chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles on neck, face and ear on left side, same side as injection. Swollen Glands also. No treatment - was too late in course of event. Weeks to clear.
no known adverse effects; an administered dose of VARIVAX underwent a temperature excursion prior to being administered; an administered dose of VARIVAX underwent a temperature excursion prior to being administered; This spontaneous report as received from a nurse refers to a patient of an unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  Since 07-JUN-2019, a dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot # R030611, expiration date: 23-OCT-2020, underwent a temperature excursion of 1.0 degree Celsius for 72 hours. On 11-JUN-2019, the improperly stored dose was administered to patient subcutaneously for prophylaxis (frequency and exact dosage were not provided). The call was made because of digital data logger, there were no previous temperature excursion. There were no adverse effects reported. The outcome of product storage error, poor quality product administered and no adverse event was unknown.
pregnant; A spontaneous report was received from a 34 year old , female health care professional, who while participating in the mRNA-1273 Emergency use program  became pregnant.  The patients' medical history included slight asthma and allergy to Sulsa antibiotics. The patient's previous pregnancy history included live, full term birth on 23 NOV 2018 with no complications. There is No family history of congenital anomalies/genetic disease in relation to patient. There is no history of alcohol, nicotine, marijuana or other illicit substances.  Concomitant medications reported as taken since conception included  OTC multivitamins for immunity.  On 27 DEC 2020, prior to awareness of pregnancy ,the patient received the first of the two planned doses of mRNA -1273 intramuscularly in left deltoid for prophylaxis of COVID-19 infection.The first day of the patient's last menstrual period was on 22 NOV 2020.The  due date was estimated on 29 AUG 2021.The estimated date of conception was not reported.  The  date on which relevant tests performed to detect pregnancy was unknown.  Action taken with the second dose of mRNA-1273 was unknown.; Reporter's Comments: This case concerns a 34-year-old female G2P1, who reported pregnancy. Last menstrual period was 22-Nov-2020. Method of contraception was unknown.  The date of conception and the type of pregnancy test used for pregnancy determination was not provided. Estimated Due Date is 29-AUG-2021.
Pfizer-BioNTech.    Covid vaccine EUA.   Side effects: pain at injection site, headache, joint pain, fatigue.  No treatment......symptoms gone within 24 hours.
About 20/30 mins after vaccines were given pt. c/o SOB, slight wheezing, pale & "not feeling well" daughter states she had been previously having these spells at home but were becoming worse & more frequent. Pt. was outside in hot car. O2 placed on pt. Physician on site & 911 called.
Patient states that about 1.5 hours after she got home after vaccination that she experienced a fever spike to 104 degress farenheit and was drenched in sweat. She also experienced hallucinations where she "needed to be running" and frantically ran through her house. She developed a migraine and began to urinate in "inappropriate rooms of the house". Patient did not seek medical attention and called us today to report. As of today patient report feeling tired and weak, fever and hallucinations have resolved as well as urination problem.  Advised that patient get evaluated by a medical professional.
Pt c/o erythema and inflammation at site that started on 9/10/03. Site is tender to palpation and erythema was approx 3 inches in diameter below injection site. Pt's mother reports the swelling and redness are starting to resolve.
3:55 pm received injection and felt fine during 15 min monitoring period late evening beginning to experience headache middle of the night (approximately 4 am) woke up with severe bodyaches morning (8 am) woke up with extreme acute stabbing pain in ears  - stabbing pain persisting all day, extreme headache and pain behind eyes, body aches, chills, spinal pain from lower back up through neck all day (spinal column feels stiff and swollen) nausea began in morning and remained low to moderate but i have been in bed all day (increases upon standing up).  2pm tingling and numbness in right arm for approximately 30 minutes (not arm where i was injected!)
Patient Reported extremely sore arm and temperature 101. Red / hot to the touch at site of injection.  Very painful. She called back 2 days later and said the pain was still bad getting a little better but had spread to her shoulder and down to elbow. Redness still there and spread from injection site all around bicep / deltoid. She is taking Tylenol for pain.
Swelling of the forearm, forehead, lip. Patient arrived at Hospital and received an injection of ephenephrine and other drugs for allergic reactions.
Patient  presented 1 day after vaccine for continued fever that  she was unable to control at home with associated headache and body aches and tachycardia.
Pain in shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in shoulder) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Pain in shoulder). At the time of the report, ARTHRALGIA (Pain in shoulder) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.
-Itching: for the first twelve hours -Bruising at injection site for over a weeks -Pain at injection site continued through  a week -Muscle soreness causing limited mobility of left arm (the injection arm)  -Soreness and aching pain throughout entire body  -Severe fatigue and exhaustion  for over one week (I could barely function, everything was slow to process)  -Fever -Headache  (Throughout entire head, it was painful and detracted from my ability to concentrate on mission planning) -Bumps on the back side of both arms which have continued to this day.
Patient received vaccine and pain started later that evening.  Pain became worse over time and began radiating down arm, up neck and around shoulder. She went to ER on 11/18/2017 and was diagnosed with shingles in that area.
PATIENT STATED SHE WENT TO HER CHIROPRACTOR AND HE HAD STATED THAT HER RESTLESS LEG SYNDROME WAS DUE TO RECEIVING THE TDAP.  SHE REFUSED TO COME TO EMPLOYEE HEALTH FOR FOLLOW-UP.
This is a prospective pregnancy case. This 27-year-old female subject was enrolled in a study. The subject received Flu Seasonal QIV on an unknown date. The subject's estimated date of delivery was 27th May 2015. On an unknown date, an unknown time after receiving Flu Seasonal QIV the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details provided: Gestational age was unknown.
Pt presents with daughter requesting a flu shot but was accidentally given a Pfizer bivalent booster vaccine. Prior to administration, pt was informed of the type of vaccine that she will be receiving, but she has difficulty hearing per daughter.  Pt's daughter was aware of the wrong vaccine and was agreeable for the pt to also receive the flu shot in addition the pfizer bivalent booster; both shots were administered. Pt's daughter called pharmacy regarding side effects from the vaccines
This case was reported by a consumer via sales rep and described the occurrence of injection site bruising in a adult female patient who received dTap vaccine. In January 2017, the patient received dTap vaccine. On an unknown date, unknown after receiving dTap vaccine, the patient experienced injection site bruising. On an unknown date, the outcome of the injection site bruising was recovered/resolved. It was unknown if the reporter considered the injection site bruising to be related to dTap vaccine. Additional information was reported as follows: This case was reported by the patient's daughter. The reporter expressed how passionate she was about protecting her children from vaccine preventable diseases. She reported that, she made her mother get a Tdap vaccine in the left deltoid at her obstetrics and gynaecology in January 2017. After receiving BOOSTRIX, her mother had bruising at the injection site which lasted for about 2 1/2 weeks. No medical attention was sought and the patient recovered fine. It was unclear if the Tdap vaccine was BOOSTRIX or not, as the reporter only stated that it was Tdap and could not specify the brand name. The reporter did not agree to be followed up.
knot & reddness @ site about size of fifty cents piece; no fever greater than 102;
My left arm and shoulder have been painful ever since I received the vaccine. I am unable to do simple tasks with my left arm. Sometimes the pain is excruciating. I have been communicating with my doctor. He was giving me advice and then he said I should come in. He noted that there is a lump in the area of the arm where the shot was administered. My Doctor believes that I am developing adhesive capsulitis. I may need to see an orthopedic doctor to get a cortisone shot and physical therapy. I am unable to do much activity with my left arm. My arm am shoulder pain wake me up throughout the night.
LPN inadvertently administered Menactra vaccine that was 4 days past expiration, Pt showed no obvious sings of ASE r/t expired dose of vaccine, LPN  reported inadvertent administration to provider right away, LPN called manufacture and manufacture stated that There is no contraindications from the CDC regarding expired vaccine at this time, Manufacture stated that the pt will need to repeat vaccine as soon as possible, LPN called and spoke with Pt legal guardian and explained what had happened, Pt legal guardian stated that the pt appeared to be normal and had no complaints regarding expired vaccine.
bifrontal h/a 1hr p/vax & lasting 2 days;tremulousness,skin pallor,hunger & tachycardia @ 48hrs post vax;sx improved p/eating lunch;
ASTHMA SYMPTONMS WORSE; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (ASTHMA SYMPTONMS WORSE) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 2) on 05-May-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 2) on 05-May-2021 and PFIZER BIONTECH COVID-19 VACCINE (Dose 1). Past adverse reactions to the above products included Allergy to molds with PFIZER BIONTECH COVID-19 VACCINE; Chemical sensitivity with PFIZER BIONTECH COVID-19 VACCINE; and No adverse event with PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Asthma (Taking DPXT since Jun-2021 for Asthma).    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced ASTHMA (ASTHMA SYMPTONMS WORSE). At the time of the report, ASTHMA (ASTHMA SYMPTONMS WORSE) outcome was unknown.            No concomitant medication was reported. The patient was usually better or about the same since taking DPXT but asthma did not got worse. patient got the Pfizer covid-19 vaccine for first two dosage and Moderna booster and it temporarily made asthma symptom worse. Over the last month the patient was having cough, chest tightness and shortness of breath and using rescue inhaler more than two times per week over last month. Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Difficulty breathing/shortness of breath/unable to catch breath. Swollen lymph nodes the size of grapes on side that injection was given.
About six minutes after vaccination I started to fell flush and tingly. Elevated heart rate which lasted for 23 hours.  After second vaccination elevated heart rate for a few hours and flu like symptoms. Remained in observation for 45 minutes to make sure. Morning sickness which may be related to early pregnancy.
At approximately 6:15 pm patient started breaking out in a rash with eyes swelling, no difficulty breathing. Provider advised mom to give the patient Epi-Pen and 25mg of Benadryl PO and then call 911. Follow up with mom per phone at 8:30 am the next morning. EMS gave Hydroxizine, did not go to the ER. Rash gone this morning, no symptoms. Thinks rash was caused by a new blanket that patient used
Sore arm; Headache; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Tiredness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included Surgery (Patient had right breast surgery done). Concurrent medical conditions included Polymyalgia rheumatica since 22-Sep-2015, Osteopenia since 29-Nov-2017, Depression since 05-Apr-2021, Hyperlipidemia since 14-Nov-2018, GERD since 14-Nov-2018, Hypertension since 16-Jun-2013, Penicillin allergy, Drug allergy (naproxen), Drug allergy (Pneumovax 23), Drug allergy (zyzal.), Anxiety and Tiredness. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, FEXOFENADINE from 29-Apr-2014 to an unknown date and PANTOPRAZOLE for GERD, LISINOPRIL for Hypertension, CELECOXIB (CELEBREX) for Pain, FISH OIL (OMEGA 3 [FISH OIL]) from 04-May-2009 to an unknown date, VITAMINS NOS (MULTIVITAMINUM) from 09-Jan-2017 to an unknown date, COLECALCIFEROL, OYSTER SHELL (CALCIUM OYSTER SHELL + VITAMIN D3) from 04-May-2009 to an unknown date and MACROGOL 3350 (CLEARLAX [MACROGOL 3350]) from 17-Jun-2013 to an unknown date for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Tiredness). On 15-Mar-2021, PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-077964 (E2B Linked Report). This case was linked to US-MODERNATX, INC.-MOD-2021-049882 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: follow-up received and included contains no new information On 14-May-2021: follow-up received and included patient demographics updated, concomitant drugs updated, medical history updated , event outcome updated. On 13-Jul-2021: Significant follow up received and contains current condition, concomitant medication, onset of the events, updated outcome of the events and causality of the events was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077964:
cough; nasal drainage; Loss of taste; Loss of smell; This spontaneous case was reported by a physician and describes the occurrence of AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), COUGH (cough) and RHINORRHOEA (nasal drainage) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: HEPATITIS B VACCINE (1 of 3 series) on 27-Nov-2020.    On 29-Dec-2020 at 2:33 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell). On an unknown date, the patient experienced COUGH (cough) and RHINORRHOEA (nasal drainage). On 14-Jan-2021, AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), COUGH (cough) and RHINORRHOEA (nasal drainage) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The patient denied any treatment measures.      Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Events (cough, nasal drainage and loss in sense of smell to seasonal allergies) updated. The outcome of events updated and information regarding patient's Hepatitis B vaccine updated. On 02-Jun-2021: Follow-up information contains non-significant information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded for the event,  Loss of taste and Loss of smell.  Very limited information regarding the event, positive test,  has been provided at this time.  Further information has been requested.
post vax initial distribution of vesicles circular around the inj site;2 other vesicular lesions on abd & lt auricular area;
COVID Breakthrough Case  Pfizer Dose 1 3/7/21 (EN6199) Pfizer Dose 2 3/31/21 (EN6207) COVID Positive 9/28/21  10/3/21: patient is a 74 year old male who is fully vaccinated for Covid-19 and tested positive for Covid-19 on 9/28. He has been experiencing headaches, body aches, fatigue, sob and cough with worsening symptoms. Denies chest pain. He had nausea, vomiting and diarrhea but those symptoms subsided on Wednesday. He has a past medical history significant for obstructive sleep apnea on CPAP, hypertension, CAD s/p stenting, mild cognitive impairment, vitamin B12 deficiency, GERD, hyperlipidemia, idiopathic osteoarthritis and anxiety/depression.  Patient became hypoxic on room air at 80%.  Supplemental oxygen applied at 2 L with improvement oxygen saturations to 99%.  Laboratory findings were significant for pCO2 66. Mild anemia HGB 12.6.  C reactive protein 9.80.  Chest x-ray showed pneumonia and lung.  CT chest no PE. Bilateral pneumonia.  Ascending thoracic aortic aneurysm 4.4 cm. Rocephin and Zithromax were initiated in ED.  10/6/21: The patient was admitted and underwent treatment for COVID pneumonia with anti microbial therapy, bronchodilators and close monitoring of his hemodynamic status.  On the day of discharge patient feels very well, denies shortness of breath, chest pain, nausea or vomiting. He is very eager to go home and was evaluated to see if he needed oxygen going home.  Patient does not need oxygen going home per the O2 walk test prior to discharge. Patient is discharged in stable conditions.  Total time spent on discharge 45 minutes
Reaction slight redness, swelling and warm feeling to Lt delt from flu shot. Got shot 10-6-15. Symptoms started 10/7/15.
Information has been received from a physician concerning a 21 year old female who on 08-OCT-2007 was vaccinated IM with a second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot# 658558/1061U). There was no concomitant medication. On 09-OCT-2007 the patient's mother called the office to report that the patient believed that she was having a reaction to the vaccine. The patient was called by the physician. It was reported that the patient woke up through the night with severe abdominal cramps. She had no nausea, diarrhea or vomiting. She possibly had a fever "I felt warm." The patient stated that she didn't feel right. She didn't want to eat because her "stomach kind of hurts." The patient was told that if she experienced any signs of wheezing, trouble breathing or swallowing or if she had a fever she needed to go to the emergency room. The physician reported that this may be influenza type of symptoms but the patient should call her mother to let the office know how she was feeling. The patient recovered. On 01-AUG-2007 the patient was vaccinated with first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) and there were no concerns. Additional information has been requested.
Had 1st shot was suppose to get 2nd last friday. Cant getbtgere until the 10th. Am i to late for 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Had 1st shot was suppose to get 2nd last friday. Cant getbtgere until the 10th. Am i to late for 2nd shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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, the patient experienced PRODUCT DOSE OMISSION ISSUE (Had 1st shot was suppose to get 2nd last friday. Cant getbtgere until the 10th. Am i to late for 2nd shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Had 1st shot was suppose to get 2nd last friday. Cant getbtgere until the 10th. Am i to late for 2nd shot) had resolved.            No concomitant medication were reported. The treatment information were unknown.
54 year old patient inadvertently received FLUZONE HD QUADRIVALENT, no  AE; 54 year old patient inadvertently received FLUZONE HD QUADRIVALENT, no  AE; Initial information received on 21-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 54 years old female patient inadvertently received 0.7 ml of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number UJ467AB and expiration date:30-Jun-2021) via intramuscular route in the right deltoid for prophylactic vaccination on 21-Sep-2020 (PT: product administered to patient of inappropriate age, wrong product administered)  Medical history was not reported.  Concomitant medications were not given to patient.  It was an actual medication error case due to inappropriate age at vaccine administration and wrong vaccine administered (same day latency).   No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sore arm; This spontaneous case was reported by an other and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Body temperature: 99.9 f 99.9 F.         No concomitant medicines were reported. No treatment information were reported. Action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-021037 (Patient Link).
-Anxiety, adrenal fatigue, binocular vision disorder, sensory overload, weakness, numbness, fatigue  None of this has completely resolved 18 months later