chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very upset stomach; Lots of nausea; This case was reported by a consumer via interactive digital media and described the occurrence of upset stomach in a adult patient who received SHINGRIX for prophylaxis.   On 16th October 2020, the patient received the 2nd dose of SHINGRIX. In October 2020, less than a week after receiving SHINGRIX, the patient experienced upset stomach and nausea. On an unknown date, the outcome of the upset stomach and nausea were not recovered/not resolved.   It was unknown if the reporter considered the upset stomach and nausea to be related to SHINGRIX.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient still experienced very upset stomach with lots of nausea. The patient asked if this was normal?
Discharge Provider: MD Primary Care Provider at Discharge: PA-C  Admission Date: 12/19/2022 Discharge Date: 12/21/2022 Covid positive date: 12/19/2022 PRESENTING PROBLEM: Generalized weakness [R53.1] AKI (acute kidney injury) [N17.9] COVID-19 virus infection [U07.1] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 73 y.o. female who presents today with generalized weakness and fatigue. Patient noted a 5 day history of myalgias, weakness, fatigue, non productive cough, fever, chills, nasal congestion, hoarse voice and decreased appetite. She denied any nausea, vomiting, abdominal pain or chest pain. Today she had onset of diarrhea and felt even more weak which prompted her to call EMS.    On arrival patient was not hypoxic or tachycardic.  Patient was found hypotensive and her blood pressure improved with 2L IV fluid resuscitation.  Lab work showed an AKI.  Chest x-ray showed some possible increased lymph nodes.  COVID-19 positive.  She was given 10 mg Decadron.  Her blood pressure stabilized but she remained profoundly weak and fatigued.  Given her AKI, COVID-19and profound weakness she was admitted with hospitalist services for further care and treatment of COVID-19 virus infection, AKI and generalized weakness.   Patient's AKI resolved with IV fluids. Her D-dimer was elevated. CTA Thorax was negative for PE and US BLE Dopplers were negative for DVT. She continued to improve and remained stable on room air, steroids were discontinued.  PT/OT evaluated with no need identified. She was discharged home in stable condition with her husband. We reviewed the quarantine suggestions for COVID-19 as well. She will call and make an appointment to follow up with her PCP.
C/O HALF DOLLAR SIZED AREA OF SWELLING AT VACCINE SITE. NO FEVER, SORENESS OR FEVER.
No additional AE reported; expired MMR II was administered to a patient today {09/12/2022); This spontaneous report has been received from a nurse concerning a 34-year-old female patient. Her concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.  On 12-SEP-2022 (also reported as today), the patient was vaccinated with one expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-R II) administered as prophylaxis, lot number T018892 with expiration date of 02-JUN-2022 (dosage regimen and route of administration was not reported) (Expired product administered). No additional adverse event reported (no adverse event).
Child was given Prevnar on 6/13/00 and had an office visit on 6/15/00 secondary to parental report of redness at site of injection. Exam revealed a 5cm erythema, target lesion with 3cm central indurated portion with brown/purple tinge.
Information has been received from a physician concerning an 80 year old female who was vaccinated with a dose of zoster vaccine live (Oka/Merck). The patient has a severe case of chicken pox". There was an unknown number of lesions. The patient sought unspecified medical attention. The patient's outcome was not reported. There was no product quality complaint. Additional information has been requested.
Throat tight. Patient stating inflammation in throat and changes in voice. Rash at administration site. Shortness of breath, Puffy face
Hard lump beneath the skin about the size of a fist per patient's report. Arm swollen, redness around the lump. Denies fever, difficulty breathing. Lump is still present at date of VAERS report.
Information has been received from a physician and  a registered nurse concerning a 61 year old retired Japanese female with a hx of bacterial endocarditis of the mitral valve who on 28OCT2003 at 0915 was vaccinated SC in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine. The pt was S/P a mitral valve replacement at the time of vaccination. On 28OCT2003 at 1200, the pt developed "redness and swelling on the spot" where the vaccine was given and that the injection site felt hard and slightly sore. Unspecified medical attention was sought and it was noted that a prescription drug was required and the arm was packed with ice. On 29OCT2003 the pt recovered. There was no product quality complaint involved. The reporter also mentioned that two other pts experienced a similar rxn. No further information is expected.
Syncope; HR 97/50, HR 70, RR 16, Temp 97.5, SpO2 97%
fever above 103 1 day following vax;fever of 102 persisting 3 days later;
started to feel a little sick; had COVID-19 test and results came back positive; had COVID-19 test and results came back positive; This is a spontaneous report from a contactable healthcare professional. A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899/expiration date unknown) via an unspecified route of administration on 27Dec2020 at a single dose for COVID-19 immunization. The patient had no relevant medical history. Concomitant medications were not reported. The patient stated that he got the vaccination on the 27th and then that same night he started to feel a little sick. He was assuming that it has just to be the side effect of the vaccine (unspecified vaccine). On 28Dec2020, he was feeling pretty sick; he did not go to the work. He had COVID-19 test (Dec2020) and results came back positive. He added that he didn't know if it was the COVID because he was reading up on the vaccines and it said that one could not get COVID from the vaccine. The outcome of the events was unknown.; Sender's Comments: The reported positive with COVID-19 test after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
child seemed to have significant delays after receiving MMRII /This unspecified child eventually went to an unknown specialist who diagnosed the child with cerebral palsy; This spontaneous report was received from a registered nurse and refers to a female child patient of unknown age. The patient's concurrent conditions, medical history, concomitant therapies, and drug reactions or allergies were not provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (strength, dose, frequency, lot #, and expiration date not reported) for prophylaxis.  On an unknown date, the child seemed to have significant delays (unspecified). On an unknown date, the patient eventually went to an unknown specialist who diagnosed her with cerebral palsy. It was reported that the patient did not have those delays until after she was administered mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). It was noted that the reporter inquired about the availability of measles virus vaccine, live (Enders-Edmonston) (ATTENUVAX) and mumps virus vaccine live (MUMPSVAX). The outcome of the event was not recovered as it was reported that the patient "did not snap out of it".  The causal relationship between cerebral palsy and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.  Upon internal review, cerebral palsy was considered to be a medically significant event.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2002USA008445:
Patient rec'd Tdap and Flu later that night (L) deltoid became red, swollen. No fever and deltoid cleaned with multiple alcohol wipes before vaccine given.
pt recv vax 29OCT97 & 5NOV97 approx 1wk p/vax pt exp ataxia;w/in 3 wk pt recovered from ataxia; Information has been received concerning a 3 year old hispanic female with a history of numerous middle ear infections (scarred tympanic membrane) who on approximately 29-Oct-1997 was vaccinated with one dose of VARIVAX. On 05-NOV-1997, approximately one week after vaccination, the patient experienced ataxia. Within three weeks, the patient recovered from ataxia. Additional information has been requested. Information has been received concerning a 3 year old female patient with no known drug allergies and a history of "numerous middle ear infections (scarred tysmpanic membrane)" who on approximately 03-Oct-1997 was vaccinated SC with one dose of VARIVAX. On approximately 10-Oct-1997, the patient presenteed to her physician with an unsteady gait, slight headache, fever and drowsiness. The physician stated that the patient had suffered from cerebellar ataxia. Within three weeks, the patient recovered.The reporter fe;t that the patient's experiences were life threatening. No further information is available. This is an amended report. It has been determined that WAES97121284 (sent on 15-APR-1998) is a duplicate report of WAES97120316 (sent on 16-JAN-1998). Therefore, WAES# 97121284 is being deleted from our files and the reports consolidated into WAES#97120316. This is corrected as amended.
Mother states "At 6:30 pm pt c/o numbness. Weakness tingling on side of body where vaccine was given. Face (side) and lip tingling, numb and droopy- only lasted a few minutes. When to see family doctor this A.M. - No recommendation - will monitor for next several months with Dr.
The pt experienced adverse reactions from the flu vaccine at the injection site which included redness, swelling (grapefruit size in diameter), rash, itching, symptoms began to resolve by 1/2/01 when she called the pharmacy.
She received the Pfizer covid vaccine on 8/4/21.  She developed some chest tightness and chest wall tenderness on 8/5/21 that lasted through 8/8/21.  She tried tylenol, but it did not help the pain at all.  She did not have any shortness of breath or coughing with this.  She did have some lightheadedness.  She states when she pushed on her chest, it was painful to touch, which made her think it was just some inflammation in her chest. She also wondered if she could have had some indigestion that caused some of the symptoms.  She has not had the symptoms since 8/8/21.
COVID-19 breakthrough. On that Tuesday morning I was involved in a cycling event and I woke up in a room with three other people and I had a pronounced sore throat. I thought it could be a cold or the environment. I didn't have any other symptoms so I rode my bike 80 miles that day. I didn't have any difficulties. In the evening I felt febrile, malaise and my throat was worse. I went to bed and woke up the next day with a headache but I was feeling better. I rode 55 miles that day with no difficulty. In the evening I felt the same as the evening before. Then I returned home Thursday and after consulting my wife, she suggested I get tested for COVID-19. I went to the clinic and they tested me for strep and COVID-19 and the COVID-19 test came back positive the strep was negative. I isolated through Sunday and rested. The symptoms except for lose of voice quality had resolved by that Sunday. The voice quality took another week or so by the 12th I was back to 100 percent.
Note: I am currently breastfeeding. Had body aches; chills; fever of 102.6; headache; nausea; cough; shortness of breath - I went to ER and that is where I received COVID positive test and positive tests for COVID Pneumonia and Microplasm Pneumonia as well.  Stayed overnight in ER observation - 2 am to 8 am . Went home next morning and was quarantined approximately 8 days. Body aches and a cough had started two days prior to injection. IV antibiotics at the hospital and oral antibiotics at home. Received nebulizer breathing treatments. Pain meds and anti-inflammatory medication.
being warmer (estimates body temperature above 99-99.2 F); This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (being warmer (estimates body temperature above 99-99.2 F)) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PYREXIA (being warmer (estimates body temperature above 99-99.2 F)). At the time of the report, PYREXIA (being warmer (estimates body temperature above 99-99.2 F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, Body temperature: 99-99.2 f (High) Patient experienced being warmer (estimates body temperature above 99-99.2 F).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2, Solution for injection), on 29Aug2021 as dose 3 (booster), single (Lot number: EW0185) at the age of 47 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Scopolamine, reaction(s): "Known allergies: scopolamine"; Keflex, reaction(s): "Known allergies: Keflex". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), 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 drug ineffective, covid-19. Clinical course: Other medication in 2 weeks: No, Product: COVID 19 treatment, Brand: Paxlovid, Treatment start date: 02Jun2022 Treatment stop date: 03Jun2022, Lot number: GC0470, Indication=Treatment of COVID-19. Adverse Event: Nausea after taking each dose of paxlovid. Adverse event start date: 02Jun2022, Recovering, If treatment ae: No.; Sender's Comments: Based on the available information and the known product safety profile a causal relationship between the reported events, COVID 19, Drug Ineffective and BNT162B2 is considered possible.
Proquad and the medicine was not checked before administering; Initial information received on 08-Nov-2021 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional via Medical Information number: 00847738.  This case involves a five years old female patient was administered MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] (wrong product administered).  The patient's medical history, past medical treatments, vaccinations, medications and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for Immunisation.  On 08-Nov-2021, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE lot U6937AA and expiry date not reported via unknown route in unknown administration site.  It was case of an actual medication error due to wrong vaccine administered (latency: same day).  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
12MAy93 fingers became painful; 13MAY93 AM edema feet; inflammation of legs & forearm; some itching; joint pain all over; 14MAY93 improving feels much better not as painful;
i was fine until then last night my arm started inching  and this morning i have a rash and its red, hard to move my rm. it is heaviness.
Pt recv vax on 4/20/98; on 4/22/98 pt exp fatigue, nausea, bloating, hepatic function abnormality
Patient complained of tight throat at 1055.  BP 121/82 at 1055.  60mg Allegra given PO at 1055. Emergency team called at 1101. Patient transported to ER.
Patient got extremely light headed, diaphoretic, nauseous, and vomited within 1 minute of shot. After sitting for approximately 10 minutes, patient felt just fine. I encouraged his friend with him that he needed to drive, or patient needed to find ride home. Patient declined any need for help, including drink/snack, ice pack to help cool down.
Information has been received from a physician concerning a female in remission from cancer who on 06-JUL-2007 was vaccinated with Zostavax (Oka/Merck) single series dose. On 09-JUL-2007 the patient went back to the physician's office with a bad case of zoster.  As of 10-JUL-2007, the patient had not recovered.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/24/2007. Follow-up information received indicated that this 67 year old female had shoulder pain, osteoporosis and a history of lymphoma at the time of vaccination. At 09:49 on 02-JUL-2007 the patient was vaccinated SC in the left arm with a first dose of ZOSTAVAX (Merck) (lot # 657764/0584U). On 05-JUL-2007 (previously reported as 09-JUL-2007) the patient developed shingles which was also described as a rash and pain. Medical attention was sought. The patient's outcome was not reported. There was no product quality complaint involved. Additional information has been requested.
Headache from 10:00pm-5:30am (3/11/21-3/12/21) and 11:00am-4:00pm (3/12/21). Sleeplessness on the night of 3/11/21.
asked to have 2nd dose of the primary series which Moderna does not have; Product administration interrupted; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (asked to have 2nd dose of the primary series which Moderna does not have), PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted) and NO ADVERSE EVENT (no adverse event) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (asked to have 2nd dose of the primary series which Moderna does not have), PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted) and NO ADVERSE EVENT (no adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (asked to have 2nd dose of the primary series which Moderna does not have), PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (asked to have 2nd dose of the primary series which Moderna does not have) and PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted).    No concomitant medication were reported. No treatment information was provided by the reporter.
After 3 hours of receiving the vaccine I felt really cold.  I had to put on sweater and still felt cold.  Also have a headache the same day.  Next day morning also headache.  And about 2 or 3 days after I feel like temperature changes in my body that last couple hours.  For headache I just have ibuprofen.
03/18/2006 Pt seen in office approx 11AM for sx reoccurring following DX 1 month ago in hospital, of Guillain Barre Syndrome. Now c/o migraine HA, continuing weakness and numbness. Admitted to hospital. Recurrent GBS or other neurological entity.
Chills, bodyaches, sweat, numbness in legs/ left arm paim in armpit, light-headed, numbness in cheeks. Numbness in lower legs, tenderness to top thighs Thurs 9/16- Now. 9/20/21
Over the last 4 months, have had lymph node swelling on left side of neck, collar bone, and ankle. Primary care physician has done an ultrasound of lymph nodes in neck and a CAT scan. Also ran tests for Lupus, and Ferritin levels. He referred me to a Hematologist for low iron, EENT for neck swelling, and waiting on referral to Immunologist. Hematologist thinks iron not low and not related top swelling. EENT thinks that ankle swelling not related to ear/neck discomfort and swelling. Hematology also did blood draws for LUPUS titers and Inflammation titers. Nothing back on them yet.
Swelling and itchiness of the upper lip and tongue about 10 minutes after the vaccination.
Just normal discomfort at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Aug2021 10:00 (Lot number: FD8448) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE DISCOMFORT (non-serious) with onset 20Aug2021, outcome "recovered" (2021), described as "Just normal discomfort at the injection site". Therapeutic measures were not taken as a result of vaccination site discomfort.  Additional information: Facility where the most recent COVID-19 vaccine administered was Public Health Clinic/Veterans. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.