chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse side effects.; a patient was administered an improperly stored MMRII vaccine.; This spontaneous report was received from a nurse referring to a 12 years old female patient. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.  On 30-SEP-2019, the patient was administered an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)(lot # R028003, expiration date was 01-OCT-2020) subcutaneously for prophylaxis. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) vaccine was stored in refrigerator that had gone out of range. The administered dose experienced a temperature excursion of 53.7 degree Fahrenheit for 6 hours 16 minutes. There were no previous temperature excursions. The temperature excursions were detected by a data logger. No adverse side effects.  Telephone call attempt on 16-OCT-2019 to obtain follow-up information was unsuccessful.
On the same day of COVID vaccination, patient presented to the ED with suicidal ideation. He was hospitalized for 2 days.
Severe vertigo with jittering eyes, loss of balance, vomiting. Started Antivert on 1/19/2021 at 7:45 pm. Better, but still very dizzy. Vomiting has stopped.
I receive Botox injections in both under arms to treat severe auxiliary hyperhydrosis. After my booster both armpits got very swollen (no rash) and felt as if the tissue had an excess of fluid trapped in the tissue. Both armpits were swollen (injection side -right was more swollen) and were painful to touch).
Chest tightness, chest heaviness, tachycardia, sent to ER and all tests for myocarditis came back clear. Ran full panel of bloodwork including ANA and tested positive for ANA and RNP--no evidence of symptoms of autoimmune disease prior. Tachycardia is only helped by beta-blocker now and further testing must be done to check for a true positive test of the ANA/RNP.
Developed lightheadedness, nausea (no vomiting, b/ tinnitus, and tingling in b/l hands. All symptoms resolved by 20 minutes of monitoring. Vitals WNL.
On the night of the vaccine, I had unexplained and significant fatigue, chills, and aches that lasted through the following day.  I also had periodic headaches and was unusually thirsty.  Two days after the vaccine, I had a slightly runny nose and cold sweats.
Within 10 minutes after vaccine, my face became extremely hot and red and left ear red and profuse sweating.  Within 30 minutes heart rate increased and a little clearing of throat.  A little over an hour nausea started and increased clearing of throat , slight feel of constricture in throat and a slight feeling of heaviness in chest, and jittery and heart rate still feels increased.   Nurse at Nursing home watched for 45minutes until I chose to leave.  In my vehicle and home is when nausea started.  Phone call contacts with nursing home staff continued for an hour.   I took 2 benadryl and 2 Tylenol, napped.  Felt better.  Nausea 3 days.  Tired and neck lymph achy.
chest pain, nausea, lethargy.  Hashimoto's disease, thyroid problem.
Breakthrough case admission after 5 vaccines MOderna 2/15/21 Lot# 010M20A; Moderna 3/15/21 Lot# 027L20A;  MOderna 11/11/21 Lot# 077C21B;  5/12/22 Moderna Lot# 004M21A;  Pfizer 10/20/22 Lot# GH9702
I was riding my bike one day, and I began to not feel well. I began to have a tightness in my chest. I finished riding and then went home and make an appointment with my doctor. I saw my doctor, who referred me to a cardiologist. I went to a cardiologist on 12/08/2022. He scheduled a stress echocardiogram for 12/21/2022. When I took the stress echocardiogram, it showed that I had possible ischemic changes. On 1/23/2023, I had a CT scan coronary angiogram. The results indicated that I had a 70% blockage in the left anterior descending artery. After the results came in, I was then referred to an interventionist cardiologist to receive a stent. On 2/2/2023, I received one stent. Ever since, I've been doing better. I was also put on Crestor, Plavix, and a baby aspirin.
27JUL93 temp 99; 28JUL93 LMT 1cm erythema & swelling-RMT 2cm erythema & swelling diffuse maculo-papular on trunk and extremities;
I awoke with flu like symptoms. Achy,chills and body pain. These symptoms lasted for approximately 3 hours and then subsided. My temperature was normal at 98.6. I took two Advil and fell much better. A little feeling of fatigue still lingers.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: FALL (non-serious), outcome "unknown", described as "I feel like I am going to fall over"; BALANCE DISORDER (non-serious), outcome "unknown", described as "Equilibrium is off, my balance is"; ILLNESS (non-serious), outcome "unknown", described as "sick"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms". Additional information: The patient's equilibrium was off, balance was, the patient felt like the patient was going to fall over. The second dose got the patient very sick, with flu like symptoms. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Drug ineffective; SARS-CoV-2 infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient had no allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "SARS-CoV-2 infection". Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details: paxlovid, from 02Jul2022 to 06Jul2022, for Treatment of COVID-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a registered nurse concerning a 13 year old white female with phenylketonuria who on 29 JUN 2007 at 9:00 was vaccinated subcutaneously into the left arm with a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 657405/0531U). Concomitant therapy that same day included an intramuscular first dose vaccination of hepatitis A vaccine (inactive) (Lot # "0282F") and intramuscular first dose vaccination of human papillomavirus vaccine (GARDASIL), (Lot # 655618/0186U). There was no illness at the time of vaccination. On 30-JUN-2007 the patient developed a three inch area of redness, swelling and pain at the injection site of "Varivax" (left arm) the patient's guardian elected to have the patient seen in the emergency room. On 02 JUL 2007 the site was observed to be only slightly red and tender to touch, with slight edema. No treatment was given. The patient was recovered on 02 JUL 2007. There were no lab diagnostic studies performed. There were no known adverse events following prior vaccinations. There was no product quality complaint. This is one of several reports received from the same source. Additional information has been requested.
dizzy; irritable; More irritable and dizzy again; This is a spontaneous report from a Pfizer Sponsored Program. A 50-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration on 27Jan2021 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included autism spectrum disorder. Concomitant medications were not reported. The patient reported, started to get dizzy, irritable. He was more irritable and dizzy again. His general practitioner said he would be ok, to drink fluids, and could take a Tylenol for the site pain. Heard it's much stronger reaction to the 2nd shot than the first. Asking if should be concerned? Outcome of the events was not resolved.  Information about lot/ Batch number requested  Follow-up attempts are completed. No further information is expected.
pt recv vax 18MAR98 in AM & pt devel intractable crying 2AM 19MAR98 which lasted until 20MAR98 10AM;no fever;CBC negative;blood cult negative;exam nl;
Headache, Myalgia, Arthralgia & Fever Narrative: headache, neck stiffness, body aches, chilling and had a fever of 100.3. taking Tylenol every 4-6 hors since Monday.
severe diarrhea; fever; Chills; Achy; This is a spontaneous report from a contactable other hcp. A 65-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EL3248), dose 2 via an unspecified route of administration, administered in Arm Right on 24Jan2021 08:20 as DOSE 2, SINGLE for covid-19 immunisation (at the age of 65 years). The patient medical history and concomitant medications were not provided. The patient previously received first dose of bnt162b2 on 02Jan2021 for covid-19 immunisation and experienced severe diarrhea. On 25Jan2021 patient experienced achy, 100.5 fever, chills. On 27Jan2021 at 08:00 experienced Severe diarrhea. Patient did not required visit to Emergency room/Physician office. Patient did not receive treatment medication. The patient underwent lab tests and procedures which included pyrexia: 100.5 on 25Jan2021. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Patient had received her second dose of SHINGRIX vaccine. She claims the vaccine process was routine and nothing out of ordinary. However, she said it was the most painful vaccine she had ever received. She said after her first dose of SHINGRIX she was fine. This time around she felt "flu-like'' symptoms. She phoned her friend to come over and help her. During the early morning she couldn't stand and had to sit. She doesn't remember what happened after that. Her friend stated that he saw the patient's hand in a claw like form and was stiff. He states she was shaking and had a blank stare. Patient mentioned her friend can over dramatize. She woke up at noon ate some cereal and fell back asleep until 6 pm.
pt recv vax 27DEC95 & lab eval 11MAR96 revealed a negative measles titer;
This report described injection site swelling in a 19 month old female who received DTaP. On 05/09/01, the vaccinee received her fourth "5 cc" left leg dose of DTaP. Two days later, on 05/11/01, the mother reported that the vaccinee's left leg was red and swollen hard greater than size of one dollar coin. There was no streaking. The registered nurse instructed the mother to apply warm compress, to administer acetaminophen (Tylenol) for comfort and to call if streaking developed or redness developed. The physician was notified. No return call was received. The reporter stated that the adverse events were moderate in severity and were related to DTaP. As of 07/20/01, the adverse event had resolved
Information has been received from a pharmacist via a field representative referring to a female patient of unknown age. On an unspecified date in October 2014 (reported as 3 months ago), the patient was vaccinated with a dose of ZOSTAVAX (dosage and lot# unspecified), subcutaneous. On an unspecified date in October 2014 (reported as 3 months ago), the patient experienced injection site reaction-mainly a rash after receiving ZOSTAVAX. The patient did not seek medical attention. The outcome of the events was unknown. Additional information has been requested.
Itching at injection site on day 8 post injection. Swelling, redness and hot to touch at injection site on day 9. ?Covid arm?
Significant discomfort/pain at injection site when left arm/shoulder is moved.  Arose morning after administration and still present 10 days later.
Pt c/o tingling in lips 15 minutes after immunization given. 1/2 hr later pt c/o tingling radiating towards cheek. Pt took 25 mg Benadryl PO at 11:30 AM. 12:05 PM symptoms have dissipated. To follow up with PMD.
No adverse event; Improperly stored PROQUAD was inadvertently administered; Information has been received from a medical assistant concerning to a 4 year old male patient. No medical history, concurrent conditions nor concomitant medications were reported. On 22-OCT-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Lot No. S012536,exp. date 20-OCT-2020) (rHA) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse event was reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA015996:
12/29/2021 PM upper epigastric  pain, nausea, vomiting, low blood pressure and high heart rate, then later within hours turned to lower blood pressure and lower heart rate abdominal tenderness. Back and forth in this condition then emergency room on morning of 12/31/2021. Hospitalized after the emergency room visit. Discharged on Jan. 2, 2021.  Still getting follow-up test and not on any treatment.
Patient received pediatric dose (orange cap) of covid-19 Pfizer vaccine instead of the adult (purple cap) dose.  The pediatric vaccine was also not diluted prior to administration.  In addition 0.25mL was given instead of 0.3mL.  The patient had no adverse reaction or symptoms due to the dosing error.
Booster; Chicken pox like outbreak; Rash; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A female patient in her 50's received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "Booster"; VARICELLA (non-serious) with onset 2021, outcome "unknown", described as "Chicken pox like outbreak"; RASH (non-serious) with onset 2021, outcome "unknown", described as "Rash".   The lot number for bnt162b2 was not provided and will be requested during follow up.
Rash/Allergic reaction all over body, nausea, vomiting, dehydration, UTI, acute kidney injury
Hard red two quarter sized inflammed area on the back of her arms where ZOSTAVAX was given. The area was very warm to touch. Instructed patient to apply cold compress and take Benadryl.
A report has been received from a Health Professional concerning a male subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. The patient experienced multiple patients received FLUMIST Quadrivalent and tested positive for Flu A. The outcome of the event of multiple patients received FLUMIST Quadrivalent and tested positive for Flu A is unknown. The report was considered to be non-serious.
Local Swelling at injection site occurring within 24 hours of injection. Local ice applied with resolution.
I was coughing and SOB.  I had running noise, vomiting, sore throat, diarrhea, and some chest pain.  I was fatigue and dizziness for a few days.  I had a fever.  I had chills.  I could not taste anything for few weeks.  I can not smell any thing as well.  I did have COVID-19 test, the came back positive.
About one month after the first dose of the vaccine my blood pressure and Heart rate were elevated. I consulted my doctor because I was due to get my second dose within days. The Urgent Care I went to advised increasing my Blood Pressure medication. I did that and it improved. I went back to my normal dosage. About one month after my second dose, I had another event where I was dizzy and nauseous as well as having elevated blood pressure and Heart Rate. I went to the ER and they identified that my Heart Rate was elevated. I was given medication for dizziness (Meclizine). I felt better that evening and within two days I felt normal. I received my Booster, and it has been 3 months. I did not have any similar events.
Days 1 and 2, 24 and 25 Feb 20201, severe interior cold, forced napping, lethargy. Day 6, 01Mar21, worked at computer for 15 minutes, became dizzy and with brain fog. Did the strain in my immune system rekindle symptoms from the April 2019 concussion? From then on, I used my sunglasses when working at computer.  Day 8, 03 March 2021, resumed half of a mild weight-lifting routine. Days 9, 10 and 11, 4-6Mar 2021, forced napping,  lethargy, some brain fog. This pattern, light exercise or chores followed by day(s) of lethargy and napping, closely resembles April through September 2020+plus as I recovered from what appeared to be COVID-19 in March 2020. The test at that time was negative.   Day 12, Sunday I learned about this site. Today, Day 13, I'm a bit lethargic but OK, having done nothing since Friday. Haven't yet attempted any significant chore.
migraine headache; Hot flashes/Hot flush; night sweats; joint aches/Joint pain; weight gain; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: ER8737, Expiration date: 31Dec2069) on 02Apr2021 via an unspecified route of administration in left arm as DOSE 1, SINGLE for covid-19 immunization and received second dose of BNT162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: ER8733, Expiration date: 31Dec2069) on 23Apr2021 via an unspecified route of administration in arm as DOSE 2, SINGLE for covid-19 immunization (age at vaccination: 62-years-old).Patient medical history included Ongoing Hypothyroidism, approx. from 2000. The patient continued taking Levithyroxine (88 mg) from an unspecified date for Hypothyroidism within 2 weeks of covid-19 vaccine and was still ongoing. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The vaccine was not administered at facility. Patient did not receive any prior vaccination before covid-19 vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. It was reported that the patient was 10 Years post menopause at the time of report. Patient did not have any known allergies. On an unknown date in Apr2021, the patient experienced Hot flashes/hot flush, night sweats, and joint aches/Joint pain. On 01May2021 the patient experienced migraine headache and on an unspecified date of 2021 patient had weight gain. It was reported that the hot flush, night sweats, joint aches/Joint pain, and weight gain was recurring. Relevant tests were reported as none. The patient did not receive any treatment for the events of Hot flashes/hot flush, night sweats, joint aches/Joint pain, and migraine headache. The outcome of the events Hot flashes/hot flush, night sweats, joint aches/Joint pain, and migraine headache was not recovered. The outcome of the event weight gain was unknown.   Follow-up attempts are completed. No further information is expected.
Flushed, Fever, Headache, Nausea, Blurred Vision, Everything moving very fast when sitting still, Dizziness, Feeling like weights are on body, Tired, Ringing in ears, loss of hearing, Numbness and weakness on right side of body,  Extreme Confusion, Sensitive to sounds and lights, Elevated blood pressure and elevated pulse, Elevated glucose levels
Two day post Pediarix lot #21918D2 in the LVL with intense 9cm diameter redness, warmth and swelling. Also received Hib #2, PCV 7 and flu.
Lethargy; Body aches; Nausea; Severe chills; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 67-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 18Mar2021 at 9:15 as single dose (at the age of 67 years) for COVID-19 immunisation. Medical history was not reported. No concomitant medication were reported. Patient had no known allergies to medications, food, or other products. The patient received first dose of BNT162b2; (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via unspecified route of administration administered in left arm on 25Feb2021 at 11.00 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was diagnosed with COVID-19 on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date, (after receiving first dose of Covid-19 vaccination), the patient experienced first episode of severe chills, body aches nausea, lethargy and headache and lasted for 2 days. On 18Mar2021 at 22:45, (after receiving second dose of Covid-19 vaccination), the patient experienced second episode of severe chills, body aches nausea, lethargy and headache. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Patient never had a reaction other than a sore arm from any other vaccine she had. It was reported that she will definitely use a different brand for future. No therapeutic measures were taken for the event. The clinical outcome of the second episode severe chills, body aches nausea, lethargy and headache were reported as resolving.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report was being submitted to amend previously reported information patient initial captured in first name field of the patient tab, removed name fromand last name field and country US added for patient in patient tab.
Patient presented to PC for New Patient Appointment. Was administered PREVNAR Pneumonia Vaccine, left deltoid, at 9:05 AM. While in exam with PCP, stared developing systemic redness and itching, not local at injection site. Reported allergies of MIRALAX and ALEVE- also rash. Reports Band-Aids cause damage to skin at application site. Methylprednisolone 125 mg once, diphenhydramine 25 mg once.
Bumps and dark spots under the eyes; Bumps and dark spots under the eyes; Swelling under the eyes; This is a spontaneous report from a contactable other healthcare professional. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date in 2021 (2-3 months ago) as an unknown, single dose for COVID-19 immunization, hyaluronic acid (RESTYLANE, Formulation: Unknown), via an unspecified route of administration from 03Apr2021 at an unspecified dose and frequency for an unknown indication. The patient's medical history and concomitant medications were not reported. Patient received Pfizer COVID vaccines 2-3 months ago. Patient injected with Restylane Silk on 03Apr2021 under eyes. Reported swelling under the eyes same day (03Apr2021). On 04Apr2021 reported bumps and dark spots under eyes. Massage only. The action taken in response to the events for hyaluronic acid was unknown. The outcome of the events was not resolved.  Follow-up needed, Information on the lot/batch number has been requested.
After the patient received the vaccine it was found that the patient was 17. There were no side effects reported during the 15 minute observation after the vaccine.
Patient called next morning after vaccination, complaining of itchy hives on elbow, buttock, breast, leg and foot. Injection sites were clear and no other complaints. Follow up later that day had no change. Follow up with patient 8/21, pt reported 90% improvement in sites. Will call 8/22. Called pt 8/23, everything improved without problem.