chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administration of the adjuvant only/No reconstitution; Administration of the adjuvant only/No reconstitution; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Administration of the adjuvant only/No reconstitution) and inappropriate dose of vaccine administered (Verbatim: Administration of the adjuvant only/No reconstitution).The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 18-SEP-2023 The reporter called to ask for information regarding a patient who received only the adjuvant portion of Shingrix (no reconstitution), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The healthcare professional asked how to proceed with this patient. The reporter did not provide information regarding patient (initials, age) nor information about the dose (lot number, expiry date, date of administration. The reporter did not consent to follow-up.
A report was received from a health care professional on 10/10/2003 concerning a 20 month old female vaccinee who inadvertently received Fluvirin vaccine on 10/10/03. On 10/10/03, the vaccinee inadvertently received Fluvirin 0.25ml intramuscularly in the thigh. This was the vaccinee's first dose. No adverse reaction was reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 11/7/03: Further information received from a health care professional on 11/07/03 indicated that the reported telephoned the vacinees' home two days after vaccination and no adverse reaction was reported. No follow up pending.
Felt chest warmness/pressure from minutes within vaccine. Brought immediately to medical area.  Felt cold, looks comfortable. on phone. no immediate sign of distress. given orange juice and observed with father present.  Patient released at 1:40 pm to her father, feeling and looking well.
An injection site (right arm). Red, swollen, itchy area. Appeared day after injection. No generalized symptoms. Symptoms receding at 3 days after injection. Comfort measures, diphenhydramine, APAP, Ibuprofen.
On 07/07/2022 while walking my dog, I noticed that I was feeling tired and had a scratchy throat. The next day I woke up with a worsening scratchy throat. I took an at home COVID-19 test later that afternoon at 3pm and the results were negative. I contacted my doctor's office and spoke with an on call nurse about my symptoms. She advised that I treat my symptoms as a presumptive positive case of COVID-19. On the next day on 07/09 at 11PM, I took another at home COVID-19 test and the results were positive. I continued to isolate and treat my symptoms with over the counter medication. My temperature never got above 98.8. I'm still experiencing some phlegm in my throat but other than that, my symptoms have gone.
Pt's arm red and swollen from shoulder to elbow. Warm to touch. Prednisone tapes given.
Patient comes into pharmacy on 05/24/21 with 2inch by 2 inch bruise on left deltoid muscle at injection site.  She states the bruise appeared the next day after the vaccine and has gotten bigger in size.  She reports little bit of headache that didn't last long .  Her had arm soreness for 3 days but now it doesn't hurt and she has no need to seek medical attention.
Experienced numbness / paralysis on left side of face and body, confusion, stroke-like symptoms. Husband took her to ER.
Approximately 6 days after injection I began to feel heat on my feet and they began to itch.  Progressed over next several days into hives covering my feet, shins/calf and up to my thighs.  Hives also appeared on my hands/fingers.  I also experienced heat/flushing of cheeks and from about 8/31 to 9/2 felt as if there was something small in my throat I was unable to clear.  It did not obstruct my breathing.  That sensation has subsided, however, the hives continue.  I have seen my provider and am currently taking antihistamines and a using a mild steroid cream on the worst of the hives.  I suspect the hives will subside over the next several days.  I do not know if it is related, but on 9/2 I became suddenly nauseous early in the morning, vomited a small amount of stomach contents and then felt fine.  I had not eaten anything new or different the previous night and had not eaten yet that morning.   I believe it is important to note that I have had no changes in medications, food, lotions, detergents, deodorants  or anything.  I have not travelled and have not been exposed to anything new.  The symptoms of this reaction are identical to my experience with Sulfa and Clarithromycin.  The signs of allergic reaction to both presented approximately 5 and 9 days after initial ingestion, respectively and both involved hives covering my lower body, hands, face and involved the same sensation in my throat.  I have not taken any of these medications in several years.
Hi there, I was COVID positive mid-December 2020. I received the Janssen vaccine in 03/19/21. After a month, I started to have headaches on a daily basis. Ended up in ER in 04/19/21 with chest pain and a horrible headache. X Ray of chest was normal. Since this event I have had more frequent and stronger  headaches more often and stronger. Mid-may my smell changed, perfumes and cleaning supplies smell supper bitter, can't stand them. Liquids some times taste like metal. I have been seen by two IM doctors and two Neurologist.  MRI of head and blood work was normal. Overall, the meds they sent me don't work. They started treating my case as a severe migraine. I have never suffer from headaches or migraine prior to been vaccinated.
itching ears; itching; soreness; bump; redness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching ears), VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (soreness), VACCINATION SITE SWELLING (bump) and VACCINATION SITE ERYTHEMA (redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced PRURITUS (itching ears), VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (soreness), VACCINATION SITE SWELLING (bump) and VACCINATION SITE ERYTHEMA (redness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (itching ears), VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (soreness), VACCINATION SITE SWELLING (bump) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include blood pressure medication.  Treatment medication include Benadryl.
Pt w/ no known drug allergies and no known medications.  Pt has a hx of getting lightheaded w/ shots or blood draw.  Pt was tingly, pale, and lightheaded immediately after vaccination.  @ 13:20 BP 90/49, HR 66, RR 14 -- > @ 13:34 109/72, 61, 16 -- > @13:37 (sitting) 109/75, 60 & (standing) 126/85, 64.  Pt stable and released from the vaccination site.
Patient received an expired FLUBLOK QIV with no reported adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case from a non-healthcare professional via Media information (under the reference 00814428).   This case is linked to case 2021SA345109 (CLUSTER).  This case involves a patient of (unknown demographics) who received an expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product used).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day).  It was reported "There were 15 patients that were administered the expired Fluzone. The Director was going to transfer me to her assistant to obtain all the patient info."  At time of reporting, it was unknown whether the patient had any adverse event or not and the outcome was unknown for the reported 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.  There will be no information available on the batch number for this case.
This spontaneous report as received from health care worker refers to a patient of unknown age. Medical history and current condition of the patient was unknown. On an unknown date the patient was vaccinated with ZOSTAVAX lot # K015308, expire date 17-DEC-2015, 0.65 ml, subcutaneous. Concomitant medication was unknown. On an unknown date unspecified amount of doses of ZOSTAVAX went temperature excursion were administered to an unspecified amount of patients and no adverse effect reported. The outcome was not reported. This is one of the two reports received from the same source. (Same reporter link). Additional information has been requested.
Malaise; Loss of appetite; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), DECREASED APPETITE (Loss of appetite) and VACCINATION SITE PAIN (Pain at injection site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Pyothorax in 2005 and Tooth infection.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced DECREASED APPETITE (Loss of appetite) and VACCINATION SITE PAIN (Pain at injection site). On 21-Jan-2021, the patient experienced MALAISE (Malaise). The patient was treated with IBUPROFEN at a dose of 400 mg once a day. On 20-Jan-2021, VACCINATION SITE PAIN (Pain at injection site) had resolved. On 26-Jan-2021, MALAISE (Malaise) had resolved. At the time of the report, DECREASED APPETITE (Loss of appetite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
swelling on her eyes; Broke out  to a rush all over; Face swell up; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face swell up), EYE SWELLING (swelling on her eyes) and RASH (Broke out  to a rush all over) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051e21a and 038b21a) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included GABAPENTIN, ALPRAZOLAM (XANAX), OMEPRAZOLE, DULOXETINE HYDROCHLORIDE (CYMBALTA), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and OXYCODONE for an unknown indication.   On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced SWELLING FACE (Face swell up) and RASH (Broke out  to a rush all over). On an unknown date, the patient experienced EYE SWELLING (swelling on her eyes). At the time of the report, SWELLING FACE (Face swell up), EYE SWELLING (swelling on her eyes) and RASH (Broke out  to a rush all over) outcome was unknown.            Concomitant medications includes ProAir and Med for arthritis. No treatment information was reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Reporter details, Patient age and gender , Concomitant medications, dose 1 and dose 2 details were updated. Event start dates were updated and events added.
2 days after giving Menactra and HPV vaccine #1, pt developed L shoulder and L arm pain, with ok strength but pain with motion.
At first several sharp pains, and then a sensation of swelling in left chest area. Internal sensation, not external/muscular. No injury to site. Feeling of pressure/inflammation consistently present for several days, then started to subside and come in waves over the next week. Still persisting after several weeks.
Vaccine not removed From Freezer at 2wk Mark - at 3wks and administered after p consult c medical facility/manu Notified pt offer repeat dose
Normally, menses always 28 days plus or minus one day for last 20 plus years.  For first time ever, Abnormal bleeding (metrorrhagia) since 10/9 for the last 12 days and irregular menses.  Still bleeding.
The patient passed out and convulsed. After some rest, water and snacks the patient was back to normal.
nausea, shivers, fever, headache, muscle soreness, soreness at injection site. treatment was stay home, extra rest, ibuprofen.
Patient was noticed to be pale today following by fainting episode after receiving HPV, varicella, PPD & MCV4. Pt was placed supine/horizontally on floor with rapid recovery of loss of awareness/return of color.
Tingling and numbness began in hands and wrists, spread from waist down to feet.  Complete numbness within three days, unable to stand, walk, grasp objects. Intense headache began evening of 7/16 and continued through 7/20. Saw PCP on morning of 7/18, suspected and blood drawn to test for Lyme, began Doxycycline. Was worse by afternoon and PCP office recommended I go to ER, which my husband took me to. I had MRI's and CT scans, bloodwork, lumbar puncture, nerve conduction test. I was admitted to the hospital on 7/19. Unable to find infection or any reason to explain the numbness.  Subsequently they found a large kidney stone in my left kidney that began causing me a lot of pain on 7/18. They removed the stone on 8/2 removal of stone relieved pain but had no effect on the numbness. While numb the first week I was unable to feel to urinate or defecate on my own and required a catheter and enemas to eliminate. I eventually regained enough sensatin to void on my own.  I began experiencing some sensation in my hands primarily after a number of days in the hospital (I don't recall exactly, at least 5 days later though). I slowly began to regain some sensation in my belly after a few more days. With physical therapy and some sensation returning I was able to stand, and eventually walk with a walker and assistance. By the time of discharge on 8/4/22 I was able to walk with walker unassisted. I am currently still experiencing numbness in my hands, and from the waist down through my feet. I have regained more sensation in all areas, and am able to walk with a cane indoors, and outdoors with a cane with someone close by for assistance. I am continuing with PT at home. I am currently unable to drive or return to my job as an Administrative Assistant.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's current conditions and medical history were not provided. On 27-FEB-2014, the patient was vaccinated with the first dose of GARDASIL (route, dose and Lot No. were unspecified). On 04-MAR-2015, the patient was vaccinated with the second dose of GARDASIL (route, dose and Lot No. were unspecified). On 13-AUG-2015, the patient was vaccinated with the third dose of GARDASIL (route, dose and Lot No. were unspecified). There was no concomitant medication described. No adverse effects were reported. Additional information has been requested.
Pt. received vaccines listed below at 4:30pm. After receiving vaccines, pt. was walking in the waiting room and sat down in one of the waiting room chairs.  RN noted patient to be unresponsive immediately after sitting down.  Unresponsiveness lasted approximately 4 seconds.  RN shook patient, and noted patient to have one generalized "jerk" of full body.  PAtient then began crying and talking to mother.  Patient was assisted back to exam room where she was helped onto exam table.  Head of exam table was elevated 45 degrees.  B/P was 110/70.  Apical pulse was 100.  Blood sugar was 100.  Patient stated she had not eaten all day and was offered juice of which she drank 4 ounces. Patient rested on exam table for 15 minutes.  B/P was recehcked - 108/70 - and apical pulse was 64.  Patient stated she "felt fine" through translator. Patient left clinic ambulatory without assistance, accompanied by parents.
Initial case received from a consumer on 09 March 2010. A female patient reported that she received FLUZONE SV (lot not reported) and H1N1 (manufacturer and lot number not reported) and subsequently experienced an adverse event. No additional information was reported.
August 6,2018 area was imflamed, warm, bruised, and knot was present at inject site. Symptoms have improved but lump is present and still hurts and itches.
mild arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (mild arm pain) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced PAIN IN EXTREMITY (mild arm pain). On 25-Apr-2021, PAIN IN EXTREMITY (mild arm pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information was reported by the reporter
COVID-19 virus test positive; COVID-19 virus test positive; Booster; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. Other Case identifier(s): 22K-163-4241286-00.  A 46 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 04Oct2021 (Batch/Lot number: unknown) at the age of 46 years as dose 2 (booster), single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Humira for Moderate to severe rheumatoid arthritis. The following information was reported: IMMUNISATION (medically significant) with onset 04Oct2021, outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Jan2022, outcome "unknown" and all described as "COVID-19 virus test positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (unspecified date) unknown results, notes: had monochrome antibodies; sars-cov-2 test: (14Jan2022) positive, notes: Covid test. The action taken for adalimumab was unknown.  Clinical Course: It was unknown if patient was enrolled in a covid-19 vaccine trial.  Causality for Humira (adalimumab): The reporter's causality for the event(s) of tested positive for covid with Humira (adalimumab) was a Reasonable possibility.  Causality for Pfizer BioNTech covid-19 vaccine (tozinameran): The reporter's causality for the event(s) of tested positive for covid with Pfizer BioNTech covid-19 vaccine (tozinameran) was a possible.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided the lack of efficacy of the vaccine (LOE) cannot be excluded.
Patient had a red sore arm after she received her vaccine on 07/03/19 pt had blisters but put hydrocortisone cream and took a benadryl. Patient will continue to take hydrocortisone cream. Patient still has red arm and tender.
A report has been received from a Health Professional concerning a 7 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. The health professional reported that she inadvertently gave FLUMIST quadrivalent to a person with asthma on 27-Nov-2013. No symptoms were reported at that time. The outcome of the event of administered FLUMIST quadrivalent to an asthmatic is unknown. The report was considered to be non-serious.
Severe head pain, lower jaw/facial pain mild chest pain, swollen left arm, hand hives, swollen eye lids
Big lump on his left arm that looks like it was bitten by a big mosquito; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Big lump on his left arm that looks like it was bitten by a big mosquito) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PERIPHERAL SWELLING (Big lump on his left arm that looks like it was bitten by a big mosquito). On 27-May-2021, PERIPHERAL SWELLING (Big lump on his left arm that looks like it was bitten by a big mosquito) had resolved. Not Provided      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.   Concomitant product use was not provided by the reporter.  No treatment medication was provided.  The patient states that will inform his physician on 28-APR-2021 morning.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: TCR form
Hospitalized 9/9/22-9/19/22 leg pain, right foot gangrene, HTN, BKA, anemia,
transverse myelitis - potentially related to immunosuppression from Humira, the herpes simplex virus or the vaccine (or combination of all 3).  Sx included areflexia, bilateral paresthesia (legs and feet), double vision, cord damage from cervical region to conus of the cord.  Also developed urinary retention.
Notified the dose I received on April 12 was stored outside of the "manufacturer temperature range". Because the efficiency cannot be determined immunology experts recommend I re-vaccinate. Dates for third dose are  April 20-22. No further details, precautions, or warnings are listed.
First dose :   Second day  of vaccination very mild fatigue ,  moderate pain  in arm Second dose :  pain in the arm began the day of vaccination, second day  at noon began chills, fatigue, joints pain and and fever at around 4 pm , highest reading 100.4  Third day feeling good for
Mild limp, toes pointing out while walking since Hep a injection in (L) thigh. Fever.