chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TIRED FOR 1 DAY; This spontaneous report received from a patient via a company representative concerned a 69 year old male of an unspecified race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient's pre-existing medical conditions included: The patient had not contacted covid up to now. The patient previously received first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, was administered on early AUG-2021 for prophylactic vaccination. On an unspecified date in 2021, the patient experienced no side effects other than tired for 3 days after shot 1 (dose number in series 1). The patient recovered from tired for 3 days in 2021. The patient received second dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, was administered on first week of JAN-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in 2022, the patient experienced no side effects other than tired for 1 day after shot 2 (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired for 1 day in 2022. This report was non-serious. This case, involving the same patient is linked to 20220719906.
Fever; feeling warm; Left arm is a littl ebit sore; A report was received from a health care professional concerning a patient of age 37 years old, male who was participating in the mRNA-1273 Emergency Use Program and experienced multiple events of left arm is a little bit sore and feeling warm.  The patient's medical history was not provided. No concomitant medications were reported.  On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273. Soon after, the patient experienced left arm is a little bit sore and feeling warm. No treatment was administered.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the events, left arm is a little bit sore and feeling warm were unknown.  The reporter did not provide an assessment for the events.
7 doses of Moderna Covid-19 Vaccine, Bivalent were administered after 30-day Use By Date.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna Covid-19 Vaccine, Bivalent were administered after 30-day Use By Date.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna Covid-19 Vaccine, Bivalent were administered after 30-day Use By Date.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna Covid-19 Vaccine, Bivalent were administered after 30-day Use By Date.) 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 EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna Covid-19 Vaccine, Bivalent were administered after 30-day Use By Date.).    No concomitant medications were reported. 7 doses of Moderna Covid-19 Vaccine, Bivalent were administered after 30-day Use By Date. Dates/number of doses: 03-Dec-2022: 3 doses, 08-Dec-2022: 1 dose, 14-Dec-2022: 1 dose and 19-Dec-2022: 2 doses. No treatment information was provided.
This spontaneous report was received from a healthcare worker and refers to a 5 months old patient of unknown gender. The patient's concurrent conditions, past medical history were not reported. On 28-DEC-2015, the patient was vaccinated with improperly stored oral, ROTATEQ (lot # K014826, expiry date 28-MAY-2016, dose, strength, vaccination site, dose number unspecified). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint (PQC) was not reported. On 26-JAN-2016, a phone call was placed to the physician. The physician was unavailable at the time of call. The phone call was transferred to the Certified Medical Assistant (CMA). The C.M.A was unable to place specific lot numbers for each of the reported vaccines that experienced a temperature excursion; M-M-R II, ROTATEQ and VAQTA, with the information already supplied for patient identifiers, date of birth and date of vaccination, at this time. The C.M.A will need to review the records. This is one of the several reports received from the same reporter. Additional information has been requested.
It started with sinusitis mostly on the right side. It seems to have migrated to my lungs. I had a portal interaction with my doctor to let her know what my symptoms were, and she sent in a prescription for AUGMENTIN. I am supposed to also use a nebulizer. She also made prednisone available if needed. I increased my prescribed medications to assist with the symptoms previously.
Fever of 102.2 that broke after 12 hours, extreme achiness and stiffness in neck, pins and needles feeling all over body that lasted 2 days
INCORRECT PRODUCT STORAGE; ADMINISTRATION OF VACCINE WHICH WAS STORED OUTSIDE OF RECOMMENDED STORAGE CONDITION; VACCINE ADMINISTERED 2 DAYS AFTER ITS BEYOND USE DATE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced incorrect product storage, administration of vaccine which was stored outside of recommended storage condition, and vaccine administered 2 days after its beyond use date. The action taken with covid-19 vaccine was not applicable. The outcome of the incorrect product storage, administration of vaccine which was stored outside of recommended storage condition and vaccine administered 2 days after its beyond use date was not reported. This report was non-serious.
A few minutes after vaccination while in the 15 minute observation period the patient had a syncopal episode lasting 45 seconds with incontinence. On initial ALS assessment patient  was found to be hypotensive with a Blood pressure of 60/P. Patient was Transported for further observation.
Information has been received from a certified medical assistant (C.M.A.) concerning a female patient age 11-12 years old who "in the last 5 months" (in 2007) was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently "in the last 5 months" (in 2007) the patient passed out within a moment of being vaccinated. Medical attention was sought, in th office. She was treated with cool compresses and rest and her blood pressure was monitored. Subsequently, the patient recovered. She will continue with the vaccination series as scheduled. This is one of four total reports received from the same source. One of the girls received the third dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) and hepatitis A virus vaccine inactivated (HAVRIX). The other girls were receiving the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The reporter did not specify which of the four patients was receiving the third dose. Additional information has been requested.
High fever, extreme dizziness, nausea and vomiting, diarrhea, feeling cold then hot, sweating, headache, extreme body aches, pain at injection site. This occurred after 5 hours after the vaccine.
Pfizer Bio-NTech COVID -19 vaccine EUA 2/3/21 - 10:30 Am began having sweating, chills, HA, fatigue and dizziness
Patient's mother called to report that daughter has redness and swelling about the size of a quarter on her upper right thigh where the vaccine was given. She reports that there are no other symptoms.
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: patient was given moderna vaccine # on 05/28/2021 and developed swelling of lip areas and tingling on the face areas. Pharmacy gave the benadry and monitor patient for 30mins. AFter 30mins patient recovered and left pharmacy.
Headache, Fever, NauseaVomiting, Fatigue Narrative:
pt recvd vax & exp mild wheezing, urticaria, stinging hands & arms to back, stomach, & legs; these sx were treated w/DPH;
Within a week of receiving the second dose began to develop heart rate even at rest in addition to strong palpitations. This culminated in constant chest pain which required a visit to the ER on Day 7 after receiving the 2nd dose. ER evaluated for heart attack (Chest Xray, ECG, blood) and was discharged as normal but that following night was still constant chest pain, palpitations and elevated heart rate. Returned to ER the next day but was dismissed with no tests other than ECG. Chest pain, palpitations, elevated heart rate at rest (>90 resting bpm), resting blood pressure >140/80 with spikes up to 180/110, and strong PVCs continued for 2 months near constantly. During that time I returned to the ER 2 more times, saw a Cardiologist who administered a Stress Echo and Upper CT and was dismissed again as "normal". I finally received a standard Echo over 2 months after onset of symptoms which also came back normal due to how late it was performed. I was prescribed Atenolol for some time during this to regulate my heart rate. Atenolol was stopped ~4 months after onset of symptoms as resting heart rate began to return to normal. I was prescribed Lisinopril for blood pressure >2 months after the onset of symptoms which did lower blood pressure over ~2 weeks. After not quite lowering it enough I was prescribed Amlodipine as well. As of 7 months after the onset of symptoms I have less chest pain, however, there are still flair ups of steady heavy chest pain/pressure occasionally. I still experience PVCs along with palpitations every day since onset of symptoms (neither of which had ever been experienced before). Current treatment plan is just to monitor as no cause of any of the above has yet to be determined although I continue to take Lisinopril and Amlodipine for an elevated blood pressure which still can spike to 140/80 even medicated.
Experienced Pain and pins and needle sensations in my hands, feet and lower legs without being to sleep well since. A local reaction was noted the following day, 10/22/2011, it was red, raised, hot, hard and itchy. I have taked a few doses of ibuprofen. I still am experiencing some pain and pins and needle sendation to hands, feet and legs.
8/1/06 child had rash on right thigh and knee getting worse over 4 days. Seen in clinic 8/4/06 Aveeno bath topical meds PRN.
Rheumatoid arthritis flare up; Mobility decreased; Impaired self-care; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 56-year-old female 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) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), MOBILITY DECREASED (Mobility decreased) and IMPAIRED SELF-CARE (Impaired self-care). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), MOBILITY DECREASED (Mobility decreased) and IMPAIRED SELF-CARE (Impaired self-care) outcome was unknown.            No Concomitant medications were reported. No treatment medications were reported.   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 56-years-old female patient with medical history of Rheumatoid Arthritis that was treated with ADALIMUMAB (HUMIRA), who experienced the unexpected, serious (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis) among other non-serious events. The event occurred on an unknown date in context to second dose of mRNA-1273 vaccine. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was not resolved. The medical history of Rheumatoid Arthritis remains a confounder to the event's Rheumatoid arthritis flare up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.; Sender's Comments: This spontaneous case concerns a 56-years-old female patient with medical history of Rheumatoid Arthritis that was treated with ADALIMUMAB (HUMIRA), who experienced the unexpected, serious (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis) among other non-serious events. The event occurred on an unknown date in context to second dose of mRNA-1273 vaccine. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was not resolved. The medical history of Rheumatoid Arthritis remains a confounder to the event's Rheumatoid arthritis flare up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.
Fixed eyes one day after vaccination for about 30 seconds, with redness of her face and no related with  fever. The same event happened  again 5 days later. No  neurologic deficit was seen afterwards. She was seen by a pediatric neurologist who ordered an EEG and a RMN that where both normal. She did not have any  treatment for these events.
Tender swollen about the size of a quarter, then became more swollen about 6 inches around.
Firm, tender large SC tissue mass at injection site, with overlying red skin and overlying vesicles/small bulla, Examined 48 hours after injection
All over body rash, head ache, severe body aches, nauseated, loss of appetite, weak, exhaustion,
After administering last vaccine (MENACTRA) pt slumped to (L) side. Pt diaphoretic, pale VS WNL. Pt lowered to exam table with feet elevated. After resting for approx 45 min, pt was walking & started falling backwards. Lowered pt to floor - pt diaphoretic, VS WNL. Pt rested approximately 30 min & WNL.
No additional AE reported; dose of VARIVAX that experienced a temperautre excursion was administered to the patient after the excursion occured; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, lot # U029496, expiration date: 21-SEP-2023, administered for prophylaxis (strength, dose number and route of administration were not provided) (product storage error).  Administered dose of vaccine experienced the temperature excursion of 7.7 degrees Fahrenheit for 30 minutes.; Sender's Comments:  US-009507513-2206USA007839:
Increased joint pain in knees, shoulders and hips. Approximately a month after second dose I began to have significantly increase in joint pain.
C/O DIZZINESS AND LIGHTHEADNESS AT 1020 PM . B/P 140/90,P74, O2 97% MONITORED & GIVEN 5 CUPS OF H2O.1030PM 142/74, 80, 96% STILL DIZZY AND GIVEN MORE H2O, 1055PM 130/76,64,100% STATES FEELING BETTER NO SYMTOMS, CALLED NEXT DAY 9/8 FEELING BETTER HYRD/EAT instructed to call provider or 911 if symptoms worsen
This spontaneous report as received from a Licensed Practical Nurse refers to a 9 years old female patient with pertinent history of hay fever and possibly ZITHROMAX reaction/allergy. The patient was vaccinated with first dose (lot # :671994/1537AA, Exp date 21-JUN-2014) and second dose (lot # :671994/1537AA, Exp date 21-JUN-2014) of GARDASIL on 20-APR-2012 and 02-JUL-2012 respectively. The patient received her third dose of GARDASIL (lot # :672652/0022AE, Exp date 28-SEP-2014) and a first dose of PNEUMOVAX 23 (671038/0811AA, Exp date 15-MAR-2013) on 06-NOV-2012, concomitant medications included: loratadine (manufacture unknown), then the patient developed fever within 24 hours of receiving vaccines on 06-NOV-2012 and went to ER. After series of tests, it was noted that her white blood cell count was elevated and spinal tap was performed and she was diagnosed with meningitis. Patient was admitted to Medical Center on 08-NOV-2012. Patient was treated with IV antibiotic (name unspecified) and her current condition was listed as "in the hospital but stable". The outcome of meningitis was unknown. Additional information has been requested.
Disease recurrence; Pfizer / BioNTech / Treatment of COVID-19 25Jul2022; Pfizer / BioNTech / Treatment of COVID-19 25Jul2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 16Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 16Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 05May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: LANTUS; METFORMIN; LOSARTAN; AMLODIPINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Jul2022, outcome "not recovered" and all described as "Pfizer / BioNTech / Treatment of COVID-19 25Jul2022"; DISEASE RECURRENCE (medically significant) with onset 11Aug2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Aug2022) Positive, notes: On 11Aug my symptoms returned and I have tested positive every day since. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence. Clinical course as follows: Took Paxlovid on 25Jul2022 (second day of symptoms). Completed full dose. On 11Aug2022 her symptoms returned, and she have tested positive every day since.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received Pfizer vaccine after making appointment for Pfizer vaccine, the first vaccine administered was the Moderna vaccine.
Child developed behavioral and personality changes. He became hyperactive, inattentive, lost eye contact, emotionally labile, defiant and had sleep difficulties after receiving the vaccine. The behavior changes were apparent to the child's family and teachers. Symptoms persisted for for 13 days and then resolved and have not recurred.
Patient is a 84 y.o. male patient of MD.   Patient presented to emergency room for generalized weakness.  Patient states that yesterday he became severely weak.  Patient also reports a cough.  Patient denies any chest pain or shortness of breath.  Patient denies any fever at home.  Patient does not use oxygen at baseline.  Hospital course as below.  Patient improved with medical treatment.  Patient weaned to room air on discharge.  Patient instructed to follow-up primary care provider within a week at discharge.    1. COVID PNA, +1/5, symptoms 1/5, vaccinated: -CXR with atelectasis versus infection -Remdesivir  -Decadron  -heparin SC DVT prophylaxis   2.  Acute hypoxic respiratory failure: -Secondary to above -Wean oxygen as able   3.  Generalized weakness: -Secondary to above -PT/OT -Social work for discharge needs   4. AKI: -monitor labs -IVF -hold home nephrotoxic meds
(l) deltoid redness given RX AUGMENTIN, Hydrocortisone cream.
aching in her bones and joints of her shoulder and elbow; unable to sleep because her left arm was very painful; unable to sleep because her left arm was very painful; aching in her bones and joints of her shoulder and elbow; Dizziness; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (Covid-19 vaccine, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, NDC number: unknown, Lot number: unknown, UDI number: EJ1686, Expiry date: unknown), via an unspecified route of administration on 27Jan2021 16:00 at single dose for covid-19 immunization. Covid-19 vaccine was a Pfizer product. Covid-19 vaccine manufacturer was unspecified. The patient medical history and concomitant medications were not provided. Caller (patient) received the Covid-19 yesterday (27Jan2021) at 4:00 pm. On 27Jan2021, she had a short period of dizziness. Two to three hours later her arm started aching in her bones and joints of her shoulder and elbow. She was unable to sleep because her left arm was very painful. She was scheduled for the next dose on 17Feb2021. Investigation Assessment was not Provided. The outcome of event dizziness was recovered on Jan2021 while unknown for events "her arm started aching in her bones and joints of her shoulder and elbow" and "She was unable to sleep because her left arm was very painful".  Information on the lot/batch number has been requested.