chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Miscarriage; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 12Jan2022 12:00 (Lot number: 3014BA) at the age of 31 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: prior vaccination. Date of last menstrual period: 17Dec2021. The patient was 4 weeks pregnant at the time of exposure to bnt162b2. The patient was 4 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 23Sep2022. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin"; Azithromycin, reaction(s): "Known allergies: Azithromycin". Vaccination history included: Bnt162b2 (Dose 1, Lot number: EN5318, Administration time: 08:00 AM, Vaccine location: Right arm), administration date: 26Feb2021, when the patient was 30 years old, for Covid-19 immunization; Bnt162b2 (Dose 2, Lot number: EN6205, Administration time: 02:00 PM, Vaccine location: Right arm), administration date: 19Mar2021, when the patient was 30 years old, for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and has not been tested for COVID-19 post vaccination. The following information was reported: ABORTION SPONTANEOUS (medically significant) with onset 11Mar2022 15:30, outcome "recovering", described as "Miscarriage". The event "miscarriage" was evaluated at the physician office visit and emergency room visit. The pregnancy resulted in spontaneous abortion (23Sep2022). The fetal outcome is intrauterine death. Therapeutic measures were taken as a result of abortion spontaneous (medication to assist with miscarriage).
This spontaneous case reported by a nurse, describes the occurrence of swollen tongue and rash in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 010M20A) for COVID-19 immunization. No medical history reported. On Feb 1, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 2, 2021, patient had a swollen tongue and rash. Patient treated with 12.5mg liquid Benadryl (diphenhydramine hydrochloride), at an unspecified dose and frequency. On Feb 3, 2021, swollen tongue and rash resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments or concomitant medication.
Within 10 minutes of receiving vaccine, patient stated that she felt a little short of breath. Pt used her rescue inhaler and, after 45 minutes of observation with no exacerbation, she felt her sxs had resolved and she left. I communicated with her on 1/11/21 and she stated that she felt fine and had no lingering symptoms.
I had vaccination on 10/07/2022. On 03/17/2023 I ended up in the hospital. I had a small pinch in my calf a few days prior. I thought it was a sports injury. The pain radiated from calf to behind my knee cap with a red line. It was sore in that area. On 03/17/2023 the pain was from top of foot up the calf all the way up to my groin. The red line was visible. I went to the urgent care and they did a MRI and CAT Scan. I had a massive blood clot and I was rushed into surgery. The blood clot was pulled out but they couldn't get all of it. I am presently on blood thinners and I am being monitored with a specialist.
~24 hours after injection, patient experienced mild fatigue, low appetite, sinus symptoms (feeling blockage in right side sinuses), exacerbation of tinnitus in R ear. Symptoms persisted 48 hours after injection.
Initial report was received on 03 September 2013 from a consumer who is also the patient. An adult female with a history of mild environmental allergies had received on an unspecified date in August 2013 an intramuscular influenza vaccine (lot number and site of administration not reported) and more than hour after vaccination developed a tickle in her throat which caused her to cough. The coughing became worse and caused difficulty breathing. The patient reported her sclera became reddened and she reported generalized body aches. The patient was evaluated and treated in the emergency room (treatments were not reported). The patient was diagnosed with an allergic reaction to the vaccine. No further information was available at the time of the report. The patient's outcome was recovered on an unspecified date. Documents held by sender: none.
Initial information received on 12-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse via phone. This case involves a patient received third dose of PENTACEL (batch number, expiry date 13 June 2018, route and site of administration was not reported) on an unspecified date. It was a case of actual medication error due to expired vaccine used. It was unknown if any adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 62-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 13-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up).    Concomitant medications were not reported.  It was reported that 51 doses from Lot AS7140C and 60 doses from Lot AS7148B were administered. No treatment information was provided.
vaccine that had expired was accidentally administered to patients with no reported adverse event; Initial information received on 05-Jul-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient and caller reported that the diphtheria-15/tetanus/5 Ac Pertussis Vaccine [Daptacel] that had expired was accidentally administered to patients with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hib Vaccine for Prophylactic vaccination.  On 28-Jun-2023, the patient received a dose 3 at a dose of 0.5 ml of suspect  diphtheria-15/tetanus/5 Ac Pertussis Vaccine Suspension for injection (expiry date: 21-Jun-2023, lot C5893AA) via unknown route in the left thigh for Immunization and expired vaccine was accidentally administered with no reported adverse event (expired product administered).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt recvd 2 doses of Engerix-B; 22JUN exp nausea, diarrhea & fever;
Very nervous prior to vaccine. After administration got up to talk to friend - fell to floor - hit chin, 1 inch laceration on chin, ice applied.
Pfizer-BioNTech COVID-19 Vaccine EUA, I don't know if this is a direct result of the vaccine but I started experiencing symptoms of a UTI in the middle of the night (frequent urge to urinate, pain when urinating).    Symptoms continued but weren't as intense the following day.
This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with a dose of VARIVAX, subcutaneously (dose, dose number, lot # and anatomical locations were not reported), 21 days after the administration of M-M-R II)(dose, dose number, lot # and anatomical locations were not reported). (Drug use for unapproved schedule). No adverse effects were reported. Additional information is not expected since the patient cannot be contacted.
This is a spontaneous report from a contactable consumer (patient). An elderly non-pregnant female patient received bnt162b2 (BNT162B2 Solution for injection, Batch/Lot number was not reported) dose 2 via an unspecified route of administration, administered in right arm on 08Mar2021 13:30 as dose 2, single dose for covid-19 immunization. Patient had known allergies to penicillin. The patient's concomitant medications was not reported. Historical vaccine included BNT162B2 (solution for injection, Lot number: ELB8982) via an unspecified route of administration, administered in right arm on 15Feb2021 01:30 PM as dose 1 single for COVID-19 immunization. Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had been not tested for COVID-19 since the vaccination. On an unspecified date in 2021 the patient experienced face swollen under left eye second shot. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient given bivalent vaccine as a second dose by errorr instead of the primary . No adverse effects noted.
Guillaine Barre Syndrome 12/21/06-records received and reviewed from reporter. GBS-with ascending peripheral hyposensation. CXR revealed pulmonary edema. Transferred to hospital.  01/16/07-records received and reviewed for DOS 12/3-12/14/06 DC DX: GBS- trach for pneumonia, transferred to ECF for rehab. numbness began in feet then tingling in hands extending to knee and elbows. Difficulty keeping right eye opened and difficultly swallowing. On 12/3/06 ataxic gait.  Decreased grip and strength in lower extremities.  Annual follow up information indications status of recipent recovery still unknown. Recipient of the letter is no longer stationd in the same area with this soldier.
took vaccination on 12/31/2019, dont know if it was Part 1; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 31st December 2019). Concurrent medical conditions included aphasia ((difficulty speaking)).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date:  02-JUL-2022 and 5-JUL-2022 Reporter's Comments: The patient took the Shingrix vaccination on 31st December 2019. She did not know if it was Part 1 of the 2nd shot regime. Outbound call was made. She mentioned that she had aphasia (difficulty speaking). She indicated this was a pre-existing condition that she had prior to receiving Shingrix. The patient indicated she thought that the shot she got was shot 2 but pharmacy in records only go back so far and they could not confirm when shot 1 was received. No further information was gathered due to customer wanting to get off the phone. Additional Supportive Information:  Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.
Temperature changes (in F): 41; administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (Temperature changes (in F): 41) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Temperature changes (in F): 41). On 13-Jul-2021, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Temperature changes (in F): 41) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment information was provided.
Mom presented to office stating 9/16/15 child developed a rash right leg lateral thigh, approximately 2 wks after Varicella injection 8/28/15.
This is a spontaneous report from a contactable consumer (patient). This female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration at single dose on 18Oct2018 for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced allergic reaction, redness, raised area in her arm and difficulty breathing with outcome of unknown. She has been managing this reaction with BENADRYL and has consulted her physician. The information on the lot number has been requested.
Information has been received from a physician concerning a 65 year old male patient with diabetes, gastrooesophageal reflux disease (GERD), allergies to IV contrast dye and a history of esophageal cancer surgery 6-8 months ago who on 23-JUN-2009 was vaccinated with a 0.65ml dose of ZOSTAVAX (Merck) (lot#663893/0128Y) subcutaneously in right arm.  Concomitant therapy included NEXIUM and an unspecified oral medication for diabetes.  On 04-JUL-2009, the patient experienced shingles like nerve pain on the left side of his body after receiving vaccine.  The patient was evaluated in an unspecified emergency room on 04-JUL-2009, diagnosed with "pre-shingles" and treated with an antiviral medication.  The patient was seen in a follow up visit with the physician on 06-JUL-2009.  The patient had no rash or lesions.  At the time of report, the patient did not recover.  Pre-shingles was considered to be disabling by the reporter.  Additional information has been requested.
it was rpt fr MD concerning pt who was vax in 1997 & in 12dec98 pt exp abortive herpes zoster type syndrome. the linear papular eruption, looked like a spider type. the eruption resolved itself in approx 10 days.
Pt recvd vax on 11SEP92 & immed following vax began vomiting;
This spontaneous report was received from an 41 year old female consumer reporting on herself. Consumer reported she usually experiences diarrhea after taking penicillin (unspecified). The patient had no pertinent medical history. On 15-AUG-2013 the patient was vaccinated with RECOMBIVAX HB (dose, route and lot number were not reported). Concomitant therapies included SYNTHROID and an unspecified treatment for birth control. About two days later of RECOMBIVAX HB vaccination, on approximately 17-AUG-2013, patient experienced "inflammation diagnosed as sclera", severe joint pain in one of her hands, extreme fatigue and swollen and red eyes. The vaccine was recommended by a Nurse Practitioner. Based on her experience after the RECOMBIVAX HB first dose, consumer stated she planned to return to the physician's office to discuss whether she should receive the second dose of RECOMBIVAX HB and might decide to discontinue RECOMBIVAX HB therapy. It was reported that the patient did not received treatment for the adverse events. Steroid (not specified) was prescribed for the eye. Patient performed a not specified type of blood test. Patient was seen in the office. The outcome of inflammation diagnosed as sclera, red eyes, swollen eyes, extreme fatigue and joint pain in one of her hands was reported as not recovered/not resolved. The relationship between RECOMBIVAX HB and the events was not reported. Additional information has been requested.
53yo F who previously experienced hives, flushing, face swelling during first vaccine dose. She returned for her second dose and began feeling a radiating burning pain down her injected arm. Pruritis reported around face and back. Pt was monitored by medical staff and ems. Vitals were wnl, lungs CTAB. Facial swelling noted that improved after 20min. Pt did report taking Allegra at 1800 prior to recieving her vaccine. She was monitored for a total of 40min with resolution of symptoms.
A rash on the site of the injection on my left arm has only gotten worse, now developing little "white heads", like Acne. At this point there is "puss" being excreted from the whiteheads.
Shortness of breath; Chest pain; rapid respiration; weakness; increased heart rate; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6199), via an unspecified route of administration, administered in Arm Left on 11Mar2021 09:00 (at age of 60 years old) as single dose for COVID-19 immunization. Medical history included Kidney stone. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient had Chest pain, shortness of breath, rapid respiration, weakness, increased heart rate on 12Mar2021 12:00PM. The adverse event result in: Emergency room/department or urgent care. No treatment received. The outcome of the events was unknown. This case Serious reported as No.
Fatigue, muscular pain, stabbing pain all over body,fever,Unable to sleep, twitches,
This spontaneous report as received from a nurse refers to patients with unknown age and gender. On an unknown date, patients were vaccinated with a dose of M-M-R II (dose, lot # and expiration date were not related) subcutaneously. Concomitant therapy was not reported. The nurse reported that improperly stored with M-M-R II may have been administered to unspecified patients on unspecified dates. No adverse effects reported. No patient contact details available. Additional information has been requested.
Nausea and dizzy after initial injection, arm pain for about a week.  After 2nd injection. Nausea and dizziness initially after injection, ice pack and water. 24 hrs after very nauseous, fatigue, arm pain, chills, fever, diarrhea. Treated with bed rest, tylenol and fluids. 72 hours after (Monday 05/03/21) facial and neck swelling, hives on neck and chest and back, redness. No shortness of breath or difficulties swallowing. Urgent care, all stats normal except BP which was about 159/84 and then 179/77 after prednisone dose. given prednisone 40 mg. Followed up on 05/04/21 with pulmonologist, script of taper prednisone 40-30-20 (3 days each then baseline at 20) keep eye on symptoms. Swelling decreases with administration of prednisone.
Swollen lymph node under left armpit; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 16Apr2021 at 11:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. 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 take any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 25Mar2021 at 09:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. On 18Apr2021 at 08:30, the patient experienced swollen lymph node under her left armpit. The patient was freaking out if this was a vaccine reaction or possible cancer or whatever. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event swollen lymph node under left armpit was not resolved at the time of the report.   No follow-up attempts are needed. No further information is expected.
having mild headache each day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 16:30 (Batch/Lot number: unknown) at the age of 65 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (lot number: EN6208, administration time:16:30, administered in left arm, dose 1, no headache in between first and second dose), administration date: 08Mar2021, when the patient was 65 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 01Apr2021, outcome "recovered" (Apr2021), described as "having mild headache each day". Therapeutic measures were taken as a result of headache. Additional information: It was also reported that the Lot/Batch number of the vaccine was SR8733 / ER8733. The event was reported as abnormal for patient to have a daily headache. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient been has not tested for COVID-19. Patient had no allergies to medications, food, or other products.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.