chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The first 10 hours I did not have any symptoms. That night about 12 hours later, I experienced headache and arm swelling at the injection site. At 3 am that morning , I had 102. fever. By the time fever broke, my arm had a goose egg the size of an actual egg.  The fever continued off and on the next 24 hours. The next day, my arm was swelling more about the size of a lemon. My whole arm was swelling. I then called my ER doctor. It felt like a hard lump. The fever I had again 102.3. I took Tylenol and Motrin and could not break fever. My heart rate went up to 125 from the fever. The next day, I felt achy, chills, nausea and then they subsided. It took about a week for the arm swelling to resolve.
Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a nurse practitioner regarding a 6 year old male pt who experienced flu-like symptoms and diarrhea.  At 6 years of age, the pt received a dose on 12/18/03.  The pt had no relevant medical history.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/18/03.  Dose regimen was 0.5mL (IN). Pt was not taking concomitant therapy.  On 12/22/03, 4 days post-immunization, the child presented to the clinic for treatment of flu-like symptoms, characterized by nasal discharge, cough, fever of 102.9 degrees F., and diarrhea.  No additional information was available at the time of this report.
Apnea 12-24 hours after vaccines. In ER. Oxygen, Acyclovir, Rocephin, propofol, succinocholine, endotracheal tube. RSV negative, influenza = negative. From ER - airlifted to hospital. 4/6/09-records received-for DOS 3/6-3/11/09-DC DX:Episodes of apnea. 1 week history of URI with runny nose and congestion. Mutliple apneic events requiring intubation.
Per patients mother the patient had redness in the arm. There was also a rash. Patient was not prescribed medication by provider.
About a week I broke out in a real bad sweat, my chest felt like somebody setting on it and my back felt like my lungs was busting  then it felt like something trying to  bust , there was so much pressure  I couldn?t hardly breathe or hold my head up.  I took 1 nitroglycerin pill and 2 aspirin  It  kept hurting and felt worse. I took another  nitro gkycerian and 2 more aspirins after sitting still taking deep breaths for about 20 minutes it eased off and went away I continued having soreness in my chest area so I took an aspirin a day for over a week and it went away
blood pressure gets really low; seasonal Asthma; low blood sugar; felt "really weak, like I have the flu"; tired every time afterwards, "I feel so crappy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (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 1, SINGLE, Lot: EL9262), for COVID-19 immunization, reaction(s): "lowblood sugar", "tired every time afterwards, "I feel so crappy", "lowblood pressure"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "low blood sugar", "tired every time afterwards, "I feel so crappy", "low blood pressure"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "difficulty, generalized weakness for several days", "chills", "Low blood pressure", "body aches"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "low blood sugar", "tired/feel so crappy", "low blood pressure", "really weak, like I have the flu". The following information was reported: HYPOTENSION (non-serious), outcome "unknown", described as "blood pressure gets really low"; ASTHMA (non-serious), outcome "unknown", described as "seasonal Asthma"; BLOOD GLUCOSE DECREASED (non-serious), outcome "unknown", described as "low blood sugar"; ASTHENIA (non-serious), outcome "unknown", described as "felt "really weak, like I have the flu""; FATIGUE (non-serious), outcome "unknown", described as "tired every time afterwards, "I feel so crappy". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reported that she has low blood pressure and wants to know how to limit and if she should take another dose. she is tired every time afterwards, "I feel so crappy". Caller said specifically after the last bivalent booster she felt "really weak, like I have the flu".  when she get the Vaccine she really had a very rough four days it does something to my blood pressure and my blood pressure gets really low and stated that when she get the Vaccine, she really had a very rough four days it does something to my blood pressure and my blood pressure gets really low. she have not had COVID, but she have Asthma and seasonal Asthma. This report is not related to a study or program.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderna shot- ?COVID arm?, rash, swelling, itching and soreness in arm 6 days after shot, lasted 5 days; swelling, itchiness and soreness  in toes appeared two weeks after shot and continues
Mom states evening of same day rec'd vax baby vomitted (7PM) & felt warm; Took temp next AM 103.6F(R);
Received 2nd dose of Pfizer COVID vaccine 1/29/2021. On 3/25/2021 developed chills, body aches, cough, and rhinorrhea. Tested positive for COVID.
redness; itching; swelling; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (redness), PRURITUS (itching) and SWELLING (swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness), PRURITUS (itching) and SWELLING (swelling). At the time of the report, ERYTHEMA (redness), PRURITUS (itching) and SWELLING (swelling) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Patient received a monovalent booster after CDC bivalent recommendation was released on 9/1/22. Patient will be informed of error and offered bivalent vaccine per current CDC recommendations/timeline. Organizational safeguards have been implemented to prevent future recurrence.   There is a list of 178 patients included in this report.
Vaccines 2/20/09 ----> mom reports LA (left arm) injection sit on 03/03/09 became red, raised, warm to touch physician diagnosed as cellulitis. Parents applied warm packs to site x3 days. 03/07/09 to physician decreased no further Tx prescribed. 03/03/09 diagnosed with non specific generalized body rash - x1 day treated with BENEDRYL.
HCP called to report a temperature excursion (see case# 01766674) and reported that ROTATEQ was administered to 2 patients on l0/26/2020 after a temperature excursion and prior to having vaccines evaluated; This spontaneous report as received from a health professional referring to a patient of unknown age and gender.  Information about concurrent condition, concomitant medication, drug reactions/allergies and pertinent medical history was not provided.  On 26-OCT-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1684163, which has been verified to be valid, expiration date reported and validated as 26-JUN-2021) orally for prophylaxis (formulation, strength, dose and frequency were not reported).  The vaccine was administered after a temperature excursion (below 36 degrees Fahrenheit/2 degree Celsius (0.9 degree Celsius to 1.9 degree Celsius) for 10 hours; above 47 degrees Fahrenheit/9 degree Celsius (9.1 degree Celsius) for 30 minutes) and prior to having vaccines evaluated. There was no previous temperature excursion reported. The call was not because of a data logger.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA010875:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26May2021 at 10:00 as dose 2, single (Lot number: EW0180) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19: the patient took paxlovid from 2nd day of symptoms shown and home tested positive The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE INJECTABLE lot EW0180 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EW0180, fill lot EP8731, and the bulk formulated drug product lot EP8612. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
This spontaneous report as received from a male consumer refers to himself of unknown age. The patient's drug reactions/allergies was none. The patient's medical history included hernia surgery, surgery on his veins and legs, tonsillitis and tonsillectomy. The patient was subcutaneously vaccinated with a 0.65 ml dose of ZOSTAVAX (lot# not reported) on 02-AUG-2012. No other co-suspects were reported. No concomitant medications were included. On 02-AUG-2012 the patient experienced shingles, 1 day after onset of therapy. The patient did not seek medical attention. No treatment information was given for the adverse event. The outcome of shingles was reported as not recovered/not resolved. The relatedness for shingles is unknown for ZOSTAVAX. Additional information has been requested.
Woke up with a fever of 103 degrees after a night of chills and muscle aches
patient returned later than 14 days for the second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient returned later than 14 days for the second dose) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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) 1 dosage form. On 28-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient returned later than 14 days for the second dose). On 28-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient returned later than 14 days for the second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided.  Action taken with mRNA-1273 in response to event was not applicable.
Initial and follow up information has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug reactions and allergies were not reported. On 16-OCT-2015, the patient received an improperly stored dose of RECOMBIVAX HB, lot # K0110535, expiration date 27-AUG-2016 (dose, frequency and route were not reported). On the same day, the patient also received an improperly stored dose of VAQTA, lot # K007827, expiration date 09-DEC-2016 (dose, frequency and route were not reported), also. No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Hearing loss in left ear; dizziness; tinnitus. Doctor prescribed Afrin and Flonase sprays at separate times. Tinnitus and hearting loss started on 10/14/07 to present.  5/9/08 Reviewed ENT office notes of 11/28 & 12/19/2007. FINAL DX:left sudden sensorineural hearing loss Records reveal patient experienced decreased hearing since 10/14/07.  Developed vertigo, tinnitus & severe fatigue 4 days later.  Seen by PCP who dx eustachan tube dysfunction.  Tx w/nasal spray, steroids & decongestant w/no improvement.  ENT exam removed cerumen impaction.  Audiometry revealed: right mild sensorineural loss; left mod sensorineural hearing loss.  Referred for MRI, labs & otologist. 6/13/08 Reviewed Otolaryngology Clinic Notes of 1/3/2008. FINAL DX: sudden sensorineural hearing loss Records reveal patient experienced sudden hearing loss 10/2007 followed 2 days later w/lightheadedness that resolved in a few hours & tinnitus.  Hearing had improved only slightly & hearing aid recommended. 1/21/2010 Hearing loss in left ear.
1 complex sz 2 wks post inject lasted 45 min; Admitted to hosp for 2 days; All test negative but child placed on Phenobarb as a precaution;
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 20-OCT-2015 23:42, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (doe and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 4.3 and -2.1 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Patient received both PNEUMOVAX 23 and FLUZONE HD on 10-4. On 10/7 patient notified pharmacy that she had a reaction that involved a rash on her arm that extended to her armpit as well as having a headache and chills. She also stated that her arm was so sore that she couldn't lift it. She is taking Ibuprofen and applying a cool compress to the area.
I have developed fairly loud tinnitus in my right ear, it is worst in the morning and sometimes gets better through the day.  I also had arm pain for a few days after the injection in the arm I received the injection in. That started about 6 hours after I received the vaccine.
Patient ran fever of up to 102, reports headache, fatigue, body aches, lack of appetite, redness, heat at site of injection. Patient used only Tylenol to treat. Patient states that 5 days later she is finally feeling a little better
Case number PHHY2011US33087 is an initial spontaneous report received from a physician on 14 Apr 2011. This report refers to a patient of unspecified gender and age. The patient was given only the CYW-135 liquid component of MENVEO vaccine (batch number: unknown) without being reconstituted with MenA lyophilized component, intramuscularly in 2010. No other adverse reaction was reported.
nausea, no vomiting, no diarrhea, tired, legs feel weak & heavy, h/a, feel faint
Patient reported feeling very light headed starting 6-12 hours after the injection continued through out the next 72 hours. Patient reported they were unable to stay at work the adverse event was so severe.
Symptoms included blurred vision, headache, feeling of heart racing, feeling of difficult breathing, vertigo.  Symptoms improved while laying.  Treatment given has been antihistamine.
Patient received tdap & meningococcal IM (R) arm on 4/14/12. Reported redness & swelling (R) arm on 4/16/12. Seen by dr for cellulitis. Treated with Cephalexin x 10 days.
It was reported that an 18 year old female pt received a Menomune A/C/Y/W-335 vaccination on 11/20/00. The pt presented to the ER with chest pain, palpitations and shortness of breath. Pt was dx'd with "WPW (Wolff-Parkinson-White) Syndrome". No further information known at the present time. Pt presently remains hospitalized. From F/U received on 5/9/01, it was reported that the pt's recovery status is unknown. "No further information available regarding this pt or this case".
Chills, headache, nightmares, low fever, plantar fasciitis, shaking, low 02(94), high pulse (120), muscle pain, eye pain, fatigue, fogginess
pt broke out in papular macular rash;no resp distress;no pallor;DPH given;
mild low grade fever; injection site arm hurt; received expired Moderna Covid-19 vaccine for a booster dose; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (mild low grade fever), VACCINATION SITE PAIN (injection site arm hurt) and EXPIRED PRODUCT ADMINISTERED (received expired Moderna Covid-19 vaccine for a booster dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer Vaccine (Primary Series of the vaccine.). Past adverse reactions to the above products included No adverse event with Pfizer Vaccine.    On 28-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2022, the patient experienced PYREXIA (mild low grade fever), VACCINATION SITE PAIN (injection site arm hurt) and EXPIRED PRODUCT ADMINISTERED (received expired Moderna Covid-19 vaccine for a booster dose). At the time of the report, PYREXIA (mild low grade fever), VACCINATION SITE PAIN (injection site arm hurt) and EXPIRED PRODUCT ADMINISTERED (received expired Moderna Covid-19 vaccine for a booster dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2022, Body temperature: high (High) mild low grade fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.
Patient got Bexsero's expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA81EZ, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th February 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 8th February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by  without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by the Medical assistant. The age at vaccination was unknown. The reporter stated that an expired dose of Bexsero was administered to the patient, which led to expired vaccine used. The reporter consented to follow up. This case is linked with US2022023434, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022023434:Same reporter. Patient 1 of 2.
1-2 minutes post flu vaccination, patient reported face flushed, tingling sensation on her entire face, increased heart rate (per patient) weird taste in mouth, dizzy/shaky and hot all over. Nurse assessed patient, and offered BENADRYL. Patient declined. Within 2 minutes symptoms subsided. Nurse suggested patient see PCP for next flu vaccination and advised she seek medical attention if symptoms return.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On unspecified date the patients were vaccinated with doses of improperly stored LIQUID PEDVAXHIB (strength, dosage, frequency and route unspecified) (lot # reported as J007097 with expiration date of 14-MAR-2016 and lot# K008873 with expiration of 06-FEB-2017). The temperature excursion for LIQUID PEDVAXHIB was unsupported with in-house stability data and the initial temperature excursion was on 15-OCT-2014. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
PT STATED LOWER BACK PAIN AFER FIRST DOSE OF VACCINE . PT IS TAKING TYLENOL/ADVIL
Don't think the vaccine was correctly administered to me/Needle didn't make it to the muscle; This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Don't think the vaccine was correctly administered to me/Needle didn't make it to the muscle) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Overweight (have very large arms).    On 20-Jan-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021 at 8:00 AM, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Don't think the vaccine was correctly administered to me/Needle didn't make it to the muscle). On 20-Jan-2021 at 8:00 AM, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Don't think the vaccine was correctly administered to me/Needle didn't make it to the muscle) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  It was reported that the patient received their first dose of the vaccine using a 1 inch needle, which the patient believes was too small. The patient also stated that as a result of the needle being too small, the vaccine was not given intramuscularly.  No treatment details were provided.   This case was linked to MOD-2021-231790 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up received on 22-JUN-2021. Follow-up received and patient information, vaccine information and event details were updated. On 02-Jul-2021: Follow-up received on 02-JUL-2021 and patient's demographics updated.
pt recv vax & devel viruses & fever & shed a lot of hair-hair thin & weak hair in all three;
Went to school 9/11/03. Teacher observed symptoms of seizure, stiffened, eyes rolled back, became limp. School transferred to hospital. Mother discharged child same date and transported to another hospital. PCP transferred child to another hospital. Child was hospitalized for 6 days. Mother states allowed medication to wear off. Hospital stated reaction to immunization. Mother states temperature 99.5 for 6 days. Discharge summary does not confirm hypotonia, hypertonia; does list stupor, abdomenal pain, gastroenteritis. msv