chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient had laryngeal edema; Initial information received on 02-Mar-2021 regarding an unsolicited valid serious case from a physician.  This case involves male patient of unknown age who had laryngeal edema (laryngeal oedema), after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  At the time of the event, the patient had ongoing Asthma.  The patient's past medical history included food allergy as reported that patient had allergy to shellfish.  The patient's past vaccination(s) included FLUZONE QUADRIVALENT with no reported adverse reactions.  The patient past medical treatment(s), concomitant medication(s) and family history were not provided.  On an unknown date (two seasons ago), the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [lot number and expiry date not reported] via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious laryngeal edema (laryngeal oedema) 20-30 minutes following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. This event was assessed as medically significant.  No laboratory data reported.  The patient treatment included self-treatment of 20mg of LORATADINE (CLARITINE) (CLARITHROMYCIN) and a rescue inhaler.  The patient recovered from  the event laryngeal oedema.  Information regarding the batch number of the suspect need to be requested.; Sender's Comments: This case concerns a male patient of unknown age who presented with laryngeal oedema after vaccination with FLUBLOK QIV. The time to onset is compatible. The patient medical history included asthma, food allergy, past vaccination included FLUZONE QUADRIVALENT and treatment included CLARITINE and a rescue inhaler. There is, however, no information regarding concomitant medication, past medical treatment and laboratory tests ruling out alternate etiologies. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Symptoms of headache; This is a spontaneous report from a contactable physician.   A 42-years-old female patient received bnt162b2 (BNT162B2) at age of 42 years, dose 2 intramuscular on 05May2021 (Batch/Lot Number: ER8730) as DOSE 2, SINGLE for covid-19 immunisation. Vaccination facility type :Other. Medical history included gastrooesophageal reflux disease Stable, vitamin d deficiency Unstable, blood cholesterol increased nstable , seasonal allergy stable, mineral supplementation. Concomitant medications included iron polysaccharide complex (FERREX) taken for mineral supplementation from 09Mar2021 to an unspecified stop date; colecalciferol (VIT D [COLECALCIFEROL]) taken for vitamin supplementation from 13Nov2020 to an unspecified stop date. The patient went to the emergency room on 10May2021with symptom of headache as was hospitalized with outcome of unknown. Treatment received: Alpha Lipoic Acid. The patient underwent lab tests and procedures which included on 15Jun2021 magnetic resonance imaging head: mild small vessel disease No mass and magnetic resonance imaging neck: cervical disc disease severe spinal stenosis. No follow-up attempts are possible. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021798632 same patient and drug, different dose.
4/1/21 - When data logger was downloaded to order vaccines on 3/31/21 it was noted for an alarm on 2/9/21 for excursion on 34.5 F for 20 minutes.  On 2/9/21 Frozen moderna was placed in the vaccine refrigerator to thaw. Called to report excursion and check on vaccine stability with each manufacturer.  Per GSK -  Case reference # 01019026; GSK vaccines "stable until expiration date" regarding the Fluarix. Per Dynavax - Case reference # DYN21000504; Heplisav-B if 34.7 F below; discard.  There was no temperature excursion for the frozen vaccines.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with the ZOSTAVAX vaccine by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 11-AUG-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
After my first and second vaccinations my sinus congestion and seasonal allergies completely disappeared. After first dose I noticed complete clearing of nasal passages; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Mar2021 (Lot number: EN6198) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergies" (unspecified if ongoing); "Nasal polyps" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 05Mar2021, outcome "unknown", described as "After my first and second vaccinations my sinus congestion and seasonal allergies completely disappeared. After first dose I noticed complete clearing of nasal passages". Therapeutic measures were not taken as a result of therapeutic response unexpected.  Additional information: The patient didnt receive any other vaccines within 4 weeks prior to the COVID vaccine and not diagnosed with COVID-19. Since the vaccination the patient been tested for COVID-19 After patient first and second vaccinations, the sinus congestion and seasonal allergies completely disappeared. After first dose  noticed complete clearing of nasal passages (I have nasal polyps) and have not needed any seasonal allergy medicine this spring. Feel absolutely fantastic.   No follow-up attempts are possible. No further information is expected.
Patient complains of Lt. hand tingling after the vaccination.  it was resolved after 20mins.  pt. left and went home.
injection site redness; injection site swelling; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE SWELLING (injection site swelling) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy, Food allergy, Dust allergy, Pollen allergy, Fruit allergy and Fruit allergy. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE SWELLING (injection site swelling). At the time of the report, VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE SWELLING (injection site swelling) outcome was unknown.        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.   Patient is also allergic to hay and pine.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up Information received  contains No New Information. On 15-Jul-2021: follow up received and medical history were added.Event dates and patient initial updated. Treatment details were added.
severe burning and was even "jumping" with the injection; Initial information regarding an unsolicited valid non-serious case was received from Nurse via Medical Information (Reference number- 00827114) and transmitted to Sanofi on 25-Oct-2021.  This case is linked to cases 2021SA361271, 2021SA345810 and 2021SA361282 (same reporter).  This case involves a 64-year-old male patient who experienced severe burning and was even "jumping" with the injection (vaccination site pain) after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2127, expiry date 30-Jun-2022) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious severe burning and was even "jumping" with the injection (vaccination site pain) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported "Nurse reports they received 50 doses of Flublok. They administered 6 so far and stopped using the product. She reports for 4 of the 6 administered to staff they have complained of severe burning and were even "jumping" with the injection. Two of the employees have had rashes and welts on arms at injection site the size of a baseball. The welts were hot to touch and raised."  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.
From initial information received on 5/21/04 from a doctor's office regarding an adverse event occurring in the USA, it was reported that a 24 year old female patient received her first dose of a pre-exposure IMOVAX RABIES vaccination, lot number W0223 (route and site of administration unknown) on 9/4/03. One week later she complained of a fever of 102.6 degrees F, an inability to concentrate and hot and cold flashes. The patient received a second dose on 9/11/03, lot number W0223 (route and site of administration unknown), but never received her third. She had exposure on 12/30/03 and was given another dose, lot number W1419, (route and site of administration unknown) and experienced the same reactions within 24 hours. The patient recovered from these events.
Varicella vaccine given 1/18/16, patient presented w/rapidly evolving rash on 1/14/16 - erythematous papules with some central vesicles, some central scabbing to circumoral, legs, arms, and torso. Given acyclovir, Calamine lotion and Aveeno baths. Rash still present but vastly improved on 1/18/16.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and allergies were not reported. The reporter stated that on an unknown dates the patient was vaccinated with the first and second dose of GARDASIL (strength, dose, route, anatomical location, lot number and expiration date were not reported) on time. Then, on an unknown date, (reported as "four to five weeks early"), the patient was vaccinated with the third dose of GARDASIL (strength, dose, route, anatomical location. lot number and expiration date were not reported). No adverse events were reported. Additional information has been requested.
Discharge once from right breast; Could not sleep on right side due to arm pain; Pain in right arm; Pain throughout deltoid - not just at injection site; Pain throughout deltoid - not just at injection site; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM9810) via an unspecified route of administration in the right arm on 12Feb2021 at 13:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included glaucoma, asthma, vasodepressor syncope, thryoid nodules, degenerative "disk" disease, mild scoliosis, osteopenia and low blood pressure. The patient had no known allergies to medications, food, or other products. Concomitant medications included estradiol (MANUFACTURER UNKNOWN), timolol maleate, brimonidine tartrate (COMBIGAN), latanoprostene bunod (VYZULTA) and ergocalciferol (VITAMIN D2); all taken for unknown indications from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3249) via an unspecified route of administration on 22Jan2021 at 14:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 12Feb2021 at 20:00, after second dose, the patient experienced discharge once from right breast, pain in right arm that the patient had still eleven weeks later. At first, pain worse when pulling up, pushing down pants. The patient could not sleep on right side due to arm pain. The patient had pain throughout deltoid - not just at injection site. Her husband massaged it nightly -said felt ropey, but that improved over time and the patient had been doing physical training (PT) exercises for old frozen shoulder issue in left arm to see if that helped (based on suggestion of physical therapist who was treating a hip issue). It makes it hurt. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events could not sleep on right side due to arm pain, discharge once from right breast, pain in right arm and pain throughout deltoid - not just at injection site were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Injection site swelling, redness and pain, started immediately post injection, fatigued that evening. Day following vaccine under arm(lymph node area) of injection arm swelling and pain.
1150 Pt reported "very dizzy". 1155 BP 134/88, P 71, T 98.6, Spo2 96% RA. Pt Hx: Bronchitis, Asthma, Htn, Bipolar, panic attacks. Pt was given water and observed for additional time. 1212: Pt stated "feeling much better, safe to drive". BP 116/85, P 67, T 96.9, Spo2 97% RA. 1215: Pt dismissed, instructed to call PCP for symptoms or 911 for emergencies.
Subsequent to receiving varicella virus vaccine live in 1996, the pt experienced chickenpox. It was noted that the pts sibling had a similar experience.
It appears injection given in the smallpox scar area of (L) arm/deltoid. Large red area (appx 3"x5") with warmth in area below injection site on upper (L) arm.
The vaccinator thought there was vaccine in the syringe when in fact there was nothing in the syringe being used. The Patient received less than 0.5cc of air.  Patient could not come back that day and stated they would reschedule with the health district to receive one dose of Janssen vaccine
Patient received her 2nd dose of varicella vaccine on 10/2/17 on Tuesday, injection site right arm was red, hot, and swollen, 10/4/17. Patient went to clinic diagnosis: cellulitis of right arm-moist heat, BENADRYL at night, ALLEGRA and PEPCID 13x10 cm area on posterior arm. MOTRIN for pain Cephalexin 500 mg tablet TID x 7 days.
Grandmother noticed 3" area of redness (slightly raised) area in deltoid area of left arm day after shot. Child said it hurt a little but it didn't stop her from doing normal activities. the mother noted that arm was warm and red 3 more days, after that was back to normal color. Denies any type reaction to previous vaccine..
Dose number: 3; Dose number: 3; body aches; headache; chills; arm that rec'd the shot was extremely sore; This is a spontaneous report from a contactable consumer (Patient).   A 70-year-old female patient received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration, administered in arm left on 11Oct2021 11:00 (at the age of 70-year-old) (Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation, administered a Pharmacy or Drug Store.  Medical history included thyroid disorder. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) in two weeks included omega-3 [omega-3 nos] (OMEGA-3 [OMEGA-3 NOS]); vit d [vitamin d nos] (VIT D [VITAMIN D NOS]); ubidecarenone (COQ-10); cholesterol (CHOLESTEROL), all taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm right Feb2021 11:00 AM (at the age of 69-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient previously received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm right Mar2021 10:00 AM (at the age of 69-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. No other vaccine in four weeks. The patient experienced arm that received the shot was extremely sore during the night (medically significant) in Oct2021 10:00 PM with outcome of recovered in Oct2021, received dose number: 3 (non-serious) on 11Oct2021 11:00 with outcome of unknown, body aches (non-serious) in Oct2021 10:00 PM with outcome of recovered in Oct2021, headache (non-serious) in Oct2021 10:00 PM with outcome of recovered in Oct2021, chills (non-serious) on Oct2021 10:00 PM with outcome of recovered in Oct2021. No treatment received. COVID was not tested post vaccination.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Woke up with chills, shaking, overall malaise that I had never experienced before.  Took 30 minutes to get out of bed and take Extra Strength Tylenol.  Symptoms dissipated in about 30 minutes.
a booster dose (0.25 mL) to a patient that should have received a full dose (0.5 mL); This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (a booster dose (0.25 mL) to a patient that should have received a full dose (0.5 mL)) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21A. and Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Nov-2021, 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 experienced ACCIDENTAL UNDERDOSE (a booster dose (0.25 mL) to a patient that should have received a full dose (0.5 mL)). At the time of the report, ACCIDENTAL UNDERDOSE (a booster dose (0.25 mL) to a patient that should have received a full dose (0.5 mL)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.  HCP said that they gave a booster dose (0.25 mL) to a patient that should have received a full dose (0.5 mL). This was patient's second dose. Patient doesn't have any underlying medical conditions.  This is a case of Accidental underdose for this 65-year-old female with no relevant medical history reported. It was reported that the patient received a second dose of 0.25 ml on 02-Nov-2021. No adverse events were reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a case of Accidental underdose for this 65-year-old female with no relevant medical history reported. It was reported that the patient received a second dose of 0.25 ml on 02-Nov-2021. No adverse events were reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
On 5/8 she had the vaccine. On 5/15 she had an episode of status epilepticus for which she is currently hospitalized. She is stable and recovering now. However, she had been stable with her seizure d/o, which for her is seizures about every 4 months. However, her last significant seizure was in Feb of 2018. The vaccine is one theory of what may have triggered her seizure.
A non-serious spontaneous report of headache and fever has been received from a non-health professional concerning an eight-year-old male, subsequent to FLUMIST. The past medical history includes asthma and the patient was recovering from cold and had a cough (typical of his asthma). No concomitant medication was reported for this patient. On 20-Nov-2010, the patient received FLUMIST. On morning of 23-Nov-2010, the patient complained of headache and had a fever of 100 degree F. He had no other symptoms and given acetaminophen and by evening of 24-Nov-2010, the symptoms had gone away. The outcome of the events headache and fever was resolved.
21 year old female patient ambulated to Hospital with complaints of abrupt urticaria 2 hours after receiving first Covid-19 Moderna vaccine.  Patient vital signs within normal limits.  Physical examination was conducted with no signs of anaphylaxis.  Patient was prescribed diphenhydramine 25mg capsules, taken 2 tabs by mouth under direct observation.  She was monitored for an additional 40 minutes, with vital signs retaken and within normal limits.  She was placed Sick In Quarters x 24 hours, and instructed to follow up with her DR should symptoms not improve.
prescribed for a skin infection a heavy rash which started 5 days ago; This spontaneous case was reported by a patient and describes the occurrence of RASH (prescribed for a skin infection a heavy rash which started 5 days ago) in an 85-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: RSV vaccine and Flu vaccine . Past adverse reactions to the above products included No adverse event with Flu vaccine  and RSV vaccine. Concomitant products included DOXYCYCLINE for Skin infection.    On 18-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (prescribed for a skin infection a heavy rash which started 5 days ago). At the time of the report, RASH (prescribed for a skin infection a heavy rash which started 5 days ago) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not reported.  The patient states that the pharmacist told to wait 7 days before starting the antibiotic.
Patient received second dose of covid 19 moderna vaccine March 30 2021 and he died exactly 2 months after that second dose.  He died in the shower chair during his shower.