chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age and gender. No information about medical history, concurrent conditions or concomitant therapy was reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # L028277, expiry date 28-JUL-2017 (dose and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was filed. This is one of several cases received from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 10-JUN-2015, the patient was vaccinated with a dose of improperly stored MMR II, lot number K015374, expiration date 18-SEP-2016 (dose and route were not reported). No adverse symptoms reported. This is one of several reports from the same source. Additional information has been requested.
After initial expected soreness, pt. developed a small lump which got hard and as big as a 50 cents piece. This slowly resolved over 5 weeks, but thereafter she had soreness in her upper arm and shoulder with pain on abdomen and internal rotation. She feels she developed muscles weakness from this injection. It is now gradually improving.
This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT INCREASED (white blood cell count went up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WHITE BLOOD CELL COUNT INCREASED (white blood cell count went up). At the time of the report, WHITE BLOOD CELL COUNT INCREASED (white blood cell count went up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: (High) went up.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided . No treatment details were provided .
3/25/2021: 1:00 AM - 99.9F temp, dizziness, nausea but no vomiting, low pitched humming in ears (not high pitched), achiness throughout body rain scale 4 out of 10. 2:00 AM: increase in temp to 100.3, took 1000mg Tylenol. Went down to 99.9F an hour later and was able to sleep because decreased pain. Throughout 3/25 : No more humming after 6:00AM, continued dizziness, nausea, achiness throughout day with the highest temperature being 100.6F two hours after taking another dose of 1000mg Tylenol around 2:00PM. 4:00 PM no more symptoms. Temp about 99.9 F. 3/26 - diarrhea occurrence x2.
Had a little cough; Fever ranges from 101 to 103 degrees F; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Had a little cough) and PYREXIA (Fever ranges from 101 to 103 degrees F) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TRAZODONE for an unknown indication.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced COUGH (Had a little cough) and PYREXIA (Fever ranges from 101 to 103 degrees F). At the time of the report, COUGH (Had a little cough) and PYREXIA (Fever ranges from 101 to 103 degrees F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, Body temperature: 101 to 103 degrees f (High) Fever ranges from 101 to 103 degrees F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was  reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Follow-up information contain correction of spelling in patient first name.
Bilateral tinnitus that began 13 hours after first dose.  Alleviated a small amount by 3 weeks.  Received second dose and symptoms came back and are significant and uncomfortable.
I started sneezing alot and I had a deep cough and felt tired. I did a home test that night and I am a nurse so i was nervous about going to work, so i did a home test and it was positive. The next day 06/16/2022 I made an appointment to get a PCR and i wanted to see if they could give my paxlivid and i am also dealing with breast cancer. And i went to the doctor and he put me on the paxlivid. After the shot the arm was red, swollen and really hot.
Right arm red and swollen around injection site. Patient was Rx-KEFLEX and Prednisone.
Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022; Patient received vaccine past its 30 day expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 day expiry date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022 at 1:49 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022 at 1:49 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 day expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 day expiry date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient's ethnicity was reported as white.  No concomitant medication was reported.  On 02-Apr-2022, the patient received the second booster dose of the vaccine.  No treatment information was reported.
RED HOT SWOLLEN AREA AROUND INJECTION SITE FOR 8 DAYS NOW.  ROCK HARD AND SWOLLEN THE SIZE OF MY PALM AND FINGERS. TERRIBLE PAIN.   I DID GO TO MY PRIMARY DR.  HE IS CONCERNED.
Information has been received from a physician concerning an infant who was vaccinated with the third dose (completed series) of Rotateq after the age of 12 months.  No symptoms were reported.  There was no product quality complaint.  Additional information has been requested.  This is one of several reports from the same source. This is in follow-up to report(s) previously submitted on 4/14/2009.   Follow-up information from the reporting administering physician indicated that the 11 month old female with no pre-existing medical conditions or allergies who on 04-FEB-2008 at 11:00 was vaccinated PO with her first dose of ROTATEQ (lot# 657665/1460U).  There was no illness at the time of vaccination.  Concomitant vaccinations administered on that same day at 11:00 included the third IM dose of DAPTACEL (lot# C2797AA).  No adverse event was noted.  No medical attention was sought.  On 28-APR-2008 the baby was seen by the physician with no history of side effects.  Additional information has been requested.  This is one of several reports from the same source.
11/15/09 - FLUMIST, developed flu-like symptoms, not feeling well. Mild headache. No improvement despite Z-PAK. HA associated with photo- and phono-phobia. Given prednisone. Now developing tenderness and hyperesthesia of the frontal, parietal occipital scalp. 3 doctors have all diagnosed me with nerve damage due to FLUMIST.
FLARE-UP COPD; A spontaneous report was received from a Consumer concerning a 61 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced flare-up COPD (chronic obstructive pulmonary disease).  The patient's medical history included COPD. No relevant concomitant medications were reported.     On 03 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the  for prophylaxis of COVID-19 infection.   On 03 Feb 2021, the patient's COPD flared up. The event was treated with levofloxacin 750 mg and prednisone.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event flare-up COPD is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of Flare-up COPD, a causal relationship cannot be excluded.  However, patient's underlying COPD is considered a confounder.
This spontaneous report as received from a physician refers to a female patient of unknown age with no drug reactions or allergies. The patient's medical history included uveitis. The patient was vaccinated intramuscularly with two doses of RECOMBIVAX HB (dose and lot number not reported) at the same time in different arms on 14-DEC-2012. No other co-suspects were reported. There were no concomitant medications. It was reported that on approximately 15-DEC-2012 (reported as "over the weekend") both sides of the patient's neck hurt and there was soreness behind both ears. The patient sought medical attention via phone. There was no treatment given for AE. No lab diagnostic studies were performed. The patient was concerned that the uveitis might return so she visited another unspecified physician who said that her uveitis did not return. At the time of the report the patient still had soreness behind both ears. The outcome of neck hurt was unknown. The relatedness for the events was unknown for RECOMBIVAX HB. Additional information has been requested.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Jun2022 as dose 4 (booster), single (Lot number: FP7135) at the age of 40 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (boster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). It was reported that the patient had no known allergies. Concomitant medication(s) included: DAYQUIL, start date: 25Jul2022, stop date: 27Jul2022; MUCINEX DM, start date: 27Jul2022, stop date: 29Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of covid-19. The COVID 19 Treatment received with Paxlovid with start date given as 28Jul2022 and stop date given as 30Jul2022.
G40.909 EPILEPSY, UNSPECIFIED 3/27/2023 SEIZURE, UNSPECIFIED G40.909 EPILEPSY, UNSPECIFIED 3/27/2023 ADVERSE EFFECT OF CANNABIS, SUBSEQ
Abdominal pain in the upper right quadrant; Fever; Chills; This spontaneous case was reported by a health care professional and describes the occurrence of ABDOMINAL PAIN UPPER (Abdominal pain in the upper right quadrant), PYREXIA (Fever) and CHILLS (Chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included GERD.    On 07-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Abdominal pain in the upper right quadrant). At the time of the report, ABDOMINAL PAIN UPPER (Abdominal pain in the upper right quadrant), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Body temperature: 101.5 f High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant Concomitant medications were reported. Treatment details included Tylenol and Pepcid AC.
He has felt ill with muscle aches/feeling lousy with muscle aches; Flu-like symptoms; Nausea; Weakness; Dizziness; Fatigue; he is pretty sick; Feeling lousy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 14Oct2021 (Lot number: FH8020) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Heart Disease", start date: 2002 (ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Lot Number: EL3249), administration date: 15Feb2021, when the patient was 69 years old, for COVID-19 immunization; Bnt162b2 (Second dose, Lot Number: EN9581), administration date: 09Mar2021, when the patient was 69 years old, for COVID-19 immunization, reaction(s): "Thought he had just caught a bug"; Flu vaccine, administration date: 2021. The following information was reported: MYALGIA (non-serious) with onset Oct2021, outcome "not recovered", described as "He has felt ill with muscle aches/feeling lousy with muscle aches"; INFLUENZA LIKE ILLNESS (non-serious) with onset Oct2021, outcome "not recovered", described as "Flu-like symptoms"; NAUSEA (non-serious) with onset Oct2021, outcome "not recovered", described as "Nausea"; ASTHENIA (non-serious) with onset Oct2021, outcome "not recovered", described as "Weakness"; DIZZINESS (non-serious) with onset Oct2021, outcome "not recovered", described as "Dizziness"; FATIGUE (non-serious) with onset Oct2021, outcome "not recovered", described as "Fatigue"; ILLNESS (non-serious) with onset Oct2021, outcome "not recovered", described as "he is pretty sick"; FEELING ABNORMAL (non-serious) with onset Oct2021, outcome "not recovered", described as "Feeling lousy". The events "he has felt ill with muscle aches/feeling lousy with muscle aches", "flu-like symptoms", "nausea", "weakness", "dizziness", "fatigue", "he is pretty sick" and "feeling lousy" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.   Additional information:  Caller stated States he is not sure what to think. He just got the booster on 14Oct2021 and the same thing that happened with his second dose of the vaccine happened again. States when he first got the third vaccine, he was fine the first couple of days. That Sunday he felt ill. Since then, he has been feeling lousy with muscle aches, flu, and nausea.  States this has been ongoing since then. Confirmed that some of the patient's similar symptoms were reported such as fatigue and muscle aches.   No follow-up attempts are possible. No further information is expected.
Right shoulder pain at site of injection, right side of face has some pain, discomfort, up to ear level. Some discomfort in upper lip under nostril, right side only.  Right arm pain has been since time of injection on 12/29/2020.  Right face pain began today, 12/31/2020 at approximately 7:30am, and has been continuing.
No adverse effects reported; during the administration, the needle disengaged from the needle hub of the plastic syringe and a large amount of the vaccine ended up on the tablet; during the administration, the needle disengaged from the needle hub of the plastic syringe and a large amount of the vaccine ended up on the tablet; This spontaneous report was received from a medical assistant referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.    On 19-JUL-2019, the patient would had been vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # S008151 (verified to be a valid lot number), expiration date reported and established as 20-NOV-2021, for prophylaxis; however, during the administration, the needle disengaged from the needle hub of the plastic syringe (needle issue) and a large amount of the vaccine was lost ending up on the table and the vaccine was not administered to the patient. The medical assistant had already shut down her computer and no adverse effects were reported.  At the reporting time, the outcome of needle issue was unknown. The causality assessment was not provided.
At approximately 5:20pm on 5/10/21 I started having jumbled speech. I would be speaking clearly and then random words would take the place of the words I was trying to say. I was unable to use the correct words my brain was telling myself to say. Then I started experiencing tingling sensation throughout my right arm. Believing that I could be having a stroke my wife rushed me to the emergency room at hospital. En route to the ER, my left arm began to have tingling sensation in it as well. Once at the ER I began hyperventilating. I was in the ER for approximately 4-5 hours, for 3 of those hours I had difficulty communicating and could not speak clearly. I was told I may have been having a complex migraine and was discharged and referred to a neurologist. I met with the neurologist and given that I have no history of headaches or migraines, they concluded that it most likely was not a complex migraine and discussed the possibility of an immune response. It has now been a week since my ER visit, since then I have been getting extremely fatigued every afternoon and my head feels spacey.
not feeling well; achiness; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well) and PAIN (achiness) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced MALAISE (not feeling well) and PAIN (achiness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (not feeling well) and PAIN (achiness) outcome was unknown.        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.   Concomitant medication includes blood pressure medications
This spontaneous case reported by a consumer, describes the occurrence of diarrhea, illness (sick), product dose omission issue (did not receive 2nd dose between days 25 and 35/unable to get 2nd dose) and pyrexia (low-grade fever) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 022M20A) for COVID-19 immunization. No medical history reported. On Feb 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 3, 2021, patient had diarrhea and pyrexia (low-grade fever). On an unknown date, patient experienced illness (sick) and product dose omission issue (did not receive 2nd dose between days 25 and 35/unable to get 2nd dose). At the time of the report, diarrhea, illness (sick) and pyrexia (low-grade fever) outcome: unknown; and product dose omission issue (did not receive 2nd dose between days 25 and 35/unable to get 2nd dose) resolved.The action taken with mRNA-1273 (Moderna COVID-19  vaccine), intramuscular: unknown. Treatment included ibuprofen for low-grade fever.
Bad nausea; headache; fever; muscle aches; fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 25-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in right arm on 15Feb2021 (Lot number was not reported, at the age of 24-year-old) as dose 2, single for COVID-19 immunization. Medical history included asthma, allergies: Pork, bananas, mold, dust and COVID-19. Concomitant medication included other medications in two weeks. The patient previously received the first dose of bnt162b2 administered in right arm on 25Jan2021 (at the age of 24-year-old) as single dose for COVID-19 immunization. No other vaccine in four weeks. On 16Feb2021 at 03:00AM, the patient experienced bad nausea, headache, fever, muscle aches, fatigue. The patient received no treatment for the events. The patient recovered from the events on unspecified date.    No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.
9 days after vaccine, patient received "covid arm" -- red, warm, swollen 2-4 inch diameter around injection site on left deltoid. not painful, but swollen and warm to the touch.  patient was told to use warm/cold compress as needed for pain/swelling- take benadryl + antihistamine and contact physician if any further adverse effects occur from the vaccine.
sz occurred @ home approx 18hr p/vax;pt was seen in ER & followed up in the clinic;
The day of the vaccine patient started feeling tired, and weak with arm pain .  As the days went by the patient started deteriorating and was feeling more tired and and weak and abdominal pain  4 days later patient decided to go to urgent care (March 4,2021)  Patient was declined because he had Covid symptoms  such as chills and fever. Patient instead got Covid tested, results came back negative. Abdominal pain that patient had was getting worse  and fever and chills had not improved. On Monday March 8,2021 patient was admitted into hospital and underwent 2 surgeries. He also had 6-8 inches of his colon cut and was left with and Ostomy bag and will be needing a 3rd surgery in June. patient was released from the hospital Wednesday 24th, 2021
Sick for 24 hs; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (Sick for 24 hs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced ILLNESS (Sick for 24 hs). At the time of the report, ILLNESS (Sick for 24 hs) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Upon in internal review on 21 May 2021, the age was corrected to unknown age. No relevant concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up was received on 06-JUL-2021: Contain No new information.