chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a background headache all day; lethargy; bit of fogginess; This is a spontaneous report from a  consumer, the patient.  A 69-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3302), via an unspecified route of administration, in the right arm on 15Jan2021 at 15:30PM (at the age of 69-year-old) as a single dose for COVID-19 immunization. Medical history included just sensitivities, not allergies, to NSAIDS and some pain meds. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medication taken within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that on the first day nothing. On 16Jan2021, the second day (as reported), the patient experienced lethargy and a bit of fogginess. The third day, 17Jan2021, the patient had a background headache all day. The events were reported as non-serious. The patient finally took (acetaminophen) TYLENOL before bed, for the headache, waking on the fourth day feeling normal. The clinical outcome of the events lethargy, bit of fogginess, a background headache all day was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
day after receiving shingrix second shot reported muscle and joint pain, cold sensation, and tachycardia. The tachycardia was alarming to the patient and lasted several hours
Information has been received from a RN concerning a 4 year old female who two years ago, in approximately 2002, was vaccinated with a dose of varicella virus vaccine live. On 06Jan2004, it was reported that the pt now has a slight varicella virus. Unspecified medical attention was sought. No additional information was provided. The physician may not be contacted. No product quality complaint was involved. Additional information has been requested.
Sunday 3/7 at 4 pm began extreme fatigue, nausea & headache. Did not work on 3/8 due to continued nausea & migraine. Tuesday 3/9 went to ER with same symptoms. Was admitted to hospital on 3/9 with acute kidney injury, nausea & Migraine. Was discharged from hospital on 3/14. Followe up with primary doctor on 3/17.  Primary DR requested more bloodwork.  Had low potassium. Ended up back in ER 3/17 with nausea and vomiting.  They pushed more fluids and sent me home. Will have follow up blood work on 3/26 and next Dr appointment on 4/19. Returned to work for 1/2 day on 3/22. Absent 3/23 for extreme fatigue.
It was reported that a 41 year old female pt received a dose of Fluzone SV '01-'02 on 10/30/01. On 11/20/01, the pt experienced numbness in her hand. On 11/27/01, she went to a hospital ER with shooting pains in her hand (reporter did not know which hand or if it was the same arm the dose of Fluzone was administered in). The pt was dx'd with brachial neuritis. This was considered to be an "Other Important Medical Event". From follow up correspondence received on 1/2/02, it was confirmed that the numbness in the patient's hand occurred in the same arm that the Fluzone product was administered. The vaccine administrator and responsible physician information was also provided. 8/11/03: No additional info is anticipated. AE coding was changed. "Brachial plexus neuropathy" is listed in the labeling for the influenza vaccine. Case is closed.
PATIENT STARTED PFIZER SERIES ON 3/25/2021 & DIDN'T FINISH WITH PFIZER. ON 6/29/2021 PATIENT RECEIVED J&J
About 10 minutes after getting KINRIX and MMRV, developed sneezing and generalized hives. Treated with diphenhydramine and prednisone, discharged home.
Excruciating pain in neck; Mouth was extremely dry; Excruciating pain in shoulders.; Arms pain; Very tired; exhausted; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL9262) via an unspecified route of administration in the left arm on 28Jan2021 at 09:30 hours (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included ascorbic acid (VITAMIN C), vitamin d nos (VITAMIN D) and ascorbic acid (CALCIUM), all from unknown dates and for unknown indications. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Jan2021 at 08:00 hours (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Feb2021 at 07:00 hours on or about day 4 after the second shot, the patient experienced excruciating pain in neck and shoulders, extremely dry mouth, exhausted(tired out), arms pain and very tired (tiredness). The patient reported that her mouth was extremely dry and sticking to her teeth. She never experienced anything like that and it was lasted well over a month, but the dryness let up somewhat. The pain in her neck and shoulder are worse some days than others. It did not go away at the time of report. She was also very tired and was exhausted. She always walked two miles and had trouble doing it. The patient did not receive any treatment for the reported events. The adverse events resulted in doctor or other healthcare professional office or clinic visit. The patient underwent lab tests which included blood test on an unknown date and the result was unknown. The clinical outcome of the event extremely dry mouth was recovered on an unknown date in 2021, while that of excruciating pain in neck, shoulders, arms pain, tired out and tiredness were not recovered at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Two days after administration of Vaccine 1/7/09, Patient was discharged and upon arriving at home became incoherent and unresponsive to verbal commands and began shaking.  Patient was taken back to hospital approximately 4-5 hours after discharge.  After admission an MRI was ordered and unsuccessful due to shaking.  Next order was a spinal tap (Lumbar Puncture), cultures were negative for bacteria, a virology was ordered, but results were never released.  The patient was then Intubated and sedated for about 2 weeks to control his shaking an catatonic state.  Doctor diagnosed as Viral Encephalitis.  Patient was then  started on Acyclovir q12h IV, and Zosyn 4.5gm IV q8h with a Dirpivan sedation protocol.  After about 2 weeks from the induced coma, patient slowly regained awareness.  Patient was more coherent and later transfered to a Rehab center for a period of 1-2 week.  Patient has no recollection of incident and has seen a slow but positive progression over the last 7 months.   9/9/09 Hospital records received DOS 1/7/09 to 1/21/09 and 1/21/09 to 2/14/09. Assessment: Viral meningoencephalitis, acute respiratory failure, high-grade fever, electrolyte imbalance, pneumonia, asthma / COPD. Shortly after discharge from prior hospitalization, patient presented with shaking, fever, and confusional state. Agitation. Mechanical ventilation. Cognitive and motor deficits with impairment in mobility, gait, functional communication and cognition. Oral thrush.
getting stuffed; runny nose; little cold; She had been exposed to Covid-19; She had been exposed to Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 13 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 14Jan2022 10:30 (Lot number: FF2589) as dose 3  booster ,single for covid-19 immunisation. Relevant medical history included: "Anorexia" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, Time: Approx. 10:30 AM, Anatomical Site of injection: Right Arm, Batch/Lot No: ER8731), administration date: 16Jul2021, when the patient was 13 years old, for COVID-19 Immunization; Bnt162b2 (Dose:2, Time: Approx. 11:00 AM, Anatomical Site of injection: Right Arm, Batch/Lot No: EW0171), administration date: 06Aug2021, when the patient was 13 years old, for COVID-19 Immunization.The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "She had been exposed to Covid-19"; FEELING ABNORMAL (non-serious) with onset 15Jan2022, outcome "unknown", described as "getting stuffed"; RHINORRHOEA (non-serious) with onset 15Jan2022, outcome "unknown", described as "runny nose"; NASOPHARYNGITIS (non-serious) with onset 15Jan2022, outcome "unknown", described as "little cold". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2022) positive.  Additional Information:Vaccine was not administered at military Facility.No prior vaccinations were done.  No follow-up attempts are possible. No further information is expected.
Swelling, rash on arms, chest, face and neck. Pain in joints, lips and tongue numb, knot in throat.
Mother stated child started having reaction when picked up from school 08/10/18 complaining of feet swelling/rash all over itching/fever. Saturday 08/11/18 Right knee/leg swelling, face swelling and hives. Was taken to ER for treatment. 6 YO female presents with mother - has noted rash with itching over her trunk and legs. Mother reports the only thing that pt. has came in contact with that was new was she had the Hepatitis A vaccine at 1 - AM on Thursday; pt. came home on Friday from school itching all over; then today she noted swelling in her feet, knees and elbows - pt. went to urgent care and they felt uncomfortable and sent her to the ED for evaluation.
73y/o female presents with localized itching to outer right arm at and around site of Moderna vaccine that started within 10min of vaccine administration. She rates the itching at a 7/10. The itching resolved at 30min post-injection. She denies pain or swelling at site of injection. She denies throat closing, lip/tongue swelling or tingling, shortness of breath, chest pain, or palpitations.   On physical exam, patient has no redness, swelling or tenderness to palpitation at site of vaccination. Lungs are clear to auscultation bilaterally. Cardiac-regular rate and rhythm
seizure at 3:30 in the morning. Partner discovered seizure activity awoken from sleeping. Last seizure activity was 2 years prior to event. No change in medications prior to immunization.
Patient became flushed and complaining of a headache at 1542.  She was also sweaty and lightheaded.  B/P 162/102, HR 105, Oxygen saturation 98%.  At 1600, patient states she feels better but still flushed and complaining of a headache.  She is type 2 insulin dependent diabetic and her morning blood sugar was 120.  She states she is unable to start her shift, called her supervisor and went home.  B/P upon discharge 142/104 with HR 80.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 13-DEC-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001529, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1901USA001125:
This is a spontaneous report from a contactable Physician via Pfizer sales representative. A 7-month-old male patient received 3 doses of PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced streptococcus pneumoniae and white blood cell count of 30,000 on an unspecified date. Reporter assessed for streptococcus pneumoniae seriousness as per hospitalization. Course of events: On an unspecified date the patient ended up being admitted to hospital where streptococcus pneumoniae was diagnosed and the child had a white blood cell count of 30,000. They did a spinal tap and it was positive for bacterial meningitis for streptococcus pneumonia. The patient was treated with vancomycin and ceftriaxone intravenously. The outcome of the events was unknown. Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient towards the occurrence of bacterial meningitis positive for streptococcus pneumonia cannot be completely excluded.
pt recv vax 30OCT96 & 1NOV96 entire rt upper arm swollen & hard;no erythema;very tender from deltoid to elbow;seen in ER sx  r/o cellulitis;ATV & DPH given;
The patient reported that she started to feel "faint and dizzy" about one hour after immunizations. She developed a headache later that afternoon. She also complained of limited range of motion of both arms. The next day, she said she felt "hot", but did not check her temperature. The headache persisted with soreness of both arms. On Nov. 6th, she reported a rash on the left side of her face, primarily on her left eye (both above and below the eye), cheek and forehead. She continues to complain of limited range of motion of both arms and "feeling hot".
Patient had regular soreness, redness of injection site. Fever, chills, fatigue hours after vaccine. Patient experienced syncope the morning after vaccination for about 15 minutes. Having bruised head and left eye.
Maculopapular vesicular rash to trunk. Fussy, low grade fever.
The day after my 2nd shot, I woke up very nauseous, ended up fainting, then processed to vomit while being unconscious still.
severe headache; chills; slight fever 100.8 degrees; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache), CHILLS (chills) and PYREXIA (slight fever 100.8 degrees) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, the patient experienced HEADACHE (severe headache), CHILLS (chills) and PYREXIA (slight fever 100.8 degrees). On 14-Nov-2021, HEADACHE (severe headache), CHILLS (chills) and PYREXIA (slight fever 100.8 degrees) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Nov-2021, Body temperature: 100.8 (High) slight fever 100.8 degrees.         No concomitant medication was reported. The treatment information was unknown.   This case was linked to MOD-2021-361849 (Patient Link).
Patient experienced numbness in fingers and which seems to be moving up and she is experiencing numbness in her hand now
Numbness of left pinky finger, heart palpitations, loss of smell, metal taste, lymph nodes on left side of neck, under arm, and chest swollen.  Heavy feeling in left leg and arm with pain.
throwing up; nauseated; I am unable to eat but I drank some Sprite; This is a spontaneous report from a contactable consumer via. A 63-year-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: ER8733), dose 2 via an unspecified route of administration, administered in Arm Left on 06May2021 11:00 (at the age 63-year-old) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included obesity from an unknown date (Verbatim: Obesity). The patient's concomitant medications were not reported. The patient previously took BNT162B2 (lot number ER8733) dose 1, administered in Arm Left on 15Apr2021 for covid-19 immunization. The patient experienced throwing up and nauseated on 10May2021, i am unable to eat but i drank some sprite in May2021. It was stated that "Caller is calling because she got her second COVID vaccine the 6 May 2021, by Pfizer. Since Monday, she has been throwing up since Monday evening around 730 or 8pm. She began to throw up. The sad thing is even to today, she hasn't thrown up, but she is so nauseated she can't eat. She was able to drink sprite and eat a saltine. She is hoping it will help. She is just not sure what is going on. She did not have a prescribing doctor. She could sit up today which is an improvement". Outcome of the event i am unable to eat but i drank some sprite was unknown and other events were not recovered.  No follow-up attempts are needed. No further information is expected.
Itching, swelling, pain, large area of redness, and hard/firm huge knot at injection site.
Dizziness, confusion, syncope, tachycardia. Went for follow up with physicians to try to find a diagnosis.
No reportable adverse event, administration error only. Patient likely given undiluted dose of Pfizer vaccine on 4/3/21. Investigation concluded an undiluted dose of 0.3 ml likely given unintentionally.  No adverse effect reported beside expected transient mild fatigue and myalgias. Patient reported full recovery when contacted on 4/8/21.
The patient was under the FDA approved age to receive this vaccine.  Patient DOB was not verified and vaccine was provided.
Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided. No treatment medications were provided by the reporter.
Pt's upper arm, swollen and red. Felt warm to touch and firm. Able to move arm, with no signs of pain.
Difficulty urinating - feeling of a full bladder, but unable to urinate freely. Pain as if bladder is overly full. Constipation - unable to defecate at all from 8/2-8/5. Slowly recovering Fever and chills - 8/2-8/4 Body aches - 8/2 - 8/4 - managed with 600mg ibuprofen every 6 hours (4 x per day)
allergic reaction to all of them; the patient's arm swelled; This spontaneous report was received from a consumer (a field employee, who also is a patient's relative) and refers to a 60-year-old female patient. She had multiple unspecified allergies. The concomitant therapies included epinephrine hydrochloride (EPIPEN). On an unknown dates, the patient was vaccinated for prophylaxis with doses of: zoster vaccine live (manufacturer unknown), pneumococcal vaccine (manufacturer unknown) and influenza virus vaccine (manufacturer unknown) (formulation, concentration, dose, route of administration, frequency, lot # and expiry date for all 3 mentioned vaccines were not reported). The reporter could not confirm if the patient had all of mentioned vaccines administered on the same day or different days and could not confirm if the vaccines were administered in the same arm or different arms. The outcome of the allergic reaction to vaccines and swelling arm was unknown. The action taken regarding all mentioned suspect therapies was not applicable. The causality assessment between the allergic reaction to vaccines and all the suspect therapies was related. The causality assessment between the swelling arm and all the suspect therapies was unknown.  This is one of the report received from the same reporter regarding the same patient.; Sender's Comments:  US-009507513-2007USA004415:
CHILLS; JOINT PAIN; FEELING UNWELL; ARM PAIN; HEADACHE; FATIGUE; INJECTION SITE PAIN; MUSCLE PAIN; This spontaneous report received from a patient via another manufacturer (Pfizer) concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: incontinence, neuropathy, depression, hypothyroid, high cholesterol, and sulpha allergy. Patient was not pregnant at the time of vaccination. Prior to vaccination, patient was not diagnosed with covid-19 and since the vaccination patient had not been tested for covid-19.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series1) (suspension for injection, route of admin was not reported batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on JUN-2021 for prophylactic vaccination on left arm. The batch number was not reported and has been requested. Concomitant medications included levothyroxine, oxybutynin, paroxetine, and simvastatin.  On 21-JAN-2022, the patient experienced chills, joint pain, feeling unwell, arm pain, headache, fatigue, injection site pain, and muscle pain (all events with dose number in series1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, joint pain, feeling unwell, arm pain, headache, fatigue, injection site pain, and muscle pain. The patient was received additionally non company suspect vaccine BNT162 (Pfizer Comirnaty) (dose number in series 2) (Form of administration was not reported, route of admin was not reported, batch number:unknown, expiry:unknown) doses were not reported, administered on JUN-2021 for prophylactic vaccination on left arm. It was unknown if the patient experienced any adverse event after vaccination with BNT 162 (dose number in series 2). This report was non-serious.
Forehead was itchy; Inappropriate age at vaccine administration; This case was reported by a consumer via call center representative and described the occurrence of pruritus facial in a 22-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pruritus facial and inappropriate age at vaccine administration. On an unknown date, the outcome of the pruritus facial and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the pruritus facial to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving the 1st dose of Shingrix, forehead of patient was itchy. The patient received the vaccine at less than 50 years of age, which led to inappropriate age at vaccine administration. The reporter did not provide any additional information and did not consent to follow-up. This case was considered as medication error with harm.