chrisvoncsefalvay/vaers-outcomes huggingface dataset:
raised area at injection site; body aches; head cold symptoms; numbness in face and fingers; tingling in face and fingers; General confusion; Disoriented; injection site painful; inability to lift/move right arm; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a adult male patient who received Men B NVS (Bexsero) for prophylaxis.   On 20th June 2019 09:30, the patient received the 1st dose of Bexsero (intramuscular) .5 ml. In June 2019, 22 hrs after receiving Bexsero, the patient experienced injection site pain and injected limb mobility decreased. On 20th June 2019, the patient experienced injection site swelling, general body pain, head cold, numbness facial, tingling of extremity, confusion and disorientation. On an unknown date, the outcome of the injection site swelling, general body pain, injection site pain and injected limb mobility decreased were not recovered/not resolved and the outcome of the head cold, numbness facial, tingling of extremity, confusion and disorientation were recovered/resolved.   The reporter considered the injection site swelling, general body pain, head cold, numbness facial, tingling of extremity, confusion, disorientation, injection site pain and injected limb mobility decreased to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported Yesterday from the date of reporting at 09:30 AM, the patient received Bexsero vaccine in his right upper arm  On the same day around 4:30 PM, 7 hours after a dose of Bexsero, the patient developed a raised area the size of half an egg injection site swelling, body aches, developed symptoms of a head cold and numbness and tingling in his face and fingers.  The patient reported that he became generally confused and disoriented at the same time. In June 2019, all of the symptoms resolved except his injection site remains an issue with the raised area, was painful and could hardly lift or move his right arm. The reporter did not consent to follow-up. The case was not associated with PQC. The patient declined any demographics, declines to provide physician information and permission to contact his physician.  The patient declined a copy of the Bexsero Package Insert (PI) and did not want to be contacted by our Safety Department.  There was discrepancy in the outcome of the event, in the structured field outcome was reported as (Recovering/ resolving) and the outcome reported in the narrative it was reported as recovered/resolved.
The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 24-MAR-2010, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine adult health maintenance and 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. On or about 02-AUG-2010, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster. The patient was was prescribed acyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (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. The outcome of the events was unknown. The events were considered to be related to zoster vaccine live (ZOSTAVAX).
Information has been received from a registered nurse with medical records concerning a 12-month-old male patient with no medical history or allergy.  The patient had no known sick contact.  On 13-SEP-2007, 19-NOV-2007 and 18-JAN-2008 the patient was vaccinated orally with the first (lot # 656705/0241U), the second (lot # 657518/1192U) and the third (lot # 657988/1193U) doses of ROTATEQ, respectively.  It was noted the patient "received the routine vaccines at 2 months, 4 months, and 6 months".  On 06-AUG-2008 the patient was brought to the emergency room by his mother where she reported her 1 year old son had had two days of vomiting and diarrhea that had stopped "last night" (05-AUG-2008).  She also reported he had been holding his left ear.  The patient was taking PEDIALYTE SOLUTION).  The physical examination revealed the patient was afebrile, otherwise normal and stable who did not appear to be in any acute distress.  Examination of his ears revealed clear auditory canals and tympanic membranes bilaterally with hearing grossly intact.  The patient was discharged from the emergency room and the mother was instructed to return with a stool sample as soon as possible, but otherwise continue the PEDIALYTE and return for any worsening symptoms.  As stool sample was returned the same day.  On 07-AUG-2008 the patient and his mother returned to the emergency room and reported that since 04-AUG-2008 (12:30 AM), the patient had loose watery foul-smelling non-bloody stools for 3 days (previously reported by the mother as 2 days) and vomiting of nonbilous & previously ingested food several hours after (e.g. banana eaten at 6 AM was vomited undigested at 5 PM same day).  The patient also felt warm.  Last episode of vomiting was early morning on 07-AUG-2008.  Then, he was able to keep down the PEDIALYTE SOLUTION) his mother was giving him to keep him well hydrated.  The patient's mother said, "He has good urine output; is playing at times and seems to be improving, intermittently stops playing to hold his belly and cringed a little bit as if he has abdominal cramps".  It was noted that on 06-AUG-2008, the patient had visited someone in the hospital but did not play on the floors.  The stool culture from 06-AUG-2008 showed heavy enteric flora and no white blood cells.  Stool rotavirus antigen test was positive.  The patient's diagnosis was ROTAVIRUS gastroenteritis without sign of dehydration.  The patient was discharged from the emergency room and the mother was given the following instructions: continue PEDIALYTE and alternate with ginger ale; no oily food; no dairy; no milk until stools are formed and patient has no more abdominal cramps; give apple, fruit; bananas, cereals; maintain strict hand washing; may give TYLENOL (max of 15 mg/kg/dose) po q4hrs for pain &/or fever; and return to the clinic immediately if symptoms worsen or persist in spite of above measures.  Subsequently, the patient recovered.  This is one of the several reports from the same source.  Additional information is not expected.  Medical records available upon request.
Kinrix (DTaP/IPV)  given to a 15 month old instead of Infanrix (DTaP).Mom and doctor notified
Information has been received from a registered nurse (R.N.) concerning a male child in elementary school (who is between grades 3-5) who was vaccinated with a dose of varicella virus vaccine live. it was reported that an outbreak of chickenpox began in an elementary school in November 2005. "Recently", "since November 2005", the male child developed chickenpox and sought unspecified medical attention. No out come was reported. No product quality complaint was involved. Additional information has been requested.
a 12 years old male patient received Ipol at ages 2 months, 4 months, and 6 months, however missed his 4-6 year dose; Initial information received on 06-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a male patient of an unknown age (patient was currently 12 years old), who missed the fourth dose of vaccine IPV (VERO) [IPOL].  The patient's past vaccination(s) included three doses of IPOL at ages 2 months, 4 months and 6 months.  The patient's past medical history, medical treatment(s) and family history were not provided.  It was an actual medication error due to missed dose.  It was not reported if the patient experienced any adverse event or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Information on the batch number was requested.  List of documents held by sender: none.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 13-MAR-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M025871, expiration date: 24-MAY-2018 (site, dose and route of administration were not reported).The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required data has been obtained. Sender's Comments: US-009507513-1611USA004113.
weak; Flu like symptoms; Sore arm; Really tired; fever after the second dose; Chills really bad; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Sore arm), FATIGUE (Really tired) and PYREXIA (fever after the second dose) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   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 an unknown date, the patient experienced ASTHENIA (weak), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Sore arm), FATIGUE (Really tired), PYREXIA (fever after the second dose) and CHILLS (Chills really bad). At the time of the report, ASTHENIA (weak), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Sore arm), FATIGUE (Really tired), PYREXIA (fever after the second dose) and CHILLS (Chills really bad) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.
38 months old inadvertently received 0.5 ml of FLUVIRIN. Initial report received from a health care professional on 28 Jan 2010: This patient (38 months old) was inadvertently administered with 0.5 ml of FLUVIRIN (batch number 987447P1) on 27 Jan 2010, intramuscularly. No adverse events were reported.
Vaccine given high on upper arm. The following day, felt worsening deep arm pain exacerbated by attempts to lift arm laterally away from body. Was in hospital that night (11/4/18) for IV antibiotics due to cellulitis after cat bite/scratches of opposite (left) arm and received IV pain medication for that. The following 2 nights woken due to pain in right arm. Currently, avoiding movements that might cause pain and preferentially using my left arm/hand.
pain and swollen hands; pain and swollen hands; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A female patient of an unspecified age received the first dose (dose 1) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included ongoing arthritis. The patient's concomitant medications were not reported. The patient was calling because she wanted to reschedule her 2nd dose shot scheduled tomorrow (on 02Apr2021) because she would be going to her doctor today (on 01Apr2021) because of her arthritis and would have a steroid shot. According to the caller, she's experiencing pain and swollen hands on an unspecified date. She took her first shot on 12Mar2021. The patient wanted to know if it was possible reschedule her 2nd dose. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
My heart was pounding so hard that it woke me up. My Oura ring was able to record the elevation in my heart rate. I went from the 50's in a dead sleep to the 80's between 7-8am. Otherwise I had general lethargy, fatigue, and arm soreness. I did not have a fever.
Hyperinflammation of groin and cervical lymph nodes after injection. Swelling chronic > 2 weeks. Enlargement noted from vaccines given in 2011 as well. Nodes < 10mm.
Chills, fever, headache, flushing BENADRYL 50mg.
Red, hot rash occurred around the injection site (about 2 inches in diameter) and lasted for two days. Parents gave ibuprofen as needed to help ease pain.
Tachycardia, throat "feels funny" - Evaluated by EMS-Cleared
fever; h/a, achy joints; inject site, painful, swollen, red; fever 100.2;
Patient experienced unusual pain at time of vaccination - it felt like needle went in deeper and hurt more than normal.  He still has a pain which is a nuisance pain,  It is felt when lifting arm over head.  it feels like it is an inner muscle pain.  the pain is described as a dull pain.
overall not feeling well; shoulder pain radiating down arm/ Shoulder pain; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of feeling unwell in an unspecified number of patients who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced feeling unwell (Verbatim: overall not feeling well) and shoulder pain (Verbatim: shoulder pain radiating down arm/ Shoulder pain). The outcome of the feeling unwell was resolved and the outcome of the shoulder pain was unknown.   It was unknown if the reporter considered the feeling unwell and shoulder pain to be related to Arexvy.     It was unknown if the company considered the feeling unwell and shoulder pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 30-OCT-2023 The field representative from Syneos reports speaking with a pharmacist.  The pharmacist reported to her that they had administered approximately 270 Arexvy vaccinations, all to patients over the age of 60.   He told her that about half of those 270 patients reported shoulder pain, with some reporting the pain radiating down their arm, and overall just not feeling well for a day or two. The reporter consented to follow up.
administered Engerix Recalled  lot; administered Engerix Recalled  lot; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric 10 mcg .5 ml and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant reported that, the patient administered Engerix B recalled Lot number back in June 2021 through July 2021, which led to recalled drug administered and drug dispensing error. The medical assistant unable to provide patients details. The reporter did not consent to follow up. This case was 1 of 70 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021223559:Original Case : US2021223559
) recently hospitalized on 04/24 after testing positive for COVID on 04/21.
had shingles, had the vaccination/ Suspected vaccination failure; shingles twice on nose; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles all one summer and fall) and pain burning (horrible burning pain).   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 and shingles were unknown.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient had shingles all one summer and fall and a horrible burning pain. The patient had shingles twice since on his/her nose and he/she believed because he/she had the vaccination he/she got right over them. The patient stated that even after your over them ,if your over tired or stressed it felt like it's coming back.  The patient would asked that anyone that has not had the vaccination go and get them. The follow up could not be possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
"I get sick every time I get a Shot"; "I have to stay at home for probably 36 hours"; back pain; weak; diarrhea; "I get sick every time I get a Shot"; dizzy; sore all over; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of ILLNESS ("I get sick every time I get a Shot"), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("I have to stay at home for probably 36 hours"), BACK PAIN (back pain), ASTHENIA (weak) and DIARRHOEA (diarrhea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced the first episode of ILLNESS ("I get sick every time I get a Shot"), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("I have to stay at home for probably 36 hours"), BACK PAIN (back pain), ASTHENIA (weak), DIARRHOEA (diarrhea), the second episode of ILLNESS ("I get sick every time I get a Shot"), DIZZINESS (dizzy) and MYALGIA (sore all over). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("I have to stay at home for probably 36 hours"), BACK PAIN (back pain), ASTHENIA (weak), DIARRHOEA (diarrhea), the last episode of ILLNESS ("I get sick every time I get a Shot"), DIZZINESS (dizzy) and MYALGIA (sore all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-427003, MOD-2021-427001 (Patient Link).
Fatigue; Fever; Dizziness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fatigue, Dizziness, Fatigue. The clinical outcome of the events was unknown at the time of report. No follow up attempts are possible. No further information is expected.
the patient was diagnosed with herpes zoster and staph infection of the left leg; the patient was diagnosed with herpes zoster and staph infection of the left leg; Information has been received from a physician referring to a 3 years 2 months old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  In approximately 2018 (reported as about two years ago), the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose detail, lot# and expiration date were unknown) subcutaneously for prophylaxis (reported as vaccination). Sterile diluent (manufacturer unknown)  (strength, dose detail, lot#, expiration date and indication were unknown)  was also suspect therapy.  On 09-FEB-2020, the patient came into the office, the patient was diagnosed with herpes zoster and staph infection of the left leg. The patient was given acyclovir and cephalexin as treatment. On 26-FEB-2020, the patient came back to the office for a follow up visit, it was reported that the patient's lesions were much better. Therapy with  sterile diluent (manufacturer unknown) was unknown. The outcome of herpes zoster and staph infection of the left leg was reported as recovering. The causality assessment was not provided.  Upon internal review, staph infection of the left leg was determined to be medically significant.
This is all following the second dose  that I received at 09:00. 10:00-1900: general malaise  19:00: sudden onset chills and dizzyness 19:30-0000 Nausea, difficulty breathing, several near syncope episodes, Slurred speech, feeling of impending doom. During this time I was unable to walk or form a coherent sentence. For the next 24 hours all of the above symptoms subsided and I was left with brain fog and fatigue.
Information has been received from a physician referring to an 18.5 old male patient. The patient's medical history, concurrent condition and concomitant therapy were not provided. On an unknown date the patient was vaccinated with RECOMBIVAX HB (lot #, expiration date, dose and route not provided). On an unknown date the patient with completed primary Hep B series required quantitative Hep B immunity which was 6 (unit not provided), the physician gave adult dose as a booster. The outcome of "hepatitis b surface antibody negative" was unknown. Additional information has been requested.
pt had periorbital swelling within 20 minutes of vaccination to urticaria, no new sob, has asthma and had some mild sob day before vaccine