chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After going to bed I had severe chills. My whole body was shivering. I had to put on extra blankets and heavy socks to counter the chills. I also experienced soreness in the arm. On the day after the shot I had some nausea. This was alleviated by eating. I also took 2 ibuprofen to alleviate headache pain.
lost 10 lbs; I vomited for three nights; lost my appetite; had diarrhea the first week; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in right arm, on 02Jan2021 at 08:30 AM (at the age of 78-years-old) at 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. No COVID prior vaccination and no COVID tested post vaccination. The patient had no known allergies. No other vaccines received in four weeks and no other medications taken in two weeks. The patient lost 10 lbs in 4 days, he vomited for three nights, lost the appetite and had diarrhea the first week, all occurred on 03Jan2021 at 12 AM. No treatment was received for the events. The patient had recovered with sequel from lost 10 lbs on 07Jan2021, from vomited for three nights on 06Jan2021, from lost the appetite and had diarrhea the first week on 10Jan2021.  Information on the lot/batch number has been requested.
Patient had pain at the injection site and it hurt to lift her arm, she was unable to life her arm due to the pain
Bell's Palsy; A spontaneous report, was received from consumer concerning a patient  of unknown age, gender, race and ethnicity, who was administered Moderna's COVID-19 vaccine, and experienced Bell's Palsy.  Patient identifier details was reported as someone from the church.  The patient's medical history was not provided. No relevant concomitant medications were reported. No information on allergies were provided. The reporter stated that the patient was physically and mentally healthy before vaccination.  On an unknown date, the patient got the second dose of mRNA-1273 (Lot number: unknown) via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection.  Ona unknown date, after receiving the second dose, the patient experienced Bell's Palsy.  Action taken with mRNA-1273 in response to the Bell's Palsy was not applicable.   The outcome of the event Bell's Palsy was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.; Sender's Comments:  MOD-2021-028166:
Stroke-Brain Stem Ischemic Stroke.  Occlusion of of left V4 distal artery.   Tracheostomy -for urgent breathing issue.-Removed December 18th Gastric Tube for feeding-because of swallowing difficulties-remains for hydration only weakness in all 4 limbs
Information has been received from a physician concerning a female who was vaccinated with 0.5 ml of Gardasil. Subsequently the patient experienced bronchospasm and shortness of breath. The patient was noted to be under a lot of stress "lately". Subsequently, the patient recovered from bronchospasm and shortness of breath. Additional has been requested.
felt like a truck hit her; chills; temperature of 101; rash on arms, hands, and tops of knees; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like a truck hit her), RASH (rash on arms, hands, and tops of knees), CHILLS (chills) and PYREXIA (temperature of 101) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (rash on arms, hands, and tops of knees). On an unknown date, the patient experienced FEELING ABNORMAL (felt like a truck hit her), CHILLS (chills) and PYREXIA (temperature of 101). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and METHYLPREDNISOLONE (MEDROL DOSEPAK) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felt like a truck hit her), RASH (rash on arms, hands, and tops of knees), CHILLS (chills) and PYREXIA (temperature of 101) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) High.         Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported.
Patient's upper arm was swollen and red, swollen area was about the size of a softball.  Symptoms set in two days after immunization and patient presented to pharmacy 5 days after immunization.  Advised her to ice the area, take some benadryl at bedtime, and to continue her meloxicam she takes regularly.
BLOOD CLOT; SEVERE HEADACHE/ FEEL LIKE A CAP ON HER HEAD; This spontaneous report received from a consumer concerned a female of unspecified age. 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: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot, and severe headache/ felt like a cap on her head. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe headache/ feel like a cap on her head and blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: AER 20210455412-Covid-19 vaccine ad26.cov2.s-BLOOD CLOT. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fever, nausea, weakness, injection site pain and injection site erythema. On an unknown date, the outcome of the fever, nausea, weakness, injection site pain and injection site erythema were recovered/resolved. It was unknown if the reporter considered the fever, nausea, weakness, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The patient experienced a fever (body temperature 101.4 degree F), nausea, weakness, and extremely painful and red arm at injection site for 4 days post shot. The patient asked how long would this last, should she contact her doctor and would the second injection cause these symptoms. If so, patient was not sure she would get it.
HUGE HEAT RASH THAT COVERS ABOUT 25% OF RIGHT SIDE TORSO NEAR THE BREAST AND ALMOST EXTENDS TO THE BACK AND STOMACH; This spontaneous report received from a patient concerned a 26 year old female. The patient's weight was 264 pounds, and height was 64 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-AUG-2021, the patient experienced huge heat rash that covers about 25% of right side torso near the breast and almost extends to the back and stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from huge heat rash that covers about 25% of right side torso near the breast and almost extends to the back and stomach. This report was non-serious.
Per patient: On Thursday 10/29, a couple of hours after the pneumonia vaccine, I started having severe pain in the arm I received the infection. At the end of the day it was very swollen and painful. On Friday, the arms continued to be very swollen and it was very red, I didn't have fever but was having chills. Today Saturday, the pain and inflammation continued and I went to urgent care. I was diagnosed with cellulitis and received antibiotics for treatment. The doctor mentioned that it is possible the vaccine was contaminated or the bacteria was at the site of the injection. I requested the record of the visit to be sent to you.
24 hrs p/vax 10FEB93 pt had tremors in arms & bodily jerks lasting 30 mins; seen by MD who gave APAP; t101;3PM had twitches in both arms lasting 20 mins to half an hr; 17FEB93 9PM pt had sz lasting 1 1/2 hrs; dx myoclonic epilepsy;
RECEIVED THE MUMPS/MEASLES & RUBELLA VACCINE ON 08/27/2019.  AN ADVERSE REACTION OCCURED 09/08/2019 - FLU SYMPTOMS. ON 09/09/2019 - RASH & NECK LUMPS DEVELOPED.  09/10/2019 - RED BUMPS, WRIST, NECK AND KNEE STIFFNESS, DIAGNOSED WITH MACULOPAPULAR RASH. 09/11/2019 - ITCHING, MINOR WRIST PAIN, 2 FINGERS ON THE RIGHT HAND SWOLLEN, STIFF JOINTS AND NICK, MORE BUMPS ON THE CHEST & BACK, LUMPS UNDER THE EAR ARE TENDER, AND LUMP UNDER THE LEFT ARM PIT IS ALSO TENDER.  THE RIGHT BIG TOE JOINT STARING TO HURT, LIMITS ABILITY TO WALK CORRECTLY.
Hair loss starting about 48 hrs after vaccine administration. Patient seen about 7 days after hair starting to come off. Basic blood work normal. Patient seen 4 days after that 1st visit. More hair loss including eyebrow and eyelashes. Some of body hair was coming off too. Patient seen by dermatology who are treating her with topical steroids.
Left arm red, swollen, warm to the touch from shoulder to elbow; pt c/o pain.
couldn't get out of bed; migraine; rash at injection site; injection site raised; 102 temperature; body ache; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (couldn't get out of bed), MIGRAINE (migraine), INJECTION SITE RASH (rash at injection site), INJECTION SITE SWELLING (injection site raised) and PYREXIA (102 temperature) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BEDRIDDEN (couldn't get out of bed), MIGRAINE (migraine), INJECTION SITE RASH (rash at injection site), INJECTION SITE SWELLING (injection site raised), PYREXIA (102 temperature) and MYALGIA (body ache). At the time of the report, BEDRIDDEN (couldn't get out of bed), MIGRAINE (migraine), INJECTION SITE RASH (rash at injection site), INJECTION SITE SWELLING (injection site raised), PYREXIA (102 temperature) and MYALGIA (body ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-107712, MOD-2021-107712 (Patient Link).
Nerve pain associated with area where flut shot given. Sharp, prickly pain when use arm when lifting. Pain lasted for about 3 weeks. Took ibuprofen 600 mg intermittently.
PT DESCRIBES NEW ONSET WEAKNESS/TINGLING IN LEGS(PRIMARILY KNEES) THAT NOW INCLUDES NEUROPATHY TYPE SYMPTOMS IN HIS HANDS AS WELL. WEAKNESS HASN'T IMPROVED UP TO THIS POINT
2:1 block with dropped beats. Heart 60 pulse - bradycardic that I could not get to increase. Full, pounding pulse - increase anxiety but rate did not increase - went to ER.
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Joint Pain-Medium, Systemic: Lymph Node Swelling-Medium
Chills and body aches( joint and muscle pain), especially in both arms. No fever.
Information has been received from a consumer concerning her daughter, who in May 2009, was vaccinated with the first dose of GARDASIL (dose, route and lot number not provided). On 09-FEB-2010, the patient received her third dose of GARDASIL (dose, route and lot number not provided). On 14-FEB-2010, the patient started experiencing joint pain in her middle fingers "around the same time she started taking birth control pills". It was unknown if the patient sought medical attention. At the time of reporting, the patient was still experiencing the pain.
Started period and spotting,  cramping, nausea from other symptoms, should not have period with this birth control, not sure if the BC is effective as this time
12-24 hrs after injection, pt developed raised,red macules over face,chest,forearms,upper back.Pt also has itchy, burning sensation.Tx w/ Benadryl.
Patient both verbally and on the form denied having had the COVID vaccine prior to 04/07/2021. However, when entered into Database it showed that the client had been fully vaccinated with Pfizer vaccine (12/28/2020 and 01/18/2021, by CVS 4158).  Facility notified. I will notify client/guardian and PCP. PHN supervisor notified, as well.
Stroke after getting the COVID-19; This is a spontaneous report from a contactable consumer received from Regulatory Authority. A female patient of unspecified age received a dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient had a stroke after getting the COVID-19 vaccine on an unspecified date with outcome of unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101169478 same reporter, product and AE, different patient
Pt was scheduled to receive Pneumococcal 23 vaccination, received Menveo instead.
3rd dose (booster) of comirnaty.; dizziness; headaches/has had more than normal headaches since booster; She is susceptible to migraines but complains that she has had more than normal; She is susceptible to migraines but complains that she has had more than normal; swelling under her armpit; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 44 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) 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), for COVID-19 Immunization; Bnt162b2 (Dose:2), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "3rd dose (booster) of comirnaty."; DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; HEADACHE (non-serious), outcome "unknown", described as "headaches/has had more than normal headaches since booster"; MIGRAINE (non-serious), outcome "unknown", CONDITION AGGRAVATED (non-serious), outcome "not recovered" and all described as "She is susceptible to migraines but complains that she has had more than normal"; SWELLING (non-serious), outcome "recovered", described as "swelling under her armpit".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt has been admitted to Hospital on February 5, 2022.  After he was escorted by police, he was found at a site trying to kill himself.   The patient has been self medicating himself with marijuana and alcohol.  Uses alcohol on daily basis.  The patient was admitted to the hospital with a psych consult and sitter.  He received 4 mg of Ativan in the ER as well as ketamine. His urine drug screen was positive for cannabis and cocaine.  COVID came back positive, but he was on room air and according to him, he received COVID vaccine.  Procalcitonin negative  Chest x-ray negative.
10/15 evening began with sore scratchy throat.  Fever began 10/16 afternoon with chills. Continued into Monday.  Temp as high 101.5. Also had headache which continues.  Reports this happened last time she received the high dose vaccine.  Did arm soreness and feeling "punky" on 10/13.
3:00 pm blurred vision began. 3:30 pm swollen throat began. 4:00 pm congestion began. 5:00 pm noticed eyes were red and yellow discharge in the inner corners. Declining health through the evening. Slept 14 hours, felt better.
Patient developed inconsolable crying for 3 to 5 hours at a time with brief, 1/2 to 3/4 hour, periods of rest in spite of Tylenol and Motrin and other comfort measures. Patient had slow improvement over 7 to 8 days. Patient had a fever and was given Tylenol every 4 hours and Motrin every 6 hours. Patient developed a rash and had a decreased appetite. ER report indicated patient was "fussy" but episode was beyond being fussy.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and unknown gender. On an unknown date, the unspecified number of patients were vaccinated with improperly stored PNEUMOVAX23 (lot # K004542 and expiry date: 19-AUG-2015) that was not supported. No adverse effects were reported. No product quality complaint (PQC) was reported for PNEUMOVAX23. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. No patients' concurrent conditions or medical history were provided. On unknown dates, these patients were vaccinated with improperly  stored (temperature: 12 degrees Celsius, time frame: 8.5  hours) doses of M-M-R II injection (lot # L012482, expiry date: 10-APR-2017, albumin status: rHA; strength, dose, route and site of administration were unspecified). No concomitant medications were reported. No adverse events were reported. Additional information has been requested.
lips started tingling and that feeling went into cheeks and progressed under her eyes; tingling in her cheeks lips and seemed to be more on her right side; Eyes were slightly numb; Eyes were slightly puffy; This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA ORAL (lips started tingling and that feeling went into cheeks and progressed under her eyes), PARAESTHESIA (tingling in her cheeks lips and seemed to be more on her right side), HYPOAESTHESIA EYE (Eyes were slightly numb) and PERIORBITAL SWELLING (Eyes were slightly puffy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Headache ("The patient had a headache 3 days before the shot.") on 23-Mar-2021. Concomitant products included ESTRADIOL, FAMOTIDINE (PEPCID AC) and ALPRAZOLAM (XANAX).   On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PARAESTHESIA ORAL (lips started tingling and that feeling went into cheeks and progressed under her eyes), PARAESTHESIA (tingling in her cheeks lips and seemed to be more on her right side), HYPOAESTHESIA EYE (Eyes were slightly numb) and PERIORBITAL SWELLING (Eyes were slightly puffy). On 05-Apr-2021, PARAESTHESIA ORAL (lips started tingling and that feeling went into cheeks and progressed under her eyes), PARAESTHESIA (tingling in her cheeks lips and seemed to be more on her right side), HYPOAESTHESIA EYE (Eyes were slightly numb) and PERIORBITAL SWELLING (Eyes were slightly puffy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.; Sender'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
Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves 73-years old patient (gender not reported) who was vaccinated with 0.5 ml FLUZONE QUADRIVALENT (batch number: UJ046AB, expiration date: 30-Jun-2019, route was not reported, in right deltoid) instead of a FLUZONE HIGH DOSE (lot number and expiry date were not reported) on 29-Oct-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to wrong vaccine administered. The patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Pallor, syncope 5min p/MMR inject, BP 90/50- head lowered w/cool compress to face & neck; Pt allowed to sit x 10min; left w/o assistance w/mom;
Patient experienced redness to chin and Left side of face.  Patient describes feeling flushed and skin was warm to touch.
Red oval lesion at injection site about 4" high X 2" wide. Warm to touch. Somewhat sensitive. This report is being filed two days after the lesion first appeared (8 days after injection). The lesion is still present at this filing.