chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; headache; felt awful; was not hungry; lethargic; didn't feel very wel; achy,sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (didn't feel very wel), MYALGIA (achy,sore arm), PYREXIA (fever), LETHARGY (lethargic) and HEADACHE (headache) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Allergy to AMOX), Allergy to antibiotic (Allergy to Cephalosporins.), Food allergy (Food Allergy) and Allergy to antibiotic (Allergy to Sulfanate).    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (didn't feel very wel), MYALGIA (achy,sore arm), PYREXIA (fever), LETHARGY (lethargic), HEADACHE (headache), FEELING ABNORMAL (felt awful) and DECREASED APPETITE (was not hungry). At the time of the report, MALAISE (didn't feel very wel), MYALGIA (achy,sore arm), PYREXIA (fever), LETHARGY (lethargic), HEADACHE (headache), FEELING ABNORMAL (felt awful) and DECREASED APPETITE (was not hungry) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (normal) not more than 100.9.     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 medications were reported No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Updated Patient Demographics, Medical History, Dose details,. Added new events Head ache, lethargy.
Covid positive PCR test taken on 4/4, with results on 4/6; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 27Mar2021 as a single dose for COVID-19 immunisation. No relevant medical history was reported. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 04Apr2021 the patient turned COVID positive for PCR test. On 04Apr2021, the patient underwent PCR test (Nasal Swab) and the result was positive as on 06Apr2021. No therapeutic measures were taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event COVID -19 was not recovered at the time of this report.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
VERY  LARGE RED INJECTION SITE, HIVES , RASH DOWN BOTH ARMS,  BENADRYL CREAM, BENADRYL TABLETS
Body, muscle and joint pain; Body, muscle and joint pain; Body, muscle and joint pain; Chills; Tired; This is a spontaneous report from a non-contactable healthcare professional. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 (13:00) (Lot number: EK5730; Expiration date was not reported) and the second dose on 07Jan2021 (07:00) (Lot number: EL0140; Expiration date was not reported), both intramuscularly on the left arm at a single dose for COVID-19 immunization at the hospital. Medical history included sulfa allergy. Concomitant medications included colecalciferol (VITA D) and magnesium sulfate (MG). On 07Jan2021 (19:30), the patient had body, muscle and joint pain; chills; and tired. The patient did not receive any treatment for the events. The patient's COVID test was negative on an unspecified date. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination. The outcome of the events, 'body, muscle and joint pain', 'chills' and 'tired', was recovering.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Patient was given Pfizer vaccine that was out of the freezer for more than 5 days.  Patient was informed of this and offered new vaccine as it becomes available.  At this time, patient showed no adverse reactions.  Patient was sent home without incident.
Boostrix given by mistake instead of HepB vaccine; Inappropriate age at vaccine administration; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 1-day-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3JS9E, expiry date 18th March 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th June 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 29th June 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-JUN-2022. Reporter's Comments: The patient was administered Boostrix by mistake instead of Engerix B. The Vaccine Administration Facility was the same as Primary Reporter. The reporter mentioned that all babies were listed the same. No real initials were reported. The reporter did not consented to follow up. Additional Supportive Information: The one year old patient received Boostrix instea of Engerix B, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Shortly after I got the vaccine - I started to develop some minor reactions. (1) began to have the inside of my mouth get puffy - not like I couldn't breath. That cleared up in about 3 days. (2) Then the inside of my nasal cavity - lost all its moisture and every time I would sneeze or blow my nose - blood + scabs would come up. I was told to use Vaseline to coat the inside until it became moist again - and it cleared up. - of course my arm was very sore (right) I was aware that was coming. It worked its way up to my right shoulder + very painful. I made an appointment with the Sports Medicine Clinic. They xrayed my right shoulder and found arthritis, and all kinds of small damage (old). I was given an injection where the arthritis was (it was done in the imaging clinic) Do to where the pain, inflamation etc was - the wanted me to see 2 surgeons that do shoulder replacements. Very good surgons. (2-18-2020) I have no broken bones in that shoulder - so I was not keen on surgery at this time because I felt it would calm down with time + PT. Now (2-24-2020) it is a bit better + some of the reactions are gone - I do not feel the vaccine did the damage in my shoulder - but I do feel it inflamed the shoulder (any may be responsible for the left shoulder + the aching of my bones + muscles). I am weaker than I have ever been and I am running a low grade fever for at least 2 months. Please feel to call me if you have any questions.
EARLY MENSTRUAL PERIOD (12 DAYS AFTER PREVIOUS PERIOD); 8 DAYS OF HEAVY BLEEDING; SLEPT ALMOST THE ENTIRE DAY; VERY SORE ARM; FELT RUN DOWN FOR ABOUT A WEEK; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced very sore arm. On 10-APR-2021, the subject experienced felt run down for about a week. On 11-APR-2021, the subject experienced slept almost the entire day. On 17-APR-2021, the subject experienced 8 days of heavy bleeding. On 06-MAY-2021, the subject experienced early menstrual period (12 days after previous period). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 8 days of heavy bleeding on 24-APR-2021, slept almost the entire day on 11-APR-2021, very sore arm on 13-APR-2021, and felt run down for about a week on 17-APR-2021, and the outcome of early menstrual period (12 days after previous period) was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Vaccine was expired on 09-Nov-2021 and administered on 10-Nov-2021/administered expired vaccine to the patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and administered on 10-Nov-2021/administered expired vaccine to the patient, after the manufacture date of expiration) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and administered on 10-Nov-2021/administered expired vaccine to the patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and administered on 10-Nov-2021/administered expired vaccine to the patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 168 doses.  The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up was received, additional reporter was added.
suspected vaccination failure/got both doses in 2020 just recovering from shingles; horrible case of internal shingles; entire body was on fire, utter hell; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and burning sensation. On an unknown date, the outcome of the vaccination failure and burning sensation were unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles and burning sensation to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 17-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got both doses of shingles vaccine in 2020 and just he/she was recovering from a horrible case of shingles that just about killed him/her. The patient stated that the entire body was on fire as it went internal, utter hell. The patient also stated that the shot did not always work. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This spontaneous report was received from a Nurse refers to a patient of unknown demography. On 14-MAR-2014, the patient was vaccinated with first dose of GARDASIL (0.5 ml) intramuscular that was improperly stored. No adverse effects reported. No further information provided. This case is linked to the case 1403USA008790 (same reporter link). Additional information has been requested.
the day after vaccine, noticed a little heart racing when doing stairs, then started noticing heart racing with walking within my house or a long cooridor at work. on day 6 while sweeping the kitchen floor checked heartrate and it was 130, then while walking around the block checked it because I can feel heart pounding and it was 149.
This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a adult female patient who received dTpa vaccine. Concurrent medical conditions included penicillin allergy. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, less than a day after receiving dTpa vaccine at an unknown dose. On an unknown date, less than a day after receiving DTaP vaccine, the patient experienced allergic reaction, nausea, fainting and head injury. On an unknown date, the outcome of the allergic reaction, nausea, fainting and head injury to be related to DTaP vaccine. Additional details were provided as follows: This case was reported by the patient's daughter. The age at vaccination was not reported. The reporter's mother got the vaccine and after she returned home from doctor, she was extremely nauseous and ended up fainting. She hit her head on the fireplace and ended up needing stitches. The reporter consulted some of her nurse friends, some of them thought it was due to the shot and some did not. There were no other issues with the patient when they did tests in the hospital. One of the friend of the reporter who is nurse said that, it could be an allergic reaction from the antibiotic in the shot (the patient was allergic to penicillin). This case has been linked to US2016GSK142670 as reported by the same reporter.
Chief complaint:  Fainting post vaccination  1500:  Sat up and briefly felt better.  Needed to lay back down due to feeling lightheaded and faint again.   1515:  Reports feeling "a little better".  Able to sit up again.  Slight headache 1522:  Sitting up in chair, drinking water, reports feeling fine.  Went home with his mother
Pt complained of swollen lymph nodes in neck and bilateral axilla, spots and fever. Lymphadenopathy; fever.
trouble breathing; fatigue; muscle and body aches; muscle and body aches; trouble standing up; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number:  EK 4176), via an unspecified route of administration on 18Jan2021 11:30 AM at single dose on left arm for COVID-19 immunization. Vaccine facility type is hospital, Medical history included dialysis patient, "dibeties" and High blood pressure. No known allergies and no COVID prior vaccination. No other vaccines in four weeks. Concomitant medications included unspecified medications (reported as "other medications in two weeks: yes"). The patient experienced trouble breathing, muscle and body aches, trouble standing up and fatigue which occurred within 1 hour after taking shot on 18Jan2021 12:15 PM. No treatment was given for the events. Outcome of the events was recovered in Jan2021. Patient was not tested for COVID post vaccination.
This case was reported by a other health professional via call center representative and described the occurrence of fever in a 61-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020) for prophylaxis. Concurrent medical conditions included hashimoto's disease. Concomitant products included calcium salt (Calcium), vitamin d and levothyroxine sodium (Synthroid). On 4th June 2018 09:31, the patient received the 1st dose of SHINGRIX. On 5th June 2018, 1 days after receiving SHINGRIX, the patient experienced fever, nausea, injection site pain, chills, tremor, headache and muscle pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever, nausea, injection site pain, chills, tremor, headache and muscle pain were recovering/resolving. The reporter considered the fever, nausea, injection site pain, chills, tremor, headache and muscle pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by office manager. The patient received Shingrix vaccine on left arm. The health care professional reported that a patient received her first dose of SHINGRIX and the following day developed fever, chills, headache, shaking, nausea, muscle aches and pains, and injection site pain. The patient took Tylenol which helped alleviate symptoms.
Initial information received on 10-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 11 years old female patient who received a second dose of FLUZONE vaccine (batch no: UJ005AF, Expiry: 30-JUN-2019) via intramuscular route in left deltoid on 10-Jan-2019 and also received same vaccine on Oct-2018. The patient's past medical history, medical treatment(s) and family history were not provided. On an unknown date following vaccination patient came for sick visit. It was actual medication error due to extra dose administered. No adverse effect was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
I took my  first shot of Pfizer on Feb. 02, 2021 and my second shot on Feb. 28, 2021. After two to three days (after the second shot) I experienced extremely severe shooting pain in my testicle region. The pain was severe enough to seek medical attention.  My doctor ordered an ultrasound.  Howerer, the ultrasound did not report any abnormalities and after about three weeks I did not experience any more pain the my testicular region.
My adverse effect were: shortness of breath, chest tightness, chest pain, and  fast heart rate.
As reported by parent, approximately day 10-11 post vacination, child broke out in red, raised rash, developed fever of 103-105F, was lethargic and anorexic.  Was treated for dehydration at local emergency room and subsequently seen by an infectious disease specialist at Hospital and diagnosed with vacine induced measles.
Significant ecchymosis posterior legs and buttocks without trauma along with hematuria. Slightly low platelet count. Spontaneous resolution.
Starting feeling unwell approx 3:00 PM same day. By evening Fever went up to and stayed 102.5-102.9, severe headache, body aches and shivering/chills despite taking 2 extra strength Tylenol every 4 hours.
My arm was a bit sore and that was it.; Inappropriate route of vaccination; I had a 12 hour vomitting bug 15 days after that vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (My arm was a bit sore and that was it.), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) and VOMITING (I had a 12 hour vomitting bug 15 days after that vaccine) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 012L20A) for COVID-19 vaccination.     No medical history reported by the reporter.  Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for Asthma.   On 24-Jan-2021 at 2:53 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 02-Mar-2021 at 4:27 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 02-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination). On an unknown date, the patient experienced PAIN IN EXTREMITY (My arm was a bit sore and that was it.) and VOMITING (I had a 12 hour vomitting bug 15 days after that vaccine). On 02-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) had resolved. At the time of the report, PAIN IN EXTREMITY (My arm was a bit sore and that was it.) and VOMITING (I had a 12 hour vomitting bug 15 days after that vaccine) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   No treatment medication provided by the reporter It was reported that the administration site of both the dose 1 and dose 2 were upper arm Patient reported that she had consulted with her general practitioner and also infectious disease neurology and allergy and immunology along with a  lot of lab blood work then only she made the decision to took vaccine   This case was linked to MOD-2021-031380 (Patient Link).
Prolonged congestion in nasal passages, head and ears, causing a nasal echoing when talking and loose, excessive phlem/sputum; only relieved with doses of sudafed, but symptoms began the next day after the second dose was received. Symptoms continue and are only relieved with Sudafed.
Significant injection site soreness, felt bad, aching all over, low grade fever, facial swelling, red splotch at injection site, headache, dizziness - onset evening of injection.
Member complains of "severe itching" from head-to-toe. Member given BENADRYL and CLARITIN by doctor.
Initial report received from an administrator of health unit on 23 Dec 2009: This patient was received FLUVIRIN 0.5 mL on 17 Nov 2009. He had pain in the arm. The entire arm also became red, swollen and warm on 17 Dec 2009. The patient had not recovered.
The patient began to feel ill and have episodes of frequent urination, increased thirst and nausea shortly after his 2nd dose of the Pfizer vaccine. On October 12th the patient presented to the Emergency Department and was admitted to the ICU for DKA and a new diagnosis of Type 1 diabetes.