chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It still going on. It started a couple days after the booster and progressively got worse. I kind of ignored it for a while but I started to get these little bumps all over my arms and legs. The ones on my legs progressively got worse and worse and they started leaking and got very very itchy. I tried over the counter cream and it didn't work. On 12/13/2021, I went to urgent care and they said it looked like a rash. They gave me prednisone. I took it for a couple days and that put me in the ER due to an adverse side event from it. In that time I've seen a dermatologist, rheumatologist, ENT specialist and this week I started fainting so I now have an appointment with a neurologist. The dermatologist said that I basically have eczema now which I have never had before.
felt tired; felt "achy" or achiness; slept a lot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FATIGUE (felt tired), MYALGIA (felt "achy" or achiness) and SOMNOLENCE (slept a lot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included Lymphedema and Anxiety. Concurrent medical conditions included Muscle atrophy (Muscle atrophy in her arms), Degenerative disc disease and Fibromyalgia.   On 02-Feb-2021 at 9:31 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced FATIGUE (felt tired), MYALGIA (felt "achy" or achiness) and SOMNOLENCE (slept a lot). On 06-Feb-2021, FATIGUE (felt tired), MYALGIA (felt "achy" or achiness) and SOMNOLENCE (slept a lot) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was not provided.   This case was linked to MOD-2021-041185 (Patient Link).
3 hours after shots patient became very unalert, hands/feet blue & ice cold, nail beds blue, 102.2 fever, ER visit & transfer to hospital & admitted.
pt recv vax & devel a rash, flu-like sx & a cough following vax w/Hep B vax; No further details were provided;
presents with pruritic rash (dermatitis) on upper buttocks and upper back that began 2 days following first dose of Pfizer COVID-19 vaccine.; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative.  A 54-year-old female patient received BNT162b2 (COMIRNATY), 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: DERMATITIS (non-serious), outcome "unknown", described as "presents with pruritic rash (dermatitis) on upper buttocks and upper back that began 2 days following first dose of Pfizer COVID-19 vaccine".  Additional information: The clinical course was reported as reporter stated, presents with pruritic rash (dermatitis) on upper buttocks and upper back that began 2 days following first dose of Pfizer COVID-19 vaccine. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A non-serious, spontaneous report of gave 62-year old female FLUMIST, was received from a health professional, subsequent to FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Additional information on 07-Nov-2008: No additional adverse events have been reported for the patient since vaccination.
specific patient that have gotten both doses of the Pfizer vaccine and have come down with covid; specific patient that have gotten both doses of the Pfizer vaccine and have come down with covid; This is a spontaneous report from a Pfizer sponsored program with Regulatory Authority support, received from a contactable other healthcare professional.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single, and via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that on an unspecified date, the reporter has patients that have gotten both doses of the Pfizer vaccine and have come down with COVID. The reporter wants to know if she gives the booster shot do the patients have to isolate for 2 weeks. She would also like to get the booster so she wants to get an answer if she would have to isolate as well. The reporter added that there is a specific patient that have gotten both doses of the Pfizer vaccine and have come down with COVID. The reporter has firsthand knowledge of the patient and was reporting on a specific patient. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unspecified date. The outcome of the events was unknown.   The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: A contributory role of BNT162B2 to event have gotten both doses of the Pfizer vaccine and have come down with COVID cannot be excluded based on temporal association and available information.
This spontaneous report was received from a 63 year old female consumer with chronic obstructive pulmonary disease (COPD), drug reactions/allergy to sulfa and angiotensin-converting-enzyme inhibitor (ACE inhibitors), pelvic nerve damage and sarcoidosis. The patient's medical history included shingles on middle August 2014. In August 2014 (reported as around third week of August), the patient was vaccinated with a dose of ZOSTAVAX (dose, dose number, lot number, expiration date and route were not reported) for prevention of shingles (also reported as prevent subsequent shingles). Concomitant therapies included LYRICA, cyclobenzaprine hydrochloride and tramadol hydrochloride. Historical drugs included sulfa and ACE inhibitors. Consumer reported that she was diagnosed with shingles in middle of August 2014, and received a dose of ZOSTAVAX to prevent subsequent shingles around third week of August. Consumer reported that shingles rash was gone but she still felt burning pain around left breast and left shoulder, where shingles rashes were, and reported that when she smokes, burning pain felt worse. Consumer noticed worsening of burning pain with smoking after receiving ZOSTAVAX. At the time of report the outcome was reported as not recovered. Patient seek medical attention at the office visit, but she did not received treatment for the event. Additional information has been requested.
Received MMR on October 12, 2004. Developed bilaterally swelling of the parotid glands beginning October 20, 2004. Seen in the office October 21, 2004. Had moderately tender and swollen areas just anterior to both ear lobes. No fever. Patient was recovering well with decreased swelling and less tenderness on October 25, 2004.
Subsequent to receiving one dose of varicella virus vaccine live, pt experienced "a very mild case of chickenpox (10 lesions)."  Within the last few days the pt has now developed full blown chickenpox.
9/3/02 phone call from client c/o "pin and pain, headache, vomiting, swollen nodes in neck and arm pits." 9/6/02 states broke out in rash-all over body and still c/o painful nodes in neck and armpit.
About 30 minutes after Yellow Fever and Hepatitis A vaccines administered, patient developed throat tightening, increased heart rate. Went on to develop SOB and hives.
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 03K20A?) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.            No Concomitant medications was reported Treatment information was not provided
Breakthrough case admission after three vaccines Moderna 02/26/2021 Lot# 025A21A;  Moderna 3/24/21 Lot# 040A21A;  Moderna 11/17/21 Lot# 039D21A
My heart is racing since the second shot and my heart rate doesn?t come down for hours after easy exercise like walking. Rapid heart rate even after a month. Left back pain, shoulder pain. No appetite and stomach pain. Digestion issues
TEETH ACHED; SWOLLEN FRENULUM OF TONGUE; This spontaneous report received from a patient 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, and batch number were not reported) 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 subject experienced teeth ached, and swollen frenulum of tongue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the teeth ached and swollen frenulum of tongue was not reported. This report was non-serious.
tongue/face numb.  Shaky/dizzy while sitting.  reported arm pain.  Refused ED.  Rapid response evaluated.  pt ambulated from cafeteria to home
AFTER SHOTS Patient's LEGS ON ALL THREE INJECTION SITES WERE RED HOT TO THE TOUCH SWELLED AND HURT TO TOUCH WHEN TAKED TO THE DOCTOR HE WAS GIVEN ANTIBOTICS AND I WAS TOLD IT WAS JUST A LITTLE REACTION, HE NEVER GOT BETTER HIS LEGS SWELLED AND BURST OPEN AND PUSS BEGAN TO POUR OUT I THEN TOOK HIM TO SEE A SPECIALIST IN ANOTHER COUNTY HE STILL HAS PROBLEMS AND THE NEXT SET OF SHOTS DID THE SAME THING. I HAVE BEEN TO A DOCTOR AND STILL NO ONE CAN TELL ME WHAT HAS HAPPENED THEY WANT TO WAIT AND SEE WHAT HAPPENS NEXT TIME HE IS GIVEN A SHOT, THERE WAS A CULTURE DONE AFTER THE FIRST SHOTS BUT DID NOT SHOW ANYTHING. Patient GET SEPTRA EVERYTIME HE GETS SHOTS NOW BUT THEY DOSEN'T SEEM TO HELP THEY STILL SWELL BURST AND POUR PUSS EVERYTIME. HE IS ALMOST 1 YR OLD AND STILL HAS SWOLLEN INFECTED SITES ON BOTH LEGS.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19".  Clinical course: Reporter called in and said her wife has covid-19 and now asking how long can she able to get the Pfizer COVID-19 vaccine, Bivalent withheld: Husband of a 70 year-old female patient called about his wife who has COVID-19 and wanted to know how long she needs to wait to get the Pfizer COVID-19 Vaccine Bivalent and stated that his wife has received the 1st three doses with the Pfizer COVID-19 Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a nurse, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 02-JUN-2015, unspecified number of patients were vaccinated with improperly stored VAQTA injection (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Follow up information has been received on 13-JUL-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received on 20-JUN-2015 with additional information on 21-JUN-2015. The patient was approximately 2 years old. The patient demographics were updated. On 09-JUN-2015 the patient was vaccinated with improperly stored VAQTA (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). Additional information has been requested. Patient, suspect therapy and narrative were updated.
baseball sized red circle at the injection site that was sore but not swollen,  still present when seen by doctor on 6/9 told it was not infected and to go ahead and get second dose when ready
Patient states a few days after getting vaccine her arm became red and she could fill a hard spot at injection site. States she also had a headache/fever. Came to pharmacy today ( over 1 week later) arm has some red spots near injection site & she states it itches. Said that it  is not as itchy as it was and redness not as bad. Told her to take Benadryl and call MD if it gets worse/does not improve after taking benadryl.
Received vaccine at 08:48 0n 02/08/2021.  Caller stated she has overall coldness.  Denies other complaints.
Developed a Superficial vein thrombosis on 08/18/21 on my right leg below the knee.  I went to the Emergency Room on 08/18/21 and left at 2:00 am 08/19/21.
Sore arm; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 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's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 for COVID-19 immunisation. The patient experienced sore arm on an unspecified date. Caller stated she had the Pfizer COVID Vaccine and didn't have a reaction other than a sore arm. She had had both doses. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous case reported by a nurse, describes the occurrence of inappropriate schedule of product administration (did not get their second dose in time/dose administered greater than 42 days) in a 79-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Apr 5, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced inappropriate schedule of product administration (did not get their second dose in time/dose administered greater than 42 days). At the time of the report, inappropriate schedule of product administration (did not get their second dose in time/dose administered greater than 42 days) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
No adverse affect reported from patient. Moderna vaccine held at lower temp than recommended by Modera (-90 to -60 degrees Celsius). Moderna deemed vaccine viable for use.
Quadracel administered ina 9 year old by a Medical Assistant with the intention of reducing number of injections/no AE; 09-year-old female patient received Quadracel/no AE; Initial information received on 06-Feb-2020 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2020SA034515 (same reporter).  This case involves a 09-year-old female patient (second patient out of twins) who received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] which was administered by a Medical Assistant with the intention of reducing number of injections (Off label use; Product administered to patient of inappropriate age).  Patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) and HEPATITIS B VACCINE (HEPATITIS B VACCINE) (no dosing details reported).  On 11-Dec-2019, the patient received a 0.5 ml 4th single dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5532AA (expiry date: 09-Oct-2020) via intramuscular route in the right deltoid for prophylactic vaccination.  It was of actual medication error due to inappropriate age at vaccine administration and off label use.  It was unknown whether adverse event was noted in the patient or not.  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.
No Medical History information was reported.    On 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced MALAISE (feeling sick), SOMNOLENCE (sleeping a lot), DYSPNOEA (shortness of breath), CHEST DISCOMFORT (tightness in chest), HYPERTENSION (BP is high), PYREXIA (fever) and HEADACHE (headache). At the time of the report, MALAISE (feeling sick), SOMNOLENCE (sleeping a lot), DYSPNOEA (shortness of breath), CHEST DISCOMFORT (tightness in chest), HYPERTENSION (BP is high), PYREXIA (fever) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Lost taste buds after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lost taste buds after 2nd dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 008B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced AGEUSIA (Lost taste buds after 2nd dose). At the time of the report, AGEUSIA (Lost taste buds after 2nd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
About 15 minutes after vaccine, I felt dizzy.  I rested for a few additional minutes but still felt the same.  My blood pressure was taken and it was elevated around 156/96.  After resting a few more minutes, I was allowed to go home.  That evening I started experiencing  a severe headache that lasted throughout the night in addition to body and joint aches.  I also felt feverish.  The next morning the symptoms remained and I took my temperature and it was 100.6 .  The fever remained for the rest of the day and reached a high of 101.2.  Tuesday morning my fever was gone and I felt much better with the exception of the body and joint aches.
herpes simplex; soreness at the injection site; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) (batch number C5E43, expiry date 10th August 2021) for prophylaxis.   The patient's past medical history included shingles.   On 30th April 2019, the patient received the 1st dose of Shingrix .5 ml. On 1st May 2019, 1 days after receiving Shingrix, the patient experienced injection site pain and influenza-like symptoms. On 4th May 2019, the patient experienced herpes simplex. On an unknown date, the outcome of the injection site pain, influenza-like symptoms and herpes simplex were recovered/resolved.   It was unknown if the reporter considered the injection site pain, influenza-like symptoms and herpes simplex to be related to Shingrix.  Additional information was provided as follows: The patient experienced typical soreness at the injection site. Four days after vaccination, the patient had herpes simplex on left side on her nose. She had not had that before. She took one medication and it went away. The reporter consented for follow up.
Patient had loss of hearing, confusion, tunnel vision.   Paramedics were called to further evaluate. Individual vitals were taken and was laid supine to bring blood pressure back up.
Initial case received from a pharmacist on 09 September 2011. A 67-year-old female patient received an intramuscular left deltoid injection of FLUZONE HIGH-DOSE (lot UH452AC) on 09 September 2011. One hour post-vaccination, the patient reported pain in her left leg, 'barely able to walk'. At the time of the report, the event was ongoing.
Pt. states that after receiving the 2nd dose of Phizer 11/2021, started experiencing symptoms of severe rash, fatigue, loss of taste and smell, confusion, vision difficulties, and bruising. Primary visits (multiple) with recommendations of Follow-Up with Neurologist, Hematologist, and Dermatologist.
This spontaneous report as received from a health professional refers to unspecified multiple patients of unknown demographics. The concurrent conditions, medical history and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored (Merck) VARIVAX (lot # L034369, Expiry: 29-SEP-2017 and lot# L034369, Expiry: 08-SEP-2017). The vaccine was stored at a temperature of 13 F for 1 hour. There were no previous excursions. There were no adverse effects. It was also reported that MMR II also appeared on the product list as temperature stability, however no doses of improperly stored MMR II were administered to the patients. Additional information has been requested.
Shortly after receiving the J&J Covid 19 vaccine the patient sat in the waiting area for the required 15 minute observation period.  About three minutes in she stood up and stated "I don't feel so good".  She was told to sit down immediately.  Before she could sit she fainted and fell.  She went into convulsions for a period of about 10 seconds on the ground and she slowly stopped and came to.  911 was called and EMS came to evaluate.  She left with the ambulance.