chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe body aches and chills began 7 hours post vaccination. Then, extreme headache followed. Subsequently, I developed a fever ranging between 100-101.5F)
major headach, upset stomach, nausea, fever, aches, sore arm at shot
lung issues; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2), administration date 02Dec2021 (Batch/Lot number: unknown) at the age of 82 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021, outcome "unknown", described as "booster"; LUNG DISORDER (non-serious), outcome "unknown", described as "lung issues". The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient's mom reported that fever began on the evening of 4/27/10. By 04/28/10 patient had fever of 102 degrees, chills, dizziness, headache, chest tightness and dry throat. Patient referred to MD for treatment. Pt. contacted MD. Called today for follow-up and Sx. are resolving.
Day after injection; arm red, swollen, painful, headache, muscle aches. After hours exchange contacted primary care physician and he suggested we go to the Urgent Care. Urgent Care gave antibiotics and steroids. Injection Site Reaction and infection. Advised to go to ER if redness/blood grew larger. Third day after injection visit to ER; arm red, swollen, painful, headache, muscle ache, extreme fatigue. Blood pooling and spreading. Sixth day after injection follow-up with primary care physician; arm red, swollen, painful, headache, extreme fatigue. Blood pooling and spreading.
Rash on lower back. Treated with Triamcinolone acetonide cream 0.1%.
influenza, injectable, quadrivalent, preservative free given 9/3 at pediatrics.  Following a cheerleading/tumbling practice on Friday, 9/25, she began to feel soreness in the BLE over the weekend. The following Monday, 9/28, she started to complain of neck pain, as well as pain and weakness from the waist down (especially in the popliteal region). She was evaluated by a chiropractor and proceeded to participate in intense tumbling sessions totaling 8 hours over the next several days. By Thursday, 10/1, her neck and shoulder pain had not resolved and, over the following weekend, she proceeded to cancel the coming week's worth of tumbling classes due to pain and weakness in the neck, shoulder, and legs. On the morning of Monday, 10/5, she attempted to step on the bus to school but was unable to pull herself onto the first step. She needed to be carried onto the bus and was evaluated at her school by the school nurse, where instability in standing was noted. She attempted to attend tumble practice that afternoon but was unable to physically participate. Later that night, her family again noticed her to be "unsteady" on her feet. She was evaluated by her PCP on the morning of Tuesday, 10/6, at which point she was referred to the hospital. 10/7 MRI Spine Cervical-Thoracic-Lumbar W W/O Contrast showed diffuse cauda equina nerve root enhancement and Lumbar Puncture  preformed CSF showed elevated protein 23, and normal WBC count of 7.
Irregular period; Unable to get pregnant; causing me not to ovulate; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (Irregular period), INFERTILITY FEMALE (Unable to get pregnant) and ANOVULATORY CYCLE (causing me not to ovulate) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced MENSTRUATION IRREGULAR (Irregular period), INFERTILITY FEMALE (Unable to get pregnant) and ANOVULATORY CYCLE (causing me not to ovulate). At the time of the report, MENSTRUATION IRREGULAR (Irregular period) had not resolved and INFERTILITY FEMALE (Unable to get pregnant) and ANOVULATORY CYCLE (causing me not to ovulate) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.   No treatment medications were reported.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Red round macular rash, each about 1cm in diameter, limited to right forearm.
sensation of "conflict in arm"; redness; upper arm itchiness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of SENSORY DISTURBANCE (sensation of "conflict in arm"), ERYTHEMA (redness) and VACCINATION SITE PRURITUS (upper arm itchiness around the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and HYDROCORTISONE for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced SENSORY DISTURBANCE (sensation of "conflict in arm") and VACCINATION SITE PRURITUS (upper arm itchiness around the injection site). 13-Mar-2021, the patient experienced ERYTHEMA (redness). On 13-Mar-2021, SENSORY DISTURBANCE (sensation of "conflict in arm") and VACCINATION SITE PRURITUS (upper arm itchiness around the injection site) had resolved. At the time of the report, ERYTHEMA (redness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Inhibiting antibodies positive: positive IgG Positive. In 2021, SARS-CoV-2 test: negative (Negative) Covid-19 tested Negative.         Patient treatment included Hydrocortisone cream and Benadryl.  Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-060017 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Added patient's demographic and medical history. Event (redness) was added.
Reaction to smallpox vaccine.  Red streaks on right arm, shortness of breath, kidney tenderness, cervical and axillary lymphadenopathy and night sweats.
No temp excursions and no symptomatic side effects reported by patient. No additional AE details or PQC; Inbound call from HCP stating that an expired PNEUMOVAX 23 was inadvertently administered past it's expiration date; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 08-MAR-2023, the patient was inadvertently vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe (dosage regimen, and route of administration were not provided), lot #U026796, expiration date: 28-JAN-2023, administered as prophylaxis (expired product administered). No temperature excursions and no symptomatic side effects were reported by patient (No adverse event).
Pain at injection site almost immediately. Gradually developed (L) arm heaviness and numbness 2 days after injection. No hives/swelling.
the child has unspecified developmental delays; patient was pregnant when she received a dose of MMR Il. Patient gave birth to a child; This spontaneous report was received from a nurse regarding a child patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. The mother of the patient was pregnant. Her last menstrual period (LMP) and Estimated date of delivery (EDD) was not reported. On an unknown date, when the mother of the patient was pregnant, she was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, strength, lot number and expiration date unknown) and the patient was exposed to the vaccine via transplacental route (foetal exposure during pregnancy). The vaccine was reconstituted with a sterile diluent. On an unknown date, the child was born and had some unspecified developmental delays. The outcome of developmental delay was unknown. The outcome of foetal exposure during pregnancy was recovered.   This case is cross referenced with 1909USA006681 (mother case).
1) Elevated heart rate of 135bpm upon waking: waited till 8:00 to contact physician. Heart rate began lowering after a couple hours. Decided not to go to doctor.  2) Headache and heart racing episodes throughout the day after shot.  3) Unable to rotate head on left side due to pain in neck for two days. Could not raise left arm the day after shot.
within a few hours, chills, pain in joints and bone and muscles, fatigue, headache; within a few hours, chills, pain in joints and bone and muscles, fatigue, headache; within a few hours, chills, pain in joints and bone and muscles, fatigue, headache; within a few hours, chills, pain in joints and bone and muscles, fatigue, headache; within a few hours, chills, pain in joints and bone and muscles, fatigue, headache; within a few hours, chills, pain in joints and bone and muscles, fatigue, headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), ARTHRALGIA (non-serious), BONE PAIN (non-serious), MYALGIA (non-serious), FATIGUE (non-serious), HEADACHE (non-serious), outcome "recovering" and all described as "within a few hours, chills, pain in joints and bone and muscles, fatigue, headache". Therapeutic measures were not taken as a result of chills, arthralgia, bone pain, myalgia, fatigue, headache. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 20Sep2023, the patient received BNT162 OMICRON (XBB 1.5) within four weeks to the previous COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration) on or about 07-APR-2010, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 04-NOV-2013, the patient was treated for a painful rash that was diagnosed as shingles. On or about 21-OCT-2014, the patient was treated at the same facility for symptoms that had worsened. The patient was diagnosed with post herpetic neuralgia, a painful and chronic condition involving nerve damage as a residual effect of multiple shingles outbreaks. 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, and pain and suffering, and other damages. Additional information has been requested.
High temp leading to one convulsion lasting one to two minutes-(maybe). Taken to hospital emergency room only.
Information has been received from a consumer from a medical office concerning a 74 year old female who on Oct 15, 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot# 642749/0111M). In Oct 2002, the patient developed injection site reaction. The patient sought unspecified medical attention. The reporter provided information regarding three other patients (WAES0210USA01938, 0210USA02077 and 0210USA02078). Additional information has been requested.
migraine/headache; migraine/headache; chills; myalgia; arthralgia; sensitive skin; flank pain; This case was reported by a physician via call center representative and described the occurrence of migraine headache in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 29th August 2019).   On 10th November 2019, the patient received the 2nd dose of Shingrix. On 11th November 2019, 1 days after receiving Shingrix, the patient experienced migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain. On an unknown date, the outcome of the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain were not recovered/not resolved.   It was unknown if the reporter considered the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain to be related to Shingrix.  Additional case details were reported as follows: The healthcare professional did not have the vaccine lot number and expiry date. The patient experienced migraine headache, chills, myalgia, arthralgia, sensitive skin, and flank pain. These events were ongoing at the time of reporting. The reporter consented to follow up. In the XML document outcome of events was reported as recovering, but its mentioned as not recovered, so kept as reported.
Within 15 minutes of injection, back if throat & back of tongue began to tingle & burn. I could feel my whole face & throat tightening up. Began to have swallowing difficulty. I was getting a woozie feeling within 30 minutes. I took 100mgm benedryl by mouth w about a pint of water. For the next 50-60  minutes, the tightness continued as far as below my collar bones  face very tight swollen. Red raised itchy rash started all over my body.  Had epipen in hand as well as stat dose of prednisone to take if necessary.  (I have an allergic reaction protocol in hand from my doc for these cases. Transport to ER is always there if needed) . Took about an hour for the benedryl to start countering the adverse affect.  Took another 100 mgm at the 4 hr post injection time mark.  By bedtime about 10pm, I felt very fatigued, throat & back of tongue very sore & raw feeling.
Singles virus broke out within one week of  receiving the 2nd COVID-19 vaccination shot. The patient reported to Dr who was then given 400 mg of anti-virals medication.  Patient did not improve and was taken to Hospital on 5/17/2021.  The Patient was transferred to Hospital on 5/26/2021 and then died on 6/4/2021.
HYPOTENSION 2/4 AND 2/5, REQUIRED BUMEX REDUCTION THEN MEDICATION D/C, VERY POOR APPETITE UNABLE TO GET. REPEAT LAB WORK, RECEIVED PNEUMOCOCCAL CONJUGATE PCV-13 LOT DP5138, 1/19/2021
Pharmacist calls to report an expired dose of Engerix-B was administered to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 52-year-old male patient who received HBV (Engerix B) (batch number 4345R, expiry date 11-AUG-2023) for prophylaxis.   On 11-SEP-2023, the patient received Engerix B. On 11-SEP-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Pharmacist calls to report an expired dose of Engerix-B was administered to a patient).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 12-SEP-2023 The reporter called to report an expired dose of Engerix-B was administered to a patient, which led to expired vaccine used. The reporter consented to follow up via email.
This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 15-AUG-2016, the patient was vaccinated with improperly stored dose of VARIVAX (lot # L042266, expiration date 27-OCT-2017, exact dose and route dose of administration were not reported). The administered dose experienced a temperature excursion of 11.5 degree Fahrenheit for 3 hours and 54 minutes. Previous temperature excursion was reported. The call was because of a data logger. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Felt Numbness in 3 fingers; Right hand was tingling; Arm was Very Sore; Could not sleep; Shoulder to elbow was burning and painful/shoulder still hurts; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Felt Numbness in 3 fingers), PARAESTHESIA (Right hand was tingling), PAIN IN EXTREMITY (Arm was Very Sore), INSOMNIA (Could not sleep) and ARTHRALGIA (Shoulder to elbow was burning and painful/shoulder still hurts) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 25-Mar-2021, the patient experienced HYPOAESTHESIA (Felt Numbness in 3 fingers), PARAESTHESIA (Right hand was tingling), PAIN IN EXTREMITY (Arm was Very Sore), INSOMNIA (Could not sleep) and ARTHRALGIA (Shoulder to elbow was burning and painful/shoulder still hurts). On 26-Mar-2021, INSOMNIA (Could not sleep) had resolved. On 28-Mar-2021, PAIN IN EXTREMITY (Arm was Very Sore) had resolved. At the time of the report, HYPOAESTHESIA (Felt Numbness in 3 fingers) and ARTHRALGIA (Shoulder to elbow was burning and painful/shoulder still hurts) had not resolved and PARAESTHESIA (Right hand was tingling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment for the event included tylenol.   This case was linked to MOD-2021-101870 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow up received on 12-MAY-2021 and the outcome of the event was updated and second dose details and AE related to it was mentioned..
I was only the MA who administer vaccines. PSR informed RN's of pt reactions. The RN's took over, so I don't know what was the reactions of the PT.
Complaint of fever X 3 days, swollen left thigh and fussy. Had induration, erythema and tenderness on left thigh.
fully vaccinated, not boosted.  Asymptomatic COVID breakthrough infection with inpatient hospital stay.
On January 7th all of my symptoms began.  7:30am: woke up feeling uneasy. Not much of a headache or no fever. 12:30: woke up from nap. Severe body aches (with sharp stabbing like pain accompanying them. Chills, severe headache . All of these symptoms accompanied me all night long. 3:30pm: I finally got a thermometer and had a fever of 100.7 which I then took 1000mg of Tylenol which helped.  7:30pm: body aches start coming back 9:30pm: headache, chills are back with a fever fever of 100.3 Took another 1000mg of Tylenol.  3:30pm: woke up from sleep to take more Tylenol, physically felt better. No fever was present and my temperature was back to 98.8.  January 8 2:00pm: feeling back to normal essentially just tired. I have been sleeping a lot too with this vaccine..
This spontaneous report was received from a pharmacist and refers to a 62 year old male patient. No pertinent medical history was reported. On 20-JAN-2016, the patient was vaccinated with ZOSTAVAX (dosing details and lot/expiration were not reported). No concomitant therapies were reported. On 01-MAR-2016, the patient called to the pharmacy and stated he experienced soreness at the injection site (onset date approximated to 2016). The pharmacist has not seen the patient since 20-JAN-2016 and she stated the patient denied redness, swelling or rash of any kind at the injection site. The patient did not seek medical attention and no treatment was given for the event. The outcome of the event was unknown. Causality assessment was not provided. Additional information has been requested.
Increasing redness and itching around injection site. Still spreading Jan 18. Area now about 6x4 ". No fever, chills, swollen lymph nodes
My son was on target with speech and gross motor skills approaching his first birthday. He said about 10 words, knew the signs for cup, food, mom and dad. Loved being held and rocked to sleep.  We took him to the doctor for a checkup for an ear infection a slight cold. They told us he needed shots, I asked them if we could reschedule the vaccinations, and they told me that it would be fine to give them to him.  Approximately 7 days following his June vaccinations in 2007, he changed completely. He no longer made eye contact with anyone, went back to babbling like an infant again and seemed to lose his motor skills. He became very clumsy. Not thinking that there would be a tie to the shots, we took him to his old pediatricians office, and they thought nothing of it.  So we figured that we just needed to do more work with him. In November of 2007, when things did not get any better we found a new pediatrician. He recommended speech therapy, behavior therapy and a hearing test. By the time we got all of the tests done, he had a 12-18 month speech delay, behavior problems, ADHD and PDD.  2/18/09 MR received from PCP. First seen a 16 months for asthma.  Spleen noted to be enlarged.  Probable Immune D/O.  18 month WCC WNL. Developmental Assess WNL. Speech Delay noted at 2 yr exam. Developmental Assess with <20 words. No Autism signs. loss of coordination, became sick all the time, loss of speech.
developed a petechial rash ~ 1 week after vaccines, diagnosed with Idiopathic thrombocytopenic purpura (HCC)
This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (administered past the 30-day use-by-date) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 042J21A) for COVID-19 immunization. No medical history reported. February 2022, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. February 2022, patient administered expired product (administered past the 30-day use-by-date). At the time of the report, administered expired product (administered past the 30-day use-by-date) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reportedly, 26 doses given after the 30-day use-by-date. It was reported the vial was initially stored in the refrigerator on Jan 14, 2022. The dates of vaccine administration were Feb 14, 2022; Feb 15, 2022; Feb 16, 2022; Feb 18, 2022 and Feb 21, 2022.