chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain on site, up his right arm; pain in his gum; Pain on site, up his right arm; pain in his gum; Pain on site, up his right arm; pain in his gum; Swelling on the face on his right side, neck, his lymph glands, his gum; Sensitivity when he eats or drinks anything hot, cold or otherwise doesn't matter the temperature; Sensitivity when he eats or drinks anything hot, cold or otherwise doesn't matter the temperature; Pain in his shoulder; Nausea; This is a spontaneous report from a contactable consumer. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, on 23Feb2021 09:00 as dose 1, single for coivd-19 immunisation. Patients medical history and concomitant medications were not reported.  On an unspecified date, patient experienced pain on site up his right arm, swelling on the face on his right side, neck, his lymph glands, his gum, he had sensitivity when he eats or drinks anything hot, cold or otherwise doesn't matter the temperature. He wears dentures, so there are no teeth where he was having pain in his gum. So pain in his shoulder, neck, gums, swelling on right side of his face, he was having nausea. Called  wanted to know will the second vaccination cause any side effect worse or otherwise. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Urticaria. Pruritus and hives. Diphenhydramine 25mg every 6 hours PRN mg PRN, Prednisone taper dose (5mg) mg every day.
The patient was given the vaccine at 1:50pm. He was fine immediately afterward. He was sent outside the clinical room to wait his 15 minutes. When the pharmacist went to release him, he was pale, dizzy, and clammy. He stated that he did not feel good. The pharmacist fanned him to cool  him down. She also gave him a wet rag to wipe his forehead. He was given two teaspoonful of Benadryl 12.5mg/ 5ml. The patient stated that he was feeling dizzy and thought he was going to faint. The pharmacy called 911. The patient removed his jacket and mask as he was hot. The EMT arrived and walked him outside* I am not sure what happened after that
Injection site tenderness for first 24 hours; swollen lymph glands; This is a spontaneous report from a non-contactable  consumer (patient). A 32-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on the left arm on 18Dec2020 11:00 at single dose for COVID-19 immunization. Medical history included tumor removal from left thigh and depression. The patient had no known allergies. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), drospirenone, ethinylestradiol (OCELLA), clonazepam, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). On 02Jan2020, patient reported injection site tenderness for first 24 hours. In less than 24 hours she had developed tenderness under her left arm, into her armpit and it continued to spread downward and also toward her breast. Patient also developed swollen lymph glands in the same areas. No treatment received in response to the events. The patient had no COVID prior to vaccination and not COVID tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events were reported as non-serious. The patient received her second dose of bnt162b2 on 08Jan2021 11:00 in the left arm. Outcome of the events was not recovered.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
Fast and hard heart beat.  So much so my chest hurt until the next day. Called neighbor to stay with me until felt better.  Did not go in for treatment yet.  Just sent PCP message on portal. Will follow up with them
This initial spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown ages and genders. On an unknown date, the patients were inadvertently vaccinated with improperly stored oral, ROTATEQ, oral liquid (Dose, lot number and route not provided). A total of 25 doses were administered. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Extreme breathing issues. I went to the ER and an xray showed clear and I had a blood test. They gave me medication because I was so anxious.  I was also very sick and weak since the vaccine. I am just now starting to get better (11/8/23).
CDC reports: 2 yo child developed fever, local rxn @ inject site, rash & hives following DTP/OPV/MMR immun. Duration of illness 2 days.
Day after vax (in afternoon), noted read area, tenderness & itchiness near where vax was given. Extended in area mildly. 1 wk after vax, has 2 area, lgr 2.5 cm eythema but no adenopathy ordered. Cold compress & antihistamine.
A nurse reports pt received vaccine 3/21/2000, he was seen by physician on 3/23/2000 for injection site reaction characterized by a 5cm area of induration, warmth and pain. He did not require treatment.
plummeting oxygen and pulse levels; plummeting oxygen and pulse levels; sharp, excruciating chest pains; major difficulty breathing; This is a spontaneous report from a contactable consumer (patient) received via COVAES. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm, on 02Apr2021 at 01:30 PM (Batch/Lot number was unknown) (at the age of 50 years old) as dose 1, single for COVID-19 immunisation in a pharmacy or drug store. Medical history included depression; asthma. Hospitalized for severe COVID-19 and hypoxia on mid Dec2020, diagnosed sequela of COVID-19 included cognitive, cardiac and pulmonary dysfunction. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has known allergies to neomycin and tobramycin. On 03Apr2021, at 01:00 AM (however, also reported as within 8 hours of first Pfizer dose), the patient experienced horrible symptoms. Most alarming was plummeting oxygen and pulse levels accompanied by sharp, excruciating chest pains with major difficulty breathing. The patient used her supplemental oxygen as treatment for the events. The patient felt worse ever since the first vaccine dose and personally decided not to take the second dose. The events did not result to emergency room or physician office visit. The patient underwent lab tests and procedures which included a negative result of nasal swab on 19Apr2021. The outcome of all events was recovered with sequel on an unspecified date in Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
itchiness; raised bubbles in their rash; A spontaneous report (US) was received from a consumer concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itchiness and raised bubbles in the rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  The patient experienced itchiness and raised bubbles in the rash.  Laboratory details was not provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported. The outcome of the events was unknown.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-014539:same reporter, different patient
Cellulitus left arm; Tx'd with IM ABx at ER x 2 days
pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In 2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's medical history was not provided. Concomitant product use was not provided by the reporter  This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
I95.9 HYPOTENSION 3/26/2023 ATHEROSCLEROSIS OF AORTA
I noticed that a day (10/14/05) after taking the Flu shot, I became very weak and tired. I waited to see if there would be any improvement but things got worse on the 18th of October. I because very sleepy, dizzy, and lost appetite. This was followed by severe back pains.  I had no choice than to go to the emergency room.
5min after vaccine became tachycardic with blurred vision and felt like she was going to pass
Patient was given Pfizer vaccine that was stored in the freezer past temperature excursion allowed. Patient has NO complaints or adverse events.
Uncontrollable shivering within 2 hours of injection, muscle aches(flu like symptoms), fever of 99.% within 4 hrs, peaked at 101.4 at 8 hrs  after injection.  Bad headache, Resting Heart rate around 20 bpm higher than normal, some dizziness and lethargic.  Soreness at injection site.
Patient had a fever (T100), severe body aches, and diarrhea one day post immunization.  [note; COVID recovered April 2020]
Approx. 3 hrs after receiving FLUZONE - became SOB - developed hives - Hx asthma. Took ADVAIR - albuterol inhalers without relief. Stated she showered & still had "breathing problems". Taken to ER (hosp. 20 miles away from campus) given IV's - Breathing treatment - oral Prednisone x 5 days released that PM.
29JUL92 Td administered; 30JUL92 swelling 25mm round, 1/8" raised, hot to touch, stiffness in arm;
9/9/13 Patient stated I received the shingles injection on 9/6/13 and did not have a reaction within the first 24 hours now area red and warm. Seen by dr per dr notes patient did not take band aid off for 24 hrs. 5 x 3 cm, red area noted. Oral antihistamine ordered. Recheck 9/14/13 area redness receding per dr note. Assessment local vaccine reaction.
Information has been received from a nurse practitioner concerning a 14 year old female who on an unspecified date was vaccinated with a dose of Gardasil (lot# 658282/0929U).  On an unspecified date the patient felt dizzy after receiving Gardasil.  The patient laid down for a "few minutes" and felt better.  No further information was provided.  Additional information is not expected.  This report is one of two reports.
Patient was seen and treated in ER for bi-lateral upper arm cellulitis, requiring IV vancomycin over a course of 8 hours for 3 days.
ITCHING, PAIN AT INJECTION SITE THAT STARTED RIGHT AFTER VACCINATION AND IS CONTINUING 2 MONTHS LATER
Pt c/o itching, swelling of injection site, redness, hardness, and uncomfortable pain that started on Feb 10th and has persisted to present day.
pt recv vax 2FEB96 & 27FEB96 pt broke out in a chicken pox-type rash w/25 lesions all over body;no further details were provided
Narrative: COVID infection following COVID vaccine series 01/28, Pfizer, dose #1 02/19, Pfizer, dose #2 01/03 COVID swab result: detected 01/29 pt cc: cough, sinus & chest congestion, rhinorrhea, fatigue, body aches, fevers, dyspnea  exposure: unknown 01/03 CXR Impression: No acute abnormality. No significant change since April 2021. 01/03 pt admit ED cc: cough sinus and chest congestion rhinorrhea fatigue body aches and fevers and chills with some dyspnea on exertion DX: COVD 19, nasopharyngitis LOS: 1 day
Information has been received from a registered a nurse concerning a 15 months old white child who on 11/21/00 was vaccinated in the right thigh with MMR. Concomitant therapy on 11/21/00, included a third dose in the left thigh of Prevnar, and a fourth dose in the right thigh of HIBTiter. On 12/01/01, the child experience a high fever (103.5 F) and an URI. Approximately three days after the fever subsided, the child experienced a mild rash was her stomach and back. It was noted that the mild rash lasted for about a day and that child was not feeling well for 10 days. FOLLOW UP information has been received  has been received and indicated that the child recovered from this experience. No further information is available .
This spontaneous report was received from a medical assistant referring to multiple patients of unknown age and gender. No information about the patients' medical history, concurrent conditions or concomitant medications was provided. On unknown dates, the patients were vaccinated with multiple improperly stored doses of VARIVAX (with lot # M024702, expiration date 18-MAY-2018; lot # M028553, expiration date 07-JUN-2018; lot # M033211, expiration date 13-JUL-2018 and lot # M037642, expiration date 01-SEP-2018 ), for prophylaxis (dose, frequency and route were not provided), the doses underwent a temperature excursion of 6 degrees Fahrenheit during 15 hours with no data logger involved and no previous temperature excursion. The vaccines were reconstituted with properly stored sterile diluent.  No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of two cases from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA004632:
Bad bodyache; Symptoms were similar to what she experienced when she had the virus.; Fever of 101.3 degrees; Bad Headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Bad bodyache), ADVERSE DRUG REACTION (Symptoms were similar to what she experienced when she had the virus.), PYREXIA (Fever of 101.3 degrees) and HEADACHE (Bad Headaches) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN (Bad bodyache), ADVERSE DRUG REACTION (Symptoms were similar to what she experienced when she had the virus.), PYREXIA (Fever of 101.3 degrees) and HEADACHE (Bad Headaches). At the time of the report, PAIN (Bad bodyache), ADVERSE DRUG REACTION (Symptoms were similar to what she experienced when she had the virus.), PYREXIA (Fever of 101.3 degrees) and HEADACHE (Bad Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        relevant concomitant products usage were not reported by the reporter.treatment details not included.
Started with slight joint pain 7 - 10 days after vaccination which has now progressed to severe joint pain in shoulders L>R and moderate joint pain in hips, knees, ankles, wrists, elbows, thumbs, and toes. Shoulders are affected the worst, pain in left shoulder is 10 of 10 and right shoulder 8 of 10. I have tried ibuprofen 800 mg TID, acetaminophen 100 mg TID, Osteo bioflex, heat packs,  and menthol salicylate.
product was stored in the refrigerator one day beyond the before use date (10 week period). Two shots of these vials were administered.; product was stored in the refrigerator one day beyond the before use date (10 week period). Two shots of these vials were administered.; This case was considered invalid as unspecified number of patients involved.   This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team, Program ID. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) and all described as "product was stored in the refrigerator one day beyond the before use date (10 week period). Two shots of these vials were administered.".  Additional information: The reporter had requested the viability information for the COVID-19 vaccine gray cap, the product was stored in the refrigerator one day beyond the before use date (10 week period). Two shots of these vials were administered. The patient received gray cap administered a couple of vaccines to a patient that was beyond use date. She wanted to know if vaccines are still viable or not.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (09Aug2022): This is a spontaneous follow-up report received from the same pharmacist.   Updated information Included: clarified that no definite number of patients received the product (stored in the refrigerator one day beyond the before use date of 10-week period) and confirmed it was more than one patient.  Follow-up (10Oct2022): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201046437 same reporter/drug/event, different patient;
This spontaneous report as received from a medical assistant refers to a patient of unknown age or gender. ON 26-SEP-2013 the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX23 with lot # 0225AE and expiration date of 03-JUN-2013 intramuscularly. No adverse effects reported. Additional information has been requested.
Left hand has been experiencing circulation issue. He described it as his hand turning bluish and ot having adequate blood flow.; Slightly elevated temperature; Achy; Chills; Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of CARDIOVASCULAR DISORDER (Left hand has been experiencing circulation issue. He described it as his hand turning bluish and ot having adequate blood flow.), INFLUENZA LIKE ILLNESS (Flu-like symptoms), PYREXIA (Slightly elevated temperature), MYALGIA (Achy) and CHILLS (Chills) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), MYALGIA (Achy) and CHILLS (Chills). In March 2021, the patient experienced PYREXIA (Slightly elevated temperature). On an unknown date, the patient experienced CARDIOVASCULAR DISORDER (Left hand has been experiencing circulation issue. He described it as his hand turning bluish and ot having adequate blood flow.). At the time of the report, CARDIOVASCULAR DISORDER (Left hand has been experiencing circulation issue. He described it as his hand turning bluish and ot having adequate blood flow.), INFLUENZA LIKE ILLNESS (Flu-like symptoms), PYREXIA (Slightly elevated temperature), MYALGIA (Achy) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: elevated (High) Slightly elevated temperature.         No relevant concomitant medications were reported.   No treatment information was provided.  Patient was experiencing circulation issue in the last 10-15 days. Patient went to the doctor and was planned for sonogram  test for possible blood clots.  Action taken with mRNA-1273 in response to the events was not applicable.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 18-year-old male patient of unspecified race received first dose of TRUMENBA at single dose for immunization via unspecified route in May2016. Medical history and concomitant medication were unknown. The patient experienced grand mal primary generalized epilepsy and seizure on 16Jul2016. The outcome of  the events was unknown.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product 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, as appropriate. The case will be reassessed if additional information becomes available.
Itchy rash developed 24 hours after injection/ Initially around ankles, wrists, and knees/ 2 days later the rash expanded to thighs and calf; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via an unspecified route of administration in the left arm on 25Sep2021 at 11:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took azithromycin (Z-PAK) and experienced drug allergy. On 26Sep2021 at 18:00, 24 hours after injection, the patient developed itchy rash, initially it was around ankles, wrists, and knees. On 28Sep2021, 2 days later, the rash expanded to thighs and calf. The event did not result in doctor or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event itchy rash initially around ankles, wrists, and knees and 2 days later the rash expanded to thighs and calf was not resolved at the time of the report.  No follow-up attempts are possible. No further information is expected.
Systemic: Pt reported mild numbness in mouth, described sensation similar to after dental anesthesia and similar senstation in righ arm 30 mins after. pt was monitored for 30 minutes and left without following up with pharmacist.-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Pt received 2 vaccinations,moderna bi-valent on L arm and flucelvax on R arm.Pt reported feeling mild numbness around mouth;described sensation similar to after dental anesthesia.Pt was monitored for 30 mins, after initial 15 mins he described similar sensation in R arm but can still feel his arm.Pt denies anaphylaxis,SOB,or light headedness.Pt was alert and oriented.Pt was advised to stay additional 15 mins for monitoring and report numbness to md however pt left without f/u with pharmacist.