chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mild-moderate left arm pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 15:15 (Batch/Lot number: unknown) at the age of 16 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 22Mar2021 22:00, outcome "recovering", described as "Mild-moderate left arm pain". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient had not received any other vaccines within 4 weeks and had not been diagnosed with COVID-19 prior vaccination. Since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Screaming, non stop crying, fever, lose of appetite, all within the night following the vaccination and some. Continued in the course of a month and a half, wheezing, dry coughing, runny nose, rash, constipation, insecure, clumsy and unable to keep balance. Prior to vaccination he was already walking, he has now stopped.
No additional AEs or PQC reported; Patient is 7 months old and this was her 3rd dose.; This spontaneous report has been received from a physician referring a 7-month-old female patient. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 03-JAN-2023, the patient was vaccinated with the 3rd dose of haemophilus b conjugate vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, at a dose of 0.5 milliliter, lot number W021181 with expiration date 21-FEB-2025, administered intramuscularly for prophylaxis (specific dosage, vaccination scheme and anatomical site of application were not provided) and with diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) at a dose of 0.5 milliliter administered intramuscularly (strength, specific dosage, vaccination scheme, anatomical site of application, lot number and expiration date were not provided) (product administered to patient of inappropriate age). No additional adverse event reported.
Diarrhea; loss appetite; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DECREASED APPETITE (loss appetite) and INJECTION SITE PAIN (injection site pain) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (tested COVID-19 positive).    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced DECREASED APPETITE (loss appetite) and INJECTION SITE PAIN (injection site pain). On 02-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) for Adverse reaction, at a dose of 1 dosage form and IBUPROFEN (ADVIL 12HOUR) on 27-Feb-2021 for Adverse reaction, at a dose of 2 dosage form. On 28-Feb-2021, INJECTION SITE PAIN (injection site pain) had resolved. At the time of the report, DIARRHOEA (Diarrhea) and DECREASED APPETITE (loss appetite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.
Pt started coughing, felt like something in nasal passage; blood spots in mouth, gums numb; MD states allergic rxn to flu vax; upper lip swollen & numb;
bad diarrhea; upset stomach; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (bad diarrhea), ABDOMINAL DISCOMFORT (upset stomach) and VOMITING (vomiting) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced DIARRHOEA (bad diarrhea), ABDOMINAL DISCOMFORT (upset stomach) and VOMITING (vomiting). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. On 03-Apr-2021, DIARRHOEA (bad diarrhea), ABDOMINAL DISCOMFORT (upset stomach) and VOMITING (vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.
Pt reported to have seizure day of immunizations (6-7 hrs) after administration. One previous seizure in summer unrelated to immunizations.
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 65-year-old male patient received BNT162b2 (BNT162B2), on 22Feb2021 at 10:00 as dose 1, single (Lot number: EN6198), in left arm, on 15Mar2021 at 10:00 as dose 2, single (Lot number: EN6207), in left arm, on 28Sep2021 at 09:30 as dose 3 (booster), single (Lot number: EW0168), in left arm and on 18May2022 at 10:00 as dose 4 (booster), single (Lot number: FM0173) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN, start date: 01May2019; BYSTOLIC, start date: 14Jan2022. No known allergies reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; negative, notes: home test on day 7; Positive, notes: positive on day 8. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 23Sep2022 to 27Sep2022.  No follow-up attempts are possible. No further information is expected.
Received second dose, Two days later diagnosed shingles; Painful rash; Painful rash; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd September 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 4th September 2022, 2 days after receiving Shingrix, the patient experienced shingles, rash and pain. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the shingles, rash and pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles, rash and pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comment: The reporter was the patient's wife. The reporter stated that 2 days after the patient received Shingrix vaccine in unknown arm, experienced painful rash then patient saw the dermatologist and he diagnosed with shingles and prescribed an unknown antiviral pill. Reporter did not have contact information for physicians. The reporter consented to follow up. Additional supportive information: This case had been linked with US2022131379 reported by same reporter.; Sender's Comments:  US-GSK-US2022131379:Same reporter
It was a very minimal reaction ...flushing itch and rash on arms / chest I was told I couldn?t do 2nd shot at facility and would need to do at a hospital here said they sent over information and til today no call so I?m assuming I am not able to take the 2nd it happened 20 minutes after shot and by the evening it was better
This is a spontaneous report from a contactable Physician Assistant communicated to a sale representative. A 16-year-old male patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on 21MAR2016 at 0.5 ml, single and MENACTRA via an unspecified route of administration on 21MAR2016 at 1 DF, single. The patient medical history and concomitant medications were not reported. The patient experienced headache, dizziness, and motion sickness on 21APR2016 with outcome of not recovered. The patient was prescribed TYLENOL and MECLIZINE.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of GARDASIL (dose, lot # and expiration date not reported) that was exposed to 20 F for an unspecified period of time, which was excursion that was unsupported by in-house stability data. No adverse symptoms were reported. Follow up information has been received on 24-APR-2014 from a nurse. The reporter mentioned that "30 patient or less" received improperly stored GARDASIL that was exposed to 20F for 11 days. Administration dates, lot # and expiration dates were not reported. Follow up information was received a health center manager. The patients' identifiers were obtained. This report concerns one of the patients. On 17-MAR-2014 at 09:15, the 20 year old female patient was vaccinated with the first dose of GARDASIL (lot # H020848, exp. 03-APR-2015) into right deltoid (dose, route not reported). The medication refrigerator was out of range on the following dates: Jan 07, temperature (Degrees Fahrenheit) 44/26; Jan 09, 36/22; Jan 11, 26/40; Jan 14. 22/26; Jan 16, 26; Jan 20, 28/32; Jan 25, 22; Jan 27, 24/26; Jan 28, 20/20; Feb 17,26/20. This is one of several reports received from the same source. Additional information is not expected.
Patient arrived at hospital via EMS after being found unresponsive by his parents at home. Had left sided paralysis in the ER, left hemineglect, right gaze, slurred speech, headache.
Temperature excurssion of vaccine while trying to vaccinate homebound individuals VAccine deemed not properly stored but given to patients CDC notified, recommend repeat vaccination
I can't walk without assistance; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization, reaction(s): "my feet and hands went numb". The following information was reported: GAIT INABILITY (disability), outcome "unknown", described as "I can't walk without assistance".  Additional information: The patient mentioned after Pfizer Covid vaccination, feet and hands went numb. After two more boosters, can't walk without assistance.  "Do you have any knowledge on how I can reverse this process and walk again?"  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300121944 same patient different dose/drug/event;
lt arm paresthesia lt neck @ 8PM; 29JUL malaise, generalized weakness, tired; 30JUL cervical lymphadenopathy, h/a, muscle back ache, flank pain, 99.2, pale; 30JUL t100.6, rib & abd muscle pain; 31JUL t102.9, sweating;
Patient was lightheaded and dizzy following her vaccine. Also nausea, flushing, and sweating.  Patient was moved to a medical room and placed in a recumbent position.  Vital signs were monitored.
Headache and tired at 9pm when I went to bed. Then sleepless night with vivid dreams, severe headache, chills, aches and pains, extreme thirst throughout the night. Next morning I took 2 Tylenol at 5am and when I woke at 7am I felt tired but better and was drenched in sweat. Remainder of this day I?ve been achey and exhausted and took a nap. Hoping I?ll feel better tomorrow.
Information has been received from the literature regarding 11 patients. The study used a retrospective electronic database chart review of all patients 18 years of age or older at a tertiary care. This review was approved by a Review Board. Subjects met inclusion criteria if they had a visit at the allergy-immunology clinic between 2002 and 2009, received an International Classification of Diseases, diagnosis of Chronic rhino sinusitis (CRS), and underwent evaluation for immunodeficiency by assessment of quantitative serum immunoglobulin levels and pneumococcal antibody titers pre- and post immunization with a PPV. The treating physician made the decision to evaluate the individual patient with CRS for immunodeficiency. All subjects had normal IgG levels (>550 mg/dL). Subjects were included if they had a sinus CT scan documenting CRS and met criteria for CRS as defined by nationally recognized consensus statements. The presence of nasal polyposis was determined by rhinoscopy or surgical pathology specimens, and subjects were subsequently classified as chronic rhino sinusitis without nasal polyps (CRSsNP) or chronic rhinosinusitis with nasal polyps (CRSwNP). Atrophy was determined in all subjects via skin testing to pollens, dust mites, pets, molds, and cockroach using Hollister-Stier extracts. Asthma diagnosis and severity was determined in accordance with the 2007 National Asthma Education and Prevention Program (NAEPP) expert panel report 3 guidelines using % FEV1 values. Subjects were excluded if they had common variable immunodeficiency, allergic bronchopulmonary aspergillosis, Churg-Strauss syndrome, primary cilliary dyskinesia, cystic fibrosis, malignancy, IgA deficiency, or any acquired immunodeficiencies (eg, HIV/AIDS or secondary to medications such as chemotherapy). Evaluation of subjects' characteristics, antipneumococcal antibody titers, and serum Ig levels was performed via Analysis of variance (ANOVA) with post hoc Tukey analysis. Analogous chi-square tests were used to compare percentage for categorical variables. Data are expressed as mean with standard deviation. A P-value less than 0.05 were considered statistically significant; such results have been marked with an asterisk in the table in which they appear. Total number of patients were 239. On an unknown date, the patients were vaccinated with PNEUMOVAX 23 (manufacturer unknown), (dose, anatomical location and lot number was unknown). Concomitant medications were unspecified by reporter. On an unknown date, the patients experienced specific antibody deficiency (had less than 50% of the pneumococcal serotypes greater than or equal to 1.3 mg/ml after PPV immunization). The outcome of the event was unknown. The author considered the event to be related to Pneumococcal vaccine. This is one of the several reports received from the same literature article. Additional information has been requested.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. The patient was vaccinated with dose 1 GARDASIL (lot # unknown) on an unspecified date in 2009. On 17-JUL-2012 the patient was in the office to receive dose 2 GARDASIL (lot # is unknown). No treatment information was reported. No adverse effect reported. Additional information has been requested.
This spontaneous report was received from a registered nurse refers to a patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 13-FEB-2019, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # R018735, expiry date: 06-APR-2020) for prophylaxis. Temperature and time frame of temperature excursion was noted as from 29-JAN-2019 (12 Degree Celsius for 1 hour 21 minutes) to 26-FEB-2019 (10 Degree Celsius for 22 minutes). It was reported that there was no previous temperature excursions. Digital data logger was noted as Yes. No adverse events were reported. The outcome of product storage error and no adverse event was unknown. This was one of nine reports mentioned in the report. Sender's Comments: US-009507513-1903USA009846: US-009507513-1903USA009847: US-009507513-1903USA009849: US-009507513-1903USA009850: US-009507513-1903USA009845: US-009507513-1903USA009844: US-009507513-1903USA009843: US-009507513-1903USA009848.
This spontaneous report was received from a patient's mother regarding her son of unknown age. Information about patient's medical history and drug allergies was not reported. On an unknown date, the patient was vaccinated with M-M-R II (dosing details not reported). It was reported that, on an unspecified date, the patient became "sensitive to some sounds" after vaccination with M-M-R II. She also reported that she had reported this adverse event approximately in 2012 (reported as 4 years ago), but could not find any record of this adverse event report in system. The outcome of hyperacusis and causality were unknown. No PQC was involved. This case is one of the two cases from the same reporter. Additional information has been requested.
is_pregnant: Yes/36 Weeks pregnant; Slight tingling/numbing sensation that started at my ear and affected the right side of my face; Slight tingling/numbing sensation that started at my ear and affected the right side of my face; headache; This is a spontaneous report from a contactable consumer or other non hcp. This is the maternal report. A 31-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration, administered in Arm Right on 02Feb2021 14:30 (at the age of 31-year-old) (Batch/Lot Number: EM9810) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included slightly under-active thyroid from an unknown date and unknown if ongoing (Pregnant and slightly under-active thyroid). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no known allergies. The patient did not diagnosed with COVID-19 Prior to vaccination and since the vaccination, has the patient been tested for COVID-19. Concomitant medication(s) included minerals NOS vitamins NOS (PRENATAL VITAMINS [MINERALS NOS; VITAMINS NOS]) taken for an unspecified indication, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for thyroid start and stop date were not reported. The reporter stated that is pregnant: yes/36 Weeks pregnant on an unspecified date, slight tingling/numbing sensation that started at my ear and affected the right side of my face on 02Feb2021 14:30 and headache on 02Feb2021 14:30. The date of last menstrual period 22May2020. The mother reported she became pregnant while taking bnt162b2. The mother was 36 weeks pregnant at the onset of the event. The mother was due to deliver on Mar2021. The mother delivered the pregnancy. The patient did not receive any treatment for the events headache and slight tingling/numbing sensation that started at my ear and affected the right side of my face. The seriousness of the events was reported as non-serious. The outcome of the events is pregnant: Yes/36 weeks pregnant was reported as unknown. Headache and slight tingling/numbing sensation that started at my ear and affected the right side of my face was reported as recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.
pt broke out with 3 patches of hives in the area the the vaccine was given on 5/18/19, by the time she had called the office on monday she was feeling better.
2 days after vaccine DTaP given, woke up with red, swollen, left arm. Size of a baseball, redness did start to go away on second day.
Numbness in both hands, achy and tingling.  Very intense and severe.  Went to my private doctor on 10/14; diagnose - MMR Arthritis - Have not been able to sleep my normal 8 hours; Used hot water, heatable bag, and fresh pineapple have only given temporary relief. Planning on going to the Emergency at closest hospital this morning.
Around 3PM is started feeling nausiated, Then I became extremely cold and could not get warm for about 3 hours.  After that I slept for 14 hours, got up shower.  After being up about 4 hours I slept another 3 hours.  I was not hungry.  Actually food upset my stomach. I still felt somewhat ill until I got up the 2nd day.  I am fine now.
This spontaneous reprot as received from an office manager refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored VAQTA injection, lot# L008665, exp. date: 10-FEB-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
significant swelling & erythema around inj site;better as of 9NOV95;
Heart burn; heart palpitations; chest pains; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Aug2021 (Batch/Lot number: unknown) at the age of 23 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPEPSIA (non-serious) with onset 2021, outcome "unknown", described as "Heart burn"; PALPITATIONS (non-serious) with onset 2021, outcome "unknown", described as "heart palpitations"; CHEST PAIN (non-serious) with onset 2021, outcome "unknown", described as "chest pains". Therapeutic measures were not taken as a result of dyspepsia, palpitations, chest pain. Additional information: Patient receive  did not any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sunday morning, 4/11/21, had severe itching in hands/feet that was improved by deep massage and hot water. Also had hives on flanks that moved up sides. Initially took Benadryl 1 tab twice and then in evening took 2 tabs d/t worsening symptoms. Next day had similar symptoms but hives also on trunk that traveled up to neck and jawline. Denies airway involvement or s/sx of blood clots.
numbness & tingling in tongue & throat after vaccine administration. Immediately taken to the ED, Benadryl & steroid given.