chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a healthcare professional on 19 April 2013. A 4-year-old female patient had received an intramuscular dose of DAPTACEL (batch number C4363BA, expiry date: 06/21/2015, dose number was not reported) in the left deltoid and an intramuscular dose of Hepatitis B vaccine (Other manufacturer, batch number: H018091, dose number was not reported) in the right deltoid, both on 18 April 2013. The patient had no illness at the time of vaccination and pre-existing physician diagnosed allergies, no birth defects and no medical conditions. The patient's concomitant medications were not reported. On 18 April 2013, post vaccination, the patient developed redness, swelling, warm to touch and a rash at the left deltoid. The patient also complained of stomach ache. The patient was seen by a physician. Corrective treatment details were not reported. No laboratory tests were performed. At the time of report, rash and stomachache had subsided and the left deltoid had some redness, minor swelling and was warm to touch. The patient had not recovered from the events. Documents held by sender: None.
PLAQUE PSORIASIS FLARE UPS; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (PLAQUE PSORIASIS FLARE UPS) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced PSORIASIS (PLAQUE PSORIASIS FLARE UPS). At the time of the report, PSORIASIS (PLAQUE PSORIASIS FLARE UPS) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication were reported.  The reporters causality for the event of PLAQUE PSORIASIS FLARE UPS was not provided.   No treatment medication were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Client received a Covid 19 Janssen vaccine at a drive threw clinic. After client received vaccination client started to drive to our designated "recovery" area. Client passed out while operating his vehicle and drove in to a building pillar.  On assessment client was diaphoretic, pale and cool to the touch but responsive to verbal stimuli.  Ringing  in ears
Day 1 injections very painful when given.  hurt all day.  Took extra /Zyrtec and Pepcid 20 mg before injection due to local reaction from first vaccine.  Stayed red and swollen 9 days without treatment of any kind.  Day 2 -woke up with arm pain, mild swelling in local area. Day3-woke up with extreme redness and swelling in top  half arm.  Took Pepcid 20 mg, applied topical hydrocortisone, and took Prednisone 40mg PO.  Heat worsened redness and swelling . Also very hot to the touch.  Had limited range of motion.  Applied cool compresses throughout the day.  Swelling slowly decreased over the day.   Day 4  Overall swelling and redness decreased.  Taking Pepcid and Prednisone again today as is still swollen and red in a large area but less swollen and have increased range of motion.  Still warm to touch.
Pt tested positive for COVID-19 on 2/10/2021 and was deceased on 2/16/2021 per the caregiver.
Pt. states that after receiving the 1st dose of Phizer 03/04/2021, started experiencing symptoms 03/19/2021 of seizure activity. Fractured frontal skull do to fall during seizure activity, Emergency Transportation to Medical Center resulting in admission for observation/discharged 03/21/2021. Primary follow-up with recommendation prescription for Keppra for treatment.
Severe diarrhea 3-5 days after receiving vaccine. Normal soreness in arm for about two days after receiving vaccine, then on 1/20/2021 (8 days after receiving vaccine), I noticed a hard lump at the injection site, that started to itch after touching it. Arm had been itchy for a few days after the injection, but itchiness returned along with arm feeling hot to the touch with a slight red appearance. Area with the lump painful to touch, with mild soreness experienced when moving arm (which had initially disappeared 3 or so days after injection).
She tested positive of Covid 19 last March 15; This is a spontaneous report from Pfizer Sponsored Patient Support Program. A contactable a female consumer (Patient herself) of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on 06Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's  medical history and concomitant medications were not reported.The patient took first dose last march 06 and  and second dose is on March 27. she tested positive of covid 19 last march 15. The patient enquiring if she needs to wait before taking the second dose of the vaccine or if she should start again from the first dose. The patient underwent lab tests and procedures which included Covid 19 test: positive on 15Mar2021.The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Left facial droop. Sent to Emergency Department via EMS 1/19/2021.
pt recv vax 11JAN94 & 14JAN94 pt devel a poison-ivy like rash on shoulders, wrists, ankles & ears; 27JAN94 presented to MD & had rash;
20yo male with Duchenne's Muscular Dystrophy. On 9/17/21  patient began experiencing palpitations and a sensation that his heart. He also noted some substernal chest pain. patient has previous suffered from medical anxiety related to the prognosis of his condition and notes worsening over the last month. He saw a psychiatrist who prescribed alprazolam 0.25mg nightly, which patient states has helped. Patient was taking Pfizer brand, "Tafil" until 9/12/21 when he switched brands to "Alzam" due to shortage. Patient also had a troponin elevation on admission of 0.09 however his baseline troponin is already mildly elevated due to his underlying heart disease. Patient has since recovered and was discharged.
All of my lymph nodes in my neck and head swelled and caused a lot of pain; All of my lymph nodes in my neck and head swelled and caused a lot of pain; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date an unknown date in Sep2021 (Lot number: unknown) at the age of 56 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset an unknown date in Sep2021, outcome "recovered" (an unknown date in 2021), and all described as "All of my lymph nodes in my neck and head swelled and caused a lot of pain". The event "All of my lymph nodes in my neck and head swelled and caused a lot of pain" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of lymphadenopathy and lymph node pain.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. She was told to email by her doctor regarding her reaction that she had with her first dose of the COVID-19 vaccine. She needed to know whether or not to take the 2nd dose. All of her lymph nodes in her neck and head swelled and caused a lot of pain. It lasted for about two months. Her doctor even ordered a CT scan to verify it was not anything else. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
COVID 19 Treatment; COVID 19 Treatment; dose number: 4/Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 44 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6198), on 18Mar2021 as dose 2, single (Lot number: EN6207) and on 26Sep2021 as dose 3, (booster) single (Lot number: FD8448) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31May2022 as dose 4 (booster), single (Lot number: 005M21A) for covid-19 immunisation. The patient's relevant medical history included: "One Lung" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Pulmonic Stenosis" (unspecified if ongoing); "Hiatal Hernia" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Deafness" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN; TRINTELLIX; RITALIN [METHYLPHENIDATE]; XANAX; STRATTERA; ESOMEPRAZOLE. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31May2022, outcome "unknown", described as "dose number: 4/Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid treatment from 13Dec2022 to 17Dec2022 for Covid-19.  Clinical course:The patient taking any other medications/products within 2 weeks of starting COVID-19 treatment was reported as yes. The patient previously receive a COVID-19 Vaccine was reported as yes. No Known Allergies.
Office visit 9/25/09 - localized, inflammatory 10 x 20 cm area of redness.
Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 07-Apr-2022; 21 patients administered with expired vaccines; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 07-Apr-2022) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 07-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 07-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that 21 vials were initially stored in refrigerator on 17-Feb-2022 and doses were administered 30 day use by date or after manufacturer date of expiry. The vials did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow-up received contains no new information.
My wife started experiencing a high fever (105.1) shortness of breath, dry cough, and fatigue.
Developed intense uncontrollable upper torsochills which lasted 30 minutes.The event resolved on its own.The next day I experienced significant muscle soreness in my upper torso(this being the area most affected by these intense chills). I sought no treatment.
punctured vial was left out at room temp and opened for more than 6 hours; A spontaneous report was received from a healthcare provider concerning a 32-year-old, female patient who received a vaccine at her work place when the punctured vial was left out at room temperature and opened for more than 6 hours (expired product administered).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On unknown date, the patient received their first of two planned doses of mRNA-1273 (Batch number: 026L20A ) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    Patient received a vaccine at her work place when the punctured vial was left out at room temperature and opened for more than 6 hours.   Treatment information was not provided.   The event was considered resolved on an unknown date.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 (lot # 026L20A)  with no associated AEs reported.
Vaccine was given subcutaneously instead of IM. Patient had bruising at site of SQ injection beginning 8/12/21.
getting the shot lost vision of half of patient right eye.; This is a spontaneous report received from a contactable consumer. This consumer reported similar events for 02 patients. This is the 2nd of 02 reports. An unspecified age and gender patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date a friend of patient was reported as after 20 minutes after getting the shot lost vision of half of patient right eye. That lasted a few minutes. Have a friend who has a friend who suffered the same effect. Outcome of event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021274179 same reporter/drug/AE, different patients.
22 hours after injection- burning sensation on back of shoulders, neck area to top of scalp.; Burning sensation on right side of neck; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 43-years-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 16Sep2021 14:00 (Lot number: EW0185) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Congenital heart defect" (unspecified if ongoing); "Ankylosis Spondylitis" (unspecified if ongoing). Concomitant medication(s) included: CLARITIN [CLARITHROMYCIN]. Past drug history included: Gabapentin, reaction(s): "Known allergies: Gabapentin". The following information was reported: BURNING SENSATION (non-serious) with onset 16Sep2021 20:00, outcome "not recovered", described as "Burning sensation on right side of neck"; SKIN BURNING SENSATION (non-serious) with onset 17Sep2021 12:00, outcome "not recovered", described as "22 hours after injection- burning sensation on back of shoulders, neck area to top of scalp.". The events "burning sensation on right side of neck" and "22 hours after injection- burning sensation on back of shoulders, neck area to top of scalp." were evaluated at the physician office visit. Therapeutic measures were taken as a result of burning sensation, skin burning sensation.  Additional Information: The patient had Burning sensation on right side of neck, 5 hours after infection. 22 hours after injection, had burning sensation on back of shoulders, neck area to top of scalp. Known allergies: Gabapentin. Other medical history: Congenital heart defect, Ankylosis spondylitis. She had no other vaccine in 4 weeks. Other medications in two weeks: Multivitamins and CLARITIN. She was reported to take MOTRIN and TYLENOL as treatment medication for adverse events. She did not have COVID-19 prior to vaccination and was not tested for COVID-19 post the vaccination.  No follow-up attempts are possible. No further information is expected.
This is a spontaneous report from a noncontactable consumer (patient). A 20-year-old female (not pregnant) patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0169), at the age of 20, left arm, on Apr 26, 2021, single dose, for COVID-19 immunization. Medical history  not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not tested for COVID-19 since the vaccination. Concomitant medication: none. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In 2021, patient experienced 23-day long vaginal bleeding (heavy) and hive-like rash for weeks. She was prescribed cream but it did not help. There was bruising on inner thigh. Treatment included ointment for rash, and new birth control to fix bleeding. The outcome of all events not resolved. No follow-up attempts possible. No further information expected.
11/2/21 Cough This is a new problem. Episode onset: 3 days. The problem has been unchanged. The cough is non-productive. Associated symptoms include chest pain and myalgias. Pertinent negatives include no chills, ear congestion, ear pain, fever, headaches, heartburn, nasal congestion, postnasal drip, rhinorrhea, sore throat, shortness of breath or wheezing. Associated symptoms comments: Chest and back hurt, worse with coughing. Nothing aggravates the symptoms. She has tried nothing for the symptoms Review of Systems  Constitutional: Positive for fatigue. Negative for activity change, appetite change, chills, diaphoresis, fever and unexpected weight change.  HENT: Negative for congestion, ear discharge, ear pain, postnasal drip, rhinorrhea, sinus pressure, sinus pain, sneezing, sore throat, tinnitus, trouble swallowing and voice change.   Eyes: Negative for visual disturbance.  Respiratory: Positive for cough. Negative for chest tightness, shortness of breath and wheezing.   Cardiovascular: Positive for chest pain. Negative for palpitations and leg swelling.       With coughing  Gastrointestinal: Positive for nausea. Negative for abdominal pain, diarrhea, heartburn and vomiting. COVID 19 treatment:   -     methylPREDNISolone (MEDROL DOSPACK) 4 MG tablet; As directed. -     Ascorbic Acid (VITAMIN C) 500 MG CAPS; Take 1 capsule by mouth daily. -     zinc sulfate (ZINCATE) 220 (50 Zn) MG capsule; Take 1 capsule by mouth daily. -     COVID+ Referral for EUA Covid Antibody Treatment
Left leg erythema surrounding vaccine administration site a few inches with a few more inches circumferentially of swelling with sifnifcant TTP. Pt refusing to walk 2/2 to pain, still in pain. Now walking with a limp, improving clincally. Suspect localized reaction but reporting to be complete.   Also received Hep A and influenza vaccine on same day to R leg without any TTP, erythema - don't have lot information available to me now to enter.
This spontaneous report as received from a certified medical assistant refers to a multiple unspecified patients of unknown age and gender. No information on patients' medical history, concurrent conditions or concomitant medications was provided. On an multiple unspecified dates, the patients were vaccinated with improperly stored unspecified doses of VAQTA lot # K012457 with expiration date 04-JUN-2017 and lot# L039659 with expiration date 15-MAR-2017 (dose and route of administration were not reported). No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
2 days after vaccine - Red - swell at site of Varivax. Overnight increased red, induration, has been a febrile 2-3 cm diameter - Cx : Cellulitis. TX : Keflex 500mg x 10 days.
fingers ache when he moves them; hand is swollen; During the night he was very cold and then very hot; whole body aches; headache; joints are aching; fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (fingers ache when he moves them), PERIPHERAL SWELLING (hand is swollen), FEELING OF BODY TEMPERATURE CHANGE (During the night he was very cold and then very hot), MYALGIA (whole body aches) and HEADACHE (headache) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Jan-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) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (fingers ache when he moves them), PERIPHERAL SWELLING (hand is swollen), FEELING OF BODY TEMPERATURE CHANGE (During the night he was very cold and then very hot), MYALGIA (whole body aches), HEADACHE (headache), ARTHRALGIA (joints are aching), PYREXIA (fever) and NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (fingers ache when he moves them), PERIPHERAL SWELLING (hand is swollen), FEELING OF BODY TEMPERATURE CHANGE (During the night he was very cold and then very hot), MYALGIA (whole body aches), HEADACHE (headache), ARTHRALGIA (joints are aching), PYREXIA (fever) and NAUSEA (nausea) outcome was unknown.            No concomitant medications were reported.   The patient did not take any medication for the treatment of the events. He only took sleeping pills
Client awoke 4/11 w/ severe headache and light sensitivity. Took Advil, over course of the day her headache subsided. She did not take her temperature, doesn't know if she had a fever. On 4/12/16 she c/o stiff neck. She did not contact her doctor, she called the health dept. Health Dept. MD called client and advised ER visit within 1 to 2 days.
fever, chills and sweats, muscle ache, head ache, fatigue, loss of appetite, brief nausea.  All resolved within 36 hours. Fever and aches mitigated with Tylenol
On 10/28/14 - developed red ears. On 10/31-11/1/14 developed red, hot, swollen legs and brief fever (labs CBC, CRP normal). On 11/3/14 developed scattered urticaria.
Note that this patient is an employee of the facility where the vaccine was administered.  Five minutes after injection on 3/31/2021, c/o chest tightness followed by nausea and heaving.  Treated for anaphylaxis, transferred by ambulance to Medical Center; and discharged to home later that afternoon.  The employee worked her regular schedule 4/2/21 and 4/5/21 with no stated complaints.  On 4/6/21, received notification from the Employee that she was to be off work through 4/12/21 as her physician feels that the vaccine has damaged her heart.  She states she has a heart rate down to 38 BPM, experiences black outs, has left sided head pain and weakness.  Her personal physician is scheduling her for Holter Monitor and Echocardiogram.  Her physician has now stated she cannot work through 4/16/21.  I have no supporting written documentation from the physician for these medical concerns.
Flu-like symptoms: fever (100.6), chills, headache, fatigue, nausea
Received MMR yesterday; this AM (R) side of face swollen, arm tender no erythema. Pt had no fever or other symptoms- DIAG: parotitis, following MMR.
Prolonged (5hours or more) profound irritability, high pitched inconsolable cry, syxs waning by 9 hours post injection.
COVID 19 bivalent booster given as a 2nd dose. no adverse event to report.