chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles; High cholesterol; Blood pressure high; Lymphadenopathy axillary; Inappropriate route of vaccine administration; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles), BLOOD CHOLESTEROL INCREASED (High cholesterol), HYPERTENSION (Blood pressure high), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccine administration) and LYMPHADENOPATHY (Lymphadenopathy axillary) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product (HUMIRA) for Ulcerative colitis and Crohn's disease.    No Medical History information was reported.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started (HUMIRA) (Subcutaneous) . In June 2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccine administration). On an unknown date, the patient experienced HERPES ZOSTER (Shingles), BLOOD CHOLESTEROL INCREASED (High cholesterol), HYPERTENSION (Blood pressure high) and LYMPHADENOPATHY (Lymphadenopathy axillary). At the time of the report, HERPES ZOSTER (Shingles), BLOOD CHOLESTEROL INCREASED (High cholesterol) and HYPERTENSION (Blood pressure high) was resolving, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccine administration) outcome was unknown and LYMPHADENOPATHY (Lymphadenopathy axillary) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: High. On an unknown date, Blood pressure measurement: High.         Concomitant Drugs Not Reported  The reporter's causality for the event(s) of shingles, high cholesterol, high blood pressure and swollen lymph node under left arm pit with Humirawas no reasonable possibility.  Treatment Drugs Not 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
Vaccine was administered at drive through event. During the waiting period, she developed wheezing and dyspnea.  She has a history of multiple allergies and self administered her own liquid benadryl 50mg and her own albuterol inhaler.  She was also given Depo Medrol 80mg IM.   Her symptoms resolved and she was monitored for an additional hour at the site.  She had an appointment already scheduled with her allergist later that day and plans to keep this appointment.  She had strict instructions to seek medical care immediately if other symptoms developed.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to Bactrim), Osteopenia, Food allergy (Allergic to Filet of sole) and Latex allergy (Slight latex sensitivity). Concomitant products included CALCIUM for Osteopenia, MONASCUS PURPUREUS (RED YEAST RICE), FISH OIL and VITAMIN E [VITAMIN E NOS] for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021 at 8:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   patient uses unspecified allergy medication one daily since 2010 for unknown indication.  Concomitant drugs included Allergy medication. Treatment medicines were not reported   The patient had Good physical health, swim a mile three times a week.   This case was linked to MOD-2021-057168 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up received on 12-MAY2021 : updated reporter details ,patient demographics, medical history, Concomitant medicines, dose 2 details, Start date of first dose of moderna vaccine was provided.
Bellyache, headache, very sore arm after the shot (not at the time of the shot), nausea, fatigue.
01/10/21 7:00 AM- chills, fever (99.9, 100.8), aches 10:25 AM- 2 Tylenol (500mg ea) 11:30 AM-  fever (101.1, 101.3), aches 3:00 PM- fever (100.8, 100.9), aches 4:30 PM- fever (99.7), aches, 2 Tylenol (500 mg ea) 8:40 PM- fever (99.1, 99.3) 10:30 PM- temperature (98.4, 98.6), aches, 2  Tylenol (500 mg ea)  1/11/2021 6:00 AM- temperature 98.2
Information has been received from a registered nurse referring to a patient of unknown age and gender. On 09-NOV-2015, RECOMBIVAX HB was stored under 32 F for 39.5 hours. Then on 06-DEC-2015 the patient was vaccinated with the improperly stored dose of RECOMBIVAX HB (lot # L018501, expiration date 22-JUN-2017, dose and route unknown). No adverse effects were reported. There was no previous temperature excursions and it was not called because of a "data logger". This is one of several reports received from the same source. Additional information has been requested.
On 12/9/2021, I woke with a severe headache. I drank water, but it only became worse and I started vomiting. I vomited 5 times within a few hours and did not eat or drink. I met with a nurse practitioner through tele-Medicine and she prescribed ondansetron 4mg tablets to help with nausea. I woke during the night to vomit (12/10), and still suffered a throbbing headache that continued through the next day. Vomiting continued until the afternoon of the 10th. I was able to take a small bit of coffee to help with the headache, naproxen, and continued with the ondansetron treatment and have been able to keep food down since. I still have drowsiness, weakness, nauseous between doses. Headache subsided.
SEVERE FLARE UP OF ECZEMA ON EARS AND NECK WITH SEVERE BODY ACHES LIKE MONO LASTED 14 DAYS AND USED OVER THE COUNTER ANTI INFLAMMATORIES AND FLUTICASONE PROPIONATE CREAM 0.05%
Information has been received on 01-MAR-2018 regarding a case in litigation from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route on or about 28-MAR-2014, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles. On or about 04-NOV-2015, the patient was treated by a physician for blistering vesicular outbreaks that were diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
A report has been received from a Pharmacist concerning an 9 year old, female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent stated on 30-NOV-2014. IT was reported that expired FLUMIST was administered to the patient on 30-NOV-2014. The outcome of the event of expired FLUMIST administered is unknown. The report was considered to be non-serious by the reporter.
4-6-21 PT GOT COVID 19 VACCINE AT AGE 15. TC TO MOTHER PER RN: D.O.B. VERIFIED AND MOM INFORMED THAT PT CAN NOT GET DOSE #2 AS SHE IS UNDER AGE LIMIT.
Poor balance within 24 hours after vaccines lasted 3-4 days, pt did not contact MD until symptoms resolved and was not examined.
Received the vaccine on 12/21/20 without a reaction 15-30 minutes after administered. On 12/24/20 experienced flush, and rash on my face with swelling of the eyes and face. The swelling has progressed since then getting larger even after treating with Benadryl and cold compresses. It is now 12/27/20, and swelling is not decreasing. Am not experiencing difficulty breathing or any other symptoms.
shortness of breath; tongue swelling; Initial information regarding an unsolicited valid non-serious case was received from a physician via agency (Reference number- 00457437) and transmitted to Sanofi on 02-Feb-2021.  This case involves a 33 year old male patient who experienced shortness of breath (dyspnoea) and tongue swelling (swollen tongue), while he received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 13-Jan-2015, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UI232AA, expiry: 30-Jun-2015) via intramuscular route in the right arm for prophylactic vaccination.  On 13-Jan-2015, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via intramuscular route in unknown administration site for prophylactic vaccination.  On 13-Jan-2015, the patient developed a non-serious shortness of breath (dyspnoea) and tongue swelling (swollen tongue) 2 hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Physician stated the patient is scheduled to have the Coronavirus disease (COVID-19) vaccine tomorrow and she was hoping to get an answer to her question before then. The caller was asking for ingredients of Fluzone Quadrivalent (she is not sure which one) and Adacel from 2015  No laboratory data was provided  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of events was unknown.
my right arm hurts; I have bad pains; my hands are swollen; fingers are swollen/Four or five fingers; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date as single dose (at the age of 74-years-old) for covid-19 immunization; tofacitinib citrate (XELJANZ XR, Prolonged-release tablet, Prolonged-release tablet) 11 mg, via an unspecified route of administration from an unspecified date to an unspecified date for an unspecified indication. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient reported that her right arm hurts. The patient also experienced bad pains and her hands are swollen, fingers are swollen. Four or five fingers. The outcome of event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
only the liquid portion of Menveo was administered to a patient; only the liquid portion of Menveo was administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA908A, expiry date 30-APR-2024) for prophylaxis.   On 10-JUL-2023, the patient received Menveo. On 10-JUL-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: only the liquid portion of Menveo was administered to a patient) and inappropriate dose of vaccine administered (Verbatim: only the liquid portion of Menveo was administered to a patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 14-Jul-2023 The reporter consented to follow-up via postal. The patient only received the liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Patient fully vaccinated, second shot on 2/12/2021 and admitted with COVID 11/25/2021. Weakness secondary to COVID-19.  Patient was not started on steroids due to being on baseline O2 requirement.  CRP and D-dimer down trended during admission. Patient also had closed fracture dislocation of finger with malunion, R otitis externa, Morbid obesity, Thrombocytopenia, Type 2 diabetes mellitus with stage 3 chronic kidney disease, with long-term current use of insulin, Hyperlipidemia, Chronic respiratory failure, Chronic diastolic heart failure, Acquired hypothyroidism, Paroxysmal atrial fibrillation, Polyneuropathy due to secondary diabetes , and Closed nondisplaced fracture of surgical neck of right humerus.
Shortness of breath, at what seems to be random moments. Increased heart rate from 75-80 bpm resting to 95-105 resting. Dizziness at random moments. All symptoms ongoing.
Information has been received from a lawyer regarding a case in litigation concerning a 66 year old male patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 01-NOV-2013, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On or about 26-FEB-2014, the patient was treated by a health care provider for the following injury resulting from his ZOSTAVAX use: shingles. The patient claims damages including: injury to himself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
dead suddenly and unexpectedly; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a 64 years old and unknown gender patient who was dead suddenly and unexpectedly while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer  (formulation, frequency, route, lot number and expiry date was not reported) via unknown route in unknown administration site for prophylactic vaccination. Information for the batch and expiry date was requested.  On an unknown date the patient was dead suddenly and unexpectedly (sudden death, latency: Unknown).  This event was assessed as medically significant and was leading to death. The cause of death and autopsy details were unknown at the time of report.  Action taken:  not applicable.  It was not reported if the patient received a corrective treatment for the event (dead suddenly and unexpectedly).  At time of reporting, the outcome was Fatal for the event dead suddenly and unexpectedly.; Sender's Comments: Sanofi company comment dated 27-Jan-2022: This case involves 64 years old patient of unknown gender who was dead suddenly and unexpectedly (sudden death) with influenza Vaccine (Manufacturer unknown). The time to onset is not reported with the role of the vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.; Reported Cause(s) of Death: dead suddenly and unexpectedly
1/18/2022-Seen at ER for sob and weakness, Covid + test. 1/20/2022-Arrive to ER with complaints of lethargy, short of breath, productive cough and a blood sugar of 400. On 6L of 02 via NC, oxygen sat 97%, HR 117, RR 35  and afebrile. CRP 11.8, D-Dimer 545, and Ferritin 968. Chest xray- moderately severe bilateral groundglass infiltrates. Admit with acute hypoxic respiratory failure secondary to bilaterla multilobar Covid-19 penumonia. Started on IV remdesivir, IV baricitinib, IV ceftriaxone, doxycycline, IV dexamethasone, lovenox and Lantus. 1/21/2022-ID consults- D/C baricitinib patient not requiring >10L/min o2 by NC (currently 6L o2 via NC) 1/22/2022- A1c 11.8, continues on 6l o2 via NC. 1/24/2022- Repeat Chest x-ray, Moderate improvement of aeration in bilateral lungs, with mild residual increased pulmonary markings in right upper lung zone and moderate increased pulmonary markings in bilateral lung zones.  One time dose IV Lasix. 1/25/2022- Patient tolerating 5L via NC o2 98%. 1/26/2022-Patient tolerating 2L via NC o2 97% 1/28/222-Preparing to discharge to sub-acute rehab, will need negative Covid-19 result. 2/2/2022- Continues on 2L o2 via NC, awaiting discharge. Afebrile.  2/7/2022-  Covid 19 negative result.  2/9/2022- Lower extremity erythema, US  Lower extremity bilateral- moderate edematous subcutaneous tissues. no abscess.  Start cephalexin. Patient is on RA o2 sat 96%.Awaiting sub-acute rehab placement. 2/18/2022- Patient temp-101,HR 120 and hypoxic with o2 sat around 76% RA. Chest xray -bilateral infiltrate. Started on cefepime and vancomycin. D-dimer 245. Discharge held  2/19/2022- Repeat chest x-ray- Bilateral patchy airspace disease concerning for diffuse type of pneumonia. UTI due to Enterococcus-urine cultures noted. WBC- 8.3 Temp-98.4 , HR- 94  2/20/2022-Afebrile and 97% o2 on RA.  Linezolid PO started, can resume discharge. 2/21/2022- Repeat chest x-ray- coarse reticular nodular interstitial opacities once again noted, no supplemental oxygen needed.  Afebrile. HR-90. CRP-4.8, WBC- 7.0, Patient refused to be discharged to Sub-acute rehab, discharge to home continue current medication.
chills, fever of 103, bodyaches, headaches, and fatigue. Started 12/26/2020 and still active.
Experienced an allergy reaction following a dose of Havrix; This case was reported by a physician via call center representative and described the occurrence of allergic reaction in a patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was recovered/resolved.   It was unknown if the reporter considered the allergic reaction to be related to Havrix and Havrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. In 2018, the patient a dose of Havrix. The reporter asked about components of Havrix due to the patient experienced an allergy reaction following the dose of Havrix. No more information was reported. The reporter did not consent to follow-up.
Pt. described as "sores" from head to toe, finally clearing now. Severe vomiting/nausea for 5 days post injection. Swelling, could not urinate for 2 days.
Yet I got a very mild case of it/ Suspected Vaccination Failure; My PC confirmed it; It was like a sunburn on my back; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Yet I got a very mild case of it/ Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: My PC confirmed it) and sunburn-like rash (Verbatim: It was like a sunburn on my back). The outcome of the vaccination failure was unknown and the outcome of the shingles and sunburn-like rash were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and sunburn-like rash to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and sunburn-like rash to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date:11-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that he/she had one shot of shingles vaccine and also a booster but yet got very mild case of shingles. It looked like a sunburn on the back. The doctor confirmed that it was shingles. The shingles did not surface so the reporter was happy that he/she had the shingles vaccine. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Patient received Moderna COVID vaccine on 3/2/21 and 3/30/21. On 1/11/22, patient tested positive for COVID. On 1/16/22, patient admitted to our inpatient med/surg unit with AKI, COVID19 pneumonia, and acute on chronic respiratory failure with hypoxia / ILD.  As of today (1/18/22), patient is still admitted in our med/surg unit.
mouth sores; This is a spontaneous report from a contactable other HCP. A 47-years-old non pregnant female patient received (BNT162B2 formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration, administered in Arm Left on 30Jun2021 12:00PM (at the age of 47-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included asthma and Paper tape allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included salbutamol sulfate and montelukast sodium all for unknown indications from unknown dates and unknown if ongoing.The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported Dose 1 mouth sores and Multiple on each side of my mouth, Upper and lower. 6-8 at a time, They went away, Dose 2 mouth ulcers. she have been getting constant sore. As they heal she get new sores. she constantly have 2. she last dose was 14Jul2021. she at the end of 2. It seems though as she think they are gone a new one starts. The patient experienced mouth sores on 02Jul2021. The clinical outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No follow-up attempts are possible.
COVID arm. Itchy raised rash about three inches in diameter around injection site. Hives also appeared on the upper back area. Rash appeared approximately 9 days after injection. Treating with topical antihistamines and oral antihistamine (benedryl) Rash has yet to be resolved.
Husband got sick on 6/23 /21 (we thought with a head cold). I got sick on 6/29 with the same symptoms, fever, chills,  cough, runny nose. On 7/1 I lost my sense of taste and smell.  We both went to get tested for COVID on 7/2 and both tested positive.  No fever on the day of testing and symptoms were mild. Much like a head cold.
Photophobia, Headache, Vertigo, Myalgia, Arthralgia. Everything resolved except very extensive photophobia and Vertigo since day of vaccination.