chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tingling sensation on her left knee down and her left elbow down/tingling on her right side; a little bit of tiredness; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling sensation on her left knee down and her left elbow down/tingling on her right side), VACCINATION SITE PAIN (sore arm) and FATIGUE (a little bit of tiredness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 29-Sep-2021, the patient experienced FATIGUE (a little bit of tiredness). On 06-Oct-2021, the patient experienced PARAESTHESIA (tingling sensation on her left knee down and her left elbow down/tingling on her right side). On 08-Oct-2021, PARAESTHESIA (tingling sensation on her left knee down and her left elbow down/tingling on her right side) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm) and FATIGUE (a little bit of tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) patient was told that she was perfect..     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 was not provided. Treatment information was not provided.
Advised has contracted rotavirus by urgent care clinic. Stomach pain, lethargy, painful crying, diarreah, and vomiting.
This spontaneous report was received from a physician via a Company representative concerning to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On 24-MAR-2016, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB lot # K020336, the expiration date: 17-AUG-2017 (dose and route were not reported). The total cumulative hours out of range were 360 hours with 34C and 168 hours with 33 C as the lowest recorded temperature and the storage type was a refrigerator. There was no concomitant medication provided nor no Product Quality Complaint(PQC) involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Generalized Tonic-Clonic Seizure; feeling unwell; slightly nauseous; still a little slow in speech and gait; still a little slow in speech and gait; This is a spontaneous report from a contactable consumer (patient).  A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via an unspecified route of administration, administered in arm right on 05Mar2021 08:00 as a single dose (at the age of 28-years-old) for Covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included epilepsy, hypopituitarism, central diabetes insipidus, neoplasm of brain, irregular menses, short-term memory loss, elevated LDL, and myopia w/ astigmatism. The patient had known allergies to surgical tape and contrast dyes. Concomitant medications included desmopressin acetate (DDAVP), lamotrigine (LAMICTAL), levetiracetam, and zonisamide; all were taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and experienced drug allergy. On 08Mar2021 at 06:15 PM, the patient experienced generalized tonic-clonic seizure, feeling unwell, slightly nauseous, still a little slow in speech and gait. Therapeutic measures were taken as a result of generalized tonic-clonic seizure, feeling unwell, slightly nauseous, still a little slow in speech and gait as Nayzilam 5 mg two doses was administered. Clinical course details as reported: the patient finished dinner and evening medications before 6 pm and started feeling unwell and slightly nauseous soon after. Laid on sofa, started to sit up at 6:20 pm, and went into a Generalized Tonic-Clonic Seizure. The patient's father administered Nayzilam 5 mg (2 doses); seizure ended and the patient went into a deep sleep until 8:00 pm. The patient was largely recovered, but still a little slow in speech and gait. The outcome of the events was recovering as reported.  Information on the lot/batch number has been requested.
This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "could not lift or rotate her arm."; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "could not lift or rotate her arm". Additional information: No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. Below is the verbatim report. Caller wanted to know if she has the correct information about getting a refund for her husband who is taking Latanaprost. The eye drops never worked, no solution came out of the bottle, relayed information from withheld and she did have the correct info. As we were talking she said when she got her 1st dose of the Pfizer Covax vaccine she could not lift or rotate her arm. It still has not gone away. When she went to get her 2nd dose the HCP told her she was the 5th person to complain about this. He told her the first dose was given in the wrong part of her arm. She is now waiting to have surgery on her arm. She said she is an RN and this has affected her job as well.  Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101619553
This non-serious spontaneous case, was initially received on 14-Aug-2017 from physician, concerning a 04-year-old child, male patient. Physician reports 10 patients who were vaccinated after multiple temperature excursions. This report was fourth of 10 reports. On 22-Mar-2017, the patient was administered with FLUCELVAX QIV (batch number: 185686 (reported as 185586 and lot number reported as 186686), expiry date: 31-May-2017, dose, route of administration, anatomical location: not reported). Multiple temperature excursions were occurred on 02-Mar-2017, vaccine was stored at 47F for 14.7h (1st excursion), 03-Mar-2017, vaccine was stored at 47F for 16h (2nd excursion) and 04-Mar-2017, vaccine was stored at 47F for 19.75h (3rd excursion) which was considered as incorrect product storage. The patient was administered with vaccine which was stored at 46F to 77F up to 24 hours instead of storing at 36-46F which was considered as drug administration error. The outcome of the event was not reported. Non-Significant case correction received on 05-Sep-2017: Description as reported for the event drug administration error was changed from vaccine was administered to vaccine was administered after the excursion occurred. Non-significant case correction received with IRD: 14-Aug-2017 Batch number (185686) was captured in the case form and narrative was amended accordingly.
Woke up with coughing and wheezing; bronchial asthma attack, lots of congestion.  Zostavax vaccine could have triggered the attack, which I haven't had one in over a year.
local reaction to L upper arm, swollen, hot/warm to touch, reddened, swelling approx 7x6 cm in diameter.  Swelling extends from shoulder to mid upper arm.  Does not circumvent the arm.
This is second of three reports from the same reporter. This is a spontaneous report from a contactable physician through  a Pfizer sales representative. A four-year-old male patient was administered a dose of PREVNAR13 by injection on the thigh on an unknown date. Five unspecified vaccines were administered on the same date. Relevant medical history was unknown. Relevant concomitant medications were unknown. Vaccines taken within the last four weeks were unknown. On an unknown date, after administration of PREVNAR13 on the thigh, the patient experienced swelling, pain and itchiness on the thigh. Relevant lab data was unknown. At the time of report the clinical outcome of the events was unknown.
Information has been received from a physician concerning a 7 year old male who on 01/18/96 was vaccinated with the second dose of Varivax (site unknown). On 02/11/02, the patient developed a chicken pox rash all over his body (about 50 spots), and was afebrile. It was reported on 02/11/02 that the child was "exposed to chicken pox 6 weeks ago. The patient sought unspecified medical attention. Additional information has been requested.
She had WCC and received Hepatitis A vaccine. A couple hrs later, she has apparent seizure.
When she got the first dose it hurt a little, but didn't hardly feel anything.; This is a spontaneous report from a contactable consumer (patient).  A 90-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot: Either EX3246 or EL3246) via an unspecified route of administration left arm, at the age of 90-year-old, on 07Jan2021 around 13:30-14:00, single dose, for covid-19 immunisation.  Medical history included glaucoma and drip down her nose and sinus.  The patient's concomitant medications were not reported. In Jan2021, when she got the first dose, it hurt a little but didn't hardly feel anything. Outcome of the event was unknown.
Breakthrough case of Covid 05/17/2022 05/11/2022 - scratchy throat, went away very quickly 05/12/2022 ? home test - negative 05/13/2022 ? head congestion, I thought it was allergies 05/14/2022 ? head congestion, I did not feel great, did not do much 05/15/2022 ? still some congestion, I did not feel badly, I worked outside all day, I felt like I had allergies 05/16/2022 ? the same as Sunday, still congested, sneezing a lot. Monday night I became completely closed off, I was not able to breathe through my nose, it was a very rough night, I could not breathe, and I was coughing. 05/17/2022 ? still not well, took home Covid test and it was positive. I called my doctor, I went to a pharmacy minute clinic a test and treatment facility, and they prescribed Paxlovid. I took my first does Tuesday.  I am currently less congested, I do not feel horrible, I have a headache, I feel like I have a sinus infection. Coughing and sneezing, it just feels like bad allergies. I am taking it easy, like I was advised.
This spontaneous report was received from a registered nurse regarding a currently 8 year old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. It was reported that the patient who, received the VARIVAX (Merck) dose 1 on 23-DEC-2008 (reported as 23-DEC-2018), dose 2 on 20-DEC-2011 and M-M-R II dose 1 on 02-OCT-2008 and dose 2 on 20-DEC-2011. Concomitant medications were not reported. On an unknown date the patient developed unspecified cancer. On an unknown date the patient was hospitalized. The patient sought the medical attention. Nurse reported that on an unknown date, 6 months ago approximately in November 2015, the patient received hematopoietic cell transplant as a treatment. The outcome of the event was unknown. Causality assessment was not provided. The reporter considered the event cancer to be life threatening and disabling. Upon internal review the event cancer was determined to be medically significant. Additional information has been requested.
Loss of appetite; Dizzy in the morning; Fatigue; Headache; Muscle ache; Waves of nausea; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), DIZZINESS (Dizzy in the morning), FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (Muscle ache) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer in 2017 and COVID-19 in January 2021. Concomitant products included APIXABAN (ELIQUIS), LETROZOLE, CARVEDILOL, ATORVASTATIN, FAMOTIDINE, VITAMIN C [ASCORBIC ACID] and ZINC for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced DECREASED APPETITE (Loss of appetite), DIZZINESS (Dizzy in the morning), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle ache) and NAUSEA (Waves of nausea). At the time of the report, DECREASED APPETITE (Loss of appetite), DIZZINESS (Dizzy in the morning), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle ache) and NAUSEA (Waves of nausea) outcome was unknown.            Treatment for the event, headache included extra strength paracetamol as needed. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-060702, US-MODERNATX, INC.-MOD-2021-035381 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060702:crosslinked US-MODERNATX, INC.-MOD-2021-035381:crosslinked
I had a high fever for 2 days, at times going up to 103.5 degrees Fahrenheit and after takingTylenol and using ice packs on the back if my neck and forehead and underarms, was able to come down to between 101 and 102 on Monday and Tuesday. After those initial days, my temperature ranged between 100 degrees Fahrenheit and 102 degrees Fahrenheit for another 3 days. After receiving the vaccine on a Sunday, I was finally close to my normal temperature by the following Saturday.  I normally run about 97.6 degrees Fahrenheit.
pt received a moderna 3rd shot booster instead of a pfizer booster shot. patient is complaining that his arm is a lot more sore than the pfizer shot - a constant pain that increases in intensity with movement
Feels like he has the covid virus; Dizziness; Headache; Muscle ache; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (Feels like he has the covid virus), DIZZINESS (Dizziness), HEADACHE (Headache), MYALGIA (Muscle ache) and CHILLS (Chills) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced SUSPECTED COVID-19 (Feels like he has the covid virus), DIZZINESS (Dizziness), HEADACHE (Headache), MYALGIA (Muscle ache), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, SUSPECTED COVID-19 (Feels like he has the covid virus), DIZZINESS (Dizziness), HEADACHE (Headache), MYALGIA (Muscle ache), CHILLS (Chills) and NAUSEA (Nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient did not receive any treatment medications.
Pt had #1 Covid immunization Friday evening. Saturday Am noticed dorsum of R hand only swollen. Some pain, not much. He did not notice any erythema but did feel it was warm compared to L hand similar area  He put ice on it  It did not improve.  He presents on day 4 after the immunization.  Dorsal aspect R hand is warm, erythematous, with mild but obvious swelling. no itching.  very little pain.  Pt has afib on warfarin He does not think pressure was held at the site for 2 min as is recommended. There was no sign of ecchymosis or subcutaneous bleeding.  The rest of his R arm appeared + palpated normally.  The arm is thin but the deltoid muscle was obvious. He was treated with cephaliexin 400 mg tid po x 5 days   He was advised to check INR (he does at home) every other day or more often if concerned + to call if INR >3 or out of range. Patient verbalized understanding.
9:00 AM  Patient appeared nervous about receiving first Hep B vaccination. Because patient was so nervous, he was asked to remain seated for 15 minutes following the vaccination.   Patient reported feeling weak with "funny vision" approximately 10 minutes after injection. Skin was dry with normal coloration.  A few minutes later, patient c/o itching on arms.  Again, skin color was normal without any rash noted.  Patient was given fluids to drink and remained seated for approximately 20 minutes.  Stated that he felt better and returned to work.   Today, patient reported that he developed hives later that afternoon and went to his local clinic.  Was treated with Prednisone and Allegra.  Returned to family MD a "few days later" when hives re-developed and treated for another 3 days with prednisone.  Continued on Allegra.  States hives went away, but continued to feel "itchy", so went to Dematologist who "would not say it was, or it was not" related to the Hep B shot.  Currently is being treated with "creams" for his skin condition which he claims is helping.
(R) upper deltoid with redness, swelling and hot 10mm x 8mm wide.
Chest pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 63-year-old male patient received BNT162b2 (BNT162B2), on 13Jul2021 as dose 2, single (Lot number: EW0141) at the age of 62 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EW0178;  Anatomical location:right arm,), administration date: 22Jun2021, when the patient was 62-year-old, for COVID-19 Immunization, reaction(s): "complaining his left arm was hurting". The following information was reported: CHEST PAIN (non-serious) with onset 13Jul2021, outcome "recovering". Therapeutic measures were not taken as a result of chest pain.  Additional information: The patient had chest pain in the left part of the chest between the breast and sternum bone. Seems like pain was there for an hours or two then resided. Patient can't explain if recovered completed or with lasting effects since patient didn't go to the doctors. Patient only had two doses of COVID-19 Vaccine.
Patient states he became nauseous after leaving immunization room. Per his brother, he fell to his knees then laid down on his back on the floor. A witness states he did not hit his head. Mom ended up seeing him before any associate and states he was rigid, eyes open, but not speaking. Called 911. Patient became coherent again but was taken to the hospital.
Flu-like symptoms day after first injection (12/8/19)---extreme muscle ache, fatigue, headache. On 6th day post-injection (12/13/19), upper right quadrant abdominal pain continuing thru 8th day (12/15/19) when I went to Hospital emergency room. I had abdominal pain and increasing, spreading right-sided only numbness in entire body from right ankle all the way upward to right ear. Abdominal pain had lasted for 3 days to that point and the numbness began mid-morning on the 8th day and became worse & more widespread by late afternoon.
the vial undergo temperature excursions; Vaccine initially stored in the refrigerator on 20 Jan 2022, Administered on 29 Mar 2022; 13 patients received  an expired vaccine for a booster dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (13 patients received  an expired vaccine for a booster dose), PRODUCT TEMPERATURE EXCURSION ISSUE (the vial undergo temperature excursions) and PRODUCT STORAGE ERROR (Vaccine initially stored in the refrigerator on 20 Jan 2022, Administered on 29 Mar 2022) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     The patient had no allergies. It was unknown whether the patient was ever had COVID-19 test or diagnosis.     On 29-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (13 patients received  an expired vaccine for a booster dose). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (the vial undergo temperature excursions) and PRODUCT STORAGE ERROR (Vaccine initially stored in the refrigerator on 20 Jan 2022, Administered on 29 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (13 patients received  an expired vaccine for a booster dose), PRODUCT TEMPERATURE EXCURSION ISSUE (the vial undergo temperature excursions) and PRODUCT STORAGE ERROR (Vaccine initially stored in the refrigerator on 20 Jan 2022, Administered on 29 Mar 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   The height of the patient is 172.72 cm.             They administered vaccine from 23-Feb-2022 until the 12-may-2022 to 13 patients, all booster dosages, after vaccines were expired. The vial was moved from freezer and was initially stored in the refrigerator on 20-Jan-2022. The vial underwent temperature excursions for 3 months. The vial was in refrigerated storage condition at the time of the excursion. Maximum or minimum temperatures reached were Maximum 44.6°F and minimum 38.8°F. The Visual inspection did not note any vaccine state change and they were in seal boxes.  No treatment information was provided by the reporter.
No additional AE reported; Nurse mistakenly administered patient a dose of VARIVAX and PROQUAD together. This occurred today, Aug 16, 2023.; Nurse states she meant to administer patient a dose of VARIVAX and MMR II together.; This spontaneous report was received from a registered nurse and refers to an 1-year-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-AUG-2023, the patientwas vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, unk, lot #X006979, expiration date: 07-MAR-2025, administered for prophylaxis (strength, and route of administration were not provided). On the same date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, unk, lot #X005166, expiration date: 15-AUG-2024, administered for prophylaxis (strength, and route of administration were not provided).  Nurse mistakenly administered patient a dose of varicella virus vaccine live (oka/merck) (VARIVAX) and  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) together (Accidental overdose). Nurse stated she meant to administer patient a dose of varicella virus vaccine live (oka/merck) (VARIVAX) and MMR II together (Wrong product administered). No additional adverse event was reported.