chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2nd dose had fever, body ache, chills, fatigue, diarrhea which all subsided by the 4th day. Minimal arm pain for both doses.; 2nd dose had fever, body ache, chills, fatigue, diarrhea which all subsided by the 4th day. Minimal arm pain for both doses.; 2nd dose had fever, body ache, chills, fatigue, diarrhea which all subsided by the 4th day. Minimal arm pain for both doses.; 2nd dose had fever, body ache, chills, fatigue, diarrhea which all subsided by the 4th day. Minimal arm pain for both doses.; 2nd dose had fever, body ache, chills, fatigue, diarrhea which all subsided by the 4th day. Minimal arm pain for both doses.; Minimal arm pain for both doses; This is a spontaneous report from a non-contactable consumer (patient). A 48-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection; batch or lot number: EL9264) via an unspecified route of administration, administered in right arm on 09Feb2021 08:30 AM (at the age of 48 years old) as dose 2, single for COVID-19 immunization. Patient was non-pregnant at the time of vaccination. No other vaccine in 4 weeks and no covid prior vaccination. The patient's medical history included known allergies to shellfish. The patient's concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection; batch or lot number: EL8982) via an unspecified route of administration, administered in right arm on 19Jan2021 08:30 AM (at the age of 48 years old) as dose 1, single dose for COVID-19 immunization and experienced headache, insomnia and minimal arm pain. On 09Feb2021, at 16:45 (04:45PM), after 2nd dose vaccination patient had fever, body ache, chills, fatigue, diarrhea which all subsided by the 4th day and minimal arm pain for both doses. Not tested for COVID post vaccination. No treatment received for the events. The outcome of the events was resolved on fourth day, unspecified date in Feb 2021, for event minimal arm pain for both doses was unknown.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a nurse (Bachelor of Science of Nursing)refers to a 31 year old female patient. The postpartum patient was vaccinated with a dose of expired VARIVAX (merck) (lot number reported as 0282Z, expiration date 12-FEB-2012) (dose, route not reported) on 14-SEP-2012. No adverse effect reported. It was unknown if the patient sought medical attention. Additional information has been requested.
High fever of 101F and was given Tylenol; shaking and jerking (from fever); no appetite; limp and fatigue and heart rate was high.
body weakness, fever, chills, vomiting, diarrhea, headache, tiredness, sharp pains in lower back, loss of apatite, a lot of gas
Patient admit to  Hospital 5/23/21 for cough, weakness and SOB x 4 days.  Pt had completed COVID19 vaccines earlier in the year and attended a family wedding 5/14/21 and developed respiratory symptoms within 3 to 4 days thereafter.  Several family members now COVID19 positive, including patient (positive test approximately 5/18).  Patient with history of COPD (on 2L 02 at home), and decision made to admit patient for close monitoring.    Vaccination History: 1/23/21   Pfizer EL3249    2/13/21   Pfizer EL9264     Hospital Course: Patient admitted to COVID19 general unit, and started on IV dexamethasone (6mg IV daily) and remdesivir (200mg IV x 1, then 100mg IV daily).  COVID19 test 5/24 was positive, and was to be sent to ODH for genotyping. Patient required 02 at 4L NC initially, then was able to tolerate 2L NC thereafter.  Patient improved with less body aches and no SOB by 5/25. Patient continued to improve and was discharged home with HHC 5/28 with remdesivir course complete and home going med of dexamethasone 6mg daily x 5 more days.
Within probably a minute, I had a hard time breathing. It wasn?t bad enough for me to alert anyone but breathing was labored for at least an hour afterwards. I had a hard time taking in a deep breath for days and possibly at least a week. I wasn?t too sure if this was related to the vaccination until I had the same reaction after the second dose (which I will also enter a report once my difficulty with taking a deep breath has passed).
Event: swelling on left side of nose between eye and nose was reported as worsened; a little painful; Swelling of the side of my nose, between my nose and my eye; This is a spontaneous report from a contactable consumer or other non health care professional (patient). A 54-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EH6203, Expiry date: not reported) via an unspecified route of administration, administered in Arm Left on 03Mar2021 (at age of 54-years-old) as dose 1, single for covid-19 immunisation. Medical history included acne from an unknown date and ongoing at times, history of this all her life. The patient's concomitant medications were not reported. On 04Mar2021, the patient experienced swelling of the side of my nose, between my nose and my eye on and swelling on left side of nose between eye and a little painful. On 05Mar2021 nose was reported as worsened. The reporter states it was a little painful and she didn't know what it was, today she woke up and the swelling was much worse, it was a little harder to open her eye, wants to know if this could be a mild allergic reaction. The patient state she has a history of acne, states it could be a bug bite, that she had one a few days prior to the vaccine but it did not swell. The patient would take EpiPen for next dose. The patient wanted to get second dose of the vaccine. The outcome of swelling of the side of my nose, nose was reported as worsened was not recovered and a little painful was unknown.  No follow-up attempts are possible. No further information is expected.
He said he was nauseated all night after the shot and he had body pain too, also very tired for 1-2 days.
Swollen lymph node in mid lateral side of my neck.   The lymph node took 4 weeks to be normal with each dose.
Pain in between shoulder blades, pain in right shoulder; Warmness in corner of the right eye.; Runny nose; Warmness in the right tricep; This is a spontaneous report received from a contactable consumer, the patient. A 44-year-old male patient received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: BN6201) via an unspecified route in the left arm on 24Mar2021 at 08:30 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included difluprednate (DUREZOL) for unknown indication received within two weeks of vaccination. The patient did not receive any vaccines within four weeks prior to the COVID-19 vaccination. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9265) via an unspecified route of administration in the left arm on 03Mar2021, as a single dose for COVID-19 immunisation. On 24Mar2021 at 19:00, the patient had pain in between shoulder blades, pain in the right shoulder, warmness in corner of the right eye, warmness in the right tricep, and runny nose. The events did not result in doctor or other healthcare professional office/clinic visit, and the emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the pain in between shoulder blades, warmness in corner of the right eye, warmness in the right tricep and runny nose was not resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Narrative: COVID infection following COVID vaccine series 03/082, Pfizer, dose #1 03/27, Pfizer, dose #2 11/23, Pfizer, dose #3 12/27 COVID swab, result: detected 12/25 pt cc: cough, rhinorrhea, headache, myalgias, dyspnea, sore throat exposure: unknown
Patient received only the grey top vial liquid conjugate component of Menveo; Patient received only the grey top vial liquid conjugate component of Menveo; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA957A, expiry date 30-SEP-2024) for prophylaxis.   On 29-AUG-2023, the patient received Menveo. On 29-AUG-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Patient received only the grey top vial liquid conjugate component of Menveo) and inappropriate dose of vaccine administered (Verbatim: Patient received only the grey top vial liquid conjugate component of Menveo).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 30-AUG-2023 The reporter reported that the vaccine clinic discovered this morning that two of three children had been received only the grey top vial liquid conjugate component of Menveo vaccine.  The reporter did not know which two of the three children patient identified actually who received only the grey vial. Only adjuvant of Menveo administered to patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This US2023118668 case has been linked to the case reported by the same reporter.; Sender's Comments:  US-GSK-US2023118668:same reporter
I got the vaccine on October 27, 2021. On November 5 at about 01:00AM, I woke up with an itchy mouth and my face started to tingle. My lips, eyes, tongue, and throat started to swell up. I took some Benadryl as soon as I started to feel symptoms and monitored. The symptoms persisted despite the Benadryl, so we went to the  Emergency Department and we waited for 3 hours. They called me back and took my vitals and they agreed that it was an allergic reaction. I was not able to talk well, but my husband did tell them that I had a response to the 2nd Moderna vaccine with the overreaction in my arm. The doctor at the ER did not seem to think it was related in the moment. They gave me prednisone on site at 02:45AM. We left with a prescription for an epi pen and prednisone. We left after the symptoms had gone down and after the prednisone. I took prednisone for 2-3 days after. They did refer me to an allergy specialist, and I called my healthcare provider and they said it was most likely a response to the vaccine since there wasn?t anything to have an allergic reaction to. Along with my reaction to the other dose. I did not do further testing for the allergies, and I was told to call the CDC. I?m currently due for my next booster.
Had period of syncope after first dose. After second dose I again suffered from syncope that is still present. I get dizzy when I lay down that last for 5 to 10 seconds. After the second dose I also became ill and missed a week of work . Respiratory difficulties, coughing, HA, etc. Seen my my MD and tested for COVID which was negative.
Pt rec'd 11 yr vaccinations on 11/24/14; S/s began 11/25/14. Seen 11/26/14 with s/s: 3"x6" area erythema with 1cm circular erythema with central papual (Lt) shoulder; (+) induration; no tender or warm to touch afebrile. Tx supportive care -> if fever dev. = start KEFLEX.
39 doses administered past the 30 day use by date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (39 doses administered past the 30 day use by date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047821A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (39 doses administered past the 30 day use by date). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (39 doses administered past the 30 day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Dose was administered after 30-day Use . Vials were initially stored in refrigerated on 13-APR-2021 from which 10 doses were administrated on 17-APR-2021 , 10 were  administrated on 19-MAY-2021 and 39 doses were administrated on 24-SEP-2021. Concomitant medications were not provided. Treatment information was not provided. Reporter did not allow further contact
01/07/2022 presents to ED for "chest pain". PMHx of "COPD, GERD, hypertension and previous gastric ulcer"
Pt with a history of CAD/MI s/p stent and OSA on CPAP was exposed to COVID at church.  His complaints are fatigue, dry cough, shortness of breath, and lack of appetite.  Pt admitted for COVID-19 infection with pneumonia.
Initial misuse report received from a healthcare professional (Doctor) on 21-Aug-2013. A 4-year-old patient (no other information ws provided regarding patient) had received the dose of PENTAEL. They got an xtra dose of ACTHIB. No adverse event was reported. List of documents held by sender: none.
Pt reported to me initially on 7/24/18 during a well visit that with the 2nd dose of HPV given above he had a large localized reaction. He reports that the left upper arm was very erythematous, swollen, and warm without streaking or increasing in size. Estimated reported size per mother was about 5-6 cm long and 3-4 cm wide. It lasted more than 1 week but less than 1 month. They could not fully recall. It later resolved and the date of next visit it was completely resolved.
Three hours after the vaccine I started developing chest pressure that lasted 45 minutes. After an hour after I  had disnea  rest which last 55 hours.  I put a call into my patient care provider and went it to get a Coivd test that came back negative. I was told If it got worse to go to the emergency room . After the 55th hour I was back to normal.
soreness at injection site; This is a spontaneous report from a contactable consumer. A 68-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via unknown route of administration in her left arm on 26Jan2021 (at the age of 68-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient did not have COVID. On 26Jan2021 the patient experienced soreness at injection site. The clinical outcome of soreness at injection site was recovered on an unspecified date. It was also reported the patient was not tested for COVID after vaccination.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Patient developed redness, swelling after 12-14 hrs after getting the shot and subsequently got an infection. Being treated with antibiotics.
Severe pain in deltoid muscle with red patch of skin below but not near injection site, swelling in lymph gland in axilla of same arm, migraine with light and sound sensitivity (48 hours), temperature of 104.7 and continued temperature over the next 48 hours and vertigo.
Heart pain, nausea, anxiety, suicidal thoughts, depression, trouble regulating body temperature, arthritis pain, psychosomatic response to vaccine triggers immediately following the vaccine and persisting for 6 months plus Followed up with GP, cardiologist, and had cardiac stress test performed, no adverse results identified
Patient had sever pain could not lift arm for a week after vaccine. Patients states doctor said could possibly be shoulder injury will get x-rays and possible physical therapy . was put on pain medication
Nurse called to report a T/E, multiple patients with unknown demographics and on unknown dates received improperly stored vaccines.; No adverse effects; This spontaneous report was received from Other Health Professional and refers to a 4-month-old female.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 13v (crm197) (PREVNAR 13).   On 01-JUN-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, unk, lot #1968386, expiration date: 23-MAY-2024, administered for prophylaxis (strength, and route of administration were not provided) which underwent multiple temperature excursion before administration (Product storage error).  This one of several reports received from the same reporter.
Rash (red, itchy)  and hardness/slight sweeling at injection site.
Patient reports feeling as though left inner eye is bruised same day as vaccination. Following day patient reports swollen eye resulting in visit to clinic. Oral and topical antibiotics prescribed for eye infection. Patient experienced pus and fluid drainage from eye. Now resolved with small scab.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had shingles, the patient said vaccine did not work. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
Pt received vaccine and within 72 hrs developed a stroke. Low platelet count. Endocarditis. Emboli to liver, spleen, kidney.
Pt had an injection site reaction develop 5 days after injection.  There was a red, pimple type looking bump about 3mm in diameter at the site of injection.
patient was inadvertently administered an expired dose of the Adacel single-dose vial with no adverse event; Initial information was received on 29-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old female patient who experienced patient was inadvertently administered an expired dose of the adacel single-dose vial with no adverse event while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunisation.  On 29-Jun-2022, the patient received 0.5 ml of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6702AA, expiry-20-JUN-2022) (formulation, and strength: unknown) via intramuscular route in unknown administration site for Immunization.    On 29-JUN-2022 the patient developed a non-serious patient was inadvertently administered an expired dose of the adacel single-dose vial with no adverse event (expired product administered) (latency same day) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event patient was inadvertently administered an expired dose of the adacel single-dose vial with no adverse event.  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 the guidelines. 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.
The pain in her arm was way less than the first time; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 02Apr2021 (Lot number: ER8734) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing), notes: Additional Information for Other Conditions: she got arthritis early. In her mid thirties; "she had knee issues" (unspecified if ongoing), notes: she had knee issues; "degeneration in her joints" (unspecified if ongoing), notes: degeneration in her joints.; "Torn rotator cuff" (unspecified if ongoing), notes: Verbatim: she has a torn rotator cuff. Concomitant medication(s) included: DULOXETINE (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "The pain in her arm was way less than the first time".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Seen in ED for cellulitis of arm where Varivax was administered 2 days prior.
PATIENT PASSED OUT AFTER RECEIVING HIS FIRST DOSE OF VACCINE. PATIENT STATED THAT HE HAD NOT EATEN ALL DAY. HE ONLY PASSED OUT FOR A FEW SECONDS, AND THEN FELT DIZZY FOR THE NEXT 5-10 MINUTES.
Pt claims that after taking the flu and pneumonia shot she experienced persistent headache and arm soreness.
Injection site red, warm, hard and tender per patient. Induration and erythema measured at 30mm x 50mm on 9/15/17 at 3 pm. Patient took ZYRTEC in morning, BENADRYL at bedtime, Ibuprofen as needed, and applied ice packs several times a day as directed.
Approx 1 hour after vaccine on 7-9-2018, mom said that his behavior was over exaggerated, speaking loudly, making strange faces. Woke up this AM on 7-10-2018 covered in hives (mostly on torso and neck) but continued to spread.
The patient presented with chest pain around 5 pm on 4/4/21.  Patient reported "pain came out of nowhere."  Patient reported pain was non-exertional and non-positional.  He described it as "a constant burning sensation" located in the center of his chest with radiation upwards toward his jaw and shoulders, bilaterally. He was transferred to COVID unit, became hypotensive, hypoxic was seen by house MD.  Lung exam crackles bilaterally. IV fluids stopped, patient was given 40 mg Lasix, Morphine 2 mg and started on  a small dose nitroglycerine drip.  POX 70s, low 80s so Bipap ordered.  Patient developed v tach and arrested, resuscitated, defibrillated, received multiple meds, intubated by anesthesia, transferred in ICU on Levophed and Epinephrine.  Arrested in ICU.  Lines were placed by ICU team, arrested again in ICU.  Was maxed out on 4 pressors, despite CPR, pulse could not be obtained, patient was pronounced dead 4/6/21 at 3:31am. 1. Triple vessel CAD 2.  Moderately severe LV dysfunction with and EF 30% 3   The recent NSTEMI is secondary to the occlusion of the SVG-OM1.  There is a large thrombus in the SVG which makes PCI of this vessel unlikely to be successful. 4  The native OM1 is chronically occluded.  It may be possible to attempt to open this with CTO techniques, however, at this time continued medical treatment. 5.  Perclose