chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling of lower extremities with warm red skin, rash on lower extremities and abdomen. Site of injection was sore and raised. Next morning, fever of 99.6 degrees Fahrenheit, felt off balance/unwell. That night had thrush. Took a zyrtec and slept. Went to emergency room on 09/18/2021, symptoms better but not fully resolved. Gave nystatin for thrush  and told to take allergy medication. April says she took the nystatin and more Zyrtec.
sore throat; it "feels like sand" and "abrasive"; throat that felt raw, rough, and irritated; throat that felt raw, rough, and irritated; throat is burning; fatigue; pain in [her] joints; she wasn't feeling well; flu like symptoms; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 65-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration on 12Feb2021 as 2nd dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient historical vaccine included BNT162B2. The patient stated that she received the booster dose which she also referred to as the second dose of the Pfizer-BiONTech COVID-19 vaccine on Friday. On 13Feb2021, the patient experienced fatigue and pain in her joints. These symptoms were gone on the Sunday (14Feb2021), but a sore throat began. The sore throat was not typical, it is not a raw or a painful feeling, but it feels like sand and abrasive. On Saturday she was not feeling well, which according to the list said flu like symptoms could be a side effect, which she did have, then Sunday she felt great and better from the symptoms, but then had a throat that felt raw, rough, and irritated. The patient asked that sore throat is a part of the side effect of the COVID-19 vaccine and asked if it was safe to use a herbal throat spray that she bought at the store because her throat is burning. The outcome of the events fatigue, pain in her joints was recovered on 14Feb2021, she was not feeling well, flu like symptoms was recovering, sore throat, feels like sand and abrasive, throat that felt raw, rough, irritated and throat is burning, was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Experienced itching in her hands, scalp and behind her ears. C/o red raised bumps near injection site. She received BENADRYL & ZYRTEC for the symptoms.
Medication error--vaccine administered prior to 18th birthday. Pt had no adverse effects following vaccination.
Chills, nausea, disoriented, dizzy, flu like symptoms that lasted 5-6 days, arm stayed red for six days, arm still has knot at injection site.
Fever 103 degrees Fahrenheit, nausea, reddened erythematous area 2cm in diameter at injection site on right thigh. Ongoing.
pt devel 1 day after vax fever 104, 102-101 (oral). saw md. 5/17.
Intense and progressing arthritis and joint pain, feeling unwell . From date on onset to today.
Redness and inflammation at injection site. Pt. fainted approx. 7 hours after receiving vaccine.
Has complaints of a headache; This is a spontaneous report received from Pfizer sponsored program COVAX US Support. A non-contactable consumer (patient) reported for a male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 01Apr2021 (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 experienced has complaints of a headache on 01Apr2021 with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
About 12 days after getting Proquad VMMR vaccination and Pnem vaccination.  My son ran 105 F fever and I took him to the ER.  His temperature was measured again and it was 102.9 F after given tylenol.  He is now 31 months old and has just been diagnosed as moderately autistic.  He had reactions to every vaccination given to him before this, but I was told it was normal.  I was also told that this fever was not anything to worry about by Dr.
Resident had a rash all over his body about 12 hours after 2nd dose of Pfizer vaccine. He started becoming SOB even with oxygen applied. On-call provider was notified and resident was treated with benadryl 25mg by mouth once. Symptoms resolved about 2 hours post benadryl dose.
CLIENT DID NOT HAVE AN ADVERSE REACTION. CLIENT WAS ACCIDENTALLY GIVEN A FLU SHOT ON 10/11/2019 AT OUR FLU CLINIC AND THEN AGAIN ALONG WITH VACCINES ON 10/25/2019.   UNFORTUNATELY, FLU SHOT WAS NOT YET ENTERED INTO SYSTEM FROM FLU CLINIC ON 10/11/2019.
10 days after2nd shot total body rash began -still thickly over chest,back, stomach,legs?still there after 3. Days-began prednisone, Allegra, Benadryl - day 2 rash still. Growing. ordered epipen.  Will see dermatologist tomorrow
Cellulitis left arm from elbow to shoulder. Heat, itching, and erythema.
10 minutes after the vaccine was administered she reported a bad taste in her mouth. The taste kept getting worse until her mouth was numb.
I got it at 8:50am at l Hospital . So far my arm is just sore and I?m a little bit tired.
Injection give in deltoid muscle in middle outside aspect. Next day patient got red rash in area below injection site and in inside aspect of the arm.  Dr. gave prescriptions for Cephalexin 250mg twice a day plus 250mg/5cc liquid (50mg twice a day) both for 7 days.
CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via a company representative (nurse) concerned a 51 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient had no prior history of headaches or migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total administered on JUN-2021 for prophylactic vaccination (dose number in series 1). The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had really bad headache and was hospitalized on 29-NOV-2021 and the original reason for hospitalization was diagnosis with COVID-19 (confirmed covid-19 infection and confirmed clinical vaccination failure). Reporter stated that the patient still had headache on the day of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000204837.; Sender's Comments: V0:20211201634-COVID-19 VACCINE AD26.COV2.S-Confirmed covid-19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20211201634-COVID-19 VACCINE AD26.COV2.S-Confirmed 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
Patient received FLUZONE HD at 9AM on 9/9/16. On 9/16/16 at 10pm he came in to let us know that on that evening he had a seizure and a couple of hours later a vasovagal episode. He will be following-up with his physician.
March 18 - Moderna Vaccine Left shoulder March 25 - April 1: Twitching at injection site, numbness down left arm - feeling of hitting funny bone in entire left arm March 29 - Dr appointment regarding above mentioned symptoms. NP at doctors office. April 1:  New symptom - numbness in toes, twitching and numbness in left arm continues periodically April 2 - April 5: Numbness in fingers and toes - especially index fingers to pinky fingers and toes. Pins and needles feeling in hands and feet, up to my knees - parethesis. went to my Primary Care Physician. Addressed paresthesia of skin, muscle twitch at injection site. April 6: Symptoms progressed. Difficulty walking due to numbness which was extending up to my knees. Called my Primary Care clinic who told me to go to the ER. April 6-7: ER. MRI showed spots in brain and spinal cord that are non specific- but look compatible with demyelination (like in Multiple Sclerosis). Because I have never had symptoms of multiple sclerosis, the neurologist called it "radiologically isolated syndrome".  April 7- April 12: Numbness in hands and feet continues. Twitching at injection site gradually stopped. Extreme fatigue, can hardly get out of bed. April 12?: Follow up visit with PCP. She prescribes sleep aid - generic Valium.  April 12- Current: Numbness in hands and feet continue. Still fatigued, but able to work and tolerate mild activity. April 22, 2021: Have follow up Neurologist Appointment Scheduled. will have another MRI and Spinal Tap scheduled at that appointment.
Chronic stomach inflammation increased to a severe state. A small amount of alcohol triggered vomiting that wouldn't stop, so I was taken to a hospital to alleviate dehydration and nausea. All bloodwork and urine samples came back normal. It has taken 10 days for me to be able to digest solid foods, though I'm still not eating completely normally and my energy levels dip throughout the day. My health is improving every day.
Patient is an 18 month old female who presented on May 17, 2021 with right outer thigh induration consistent with likely cellulitis s/p immunization with Hib on May 3rd, 2021.
a bit of soreness; This case was reported by a consumer and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix 2 months before the time of reporting and experienced only a bit of soreness. For tolerances of 2nd dose refer case US2019AMR160237, reported by same reporter.
Narrative: Patient was hospitalized for PE. No associated thrombocytopenia (plts: 218 during admission)
The patient presents with Fall, just prior to arrival. Per EMS report, pt experienced a ground level fall at Cove assisted living. At ED, pt reports to have been feeling general weakness, dizziness, and nausea. Pt is currently COVID-19 positive and has been medicating with Doxycycline for an UTI.   Associated symptoms: nausea, dizziness, General weakness.
It was reported that a patient received the first dose of GARDASIL 9 over a year ago; No adverse event; This spontaneous report was received from a Medical Assistant, referring to an approximately 21 year old patient of unknown gender. Information regrading the patient's pertinent medical history, concurrent conditions, known allergies and concomitant therapies was not provided.      Approximately in 2020 (reported as "over a year"), the patient was vaccinated with the 1st dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route of administration, lot # and expiration date were not provided) for prophylaxis.  It was reported that, at reporting time, the patient had not received any other doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccination series. The patient want to be vaccinated to complete the series. No adverse events were reported.
No additional AE; TE with PROQUAD.  Improperly stored; This spontaneous report was received from a medical assistant referring to a 12-month-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 10-JUL-2023, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection (0.5 ml, lot#: W029555, expiration date: 14-MAR-2024; strength, and route of administration were not reported) operated by a healthcare professional for prophylaxis. The vaccine administered was improperly stored and experienced temperature excursion (TE) (product storage error). No adverse effects were reported (no adverse event).    This case was received from the same reporter with another 20 cases.
After receiving 2nd dose of COVID Pfizer vaccine on July 23, 2021, I developed a blood clot in my lower right leg. I did not know it was a blood clot until I went to the Emergency Room at Medical Center on August 7, 2021. I am currently being treated by Oncology. I am currently prescribed Eliquis 5 mg tablet twice daily.
4 days after the vaccine was given buy daughter had an elevated hart rate and has had its since the vaccine was given  4 days after the vaccine a visit tot he emergency room because of elevated hard rate. Still has it When her hear rate goes high she makes her self throw up to bring it down which is does for a bit but then goes right back up.  The did this all of Sept 2021 tp present. Telehealth call with doctor October 2021 live visit with doctor November 2021  cardiologist December 2021  heart rate monitor Dec 2021 Call with Doctor Jan 3 2022 was told she cannot play lacrosse be cause of elevated heart rate and need to see another cardiologist where she goes to school.   The patient is on a (Privacy) scholarship to (Privacy) because she cannot (privacy) she will lose her scholarship and will risk not being able to attend this school because of the cost without a scholarship
No adverse effects reported; HBP called to report a TE with PROQUAD.  Administered. TE case reference 02388618. Vaccine was stored in the refrigerator instead of the freezer from 4/17/2023 until 5/11/2023 (a total of 552 hours). Administered on 5/10/2023.; This spontaneous report was received from a medical assistant referring to a 2-year-old patient of unknown gender.  The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 10-MAY-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live albumin status recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, at a dose of 0.5 milliliter, lot # W039840 with expiration date on 12-JUN-2024, administered subcutaneously for prophylaxis (strength, vaccination scheme frequency and anatomical location were not provided) (product storage error). The administered dose of the vaccine experienced a temperature excursion (TE) as it was stored in the refrigerator instead of the freezer (from 17-APR-2023 to 11-MAY-2023) for a total of 552 hours. Additionally, it was confirmed that no adverse effects occurred.
Information has been received from a registered nurse concerning a 27 year old Caucasian Male patient who on 04/14/99 and 03/23/99 was vaccinated with a 1st dose of Hepatitis B recombinant. On 05/31/00 the patient sought unspecified medical attention and was diagnosed with Hepatitis B. His symptoms included right upper quadrant discomfort and fatigue. The patient was not jaundiced. The patient's "initial test" was positive for Hepatitis B and his 2nd test "didn't show any results to Hepatitis B". It was noted that a physician felt that the results of the 2nd test were "impossible to be right". The patient is "OK at present". The reporter expressed a concern with the lot. Follow up information from a registered nurse reported that as of 06/27/00 the patient is "OK" according to a physician. It was noted that it is unlikely that the patient received the 3rd dose of Hepatitis B vaccine Recombinant. On an unspecified date the patient recovered.
This spontaneous report was received from a male patient of unknown gender via nurse practitioner regarding himself. Concurrent condition included prevention of pneumococcal disease. The patient's medical history included high blood pressure. Concomitant medications included unspecified high blood pressure medication. On an unknown date in December 2018 (reported as about a month ago), the patient was vaccinated with first dose of PNEUMOVAX 23 (strength, dose, anatomical location, lot# and expiry date were not reported) for prevention of pneumococcal disease. On an unknown date in December 2018 (reported as since the time of vaccination), the patient experienced pain in the shoulder of the arm where patient received the shot. The patient also reported that "the pain has gotten worse and it had become hard to move his arm". The patient sought medical attention. The patient did not receive any treatment. No lab test were performed. At the time of reporting, the outcome of the event was not recovered. Causality assessment was not provided. No Product Quality Complaint (PQC) was involved.
Rash developed on legs 5 min. after vaccine administered. 6.25mg Benadryl po administered. Pt observed. Rash cleared within 15 mins.
2mins - BP pressure went high for an hour, felt dizzy 29Mar2021 for 1st dose. One month later I had severe abdominal pain and was hospitalized , Had protein in urine and blood. for 9 months and hospitalized twice . 3 days in Sep 9 to 10 Sep and 4 days in Sep202115- 17Sep 2021   2nd dose - BP was high and went down in a few minutes . 3hrs after I had fever 104, extremely weak, Cant bring down, chronic migraine and chest was beating. The fever lasted for 1 week. It started going down to 101, My migraine stayed and felt like I was stayed. Lymph nodes on right enlarge. I couldn't walk my chest was hurting. Extremely weak and couldn't move and sweating. Didn't see doctor - maybe did virtual doctor.  In 29 Nov 2021 - Diagnosed with endomitosis and went for surgery
pt devel severe local rxn p/vax;this is one of three pt's form this site who exp the above rxn;this adverse event may have been previously reported to the FDA by the reported;
Onset of diarrhea and nausea, within 5 hours, post vax. Stomach cramping incident, lasting 6 days.
Diffuse erythematous multiforme-mild form. Itching back/chest/legs.
second dose they did have headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 68-year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "second dose they did have headaches".   Follow-up: This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101381084 Same reporter/vaccine/event, different patient
On 4/6 my son noticed changes with his vision which continued to 4/7 at which time we brought him to his pcp. She referred us to his eye doctor. They got him in that afternoon, did an exam, told us to follow up that Friday. At the 4/9 follow up he was diagnosed with sixth nerve palsy on the left eye. We scheduled a MRI and lab work. Lab work came back fine. He went for the MRI on 4/16. The MRI showed several brain lesions pointing towards MS. We went to a medical center on 4/20 where they thought the finding lesion were incidental and not related to MS. We saw a neuro-opthamologist on 4/21, who said he felt my son did have MS with sixth nerve palsy. We saw a neurologist on the afternoon of 4/21 who said patient didn't meet the criteria of MS and to follow up another MRI in 3 months. That weekend patient started with areas on numbness. He was due for second covid injection which all providers agreed with us getting. He got his second dose on 4/24 during this flare of numbness. We went back the neurologist on 4/26. Patient was given a three day iv steroid infusion, lab work and follow up MRI. The follow up MRI showed more lesions in his brain which lead us to the neurologist in another state. Dr reviewed both MRIs, felt the lesions were incidental, the flare of numbness as well at the sixth nerve palsy of his eye were related to inflammation related to the vaccine he received.
Arrived at the ER unresponsive and possibly a seizure at home. Child was intubated and given Propoful. Given Ativan, and Dilantin. Transferred to WVU. Once at WVU, febrile 102.7. Febrile seizure was the diagnosis.
Received Tdap (LD) on 6-16-14. Had small amount of redness starting on 6-18-14. On 6-22-14 redness and swelling increased. On 6-23-14 presented to clinic with area of redness, swelling 150 x 150 mm. On 6-24-14 client reports redness swelling subsiding.
This spontaneous report was received from a medical assistant concerning a 20 year old patient of unknown gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported. On an unknown date, the 20 year old patient was vaccinated with PROQUAD (strength, dose, frequency, routed, lot# and expiration date were unknown) for prophylaxis. No adverse symptoms were reported.
About 12 hours post the vaccine I experienced extreme chills, body aches, fever, back pain, tiredness.
WRONG DOSE (PEDI 10MCG) WAS GIVEN TO PT AS SECOND DOSE THEN IT WAS REPEATED WITH CORRECT DOSE OF 30MCG . NO ADVERSE EFFECT REPORTED
Red splotches around injection site tender and hot to the touch. One big one right around injection and smaller ones around
This spontaneous report was received from a registered nurse via company representative refers to a female patient of unknown age (reported as early 20s). On an unknown date in 2007, the patient was vaccinated with one dose of GARDASIL, (lot number, expiry date and route was not reported). Concomitant medications were not reported. On an unknown date, after administration of the vaccine the patient was diagnosed with HPV (human papilloma virus). The nurse reported that the patient did not receive subsequent doses after starting the series. The outcome of the reported event was unknown. Additional information is not expected.
PT waited required 20 mins then walked back to school a short distance from health dept. Teacher called and spoke w/PHN at 10:45 - states PT shaky and heart racing - requests direction on what to do. Advised teacher to call for ambulance and then notify parents. PT transported to a medical center ER. PT reports they gave him Benadryl and steroids but he can't remember the name of the other medicine (Pepcid).
13MAY92 tc from mom states pt t103; seen in ER 12MAY92 record requested; 11MAY92 copy of ER visit recvd; dx probable viral illness;
Symptoms: Migrating rash over whole body including palms of hands.  Itchy. Swelling of wrists, eyes. Skin sensitive to touch. Treatment: Prednisone 20 mg twice daily by mouth for five days, coupled with Benadryl Allergy 25mg per tablet (50 mg taken with each dose) twice daily (morning and evening - Total 100 mg per day.