chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Boostrix reaction; This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a 75-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix at an unknown dose. On an unknown date, unknown after receiving Boostrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient had a reaction to the Boostrix vaccine years ago. They suspect it was to the Equine blood used during manufacturing. The reporter was did not consent to follow-up. The reporter had no additional information on the previous vaccination
fatigue; fever; worse headache ever; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), PYREXIA (fever) and HEADACHE (worse headache ever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced FATIGUE (fatigue), PYREXIA (fever) and HEADACHE (worse headache ever). The patient was treated with TRAMADOL ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, FATIGUE (fatigue), PYREXIA (fever) and HEADACHE (worse headache ever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medicines were not provided  Action taken with mRNA-1273 in response to the event was unknown   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow up was received contact information were added
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-DEC-2017, the patient was inadvertently administered an expired dose of ROTATEQ orally, lot# M007307 and expiration date 30-NOV-2017 (dose was not reported). There were no adverse effects reported.
The patient did not experience any additional adverse experience as a result; multiple droplets were not administered; medication was leaking from the site where the syringe and needle meet at the lure lock.; This spontaneous report was received from a healthcare worker referring to a male patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.      On 11-SEP-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (0.5 milliliter, lot # S023475 with expiration date 26-MAR-2022; frequency and route were not reported) for prophylaxis. When administration, the patient's dad noticed that medication was leaking from the site where the syringe and needle meet at the lure lock. The reporter stated enough of the medicine leaked out as the father noticed it, but she felt like it was around 3 drops (incorrect dose administered and syringe issue). The reporter confirmed the product was a prefilled syringe that she attached a needle to. The patient did not experience any additional adverse experience as a result. Product syringe disposed of in the sharps container and not available for return. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; manufactureraddress: manufacturercity: manufacturerstate:  manufacturercountry: devicelotnumber: S023475; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Received a booster at 17 years of age; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received a booster at 17 years of age) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received a booster at 17 years of age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received a booster at 17 years of age) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.  Reporter queried that if a 16 years old patient received Moderna dose 1 and 2, properly spaced and then received a booster at 17 years of age, does this individual need to repeat any of the doses.   This case was linked to MOD-2022-563487 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2022: Live follow-up document received: Reporter's contact number was reported.
Approximately 2.5 days following my mothers fist covid-19 vaccine dose, she had a stroke and was admitted to the emergency room. She survived the stroke and following a brief stay at a skilled nursing facility, is still undergoing physical, occupational, and speech therapy.
WOKE UP WITH DULL ACHY PAIN IN MIDDLE BACK AND LARGE SWOLLEN WARM INDURATION AT VACCINATION SITE.
PATIENT RECEIVED 2 BOOSTER DOSES OF MONOVALENT PFIZER BOOSTERS. PATIENT CAME IN FOR BIVALENT PFIZER BOOSTER.
pt took a nap 2hr p/vax, woke up screaming;cried for almost 4hr;started to ER & pt fell asleep so parents drove for 4hr & pt cont to sleep & didn't take to hosp;next day very fussy went on for 7 days;
Hives began three days post vaccine.  Steroid shot rec'd at urgent care center; script for steroid dose pack which was started the following morning.
This spontaneous report was received from a medical assistant and refers to a currently 11 years old patient of unknown gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medication was not reported. On an unknown date, the patient was vaccinated with and improperly stored dose of GARDASIL 9, lot # L024993 with expiration date 17-SEP-2017, (route of administration and dose number were not provided). No adverse effects were reported. It was reported that the vaccine experienced a temperature excursion of 29F for 16 days. This is one of several reports received from the same reporter. Additional information is not expected since no consent was given to reach follow up.
Patient reports chills, fever, muscle aches, headache, 100.1 within 24 hours. Also report loss of appetite, fatigue.
Initial unsolicited report received from Nurse on 31-May-2018. This case involves a patient (age and gender not reported) who was administered only with PENTACEL was not given HIB (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to inappropriate reconstitution technique. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Patient admitted for COVID on 10/13/2021.  Currently an inpatient with respiratory failire.  Vaccinated with 2 doses of Pfizer COVID vaccine on 4/12/21, and 3/22/21.
Having trouble breathing while walking; My throat started closing around 10:30am; Harder for me to swallow; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Having trouble breathing while walking), OROPHARYNGEAL DISCOMFORT (My throat started closing around 10:30am) and DYSPHAGIA (Harder for me to swallow) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OLANZAPINE (ZYPREXA), VALPROATE SEMISODIUM (DEPAKOTE), METFORMIN and GABAPENTIN for an unknown indication.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Having trouble breathing while walking), OROPHARYNGEAL DISCOMFORT (My throat started closing around 10:30am) and DYSPHAGIA (Harder for me to swallow). At the time of the report, DYSPNOEA (Having trouble breathing while walking) and DYSPHAGIA (Harder for me to swallow) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
started getting itchy and skin eruptions all over the hands and feet, still occuring 7 days afterwards
11 days after 2nd dose, I am experiencing heavy spotting, cramps, & diarrhea. Not sure if they are inter-related or not. This is the 1st time I've ever experienced spotting.
On 12/13/22, 12 Pfizer Bivalent boosters were administered at two shelters.  The two loose unpunctured vials had expiration dates of 12/09/22.  The vaccine had expired 4 days earlier, expirations are on the boxes and not vials so nurse was unaware.  Call to facility, told to complete VAERS and call manufacturer. If not viable: follow CDC guidelines which is to notify client and re-vaccinate in 8 weeks.  Pfizer requested data logger temps and calibration certificate as well as event details. Per Pfizer, we are within the 75 days of stability assessment.
pt recv vax arm swelled to 3x its size & was painful;also exp facial swelling;pt has recovered;this is one to two pt from this site;
LITTLE ACHY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-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 07-APR-2021, the subject experienced little achy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little achy was not reported. This report was non-serious.
Muscle pain. Tired - slept most of the day. Headache. Chills. Upset stomach. Fever of 100.3 F.  Lasted 24 hours.
Ringing of the ears constantly; This is a spontaneous report from a non-contactable consumer, the patient. A 59-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Aug2021 at 13:00 (at the age of 59-year-old), as a single dose for COVID-19 immunisation. Medical history included known allergy to sulpha drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On 31Aug2021, the patient experienced ringing of the ears constantly. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included appointment with ear specialist. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ringing of the ears constantly was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within approximately 24 hours of vaccination, patient developed diffuse rash on all extremities. It is itchy and unimproved with Benadryl or Zyrtec. Cannot determine any other cause of rash (no changes in soap/detergent, no known environmental exposures, etc.) and she feels it may be related to the Hep B vaccine. This is 3rd dose in series and she also believes she got it as a child but titers for school were low so they were requiring her to get it again.
Acute CNS demyelinating disease affecting brain and spinal cord with diplopia and left hemiparesis.
I am an internal medicine resident at a hospital.  By the end of one my call days I started having substernal chest pain, non radiating that was worsened with breathing. I initially thought it was heartburn so I took tumms followed by PPI without any improvement. The pain continued to worsen so I did a quick bedside echocardiogram on myself (poor quality probe), however did not appreciate any effusion, wall motion abnormalities or change in EF. I continued my shift and went home in poor shape unable to speak due to pain on deep breathing. When I laid on my bed the pain worsened significantly and improved when sitting up, so I suspected pericarditis and started NSAIDs. Symptoms improved significantly the following morning and resolved in 36-48 hours with the NSAID course. I never did an EKG to confirm the diagnosis and was never started on anything other than the NSAID course due to uncertain diagnosis. After hearing concerns with myocarditis with pfizer I thought I would report my case knowing it is nearly 2 months after vaccination and there is no definitive diagnosis.
15 yr. old male with 2 of seizures, 3 days after patient was given HPV vaccine 4/29/13.
A few months after the injection, I noticed general weakness, lightheadedness, shortness of breath. In January, we tested positive for Covid. Late January, I started seeing the cardiologist thinking my pacemaker was not working right or that something was going on with my heart issues. Stress tests, blood tests, all the testing they did said I was not in afib and the pacemaker was working but the symptoms were still occurring. At that time, the doctor felt that maybe Covid was an issue. At that point, my blood pressure started jumping all around...way high and way low. At this point, we're going to a second cardiologist that deals with the veins and arteries. In my mind, if all the arteries and veins are working properly, I feel like it might have something to do with Covid or the shots.
This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer (patient's mother). A 3 year-old male patient of unspecified ethnicity received a single dose of PREVNAR 13 via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced encephalitis and also nearly lost his leg when the muscle necrotized. Outcome of events was unknown. No follow-up attempts are possible. No further information is expected.
This spontaneous case was initially received on 24-Feb-2016. The case report was received from a Non Health professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/ event (s): The patient received AFLURIA for indication not provided. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/ event (s) and outcome: On an unknown date, after starting/ treatment with AFLURIA the patient experienced pain and swelling in her left arm (non serious, outcome: Not Recovered/ Not Resolved) for several months after the vaccine was administered. No additional information was provided. Action taken: discontinued. Event treatment: Details manually to be entered. Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate.
Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival; Total duration of the excursion refrigerated temps for max of 4 hrs; They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)), PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)), PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Reporter stated that it was unknown if the vial was undergone a previous temperature excursion. The storage condition at the time of the excursion was frozen storage/refrigerated storage. The state of the vaccine at the time of the excursion was partially thawed/liquid. The maximum temperature reached was 8 degree Celsius. The total duration of the excursion refrigerated temperatures for max of 4 hours. The temperature fluctuations occurred as frozen-refrigerated and refrozen.  And also stated that the vial was moved to the fridge on 06-Oct-2021 and administered post 30 days.  No treatment information was provided.   This case was linked to MOD-2022-496015 (Patient Link).
Fever, headache, and  severe body aches began approximately 10 hours after the injection and persisted for approximately 20 hours.
TESTED POSITIVE FOR COVID-19; This spontaneous report received from a patient concerned a 36 year old female of unspecified ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 19-SEP-2021) dose was not reported, 01 total administered in left arm on 09-APR-2021 for prophylactic vaccination.  After receiving vaccination on an unspecified date, the patient had tested positive for covid-19 with an at home test. Laboratory data included: COVID-19 virus test positive (dates unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid-19 was unknown. The patient additionally received non-company suspect vaccine MRNA 1273 (form of administration, route of administration, batch number: 071F21A, expiry: 28-JAN-2022), dose was not reported, administered on 28-OCT-2021 for prophylactic vaccination.  This report was non-serious.
1st shot - Severe diarrhea and nausea for 1 month. Lost 10 lbs, severely dehydrated, light headed, loss balance, weak lost two week off work.  2nd shot - felt vaccine go in my groin, begin experiencing severe pain and a limp, ache in left calf, left knee begin to swell, could not lift my left leg, lost appetite, nausea, loss time from work due to weakness and nausea.
Contacted patient to advise late on booster dose of MMR. States developed swelling in lymph nodes by left ear after receiving shot. She also had a headache. She tried. BENADRYL with no relief: went to emergency room 7 days later: was given VICODIN for pain.