chrisvoncsefalvay/vaers-outcomes huggingface dataset:
booster shot; soreness in the arm; little sleepy the next day.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (Formulation: Solution for injection) (Batch/Lot number: unknown) as dose 1, single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster shot"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness in the arm"; SOMNOLENCE (non-serious), outcome "unknown", described as "little sleepy the next day.".  The lot number for bnt162b2 was not provided and will be requested during follow up. Additional information: I have received both shots and the booster shot. I had no reactions, just some soreness in the arm and a little sleepy the next day.  No follow-up attempts are possible. No further information is expected.
Information has been received from a pharmacist concerning a patient who on 10-FEB-2011 was vaccinated with 0.5 ml PNEUMOVAX 23 (lot # 667712/1211Z, expiration date 01-FEB-2012). On 10-FEB-2011 the patient experienced a rash on the arm of the injection. The outcome of rash on the arm of the injection was unknown. Additional information has been requested.
Seen here yest for 11 yo WCC, rec'd GARDASIL (L arm) and MENACTRA (R). Site started to feel sore last evening; worse on awakening this AM. Went to school but wound up in clinic, crying re. arm pain.  Parents called to pick her up early. Dad states child had a similar reaction, though less severe, to her Tdap in July of this year. The patient is 11 year, 7 month old female who presents with a complaint of skin problems. The onset of the skin problems has been sudden and they have been occurring in an intermittent pattern for 1 day. The course has been increasing. The problem is characterized as a change in skin color. Lesions are described as red. There has been no associated fever (Child received 11yr injections on yesterday (HPV, and MENACTRA vaccine) and is now have returned to office due to Rt arm is red, swollen and hot to touch. Child received the MENACTRA in Rt arm yesterday).
COPD; Hot to Touch Sensation - Near Injection Site; Swelling - Near Injection Site; Pain - Near Injection Site; Fever (102F); A spontaneous report was received from a consumer concerning a 78-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events COPD, hot to touch sensation - near injection site, swelling - near injection site, pain - near injection site, fever (102f).  The patient's medical history, as provided by the reporter COPD . Concomitant medications reported were Advair, Albuterol for drug use for unknown indication.  On 30 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: N A (Card Not Available)) intramuscularly for prophylaxis of COVID-19 infection.  On 30 Jan 2021, the patient experienced the events hot to touch sensation - near injection site, swelling - near injection site, pain - near injection site, fever (102f).  Treatment details included Advil - Self medicating to try to alleviate symptoms.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, COPD, hot to touch sensation - near injection site, swelling - near injection site, pain - near injection site, fever (102f) was unknown.
Lack of efficacy - patient received 3 doses of Covid-19 vaccine Patient then experienced symptoms and had a positive Covid-19 test; Lack of efficacy - patient received 3 doses of Covid-19 vaccine Patient then experienced symptoms and had a positive Covid-19 test; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 33 year-old male patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) at the age of 33 years as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: IMMUNISATION (medically significant) with onset Nov2021, outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant) with onset 03Dec2021, outcome "recovering", COVID-19 (medically significant) with onset 03Dec2021, outcome "recovering" and all described as "Lack of efficacy - patient received 3 doses of Covid-19 vaccine Patient then experienced symptoms and had a positive Covid-19 test". The event "lack of efficacy - patient received 3 doses of covid-19 vaccine patient then experienced symptoms and had a positive covid-19 test" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Dec2021) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Pale, Nausea, lightheaded. B.P=84/60 history of vasovagal response after previous vaccination Vital signs returned to normal after approximately 40 minutes. Recorded by RN
Next day after shot the site was hot to touch and red - 1 week later started itching and swollen and hard and a large rash - had the pharmacist to look at it and his reply was that is normal?
This spontaneous report refers to an 80 year old male patient (also the reporter) with drug reaction/allergies to penicillin. Within 2013, and thyroid cancer The patient's medical history included surgery to correct clogged arteries, 2 heart attacks, 2 strokes and surgery to correct clogged arteries. On 14-JUL-2013 the patient was vaccinated with ZOSTAVAX injection. Dose, lot and expiry date were not reported. Concomitant medications included unspecified medications for his heart and other conditions. On 28-JUL-2013, 2 weeks after vaccination, the patient developed shingles. The patient explained that he was given unspecified pain-killer tablets for the treatment of the outbreak that had not worked. The outbreak had occurred under his arms and up to the top of his shoulder and neck. The outbreak was not itchy, but rather painful. The patient mentioned that the sensation also occurred within his stomach, which he described as spasms or waves of pain that occurred periodically. The outcome of events was reported as not resolved. The patient had spoken to his physician to seek medical attention. Additional information has been requested.
On the 7th day after my first dose of the COVID vaccine, I developed an itchy, red, oval-shaped welt around the injection site. It is currently just over an inch large.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received SHINGRIX. On 5th March 2018, the patient received SHINGRIX. On 7th March 2018, 2 days after receiving SHINGRIX, the patient experienced injection site erythema, pain in arm and erythromacular rash. On an unknown date, the outcome of the injection site erythema, pain in arm and erythromacular rash were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, pain in arm and erythromacular rash to be related to SHINGRIX. Additional details were provided as follows: The patient's arm was very sore and she had a large red area around the injection site. She also had some red spots on her face.
17 year old was given Flublok by accident due to grabbing the wrong vaccine/no AE; 17 year old was given Flublok by accident due to grabbing the wrong vaccine/no AE; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 17 years old male patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] [lot QFAA2042, expiry date not reported] via an intramuscular at the left arm for prophylactic vaccination by accident due to grabbing the wrong vaccine (product administered to patient of inappropriate age, wrong product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA).  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered. (latency: at the same time of vaccination)  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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.
18Aug95 pt recv 1 dose vax. 24Feb98 pt devel chickenpox w/less than 100 lesions.
Rash on injection site with elevation or hardness approx 3.5cm and redness 5cm separate from red macular rash from bilateral elbows to wrist and on neck area exposed to sun. Brief itching BENADRYL 25 mg taken every 6hrs. Seen on 03-15-2010 by Dr. No further treatment 03-16-2010 rash fading.
Blood pressure dropped, became increasingly dizzy, abdominal pains upper left quadrant that lasted for 3 days.
Numbness in arm that received vaccine. Numbness traveled to leg on the same side of body. Patient went to emergency room. She was sent home and her symptoms resolved.
Achy for 48 hrs; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient experienced pain after vaccination. The patient asked would any after effects occur 5 days after injection.
This spontaneous report was received from a medical assistant and refers to a 15 month old patient of unknown gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 03-NOV-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M005921, expiration date 02-FEB-2018; site, dose and route of administration were not reported). No adverse effects were reported. This is of several reports received from the same source. Additional information is not expected as no further information is available.
generalized body aches the next morning; Pain at injection site within a few hours; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2023 at 16:30 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 48 years intramuscular, in right arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUARIX), on 18Sep2023 as dose 1, single (Batch/Lot number: unknown) intramuscular, in right arm for immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 18Sep2023 at 20:00, outcome "recovering", described as "Pain at injection site within a few hours"; PAIN (non-serious) with onset 19Sep2023, outcome "recovering", described as "generalized body aches the next morning". Therapeutic measures were not taken as a result of vaccination site pain, pain.   Additional information: Patient has no known allergies. Patient did not receive other vaccine in four weeks. Other medications in two weeks included statin.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Started with impaired speech, muscle weakness, lack of balance, shallow breathing, and difficulty swallowing  Currently being treated for suspected Myasthenia Gravis as a result  Taking Mestinon for symptoms
No additional AEs/no PQCs; a dose of PROQUAD was administered on 10/31/2022 after a temperature excursion.; This spontaneous report has been received from an office manager referring to a 6 years old patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions, or concomitant medications.     On 31-OCT-2022, the patient was vaccinated with an improperly storage dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA)(PROQUAD) lot # W017571 with an expiration date on 29-NOV-2023, for prophylaxis, after a temperature excursion.  The dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA)(PROQUAD) was exposed to a temperature excursion of 6 degrees Fahrenheit (°F) up to 14°F (10.91 F), during a time frame of 1 hour. There was no prior temperature excursion and no adverse events were reported.
Female patient who was vaccinated with a dose of hepatitis B virus vaccine.  It was reported that several years ago the patient had an allergic reaction to the vaccine.  It was noted that the brand of the vaccine was unknown and it was not known that component the patient was allergic to.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information is not expected.
after firs vaccine black stools now back to normal; This spontaneous case was reported by a consumer and describes the occurrence of FAECES DISCOLOURED (after firs vaccine black stools now back to normal) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FAECES DISCOLOURED (after firs vaccine black stools now back to normal). At the time of the report, FAECES DISCOLOURED (after firs vaccine black stools now back to normal) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment drug details was reported.
Within minutes of getting the vaccine I had increased heart rate and I was really nauseous. I went to the bathroom because I thought I was going to throw up or have diarrhea. I did have some diarrhea. My heart rate stayed in the 150s until the next day. That night I had a bad headache. I continued to feel bad. I went to the doctor on 01/13/2021 for a routine doctor?s appointment and I told them how awful I felt. She told me to take some Tylenol before getting the second dose. After that I met a girlfriend of mine who was in the hospital. We went out to celebrate her moving and I had half a glass of champagne with her at lunch. I went home and did not felt good. Continued with a headache. On Thursday I woke up feeling really bad. I took some Trezix. I started getting some really bad abdominal pain. I went to the ER and they said it was pancreatitis. They did a CAT scan and blood work. Everything inside was not feeling great. Then I was hospitalized  for 3 days. The doctor said it must have  been because of the champagne. I have not had any episode since then. I have not taken any alcohol since then.
It has been five days since the patient had the vaccination and he has been experiencing radiating pain to the shoulder and arm. I'm worried that the vaccine might have been given too high on the arm. He is going to follow up with his doctor.
At5p.m. I felt fatigued and got weaker,by 7 p.m. I felt severe muscle pain along with shivering ,fever and sweating . It felt like full blown flu symptoms.This continued until 7a.m. The next morning and symptoms slowly declined,but a headache along with tiredness continued until the morning of September 20. As of this date all symptoms have subsided.
Flushing, elevated blood pressure, elevated temperature, on and off throughout the day for several weeks. Did not seek treatment.
Information has been received from a medical assistant concerning multiple unspecified patients (ages and genders were not indicated). The pertinent medical history of patients and their concurrent conditions were not provided. It was reported that on an unknown date multiple unspecified patients were administered improperly stored doses of GARDASIL 9 lot # L048237, expiration date 08-MAY-2017 (concentration, dosage and therapy route were not provided). There were no concomitant therapies reported. No adverse effects were reported. The vaccine was exposed to 88 F for 735 hours and 15 minutes. There was no data logger or previous exposures. No product quality complaint (PQC) was involved. This is one of five reports from the same source (MARRS # 1608USA010369, 1608USA010370, 1608USA010371, 1608USA010372). Additional information has been requested.
Fever; chills; muscle soreness; generalized weakness; took the first dose of bnt162b2 on 16Dec2020/the second dose on 05Jan2021; This is a spontaneous report from a contactable other health professional (reported for herself). A 24-year-old female patient (not pregnant at the time of vaccination) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided) via an unspecified route of administration on 05Jan2021 16:45 at single dose at right arm for COVID-19 immunization. Medical history was none, no Allergies to medications, food, or other products. Concomitant medication received within 2 weeks of vaccination included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient previous took the first dose of bnt162b2 (lot number: EK5730) on 16Dec2020 16:30 at single dose at right arm for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Jan2021 12:00, the patient experienced fever, chills, muscle soreness, generalized weakness. No treatment received for the adverse events. The report was non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events "fever", "chills", "muscle soreness", "generalized weakness" was recovering.  Information on the lot/batch number has been requested.
Patient received vaccine and was advised to wait 10 minutes after appointment to monitor for adverse reaction. The patient exited the room with mother to go to the bathroom because he was not feeling well. Patient fainted without hitting his head while in the bathroom. Mother caught the patient in the fall. He proceeded to regain consciousness and vomited. Doctor assessed immediately and ensured he was okay before leaving. Following incident, mother stated this happens when he gets too warm. It was a warmer day and was warmer than usual in the office.
Gave flu vaccinations at my place of employment.  Received shot at 11:30a.  At 2:30p, I began to feel very dizzy and legs and arms became tingly.  Felt disorientated.
pt recvd vax & had inc t 100-101; d & thick rash on trunk of body; some on face & extremities; restless at night;
This spontaneous report was received from a nurse prescriber and refers to a male patient of unknown age. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On an unknown date, the patient was vaccinated with (wistar ra 27-3) M-M-R II for prophylaxis (dose, route of administration, lot number and expiration date were not provided). On an unknown date, the patient had low titers. The outcome of the event was unknown. The relatedness between the event and (wistar ra 27-3) M-M-R II was not provided.
anxiety, indigestion  administered 25mg liquid Benadryl orally, patient left stable
PATIENT STATED SHE FELT BACK PAIN, LEG PAIN,  AND CHEST PAIN IMMEDIATELY AFTER GETTING THE VACCINE, PATIENT WAS OBSERVED FOR 15 MINUTES AND FELT WELL ENOUGH TO GO HOME; HOWEVER, PATIENT CALLED PHARMACY TODAY 4/23/21  FOR THE FIRST TIME SINCE 4/8/21 STATING HER CHEST PAIN AND LEG PAIN HAVE INCREASED SINCE GETTING THE VACCINE. PATIENT WAS COUGHING ALOT WHILE TALKING ON THE PHONE AND CRYING DUE TO THE CONCERN OF JENSSEN VACCINES IN THE NEWS. I ADVISED THE PATIENT THAT SHE SHOULD GO TO THE EMERGENCY ROOM FOR FOLLOW UP DUE TO CONCERNS OF HER EXPERIENCING CHEST PAIN AND LEG PAIN IN ORDER TO ELIMATE THE POSSIBILITY OF ANY CLOTS.
extended second Moderna dose up to 90 days; efficacy is greater; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (extended second Moderna dose up to 90 days) and THERAPEUTIC PRODUCT EFFECT INCREASED (efficacy is greater) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (extended second Moderna dose up to 90 days) and THERAPEUTIC PRODUCT EFFECT INCREASED (efficacy is greater). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (extended second Moderna dose up to 90 days) and THERAPEUTIC PRODUCT EFFECT INCREASED (efficacy is greater) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reportedly, Caller had declined consent to document demographic details of the call.  Caller had stated that some people had extended their second Moderna COVID-19 dose up to 90 days. He had read that extending the second dose after the first dose for 2 to 3 months had shown greater.No additional detail provided. Consent not given for Safety follow-up.  Treatment product information was not provided.  Concomitant product use was not provided.
Developed severe pleuritic chest pain x 5 days, went to ER on 2/5/2021, D Dimer over 4000, CT chest showed bilateral segmental and sub segmental Pulmonary Emboli. Initial Ultrasound of legs was negative for DVT, follow-up U/S on 2/9/2021 was positive for large Femoral vein DVT. All family history, medical history and other risk factors for coagulation disorder was negative. I was initiated on anticoagulation therapy. (Enoxaparin)