chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pulse is racing on the right side of my neck It's still pulsating racing of the pulse is still there; pressure was still too high; headaches; throbbing at night/ throbbing; blood pressure is unstable since then it's still up and down; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (throbbing at night/ throbbing), BLOOD PRESSURE FLUCTUATION (blood pressure is unstable since then it's still up and down), HEART RATE INCREASED (pulse is racing on the right side of my neck It's still pulsating racing of the pulse is still there), BLOOD PRESSURE INCREASED (pressure was still too high) and HEADACHE (headaches) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced PAIN (throbbing at night/ throbbing), BLOOD PRESSURE FLUCTUATION (blood pressure is unstable since then it's still up and down) and HEADACHE (headaches). On 26-Jan-2022, the patient experienced BLOOD PRESSURE INCREASED (pressure was still too high). On 27-Jan-2022, the patient experienced HEART RATE INCREASED (pulse is racing on the right side of my neck It's still pulsating racing of the pulse is still there). At the time of the report, PAIN (throbbing at night/ throbbing), BLOOD PRESSURE FLUCTUATION (blood pressure is unstable since then it's still up and down), HEART RATE INCREASED (pulse is racing on the right side of my neck It's still pulsating racing of the pulse is still there), BLOOD PRESSURE INCREASED (pressure was still too high) and HEADACHE (headaches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Blood pressure measurement: abnormal (abnormal) blood pressure is unstable since then. The doctor changed her medications but it's still up and down.. On 26-Jan-2022, Blood pressure measurement: high (High) pressure was still too high. On 27-Jan-2022, Heart rate: pulse is racing (High) The pulse is racing on the right side of her neck..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided  Patient reported that she took the first dose of Moderna COVID19 Vaccine on 01Nov2021, but since then she's having headaches, throbbing at night, and her blood pressure is unstable since then.The doctor changed her medications.  Last night 27Jan2022, it was throbbing. The pulse is racing on the right side of her neck. It's still pulsating. The pharmacist wouldn't give her the second dose of Moderna because they want to wait until her blood pressure is stable.  Patient got a test but nothing is wrong and She was going to do a blood test from the doctor and she was supposed to be doing a scan or ultrasound on 28-Feb-2022.
Redness, slightly distal (`2in)to site of injection.; swelling slightly distal (`2in) to site of injection; Booster dose taken on 27Oct2021; This is a spontaneous report from a contactable nurse. A 26-year-old non-pregnant female patient received third (BOOSTER) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 27Oct2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to non-steroidal anti inflammatory drugs (NSAIDS). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and also received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 30Oct2021, the patient experienced redness and swelling slightly distal to 2 inches to the site of injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not 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 redness and swelling slightly distal to 2 inches to the site of injection were resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
21 YO M C/O CONSTANT, NON-THROBBING, PRESSURE TO TO LEFT TEMPORAL LOBE. PT STATES THE PRESSURE STARTED OFF AS A GENERAL HEAVY FEELING BEFORE LOCALIZING TO THE LEFT TEMPORAL LOBE. PT DENIES ANY NUMBNESS, TINGLING, ACUTE PAIN, OR VISION DISTURBANCE.
No additional adverse effects to report; his son was administered an expired ROTATEQ vaccine; This spontaneous report was received from the father's son, a patient of unknown age. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 26-JAN-2021, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), 1 dosage form, oral (lot number and expiration date were not reported) for prophylaxis. No additional adverse effects were reported.
loss of taste; Loss of smell; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste) and ANOSMIA (Loss of smell) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (loss of taste) and ANOSMIA (Loss of smell). At the time of the report, AGEUSIA (loss of taste) and ANOSMIA (Loss of smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Just received the vaccine, hurt hand shoveling snow; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date, as single dose, for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient just received the vaccine, and his hurt hand while "shoveling snow". The patient was asking if he could take a pain reliever. The outcome of the event was unknown.   Information on lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
pfizer vaccine 11/7/2021, and she had u/s on 11/11/21 showing RUE DVT, Near the elbow at the site of a previously placed peripheral IV there is a a short segment acute appearing occlusive DVT within the more anterior of  the paired brachial veins.   Note from 30 Nov 2021: 21 yo female with PMH of SSA, avascular necrosis R hip s/p arthroplasty, hx acute chest, LE DVT on Xarelto admitted for acute pain.  She has had a prolonged hospitalization and been treated with high doses of oral and parenteral opioids.  She has had multiple local interventions to attempt to control the pain including trigger point injection.  She declined exchange transfusion after discussion   1. SSA -follows with Dr. -discharge 11/7/21 after admission for pain crisis -Hgb 9.1, MCV 113 on Hydrea 1000mg po daily, folic acid 1mg po daily  -PTA tylenol 650mg prn, neurontin 400mg 4 times daily, motrin 600mg prn q6hrs, oxycodone 15mg q4hr prn -retic much better- 120 -TB 0.5 -B12 296, folate >22 -ferritin 609, TIBC 332, % sat 46, iron 152 -CT Chest per #3 -We discussed outpatient management of sickle cell disease including the possibility of pulmonary transplant, which she would be willing to reconsider   2. LLE DVT/RUE DVT -9/5/21 LLE U/S: Thrombosed calf veins without femoral-popliteal deep venous thrombosis.  -covid + 8/23/21 -PTA Xarelto-admits to compliance -covid vaccine 7 Nov 2021 -11/11/21 RUE U/S: Near the elbow at the site of a previously placed peripheral IV there is a a short segment acute appearing occlusive DVT within the more anterior of the paired brachial veins.    3. ID -11/11/21 CT Chest: No evidence of acute central or major segmental pulmonary embolism. Evaluation of the pulmonary arteries limited despite repeated attempts. Development of clustered nodular and groundglass opacities in the left upper lobe consistent with pneumonia. Trace left pleural effusion, likely reactive. Development of mild right axillary lymphadenopathy, likely reactive from reported recent COVID-19 vaccination in the right arm. Cholelithiasis. Stable osseous findings of sickle cell disease.  -normal WBC, afebrile, no cough/SOB or hypoxia   -pulmonary consulted, completed 5 day course of doxycycline    4.  Avascular necrosis -MRI 11/25/2021: Evidence of prior bone infarctions, with no new bone infarctions identified -Appreciate orthopedic surgery evaluation, she will have outpatient follow-up     Recommendations: -Appreciate pain service assistance, agree with current pain management -Will continue Hydrea at 1000mg po daily at d'c, to be adjusted outpatient -Continue Xarelto -B12 298, continue replacement 1000mcg po daily -continue folic acid 1 mg po daily
Developed the shingles rash . I thought it was an allergic reaction to  a new med at first so I did not seek treatment.  I still have the rash at this time.
This spontaneous report was received from a pharmacist and refers to a five patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients was vaccinated with ZOSTAVAX 19400 PFU (dose, route and site of administration were not reported) lot # M040145 with an expiration date on 08-JAN-2018 or lot #M040145 with an expiration date on 26-DEC-2017, pharmacist was unsure which patient received which lot number. Concomitant therapies included sterile diluent (manufacturer unknown). On unknown dates, the patients developed shingles, they developed rashes along their backs. Two from unspecified patients had confirmed cases of shingles by unspecified physicians. The pharmacist offered Polymerase Chain Reaction (PCR) Testing kit. The outcome of the events and the relatedness between the event and ZOSTAVAX were not reported. Additional information has been requested.
sore throat; flu like symptoms; malaise; injection site pain; fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (malaise), VACCINATION SITE PAIN (injection site pain) and PYREXIA (fever) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN and FUROSEMIDE for Hypertension, APIXABAN (ELIQUIS) for an unknown indication.   On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 20-May-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (malaise), VACCINATION SITE PAIN (injection site pain), PYREXIA (fever) and MYALGIA (body aches). At the time of the report, OROPHARYNGEAL PAIN (sore throat), INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (malaise), VACCINATION SITE PAIN (injection site pain), PYREXIA (fever) and MYALGIA (body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided. Action taken with mRNA-123 is not applicable.
Body aches, muscle pain, restless legs, chills, sweats, flushed face - all approximately one day Headache - 2 days Tighening in chest when breathing - going on 2 days Head congestion - 1.5 days Tired - 2 days Foggy brain - 2 days
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Relevant medical history and concomitant medication were not provided. On 07-SEP-2013 the patient was vaccinated COMVAX dose 1 for prophylaxis. Lot number, dose, route and frequency were not provided. On 11-JAN-2014, the patient was mistakenly administered PENTACEL, instead of the 2nd dose of COMVAX. No adverse effect was reported. Additional information is not expected.
1st dose on 2nd June 2023 and 2nd dose 31 August 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 56-year-old male patient who received HAB (Twinrix) (batch number 797F9, expiry date 30-DEC-2025) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 2nd June 2023).   On 31-AUG-2023, the patient received the 2nd dose of Twinrix. On 31-AUG-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose on 2nd June 2023 and 2nd dose 31 August 2023).  The outcome of the drug dose administration interval too long was 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: 31-AUG-2023 The pharmacist called to report a late second dose was administered to a patient. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccinations schedule. (Drug dose administration interval too long) plus 7 days. The vaccine administration facility is the same as primary reporter. The reporter did not consent to follow up.
7/17--7/20 30y.o. G4P2012 at 28w3d by L=1st trimester who c/o SOB that has been getting progressively worse over the past two weeks. The pt came to triage mostly because she was worried about how the baby is being affected by her anemia and symptoms. Began having contractions 7/18. 7/19 SVD of baby. Pt and baby discharged 7/20.
Profound exhaustion that hasn't subsided, and my vaccine was five months ago. I used to walk 10,000 steps a day, and took a two-mile walk every morning. Now, on a good day, I can walk 1,000 to 2,000 steps, and no more daily walks. I've gone from an active person to housebound and sometimes bed-bound. In addition, I have severe muscle and joint pain, severe weakness that hasn't subsided and post-exertional collapse that has not subsided. Skin rashes; one was biopsied and showed purpuric  dermatitis. Brain fog makes it difficult to think, write, pay bills and fill out this form. Because of my adverse reactions, my doctor has advised me not to get a second vaccine or booster shots.
A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a four-year-old male who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medical history nor concomitant medications were reported. The patient is one of siblings who received the FLUMIST on 31-Dec-2008, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with same lot# delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case in submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient's demographics and outcome of adverse event. Additional information received on 10-Apr-2009. product complaint investigatin results.
An area about 3 inches in diameter around the injection site became warm, slightly red and developed  an itchy subcutaneous rash on April 22 or April 23. Today is April 28 and the symptoms are starting to reduce.
BLOOD GLUCOSE STABILIZATION/UNEXPECTED THERAPEUTIC BENEFIT; This spontaneous report received from a consumer concerned a 75 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. Concomitant medications included insulin aspart for type 2 diabetes, insulin degludec for type 2 diabetes, liraglutide for type 2 diabetes, and metformin for type 2 diabetes. On JUN-2021, the subject experienced blood glucose stabilization/unexpected therapeutic benefit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood glucose stabilization/unexpected therapeutic benefit was not reported. This report was non-serious.
This report has was received from a pt and has not been verified by a physician or other health care professional. In 1998-1999, the pt received his first 2 injections with Hep-A vaccine. Afterward on 5/25/2000, while he was in Europe, he experienced chills, fever, weakness, muscle pain and flu-like symptoms. He continued his trip without treatment, went to Florida and was dx'd with a UTI and started on Bactrim DS. The pt went home to California and experienced jaundice, dark urine and clay colored stools. All drugs were discontinued. The most recent information received on 6/30/00, reported the pt felt better and his symptoms resolved. However, the lab values performed on 6/29/00, showed only a slight improvement. Pt was to consult a gastrointestinal specialist. Additional information has been requested. FU info states as a child the pt ate much raw shellfish and maybe had hepatitis A previously. The patients wife reported the hepatitis A that her husband is recovering from was "probably caused by an allergic reaction to Bactrim which was prescribed for his urinary tract infection.
Cough, SOB, weakness, pt suffered cardiac arrest, was intubated, pt was given remdesivir, care was withdrawn and pt passed away on 12/2/2021
Two weeks, post vax, child developed atypical seizure like episode involving an unusual giggling, lasting 10 seconds, and clenched fists and teeth and dazed look and twitching eyebrows. No family history of seizures. Mom brought child on 3/8/2000.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ route defaulted to oral (dose was not reported), lot # K001196, expiration date 22-OCT-2015. Total number of doses administer was 6. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv ax 1MAY96 & 13MAY96 lab eval revealed elevated ALT 72;no further details were provided;
This spontaneous report was received from a certified medical assistant refers to a patient of unknown demographics. On 08-NOV-2012 the patient was vaccinated with PNEUMOVAX23 (lot # H016283 in verification process, expiration date 21-FEB-2014) intramuscularly. No concomitant medications were reported. Within 24 hours (on 09-NOV-2012) after the injection the patient developed extensive swelling of the arm that received the injection. The patient was given SOLU-MEDROL (manufacturer unspecified). No lab studies were performed. The patient was recovering from the event. The patient sought medical attentions for the event by calling physician. This is one of the two reports from the same source. Additional information has been requested.
I felt tired and sore after receiving the vaccine. I was exposed to COVID-19 from my husband. I tested positive for COVID-19 in 01/2023. I contacted my doctor, and I got a prescription for PAXLOVID and ondansetron. I tolerated PAXLOVID without any complications. I could not tolerate ondansetron as it gave me diarrhea. As of today, I am feeling better with no lingering symptoms.
Generalized itching, esp periumbilical . Circular rash around injection site noticed 1-2 days after itching started. Itching resolved after 2 days, rash took 2 days to resolve once noticed.
no adverse effects reported; female patient received an extra dose of properly stored gardasil 9; This spontaneous report was received from a medical assistant refers to a 15 year old female patient. The patient's concurrent condition, concomitant medication and medical history were unknown. On 02-OCT-2019, the patient was vaccinated with extra dose of properly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # S008154  with expiry date 20-NOV-2021 (dose, frequency, route of administration, lot # and expiry date unspecified) for prophylaxis (extra dose administered). No adverse effects reported (no adverse event). The outcome of the events was unknown.
My son Passed out 30 seconds after shot, seizure like shaking, high fever and vomiting, took him an hour just to sit up in the dr. Office. then he was nausea all day after shot. He was sick on and off for a year after vaccination his immune system didn't seem to be working.
patient came in for flu shot appeared normal, was communicating with me but had said how hard it is to breath with these masks on. she was also thankful to have a chair to sit in. adminsitered shot and patient seemed normal was communicating with me and then became unresponsive but was still breathing. called 911 and she was still breathing but not responding and had her head down.
This spontaneous case reported by a consumer (subsequently medically confirmed), describes the occurrence of erythema (red arm), vaccination site warmth (hot to the touch), pain in extremity (sore arm) and peripheral swelling (swollen arm) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 001A21A) for COVID-19 immunization. The patient's past medical history included no adverse event. On Mar 15, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced erythema (red arm), vaccination site warmth (hot to the touch), pain in extremity (sore arm) and peripheral swelling (swollen arm). At the time of the report, erythema (red arm), vaccination site warmth (hot to the touch), pain in extremity (sore arm) and peripheral swelling (swollen arm): resolving. The action taken with mRNA-1273 (Moderna COVID-19  vaccine), intramuscular: unknown. Concomitant medications not provided. Treatment for the events: antibiotic.