chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a consumer on 16 October 2016. This case involves a patient (age at onset of event and gender not reported) who was vaccinated with Flu shot (batch number, expiry date of the product, route and site of administration, dose and dose in series were not reported) on an unspecified date. It was reported that the patient had been receiving flu shots every year. No further information regarding medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient started getting bad stomach pains, sweating profusely with sweat really smelling bad. It was reported that patient almost called the emergency. Laboratory data and corrective treatment were not reported. Patient was recovered from the events may be after a duration of about 45 minutes. The reporter's causality assessment was not reported but the pharmacy which the patient had called, 'didn't think it was was the injection'. List of documents held by sender: none.
On 06/19/2003 patient RTC- left deltoid red, hot with 100 x 95 mm reaction. This observation noted by RN on duty at time and seen as well by MD per her note in chart.
Itchy rash started 3 days after she received the 2nd Shingrix shot per patient. She said it is all over her body and is itchy enough to prevent her from sleeping.
She developed fatigue, dizziness and static in her vision. It came and went for the first few weeks, and has now become permanent and is present 24/7. It has been diagnosed as Visual Snow Syndrome.
Shoulder was also sore the next day; left cheek went numb, has some numb spots(Bell's palsy symptoms); This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOAESTHESIA (left cheek went numb, has some numb spots(Bell's palsy symptoms)) and ARTHRALGIA (Shoulder was also sore the next day) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included LEVONORGESTREL (MIRENA) and LYSINE for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced HYPOAESTHESIA (left cheek went numb, has some numb spots(Bell's palsy symptoms)). On 16-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRALGIA (Shoulder was also sore the next day). On 18-Jan-2021, ARTHRALGIA (Shoulder was also sore the next day) had resolved. At the time of the report, HYPOAESTHESIA (left cheek went numb, has some numb spots(Bell's palsy symptoms)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up Information received on 04-JUN-2021  contains no newinformation On 08-Jul-2021: Follow-up received which contains updated outcome of event from not recovered to recovered.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Pt presented for following Sx: fever (up to 103.9), body aches, headaches, bladder incontinence, fatigue. Onset of Sx occurred Monday evening after receiving Tdap and Prevnar vaccines.
Information has been received from a medical assistant concerning an 8 week old female patient who on 01-JUL-2009 was vaccinated with a recommended dose of ROTATEQ (lot number not reported) via oral administration.  On 08-JUL-2009, the patient experienced vomiting after receiving vaccine.  The patient had sought medical attention by calling the office.  On 09-JUL-2009, the patient recovered from vomiting.  Additional information has been requested.
Cough, shortness of breath, chest tightness, subjective fever, significant h/o coronary disease. Sent to Emergency Department for care.
Pt presented to the monitor with c/o of racing heart rate (HR). Monitor referred pt to myself. Pt reports after feeling like her heart was racing she checked and noted a HR of 110. Pt was provided a seat in the more private monitoring location. Coat removed and water provided. 9:40am = HR now 6. Pt continued to be seated. 9:50am = HR of 80. 9:55 am = HR of 78. Pt has drank 6 ounces of water. No other changes noted on physical assessment. Asked pt to stand and no dizziness reported. Pt counseled to follow with her MD in anything was to happen and noted the V-safe information. Pt d/c.
Pressure in my right ear. "Whoosing sound in right ear". Felt like head cold but isolated to the right side. I work as a RN, a work a case of vertigo sent me to the ER 10/11/15 CT Showed mild hydrocephalus.
Broke her tooth; Half of the enamel bonding came off; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH INJURY (Broke her tooth) and ENAMEL ANOMALY (Half of the enamel bonding came off) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced TOOTH INJURY (Broke her tooth) and ENAMEL ANOMALY (Half of the enamel bonding came off). At the time of the report, TOOTH INJURY (Broke her tooth) and ENAMEL ANOMALY (Half of the enamel bonding came off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Swollen arm, fatigue - first day. Bruise on arm and other body parts, does nothing but sleep, wouldn't eat - second day. He had blood work done a week later and he was anemic, low red and white blood cells and platelets. Still has a lump and bruise at injection site. has to go in for routine blood work every two weeks - today 09/26/2016.
Information has been received from a physician concerning a female (age not reported) who on 19-JAN-2007 was vaccinated with one 0.65 mL dose of Zostavax. The physician reported that the patient came into the office on 12-MAR-2007 with a break through itchy rash after being vaccinated. There was an unknown amount of lesions that appeared on her upper and lower back. The patient's status was not reported. There was no product quality complaint. Additional information has been requested.
Developed Hives 3-4 days after the vaccine.  This also occurred after 2nd shot but several months after the time of vaccine.  The hives this time where located on chest, stomach, upper arm.  Welty in appearance but most looked like little line.  some weeped with developed of scabbing.  Itched.  Treated by dermatologist with two antihistamine (Pepcid AC and Zyrtec) and now using a cream and ice pack as well.  No improvement in hives and continues to have new flairs.
No additional AE; HCP reported VARIVAX was administered after a temperature excursion to a patient. VARIVAX was administered on Jul 29, 2022. No further information provided.; This spontaneous report has been received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and drug allergies were not provided.   On 29-JUL-2022, the patient was vaccinated with improper storage varicella virus vaccine live (Oka/Merck) (VARIVAX) once as prophylaxis (lot number W011625 had been verified to be a valid number; expiration date reported and established as: 06-APR-2024; dose, route of administration, and anatomical location were not provided).   The vaccine experienced a temperature excursion of minus 8.1 Celsius degree with time frame of 1 hour 58 minutes and 0 seconds. It was stated that no previous temperature excursion occurred.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA002443: US-009507513-2208USA002737: US-009507513-2208USA003187: US-009507513-2208USA002739:
3 or 4 days later, I came down with what they call "COVID-19 arm"- a red rash about 4 in long and 3 in wide. Very itchy and bumpy. About 2 weeks afterwards the same spot developed a big bruise. Ever after that I started to bruise very easily over everything. Fast forward, I was referred to urgent care because my platelet count was so low. The doctor told me that my frequent bruising all over my body was due to the low platelet count. It came up that the timing started after my first vaccination. The doctor prescribed steroids to help. I still have to go in every few weeks to check my platelet levels. They have gotten better but are still not recovered by any means.
This case was reported by a nurse and described the occurrence of dizziness in a patient who received HAVRIX 1440. On an unknown date, the patient received HAVRIX 1440 1 ml. On an unknown date, unknown after receiving HAVRIX 1440, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown. It was unknown if the reporter considered the dizziness to be related to HAVRIX 1440. Additional details were provided as follows: The age at vaccination was not reported. The patients had adverse reaction to medication. The customer also stated she contacted the vendor. The customer had been notified in writing that their complaint was forwarded to GlaxoSmithKline vaccines for investigation and said that to respond directly to the complainant in this matter and copy Health Office at provided address. This case is 1 of the 4 cases reported by the same reporter.
Vaccine given 11AM 11/6/2004. Overall swelling started at 1PM by 2300 swelling severe, to ER.
Information has been received from a nurse concerning a female who was vaccinated with Gardasil. Subsequently, "within last week or week and a half," the patient developed a fever and was admitted to the hospital for 24 hours. Additional information is not expected.
immediately after the dose she developed chest pain that radiates to the upper back, lower back and hips
Tenderness in arm 9 days post injection followed by heat and erythema at injection site not previously there currently increasing in size.
Information has been received from a physician concerning an 18 month old female patient with no allergies and no pertinent medical history, who on 1/6/04 was vaccinated with a dose of varicella virus vaccine live (lot # 646360/0571N). There was no concomitant medication. On 7/20/04, the patient was diagnosed with a mild non-dramatic case of varicella. She had 10-15 pox and no fever. Treatment was not required. The patient has recovered from mild non-dramatic varicella. There was no product quality complaint reported. The physician also reported that the patient's mother was not immune so she was given varicella-zoster immune globulin and she also had a minor breakout of chicken pox. Additional information has been requested. The physician also mentioned another female patient who experienced a similar reaction following vaccination with varicella virus vaccine live (lot #620630/1345D) (WAES0408USA01536).
Parent reports short sz like event 2-3 hours post vaccines x1 and then similar event within 48 hours at day care - no hospitalization. Event last < 5 min, EMS evaluated at scene and referred her. No prior illness, afebrile at time per parent.
Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with unspecified doses of improperly stored VAQTA 25/0.5 (lot # K019560 with expiration date of 02-JUN-2015, dose and route unknown). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
When vaccine occurred had immediate severe pain in LT deltoid, continues to have severe pain in LT arm with movement along with numbness and tingling. She has pain anytime she moves her arm and has noticed a senstation loss to deltoid as well.
This is the 2nd dose for boosting. The first dose was a month ago.  ~11:00 AM, she became very fussy and cried a lot. She seldom cries that much. ~2:00 PM, we found her right facial palsy especially when smiling and swelling eyelid on both sides.
Information has been received from a pharmacist concerning a 54 year old female with fibromyalgia who on 13-OCT-2008 was vaccinated with PNEUMOVAX 23 0.5 ml IM (therapy site unknown).  Influenza virus vaccine (manufacturer unspecified, route unknown) was given on the same day in the same arm.  After receiving PNEUMOVAX 23 the patient developed swelling, pain and redness at the injection site.  The patient telephoned and reported to the pharmacist that the area affected was about 6 inches around her arm, and felt like a burning sensation.  At the time of this report, patient was recovering.  A Lot check has been initiated.  Additional information has been requested.  This is one of several reports received from the same source.
A week later I began to develop symptoms. Injection site was hot to touch and itchy as well as a red rash around the injection site.
They do not know what vaccine was supposed to administered at this time; Kinrix was administered to a 4 month old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number 5AY2J, expiry date 10-JUN-2024) for prophylaxis.   On 13-MAR-2023, the patient received Kinrix. On 13-MAR-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: They do not know what vaccine was supposed to administered at this time) and inappropriate age at vaccine administration (Verbatim: Kinrix was administered to a 4 month old). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date-14-MAR-2023 The reporter reported that Kinrix was administered to a 4 month old.  They did not know what vaccine was supposed to administered at this time.  The reporter was consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter. The Kinrix was administered to a 4 month old which led to inappropriate age at vaccine administration. They did not know what vaccine was supposed to administered at this time which led to wrong vaccine administered
Within 5 minutes, post vax, pt became diaphoretic, cold and pale with no evidence of seizure activity. Within a few minutes, pt was complaining of being sleepy and slept for 2 hours but was still clammy and he was faint when standing up. He was fed and seemed to improve. He vomited on the way home from office and was clammy again. Admitted to hospital for observation. Seemed totally recovered by 12 hours, post vax.
Guillain-Barré syndrome,  started in one hand then both and both feet, months later still have numb feet but have regained feeling in hands.  Nerve pain still exist.  strength in right hand has returned as well as left knee.
Hives - BENADRYL. Patient reported after returning home. Instructed to take BENADRYL and go to ER if anaphylactic or sxs worsen.
Dizziness and weakness; Numbness and tingling; Other ADVERSE REACTION Reported: Electrolyte imbalance requiring hospitalization for More than 48 hours with repeated hematology follow up.  Patient is a 54-year-old woman with history of Roux-en-Y gastric bypass surgery and some alcohol abuse who presented to the hospital with fatigue, headache, muscle cramps and weakness.  She also had a slight fever that followed her 2nd dose of COVID-19 vaccine.  She had basic lab work which revealed pancytopenia along with multiple electrolyte disturbances including hypokalemia, hypomagnesemia, hypocalcemia and hyponatremia.  She admits that she had heavy alcohol use over the weekend with binge drinking of liquor.  She otherwise does drink a couple of mixed drinks a night.  She has also been trying to lose a lot of weight.  She says that she lost about 60 lb in the last 6 months on purpose.  She is doing this so that she can have a panniculectomy and tummy tuck.  She recently had a breast reduction in November.  She has not been following with a dietitian or having her vitamin levels checked.  Despite having pancytopenia, her levels remained pretty stable during her stay.  She had a peripheral smear sent which was pending at the time of discharge.  She was also checked for vitamin deficiencies.  She is given a dose of IM B12, IV iron, IV calcium and started on oral calcium vitamin-D supplements.  She does take a daily multivitamin.  Due to her reported history of heavy alcohol use she is also given thiamine and folate.  After speaking with Hematology, recommendations were for her to have a follow-up appointment which is scheduled on February 10th.  I also put in a referral for a dietitian to evaluate her for further recommend deficiencies in the setting of Roux-en-Y gastric bypass surgery with heavy weight loss.  I prescribed her calcium vitamin-D along with folic acid.  I recommended she continue her multivitamin.  I also recommended that she abstain from alcohol use.
Approximately 3-4 hours after receiving DPT vaccine, my son started crying unconsolably. He ran a slight fever, couldn't be comforted, and every so often would shiver/begin to shake. He was seen to have his eyes roll back and his mouth quiver. If I shook him lightly he seemed to stop. Called doctor; told was nothing; now suffers from speech delays and processing problems. Will enter regular education, but received special education assistance.  Nurse follow up on 08/19/04 states: "No new information." Per follow up report-Patient continues to demonstrate difficulties in speech and language, processing, and academic development. He will begin kindergarten this year, but I suspect he will have a difficult time keeping up with the curriculum.
chronic headache, sore throat, muscle/joint pain, intermittent nausea, general malaise
Approximately 24 -36 hours following DTaP administration, parent called stating the child's leg was red, warm to the touch and swollen about 4 1/2 in diameter. Was referred to an after hours clinic. Diagnosis was allergic reaction versus infection. Given Benadryl and Keflex then on 4/5/00 the child developed a fever and was seen by MD. Dx was local reaction and given symptomatic treatment.
Today is the day 5 since receiving the first dose of the Moderna vaccine.  Within the first 24-36 hours, I experienced the to be expected symptoms (headache, tiredness and body aches); however, I continue to experience the following symptoms:  ? Shortness of breath ? Difficulty taking a deep breath ? Lightheadedness ? Dizziness  ? Low heart rate ? Fatigue  These symptoms developed within 24-hours of receiving the vaccine and continue to persist.
Sore upper arm from the first 24 to 36hrs.  Severe (can't sit >15min; can't lie down >3hrs) lower back pain starting 6 days after the shot and still ongoing 13 days after pain started.
Patient said he started getting numb on tips of both feet/toes on Friday Morning.  By Saturday he started getting numb in the shin area and knees.  Sunday numb in waist and hands.  Monday he went to the doctor, stated he couldn't walk.  Dr. sent him to hosp.  He was directly admitted to ICU.  A lumbar puncture was performed and immune globulin started (15 bottles).  protein levels extremely high in spinal fluid.  Hospitalized one week.  Presently has braces on both legs, using a walker, receiving physical therapy.  To follow-up with primary physician in one week.  To follow-up with neurologist in three weeks.  Requesting info on lot # and manufacturer. Information from 60 day follow-up report states: 1/18/06 Spoke with patient regarding recovery status his knees down has no feeling, has regained feeling in thighs with pain consistantly. He has braces on his legs. Presently no therapy is being provided. Physician is estimating recovery to be 6-12 months.  12/29/05 Medical record received for 10/17-10/21/2005 FINAL DX: Guiliain Barre syndrome, dyspnea.  Records reveal patient experienced progressive aching & weakness of legs, numbness of feet & difficulty walking x 2 days & 2 days s/p flu shot.  Reflexes absent.  Neuro & Pulmo consult done, ICU, tx w/IVIG.  Improved & d/c to home.
Went to the Medical Center for chest pain, fever, shortness of breath one day after receiving the vaccine.
Arm pain and tenderness with local swelling at injection site; painful to raise arm.  Tx'd with NSAIDS.  Pt reports had sweats & chills the evening of immunization
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Crying, screaming, left thigh swollen, red, hot to touch.  Temperature 99-100 (R).
Patient  received vaccines then left. She came back about 30 mins later and said she had vomited, and came back to the pharmacy complaining of feeling "faint/funny". We checked her Blood pressure : 190/109 (usual is 110/70 and does not take bp meds). Had patient sit down, gave her a water, cool compress, and also gave her 50mg of Diphenhydramine. She declined my offer to call 911 since her husband was only a few blocks away. No swelling of lips or breathing issues, or fainting spells. Patients husband came and took her to the E.R next door.
KINRIX was used in 4 mo old rather than INFANRIX no adverse event was reported.
Hives at site of vaccine 3 days afterward. Then 7 days afterward full body hives starting base of skull, going up into scalp then descending down over torso -- very itchy.
Patient said that he experienced arm pain in the arm that was vaccinated later that night. He has experienced continued arm pain, including injection site pain and pain radiating down his entire arm and still continues to experience this pain. He described the pain as mostly dull achy pain, but with sometime shooting pain down his forearm. I recommended him to speak with his doctor about this pain.