chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Also have cancer thank you Lord for hospice; Hospice / so good helping me with the pain; I have them now, and I've had the shot; I have them now, and I've had the shot / Suspected vaccination failure; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), cancer (serious criteria hospitalization and GSK medically significant), pain (serious criteria hospitalization) and shingles. On an unknown date, the outcome of the vaccination failure, cancer, pain and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, cancer, pain and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication. The patient had cancer and the patient stated that, thank you Lord for hospice they have been so good helping with the pain. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset was unknown.
tingling; pins and needles; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling) and PARAESTHESIA (pins and needles) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced PARAESTHESIA (tingling) and PARAESTHESIA (pins and needles). At the time of the report, PARAESTHESIA (tingling) and PARAESTHESIA (pins and needles) had not resolved. Not Provided          Concomitant medication include birth control  Treatment information was not provided.
Received Heplisav-B 5 months Ago and Currently Has Shingles; Initial Report Received on 24-Aug-2022.  A pharmacist reported that a female (age, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient developed shingles.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient received the first dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) in an unspecified site, route not reported.   On an unspecified date, the patient received the second dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) in an unspecified site, route not reported.   On an unspecified date, 5 months after having received the second HEPLISAV-B vaccination, the patient reported having shingles. The status of shingles is not resolved.  No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
hives; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (hives) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030l20a and 031m20a) for COVID-19 vaccination.     The patient's past medical history included Tumour (painful tumor on face) in December 2020. Concomitant products included METFORMIN, GLICLAZIDE, COLCHICINE and LISINOPRIL for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient experienced URTICARIA (hives). At the time of the report, URTICARIA (hives) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported.   This case was linked to MOD-2021-059555 (Patient Link).
This spontaneous report as received from a pharmacist refers to a patient of unknown gender and age. The reporter stated that on 08-MAR-2013 an expired dose of GARDASIL (dose, indication and route of administration unknown) (lot number and expiration date 667194/1271Z; 11-DEC-2012) was given to the patient. Concomitant medications were not reported. No adverse event was reported. Additional information has been requested.
skin hurt; had head pain but not a headache; This is a spontaneous report from a contactable other healthcare professional. A contactable other healthcare professional reported for his 50-year-old female patient (sister) that she received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. On an unspecified date, the patient experienced skin hurt and had head pain but not a headache. The reporter was just checking in about a reaction to the second vaccine shot. Not too worried. His 50-year-old sister, in good health, received her second shot at noon and at about 6pm all of her skin hurt and she had head pain but not a headache. Checked NCBI, etc, websites and found nothing about generalized skin pain. Curious about thoughts. Not unhappy at all. Hang in there, all of you. He was a former EMT (emergency medical technician). Outcome was unknown for both the events.  Follow-up (01Apr2021): This is a follow-up spontaneous report from a contactable Other HCP. This contactable Other HCP reported for patient.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  No further information is expected.
Received Pneumovax and Influenza, one in each upper arm.  Left upper arm very swollen, red, warm, painful.  Patient summary does not identify which vaccination was given in which arm, unable to learn which vaccination I am reacting to. Called Clinic, nurse never responded.  Went back to location, they said there was a computer problem yesterday and all records are lost, unable to tell me which vaccine was given in my left arm, which vaccine I am reacing to.
I was given the Moderna covid vaccine on January 21. I only had swelling and redness to the injection site.  But today my back is covered in swollen red spots that are itchy and my lips are extremely swollen.   I have not used anything different on my body nor have I consume anything different.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient received BNT162b2 (BNT162B2), on 08Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (13Sep2022) Negative; (14Sep2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 includes that the patient was on Paxlovid from 09Sep2022 to 14Sep2022.  No follow-up attempts are possible. No further information is expected.
IS SUFFERING FROM ALOPECIA AREATA AND LOOSING ALL HAIR ON HIS BODY
This spontaneous report was received from a healthcare professional and refers to a currently 14 months old, female patient. The patient's medical history and concurrent conditions were not reported. On 02-NOV-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Vaccine administration error - administered vaccine underage.  No adverse effects were noted following 15 minute wait period.
No adverse effects. Patient was given HPV Gardasil first dose at the age of 53 even though CDC only recommends up to age 45. Patient states his PCP requested that he obtain the vaccine. Patient displayed no symptoms.
condition worsened; Flu like symptoms; Shortness Of Breath; In Bed For 1 Week (After Second Shot),tired; Headache; Arthralgia; Myalgia; Fever; Chills; Nausea; Vomiting; This spontaneous case was reported by a patient and describes the occurrence of CONDITION AGGRAVATED (condition worsened), INFLUENZA LIKE ILLNESS (Flu like symptoms), DYSPNOEA (Shortness Of Breath), FATIGUE (In Bed For 1 Week (After Second Shot),tired) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced CONDITION AGGRAVATED (condition worsened), INFLUENZA LIKE ILLNESS (Flu like symptoms), DYSPNOEA (Shortness Of Breath), FATIGUE (In Bed For 1 Week (After Second Shot),tired), HEADACHE (Headache), ARTHRALGIA (Arthralgia), MYALGIA (Myalgia), PYREXIA (Fever ), CHILLS (Chills ) and VOMITING (Vomiting ). 05-Apr-2021, the patient experienced NAUSEA (Nausea). On 12-Apr-2021, FATIGUE (In Bed For 1 Week (After Second Shot),tired) had resolved. On 14-Apr-2021, CONDITION AGGRAVATED (condition worsened), INFLUENZA LIKE ILLNESS (Flu like symptoms), DYSPNOEA (Shortness Of Breath), HEADACHE (Headache), ARTHRALGIA (Arthralgia), MYALGIA (Myalgia), PYREXIA (Fever ), CHILLS (Chills ), NAUSEA (Nausea) and VOMITING (Vomiting ) had resolved.            Treatment information was not provided.   This case was linked to MOD-2021-058172 (Patient Link).
Patient received initial dose of Moderna Covid Vaccine.  After 20 minutes, she reported feeling "drunk" foggy.  Her VS 143/81 HR 70 02Sat 99%. @ 1432.  VS 145/94 HR 66 @1445.  Symptoms had resolved.
pain in the left arm in the injection area, extreme body pain and dizziness (3 days)
Swollen eyes, cheeks and mouth, fever, vomiting, redness all over face, cough, wheezing. I took her to Urgent Care and they advised that it was normal and to administer Tylenol.
11/17/99 am, noticed swelling of L/arm slightly larger than a 50 cents piece. Advised to see PMD.
Local reaction 3x2 1/2 irregular in shape; seen by MD who advised was local reaction to DTP; apply cold compress & if size inc or changes in color to see MD;
Small scabs rear calf / shines; This case was reported by a consumer via call center representative and described the occurrence of scab in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced scab. On an unknown date, the outcome of the scab was unknown.  It was unknown if the reporter considered the scab to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient received shingrix vaccine and developed small scabs rear calf,shines.
Patient experienced left side weakness, pain on the left side from back of leg all the way up to her head, fever, muscle pain, swollen left arm, chest, and armpit. She felt like she was having a stroke.
Tinnitus! Started the day after the vaccine.  Accompanied by headache.  Arm pain was intense but anticipated .  Started the day after and nearly gone 4 days afterward. Joint pain and fatigue also expected and gradually easing up.  But the tinnitus is relentless. I have NEVER had it before.
covid test result=Positive / covid test date=Jul/2021; covid test result=Positive / covid test date=Jul/2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Mar2021 17:30 (Lot number: EN6205) at the age of 57 years as dose 1, single and administered in arm right, administration date 25Mar2021 17:30 (Lot number: ER8727) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2021, outcome "unknown" and all described as "covid test result=Positive / covid test date=Jul/2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jul2021) positive, notes: Nasal Swab; (Jul2021) negative, notes: Nasal Swab; (17Dec2021) negative, notes: Nasal Swab; (01Jan2022) negative, notes: Nasal Swab; (May2020) negative, notes: Nasal Swab; (Jun2020) negative, notes: Nasal Swab; (Oct2020) negative, notes: Nasal Swab; (Apr2021) negative, notes: Nasal Swab; (Jun2021) negative, notes: Nasal Swab; (Jul2021) positive, notes: Nasal Swab; (16Dec2021) negative, notes: Nasal Swab. No other vaccine in four weeks. No covid prior vaccination. covid tested post vaccination. Conclusion of Previously Completed Investigation (RA): The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot ER8727 was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot# EN6205 and ER8727. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.
side of mouth swelling, side of mouth numb. Evaluated by EMS- Transported to Emergency room/department or urgent care.
At 1:10 pm, I felt warmth all over my body, face, my heart started racing up to 109 per minute. I felt dizzy soon after. The nurse observing checked my vital signs and found my blood pressure to be at 190/92. After 30 minutes, my face and ears felt really hot, my face was flushed, eyes were hot. My temperature was taken and it was 101.3. At around 6:30 pm, I developed mild headache and body aches. The next morning, my left arm was sore.
A dose leaked around and down the arm; A spontaneous report was received from other healthcare professional concerning a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine, whose dose leaked around and down the arm.    There were no medical history and concomitant medications provided by the reporter.  On an unspecified date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number was unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unspecified date, the patient's vaccine dose leaked around and went down the arm. Patient was not revaccinated. No additional information was available at the time of this report. No treatment information was provided for the event. Reporter provided consent to follow-up.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event dose leaked around and down the arm was considered to be resolved on on an unknown date.; Reporter's Comments: This report refers to a case of Incorrect dose administered for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case of Incorrect dose administered.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-005623: US-MODERNATX, INC.-MOD-2021-005687: US-MODERNATX, INC.-MOD-2021-005689: US-MODERNATX, INC.-MOD-2021-005692:
COVID arm, rash swelling, pain, headache fever. Feeling of having the flu, but lasted only a week.
Fever; Chills; Nauseated; Diarrhea; This is a spontaneous report from a contactable consumer or other non-HCP. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 07May2021 as DOSE 1, SINGLE (Age of vaccination: Unknown) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 07May2021 the patient experienced fever, chills, nauseated, diarrhea. The outcome of event was unknown.  Information on the lot/batch number has been requested.
ED to Hosp-Admission Current  8/26/2021 - present (6 days) Patient presents with ? Shortness of Breath     1. COVID-19 infection.  Patient is severely hypoxic and currently on high flow oxygen at 6 L, 50% FiO2.  Patient is fully vaccinated for COVID-19.  Will obtain ABG on admission due to her mental status changes.  I did discuss about treatment options with the patient as well as her family over the phone.  We will start patient on IV Decadron x10 days, remdesivir and plasma.  We will consult infectious disease due to her rapid progression of respiratory decline.  I have also discussed this patient with the pulmonary team.  Will try proning position.  Consent obtained and given to the bedside RN in the emergency department.  Will obtain D-dimer and trend inflammatory markers.   2. History of COPD with acute exacerbation.  Patient is on steroids.  Scheduled DuoNeb as well as as needed DuoNeb therapy.  Continue home inhalers.   3. History of stroke.  Continue patient on Plavix and atorvastatin.   4. Hypertension.  Continue patient on Coreg.   5. AKI on CKD stage III.  We will hold oral diuretics.  AKI likely prerenal etiology.   6. Hyperlipidemia.  Continue patient on atorvastatin.   7. GERD.  Continue patient on Protonix daily.   Disposition: Pending clinical improvement.  Patient will need OT/PT evaluation for safe hospital discharge.   Total critical care time spent 50 minutes (2:00 pm to 2:50 pm) coordinating patient's care with ED team, ICU team as well as speaking with pulmonary team.
8 days after booster shot, patient broke out in a rash (Not Hives) on Torso, Neck, Arm, Legs/Rash disappears and comes back again in another place; This spontaneous case was reported by a consumer and describes the occurrence of RASH (8 days after booster shot, patient broke out in a rash (Not Hives) on Torso, Neck, Arm, Legs/Rash disappears and comes back again in another place) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In October 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, the patient experienced RASH (8 days after booster shot, patient broke out in a rash (Not Hives) on Torso, Neck, Arm, Legs/Rash disappears and comes back again in another place). At the time of the report, RASH (8 days after booster shot, patient broke out in a rash (Not Hives) on Torso, Neck, Arm, Legs/Rash disappears and comes back again in another place) had not resolved.            No concomitant medications were reported. Treatment medication included Montelukast. Patient reports that Rash disappears & comes back again in another place. It started 8 days after the booster shot.   Reporter did not allow further contact
did not receive the second dose of the Moderna COVID-19 vaccine/four month gap after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not receive the second dose of the Moderna COVID-19 vaccine/four month gap after the first dose) 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 reaction.    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 PRODUCT DOSE OMISSION ISSUE (did not receive the second dose of the Moderna COVID-19 vaccine/four month gap after the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (did not receive the second dose of the Moderna COVID-19 vaccine/four month gap after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Got extremely red eye.  Believe it was pink eye. It was draining clear and white thick fluids for 3 to 4 days. It wasn't personally noticeable until my spouse stated approximately 8 to 10 hours after 1st Pfizer Covid 19 Vaccination was administered that it was.
Facial edema with urticarial to face, chest, lower abdomen. Right periorbital edema worse than left.