chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Accidental underdose; an adult patient had inadvertently received a pediatric dose of Engerix-B; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 20-year-old female patient who received HBV (Engerix B pediatric) (batch number 333M4, expiry date 07-APR-2024) for prophylaxis.   On 16-JUN-2023, the patient received Engerix B pediatric. On 16-JUN-2023, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: Accidental underdose) and adult use of a child product (Verbatim: an adult patient had inadvertently received a pediatric dose of Engerix-B). The outcome of the accidental underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 16-JUN-2023 The nurse called to inform that earlier that day an adult patient had inadvertently received a pediatric dose of Engerix B, which led to accidental underdose and adult use of a child product.  According to the nurse, it was the first dose of the second scheme of the patient since according to a titers test, the patient was not immune. The reporter consented to follow up.
ST arthralgias; Sick; Cough; Fatigue; Chills; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 41-year-old male patient received BNT162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 01, prev dose lot number: EL3247), administration date: 28Jan2021, when the patient was 39-year-old, for Covid-19 immunization; BNT162b2 (Dose: 02, prev dose lot number: EL3247), administration date: 18Feb2021, when the patient was 39-year-old, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 28Apr2022, outcome "unknown"; COUGH (non-serious) with onset 28Apr2022, outcome "unknown"; FATIGUE (non-serious) with onset 28Apr2022, outcome "unknown"; ARTHRALGIA (non-serious) with onset 28Apr2022, outcome "unknown", described as "ST arthralgias"; ILLNESS (non-serious) with onset 28Apr2022, outcome "unknown", described as "Sick". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of arthralgia, illness, cough, fatigue, chills.  Additional information: The patient receive any other vaccines within 4 weeks prior to the COVID vaccine: Unknown. Prior to vaccination, was the patient diagnosed with COVID-19: Unknown. Since the vaccination, the patient had been tested for COVID-19. COVID test post vaccination: covid test type post vaccination: Unknown. COVID test name post vaccination: Home Ag.  No follow-up attempts are possible. No further information is expected.
pt recv vax 15MAR97 & pt devel mult sclerosis sx which included paresthesias in extremities;26JUL97 an MRI of brain revealed some inflammatory changes in rt maxillary sinuses & mult small round foci of inc signal;
sl anxious p/vax-walked to car, talking, no c/o-5min drive to home c/o h/a in car-had to lean on car for support p/exiting, became limp 5-10sec;parent laid pt on driveway;no recall of incident;
Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced NAUSEA (Nauseous). The patient was treated with CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) at an unspecified dose and frequency. At the time of the report, NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
headache, body aches, extreme fatigue, pain at injection site, fever under 100 degrees, itchy Eyes , sore throat
Extreme dehydration; Nausea; Vomiting; Severe ataxia; mad global cortical atrophy; This is a spontaneous report from a contactable nurse (patient).   A 70-year-old female patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6207) at single dose, in the right arm, on 11Mar2021, for COVID-19 immunisation. Relevant medical history included Sjogren's disease form an unspecified date. The patient previously, on 18Feb2021, at 11:45 AM, at the age of 70 years, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6200) at single dose, in the left arm, for COVID-19 immunisation. On 24Feb2021, at 11:00 PM, the patient experienced an unspecified adverse event. Concomitant medications included levothyroxine 112 ug, from an unspecified date, for an unknown indication. On 16Mar2021, mad global cortical atrophy was reported. On 27Mar2021, the patient experienced extreme dehydration, nausea, vomiting and severe ataxia. Physician Office Visit and Emergency Room Visit were required. The patient received on 27Mar2021 normal saline (NS) 2L in ER over 2hr for extreme dehydration, nausea, vomiting and severe ataxia. Relevant laboratory tests included computerised tomogram (CT scan w/o contrast) on 12Mar2021: multifocal to confluent areas of decreased attenuation in the deep white matter ascending into the basal ganglia consistent with mod severe small vessel ischemic/degenerative finalizing; Magnetic resonance imaging head (MRI Brain w/o contrast) on 16Mar2021: no acute findings. Mad global cerebral atrophy and severe renascent small vessel ischemic white matter disease; MRI Neck on 16Mar2021: unremarkable and MRI Head w/o contrast on 18Mar2021: unremarkable. Clinical outcome of the events was unknown at time of this report.; Sender's Comments: Based on the information currently available causality between reported events and suspet product BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) cannot be completely excluded. 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.
2 weeks after receiving this vaccine, I started my period. It was extremely heavy and painful. Since then, my periods have been extremely heavy and painful (they were NOT this way prior to me receiving the vaccine) and have caused me to have to have a uterine ablation to ease the pain.
pt cried on way home from clinic of pain in lt arm, but pain disappeared next day; in 10 days had high fever 105 @ noc; mom called ask nurse; taken to MD AM pt had welts all over body; also had ear infect;
Fever; Inappropriate age at vaccine administration; This case was reported by a physician via sales rep and described the occurrence of fever in a adult patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received Pediarix at an unknown dose. On an unknown date, unknown after receiving Pediarix, the patient experienced fever and inappropriate age at vaccine administration. On an unknown date, the outcome of the fever and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the fever to be related to Pediarix.  Additional information received were as follows: The case was reported by the physician who reported for herself. The age at vaccination was not reported. The patient had experienced fever with Pediarix. The patient received Pediarix, which led to inappropriate age at vaccine administration.
Swelling below injection site that radiated to elbow, forearm and wrist. Lasted 5 days after injection. Also had redness.
Received Flu Booster dose on 12/31 (#1 was given 10/29/18). That NOI febrile, per mom had staring spell with increased saliva, no seizure movement noted, staring spell lasted 10 min. Seen ER, did not feel was febrile seizure. Seen in our office 1/2 DX BOM. DX BOM 1/2 in our office pt given AUGMENTIN.
fever; headache; body aches; chills; This is a spontaneous report from a contactable consumer (patient).  A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730 and expiration date: Mar2021), via an unspecified route of administration on 19Dec2020 at single dose for covid-19 immunization. It was the first dose. Medical history included the patient was Cancer survivor and the patient was not taking any chemo or any radiation. In 2003 the patient took chemo radiation. Concomitant medications included anastrozole, citalopram, alendronate sodium (ALENDRONATE). The patient stated she was having a couple symptoms including fever, headache, body aches, and chills on an unknown date in Dec2020. Treatment included the patient had been taking Excedrin, It had aspirin in it and Tylenol in it and Tylenol is 250 mg and Aspirin is 250 (unit was not specified). The patient was wondering how long her symptoms are going to last. The patient thought the lab test has been about a month. The outcome of the events was unknown.
high pitched crying, swollen red painful leg, collaspe w/clammy cool skin, 1st day, infantile sz, loss of skills, stiffness of muscles, loss of muscle tone, disinterest in surroundings, congestion, runny nose, escema developed allergy soy;
After first round of vaccines  HEPA, MCV4, MMR were administered pt reported feeling like he was going to faint. Pt fainted, eyes rolled back, experienced convulsions for less than a minute. Pt   was laid down with legs elevated,  BP, HR, O2 stat were taken. Pt was given a Pedialyte popsicle. Pt reported feeling better. After second round of vaccines  TDaP, VZV and Influenza were administered, pt reported feeling like he was going to faint and fainted.  Pt was laid down, vitals were taken again. Pt reported feeling better.  Pt sat down for another 15-20 min, reported feeling well and was able to ambulate safely without assistance.  Nurse escorted pt the building front door, asked pt if he fell well, pt reported he felt well. Nurse advised pts mother to call clinic if she had any question or concerns. Mother of pt agreed with plan. Pt went home with mother.
Dr. informs that after the administration of the vaccine against Covid-19 on the date 4-13-2021 and the next day on 4-14-2021 she began to present with severe tinnitus
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 11-JAN-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength 0.5 mL, lot # L027282, expiration date 21-SEP-2017, dose and route were unknown). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the excursion was 56, 33, and R. This is one of several reports received from the same source. Additional information has been requested.
The first vaccine was administered on December 30, 2020 from a local pharmacy.  She was diagnosed with COVID on January 3. She was in and out of ER for 3 days, when we finally took her home and got hospice care. On January 19, 2021 Dr's office told us that she could get the 2nd vaccine the next day. She received the 2nd vaccine on January 20, 2021 from a local pharmacy. On January 21 she became disoriented and was sleeping most of the time, by Friday, January 22, she could not walk and was incoherent most of the time.  The evening of January 22, we presume she had a stroke, but was not officially diagnosed.  Her oxygen level dropped to 42 and her blood pressure was 287/182 with seizures that lasted about 1 minute.  She died on January 29, 2021.
This spontaneous report as received from a nurse, refers to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not provided. On 23-DEC-2015, the patient was vaccinated with improperly stored dose of M-M-R II therapy type unknown (dose, frequency, route of administration and indication were not reported, lot # L001336 with expiration date: 13-JAN-2017). Concomitant medications were not reported. No adverse events were reported. The administered dose was stored in 47 F for 8 hours. There was no previous temperature excursions. Data logger was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
I have had Tinnitus since receiving my second dose. I mentioned it to my doctor, and she referred me to an ENT doctor. I have not been prescribed any medications. It is low-grade. It is not debilitating, but itis always there. It hasn't gotten any better, but it hasn't gotten worse either.
Chronic urticaria Itchy / painful hives Joint pain at site of hives on forearms Internal (muscle?) pain at site of hives on chest Soreness at site of hives (feels bruised,  although there is no discoloration other than red wheals)
I have been experiencing extreme pain in my face, throat, tongue, and ear. I went to the Emergency Room at Hospital. I was diagnosed with glossopharyngeal neuralgia. I was prescribed with Prednisone, Gabapentin, and Valacyclovir.
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT. On an unknown date, less than a year after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site pain, injection site swelling and injection site redness. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site redness were recovered/resolved. The reporter considered the injection site pain, injection site swelling and injection site redness to be almost certainly related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The age at vaccination for the patients was not reported. The nurse reported to field representative that about 4 patients experienced some combination of pain, redness and swelling at the injection site after receiving FLULAVAL QUADRIVALENT. The reaction in these patients was more than she was used to see. At least some of these patients were seen at the healthcare professional office for the reaction. The nurse did not seem concerned by these reactions. The reporter did not want to be contacted and would not provide any additional information.
3-4 inch area around the injection site became very red and warm to touch, and an itchy & painful rash appeared on both arms, scalp and forehead that was exposed to about 30 minutes of sunlight. Treated with anti-itch cream.
A nurse reported that a 45 year old male had a decreased therapeutic response to the hep B vaccine recombinant (Engerix B) immunization series. The subject's medical history, concurrent conditions, and concurrent medications were not specified. The subject received injections of Engerix B on a 0, 1 and 6 month schedule. On 2/6/03, 30 days after receiving the third injection of Engerix B, a titer was found to be below the protective level.
10:00 am client received his COVID19 vaccination. Immediately the client fainted and fell out of his chair on his left shoulder. He did not hurt his head. Client was lying flat on the floor and then started having seizures and was placed on his left side.  Episode lasted 3 seconds. Client was able to answer questions and alert and oriented x 4 and no complaints of pain or discomfort. 10:07 1st vitals taken.  10:09 am client stood up and walked to observation area. Client was under observation for 30 minutes.
It was reported that a 31 year old female received Fluzone WV '98-'99 USP on 10/27/98. "Recipient reported that at approximately 14:00, she began feeling hot with mucous rising in her throat. She began coughing and by 15:00, she was experiencing "burning" in her chest and throat, along with shortness of breath. She took Benadryl, which alieviated the burning in about 20 minutes. She called her MD, who prescribed more Bendadryl, mild tachypnea persisted until the following morning, when it resolved." From additional information received on 12/10/98, it was reported, "Reviewed, no additional information at this time, 12/8/98".
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EP7534), on 09Apr2021 as dose 2, single (Lot number: EW0153), on 16Aug2021 as dose 3 (booster), single (Lot number: FA3120) and on 10Jan2022 as dose 4 (booster), single (Lot number: 33036BD) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN, start date: 01Jul2014, stop date: 20May2022; RAMIPRIL AUROBINDO, start date: 01Oct2019, stop date: 20May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) negative, notes: I tested negative after treatment; (30May2022) positive, notes: Intested positive again on 30May2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: Paxlovid was taken for covid-19 and After finishing the Paxlovid treatment on 25May2022, I had a relapse with all symptoms except fever.  No follow-up attempts are possible. No further information is expected.
Fever of 100.9  Body aches Chills Loss of appetite Headache  Brain fog
Sore arm for a few days. Five days later, pain in left armpit began.   One week later, today, armpit pain still noticeable and annoying.  Same day, shot site became itchy. When I looked at the site, it was red, about the size of a lemon, and had become hard.
pre-sz aura-came to sick call @ job about 1-2mo p/vax 10AUG94;told nurse was not suppose to recv tetanus shot d/t sz disorder;did not report any rxn @ that time;later reported 27OCT95 tetanus shot caused pt to feel as poss sz;
10 X 12 cm red patch on L thigh 2 days with vaccine administration tender + hot no systemic signs or symptoms.
Vaccine 130 pm.  Lost contro of arms andlegs around 8 pm. Hit filing cabinet and tore skin off to my skull. Taken to trauma unit at campus. Received 13 stitches and a tetnus shot
Varicella was given on 8-17-12. On 8-18-12 developed redness and swelling at site. Mom took to urgent care on 8-19-12 and was given BENADRYL and prednisone. Arm better 8-20-12.
get flu like symyons; Initial information was received on 17-Nov-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (age and gender unspecified) who get flu like symyons (influenza like illness), when received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was  get flu like symyons (influenza like illness) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE.   No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Pt. had redness at the site day of shot. Two days post immunization she has full body itching, scratching in her throat, redness. Site is bumpy, raised, and warm to touch.
I started having swelling, armpit got swollen (lymph nodes), top clavicle got really large and under neck lymph nodes got swollen. I'm still exp swelling top clavicle lasting 2 months. I did see my PCP was told it was  inflammatory response.
severe COVID-19 pneumonia requiring ICU admission and intubation - patient now terminally extubated and on comfort care
12/23 @ 6:00 PM:  "lungs felt like they were filling up", had a little hacking cough and feeling of heat on chest area.  She went to bed. 12/24 @ 2:00 AM:  Hands from wrists to fingertips were "throbbing, burning terribly and were swollen". 12/25:  Palms of hands "OK" but had little blisters on them.  Had a feeling of pressure from the second knuckle to the tip of each finger 12/26:  Pain was gone but had a "blood blister" on the tip of each finger and they were "tender to the touch" 12/28:  Went to doctor's office for B/P check.  Mentioned aforemention to nurse who told PAC. Since: Hands have peeled, bloodblisters healed but have marks on hands where affected.
Bought to the hospital for respiratory failure, found have COVID 19. She required increase in oxygenation, and seen by infectious disease. She completed a course Remdesivir, Decadron, and anticoagulation, with improvement. The patient returned to her baseline, did not require oxygen upon discharge. The patient did have a 2-D echo showed ejection fraction 25%, which is decreased from 45% roughly 6 months prior. The patient was seen by cardiology, and LifeVest was approved fourth short-term coverage since checked for heart function recovery. The patient was agreeable. She will follow-up with cardiology as an outpatient, and will likely need ICD after 3 months if no improvement in heart function
Hives, rash-welps ,itchy, hot flashes, swollen feet, hands, arms. Sore arms, knees, ankles, knuckles. Treated with Steroid shot: peridsone medication and Benedryl and Zyrtec.
From initial correspondence received at a manufacturer on 11/21/02, it was reported that a 3 y.o. child received 0.5 ml dosage of Tripedia lot #U0581AA, in the right leg on 8/14/02. Nurse thinks the dose # in series is #5. PT experienced large areas of erythema and a warm, swollen patch around the inject site (2x3 inches). Onset date is unknown. The site of the erythema was not reported. The PT recovered.
Ringing in ears along with mild pain. Occasional heavy pressure and pain in ears when opening mouth.
This report has been received from the nurse reported that VARIVAX (Merck) (lot# H020587, expiration date 13-NOV-2014) and PROQUAD (MARRS# 1311USA012185) were through unsupported temperature excursions on 26-JUN-2013, 01-JUL-2013, 22-JUL-2013 thru 31-JUL-2013 and the entire month of August 2013. On 26-AUG-2013 the patient was administered the unsupported VARIVAX (Merck) (dose and route not reported). No adverse effects reported. This is one of several reports received from the same source (MARRS# 1311USA002616, 1312USA003307, 1312USA003308, 1313USA003309, 1312USA003306, 1312USA003311, 1312USA003312, 1312USA003313, 1312USA003314, 1312USA003315, 1312USA003316, 1312USA003317, 1312USA003399, 1312USA003400, 1312USA003401). Additional information has been requested.