chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rheumatoid arthritis flaring up; Possible COVID; COVID; Heart Palpitations; MARKETING PROGRAM NAME NOT AVALIBLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4369758-00 (Company).  A 66-year-old female patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Batch/Lot number: unknown), on 09Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 18Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Lot number: 1155990) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis flaring up"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "Possible COVID"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "COVID"; PALPITATIONS (non-serious), outcome "unknown", described as "Heart Palpitations". The patient underwent the following laboratory tests and procedures: Cardiac function test: Unknown results. The action taken for adalimumab was dosage not changed.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira (Adalimumab):The reporter's causality for the event (s) of heart palpitations and rheumatoid arthritis started flaring up with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event (s) of possible COVID was not provided.Causality for Pfizer BioNTech Covid-19 Vaccine (Tozinameran) :The reporter's causality for the event (s) of heart palpitations and rheumatoid arthritis started flaring up with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event (s) of possible COVID was Possible.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative , a possible contributory role of the suspect vaccine  to reported event of 9 LOE ,    palpitations ,rheumatoid arthritis flare up  cannot be excluded.
Patient called and said she woke up this morning with numbness and loss of feeling in the hand and arm she was vaccinated in.  Patient will contact personal physician.
Within 5 minutes of receiving vaccine, states she felt like the "fluid was being drawn out of my knees".  Client had both knees replaced 1 year ago-states the knee pain persisted for 2 weeks.
Patient broke out in hives across left chest and across her back following the vaccination.  The patient did not notice this until approximately 25 minutes after her vaccination and had left the clinic area.  She returned with these symptoms, and was taken to the emergency department for further evaluation.  She denied any shortness of breath or difficulty breathing.
She received 2nd Moderna covid vaccine 2/18/22.  She had body aches and chills. The next day, developed vertigo. She has developed tingling and numbness to lower extremities and face.  She noticed weakness walking up the stairs over the past week.  She has never had any reaction to vaccines again. She has brought a timeline of symptoms as below 2/21/22: developed weakness in legs, felt tired, ShOB, fingers in right hand tingling, tingling in fingers and face 2/22/22: arms numb and feeling sore, pulse at 171 and out of breath from walking around campus, trouble with stairs, feeling unstable in legs, lungs feeling heavy. She noticed neck feeling numb and tingling.  2/23/22: tingling.
Moderna.. tongue and left side of throat felt numb. NP checked and there was no angioedema and said another 20 something had that happen a couple of weeks ago. It did go away after an hour.
expired Moderna vaccine administered past 12 hours puncture time; expired Moderna vaccine administered past 12 hours puncture time; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered past 12 hours puncture time) and PRODUCT STORAGE ERROR (expired Moderna vaccine administered past 12 hours puncture time) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered past 12 hours puncture time). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired Moderna vaccine administered past 12 hours puncture time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered past 12 hours puncture time) and PRODUCT STORAGE ERROR (expired Moderna vaccine administered past 12 hours puncture time) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient took 1st booster vaccine. It was reported that the vial was initially stored in the refrigerator on 04-Apr-2022. The vial was first punctured on 04-Apr-2022 at 1:55 PM and administration of vaccine on 05-Apr-2022 at 9:00 AM - 1:40 PM. The vial was stored in refrigerator post puncture. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was reported as unknown, the vial was not exposed to room temperature for >24 hours. The vial did not undergo any temperature excursions. No treatment information was reported.
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Chills-Mild, Systemic: Fever-Mild, Additional Details: red, swollen, warm injection site reaction. pt experienced fever and body aches for 24 hours after injection. it was tempered with tylenol
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE DRUG INDUCED POLYNEUROPATHY PERIPHERAL NEUROPATHY ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY 12/24/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Patient was to get the Moderna Covid-19 Bivalent Booster but was administered the above vaccine in error.  Patient was notified on the same date of error and self-monitored symptoms instead of seeking care.  Patient reported slight headache lasting 2-3 hours on 09/11/22.
adult patient received one dose of pediatric Havrix (720 EL.U./0.5mL); adult patient received one dose of pediatric Havrix; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a adult female patient who received HAV (Havrix 720 Junior) (batch number 95EJ7, expiry date 2nd February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th May 2022, the patient received Havrix 720 Junior .5 ml and Havrix Pre-Filled Syringe Device. On 13th May 2022, unknown after receiving Havrix 720 Junior and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product 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:13-May-2022 Reporter's comments: An adult patient received one dose of pediatric Havrix. The consent to follow-up was given. Additional Supportive Information: An adult patient received one dose of pediatric Havrix, which led to underdose and adult use of a child product.
8/17/06 redness and swelling of left thigh felt "warm to touch." Pt seen in ER and given antibiotics for possible infection in leg. Pt had swelling decrease and subside over the course of 3 days.
p/vax pt exp a chickenpox rash w/approx 50 lesions on the top of knees, elbows, upper arms & groin area;itchiness;
My veins are becoming more prominent. Most noticeable are the veins in the middle of my chest and around my right ankle. Looks like varicose and spider veins are developing.
Information has been received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date the patient was vaccinated with doses of improperly stored GARDASIL (lot# K016966, expiration date 10-MAY-2017, strength, dose and route unknown). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
A report was received from a health professional on 10/12/01 concerning a patient of unknown demography who had received an overdose of Fluvirin on 10/12/01. On 10/12/01the patient was have a number of vaccinations and was inadvertently given 2 doses of Fluvirin within a time frame of a few minutes. There were no Adverse Events reported at the time of reporting.
Received an expired 2nd dose of Moderna COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired 2nd dose of Moderna COVID-19) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired 2nd dose of Moderna COVID-19). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired 2nd dose of Moderna COVID-19) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.
chills,fever,nausea  weakness body  aches  loss of appetite  weaskness in  legs   sleepiness  vomiting   confussion
Patient presented to the clinic for his covid vaccination(moderna #1) Side effects were reviewed with the patient. Injection given at 1505 and patient was waiting in the waiting room. At 1515 nursing heard a yell for help. The nurse came down the hall and noticed the patient was stiff and rigid in the chair. He attempted to get up and fell against the wall and table in the corner sliding down the wall. Dr. was notified and was present to evaluate the patient. Initially the patient was pale, diaphoretic, and disoriented. First BP while patient was lying down was 99/54 HR 44. Glucose finger stick was 109. Patient begane to come to and was  able to sit up and felt ok doing so. He was complaining of neck pain. Patient was able to sit in the chair and  continue to be monitored by nursing. An Ice pack was applied to the back of the neck and he was drinking sweetened sparkling water. He continued to improve with feeling better and was up and walking at the end of monitoring. Last BP was 111/79 pulse 67, O2 99% on room air. Patient was released by Dr.  to patients girlfriend and friend at 1551
COUGH; This spontaneous report received from a consumer via a company representative concerned a male 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 covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cough. This report was non-serious. This case, from the same reporter is linked to 20221258056 and 20221258060.
Arm was all red; Arm swelled up pretty bad/swelling was about the size of a softball and stuck out, like a quarter edge; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm was all red) and VACCINATION SITE SWELLING (Arm swelled up pretty bad/swelling was about the size of a softball and stuck out, like a quarter edge) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Arm was all red) and VACCINATION SITE SWELLING (Arm swelled up pretty bad/swelling was about the size of a softball and stuck out, like a quarter edge). At the time of the report, ERYTHEMA (Arm was all red) and VACCINATION SITE SWELLING (Arm swelled up pretty bad/swelling was about the size of a softball and stuck out, like a quarter edge) was resolving.            The reporter reported that, his wife had received the first two doses of Moderna COVID-19 vaccine, and this events were after she received her booster dose of the Moderna COVID-19 vaccine. No medical history was provided by the reporter. Relevant concomitant medications were not reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up received on 15 Nov 2021 contain Additional information received and event details were added. On 15-Nov-2021: Follow-up received on 15 Nov 2021 and does not contain any new information
Confusion, Dizziness, Headache, Myalgia, Arthralgia & Fever Narrative:  Employee c/o of fever 101., chills, body aches, congested, H.A. foggy brain.
C/o low-grade fever, myalgias, headache, and localized swelling past the elbow of the RUE
Later on day of administration, started feeling nauseous. The following day I got extremely nauseous and ended up vomiting once. I believe I may have had a fever as well but my temperature was not taken so this is unconfirmed.
Immediately after Tdap was given the shot site swelled up about the size of a marble the nurse said it was a reaction and I should report it Later that nite the area went down just tender to touch
PFIZER-BIONTECH COVID-19 VACCINE EUA.  PATIENT VACCINATED WITH SECOND DOSE ON 2/8/21.  PATIENT REPORTEDLY DISCHARGED TO HOSPITAL WITH PNEUMONIA ON 2/16/21.  NURSING FACILITY WAS ADVISED THE PATIENT LATER PASSED AWAY AND WOULD NOT BE RETURNING.
HPV given, pt. c/o hurt, really hurt, then she started shaking, eyes rolling around, lip color faded to pale, pale. I immediately laid pt back on exam table, ask her if she was ok, and she answered ok.  Shaking stopped within 20sec of laying down.  I gave her a peppermint and ask her to chew it up and swallow it.  Color to lips then returned within 1-2 mins.  5-7 mins after episode started pt is upright and walking to check out unassisted, color good, coherent.
muscle damage; nerve damage; This case was reported by a consumer via interactive digital media and described the occurrence of muscle damage in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles 4 years ago).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle damage and nerve damage. On an unknown date, the outcome of the muscle damage and nerve damage were not recovered/not resolved.   It was unknown if the reporter considered the muscle damage and nerve damage to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-FEB-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient had shingles 4 years ago, a band from the center of chest around left side to the center of back and this unpleasant experience lasted nearly 3 months The patient got the Shingrix vaccinations about 18 months later.  The was still feeling the effects of muscles and nerve damage.  The reporter stated that get vaccinated if you were over 50.  No guarantee you would not get shingles but it would reduce the chances of getting it. Additional supportive information: This case was found as duplicate of case US2023AMR031915 All the information from the case US2023AMR031915 was merged into this case. The case US2023AMR031915 was deleted and this case stand as case of record for this patient.
I received my covid-19 Pfizer BioTech vaccine on October 28th 2021. Since receiving the vaccine I had numbness and tingling in vaccinated arm. Since Sunday November 7th 2021 my right hand is numb and tingly. I have pain in my right elbow. It makes it difficult to do my dad to day job. I have never had any of these issues previously.
Tingling sensations in fingers Lt hand, bilateral upper anterior thighs started ? after injection and are continuing on and off; tingling of toes both feet on 5-18-15 but now resolved. Dizziness, nausea, headache, fatigue since injection. Vomited on 5-18-15 pm. Syncopal episode immediately after injection. No treatment given.
Patient received Janssen vaccine in May at a different site..  Her RA physician told her to get a Pfizer vaccine to increase her antibody load. On the form she checked that she had never received a Covid vaccine before. A first Pfizer dose was administered.
Has red spot around injection site on (LA). Pt claims the spot is getting bigger - not smaller. Does not hurt or bother her. Sometimes itchy. At ZOSTAVAX side.
Pt had red, swollen, and itching at site of injection. Pt was given diphenhydramine 50 mg/ml right deltoid IM.
Started with neck pain and muscle aches the day after and grew in severity. Sept. 20, 2021 woke up with sever neck pain and immobility of the neck. Urgent care prescribed baclofen for 2 weeks. During the two weeks pain moved to right side of body consisting of numbness, nerve pain, muscle spasms in the arms, legs, face, hands, feet and back.  Starting in Oct. 2021, pain moved to both sides of the body. Severe nerve pain, muscle spasms, fatigue, stuttering and numbness/tingling. Sought treatment from Neurologist, Orthopedic surgeon, and emergency room visit. Doctors unable to diagnose from tests, including MRI, ultrasound, and blood work. Jan. 2022, started care from Local Hospital. Tests run from primary doctor, speech therapist and Neurologist included Ultrasound, CT scan, bloodwork, and urinalysis. doctors unable to diagnose from tests. Many hypotheses from the doctors have been ruled out including Stiff persons syndrome, Lyme disease, Vitamin Deficiency, and multiple sclerosis. March 10, 2022 primary doctor suggested that symptoms could be consistent with Vaccine injury.
pt recvd vax; states inc t of 103 R & had sz lasting 2-3 min; to hosp for 3 days; under care of MD; had sz oct94;
Local reaction: swelling left leg > right firm. No redness or warmth. Parents report redness. Given Tylenol and cold compass.
Lightheaded, dizzy, eyes rolled back, cyanotic mouth, grunt - passed out for roughly 10 seconds. Monitored in office for 1 hr x 2 more episodes "light headed" after passing out hr lower 50's orthostatic by BP.
Information has been received from a Registered Nurse referring to a 16 month old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 19-JUN-2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB (route not reported, lot # K025002 with expiration date 20-JUL-2017, dose 0.5 (unit not provided). Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Client remained in clinic 40 minutes, post vax. Went to Rx to purchase Benadryl and states she started having difficulty breathing. She went to the ER, then to her private MD. 3 days, post vax, client states she's having "asthma-like symptoms: (recovering).
p/vax pt itchy then pt became sleepy then p/1hr loss complete consciousness;
This case was reported by a consumer and described the occurrence of chest pressure in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 19th June 2018, 50 mg injection). On 16th January 2019, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced chest pressure, injection site pain, shivering, headache, fever, tiredness and feelings of weakness. On 16th January 2019, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the chest pressure, injection site pain, shivering, headache, fever, tiredness, feelings of weakness and drug dose administration interval too long were unknown. It was unknown if the reporter considered the chest pressure, injection site pain, shivering, headache, fever, tiredness and feelings of weakness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 19th June 2018, the patient received 1st dose of SHINGRIX and on 16th January 2019, the patient received the 2nd dose of SHINGRIX, which led to lengthening of the vaccination schedule. The patient experienced terrible reaction from the 2nd injection. Sore arm where shot was given, Terrible shivering, headaches, fever, feeling tired and weak feeling. Also, pressure in chest. The reporter called Pharmacy and their pharmacist said he was sick for 2 and half days. The patient said providers in pharmacy who administer the injections should prepare people. The patient's doctors office was unprepared on the side effects. This information needed to be communicated. It was bad enough that the patient had to wait 7 months for second injection.
PT GIVEN VACCINES ON 02212003 IN OUR OFFICE.  MOM STATED PT O.K. UNTIL SAT A.M. REPORTS AFTER EATING BREAKFAST (PT. HAD EGGS) (HAS HAD BEFORE). PT FACE SEEMED TO SWELL AND PT STARTED TO GET WHELPS. RESCUE SQUAD WAS CALLED SAW PT AT HOME. PER MOM SQUAD STATED ALLERGIC REACTION HAPPENING. NO THROAT SWELLING AND NO DIFF BREATHING.  PT HAD EMESIS BEFORE SQUAD CAME X 1.  TAKEN BY CAR TO ER.  HOSPITAL ADVISED MOM TO ADVISE PCP OF REACTION AND SUGGESTED BENADRYL. SX. LASTED FROM 11AM ON SATURDAY 02/22/03UNTIL APPROX 7PM ON 02222003  WHELPS WERE UNDER EYES, KNEE CAPS, NAVAL, EARS, WITH BENADRYL PT FINE. PT NEVER DEVELOPED FEVER PER MOM.
it was weird; a little soreness that didn't seem to bother her very much; 8 days later she got a rash. It was red and round; 8 days later she got a rash. It was red and round; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: FL1283, Expiry Date: not provided), dose 1 intramuscularly administered in Left arm on 18Jan2021 as single for covid-19 immunisation. Medical history included none. Patient has no family medical history. The patient's concomitant medications were not reported. The patient stated that the reaction to the first dose was much milder and she had no tiredness. On an unspecified date in Jan2021, it was very weird, she had a little soreness that didn't seem to bother her very much, but 8 days later she got a rash. It was red and round, but not as big as the rash with the second dose. It's still slightly there, but it's very light. No relevant tests were reported. Outcome of the events was reported as not resolved. Follow-up attempts are completed. No further information is expected.