chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Intense ringing in right ear lasting a minute.; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 12Apr2021 at 13:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included none. Patient had no known drug allergy. Concomitant medications included men's perfect multi (PURITY PRODUCTS), glucosamine; chondroitin sulfate (GC FLEX) all from an unknown date for an unspecified indication. 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 13Apr2021 at 07:45, the patient experienced intense ringing in right ear lasting a minute. Then subsided to a sustained ringing with sporadic intense bouts. Right ear continued to ring all day. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. The clinical outcome of the event intense ringing in right ear lasting a minute was not recovered.   No follow-up attempts are needed. No further information is expected.
Red band of raised skin about 5 inches below injection site extending about 4 inches. Appeared in the morning of 11-6-16. Patient did not complain of pain, itching, difficulty breathing, or warmth of rash.
Dose administered >12 post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 post puncture) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 post puncture). On 09-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  The patient was administered with dose > 12 post puncture. Reportedly, it was patient's first dose.   This case was linked to MOD-2021-347329 (Patient Link).
Patient verbalized itchiness on right arm, right face & feeling of warmth  10 minutes after vaccination. Patient was given 7.5mL PO @4:37 pm. At 4:52, patients vital signs were taken as124/74mmHG, 80bpm, 18 respiration, 97.9 F sublingual temperature. Patient verbalized resolution of symptoms. Patient was sent home in stable condition.
about time after third moderna covid vaccine pt developed fatigue.  #3 vaccine moderna 11/15/21.  I fist saw him 12/13/21 complaining of fatigue.  work up revealed ana 1:10240 and anti ds DNA 13 (0-4 nml).  C3 and C4 very low.  platelets nml at 170 K   in 2/21 but now dropping to 110K.   also albumin dropped 4.0 to 2.7 and he has edema.  he is the wrong ethnicity, gender and age to develop Lupus so I am somewhat suspicious of the vaccine.  timing is very suspicious....though he mentioned his father had Lupus.  Is seeing rheum 1/7/22.  CT belly pending and echo done results still pending.    Also transaminases 250 and alk phos same.  were previously normal  1/21 on routine
Extreme lethargy began about 9am on 5./29/2021  and continued up to 10pm when a hemiplegic migraine began.  About 8am on 5/30/21 the hemiplegic migraine still had not cleared up and was most extreme , with severe headache , slurred speech, paralysis of one side , beginning to go to to other side , altered mental status , cannot recall names of things , calls dog paper and thinks that is the correct term
TRANSIENT THROMBOCYTOPENIA WITH GLYCOPROTEIN SPECIFIC PLATELET AUTOANTIBODIES; DENTAL PAIN; This spontaneous report was received from literature. This report concerned a 71 year old female. The patient's height, and weight were not reported. The patient's past medical history included: polymyalgia rheumatica, and acute right ear infection, and other pre-existing medical conditions included: The heparinplatelet factor 4 antibody enzyme-linked immunosorbent assay, both of which had unremarkable findings (the assay optical density was 0.057; reference, <0.400). The patient was previously treated with prednisone for polymyalgia rheumatica. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown ) one total dose, start therapy date were not reported for prophylactic vaccination. The batch number not reported has been requested. No concomitant medications were reported.  The 35 days after vaccination she developed headaches in the left temporal region, prompting evaluation by her rheumatologist for possible giant cell arteritis given her history of polymyalgia rheumatica. She did not report recurrence of polymyalgia rheumatic symptoms, and giant cell arteritis. The patient's headaches were ultimately attributed to referred dental pain due to occlusal trauma from a temporary dental bridge, and they resolved after dental intervention. The patient results were positive for platelet autoantibodies directed against all 3 glycoproteins at optical densities (transient thrombocytopenia with glycoprotein specific platelet autoantibodies). Laboratory data (dates unspecified) included: Autoantibody test (NR: not provided) Positive (units unspecified), negative, C-reactive protein (NR: not provided) 1.0 mg/L, Complete blood count (NR: not provided) Not reported, Erythrocyte sedimentation rate (NR: 0 - 22) 8 mm/h, Nuclear magnetic resonance angiography brain (NR: not provided) unremarkable findings, and Platelet count (NR: not provided) 143 X 10 9 cells/L, 429 x109 cells/L, 96 X 10 9 cells/L, 76 X 10 9 cells/L, 248 X 10 9 cells/L, 67 X 10 9 cells/L, 56 X 10 9 cells/L, 115 x 10 9 cells/L, 55 to 110 X 10 9 cells/L, 59 X 10 9 cells/L. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dental pain, and was recovering from transient thrombocytopenia with glycoprotein specific platelet autoantibodies. This report was serious (Other Medically Important Condition).  The author emphasized if antiviral spike protein antibodies cross-reactive with platelet glycoproteins resulted in this clinical presentation, thrombocytopenia due to this mechanism could occur with other SARS-CoV-2 vaccines.; Sender's Comments: V0;20210929329-covid-19 vaccine ad26.cov2. s-Thrombocytopenia with glycoprotein specific platelet autoantibodies. This event is considered unassessable. The event 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.
While the needles were still in the child during injection of the vaccines: He screamed and then immediately and fully passed out within half a second of the end of the scream. The injections were then finished. The nurses then placed the baby into my arms. He had no muscle reaction at all, it was like holding something dead.  The nurses acted as if this was common and sent us home. His muscles began working about 6 hours after the vaccination.  He didn't regain full conciousness until the next day. By then he had forgotten how to grasp towards objects, how to smile, etc. He had forgotten how to do absolutely everything that he had ever learned. It was like having a newborn again.   He has stayed about a year behind his age group in development ever since. At age 6 he failed the school given tests in the catagories of speech,motor skills and adjustment.  I have stopped vaccines since then in an effort to keep my child from becoming a "vegetable". The clinic refused to admit the child had a reaction to the shots they had given him. I found out later that they were afraid that they might lose some funding if they had reported a vaccine reaction.  In a very real sense they have sacraficed my son for money.
9/27 morning temp 100.2, 12 noon 100.7 delusions, 09:00 pm fever 102.7 orally vomited x 1, chills 325 mg Tylenol, sponge bath, increased high fever 100.2 - 100.4 through night. 9/28/2000 am neg fever much improved.
No adverse reaction at time of leaving clinic.  Patient was given Adult Hep A vs Peds Hep A
03/15/2021: Presented to the emergency department approx 10 days s/p laparoscopic appendectomy  for further evaluation of persistent fatigue, intermittent nausea, poor appetite, occasional lower abdominal pain, as well as increased WBC over the past week. Patient admitted with a pelvic abscess and a drain was placed.
had all his Dtap, also received Boostrix and Tdap on 2022; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 12-year-old male patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   Previously administered products included Dtap vaccine  (received all Dtap vaccines, with the last being administered in 2015) and Boostrix (received Boostrix on 25th August 2022).   On 17th October 2022, the patient received Tdap Vaccine. On 17th October 2022, unknown after receiving Tdap Vaccine, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 20-Oct-2022 Reporter's comment: The reporter did not think that was Boostrix that was administered by the other health care professional, but rather another Tdap or TD based on the lot number provided.  The reporter checked the lot number and it did not match a GlaxoSmithKline vaccine.  The reporter consented to follow up via postal. Additional supportive information: The licensed vocation nurse stated that they administered Boostrix to a patient and then received another Tdap (or possibly TD) from his provider, which led to extra dose administered. The case was kept valid in worst approach considering the suspect was potential GSK one, as in whole source document there was no lot number was reported regarding which reporter was mentioning that it did not match with GSK vaccine.
Pfizer COVID Vaccine/ reports pneumonia diagnosed Dec2021 and concerns for new COVID variantS; Pfizer COVID Vaccine/ reports pneumonia diagnosed Dec2021 and concerns for new COVID variantS; This is a spontaneous report received from contactable reporter(s) (Nurse), Program ID:.  A 26-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing); "Pneumonia", start date: Dec2021 (unspecified if ongoing), notes: Pneumonia Previously Reported 05Jan2022/Reported Pneumonia diagnosed Dec2021. The patient's concomitant medications were not reported. The following information was reported: COVID-19 PNEUMONIA (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Pfizer COVID Vaccine/ reports pneumonia diagnosed Dec2021 and concerns for new COVID variantS".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Covid19 Pneumonia, drug ineffective.
Pt recvd vax & 4 hrs p/inject had itching, rash, fever, chills, h/a, & malaise; sx resolved in 24 hrs;
Patient stated that she woke up with a sore left arm and was red and swollen. She took Tylenol and put ice on it and went to work. She said the next day, her arm was still sore and swollen and it swelled into a perfect square on her left arm. She continued to take Tylenol and went to work.  Today she came to the pharmacy after work and showed me her arm, no swelling but a little redness still there.  She states that now it is sore into her neck but soreness diminished in her arm.  Slightly tender to the touch.
COVID -19 Positive after the first dose; Fever 102.2degree F; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID -19 Positive after the first dose) and PYREXIA (Fever 102.2degree F) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     The patient's past medical history included Heart disorder, Lung cancer (Stage 1 Lung Cancer) and Surgery (Lung surgery that removed 1/3 of lung). Concomitant products included LISINOPRIL, PRAVASTATIN, CARVEDILOL (COREG) and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PYREXIA (Fever 102.2degree F). On 26-Mar-2021, the patient experienced COVID-19 (COVID -19 Positive after the first dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID -19 Positive after the first dose) outcome was unknown and PYREXIA (Fever 102.2degree F) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Body temperature increased: elevated (High) 102.2. On 24-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative. On 26-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     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.   Patient reports taking a WATER PILL (NOS).
Patient had no record of Hepatitis A vaccine and wanting the vaccine.  After receiving the vaccine, she found another record from her cell phone that she already received 2 doses of Hep A vaccine.
Resident per her usual health when dietary staff were into apartment at 0730 with her breakfast. Resident conversing, appropriate, with no focal deficits with ADL. Resident baseline with mild confusion, generalized weakness, using a 4 wheeled walker when ambulating. Med care manager into room at 0830 with am medications. Resident was lying partially on her bed, non responsive.  EMS was called immediately and resident was transported to Hospital ER. Wellness nurse was notified later that resident was admitted for rule out CVA.
Throbbing pain in leg right next to my shin bone; Kept me awake at night; Developed a small blood clot in the vein running along shin bone; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Developed a small blood clot in the vein running along shin bone) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Throbbing pain in leg right next to my shin bone), INSOMNIA (Kept me awake at night) and THROMBOSIS (Developed a small blood clot in the vein running along shin bone) (seriousness criterion medically significant). At the time of the report, PAIN (Throbbing pain in leg right next to my shin bone) and THROMBOSIS (Developed a small blood clot in the vein running along shin bone) had resolved and INSOMNIA (Kept me awake at night) outcome was unknown.            No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-017541 (Patient Link).
positive for COVID; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 10Apr2021 (Batch/Lot Number: EW0158) (at the age of 46 years old) as 1st dose, single for COVID-19 immunisation  Medical history included ongoing type 2 diabetes (had this for about a year and a half, from unspecified date). There were no concomitant medications. The patient stated that she got COVID, she was thinking on 18Apr2021 and on 20Apr2021 she was tested and she was positive for COVID. She had the "15 rapid COVID test" and the "nasal swab COVID test" and both were positive. She is due for her second COVID vaccine on Saturday. The outcome of the event was unknown.
This spontaneous report as received from a physician refers to a male patient of unknown age with no pertinent medical history and sulfa allergy. The patient was vaccinated with a dose of ZOSTAVAX (Lot # H011047, expiration date 09-SEP-2013) on 02-OCT-2012. No other co-suspects were reported. Concomitant medications included RESTORIL and lisinopril (manufacturer unknown). The physician reported that on 02-OCT-2012, the patient developed low grade fever, general muscle aches, pain and swelling in his arm, joint pain, right shoulder pain and ulnar neopathy. The patient was treated with ibuprofen and acetaminophen, LORTAB. There were no lab diagnosis or studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
For Chest pain, high colesterol, prescription for Creator 10 mg at the beginning of 2023, on july the colesterol level was decreased to normal range. Diarreas symptoms, MTI and CT were performed with  finding in liver and pancreas  in 2022 and 2023, ( cysts of 1 cm) . The cysts is in monitoring every year since 2022
Got hospitalized for my injury for my back; This is a spontaneous report from Pfizer Sponsored Program COVAX Support from a contactable consumer or other non-healthcare professional. A 43-years-old male patient received the first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection) via an unspecified route of administration, administered in Arm Right on 18Jun2021 (at the age of 43-years-old) (Batch/Lot Number: EW0181, Expiry date was not reported) as a single dose for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications reported. On an unspecified date in Jun2021, the patient experienced got hospitalized for injury for his back. It was reported that the patient received his first dose of the vaccine last 18Jun2021. He was scheduled to have the second dose last 10Jul2021. However, he missed his shot because he was in the hospital. He called in to know how to get the second dose of the vaccine. He stated that he got hospitalized for his back injury which was not related to the vaccination. The patient was hospitalized for got hospitalized my injury for my back from Jun2021 to an unknown date. Laboratory tests on an unspecified date in Jul2021 included sars-cov-2 test: negative (COVID test 5-6 days ago. The COVID-19 negative. Everything was negative). The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information, it cannot be ascertained with reasonable possibility that suspect therapy BNT162B2 has caused or contributed to the reported event back injury.
PATIENT STARTED HAVING HORRIBLE HEADACHE ABOUT 12 HOURS AFTER MODERNA VACCINE. NOTHING OTC WOULD HELP ALLEVIATE  THE HEADACHE PAIN FOR ABOUT 10 DAYS. SHE STIL HAS SOME LINGERING HEADACHE. HER DR. ADVISED HER NOT TO GET THE 2ND DOSE.
Patient received his second dose of Moderna early, this was a vaccination error. First dose was 3/19/21 with second dose today 4/9/21. This is 21 days apart.
Caller states she received her first dose of the Pfizer Covid vaccine 04Mar2021. She received a positive Covid PCR test on 10Mar2021; This is a spontaneous report received from a contactable consumer. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 04Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she received her first dose of the Pfizer COVID vaccine on 04Mar2021 and on 10Mar2021 she received a positive COVID PCR test. The patient stated that she wanted to know if the positive COVID test could be from the vaccine and inquired about guidance for getting the second dose with having a positive COVID viral test. The outcome of the event was unknown.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
6 days after shot my arm became itchy at the site of the shot and soon enlarged to maybe 6 inches wide and swollen to a deep pink color. I took an antihistamine and the itching got better but the swollen area has gone down to my elbow. I have no pain but should I be concerned or seek medical attention?
Vomiting; diarrhea; This is a spontaneous report from a Non-contactable consumer (patient). A 95-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 03Mar2021 at 11:00 as 2nd dose, single dose in the right arm for covid-19 immunisation. The patient medical history included glaucoma and had known allergies with Penicillin. The patient did not receive any other vaccines within four weeks prior to the 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 previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: UNKNOWN), via an unspecified route on 10Feb2021 at 13:30 as 1st dose, single dose in the right arm for covid-19 immunisation. The patient concomitant medications included Baby aspirin, azopt drops, b complex vitamin, meto. On 03Mar2021, the patient experienced vomiting and diarrhoea. The patient did not received treatment for events. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Client states she began having sporadic "pulsing" near stomach/rib cage area and it was visible externally
Patient called clinic and reported that she had experienced pain at the injection site on left deltoid after she received a flu vaccine. Evaluated in clinic by Dr on 5/10/17 and noted below as documented in office visit: Comment: suspect musculoskeletal following vaccine led her to not move her arm, this then has led to a frozen shoulder; there is no evidence of nerve damage or infection following the vaccine. Patient was referred to physical therapy.
Got Pfizer vaccine on 3/10/21 and 3/31/21.  Symptom onset on 7/15 with cough, runny nose and nasal congestion.  Tested positive for Covid-19 on 7/21/21.
Fever, injection site hot to touch, general malaise flu like symptoms, runny nose, conjestion, third day woke up with redness extending down my arm.  Redness continued to get worse looked like stripes of welts continuing down the arm.
The day after the shot (4/24/21) I had stomach cramps and oils not stop crying. The next day (4/25/21) the cramps continued, along with a massive appetite.  The following day (4/26/21) at about 3:50am I woke up to heavier cramping and started my period a week early. I usually start my period at the same time of the month, but after the vaccine shot, period symptoms started and my period began earlier than normal.