chrisvoncsefalvay/vaers-outcomes huggingface dataset:
covid arm; soreness with red and hot muscle; soreness with red and hot muscle; rash down the arm; soreness with red and hot muscle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm), ERYTHEMA (soreness with red and hot muscle), FEELING HOT (soreness with red and hot muscle), RASH (rash down the arm) and MYALGIA (soreness with red and hot muscle) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-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 VACCINATION SITE REACTION (covid arm), ERYTHEMA (soreness with red and hot muscle), FEELING HOT (soreness with red and hot muscle), RASH (rash down the arm) and MYALGIA (soreness with red and hot muscle). At the time of the report, VACCINATION SITE REACTION (covid arm), ERYTHEMA (soreness with red and hot muscle), FEELING HOT (soreness with red and hot muscle), RASH (rash down the arm) and MYALGIA (soreness with red and hot muscle) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided.   This case was linked to MOD-2021-302001 (Patient Link).
Large local inflammatory reaction at left deltoid. Resolving at 72 hrs s/p immunizations.
Pt has annual routine mammograms which have always been normal. Her mammogram was normal 8/18/21. She was vaccinated for covid 19  in 12/21. On 8/22/22 her mammogram revealed a left breast mass- diagnosed with invasive mammary cancer and is currently ondergoing  chemotherapy treatment and had a partial mastectomy.
BIRTHDATE ON VACCINE CONSENT FORM WAS FILLED OUT BY PARENT AND BIRTHDATE WAS LISTED 1/29/2009. WE WERE NOTIFIED THAT POTENTIALLY THE BIRTHDATE IS ACTUALLY 1/29/2010. UNABLE TO CONFIRM WITH PARENT CORRECT BIRTHDATE
Under age for receiving Moderna. Under the age of 18 is contraindicated for the administration of the vaccine.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On 19-NOV-2013, the patient was vaccinated with ZOSTAVAX lot # H014366, expiry date 06-NOV-2013, 0.65 ml, subcutaneous (it was expired). Concomitant medication was not reported. No adverse effects reported. Additional information has been requested.
After the patient received her first Moderna vaccine, patient was in observation area to be observed for any reactions. At 1515 8/13/21 patient complained about tingling of the lips and stated that she had a hard time breathing with pressure on her chest, and felt hot and diaphoretic. Patient was placed on bed in semi fowlers position, patient was instructed to drink water and juice, ice packs were placed on her back. Blood pressure was taken at 1520, BP 126/88 and heart rate was 93, O2 100%. Patient was then placed in side lying position with support on back, RN supervisor then called 911 because patient was not improving and looked pale and fatigued. A second blood pressure was taken at 1545, BP 101/58 HR 97. Paramedics arrived at 1553 and took patient to hospital.  Patient reported being  over 8 months pregnant with recent history of adverse reaction to Tdap vaccine 6/24/21.
Nausea; Chills; Extreme Fatigue; Body feels hot inside; Flushed Face; Dull ache on injection site; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 70-year-old female (non-pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EN6199, Pfizer NTEC), via an unspecified route of administration in right arm on 10Mar2021 1at 0:15 (at the of 70-year-old) as dose 1, single for covid-19 immunization. Medical history included chronic fatigue syndrome, fibromyalgia, type 2 diabetes, asthma and very sensitive to most medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other medication in 2 weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient experienced, nausea, chills, extreme fatigue, body feels hot inside, flushed face, dull ache on injection site on 10Mar2021 and ongoing for 19 days now. The adverse events resulted in physician office visit and emergency room visit. The patient did not receive any treatment. The clinical outcome for events was not recovered.  Follow-Up (15Jul2021): Follow-up attempts are completed. No further information is expected.
Patient had a cross sensitivity to an ingredient, aluminum, in the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of CROSS SENSITIVITY REACTION (Patient had a cross sensitivity to an ingredient, aluminum, in the Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CROSS SENSITIVITY REACTION (Patient had a cross sensitivity to an ingredient, aluminum, in the Moderna vaccine). At the time of the report, CROSS SENSITIVITY REACTION (Patient had a cross sensitivity to an ingredient, aluminum, in the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. Patient had to finish the COVID-19 vaccination with Janssen. No treatment medication was reported by reporter.
Case number PHEH2014US016200 is an initial spontaneous report received from the pharmacist on 12 Aug 2014. This report refers to a 15 year old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: A14041) intramuscularly on 11 Aug 2014. It was reported that the Men A lyophilized component of MENVEO was reconstituted with sterile diluent which was used with MMR (other manufacturer, batch number: not reported) and varicella vaccine (other manufacturer, batch number: not reported) instead of the Men CYW-135 liquid component of vaccine. It was reported that she held her breath immediately after vaccination with MENVEO because it was the last of three vaccinations that she received on the same day. The outcome. seriousness and causality of events were not reported. No further information was provided.
09/11/2019 Patient received 1st Shingrix vaccine in right arm Lot GL2HR EXP 05/22/2021 11/12/2019 Patient received 2nd Shingrix vaccine in left arm GL2HR EXP 05/22/2021 12/09/2019 Patient is seen at PCP for dizziness and falls 2 to 3 times a week for last 3 weeks 01/31/2020 Patient presented to pharmacy stating that he and his doctor feel that his symptoms of muscle fatigue and paralysis maybe due to the Shingrix vaccines he received.
within 1 hour after- arm soreness and fatigue 1 hour to 10 hours after- fatigue, progressive muscle soreness 15 hours after- fever, fatigue, muscle soreness, arm soreness, malaise
Fever and vomiting began night of shot and continue 19 days later. She has hardly eaten since the shot, but continues breastfeeding for nutrition. Before the shot she was always smiling and since 1/26 she didn't smile until 2/12. She hits herself in the head while crying and is inconsolable. She is pale and has stopped using words. Lethargy and frequently wakes crying in the night and wakes up crying. Every night 1/25 and morning since 1/26. If you try to get eye contact she looks away screaming. Previously never had this. Random crying fits throughout the day lasting 15-30 minutes with no common trigger. Her twinkle is gone from her eyes, has a vacant look.
No Adverse event's to report. The Issue is he was not 18 years old and some how got into the clinic and was not detected as being under 18 at the Time.
1 week after initial injection arm started to develop lump and extreme itchness.  Day after injection of vaccine sore arm but other then that fine until today.  Also developed a herpes simplex 1 on lip. RMG UCCMTE was written on card I received.
Approximately a week after injection, she developed a problem with smells of foods, says food smells like sewage.  Has to hold her nose to eat since then.  Contacted her Dr. and they said to make appointment with ENT doctor.  Still waiting for appointment.  Unknown if permanent.
This spontaneous report was received from a nurse practitioner and refers to a multiple patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with RECOMBIVAX HB lot # M020926 with an expiration date 11-AUG-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). There was no adverse effect reported. Administered doses of RECOMBIVAX HB experienced the temperature excursion between 0 and 2 degrees Celsius for 37 hours. A digital data logger was involved. There was no previous temperature excursion. Product quality complaint (PQC) was not reported. This is one two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA012078:
Infant began vomiting 6 hrs prior to presentation to office, in office was tachycardic, shocky, with absent bowel sounds and bilious emesis.  Treatment included intubation, intra osseous fluid bolus and stat med evac helicopter transfer to hosp where intussusception was reduced laparoscopically.  Pt remained intubated in the ICU at this time.
Painful lump on right sub clavicular region. Lump about size of walnut. Movable. Painful and achy to touch. Burning sensation once disturbed.
Patient had altered mental status suddenly, was sleepy, hard to focus, eyes were blinking, took a long time to answer questions. I was concerned about a toxic ingestion so I sent to ED work up was negative but, patient will se neurologist and get EEG to rule out seizure.
About 2 hours after vaccination site was very sore (similar to Anthrax shot), about 6 hours after shot slight fever and chills/sweating started, along with fatigue and headache. Symptoms persisted for approx. 48 hours and receded.
Patient had the second COVID vaccine and the next day she was not able to lift or move her arms. She has been having body aches and is barely able to move her neck. She reports she is feeling better today than yesterday. The red area and tenderness have decreased in her arm.
patient who was administered Prevnar 13 got pneumonia a few weeks after receiving it; patient who was administered Prevnar 13 got pneumonia a few weeks after receiving it; This is a spontaneous report from a contactable healthcare professional via Pfizer Sales Representative. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported.  It was reported that patient who was administered Prevnar 13 got pneumonia a few weeks after receiving it. Outcome of the event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the event drug ineffective (pneumonia) with pneumococcal 13-valent conjugate vaccine can not be fully excluded.
Immediate pain at injection site.  Felt like the needle touched the bone.  Three months later, the site is still sore and causes pain while the arm is at rest. Mobility is slightly limited in that arm.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On unknown dates (reported as since 18-NOV-2016), the patients might have been administered with M-M-R II (lot # L039551, expiry date: 07-OCT-2017) (route: subcutaneous) (incorrect product storage). The vaccine was stored at a temperature of 9 C for 176 hours (a maximum temperature reading of 9 C in the morning for 11 days, from 18-NOV-2016 to 28-NOV-2016 evaluated for 16 hours each day). There was no previous temperature excursion. Data logger was not involved. No adverse effects have been reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA001924: US-009507513-1612USA001916: US-009507513-1612USA001929.
Red splotchy area appeared at site of vaccine administration measuring approximately 5 in by 3 in.  The perimeter was more intensely red than the rest of the area.  The red splotchy area lasted for approximately 3 days.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 6/17/2022 Discharge Date: Jun 19, 2022  PRESENTING PROBLEM: Weakness [R53.1] COVID-19 [U07.1]   HOSPITAL COURSE: 68 year old male who presented to ER on 6/16/22 with complaints of dehydration and generalized weakness. He had acute onset of overall weakness and difficulty walking. He had no complaints of vomiting or diarrhea. No complaints of cough, but he was noted to be tachypnic. He had CXR done a that time that was concerning for lingular infiltrate. He was discharged home with oral ATB. He returned to the ER on 6/17 after fall at home. He was unable to stand on his own and therefore sister brought him back to the hospital. At this time, he tested positive for COVID. His sister did not feel comfortable taking him home for fear of recurrent fall.   Patient was admitted observation for monitoring. He was continued on Rocephin and Zithromax for lingular pneumonia. He was also started on Decadron for COVID. He has history of sleep apnea and required 1L oxygen while sleeping. He had no oxygen requirements during the day. He worked with therapy who felt he was strong enough to discharge home. He admits that he does not always use his walker at home as he is afraid of scuffing up the walls. He was encouraged on walker use at all times for safety as he has chronic gait instability and frequent falls.   He will discharge to complete the course of ATB that was prescribed to him on 6/16 (ceftin and doxy). He is a candidate for Paxloivid as symptoms started < 5 days ago and therefore prescribed at discharge.
Woke up the next morning feeling, I didn't have 5 mins to live. All my children had gone to school they are teachers. I finally got a hold of my grand daughter who gave me some tea-ice bag.
sore left injection site arm; fatigue; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), VACCINATION SITE PAIN (sore left injection site arm) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033321A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced DYSPNOEA (shortness of breath). On an unknown date, the patient experienced VACCINATION SITE PAIN (sore left injection site arm) and FATIGUE (fatigue). On 23-May-2021, DYSPNOEA (shortness of breath) had resolved. At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) and FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Information has been received from an unspecified source concerning a female patient who on an unspecified date was vaccinated with an unspecified dose of GARDASIL (Lot# unknown). It was reported that on an unspecified date, the patient experienced hair loss. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
Pt states she immediately felt the injection site begin to itch. She states the itching increased and the area is now raised, swollen and warm to the touch (pt has dark skin so no redness is apparent). She exhibits nasal discharge, sneezing but no temperature.
This spontaneous report as received from a nurse refers to a 43 year old female patient. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates, "as a child", the patient received two doses of M-M-R-II (strength, dosing details, anatomical location, lot# and expiration date were unknown). The nurse stated that there was no documented doses of M-M-R II in the patient's medical record but she is assuming the patient received them. On an unknown date in 2008, the patient was diagnosed with Lupus. On an unknown date the patient had titers drawn (antibody test), which showed she was positive for immunity to measles and mumps, but negative for immunity to rubella. The reporting nurse was not positive whether the patient has ever received M-M-R II, but since she stated that she was assuming, she reported this adverse event to be filed as a precaution. The outcome of the events were unknown. Causality assessment was not provided. No product quality complaint was involved. Upon internal review the event systemic lupus erythematosus was considered to be medically significant. Addition information has been requested.
Patient given first dose of COVID19 (moderna) on 2/1/2021 when that night she experienced fevers, sweats, headaches, and body aches. Patient reports her fever broke on Tuesday night, early Wednesday morning. Has been more fatigued than usual but is feeling better overall. Patient did not take ibuprofen or tylenol d/t her warfarin medication.
Patient said she experienced nausea, vomiting, and diarrhea shortly after the vaccination. She said that the diarrhea lasted 3 to 4 days and that overall for about 10 days she did not feel well. She said she is feeling better now and that she did not seek any treatment for her adverse reactions and that it cleared up on its own.
Patient felt faint and had to lie down for about 10 min. after receiving flu vaccine.
Chest tightness/ heaviness ( like an elephant sitting on my chest ), severe headache , and ringing in ears began about 1 hour after vaccine given. Fever greater than 102 / chills began about 2 hours after vaccine given. Severe body aches, nausea, and extreme fatigue, extreme weakness, dizziness, and chest pain when taking a deep breath  began within 4 hours after vaccine.
Intense Pain from hips to toes for 2 days . Now continue to ache . Also had dizziness that comes and goes .
Well circumscribed 14cm wide rash on L deltoid-site of injection. The rash is warm and associated with a mild fever.
Fever day of shot, chest congestion x 1 week. Treated with Tylonel and cough suryp
pt devel herpes zoster w/in 7 days of receiving 1st dose of HEB vax; dx'd & rx'd by PMD
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to about 6 patients of unknown age (gender unknown). On an unknown date, about 6 patients were vaccinated with (Oka/Merck) VARIVAX, subcutaneous (strength, dose, frequency unknown). Patient were vaccinated with (Oka/Merck) VARIVAX which was improperly exposed to 10F for 3 days and to 5-9.6F for 360 hours. No known adverse effects. Follow up information has been received from nurse. Nurse stated that an unspecified number of patients received doses (unspecified in series) of (Oka/Merck) VARIVAX exposed to 16 F for 120 hours. Nurse stated that the affected lots were lot #J009990; expiration date: 13-AUG-2015 (also reported as 12-AUG-2015) and lot # J012210; expiration date: 28-AUg-2015. No adverse effects reported. This is one of the several reports from the same source. Additional information has been requested.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 5:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 5:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator, or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported. Total 280 patients received Moderna Covid 19 stored at minus 82 degrees Fahrenheit. No treatment information was provided.   This case was linked to MOD-2021-402935 (Patient Link).
This spontaneous report as received from a consumer refers to a female patient of unknown age (demographics unknown). On an unknown date the patient was vaccinated with ZOSTAVAX (dose and route not provided). On an unknown date, after receiving the ZOSTAVAX, the patient experienced coughing and wheezing, and was therefore hospitalized (location and duration unknown). The patient also reported that she has been using many other "unspecified medications" (names/dosages/frequencies/manufacturers unknown). The patient stated she had been using an unspecified "nebulizer" treatment to help her breathe. It was unclear as to when this patient started using the "nebulizer" treatment. There was no mention of a physician in this case. It was reported that the patient sought medical attention. The outcome of coughing and wheezing is unknown. Additional information is not expected.