chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DIZZINESS, CHILLS, FEVER?, EXCRUCIATING EAR PAIN, NAUSEA, PAIN BILATERAL ANTERIOR LATERAL NECK, HUGE HEADACHE, WEAKNESS. SYMPTOMS STARTED 3-4 HOURS AFTER  FLU-SHOT AND LASTED TILL EVENING OF 10/09/2014. 10/10/2014 WOKE UP WITH NO SYMPTOMS OF ANY KIND!!!!
p/vax pt c/o pain to left arm w/tingling. started w/pain to shoulder @ right, redness & swelling.
This spontaneous report was received from a healthcare professional and refers to a currently 13 months old, male patient. The patient's medical history and concurrent conditions were not reported. On 28-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVXA (Merck) lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
PATIENT WAS 12 YEARS OLD AT THE TIME THE VACCINE WAS GIVEN. HE WAS GIVEN A PEDIATRIC PFIZER DOSE INSTEAD OF THE ADULT DOSE FOR HIS BOOSTER.
About 9 days after my 1st dose of Moderna vaccine, I began to have itching on my right upper arm in the area of the injection.  That continues today.  Two days after I noticed the itching, the upper arm was hot to the touch, red, and swollen.  The area is about 6" in diameter.  I did not have an elevated temperature, but I felt slightly nauseous and light-headed on March 5.    I had no reaction to the shot until a week and a half to two weeks after the injection.   I still have a red, itchy area on my right arm.  It seems to be slowly improving.
I was awakened at 03:05AM on May 16th with burning in chest that rose up through my throat.
Tingling lips - with in 5 min Tingling Tongue - with in 5 min Tongue swelling - with in 10-13 min Itching - with in 15 min Trouble breathing - with 30 min - EPI administer  Headache - with in 7 min Benadryl - 2 pills given before EPI to help but did nothing In ambulance IV Started Hospital IV bag of fluids put on board, Duliad for headache & Zofran.
Medical staff administered the vaccination and turned to put the needle in the sharps container, then patient passed out from a seated position to her knees then flat on the floor. Medical staff came to get the pharmacist on duty. We straightened her out and checked to make sure she was still breathing - she was still breathing. I went to call 911 and came back in the room with the phone while I was directed to do a breathing  test by the operator. Patient was moaning off and on during the time she was passed out. She was not responding  to verbal commands. She came to as the paramedics arrived. They took her to the hospital.
two different doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (two different doses) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (two different doses). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (two different doses) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received two different doses (one Pfizer 4 weeks) and Moderna vaccine.Safety consent for follow-up. Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
24hr p/vax pt was very fussy-about 340PM on 24JAn97 pt began to cry uncontrollably, mom said it was a high pitched scream, had jerking wouldn't stop crying-lasted for 45min;-that noc 4AM same thing happened but only lasted 20min;
Information has been received on 02-JAN-2018 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 19-FEB-2016, a healthcare provider at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 17-JUN-2016, the patient was treated by a physician at the physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
shook x 15 seconds, vomited, stooled then fell sleep x 3hr;MD not notified until next day (office took message) talked extensively w/family on phone;
PT REPORTS DIZZINESS CLAIMS DID NOT EAT. LATER CRACKER AND WATER WAS GIVEN REPORTED FINE.
lightheadness, tingling-warm, anxious, observation, water offered, symptoms resolved.
Injection site soreness, fever 101F, chills/rigors, severe nausea
My left arm is in excruciating pain I cannot use nor could I sleep first night. Arm is almost dead in some ways. I cannot life past my mouth as cannot even extend very well.  Severe pain, aching also pain down shoulder into right hand. I have tried icing, heat, applied Cold spray. It is slightly painful 2 days later but still lots of pain. I cannot use arm to do chores. Even brushing teeth was hard. Arm was fine till 10 hours later then became worse and worse. Plus have little strength in arm. I cannot use arm to dry myself after shower.  Arm continues to be painful, aspirin does nothing to alleviate pain.  I regret getting vaccine and have doubts to complete series as I heard second shot worse.  I have not sought treatment yet but may go see my PCP this week.
Tongue felt numb.  It felt full or swollen but did not look excessively swollen.   It occurred after twenty minutes after vaccination.  Returned to site and nurse asked me to move tongue left to right which I was able to do.  Went to ER and given prednisone and benhydral and Prilosec.  Left ER with rx for listed meds.  Only took benhydril so far and Prilosec.  After two days half the tongue the vertical middle feels normal and other half slowly feeling normal.  Tongue also felt itchie over weekend.  Also. Skin felt pinchie in ER and at home for a short time
This is a spontaneous report from a contactable physician. A 16-year-old male adolescent patient of an unspecified ethnicity received TRUMENBA via an unspecified route of administration, on an unspecified date, single dose for immunization. Relevant medical history and concomitant medications were not reported. On an unknown date, the patient experienced arm soreness and nausea. It was reported that the patient experienced similar side effects with other non-elated vaccines. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
first shot i woke up 7 days later to rash and itchy at site and very Hard...this SECOND shot i got i woke up next day with swollen arm and pain..took benedryl and icepack..will watch it and tell my family doctor.  thank you...i did NOT get sick..
In September 2022 I noticed I was having pain in right ear. I went to the doctor and received some medication to help the symptoms. However, the problem persisted. One day in mid-December, I woke up and I was in severe pain in my jaw and my ear. I visited with a doctor again and received pain relievers and was told to take SUDAFED. The pain in my ear is a constant ache and my ear feels full. My right lower jaw swelled a little bit near my ear with constant pain like a toothache. The pain will resolve itself and return and as of today I have a slight pain in my ear.
inflammation of vaccination site and under her arm; Headache; Inflammation under her arm projecting to breast; body aches (all over her body); acute pain in the arm where shot was administered; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INFLAMMATION (Inflammation under her arm projecting to breast), MYALGIA (body aches (all over her body)), VACCINATION SITE PAIN (acute pain in the arm where shot was administered), VACCINATION SITE INFLAMMATION (inflammation of vaccination site and under her arm) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced INFLAMMATION (Inflammation under her arm projecting to breast), MYALGIA (body aches (all over her body)), VACCINATION SITE PAIN (acute pain in the arm where shot was administered) and HEADACHE (Headache). On an unknown date, the patient experienced VACCINATION SITE INFLAMMATION (inflammation of vaccination site and under her arm). At the time of the report, INFLAMMATION (Inflammation under her arm projecting to breast), MYALGIA (body aches (all over her body)), VACCINATION SITE PAIN (acute pain in the arm where shot was administered), VACCINATION SITE INFLAMMATION (inflammation of vaccination site and under her arm) and HEADACHE (Headache) outcome was unknown.            No concomitant medication was reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Follow up received included no new information. On 04-Nov-2021: Follow up was received and included no new information.
Swollen, puffy and very warm at site  of injection. Very itchy.  About 6 inch diameter affected.
On the next day of the second shot of vaccination, a swollen spot appeared about a half inch from the injected spot. The swollen part was prominent and slightly pink. It was painful. The swollen part was about 1.25 inch in diameter in the afternoon, and 1.5 in the evening. The next day (today and the 2 days from the inoculation), the swollen part was not so prominent anymore, but it was spread out to 2 inches in diameter. And it had become itchier. I didn't have this kind of adverse reaction when and after I got my first shot on May 22nd.
Chest pain focused in the middle of chest, sharp and feels like increased pressure. Pain comes and goes; best way to describe it is severe heartburn; This is a spontaneous report from a non-contactable Pharmacist. A 28-years-old male patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number EN6200), via an unspecified route of administration on 22Feb2021 at 09:30 AM (at the age of 28-years-old) administered in Arm Left as a single dose for COVID-19 immunisation at Public Health Clinic/Veterans Administration facility. The patient had received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number EN5318), via an unspecified route of administration on 01Feb2021 at 08:00 AM (at the age of 28-years-old) administered in Arm Left as a single dose for COVID-19 immunisation at Public Health Clinic/Veterans Administration facility. Medical history included ADHD, seasonal depression (all from an unknown date and unknown if ongoing). Concomitant medication(s) included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); caffeine; bupropion; colecalciferol (VITAMIN D) (all taken for an unspecified indication, start and stop date were not reported). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 22Feb2021 at 18:00PM, the patient experienced Chest pain focused in the middle of chest, sharp and feels like increased pressure. Pain comes and goes, best way to describe it is severe heartburn (although never had heartburn prior to this). Therapeutic measures were taken as a result of chest pain focused in the middle of chest, sharp and feels like increased pressure. pain comes and goes (chest pain), best way to describe it is severe heartburn (dyspepsia) and Took tums with no improvement. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
muscular pain in my arm/muscular pain in my shoulder; Pain/still hurts; limited use of my right arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of myalgia upper extremities in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced myalgia upper extremities (Verbatim: muscular pain in my arm/muscular pain in my shoulder), pain (Verbatim: Pain/still hurts) and mobility decreased (Verbatim: limited use of my right arm). The outcome of the myalgia upper extremities, pain and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the myalgia upper extremities, pain and mobility decreased to be related to Shingles vaccine.     It was unknown if the company considered the myalgia upper extremities, pain and mobility decreased to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-Mar-2023 The case was received from the patient via interactive digital media. The patient stated that unfortunately got the shot side effect of muscular pain in his or her arm and shoulder.  3 months and still hurts. The patient hoped that the pain and limited use of his or her right arm from the vaccine 6 months ago did not stay with him or her for life. The patient really wish he or she had not got the shot. No second shot for the patient. The follow-up could not be possible as no contact details were available.
Injection site is a little red, lower down on the arm, there is a circle on her right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site is a little red, lower down on the arm, there is a circle on her right arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site is a little red, lower down on the arm, there is a circle on her right arm). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site is a little red, lower down on the arm, there is a circle on her right arm) outcome was unknown. Not Provided          Concomitant medications were not provided. Treatment information was not reported.    This case was linked to MOD-2021-029193 (Patient Link).
Patient stated that about 2 hours after the shot she started to feel pain in her arm where she got the shot. Later she stated that for 3 days her left arm felt paralyzed and that she couldn't lift her arm to even wash her hair. I asked if she at all contacted her primary care and she said no. Patient came in today and said that she was much better and she showed me that she could lift her arm fine now.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 13-AUG-2015, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB (lot # K025006; expiration date 22-JUL-2017) dose and route of administration were not reported. Concomitant therapy was not reported. No adverse events have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
AFTER VACCINATION DEVELOPED LEFT UPPER ARM SORENESS, REDNESS, SWELLING. NO FEVER CHILLS NAUSEA VOMITING.
Developed Left sternal chest pain with radiation to L upper arm with numbness and tingling of 3 fingers on left hand (Vaccine was administered in Right arm). Presented to ER, EKG showed inferior lead changes suggestive of ischemia.  Was admitted overnight onto telemetry floor, no adverse s/s noted.  Labs normal.  CXR normal.  Discharged next day, 1/23/21, with recommendation for cardiology follow up.  Stress test, echo, and potentially cardiac MRI recommended, awaiting scheduling.  Cardiology follow up scheduled Mon, 2/1/21.
2-month-old patient that was given FLUZONE QUADRIVALENT NP, with no reported adverse event; Initial information received on 17-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old female patient who was given influenza quadrival a-b vaccine [Fluzone Quadrivalent], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis b vaccine; diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (Pentacel); pneumococcal vaccine conj 13v (crm197) (Prevenar 13); and rotavirus vaccine for immunization.  On 17-Nov-2022, the patient received a dose of 0.5 ml once of suspect influenza quadrival a-b vaccine Suspension for injection standard (lot UT7759KA, expiry date- 30-JUN-2023) via intramuscular route in the left vastus lateralis for Immunization, with no reported adverse event (product administered to patient of inappropriate age) (latency same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the guidelines. 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 throat/earache, diagnosed as a lymphatic reaction to the vaccine.  9 week pregnant at the time.
T103 3NOV Pm rt leg inflamed & swollen 4NOV Am erythema from shot site medial to knee & around knee sl edema of erythema side, not hot, ibuprofen;PDH;
PERIPHERAL NEUROPATHY 2/28/2023 GANGRENE OF LEFT TOE PERIPHERAL NEUROPATHY 2/28/2023 GANGRENE OF LEFT FOOT
Started to developed hives on upper body 1-3 hours after shot. Took Benadryl and resolved within 48 hours of onset.
Suspected Vaccination Failure; I've had shingles, got the vaccine, then got shingles AGAIN; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for himself/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Brain damage; Crohn's disease relapse; Stress; Lyme disease; This spontaneous case was reported by a consumer and describes the occurrence of BRAIN INJURY (Brain damage), LYME DISEASE (Lyme disease) and CROHN'S DISEASE (Crohn's disease relapse) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced LYME DISEASE (Lyme disease) (seriousness criterion medically significant). On an unknown date, the patient experienced BRAIN INJURY (Brain damage) (seriousness criterion medically significant), CROHN'S DISEASE (Crohn's disease relapse) (seriousness criterion medically significant) and STRESS (Stress). At the time of the report, BRAIN INJURY (Brain damage) and STRESS (Stress) outcome was unknown and LYME DISEASE (Lyme disease) and CROHN'S DISEASE (Crohn's disease relapse) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.  Patient had TICK BITE FROM A DOG   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 27-year-old male patient, with no reported medical history, who experienced the unexpected serious (medically significant) events of Brain injury, Lyme disease, and Crohn's disease after receiving the 1st dose of mRNA-1273 vaccine on an unknown date. Patient experienced Crohn's flare after vaccination. Clinical course and treatment details were not reported. It was reported that patient got tick bite from dog. On unknown date, patient received Adalimumab (unknown indication) which could be considered as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 27-year-old male patient, with no reported medical history, who experienced the unexpected serious (medically significant) events of Brain injury, Lyme disease, and Crohn's disease after receiving the 1st dose of mRNA-1273 vaccine on an unknown date. Patient experienced Crohn's flare  after vaccination. Clinical course and treatment details were not reported. It was reported that patient got tick bite from dog. On unknown date, patient received Adalimumab (unknown indication) which could be considered as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.