chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received via a search of the scientific literature on 25 July 2011. A 17-month-old female patient presented to the emergency department with acute onset of inability to bear weight on her left leg 10 days after she had received a DPT vaccination (date and route of administration not reported) in her left thigh during a pediatric well baby visit. She had no history of constitutional symptoms or trauma. Physical examination demonstrated a fullness with measured asymmetry to her left thigh. Laboratory and diagnostic findings included CBC results - white blood cell count of 12,300; with 32 neutrophils, 49 lymphocytes, 9 monocytes and 10 eosinophils. She had elevated creatine phosphokinase (CPK) and minimal elevation of aspartate aminotransferase (AST) and alanine aminotransferase (ALT). Sedimentation rate was 12, and C-reactive protein was minimally elevated. Radiographs of the left femur demonstrated soft tissue swelling, but no osseous abnormality. MRI demonstrated myositis involving the vastus medialis, vastus intermedius and vastus lateralis muscles with edema and a central serpigenous collection of fluid. Culture of the fluid revealed no growth. Following intravenous gadolinium there was prompt hyperemic enhancement of the muscles, with an area of low signal representing the abscess and surrounding ring enhancement. There was no mass identified and the marrow had normal signal characteristics. Post contrast image showed the long length of the myositis surrounding the shaft of the femur with a central area of nonenhancement representing the sterile abscess, surrounded by the ring enhancement. The patient was discharged from the hospital without receiving antibiotics or invasive surgical intervention. With conservative therapy, the pediatrician reported that the patient returned to normal activity within seven days. Documents held by sender: None.
my smell and taste senses were completely altered and everything has the exact same chemical taste.; my smell and taste senses were completely altered and everything has the exact same chemical taste.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Jan2022 13:00 (Lot number: FE3594) at the age of 29 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FE3594, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 05Jan2022, for covid-19 immunisation.  The following information was reported: PAROSMIA (non-serious), TASTE DISORDER (non-serious) all with onset 02Feb2022 06:00, outcome "not recovered" and all described as "my smell and taste senses were completely altered, and everything has the exact same chemical taste.". Therapeutic measures were not taken as a result of parosmia, taste disorder.  Additional information: The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. The patient had not been tested for covid tested post vaccination. The patient had no known allergies. The patient had no other medical history. Adverse events start time: 06:00 AM. A few days after receiving my second dose of the Pfizer vaccine my smell and taste senses were completely altered and everything has the exact same chemical taste. It has now been about 50 days and I still do not have my smell or taste back; everything is still altered. Only thing that has changed is sweet stuff now has a artificial vanilla extract smell and taste, this change came about two weeks ago.  No follow-up attempts are possible. No further information is expected.
Patient was injected with Menactra and Gardasil on 8-22-07. On 8-25-07, she started with fatigue, epigastric pain, nausea, and decreased appetite. She vomited twice before seeing me on 09-01-07. She had lost 5 1/2 lbs and was treated with Zofran.
1 hour post Moderna booster my heart started pounding very hard which lasted for several days. 2 days after the booster I woke up in the middle of the night feeling like I was going to pass out, sweating profusely and nauseous. I attempted to walk to the bathroom and almost fell. This happened the following night and a couple of days later the same thing happened during the day. I became severely dizzy, could not walk straight, felt like vomiting and became sweaty. Never had a temperature. A couple days after my left arm became completely numb which lasted approximately 10 minutes, had intermittent numbness in left hand and lower arm. At a separate time I experienced numbness from left shoulder up the left side of my face and head which lasted 15 minutes. I having been on and off sweating, brain fogginess, headaches and fairly severe fatigue since then.
PATIENT SEEN IN THE ER WITH POSSIBLE VIRAL MENINGITIS, ER REPORT STATES POSSIBLE CAUSE AS RECEIVING THE FLU-MIST VACCINE. 11/09/09 Medical records received for DOS 10/23.  Final DX: Viral meningitis.  Three s/p vaccine: C/O fever, HA, nausea,   body aches, vomiting, flu-like sx. Muscle aches. Photo and phonophobia.  CSF WBC increased. Viral syndrome w/meningitis. Migraine.
2 minutes after the 1 pfizer dose, the patient fainted.  Water was given with one 500 mg of tylenol, and the patient seemed better.   911 was called, and after the EMT arrived her vitals were checked which was normal.  Afterwards, she felt better and went home with her parent.
Patient presented to hospital with 1 day of extreme lethargy 2 days after receiving the Moderna COVId-19 vaccine. Patient had Mohs surgery on a L forearm lesion with cryotherapy to scalp on 27 Jan. He went to daycare problem on 28 Jan, in normal state of health. upon return, patient felt warm and had difficulty standing out of car. Wife let him rest on a chair in the kitchen and found him on the floor in the morning, for a unknown amount of time, unwitnessed descent to floor.
headache; can barely stand; eyes are blurry; I walk, but stop because my head hurts really  bad; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 39-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration on 03Sep2021 (at the age of 39 years) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration on an unknown date (at the age of 39 years) as dose 1, single for COVID-19 immunization. The patient got 2nd dose on Friday, 03Sep2021, since then she had headaches and now it was worse, she could barely stand up. She walks, but stop because her head hurts really bad, her eyes were blurry, she had a big headache not sure if it had to do with the blurriness or not. The outcome of all the events was unknown.   Follow up attempts are completed. No further information is expected.
I just don't feel right, I don't feel good; I am in a lot of pain; pain from my neck down; Every muscle in my body and joint hurts; Felt sluggish; My legs are starting to hurt; Burst of energy; I am tired, Starting to get fatigue; My knees and my legs are starting to hurt, and joint hurts; Got a headache, headache will not go away, headache is getting worst; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Felt sluggish), PAIN IN EXTREMITY (My legs are starting to hurt), FEELING ABNORMAL (I just don't feel right, I don't feel good), PAIN (I am in a lot of pain) and NECK PAIN (pain from my neck down) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma. Concomitant products included FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA), MONTELUKAST and FEXOFENADINE for an unknown indication.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, the patient experienced SLUGGISHNESS (Felt sluggish), PAIN IN EXTREMITY (My legs are starting to hurt), ENERGY INCREASED (Burst of energy), FATIGUE (I am tired, Starting to get fatigue), ARTHRALGIA (My knees and my legs are starting to hurt, and joint hurts) and HEADACHE (Got a headache, headache will not go away, headache is getting worst). On 17-May-2021, the patient experienced FEELING ABNORMAL (I just don't feel right, I don't feel good), PAIN (I am in a lot of pain), NECK PAIN (pain from my neck down) and MYALGIA (Every muscle in my body and joint hurts). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 UNK. At the time of the report, SLUGGISHNESS (Felt sluggish), PAIN IN EXTREMITY (My legs are starting to hurt), FEELING ABNORMAL (I just don't feel right, I don't feel good), PAIN (I am in a lot of pain), NECK PAIN (pain from my neck down), ENERGY INCREASED (Burst of energy), FATIGUE (I am tired, Starting to get fatigue), ARTHRALGIA (My knees and my legs are starting to hurt, and joint hurts), HEADACHE (Got a headache, headache will not go away, headache is getting worst) and MYALGIA (Every muscle in my body and joint hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications Montelukast and Fexofenadine were taken daily and dulera was taken twice a day by the patient.
This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for Covid 19) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for Covid 19). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for Covid 19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, SARS-CoV-2 test: unknown (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. As reported  patient experienced signs and symptoms of COVID-19. Concomitant medications were not reported. Treatment information was not reported.
Large 5" area of redness on right arm with 4" induration upper arm.  Lower arm-some redness, no induration with 1" redness.
For about 2 days, all I wanted to do was sleep.; Felt really fatigued; Blinding headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (For about 2 days, all I wanted to do was sleep.), HEADACHE (Blinding headache) and FATIGUE (Felt really fatigued) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029K20A) for COVID-19 vaccination.     The patient's past medical history included Blood pressure low (The patient was on a ventilator for about a week because her blood pressure was 40) and Pacemaker insertion (cardiac). Concurrent medical conditions included Bradycardia.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced HEADACHE (Blinding headache). On 19-Feb-2021, the patient experienced SOMNOLENCE (For about 2 days, all I wanted to do was sleep.) and FATIGUE (Felt really fatigued). At the time of the report, SOMNOLENCE (For about 2 days, all I wanted to do was sleep.), HEADACHE (Blinding headache) and FATIGUE (Felt really fatigued) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.
Arm with slight pain at inject site. Increased in severity on 5th day to point at which arm from shoulder to elbow throbbing. Treated with heating pad- Has decreased significantly since (arm hurt for 2 weeks following flu vaccine).
UPPER LIP NUMBNESS NO SOB NO RESPIRATORY DISTRESS AND STABLE VITAL SIGNS B/P114/76 P-53
Child was given VARIVAX lot # Merck 0059Y exp 1/8/11, 9/10/09 seen in office 10/1/09 documented VARICELLA.
Varicella-like rash and urticaria, began two days following vaccine, lasted two weeks with treatment consisting of valcyclovir, claritin, zantac and singulair.
So tired; chills; Have some muscle pain; Low-level headache and headache kind of weird; I feel like I had a fever but when I take it I don't; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FATIGUE (So tired), CHILLS (chills), MYALGIA (Have some muscle pain), HEADACHE (Low-level headache and headache kind of weird) and PYREXIA (I feel like I had a fever but when I take it I don't) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (taking bloodpressure medication). Concomitant products included AMLODIPINE for Blood pressure.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced FATIGUE (So tired), CHILLS (chills), MYALGIA (Have some muscle pain), HEADACHE (Low-level headache and headache kind of weird) and PYREXIA (I feel like I had a fever but when I take it I don't). At the time of the report, FATIGUE (So tired), CHILLS (chills), MYALGIA (Have some muscle pain), HEADACHE (Low-level headache and headache kind of weird) and PYREXIA (I feel like I had a fever but when I take it I don't) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.     Treatment information was not provided.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Soreness at injection site in arm lasting 2 days; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates unknown), via an unspecified route of administration on left arm, on 26Jan2021 at 08:30 AM, at a single dose for COVID-19 immunization at clinic. Medical history was not reported. Patient had no allergies to medications, food, or other products. Concomitant medications included sertraline hydrochloride (ZOLOFT), atorvastatin (LIPITOR) and amlodipine besilate (NORVASC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. On an unknown date in Jan2021 at 09:30 AM, the patient experienced soreness at injection site in arm lasting 2 days. The patient assessed the event as non-serious. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient recovered from the event on an unspecified date in Jan2021.  Information on the lot/batch number has been requested.
Bad mensural cramps; Full body shakes; vomiting; dizzy; heavy period; pain; This is a spontaneous report from a contactable consumer (patient reported for herself). A 28-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 (pending clarification) via an unspecified route of administration, administered in Arm Left on 28Apr2021 13:00 at the age of 28 years old (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. On 09May2021 5:00, the patient experienced Bad mensural cramps, Full body shakes, vomiting, dizzy, heavy period two weeks after 2nd dose. Ended up in the emergency room.  Still in pain 3 days later. The adverse events result in Emergency room/department or urgent care. No treatment. Seriousness criteria was hospitalization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovered with sequel in May2021.  Information on the lot/batch number has been requested.
fever >102 x 24hrs. 48hrs out still have fever >100. general aches and pains. left axilla lymph nodes very swollen, inflamed, and tender (cannot fully rest arm on side because of discomfort, injection received in left arm).  stiff neck and fatigue.
flu like symptoms; Aching; overall yucky; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, general body pain and feeling abnormal. On an unknown date, the outcome of the influenza-like symptoms, general body pain and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, general body pain and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's husband. The reporter stated that, within 24 hours after vaccination, the patient experienced flu like symptoms including aching and overall yucky. The reporter stated that, the symptoms were resolved within 3 to 4 days. For the tollerence of 2nd dose refer case US2020040962, reported by same reporter for same patient. This case has been linked with case US2020040957, reported for the patient's husband.
This case was reported by a other health professional via sales rep and described the occurrence of chills in a 51-year-old female patient who received SHINGRIX for prophylaxis. On 31st July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced chills, fever, influenza-like symptoms, nausea, stomach pain, injection site swelling, injection site erythema and muscle pain. In August 2018, the outcome of the chills, fever, influenza-like symptoms, nausea, stomach pain, injection site swelling, injection site erythema and muscle pain were recovered/resolved. It was unknown if the reporter considered the chills, fever, influenza-like symptoms, nausea, stomach pain, injection site swelling, injection site erythema and muscle pain to be related to SHINGRIX. Additional information was received as follows: In 2018, the patient experienced chills, feverish, flu like symptoms, nausea, severe stomach pain, injection site swelling and redness, muscle pain in injection arm for a week. The reporter agreed to follow up from GlaxoSmithKline.
A covid vaccine vial was reconstituted twice, this patient received a diluted dose of the vaccine, the patient was contacted about the issue, and patient refused to get revaccinated at this location
Large red swollen area on right upper arm after receiving two shots (I believe it was either a meningitis booster or MMR booster and flu shot); warm to the touch; measured 7.5cm in diameter.
Pt had at least 2 (possibly a brief 3rd) short less than or equal to 2 min episodes of rhythemic extre. jerking and "eyes rolling back in head," both spontaneously stopped. Temp 104 axillary.
Fever up to 103.2 after shots were given. Shots given at 1055AM on 10-31-11 and fever started that night. The next day fever was down per parents & child was acting normally. Pt. given f/u appt 11-3-11 but did not show up & did not return phone call. Will try calling again.
Swollen injection site Swollen arm Largely Swollen lymph nodes Headache  Dizziness Inability to lift arm for more than 2 minutes Intense pain to touch Axillary pain
Rash all over body and face starting on Friday, April 5th.  Swollen hands, arms and feet.  Itchy and burning.  Took Benadryl.
At the end of January 2000, the pt experienced a mild case of chickenpox. No further information is available.
26NOV97 inconsolable crying for 3hr;no fever;tx APAP
Pregnant patient miscarried; got pregnant in between the first and second dose; A spontaneous report was received from a pharmacist ,concerning a 38-year-old, female patient , who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced getting pregnant in between the first and second doses (Exposure during pregnancy) and miscarried/abortion spontaneous.  The patient's medical history was not reported. Concomitant medications were not reported.  On 15 Jan 2021, patient received the first of two planned doses of mRNA-1273 (Lot/batch: unknown) vaccine intramuscularly for prophylaxis of COVID-19 infection.  Between an unknown date and 17 Mar 2021, the patient become pregnant and experienced a miscarriage.  On March 17 2021, the patient received the second of two planned doses of mRNA-1273 (Lot/batch: unknown) vaccine for prophylaxis of COVID-19 infection.  The event, miscarriage, was medically significant.  Laboratory details were not reported. Treatment information was not reported.  Action taken with mRNA-1273  in response to the events was not applicable.  At the time of report , the outcome of events; got pregnant in between first and second dose and pregnant patient miscarried were, were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
L deltoid redness and hardness pt. denied any pain except when someone touches with hand. Mom noticed 48 hours after immunizations treatment - cold compress, Motrin + Benadryl.
Next day welt at injection site, stiff arm, full body joint pain, painful breathing / shortness of breath, ringing in ears for hours, and headache. Recommended by nurse line to go to ER. Joint pain and ringing in ears continue on 2 NOV 2023 after discharge.  Had previous shot a year ago with only injection site pain, second shot given 31 October lead to above symptoms
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 18-JUN-2017, the patient may received an improperly stored dose of ROTATEQ orally, lot # M007124, expiration date 05-OCT-2017 (dose was not reported) for prophylaxis. The vaccine was stored at a temperature between 32°F and 35°F, during 48 hours. The report was because of a data logger and there were no previous temperature excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Pt fainted 30 sec after inj- Pulse 50 x 30 min. No injury 45 min later discharged. B/P 90/60 Sx resolved B/P increased Pulse increased 60