chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Complain of nausea, then emesis X 2, described hands as "hot" and red in color, then redness spread to both wrist area, then developed itching of hands/wrists, then developed itching across chest and back.
Pt phoned - stated had weakness and dizziness with shortness of breath.  I called Dr, who spoke to patient.  Patient had not been using their oxygen (COPD).  Son and Doctor monitoring patient.
heat at the injection site; pain at the injection site; swelling at the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site warmth in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th November 2022, the patient received Shingrix. In November 2022, less than a week after receiving Shingrix, the patient experienced injection site warmth, injection site pain and injection site swelling. On an unknown date, the outcome of the injection site warmth, injection site pain and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth, injection site pain and injection site swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-NOV-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient had reported that he/she had got the Shingrix vaccine on Tuesday and at the time of reporting he/she still had the pain, swelling and heat at the injection site.  The reporter had asked that for how much longer will this last. Additional supportive information: Follow-up would not possible as no contact details were available.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and unknown gender. Drug reactions or allergies and pertinent medical history were unspecified. On an unknown date, VAQTA was improperly stored outside the temperatures recommended in the product insert and was administered to an unspecified number of patients for prophylaxis (strength, dose, dose number, route and lot number were unspecified). Concomitant therapies were unspecified. The outcome of received improperly stored vaccine was unknown. This is one of several reports received from the same reporter where other patients were vaccinated with improperly stored PNEUMOVAX 23 (MARRS # 1407USA002446) and GARDASIL (MARRS # 1407USA005269). Additional information has been requested.
Person who administered noted they had gotten new doses and the needles were different. She also indicated she wasn?t real confident she knew how to use them.
had my first shot a few years ago, second shot did not do it; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received a few years ago).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The reporter Went to get the second shot, did not do it. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked why did the shots cost so much.
9/21/2009 Sent home from school bad headache, nausea, muscle aches, weakness. 9/29/2009  not allowed to give blood came home early from school nausea & vomiting weak feels numbness all over 9/30/2009 stayed home from school, weak nausea & vomiting feels weak, numbness in legs, difficulty walking 10/1/2009 home from school tingling from trunk into legs, weak, nausea vomiting, difficulty walking 10/2/2009 Back to school, tired weak, numbness 10/3/2009 Resumed vomiting again in the evening 10/5/2009 to pediatrician difficulty walking, nausea, weakness 10/6/2009 ER RX Zofran for nausea sent home 10/7/2009 ER IV hydration sent home 10/8/2009 weakness worsens 10/9/2009 to pediatrician vomiting dehydrated admitted to hospital from pediatrician's office unable to walk/stand. Dr. noted enlarged thyroid U/S thyroid and abdominal -- normal Ct Scan abdomen -- normal 10/10 Blurred vision in left eye 10/11/2009 MRI back -- transverse myelitis 10/12/2009 MRI brain--lesions in brain consistent with A.D.E.M. Spinal tap and start IV Steroids transfer to Hospital 10/13/2009 Diagnosed with Acute Disseminated Encephalomyelitis and Transverse Myelitis Infectious Disease ruled out a viral cause and states consistent with vaccination reaction. 11/05/2009 Consultation at Hospital Multiple Sclerosis Center and A.D.E.M. diagnosis confirmed by pediatric neurologist.    1/6/2010 ED records for 10/6 and 10/8/2009 patient with c/o's nausea/vomiting and diarrhea, IVF, IV Zofran 1/6 and 1/7/2010 MR for 10/9-10/12/2009 patient admitted nausea. vomiting and progressive weakness transferred to another facility for continued care on 10/12/2009 1/6/2010 MR and DC summary for 10/12-10/16/2009, patient with c/o's numbness, weakness, ataxia, nausea/vomiting, tingling and hand tremors, diplopia  LP, Neuro and Opthalmology, ID consults, IV Solu-Medrol x 5 days with resolution of sx. dc'd home on steroid taper and f/up with PCP DC DX: Weakness, improving. Ataxia, improving. Numbness improving. Demyelinating disease of CNS.
DAVELOPED BODY ACHES, FEVER, AND CHILLES THAT LASTED UNTIL 1/21/21 @6AM.
patient received the first dose of Shingrix 1.5 years ago; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose 1.5 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient received the first dose of Shingrix 1.5 years ago). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 25-Oct-2023 The pharmacist called to inquired that the patient would have to repeat the series. The reporter did not consent to follow-up. Till the time of reporting, the patient did bot receive second dose of Shingrix, which led to incomplete course of vaccination.
This spontaneous report as received from a non-medical healthcare worker refers to a patient of an unknown gender and age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (dose, lot#, expiration date and route and administration were not reported). On an unknown date, 5 weeks after the first dose of GARDASIL, the patient was inadvertently vaccinated with the second GARDASIL. There were no adverse effects reported. Product quality complaint (PQC) was not involved. Additional information is not expected as there was not consent for further contact.
Allergic reaction; Rash on the left side of face; A spontaneous report was received from a consumer, who was a 56-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, allergic reaction and rash on the left side of face.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included hydroxychloroquine.  On 02 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 02 Jan 2021, within a few minutes of vaccine administration, the patient developed an allergic reaction. She had a rash on the left side of her face that was still ongoing. Treatment for the event included 50mg diphenhydramine.     Action taken with mRNA-1273 in response to the events was unknown. The patient inquired whether she should get the second dose or not, since she was scheduled for second dose on 30 Jan 2021.  The outcome of the events, allergic reaction and rash on the left side of face, was considered not resolved.; Reporter's Comments: Company comment: This case concerns a 56-year-old female patient, who experienced unexpected events of allergic reaction and rash on the left side of her face. The event occurred on the same day within a few minutes after the administration of the first dose of the Moderna COVID-19 vaccine administered.  De-challenge and re-challenge were not applicable. Based on the strong temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded.
NON STOP HEACACHES!!  Every day, never a day with no headaches.  Worst are at work on computer.  After a short period of time, i have a headache so bad, i have had to start leaving work early.  Doctor gave 3 perscriptions, none took away the headache and some of the med's made me feel horrible with terrible side effects!!
This spontaneous report as received from a pharmacist refers to 3 patients of unknown age and gender. On an unknown date those patients were inadvertently vaccinated with an improperly stored ZOSTAVAX (dose, units, route of administration, anatomical location, lot number were not reported). No adverse effects reported. Additional information is not expected because the reporter refused to be contacted.
I was diagnosed with venous stasis in my left calf and prescribed compression socks.   I was experiencing cramping in my left calf. I had been experiencing sciatica in my left leg since the 2nd moderna shot.   Though I have had sciatica before I had not had that kind of cramping or venous stasis before.
Sick; This case was reported by a pharmacist via call center representative and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported, however captured age group as Adult. The patient received 1st dose of Shingrix 7 months prior to this report and was very sick and due to this was unable to receive 2nd dose. The reporter consented for follow up.
A month after my second does I developed Lyphocytic Colitis. Never had this disease or anything related to it.  No one in my family has ever had Colitis either.
Initial symptoms: pain at injection site, muscle aches and headache 12 hours after vaccine. Took Advil and felt much better.   Periorbital Edema approximately 24 hours after vaccine administration? started in right eye and 5 hours later presented in both eyes. Initially no medicine taken? no itchy, pain or watery eyes  Went to sleep and woke up at 9am following day (11/13/22) both eye lids extremely swollen, watery and somewhat itchy.  Took 2 pills of Benadryl. Symptoms starting to subside.
Case number PHEH2014US025064, is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to an 86 year old female patient. Medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 05 Nov 2014. Nurse reported that patient received FLUVIRIN that was at 49 degree F 12 times over a period of 34 days. The temperature excursion began around 16 Oct 14. 12 separate temperature excursion lasting 30 minutes each in which the temperature was 46-49 degree F during each of those excursion. No adverse event was reported following this maladministration. No further information was provided.
Client states that she has weakness, body aches, and dizziness since vaccine.  Continues to have these symptoms
The day after receiving vaccination the patient developed a red, bumpy, itchy rash on the arm of vaccination, that continued to spread two days after vaccination.  Saw MD the day after vaccination and was treated with prednisone.
I felt fine until about 12 hours after vaccine. Then i had a headache, body aches, chills, fever, diarrhea, and was tired. About 24 hours qfter i started feeling the effects i felt better. I felt better during those 24 hours when i took a 600mg ibuprofen
Systemic: Seizure-Severe, Additional Details: Patient was taken to the ER via ambulance after having a seizure in the pharmacy.  She was given Benedryl as she was thinking she was having allergic reaction.  She has been on Tegretol to control her seizures.  She didn't let us know she had seizures in her past.  She did not let the pharmacist know until the next day that she is not allowed to be given the Flu or Pneumonia shot.  She will not be getting her second dose even though her doctor at the ER told her not to be scared to.
This spontaneous case was initially received on 24-Feb-2016. The case report was received from a Non Health Professional and concerns a 48 years old female patient. Weight: 125 pounds, Height: 63 inches. Concurrent medical condition (s), medical and drug history: The patent has a medical history of allergy to bees and allergy to metals. She had flu shots in the past but not sure if the vaccines were AFLURIA. For concomitant medication and therapy dates refers to the appropriate report sections. Suspect drug (s), timing and conditions surround the onset of reaction (s)/ event (s): The patient received AFLURIA for indication protection against influenza virus on 26-Oct-2015 - 26-Oct-2015, Batch no: not provided, Route of administration: Intramuscular, Dose: no information provided. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/ event (s) and outcome: On 26-Oct-2015, about 1-2 hours after starting / treatment with AFLURIA, the patient experienced itchy (non serious, outcome: Recovered/ Resolved). Later in the day, she developed throat tightness/throat was getting tight (non serious, outcome: Recovered/ Resolved). She went to the hospital and was treated at the hospital (did not know what she was treated with). She did not stay overnight at the hospital and symptoms resolved on 26-Oct-2015 after treatment. Action taken: discontinued. Event treatment: Details manually to be entered. Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate.
No adverse event; Patient received first dose on 19Jan2021 and second dose on 27Feb2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 19Jan2021 and second dose on 27Feb2021) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A, 014M20A, 058H21A and 051B22A) for COVID-19 prophylaxis.     Patient didn't had any drug allergy.  Concurrent medical conditions included Diabetes, Thyroid disorder and Blood pressure abnormal. Concomitant products included LISINOPRIL, LEVOTHYROXINE SODIUM (SYNTHROID), COLESEVELAM HYDROCHLORIDE (WELCHOL), DULAGLUTIDE (TRULICITY), LEVOFLOXACIN (LEVOXL), METFORMIN, ATORVASTATIN, ALLOPURINOL and FENOFIBRATE for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 19Jan2021 and second dose on 27Feb2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 19Jan2021 and second dose on 27Feb2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            It was reported that the patient took Paxlovid from 20Mar2023 to 25Mar2023 for treatment of COVID-19.  Patient had tested negative for COVID-19 test on 29Mar2023. However, on 31Mar2023, patient started to experience symptoms again and on 1Apr2023, patient tested positive for COVID-19. For COVID-19 the outcome was provided as not recovered and patient was neither hospitalized nor received any treatment for it.   Treatment medication information was not provided.
Patient states he felt tingling and a strange sensation on vaccinated arm down to the hand. Symptoms subsided within a couple of minutes.
Sores mouth; Fever blister; Pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a 69-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) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In July 2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant) and ORAL HERPES (Fever blister). On an unknown date, the patient experienced STOMATITIS (Sores mouth). At the time of the report, PNEUMONIA (Pneumonia), STOMATITIS (Sores mouth) and ORAL HERPES (Fever blister) outcome was unknown.            No concomitant medication provided. No treatment information mentioned.  The reporters causality for events with HUMIRA was no reasonable possibility.  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 69 year old female patient with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) event of Pneumonia, unknown days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient also received the second dose from the same vaccine on an unknown date. No information on exact date of the events and vaccination schedule, detailed clinical course, relevant investigations, treatment and outcome of the event was available in the report. Concomitant adalimumab could be a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 69 year old female patient with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) event of Pneumonia, unknown days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient also received the second dose from the same vaccine on an unknown date. No information on exact date of the events and vaccination schedule, detailed clinical course, relevant investigations, treatment and outcome of the event was available in the report. Concomitant adalimumab could be a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
7-10 days after vaccine head was itchy, enough to wake client up at night. Scratching. Started at crown of head and approximately half of clients hair fell out.
A non-serious, spontaneous report of four patients over 49-years of age got H1N1 LAIV was received from a non healthcare professional concerning four adults of unknown gender. No past medical history and concomitant medication were reported for these patients. In Nov-2009, these patients received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
No adverse event; 4 doses in total were administered after the 30 day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 doses in total were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Feb-2023, 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 16-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 doses in total were administered after the 30 day BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 doses in total were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 (4 doses in total were administered after the 30 day BUD).    This case was reported for adult patient 4.  No concomitant medications were reported.  It was reported that 4 bivalent doses in total were administered to adult patients after the 30 day BUD. Two doses administered on 04-Feb-2023, one dose on 05-Feb-2023 and one dose on 16-Feb-2023. It was also reported that patient had no reported symptoms.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-711667 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-711667:Master case - 1st adult
Myalgia Fatigue, swollen lymph nodes in neck, and O2 Sats at 91% Narrative:
pt recvd DTP/OPV/HIB on 15FEB93 & fever to 103 starting about 9 hrs p/vax; persistent crying & irritability through noc to next day; office visit 16FEB, t101.5, fussy, lt thigh puffy & tender; also vomiting;
The symptoms I got were: Headache, body ache, fever, and very cold chills.  The symptoms last for two days.