chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PRODUCT ADMINISTERED to PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; INTENTIONAL MISUSE; This spontaneous report received from a lawyer via a company representative and concerned a 17 year old patient (sex unspecified).  The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855835, expiry date 27-APR-2022) 0.5 ml, on an unspecified date for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date the vaccine was administered by a non-medical professional (a biology teacher) to the patient, without the parents permission. The patient was 17 at the time of vaccination which constituted off label use (product administered to patient of inappropriate age). The biology teacher who administered the vaccine was arrested on 31-DEC-2021 and charged with unauthorized practice of a profession, after police determined that she was not a medical professional (intentional misuse). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product administered to patient of inappropriate age, off label use, and intentional misuse was not reported. This report was non-serious.
I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 2/27/2021 DIASTOLIC HEART FAILURE, ACUTE I82.412 ACUTE DVT OF LEFT FEMORAL VEIN 2/28/2021 DIASTOLIC HEART FAILURE, ACUTE
This spontaneous report as received from a physician refers to a patient of unknown age who on an unknown date, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot number not reported). The physician reported that on an unknown date, the patient experienced shingles after administration of ZOSTAVAX. At the time of the report, the patient outcome was unknown. Additional information has been requested.
Pt's school nurse called pt c/o SOB at school. Also c/o itching and Welt at site of 2nd Gardasil injection site. Advised to send pt to closest ER for evaluation.
Extreme heat in bilateral feet that ascended to pelvic region over a two week period.  Paresthia over entire body.  Biateral hand, arm weakness and muscle tremors.  Numb lips, needle and pricking sensation all over body.  Tongue tremors, tongue spasms.  Muscle twitches.
Patient came in to office  on 10/31/22 due to Left arm still hurting after influenza vaccine received 10/26/22 in left Deltoid (Flulaval Quadrivalent, preservative-free, Lot AC5R3). Patient reports having been awoken from the muscle "jiggling" last night (10/30/22; spasm/cramp). Pain has improved slightly since vaccination; since "Friday feeling weird / off" and self-medicating intermittently with Ibuprofen and/or Tylenol. ROM intact; L arm hurts slightly when moving arm backwards. Patient denied numbness, tingling, weakness in Left hand/fingers. No visible swelling / redness; lump palpable at least 3 fingerbreadths below the L acromion, slightly off-center/distal. No fever noted by patient. Patient was advised and shown how to create an injury report, and if she wishes, to see an LIP. Patient was advised to inform LIP that this is a comp. case and provide claim number. Patient was advised in the meantime to apply intermittent heat (warm compress) and to monitor for S/Sx requiring urgent medical care: Temp >= 101.3 F, increased swelling/redness/warmth locally/ soreness, decreased range of motion.
11/4/2021- Child noted to be sleepy and started with projectile vomiting and diarrhea, vomiting continued until 11/6/2021, continues with diarrhea through today. 11/8/2021 acting tired and not drinking as much, but no vomiting. Mother contacted PCP on 11/8/2021 and addressed concerns and was advised to contact.
cough; This is a spontaneous report from a contactable consumer (patient) via Pfizer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Medical history included cough from an unknown date and unknown if ongoing. It was reported that the patient always has a cough when winter is over. The patient's concomitant medications were not reported. The patient experienced cough on an unspecified date after the first dose. Treatment with cough medicine was taken for the event. The outcome of the event was unknown. The patient was querying where to get her 2nd dose.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
40 seconds after shot:  tingling in left arm and left hand with then wooziness.   Tingling itching sensation and mind pain in left arm and hand continued for a few hours then spread into left leg which continued into the next day.  Moderate left shoulder tenderness 6 hours after shot lasting 2 days.    6 days after shot severe lethargy, body aches and brain fog which is current on 01/06/21.
?Vaccine Arm? my armpit felt slight swollen on the 17th of August and on the 18th and 19th it proceed to my right right.  My right arm feels very tender and is painful to move.
This is an instance of COVID-10 breakthrough disease after which death occurred.   The individual was vaccinated with the Moderna product on 02/05/2021 and 03/18/2021. The lot number nor injection site is not available for the dose administered on 03/18/2021.   The individual had a symptom onset date of approx 12/14/2021 and presented to emergency departmentt on 12/16/2021; they were found to be hypoxic and tested positive for COVID-19 via PCR test on 12/16/2021. They were also admitted to hospital on 12/16/2021. This individual had many complex underlying health issues, and was described as being immunosuppressed. They passed away on 12/17/2021 after declining to continue aggressive cares.
Chills, low fever, fatigue, muscle pain,  nausea, headache, and soreness at injection area
red, swelling  "three times of normal"of injection site, defined borders, lightheadness lasted for a few days, symptoms have improved over the days although tenderness is still felt three days out
23 year old male that presented to the clinic at around 2AM on 17 Jun 2016 with hypotension, weakness in his legs, flushing, voice changes, fullness feeling to his throat, overall fatigue, shakiness, burning sensation over his eyes that is relieved with pressure and chills that started around 2100 after an arm and ab workout.  Pt felt like he might be dehydrated so he tried to drink several bottles of water. Pt was given 2L of NS, 125mg solumedrol IV, 12.5mg Benadryl IV, 150mg Zantac po and was then admitted to the ICU for monitoring. A cbc, cmp, cardiac panel, UA, drug screen did not have any significant results. Pt improved over the course of 5-6 hours and after 24-30 hours in the hospital and repeat labs that were again negative the patient was discharged home. Pt was instructed to not get the anthrax vaccine in the future and to follow up in 1 week.
This spontaneous report as received from a nurse practitioner refers to a 12 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 22-DEC-2014, the patient was vaccinated with the dose of PEDVAX HIB lot # K008680 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Dizziness, headache after second dose of COVID-19 mRNA vaccine IM in left deltoid. Transferred to urgent care for evaluation. Patient monitored and symptoms resolved. Discharged in stable condition.
pt recv vax 9AUG96 pt devel atypical rash;7OCT96 4-5 lesions appeared all over body but concentrated under arms & on abd;it was reported that only a few had actually blistered;pt afeb;
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 28-JAN-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to different temperature excursions (date unspecified): lasting for 40, 232, 88, and 320 hours, with the lowest recorded temperature of 34, 33, 30, and 29 degrees Fahrenheit (1.11, 0.55, -1.11, and -1.66 degrees Celsius) respectively; and lasting for 64 hours, with the highest recorded temperature of 48 degrees Fahrenheit (8.88 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
1wk p/vax pt devel chest pains, anxiousness, hyper & nervousness;these sx resulted in a visit to ER;EKG & x-rays came out nl;
pt recv flu vax 14OCT98 1300 & diarrhea started on 16OCT98;has had until 22OCT98 (still has);rash started 22OCT98 over entire body which is pinkish red, flat & no open areas;no itching w/rash;afeb;also has fatigue, achiness & dizziness;
Awakened with body covered with hives (red outside and white or bruise looking center) using Alevo baths and anti itch cream, Benadryl, Zyrtec.
Hot and cold flashes; Couldn't sleep; Forcing food down; Just didn't have the energy; Left arm felt like I was kicked by a donkey,pressure on boht arms and radiates to my right arm; [third dose] really kicked my butt; nauseous; Worst flu that I've ever had; Getting really cold in the extremities in my fingers and toes; Felt icky; Arm was really sore; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE ([third dose] really kicked my butt), PERIPHERAL COLDNESS (Getting really cold in the extremities in my fingers and toes), FEELING ABNORMAL (Felt icky), INFLUENZA (Worst flu that I've ever had) and FEELING OF BODY TEMPERATURE CHANGE (Hot and cold flashes) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A, 044A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ulcerative colitis.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2021, the patient experienced PERIPHERAL COLDNESS (Getting really cold in the extremities in my fingers and toes), FEELING ABNORMAL (Felt icky) and PAIN IN EXTREMITY (Arm was really sore). On 14-Sep-2021, the patient experienced INFLUENZA (Worst flu that I've ever had). On an unknown date, the patient experienced MALAISE ([third dose] really kicked my butt), FEELING OF BODY TEMPERATURE CHANGE (Hot and cold flashes), INSOMNIA (Couldn't sleep), DYSPHAGIA (Forcing food down), ASTHENIA (Just didn't have the energy), LIMB DISCOMFORT (Left arm felt like I was kicked by a donkey,pressure on boht arms and radiates to my right arm) and NAUSEA (nauseous). At the time of the report, MALAISE ([third dose] really kicked my butt), PERIPHERAL COLDNESS (Getting really cold in the extremities in my fingers and toes), FEELING ABNORMAL (Felt icky), INFLUENZA (Worst flu that I've ever had), FEELING OF BODY TEMPERATURE CHANGE (Hot and cold flashes), INSOMNIA (Couldn't sleep), DYSPHAGIA (Forcing food down), ASTHENIA (Just didn't have the energy), LIMB DISCOMFORT (Left arm felt like I was kicked by a donkey,pressure on boht arms and radiates to my right arm), PAIN IN EXTREMITY (Arm was really sore) and NAUSEA (nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: 92 (Low) Result : oxygen level would go down to 92.         Concomitant product was not provided by the reporter.    No treatment information was provided.
Arm is getting sore; the arm where the shot was given was swollen and red; the arm where the shot was given was swollen and red; started feeling little warm; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, NDC number, UPC number and Expiration date were Unknown), via an unspecified route of administration on 28May2021 as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included deafness (deaf, hard of hearing) from an unknown date. The patient's concomitant medications were not reported. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unspecified date for covid-19 immunisation. It was reported that, the patient got the vaccination yesterday the second one, and felt fine but today on 29May2021, well all throughout the night the patient experienced arms were getting sore, that morning by time went to the store and got back home started feeling little warm and the arm where the shot was given was swollen and red. The Interpreter also asked, what can be done and if the patient can take Tylenol for that? Reporter seriousness for Arm is getting sore; started feeling little warm and the arm where the shot was given was swollen and red was Unspecified. The outcome of the events was not recovered.  Information related to batch/Lot no. was requested.
UrticariaPruritus and injection site reaction (itching/swelling), general malaise.
Expired dose of engerix-B administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number 29ZB7, expiry date 29th September 2021) for prophylaxis.   On 10th November 2021, the patient received Engerix B. On 10th November 2021, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The the patient received expired dose of Engerix B, which led to expired vaccine used. No other details were available. The reporter consented to follow up.
Interchange of vaccine products; COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 64-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Aug2023 at 10:00 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Feb2021 at 12:00 as dose 1, single (Lot number: 042L20AA), in left arm, on 04Mar2021 at 12:00 as dose 2, single (Lot number: 032M20A), in left arm, on 14Sep2021 at 12:00 as dose 3 (booster), single (Lot number: 939906), in left arm, on 03May2022 at 12:00 as dose 4 (booster), single (Lot number: 004m21a), in left arm and on 19Oct2022 at 12:00 as dose 5 (booster), single (Lot number: 049D22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Onion" (unspecified if ongoing). Concomitant medication(s) included: LYSINE, start date: 01Nov2022; FAMOTIDINE, start date: 01May2020; ESTROGEN vaginal, start date: 01Mar2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Aug2023 at 10:00, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID 19 Treatment included Paxlovid (Treatment start date: 28Sep2023, Treatment stop date: 03Oct2023). Other medication in 2weeks included HEB (start date: 01May2020). No other medical history.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This spontaneous report was received from a certified medical assistant and refers to a 4 month old, male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 25-APR-2016 at 12:15, the patient was vaccinated with improperly stored first dose of ROTATEQ lot # L033543, expiry date 30-MAY-2017, orally (dose was not reported). No adverse symptoms were reported. The patient had no illness at the time of vaccination. Administered vaccine experienced temperature excursion of 34 degrees Fahrenheit for a total time of 65 hours. There was no previous temperature excursion. Digital data logger was not involved. This is one of several reports received from the same source. Additional information is not expected, as all scheduled correspondence was received.
On 1/13/00, the pt received his first right arm dose of Lymerix.   Following the first dose on 1/13/00, the pt experienced severe arm pain which kept his awake all night. No treatment was given.  The most recent information received on 1/14/00, reported the condition of the pt as unknown.
Within 30 seconds of vax, pt complained of dizziness, eyes rolled backward, loss of consciousness, unresponsive to verbal or tactile stimuli, no respiration for 10-15 seconds, observed jerky involuntary movement of upper body and arms, release of urine, pulse rapid but present at approximately 17:55. Increased response, pale, respiration spontaneous, and talking at 18:00. Rescue squad arrived. Pupils dilated during episode - decreased post incidence.
This retrospective pregnancy case was reported in a literature article and described the occurrence of spontaneous abortion in an adult female subject who was vaccinated with H1N1 (manufacturer unspecified). On an unspecified date, the subject received an unspecified dose of H1N1 (unknown route and injection site, batch number not provided). The subject's last menstrual period was on unspecified date and estimated date of delivery was not provided. The subject received the vaccine between the 1st day of last menstrual period and estimated date of conception. On unspecified date, at an unspecified time after vaccination with H1N1 and at unspecified weeks gestation, the subject experienced a spontaneous abortion. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. The authors reported 33 other cases. Summary of the article: The potential serious consequences of maternal influenza infection in pregnancy have long been recognized; pregnant women are at increased risk for influenza-associated morbidity and mortality. As reviewed recently, there are limited data on the safety of influenza vaccine in pregnancy; however, to date, there has been no indication that seasonal influenza vaccines containing inactivated virus pose a risk to the mother or the foetus. This has led to the current recommendation that all pregnant women be vaccinated with the seasonal influenza vaccine regardless of trimester. Despite these recommendations, vaccination rates remain less than optimal. Surveys have demonstrated that mother's concerns about safety contribute to poor compliance with vaccine recommendations. This situation was escalated during the 2009-10 H1N1 season, when lack of safety data about the H1N1 was coupled with intensive public health messaging that emphasized the need for all pregnant women to be vaccinated. Additional safety information on H1N1-containing vaccines when used in pregnancy was therefore needed. The purpose of this study was to evaluate the foetal risk and relative safety of the H1N1. To assess risks and relative safety of the H1N1-containing vaccines, the author conducted a prospective cohort study of H1N1-vaccine-exposed and unexposed comparison women who were recruited during pregnancy and followed to outcome between October 2009 and August 2012. There were 1032 subjects available for analysis; 841 women were exposed to a H1N1-containing vaccine in pregnancy, and 191 women were unexposed to any influenza vaccine in pregnancy. Nine of 328 (2.7%) first-trimester-exposed pregnancies resulted in an infant with a major birth defect compared to 6/188 (3.2%) in the unexposed. The hazard ratio (HR) for spontaneous abortion was not elevated. Adjusted HRs for preterm delivery were elevated for exposure anytime in pregnancy, specifically with exposure in the 1st or 2nd trimester. However, the mean decrease in gestational age in the exposed pregnancies was approximately three days. In conclusions, no meaningful evidence of increased relative risk or HR for major birth defects, spontaneous abortion, or small for gestational age infants was demonstrated.
No treatment given. No tests taken. Immediate effect upon returning home: soreness in arm and breast on side of shots, chills, fever, nausea, weakness, lack of appetite, weakness, continued to present time. Pt saw doctor (Nov. 10 2009) with weakness. (Nov 14), (Nov 20), (Nov 24) emergency room visits. Admitted to hospital (Nov. 24). Admitted to nursing home (Nov 30, 09). Pt needs assistance in all areas, (totally) incapacitated. Only walks with assistance.
Information has been received from two Licensed Practical Nurses referring to unspecified number of patients (age and gender were unknown). Information regarding concurrent conditions and medical history was not provided. On 09-JUL-2014, VAQTA was improperly exposed to 10.9C for 17 hours. On unspecified dates after this, unspecified number of patients were vaccinated with doses of the improperly stored VAQTA, intramuscularly (strength, dose, dose number and lot # were not reported). Concomitant therapy was not reported. No known adverse effects. This is one of several reports received from the same source. Additional information has been requested.
Left deltoid swollen, red, & itching.  Pt c/o n/v, body ache.
Pt said after the vaccine, was fine for 24 hours then on day 2,3,4 she had a red rash at site of injection. a little tender to the touch. she did not take any tylenol or contact md/pharmacy regarding adverse event.
Patient state she had a white color bump 1cm away from injection site.  She states over the weekend there was red swelling with a white hard bump in the middle of the swollen area.
Fever 105 degrees F 11-/-09 10:30 PM  - Brought to hospital ER and admitted for fever 11-5-09 - Fever started 11-1-09 102 degrees F.  Currently hospitalized. 11/24/09 ER records received for date 11/5/09. DX: dehydration, febrile illness. Presenting SX: fever, irritable x24hrs. Assessment: pt received flu shot x1wk ago, presents with fever. (+)dehydration, admitted. Blood work shows bandemia. Pt parent states was immunized 10/25 x4 vaccines.
Symptoms started with nasal congestion on 1/23/2010. On 1/25/2010, patient started to have a sore throat with mild fever. Patient began to take Advil and guaifenesin to relieve fever and congestion. Patient's fever continued, sinus congestion increased, and ears became congested. A cough developed on 1/28/2008. Patient began to cleanse sinuses with saline on 1/29/2009 - much mucus was expelled. She also began to take cough syrup regularly. Patient spent most of her time on the couch - too weak to perform her normal activities. Patient called doctor on 2/1/2010. Azithromycin was prescribed. The next morning the fever broke, sinus congestion is gone, but patient is still weak and experiencing problems with her ears.
Headache, eye pain, chills, joint pain, high fever (103.2 ° F), tooth pain, nausea, raised and itchy tattoos.