chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pulled his band aid there was a little blood; This is a spontaneous report from a contactable consumer (wife of patient). An 80-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 27Jan2021 at single dose (left arm) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Her husband had his first dose today but at a different location and when he pulled his band aid there was a little blood. This was his first dose and it was given in his left upper arm. Outcome of event was unknown.  Information about Lot/ Batch has been requested.
My arm got red & itchy and was warm to the touch with the redness spreading down my arm ER nurse spoke with my family physician who ordered Keflex.
Bell Palsy again after first dose of Shingrix, ended up in hospital; This case was reported by a pharmacist via call center representative and described the occurrence of bell's palsy in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included bell's palsy (had history of bell's palsy).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced bell's palsy (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.  Additional deatils were provided as follows: The age at vaccination was not reported. The batch number and expiry date of Shingrix was not provided. The patient developed Bell's palsy again after shingrix vaccination and ended up in hospital. The reporter consented to follow up.
Vasovagal / syncope episode  with subsequent fall to the ground, striking head; taken to the Emergency Department, stated prior to syncopal episode felt lightheaded, sweaty, clammy. Patient discharged to home within 3 hours of ED admission.
Started itching right away, 30 minutes after shot , felt weak ,dizzy  home early form work. That night I  started aching form my lower back down to my  legs., took 600mg ibuprofen, tylenol,  did not help took these meds  for days. Every night after that legs lower back ache , feet burn for at least a week. Chest pain over that weekend. Seen in clinic by one of our providers days after.   Went to local ER ,that weekend of 1st shot.2nd shot on Oct 21st ,heart has been racing ever since woke up one morning pule was 97, b/p has been running high ever since second shot, out of no where my heart will start racing and I start feeling jittery.  Leg pain again with 2nd shot , both legs.
10/05/12 received intramuscular injection FLUZONE 0.5 mL at left deltoid. On 10/10/2012 pt reported numbness, tingling at left face with drooping of left face - pt advised to go to ER where diagnosed with Bell's Palsy and treated with prednisone until 10/22/2012. Symptoms resolving by 10/22/2012.
1st and 2nd dose Pfizer vaccine given instead of the Pfizer COVID Bivalent booster
This spontaneous report was received from a male patient who is also a physician regarding himself. No medical history was reported. On an unknown date approximately April 2011 (reported as over 2 years ago), the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry, route not reported), 0.65 ml. No concomitant medications were reported. On an unknown date approximately April 2011, the patient immediately felt pain at the injection site. This prolonged pain lasted for about a week and then the pain went away. The patient stated that receiving the ZOSTAVAX injection was more painful than all the other immunizations he had ever received. No medical attention was sought. No treatment was received. Additional information is not expected.
Patient admitted 2 days post 3rd vaccine for increased extremity weakness. History of  medulloblastoma of cerebellum, malignant and fibrous histiocytoma of skin. Patient with progressive intramedullary Cspine lesion. Currently admitted.
patient accidentally received 2 doses of Engerix-B, having received the pediatric formulation they are an adult; patient accidentally received 2 doses of Engerix-B, having received the pediatric formulation they are an adult; patient accidentally received 2 doses of Engerix-B, having received the pediatric formulation they are an adult; patient accidentally received 2 doses of Engerix-B, having received the pediatric formulation they are an adult; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 63-year-old male patient who received HBV (Engerix B pediatric) (batch number N73FA) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) (batch number AX205) for prophylaxis.   On 01-MAR-2023, the patient received the 2nd dose of Engerix B pediatric. On 26-JAN-2023, the patient received the 1st dose of Engerix B pediatric. On 26-JAN-2023, not applicable after receiving Engerix B pediatric and an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: patient accidentally received 2 doses of Engerix-B, having received the pediatric formulation they are an adult) and underdose (Verbatim: patient accidentally received 2 doses of Engerix-B, having received the pediatric formulation they are an adult). On 01-MAR-2023, the patient experienced adult use of a child product (Verbatim: patient accidentally received 2 doses of Engerix-B, having received the pediatric formulation they are an adult) and underdose (Verbatim: patient accidentally received 2 doses of Engerix-B, having received the pediatric formulation they are an adult). The outcome of the adult use of a child product, underdose, adult use of a child product and underdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-JUL-2023 A pharmacist called in to report that a patient accidentally received 2 doses of Engerix-B, having received the pediatric formulation even though they are an adult and wished to receive information about how to proceed.  Partial information was given about the event, patient and vaccine.  The Vaccine Administration Facility was the same as Primary Reporter. Consented to follow up.
Herpes Zoster on left arm & back. No history of chicken pox disease on Acyclovir. Had VARIVAX on.
26MAR92 pt exp hives; sent to MD given liquid DPH; emesis of poliovax;
pt devel meningitis, neuropathy & general flu-like sx for approx 3 months following vax w/hepatitis B vax; addtl info has been requested;
throwing up/vomiting; chills; aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 12Apr2021 (Batch/Lot number: unknown) as single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious) with onset Apr2021, outcome "unknown", described as "throwing up/vomiting"; CHILLS (non-serious) with onset Apr2021, outcome "unknown", described as "chills"; PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "aches".  Additional information: Caller explained she was 2 days without symptoms then "woke up throwing up, had chills, and mainly aches".  caller asked when should his wife's symptoms (vomiting, chills and aches) from the fist dose of the Pfizer-BioNTech COVID-19 vaccine subside. Received response as Side effects that you may experience throughout the rest of your body; (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter". from CONS -How long side effects last_final.Caller asked for general recommendations on getting a COVID-19 test for individuals with a recent vaccination with the first dose of the Pfizer-BioNTech COVID-19 vaccine received response as The Pfizer-BioNTech COVID-19 Vaccine does not contain SARS-CoV-2 and cannot give you COVID-19.1"; Per CDC "These interim considerations also state that if you currently have a COVID-19 (either before the first dose of vaccine or in between your first and second dose of vaccine), you should wait until you have recovered from the infection, show no symptoms and completed any required isolation.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
10-12 hour of fever, emesis, delirious per Mom after BOOSTRIX.
Patient presents to the ED with complaints of shortness of breath on exertion, nocturnal cough, fever, diarrhea, nausea, vomiting, and poor PO intake. She had tested positive for COVID-19 the day prior to presentation. She was admitted for COVID pneumonia, hypoxia and elevated D-Dimer. She was discharged 3 days later in stable condition.
diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): EC-2021-099746.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (initial pfizer dose), single for covid-19 immunisation; lenvatinib mesilate (LENVIMA), since 06Sep2021 (Batch/Lot number: unknown) for endometrial cancer; pembrolizumab (KEYTRUDA) (Batch/Lot number: unknown) for endometrial cancer. Relevant medical history included: "Endometrial Cancer" (unspecified if ongoing), notes: Started Lenvima 10mg on 9/6/2021. Also on Keytruda. The patient's concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for lenvatinib mesilate and pembrolizumab was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional Information: Patient report changes to her finger nails of thinning and some linear dark nail lines.She also reports hoarseness and continued fatigue. Fatigue and mouth sores are improving. She reports diarrhea for one day after COVID booster las week and is unsure if the Lenvima, Keytruda, or COVID shot caused the diarrhea. She also reports a previous wound on leg, that was present prior to Lenvima, has slowed down in healing since starting Lenvima. She reports normal Thyroid levels at this time. She does believe the other issues mentioned are related to Lenvima. PI reviewed. Medical History:C54.1 Endometrial Cancer. Started Lenvima 10mg on 9/6/2021. Also on Keytruda.
12 hours after receiving vaccine patient experienced pain in right arm, headache, fever (did not have working thermometer to check her temperature), chills and hallucinations.  Symptoms persisted for 36 hours.  She did not report symptoms until they had resolved.
Really worn down/wound up sleeping about 10 hours; chills; shaking; hyperventilating(gasping); chest pounding; This is a spontaneous report from a contactable consumer (patient). This 72-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, on unspecified date in Jun2021 (at the age of 72 years old), as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunisation and no adverse event was reported. The patient was 72 years old while taking BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose. Patient reported that after receiving second dose, the next day (in Jun2021) he was really worn down, wound up sleeping about 10 hours that night (which was not normal) but then felt better the next day. He stated that after he received his 2nd COVID-19 shot, he had chills, shaking, was hyperventilating (gasping) and had chest pounding. Outcome of the event sleepy was recovered on an unknown date in Jun 2021 and for other events it was unknown.  Information on lot/batch number has been requested.
As described by pts mom peculiar high pitched cry persisted most of day following vax; not reported until f/u appt 15NOV91; complete recovery by 31AUG91;
covid 19/ had little fever; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19/ had little fever) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 013F21A, 020B21A and 003A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (covid 19/ had little fever). At the time of the report, COVID-19 (covid 19/ had little fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Nov-2023, SARS-CoV-2 test: Positive.         No concomitant medication was reported.  It was reported that patient was taking care of her husband who was a cancer patient. She was concerned that she will transmit the COVID to her sick husband. No treatment information was reported.   Reporter did not allow further contact
Pt stated that bruising started almost right off on 1/6/21 but itchiness redness and swelling started approximately a week later on 1/13/21.
Shivering began about 12 hours after injection. Continued for roughly 2 hours, accompanied by chills. Next morning tired, but no ill effects.
Approximately 3-5 minutes after vaccination the patient fainted.  He hit the back of his head on the floor.  When I approached the patient he was conscious and visibly upset.  His head had no contusion and was not bleeding.  His pulse was normal and he had no signs of allergic reaction.  His pupils appeared normal and no concussion was suspected.  He was given water and after being seated for a few minutes he stated he felt much better.
Patient was A/O x4 and expressed concern with the administration of the shot. History of seizures when very anxious but is not a disqualifying medical concern per ?Pre-vaccination checklist?.  NP reassured the patient and with the consent of the patient administered the 2nd dose of Pfizer vaccine at approx 1350. Patient become hysterical, diaphoretic and began hyperventilating. At approx 1357 the patient began a Tonic Clonic seizure. NP attempted to pull patient out of vehicle. Ops manager was notified and pulled the patient out of the car and into the shade. Another worker attempted to open airway while worker grabbed the response bag and called 911 and NP assisted with patient. Patient was rolled over on her side so she could discharge vomit. NP was kneeling on one knee assisting opening of the airway was knocked over by patient and hyperextended her thumb. Seizure lasted for approximately 3 minutes before patient was able to become conscious. HR 101, 96%, 105/p, 20+ resp. EMS arrived at approx 1405. Patient refused transport and waited for a friend to pick her up. Friend did not show up but patient was able to obtain A/O x4 for over an hour. We highly recommended for her to find a ride but refused.
Hep B 1ml was administered past expiration date 1/25/23; notified patient
Felt cold but eventually it warmed up; Had a little bit of a temperature (103F)/102 F/ 101F/99.8F; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Felt cold but eventually it warmed up) and PYREXIA (Had a little bit of a temperature (103F)/102 F/ 101F/99.8F) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L21B, 051F21A, 031M20A and 028L20A) for COVID-19 vaccination.     Patient did not had any COVID-19 diagnosis prior to or after getting the vaccine.  Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE (Flu shot sometime last year close to the date of the 1st booster but not at the same time). Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE. Concurrent medical conditions included Hypertension, Palpitation and Thyroid disorder. Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE) for Thyroid disorder.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, the patient experienced FEELING COLD (Felt cold but eventually it warmed up) and PYREXIA (Had a little bit of a temperature (103F)/102 F/ 101F/99.8F). On 12-Apr-2022, FEELING COLD (Felt cold but eventually it warmed up) had resolved. At the time of the report, PYREXIA (Had a little bit of a temperature (103F)/102 F/ 101F/99.8F) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2022, Body temperature: 103f 103F, 102f 102F, 101f 101F and 99.8f 99.8F.         It was reported that on 12 April 2022, when patient woke up, she had a little bit of a temperature and felt cold but eventually it warmed up. Patient ate some and eventually she felt better. She checked her temperature before she called and it was 102F, and during the call she checked it again and it went down to 101F and 99.8F.  Patient did not take any medications for fever.   This case was linked to MOD-2022-538987 (Patient Link).
Localized, red, swollen, area, hot and sore for a week. No meds, symptoms went away in a week.
Full body aches, dizziness, nausea, fatigue, and headache that lasted until 2/2/2021. (Other side effects resolved by 1/30/2021 )
DIAPHORETIC; FELT LIKE PASSING OUT; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 on an unspecified date for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the patient experienced diaphoretic. On 07-APR-2021, the patient experienced felt like passing out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from diaphoretic, and felt like passing out. This report was non-serious. This case, from the same reporter is linked to 20210417256, 20210417209, 20210417122, 20210417469, 20210417550, 20210417620 and 20210418457.
I got my shingles vaccine on September 09/2021 one week later I started feeling shortness of breath and it continued till November. I got my Booster on October 06/2021 on October 09/2021 at around 8:00 PM I started to experience aches all over my body, fever for 36 hours, fatigue, my tinnitus got worse, dizziness. The next day I felt over heated it lasted till the evening. After 4 days I started feeling a little better. On October 15/2021 I got more symptoms and the same reactions started happening again. It continued for a week. My urine got dark orange color. On the Oct 22 I called my doctor. she gave me antibiotics for a week.
Chills, fever up to 102F, nausea, abdominal pain, body aches, fatigue, headache, injection site temp up to 105F + swelling + tender to touch
Congenital anomaly or birth defect; Patient lost baby 4 weeks prior to estimated date of birth. Emergency c section.; This is a spontaneous report from a non contactable consumer (parent) or other non HCP. This consumer (patients mother) reported for patient.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient was not tested for COVID-19. On an unspecified date, the patient experienced congenital anomaly or birth defect, patient lost baby 4 weeks prior to estimated date of birth. emergency c section. Events resulted in Emergency room/department or urgent care. Events were considered as serious (hospitalization, congenital anomaly). The clinical outcome of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101016416 Mother case/Fetal case
Uncontrollable crying since receiving 2 month immunizations; child able to sleep at night but cries throughout the daytime hours; did not do this before receiving immunizations.