chrisvoncsefalvay/vaers-outcomes huggingface dataset:
earache in her right ear returned after receiving her second Moderna dose; 2nd dose administered after 37 days; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (earache in her right ear returned after receiving her second Moderna dose) and INTENTIONAL PRODUCT USE ISSUE (2nd dose administered after 37 days) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced EAR PAIN (earache in her right ear returned after receiving her second Moderna dose) and INTENTIONAL PRODUCT USE ISSUE (2nd dose administered after 37 days). On 16-Apr-2021, INTENTIONAL PRODUCT USE ISSUE (2nd dose administered after 37 days) had resolved. At the time of the report, EAR PAIN (earache in her right ear returned after receiving her second Moderna dose) had not resolved. Not Provided          No concomitant medications were reported.  Patient reported that  she has spoken to her physician again, and he believes her earache is related to "allergies."  Patient reports her physician could not definitively determine if there is a causal relationship between her symptoms and the Moderna COVID-19 Vaccine.   This case was linked to MOD-2021-081289 (Patient Link).
Face swelling, hives and mom states obstructed airway - received BENADRYL and steroids at ER.
Mother stated that her son was having a reaction to the vaccines administered on Tuesday 08-01-2023. She stated that his arm was red, bruised, swollen around injection site and was hard around the " hole ". He also had a couple of bubbles at injection sites. Patient was also feverish. Mother stated that she administered ibuprofen and was putting cool compresses around sites. I suggested to her that she could take her son to his primary care provider if she felt that it was necessary and for further treatment. Educated regarding VIS forms that she received at time of vaccine administration and she verified that she did read them and noted the side effects listed.
2/7/2022 Woke up in the middle of the night and was very off balance and had to use objects to make it to the bathroom. Began losing use and dexterity of left arm. Symptoms worsened and on the 10th my son had to pick from work and take me to an urgent clinic. After failing multiple coordination and strength tests the Doctor believed I was having a stroke and instructed me to go straight to the ER. He asked if I had a driver or if they needed to provide me with an ambulance. I told him that my son was with me to drive. He wrote me a note to give to the front desk of the ER and told me to get there quick. I arrived at the ER and they performed an MRI, EKG, carotid doppler, blood work, and urine. They determined that I was having a stroke and I was admitted to the hospital. Started working with an occupational therapist. Spent 2 days in the hospital and was discharged with 16 weeks of physical and occupational therapy. Also had an appointment with another department for a brace for my left foot, which had developed drop foot. I was unable to work for 3 months. Neurology insisted I go to the eye doctor to check for loss of peripheral vision, the pressures in my eyes was very elevated so I was sent to a glaucoma specialist. The glaucoma specialist diagnosed me with narrow closure glaucoma. On 4/11 had to have laser surgery on my left eye to relieve the pressure and then the same surgery on the right eye on 04/18.
Tested positive for COVID on 22Oct2023; Tested positive for COVID on 22Oct2023; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 at 10:45 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, on 19Sep2023 as dose number unknown, single; ESTRADIOL; NASONEX. Past drug history included: Bactrim, reaction(s): "known allergies: Bactrim". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Oct2023 at 10:00, outcome "recovering" and all described as "Tested positive for COVID on 22Oct2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Oct2023) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Information has been received from a registered nurse concerning a 12 month old male (the doctor's son) with no relevant medical history who on 10-JUN-2008 was vaccinated with 0.5 ml VARIVAX (Oka/Merck) by subcutaneous injection (lot number and injection site not reported) and a dose of MMR vaccine and "other vaccinations" at another physician's office. On 13-JUN-2008 the patient experienced a fever of 102F. On 14-JUN-2008 the patient experienced a rash on trunk and back, Unspecified medical attention was sought. On 16-JUN-2008, the patient's rash was clearing and no fever noted. Additional information has been requested.
3cm area of edema/erythema to R deltoid without evidence of abscess/fluctuants/induration.
injection site lump; injection site redness; injection site bruise; Patient got a subqutaneous injection instead of Intramuscular; Initial information received on 25-Oct-2021 regarding an unsolicited valid non-serious case received from a pharmacist via Media Information (under the reference 00826944).  This case involves a 65-year-old female patient who experienced injection site lump (vaccination site mass), injection site redness (vaccination site erythema) and injection site bruise (vaccination site bruising) after receiving DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] she got a subqutaneous injection instead of Intramuscular (incorrect route of product administration).  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 02-Oct-2021, the patient received a 0.5 mL total dosage form of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [Dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for Tuberculin (TB) skin test 0.5ML strength: standard except for Fluzone high dose, lot U66846AA, expiry date 16-Oct-2022] via subcutaneous route in the left arm for prophylactic vaccination.  On 02-Oct-2021, the patient developed a non-serious injection site lump (vaccination site mass), injection site redness (vaccination site erythema), injection site bruise (vaccination site bruising) same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was an actual medication error due to incorrect route of vaccine administration (latency same day). No other vaccine.   It was reported "The caller stated that they administered ADACEL to a patient in the deltoid muscle of the arm on 21-Oct-2021. The caller stated that the patient called and reported injection site lump, brise and redness. She also said that the needle that was on the syringe did not go all the way in, so she believes she got a subqutaneous injection instead of Intramuscular."  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Patient with syncope while sitting about 30 seconds after administration of vaccine.  Patient had some spastic movement of upper extremities and lost control of bladder and voided.  Patient awakened spontaneously after approx 30 seconds and was alert and oriented. Had some diaphoresis.  BP was 100/77 supine.  Pt was able to sit up and drink apple juice 5 minutes later and then 5 minutes later was able to ambulate out of the office with her mother.
This spontaneous report has been received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. The nurse stated that the patient started human papillomavirus (HPV) series with GARDASIL 9 administered on an unknown date for prophylaxis (dose, route of administration and anatomical location were not provided). Then, on an unknown date in 2017, the patient was inadvertently vaccinated, as second dose of GARDASIL 9, with an expired dose of GARDASIL with lot number K010215 and expiration date on 17-JAN-2016 (also reported as 05-MAY-2017) (dose, dose number, route of administration and anatomical location were not provided), administered for prophylaxis. No adverse effects were reported.
Started with fatigue about 12 hours after injection and then developed worsening shortness of breath which kept him awake and felt to him like pulmonary edema but did not improve with lasix; explosive diarrhea and abdominal cramping; then dramatic worsening of breathing with air hunger progressing rapidly to complete respiratory failure - he turned blue and became unconscious just as paramedics arrived. Taken to ER and intubated, noted to have mottled skin and fever on ER report but normotensive until sedated for intubation. Admitted to ICU. Extubated just over 24 hours after admission and weaned off pressor support (seemed to need it only when sedated). Given IV antibiotics. Had fever for 2 days and then better. Local skin reaction to shot also better after fever resolved.
Red face; Itchy arm; Swelling; Headache; Low grade fever (99.8); This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Red face), PRURITUS (Itchy arm), SWELLING (Swelling), HEADACHE (Headache) and PYREXIA (Low grade fever (99.8)) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 immunisation.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced ERYTHEMA (Red face), PRURITUS (Itchy arm), SWELLING (Swelling), HEADACHE (Headache) and PYREXIA (Low grade fever (99.8)). At the time of the report, ERYTHEMA (Red face), PRURITUS (Itchy arm), SWELLING (Swelling), HEADACHE (Headache) and PYREXIA (Low grade fever (99.8)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Approximately 30 to 60 minutes after receiving Flumist, pt. developed syncope with loss of consciousness.  Transferred to local hospital via ambulance. B/P normal, awake and oriented, diagnosed with syncope.  Returned to ER on 10/19/2013 and diagnosed with URI/cough and viral syndrome.
Pt received one dose of Flulaval which is indicated for adult use only.  Injection was in right deltoid.  Per parent, patient had no reactions and is doing fine.
Onset of shakes, fever 102 degrees, malaise less 24 hours after receipt of vaccine. Pt then slept 12 hours. Next day symptoms continued (7/13/05). Swelling of LA noted upon dressing in am of 7/14/05. Left axillary lymphadenopathy, accompanied by redness of upper arm. Pt had ov with HCP. Dx'd with cellulitis. Rx'd with abx. Symptoms resolved with tx.
1) Rapid Onset of Severe Fatigue, Acute: Accompanied by Atypical Chest Pain, Severe Dizziness, Extremely low energy, Light headed-ness, loss of strength and difficulties walking. Admitted to Emergency Room via EMS on August 24, 2021. Symptoms still persist after discharge from Emergency Room.  2) Additional Symptoms after discharge from Emergency Room on August 24, 2021: Low Energy, Balance Issues, heart palpatations, Worsening Insomnia, Continuous Fatigue. Symptoms continue today. 3) Additional Events & Symptoms after 2nd Dose of Janssen COVID-19 Vaccination on 11/18/2021. See next Report filed for 2nd Dose (Booster).
This spontaneous case was initially received on 03-Nov-2015. The case report was received from a Health Professional and concerns a 33 years old female patient. Weight: 240 pounds, Height: 74 inches. For concomitant medication and therapy dates refers to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for indication Protection against seasonal influenza virus on 09-Oct-2015 -09-Oct-2015, Batch no: T51608, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug (s): No additional drugs suspected.
Chills sweats vomiting diarrhea body aches no energy slept for most of day
shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 11th April 2019, 57 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacy has the patient who got his 1st Shingrix 2 months ago, and was due for his 2nd dose on the date of reporting. The patient developed shingles 2 days before his 2nd dose was due. The pharmacy asked how should we proceed with the vaccination schedule given these circumstances.
3hr p/vax pt became listless;7hr p/vax temp went to 102;APAP given through noc et temp remained inc on 29JAN97 next AM 7:30 temp 104 et pt listless;took to MD;
I have them now. Dr. told me the same thing about the covid vaccines/Suspected vaccination failure; I have them now; This 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.   The patient's past medical history included covid-19. Previously administered products included Covid-19 vaccine (received 1st, 2nd and 3rd dose on an unknown date).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that he/she had them now.  It had been a month. The patient's doctor told him/her the same thing about the covid vaccines.  The patient had three. He/she almost died from Covid. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible, as no contact, details were available.
A nurse administered Tetanus and Decavac instead of Fluzone to 10 families (14 patients) in a span of 3 weeks.
Redness and swelling; Redness and swelling; Itchy at the Injection area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy at the Injection area), VACCINATION SITE ERYTHEMA (Redness and swelling) and VACCINATION SITE SWELLING (Redness and swelling) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029620A - 029C20A not sure) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy at the Injection area). On 31-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness and swelling) and VACCINATION SITE SWELLING (Redness and swelling). On 03-Feb-2021, VACCINATION SITE ERYTHEMA (Redness and swelling) and VACCINATION SITE SWELLING (Redness and swelling) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itchy at the Injection area) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
eye irritation; very large puffing eye that I could not open; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: EYE IRRITATION (non-serious), outcome "unknown", described as "eye irritation"; PERIORBITAL SWELLING (non-serious), outcome "unknown", described as "very large puffing eye that I could not open".  Customer Verbatim: I received my 1st shot and within 7 days started experiencing eye irritation which later turned into a very large puffing eye that I could not open I received meds but my physician was very curious he had 2 patients in 2 hours with the same thing. Later that week I received an article about this same issue being studied in withheld.  Follow-up (18Feb2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200073208 same reporter/drug/event, different patient;US-PFIZER INC-202200073160 same reporter/drug/event, different patient
I tested positive for covid antigen on April 25th. I took 2 tests. The rapid tests.
Injection arm very sore by 20:00 day of vaccine. Awakened with body aches at 03:00 and chilling. No fever. Went to work (frontline healthcare worker) at 08:00 but left work early (14:00) for worsening body aches moderate joint pain and increasing fatigue. Polyarthralgias and myalgias intensified as did chilling. By 10:30, abdominal pain had begun. And diarrhea had begun. The next 12 hours were continued intensity of abdominal pain (diffuse intense cramping), and severe myalgias and poly arthragias. I took additional naproxen (440mg w good 16 hours from am dosing at 07:00).  I was unable to do any thing but try to rest between bouts of diarrhea. Nausea developed  (moderate) but no vomiting.  No fever despite intense and unrelenting chills for about 24 hours.  Continued fatigue into post vaccine day 2 (12/19/20) but improved pain and resolution of GI symptoms. On 12/20, only mild polyarthralgias of hands, arms, low back, knees, feet, and hips.
Received Expired Vaccine beyond the manufacturer's expiration date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine beyond the manufacturer's expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine beyond the manufacturer's expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine beyond the manufacturer's expiration date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported.  Vial did not undergo any temperature excursions.  The vial was initially stored in the refrigerator on 13 APR 2022.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2022: Live follow-up added: Reporter added, initial reporter address, the date of vial was initially stored in the refrigerator was updated
Headache 20 mins after vaccine pain 2/10  Assessment: Vitals:  B/P: 124/72 HR: 67 Resp.: 20  O2sat: 97 Skin Signs: Warm and dry Resp.: Breath Sounds Clear Bilaterally  Treatment: Vital signs & Assessments  Repeat Assessment  Vitals: B/P: 124/70 HR: 65 O2Sat: 93 Treatment: Vital signs & re assessment   Told to take Tylenol if HA returns. Nearly gone at discharge @ 17:05. Recommended plenty of fluids. Assisted by wife and caregiver to door. States feeling better.
pt rcvd vax; pt devel flu-like symptoms for 1 wk & a feeling of run down;