chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm sore within one hours after vaccination - soreness worsened through the day and hurt for 2 -3 days - also bruised at area of injection site. Saturday 3/6 started feeling achey and warm. Saturday night felt like I had a fever - no access to a thermometer - Sunday very tired and slept most of the day.  Approximately Wednesday 3/10 noticed my arm had a small red rash near injection site - warm to touch . As of 3/16 the rash has lightened but still itches - is about the size of a half dollar.
This case was reported by a healthcare professional and described the occurrence of frozen shoulder in a subject of unspecified age and gender who was vaccinated with Influenza vaccine (manufacturer unspecified). On an unspecified date, the subject received a dose of Influenza vaccine (injection, unknown). At an unspecified time after vaccination with Influenza vaccine, the subject experienced frozen shoulder. At the time of reporting the outcome of the event was unspecified. The orthopedist reported two other cases of frozen shoulder following influenza vaccine. Additional cases see A0761235A and A0761286A.
4 hrs p/vax given pt started w/h/a, fever 100 & vomiting; vomiting lasted 2 hrs (6-7times) fever persisted to 102.5 & finally seen by MD 2 days p/vax; dx w/OM
Fever X 4 days. Temperature 103F on 3/20/2021. Tylenol, fluids. If fever persists, see in office
This case was reported by a other health professional via call center representative and described the occurrence of drug maladministration in a patient who received INFANRIX. Co-suspect products included HAVRIX, KINRIX, BOOSTRIX, ENGERIX B and FLUARIX Quadrivalent for an unknown indication. On an unknown date, the patient received INFANRIX at an unknown dose, HAVRIX at an unknown dose, KINRIX at an unknown dose, BOOSTRIX at an unknown dose, ENGERIX B at an unknown dose and FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, an unknown time after receiving INFANRIX, HAVRIX, KINRIX, BOOSTRIX, ENEGRIX B AND FLUARIX Quadrivalent, the patient experienced drug maladministration. On an unknown date, the outcome of the drug maladministration was unknown. Additional details were provided as follows: The patient age at vaccination was not reported. The healthcare professional stated that the adverse event was already reported. The patient received INFANRIX, HAVRIX, KINRIX, BOOSTRIX, ENGERIX B AND FLUARIX, which led to maladministration. The healthcare professional did not provide details concerning the number of patients, individual patient info or vaccine lot numbers and expiration dates.
No adverse effects reported; she was administered GARDASIL (unspecified lot and expiration) "15 years ago" at the age of "35" which at the time was outside of the indicated age range for GARDASIL; Information has been received from a 35 years old female physician referring to herself. There was no information about the patient's concurrent conditions, concomitant therapies, medical history drug reactions/allergies provided.  On an unknown date in 2004 (reported as 15 years ago), the patient was administered quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, dose, route, lot# and expiration date were unknown) for prophylaxis, which was outside of the indicated age range (Inappropriate age at vaccine administration). No adverse effects were reported.
Immediate and excessive pain continuing for 3 wks;  Followed by prolonged weakness in left arm for past 4 months.
Rheumatoid arthritis; This case was reported by a pharmacist via call center representative and described the occurrence of rheumatoid arthritis aggravated in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number A55XP, expiry date unknown) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On 10th March 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced rheumatoid arthritis aggravated (serious criteria GSK medically significant). The patient was treated with steroids nos (Steroid (Not Specified)). On an unknown date, the outcome of the rheumatoid arthritis aggravated was unknown.   It was unknown if the reporter considered the rheumatoid arthritis aggravated to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient who was currently taking steroid medication because of a medical condition, Rheumatoid arthritis, and wanted to receive the second dose of Shingrix.   The pharmacist did not know how was the medical condition before Shingrix The reporter did not consent to follow-up.  No patient initials, and no vaccine expiration date was provided.
on the site of my shot the whole under of my arm like my armpit area is very, very swollen I mean like a size of lemon; very tender and swollen; tender; This is a spontaneous report from a contactable consumer (patient).   A 36-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (at the age of 36-years-old) as dose 2 (Lot Number: FF2588) and as dose 1, single (Lot Number: EW0181) for covid-19 immunization.  Medical history included hypertension. Concomitant medications included amlodipine and losartan taken for hypertension.  Patient experienced swelling under armpit area on the site of vaccine shot. It was reported that the swelling had like a size of a lemon and it was very tender and swollen. The events were treated with Tylenol 3 times since yesterday 500 mg. The outcome of the events was unknown.
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 45 min after receiving SHINGRIX, the patient experienced injection site pain, fever, general body pain, headache and nausea. On an unknown date, the outcome of the injection site pain, fever, general body pain, headache and nausea were recovering/resolving. It was unknown if the reporter considered the injection site pain, fever, general body pain, headache and nausea to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was completely healthy and felt well prior to the injection. The patient did not have any reactions to previous vaccinations. The patient developed a reaction to SHINGRIX which started 45 minutes after receiving the vaccine. The patient had extreme soreness at the injection site. She had fever (body temperature: 100.5 degree F) and terrible body aches all over and also headache and slight nausea. At the time of this report, the symptoms were subsiding but not completely resolved. There was no cough and no shortness of breath (SOB) were observed. The patient's body temperature was 99.5 degree F on the reporting date. On 20th July 2018, the patient made it through work, but had been in bed most of the day on the reporting. The patient did not take any TYLENOL or ibuprofen for symptoms and was advised to push fluids in the evening on the reporting date. The patient would like to get the 2nd dose of SHINGRIX in 2 to 6 months. It was unknown if the nurse gave consent to be followed up.
This spontaneous report was received on 29-SEP-2017 and 02-OCT-2017, from a registered nurse and a physician assistant referring to a 1 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On 29-SEP-2017, the patient was inadvertently vaccinated with a dose of GARDASIL 9 lot # N010497 and expiration date: 15-JAN-2020 (strength, route and anatomical location were not reported) for prophylaxis; instead of a LIQUID PEDVAXHIB, and in addition, it was unspecified how or why the error occured. No adverse effects were reported.
Got covid after first dose; Got covid after first dose; This is a spontaneous report received from a consumer based on information received by Pfizer.  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), intramuscular on an unspecified date as single dose for covid-19 immunisation. The patient also received pancreatin (CREON), oral from an unspecified date at unspecified dose for exocrine pancreatic insufficiency (EPI) not associated with cystic fibrosis.  Medical history and concomitant medications were not reported.  It was reported that on an unknown date the patient got COVID after first dose of bnt162b2 vaccine. The outcome of the event was unknown.  The action taken for pancreatin was unknown. Causality assessment as per reporter was not reported.  Information about batch/Lot number has been requested.
extreme fatigue; brain fog; Occasional mild chills; hot flashes; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 23Apr2021 at 09:00(at the age of 37-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Concomitant medications included liothyronine (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN) started on an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 26Mar2021 at 09:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was 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 vaccination. On 23Apr2021 at 21:00 the patient experienced extreme fatigue, brain fog, occasional mild chills and hot flashes. The events resulted in doctor or other healthcare professional office/clinic visits, and the emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the event extreme fatigue, brain fog, occasional mild chills and hot flashes were not recovered at the time of the report.   No follow-up attempts are needed; information about the lot number cannot be obtained.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment information was provided.  Patient took vaccine on Deltoid.   This case was linked to MOD-2021-361706 (Patient Link).
leg pain; This is a spontaneous report from a contactable other hcp via Pfizer Sponsored Program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified dated, the patient experienced leg pain. The physician was aware.  Information about lot/batch number is requested.
flu; Initial information received on 07-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves a patient of unknown age and gender who developed flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect influenza vaccine produced by unknown manufacturer (dose, strength, formulation, lot number, expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed flu (influenza) (unknown latency) following the administration of influenza vaccine.  Reportedly, Got the flu shot still got the flu.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event.
soreness in arm the day after; This is a spontaneous report from a contactable consumer. An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unknown date in Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received any other vaccines within 4 weeks prior to the COVID vaccine was reported as unknown. The patient experienced soreness in arm the day after vaccination on an unknow date in Jan2021. The seriousness of the event was reported as no. The treatment received for the adverse event was reported as unknown. The outcome of the event was unknown. Prior to vaccination, the patient diagnosed with COVID-19 was reported as unknown. Since the vaccination, the patient been tested for COVID-19 was reported as unknown.  Information on the lot/batch number has been requested.
A consumer (and health care professional) reported the following informationvia Novartis on 5 NOV 2009: An 11-year-old female patient was vaccinated with H1N1 (batch no. unknown) on 31 OCT 2009. She experienced flu like disease (elevated temperature up to 37.9 C, sore throat and cough) on 1 NOV 2009 persisting for four days. She had recovered at reporting date. Her father was also vaccinated. Please see cases MA2009-3704 and MA2009-3705. This case was initially reported as MA2009-3707. Follow up information received from consumer on 03 Feb 2010: No new medical information was received.
C/o severe pain and reddness since the evening of injection.  Took Tylenol PM for the pain last evening.  Member stated limited ROM due to pain, difficult to drive and dress this am. Several red patches noted on R deltoid, member denied itching, but stated severe pain. Was seen by Dr. stated the red patches were hives.
Intermittent ongoing diarrhea. Eventually soreness across the bottom of my abdomen. 3 episodes of night sweats. At times I had a dull headache. I felt washed out. I called my doctor and he said he needed to see me. Saw his physician?s assistant on 12/28/2021. She asked a lot of questions, didn?t have a fever and everything was normal. Lower bottom part of stomach was sensitive to the touch. Sent me straight to get a CAT scan at the imaging department. Determined that it was diverticulitis and that there was infection in a pus bag that had formed. She put me on Cipro and another strong antibiotic that I took 4 times a day. I took those for 10 days and didn?t miss a dose. I had to eat liquids. First 2-3 days I ate crackers and 7-up and soup. And a bland diet. Still having diarrhea after the medication. On 01/12/2022, I had a regular doctor appointment. They had seen my CAT scan and discussed that I should be okay going home. I had a colonoscopy scheduled for the 01/28/2022 with the same doctor who did my colonoscopies previously. And he said I was doing fine and that it had healed. Now it?s the end of February, I don?t go to the bathroom nearly as much. But I?ve already been twice this morning and it was fluid and loose. I don?t feel bad. I was able to eat dinner last night and a cup of coffee this morning. Not sure how this began. Don't consider myself fully recovered because of the intermittent ongoing diarrhea
Became aware of individual when noted to meet the case definition for a Vaccine Breakthrough case. He is a resident of a facility who report he was brought to the hospital for respiratory complaints and tested Covid + at the hospital. Has a history of "underlying respiratory issues" per the facility.
THE PATIENT SAID A COUPLE OF HOURS AFTER HER SHOT SHE HAD EARS CLOSING UP, LEFT JAW TENDERNESS AND NECK PAIN.
Patient was fully vaccinated with Pfizer (3/10/21 and 3/31/21). Patient was hypoxic with a saturation of 77% and has been admitted since 12/6/21
Roughly two weeks after receiving the booster, any slight irritation of the skin that occurs began to cause a break out in hives. The symptoms are synonymous with dermatographia urticaria. I am constantly itchy without antihistamines.   This happened the first time I received the booster (December 2021) but at the time I did not know it was related to the vaccine. Now that it has occurred twice after receiving the covid vaccine, I know it isn't a coincidence.  The first time it occurred the side effects lasted two months.
3NOV92 took flu shot 7PM had temp 99.8, diaphoresis, shaking, chills & muscle aches; site of inject very tender; unusual stinging when med injected;
Kinrix was given to two patients 4 months of age; Kinrix was given to two patients 4 months of age instead of Pediarix.; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th May 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 28th May 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows:  The licensed vocational nurse reported that Kinrix was given to a 4 months old patient instead of Pediarix, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter did not consent to follow-up. This case has been linked with US2021120511, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021120511:Same reporter
immunocompromised condition; This spontaneous report was received from a nurse via Pfizer and refers to an elderly (age reported as "65+") patient of unknown gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On an unknown dates, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection (exact dose, route of administration, anatomical location, lot #, and expiration date were not reported) and pneumococcal vaccine conj 13V (CRM197) (PREVENAR 13) (exact dose, formulation, route of administration, anatomical location, lot #, and expiration dates were not reported), both for prophylaxis.  On an unspecified date, the patient developed immunocompromised condition. The outcome of the event was not reported.  The causality between the event and the suspect vaccines was not provided.  Upon internal review, the event of immunodeficiency was determined to be medically significant.
0.25 ml Fluviron given. Rec for > 4 yrs. Box marked but not on actual vial. Pt had no reaction.
spike in her blood sugar glucose for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (spike in her blood sugar glucose for 3 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic and Diabetes.   On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (spike in her blood sugar glucose for 3 days). At the time of the report, BLOOD GLUCOSE INCREASED (spike in her blood sugar glucose for 3 days) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Blood glucose increased: (High) Spike in her blood sugar glucose.         No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Felt sick; Could not move; Fever ( 100 to 102 F ); This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt sick), HYPOKINESIA (Could not move) and PYREXIA (Fever ( 100 to 102 F )) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient was on oxygen for 2 months) in March 2020. Concurrent medical conditions included Penicillin allergy and Allergy to antibiotic.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Felt sick), HYPOKINESIA (Could not move) and PYREXIA (Fever ( 100 to 102 F )). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (Felt sick), HYPOKINESIA (Could not move) and PYREXIA (Fever ( 100 to 102 F )) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) 100 to 102 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported   This case was linked to MOD-2021-321083 (Patient Link).
Abnormal uterine bleeding. Started morning after an evening 2nd dose.  Normally 28 day cycle very routine. Started a week early and has not stopped since, 8 and a half weeks so far.  Large clots at times. Is a change from baseline, not blamed on stress please. As still ongoing and labs pending, uncertain outcome at this time.
2 weeks after shot developed peripheral neuropathies, balance issues, weakness/shuffling of feet (like parkinsons/autoimmune). All symptoms are similar to Guillain-Barre Syndrome (patient has not been diagnosed, symptoms are similar)
Case number PHHY2012DE047844 is an initial literature report received on 16 May 2012. Authors performed a controlled observational prospective cohort study on H1N1 vaccine safety in pregnancy. This case refers to a baby (sex not specified) born to a 35-year-old mother. The mother was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) at 29 weeks and 4 days of gestation (see linked mother file: PHHY2012DE047843). The baby was exposed to these vaccines via trans-placental route. At 42 weeks of gestation the baby was born and presented with hemagioma (1.5 x 3 cm x 1 mm) in right wrist. The seriousness and causality was not reported. Authors concluded that there was no indication yet for any unwanted effect of H1N1-vaccination to the pregnant woman or the unborn. However, lack of evidence of increased risk might not be interpreted as evidence of no risk. Larger studies were needed to confirm the anticipated safety of immunization during pregnancy.