapro"; Afron, reaction(s): "several allergies: Afron". The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "while receiving the injection it felt weird"; VACCINATION SITE PAIN (non-serious), outcome "recovered with sequelae", described as "as soon as the pharmacist put the needle in.....it started hurting.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Difficulty breathing, coughing, wheezing, sore lymph node under armpit on arm where vaccine was administered
Extreme pain in mid-back that radiates around torso, creating a constricting feeling when I try to breathe. Hurts to lay down or lift objects. Heart rate is elevated from 50-60s to 80-90s. Some numbness in hands. Some feelings of disorientation.  I have not sought healthcare yet, although plan to if the pain worsens.
urticarial rash at injection site within 24 hrs also fever, chills, fatigue
Patient developed a diffuse vesicular, papular rash over entire body. Consistent with varicella like rash. Reportedly had a mild case of chicken pox when she was 3 years old.
This spontaneous report as received from a consumer refers to her 3 years old nephew who on an unspecified date. The patient was vaccinated with a dose of M-M-R II (dose, route and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The consumer reported that her nephew had a sensitivity to the M-M-R II vaccine at an unspecified time. At the time of the report the patient's outcome was unknown. Additional information is not expected.
This spontaneous report as received from a Medical Assistant, refers to multiple unknown patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were administered improperly stored doses of GARDASIL 9 lot # M007764, expiration date 30-JAN-2018 (dosing details were not reported) for prophylaxis. The vaccines were exposed to temperatures ranging from 33F to 35F for cumulative total time frame of 72 hours out of recommended storage range. There were no previous excursions reported. The temperature excursion was recorded by a data logger. No adverse effects were reported. There was no product quality complaint involved. No further information was provided. This is one of the several reports received from the same reporter. Follow up information was received on 09-DEC-2016. As of 09-DEC-2016, All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Narrative was updated. Sender's Comments: US-009507513-1611USA000222: US-009507513-1611USA000223: US-009507513-1610USA001301: US-009507513-1611USA000221: US-009507513-1611USA000221: MERCK 1611USA000221: Mfr number.
This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is a second of two reports. A patient of unspecified age, ethnicity and gender, received TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced high fever, body aches, dizziness, fatigue and polyuria on an unspecified date. Outcome of the events was unknown. Information on the batch number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2017544111 Same reporter, similar events in different patients".
He did not have an adverse reaction to the vaccine. On 12/06/2022, he woke up and went to the bathroom and he had blood in his urine. He also had difficulty walking and very week. We called an ambulance and took him to the emergency room. They lost the urine sample, but we feel it was a urinary tract infection. As of today, he is feeling better.
Broke out it a hot rash the first night.  Both my knees  exhibited excruciating pain to where it felt I was having  knee surgery without anthesis nothing  helped with the pain.  General aches through out whole body settling in the joints.  Fatigue, migraine headache, loss of smell on and off through day.  Loss of appetite on and off. Injection site has a large redden area warm to touch approximate size   of a silver dollar if not bigger, lymph node under left  arm pit is swollen and sensitive to the touch, movement aggravates the arm pit.  Evening time body breaks down in an allergic rash.
Sudden hearing loss; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 05Apr2021 at 18:00 (6:00 PM) (at the age of 32 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation.  The patient medical history was not reported. Concomitant medications included spironolactone and atomoxetine. The patient experienced sudden hearing loss on 06Apr2021. The patient did not receive treatment for the event. It was unknown if the patient has COVID prior to vaccination and was not tested for COVID post vaccination.  The patient did not receive other vaccine in four weeks. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Pt. was given Hep B 3 left deltoid on July 2, 2018. Previous 2 doses without any problems. The next day, was busy and did not notice any problem. On July 4th noticed redness, swelling, itching at injection site. Cold compresses applied. Today less symptoms. O/E - well defined induration, erythema medial to injection site. Advised continue cold compresses, diphenhydramine. F/U if not improved, worse.
pt recv vax & w/in 24hr pt devel a fever of 104 & was irritable;MD stated that sx were transient;PT was unable to locate pt records in f/u;
Severe epigastric pain-MD Visit GI referral  Swollen thyroid nodule requiring MD visit, TSH blood level drawn, Thyroid ultrasound; resulted in grade 2 nodule requiring monitoring and yearly ultrasound
Client was diagnosed with blood clot after first vaccination in the lung Lower right.  After second vaccine had acute thrombosis of the left leg.  Client was hospitalized for both events.
Positive Covid-19 test on 2/9/2021, symptoms began 2/7/21
This case was reported by a nurse and described the occurrence of wrong vaccine administered in a 20-month-old female patient who received KINRIX (batch number AC20B235AA, expiry date 15th January 2015). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information: A 20 month old female patient was inadvertently administered KINRIX.
11 year-old girl was administered a Menactra vaccine that had expired on 31May2020,No AE; Initial information was received on 05-Jun-2020 regarding an unsolicited valid non-serious case from a consumer (medical student).  This case involves an 11 years old female patient who was administrated with 0.5 ml dose of an expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number not reported, expiration date 31-May-2020) via intramuscular route in unknown administration site on 04-Jun-2020 for prophylactic vaccination.  The patient medical history, medical treatment, past vaccination, concomitant therapy and family history were not provided.  It was a case of actual medication error case due to expired vaccine used. An 11 year-old girl was administered a Menactra vaccine that had expired on 31-May-2020.  At the time of report, adverse event was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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 the batch number for this case.
Blood Pressure rapidly started going up and pulse did too.  159/111 pulse 103 on 2/19/21 8:54am, continued 169/120 p96 on 2/20/21 5:48am, 162/105 p76 on 2/2021 7:25pm, 201/119 p 85 8:40am Finally was able to see physician at a local Clinic.  She sent me to the emergency room.  They ran a lot of tests but did not give me any test results.  My normal blood pressure ave is 126/88 p 54.  Since then I have had to be on medication for my blood pressure and it is still high and not stable.  Just for the month of August it averages 151/102 P61, Best is 120/82, and worst is 184/115.
Post vax, the pts experienced a cellulitis type reaction consisting of a hard bump at the injection site and streaking. The reporter felt that this experience occurred after the first dose that the pts received. Additionally, it was noted that the pts were referred to a physician who has been treating with oral antibiotics.
At day 13 after the shot, I noticed that my left breast was swollen, had pitted skin like an orange, was red, and had a large ridge through it. I am nursing and though possibly I had an infection, but never developed severe pain or fever as with mastitis. On  able to consult with a doctor on 5 March. He ordered an ultrasound of the breast to rule out any malignancies. The ultrasound found a superficial thrombophlebitis in the breast under the exact area of swelling, discoloration, and skin puckering.  After 3 weeks, the swelling has disappeared and the breast only remains slightly discolored the chorded vein is no longer able the be felt as it was previously.
Woke up  dizzy and nausea    started vomiting and dry heaving     arrived at urgent care (per PCP instruction)  at 6:25  given  zofran-odt    and IV infusion  for hydration
Slightly raised, reddened, and warm area measuring 2x1 1/2" on left mid lateral thigh when seen on 8/3/06 for reaction.
anxious; cognition has degraded; wounded; his confusion was the worst I've ever seen. He was totally inattentive; totally inattentive; This is a spontaneous report from a contactable consumer (patient's daughter). A 93-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EJ1686) via an unspecified route of administration on the left arm on 16Jan2021 12:30 at a single dose for COVID-19 immunization. Medical history included type 2 diabetes, CHF, impaired kidney function, atrial fibrillation, multiple strokes, dementia/memory issues, confusion. Concomitant medications were not reported (unspecified 15 meds). The patient previously took blood thinners. It was reported that the patient suffered from memory loss and dementia, and on 19Jan2021 his confusion was the worst the reporter had ever seen. He was totally inattentive - like, he kept tuning out until she said, Dad, Dad. Then he'd listen and it was as if he couldn't remember the sentence from 2 minutes ago. He was having difficulty putting together a coherent thought. He was not in any pain. The patient still functioned well. She said since receiving the 1st dose of the vaccine, she noticed that her dad's cognition has degraded in a very concerning way. He was very confused and anxious. She said this was all new behavior, and just started to happen after her dad received the vaccine. Then last night on 19Jan2021, apparently he wandered, which he never does, and he tried to push a nurse or aide, and tried to go into a neighbor's room, a friend, so he was looking for a safe place, and he was hitting a doorknob, and he is on a blood thinner, so he wounded himself and bled, he is on blood thinners, he didn't bleed out, she wrapped his wrist and it's fine. No treatment was received for the events 'his confusion was the worst I've ever seen. He was totally inattentive'. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the vaccine was administered was in a facility. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the event 'his confusion was the worst I've ever seen. He was totally inattentive' was not recovered while unknown for the other events.
Severe headache, raised lump about 3 in diameter, warm redness covering the back of my arm from elbow to armpit.