chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received vaccine at 306p and at 316p began to have seizure like activity for 30 seconds. VSS EMS here to assess pt, pt to ER
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 33 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on 13-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JUL-2021, the patient did a IgM + IgG rapid antibody test and it came out negative. On 05-JUL-2021, the patient had a blood test for antibodies-SARS-CoV-2 (Anti-S) by the electrochemiluminescence method and it came back negative. Both test results indicated suspected immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210724419-covid-19 vaccine ad26.cov2.s-suspected immunological vaccine 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
11/15/2000 with swelling left side neck that still persists, also hives on arm that shot was given in with ring around injection site. Took Benadryl, Ibuprofen.
Tinnitus in left ear; Hyperacusis in left ear; Some light sinus symptoms like scratch tonsils and drainage.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6204) via an unspecified route of administration in the left arm on 18Mar2021 at 12:30 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL9266) via an unspecified route of administration in the left arm on 25Feb2021 at 17:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. On an unknown date in Mar2021, the patient experienced just some light sinus symptoms like scratch tonsils and drainage. On 23Mar2021 at 07:30, 4 days after the vaccination the patient experienced tinnitus and hyperacusis in left ear. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the reported events which included prednisone taper. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events light sinus symptoms like scratch tonsils and drainage, tinnitus in left ear and hyperacusis in left ear were recovering at the time of this report   No follow-up attempts are needed. No further information is expected.
Patient reports rash on left lower forearm developed 1-2 days after first vaccine listed above went away in a few day, patient reports the same red raised bump like rash developed on left forearm and lower back after 2nd vaccine listed above (1-2 days later ) and rash lasting over 2.5 weeks.
pt recvd vax; c/o feelingss of warmth, perspiration, shaking, tightness of diaphragm & throat; meds given by MD; Epi given at c/o sxs, ER visit
1605 vaccines x2 given per MA to left delt   1606: called to bedside per MA. Pt pale & extremely diaphoretic. BP cuff attached, pt responded to painful stim- sternal rub.   1607: pt A&Ox4 and responding to verbal stim. Asking for BP cuff to be moved to different arm. Pt states hx of syncopal episodes s/p imms as a child.    1610: BP 88/50, HR 61 99% pt A&O x4- remains supine. gatoraid given to patient   1612 99/63 HR 62. Pt remains supine and talking with nursing   1614: pt in sitting position, denies dizziness.  109/74 HR 90   1616: pt transitioned to chair- ambulates without diff per self with nursing as stand by assist. Offered chex mix.    1620: pt sitting, tolerating chex mix without issue. Instructed pt okay to leave at 1630. Pt verbalized understanding    1626: pt texting on phone, talking with nursing, denies dizziness. Denies HA.  102/66  HR 71  99%. States walking back to apartment in east quad. Plans to talk to friend on the way home.    1633: MD evaluated pt at bedside. Pt states friend is picking her up instead. Okay for pt to leave.
It gave severe cramps and muscle spasms; sleepiness; pain; This spontaneous case was reported by a pharmacist and describes the occurrence of MUSCLE SPASMS (It gave severe cramps and muscle spasms), SOMNOLENCE (sleepiness) and PAIN (pain) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (It gave severe cramps and muscle spasms), SOMNOLENCE (sleepiness) and PAIN (pain). At the time of the report, MUSCLE SPASMS (It gave severe cramps and muscle spasms), SOMNOLENCE (sleepiness) and PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.
Blood clot in lungs; Pneumonia; A spontaneous report was received from a consumer concerning her husband, male patient who developed blood clot in lungs/pulmonary embolism, pneumonia/pneumonia.   The patient's medical history included Parkinson's. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273  for prophylaxis of COVID-19 infection.   On 4 Mar 2021 the patient was admitted due to blood clot in lungs and pneumonia. The medically significant event caused hospitalization. Treatment of the event included blood thinners.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events blood clot in lungs and pneumonia was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
On 1/24/2021 at 6 a.m. the outer side of left wrist is sore and hand is swollen.   I have not received any treatment yet.
Angioedema severe, BENADRYL/steroids/Epi at urgent care, no prior hx of reaction to vaccine.
This spontaneous report was received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with a dose of improperly stored M-M-R II, lot # L012482, expiry date 10-APR-2017 via subcutaneous and intramuscular routes (dose, strength, vaccination site unspecified). No adverse effect were reported. Product quality complain (PQC) was not involved. No further information was provided. This is one of three reports received from the same reporter. Additional information has been requested.
pt recv vax; devel pain, warmth, and erythema at inject site and low grade fever;
A week to ten days, I developed bruising and itching on my lower legs. Went to urgent care and ended up getting an ultrasound, did not show clotting and now I have developed edema in my legs. It's mostly just itchy and generally painful on my legs. I have reached out to my primary care and have an upcoming appointment. I was given Betamethasone that I have not used.
In study female subject born on 02Dec1983 was vaccinated with 0.5ml, IM of investigational vaccine (study is still blinded). Per protocol, this 22 yr old female subject was seen at the investigative site for influenza-like illness including fever (102.0F) sore throat, cough, myalgia, and chills. Onset of symptoms was 07Apr06, 157 days after vaccination (vaccination date 01Nov05). Viral culture was positive for influenza B. The investigator considered the event as not related to vaccine. Follow up report pending with resolution date and outcome information. Seriousness criterion: medically significant (OMIC). Possible for vaccine failure. The reported events except for vaccine failure are not expected. On a case level, the case is considered expected due to vaccine failure. Follow up 26Apr06 Complete recovery. Concomitant medications: Trinessa started in 2000 and Zoloft started in 2002. The reported events except for vaccine failure are not expected. On a case level, the case is considered expected due to vaccine failure. Follow up 27Jun06 today we received the information that the study has been unblinded on 26Jun06. The subject received Fluvirin (lot 61122). The reported events except for vaccine failure are not expected. On a case level, the case is considered expected due to vaccine failure.
Metallic taste; This is a spontaneous report received from a Pfizer sponsored Colleagues Immediate Family and Household Vaccination Program. A contactable consumer reported that a patient of unspecified age and gender received bnt162b2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient suffered from Metallic taste on an unspecified date. Outcome was unknown.  No follow-up attempts are needed. No further information is expected.
swollen lymph nodes the size of a lemon; Fever; Chills; Ackyness; Soreness; Nausea; Dizziness; Sweating; Felt clammy; A spontaneous report was received from a consumer concerning a 55-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple event(s) of swollen lymph nodes the size of a lemon on left arm, fever, nausea, dizziness, chills, sweating, soreness, ackyness and felt clammy.  The patient's medical history included hypertension. The concomitant medications reported included chlorthalidone.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 28 Dec 2020, the patient experienced multiple events of swollen lymph nodes the size of a lemon on left arm, fever, nausea, dizziness, chills, sweating, soreness, ackyness and felt clammy. Treatment for the event(s) included Acetaminophen.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the event(s), swollen lymph nodes the size of a lemon on left arm, fever, nausea, dizziness, chills, sweating, soreness, ackyness and felt clammy were considered unknown.; Reporter's Comments: This case concerns a 55-year-old male with PMH of COVID-19 who had NS unexpected pain, lymphadenopathy, dizziness, hyperhidrosis, cold sweat, and NS expected fever, chills, nausea, myalgia.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment included acetaminophen. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Chills; Muscle ache; Headache; achy all over; Fever; lightheaded; Fast heart rate; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6204; Expiration Date: Jun2021), via an unspecified route of administration on 17Mar2021 (at the age of 66-year-old), as dose 2, single in left arm for COVID-19 immunization. The patient's medical history included heart racing; last fall was in 2020, after exertion, was checked out and everything came back normal. Concomitant medication included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunization. On 17Mar2021, after the second dose of vaccine, the patient experienced fast heart race, chills, muscle ache, headache, achy all over, fever and lightheaded. The patient underwent lab tests and procedures which included body temperature: 99-100 degrees on 17Mar2021, heart rate: fast, during night it was 90 on 17Mar2021 and heart rate: 112, morning it was still high, running around 112 on 18Mar2021. The clinical outcome of all the events was reported as not resolved.  No follow-up attempts are possible. No further information is expected.
I had my last menstrual period in Sept 2020. Then got one in May 2021 and June 2021. I joked it was due to the Pfizer vaccine doses given in March and April. Then no menses until the booster shot on 12/5/2021 (9 days later a period). Coincidence? Maybe, but my sister advised I make an official report.
Initial report received from a healthcare professional on 13 August 2013 and follow up information received on 15 August 2013. A 02-month-old female patient had received intramuscular first dose of PENTACEL vaccine (lot number: C4485AB) in the left thigh, a dose of PREVNAR vaccine from Pfizer (lot number G57196 and route of administration was not reported) in the right thigh and intramuscular dose of Hepatitis B vaccine from other manufacturer (lot number J005078) in the left deltoid on 13 August 2013. The patient was well and had no illness at time of vaccination. On 13 August 2013, the patient developed large area of redness that spread to the entire left thigh (front and back) to the knee and up to hip and leg immediately after vaccination and the patient was crying immediately after vaccination. Laboratory investigation and corrective treatments were not reported. As of 13 August 2013, the outcome of the events was unknown. List of documents held by the sender: None. Follow-up information received from a healthcare professional on 21 October 2013. The patient had not undergone any laboratory test. The adverse reaction was occurred on the whole thigh. The patient had received the PREVNAR vaccine intramuscularly. The patient was recovered from adverse events.
Right eye itchiness; red eye; This is a spontaneous report from a non-contactable consumer. A 50-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration in the left arm on 02Mar2021 at10:00 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Patient relevant medical history included sensitive skin/eczema when under stress. Patient was allergic to any medications, food, or other products was unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 04Mar2021 at 18:00, the patient experienced right eye itchiness and moderately red (lower half) for 3-4 days. The patient did not take any treatment for adverse events. The clinical outcomes of eye itchiness and moderately red (lower half) was recovered.    No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a physician assistant refers to a 13 years old female patient with celiac disease. The patient did not have drug reaction or allergies. The patient was vaccinated with 0.5 ml GARDASIL (lot number not provided) intramuscularly on 15-OCT-2012. No other co-suspects were reported. There were no concomitant medications. The patient developed an enlarged lymph node above her clavicle on approximately 18-OCT-2012, 3 days after she was given the GARDASIL injection. No treatment information was given for adverse event. Blood labs were performed and results were unknown. The parent of patient contacted physician assistant for seeking medical attention. The outcome of adverse event was unknown. Additional information is not expected.
Facial numbness, tongue swelling. Rash to arm and back. Treatment with Prednisone, Benadryl, Pepcid.
Patient and legal guardian (Father- ) came in for second dose of COVID vaccine. Upon arrival, was checked to see vaccination history. First dose was found under file with DOB of . First and second dose consent forms showed DOB of . Both patient and father were asked if the consent forms had the correct DOB and both attested yes. After explanation of the concern, father said it must be an input error in . The pediatrician's name () was called however they were closed. After another verbal attestation, the second dose was administered on 8/20/2021. The pediatrician was called on 8/24/2021 and confirmed DOB is  and therefore patient was 11 years of age at time of COVID vaccinations.
Experienced all common symptoms as well as other I have not heard of. Mental fogginess began at 8 PM (8 hrs after shot) and lasted until late the next evening Chills began at 8:30 PM and continued until early Friday AM. There were also a few instances of hot flashes in between the chills. About 10 hours after the shot the following began: headache (I rarely get headaches), nausea, muscle aches - mostly my quadriceps, low back pain, pain in the back of my neck, general lethargic feeling. These all lasted into Thursday evening, except the low back pain, which lasted into Friday AM. I felt a dull pain in all my back teeth that lasted about a day and was intermittent. See page 2 for more.
This medically confirmed health authority report (initial receipt 23-NOV -2016) concerns a 29 year old female patient. On an unspecified date, the patient received influenza seasonal vaccine (manufacturer and batch number not reported).  On an unspecified date, the patient reported that the injection hit the nerve. The outcome was not reported. Linked case: 2016059213 (same patient). Case correction 08-MAR-2016: LLT for AE 1"injection hit nerve" re-coded to "injection site nerve damage", case downgraded to non serious.
3" X 3" redness w/sl swelling, size of small baseball @ site;
2 days after receiving MMR vaccine pt. C/O swollen glands, fever, rash to face, chest and body.
night sweats that started the first night after the vaccine. I had mild swelling and moderate pain around the site initially. Then on 6/6, I developed moderate erythema and swelling surrounding site. I e also had intermittent nausea and malaise with excessive tiredness.
I had fever and chills, general muscle ache ,and big head congestion. It all came over me in a hurry. Following that the fever and chills went away after 24 hours. The congestion remained for a few days. What caused me to go to doctor was a earache that was unbearable. I was completely deaf in my ear. I was put on medication to help my breathing. It was couple of days after the antibiotics helped the ear pain and slight shortness of breath persisted. My pulmonologist wanted to keep me on prednisone for a longer amount time.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 24-DEC-2015 at 15:25, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 6.3 and 5.3 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a physician concerning a female patient who on an unspecified date, was vaccinated with the second 0.5 ml dose of GARDASIL (lot # not provided). The physician stated that the patient developed facial rash about a week after she received her second dose of GARDASIL. There was no adverse event after the first dose. The patient had decided she would not complete the series. At the time of the report, the patient recovered. The patient sought unspecified medical attention. She did not receive any treatment. The relatedness for facial rash was unknown for GARDASIL. Additional information has been requested.
AFTER VACCINATION CAN FEEL TASTE OF IT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the subject experienced after vaccination can feel taste of it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of after vaccination can feel taste of it was not reported. This report was non-serious.
Having side effects of Lethargy and jitteriness.one and two days after 2nd dose; Having side effects of Lethargy and jitteriness.one and two days after 2nd dose; This is a spontaneous report from a contactable other hcp (patient's husband). A female patient of unspecified age received second dose bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: Unknown, Expiry date: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose of COVID-19 vaccine. On an unspecified the patient experienced having side effects of lethargy and jitteriness, one and two days after 2nd dose. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
On 3/2/2021, clinic was notified by patient's family that patient had deceased on 2/28/2021 from a heart attack. Unsure of any relation to the Moderna vaccine but reporting for due diligence.
Patient called to report an adverse reaction he had almost 3 months ago. Patient stated he started to develop an elevated bump ( 1/4 inch raised) which was  3 inches in diameter a few days after receiving a flu shot. The area was not red, painful or itchy and he did not seek medical attention.  Only after a couple of months did he see a medical doctor. According to the patient, the doctor believed he had a hematoma and gave him instructions to treat. Even after following the doctor's directions he did not see any improvement and contacted the pharmacy to report and find more information.
Chronic fatigue and pain at injection site years after the first dose of Gardisal. Also chronic pain in joints all over the body especially at back around kidneys, knees, and feet.
Pt. felt very weak since she got the shot, very exhausted, a little pain in the site of administration. There was a 2" diameter redness. Pt was nauseated. Symptoms started in 11/29 at night time.