chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient has not experienced any adverse effects as of 9/22/22.  Pfizer Bivalent COVID-19 vaccine was inadvertently administered  for a second dose in a 2-dose series by the administering nurse.
pain swelling at injection site (02/11/2010) nausea, increased wheezing, chills, extreme weakness, wooziness (02/12/2010) extreme congestion, scratchy throat, followed by respiratory infection by 02/16/2010 treated with Avelox 400 mg 1x day
Developed urticarial rash 4/16/14 - interm. hives and itching over next 1-2 weeks - some pressure urticaria lesions, others papular, itchy, no vesicles present; seen 4/29/14 started oral antihistamine medication.
Administered vaccine subcutaneously. In the past you could administer either subcutaneous or intramuscularly
I received the vaccine in my left shoulder with no issues, minimal discomfort.  At about 3 hours afterward, I noticed pain when moving my left arm, located at the injection site.  At this point, it was still within the range of typical soreness after receiving an injection.  However, by 6pm, it was difficult to raise my arm.  At 9pm, I realized my entire shoulder is swollen, hard to the touch, and I can not lift my arm.
Pt recvd vax on 11AUG92 & 24 hrs later, devel back pain, fever, malaise, fatigue, abdo pain w/tenderness over liver; sx persisted for 5 days; 16AUG92 seen by MD; lab eval showed inc liver enzymes & blood glucose;
Patient was administered the incorrect dosage of Pfizer (0.1).  Vaccinator notified the site leader in regards to the above.  Site contacted patient and advised patient to return facility to receive the remaining dosage of 0.2.  0.2 was administered and patient was fully vaccinated with he correct dosage of 0.3
Started feeling "mental fuzziness".   Developed fever up to 100.8 degrees. Noted induration at injection.  Induration went from shoulder area to mid arm.  Warm to touch.  Felt burning sensation at site.
Chills, body aches, low grade fever, fatigue, all starting  24 hours after the second dose.
Headache Aches Very sore arm shot arm Lymph nodes left side neck enlarged for a few hours   Note!! 2nd dose...headach ... chills..and on opposite hand and top of forearm. .numb and  arthritic for 2 days!
I'm reporting this as this patient notified me that they received 5 COVID-19 vaccinations, which one was not even reported. All vaccines this patient received were not FDA approved, as well as the three doses this patient received after the first two doses were only a couple months apart. This is alarming to me as this seems like a case of medical malpractice being that only two doses plus a booster six months from those two doses were approved. From the time span of January 2021- August 2021, this patient received 2 doses of Moderna and 3 doses of Pfizer.
Arm was swollen; left arm was tingling; swollen lymph nodes in her neck; arm was warm; body aches; chills; fatigue; headache; This spontaneous case was reported by a nurse and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen), PARAESTHESIA (left arm was tingling), LYMPHADENOPATHY (swollen lymph nodes in her neck), FEELING HOT (arm was warm) and MYALGIA (body aches) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen), PARAESTHESIA (left arm was tingling), FEELING HOT (arm was warm), MYALGIA (body aches), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache). 26-May-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes in her neck). On 31-May-2021, PERIPHERAL SWELLING (Arm was swollen), FEELING HOT (arm was warm), MYALGIA (body aches), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache) had resolved. At the time of the report, PARAESTHESIA (left arm was tingling) and LYMPHADENOPATHY (swollen lymph nodes in her neck) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Concomitant information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: no new information.
Started about 5-10 min after getting vaccine and unresolved 1 hour post vaccine - symptoms persisted Dizziness, not feeling right, nausea, pain in right side of face Patient transported  to ER for evaluation at 12:00 pm
She could not sleep the whole night; Right hand is swollen; She has a sprained wrist; Her hand, that is somewhat in pain from the sprain, and is most of the time fine, was in; Her left knee was hurting her a lot worse; Sore arm; First dose: sore arm; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6206) via an unspecified route of administration (age at vaccination 60-year) in Left Arm on 09Mar2021 as single dose for COVID-19 immunization. Medical history included accident (The accident was 25 years ago, and they told her that she had shrunk an inch from the accident. It is hard for her to say) and cardiac disorder (Her dad has heart disease) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 09Mar2021 the patient experienced sore arm after receiving first dose; On 30Mar2021 her hand, that is somewhat in pain from the sprain, and is most of the time fine, was in; her left knee was hurting her a lot worse; sore arm; her right hand is swollen and she has a sprained wrist. On 30Mar2021 09:30 she reported she could not sleep the whole night. The seriousness of all the event was reported as non-serious. Her left knee was hurting her a lot worse was recovering. The clinical outcome for all other events was unknown.  No follow-up attempts are needed. No further information is expected.
Headache; Bodyaches; Nausea; Vomiting; Osteoporosis; Bone Pain; Joint Pain; Fever; Chills; This spontaneous case was reported by a patient and describes the occurrence of OSTEOPOROSIS (Osteoporosis), BONE PAIN (Bone Pain), ARTHRALGIA (Joint Pain), PYREXIA (Fever) and CHILLS (Chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure increased (Controlled by medications) since 2008, High cholesterol (Controlled by medications) since 2008 and Acid reflux (esophageal) (controlled by medcations) since 2008. Concomitant products included FLUOXETINE HCL, PANTOPRAZOLE, ATORVASTATIN, METOPROLOL and VALACYCLOVIR [VALACICLOVIR] for an unknown indication.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 03-Mar-2021, the patient experienced OSTEOPOROSIS (Osteoporosis), BONE PAIN (Bone Pain), ARTHRALGIA (Joint Pain), PYREXIA (Fever) and CHILLS (Chills). On an unknown date, the patient experienced HEADACHE (Headache), MYALGIA (Bodyaches), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with ZOLEDRONIC ACID (RECLAST) for Osteoporosis, at an unspecified dose and frequency. On 03-Jun-2021, BONE PAIN (Bone Pain) had resolved. At the time of the report, OSTEOPOROSIS (Osteoporosis), ARTHRALGIA (Joint Pain), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Bodyaches), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal normal. On an unknown date, Bone scan: abnormal (abnormal) Significant osteoporosis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
Patient was administered Kinrix prior to manufacturer recommended age of 4 yrs. No adverse results noted.
This spontaneous report as received from a company representative (information received from a registered nurse) refers to a 12 year old female patient. On 06-AUG-2013 the patient was vaccinated with GARDASIL dose 1, intramuscular. Dose and lot number were not reported. Other suspect therapies included hepatitis A vaccine, (manufacturer unknown) and meningococcal vaccine (manufacturer unknown). Dose, dose number and lot number were not reported. The nurse, who also participated in the care of this patient, reported that the patient experienced syncope, "nearly fainting" in the office "about 20-25 minutes" after administration. The patient recovered on-site with rest and a cold pack and the staff continued observation for another 20 minutes after recovery was achieved. The patient is said to have "fully recovered". Outcome of syncope and nearly fainting was reported as recovered/resolved. Reporter causality assessment was not reported. Additional information has been requested.
02-03-17 Nausea - vomited early AM of 2-04-17. Severe pain below injection site on 2-4-17 with swelling and redness. Swelling and redness worsened over next 2 days - then slowly receded. Involved my whole upper arm down to elbow.
NUMBNESS; TINGLING; SLEEPINESS; SORE ARM; TIREDNESS; FEVER; This spontaneous report received from a patient concerned a 59 year old female. 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: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced sleepiness. On MAR-2021, the subject experienced sore arm. On MAR-2021, the subject experienced tiredness. On MAR-2021, the subject experienced fever. On APR-2021, the subject experienced tingling. On APR-2021, the subject experienced numbness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on APR-2021, and the outcome of fever, tiredness, sleepiness, numbness and tingling was not reported. This report was non-serious.
This spontaneous report as received from a nurse refers to a 50 year (reported as 50s years) old female patient. On an unknown date the patient was vaccinated with VARIVAX (subcutaneous, dose not reported) and ZOSTAVAX, (subcutaneous, dose not reported). These two doses were separated by at least 4 weeks apart. Pertinent medical history and concomitant medications were not reported. The reporter stated that this was not a mistake and vaccinated the patient as she asked to do so. The outcome of the event was unknown. The reporter also stated that the patient now wants to know if that dose of ZOSTAVAX can be used as second dose for the chicken pox. No adverse effects reported. No further details provided. Additional information has been requested.
Shortness of breath that has been gradually worsening in the last month, intermittent chest pain like a funny feeling of tightness.
This spontaneous case reported by a consumer, describes the occurrence of erythema (red arm), peripheral swelling (swollen arm) and rash on her arm in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 031M21A) for COVID-19 immunization. No medical history reported. On Feb 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 25, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 30, 2021, patient experienced erythema (red arm), peripheral swelling (swollen arm) and rash on her arm. At the time of the report, erythema (red arm), peripheral swelling (swollen arm) and rash on her arm outcome: unknown/not provided. No concomitant medication or treatment information reported. The patient received both scheduled doses of mRNA-1273 prior to the events. The action taken with the drug in response to the events: not applicable.
Scaly rash all over her body that was itchy....like eczema except worse. Now possible allergy to dairy.
Swelling, redness and pain at injection site.  Severe headache, dizziness, stiffness in neck, joint pain
Headache; little fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PYREXIA (little fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced HEADACHE (Headache) and PYREXIA (little fever). At the time of the report, HEADACHE (Headache) and PYREXIA (little fever) outcome was unknown. Not Provided          Patient had her first dose of Moderna vaccine on 11/03/21 with batch number 048A21A. Concomitant medications of the patient were not provided. No treatment medications of the patient were reported.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.
Fever of 101.5 recorded at 6:00 pm on 9/25/2019 which was the day after the vaccination.  Throughout the day, I felt miserable at work.  I could not keep my hands warm.  I had to wear a jacket which is very unusual for me.  I had a headache and muscle aches all day.  When I got home, I slept for 12 hours and felt much better the next day.  I had these exact same reactions to the first dosage of Shringrix vaccine (101 fever) which I received on 3/7/2019 [I did not file a VAERS report for that].
Presented to the hospital on 10/02/2021with increasing shortness of breath, confusion and increasing leg edema.  Tested positive for COVID. He had severe AKI and volume overload required initiation of HD on 10/4.  10/6, respiratory  status declined requiring mechanical ventilation.  He was transitioned to CMO and expired 10/11/2021.
Patient was administered Hep A vaccine about 1:30 and at about 1:35pm he was standing in the hallway, he was dizzy and felt tired and proceeded to fall to his left to the floor.  He proceeded to convulse in his neck, legs eyes and tongue and lost control of his bladder.  He would not respond for about 30 sec. without opening his eyes.  He then opened his eyes and pupils were dilated, they returned to normal size and he was able to answer all questions from the nurse.  The nurses had him sit up, staying on the floor, his face was ashen for several minutes.  He was given a cup of water and was observed by the nurse for about 10-15 afterwards.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.) and POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patients) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 001A21A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.). On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patients). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.) and POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patients) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. It was reported that there are 4 days temperature data (between 4/1/2022 and 4/4/2022) for the freezer storage unit, however it never reached an acceptable range and was always warm by at least 2 degree C. Between 2/22/21 to 4/26/22 there was no other temperature data available. Total 6640 doses of COVID-19 Moderna Vaccine were received by this facility during this time period and LOT numbers were provided (057M21A, 025L21B, 066H21A, 069H21A, 027H21B, 032F21A, 011F21A, 004F21A, 025C21A, 017C21A, 002C21A, 042B21A, 031B21A, 027B21A, 026B21A, 016B21A, 008B21A, 045A21A, 001B21A, 029A21A, 025A21A, 001A21A). Some vials may have been moved to a refrigerator at some point. There was no temperature data for that storage unit. Treatment information was not reported.
Diarrhea; Weakness in the legs; Back pain; Injection site soreness; Fatigue; A Spontaneous report was received from a healthcare professional concerning a 70 year old female patient who was participating in the mRNA-1273 Emergency Use Program and developed diarrhea, injection site soreness, back pain, weakness in her legs, and fatigue.   The patient's medical history included elevated cholesterol, hypertension, and an unspecified thyroid disorder. Concomitant medications reported included atorvastatin, olmesartan, and levothyroxine.    On 30 Dec 2020, approximately two days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 01 Jan 2021,the patient experienced diarrhea, injection site soreness, back pain, weakness in her legs, and fatigue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events diarrhea, injection site soreness, back pain, weakness in her legs, and fatigue was not reported.  Reporter causality for the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
PT came to the clinic on 2/11/2020 c/o hives to left arm. stated it started on 02/10/2020. No pain, no fever, no chills. Just very itchy. given a dose of cetirizine 10 mg and applied hydrocrostisone.
Within 3 hours I had chills and fever, fatigue, no appetite, slept for 14 hours one day this lasted 2 days and it was probably a week before I got my energy back and my stopped aching I could not stop shaking with the chills even with many blankets on. My temperature went up to 103 this has been happening since I have had to take the 65 and over vaccine  (about 3 or 4 years) before that no problem with the flue vaccine.
Eczema. Cut out gluten and dairy which May have helped a little but not much. Stopped giving DTaP and eventually the eczema went away. Now he eats gluten, dairy, etc and has no dietary restrictions and no more eczema.
have the vaccine, still got shingles/ Suspected vaccination failure; Shingles in eye; Shingles on face and head; This serious 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: have the vaccine, still got shingles/ Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Shingles in eye) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles on face and head). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and shingles were not reported.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and still experienced shingles on his or her face, head and eye. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Patient received vaccination 9/27/2017 in the left deltoid muscle one inch below the FLUZONE HIGH DOSE vaccination. She returned to the pharmacy Friday with a reddened area below the PNEUMOVAX injection site and extending proximally about 5 inches. She said the area was hot.  She said the reaction started the evening of 9/27/2017. I sent her to see her doctor. I called the doctor's office to tell them she was on her way. After seeing the doctor I called to see how she was doing on 9/29/2017 but I had to leave a message. She returned my call on 9/30/2017 and said after the physician gave her an injection (she did not know what) the area was looking and feeling much better.
Running a slight fever; Chiling; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Running a slight fever) and CHILLS (Chiling) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, the patient experienced PYREXIA (Running a slight fever) and CHILLS (Chiling). At the time of the report, PYREXIA (Running a slight fever) and CHILLS (Chiling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information was provided.
Came to ER with c/o CP,SOB and fever.H/O COVID +.No headache,LOC,seizures,abdominal pain.C/O pain and swelling AV shunt LUE.was found to have bacteremia in jail.
Two weeks to the day, high fever up to 103.5 for a week; tired slept for about a week, shaky, no appetite. Could barely function.
Shortness of breath, chest pain and faster heartbeat (experienced more than normal heartbeats in a min; 3-4 extra a min). Urgent care visit in January and referred to a cardiologist.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LISINOPRIL and METOPROLOL for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      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.