chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Short-term I was just wiped out. Over the long-term, I've been having heart issues. They've just been increasing over time, and it's gotten to the point that it's becoming unbearable. My heart feels like it's going to explode. It's like each time it pumps, it shakes my whole body. I have extremely poor blood flow and severe Raynauds.  I started getting tremors in my hand shortly after my booster (Pfizer) in November 2021. The tremors spread to my knees and then to my stomach. It feels like my internal organs are vibrating. It's the worst when I lay down for bed at night. I don't know if it's a combination of both, or if it was J&J or Pfizer. I just want my hands to stop shaking. I'm 25 and can no longer write. Exercise was my life and I can no longer run due to my heart. I had a psychotic episode in June of 2021, I don't know if that's related, but I never had these before. I feel like I've had significant personality changes and behavioral problems since taking it. My whole body hurts, especially my spine and neck. I tried a chiropractor, but it didn't really help. My hands and feet are always white/purple.
Approximately 10 minutes following vaccine, I began to experience all over body itching, the pharmacist provided 2 Benadryl tablets and had me wait for an additional 30 minute (45 minutes total) I never experienced any throat tightening. I took an additional dose of Benadryl before bedtime. The next day the itching was still severe and I felt the Benadryl made it worse. I was advised to take a dose of Zyrtec in place of the Benadryl. The following morning the itching remained unchanged following another dose of Zyrtec. The Covid hotline then advised calling my primary physician who prescribed a  6day 20mg Prednisone  course (3 tabs -2 days, 2 tabs-2 days, 1 tab -2 days) and advised against receiving the 2nd Pfizer dose but recommended the J&J in the future.
I tested positive for COVID on 5/10/22.  I had Moderna vaccines on 2/2/21 and 3/2/21 and boosters on 9/4/21 and 3/30/22
Patient presented to the ED and was subsequently hospitalized for Acute exacerbation of chronic low back pain within 6 weeks of receiving COVID vaccination.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 09-NOV-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The patient was prescribed valacyclovir for management of his painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Vaccinee was vaccinated twice, on 3/3 and 3/18.  On Day 9 after first vaccination, she had dizziness, headache, and nausea, and stayed home in bed for about 36 hours, missing one day of work.  She said that these symptoms got better on bedrest and ibuprofen.  Then, due to no take on the first try, she was re-vaccinated on 3/18.  This time, on day 2 (3/20/03) she again became dizzy and nauseated with headache, although not as bad as the first time, and she was able to continue working.  She describes dizziness was associated with rapid head-turning.  Didn't see a provider.  Still feeling slightly fatigued, but not dizzy, headachy, or nauseated.
Vaccine was taken out from freezer on 20-Apr-2022, expired on 20-May-2022 and administered on 24-May-2022; Patient was given expired (4 days expired) Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given expired (4 days expired) Moderna vaccine) and PRODUCT STORAGE ERROR (Vaccine was taken out from freezer on 20-Apr-2022, expired on 20-May-2022 and administered on 24-May-2022) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A, 017E21A, 013M20A and 037K20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given expired (4 days expired) Moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was taken out from freezer on 20-Apr-2022, expired on 20-May-2022 and administered on 24-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was given expired (4 days expired) Moderna vaccine) and PRODUCT STORAGE ERROR (Vaccine was taken out from freezer on 20-Apr-2022, expired on 20-May-2022 and administered on 24-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  On 24-May-2022, the patient was given expired (4 days expired) Moderna vaccine lot 033K21-2A (manufacturer expiration date 20-May-2022) Intramuscular 0.25mL as a fourth dose. Moderna vaccine lot 033K21-2A with manufacturer expiration date 20-May-2022 was taken out of freezer on 20-Apr-2022. Out of freezer expiration date was 20-May-2022.  The vial was initially stored in the refrigerator on 20-Apr-2022. The vial did not undergo any temperature excursion.  No treatment medications were provided.
Narrative: Unknown if patient passing away was due to COVID vaccine however, it is being reported as Vaccine Adverse Drug Event as the patient passed away within 42 days of receiving the vaccination.
DURING THE OPEN POD THE PATIENT RECEIVED 2 DOSES OF MODERNA VACCINE
Patient reported waking up at 3am with severe/debilitating pain in the left shoulder and neck area. Patient went to ER and was told that there was no infection or injury but the immunization was likely too high on the shoulder. Patient was released and saw primary physician and was told the same thing (no infection or damage but the injection site was too high and likely the source of the pain). Checked in with patient 2/8/19 at 2 pm and patients reports feeling better. There is still pain but it is gradually subsiding.
Pt. received BOOSTRIX vaccine today (8/19/18). While standing in line at the store w/her mom per manager, pt. pass out and hit her chin on the floor. Pt. was conscious. Bleeding on chin and may require stitches. Bleeding stop and pt. was given super drink. Manager offer to call 911 but Mom said no.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Lot number: EL8982), in left arm, on 05Feb2021 as dose 2, single (Lot number: EL9265) and on 08Oct2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESYLATE, start date: 01Dec2020, stop date: 25Jul2022; ENALAPRIL, start date: 01Dec2020, stop date: 25Jul2022.   The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, suspected covid-19. Clinical course: There were no known allergies reported. Anti viral details: product: COVID 19 treatment, brand: Paxlovid, treatment start date: 12Jul2022, treatment stop date: 16Jul2022, indication: treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
Pt requested IPV for travel to foreign country, which was administered by travel clinic. Two weeks post vax, developed lower extremity weakness. Consulted physician, was hospitalized and subsequently dx with Guillian Barre syndrome. I currently recovering.  60 day follow-up dated 09/28/00 states still recovering.
This spontaneous report was received from a pharmacist, via a company representative, referring to a currently 56 male patient, with shellfish allergy. The patient's medical history and concomitant therapies were not reported. On 31-MAY-2017, the patient was vaccinated with ZOSTAVAX injection under the skin (subcutaneous), for shingles. The patient visited an Immediate Care location on 03-JUN-2017 because he developed hives all over his body on an unspecified date. It was unknown what treatment the patient received. On 04-JUN-2017, the patient went to the Emergency Room at an unspecified hospital where the patient was administered unspecified oral medications. The outcome of urticaria was reported as recovering/resolving (the patient "was better"). The causality between urticaria and ZOSTAVAX was not reported. Additional information has been requested.
Left arm pain, headache, weakness on date of vaccination. 2 Extra strength Tylenol taken. Symptoms improved next morning.
Migraine headaches, muscle aches, chills began 24 to 48 hours after immunization. Blurred vision alternating between left and right eye onset 5/31/2015 to present date.
pt recvd vax & w/in 24 hrs pt exp canker sores;sx resolved 48hrs p/sores appeared
Nausea, Throw up, Fever, swollen throat.  Severe headache in early morning of 12/13/2015 abated late on 12/14/2015.
This spontaneous report has been received from a registered nurse referring to a pediatric patient of unknown age. The patient had no pertinent medical history, drug allergies/reactions or concomitant therapies reported. The nurse reported that on an unknown date, the pediatric patient was administered with an adult dose of RECOMBIVAX HB (lot #M018645, expiration date: 31-MAY-2018) (dose, frequency, and anatomical location were not reported) for prophylaxis. No adverse effects or additional information were reported. No product quality complaint was involved (PQC). Additional information has been requested.
had a reaction to vaccine; This case was reported by a consumer and described the occurrence of adverse reaction in a 63-year-old patient who received Herpes zoster (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 adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving the vaccine the patient had a reaction. The follow up consent was granted.
Fever. Tenderness at injection site. Red line running from injection site down arm towards torso.
Severe chills; joint pain; sweating; fever of 102.4 deg; zero energy; confusion;  lasted 48-72 hours
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 18-JAN-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M025871, expiration date: 24-MAY-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required data has been obtained. Sender's Comments: US-009507513-1611USA004113.
the patient experienced syncope post administration with GARDASIL; Information has been received from a nurse referring to a 9 years old female patient. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 23-AUG-2019, the patient received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R032768, expiration date: 31-AUG-2021, strength, dose and frequency were unknown) intramuscularly for prophylaxis. She experienced syncope post administration with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On the same day, the event was resolved.  The causality between syncope and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  Upon internal review, syncope was determined to be medically significant.
A report has been received from a Health Professional concerning a 13 year old, male patient, who received FLUMIST. The patient's medical history included closure of aortic tunnel. Concomitant medications included acetylsalicylic acid. FLUMIST was started on 15-Oct-2015. It was reported that a 13 year old patient had received FLUMIST, while he was on aspirin therapy. The outcome of the event FLUMIST administered to child taking aspirin was unknown. The report was considered to be non-serious.
1)  12 hr post injection very red and hot at injection site about 8" diameter area 2)   15 hr post injection very minor dizzy spell did not last more than  20 seconds 3)  48 hour post injection, took 200mg  advill for red hot injection area 4)  60 hour post injection,  beginnings of  anaphalaxis - throat  swelling, closing.  Took one otc 25mg benadryl
9/7/10 Onset symptoms flu-like: fever (101.6), body aches, shills HA x 24 hours. Pt exam enlarged, lymph nodes, submand, cervical , supra cervical. No axillary enlg nodes, negative findings for heart/lung; ENT; bulging TM, left. Labs revealed possible pyelonephritis/BTELS. Pt sent to ER same day. Chief complaint is: fever, bodyaches, headaches x 24 hours.
A healthcare professional reported that a 65 year old female received an injection of Pnu-Imune 23 and Tetanus Toxoid vaccines on 7/19/00. The next day, the pt developed an injection site reaction at the site of the Pnu-Imune 23 administration. She was dx'd with cellulitis and treated with Rocephin and Keflex. This is 1 of 2 pts from this facility who experienced this event following receipt of Pnu-Imune 23, lot 462810.
Pt was incorrectly administered Shingrix vaccine, no s/sx at the time of administration
As soon as he injected me I had tingling all the way down my arm and into my fingers. That lasted for a while then turned to pain.  The site was extremely swollen for over a week and sore to the touch,  The tingling still happens off and on. My arm feels tired and has pain from my shoulder around and under the arm down . Taking aleve alleviates it somewhat but it doesn't go away. Unknown at this time if it will go  away.
Initial report from immunizing pharmacy, referring to prescriber. Patient felt light-headed after vaccine, reports swollen lymph node in neck of left side starting 3 days after vaccine. now has swollen nodes in left axilla and groin.
Reddish blue rash from hand all the way up to the elbow on right arm. No tingling or numbness.
Information has been received from the mother of a 13 year old male with no past medical history and no concurrent medications who on 08/31/2000 and in September 2001 was vaccinated with varicella virus vaccine live. The pt's mother reported that within 4 to 5 days of both vacinations, the pt developed "symptoms of mono." The pt had a sore throat with sores in throat, a fever, and lethargy. The pt missed 7 days of school. Unspecified medical attention was sought. Additional info has been requested.
This spontaneous report as received from a health professional refers to an unspecified number of patients of unknown age and gender. The patient's medical histories and concurrent conditions were not reported. The healthcare professional reported that beginning on 04-FEB-2015, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (administration route, lot numbers and expiration dates were not provided). No concomitant therapies were reported, neither was any adverse event. Additional information is not expected, since there was no consent to follow up.
Patient received her first dose of Moderna vaccine on 1.12.2021. Approximately 4 hours post-vaccination she reports being suddenly weak, confused, and sweaty. She is a retired RN, took her HR, which was 108 (patient reports it is normally in the 50-60's) and BP was 123/57 (normally higher in the 130/70-80 range). Patient does report she had difficulty speaking and may have had difficulty breathing. Patient took 2 baby aspirins "in fear that it may have been her heart." Patient states that it took around 1 hour for the "episode" to pass. Patient states that she did not seek emergency care in fear of catching COVID. Instructed patient to call PCP to ask about appropriateness to receive 2nd vaccine. Patient states that she will and will request an epipen from her PCP as well. Patient encouraged to seek emergency care if a similar situation arises again.
swelling and redness around the eyes,tachycardia, cold hands, cold and clammy forehead
Patient reported fatigue the day of the 1st injection; This is a spontaneous report from a contactable healthcare professional. An adult male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown) at the hospital, intramuscular in the left arm on 06Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. Patient reported fatigue the day of the 1st injection on 06Jan2021. No other symptoms were reported. No treatment was received for the event. The event was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the event on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Got a flu vaccine and a pneumonia vaccine in same arm at request of patient. Patient began to get soreness and itching. Went to ER and got antibiotic and pain pill.
02/02/2003 Woke up with hives covered fore arms, waist, and shoulder blades. Prescribed Zyrtec 10mg #20 on 02/03/2003. Hives had subsided by 02/04/2003 am
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 71-year-old male patient received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Batch/Lot number: unknown), on 21Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 04Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing), notes: Other medical history diabetes; "hypertension" (unspecified if ongoing), notes: Other medical history: hypertension; "CAD" (unspecified if ongoing), notes: Other medical history: CAD; "Hyperlipidemia" (unspecified if ongoing), notes: Other medical history: Hyperlipidemia. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: product=COVID 19 Treatment; Negative, notes: Patient has a positive test after having a negative test; Positive, notes: Patient has a positive test after having a negative test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Patient received other medication in 2 weeks. Anti viral details product=COVID 19 Treatment.   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 available information in the case, the causal association between the events "COVID-19', 'vaccination failure' and the suspect drug BNT162B2 cannot be excluded.
pt recv vax 11DEC97 & same day exp redness, swelling, itching which spread down lt arm to lt hand;26DEC97 was seen by MD;had maculopapular eruptions w/blisters in lt axilla, lt hand, lt upper extremity from deltoid to hand;
Hx of CAD. hyperlipdemia, presenting to the ED and admitted with COVID has non-productive cough, low grade fever, body aches, malaise, fatuque and poor appetite.
approx 18hr p/vax pt arm began to get red & swell;by next day severe redness, induration, & swelling w/soreness;dark spot 10 days p/vax;
I was at rest and started a sudden rapid heartrate 100 to 150 for two continuous hours before it went below 100. Increased anxiety, and that was basically it. I had at the time jaw pain, and they suggested I get medical care. I went to the ER, but I didn't stay or get checked out because my symptoms stopped. The next episode was September 14th and that was exactly the same.  Determined it is Atrial Tachycardia. I will get a cardiac ultrasound next and that is not yet scheduled.
This spontaneous report as received from a nurse regarding a 20 year old male patient. On an unknown date the patient was vaccinated with RECOMBIVAX HB (lot #, dosage regimen were unspecified). Concomitant medications were not reported. On an unknown date the patient had titers drawn at unspecified physician office which indicated he has not responded to the series of hepatitis B vaccine which he received. Reporter stated that vaccine series were administered by another physician practice (unspecified), and she had no original vaccination series data and original product used for patient vaccination. Patient had not experienced any adverse effect due to low titers. The causality and outcome of event was unknown. Additional information has been requested.
Patient complaining of very sensitive pain at site of injection. Also headache the night of injection. Following day experiencing severe muscle pain that made it difficult to walk. By Midday felt very nauseous and passed out for a few seconds . He came to and was then feeling very warm, Took temperature it was 99. Advised patient to take 2 TYLENOL and see how he felt. After a couple of hours his temperature had gone back to normal and had finally fallen asleep. Followed up Friday 2/9/18 left two messages but have not heard back. Also reported it to his primary care doctor.
I became dizzy, weak and faint, to where I called 911 and was assessed. I then have been having SOB since 3/28/2021