chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of stopped breathing in a 2 week old female subject who was vaccinated with hepatitis B vaccine recombinant for prophylaxis. A physician or other health care professional has not verified this report. On 4/6/05, on her date of birth, the subject received 1st dose of Engerix B (0.5ml, unknown). On 4/20/05, 14 days after vaccination with Engerix B, the subject was taken to the emergency room because she stopped breathing. In the emergency room, she was described as having listlessness. On 4/20/05, the subject recovered in the emergency room after approximately 30 minutes, but was admitted to the hospital for observation. The vaccination series with Engerix B was discontinued.
Woke up with extreme severe migraine dizziness, vertigo nausea and loud tinnitus!  Scalp and face tingling.  Ear fullness,  head pressure,  sinus pressure,  visual haze, brain fog.  Never experienced this in my life!  Persisting for weeks and weeks and continues.  Still ongoing.  Please help!
Fatigue, chest pressure. Followed up with PCP EKG showed ST elevation; scheduled stress echo next week.
Systemic: Blood Disorder  (diagnosed by MD)-Severe, Additional Details: Patient ended up with blood clots and died 10/7/21. Had no other side effects from the vaccine. Patient's wife stated he was fine and had no issues until on 10/7 when he was having trouble breathing and then required CPR. He did not survive. Dr's determined it was blood clots caused by the vaccine.
10-25-13 3:30PM in the morning patient had a 103.5 fever and was delirious, out of her head could not respond so I (husband) had her sent to hospital.
extreme fatigue; chills; This is a spontaneous report from a non-contactable other HCP communicated to a Pfizer colleague.   A patient (demographics unknown), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On an unspecified date after the 1st dose of vaccine, patient experienced extreme fatigue and chills. She was knocked out for like 4 hours (as reported). At the time of the reporting event outcome was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Muscle aches, headache, nausea, fatigue, heart felt like someone was squeezing it.
Systemic: Blood Disorder  (diagnosed by MD)-Medium, Systemic: Cardiac Disorder (diagnosed by MD)-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Fever-Medium
Rt leg, red, swollen, warm to touch. C/o itching parents noticed 11/18/04 at night. Measured and area circled 3 1/2 L x2 1/2 W. given Hydrocortisone cream 2% prescribed Tylenol for pain, cool compresses to f/u if worse. To f/u with allergist.
On May 16 (day after vaccination), developed a bad cold, cough.  We expected this.  We gave him motrin to help with the symptoms. Then on May 19 at 1400 the school nurse called me to say that he had developed a nose bleed.  No injury/no inciting event.  They had been putting pressure, ice, etc on it for about 2 hours.  We picked him up.  No more nose bleeding after the initial pressure/rhinorocket and he did not go to the Emergency Room.  The congestion, cough improved.  No problems with the second dose of the vaccine on June 5.   Since then, he has complained about things tasting funny/bad and not being able to smell as well.  He did not mention this to his primary care doctor during his physical this summer nor did his father let her know (he was at the visit with our son).  has complained of this fairly regularly and he relates it back to the nose bleed.
Patient reports itchy throat and watery eyes approximately 30 minutes after vaccine. Dr. assess patient and ordered BENADRYL 25 PO x1. Medication taken with water without any swallowing complications. Monitored patient for 1 hour. Patient reassessed after one hour, patient reported itchy throat and watery eyes relieved.
Headache; Neck pain; This is a spontaneous report from a non-contactable consumer (office manager). This report was received via a Pfizer sales representative. A 17-year-old female patient received the first dose of meningococcal group b rlp2086 (TRUMENBA, lot number and expiry date not reported), via an unspecified route of administration in Apr2019 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in 2019, after the first dose of meningococcal group b rlp2086, the patient had neck pain and headache; and ended up in an emergency room. The patient did not want the second dose of meningococcal group b rlp2086, and the reporter wanted to know what they should do regarding the second dose (pending clarification). The outcome of the events, neck pain and headache, was unknown.  Information on the batch/lot number has been requested.
RASH ON BOTH RIBS --BRIGHT RED RASH WITH RAISE BUMPS
Patient's mother described mucous watery diarrhea, 6-8 times a day for 5 days, with one episode of vomiting, slightly crabby. Was eating and sleeping fine otherwise. Seen 5/16/18 and stool is a bit firmer now. Did have blistery diaper rash with increased stools, healing now. No fevers, no other s/s.
a twitch under her rib cage on her right side of her body; Slight chills; Pain in the injection site; warming of the body/ feels warms in the arms/warm feeling in the legs; Twitch in the other arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (warming of the body/ feels warms in the arms/warm feeling in the legs), MUSCLE TWITCHING (Twitch in the other arm ), MUSCLE TWITCHING (a twitch under her rib cage on her right side of her body), CHILLS (Slight chills) and VACCINATION SITE PAIN (Pain in the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02ALL0A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced FEELING HOT (warming of the body/ feels warms in the arms/warm feeling in the legs), MUSCLE TWITCHING (Twitch in the other arm ) and VACCINATION SITE PAIN (Pain in the injection site). On 25-Jan-2021, the patient experienced MUSCLE TWITCHING (a twitch under her rib cage on her right side of her body) and CHILLS (Slight chills). At the time of the report, FEELING HOT (warming of the body/ feels warms in the arms/warm feeling in the legs), MUSCLE TWITCHING (Twitch in the other arm ), MUSCLE TWITCHING (a twitch under her rib cage on her right side of her body), CHILLS (Slight chills) and VACCINATION SITE PAIN (Pain in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  No treatment information was provided.
A few days after I got the shot I started having night sweats, nausea. The night sweats went away until I got my second vaccine. Now I have them every night. They are not as bad. My doctor put me on medicine. I have fluid around my heart. Pericardial effusion is what I was diagnosed with. I also have small cell vasculitis. My red blood cell dropped.
Patient received TDAP 07/20/2010 (L) deltoid returned 07/22/2010 - area tender -  inflamed - hypertrophy 3.5 cm diameter. Returned 07/26/2010 unimproved area enlarged to 5.5 cm diameter w/surrounding erythema. Moist heat wrap.
Next day after vaccination, I started getting sick. I wasn't holding anything down and this lasted 3 days and extremely sore arm
Patient got light headed,  lost consciousness and body started to shake.  Pt evaluated by RN and DO, monitored closely for approximately 30 minutes.  Patient then release home.
This report is regarding the Pfizer COVID-19 vaccination you received on the above date, which was lot  number FD0809. Guidance from the Department of  Health, Centers for Disease Control and Prevention (CDC), and Pfizer has determined that the  dose of vaccine that you received is valid.
and it made her feel/think weird; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional (patient) via Medical Information (Reference number- 00770570) and transmitted to Sanofi on 15-Sep-2021.  This case involved an unknown age female patient who feel/think weird (feeling abnormal) while receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious feel/think weird (feeling abnormal) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported "Caller is a patient that was wanting to know more about the ingredients in our FLUZONE QIV vaccine. Patient unsure if she received it from MDV (multidose vial) or not, and could not give me date she received vaccine. She asked about "nano-particles" and how she had done research online about how we are putting them in our vaccines without disclosing that information. She then accused us of tracking her and her kids through the vaccine. Caller states she could feel the vaccine in her and she could now think of something and it would show up on her phone later in the day. Caller refused to give most demographic information other than name and phone number. Caller ended call after I listed the ingredients in the prescribing information for her and let her know I had no other information in regard to what she was asking for. Was not able to offer survey".   No relevant laboratory data was provided.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
received 3 doses of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 77-year-old male patient who received Herpes zoster (Shingrix) (batch number NE49X, expiry date 23rd August 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 15th May 2018 with lot X3M27 and expiry date 29th August 2020) and Shingrix (received 2nd dose on 14th July 2018 with lot B9739 and expiry date 22nd November 2020).   On 29th November 2021, the patient received the 3rd dose of Shingrix. On 29th November 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 03-May-2022 Reporter's comment: Pharmacist reported that he/she had a patient that received 3 doses of Shingrix over a 3 year time period.  Consented to follow-up. Additional Supportive Information: The patient received 3 doses of Shingrix, which led to extra dose administered.
Patient was given 2 flu shots at the same time by different RN's. Should have received 1 polio and 1 flu shot. Patient checked 12-7-06 and 12-8-06: minimal induration (<5mm) at flu injection sites. Facility called CDC Immunization hotline medical provider "no increase in reaction with an increased number of flu doses even if given at the same time."
Fever, slept a lot. Regressed completely within the week, stopped saying mom, waving, playing... diagnosed with Autism a year later. Never regained speech, communication. Didn't walk till almost 2. He became another child after the vaccine.
pt recvd vax; throat felt raw, tongue, mouth & lips swollen, eyes bulging, diff breathing & anxiety
Patient completed second COVID-19 vaccine in January 2021 (unknown which manufacturer). Patient was at a family gathering and had close contact with a relative who later tested positive for Sars-cov-2. Patient subsequently started symptoms (sore throat, headache, nasal and ear congestion associated with myalgias) and presented to clinic where we had a positive rapid COVID-19 test. He was then sent to ED where he again tested positive for Sars-cov-2 on RVP PCR.
This case was reported by a healthcare professional and described the occurrence of fatigue in a 24-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 21 February 2012 the subject received 1st dose of ENGERIX B at 1 cc in the left arm. On 21 February 2012, 1 to 2 hours after vaccination with ENGERIX B, the subject experienced fatigue, musculoskeletal stiffness (neck and shoulder stiffness) and was unable to eat. This event was considered medically significant via GlaxoSmithKline. The physician's assistant reported that the patient's symptoms improved on 24 February 2012 and then resolved on 1 March 2012.
Polymyalgia rheumatica; This is a spontaneous report from a contactable consumer reporting for her husband. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization and experienced mild body aches. The patient  body aches worsened dramatically after dose #2 on unspecified date. He was diagnosed yesterday by his physician with polymyalgia rheumatica with the outcome unknown. Treatment were received as a result of polymyalgia rheumatica. While not 100% certain, it appears to have developed from the vaccine.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Client is age 17 and received Pfizer 5-11 formulation. Multiple safeguards to prevent this type of error were in place, including color-coded wristbands, staff education prior to the clinic and just-in-time training at clinic, only one vaccine type per vaccinator station, and at least 2 points in clinic flow where age and vaccine type are verified. Due to errors by multiple staff members, this error happened. The client and guardian (father) were immediately informed of the error. Per CDC guidance, the client may receive another age-appropriate dose of Pfizer vaccine in 21 days; the client/guardian were encouraged to discuss this with his pediatrician. At the time of this submission, no known adverse effects have occurred.
14MAR95 420PM phoned stating pt had been crying for an hr; given APAP & cool wet cloth; 14MAR95 seen in Er; MD inc APAP to leg red & swollen; warm compresses to leg; 15MAR95 leg nl; stopped crying in ER:
VACCINE WAS EXPRIED AND THE MANUFACTURE SAID " For doses administered between Oct. 1 and Oct. 19, with manufacturer data to support the stability and efficacy, revaccination is not indicated, and patient notification is not require" FOR THE LOT NUMBER "FL2757.
adverse reaction; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION COMPLICATION (adverse reaction) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041LZ0A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-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 VACCINATION COMPLICATION (adverse reaction). At the time of the report, VACCINATION COMPLICATION (adverse reaction) 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.
Confusion SEVERE FATIGUE, NIGHT SWEATS, NO APPETITE, CHILLS, DIFFICULTY CONCENTRATING Narrative:
first dose of Moderna COVID vaccine. within a five minutes, had tachycardia, relative hypertensive syndrome.  no wheezing or hives or itching.  no anaphalaxis symptoms.   Patient was observed and discharged to home.  doing well.  In an attempt to determine mechanism of the reaction we are ordering serum and urine catacholamines and serotonin studies  results are pending.    we have seen at least three others with a similar hyperdynamic tachycardia with relative hypertension immediately following the first dose of Moderna COVID vaccination.
After vaccine given on 3/21/11 in Rt thigh redness with swelling x 2days. Now on 4/27/11 (+) blotchy redness with pain in area where injection given.
12:32: Approximately 2 mins after administration of vaccine stated  that she felt nauseated. I had her sit down. She leaned  head against wall and put her feet up in another chair. 12:42 She said she felt faint and asked for water. After she  took a sip she verbalized that she was everything. We waited and watched in a few minutes she felt better. After waited and watched in a few minutes she felt better. After had wait x 30 more mins for observation.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021 at 12:54 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided.  Treatment information was not provided.
Welt at site of injection with some redness.  Resolved within a few hours without any treatment.
Anaphylaxis reaction involving closing throat, numbness of lips, and redness of hands. Occurred 20 minutes after injection. Treated with Epinephrine IM self administered and 2 ounces Benadryl oral self administered. Overt symptoms abated within 15 minutes. Transported via emergency squad to local hospital 20 minutes after onset of symptoms. Administered prednisone and pepcid at hospital. Held for observation for 2 hours before discharge, Lingering symptoms included thickness of throat and numbness of lips for approximately 7 days. No further symptoms after 7 days.
Pt found unresponsive in her home. Admitted to ICU 3.25.21 from ER with DX respiratory failure, pneumonia, UTI, elevated D-Dimer. Placed on BIPAP, then intubated 3/26/21
muscles aching; soreness around the injection site; joints were on fire; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd May 2019, the patient received the 2nd dose of Shingrix. On 3rd May 2019, 2 hrs after receiving Shingrix, the patient experienced muscle pain, injection site pain and burning sensation in joints. The patient was treated with intravenous fluid (nos) (Intravenous Fluids). On an unknown date, the outcome of the muscle pain, injection site pain and burning sensation in joints were recovered/resolved.   It was unknown if the reporter considered the muscle pain, injection site pain and burning sensation in joints to be related to Shingrix.  Additional details were provided as follows: This case was reported by the consumer for herself. The patient got a dose of Shingrix injection in the right deltoid, and that she had a violent reaction. Two hours after the injection the patient experienced the normal soreness around the injection site, but it got worse and then all of her muscles were aching. The patient stated it felt like her joints were on fire.  The patient went to Emergency Room and the physician was able to reverse the reaction with intravenous (IV) fluid (patient not sure what medications she was given) and the pain dissipated over the next 3 hours.  The patient went home after 5 hours in the emergency room feeling no pain and fully recovered. The patient did not have the opportunity to tell her primary care physician below yet.  The reporter gave consent to follow up, and to contact the physician and provided contact details for the same. The reporter did not have record of lot or expiration date.
This patient was given the 0.25mg booster vaccine 2 months earlier than she was supposed to.
Headache, Myalgia, Arthralgia & Fever Narrative:  Patient received J&J vaccine x 1 dose on 04/06/21. Patient reports symptoms of injection site pain/redness/swelling/itching, as well as general symptoms of chills, fever, headaches, joint pain, body aches, fatigue, and swollen glands which began the day of the receipt of vaccine. Per patient report "on the first day, felt flushed and tired. On 2nd day, injection site was sore. On 3rd day, fever/headache, lymph node in arm pit swollen, chills (shaking like blood sugar low). Site pain on 5th day." Also reports "asthma symptoms". Of note, patient has history of asthma. Reports taking low dose aspirin and Tylenol for symptoms. Patient has fully recovered from event.
Fever; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 24Mar2021 at 15:15 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. Concomitant medications included cetirizine hydrochloride (ZYRTEC)  for unknown indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient experienced fever. The patient reported that fever developed exactly 7 days after the first dose. On 31Mar2021, the patient underwent nasal swab test for COVID-19  and the result was negative. On 01Apr2021, the patient underwent nasal swab test for COVID-19 and the result was negative. The patient did not receive any treatment for the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event fever was resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
Apnea, cyanosis, resp arrest; Rescued & transferred to Hosp;