chrisvoncsefalvay/vaers-outcomes huggingface dataset:
intense and frequent migraines, getting them 1-2 times weekly; extremely fatigued; nauseous; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non-pregnant female patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EN6207 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 02Apr2021 as dose 2, single (at the age of 33-years-old) for COVID-19 immunisation. The patient medical history included allergy to penicillin and migraine (had gotten 2-3 a year prior) (both from an unknown date and unknown if ongoing). Historical vaccine included patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EN6202 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 12Mar2021 as dose 1, single (at the age of 33-years-old) for COVID-19 immunisation. Patient did not take any other vaccine in four weeks and had no other concomitant medications in two weeks prior to COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested with COVID-19, post vaccination. On 12Apr2021, patient had intense and frequent migraines within a few weeks on her final dose. Patient had gotten 2-3 a year prior but now was getting them 1-2 times weekly and was extremely fatigued and nauseous. Patient stated that now almost 4 months later they have started to decrease, and patient was getting 1-2 a month. Patient was unsure if they will go completely back to a rare occurrence at this point but at least seem to be slowing down. No therapeutic measures were taken as a result of events. The outcome of all the events was recovering.    Follow-up attempts are completed. No further information is expected.
Myalgia and erythema multiforme.  Cephalexin mg BID.
Followed by Infectious disease for two "episodes" of fever starting Jan 2 2019. He had low energy, decreased appetite, and an 8 pound weight loss. On 10/10/2018 he had elevated inflammatory markers. On 12/19/2018 he had cervical and supra-clavicular lymphadenopathy. Biopsy did not show neoplasm. Mother is convinced that all of this was initiated post HPV vaccination, and she requested that we submit a VAERS report.
Information has been received regarding a case in litigation from a lawyer and a 61-year-old female patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 15-FEB-2017, the female patient was administered the ZOSTAVAX by a healthcare provider at a clinic (Lot number, dosage and route of administration not provided). On or about 17-JUL-2017, the patient was treated by a healthcare provider at the clinic for the following injury resulting from her ZOSTAVAX use: Shingles. The patient claims damages as a result of: injury to themselves, loss of consortium, loss of services (not specified) and economic losses. The outcome of the shingles was unknown. Additional information has been requested.
Patient received flu shot on 12/1/20 and had tenderness within 24 hours after and the pain continued in arm/shoulder with limited range of motion. Patient was asked to fill out incident report and seek further medical advice for injection site injury.
On and off headache that sometimes radiates at the back or in the front; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (On and off headache that sometimes radiates at the back or in the front) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-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 an unknown date, the patient experienced HEADACHE (On and off headache that sometimes radiates at the back or in the front). At the time of the report, HEADACHE (On and off headache that sometimes radiates at the back or in the front) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was reported.
Initial report received on 07 April 2010 from a health care professional, who is also the patient. A 56 year old male patient, with no known allergies, inadvertently received a 0.1 ml intradermal injection of ADACEL (lot number not reported) in the forearm on 05 April 2010 instead of Tubersol. An unspecified amount of time later, on the same day, the patient developed a bump approximately the size of a dime that was surrounded by redness approximately the size of a half dollar. He also developed itchiness and burning which seemed to have resolved with the use of hydrocortisone cream. At the time of the report, the patient had not recovered; the bump and redness persisted.
Employee faxed in injury report on 12/13/18 to document an adverse reaction that occurred from a flu shot she received through the wellness fair on 11/5/18. The employee reports she started to experience a bilateral numbness and tingling in her feet about 3-4 days after getting her flu shot (the weekend of 11/09/18-11/11/18). She waited about a week to see if the symptoms would go away but they progressively worsened so she went to her PCP who did lab work. Those labs came back negative and she was placed on meds for neuropathy. The symptoms progressed further to numbness in both legs, both arms and abdomen to the point where the employee had difficulty standing up She went to ER for care and the provider there directed her to follow up with a neurologist. The employee looked up a neurologist through her insurance who ordered an EMG.  This results of this test per the employee's report was that she was diagnosed with Guillian Barre.  She was then admitted to the hospital on 12/13/18 for treatment with IVIG until her discharge date of 12/17/18. EE continues to have numbness in her lower extremities.
1/8/22 Pt was admitted to the hospital.  On 1/4/22, she presented to an urgent care w/URI symptoms and a household exposure to SARS-CoV-2. She tested positive. Room air pulse ox was 96%. She was discharged to home w/ approp instructions.  She presented to the ED on 16/22 with dyspnea on exertion and room air pulse was 85%. Her exam was otherwise unremarkable. She was discharged to home on O2 per nasal canula-1L at rest and 3L w/exertion. She was started on Decadron and placed in facility. 1/8/22. Facility physician sent pt to the ED for sats in the 70's despite 3 L O2 per NC. per D/C summary patient is a 36 y.o. female patient of CNP pmh dm2, RA, htn who presents to ED with increasing shortness of breath and cough for the past 8 days   Severe sepsis?present on admission Acute respiratory failure with hypoxia Secondary to Covid-19 Pneumonia With superimposed bacterial infection from MRSA Date of onset of symptoms: 12/31/21 Symptoms present on admission: cough, shortness of breath, fever, nausea Date of covid positive test: 1/4/22 Vaccination status: vaccinated with J&J June 2021  Imaging: 1/8/22 CTPE study with multifocal pneumonia Oxygen requirements on admission: high flow NC 13L Current oxygen requirements: Saturating well on room air, ambulated in the room and oxygen saturation dropped down to 90% on room air. Not qualifying for home oxygen, already has home oxygen arranged from recent ED visit Medical therapy: dexamethasone 20 mg daily 1/9?1/12, will discharge home on dexamethasone 6 mg p.o. daily for 5 more days. S/p   remdesivir 1/8?1/12, Rocephin and doxycycline started 1/8. Switch to oral cefdinir and doxycycline for 5 days at time of discharge MRSA swab positive Consultants following: ID and Pulmonary  special isolation end date: Today    Lactic acidosis--resolved Lactic acid 3.7-- >1.3. Suspect due to respiratory failure with hypoxia
SEVERE CONTINUOUS TINNITUS BOTH EARS- WHOOSHING RT SIDE, RUMBLING & CRICKET NOISE LEFT SIDE
receiving two polio doses in error with no adverse event; Initial information received on 23-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 9 months old female patient who was receiving two polio doses in error with no adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Immunisation.  On 22-Jun-2022, the patient received a dose of 0.5 ml of suspect IPV (VERO) lot U1C571M, expiration date: 17-Jun-2023, (formulation: unknown) strength: standard, via intramuscular route in the left leg as immunization. This would be third dose of the patient.  On 22-JUN-2022 the patient was receiving two polio doses in error with no adverse event (incorrect dose administered) same day following the administration of IPV (VERO).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (receiving two polio doses in error with no adverse event).  At time of reporting, the outcome was Unknown for the event receiving two polio doses in error with no adverse event.  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 the Directive 2001/83/EC 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.
body aches, chills, feeling sluggish, couldn't sit up, wasn't hungry or thirsty
Site: Pain at Injection Site-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: brusing in hand after noticed tingling in arm immediately after shot
grandma & mom reports pt broke out w/red bumps or whelps on face, chest, legs, eyelids on 26JUN92 & fever 103-104 thru 26JUN92; bumps or whelps turned to black-blue spots;
Injection was in non-dominant UE.  2 days post vaccine, redness and swelling increasing in non-dominant (LUE) 3CM greater than RUE at deltoid insertion, along with pain at 3-4/10 on 0-10 pain rating scale.  Pain at post vaccine day 2 not related to movement or pressure.  Regular ibuprofen use at 600 mg TID to alleviate pain, unsure of impact on inflammation and edema.  Redness and swelling noted from scapula to mid humerus, lateral aspect of UE.  Tenderness to touch migrating from injection site on day one, through scapula-deltoid-triceps region through biceps and anterior aspect of UE on day 4, without redness noted, appears to be mild swelling day 4 of biceps with discomfort in palpation.  Symptoms at this time reported by patient, who is a physical therapist - doctor, Plan to consult MD tomorrow if symptoms are not improved.  Similar clinical presentation to progressing cellulitis or response to allergic reaction to bee-sting.  Plan to follow up with MD on 2/10 if symptoms do not significantly resolve.
BACK PAIN; SHORTNESS OF BREATH; CHEST TIGHTNESS; EXHAUSTED/VERY TIRED; HEADACHE; CHILLS; FEVER; DIZZINESS; This spontaneous report received from a patient concerned a 24 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included depression, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. Concomitant medications included desvenlafaxine for depression. On 20-MAY-2021, the subject experienced dizziness. On 20-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) Between 100.3 -102.7. Treatment medications included: acetylsalicylic acid/chlorphenamine maleate/phenylpropanolamine hydrochloride. On 21-MAY-2021, the subject experienced chills. On 21-MAY-2021, the subject experienced headache. On 22-MAY-2021, the subject experienced back pain. On 22-MAY-2021, the subject experienced exhausted. On 22-MAY-2021, the subject experienced shortness of breath. On 22-MAY-2021, the subject experienced chest tightness. The action taken with covid-19 vaccine  was not applicable. The patient recovered from dizziness on 22-MAY-2021, and fever on 21-MAY-2021, had not recovered from headache, back pain, exhausted, shortness of breath, and chest tightness, and the outcome of chills was not reported. This report was non-serious.
erythema and swelling on injection arm below the actual injection site; erythema and swelling on injection arm below the actual injection site; Face and neck rash; This is a spontaneous report from a contactable physician. This physician reported for herself. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 16Dec2020 18:00 at single dose for covid-19 immunization. It was the first dose. The COVID-19 vaccine was administered at Hospital. The patient's vaccine location was left arm. Medical history included hypertension (HTN), and mild asthma, the patient's known allergies included Black pepper, hydroxychloroquine sulfate (PLAQUENIL), hydrochlorothiazide (HCTZ), almond extract. Concomitant medications included Losartan, spironolactone, progesterone, metformin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced face and neck rash, erythema and swelling on injection arm below the actual injection site, adverse event start date was provided as 16Dec2020 06:00 PM. The patient Took fexofenadine 360mg for facial rash. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The outcome of the events was Recovering.
Chills, fever; swelling/redness/tenderness to outer aspect of upper L arm immediately after injection, on third day of symptoms when seen by PCP.
Pt was seen in urgent care on 5/26/06. Diagnosis was cellulitis vs local reaction. She was started on Keflex. On 5/27/06, she was seen in the pediatric clinic by MD. Reaction to DTAP described as area of redness and growing. Pt is able to use arm. MD instructed parents to continue antibiotic and RTC if no improvement or worsening. Resolved per mom 5/31/06.
Since around October 14, 2020, I have had recurring, alternating painful ankles and feet with edema.  Signs and symptoms match sprained ankles, cellulitis, gout.  Swelling, pain, limping, shinny skin, edema subcutaneous, dry skin, skin peeling, redness, slight  warmth.   When the left ankle is swollen, the right foot will be formal.  When the right foot is swollen, the left foot is normal.  They take turns being swollen.   NO FEVER NO PUS  NO INFECTION      Rocephin 2 rounds of 3 day injections - no change Keflex - No change Ice packs - no change Legs elevated at night  - swelling gets better, but comes back within 5 minutes   This is all speculation.  Medical staff says that they are not sure what is causing this.  I have seen about 8 physicians.
This case was reported by a health professional and described a 42 year old male who did not respond to the hep B vaccine recombinant (Engerix B) immunization series. The pt's medical history, concurrent conditions, and concurrent medications were not reported. The pt received injections of Engerix B on 5/23/01 (5235A4), 9/25/01 (5239A4) and 5/7/02 (5242A4). On 4/24/03, a hep B surface antibody titer measured less than 2.0.
RN went to administer Heb B Vaccine, upon administration, noted that vaccine was leaking out of connector, RN attempted to tighten connection of needle and syringe, RN attempted to push more of med, more vaccine noted still leaking from needle. RN removed needle and syringe since majority of vaccine had leaked out of syringe. New syringe and set up obtained, different Hep B vaccination administered to pt. Pt remained in clinic for additional monitoring, no side effects noted, PCP notified.
At about 3:45 a.m. I woke up from a disturbed sleep and felt "off".  When I rolled over on my left side I detected a very irregular heartbeat.  I took a wrist pulse and got the same.  I have been diagnosed with atrial fibrillation several years ago and have a heart care/heart monitoring app on my phone.  I took a reading at 4:28 a.m. and it reported "Atrial Fibrillation" at 60 BPM.  I took 100 mg tab of previously prescribed flecainide acetate.  I took a further reading at 5:41 a.m. and it reported "Normal Sinus Rhythm at 59 BPM. I have a low resting heart rate, usually around 48-52 BPM.
Burning sensation; Itching; Cellulitis; A spontaneous report was received from a consumer concerning a 79-year-old, female patient, who burning sensation, itching/ Injection site pruritis, and cellulitis.  The patient's medical history was not provided.  Concomitant products known to have bee used by the patient, within two weeks prior to the event, included Synthroid and Metoprolol.  On 12 Feb 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (batch number: 006M20A) via unknown route for COVID-19 infection prophylaxis.   The patient experienced bump like a hard ball, burning sensation, redness, itching, and pain at the injection site after the first dose of vaccine.  On 24 Feb 2021, the patient was referred to a doctor and was diagnosed with cellulitis.  Treatment medication was reported as Antibiotics for eight days.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events, burning sensation, itching, and cellulitis were considered not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Kidney stone; This is a solicited report based on the information received by Pfizer (MFR Control No. #21K-163-4122796-00). The male contactable consumer (patient) reported for himself.   A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported; information was not available in the patient's file) as dose 1, single (at the age of 67 years old) for COVID-19 immunization;.  Medical history included moderate to severe adult Crohn's Disease from an unknown date. The patient's concomitant medications were not reported. The patient previously took vancomycin and experienced vancomycin allergy, and sulfa drugs and experienced sulfa drugs allergy. On unknown dates, the patient experienced no antibodies for COVID vaccine and COVID vaccine did not work; assessed as non-serious by reporter. On 15Oct2021, the patient experienced kidney stone. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient underwent lab tests and procedures which included antibody test: No antibodies for covid vaccine on unspecified date, ultrasound kidney: Kidney stone on Oct2021. The action taken in response to the event for adalimumab was dose not changed. The outcome of the event was not recovered.  Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of NO ANTIBODIES FOR COVID VACCINE, COVID VACCINE DID NOT WORK and KIDNEY STONE with HUMIRA(ADALIMUMAB) was no reasonable possibility.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the event Nephrolithiasis and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "mild headache"; CHILLS (non-serious), outcome "recovered", described as "chills". Additional information: With the 2nd dose she had mild headache and chills. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt received shot around 8:53 am. She fainted around 9:05 am during her 15 minute after shot waiting period. She said she had not eaten and was nervous. she felt dizzy and lightheaded. an ambulance was called and she refused medical treatment. she was alert and was able to walk out of the store on her own
noted to be very restless all evening, walking the hallways, early morning hours rt noted to have expired in his bed
No additional AE reported; Co-administration of PROQUAD and VARIVAX; This spontaneous report was received from a nurse concerning a 12 month old patient, gender not provided. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.      On 14-SEP-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter for prophylaxis (lot number T034615, has been determined to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date establish as 10-APR-2022) and with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter for prophylaxis (lot number T035401, has been determined to be valid for varicella virus vaccine live (oka/merck) , expiration date establish as 16-OCT-2022) (inappropriate schedule of product administration) (strength, route of administration and anatomical location were not provided for any vaccine) .      No adverse event reported.
HEART ISSUES; This spontaneous report received from a consumer via a company representative concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced heart issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart issues was not reported. This report was non-serious. This case, from the same reporter is linked to 20211245826.