chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle spasms; SORE; This is a spontaneous report from a contactable consumer (patient). A patient of unknown gender and age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. On unknown date, the patient experienced muscle spasms and sore after 11 days. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt recv vax OCT95 & devel redness & warmth to the inj site;no tx necessary;pt has recovered;
felt bad week of 4/22 nausea, upset stomach, Wed 24th had diarrhea, headache migraine-type, sweating all week (unusual) while working. Worked 4-22, 4/24, 4/25, 4/26, 4/27.  Rash developed 4/26. No reported places of patients known to have measles. Rash worsened on Sat 4/27 seen by RN diagnosed with vaccine-related Measles. She was measles screening at the time
+ 6-8 lesions noted on neck, back and inner thigh on 1/24/08. + Itchy. 1/25 had 15-20 vesicular lesions. Afebrile. Benadryl and Hydrocort prn.
I had a lump under my arm for a few months. My doctor sent me for an ultrasound and they did both an ultrasound and a mammogram. They found swollen lymph nodes and told me it was from the vaccine most likely.
Large brown spot on right cheek and small brown spot on two fingers; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0186) via an unspecified route of administration in the left arm on 15May2021 at 15:00 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to food, medications or other products. Concomitant medication included RIDDLIN for unknown indication and start date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17May2021 at 07:00, the patient experienced large brown spots on right cheek and small brown spot on two fingers. It was reported that the event did not result in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event large brown spots on right cheek and small brown spot on two fingers was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous consumer report (initial receipt: 01-Oct-2012) concerns a female patient. On an unknown date the patient received an unspecified flu vaccine (manufacturer, brand name and batch number were not provided) injection at a dose of 0.5 mL intramuscularly for 'vaccine'. It was the second time she had gotten the vaccine. Later in the day the patient's eyes began tearing and she kept falling asleep. Later she had a burning throat and could not swallow. She woke up early in the morning and her eyes were swollen shut and she could not breathe. She reported green mucous coming from her eyes. The patient took diphenhydramine. She still had muscle aches a funny taste in her mouth. The patient sought medical attention by calling the pharmacy. The event outcome was not recovered.
After shot became tired. Took a 2 hour nap that was so deep I felt I was under anesthia. It was very restful. The next day I went on a hike and had breathing issues. I was fine after the next day.
HEADACHES; NAUSEA; FATIGUE; CHEST TIGHTNESS; DIZZINESS; VERTIGO; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered to the left arm, on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced chest tightness. On MAR-2021, the subject experienced dizziness. On MAR-2021, the subject experienced vertigo. On 16-MAR-2021, the subject experienced headaches. On 16-MAR-2021, the subject experienced nausea. On 16-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, and vertigo, and the outcome of chest tightness, dizziness, headaches and nausea was not reported. This report was non-serious.
COVID-19 virus test positive; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient states he took Tylenol for treatment of event.   This case was linked to MOD21-076049 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: No specific follow-up information recorded.; Sender's Comments:  MOD21-076049:Follow Up received
No adverse effects were reported; Patients were administered improperly stored vaccines doses; This spontaneous report was received from a registered nurse, concerning a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 13-APR-2019, the patient was vaccinated with improperly storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, lot #R034700 and expiration date 16-JUN-2020 (strength, dose, frequency and route of administration were not reported); with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot #R033080 and expiration date 06-JUN-2020 (strength, dose, frequency and route of administration were not reported); and with hepatitis a vaccine, inactivated (VAQTA) for prophylaxis lot #S001485, expiration date 12-MAY-2020 and lot #R012988 and expiration date 30-MAY-2019. No adverse effects were reported.   The temperature excursion was reported as below 36°F (35.4°F) during a time frame of 27 minutes. Previous temperature excursion was reported as below 36°F (35.4°F) during a time frame of 15 minutes.   A digital data logger was involved.    This is one of several reports received from the same  reporter.; Sender's Comments:  US-009507513-1904USA012221: US-009507513-1905USA002744: US-009507513-1905USA002745: US-009507513-1905USA002746: US-009507513-1905USA002747: US-009507513-1905USA002748: US-009507513-1905USA002749: US-009507513-1905USA002750: US-009507513-1905USA002751: US-009507513-1905USA002752: US-009507513-1905USA002753: US-009507513-1905USA002754: US-009507513-1905USA002755: US-009507513-1905USA002756: US-009507513-1905USA002758: US-009507513-1905USA002759: US-009507513-1905USA002760: US-009507513-1905USA002761: US-009507513-1905USA002762: US-009507513-1905USA002763: US-009507513-1905USA002764: US-009507513-1905USA002765: US-009507513-1905USA002766: US-009507513-1905USA002767: US-009507513-1905USA002768: US-009507513-1905USA002769: US-009507513-1905USA002770:
SORE THROAT; TERRIBLE COUGH; NO APPETITE; RUNNY NOSE; DARK GREEN MUCOUS; AFFECTING VOCAL CHORDS; FEVER; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included stroke. The patient was previously treated with apixaban for stroke. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180502) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAR-2021, the subject experienced fever. On APR-2021, the subject experienced sore throat. On APR-2021, the subject experienced cough. On APR-2021, the subject experienced no appetite. On APR-2021, the subject experienced runny nose. On APR-2021, the subject experienced dark green mucous. On APR-2021, the subject experienced affecting vocal chords. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and had not recovered from sore throat, cough, no appetite, runny nose, dark green mucous, and affecting vocal chords. This report was non-serious.
Initial report received on 24 August 2007 from a physician in the United States. A 13 year-old female patient, with no concurrent illnesses, use of other medications or any pre-existing medical conditions had received a first dose, left deltoid intramuscular injection of Menactra, lot number U2330AAA, on 14 August 2007. Immediately following vaccination with Menactra, the patient "fainted." It was not reported how long the patient had lost consciousness. No relevant diagnostic testing or laboratory data were performed. It was reported the patient recovered.
Lymph node on left side of neck swelled up.  Left side of tongue slightly swollen.
Got the first Moderna COVID-19 vaccination 27Apr2021. Has not gotten the second; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Got the first Moderna COVID-19 vaccination 27Apr2021. Has not gotten the second) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Got the first Moderna COVID-19 vaccination 27Apr2021. Has not gotten the second). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Got the first Moderna COVID-19 vaccination 27Apr2021. Has not gotten the second) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Follow-up on 26 Jul 2021 consumer stated that she is doing good, got her second dose of vaccination, not experienced any side effects.  No Concomitant medications were provided.  No Treatment information provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up received, contains second dose information.
Patient stated a little while after receiving shot and into the next several days, her arm was swollen, red, itchy at site of injection. She did notice it improving so while she noticed the effects described above as early as 10/25/13 she first brought them to the attention to me at the pharmacy at approx 6pm 10/29/13.
on Monday 4/5/2021, approximately 5 hours after the shot it started with fever and chills, then convulsions and tremors.  Muscle contractions were so severe that both knees dislocated.  The spasms and contractions lasted for about 4 hours.  fever , chills, body aches, and headache lasted until late Wednesday 4/7/2021.  Currently still have headache, body aches, fatigue, and loud non-stop ringing in my ears.  I already had ringing in my ears before the shot but now it's much louder and constant.
Dime sized red area on L thigh at site of imm. firm to touch not painful. Afebrile.
tinnitus; This is a spontaneous report from a contactable or other health care professional (patient). A 60-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3249), via an unspecified route of administration, administered in arm left on 27Jan2021 13:00 as dose 2, single (age at vaccination 60-years) for COVID-19 immunization. The patient's medical history included allergy to thimerasol. Concomitant medications included acetylsalicylic acid (ASPIRIN) taken for an unspecified indication. The patient did not have covid prior vaccination and was not tested covid for post vaccination. The patient did not receive any other vaccine within four weeks. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. On 29Jan2021, the patient stated that approximately 48 hours after second dose experienced constant tinnitus. Has not stopped at all for over 2 weeks. The treatment was not received for the event. The outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
IV administration instead of IM; This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 54-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2022-2023 season) (batch number (10)G2979, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th October 2022, the patient received Fluarix Tetra 2022-2023 season (intravenous) and Fluarix Tetra Pre-Filled Syringe Device. On 13th October 2022, unknown after receiving Fluarix Tetra 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-OCT-2022 Reporter's Comment: Director stated an registered nurse at the facility gave a dose of Fluarix intravenous instead of intramuscular. No further details were provided.  The reporter consented to follow up. Additional Supportive Information: Director stated an registered nurse at the facility gave a dose of Fluarix intravenous instead of intramuscular, which led to intramuscular formulation administered by other route.
Information has been received from a registered nurse (R.N.) referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with improperly stored PROQUAD (Merck) (dose, route, frequency, lot# and expiration date not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
The pharmacist at the local Clinic incorrectly injected a Covid-19 Booster Shot instead of a Flu Shot that I requested, which lead to me taking a total of (2) Covid-19 Moderna shots and 2 Moderna Booster Shot (4 Shots in total). I am not Immunocompromised; the first booster shot that I have taken previously was on 12/12/2021. I experienced slight fever, tiredness, headache and pain in my arms following the injection.
Burning sensation in chest, pressure in chest, shoulders, and neck. No treatment seeked. Symptoms stopped by the next morning
red welt 4" by 1.75", swelling, pain and tenderness Left Arm.
Fever (up to 102.3 F), chills, muscle aches, nausea, fatigue, weakness, lightheadedness for 72 hours
Fever; Malaise; Flu like symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number D9474, expiry date 10th September 2021) for prophylaxis.   The patient's past medical history included multiple sclerosis.   On 14th March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, malaise and influenza-like symptoms. On an unknown date, the outcome of the fever, malaise and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the fever, malaise and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows:  There was no resolution date for fever, malaise, and flu like symptoms. For tolerance for dose 2, refer case US2019GSK095707. There is a discrepancy with respect to the outcome of the events fever malaise, and flu like symptoms. In Agency core the outcome is reported as recovered for all three events, however in provided source document it is recovering/resolving with sequelae. The outcome of these events retains as per the Agency structural field.
Itching; hives and welps from head to toe; This spontaneous case was reported by a non-health professional and describes the occurrence of PRURITUS (Itching) and URTICARIA (hives and welps from head to toe) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 07-Aug-2021, the patient experienced PRURITUS (Itching) and URTICARIA (hives and welps from head to toe). At the time of the report, PRURITUS (Itching) and URTICARIA (hives and welps from head to toe) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna
PATIENT REPORTED SWOLLEN TONGUE WITH DIFFICULTY IN SWALLOWING. RIB TIGHTNESS. ALTERED TASTE WITHIN 24 HOURS OF VACCINE. CRUSTY EYE NEXT MORNING FOLLOWING VACCINATION.
11/29/21 presents to EC ED for "fevers, weakness, decreased PO intake, SOB and diarrhea". PMHx of "CHF, Atrial fibrillation, CAD, HTN, CKD, CLL, lower GIB, gout, testicular Ca"
consumer did not receive his 3rd dose per prescribing information (PI) recommendations and is now requesting the 3rd dose today; No additional adverse events reported; This spontaneous report was received from a Nurse Practitioner (NP) and refers to a currently 70-year-old male patient. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On an unknown date in September 2019, the patient was vaccinated with the first dose of hepatitis B vaccine (Recombinant) (RECOMBIVAX)1 ml, (route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date in October 2019, the patient was vaccinated with the second dose of hepatitis B vaccine (Recombinant) (RECOMBIVAX) 1 ml, (route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. It was reported that the consumer did not receive his 3rd dose per prescribing information (PI) recommendations and was then requesting the 3rd dose on 14-OCT-2021, outside the recommendations of the PI. NP stated while she was making a plan of care and calling the company for recommendations for administering the 3rd dose, the consumer grabbed his paper work and left without the 3rd dose being administered (inappropriate schedule of drug administration). No additional adverse effect was reported.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 31-MAY-2017, the patient was vaccinated with a dose of improperly stored VAQTA lot # N005274 with an expiration date of 03-APR-2018 (exact dose, route of administration and anatomical location were not provided), and a dose of RECOMBIVAX HB lot # M035487 with an expiration date of 23-FEB-2019 (exact dose, route of administration and anatomical location were not provided). Administered doses of vaccines underwent a temperature excursion of 35 degrees Fahrenheit (F) for 50 minutes which was detected by a digital data logger. There was a previous excursion reported of 33 F for 4 hours. No adverse events occurred. No product quality (PQC) complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA000908:
nonspecific small raised red bumps on back that spread to pts trunk, rash was pruritic in nature as well
8/6/21: 80-year-old morbidly obese gentleman, well-known patient from my office practice, has BMI of 44.2, has been sick for the last 2-3 days.  Apparently, his brother visited him, who was tested positive for COVID.  Per pt, tested positive for COVID the day before he presents on 8/5/2021.  He has been having exertional shortness of breath, generalized weakness, unable to walk, not eating/drinking, and subsequently he was sent to emergency department.  Of note, patient received Pfizer COVID-19 vaccine, last dose administered March 2021 8/14/2021: Patient discharged home
Vomitting continuosly, could not eat or drink, Fever, lethargic, serious drop in all Vitals: including BP, oxygen level.  Patient needed to go on oxygen. Called doctor and docttor advised it was a reaction to the vaccine and to send patient to ER, but patient refused to go to hospital. Patient recovered within 2 days, but was touch and go.
Shingles; This is a spontaneous report from a contactable consumer (patient herself) via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 52 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ew0153) via an unspecified route, administered in Right Arm on 08Apr2021 at 13:30 (52-year-old at vaccination) as a Dose 1, Single for COVID-19 immunization. The patient was non-pregnant at time of vaccination. The patient's medical history included known allergies to Penicillin, Sulfa drugs. The patient's concomitant medications were not reported.  The patient previously took septra and experienced allergy. Facility type vaccine was reported as Other. The patient was not diagnosed for Covid prior vaccination. The patient had not received any other vaccine within four weeks prior to vaccination. On 15Apr2021, the patient experienced shingles. Ae resulted in Doctor or other healthcare professional office/clinic visit. The patient was not tested for covid post vaccination. No treatment received for the event. The outcome of the events was Not recovered.
pt recv vax 18NOV94 & 19NOV94 temp; 20NOV temp 106.8; no other sx;