chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had 3 Moderna vaccines, 3 Pfizer vaccines.; Had COVID, had the vaccines, this was the 6th dose.; Had COVID, had the vaccines, this was the 6th dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown), as dose number unknown, single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Had 3 Moderna vaccines, 3 Pfizer vaccines."; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Had COVID, had the vaccines, this was the 6th dose.". Clinical course: Has medications he was on since before COVID, never had reaction. Had 3 Moderna vaccines, 3 Pfizer vaccines. Does not have any information for previous 5 doses, just that he had them.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
A non-serious spontaneous report of received expired FLUMIST was received from a health professional concerning a six-year-old female. Neither medical history nor concomitant medication was reported for this patient. The product expired on 02-Jan-2011. On 04-Jan-2011, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
pain @ site of inj persisting 7wk p/vax;also c/o tingling in fingers which initially occurred more than it does presently but still bothers pt;between lt shoulder & elbow had dull ache;now has tingling sensation only;
Red itchy, splotchy rash on hands; Red itchy, splotchy rash on hands; Red itchy, splotchy rash on hands; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 25Apr2021 at 18:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); taken for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 29Apr2021, the patient experienced red itchy, splotchy rash on hands approximately 4 days after vaccine and were continuing still at the time of this report. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events red itchy, splotchy rash on hands were not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Following the vax, the pt experienced a fever of 101F which subsided the following day. One day, post vax, the pt experienced vomiting. Additional information has been requested.
Since I got the shot Tuesday as today it's Saturday August 14th I still have my rash, the welt and the itching. Using ice and Benadryl cream to try to stop the itching.
Tdap administered at 1:57pm. Patient checked out at clerk at 2:14pm and remained in building with no complications for uncertain time. Patient left building then returned at 4:00pm complaining of "lightheadedness, warmth and sweat". Patient taken to private room where vitals were monitored and juice and crackers were given. Eaten completely. Patient states "I had a blood glucose test at my OBGYN this morning and I haven't eaten since". Patient alert and oriented x 4, skin warm and dry. Patient encouraged to report incident to her OBGYN. She verbalized understanding. Patient reported feeling "much better", denied any lightheadedness nor other concerning symptoms at 4:40pm. Patient provided current contact information for RN follow-up. Patient left building at 4:43pm.
single vesicle in the immunized arm which subsequently scabbed over; This case was reported by a other health professional via interactive digital media and described the occurrence of scab in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced scab. On an unknown date, the outcome of the scab was unknown.   It was unknown if the reporter considered the scab to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age was not reported but it was selected as an adult as per vaccine indication. The reported mentioned that the patient developed a single vesicle in the immunized arm which subsequently scabbed over. The reported asked should receive 2nd dose. No other information was available.
Heart palpitations after several days of second Pfizer vaccine. It happened with the first dose too, but went away after a few days. This time, it seems to be sticking around and not getting any better. We took Pt to the ER on 1/27/2022 in the middle of the night because his heart rate was up to 135. They did an EKG and blood work. All came back normal. He is looking lethargic, not sleeping well. Having some bad dreams and nigh sweats. We are monitoring his heart with an oximeter and it is fluctuation constantly. While it mostly is staying with in the range of "normal for his age", it doesn't stay stable and then goes into a higher heart beat when lying down.
swelling in left armpit; tightness in chest and around upper rib cage; dry cough; Fever 102.3; pain at injection site; severe joint and muscle pain; chills; severe joint and muscle pain; This is a spontaneous report from a contactable consumer or other non-health care professional. A 45-year-old female consumer (non-pregnant Patient) started to receive second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN 600) via an unspecified route of administration and administered in left arm on 02Mar2021 16:15 as second dose, single dose for COVID-19 immunization. Medical history included Beta thalassemia minor. The patient concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6201) via an unspecified route of administration, administered in left arm on 13Feb2021 16:15 as 1st dose, single dose for COVID-19 immunization. The patient did not experience COVID-19 prior vaccination and not tested for Covid-19 and no known allergies. On 03Mar2021 patient experienced fever 102.3 severe joint and muscle pain, chills, swelling in left armpit, pain at injection site, tightness in chest and around upper rib cage. After 36 hours, all symptoms but chest tightness and dry cough subsided. Now at more than 48 hours post vaccine, chest tightness and dry cough remain. The patient underwent lab tests and procedures which included pyrexia: 102.3 on 03Mar2021. The patient did not receive any treatment for events, no other vaccination in other four weeks and no other medication in 2 weeks. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on unknown date, refer case US2020AMR079298.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received Shingrix and experienced a sore arm and it has lasted for months. The reporter consented to follow up.  This case linked with US2020078681, reported by same reporter.
Received the 2nd dose of Pfizer/BioNTech COVID vaccine on 1/12/21. Then, 2 days later (1/14/21) I had a CBC with diff drawn, as I am currently being worked up for possible ITP and have been getting a CBC with diff every 2 months to monitor my blood counts. My platelets and other blood counts had been trending up and were back in normal ranges when they were last checked back in November. However, when they were checked again in January after the COVID vaccine series, there was evidence of thrombocytopenia and leukopenia. I did not have any symptoms related to decreased blood counts.
Headache within 30 minutes after vaccine that has persisted for almost 24 hours. Headaches are usually associated with the intranasal vaccine not the shot.
Patient presented having had one dose of J&J in March and one dose Pfizer in May. He sought out the Pfizer vaccine b/c he wants protection against the delta variant. Per Health Dept medical director 2nd Pfizer dose was given with no guarantees of efficacy against delta.
Initial information received on 25-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 43 years old patient (gender not reported) who received vaccine FLUZONE HIGH DOSE (batch number, expiry date, dose, route and site of administration were not reported) on 18-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to inappropriate age at vaccine administration and overdose. It was unknown whether patient experienced any adverse reaction after the vaccination. 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. Documents held by sender: none.
Right arm with area of 2 cm x 2 1/4 cm erythema. No pain with palpation. Very minor firmness at site.
Patient had exited the vaccination tent and began to feel "weak" and turned and ran into the vaccination tent.  In f=doing so he ran into an employee that was scanning people out of the tent.  Once inside the tent a medic came to his aid and assisted  him to the ground.  The med crew and doctor came to immediate aid and patient was placed on the stretcher and care rendered.  Patient was transferred to the observation tent and observed until he decided he would leave on his own.  The employee that was bumped into was asked if she was ok and she confirmed she was fine.
PATIENT RECEIVED A BOOSTER SHOT OF PFIZER AND HAD A VAGAL RESPONSE. SHE STARTED TO SWEAT AND TURN PALE. SHE FELT FAINT AND WEAK. BP WAS 127/83 P 77. SHE COMPLAINED OF HER FEET TINGLING. I KEPT HER TALKING SO SHE DIDN'T PASS OUT. SHE WAS HOT AND SWEATING AFTER 5MINS HER COLOR CAME BACK AND SHE WAS NO LONGER SEEING SPOTTY. SHE WAS NO LONGER FEELING WEAK AND FAINT BUT COMPLAINED OF A HEADACHE AND LEG TINGLING. SHE HAD SOME WATER AND WAS GIVEN SOME ORANGE JUICE. HER BP WAS 115/75 P 64. SHE FELT FINE AFTER A FEW MORE MINUTES AND THEN LEFT.
Breakthrough case admission after 4 vaccines Pfizer 2/6/21 Lot#EL1283;  Pfizer 2/27/21 Lot# EL9267;  Pfizer 11/1/21 Lot# 3302680;  Moderna 4/4/22 Lot# 002M21A
Pfizer-BioNTech COVID- 19 Vaccine EUA: During the post-vaccination observation period, vaccine recipient experience an allergic reaction. They developed headache and throat closing. They were treated by EMS on site with diphenhydramine and methylprednisolone. They were transported to emergency department at Regional Medical Center. They reported itching, swelling, and tingling around the mouth. During reexamination, the patient?s symptoms did not recur and they were discharged to home. Registered 03/03/2021 3:00 PM, Discharged 03/03/2021 6:13 PM.
No additional adverse event; an improperly store PEDVAX that experienced a supported excursion was administered to a patient.; This spontaneous report was received from a nurse and refers to an unknown age and gender patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 28-OCT-2022, the patient was vaccinated with an improperly store haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #U031544, expiration date: 23-JUN-2024, administered intramuscularly (strength, dose, anatomical site injection were not provided) (product storage error), the suspect vaccine was exposed to a temperature of33 degree Fahrenheit for a time frame of 9 minutes. No previous temperature excursion was provided. No adverse event was reported.
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable pharmacist (patient).  A 72-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 22Jan2021 13:00 (Batch/Lot Number: EL9261) as SINGLE DOSE, dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 (Batch/Lot Number: EN6201), at the age of 72-years at vaccination, as SINGLE DOSE for covid-19 immunisation. Medical history included none. The patient did not have COVID prior vaccination. The patient was not patient at the time of vaccination. The patient's concomitant medications were not reported. The patient got COVID and underwent PCR with saliva with positive result on 10Mar2021. The outcome of the events was recovered. No treatment was received for the events.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 5 (booster), single (Lot number: Gh9694) at the age of 66 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Feb2021 as dose 1, single (Lot number: Fl3249), on 10Mar2021 as dose 2, single (Lot number: En6205), on 05Oct2021 as dose 3 (booster), single (Lot number: Fe3590) and on 13Apr2022 as dose 4 (booster), single (Lot number: Fp4554) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Positive, notes: 3 days later symptoms returned and tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 and included Paxlovid. Clinical course: 2 days after completing 5 day Paxlovid treatment tested negative 3 days later symptoms returned and tested positive.
BLOOD CLOTS; This spontaneous report received from a consumer concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. 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: Unknown expiry: unknown ) dose, start therapy date were not reported, 01 total, administered for prophylactic vaccination. 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 blood clots. As per the reporter "he heard rumors in his neighborhood that someone down the street was vaccinated with the Janssen Covid-19 vaccine and had blood clots. He said that there are rumors always being spread and did not believe it to be true nor did he want to provide any further detail regarding the incident." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210854934-COVID-19 VACCINE AD26.COV2.S-BLOOD CLOTS. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
24 hours later - arm red, swollen and hard from shoulder down to midway to elbow, outside. Only complained of itching.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JUN-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N002336 with expiry date 19-JUL-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
Information has been received from a physician concerning a 6 year old male with developmental delay and seizures, who on 11-SEP-2001 was vaccinated with the first dose of Varicella virus vaccine live (Oka/Merck) (Lot #638242/0563L) into the right deltoid. Concomitant therapy included dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) and a dose of poliovirus vaccine inactivated (unspecified). On 28-JUN-2007, the patient developed a moderate varicella infection with 50 to 500 blisters. No medical attention was sought. No diagnostic studies or lab tests were performed. On 05-JUL-2007, the patient recovered. There was no product quality complaint. Additional information has been requested.
I am the epidemiologist reporting on behalf of 68 year-old female patient.   Patient received their first and second doses of the Moderna vaccine on 4/21/21 and 5/18/21 respectively, according to immunization records.   Patient received their third dose of the Moderna Vaccine on 11/22/21.   The patient was found deceased at home on 11/23/2021 (1 day after third dose). The death certificate lists ?hypertension (5 years)? as the immediate cause of death. Other significant conditions contributing to the death but not resulting in underlying cause include hyperlipidemia. I have no further information regarding the patient?s medical history.
Day 1: pounding headache, radiating pain from top of head down the neck on the left side (pain scale 3-4) Day 2: pain on left side of head and neck intensifies to an 8-9 (treatment: ibuprofen), loss of mobility in face. (PCP emailed with no immediate response) Day 3: full loss of mobility and control on entire left side of face. Emergency room visit diagnosis: Bell's Palsy. Head neck pain persist (no more ibuprofen taken because of stomach pain) ER doctor prescribes 5 day course of Prednisone. Day 4-7: Bell's Palsy symptoms persist unchanged. (Treatment: Acupuncture, 2 visits) Pain on left side of head neck persist at a pain scale of 2-3.
I was vaccinated twice with Pfizer in 2020-2021. I got a first Pfizer booster in early 2022 and a second booster in November 2022. I began having taking Oregano Oil in December. I started having allergic reactions that included difficulty breathing, wheezing, itchy neck, itchy ears and severe cough. I had to take Benadryl to stop the reactions. I didn't know what was causing this at first, so I discontinued the oil and a few foods. I would have a few days free of reaction and then it would come back. I kept a food diary that lead me to discover that I could no longer eat pasta sauce, pizza sauce or anything with thyme or oregano or possibly basil.
Loss of cognitive function and critical thinking skills, reduced ability to communicate, acute hemiplegia of the left arm & leg
Sporadic Muscle Spasms; This case was reported by a nurse via call center representative and described the occurrence of muscle spasm in a 24-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number MF9EA, expiry date 1st June 2021) for prophylaxis.   Concurrent medical conditions included muscular dystrophy.   On 14th August 2019, the patient received Boostrix. On an unknown date, less than a month after receiving Boostrix, the patient experienced muscle spasm. On an unknown date, the outcome of the muscle spasm was unknown.   It was unknown if the reporter considered the muscle spasm to be related to Boostrix.  Additional details were provided as follows: The patient received dose of Boostrix in the right deltoid. The healthe care professional stated that, the patient had muscular dystrophy, then received boostrix vaccine and experinced muscle spasms. The reporter consented to follow up.
A 0.5 cm in distal erythematous lump on Rt. (R) thigh.
patient found dead in the morning by his son.  presumed cardiac cause of death, although flu vaccine given 10/12/09 seems unlikely as a cause, it can not be excluded. Autopsy  is not planned.  12/31/09 Death Certificate received. DOD 10/15/09. Cause of Death: Unknown. Other conditions: End Stage Kidney Failure. Cardiomyopathy.
Information has been received from a certified medical assistant concerning a female with no medical history and no know allergies who on approximately 29-AUG-2008 was vaccinated with a second dose of GARDASIL. There was no concomitant medication. The certified medical assistant reported that the patient developed swelling after injection on approximately 29-AUG-2008 and a hard knot days later around the injection site. It was reported that the patient exercised regularly and noticed that the knot at the muscle area was noticeable when she flexed her arm. At the time of reporting the patient had not recovered. Patient sought medical attention: was seen. There was no product quality complain. Additional information has been requested.