chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 33 year old female nurse with a history of migraines and depression who on 04/04/2002 tested "equivocal" for a measles (rubeola) titer with a value of 0.96. On 04/05/2002 the pt was vaccinated with a third dose of tuberculin (TUBERSOL). On 04/09/2002 the pt was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot #640634/1093L) SC in the left arm. It was reported that the pt had an afebrile upper respiratory illness at the time of vaccination. Concomitant therapy included bupropion HCl (WELLBUTRIN), levofloxacin (LEVAQUIN), pseudoephedrine HCl (SUDAFED), ibuprofen and zinc gluconate (COLD-EEZE). On 05/20/2002, a repeat rubeola titer was performed with a value of 0.87. The repeat titer post vaccination was lower than the baseline titer. Unspecified medical attention was sought. It was reported that the pt was to receive no further intervention. No additional info is expected.
late due to Covid-19; lower back part of my arm above the elbow not the deltoid muscle area; administered incorrectly. It was given subcutaneous; mark at the injection / with swelling; mark at the injection site which expanded / raised / area started to spread; mark at the injection / hot; tender to the touch; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of erythema (1st dose recived in November 2019, refer case US2020AMR124245).   On 4th July 2020, the patient received the 2nd dose of Shingrix (subcutaneous). On 4th July 2020, less than an hour after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, papular rash, injection site warmth, vaccine administered at inappropriate site and intramuscular formulation administered by other route. In July 2020, the patient experienced tenderness. On an unknown date, the patient experienced social problem. On an unknown date, the outcome of the extensive swelling of vaccinated limb, papular rash, injection site warmth, tenderness, vaccine administered at inappropriate site, intramuscular formulation administered by other route and social problem were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, papular rash, injection site warmth and tenderness to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient was late for 2nd dose due to COVID, which led to social problem. The patient received injection on the back of her right arm subcutaneously, which led to vaccine administered at inappropriate site and incorrect route of vaccine administration. The patient had initial mark at the injection site which expanded to 4 by 6 inches and was very raised and hot with swelling within an hour or the injection. The area started to spread towards her elbow from higher on the arm and at the time of reporting it was fading but tender to the touch. The reporter explained that prior to the second dose injection, the pharmacist was using rubbing alcohol in her armpit on the soft part of her arm and she injected the vaccine under her skin in the back of her right arm above the elbow and not in the deltoid muscle. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR124245:same patient
Information has been received from a physician referring to unspecified number of patients of unknown age and gender. On unspecified dates the patients were vaccinated with improperly stored doses of oral, ROTATEQ (lot # L020865, expiration date 09-FEB-2017, dose unknown) orally, which were under the temperature of 24 degree with time frame reported as 838 hours. The temperature was back in range at the time of the report. No previous temperature excursion was reported. No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient stated they were a nurse and asked to see the vial that the medication was being drawn from. While I was retrieving the vial, the patient took the needle and claimed they injected themselves with the vaccine in their left thigh. There was no witnessing the event either in person or via cctv due to HIPAA privacy screens. After explaining to the patient that we could not verify whether or not she actually gave herself the  vaccine, or just wasted the dose and claimed she did, the patient eventually left.
ErythemaMultiform, UrticariaPruritus, injection site arm pain, swelling Narrative:
The lab results were significant for a positive COVID-19 PCR test/fatigue, malaise, myalgias and cough productive of clear sputum; The lab results were significant for a positive COVID-19 PCR test/fatigue, malaise, myalgias and cough productive of clear sputum; This is a literature report for the following literature source(s):   A 32-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single and on 30Mar2021 as dose 2, single for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetes mellitus" (unspecified if ongoing); "end-stage renal disease (ESRD)" (unspecified if ongoing); "secondary to diabetic nephropathy" (unspecified if ongoing); "hemodialysis (HD)" (unspecified if ongoing); "SLE" (unspecified if ongoing); "antiphospholipid syndrome (APS)" (unspecified if ongoing); "peripheral arterial disease (PAD)" (unspecified if ongoing); "balloon angioplasty of right anterior and posterior tibial arteries" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE taken for systemic lupus erythematosus; PREDNISONE taken for systemic lupus erythematosus. Past drug history included: Insulin for type 1 diabetes mellitus; Warfarin, reaction(s): "splenic infarct on warfarin". The following information was reported: VACCINATION FAILURE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 14Jan2022, outcome "unknown" and all described as "The lab results were significant for a positive COVID-19 PCR test/fatigue, malaise, myalgias and cough productive of clear sputum". The patient was hospitalized for vaccination failure, covid-19 (start date: 14Jan2022, discharge date: 2022). The patient underwent the following laboratory tests and procedures: Blood glucose: (Jan2022) 471 mg/dl, notes: hyperglycemia; SLEDAI-2 K scores: (Jan2022) 20; Neutrophil count: (Jan2022) 14.6 x10 9/l, notes: neutrophilic leukocytosis; Oxygen saturation: (Jan2022) 96 %, notes: on room air; Respiratory rate: (Jan2022) 14, notes: Unit: per min; SARS-CoV-2 antibody test: (Jan2022) greater than 250, notes: elevated; SARS-CoV-2 test: (Jan2022) Positive; Vital signs measurement: (Jan2022) Normal. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300148407 Same Article/drug/event; Different Patient;
bone pain; joint pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (bone pain) and ARTHRALGIA (joint pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced BONE PAIN (bone pain) and ARTHRALGIA (joint pain). At the time of the report, BONE PAIN (bone pain) and ARTHRALGIA (joint pain) outcome was unknown.            No concomitant medications provided. No treatment information provided.   This case was linked to MOD-2021-200584 (Patient Link).
Arm have a big red nod; feels like there is a fever in her arms; Arm have a big red nod; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Arm have a big red nod), VACCINATION SITE WARMTH (feels like there is a fever in her arms) and VACCINATION SITE ERYTHEMA (Arm have a big red nod) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE MASS (Arm have a big red nod), VACCINATION SITE WARMTH (feels like there is a fever in her arms) and VACCINATION SITE ERYTHEMA (Arm have a big red nod). At the time of the report, VACCINATION SITE MASS (Arm have a big red nod), VACCINATION SITE WARMTH (feels like there is a fever in her arms) and VACCINATION SITE ERYTHEMA (Arm have a big red nod) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Patient said the night of the injection - posterior of the site of the injection area was red, warm, swollen and itchy. She said she had supervisor look at it and was told it was a local reaction and to take BENADRYL for it. Patient said she didn't have any and wouldn't take it anyway since it makes her too sleepy. She called Infection prevention coordinator 4/25/14 (left msg re: reaction). I saw pt 4/28/14 at 1540. She said "it was good all weekend" area slightly bruised purple/yellow no swelling - denied itching or pain at site.
I developed a dry cough, head congestion, some body aches on 7/22.  I tested positive on 7/25. I called my doctor on 7/26 and received Paxlovid.  I finished the medication on 7/31. Still have some fatigue.
Chills: lasted one hour, started 14 hours after shot Muscle soreness: lasted twelve hours, started 14 hours after shot Headache: lasted twelve hours, started 14 hours after shot Eye ache: lasted twelve hours, started 14 hours after shot Throat ache: lasted twelve hours, started 14 hours after shot Mild fever: lasted twelve hours, started 14 hours after shot Stomach tenderness: lasted twelve hours, started 14 hours after shot Tiredness: lasted 24 hours
Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves 10 patients who had vaccine stored at temperature outside the recommended range standard/in a refrigerator since Sept 2018 with unrecorded temperature, while he/she received vaccines FLUZONE QUADRIVALENT and TENIVAC and while treated with TUBERSOL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient started taking TUBERSOL dosage unknown route unknown (with an unknown batch number) for Tuberculin test. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U5526AA, expiry date - 15-Dec-2018 via unknown route. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route. It was a case of actual medication error due to incorrect product storage. It was unknown if any adverse event occurred or not. 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.
Headache, NauseaVomiting, fatigue Narrative: severe headache, severe fatigue, nausea; started 12/25/2020 at 04:00am lasted until 15:00pm
Chest pain around my heart (left side of chest) began the day after my 2nd Pfizer COVID-19 shot. It seemed to ebb and flow - some days worse than others - until it culminated in a significant amount of pain on August 22nd, leading to my making an appointment with my primary care office (Dr., listed elsewhere on this form) on Aug. 23rd. The pain on Aug. 22nd and 23rd consists of severe soreness/tenderness in about a 2 inch diameter even when barely touching my chest/ribs from the skin. This pain also seems to go deeper into the chest, not just on the surface. As mentioned, the surface pain in particular has increased significantly in the past day. I can't think of any other obvious cause of this soreness such as a direct impact to my chest.  Daily I take (and have taken) Meloxicam for a pre-existing inflammatory condition (enthesitis). In addition, I took over the counter ibuprofen for several days following my 2nd injection.
pt recvd vax; 1 wk p/dose 1,exp purpura of arms & legs;1 wk p/dose 2,pt exp again purpura of arms & legs;seen by MD;sxs resolved
Within minutes felt flush,dizzy,tingling warmth from face down. Withun hours my back muscle began to draw up tight in muscle spasms/pain. Arm pain but not comparable to the back pain. Tight,drew up back muscle. Hurt to touch my back with a hand. Hurt to lay on my back for bed and later woke from sleep due to pain. This severe back pain lasted 5 days then moderate pain went on throygh day 14. After that back pain eased to mild and shoulder pain was more present and lasting as of day 20 past vaccine. Shoulder pain when arm lifts or rotates. Around day 15 an itchy rash emerged on legs mostly. Unsure if its related. Within a day of the vaccine I broke out in severe acne as a fine all over face bumps, very tiny fine bumps all over. Along with this, I felt emotionally very anxious and irritable, emotionally liable. This is out of  character and has remained since the shot 20 days ago. This emotional instability sincethe vaccine led to an anxiety attacks on day 3 and 17. I feel it has personally affected me hormonally with the break outs and anxiety. I am currently still awaiting resolution to all health effects the shot has caused
Narrative: Hypothermia, Hypercarbia - pt was treated at outside hospital. pt passed away within 42 days of getting vaccine
First arm so sore, swollen, difficult to lift or touch. Next morning, ache all over, headache that would not go away, hoarseness, fever of 100.
Patient broke out in rash on both legs and on face and head.  Patient was given 1ml Benadryl and stayed in office for 45 minutes.  By the time patient left rash was almost gone.
COVOID vaccine breakthrough case.  Moderna 3/12/21 044A21A, 4/9/21 018B21A, and boosted on 12/23/2021 066H21A.
Patient received vaccine on 9/27/12 at 5pm, by 7:30pm she has soreness all over body, achy all night, can't sleep, can't turn in bed. Next day, hard time walking, sore throat. She said she have not contact her doctor, pharmacist advise to take TYLENOL/MOTRIN.
This initial spontaneous report was received from a pharmacist and also a 44 year old female patient. Concurrent conditions included bipolar disorder, high blood pressure, and diabetes.  Concomitant medications included aspirin and unspecified diabetes, bipolar, and high blood pressure medication. She had no drug reactions/allergies. On 08-DEC-2015, the patient was vaccinated with PNEUMOVAX 23 at a pharmacy to prevent pneumonia (lot # K009874; expiration 19-MAR-2016). The patient reported that she started coming down with symptoms on 25-AUG-2018 and went to an urgent care facility on 26-AUG-2018 where a chest x-ray determined that she had bacterial pneumonia. The pharmacist stated that the patent called the pharmacy on 29-AUG-2018 to inform that she was diagnosed with pneumonia. She was treated with antibiotics and TYLENOL. The pharmacist reported that the patient was currently taking an unspecified antibiotic regimen for the pneumonia. The patient was recovering from the bacterial pneumonia at the time of the report. Causality was not specifically reported. The patient requested compensation for pain and suffering due to pneumonia after being vaccinated with PNEUMOVAX 23. Upon internal review, bacterial pneumonia was considered to be medically significant. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 52-year-old patient who received Shingrix for prophylaxis. Concomitant products included Shingrix. On 13th December 2018, the patient received the 2nd dose of Shingrix (intramuscular). In December 2018, less than a week after receiving Shingrix, the patient experienced injection site pain, general body pain and feeling cold. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, general body pain and feeling cold were recovered/resolved. It was unknown if the reporter considered the injection site pain, general body pain and feeling cold to be related to Shingrix. Additional details were provided as follows: The patient had received both doses of Shingrix. After each dose he had some pain at the injection site, but his whole body ached like he got beat up and he felt very cold as well. The symptoms resolved after a day and a half. The consent was provided for follow-up. For tolerability of the first dose of Shingrix, refer case US2018227663.
pain throughout most of my joints; This case was reported by a consumer via interactive digital media and described the occurrence of joint pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th May 2020, the patient received the 1st dose of Shingrix. On 13th May 2020, 1 days after receiving Shingrix, the patient experienced joint pain. On an unknown date, the outcome of the joint pain was not recovered/not resolved.   It was unknown if the reporter considered the joint pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix yesterday day before reporting and woke up at 3 am with aching pain throughout most of his/her joints. The reporter asked was this side effect, if so then how long did it last.
Didn't have taste; Fever; Body aches; Chills; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of AGEUSIA (Didn't have taste), PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Chills) in a 21-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concomitant products included PROMETHAZINE for Nausea and Vomiting.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 26-Mar-2021 and the estimated date of delivery was 31-Dec-2021. On an unknown date, the patient experienced AGEUSIA (Didn't have taste), PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Chills). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, AGEUSIA (Didn't have taste), PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-May-2021, SARS-CoV-2 test: positive (Positive) COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reports that she is currently in a high-risk pregnancy.
pt recvd vax 1030AM that evening sought medical attention @ ER for fever of 104 7 was told pt had ear infect & was put on Augmentin; pt came in 26SEP95 for a f/u 7 was reassured by MD it was viral illness
DIaphoretic, dizzy, temporary loss of vision immediately following vaccination; obtained water for patient to sip, cold compress for forehead; patient poorly hydrated and had not recently eaten when questioned; observed patient directly for 15 minutes with additional staff and patients symptoms improved- observed for an additional 15 minutes and patient reported resolution of all symptoms and was able to drive home; patient did call later in the day and reported left hand partial numbness and tingling, as well as some facial tingling; advised to call PCP and report to ER if worsening symptoms
Hx of having passed out for about 1-2 minutes 29 hrs after flu vaccine was given and her lips also swollen at that time.
Pt. vaccinated at 3:40 pm.  Approx 5 minutes after mom reports slight raised hives to left neck.  Assessed patient, small area of hives noted.  Pt. denies itchy or SOB or throat tightness.  VS:  BP 120/76  HR 89  O2 Sat:  99%  RR 14  Assessed patient every 5- 10 minutes.  Vitals: WNL  Lead nurse notified and Clinic Manager.  Asked mom if ok to give Benedryl. Same given per facility protocol 25 mg PO.  Monitored pt.  VS:  416 pm  BP 104/70  HR 92  O2Sat 98%.  Hives to left neck cleared.  Advised mom if s/s persist or worsen to seek professional medical care and to make appt. with primary care re:  allergic reation.  Advised pt. to drink plenty of H20 DC to home with mom.  Denies S/S
This spontaneous report as received from a pharmacist 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 15-JUL-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # M000442, expiration date 31-MAR-2018 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Severe chills first night of getting injection. Very severe muscle and nerve ending body pain. Starting 2 hours after injection through whole body and continuing today still. More so this past week during the night and easing during the day. Ongoing muscle weakness during the day.