chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Sharp pain under ribcage; Shallow breathing; could not sneeze; Could not lift chest and shoulders due to pain; This is a spontaneous report received from a contactable consumer (reporting on herself). A 66-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8737; Expiration Date was not reported), via an unspecified route of administration in Arm Left on 31Mar2021 as single dose for COVID-19 immunization. Medical history included histoplasmosis, calcification metastatic, arthritis all from an unknown date and unknown if ongoing. No history of all previous immunizations with the Pfizer vaccine considered as suspect. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that patient states she was diagnosed with this at about 10 years of age. On an x-ray she had years ago it said that the infection was cleared, there was signs of the prior infection, calcifications on her lungs are permanent, and there was some arthritis noted. Patient states that she has a question related to the first dose of the Covid Vaccine. States she received the first dose about 3 weeks ago on 31Mar2021. Says that during that day she experienced no side effects and did not expect to have any. The next day throughout the day she was okay. On 01Apr2021 at around 18:00 or 19:00, States then she had some chills, which she states was to be expected. Says then something odd happened, she had a pain on her right side under her ribcage; a sharp pain. She states that the night before she had done some mild exercise and stretching, does not know if that was a factor in her pain. She states that it was very painful. She had to breath shallow because it was less painful when she breathed shallow. Says it stifled her ability to sneeze because the pain wouldn't allow her to lift her chest and shoulders. States the pain stayed the same degree. About 6 days later it subsided and went away completely, but she believes it was gone completely after 4-5 and a half days. States there was no remnants of the pain. A lung x-ray had a black spot on it indicating that. States she had another x-ray years ago that showed that the infection was cleared, there was signs of the prior infection, calcifications on her lungs are permanent, and there was some arthritis not-ed. Patient was wondering if given her history of histoplasmosis and her side effects from the first dose of the vaccine if she should get the second dose. Says it was scheduled for the day after to-morrow Patients weight reports as 112-116 pounds, states that it varies at times. The outcome of the events was recovered.   No follow-up attempts are needed. No further information is expected.
patient was given the vaccine and then went to observation room.  While there, he complained of dizziness and became diaphoretic and passed out for about 10 seconds. Vitals were taken and a rapid response was called for the team to come.  He came back and felt thirsty and was pale.  He was then transferred to Urgent Care to be observed before being discharged.
This spontaneous report as received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients received improperly stored (temperature: 34 degrees Fahrenheit and 51 degrees Fahrenheit for 14 hours; no previous excursion was reported) doses of RECOMBIVAX HB lot # K021444 and expiration date: 17-SEP-2016 (dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
pt recvd vax;noticed "inside chest,between shoulders & chest,core,a quivering shakey" feeling;unable to go to sleep;in am,all "weird feelings" were gone;denies any sweating,palpitations,dizziness,SOB;ill 1 wk later w/ URI;
Within 10 minutes of administration of the Pediarix the patient became limp and unresponsive, although breathing on his own and maintaining his skin color. The event lasted for about 5-6 minutes.
Patient was administered Moderna Covid 19 Vaccine. After 20 minutes the patient began feeling light headed. He reported feeling tired and felt like he might pass out. His chest began to tighted/hurt and began to get clammy. He has allergies to medication and I asked him if this how he feels prior to his prior allergic reaction in the past....He was rubbing his arms and told me yes..I gave him a dose of benadyrl .. EMS was called and they were given all information. I was taking his blood pressure when they arrived. It was 197/103 pulse 82. Patient left with EMS
Admit with COVID infection and resp failure. Given plasma, steroids, rocephin and zithromax, vit-c, vit-d, zing and singulair.  Leading to acute respiratory failure with hypoxia. Chest x-ray does not reveal any evidence of pulmonary infiltrates. Continue oxygen via nasal cannula at home. Status post 1 unit of convalescent plasma transfusion during this admission. Patient did not require remdesivir. Patient has been advised to complete the course of oral steroids as an outpatient along with vitamin supplements. Improved and discharged home.
Vaccine breakthrough infection; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Feb-2022 and was forwarded to Moderna on 23-Feb-2022.    This literature-non-study case was reported in a literature article and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: (Privacy)    No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) (seriousness criterion medically significant). At the time of the report, VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) to be related.    Treatment and concomitant medications  were not reported  Company comments: This literature case concerns a  patient of unknown age and gender with no relevant medical history, who experienced the serious unexpected events of vaccine breakthrough infection. The events occurred on an unknown date following an unspecified dose of mRNA-1273 vaccine. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing infection. The rechallenge was unknown as the dosages and time of event onset were not reported. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-491471, MOD-2022-491472, MOD-2022-491473, MOD-2022-491474, MOD-2022-491475, MOD-2022-491476, MOD-2022-491477, MOD-2022-491478, MOD-2022-491479, MOD-2022-491480, MOD-2022-491379 (Patient Link).; Sender's Comments: This literature case concerns a  patient of unknown age and gender with no relevant medical history, who experienced the serious unexpected events of vaccine breakthrough infection. The events occurred on an unknown date following an unspecified dose of mRNA-1273 vaccine. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing infection. The rechallenge was unknown as the dosages and time of event onset were not reported. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
The subject was vaccinated as a part of a clinical trial examining post-exposure antibiotic prophylaxis for pertussis.  As a aprt of the study all persons, if eligible, receive the licensed Tdap vaccine.  The subject was vaccinated by a member of the study team at 09:13 in the right deltoid on August 28, 2007.  She had not experienced any adverse effects when evaluated at 09:18.  Later that day she developed fever up to 102.5°F, arthralgias, and a stiff neck, prompting her to present to the Emergency Department.  She stated she was treated with intravenous fluids, analgesics, and antihistamines.  She was discharged home from the Emergency Department.  Her symptoms resolved within approximately 36 hours.     Subject was screened for contraindications to vaccination at the time of enrollment.  During screening, she reported no history of an allergic or adverse reaction to diphtheria, tetanus, or pertussis vaccines.  Subsequent to the adverse event, the subject learned from her mother she had previously experienced a severe reaction to a tetanus, diphtheria, and pertussis vaccine as a child.
chest tightness; nasal drainage; This is a spontaneous report from a contactable healthcare professional. A 35-year-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot, expiry unspecified), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported that he received the vaccine on 23Dec2020 and in Dec2020, the patient experienced chest tightness and nasal drainage. Outcome of events was unknown.  Information on the lot/batch number has been requested.
Redness, swelling and itching over vaccination site starting 1 week after administration . I have pictures of area if they would be of help.
scratchy throat, cough, chills, body aches  starting 11/7/21
PAIN, SWELLING AND REDNESS ON LEFT ARM @ INJECTION SITE. REDNESS AND SWELLING MEASUREMENTS ARE 7CM X 8CM. SITE FEELS WARM TO TOUCH.                                               ADVISED TO APPLY ICE PACK TO THE SITE AND TO CALL BACK IF SYMPTOMS WORSEN.
cirrhosis of the liver; Low platelets; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced low platelets and cirrhosis of the liver on an unspecified date. The outcome of events was unknown.  Information on the lot/batch number has been requested.
I started to get itchy all of my body. There were raised red bumps on different parts of my body. I've been treating it with Benadryl. After about a week and a half I contacted my doctor and he told me to take Zyrtec. The Zyrtec controls the symptoms maybe about 90% but they have not gone away.
Vertigo; Dizziness; Arm pain; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 04Apr2021 at 13:30 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: UNKNOWN) via an unspecified route of administration on unknown date  as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Apr2021 the patient experienced vertigo, dizziness, arm pain and fatigue. The patient did not receive any treatment for the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events vertigo, dizziness, arm pain and fatigue were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Large swollen lump at injection site, redness extending several inches down the arm.  Intense itching and burning.  Sweating, Nausea/vomiting.
Patient reported a rash (hives) on his back that began three days post-vaccination. The rash lasted for six days. The patient did not seek medical care. Unable to contact the patient.
This 22 year old received her first anthrax vaccination on November 20, 2003.  She advised the corpsman of irregularities in her menstrual cycle and she tested negative for pregnancy.  She stated she was feeling "sick" prior to and for seven days post vaccination with nausea and vomiting 2-3 times a day around lunchtime.  She stated food made her vomit which resulted in sharp epigastric substernal chest pain.  The pain worsened while lying flat requiring her to stand up or lean forward for relief. This pain was centered mid chest right > left on a 6/10 scale that lasted for a few seconds. She reported to medical and was advised this was a possible stress reaction.  She denied any myalgia, arthralgia, fevers, headaches, rashes, or any breathing problems.   She required no medication to relieve her discomfort as it resolved spontaneously.  She stated she received her second anthrax vaccination on January 27, 2003.  However, DEERS records the second vaccination as December 5, 2003 and the third vaccination on December 19, 2003.  She stated she was ill with similar symptoms as anthrax #1 but they were worse, again lasting for one week.  She reported the nausea and vomiting occurred after lunch with an "increase in stomach fullness".  She reported 20-30 minutes after eating she felt hungry as if she had not eaten.  She denied any specific food group or position change as recreating this discomfort.  She slept easily at night.  She also reported a sharp spasmodic headache at 7/10 that lasted for a few minutes three times a day while "cranking" (KP duty).  These headaches would resolve spontaneously.  She reported to medical and completed a full lab evaluation that revealed "kidney failure."  Her menstrual cycle began February 20, 2004 lasting 3 days. She was referred to the GYN clinic for further evaluation of "dysmenorrhea secondary to kidney failure".   In February 2004 she was preparing for deployment with the Regional Support Group (RSG).  Further medical evaluation prompted evaluation for lupus and ultimately sent to a kidney specialist in March 2004 for renal failure.  Review of her past medical problems revealed proteinuria during a pre-enlistment physical in January 2003 and a positive PPD while in boot camp (June 5, 2003) with implementation of INH therapy in July 2003.
No adverse event; Nurse reporting improperly stored MMR II and VARIVAX in freezer; This spontaneous report was received from a nurse, referring to a 4-year-old child.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, it was reported that a nurse improperly stored measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (OKA/MERCK) (VARIVAX) in the freezer (Product storage error). On 19-APR-2022 at 13:30, the patient received the first dose of measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live (albumin status of rHA (recombinant human albumin)) (M-M-R II), valid lot #U007684 with expiration date on 09-MAR-2023 (strength, and route of administration not provided); and varicella virus vaccine live (OKA/MERCK) (VARIVAX), valid lot #U028164, with expiration date on 09-SEP-2023 (strength, and route of administration not provided). Both vaccines were administered as prophylaxis. No adverse events were reported. No additional information was provided.  The causal assessment between the vaccines and the event were not reported.
pt recv vax 11JUN97 & pt was in 5th or 6th wk of gestation (LMP 11MAY97) on 9JUN97 pt exposed to varicella & 11JUN97 accidentally vaccinated waverings (globulin was indicated);pt devel gen varicella rash;
Developed Acute L arm swelling + redness. Was seen on 3/18/09 + started on Keflex. Was seen again on 3/20/09 redness + swelling had improved.
The patient stated that he was there for a flu shot. Instead, a COVID-19 vaccination was administered. He received his COVID-19 booster dose 2 weeks prior to today.
Developed cough, malaise and sweating on 1/29/08 then noticed swollen glands neck/face on 2/4/08.  Has significant left parotid area swelling at presentation to clinic 2/5/08.  Vital signs 979-84-16, 150/106 (previous 12/07 152/100).  Breath sounds clear.  No obvious salivary gland obstruction, pharynx unremarkable except right submandibular nodes swelling and left parotid swelling.  Taking Aleve, Benadryl.  Referred to primary health provider.
Provider and patient's mother both requested for the patient to receive the flu vaccine.  The Med Aid gave the flu vaccine and as she was documenting the administration she realized he had already had a flu vaccine on 10/2/2023.  The patient was observed in clinic for approximately 15 minutes.  The patient tolerated the dose well and had no adverse side effects while in the clinic.
Pt recvd 1 dose of Engerix-B 16JUL9 & 31JUL92 devel a rash; pt was seen by MD;
Sore arm; Falls asleep, sleeps 4 to 5 hours; Falls asleep; Tiredness/ feeling exhausted/ fatigue that is immense and overtakes her body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), SOMNOLENCE (Falls asleep, sleeps 4 to 5 hours), INSOMNIA (Falls asleep) and FATIGUE (Tiredness/ feeling exhausted/ fatigue that is immense and overtakes her body) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 036A21A) for COVID-19 vaccination.     The patient's past medical history included Lymph node excision (Ten lymph nodes were taken out due to cancer.). Concurrent medical conditions included Cancer.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), SOMNOLENCE (Falls asleep, sleeps 4 to 5 hours), INSOMNIA (Falls asleep) and FATIGUE (Tiredness/ feeling exhausted/ fatigue that is immense and overtakes her body). At the time of the report, PAIN IN EXTREMITY (Sore arm), SOMNOLENCE (Falls asleep, sleeps 4 to 5 hours) and FATIGUE (Tiredness/ feeling exhausted/ fatigue that is immense and overtakes her body) had resolved and INSOMNIA (Falls asleep) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. Patient experienced sore arm felt like having a flu shot. No treatment information was provided.      Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up information received on 12-Jul-2021 updated events outcome to resolved.; Sender's Comments:
Muscle spasms at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: unknown) via an unspecified route of administration in the  left arm on 15Apr2021 at 10:15 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. On 15Apr2021, the patient experienced muscle spasms at the injection site each day, it came and went but they occur several times each day and multiple spasms per event. The patient did not receive any treatment for the reported event. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event muscle spasms at the injection site were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
IMMUNIZATION & SCHOOL PHYSICAL 5/14/02 TEMPERATURE UP TO 103 PER MOTHER 5/15/02 SEEN IN CLINIC FOR FEVER & C/O ABDOMINAL  PAIN 5/16/02 TEMP RESPONDING WELL TO TYLENOL (98.8) EXAM WNL. ADVISED TO INCREASE NONCAFFIENATED LIQUIDS, TYLENO q 4 PRN.  RV IF NOT IMPROVING.
Vaccine on 12/22/2020 and started feeling bad on 12/27/2020 and tested positive on 12/30/2020 for COVID 19  Was advised to fill this out by my PCP
2 days later began with headache, dizziness, weakness, on 1/25/21 was admitted to hospital with severe leg weakness, inability to walk, urinary incontinence
1 week post vaccination, left arm local red, warmth, inflammation, itchiness. Physician prescribed antibiotics because they weren't sure if it was an infection or reaction due to the late presentation.
This spontaneous report as received from a nurse refers to a unspecified number of patients (gender and age unknown). Over the past 3 months (since approximately September 2012) the patients were vaccinated with a dose of GARDASIL (lot number, route and dose were not reported). The nurse reported that the patients may have received improperly stored GARDASIL over the past three months. No symptoms were reported. No other details were provided. This case is related to case MARRS # 1212USA005493 and case MARRS # 1212USA005494 (same reporter link). Additional information has been requested.
doses were administered from one expired vial; vial was moved from the freezer to the refrigerator on 09Jul2021 and puntured on 11Jun 2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were administered from one expired vial) and PRODUCT TEMPERATURE EXCURSION ISSUE (vial was moved from the freezer to the refrigerator on 09Jul2021 and puntured on 11Jun 2021) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vial was moved from the freezer to the refrigerator on 09Jul2021 and puntured on 11Jun 2021). On 09-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were administered from one expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were administered from one expired vial) and PRODUCT TEMPERATURE EXCURSION ISSUE (vial was moved from the freezer to the refrigerator on 09Jul2021 and puntured on 11Jun 2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant use were reported No treatment medication were reported.  A public health assistant called-in on 09 Aug2021 to report five doses were administered from one expired vial. The vials lot number was 041B21A. The vial was moved from the freezer to the refrigerator on 09Jul2021. The vials was first punctured on 11 Jul2 021. The vial was left in the refrigerator and on 08Aug2021 five patients were given doses from the expired vial. The caller confirmed the vial never went through any temperature excursions.