chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient stated that she could not walk and began to lower herself to the floor slowly and then began clench her arms and hands and lay on the floor.  She also lost control of her bladder during this episode.  Provider was present for the end of the episode.  After about 30 seconds the patient was able to sit and talk and respond accordingly, but was tearful.
ACHY; MIGRAINE; FEVER; This spontaneous report received from a parent concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included brain tumor, and concurrent conditions included asthma, migraine, and allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On 09-APR-2021, the subject experienced achy. On 09-APR-2021, the subject experienced migraine. On 09-APR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, migraine, and fever. This report was non-serious.
paralyzed/quadriplegic; fractured a cervical vertebrae; fall; Initial information was received on 01-Dec-2022 regarding an unsolicited valid serious case received from a consumer/non-health-care professional.  This case involves 60 years old male patient who reported paralyzed/quadriplegic, fractured a cervical vertebrae and fall after receiving influenza quadrival A-B vaccine [Fluzone quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 21-Feb-2022, the patient received an unknown dose of suspect influenza quadrival A-B vaccine (Suspension for injection) (lot: UJ493AAA, expiry date: 30-Jun-2021) (strength, frequency was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient had a serious event paralyzed/quadriplegic (Quadriplegia) and fractured a cervical vertebrae (cervical vertebral fracture) (unknown latency) following the administration of influenza quadrival A-B vaccine.  On an unknown date the patient had a non-serious event fall (unknown latency) following the administration of influenza quadrival A-B vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.  Seriousness Criteria: Medically significant and disability for event paralyzed/quadriplegic. Medically significant for fractured a cervical vertebrae.; Sender's Comments: Sanofi Company Comment dated 05-Dec-2022: This case involves 60 years old male patient who reported paralyzed/quadriplegic, fractured a cervical vertebrae and fall after receiving influenza quadrival A-B vaccine [Fluzone quadrivalent]. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. However, lack of information of past and concomitant medication, vaccination history, family history and any relevant medical history of patient, any concurrent conditions and lab investigations precludes comprehensive case assessment.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/23/2021 J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/23/2021
Patient rec'd pfizer (grey cap) after it was stored in freezer for 22 days- rec'd replacement dose on 6/3/22
some arm soreness; Initial information received on 24-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to cases 2020SA340519 and 2020SA346488.  This case involves female patient of an unknown age who experienced some arm soreness (pain in extremity), while she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious some arm soreness (pain in extremity), (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that he does not know which ones they got. The wife he said got a high dose flu vaccine but he does not know name.   Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information on the batch number to be requested for this case.
Information has been received from a pharmacist referring to a 28 year old female patient. The patient was not pregnant. Concomitant therapies and medical histories were not reported. On 06-FEB-2015 the patient was vaccinated with a dose of M-M-R II (lot # K005574, expiration date 17-APR-2016, 0.5 ml) subcutaneously. Concomitant therapies were not reported. In the morning of 23-FEB-2015, the patient broke out in a rash on both of her arms. No treatment was given for the adverse events. None lab diagnostics were performed. The patient sought medical attention by calling her pharmacist on 23-FEB-2015. The outcome of the event was unknown. Additional information has been requested.
Fever of 104 degrees F and rash at injection site that looked like chicken pox.
Hive like rash to the entire body; 3cm inflamed hot lesion at the site of injection.
ED visit for shortness of breath in pregnancy. Symptoms resolved. Normal labor and delivery. Hospital admission within 6 weeks of receiving the COVID vaccine.
Initial information was received from a physician, and follow up information from a nurse concerning a female patient who was vaccinated with her second (also reported the first dose) dose of GARDASIL (lot number and site not reported) 0.5 ml IM. Subsequently, the patient experienced swelling at the site of injection. The area was about the size of an egg. The swelling lasted for 2 weeks. The patient had recovered from swelling at the site of injection. Additional information has been requested.
Patient's reported birthdate and stated patient was 12 year old and Insurance D.O.B. showing patient was 11 year old after doses given.  Patient's parents state that patient is 12 years old but date of birthday was incorrect with insurance showing that patient was 11 years old this is a reportable event.  Pfizer vaccine is only authorized to be given to patients that are 12 years of age or older.  Patient received second dose on 07/21/2021 with no reported adverse events so far.
Suspected vaccination failure; shingles; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (patient had very bad chickenpox when he/she was young which left scars).   In December 2020, the patient received the 2nd dose of Shingles vaccine. In October 2020, the patient received the 1st dose of Shingles vaccine. In February 2021, between 1 and 3 months after receiving Shingles vaccine and between 3 and 5 months 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 and Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient received two doses of Shingles vaccine and still got shingles. The patient was glad that he/she got the shingles vaccine. This case was considered as suspected vaccination failure as details regarding laboratory test confirming herpes zoster were unknown at the time of reporting.
Extreme fatigue; headache; diarrhea; stomach pain; joint pain; chills; upset stomach; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown, expiry date not reported), via an unspecified route of administration in the left arm on 29Jan2021 18:15 at single dose for COVID-19 immunization. Medical history included COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 (lot number: unknown, expiry date not reported) in the left arm on 08Jan2021 07:15 PM at single dose for COVID-19 immunization. On 30Jan2021 13:00, the patient experienced extreme fatigue, headache, diarrhea, stomach pain, joint pain, chills, and upset stomach. No therapeutic measure was taken as result of the events. Clinical outcome of the events was recovering.  Information on the lot/batch number has been requested.
Information has been received from a nurse practitioner concerning her 14 year old daughter with no reported medical history who in February 2007, was vaccinated with the first dose of Gardasil intramuscularly. There was no concomitant medications. The patient felt woozy and fainted approximately 5 minutes after receiving the vaccine. Subsequently, the patient recovered from the events. Additional information has been requested.
fever blister; This case was reported by a consumer via call center representative and described the occurrence of fever blister in a 56-year-old female patient who received Hepatitis A vaccine for prophylaxis.   Co-suspect products included MEASLES MUMPS RUBELLA VACCINE for prophylaxis and TYPHUS VACCINE for prophylaxis.   The patient's past medical history included fever blister.   On 7th August 2019, the patient received Hepatitis A vaccine, MEASLES MUMPS RUBELLA VACCINE and TYPHUS VACCINE. On 8th August 2019, 1 days after receiving Hepatitis A vaccine, the patient experienced fever blister. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the fever blister was recovering/resolving.   It was unknown if the reporter considered the fever blister to be related to Hepatitis A vaccine.  Additional details were provided as follows: The patient stated that she received the Hepatitis A vaccine and developed a fever blister. The patient was taking Valtrex for the fever blister. The patient did not consent to follow up. The patient did not have any additional information.
Information has been received from a licensed practical nurse concerning a 14 year old female who was vaccinated with the first dose of GARDASIL. There was no concomitant medication. Subsequently the patient experienced a near fainting episode. The patient recovered from near fainting episode after 5 - 10 minutes. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
I was having a fast heartbeat, and then in the morning I couldn't breathe. I was wheezing and having difficulty breathing. I went to the hospital, and discovered that I was having heart failure. I did not have any blocked arteries in my heart so it's an undiscovered reason as to why I have heart failure. The doctor believes it had something to do with a upper respiratory virus I had in February 2020 that involved a bad cough. The virus I had was not covid though. My heart efficiency is at 40% and it should be at 55%. I am able to breathe normal again, but I still have heart failure. My doctor prescribed me 4 different medications, and one of them is Entresto.
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose delayed beyond 42 days) and ADVERSE DRUG REACTION (Had a severe reaction to the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COVID-19 in 2020. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose delayed beyond 42 days) and ADVERSE DRUG REACTION (Had a severe reaction to the vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose delayed beyond 42 days) and ADVERSE DRUG REACTION (Had a severe reaction to the vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication was not reported. Treatment medication was not reported. The patient had a severe reaction to the vaccine and hence declined to get the 2nd dose.
It was reported in a published article, that a female with a history of a premature birth was vaccinated, while hospitalized for cervical banding at 13 weeks gestation with another pregnancy, with a dose of rubella virus vaccine live II due to inadequate titers. Subsequently the pt delivered a baby girl prematurely at 27 weeks gestation. The infant "had a very stormy start to life, and spent 115 days in NICU. Despite her fragility and precarious state, the infant was immunized in the nursery and suffered a severe and near fatal reaction to her second set of immunizations. She was stabilized and discharged home a few days later on oxygen and an apnea monitor. She was promptly noted to be developmentally delayed and was diagnosed with early-onset autism." In conclusion, the author stated that "vaccination of women around conception lead to stillbirths, premature delivery and vanishing twins. It can also be frequently associated with early-onset autism." Upon internal review, premature delivery, severe and near fatal reaction to immunizations, and early-onset autism were determined to be other important medical events (OMIC). No further info is available.
Heart attack - 5/22/2021; occurred at PRIVACY Hospital in PRIVACY after a bike ride and increasing symptoms of shoulder pain, profuse sweating, arm numbness
swelling of rt lymph nodes; rash 6 hrs later, swelling in throat area, headaches (constant), fever 101, rash blisters in mouth, joints achey, severe itchyness, lightsensitivity;
Left axillary lymphadenitis starting on 6/12/2021 at 0800.  No systemic infection.  LN is 1.6 cm.
I had a fever of 100.5 that lasted for about 24hrs, chills, post nasal drip, major headache and major brain fog that got worse as the day went on. I had a cough begin post COVID but did not have it during infection. I caught FLU on February 9th and the cough started then but has not gone away.
Very sore throat and fever ran for first week; then lung and sinus congestion ran the second week and is still continuing. Ache in body is ongoing with some stomach disorder. Treatment was R & R with NeoCitran Cold and Flu medicine once or twice a day.
WENT TO BED AFTER RECEIVING THE SHOT. WOKE UP WITH TINGLING/TICKLING SENSATION ALL THROUGHOUT BODY INSIDE AND OUTSIDE. SPINE WOULD TINGLE WITH DEEP BREATH. BRAIN TINGLED/TICKLED WITH EACH STEP. SWALLOWING FOOD TICKLED THROAT. CLOTHES WOULD TICKLE SKIN.  NOT SURE ABOUT DIFFERENCE BETWEEN TICKLING AND TINGLING AS I DO HAVE A HIGH PAIN TOLERANCE.
AT AN OFF SITE LOCATION HE RECEIVED MODERNA BRAND VACCINE. ON 3/14/2021 HE RECIEVED PFIZER BRAND FROM ANOTHER ORGANIZATION LOT NUMBER WAS EN6202 IN MARCH. HE UNDERSTANDS THE SERIER IS COMPLETE.
Pt with syncopal episode after FLUZONE - had prodrome of dizziness - likely vasovagal episode. Recovered fully within several minutes.
Patient unresponsive at home after being discharged on 12/12/09 at 9:15pm. Patient arrested, brought to hospital and pronounced dead at 11:40 PM.
VACCINE WAS GIVEN 2.5 HOURS AFTER IT WAS DRAWN IN A SYRINGE AND KEPT AT ROOM TEMPERATURE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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: Unk) dose was not reported, administered on 12-MAY-2021 16:30 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 12-MAY-2021, the subject experienced vaccine was given 2.5 hours after it was drawn in a syringe and kept at room temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine was given 2.5 hours after it was drawn in a syringe and kept at room temperature was not reported. This report was non-serious.
Moderna   Shot 1- 8/27/21. At 2pm Arm, neck soreness   8/28/21- left side soreness, burning: arm, neck, shoulder blade  9/4/21- neck pain started.  9/7/21- sac measuring 6-0 weeks was empty. By LMP 7-5 weeks  9/14/21- ultrasound showed yolk sac and fetal pole measuring 6-2 weeks. 77 bpm faint heartbeat.  9/14/21 @ 630pm- started spotting brown discharge.  9/15/21 @ 6am- heavier brown discharge until about 10am. Went away.  9/16/21 @ 130pm- Red blood on underwear and toilet paper. Continues.  9/17/21- cramping and continued red blood all day.  9/17/21 @2pm- intense cramping, heavy gushing bleeding. Passed placenta.  9/17/21 @3pm- intense cramping, heavy bleeding. Passed gestational sac. Rest of day continued light cramping and lighter bleeding.  9/21/21- confirmed miscarriage at Ob. Passed more tissue/bleeding   9/24/21- continued bleeding, passed tissue. Second Moderna shot. Intense rt arm and neck pain.  9/25/21- intense pain/burning on right side (arm, neck, upper back).  History of 1 previous healthy pregnancy, live birth in 2017.  EDD: May 10th, 2022 for this pregnancy prior to miscarriage.
No adverse affect reported from patient. Clinic held Moderna vaccine at lower temp than recommended by Modera. Vaccine was held at -90 to -60 degrees Celsius. Moderna deemed vaccine viable for use.
shaking chills, fever, myalgias, fatigue increasing over course of 8-24 hours after injection; severe enough that could not work
This spontaneous report was received from a nurse and refers to a 59 year old female patient. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 07-FEB-2018, the patient was vaccinated with expired dose of ZOSTAVAX, lot # N009167, expiration date: 02-FEB-2018, for prophylaxis (dose and route of administration were not reported). No adverse effects were reported.
Patient was administered a Pfizer Covid-19 vaccine that was exposed to a temperature excursion. (Vaccine was between 8-14.5 degrees C for 7hrs and 48 minutes). Pfizer was contacted and advised the clinic to consider the dose as invalid and to revaccinate. Patient was revaccinated on 03/19/21 and has since received dose2 on 04/09/21.
I had adverse reactions to vaccine #1 and vaccine #2. With vaccine #1 on 3/30 I developed a bad skin rash under my arms. With vaccine #2 I experienced the expected side effects (low grade fever, body aches) but then developed a very swollen lymph node under left arm - still going on five days later. I also experienced terrible SVT & heart palpitations two days after the second vaccine. This was very scary and unsettling.
Quarter-size area of erythema at injection site on right thigh with a few isolated vesicles, blanchable, nontender - observed by MD 9 days after injection. Tx: BENADRYL.
MMR 16NOV90, on 02DEC90 developed general aches, joint pain, swollen knees, hands stiff & sore; URI. 10DEC90, sx's improving.
Headache Face/chest flushed, warm to touch. States loss of hearing with  ringing in the ears afterward that last a couple of seconds then hearing  returned to normal. Narrative:
Pt experiencing radiating extreme soreness and pain starting in injection arm and spreading across whole body, "worse than the flu" a few hours after receiving the vaccination. She had chills and used an electric heating pad to help with chills, soaked in an Epsom salt bath. The extreme soreness persisted and pt is still experiencing side effects 2 days later though not as severe today.
Child came to clinic on Friday (10/27/2000) around 10:30 am with mother and brother to receive her first Hepatitis B injection. IZ was given in left deltoid without incident or problem. Mother called health department around 1:45 later that afternoon, and stated her daughter's left hand and arm were swollen and red. Denied any bruising at IZ site. Strong radial pulse palpated. Mother denied any respiratory distress. Mother instructed to contact PMD immediately for evaluation of possible allergic reaction to IZ. Requested mother to contact the health department after physician examination. Mother called health department around 4:00 to report that PMD diagnosed an allergic reaction. Daughter was put on steroid medication (prednisone) and Allegra; mother was instructed to return for epinephrine injection if swelling became worse or if respiratory problems developed. Mother was also instructed by PMD that no further Hep B was to be given. Mother stated that hand and arm were still swollen and neck was now involved. Phone call made on Saturday (10/28/00) to check on Rachel's condition. Mother stated that there was still swelling, but no further problems. Stated that child has always been more sensitive to her immunization that her other children (high fever, soreness at site, irritable). Stated child has a history of severe swelling in extremity after bee sting. Informed mother that an adverse reaction from would be completed and forwarded to the Vaccine Adverse Event Reporting System.
Next day; some pain at injection site, flu like symptoms; feeling tired and week, shivering, fever, nausea, muscle aches. Had to leave work and go to bed. Could not function normally the day after the injection. Same symptoms continued the second day after the injection with slight improvement later in the day, however a slightly raised rash appeared between my neck and shoulders with the same rash at the injection site.  All these symptoms continued into and throughout day three which is the time of this report. Generally the flu like symptoms improve each day, however the extent of the side effects was much more intense and encompassing than any other vaccine I have every received.
up in middle of noc cried, sore legs no fever; cried for 3 days; not consolable; nursed poorly; crying would stop 15-20 min & start up again; not self for about 2-3 wks p/shots;
Fever 102 for 2 days, 9 days after vaccine administered. Rash developed on 10th day.
It was reported that a pt (7 of 9) received a Tripedia vaccination the week of 3/23/01. Reportedly, sometime after the vaccination (date not specified), the pt developed a large local reaction at the injection site. From additional correspondence received on 5/16/01, it was reported, "unable to locate pt name". This case is closed.