chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via sales rep and described the occurrence of neuropathy in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 8th March 2019, the patient received SHINGRIX. In March 2019, less than a month after receiving SHINGRIX, the patient experienced neuropathy (serious criteria GSK medically significant), numbness and weakness. The patient was treated with gabapentin, ibuprofen and methylprednisolone (Medrol). On an unknown date, the outcome of the neuropathy, numbness and weakness were not recovered/not resolved. It was unknown if the reporter considered the neuropathy, numbness and weakness to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine in left arm. The side effects listed extend from the patient's left arm up to her ear. The effects had not resolved till the date of reporting.
12MAY97 around 8PM pt started coughing-unusual cough, running t101 13MAY97 5AM awoke coughing-fever 101 c/o h/a, dizziness & vomited in 4hr, t102, tx w/APAP highest t104, c/o pain, warm @ inj site, dizziness & h/a;
Patient called to say that a couple days after her 2nd Pfizer COVID vaccine she developed a red,  swollen arm and is having tingling in the same arm. She said this reaction did not occur at the injection site, but further down the arm.
Rash, urticaria, and dermatographism started about 2 weeks after I got the Moderna booster shot.  The reaction occurred in all body parts but would only affect a few body parts at a time.  Cold compress and benadryl helped in the beginning but benadryl was very sedating. My primary care doctor prescribed prednisone and triamcinolone cream to hold me over until I was able to see my allergist.  My allergist recommended to take Allegra 24 Hr 180 Mg tablets twice daily and have been continuously taking it this way since then.
Felt cold, tired, fever starting at 99.1 F at 8 AM 4/14/2021, rose to 100.1 F at 4 PM 4/14/2021.   No treatment,  rested, felt fine the next day (4/15/2021).
Administered an HPV vaccine on patient on her left arm. Gave apple juice prior to giving vaccine. Patient drank all of the apple juice. Once vaccine was administered, patient got up too quickly and asked if she can remain seated. She sat back down on the bed table, said she was okay. Once I walked out of the room her brother came out and she fainted and we elevated her legs. Took her blood pressure right away, and it was 131/65 Once patient laid down for a few minutes, we retook blood pressure, and it was 100/65, 88/50, 96/61. Patient was feeling nauseous and was pale, but never vomited. Mom brought her something to eat, and after she ate she felt better. Patient was able to get up and walk, felt better and left with mom. Dr said it was okay for patient to leave and will follow up with patient.
Swollen arm Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen arm Injection Site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swollen arm Injection Site). On 30-Jan-2021, VACCINATION SITE SWELLING (Swollen arm Injection Site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided by the reporter. Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Non-Significant follow up appeneded
Pts MD reported that infant came in for 6mo baby check on 10/17/06 and had abscess to right upper thigh. Mother informed MD that some redness and swelling was there following last shot. But had not had checked until 10/17/06. MD did incision and drainage of abscess which was 1cm x about 2cm deep and removed 50C fluid. Infant is on antibiotic and is having wound packed. MD anticipates no problems with recovery and no contraindications to further immunizations.
soreness has toned down a bit; his upper arm was tender and sore and it radiated down his left arm; especially uncomfortable since he sleeps on that shoulder; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 18-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (his upper arm was tender and sore and it radiated down his left arm), INSOMNIA (especially uncomfortable since he sleeps on that shoulder) and ARTHRALGIA (soreness has toned down a bit) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN (his upper arm was tender and sore and it radiated down his left arm) and INSOMNIA (especially uncomfortable since he sleeps on that shoulder). On 18-Feb-2021, the patient experienced ARTHRALGIA (soreness has toned down a bit). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain and Arthralgia, at an unspecified dose and frequency. At the time of the report, PAIN (his upper arm was tender and sore and it radiated down his left arm), INSOMNIA (especially uncomfortable since he sleeps on that shoulder) and ARTHRALGIA (soreness has toned down a bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Contact detail updated
myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Myocarditis following immunization with mRNA COVID-19 vaccines.    No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, Troponin: elevated (High) Elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis) to be possibly related.    No concomitant medication was reported.  Patient symptoms began few days after receiving the product. Patient presented with acute onset of marked chest pain Infectious, ischemic, or autoimmune etiologies was not identified for myocarditis. Patient was physically fit by military standards and lacking any known history of cardiac disease, significant cardiac risk factors, or exposure to cardiotoxic agents. No structural abnormalities were noted on echocardiogram. Patient also visited hospital for chest pain. Patient received supportive care.  Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded.   Author conclusion: the clinical course suggests eosinophilic hypersensitivity myocarditis as described in the context of other drug-associated and vaccine-associated myocarditis.   This case was linked to MOD-2021-284001, MOD-2021-284002, MOD-2021-284003, MOD-2021-245527, MOD-2021-284005, MOD-2021-284006, MOD-2021-284007, MOD-2021-284008, MOD-2021-284009, MOD-2021-284010, MOD-2021-284011, MOD-2021-284012, MOD-2021-284013, MOD-2021-284014, MOD-2021-284015 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Upon internal review on 06-Sep-2021 E2B Company Number was updated from US-MODERNATX, INC.-MOD-2021-245527 to US-MODERNATX, INC.-MOD-2021-284004. On 05-Jul-2021: Follow up received by safety 07-Jul-2021 included the full text article added with no new information. On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included the full text article added with no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded.
Aches.pain, shakes, temp>100 and as high as 100.8. Cough. Tired.Missed work.
dizziness; pressure in my left ear; severe headache/ not as severe as before now; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), EAR DISCOMFORT (pressure in my left ear), HEADACHE (severe headache/ not as severe as before now) and NAUSEA (nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), EAR DISCOMFORT (pressure in my left ear), HEADACHE (severe headache/ not as severe as before now) and NAUSEA (nausea). At the time of the report, DIZZINESS (dizziness), EAR DISCOMFORT (pressure in my left ear), HEADACHE (severe headache/ not as severe as before now) and NAUSEA (nausea) outcome was unknown.            Other concomitant medications include a diuretic  Treatment information, if any, was not provided by the reporter.
I got the shot shortly after 9:00 a.m. and woke up with a very heavy menstrual cycle. I hadn?t had a period since April so thought I was going through menopause. The only time I have passed this much blood and clots was after giving birth. I went to the doctor today as it is still very heavy. I am now 10 days into having this. It would be extremely helpful if you can provide information of how long is it okay to be bleeding like this. My doctor did a pelvic exam and notated I am still clotting and bleeding heavily. She prescribed medroxyprogesterone to stop the bleeding. I am going to hold off on taking that for another week to see if it will slow down or stop. The side effects of that pill are not the greatest. I don?t regret getting the Moderna shot. I am letting you know so you can help women with what to expect and how long should it last before you menstrual cycle is a concern.
After about 2 hours, I felt a pull in my shoulder which led to excruciating pain throughout my shoulder and arm. I couldn?t sleep, so I contacted a dr online at 6 in the morning. I was able to see my doctor later that day, and she said the vaccine was injection too high (in my shoulder) opposed to in the deltoid muscle. I am now taking oral steroids and have an orthopedic appointment tomorrow.
My first dose on may 18th 2021. Side effects hit me 45 minutes later.  Head ache, chills like flu, my felt hot like I was on steroids.  No fever. pain in arm where I recieved the shot,  loss of appetite,  weakness in my body. Body ached to the point I cried. It lasted for 5 days.
3 1/2 inch x 3 1/2 inch red area around injection site. Slight swelling 2cm at site of injection site "itches". Right arm - Hep A.
I began breaking out in hives.  With every touch, scratch or run everywhere on my body other than my face breaks out In red streaks and whelps.  I am 7 days out and still itching and breaking out in hives all over. 3/4/21.
administered an expired Pentacel to patient this morning and the expiration date is 19May2018; Initial information received on 26-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old patient who experienced administered an expired pentacel to patient this morning and the expiration date is 19may2018, while he/she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  On an unknown date, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5339AA, expiry date- 19-May-2018 via intramuscular route in left thigh.  The patient developed a non-serious administered an expired pentacel to patient this morning and the expiration date is 19may2018 (expired product administered) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  (Other relevant tests included No lab data.) Final diagnosis was administered an expired pentacel to patient this morning and the expiration date is 19-May-2018.    It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Not Applicable for administered an expired pentacel to patient this morning and the expiration date is 19may2018.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Dizziness, NauseaVomiting, fatigue, arm pain, chills Narrative: Dizzy, nausea, vomiting, fatigue, arm pain, chills.
Shortly following vaccine administration I experienced the following symptoms: itchy rash/hives on forearms, sore throat with extreme dizziness, a piercing headache, and a mildly swollen face and throat
Died within 24 hours after getting the vaccine; This spontaneous case was reported by a physician and describes the occurrence of DEATH (Died within 24 hours after getting the vaccine) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information was provided.  It was stated that the patiet died within 24 hours after getting the vaccine. HCP would like to suggests that the recommendation be made for patients with a cardiac condition or a life threatening disease to be monitored and not be alone after getting the vaccine for 48 hours.  Company comment: This case concerns a 54-year-old female patient with no medical history provided, who eventually died within 24 hours after she received the mRNA-1273 vaccine (serious unexpected event of Death). The cause of death and autopsy results were not provided. It remained unknown which dose of the vaccine the patient received before she died. No further information was provided at the moment. The re-challenge is not applicable as the patient died. Limited information precludes a meaningful medical assessment in this case. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 54-year-old female patient with no medical history provided, who eventually died within 24 hours after she received the mRNA-1273 vaccine (serious unexpected event of Death). The cause of death and autopsy results were not provided. It remained unknown which dose of the vaccine the patient received before she died. No further information was provided at the moment. The re-challenge is not applicable as the patient died. Limited information precludes a meaningful medical assessment in this case. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Presents to ED Cough (Without SOB) covid + staff, 90% on RA, productive cough COVID 19 PNA and acute hypoxemic respiratory failure from it. Was managed with Remdesivir, systemic steroids, supplemental O2 and lovenox.
Did not feel well after the first dose of the Moderna Covid 19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Did not feel well after the first dose of the Moderna Covid 19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Did not feel well after the first dose of the Moderna Covid 19 vaccine). At the time of the report, MALAISE (Did not feel well after the first dose of the Moderna Covid 19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Drug details were reported.  Patient received the booster dose of the Moderna Covid 19 vaccine on January 2022 or beginning of February 2022.  No Treatment information was provided.   This case was linked to MOD-2022-526723 (Patient Link).
Ankylosing spondylitis flare; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4463385-00 (Agency).  A 29-year-old female patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 29 years intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Batch/Lot number: unknown), oral for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANKYLOSING SPONDYLITIS (medically significant), outcome "not recovered", described as "Ankylosing spondylitis flare". The action taken for upadacitinib was unknown.  The reporter considered "ankylosing spondylitis flare" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the event Ankylosing spondylitis flare and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sore arm (unable to lift, move well), swelling, redness (half dollar size at sight), sore throat, headache, low grade fever.,
Expired vaccine administered to the patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator on 04-Apr-2022. The vial did not undergo any temperature excursions. It was reported that pharmacist thought that the vaccine expired in Jun-2022, however it was expired on 01-Apr-2022.  No treatment information was reported.
Took Vivotif which was left out of the refrigerator for little less than 24 hours; Spontaneous report received on 27DEC2019.  A male consumer reported that he "took Vivotif which was left out of the refrigerator for little less than 24 hours" (PT: Product storage error). He was receiving Vivotif for immunisation. On 23DEC2019, the consumer stated that he left the Vivotif out of refrigerator for a little less than 24 hours at 68 degree Fahrenheit. He did not have the lot number. On 27DEC2019, he took the dose of Vivotif. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took a dose of unrefrigerated Vivotif (Incorrect product storage). The causality of the event is assessed as not applicable due to the nature of the event.; Sender's Comments: A consumer took a dose of unrefrigerated Vivotif (Incorrect product storage). The causality of the event is assessed as not applicable due to the nature of the event.
Pt entered observation @ 1645.  @ 1704 states prickles felt on back and arm.  States s/s had been going on about 10 mins before she said anything.  Benadryl 25mg given @ 1705.  Does have allergies to Flu Vaccine, MRI Dye, Vicodin, Buspar, Lisinopril, Suchycin. Celexa, Prev Pack, Lexapro, Penicillin, Hydrocodone, and Fluoxetine.  Remains to voice s/s @ 1729.  Red Blotchy areas noted to face and neck.  Pt states this is normal for her when her anixety level is high.  V/S were taken @ 1733 BP-193/105, P-74, R-18, 02-100% on L arm.  V/S obtained on R arm @ 1731 BP-193/111, P-76, R-18, O2-100%.  States that takes BP meds daily @ night, in which she hasn't taken her meds all day.  Takes Amlodipine 5mg, Klonopin 0.5mg, Vit D 1000, MVI, Clartin 5mg, and Zantac 150mg.  Stil continues to voice s/s @ 1739.  BP remains elevated.  Patient sent to ER @ 1740.  Pt entered registration @ ER @ 1745.  Pt continue to voice s/s of prickling noted to body.  Denies SOB nor trouble w/ breathing.
Patient hospitalized for Robotic low anterior resection, right oopherectomy for malignant neoplasm of sigmoid colon within 6 weeks of receiving covid vaccination.
pt. experiencing redness to chest and some itching on L. thigh.   pt. states this reaction is normal with contact with her dog? she recently had contact.  pt. denies any other S/S.   pt. advised to wait an additional 15 mins.