chrisvoncsefalvay/vaers-outcomes huggingface dataset:
miscarriage; super tired; super sore; sore arm; This is a spontaneous report from a contactable consumer (patient's husband). A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7533) via an unspecified route of administration into left arm on 09Apr2021 13:30 (at the age of 39-year-old) as single dose for COVID-19 immunisation. Medical history included ongoing colitis. Concomitant medications included mesalazine (MESALAMINE) taken for colitis from an unspecified start date and ongoing and other unspecified medications. Historical vaccine includes first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199) into left arm on 19Mar2021 (at the age of 39-year-old) for COVID-19 immunization and patient received first dose of BNT162B2 while pregnant. On 09Apr2021, it was reported that the patient experienced sore arm. On 10Apr2021 she was super tired and super sore. On 11Apr2021, patient reportedly had miscarriage. The mother was 3 weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. The fetal outcome was intrauterine death. The events reportedly resulted to emergency room  visit. The patient underwent lab tests and procedures which included blood test on 11Apr2021 showing she was only 3 weeks pregnant and sonogram: no fetal heartbeat on 11Apr2021. The event miscarriage was treated with 10 pills of Hydrocodone. Outcome of event miscarriage  was unknown while for all other events was not recovered.
Tinnitus; Fullness in ears; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 11:30 (Batch/Lot number: unknown) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BUSPIRONE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Past drug history included: Tetracycline, reaction(s): "Drug allergy", notes: known allergies: tetracycline. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: unknown, Anatomical location: Arm Left, Administered time: 11:30), administration date: 01Mar2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 07May2021 22:00, outcome "not recovered", described as "Tinnitus"; EAR DISCOMFORT (non-serious) with onset 07May2021 22:00, outcome "not recovered", described as "Fullness in ears". The events "tinnitus" and "fullness in ears" were evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus, ear discomfort.  Additional information: The event resulted in a visit to the doctors or other healthcare professional office/clinic visit. Treatment included unspecified antibiotic. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. 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 4 weeks prior to the COVID vaccine. Device Date: 26May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. received Vaccine on 8/14/06, presents to clinic on 8/25/06 with a knot to left deltoid the size of 3mm(roughly) and some tenderness upon palpating.  No fever, slight discoloration to area of injection.
Swelling, erythema, blistering, pain, swelling extending to below left elbow left upper arm firm to touch. Symptoms first observed by mother on 10/27/10 at 6:30pm.
This spontaneous report as received from a consumer via Clinic refers to a currently 39 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-AUG-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (lot # L049314, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1801USA000166.
pt recvd vax & devel rhabdomyolysis & was hospitalized; lab eval revealed serum CPK 79,900;
RECEIVED 2.5 ML OF THE VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 51 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, expiry: 07-MAR-2022) 2.5 ml, administered on 20-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-NOV-2021, the patient experienced received 2.5 ml of the vaccine. On 20-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received 2.5 ml of the vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211220146, 20211219681, 20211219953, 20211220152, 20211220152, 20211200723, 20211200752, 20211200769, 20211201046, 20211201228, 20211201963, 20211202193, 20211202207, 20211202246, 20211202250, 20211202371, 20211165041, 20211200675, 20211200717, 20211200723, 20211201082, 20211200994, 20211201168, 20211201179, 20211201286, 20211219871, 20211220527, 20211220697 and 20211220928.
14 days post vax the pt reported that she developed a metallic taste in her mouth which did not affect the taste of food. No treatment was given. Physician was uncertain as to the onset date of the adverse event. Approximately 2 weeks later the pt received the second dose of Lymerix. The most recent information reports the outcome of the event as uncertain per the physician.
SUSPECTED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; LOOKS TERRIBLE; This spontaneous report received from a patient via a company representative concerned a male of an unspecified age and origin,. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known medical history. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown and expiry: unknown) dose was not reported, 1 total administered on an unspecified date of SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, reporter stated that the patient was tested positive for Covid-19 polymerase chain reaction (PCR) (confirmed covid-19 infection), and she was unaware of his symptoms (suspected clinical vaccination failure) however she said that patient was not feeling well and looks terrible. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection, looks terrible and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000196854.; Sender's Comments: V0:20211018993-Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 35-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included Polycystic ovary (PCOS in 20's, but no issues conceiving). Concurrent medical conditions included Drug allergy (sulfa), Angina pectoris, Coronary bypass in 1990 and Cardiac catheterisation on 28-Dec-2020. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE], PROBIOTICS, VITAMIN D, CETIRIZINE HYDROCHLORIDE (ZYRTEC), CLARATIN, VITAMIN B6 and DOXYLAMINE SUCCINATE (UNISOM) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. The patient's last menstrual period was on 20-Aug-2020 and the estimated date of delivery was 30-May-2021. On 26-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy.  On 26-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Oct-2020, Investigation:. On 26-Oct-2020, Ultrasound scan: normal normal. On an unknown date, Investigation: 09nov2020 invitae  - WNL. On an unknown date, Scan: 17nov2020 (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient previously had live full-term birth on 20-SEP-2018 The patient previously had Spontaneous abortion on 25-JUL-2020  No treatment medication was reported.  Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this 35-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 35-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
received fluzone quadrivalent rather than fluzone high dose with no reported adverse event; Initial information received on 27-Oct-2021 regarding an unsolicited valid non-serious case received from a other health professional via Regulatory Authority (under the reference 00830730).  This case involves a 77-year-old female patient received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] rather than INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (wrong product administered).  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to wrong vaccine administered (latency: same day).  It was reported "Caller states a patient female age 77 received FLUZONE QUADRIVALENT rather than FLUZONE HIGH DOSE; caller would like to know if FLUZONE HIGH DOSE should be administered or if the FLUZONE QUADRAVALENT is suitable."  At the time of reporting, no 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.  There will be no information available on the batch number for this case.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies : Penicillin" (unspecified if ongoing), notes: Known allergies : Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti viral details Product was COVID 19. Treatment brand was Pfizer. Treatment start date on 26Sep2022. Indication treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Approx 825AM pt became clonic w/eyes rolling back in head, teeth clenched, back arched severely; very stiff w/arms drawn up next to head, unresponsive; No LOC lasted approx 2-3min; Child taken to Hosp;
After completion of visit but before leaving clinic, pt reported feeling dizzy after getting Hep A/B vaccine. Reported dizziness, then later shakiness "like shaking under my skin." Never had this reaction after a vaccine before, says she only had this after an epinephrine injection. Denied shortness of breath, tongue selling, difficulty breathing or swallowing, itching, hives. On exam, lungs CTA, throat non-edematous, skin without rash/hives. Pt was monitored in the clinic, BP while symptomatic was 126/79. Pt's brother was coming to pick her up. Advised that since clinic will be closing, she could go to ER for observation. However she declined, prefers to have her brother take her home. I am suspicious that this is a vasovagal reaction, no e/o allergic reaction at this time, so I think this is reasonable. Educated pt on s/s of severe allergic reaction, advised to have someone stay with her the rest of the evening and go directly to ER if experienced. Pt verbalized understanding, feels safe with this plan. Called pt at 6:30pm, she says she is resting, still feels a little shaky but no new symptoms. Her daughter is there with her, they are about to eat dinner. Tells me she hasn't eaten since breakfast, trying to lose weight. I advised her to eat something, stay hydrated, and maintain same precautions as before.
Patient presented with rash.  Some papular, some scabbed lesions to scalp, trunk, upper thighs, arms-  Total number lesions approx 15 to 20.  Patient also with 1 posterior auricular node  on right side.  Rash noted on 2/7/05.  Patient without other symptoms.  No fever, otherwise well.  Rash is pruritic.
FEVER, Diarrhea, rash, swollen arm, generalized body pain, difficulty walking and breathing.
fever (101.3F; chills (violently shaking and lasted about 1.5 hours, hard to talk and walk; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever (101.3F) and CHILLS (chills (violently shaking and lasted about 1.5 hours, hard to talk and walk) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever (101.3F) and CHILLS (chills (violently shaking and lasted about 1.5 hours, hard to talk and walk). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever (101.3F) and CHILLS (chills (violently shaking and lasted about 1.5 hours, hard to talk and walk) had resolved.
Felt some general fatigue in the first few days after the shot. However, on Monday (September 20th) I started feeling light headed, the arm that the shot was given in (the right arm) began tingling from the shoulder to the hand, and I began to experience a pounding heart and chest pains along with localized pain on the right side of the body. I started taking two aspirin every four hours or so and the symptoms abated Tuesday.
Chills, severe headache, nausea, feeling of almost passing out, very tired. Slept in bed for 2 days, took ibuprofen.
chills, fever, arthralgia, myalgia, mild nausea , decreased appetite, headache   36-48 hours
Trigger finger; tender and sore in one finger and leads to all of the fingers on the same arm; middle finger was locked; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 02Mar2021 (Lot number: EN6201) at the age of 54 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: TRIGGER FINGER (non-serious) with onset Mar2021, outcome "not recovered", described as "Trigger finger"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "not recovered", described as "tender and sore in one finger and leads to all of the fingers on the same arm"; JOINT LOCK (non-serious) with onset Mar2021, outcome "not recovered", described as "middle finger was locked". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of trigger finger, pain in extremity, joint lock. Additional information: Treatment included paracetamol (TYLENOL) 650 mg capsule as pain relief, taken only twice from 02Mar2021 and ongoing.  No follow-up attempts are possible. No further information is expected.
Developed cellulitis/rash at injection site on left thigh with some blistering.  Seen at acute care center day after vaccines given and given keflex; then seen at our office the next day for continued spread and given ceftriaxone with resolution of the rash over the next 2 days.
No adverse event; lower than authorized dose of Moderna bivalent vaccine administered to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 27-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 27-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients).    The concomitant and treatment medication was not reported. This case is reported for 13th patient out of 18 patients.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666280:
Administered expired vaccine to the patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 102 doses.  The vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to MOD-2022-581986 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow up received included non significant information of secondary reporter was added.
Rash on arms, hands, back and one on ankle; Spontaneous report received on 27FEB2020.   A caregiver (consumer's mother) reported that her daughter developed "rash on arms, hands, back and one on ankle" (PT: Rash) following the course of Vivotif for immunisation. The consumer took the course of Vivotif from 22JAN2020 to 28JAN2020. On 20FEB2020, she developed rash. On 27FEB2020, she had rash on her arms, hands and back. It was reported that that the consumer did not have the rash on her stomach and legs except for one on her ankle. The wellness center at her college described it as rash (red round spots) and not hives. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was not recovered at the time of report.  Concurrent medical condition included general allergy and pityriasis versicolor.  Concomitant medications included Albuterol HFA 108 90 base (salbutamol; as needed) which she usually takes before exercise, Singulair (montelukast; 5 mg every night) for general allergy and Benzaclin (benzoyl peroxide/clindamycin) gel as needed for pityriasis versicolor.  Company Comment: A consumer developed rash on arms, hands, back and one on ankle (Rash) three weeks after completing Vivotif course. The patient has a medical history of general allergies and pityriasis versicolor and was using Singulair, Albuterol and Benzaclin gel as needed. Considering patient developed rash after three weeks of completing vivotif course and history of allergies and pityriasis versicolor, the causality of Rash is assessed as unlikely with Vivotif.; Sender's Comments: A consumer developed rash on arms, hands, back and one on ankle (Rash) three weeks after completing Vivotif course. The patient has a medical history of general allergies and pityriasis versicolor and was using Singulair, Albuterol and Benzaclin gel as needed. Considering patient developed rash after three weeks of completing vivotif course and history of allergies and pityriasis versicolor, the causality of Rash is assessed as unlikely with Vivotif.