chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a nurse on 26-May-2017. This case involves a patient (age, gender not reported), who was vaccinated with QUADRACEL (batch number: C5222AA, expiry date, dose, dose in series and site of administration not reported) and MEASLES, MUMPS AND RUBELLA VACCINE (MMR) (batch number: M045393, expiry date, dose, dose in series and site of administration not reported) and VARIVAX (batch number: M045205, expiry date, dose, dose in series and site of administration not reported) on 25-May-2017. Patient's medical history and concomitant medications were not reported. On an unknown date, shortly after vaccination, the patient began vomiting with temperature of 99 degree F. No rash, redness or swelling. Patient's other lab data and corrective treatment was not reported. The outcome of the events were not reported. Follow up information received from a Nurse on 20 June 2017. The four-year-old female patient who was vaccinated with QUADRACEL in left lower extremity, MMR in right lower extremity and VARIVAX in left lower extremity on 22 May 2017 at 4.30 pm. Patient had no illness at the time of vaccination and pre-existing physician diagnosed allergies allergies, birth defects, and medical conditions. Patient had no other vaccinations within 4 weeks and no adverse event following prior vaccination. On 23 May 2017 at 3 pm, 22.5 hours (reported as 24 hours), patient vomited twice and had diarrhea. On the same day, at the end of the day in evening, one day following vaccination, patient felt nauseated, had stomach flu, viral GI (Gastrointestinal) bug (tummy bug). On 24 May 2017 in the night, two days following vaccination, patients had 102.7 fahrenhiet temperature. On 25 May 2017 in the morning (AM), three days following the vaccines, patient had 100.6 fahrenhiet temperature. No other lab data and corrective treatment to report. On an unknown date, patient recovered from the events. Documents held by sender: none.
Patient presented 6/3/2021 with thrombus in the top of the basilar artery. Received IV alteplase. Went for mechanical thrombectomy, but catheter angiogram showed resolution of basilar thrombus. He is improving neurologically, currently has some L visuospatial neglect, left lower motor neuron facial weakness and mild dysarthria. He remains hospitalized. This week he will have MRI of brain, cardiac MRI and transesophageal echocardiogram performed. He may have right heart catheterization and closure of the patent foramen ovale.
Pt complained of sore throat and difficulty swallowing  and coughing during post vaccination observation period. No breathing difficulties, Epi-pen given when stated lips tingling. O2 saturation 99%. Transferred to ED,, hypertensive, No oropharyngeal swelling, no tongue swelling, no lip swelling. Given Pepcid, Benadryl, Solu-Medrol, IV fluids.  Monitored for the next 4 hours, then discharged to home.
Body aches and fatigue/these are the same symptoms that she had with her previous doses of the Pfizer Covid Vaccines; Body aches and fatigue/these are the same symptoms that she had with her previous doses of the Pfizer Covid Vaccines; This is a spontaneous report received from contactable reporter (Consumer or other non HCP), Program ID). The reporter is the patient.  A 60-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), on 23Jun2021 as DOSE 2, SINGLE (Lot number: EW0183) at the age of 59 years, in left arm for COVID-19 immunization. The patient's relevant medical history included: "Breast cancer", start date: 09Sep2009 (unspecified if ongoing), notes: Ibrance that she is prescribed for breast cancer. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Received by the caller on 27May2021; Lot Number: EW0183; Administered in the caller's left arm; NDC and Expiry Date are unknown.), administration date: 27May2021, when the patient was 59-year-old, for COVID-19 Immunization, reactions: "Body aches and fatigue/these are the same symptoms that she had with her previous doses of the Pfizer Covid Vaccines". The following information was reported: PAIN (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "Body aches and fatigue/these are the same symptoms that she had with her previous doses of the Pfizer Covid Vaccines". Additional information: Transferring agent states that the caller is asking about Ibrance that she was prescribed for breast cancer. The caller mentioned that she got the Bivalent Covid Booster Vaccine last Friday (16Sep2022). She wants to know if there is a certain time after having the vaccine that she should wait to start her Ibrance? Caller states that she has not started taking the Ibrance yet. Since she got the new booster vaccine she wanted to double check about starting it. The patient experienced body aches and fatigue for a couple of days. Caller states that these are the same symptoms that she had with her previous doses of the Pfizer Covid Vaccines. States that it was nothing major. Caller states that with this Bivalent booster dose of the vaccine the fatigue is more intense. Caller states that prior to this dose of the vaccine she had just finished radiation that caused an infection. Caller states that due to that infection she had stopped eating and had lost about 5 pounds. States that the fatigue this time with the vaccine is just more intense. Since she has never taken Ibrance, the caller is anxious that she will get over these symptoms and possible have new ones to deal with when she starts the Ibrance. Caller states that she has some questions about Ibrance also before she starts it.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201173720 same patient, different vaccine(different dose), different event;
Iritis/Uveitis in left eye four days after second vaccination.; Iritis/Uveitis in left eye four days after second vaccination.; This is a spontaneous report from a contactable consumer (Patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection; Lot Number: EW0176), via an unspecified route of administration, administered in left arm on 08May2021 at 12:00 PM (at the age of 41-years-old), as dose 2, single for COVID-19 immunisation. Medical history included ankylosing spondylitis. The patient had no known allergies. The patient concomitant medications included unspecified medications in two weeks of vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection; Lot Number: EW0158), via an unspecified route of administration, administered in left arm on 17Apr2021 at 12:00 PM (at the age of 41-years-old), as dose 1, single for COVID-19 immunisation. No other vaccine in four weeks. The patient had no covid prior vaccination. On 12May2021 at 12:00 PM, the patient experienced iritis/uveitis in left eye four days after second vaccination. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient received opthalmic treatment for events. The was not tested for COVID-19 post vaccination. The outcome of the events was recovering.
This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about patients' concomitant medications, pertinent medical histories, drug reactions or allergies reported. On unspecified dates, since 14-AUG-2015, the patients were vaccinated with doses of ROTATEQ (lot #K023537, expiration date 22-JUN-2016; doses, frequency were not reported; oral route of administration), which were exposed to temperatures outside of the recommended range. No adverse experiences had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
hives and welts; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had her second Covid vaccine 3 weeks ago. She is at the salon getting her hair colored and is having a reaction of hives and welts. Her colorist states she has not changed anything and is using the same products she has always used and has not had issues with this before. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Joint pain, fever, chills, headache, body aches, exhausted  Started approx 24 hours after vaccine. Took Tylenol for fever and pain.  Stayed in bed the entire day. Symptoms lasted approximately 24 hours afterwards I had no residual symptoms.   I did miss 1 day of work the day of reaction.
Interchange of vaccine products; testing positive for Covid; testing positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Sep2023, outcome "unknown" and all described as "testing positive for Covid"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was prescribed Paxlovid by her doctor yesterday after testing positive for Covid Tuesday morning. She has had "all of her boosters up until now." The first two vaccines she received were the Pfizer Covid-19 vaccines, then she received a Moderna booster, then a Pfizer booster, then a Moderna Bivalent vaccine, and was scheduled to receive the most recent Comirnaty vaccine on 08Oct, however she had to cancel her appointment.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
Pt given immunizations getting up to leave felt faint or fainted. Alert and oriented after 15 seconds.
Broke up in shingles on the left side of their face; A lot of pain, mostly in their mouth; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Broke up in shingles on the left side of their face) and ORAL PAIN (A lot of pain, mostly in their mouth) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Concomitant products included BIFIDOBACTERIUM INFANTIS (ALIGN) for Supplementation therapy, ROSUVASTATIN CALCIUM (CRESTOR) and FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Broke up in shingles on the left side of their face) and ORAL PAIN (A lot of pain, mostly in their mouth). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; VALACICLOVIR HYDROCHLORIDE (VALTREX) at a dose of 1 gram three times a day; LIDOCAINE at an unspecified dose and frequency; MUPIROCIN at an unspecified dose and frequency and METHYLPREDNISOLONE at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Broke up in shingles on the left side of their face) and ORAL PAIN (A lot of pain, mostly in their mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-036002, MOD-2021-036002 (Patient Link).
vaccine was 8 am, fever and "normal" reactions began about noon. tylenol was given around 10, 2, 8,  approx 10 and 2 and,  high fever over 103 began around 8pm. would not decrease even with tylenol. vommitting began around midnight and stopped about 4 am. fever was gone around the 24 hours from vaccine mark. not much food that next day and no bowl movements either.
This case was reported by a consumer and described the occurrence of pain in arm in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 12th November 2018, the patient received the 2nd dose of SHINGRIX. In November 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm and fever. On an unknown date, the outcome of the pain in arm and fever were unknown. It was unknown if the reporter considered the pain in arm and fever to be related to SHINGRIX. Additional details were received as follows; The age at vaccination was not reported but it could be 71 or 72 years. Monday at 5pm, the patient received a dose of SHINGRIX. The patient presented with arm hurt, he could feel air the amount of water.  The patient went bed about nine (1 or 2 was normal). At the time of reporting, the patient had eat two, drank more and sat and read. I started taking my temp at three. should not be given if there was a strong reaction. This case was linked with case US2018GSK208789, reported by the same reporter for the same patient.
First dose of Shingrix in September 2019 and hasn't received the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on September 2019 from lot number m9512).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: First dose of Shingrix in September 2019 and hasn't received the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 15-MAY-2023 The reporter requested information on how to proceed if patient did not received the second dose. The reporter did not consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Pain and swelling in joints; Pain and swelling in joints; This is a spontaneous report from a contactable Nurse(patient).   A 53-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EH9899) via intramuscular route of administration, administered in left arm on 07Jan2021 at 09:00 (at the age of 53-years-old) as UNKNOWN, SINGLE for COVID-19 immunization. Covid prior vaccination: No. Patient did not receive other vaccine in four weeks.  Medical history included hypertension from an unknown date and unknown if ongoing. No known allergies were reported. Concomitant medication(s) included irbesartan taken in two weeks(150-12.5) for an unspecified indication, start and stop date were not reported. The patient experienced pain and swelling in joints on 17Jan2021 at 03:00. Therapeutic measures were taken as a result of pain and swelling in joints which included treatment with Meloxicam 7.5 mg daily. Patient was not tested for Covid post vaccination. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.  .
Fever; Axillary lymphadenopathy with pain and bruising; Axillary lymphadenopathy with pain and bruising; Axillary lymphadenopathy with pain and bruising; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 10Apr2021 at 15:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN), propranolol hydrochloride (PROPRANOLOL) and valsartan (MANUFACTURER UNKNOWN), all used for unknown indication from unspecified dates, unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 20Mar2021 at 14:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 08:00, the patient experienced fever and axillary lymphadenopathy with pain and bruising. No therapeutic measures were taken as a result of these events. These events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events fever and axillary lymphadenopathy with pain and bruising was recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
There were no additional AEs; A patient received first dose of GARDASIL in 2016 and then subsequent doses of GARDASIL-9 in 2018; A patient received first dose of GARDASIL in 2016 and then subsequent doses of GARDASIL-9 in 2018; Information has been received from a registered nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2016, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (anatomical location, administration route, lot number and expiration date were not reported) for prophylaxis.   Later on an unspecified date in 2018, the patient received a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  (anatomical location, administration route, lot number and expiration date were not reported) and subsequently on 19-JAN-2021, the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  (anatomical location, administration route, lot number and expiration date were not reported) both doses as prophylaxis.   No adverse events were reported.
There is a tortuous left vertebral artery V4 segment with aneurysmal dilatation and a focal outpouching along the midsegment measuring approximately 6 x 3 mm.
Approx. 10 min post vaccination, while in the lobby, had sudden dyspnea, wheezing, profuse nasal discharge, sneezing. Given EPIPEN Jr, BENADRYL 25 mg, Prednisolone 30 mg po, and an albuterol nebulizer. His respirations improved and wheezing stopped. Developed hives also! Left office 20 min. later improved. PO2 = 99%. To continue BENADRYL 25mg po q 6 hrs x 2 days. Prednisolone 30mg, po qd x 2 days.
Patient noticed that arm got red and got bigger over time that evening. Patient said redness was close to 12 inches in length. Patient got feverish. The second day patient put on a cold pack for 20 minutes at a time, that alleviated the burning and redness slightly. Patient did not take any TYLENOL. Patient said the redness on day 3 progressed to pinkness, but still is hot. Patient is no longer feverish.
13 years old patient received the Moderna Covid19 Vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 years old patient received the Moderna Covid19 Vaccine.) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 years old patient received the Moderna Covid19 Vaccine.). On 13-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 years old patient received the Moderna Covid19 Vaccine.) had resolved.            No concomitant medication were reported.  No treatment information was provided by the reporter.  Company Comment:This is a spontaneous case concerning a 13-year-old, male patient with no relevant medical history, who experienced the non serious event of product administered to patient of inappropriate age. The event product administered to patient of inappropriate age occurred right after the first dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 13-year-old, male patient with no relevant medical history, who experienced the non serious event of product administered to patient of inappropriate age. The event product administered to patient of inappropriate age occurred right after the first dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Rash, pain, and tingling at injection site left deltoid started 8 days after the vaccine. Then a vein swelled and became hard and extremely painful. It started in my left armpit and went all the way through my biceps to my elbow.  Unable to fully extend left arm due to pain. The vein was cord-like and painful. Lymph nodes on the left side of my body were also swollen in the neck, armpit, and groin.
Extreme right arm pain first day home from the hospital after birth of my daughter. It lasted 2 days. Currently, I cannot fully extend my right arm the way that I used to, or compared to my left. No pain, but reduced mobility which makes it difficult to do some things.
I definitely have sight redness and itching going into my shoulder/back and armpit into my trunk extremely tender as if in lymph node soreness.   I also have throat irritation in the back of throat and Uvula(no airway constriction). Tuesday I felt very sore in my joints, very out of sorts with no energy. Wednesday morning I was not as lethargic but was dizzy and nauseous. Today I went back to work but the area is still itchy, tender into the armpit and throat is still bothering me. rash in the back of my throat, swelling, skin rash and pain in arm pit and trunk.  It?s been 5 days and I still have side effects with rash in the back of my throat, swelling, skin rash and pain in arm pit and trunk.
Patient had 2 vaccines on 10/7/21 at 7:55pm.  The patient had sore arms and had severe diarrhea around 10pm on 10/7/21, the patient was transported by ambulance on 10/7/21 and treated at the hospital ER department.
Pain at injection sight with severe swelling redness heat.  Dizziness.  Fatigue.  Excessive sleeping.  Headache.  GI distress.  Muscle aches.   Chills.  SHINGLES!!!!  Near injection site.  Responded to Valtrex.  Some residual post herpatic neuralgia.