chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Missed the 37 day mark to get the second dose; arm got a little bit red; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Apr-2021 and was forwarded to Moderna on 15-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (arm got a little bit red) and PRODUCT DOSE OMISSION ISSUE (Missed the 37 day mark to get the second dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm got a little bit red). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the 37 day mark to get the second dose). At the time of the report, VACCINATION SITE ERYTHEMA (arm got a little bit red) and PRODUCT DOSE OMISSION ISSUE (Missed the 37 day mark to get the second dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient had an appointment for 11Apr2021 for the second dose, but since the vaccine was not available, she was rescheduled for 13 May2021.  No Concomitant medications were reported.  No Treatment information was reported.   This case was linked to MOD21-076028, US-MODERNATX, INC.-MOD-2021-077864 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: AE Outcome updated and FU declined; Sender's Comments:  MOD21-076028: US-MODERNATX, INC.-MOD-2021-077864:Husband's case
Diarrhea; Chills; flu; This is a spontaneous report from a non-contactable consumer (patient). This female patient of unspecified age (reported age was 61, unknown unit) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Apr2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. Patient had her first dose of the PFIZER-BIONTECH COVID19 VACCINE on 02Apr2021 (reported as this past Friday, as of 05Apr2021). Patient reported diarrhea and "chills and whatnot" and wanted to know if this was normal. Never had flu shot before, but patient had the flu. The outcome of events was unknown. This report was assessed by the reporting consumer was non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Nauseous (lasted about 5-8 minutes) Purplish/bluish blinding light where vision was blocked (30 sec-1min approximately)
Severe pain in both legs and hips. Unable to stand or walk for a long period of time.  Has taken Advil. Patient described pain as a 10/10.
I started feeling intense pain in my legs about ten days after the Shingrix vaccine which went on for several days . I spoke to my doctor and by the fourth day and a emergency room visit I was no closer to a diagnosis . I finally saw a neurologist and he sent me to the hospital. They determined it was Guillain -Barre Syndrome.
Within a few days after receiving the fourth anthrax shot, patient experienced aching joints, episodes of being light headed, loss of concentration, memory loss, and moderate to severe fatigue.  These symptoms lasted for appoximately two months.  Other Anthrax shots administered 10/06/1998, 10/19/1998, 11/03/1998.
SLIGHT CHILLS FOR FEW HOURS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced slight chills for few hours. The action taken with covid-19 vaccine  was not applicable. The patient recovered from slight chills for few hours on APR-2021. This report was non-serious.
Myocarditis/Pericarditis  Strong chest pain High fever 24 Hours Strong body aches and headaches Tiredness
About ~40hrs after injection hives were observed covering torso, groin, and neck.; Headache; Sore throat; Sore joints; Injection site turned bright pink; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: ER8729) via an unspecified route of administration in the left arm on 10Apr2021 at 10:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy, source unknown. The patient did not receive any medication within two weeks of vaccination. The patient previously took the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EN6207) via an unspecified route of administration in the left arm on 18Mar2021 at 15:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient had not been not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 12Apr2021 at 06:00, about ~40hrs after injection, the patient experienced, hives covering torso, groin, and neck, headache, sore throat, sore joints, and injection site turned bright pink (coloring similar to the hives). The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No therapeutic measures were taken for the reported events. The clinical outcome of the events hives covering torso, groin, and neck, headache, sore throat, sore joints, and injection site turned bright pink (coloring similar to the hives) was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
New onset seizures with 2 episodes of cardiorespiratory arrest on the day of onset.  Follow up:  Status epilepticus, aspiration pneumonitis.
suspected Vaccination failure; had both doses of the vaccine two years ago - and the shingles last month; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient had both doses of the vaccine two years ago and the shingles last month. The patient experienced shingles 3rd time. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles not provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR088540:
On 03/25/2021 client states she waited for her 30 minute waiting period following vaccine and about 10 minutes after leaving started to develop hives on hands/wrists/arms that continued spreading to sides and lower back.  Client notified Health Dept on 03/26/2021, and client enouraged by writer to seek medical care.  Writer spoke with client on 03/29/2021 and client states has not sought medical care or assessment.  States she has no SOA, swelling, coughing, wheezing or any other s/s of adverse reactions.  States hives remain.
Resident initially expirienced tingling in both hands. This progressed to her experiencing numbness to both arms and trunk of her body and both feet. She said she has felt this way since the day after her vaccination with the intradermal vaccine for Influenza on 09/13/2012. Symptoms began on 09/14/2012. When she reported adverse event to local health department, She was advised to be evaluated at nearest hospital.
This spontaneous report was received from a licensed practical nurse and refers to a 11 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-JAN-2016 and on 14-MAR-2016, the patient was vaccinated with doses of GARDASIL 9 (lot # L007560, expiration date, exact dose, route of administration and anatomical location were not reported), that had experienced a temperature excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
find one case of someone else experiencing a bladder problem after the vaccination; This is a spontaneous case is received reported from a contactable consumer or other non HCP. A female patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration Date: UNKNOWN) via an unspecified route of administration on 04Feb2021 17:30 as SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that she looked up a report and was able to find one case of someone else experiencing a bladder problem after the vaccination on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included urine analysis: no result on.   No follow-up attempts are needed information about lot/batch number cannot be obtained.
Localized tenderness and swelling at site of vaccine that increased in size every few hours until larger than a grapefruit.
Dizziness, increased blood pressure, dry mouth Narrative:  Within 10 minutes of receiving vaccine patient complaining of dizziness, increased blood pressure and dry mouth. Sent to urgent care within the building for evaluation. EKG performed. No meds given
1 day p/vax pt presented to Er w/status epilepticus;exp approx 45min of tonic clonic sz;had dec level of consciousness for about 6hr afterwards;
Upon IM inj.-immediate wheel appeared at site - palpital for SQ fluid, none found. Pt denied any other s/s of adversity. Pt remained on site x 15 minutes - again denied adverse s/s 2/1/10 pt was phoned by Rph - still denies further s/s.
had COVID six weeks ago; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (had COVID six weeks ago) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049l21a, 065e21a, 038a21a and 030m20a) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2022, the patient experienced COVID-19 (had COVID six weeks ago). At the time of the report, COVID-19 (had COVID six weeks ago) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2022, SARS-CoV-2 test: (Positive) Patient had COVID six weeks ago.         It was reported that patient was expecting to receive a booster dose on Thursday and had COVID-19 infection six weeks ago. No treatment information was reported.   Reporter did not allow further contact
JOINT PAIN; SORE ARM; MUSCLE ACHES; HEADACHES; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included hit by a drunk driver when was 20, and concurrent conditions included osteoarthritis, and body aches. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, the subject experienced joint pain. On 03-JUN-2021, the subject experienced sore arm. On 03-JUN-2021, the subject experienced muscle aches. On 03-JUN-2021, the subject experienced headaches. On 03-JUN-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle aches, headaches, joint pain, and sore arm, and the outcome of injection site pain was not reported. This report was non-serious.
Pt returned to HD with c/o reddness and pain at the injection site, onset day of vaccination.  Now presents with redness and soreness of deltoid muscle extending into the axilla.  Pt taking Tylenol with some relief.  Encouraged pt to continue with tylenol and return if symptoms worsen.
weakness; Difficulty breathing; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DYSPNOEA (Difficulty breathing) and NAUSEA (nausea) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013020A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ASTHENIA (weakness), DYSPNOEA (Difficulty breathing) and NAUSEA (nausea). At the time of the report, ASTHENIA (weakness), DYSPNOEA (Difficulty breathing) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Body aches Sore back Fever - temp was 102 Fatigue Took 3 doses of Tylenol which seems to have helped. 24 hours later still feeling pretty sore and tired.
first dose 4 years ago, skipped the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (the patient received his first dose of Shingrix 4 years ago from reporting).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 6-JUN-2022 Reporter's Comments: The pharmacist reported the patient received his first dose of Shingrix 4 years ago and skipped the second dose. The reporter give consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive second dose, which led to incomplete course of vaccination.
The side effects are unknown. The wife said he did not feel well after taking the vaccines and  could not move .He is now hospitalized. per wife, doctors at the hospital were not able to figure out if the weakness that he is experiencing now from vaccines or something else.
A circular rash around the injection site appeared 12 days following the first dose of the Moderna Vaccine (1/16/2021). I had no other symptoms. The rash was red and warm to the touch. Two days later (1/18/2021), the redness had begun to fade. I visited an urgent care clinic to be sure it was nothing more serious. The clinician stated that it looked like a typical site reaction. She prescribed Benadryl and methylprednisolone and advised me to report to the Health Department where I received the vaccine. At this point, I have only taken the Benadryl and I estimate that the rash has faded by 85% (1/19/2021).
This spontaneous report was received from a medical assistant refers to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On 31-MAY-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L027070, expiry date: 30-APR-2017). No adverse effect was reported. Additional information has been requested.
Atrial fibrillation with RVR. ED visits and hospital admission. These visits were within 6 weeks of receiving the COVID vaccine.
Skin on left  arm started to show patchy red areas before swelling in size. Most of the swelling is below the injection site, from mid-arm to the elbow and is noticeably hot to the touch.
Td 0.5cc IM left deltoid 06/07/03. Thereafter on 06/08/03 the pt noted "redness, soreness and swelling" of immunization site. No fever, "chills", weakness; no neuropathic type pain.
6 days after vaccine she developed recurrent soreness in the arm where she got the shot and hives on her legs.  These resolved within 24 hours without intervention.
Adult patient received pediatric 10 mcg dose; Adult patient received pediatric 10 mcg dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 48-year-old male patient who received HBV (Engerix B 10 mcg) (batch number YY2R3, expiry date 12th May 2024) for prophylaxis.   On 21st September 2022, the patient received Engerix B 10 mcg 10 ug. On 21st September 2022, unknown after receiving Engerix B 10 mcg, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 21-SEP-2022 Reporter's Comment: The reporter was a medical assistant. The reporter reported that an adult patient accidentally received a pediatric 10 mcg dose instead of the adult 20 mcg dose. The reporter wanted to know how should proceed. The reporter did not consent to follow up. Additional supportive information: The adult patient was administered a pediatric dose of Engerix B 10 mcg, which led to underdose and adult use of a child product.
Employee states that approximately one hour after vaccination, she developed tingling to the right arm, cough with some throat tightness and irritation.
PATIENT CLAIMS OF GETTING FLU AND GETTING SICK FROM FLU VACCINE.
Tdap given in Error instead of Dtap given Tdap Sanofi Pasteur Lot # U6853AA Exp: 11/06/22 R thigh.
Sore arm after first dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06Apr2021 (Lot number: EW0150) at the age of 66 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Apr2021, outcome "recovered" (09Apr2021), described as "Sore arm after first dose".  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine.   No follow-up attempts are possible. No further information is expected.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/23/2023 ABNL CHEST CT SCAN    ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 3/29/2023 ABNL CHEST CT SCAN    ACUTE HYPOXEMIC RESPIRATORY FAILURE R09.02 HYPOXEMIA 3/23/2023 ABNL CHEST CT SCAN    ACUTE HYPOXEMIC RESPIRATORY FAILURE
Information has been received from a physician concerning a male child who on approximately 04-Oct-2006 was vaccinated with a dose of Rotateq vaccine (human-bovine). The physician reported that on approximately 04-Oct-2006, after receiving the vaccine, the patient would not stop crying. The child was sent to the hospital due to the non-stop crying. After three hours in the hospital waiting room, the child stopped crying. The child was subsequently seen by a physician and sent home. It was noted that the child "didn't have any medication and was not incapacitated. Additional information has been requested.
Case number PHEH2014US019160, is an initial spontaneous report received from a nurse on 19 Sep 2014. This report refers to a 61-year-old male patient. Past medical history and concomitant medication was not reported. On 18 Sep 2014, the patient was inadvertently vaccinated with FLUVIRIN (batch number: 1412001) intramuscularly at a dose of 1.0 ml instead of the recommended 0.5 ml dose. No adverse event was reported following this medication error (overdose).
Information has been received from a nurse practitioner concerning a 26 year old female with chronic vaginitis who on 17-MAY-2007 was vaccinated with a first dose of Gardasil (lot # 57736/0389U). There was no concomitant medication. On 19-MAY-2007 the patient developed a rash on her interior and posterior trunk and a little bit on her arms. The rash was described as kind of flat and raised, and was itchy and red. The patient went to the urgent care emergency room and was administered steroids which helped the rash. At the time of the report, the patient was recovering. Additional information has been requested.
Patient was diagnosed to have COVID 19 infection, came in with malaise, fever, nausea and vomiting, and was admitted. Developed hypotension and was moved to ICU. Was noted to be in shock, cardiogenic shock was considered however, could be from volume depletion. BP improved and moved out of ICU. Was managed for COVID 19 PNA and acute hypoxic resp failure with steroids, remdesivir and supplemental O2.  Pt is improved and is off O2. Eager to go home. Will DC on prednisone taper
did not receive 2nd dose yet.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 7th September 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional details was reported as follows: The age at vaccination was not applicable to this report. The patient received 1st dose of Shingrix more than 1 year ago. Till the reporting, patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Batch number and Expiration date were not reported during conversation but mentioned they have them available just not able to find them. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019AMR090769:same reporter