chrisvoncsefalvay/vaers-outcomes huggingface dataset:
16 year old patient received FLUBLOK QI/ NO AE; Initial information was received on 23-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist (Reference number- 00329784) and transmitted to Sanofi on 23-Oct-2020.  This case is linked with case 2020SA300754 (same reporter).  This case involves a 16-year-old male patient who was vaccinated with 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA2029 and expiry date 30-Jun-2021) via an intramuscular route in the left deltoid on 16-OCT-2020 for prophylactic vaccination (Product administered to patient of inappropriate age).  The patient's medical history, past medical treatment, concomitant medication and family history were not provided.  No other vaccines were given.  It was a case of actual medication error due to inappropriate age at vaccine administration (latency was on same day).  At the time of reporting, patient had no 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 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.
Narrative: Patient became hypotensive, lost consciousness and pulse for about 20 seconds, Paramedics were contacted and patient was taken to outside emergency department for management.
Heart rate 163 beats per min. at 01:00 am on 10/6/2021.
Site: Swelling at Injection Site-Medium, Additional Details: Patient states there was swelling at the injection site with limited range of motion. Patient was wearing a sweater so I told her twice it would be easier if she pulled her arm out of the sleeve, but each time I asked, she just pulled the sleeve up higher. She is claiming the shot was given too high but that was impossible since her sleeve was in the way.
slight muscle ache at the injection; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (slight muscle ache at the injection) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included Skin tightness (Fibroblast Plasma pen surgery for her face to get rid of wrinkles) on 05-Mar-2021 and Skin tightness (second dose of the plasma pen) on 15-Mar-2021.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (slight muscle ache at the injection). At the time of the report, MYALGIA (slight muscle ache at the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood thinners.  No treatment information was reported.
Muscle aches  began 7 hours after injection. Fitful sleep accompanied by muscle aches and headache. A huge rash larger than my hand formed at the injection site, was red and hot. Extremely sore  arm, with bruise at injection site (along with rash). Fever of 101. This lasted for 24 hours and subsided, but rash remained for 4 days, with extreme itching under the skin still occurring a week later, with occasional hot arm where rash was.  Also loss of appetite and irregular bowel movements/stools. Occasional unexplained headaches. Irritability.  Most concerning part was/is rash and the lingering subcutaneous itching.
Initial report was received 04 June 2009 from a health care professional as part of a cluster.  A 47-year-old female patient with no concurrent illness and no pre-existing medical conditions, had received a right deltoid injection of ADACEL, lot number UF455CA (corresponding Sanofi Pasteur Ltd, lot number C3004) between 3 and 4 PM on 16 January 2009, and the following morning at 11 AM on 17 January 2009, she developed shaking chills, a mild headache, profound lethargy, some muscle aches and night sweats.  The events did not require a doctor's visit.  According to the reporter, the patient took Ibuprofen and felt better the following morning on 18 January 2009, and recovered.  This patient is one of a cluster of five identified patients, out of a possible 6 or 7 patients.  The other four identified patients have been captured in case number 2009-00586, 2009-02398, 2009-02399, and 2009-02400.  This case also has the same reporter as case number 2009-00128.
Vomiting w/diarrhea signs of encephalopathy t102 ax;
I got it and got a rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got vaccine and got a rash but the after effects sucked. No contact details were available.
Pt received a hep B vaccine on 5-18-2011. On 5/19/2011 she experienced pain, redness, swelling, itching at injection site (Rt deltoid).
Hives started evening of flu shot. Covering legs, back, arms, feet. Received 10/17/03. Itchy. Treated with Benadryl and Calamine cream/lotion.
Day after vaccine administration, patient had swelling of the right upper arm around the Varicella administration site. Went to the Emergency Room. Diagnosed with likely immunization reaction and not cellulitis. Given prescription for Clindamycin if it got worse. Mom started above on June 2.
2-17-22 Patient called to report redness and itching at Left deltoid area. Swollen to "size of small plate."
Severe headache with nausea and vomiting for about 24 hours. Sweats and chills. Tinnitus much worse.
3 inches X 3 inches puffy swollen firm area over the glenohumeral joint, injection site 8.9cm below the swollen area, limited ROM.
Similar to what I have previously reported for my first Janssen vaccination back in March, I had Gr 1 chills for about an hours, starting at 11 hours after my shot, followed by Gr 1 headache, insomnia, and feeling of fever/hot skin without the true presence of a fever.
Left arm swollen and sore. Mom noticed swelling 7/10/2002 at approximately 1:00 pm, but waited to see if it would go down. As of 07/12/2002, swelling has not decreased-contacted this office and is going to contact pediatrician. Arm not sore or swollen on 07/14/02.
The patient is convinced she may have received  less than adequate dose for her second Pfizer vaccine installation.
Extreme tiredness and fatigue.  My daughter missed an entire week of school.  I have a feeling that she suffered this reaction because she received the live virus - the flu mist.  I wonder if she would have had the same reaction had she received the dead virus by injection
rt arm -deltoid muscle is mildly tender w/palpation;no masses;no lesions or erythema @ either inj site;sl inc warmth @ bicep & triceps;small amount of localized edema @ rt upper arm, shoulder & elbow;small localized edema @ arm;
3 months after I received the Td vaccine I noticed swelling, warmth, and readness to my left deltoid muscle.  This progressively got worse until 5 months later when it was very tender and painful.  It woke me from sleep and I went to the ER and was diagnosed with cellulitis.  I took Keflex 500mg BIDX10 days and the swelling resolved a little.  I had an MRI later that week and it revealed 'infiltrate' in my whole deltoid muscle.  I then had a muscle biopsy.  I then developed a reactive arthritis in most of my joints, diagnosed by my newly aquired rhuematologist to be due to the inflammatory process in my left deltoid.  The arthritis is slowly resolving, I was taking 12 advil a day and am now down to three a day.
She got her vaccine, it took about an hour or two and her arm just swelled up really big, and she felt really sick.  She laid down thinking it was the shot and that it would go away.   She was sick for at least a week, and just laid in bed, and the swelling went down some, and did not feel as good as she had, and not the same as before the vaccine.  She went to her doctor as she did not what to do as it did not get better.  She told her that she thought it was broken and wanted an x-ray, which she had a couple of months ago.  The x-ray showed an old injury to her rotator cuff and healing/arthritis and a possible spur.  She hurt where she had the shot and it still hurts there.  She had a battery fall on her and had to go to the ER and get stitches, and she was given an antibiotic as a precaution from infection, and then started to have vision problems, and other symptoms, and took that for 7 days.  Her vision since then has been really bad.  They checked her heart a lot and checked to see if she had COVID or other respiratory issues.  They seemed to be puzzled.  She did not eat or drink for a while.  Her symptoms have improved but felt that her body had overreacted to that antibiotic that she had never had before.  She now can get up and go to the store, and feels that her body is prone to reactions.
no adverse event; Varivax that underwent a temperature excursion was administered; This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 22-JUN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T028307 that expires on 20-AUG-2022 for prophylaxis (dose, route of administration and administration site were not reported).  The administered dose of the vaccine experienced a temperature excursion of -50 degrees Celsius to  -15 degrees Celsius (-12.8 degrees Celsius) for 40 minutes and at 12.7 degrees Celsius for 1 hour as recorded by a data logger. There was no adverse effect reported.  No product quality complaint was involved.
pharmacist inadvertently mixed the YF-VAX with sterile water instead of the proper diluent along with the vaccine and administered it to 2 patients with no reported adverse event; Initial information received on 25-Sep-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 2 patients with unknown age and unknown gender for whom pharmacist inadvertently mixed the yellow fever vaccine [YF-VAX] with sterile water instead of the proper diluent along with the vaccine and administered it to 2 patients with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patients received a dose of suspect yellow fever vaccine Solution for injection (lot number, expiry date, dosage, strength- not reported) via unknown route in unknown administration site for Immunization. Information on the batch number was requested.  On an unknown date the pharmacist inadvertently mixed the yellow fever vaccine with sterile water instead of the proper diluent along with the vaccine and administered it to 2 patients with no reported adverse event (product preparation error) (latency- same day). Caller asks for manufacturer's guidelines on this situation.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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.
This spontaneous report was received from a nurse regarding a currently 18-month-old patient of unknown gender. The patient's concurrent conditions, historical conditions, past drugs and concomitant medications were not reported. On an unknown date the patient was vaccinated with a dose of LIQUID PEDVAXHIB (lot # R005116 and expiration date: 20-NOV-2020) (dose and route were unknown) for prophylaxis following a temperature excursion and no adverse effects (no adverse event) were reported. The temperature and timeframe were at or above 32 degree Fahrenheit to 35 degree Fahrenheit (0 degree Celsius to 1 degree Celsius) (34.6 Fahrenheit) (multiple excursions) for 34.5 hours and previously also had temperature excursions at 47 degree Fahrenheit to 77 degree Fahrenheit (9 degree Celsius to 25 degree Celsius) (49.2 Fahrenheit) for 320 minutes. The call was because of a data logger. This is one of the two reports received from the same reporter.; Sender's Comments: US-009507513-1812USA000178:
NO AE REPORTED, HOWEVER, VACCINE WAS ADMINISTERED IM INSTEAD OF SQ, PER BAVARIAN NORDIC, NO REPEAT DOSE REQUIRED
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 1-year-old patient who received DTPa (DTaP vaccine) (batch number 9HP9Z) for prophylaxis.   On 27-FEB-2023, the patient received DTaP vaccine. On an unknown date, an unknown time after receiving DTaP vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter US-GSK-US2023AMR060668:Original Case : US2023AMR056407 US-GSK-US2023AMR060653:Original Case : US2023AMR056407
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age and gender. No information on the patients' concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with unspecified doses of improperly stored PROQUAD, lot # L031602, albumin status rHA, expiration date: 18-FEB-2017 and lot # M006106, albumin status rHA, expiration date: 01-AUG-2017 (route of administration was not reported). No adverse reactions were reported. Additional information has been requested.
a lot of blood in his stool twice in the morning; Felt "really bad"; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (a lot of blood in his stool twice in the morning) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced FEELING ABNORMAL (Felt "really bad") and PYREXIA (Fever). On 23-Apr-2021, the patient experienced HAEMATOCHEZIA (a lot of blood in his stool twice in the morning) (seriousness criterion medically significant). At the time of the report, HAEMATOCHEZIA (a lot of blood in his stool twice in the morning), FEELING ABNORMAL (Felt "really bad") and PYREXIA (Fever) outcome was unknown.            Concomitant product use was not provided. Treatment included Ibuprofen and Tylenol.  Action taken with mRNA-1273 in response to the events was not Applicable.  Company comment: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.; 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.
Got really sick; Diarrhea; sick to her stomach; Ache; Headache; Chills; fever of 102 F; felt so weak; could not go out to do grocery shopping; Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt so weak), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not go out to do grocery shopping), ILLNESS (Got really sick), DIARRHEA (Diarrhea) and ABDOMINAL DISCOMFORT (sick to her stomach) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 002B21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised (moderately immunodeficient).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced ASTHENIA (felt so weak), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not go out to do grocery shopping) and FATIGUE (Exhausted). On 17-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (Got really sick), DIARRHEA (Diarrhea), ABDOMINAL DISCOMFORT (sick to her stomach), PAIN (Ache), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (fever of 102 F). On 19-Aug-2021, ILLNESS (Got really sick), DIARRHEA (Diarrhea), ABDOMINAL DISCOMFORT (sick to her stomach), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (fever of 102 F) had resolved. At the time of the report, ASTHENIA (felt so weak), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not go out to do grocery shopping) and FATIGUE (Exhausted) outcome was unknown and PAIN (Ache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Aug-2021, Body temperature: 102f (High) fever of 102 F.         Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-320913 (Patient Link).
chest wall was hurting; Left breast was hot burning/ Left breast was hurting; chest wall was hot burning; sinus infection; Intense itching from top of my head to bottom of feet; Left breast was red/ Left breast was red; cough; Rash in the mid section; e\Extreme chills; Fever; extreme chills, fever, diarrhea for 10 days; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (chest wall was hurting), BREAST PAIN (Left breast was hot burning/ Left breast was hurting), CHEST PAIN (chest wall was hot burning), SINUSITIS (sinus infection) and DIARRHOEA (extreme chills, fever, diarrhea for 10 days) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chemotherapy. Concurrent medical conditions included Breast cancer stage IV since 2001 and Neuropathy. Concomitant products included VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced DIARRHOEA (extreme chills, fever, diarrhea for 10 days). On an unknown date, the patient experienced MUSCULOSKELETAL CHEST PAIN (chest wall was hurting), BREAST PAIN (Left breast was hot burning/ Left breast was hurting), CHEST PAIN (chest wall was hot burning), SINUSITIS (sinus infection), PRURITUS (Intense itching from top of my head to bottom of feet), ERYTHEMA (Left breast was red/ Left breast was red), COUGH (cough), RASH (Rash in the mid section), CHILLS (e\Extreme chills) and PYREXIA (Fever). At the time of the report, MUSCULOSKELETAL CHEST PAIN (chest wall was hurting), BREAST PAIN (Left breast was hot burning/ Left breast was hurting), CHEST PAIN (chest wall was hot burning), SINUSITIS (sinus infection), DIARRHOEA (extreme chills, fever, diarrhea for 10 days), PRURITUS (Intense itching from top of my head to bottom of feet), ERYTHEMA (Left breast was red/ Left breast was red), COUGH (cough), RASH (Rash in the mid section), CHILLS (e\Extreme chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment include Antibiotics and Sleepy ill herbal supplement.
Around 11:30pm, I woke up with incredible chills and had them for about 1.5 hours. Around 1:45am/2:00am on 1/13/2021, aches began, so I went downstairs to take acetaminophen. Increased heart rate and sweating while in the kitchen (had to sit down on the floor), eventually took Tylenol, and as I was heading back upstairs with cup of water, I passed out (less than 30 seconds) dropping the cup of water. Heaved/vomited small amount of liquid two or three times. Made it back to bed and began to feel better around 4:00am 1/13/2021.
This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# ER8730), at the age of 75, via an unspecified route of administration, right arm, on Mar 31, 2021, at 11:00, single dose, for COVID-19 immunisation. Medical history included high blood pressure, arthritis and COVID-19. The patient did not have a history of allergies to any food or medications or other products. Concomitant medications included Celebrex (celecoxib), Novasen (acetylsalicylic acid) and daily vitamins for an unknown indication, on an unknown date. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 75, via an unspecified route of administration, left arm, on Mar 10, 2021, at 11:00, single dose, for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. On Apr 2, 2021, patient experienced more tired than usual, seemed to be in fog at times and really sore at injection site at times (like someone was hitting the patient). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures taken for the events. The clinical outcome of more tired than usual, seemed to be in fog at times and really sore at injection site recovered with sequelae on an unknown date in Apr 2021. No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information expected.
I have tinnitus and this is new for me. I have eliminated taking Advil and occasional alcoholic beverages. I explored all side effects of my current medications and none would be the cause as I have been taking them long term. The Covid vaccine is the only new item and I have read online that others have had tinnitus following being Covid vaccinated.
Arthritic pain in back, neck, wrists, and ankles. Symptoms continuing to present. Patient concerned of  bi variant Booster.  No treatment other than exercise , due to kidney disease.