chrisvoncsefalvay/vaers-outcomes huggingface dataset:
unable to function and have to miss work or schedule appointment; Extreme body aches; Fever 100 or higher; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to function and have to miss work or schedule appointment), MYALGIA (Extreme body aches) and PYREXIA (Fever 100 or higher) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (twice).    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to function and have to miss work or schedule appointment), MYALGIA (Extreme body aches) and PYREXIA (Fever 100 or higher). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to function and have to miss work or schedule appointment), MYALGIA (Extreme body aches) and PYREXIA (Fever 100 or higher) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: Fever 100 or higher.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Patient had received dose 1-3 of Moderna monovalent vaccine. Batch numbers reported were 011M20A, 026A21A, 012F21A.  Overall health of patient was excellent. Starting about 8-10 hours after the shot, patient was sick for 1.5 - 2.0 days. Fever 100 or higher, extreme body aches (this was the worst part), unable to function and had to miss work or schedule appointment at the beginning of the weekend. So, patient was prepared to be sick. Patient had covid twice, and the recollection that having covid was not as miserable as having the shot. Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-030948 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2023: Batch number was added. Product coding was updated. On 28-Sep-2023: Additional reference number was added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-030948:Monovalent
Began with chills but no fever.  By 7:00 PM nausea, diarrhea and feeling hot but denied fever.  Never vomited but did take compazine suppository due severe nausea.  Reports feeling "fine" today 10/4/11.
Pfizer vaccine was administered outside of our facility - reported by patient  J96.00 ACUTE RESPIRATORY FAILURE 12/23/2021 HYPERLIPIDEMIA
Nurse/doctor hit blood vessel during vaccine injection. I bled afterwards but did not feel it.  Immediately that evening I began to feel symptoms of fatigue. This grew into an overall feeling of sickness and 3 days later, I had major brain fog. This then developed into high anxiety.  However after about day 6 I felt normal again. Then 20 days later, I am feeling the same symptoms again. My armpit is swollen and having brain fog and anxiety.
Syncope lasted < 30 seconds . Dt -was fine afterwards BP 100/80.
Booster shot after J& J  1/11- Felt tingling in lips 10 minutes after shot. I could smell the medicines and taste them in my mouth.  Diarrhea started at 3:00, fever soon after.   Starting on 1/11 4:30 pm, Fever and All of my joints from my jaw down to my fingertips and toes were in fire and stinging, lasting until  10:00 am on 1/12.    Severe headache throughout.  Pure exhaustion and not functioning  until 10:00 on 1/13.  Not able to eat from 1/11 1:00 pm until 1/13 1:30 pm, wicked belly pains once I?ve eaten as well.  I really thought I might die, it was horrible.
soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at injection site) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013620A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (Under Chemotherapy). Concomitant products included CYCLOPHOSPHAMIDE, DOXORUBICIN HYDROCHLORIDE, PREDNISONE, RITUXIMAB, VINCRISTINE SULFATE (R CHOP) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site). On 17-Jan-2021, VACCINATION SITE PAIN (soreness at injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Pt was screened and given Anthrax vaccine.  About 6 hours later Pt reported to the Urgent Care Clinic.  Pt had Pain in back legs and general Maliasie felling.  Pt had chills, cough and a swollen throat.  Pt was told he had Pharyngitis given Ibuprofen and sent home.
This spontaneous report was received from a pharmacist, referring to a 19 year-old (currently 22 year-old) female patient. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. Approximately on an unspecified date in 2012 (reported as "five years ago"), the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose, lot number, expiration date were not reported) intramuscularly, for prophylaxis. Approximately on an unspecified date in 2014 (reported as "three years ago"), the patient was vaccinated with the second dose of GARDASIL 9 (strength, dose, lot number, expiration date were not reported) intramuscularly, for the same indication. No adverse effects were reported.
small patch of rash around the injection site; she had a bright red kind of bumpy rash; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Previously the patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. On an unspecified date, the patient experienced small patch of rash around the injection site and she had a bright red kind of bumpy rash. It was reported that the first day after the callers second shot of the Pfizer covid 19 vaccine she had a small patch of rash around the injection site, then two days after the second shot she had a bright red kind of bumpy rash that went down to the elbow, it lasted for 11 days. She talked to her pharmacist and they said yes it was definitely the vaccine. The last time she was tested for allergies she had 3 pages with 2 columns on each page of allergies. On an unspecified date, the patient underwent lab and procedure which included Allergy Test, last time she was tested for allergies, she had 3 pages with 2 columns on each page of allergies. Outcome of the events was recovered in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a gynecologist via a company representative referring to multiple female patients of unknown age. Information regarding concomitant therapy, concurrent condition and medical history was not reported. On unknown dates, the patients were vaccinated with GARDASIL 0.5 ml injection (lot # and expiration date were not reported; 0.5ml) intramuscularly. It was reported that the patients experienced encephalitis and died (date not reported). It was unknown if autopsy was performed. The causality between encephalitis and the vaccine was unknown. Upon internal review, the event encephalitis was considered to be medically significant. Additional information has been requested.
Client states "left arm started to tingle and feel numb after the injection". She states " the injection was too low on my arm to be in the deltoid".  No redness, swelling or distress noted. Injection site post vaccination was noted to be approx. 1 1/4 hand widths from the top of the shoulder.
During the middle of the night (after immunization was given). Pt became dizzy/lightheaded and nauseous. She also developed a rash on her arm in which the pneumovax was given. The rash is on her left arm from shoulder to elbow.
Patient quit breathing at home on 06/08/19. Parents started CPR and called 911. Patient taken to hospital, arrived in asystole. Unable to be revived. Underlying medical conditions as noted above.  *Note - RotaTeq vaccine given via G-Tube*
I started experiencing diarrhea, a fever, and felt achy all over on February 18, 2023. I thought I was getting a sinus infection, I called, made an appointment with the doctor's office to have an exam. Once I was there, she felt that it may be more than just a sinus infection. She tested me for COVID-19 and Influenza A and B, the COVID-19 test came back positive the Influenza A and B came back negative. i was prescribed the antiviral Paxlovid. While on the Paxlovid, I was instructed not to take two of my medications. Within twenty-fours of taking the medication my fever was gone, by day two the diarrhea was gone. I am feeling so much better now, no lingering side effects.
Patient was accidently given the pediatric dose, instead of the adult dose for Pfizer.
Nausea, vomiting, diarrhea, abdominal cramping intermittently for nearly 2 weeks before admit to ED. Presents upon admission with acute renal failure, proteinuria, E. Coli UTI, hypocalcemia, hypoalbuminemia, elevated serum osmolality, metabolic acidosis, lymphopenia. Treated with plasmapheresis x 5 sessions + cytotoxic therapy (cyclophosphamide) + hemodialysis 5/28 and 5/29. Outcome pending, patient still receiving treatment inpatient.
Developed what I have determined as  delayed cutaneous hypersensitivity. Hardness at injection site, slight redness, and severe itching on the left arm from shoulder to elbow.
COVID infection. Specimen collected on 8/24/21 (per ED notes). Patient died on 09/13/21.
Case number PHEH2012US021203 is an initial spontaneous report received from a pharmacist on 16 Oct 2012: This case refers to a 20-years-old female patient. She was vaccinated with MENVEO vaccine (batch number: not reported), subcutaneously on 15 Oct 2012. No adverse reaction reported following this administration error.
numbness in the arm; A little bit sore; This is a spontaneous report from a contactable consumer (patient) from Pfizer sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 09May2021 as a single dose for covid-19 immunization. Medical history included covid-19 on an unknown date in 2021 to an unknown date. The patient's concomitant medications were not reported. The patient experienced numbness in the arm and a little bit sore on an unknown date in 2021. She was schedule for the second dose on 30May2021, however she requested for an earlier schedule because she had an important appointment to attend and originally it was in Apr2021, but it was cancelled because she was tested positive to covid-19, so she need to take rest. The vaccine facility was the one who administered her first dose however when she asked if she could take the 2nd dose earlier than the original schedule, she was advised to call Pfizer and ask for medical advice. The patient underwent lab tests and procedures which included sars-cov-2 test: positive in 2021. The outcome of both the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received two vaccines.  He was seated as he received the vaccines.  A couple of minutes after he started feeling dizzy.  He sat down but then got back up too soon.  He walked a few steps then passed out.  He fell backwards and hit his head on the floor.  He was bleeding from the back of his head.  He passed out for about two minutes.  He did not stop breathing.  Then he came to but was very confused.  He seemed to be in a lot of pain from his head injury.  911 was called immediately.  He was taken to the hospital.
I just had a FIT (Fecal Immune Test) test that you take every year for blood in your stool that was in the first week of October. I was notified that it came back positive for blood. I haven't gone yet to see if there's anything inside my colon. Who knows if it's related, but I have never had a positive FIT test and I've been taking them for years. Updates to come.
Patient developed covid after all 3 vaccines Moderna; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient developed covid after all 3 vaccines Moderna) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient developed covid after all 3 vaccines Moderna). At the time of the report, COVID-19 (Patient developed covid after all 3 vaccines Moderna) outcome was unknown.            No relevant concomitant medications were reported.   No treatment information was 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. Company comment: This spontaneous case concerns a patient of unspecified age and gender, with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 that occurred on an unknown date in context to third dose of mRNA-1273 vaccine. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was unknown. Ongoing pandemic remains a confounder for the event COVID-19. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.; Sender's Comments: This spontaneous case concerns a patient of unspecified age and gender, with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 that occurred on an unknown date in context to third dose of mRNA-1273 vaccine. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was unknown. Ongoing pandemic remains a confounder for the event COVID-19. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.
Resident received Pneumovax on 4/3/06 0.5cc IM injection. Area of injection became red, swollen and hard 16cm x 15cm. Resident complained of pain. Right arm/elbow. Reaction reported by nurse on 4/5/06.
Approximately 2 weeks post vax, pt experienced joint pain and numbness of the digits of the right hand more so than the left hand, numbness of the wrists and non-specific calf soreness.
Covid-19 vaccine that were given beyond the 30 day use by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date.) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 vaccination.     No Medical History information was reported.  On 14-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date.) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  A series of patients at a clinic received their second booster dose with a vial of Moderna that went past 30 days at 7-8 degree Celsius. At the time of administration it was approx. 6-10 days past the 30 day window. At the time of report, no patient contacted about any reactions.  Treatment information was not provided.   This case was linked to MOD-2022-542869 (Patient Link).
1st dose of Shingrix. developed left posterior lateral shoulder pain that persisted over 6 weeks after the vaccine and has yet to improve. no swelling occurred.
Pt waiting after vaccination. At about 30 minute mark pt reported throat itching. nurse monitored pt. Symptoms progressed to throat clearing/cough. Epinephrine administered. Benadryl administered IM. Ambulance called. While waiting for ambulance pt reported feeling tongue thickness. @nd dose of epinephrine given while awaiting ambulance. Paramedics evaluated pt and advised ER. pt refused. Advised pt to seek medical attention for any new/worsening symptoms. Advised pt not to drive home but have someone else take her home and to not be alone. pt daughter came to clinic and nurse witnessed pt enter vehicle.
Transverse myelitis, etiology unknown. Had weakness and numbness rising to mid chest level. Admitted to hospital 9/7/07.  Discharged 9/12/07.  Attending physician MD. Treated with steroids.  Almost completely resolved at present.  10/19/07 Reviewed hospital medical records which reveal patient experienced progressive ascending paresthesias & weakness of lower extremities x approx 2 wks.    Neurosurgery & neurology consults done.  Admitted 9/7-9/12/2007.  Tx w/high dose IV steroids.  Improved on titrating oral steroids to pcp & neuro f/u. FINAL DX: Transverse myelitis; type 2 DM secondary to steroids; elevated WBC due to steroids.
Patient previously received Jansen dose on 3/8/21  & shouldn't have received Pfizer
Prior to this vaccination, I had mild and manageable tinnitus. After the vaccination, it has become so bad, I can't sit in silence, read a book or focus. It is deafening and causing pain in my ears. It has woken me up in the middle of the night. It is so unbearable I started wondering if it was connected to the vaccination. I literally just looked it up. I was shocked to see it is and I'm not the only one. It's interfering with work and my daily life. I am waiting to see the specialist.
Increased menstrual cycle, had mostly stopped for every 3 months. Now is every 2 weeks and is back to where it was and worse before I was put on birth control. Includes severe menstrual pain.
Within seconds of the vax, the pt went into deep anaphylactic shock. Lost consciousness, BP dropped, turned blue-grey, breathing difficulty, remained unconscious for 10 minutes. No treatment given. Was alert within 2 hours.
45 minutes post vax, the pt began the sensation of swollen lips and periorbital edema and the sensation of difficulty breathing. Symptoms gradually diminished but still has subtle facial erythema 5 days later.
Very sore arm, shouler, elbow, radiated down to forearm and hand.  Unable to move arm.  Eventually drowsiness, dizziness which gets worse as day goes on.  Different set of aches daily.
PATIENT RECEIVED 1 SHOT OF PRIMARY MODERNA ON 12/27/21 AND THEN GOT A 2ND SHOT OF JANSSEN ON 1/4/22 WITHOUT COMPLETING THE PRIMARY MODERNA SERIES AND THEN CAME TO OUR CLINIC AND RECEIVED THE MODERNA BIVALENT. I SPOKE WITH THE PATIENT AND PATIENT SAID THE PLACE WHERE HE GOT HIS FIRST MODERNA VACCINE DID NOT HAVE THE VACCINE AVAILABLE SO HE WENT TO A PHARMACY AND GOT JANSSEN.
Information has been received from a physician concerning a 25 year old female who on 24-MAR-2008 was vaccinated intramuscularly with her first dose of GARDASIL (lot# not reported). On 24-MAR-2008 the patient experienced stomach cramps, nausea and insomnia. Subsequently, the patient recovered on 25-MAR-2008 from the stomach cramps, nausea and insomnia. The patient sought medical attention by calling the physician's office. Additional information has been requested.
Nose started dripping.  Nose started running profusely. Sore throat started. Aches started.  Took temperature that read normal. Coughing started second day.  Third day runny nose stopped. Aches stopped.  Sore throat stopped.  Cough remains with stuffy feeling on this sixth day.
Severe watering of the eyes, especially in the morning, accompanied by itchy eyes and also sneezing.
FEVER FOR THE PAST 10 DAYS.   WITH DEVELOPMENT OF FULL BODY RASH, DRY MOUTH AND THROAT.
Pain, swelling, redness, large circle @ inj site.  Taken to PCP & informed to switch from Ibuprofen to TYLENOL.
Swollen right thigh, red, warm to touch.  Hot packs, augmentin.
One week after receiving the vaccine I developed an itchy, swollen, red rash at the injection site.
pt recv vax 31OCT95 & pt devel body aches, malaise & itching @ the inj site;pt has recovered from these adverse events;