chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AEs/no PQCs; HCP called in and reported that the improperly stored vaccine was administered on 09/12/2022; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 12-SEP-2022, the patient was administered a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot # W011625 with expiration date 06-APR-2024, for prophylaxis (exact dose, route of administration and anatomical site were not provided) (product storage error). The vaccine was improperly stored for 2 hours and 30 minutes in the temperature ranging from -10 degrees Celsius (C) up to 8 C (-4 C). It was unknown if data logger was used to capture the temperature excursion. There was no previous temperature excursion. No additional adverse events were reported (no adverse event).
First few days were arm soreness; started ibuprofen 600 mg three times daily; On Monday pain started radiating to elbow down to middle 2 fingers, with tingling and numbness more distinctly since Monday
Father reports that child broke out in hives, post vax, 1st Hep-B on 9/28/00. Mom is a nurse and treated child with Benadryl and the only thing that was different with child on that day, father reported, was Hep-B vaccine. Father reported this on 2nd visit for Hep-B.
This spontaneous report was received from a registered nurse who reported that an unspecified number of patients were administered M-M-R II (dose, route and lot # not reported) and ROTATEQ (dose, route and lot # not reported) that may have been exposed to 10 degrees C for an unspecified length of time. No adverse effect reported. Additional information has been requested.
pinkeye in both eyes; nausea; mild fever; joint pain; fatigue; sciatica; This is spontaneous report from a contactable consumer (patient). A 33-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0169) via an unspecified route of administration on 24Apr2021 at 14:15 (at the age of 33-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included anxiety, irritable bowel syndrome (IBS), and penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included omeprazole, sertraline, hydroxyzine hcl, and buspirone hydrochloride (BUSPAR) from unknown dates for unknown indications. The patient previously received dose 1 of BNT162B2 (lot number EW0150) on 03Apr2021 at 10:00 as a single dose in the right arm for COVID-19 immunization. ON 25Apr2021 at 03:30 the patient woke up with pinkeye in both eyes. She also experienced nausea, mild fever joint pain, fatigue, and sciatica. The events were reported as non-serious. The patient was not hospitalized as a result of the events. The patient was treated with pinkeye drops: polymyxin B and trimethoprim. The outcomes of nausea, mild fever, joint pain, fatigue, sciatica, and pinkeye were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
My arm had at the top had a knot about the size of a golf ball and then my arm was red and swollen down to my elbow,
Pt received Pfizer vaccination at 1340 today   Waited 15 minutes in monitoring room after vaccination without incident   Went to drive, home, felt "short of breath and like throat was tight", returned to clinic   1530:  Pt entered clinic, put in exam room Epi pen to bedside Vitals:  118 HR, BP 137/86, O2 97% Lungs clear to auscultation throughout Respirations equal and unlabored Oropharynx clear   NKDA Hx of asthma (has not needed rescue inhaler in one year) and migraine (PRN Maxalt)   1540 Vitals HR 102, O2 97% Drinking water, no distress   1545, states throat feels titer Lungs clear throughout O2 97, HR 107 BP 134/84 Prednisone 40 mg given PO   1600, states feeling better (less tight) Respirations equal and unlabored Conversing without difficulty HR 103 BP 134/85 96% Drinking water in no acute distress     1606 Lungs clear throughout Oropharynx clear O2 97%, HR 104     1612 96% HR 102 BP 121/80 Respirations equal and unlabored  States feeling better Calling friend for pick up   Advised patient if ANY worsening symptoms (shortness of breath, trouble swallowing, trouble talking, drooling, etc) he is to call 911.  States understanding of this.
Received injection on 9-11-12, after getting home, she developed rash on chest and upper back and achiness.
Started vomited and stomach ache at 1200 AM vomited x3. Right arm swollen and warm. Diarrhea x2 this AM.
Dementia type symptoms affecting memory, thinking and social abilities severely enough to interfere with my wife's daily life activities to include Agnosia, loss of ability to recognize objects,
No adverse event; patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 29-Sep-2022, the patient experienced UNDERDOSE (patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine).    Concomitant drugs were not reported. It was reported that patients did not report any AEs. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-654905, US-MODERNATX, INC.-MOD-2022-654906, US-MODERNATX, INC.-MOD-2022-654910 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654905:Patient 2 US-MODERNATX, INC.-MOD-2022-654906:Patient 3 US-MODERNATX, INC.-MOD-2022-654910:Patient 4
Pain at injection site; Transient fever; Chills; This is a spontaneous report from a contactable consumer. An adult male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 06Jan2021 at a single dose on left arm for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 17Dec2020 at a single dose on left arm for COVID-19 immunization. The patient experienced pain at injection site, transient fever, and chills on 06Jan2021. No treatment received for adverse events. The patient underwent lab tests and procedures which included COVID test result = Negative on Dec2020.  The outcome of the events was recovering. The events were assessed as non-serious. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was also unknown Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 on Dec2020, result was negative.  Information on the lot/batch number has been requested.
Joint swelling, pain and stiffness on both left and right side of the body. Knees swelling, finger and toe joints swelling, red, warm and painful. Wrist stiffness and pain. Started every couple weeks, then went to weekly. Seeing Rheumatogist
Approximately 22 hours after receiving the updated Pfizer booster, I experienced pain in the left axillary region, as well as above the left clavicle bone. I believe the lymph nodes are swollen. The size of the swollen area in the axillary is about baseball size, and about golf ball size above the clavicle. It VERY painful. OTC pain relievers have not helped.
left numb on my left side; severe headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 22Jul2021 19:00 (Lot number: EW0177) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st Dose., Anatomical Site of injection: Right arm, Route of administration: Intramuscular, Batch/Lot Number: EW0178), administration date: 01Jul2021, when the patient was 39 years old, for COVID-19 immunization, reaction(s): "Pain", "Numb", "Severe Headache". The following information was reported: HYPOAESTHESIA (non-serious) with onset 22Jul2021 21:00, outcome "unknown", described as "left numb on my left side"; HEADACHE (non-serious) with onset 22Jul2021 21:00, outcome "unknown", described as "severe headache".  Additional information: VACCINATION FACILITY TYPE: Pharmacy or Drug Store. PATIENTS MEDICAL HISTORY: None.  No follow-up attempts are possible. No further information is expected.
PATIENT RECEIVED A SUBCUTANEOUS INJECTION TO HIS LEFT ARM. NO ADVERSE EVENTS OCCURRED. PATIENT WAS UNABLE TO RECEIVE AN INTRADERMAL INJECTION, THEREFORE VACCINE WAS ADMINISTERED SUBCUTANEOUSLY.
Fever greater than or equal to 105 degrees F next day (within 24 hrs).
On Friday, August 27, 2021 at 10:54am, 34 YO F was given a second dose of Moderna vaccine. The vaccine administered on 8-27 was withdrawn from a vial that had been punctured on 8-26 at 8:28am.
Fever, nauseated. Vomiting, light headed, dizzy, Seizures, body felt f t open could move, joint aches, huge bruise , injection sire swollen migraine. Lack of appetite, high blood pressure fluctuated between 165 to 190 and 80 to 100.  Head feels swollen.
first dose about 4 months ago but have waited to get my second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose about 4 months ago but have waited to get my second dose) 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 09-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose about 4 months ago but have waited to get my second dose). On 09-Aug-2021, PRODUCT DOSE OMISSION ISSUE (first dose about 4 months ago but have waited to get my second dose) had resolved.            No concomitant medications were reported. No treatment medications were reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   Reporter did not allow further contact
She had a toothache; tooth infection; tooth loss; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TOOTHACHE (She had a toothache), TOOTH INFECTION (tooth infection) and TOOTH LOSS (tooth loss) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced TOOTHACHE (She had a toothache) and TOOTH INFECTION (tooth infection). In April 2021, the patient experienced TOOTH LOSS (tooth loss). The patient was treated with AMOXICILLIN for Tooth infection, at a dose of 500 mg three times a day. At the time of the report, TOOTHACHE (She had a toothache), TOOTH INFECTION (tooth infection) and TOOTH LOSS (tooth loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
Moderna COVID-19 Vaccine EUA. Large bump (1/2 inch raised from the rest of my arm)  on injection site appeared roughly a week after vaccine. Roughly 2.5 inches in diameter and firm to the touch. Mildly itchy and red with a few small bumps.
This was not an adverse event.  I am reporting that this dose of the Covid 19 vaccine was given out of the recommended range.  This dose was given on day 15 not 17-21.  She did not have a reaction.
fever; Excruciating pain; Swollen; Extremely fatigued; This is a spontaneous report from a non-contactable consumer (patient) reported for herself. A female patient of an unknown age received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: unknown), via an unknown route of administration on an unknown date as dose number unknown, single for COVID-19 immunization. The patient's medical history included strep throat, fibromyaglia, high blood pressure, depression, anxiety, tinnitus in right ear, Chiari malformation and stomach ulcers. Concomitant medication was not reported. On unknown date, it was reported that patient experienced fever, excruciating pain, swollen and extremely fatigued. The outcome of events was recovered on an unknown date.  No further information was reported. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I was diagnosed with right side bells palsy, I was told to take use artificial tear drops in eye, Valtrex, prednisone tapered and pecid  .
Patient reports onset of elevated heart rate of 130 bpm right after vaccine, did not report to anyone at the time. Elevated heart rate lasted 5-6 hours and resolved without intervention. Patient noted feeling short of breath during that same time but was able to do all normal daily activities. Has not had return of elevated heart rate since then that is not related to exercise.
I developed Raynaud?s which I did not have before.  I have pics of my hand with my fingers completely white if needed.  After a covid exposure two days later I went home and developed hives.  I also have had HSV1 my whole life but since the vaccination.  I can?t seem to keep them gone.
Pain, stiffness and spasms in left neck, arm and shoulder...Symptoms are worse when laying down.
On 10/10/17 patient started with chills around 10:30am and realized she had a low grade fever that afternoon around 1pm. She had pain in her arm but figured all these were normal since she received multiple vaccines. She worked all day on Tuesday, but after that day she got worse. Her temperature got up to 103.5F and she started with a headache. She was taking Tylenol and Ibuprofen around the clock and her temperature was not subsiding. She went to urgent care on Thursday and they sent her to ER because "they were worried [she] was septic." In the ER they diagnosed her with cellulitis and told her she "had a bacterial infection because the vaccine injection site was not cleaned well."  The cellulitis was in her left arm. She said they gave her two IV antibiotics and they sent her home with antibiotics to take by mouth and pain medication. They did blood work and sent a culture of the bacteria that she will get back when she follows up with her doctor next week. She was out of work Wednesday, Thursday, and Friday and was back to work on Monday October 16, 2017.
Patient is fully vaccinated.  COVID + on 12/26/2021 on date of hospitalization. admitted to Hospital on 1/21/2022 for Inpatient rehabilitation after he was  admitted to Hospital on 12/26/2021 for altered mental status and worsening right foot pain due to wound infection. Patient also tested positive for COVID infection. Patient underwent right BKA on 1/8/2022. Patient denies chest pain or SOB. He was found to have acute kidney inury and bad wound on his foot. Elevated troponin (Lovenox). Elevated D dimer. Toxic metabolic encephalopathy, Rhabdomyolysis, Osteomyelitis of right foot (antibiotics).  Anemia, HG 7.7, PRBC given. Breo inhalter and albuterol for COVID. Discharged to rehab
Skin inflammation; Eczema and it caused him to flare up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program (159558). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Sep2021 (Lot number: FE3592) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Eczema" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose no: 1, Anatomical location: Right arm, lot/Batch number: EW0169), administration date: 26Aug2021, when the patient was 57 years old, for COVID-19 immunization, reaction(s): "Chest pain". The following information was reported: DERMATITIS (non-serious) with onset 23Sep2021, outcome "recovering", described as "Skin inflammation"; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "recovering", described as "Eczema and it caused him to flare up".  inflammation after the second dose. He thought the chest pain started right after the vaccine and lasted few days after that. He clarified that it started immediately and continued on for about 10 days. Skin inflammation started after the second dose. He has a history of eczema and it caused him to flare up. It has improved and is under control now. It got out of control in the beginning of Nov2021. Time the Vaccination Was Given was between 08:00-09:00. No additional vaccines were administered on same date of the pfizer suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) were given. There were no AE(s) following prior vaccinations. There was no family medical history relevant to AE(s). there were no relevant Tests done.   No follow-up attempts are possible. No further information is expected.
EXPIRED VACCINE USED; POOR QUALITY DRUG ADMINISTERED; This spontaneous report received from a pharmacist concerned a 21 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-JUL-2021, the patient experienced expired vaccine used. On 09-JUL-2021, the patient experienced poor quality drug administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine used and poor quality drug administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915646, 20210915719, 20210916300, 20210916697, 20210916959, 20210917160, 20210916965, 20210915661, 20210915623, 20210916808, 20210915748, 20210916715, 20210917163, 20210916907, 20210916553, 20210916768, 20210917515, 20210917226, 20210916910, 20210915852, 20210916658, 20210917500, 20210916584, 20210916811 and 20210918425.
7-8cm diameter area of erythema & induration over lt deltoid arising w/in 24hr of vax;
Transverse myelitis/idiopathic; This is a literature report.  A 37-year-old female patient received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYELITIS TRANSVERSE (medically significant) with onset 27Dec2021, outcome "unknown", described as "Transverse myelitis/idiopathic".; Sender's Comments: Based on the information currently available, a possible contribution of the suspect drug administration to the reported event cannot be excluded, due to a plausible temporal relationship. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article;drug/different patient;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 03-APR-2009, the patient was inoculated with ZOSTAVAX at physician office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of shingles, or severe herpes zoster. On or about 11-SEP-2014, the patient was treated at physician office for the onset of rash, which was diagnosed as shingles. He was prescribed VALTREX and ZOVIRAX for management of his painful symptoms and chronic pain. On or about 27-SEP-2014, the patient sought subsequent treatment from the physician office for the diagnosis as of post herpetic neuralgia, a chronic condition of pain and nerve damage secondary to herpes zoster infections. He was prescribed Gabapentin for management of his painful symptoms and chronic pain. On or about 01-DEC-2014, the patient sought further treatment from the physician office for his post herpetic neuralgia, a chronic condition of pain and nerve damage secondary to herpes zoster infections. He was prescribed Tramadol for management of his painful symptoms and excruciating pain. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient suffered and continues to suffer painful and ongoing injuries and damages, and required and continues to require extensive medical care and treatment. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Headache, cold chills, body aches, and fever of 100°F.  The effects lasted for 10 hours and was back to normal by morning.
Needle retracted prematurely, vaccine dose splashed onto patient. Patient did not receive full dose of second vaccine.