chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe pain in left arm causing limited mobility, unable to raise arm.  Numbness in left arm, left forearm, left hand.  Numbness in left shoulder blade, and base of neck down to mid vertebrae.   Twitching/spasm muscles up and down spine across full length of back.  Headache.  Light sensitivity.  Extremely exhausted.
Information has been received from a nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with RECOMBIVAX HB (dose, strength, frequency, route of administration, anatomical location, lot # and expiration date were not reported), for prophylaxis. Concomitant therapies included properly stored sterile diluent (STERILE DILUENT). The administered vaccines were improperly stored at temperature greater than 9°C but less than 25°C for 1 hour and 13 minutes without any previous temperature excursion; this information was registered in a digital data logger. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA002314: US-009507513-1706USA002915: US-009507513-1706USA002916: US-009507513-1706USA002917:
Pt. reported upper lip itching, tingling in both cheeks.  Pt. refused benadryl and stated that sypmtoms are improving.  ER precautions given and pt. released.
Fatigue; Low grade headache; General icky feeling; Intermittent shortness of breath.; Chills; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Mar2021 at 12:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Medical history included severe iron deficient anemia and COVID-19 (COVID 4 mos). The patient did not have allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021 the patient experienced chills about 5-9 at night followed by fatigue about 9-2 AM. Six days later still have low grade headache, general icky feeling, and intermittent shortness of breath. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the event chills was recovered on 29Mar2021 at 21:00 and fatigue was recovered on 30Mar2021 at 02:00 while the outcomes of low grade headache, general icky feeling, and intermittent shortness of breath was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Instead of being given a COVID-19 vaccine, patient was stuck with a syringe and needle that did not have any vaccine drawn up in it at the time, only air. This error was caught when it was discovered that there were syringes missing that had not had vaccines drawn up in them yet. The patient was still in the building, had been poked about 2-3 minutes prior to the error being discovered, so the vaccine was then administered to the patient correctly. Pt discharged home will no adverse effects.
Came down with symptoms on 08Aug2021 - headache, fever of 101.2+ and cough. Tested negative on 8/9/21 with Abbott BinaxNow kit and positive on 8/10/21 with Abbott BinaxNow kit; Came down with symptoms on 08Aug2021 - headache, fever of 101.2+ and cough. Tested negative on 8/9/21 with Abbott BinaxNow kit and positive on 8/10/21 with Abbott BinaxNow kit; This is a spontaneous report from a contactable consumer (patient). A 21-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8729), via an unspecified route of administration, administered in Arm Left on 14Apr2021 (at the age of 21-years-old) as dose 2, single and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER2613) via an unspecified route of administration, administered in Arm Left on 22Mar2021 16:00 (at the age of 21-years-old) as dose 1, single for covid-19 immunization at other. The patient medical history was not reported. There were no concomitant medications. No known allergies and no other medical history. No other vaccine in four weeks and other medications in two weeks. No covid prior vaccination. Covid was tested post vaccination. On 08Aug2021 21:00, the patient came down with symptoms of headache, fever of 101.2+ and cough. Tested negative on 09Aug2021 with Abbott BinaxNow kit and positive on 10Aug2021 with Abbott BinaxNow kit and then positive with hospital clinic test on 10Aug2021. Lost sense of smell and taste but symptoms resolved within 8 days. Still cannot taste much. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included body temperature: 101.2 on 08Aug2021, sars-cov-2 test (nasal swab): negative on 09Aug2021, blood test: positive on 10Aug2021, sars-cov-2 test (nasal swab): positive on 10Aug2021. The patient received treatment for events. Received Tylenol for fever and monitoring pulse and oxygen. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
The first thing I noticed was a very painful point in my stomach at first in the upper part of my stomach. Very painful, like a burn then a headache. My husband took my blood pressure and I'm usually around 110/70. I felt a lot of pressure in my head and pain in my stomach, so he took my BP and he found out I had 159/90-100 and he said it was very high. I don't think I took anything, but I tried to calm down and relax. He retook my blood pressure, and it was lower 139 and eventually went lower. It was that moment for an hour like that. The pain continued the next day all day and I called the doctor and made an appointment and started the follow up. The first appointments were by phone in March. I was scheduled an endoscopy for May 26, 2021. The rest of the appointments afterwards were by phone until August for pap smear. September 14, 2021, we reviewed the results of the endoscopy, and it had indicated minimal chronic gastritis. I don't feel the episodes anymore. Now I have sensitivity in the upper stomach. I watch what I eat now. The doctor did also ask if I was under any stress and I can't say if I was or not, but that health event stressed me. The days with pain stressed me. He said stress can cause pain, but I'm not sure how this started and the pain continued. The day of the event, the stress started because the pain moved from the upper stomach to the left side of my body and the breast. Something felt like there was something wrong happening to me. Tried to relax that day, but that's when I started stressing. The only thing the doctor checked was my stomach. December 3, 2021 was another follow up for the abdominal pain and he sent me to get lab tests for CBC (WBC were still low at this time) and allergies. Also, between May-September, I had scratchy bumps that took time to heal which was why I was tested for allergies. Started taking Vitamin C after and the bumps resolved. I still feel the pain in the upper stomach, but I try eat different things and change my diet, lower my stress, etc.
SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient 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, and batch number were not reported) dose was not reported, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in 2021, the subject experienced suspected clinical vaccination failure, the patient reports to be tested positive for Covid-19 multiple time within 90 days after vaccination. On 01-FEB-2021, the subject experienced suspected covid-19 infection. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 16-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210534882-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Started as a rash on the upper arms, then it spread to the legs and eventually over most of the body.  The patient also had chills and ran a fever, along with having a headache and slight cough, The rash itches with heat and has spread over the course of a few days. The rash did not spread onto the hands, feet, or face. The patient has taken Benadryl and noted that it has seemed to be helping. Today the patients only complaint was of the rash, though she said it seemed to be improving.
This case was reported by a non-health professional via sales rep and described the occurrence of swelling arm in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 17th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 1 day after receiving SHINGRIX, the patient experienced swelling arm, pain in arm, numbness, nausea and influenza-like symptoms. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the swelling arm, pain in arm, numbness, nausea and influenza-like symptoms were unknown. It was unknown if the reporter considered the swelling arm, pain in arm, numbness, nausea and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The patient experienced severe swelling on the arm, pain outside of arm, under arm numbness into the muscles. All symptoms started 24 to 30 hours after injection. The patient had half day loss of work. The patient took 8 days for swelling to go down. The reporter was agreed to provide follow up information.
"Covid arm" large (3 x 3")  itchy rash appeared  under injection site on left arm, 9 days after vaccination.   Rash /redness area increased in size, but itching subsided.  Rash/redness remains after seven days.
have not gotten the flu since not getting the shot; Initial information regarding this unsolicited valid non-serious media case was received from a consumer (patient) and transmitted to Sanofi on 17-Dec-2020.  This case involves a patient with unknown demographics who had flu (Influenza), while the patient received INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination details, concomitant medications 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 unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza), unknown latency following the administration of INFLUENZA VACCINE. It was reported that the patient had stopped taking flu shot since 15 years and since then the patient did not get the flu.  Relevant laboratory test was not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
Fever 101.5 started 4/9 pm fever lasted 3 days Headache started 4/9 and lasted 4 days Chills started 4/9 pm and lasted 3 days Nausea started 4/9 pm and lasted 3 days Lethargy started 4/11 and still have (4/13) Pain started 4/9 and lasted 3 days Loss of appetite started 4/9 and still have (4/13) Shallow breathing started 4/10 and lasted 2 days Racing heart started 4/10 and lasted 2 days
Not feeling good; sweat; Sore throat; Chills; My body hurts; A lot of pain in my eyes; Feeling like hot and then cold; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling good), FEELING OF BODY TEMPERATURE CHANGE (Feeling like hot and then cold), HYPERHIDROSIS (sweat), EYE PAIN (A lot of pain in my eyes) and OROPHARYNGEAL PAIN (Sore throat) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jul-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Feeling like hot and then cold), EYE PAIN (A lot of pain in my eyes), CHILLS (Chills) and MYALGIA (My body hurts). On an unknown date, the patient experienced MALAISE (Not feeling good), HYPERHIDROSIS (sweat) and OROPHARYNGEAL PAIN (Sore throat). The patient was treated with IBUPROFEN for Chills, at a dose of 1 dosage form every six hours. At the time of the report, MALAISE (Not feeling good), FEELING OF BODY TEMPERATURE CHANGE (Feeling like hot and then cold), HYPERHIDROSIS (sweat), EYE PAIN (A lot of pain in my eyes), OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and MYALGIA (My body hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported.   It was reported that, on 25-Jul-2021, patient started with chills. Since then, he has to take every 6 hours an Ibuprofen pill which helps him not feel that cold. However, when the cold passes, he starts to feel hot. And it is like a cycle: the whole day patient is feeling cold and hot. He also stated that he is experiencing a lot of pain in the eyes and a lot of pain in the body. He mentioned that he has a sore throat, like there is an infection in the throat. He still has these symptoms to this day.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Added reporter details and events.
Started having tingling in her mouth, post nasal drip, and feeling like her skin in her mouth was sloughing off an hour later.
Client had 2nd dose of COVID vaccine, ten minutes later reported her fingers felt tingly.  Vital signs stable, denies any other symptom.  "Tingling sensation" resolved 15 minutes later, client able to go home.
Narrative:  Patient requested to have the "single shot, J&J" Vaccine. Nursing contacted the provider requesting the order be put in for the immunization. This provider asked if patient could give consent and nursing noted he was alert and oriented and clear on his desire for the "one shot immunization". Immunization tab checked and no documented covid immunization noted. Order entered and immunization administered. Upon discharge nursing told his granddaughter that her had his immunization while he was here. GD stated he already had the vaccines at the center (outside clinic). The patient's chart was then reviewed and it was noted in the admission H&P that patient had been previously vaccinated but it had not been logged in his immunization record within the chart so this writer/provider was unaware. No lot numbers available for outside the documentation, but record indicates patient received Moderna COVID vaccine dose #1 on 3/20/21 and dose #2 on 4/7/2021. Patient received J&J vaccine on 5/21/21 while inpatient at the hospital. He left the hospital AMA later that afternoon. No known adverse effect from the second vaccination. He had phone contact with PCP on 5/25/21 and reports his breathing is terrible but admission was for pleural effusion and SOB. The patient is scheduled for thoracentesis on 5/27/21. At the point of entering this report there has been no adverse effect from receiving 2nd COVID vaccination.
Swollen (Injection); Redness (Injection SIte); Itchiness (Injection Site); A spontaneous report was received from a consumer concerning a 66-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swollen (injection), redness (injection site), itchiness (injection site).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 17 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 038K20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Swollen (Injection), Redness (Injection SIte), Itchiness (Injection Site).  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), swollen (injection), redness (injection site), itchiness (injection site) was unknown.
pain significantly increased and has remained elevated following the second dose of the vaccine (Neuropathic pain); pain significantly increased and has remained elevated following the second dose of the vaccine (Neuropathic pain); This is a spontaneous report from a contactable physician (patient). A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration and administered in left arm at age of 63-years, on 11Mar2021 15:30 (Lot Number: EN6205) as single dose for covid-19 immunisation. Medical history included ongoing burning mouth syndrome and a neuropathic pain condition (patient had the condition for over 8 years). The patient was not pregnant. Concomitant medication included metoprolol; escitalopram oxalate (LEXAPRO); cetirizine hydrochloride (ZYRTEC) and ibuprofen (patient received them within 2 weeks of vaccination). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration and administered in left arm at age of 63-years, on 18Feb2021 12:30 PM (Lot Number: EL9266) as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that, following the second dose of the vaccine, her pain significantly increased and had remained elevated. She had been working with her pain specialist to change medication to find help for this intense pain. She had the condition for over 8 years so was very familiar with it and had never experienced an increase in pain at this magnitude. Above events started on 12Mar2021 and resulted in "Doctor or other healthcare professional office/clinic visit". Treatment was received included that "Changing medications". The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since the vaccination. Events outcome was not recovered.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a nurse and refers to a 6 month old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 09-OCT-2017, the patient was vaccinated with improperly stored vaccines, RECOMBIVAX HB (dosing details not reported) (lot # N009802, expiry date: 19-DEC-2019) and ROTATEQ (dosing details not reported) (lot # N009948, expiry date: 12-OCT-2018, orally) for prophylaxis. No adverse effects were reported. The administered vaccines underwent a temperature excursion from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011.
Pt was seen in ER for CP on 1/24/21 for CP and underwent a negative w/u, she was dx with costochondritis and sent home with improvement in dx on naproxen. She received her first COVID-19 vaccine on 2/3 and states she immediately developed cough, dry mouth, congestion, fevers (101), chills, and worsening CP. She was still having symptoms we we talked on 2/18 and was seen on 2/20. CXR revealed b/l pleural effusions and she was sent to ER. She was started on cefpodoxime and azithromycin and sent home. I saw her for f/u on 2/22 and f/u CXR showed worsening effusions and she was sent back to ER. CT showed b/l pleural effusions, ground glass opacities, and pericardial effusion. She underwent thoracentesis and 400ml ex was removed. Her inflammatory markers were extremely elevated (ESN=132, CRP=14.9) and her ANA has since returned positive in a titer of 1:320 in a speckled pattern. She was started on prednisone and has had significant improvement in symptoms. She is back home now and awaiting rheumatology f/u to confirm if she has a new dx of SLE, (am uncertain what role the vaccine played in this given she had some possible prodromal sx prior to receiving the vaccine but she did note that her sx markedly worsened after her vaccine.
10 days after the Covid Booster, he suddenly had vertigo, tinnitus, and loss of hearing in his left ear. The vertigo subsided after 3 days, however the hearing loss and tinnitus did no subside. He was seen by an urgent care immediately, followed by his pediatrician in early February 2022. At that pediatrician he failed his hearing test for the first time. On June 1, 2022 he failed for a second time. On July 8, 2022, he was tested by an audiologist and found to have sudden onset sensorineural hearing loss of the left ear with tinnitus.
DTP/OPV/HIB TITER recvd on 6AUG91; ON 9AUG91 crying 3-4 hrs straight; used APAP & mylicon w/o relief;