chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 58 year old female consumer (62 inches, 184 pounds) with allergies to monosodium glutamate and glycerin, high blood pressure, arthritis, low potassium level, asthma, gastroesophageal reflux disease, migraines, gout and a history of urinary tract infections, anxiety, muscle spasms and shingles (2010). On 21-SEP-2012, the female was vaccinated with ZOSTAVAX (lot number reported as 0006-4963-41 "possibly") under the skin in the left arm. Concomitant medications included: triamterene + hydrochlorothiazide (manufacturer unknown), potassium, glucosimine, multivitamins over the counter (OTC), vitamin D OTC, mometasone furoate (MSD), FLEXAMIN, ZANTAC, PROVENTIL, allopurinol, trimethoprin and diazepam. On 23-SEP-2012, a few days after she received the ZOSTAVAX, she began not feeling very well and them noticed she had a sore and scratchy throat. The next day she began breaking out all over her body with red, fluid like blisters. She reported some of them have begun crusting over and as 27-SEP-2012 she was still noticing new "bumps". The female describes this as looking just like the chickenpox. She did not seek medical attention. She reported having an MRI and EEG in the summer of 2012 (reason and results not reported). At the time of this report, the events were ongoing. Additional information has been requested.
Experienced breakthrough bleeding for a few days now. I am on continuous birth control (oral contraceptive, skip placebo pills) because of my endometriosis.
Information has been received from a physician concerning a 69 year old female patient with allergic to penicillin and a history of laminectomy in 2008 who on 26-AUG-2010 was vaccinated with the first 0.65 ml dose of ZOSTAVAX (Merck) (exp:29-APR-2011, lot # reported as 10711Z which is not valid for ZOSTAVAX (Merck)). Concomitant therapy included ANALPRAM-HC cream, estradiol, hydrochlorothiazide, PRAVOCHOL, prednisone, triamcinolone acetonide and cholestyramine resin. The reporter stated that the patient was given ZOSTAVAX (Merck) in her right arm and ADACEL (Sanofi) in her left arm concomitantly, and after the vaccinations she experienced moderate to severe swelling in her right arm. The reporter also stated that one week after getting the vaccines, the patient complained of pain in her left leg, which the doctor described as "L4 distribution" because it came from her L4 vertebrae. The patient was sent to a specialist who diagnosed her with post herpetic neuralgia. The specialist thought that it was due to ZOSTAVAX (Merck), but the doctor did not think so. At the time of reporting, the patient had recovered from moderate to severe swelling on her right arm, the outcome of post herpetic neuralgia was unknown. Additional information has been requested.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with an unspecified number of improperly stored doses of oral, ROTATEQ (lot# L008578, exp. date: 14-DEC-2016) (strength, dose and frequency were not reported). The doses of oral ROTATEQ were in temperature minus 1.2 Celsius degree for 18 hours and 32 minutes. There was no previous temperature available. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Foot pain 1 day after, 2 days after weak, and short of breath with cough; went to ED. Admit for CHF
I have double vision and neuro musclar issues and they said I have mythenias gravis no cure medicine and major surgery needed for rest of my life
Left arm is weak. My arm feels like it can't lift or type. Like the muscle in the arm is failing. The left arm has become weakened.; A type of muscle fatigue on the left side of the body; A lack of hand and muscle coordination; This is a spontaneous report from a contactable consumer (patient reported for himself). A 70-year-old male patient received first dose of BNT162B2 (COVID 19, Pfizer, Solution for injection) via an unspecified route of administration, administered to her left arm on 04Mar2021 01:30 PM (at the age of 70-year-old) (Lot number: Unknown) as single dose for Covid-19 immunisation. The patient's medical history included heart valve replacement. Concomitant medications included atorvastatin at 40 mg day, acetylsalicylic acid (BABY ASPIRIN) and colecalciferol/magnesium oxide/vitamin B1 NOS (MAGNESIUM 400) (other medications in two weeks). On 04Mar2021 03:00 PM, the patient experienced left arm is weak. His arm felt like it could not lift or type. Like the muscle in the arm was failing. The left arm had weakened. it had lasted for two days. A type of muscle fatigue on the left side of the body. A lack of hand and muscle coordination. No COVID tested prior or post vaccination. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Chills - 3 to 4 hours, fever - 36 hours, achiness - 24 hours, head ache - 24 hours Took Tylenol every 6 hours
Mild itching and hives over stomach, groin, armpits, elbows and forearms.
Per phone triage notes per mom. Child vomited at 3:15 pm on 5/2/12 and again at 3:45 pm 5/2/12 and again at 5:30pm, 730pm, and 930pm on 5/2/12. He then vomited next on 5/3/12 at 1130am at school after he drank grape juice. Temperature of 99.4 axillary started at 3:15 pm on 5/2/12 and continued until 5/3/12. As of 5/4/12 no further vomiting or temperature.
Rash running down both arms; Itching; Difficulty breathing; Feeling of throat tightening; Lip swelling; This case was reported by a nurse via call center representative and described the occurrence of rash in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA384A, expiry date 31st August 2021) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) (batch number ABXB06DA, expiry date 31st March 2022) for prophylaxis.   On 9th October 2020, the patient received the 2nd dose of Menveo (intramuscular) and Bexsero (intramuscular). In October 2020, 1 hr after receiving Menveo and Bexsero, the patient experienced rash, pruritus, difficulty breathing, throat tightness and lip swelling. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the rash, pruritus, difficulty breathing, throat tightness and lip swelling were recovered/resolved.   It was unknown if the reporter considered the rash, pruritus, difficulty breathing, throat tightness and lip swelling to be related to Menveo and Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. Approximately one hour after receiving the Menveo and Bexsero the patient developed a rash running down both arms, itching, difficulty breathing and feeling of throat tightening.  The patient self treated with Benadryl and the symptoms improved, approximately 4 hours later the symptoms began to return and the patient developed lip swelling.  Another dose of Benadryl was administered and the symptoms completely resolved without medical intervention.  The reporter consented to follow up.
Pt received ADACEL (Tdap) & MENVEO vaccines 8/6/11 at 12:00 PM. On 8/7/11, 3:45 AM pt woke with dizziness, nausea, fever, vomiting, SOB & heavy chest. Went to ER dept. Monday 8/8/11 went to ER again with complaints of stiff neck & massive headache.
Patient was due for a flu shot recommended for 65 years and older patients. Medical administrator at facility assisted pharmacist in paperwork and  communicated to pharmacist  that patient was over 65 years old. After flu clinic was completed and paperwork was inspected afterwards, it was noted that patient was not over 65 years old.
Red, swollen arm (started at injection site and traveled down arm towards wrist), itching.
mom reports excess crying, not sleeping, T103.8, diarrhea;breast feeding constantly is the only thing that calms pt;saw MD on Tuesday, illness r/o;mom called hlth dept Wednesday to report cont s/s;controlling w/APPA & motrin;
12/05/21 presents to ED for "dyspnea". PMHx of "morbid obesity, COPD, CKD, HTN"
my covid booster was on 10/25/2021.  on 12/1/2021 I began experiencing headache and blurred vision which continued thru 1/3/2022.  on 1/3/22 I went to ER with double vision which lasted approximately 30 seconds.  From 1/3/2022 thru 1/10/2022 I continued to experience headache and blurred vision.  on 1/10/2022 I went to ER with tingling of lips tongue and gums while also continuing to experience blurred vision.  while in the emergency room on 1/10/2022 I experienced another episode of double vision which lasted for approx. 30 minutes.  on 1/10/2022 an MRI scan showed that I had experienced two different strokes within the cerebellum.
This spontaneous report as received from a registered nurse refers to a 6 month old female patient. On 30-APR-2013, the patient was administered expired oral ROTATEQ (lot # 0923AA; expiry date: 25-APR-2013) 2ml oral. No adverse effects were reported. The outcome of the event was unknown. This is one of three reports from the same reporter. Additional information has been requested.
pt recvd vax & on 23OCT93 devel a generalized rash which was itchy; No further details were provided
Patient has no none adverse event but was made aware that the Havrix that was given on 06/22/23 had expired on 06/17/2023. Patient expressed no concerns or side effects from vaccine.
Urticarial-type rash noted to upper chest extending up towards anterior neck and upper back that is erythemic and itchy. 5.5in x 3in. area of erythema/swelling/warmth to left bicep area with mild tenderness to touch.
6 X 4 induration, pain on LT arm cold compress, OTC Benadryl
vertigo, lightheadedness.  Turning my head can bring on symptoms. Turning over in bed at night at times leads to vertigo.
pt recvd vax 19JUN95 & 21JUN pt was brought to MD's office w/swelling over fontanelle & questionable intracranial pressure inc;CBC & spinal tap performed (results pending);pt also has a sl fever 99.8;no other clinical details provided;
30 days after receiving the vaccination, patient passed away due to blood clots and being sepsis.
off label use; Low temperature 93.9 F to 94 F after booster shot; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE DECREASED (Low temperature 93.9 F to 94 F after booster shot) and OFF LABEL USE (off label use) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059E21A, 036B21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BODY TEMPERATURE DECREASED (Low temperature 93.9 F to 94 F after booster shot). On an unknown date, the patient experienced OFF LABEL USE (off label use). At the time of the report, BODY TEMPERATURE DECREASED (Low temperature 93.9 F to 94 F after booster shot) outcome was unknown and OFF LABEL USE (off label use) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Aug-2021, Body temperature decreased: 93.9 f to 94 f (Low) Low.         No Concomitant medications were reported.  No Treatment information was reported.     This case was linked to MOD-2021-292888 (Patient Link).
loss of mobility and could not walk for approximately two days; loss of mobility and could not walk for approximately two days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US295201_NS.  A 52-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: KESIMPTA. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: MOBILITY DECREASED (non-serious), GAIT INABILITY (non-serious), outcome "unknown" and all described as "loss of mobility and could not walk for approximately two days".  Additional information: Patient stated that he received two Covid-19 booster shots while on Kesimpta therapy.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a physician for GARDASIL, a Pregnancy registry product, concerning a 21 year old female who on 09-AUG-2010 was vaccinated with the first dose of GARDASIL (Lot # 662765/0821Y, Exp date 25-JUN-2011). Concomitant therapy included ACIPHEX and "roresterin". On 09-AUG-2010, after receiving the first dose, the patient experienced headache, fever at 100.4 degrees Fahrenheit (also reported as 100.7 degrees Fahrenheit), body ache, swollen lymph nodes, and nausea. The patient also may be pregnant. The physician sated he was planning to examine the patient and ordered a complete blood count. At the time of the report, the patient outcome was unknown, The last menstrual period and the date of the delivery were unknown. The patient sought medical attention by visiting the physician's office. Follow up information has been received from the physician who stated that the patient was not pregnant and was on birth control when administered GARDASIL. Her last menstrual period date was 01-AUG-2010. No further information is available.
Had swelling at the injection site, considerable swelling about two and half to three inch; Very sore to touch; Itching in her whole arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 93 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 (Batch/Lot number: unknown) at the age of 93 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Verbatim: Hypertension. The patient took concomitant medications. Vaccination history included: Bnt162b2 (First dose), administration date: 2021, for COVID-19 Immunization; Bnt162b2 (Second dose), administration date: 2021, for COVID-19 Immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 02Oct2021, outcome "not recovered", described as "Had swelling at the injection site, considerable swelling about two and half to three inch"; PAIN OF SKIN (non-serious) with onset 02Oct2021, outcome "not recovered", described as "Very sore to touch"; PRURITUS (non-serious) with onset 02Oct2021, outcome "not recovered", described as "Itching in her whole arm". Therapeutic measures were taken as a result of vaccination site swelling, pain of skin, pruritus.  Additional Information: She had swelling at the injection site, considerable swelling about two and half to three inch, very sore to the touch and she is having itching in her whole arm and it's still persisting today like I said she got the shot early on 01Oct2021 and it's still persisting the day.  Follow-up attempts completed. No further information is expected.
The vaccine listed above (bivalent) vaccine was inadvertently administered as first COVID vaccine dose for a five year old patient as opposed to the monovalent vaccine. The patient would have received this dose as a third dose-booster. Provider recognized shortly after while the patient was still in the office with parent/guardian. Parent/guardian informed of situation and follow up. Wrong dose inadvertently administered, no adverse event.
Patient had seizure like symptoms after getting vaccinated.  Patient came around after 3 to 5 minutes and vomited.  Patient denied trip to hospital after EMS arrived.  Patient stayed near the pharmacy until she felt better then when home.
5 days following vaccine ---->  nausea, vomiting. body aches, fever to 102; headache
Info has been received from an RN concerning an 8 year old male who on 1/4/99 was vaccinated in the left thigh with a 1st dose of varicella virus vaccine live (lot 624724/1327E). The mother stated that her son was feverish on the evening of 12/25/05. He was fine from 12/26/05 through 12/28/05. He woke up with spots on his back, arms and chest the morning of 12/29/05. No medical attention was sought. It was unknown if the pt recovered from the spots. Additional info is not expected.
Pt. has a red raised rash at the injection site on her right arm. She states it is warm to the touch and is approximately the size of a quarter. She also states there is the development of a second raised rash just above the injection site and is not sure if it is related to the vaccination, but it does concern her. The day of the vaccination and for a few days after she says her arm was sore, more so than with any other vaccination she has received. Approximately five days after the vaccination, she noticed the rash on her arm while looking in the mirror. She came to the pharmacy to ask about the rash one week after the vaccination and I obtained the information for this report. I recommended she consult her physician if the rash does not improve or gets worse.
Report a side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Report a side effect) 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 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 VACCINATION COMPLICATION (Report a side effect). At the time of the report, VACCINATION COMPLICATION (Report a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment medications reported.
Diarrhea requiring 12 hour hospitalization for dehydration and low bicarb.
Lightheadedness; Anxiety; This is a spontaneous report from a non-contactable healthcare professional. A 69-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration on an unknown date (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date in 2021, during her 15 minute waiting period after the injection, the patient began to experience lightheadedness. The patient denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial swelling, lip swelling and tongue swelling of double mask for a brief moment. Follow up response to treatment was excellent. The patient was discharged and was stable to go home and follow up with PCP (primary care physician). It was reported that differential diagnosis as Vaccine-Related Anxiety (include misc mental health). On an unknown date in 2021, Blood pressure was checked and the patient was evaluated. The patient was doing well and she felt better knowing her blood pressure was okay and not high. The patient was pleased with care and denied any concerns and she was able to ambulate out of the facility without assistance. Therapeutic measures were taken as a result of the event which was not specified. The clinical outcome of the events lightheadedness and Anxiety was unknown at the time of the report.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: AE "Anxiety" was added and coded as such.
pt recvd vax; pt devel diarrhea & pt tongue turned black & pt saliva turned brown;
Patients husband called and indicated he saw a rash on his wifes arm at the injection site. It is red and somewhat raised with no complaint of pain or heat.
Patient received 4 month vaccines: Prevnar, Pentacel and Rotavirus. Shortly after...developed petechiae rash at both thigh injection sites.
received Menveo reconstituted with Pfizer Covid diluent; received Menveo reconstituted with Pfizer Covid diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA569A, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Menveo lyophilized powder portion after being reconstituted with pfizer covid diluent when the patient was supposed to get the covid pfizer, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No reactions reported. The reporter consented to follow up. This case was linked with 12 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR243469:same reporter US-GLAXOSMITHKLINE-US2021AMR243478:Same reporter US-GLAXOSMITHKLINE-US2021AMR243472:Same reporter US-GLAXOSMITHKLINE-US2021AMR243477:Same reporter US-GLAXOSMITHKLINE-US2021AMR243469:Same reporter US-GLAXOSMITHKLINE-US2021AMR243475:Same reporter US-GLAXOSMITHKLINE-US2021AMR243473:Same reporter US-GLAXOSMITHKLINE-US2021AMR243476:Same reporter US-GLAXOSMITHKLINE-US2021AMR243474:Same reporter US-GLAXOSMITHKLINE-US2021AMR243470:Same reporter US-GLAXOSMITHKLINE-US2021AMR243480:Same reporter US-GLAXOSMITHKLINE-US2021240689:same reporter
Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Headache-Severe, Systemic: Weakness-Severe, Additional Details: pt says they cant get up out of bed day after booster dose, dizzy,headache
Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 65 years old patient (gender not reported) who experienced reactions to the FLUZONE HD because it was too strong of a dose, while she received vaccines FLUZONE HIGH DOSE. The patients past vaccination(s) included FLUZONE QUADRIVALENT was received twice in two separate visits. The patients past medical history, medical treatment(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and Exp. Date not reported) via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious reaction (adverse drug reaction) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was reported that; patient has reactions to the FLUZONE HD because it is too strong of a dose but last year received the QUAD FLUZONE (not HD) twice in two separate visits to get the full recommended HD dose for her age of over 65. No information about relevant tests reported. Final diagnosis was reactions to the fluzone hd. No information about corrective treatment reported. The patient outcome was unknown for event. List of documents held by sender: none.