chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient. A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Lot number: EK5730), on 01Jan2021 as dose 2, single (Lot number: EK4176) and on 29Sep2021 as dose 3 (booster), single (Lot number: EW0170) at the age of 43 years for Covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR, stop date: 10Jul2022; FLUOXETINE; ATIVAN; SPIRONOLACTONE; ALBUTEROL [SALBUTAMOL]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The event "Covid-19 treatment" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jul2022) Negative, notes: in the morning. went to ER on 25Jul and nothing has been found. Covid antigen test is negative also; (unspecified date) Positive, notes: Treatment of COVID-19; (10Jul2022) Unknown results, notes: test on 10Jul. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Other medication in 2 weeks product are Albuterol, stop date: 10Jul2022; FLUOXETINE; ATIVAN; SPIRONOLACTONE; ALBUTEROL [SALBUTAMOL]. On 24Jul (day 14 after Covid+ test on 10Jul) I began experiencing tachycardia, fatigue, tingling in my arms, mild cough restarted, no appetite and shakiness in the morning. Went to ER on 25Jul and nothing has been found. Covid antigen test is negative also. Today is day 4 of these symptoms. Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
MCV shot given left arm 5-13-14. 5-14-14 left arm red, warm and hard just below shot site. No fever.
After experiencing 'normal' post-vaccine reaction (headache, chills, joint pain, tiredness for approx 24 hours), new symptoms came on approx. 48 hours after vaccine. Included extreme lower back pain; tingling, tightness, and weakness in legs; difficulty walking and unable to sit due to pain level.
Possible administration of vaccines after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) for prophylaxis, hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis, hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) for prophylaxis, flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, Rota (Rotarix lyophilized formulation) for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 2nd December 2021, the patient received Infanrix, Infanrix Pre-Filled Syringe Device, Havrix, Havrix Pre-Filled Syringe Device, Engerix B, Engerix B Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, FluLaval Quadrivalent 2021-2022 season, Flulaval Tetra Pre-Filled Syringe Device, Boostrix, Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Infanrix, Infanrix Pre-Filled Syringe Device, Havrix, Havrix Pre-Filled Syringe Device, Engerix B, Engerix B Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, FluLaval Quadrivalent 2021-2022 season, Flulaval Tetra Pre-Filled Syringe Device, Boostrix, Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   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 provided as follows: The age at vaccination was not reported. The medical assistant reported that, a below temperature excursion of negative 2.0 degree celcius for 6 minutes for Infanrix, Havrix, Engerix B, Pediarix, Flulaval QIV, Rotarix, Boostrix, which led to incorrect storage of drug. No priors excursions. The reporter was not completely sure if any of their patients might have been vaccinated with any of these vaccines. No details from patient or patients or any other details provided as reporter was not sure this happened or not. The reporter consented to follow up.
Care team inadvertently gave a duplicate varicella vaccine. CDC vaccine hotline consulted and care expectations given to parent.
Immediately after injection developed swollen glands-sore throat-felt very malaise 2-3d presently c/o dizziness-weak-had 99.7 temp-present 97.9.
Developed axillary lymphadenopathy about 24-36 hours after second dose of Pfizer COVID-19 vaccine. Lymphadenopathy was palpable and visible when arm raised. Significant enough to cause numbness and tingling in arm and hand. Lasted about 24-36 hours, resolved with no treatment.  Patient also had chills, body aches, and fatigue associated with vaccine which began about 12 hours after the dose and lasted for about 24 hours. Lymphadenopathy developed after these other symptoms had resolved, also with no treatment.
Pt recvd 3 doses of Engerix-B & titer were checked 6 months p/last dose & titer result was neg;
- SEVERE SWELLING, PAIN  - ITCHING - LIGHT FEVER  - BLOTCHY  FOR OVER 1 MONTH
The patient reported a raised, red 6 inch welt that is hot to the touch. She descrived it as "on fire" and stated benadryl has not given her any relief. She did say it has not improved or gotten worse since Friday.
This case was reported by a consumer via call center representative and described the occurrence of heart rate increased in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 5 min after receiving SHINGRIX, the patient experienced heart rate increased, tremor of hands, muscle twitching, pain localized, energy decreased and joint pain. On an unknown date, the outcome of the heart rate increased, tremor of hands, muscle twitching, pain localized, energy decreased and joint pain were unknown. It was unknown if the reporter considered the heart rate increased, tremor of hands, muscle twitching, pain localized, energy decreased and joint pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's heart rate jumped to 125 about 5 minutes after the injection and hands shook. The patient experienced calves quivered which continued for 3 to 5 days and also experienced local pain lasted for 3 days, low energy and joint pain for a week. This was 1 of 2 cases, reported by same reporter for same patient. Lab Comments: Lab test performed on an unknown date.
pt recv vax; 15may96 devel chicken pox w/ clear fluid filled pruritic blisters from head to feet; reporter felt that pt failed to respond to the vaccine;pt's brother was also vaccinated w/ varivax at the same time; devel chickenpox on 29apr
on 19MAY pt developed some vomiting, felt mildly ill, had a low grade fever; 21MAY broke in maculopapular rash;
Axillary lymph nodes enlarged/Swollen and sore lymph nodes under arm pit of left arm (same side as covid injection); Lymph node pain/Swollen and sore lymph nodes under arm pit of left arm (same side as covid injection); Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Axillary lymph nodes enlarged/Swollen and sore lymph nodes under arm pit of left arm (same side as covid injection)), LYMPH NODE PAIN (Lymph node pain/Swollen and sore lymph nodes under arm pit of left arm (same side as covid injection)), HEADACHE (Headache) and FATIGUE (Fatigue) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for an unknown indication.    No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Aug-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 30-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Sep-2021, the patient experienced FATIGUE (Fatigue). On 01-Oct-2021, the patient experienced LYMPHADENOPATHY (Axillary lymph nodes enlarged/Swollen and sore lymph nodes under arm pit of left arm (same side as covid injection)), LYMPH NODE PAIN (Lymph node pain/Swollen and sore lymph nodes under arm pit of left arm (same side as covid injection)) and HEADACHE (Headache). At the time of the report, LYMPHADENOPATHY (Axillary lymph nodes enlarged/Swollen and sore lymph nodes under arm pit of left arm (same side as covid injection)), LYMPH NODE PAIN (Lymph node pain/Swollen and sore lymph nodes under arm pit of left arm (same side as covid injection)) and FATIGUE (Fatigue) was resolving and HEADACHE (Headache) had resolved.            Concomitant product use was not provided by the reporter. The patient received 3rd Covid vaccine on 30 Sep 2021 and now had fatigue. Headache 24 hours after receiving 3rd Covid vaccine. Swollen and sore lymph nodes under the arm pit of the left arm (same side as Covid injection) 24 hours after the injection on 30 Sep 2021 and diminishing in size and soreness as of 04 Oct 2021. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of SWOLLEN AND SORE LYMPH NODES UNDER ARM PIT OF LEFT ARM (SAME SIDEAS COVID INJECTION) onset 01 Oct 2021, SWOLLEN AND SORE LYMPH NODES UNDER ARM PIT OF LEFT ARM (SAME SIDE AS COVID INJECTION) onset 01 Oct 2021, HEADACHE and FATIGUE with SKYRIZI(RISANKIZUMAB) was no reasonable possibility. Treatment information was not provided.  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
Second dose scheduled 42 days later; A spontaneous report was received from a 56-year-old female consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and had second dose Moderna COVID-19 vaccine scheduled for 42 days later.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   After receiving the first vaccine on 05 Jan 2021, the second appointment was canceled so the computer system made her another appointment for her second Moderna Covid-19 vaccine on 16 Feb 2021 which is 42 days later and not within the recommended timeline. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, had second dose Moderna COVID-19 vaccine scheduled for 42 days later, was considered resolved.; Reporter's Comments: This report refers to a case of intercepted medication error for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case of intercepted medication error.
He started vomiting just before midnight and he was vomiting violently for about 6 hours. The next morning,  I kept him home. Vomiting was slowing down. There was no fevers as of yet. He was very tired. He started having abdominal pain. We made an appt with the doctor. The next day, he started having fevers to 101.9. I gave  him Motrin and that brought the fever down. He started food and drinks again. The day after all of his symptoms resolved.
9/2/2023 - 9/5/2023 (3 days) Discharge Disposition: Home or Self Care presents to the emergency room complaining of increased shortness of breath over the past 1-2 days.   043A21A 8/30/2021
received Menveo reconstituted with Pfizer Covid diluent; received Menveo reconstituted with Pfizer Covid diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA569A, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received menveo lyophilized powder portion after being reconstituted with pfizer covid diluent when the patient was supposed to get the covid pfizer, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No reactions reported. The reporter consented to follow up. This case was linked with 12 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021240689:same reporter US-GLAXOSMITHKLINE-US2021AMR243472:Same reporter US-GLAXOSMITHKLINE-US2021AMR243469:Same reporter US-GLAXOSMITHKLINE-US2021AMR243473:Same reporter US-GLAXOSMITHKLINE-US2021AMR243474:Same reporter US-GLAXOSMITHKLINE-US2021AMR243475:Same reporter US-GLAXOSMITHKLINE-US2021AMR243476:Same reporter US-GLAXOSMITHKLINE-US2021AMR243477:Same reporter US-GLAXOSMITHKLINE-US2021AMR243478:Same reporter US-GLAXOSMITHKLINE-US2021AMR243479:Same reporter US-GLAXOSMITHKLINE-US2021AMR243480:Same reporter
lymphadenopathy post clavicle both. tenderness to left clavicle Narrative:
pt recvd vax & subsequent pain & dec ROM on rt shoulder d/t pain;no sensory or motory strength loss; no documented fever; ESR=60; CPK nl; Xray showed AC joint DJD;clinically most c/w bursitis;
I received the vaccine in my left arm, and late in the evening, my left breast became VERY painful, and breathing hurt on that side. I took two TYLENOL and went to bed. The breast pain lessened by morning, but 36 hours later, deep breathing is still painful on that side.
The morning after the vax, the pt complained of dizziness with a fever of 101.5 and chills. Fatigue, loss of appetite, body aches all over. The pt remained in bed for 2-3 days, drank fluids and took Tylenol. The area is approximately 2-3 inches in diameter with redness and induration on the right deltoid area. The arm is red hot to the touch and sore. The pt has experienced lingering fatigue.
24 hours after immunization, area red/swollen; went to ER. Rx given of Keflex and instructed to use Benadryl. Follow up with PCP on 8/2/04. Keflex discontinued 8/2/04 by PCP. Zyrtec given.
On 4/3/19 developed one vesicle on his forehead. Soon after became covered in a pink/red macular rash over neck, trunk, and arms. Slightly itchy. Not very bothered by it. No fever or cold sx. Seen here in our office that day (4/3). Mom pregnant and due to deliver any day. Rash has worsened over night 4/4/19 had spread to his face and has more spots all over. Still with no other sx of fever or irritability or cold sx. Consulted with Mom's OB- she had a measles titer drawn here in office. Consulted with public health specialists. Made an appointment with pediatric dermatology for today.
This case was reported by a consumer via call center representative and described the occurrence of meniere's disease in a 50-year-old male patient who received SHINGRIX for prophylaxis. On 21st March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced meniere's disease (serious criteria GSK medically significant), deafness (serious criteria GSK medically significant), tinnitus, influenza and adverse reaction. On an unknown date, the outcome of the meniere's disease, deafness, tinnitus, influenza and adverse reaction were unknown. It was unknown if the reporter considered the meniere's disease, deafness, tinnitus, influenza and adverse reaction to be related to SHINGRIX. Additional details were provided as follows: On 15th July 2018, the patient received 2nd dose of SHINGRIX. The patient experienced severe reactions like the flu and was told that it was expected and was told that it had nothing to do with SHINGRIX. The patient experienced sudden deafness in one ear in between the two doses of SHINGRIX. At the time of reporting, the patient visited a second specialist and confirmed abnormal Magnetic resonance imaging (MRI) and experienced Meniere's disease which never had prior along with hearing loss in his ear and constant tinnitus. The neurological otolaryngology specialist had confirmed that these symptoms were due to zoster virus and wanted to report the severe reaction for SHINGRIX. The patient had not experienced any symptoms of the zoster virus and only got the vaccine due to his age and risk of exposure. Lab Comments: on an unknown date magnetic resonance imaging (MRI) was performed.
Patient advised "full-bodied irregular menses" concern 10 days after receiving second dose. Patient advised concern as she is 3 years postmenopausal.
Spinal neurological damage, inflammation in thoracic spine, partial paralysis in feet and legs,  urinary incontinence.
I got my booster 11/04/2021 and I also ended up having a breakthrough COVID case on 11/10/2021. Toward the end of 11/2021, I had pain in my right arm which is the same arm as my vaccine. It started gradually and ended up being very painful. It didn't hurt on the surface. I could feel the pain inside my arm. It even hurt even when using a soap dispenser. In February, I sent a text to my doctor she prescribed Meloxicam 15mg once daily and Neurontin 100mg 2-3 times daily. This seems to make the pain bearable. I saw a doctor for the pain on 03/15/2022. The doctor put in for a MRI. I am still waiting for that appointment. I did fall and hurt my arm even more, now I am in physical therapy.
At 10:11am, VS 129/98, Apical HR for 1 full minute-102, R-18, 97%-O2 stat, Pt stated, "he feels flushed, feels very nervous, didn't take hypertension medication this morning, had 2 burritos for breakfast."  At 10:30am, Pt stated, "he felt better " Will cont to monitor til 10:45am. At 10:45am, listened to apical HR for 1 full minute-92, O2 stat-98%, Pt stated, 'he feels good and is fine.  Cleared for dismissal.
Jannsen (J*J) - High Fever; Body Aches; Chills
6 days after receiving the first Moderna Covid 19 vaccination, a red itchy sore rash developed around the injection site, approximate size  4"x6", which was warm to touch.  This slowly dissipated over the following 5 days.  However, on the morning of 2/9/21 the same symptoms reappeared without the itching and pain.  Because of this delayed, but concerning reaction, I was seen by my PCP listed above.  MD recommended use of topical hydrocortizone or oral antihistimine as needed.  Also prescribed Augmentin to be taken if the area becomes more red, hot, swollen, and painful.  If the area is not better within 48 hours, to be seen right away by PCP.  NOTE: SECOND INJECTION OF COVID VACCINE CANCELLED BY MD
Broke out in hives; Trouble breathing, shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Trouble breathing, shortness of breath) and URTICARIA (Broke out in hives) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced DYSPHONIA (Trouble breathing, shortness of breath). On 24-Feb-2021, the patient experienced URTICARIA (Broke out in hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 24-Feb-2021, URTICARIA (Broke out in hives) had resolved. At the time of the report, DYSPHONIA (Trouble breathing, shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
Dizziness, body aches 7/10. Stable, released from vaccination site.
Fever 103-104. Pain at injection site. Extreme body aches. Chills. Extreme fatigue. Headache. Upset stomach.
H/A, FEELING CONGESTED, DYSPNEA SHORTNESS OF BREATH.
Reaction to PNEUMOVAX. Day 1 no reaction. Day 2 redness 1-2 inches below injection site. Day 3 +4 +5 fever and swelling of arm from elbow to shoulder - became hot and hard to the touch. Day 6/7 - showing improvement.
Moderna COVID-19 Vaccine EUA Within one hour of injection, my right arm was tingling and face felt flushed. Those symptoms lasted 30-45 minutes and resolved with no intervention. Within 6 hours of injection, pain at the injection site observed. Within 12 hours of injection, as well as pain at the injection site, general muscle aches and joint pain observed and resolved with no intervention within 24 hours of initial injection. Pain and tenderness at the injection site still observed within 24 hours of injection but better and slowly resolving  with no intervention. No redness, warmth, swelling  of injection site and throughout body observed within 24 hours of initial injection.
A report has been received from a Health Professional concerning an 11 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. The health professional reported that patient received expired FLUMIST quad on 02-Dec-2013. The outcome of the event of administration of expired product is unknown. The report was considered to be non-serious.
Fever land fatigue lasting 5 days.  Menstrual cycle 14 days late and menses times 14 days  Asthma exacerbation
I received my vaccine at 2:15PM and I felt completely fine. At 3 in the morning I couldn't breathe and was having chest pain and I have an inhaler and it did not work. I went to my dads house to do a breathing test and i was experiencing pain, chills, a slight fever. I took myself to the ER bc i couldn't take it anymore, they did a chest x-ray and everything looked normal. They gave me a breathing treatment, and also a steroid shot to send me home, because they think that I am experiencing bronchitis.