chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tinnitus; This is a spontaneous report from a non-contactable nurse, the patient. A 30-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration on 26Jun2021 at 16:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Jul2021, a few days after receiving the COVID vaccine, the patient experienced tinnitus. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event tinnitus was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected
CHANGE IN VOICE; SWEATING; SORE THROAT; COUGH (THROAT WAS RASKY); TIREDNESS AND FATIGUE; FEVER; This spontaneous report received from a patient concerned a 64 year old male. 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: 1808978, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 04-APR-2021, the subject experienced tiredness and fatigue. On 04-APR-2021, the subject experienced sweating. On 04-APR-2021, the subject experienced sore throat. On 04-APR-2021, the subject experienced fever. On 04-APR-2021, the subject experienced cough (throat was rasky). On 04-APR-2021, the subject experienced change in voice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiredness and fatigue, sweating, sore throat, fever, cough (throat was rasky) and change in voice was not reported. This report was non-serious.
Female smoker w/ obesity, insomnia, HL, anxiety, bronchitis, diverticulitis, GERD, OA, COPD, MIx2 and HTN was given her 1st dose of Moderna Covid19 vaccine (lot # 046B21A) at 1310 4/13/21.  Patient had hot flash and was fanning herself within 5 minutes of 15 minute observation time.  After 15-20 more minutes, patient developed mild chest pain, nausea, diaphoresis and shortness of breath.  Patient reported feeling light headed.   Patient was moved to the recliner and her legs elevated.  Patient found to be hypertensive.  Initial BP 162/106.  At 1346, BP 180/84.  At 1352, NIBP 186/93, pulse 80's and regular.  Per NP, bilateral diminished breath sound with wheezes.  SaO2 on room air 97-99%, with the labored breathing  and chest pain.  Placed on oxygen 2L pm via NC.  EMS notified for transport to ED.  Chest pain increased 8/10.  Patient refused nitroglycerin but accepted ondansetron 4mg po for nausea.  Also given 324mg aspirin.  In ED, EKG and Chest XR obtained.  Both were normal.  BP still elevated at 1442 171/83.  Patient stable.
Woke up with onset of left sided facial weakness, paralysis, and numbness around 0600. Was evaluated in the ER and diagnosed with Bell?s Palsy.
Pt c/o fever, muscle ache and red blotches rash at injection site. Pt is doing fine. Case closed.
non immune to hepatitis A; This non-serious case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a male patient who received Hepatitis A vaccine for prophylaxis.   Previously administered products included Hepatitis B vaccine.   On an unknown date, the patient received Hepatitis A vaccine. On an unknown date, an unknown time after receiving Hepatitis A vaccine, the patient experienced therapy non-responder (Verbatim: non immune to hepatitis A).  The outcome of the therapy non-responder was unknown.   Additional Information: GSK Receipt Date: 11-OCT-2023 The reporter stated that a patient received the individual Hepatitis A & Hepatitis B vaccines a few years ago. He had since become non immune to Hepatitis A but still was immune to Hepatitis B. The vaccine administration facility is the same as primary reporter.  The Healthcare professional did not know the brand Hepatitis A the patient received.
Information has been received from an 81 year old female patient with a history of thyroid problem who on 18-MAY-2010 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included SYNTHROID. On 18-MAY-2010 (also reported as a day or so after receiving the vaccine), the patient began experiencing weakness which had progressively become worse over time. As of this morning, she woke up with the feeling of "pins and needles all over my body" and she stated that she could feel rashes "popping up" everywhere, with the most troublesome rashes being in both her left and right eye. The patient went to a doctor on Friday due to the extreme weakness and he took bloodwork and a urinalysis to look into it. The patient said that she would be going again today as soon as they open due to the rashes that had begun. At the time of the report, the patient had not recovered. Additional information has been requested.
Hit by a truck.  Base of skull hurt so badly, I didn't want to move.  Flu-like symptoms:  chills and achy.  I do not know if I had a fever.  I could barely move my left arm.
Swelling at site of injection. Started as small circle and now large as a baseball and painful to patient. This was due to ZOSTAVAX vaccine. Patient OK after a few days.
Food poisoning; Stomach virus; This spontaneous case was reported by a consumer and describes the occurrence of FOOD POISONING (Food poisoning) and GASTROENTERITIS VIRAL (Stomach virus) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No medical history was provided.     On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced FOOD POISONING (Food poisoning) and GASTROENTERITIS VIRAL (Stomach virus). On 03-Mar-2021, FOOD POISONING (Food poisoning) and GASTROENTERITIS VIRAL (Stomach virus) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  On 26-Feb-2021 the patient bought and ate a rotisserie chicken.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Non significant follow-up appended
Dizziness (very close to fainting), threw up, very fast heart beat, difficult to breathe, very weak, very pale, fever, very chilled. Symptoms lasted from 4:30 PM (day of shot) until approximately noon next day. No treatment.
had a response to her nervous system; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "had a response to her nervous system".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Muscle spasms in lower & mid back, lower back pain, pain front of hips, quads painful & weak, extremely painful headache, stiff neck, fever of 101.2, chills, night sweats, kept waking up throughout night, elevated heart rate (more than 10 bpm above normal), sinus pressure, no appetite, nausea, decreased heart rate variability
Received the shot in my left arm on March 27, 2021.  By 4:30 p.m., on March 28, 2021, I had a fever of 102.4, aches, headache.  March 29, 2021, woke up and took a shower and noticed my left lymph node was swollen (size of half a grapefruit.  No pain or heat coming from the area.  Was still swollen on March 30, 2021 and placed a call in for the doctor to contact me.  The doctor contacted me on March 31, 2021 and I was placed on an antibiotic.  The swelling went down in my lymph node in a few days from starting the antibiotic.  I am still not feeling well, low energy and breathing is not right.  Deep breaths are difficult and still have body aches.
The patient passed out  and hit her head on the floor as seen by another customer as she was walking in store toward the pharmacy  after getting her covid shot.  According to the customer who saw it /helped her initially she was passed out for about 3-4 minutes and sounded like she was snoring , then came to on her own .  She was found sitting up on the floor and talked /responded to our questions , knew her name . and stated she felt dizzy and nauseated .  She took a small amount of orange juice.   She had a bump on the front of her forehead.   Paramedics were called and she was taken to a local hospital to be checked out .
"Covid arm" - large red welt appeared at injection site one week later. Itchiness and pain reported.
Localized allergic Rxn about about 20 cm eryth/imdurated, warm patch on upper right arm.
The depo and covid shot counter reacted and I was in and out of hospitals and doctors offices and I was Admitted into hospital for three days from a infection from two shots
To ED with c/o upper abdominal pain, sharp 8/10, intermittent not related to meals. History of DM, HTN, ulcerative colitis. Elevated lipase-298 and CT abd shows pancreatitis. Admitted.
Developed hives on face, arms and later in the day, possibly starting at the site of injection. Went to ER after giving Benadryl. ER gave more Benadryl and a steroid X 1. Hives continued at least 2 days.
Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SINUSITIS (Sinus infection). At the time of the report, SINUSITIS (Sinus infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Patient visited doctor and patient was put on antibiotic.   Reporter did not allow further contact
Vaccines were kept frozen until they are ready for administration; administered moderna vaccines beyond the use date and/or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered moderna vaccines beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered moderna vaccines beyond the use date and/or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered moderna vaccines beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter.  Vaccines were kept frozen until they were ready for administration which meant they would be in the fridge about one to three days. They tend to store one to three bottles in the fridge to thaw out and was ready for the patients when needed. At worst case scenario they would have been in the fridge for about week if no one came in to be vaccinated.  No treatment medication was provided by reporter.
Weakness, Headache; wheezing; with loss of appetite over several days through 12/04/2010.  Then began some improvement.  By Tuesday 12/07/2010 she states she felt better in the am but worse as the day progressed.  She called us to report in on Wednesday 12/08/2010 and stated was again feeling better in the am.  Recommended she also notify her personal doctor of her symptoms as well.
approx 12hrs p/vax pt awoke crying "body twitching all over x 3hrs;mom reported this rxn 27OCT95 when due for next set of immunizations;to give DT in place of DTP
Red itchy and hot to the touch.  it was primarily 6-7 inches around the arm where the vaccine was received it was 3-4 inches wide and 6-7 inches long.
06JUN95 given vax parents relate 10JUn pt exp inflamed eyes; then 13JUN pt started feeling warm early 15JUn pt awoke w/elevated temp & vomiting; t103.3 reported; parents took pt to ER; MD felt related to viral infect
p/vax pt devel subjective fever (no temp was actually recorded(, h/a, nausea & congestion;pt devel 25 vesicular lesions;following day a red, raised rash appeared @ inj site;pt devel myalgia & a cough;
Positive COVID test with respiratory symptoms; Positive COVID test with respiratory symptoms; respiratory symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL3247) at the age of 38 years, in left arm, on 22Feb2021 as dose 2, single (Lot number: EL3247) at the age of 38 years and on 17Nov2021 as dose 3 (booster), single (Lot number: FF8841) the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RESPIRATORY SYMPTOM (non-serious) with onset 29May2022, outcome "not recovered", described as "respiratory symptoms"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jun2022, outcome "not recovered" and all described as "Positive COVID test with respiratory symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Apr2022) Negative, notes: Nasal Swab; (29May2022) Negative, notes: Nasal Swab; (01Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, respiratory symptom.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date the patient developed a fever, and itchiness, pain, redness and swelling at the unspecified injection site. The outcome of event was reported as recovered/resolved. The patient has sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Starting within 24 hours of injection: lower abdominal pain and cramps, which are still ongoing more than 72 hours post injection. Starting Thursday, 04/29/2021 at around 11 pm (about 77 hours post injection), noticed tiny blood spots under skin, all over both legs (most similar to immune thrombocytopenic purpura) and swelling of lower extremities.
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 72 years old female patient who experienced raised wheal at the site of injection, bruising at the site of injection, severe pain and difficulty raising her left arm, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 08-Oct-2018, the patient received a 0.5 ml once dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ0308A, expiry date- 05-May-2019 in the left arm. On 08-OCT-2018, in the evening the patient developed a non-serious raised wheal at the site of injection following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On 08-OCT-2018, in the evening patient developed a non-serious bruising at the site of injection following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date patient developed a non-serious severe pain following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date patient developed a non-serious difficulty raising her left arm following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. (Other relevant tests included No lab test.) Final diagnosis was difficulty raising her left arm, severe pain, bruising at the site of injection and raised wheal at the site of injection. No lab data reported. Patient received CELEBREX as corrective treatment. The patient outcome is reported as Unknown for raised wheal at the site of injection, as Unknown for bruising at the site of injection, as Unknown for severe pain and as Unknown for difficulty raising her left arm.
Approx. 10 min. after receiving vaccines, the patient states she felt dizzy and she fainted. She responded within less then a minute. We elevated her feet, placed a cool cloth on her forehead. Her pulse was strong at 70 BPM. She was given water and a candy to suck on. After a few minutes she was up to a chair feeling "fine" although she was quite pale, her color returned to her lips, her pulse was 76 BPM. After waiting approx. 10 min. in the waiting room, she left our clinic with her mom.
He is having a fever of a 100.9; He is having really bad chills; He is just shaking up; This is a spontaneous report from contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: expiry date: unknown) via an unspecified route of administration, in Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine (COVID-19 Vaccine from Pfizer) yesterday. The patient's wife reported that the patient had fever of a 100.9, really bad chills, and was shaking up. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Extreme muscle pain in right arm, upper & lower arm, pain is in the muscle not the joint(s).  I have had this pain for several months. I have pain while driving, using the mouse & keyboard at the pc.
I took the Pfizer covid vaccine series I recently developed a serious allergies to amoxicillin; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 61-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMOXICILLIN. The following information was reported: DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "I took the Pfizer covid vaccine series I recently developed a serious allergies to amoxicillin".  Additional information: Clinical course: Patient took the Pfizer covid vaccine series and recently developed a serious allergies to amoxicillin which patient never had prior to vaccine.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
L upper arm tenderness and erythema at site of vacc. 6/29/07 seen at local ER for fever and myalgias.
Resident walked in requesting Moderna bivalent booster. Post vaccination, resident noted to have received a bivalent booster (Pfizer) on 10/24/22, as per the CDC POV card provided by the client. Education provided to the POC, Counselor, and client regarding increased risk of adverse effects of the vaccine, verbalized understanding. Client stayed for observation post vaccine administration, and left without any complications.
Chills; fever; body ache; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Jan2022 16:00 (Lot number: 33036BD) at the age of 15 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0217, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM, Route of Administration: Intramuscular), administration date: 05Jun2021, when the patient was 15 years old, for Covid-19 Immunization, reaction(s): "Body aches", "Fever", "Dizziness", "pain(arm)", "soreness at site of injection"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0182, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM, Route of Administration: Intramuscular), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Jan2022 16:00, outcome "unknown", described as "booster dose"; CHILLS (non-serious) with onset 14Jan2022 02:00, outcome "recovering", described as "Chills"; PYREXIA (non-serious) with onset 14Jan2022 02:00, outcome "recovering", described as "fever"; PAIN (non-serious) with onset 14Jan2022 02:00, outcome "recovering", described as "body ache". Therapeutic measures were taken as a result of chills, pyrexia, pain.  Follow-Up (21Jan2022): Follow-up attempts are completed. No further information is expected.
Chills; slight fever; woozy; aches everywhere; weary; lump under left arm; This is a spontaneous report from a contactable consumer(patient) reported for herself. A 62-year-old non-pregnant female patient received third dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FF2590) via an unspecified route of administration, administered in left arm on 13Oct2021 at 16:00 pm (At the age of 62-year-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history was not reported. Concomitant medications in 4 weeks included influenza vaccine (FLU) (Batch/Lot Number was unknown) via an unspecified route of administration, administered in right arm on 06Oct2021 taken for an unspecified indication. The patient previously received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in left arm on 26Mar2021 04:00pm (At the age of 61-year-old) as dose 2, and first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6205), via an unspecified route of administration in left arm on 03Mar2021 at 05:15 pm (At the age of 61-year-old ) as dose 1 single for COVID-19 immunization.The patient had not diagnosed with COVID-19 Prior to vaccination and since the vaccination. On 14Oct2021 at 06:00 am, the patient experienced chills, slight fever, woozy, aches everywhere, weary, lump under left arm. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Myalgia, Fever, SkinRash, NauseaVomiting, chills, rhinorrhea, sore throat
Breakthrough case admission after 2 vaccines Moderna 8/15/21 Lot# 002F12A;  Moderna 9/12/21 Lot# 037F21A