chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient was tested positive with Covid-19 after his first dose; the patient was tested positive with Covid-19 after his first dose; This is a spontaneous report from Pfizer-sponsored program. A contactable other HCP reported that a male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient the patient was tested positive with Covid-19 on unknown date after his first dose. Outcome of event was unknown.   Information on the lot/batch number has been requested; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 cannot be completely excluded. However, it is unlikely that the patient would have fully developed immunity as full immunity is expected 7 days after 2nd dose.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 16-OCT-2009, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 20-JUL-2014, the patient was treated at a health center for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Upon administration of the Pfizer Vaccine patient c/o not feeling well which included weakness and dizziness. Patient was offered evaluation by EMT, and declined further treatment. Patient was offered and accepted oral fluids. About 5-10 mins after symptom onset patient reported "I feel much better".
Expired vaccine given to patient in error.   Patient notified to that she needs another Influenza Vaccine ASAP.
2-3 days after vaccination observed shingles develop in exact place on back, where they had developed 2-3 years ago. Doctor visit in April confirmed that it was shingles and given medication to take. Lasted 3 weeks from start.
Fatigue, body aches, temperature (high 103), pneumonia symptoms including coughing and expelling mucus.
Patient was on observation area after receiving vaccine. Patient fainted falling face first onto the floor from seated position. Patient denied history of anaphylactic reaction to any inject-able medication. EMS was called and patient left with EMS.
Red blotchy rash on upper arm  Entire upper body is itchy: Arms, head, face, eyes, nose, chest, back
High fever, lethargy, euphoria/light headed, dizzy, extreme vertigo, massive migraine, extreme fatigue. Missed the entire week of work due to symptoms from shot.
pt recv vax; devel a gen rash on chest & "total body" described as hives; exp no resp distress; required ER;
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age with no pertinent medical history and no drug reactions/allergies. On 15-FEB-2013 the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX subcutaneously. There was no concomitant medication. In February 2013, a few days after she received ZOSTAVAX, the patient developed an injection site rash that was warm to touch. The pharmacist declined VZVIP packet. The patient contacted pharmacist for medical attention. No treatment was given for the events. No lab diagnostics studies were performed. The outcome of injection site rash that was warm to touch was reported as not recovered. Additional information is not expected.
12 hours after vaccination got chills and a fever of 102. Fever lasted for 18 hours at which point it died down quickly. 500mg Tylenol every 6 hours reduced fever to 101F at most.
had my first shingrix dose last fall / I am now due for the second dose / Can I get the second dose of shingrix within 10 months of the first; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on last fall in 2020). Concomitant products included COVID-19 VACCINE.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not applicable to this report. In March 2021 (4 weeks ago), the patient received 1st dose of Covid vaccine. The patient asked was there a difference between the 1st and 2nd dose of Shingrix and could he/she get the 2nd dose of Shingrix within 10 months of 1st dose without it affecting the efficacy. The patient was now due for the 2nd dose of Shingrix and till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The patient stated that his/her pharmacy said that he/she could not get it until 2 weeks after his/her 2nd COVID vaccine that was not until July and patient asked was this true. The follow-up would not possible as no contact details were available.
Initial report received from a healthcare provider on 10/14/05. A 31 year old female patient with no pre-existing medical history received an injection of Fluzone SV 2005-2006 USP, lot number unknown, on 10/14/05. Route and site of administration was not reported, and number of previous doses was unknown. She immediately, felt faint, hot and sweaty, and her throat felt swollen. She was seen by a physician, but treatment was not reported. The patient denied illness at the time of vaccination and was on no medications. At the time of this report, the patient had recovered. (OMIC)
Pt complaint of nausea w/o vomiting 10 min post vaccination. Pt given Pedialyte for rehydration. BP - 116/77 V/S obtained WNL
Tested positive for COVID-19; Tested positive for COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4236809-00 (Abbvie).  A 74 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date Aug2021 (Batch/Lot number: unknown) at the age of 73 years as dose 3 (booster), single, intramuscular, administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive: positive. The action taken for adalimumab was unknown.  Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and VACCINATION FAILURE,  COVID-19 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
deep red streak about 2-3 inches in diameter inside of arm that runs from top of arm  to  below elbow. Streak is not sore to touch or warm to touch. developed 3 days after receiving pneumovax 23
In left area near the injection site was sore. By the next day my arm had trouble with movement and could not lift my arm above my head. On the third day little to no pain near the injection site and full movement in my arm.
Joint pains (feet, hips, shoulders). Medications (NSAIDS, pain medicines); Physical therapy, musculoskeletal stiffness. Fatigue, thoracic region back pain; MRI; NSAID. The follow up received on 10/1/03 states hospitalization was for infection and inflammation of finger on R hand s/o laceration. Range of motion limited in both shoulders (hypokinesia). Osteoarthritis both hips.  60 day follow up on 11/20/2003: "Vaccine recipient did not recover from the adverse event.  Joint aches/osteoarthritis hips rotator cuff injuries, including complete tear in right supraspimatous muscle with accompanying significant inflammation.  Tests for HLA 4 were positive."
herself tested positive for the Covid virus; herself tested positive for the Covid virus; eye sight is not right and my sugar level is super high; eye sight is not right and my sugar level is super high; four blood noses; This is a spontaneous report from a contactable consumer (patient husband). A 49-years-old female patient (wife) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 06Mar2021 (at the age of 49-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer COVID-19 vaccine on 06Mar2021 and she was scheduled to receive the second dose on 27Mar2021. On 23Mar2021, the patient started experiencing a wet cough. She received a positive PCR test on 25Mar2021 and started having some symptoms. The patient entered the hospital on 26Mar2021 and was admitted for nine days due to low oxygen, in which they gave her remdesivir, plasma, and steroids. She was discharged from the hospital on 03Apr2021. She had ended isolation. She is home now. She still cant smell or taste anything. She retested two weeks later as a follow up and was still positive for Covid. Her "eye sight is not right and my sugar level is super high," in which she believes is from the steroids she was given. She had four blood noses last week, in which she has never had a blood nose in her life. The first week she was very tired, using the bathroom constantly, and had no taste or smell. Her infectious disease doctor told her based upon her treatment regiment, she would need to wait until after 04Jul2021 to get vaccinated and that she would need to get the series again, "as if it was new." She still has not received the second dose of the Pfizer Covid-19 vaccine. She was told she couldn't receive the second shot until 03Jul2021. They advised her to wait 3 months before receiving the vaccine. Also read it is recommended to wait 3 months before getting the vaccine if you received a plasma treatment. These interim considerations also state that if you currently have a COVID-19 (either before the first dose of vaccine or in between your first and second dose of vaccine), you should wait until you have recovered from the infection, show no symptoms and completed any required isolation. Lastly, the interim considerations state that a prior COVID-19 infection may lower the risk of getting infected again (for a certain amount of time) so if vaccine supply is low, some people with a recent COVID-19 infection may choose to wait to receive their first dose of COVID-19 vaccine. You should talk to your doctor or other health care professional about this. Pfizer is independent of these recommendations. The clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.
NUMBNESS AND TINGLING ON LEFT LEG. IT STARTED ON LEFT HIP AND WENT DOWN TO LEFT FOOT.
By 9/27/10 patient was having pain in the right hip area where he received the vaccine (flu). By 9/28/2010, he couldn't walk the pain was too extreme. By 10/1/2010, 3 days later, his right knee was inflamed & infected (please) see story (attached).
pt started crying @ time of vax & did not stop till late that noc;mom called next AM to say crying had finally stopped & pt acted nl
Itching; Headache; Body Ache; Chills; This is a spontaneous report from a contactable consumer (patient) for herself. A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Lot Number: ER2613), dose 1 via an unspecified route of administration on 24Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced itching with outcome of not recovered, headache with outcome of unknown, body ache with outcome of recovered in 2021, chills with outcome of recovered in 2021. Clinical course: She had taken a Pfizer COVID Vaccine that her first one on March. She though her first shot was on March 23rd or 24th. She had itching and headache and body ache. Chills and body ache lasted 2 days  and she was still dealing with itch and she contact the location where she got the shot and she got home she took diphenhydramine hydrochloride (BENADRYL) (Lot Number: 1703350) and she still having itchiness and she called her primary care and she said well take cetirizine hydrochloride (ZYRTEC) at the reporting date she got and take the second  shot. She still had issue on 24th and this was like three weeks out and she was still itching. She still had itch before she took the second shot everyone tell her go ahead and do it, it's the same dose so she knew it's expected, she took the second shot (lot number: EW0164) yesterday 14Apr2021 same reaction but she was still having itchiness it was going to three weeks. "  Reporter reported seriousness is no. When probed for did Benadryl help her, she stated: no, she meant all its do was knock her out to sleep but when she woke up she was still having itchiness scratching around the neck. The patient received second dose of shot COVID Vaccine (lot number: EW0164).   No follow-up attempts are needed. No further information is expected.
Discharge summary "Hospital Course: Patient is a 64 year old male with a past medical history of quadriplegia, being cared for at home by family, blindness, HTN, DM, epilepsy who presented to the ED with 3-4 day hx of cough, SOB, fever and diarrhea.    The following issues were addressed during his hospital stay:   Sepsis Acute respiratory insufficiency Likely due to COVID 19 infection SIRS: tachycardia 129, tachypnea 36, temp 103.8 on admission, hypoxic down to 88% -vitals are within normal limits, greatly improved from admission -continue ceftriaxone -discontinued decadron and remdesivir due to improvement and nonsevere disease -scheduled mucomyst, mucinex, mucomyst nebs -PRN chest physiotherapy, albuterol nebs -blood cultures x2 - 1/2 staph epidermidis, likely contaminant   Abnormal urinalysis -on ceftriaxone -urine culture, E.coli 10,000 CFU/mL   T2DM - SSI, accuchecks HTN - continue home atorvastatin and lisinopril Epilepsy - continue home levetiracetam Quadriplegia   Patient was discharged in stable condition. Physical exam on discharge"
PATIENT REPORT FEELING LIGHT HEADED, DENIED SOB OR DIFFICULTY BREATHING. NO  CONTINEOUS SYMPTOM AND PATIENT WAS ADVISED TO LIE FLAT WITH FEET ELEVATED AND ENCOURAGED TO HYDRATE. PATIENT REPORTS FEELING BETTER WITHIN A FEW MINUTES . PATIENT WAS EDUCATED TO NOTIFY MEDICAL PROVIDER AND  OBSERVERS IN SYMPTOM WORSEN OR UNRESOLVED
No additional adverse effect; the patient was inadvertently administered a dose of VARIVAX on 12/3/2019 that had been improperly stored; This spontaneous report was received from a physician concerning  a patient of unknown age and gender.  Concomitant therapy included sterile diluent. The patient's pertinent medical history, concurrent conditions and drug allergies or reactions were not reported.     On 03-DEC-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number S020464 and expiration date 02-JUL-2021 ) for prophylaxis (dosage schedule, route, and anatomical location were not reported). The administered dose of the vaccine experienced a temperature excursion of 9.3°C degrees Fahrenheit for 1 hour as recorded by a data logger. No previous temperature excursion was reported. There was no adverse effect reported.
This is a spontaneous report from a contactable Other-HCP. A currently 19-year-old female patient of an unspecified ethnicity received the 1st dose of TRUMENBA via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient passed out, experienced fever, lethargy, weakness. The events outcome was unknown. The patient was not deceased. The reporter was willing to be contacted again on the reported adverse events. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Patient passed out directly after receiving her second vaccine of the day, the flu vaccine. She regained consciousness within 1 minute and we applied cold pack to her neck and gave her cold water to drink. patient remained in the store under observation for 30 mins and felt fine when she left. No residual dizziness or light headedness.
Severe gas bloating; stomach cramps; Nausea; Feeling very weak; This is a spontaneous report from a non-contactable consumer reported for herself. An 87-year-old female patient received first dose of bnt162b2 (BNT162B2, COVID 19), via an unspecified route of administration on 05Feb2021 10:30AM on right arm at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced severe gas bloating, stomach cramps, nausea, feeling very weak on 07Feb2021 with outcome of not recovered. She is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment received for the adverse event was unknown. The case was assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I had body aches, headaches, and I felt like my head was spinning. I felt foggy and coughing up phlegm, I felt this way for a week. Afterwards, I tested positive for COVID-19. I continued to have a tingling sensation in my spine for two weeks, I have not returned to work. I was prescribed Paxlovid but I decided not to take it.
Hives covering entire body; heavy and labored breathing. Treated in ER with Benadryl and continued with Benadryl for 2 days. The 60 day follow up received on 12/3/03 stated autism caused by mercury poisoning-undergoing testing for mercury poisoning at this time. "Leaky gut" syndrome causing pt to be on a special diet and supplements.
She said she has always been regular as a clock and she is now 4 days late.  She has not been sick, stressed and has not lost or gained any weight.
mild cold-like symptoms, runny nose, scatchy throat, occasional cough, no fever, good energy level
Vaccine given outside of the recommended age range, CDC contacted regarding this. They stated there are no concerns.
This spontaneous report as received from a health care worker refers to unspecified patients of unknown age and gender who on an unknown dates, since February 2015, had been vaccinated with improperly stored VARIVAX (Merck) (dose, route, lot # and expiration date were not provided). No adverse effects were noted. Additional information is not expected because the reporter refused additional contact.
several severe morning charley horses; some lower leg cramping; had heart palpitations followed by a low fever; chills; body aches; upset digestive tract; had heart palpitations followed by a low fever; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 02Apr2021 at 14:20 as dose 2, single (Lot number: ER8737) at the age of 69 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1st, Anatomical Site of injection: Right or Left Arm, Route of administration: Intramuscular, Batch/Lot number: EN6208), administration date: 12Mar2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "several severe morning charley horses", "some lower leg cramping". The following information was reported: PAIN (non-serious) with onset Jul2021, outcome "recovered" (07Jul2021), described as "body aches"; CHILLS (non-serious) with onset Jul2021, outcome "recovered" (07Jul2021); PALPITATIONS (non-serious) with onset Jul2021, outcome "unknown", PYREXIA (non-serious) with onset Jul2021, outcome "recovered" (07Jul2021) and all described as "had heart palpitations followed by a low fever"; ABDOMINAL DISCOMFORT (non-serious) with onset Jul2021, outcome "unknown", described as "upset digestive tract"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "several severe morning charley horses"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "some lower leg cramping". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After her Pfizer vaccines in Mar2021 and Apr2021, patient occasionally experienced several severe morning charley horses, and some lower leg cramping. In Jul2021, patient had heart palpitations followed by a low fever, chills, body aches, and upset digestive tract. She had an Echocardiogram on 11Aug2021 that was normal. The palpitations subsided. On 19Nov2021, a cardiologist said my heart was normal, with only minor heart palpitations that didn't require medication.