chrisvoncsefalvay/vaers-outcomes huggingface dataset:
heat, burning area on T-5 area;erythema & blotches @ inj site (present w/all injects);
Local site rxn-redness and swelling at site. (Left arm) muscle sorness in left arm.
Significant swelling to R arm from Deltoid down to forearms. Erythema, warmth low grade fever.
approx 3 hrs p/vax administration pt exp chills, malaise, SOB, etc; tx'd & released;
Severe muscle weakness couldn't move arms nor legs; Loose palm movement; He has a super pubic tube and the bag wasn't very clean; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Severe muscle weakness couldn't move arms nor legs), HYPOKINESIA (Loose palm movement) and CATHETER MANAGEMENT (He has a super pubic tube and the bag wasn't very clean) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-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 MUSCULAR WEAKNESS (Severe muscle weakness couldn't move arms nor legs), HYPOKINESIA (Loose palm movement) and CATHETER MANAGEMENT (He has a super pubic tube and the bag wasn't very clean). On 30-Jan-2021, MUSCULAR WEAKNESS (Severe muscle weakness couldn't move arms nor legs) and HYPOKINESIA (Loose palm movement) had resolved. At the time of the report, CATHETER MANAGEMENT (He has a super pubic tube and the bag wasn't very clean) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: unknown (Inconclusive) Inconclusive. On an unknown date, Magnetic resonance imaging head: negative (Negative) Negative. On an unknown date, Magnetic resonance imaging heart: negative (Negative) Negative. On an unknown date, X-ray: unknown (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: NNI
This spontaneous report was received from a healthcare worker refers to an unspecified patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored GARDASIL (lot# K006117, expiry date 14-JAN-2017). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Pt received shot (HPV #2) on 7/2/15. On 7/3/15 pt passed out, received a concussion, and began with severe HA and malaise. Was seen in ER x 2 (CT was wnl). Came to my office (her PCP) today for f/u with continued HA (headache) and malaise.
This spontaneous report was received from a nurse practitioner via company representative and refers to a 17 year old male patient. In approximately June 2016 (reported as "within two weeks"), the patient was vaccinated with the first dose of a three dose series of GARDASIL (intramuscularly in the arm, dose was not reported, lot number was reported as L03510551417, expiration date unknown). In approximately June 2016, one week after the vaccination, the patient's arm swelled from the upper arm down to the wrist. He sought medical attention (reported as "taken to hospital") where he was given an ultrasound, which result was not provided. No treatment was given for the event. The swelling resolved on its own in approximately June 2016. Causality assessment was not reported. The physician could not identify a cause for the swelling, however patient's mother considered the event to be vaccine related. It is too soon to determine if the patient would continue with dose two and three of the GARDASIL series. Additional information has been requested.
body aches; fatigue; flu like symptoms; dizziness; headache; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, between 3 and 5 months after receiving Shingrix, the patient experienced general body pain, fatigue, influenza-like symptoms, dizziness and headache. On an unknown date, the outcome of the general body pain, fatigue, influenza-like symptoms, dizziness and headache were recovered/resolved.   The reporter considered the general body pain, fatigue, influenza-like symptoms and dizziness to be related to Shingrix. It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The patient had dose of Shingrix and felt as if was getting the flu having body aches and fatigue.  The patient also had headache and dizziness. For the tolerance of 2nd dose refer case US2019AMR201634.
The patient experienced headache, diarrhea, injection pain, and nausea.   Symptoms subsided between 24-48 hours following booster.
This spontaneous report was received from a nurse, and it refers to a patient of unknown age and gender. The patient's current condition included unspecified autoimmune disorder and being immunocompromised. The patient's concomitant medications included unspecified immunosuppressant therapy. No information was provided regarding the patient's medical history. On 05-JUN-2018, the patient was vaccinated with M-M-R II lot # N023150 with expiration date of 24-AUG-2019, for prophylaxis (dose, route of administration, lot number and expiration date were not reported). Despite the fact, the vaccine was contraindicated for people that had a weakened immune system, such as an immune deficiency, an inherited immune disorder. There were no adverse effects reported and no further information was provided.
Memory impaired/MEMORY ISSUES; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (Memory impaired/MEMORY ISSUES) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced MEMORY IMPAIRMENT (Memory impaired/MEMORY ISSUES). At the time of the report, MEMORY IMPAIRMENT (Memory impaired/MEMORY ISSUES) had not resolved.            No concomitant medications were reported. The reporter causality for the event of Memory impaired was Not related for cosuspect humira. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The Humira drug was available as Solution for injection in pre-filled pen. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Patient received the incorrect Moderna booster dose of 0.5mL instead of 0.25mL (after receiving the Johnson & Johnson vaccine). Patient said she did not have any adverse effects from the vaccine.
Patient received Menactra on 8/4/2008 and developed leg swelling within a few days.  She presented to my office on 8/19/2008 with symptoms of lupus.  09/19/2008 PCP records received for OVs 8/18/08 and 8/21/08. Pt presented with c/o several week hx of swelling and pain of the lower extremities which began following meningococcal vax on 8/4/08.  Ankles tender to touch. Intermittant fever and lower extremity bruising and feeling cold.  PE (+) for bruising and ankle edema. DX:  arthritis. Seen for F/U. Unable to stay at college due to difficulty walking around campus. New onset erythema and ankle pain.  HYperpigmented lesions noted on lower legs. Increased edema and pain. Suspected DX:  Lupus. Refered to Rheum. Rheum consult dated 9/11/08 received. Assessment:  Mildly abnormal LFTs, mildly elevated anti-smooth muscle antibodies, (+) ANA, erythema nodosum type lesions, malaise and almost a serum sickness-like reaction following meningitis immunization. No specific dx made.  Refered to GI. GI eval 9/16/08 with reported onset of lower extremity muscle/joint pain and swelling, feeling poorly and erythema nodosum. Clinical Impression:  Profound antibody response to vaccination, most likely a non-specific immune mediated reaction trigger by vaccination. Not Lupus.  LFTs improving.
Patient reports tingling and numbness down whole arm after receiving vaccine; could feel and move hands after 20 minutes but could not lift arm without assistance. Refused EMS transport; mother of patient opted to take her mother to urgent care.
This spontaneous report as received from a registered nurse refers to a 5 months old patient of unknown gender. The nurse reported that on 03-FEB-2014, the patient was vaccinated with the second dose of ROTATEQ, lot #J007283; expiration date: 27-SEP-2014. Route and dose were not reported. On 17-MAR-2014, the patient received the third dose of ROTATEQ, (Lot # J008735), expiration date: 24-MAR-2015. No other co-suspect or concomitant medications were reported. The nurse reported that both doses received by patient were vaccines improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected.
Patient transferred from another ED for dialysis. Hyperkalemic and bradycardia in the ED. She was shifted with insulin/D50 and given bicarb/calcium. On arrival, she went for dialysis and electrolytes were given.  She had two dialysis runs, whereupon fluid was pulled off. UCx showed it was sensitive to Zosyn. She received 4 days total of treatment, so it was not continued on discharge. ED visit and hospital admission within 6 weeks of receiving the COVID-19 vaccine.
No adverse event; Patient was administered a lower than authorized dose of the Moderna booster; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient was administered a lower than authorized dose of the Moderna booster) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 10-Aug-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Aug-2022, the patient experienced UNDERDOSE (Patient was administered a lower than authorized dose of the Moderna booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient was administered a lower than authorized dose of the Moderna booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient was administered a lower than authorized dose of the Moderna booster).    No concomitant product use was provided.  On 10-Aug-2022, the patient received a 0.25 mL dose from the dark blue cap with the purple border, instead of 50 mcg/0.50 mL dose.   The patient had not reported any adverse reactions to this dose yet.   No treatment medication was provided.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the long term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2016, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient received his second dose of Pfeizer's COVID-19  vaccine on 8/12/2021; on 8/14/2021, the patient developed chest pain.  On 8/15/2021, the patient had recurrence and worsening of his chest pain.  He was admitted to the hospital and was found to have elevated troponins, electrocardiogram with nonspecific ST changes.  His chest pain also worsens with deep inspirations. There was suspicion for Myopericarditis.
Intussusception 01/7/12 reduced intraoperatively 1/8/12.
Getting shingles from the shot/ suspected vaccination failure; Eye getting shingles; Got blind in one eye; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Getting shingles from the shot/ suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Eye getting shingles) (serious criteria GSK medically significant) and unilateral blindness (Verbatim: Got blind in one eye) (serious criteria GSK medically significant). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and unilateral blindness were not reported.   The reporter considered the vaccination failure and ophthalmic herpes zoster to be possibly related to Shingles vaccine. It was unknown if the reporter considered the unilateral blindness to be related to Shingles vaccine.     The company considered the vaccination failure and ophthalmic herpes zoster to be possibly related to Shingles vaccine. It was unknown if the company considered the unilateral blindness to be related to Shingles vaccine.   Additional Information: This case was reported by patient friend via interactive digital media. The reporter reported his or her friend received Shingles vaccine and experienced shingles in eye and hot blind in one eye. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible, as no contact details were available. According to narrative verbatim the causality was conservatively captured as possible.
Patient takes allergy shots 3 times a week and she wants to received Shingrix second dose./ first dose was on April 19th 2021; This case was reported by a pharmacist via call center representative and described the occurrence of allergy in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th April 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced allergy. The patient was treated with allergens (nos) (Allergy Shots). On an unknown date, the outcome of the allergy was not recovered/not resolved.   It was unknown if the reporter considered the allergy to be related to Shingrix.  Additional details were provided as follows: The age of the patient was over 50 years old. The age at vaccination was not reported. Pharmacist was looking for information about Shinrgix second dose for the patient who took allergy shots 3 times a week and she wanted to receive Shingrix second dose.  No information was provided about allergy product type or brand name.  The reporter did not consent to follow-up.
L upper arm with redness, edema, warm to touch "sore". No shortness of breath.
Patient began having numbness in left great toe on 3/14/2022 which then spread to right great toe.  Numbness then spread to her hands and fingertips.  On 3/20/2022, patient then noticed facial droop and was admitted to the hospital from 3/20/2022-3/26/2022  and was diagnosed with Gullian Barre syndrome.
Medical assistant calls to report PNEUMOVAX 23 lot#u035117  8/18/2023 administered after expiration date.   See AE case 02467053   No further AE.  No PQC  MIR request case 02467042.; Medical assistant calls to report PNEUMOVAX 23 lot#u035117  8/18/2023 administered after expiration date.   See AE case 02467053   No further AE.  No PQC  MIR request case 02467042.; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 07-SEP-2023, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, one time, lot #u035117, expiration date: 18-AUG-2023, administered for prophylaxis (strength, and route of administration were not provided).  On 07-SEP-2023, medical assistant called to report pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was administered after expiration date. See adverse event (AE) case 02467053.  No further AE. No product quality complain (PQC). Request case 02467042.
given adacel instead of daptacel with no reported adverse event; Initial information received on 21-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old female patient who was given diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] instead of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine A/C/Y/W CONJ (CRM197) (MENVEO) for Prophylactic vaccination (immunization).  On 21-Jun-2023, the patient received a dose 1  dose 0.5 ml of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection lot 2CA18C1 expiry date: 29-Nov-2024 via intramuscular route in the left arm for prophylactic vaccination (immunization) and was  given adacel instead of Diphtheria-15/Tetanus/5 AC Pertussis Vaccine  with no reported adverse event (wrong product administered) on the same day.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event given adacel instead of daptacel with no reported adverse event.   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.; Sender's Comments:  US-SA-2023SA191326:
immed onset of arm pain, traveling from site distal to full length of arm; 1 hr later pt presented c/o of anxiety, queziness uncomfortable lying or sitting or standing crying; severe arm pain traveling into neck & jaw;
Slightly lightheaded.  Checked B/P and observed.  B/p on discharge 146/80 and lightheadedness subsided
Admitted with cough, SOB, lightheadedness; + covid in ED; CXR wit patchy infiltrates bilat; Dx Covid PNA Labs: D-dimer 2.39; CRP 3.8; Ferritin 102; Tx: Patient started on IV Zosyn, azithromycin, dexamethasone, Lovenox, solu-medrol.  Also rec' d remdesivir, baricitinib, zinc, Vit C; Patient initially required high-flow nasal cannula, BiPAP noninvasive ventilation, prone ventilation.  Thoracentesis on 2/13 for pleural effusion;  During course of hospital stay, patient gradually improved.  Back to baseline for home O2 by d/c.
Main Symptom: Arrhythmia (Irregular Heartbeat), led to chest pain, dizziness, fainting, and drop in heart pulse. The day before AE symptoms: low grade fever, headache, body-ache.
Right shoulder of deltoid area of injection site warm to touch, red, with lineated border from surrounding unaffected skin. Start Hydrocortisone Cream, 1 %, 1 application to affected area, Externally, Twice a day, 07 days. Notes: Suspicion is now cast on the KINRIX as the main culprit of this vaccine reaction. I'm using skin marker to delineate the area and will f/u in 2-3 days time. Mom has BENADRYL and will continue to dose appropriately.
Mother states that Left upper arm became very red, swollen, and warm to touch after receiving vaccines. Mother states that area measured between 9-10 cm. Mother immediately medicated child with Motrin and Benadryl. Mother did notice a decrease in redness and swelling after child received medication. Mother states on 01/11/2011 area is bruised and still slightly red.
The mother of the patient gave her some Tylenol 1 1/2 hours before her immunizations. Approximately 1/2 hour after the shots, the mother states the child feel asleep. When the mother tried to awaken the infant she was unable to do so. She took the infant to the ER per squad. In the ER the infant was observed until 6 PM. Then sent home per private auto. No treatment given. ER physicians diagnosed: Hypotonic Episode.
Patient presented to pharmacy with Bell's Palsy like reaction. Went to immediate care and referred to emergency room in which patient denied attendance. Patient made appointment with doctor for follow-up instead