chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received 0.5 mL instead of 0.25 mL for booster dose; THe patient received a single dose of Johnson nad Johnson and then booster dose of Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received 0.5 mL instead of 0.25 mL for booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (THe patient received a single dose of Johnson nad Johnson and then booster dose of Moderna) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Received 0.5 mL instead of 0.25 mL for booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (THe patient received a single dose of Johnson nad Johnson and then booster dose of Moderna). On 22-Oct-2021, INCORRECT DOSE ADMINISTERED (Received 0.5 mL instead of 0.25 mL for booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (THe patient received a single dose of Johnson nad Johnson and then booster dose of Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported.  The patient received a single dose of Johnson and Johnson vaccine, and then received booster dose of Moderna COVID-19 Vaccine. The patient was not asked whether immunocompromised or not.
Nausea; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and DIARRHOEA (Diarrhea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.    Co-suspect product included non-company product ONDANSETRON (ZOFRAN [ONDANSETRON]) for an unknown indication.    No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ONDANSETRON (ZOFRAN [ONDANSETRON]) (unknown route) 4 mg. On 04-Mar-2021, the patient experienced NAUSEA (Nausea) and DIARRHOEA (Diarrhea). At the time of the report, NAUSEA (Nausea) and DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was provided.
pt states exp swelling of the tongue, diff swallowing & chills approx 4hrs p/vax;these sxs lasted approx 2hrs & did not seek tx
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with ZOSTAVAX by a physician as recommended for Permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In October 2015, the patient was treated the same physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Approximately 3 minutes after receiving the Pfizer covid vaccine, I began feeling tingling in the tip of my tongue. The tingling continued to spread over the next 10 minutes to both sides of tongue, towards the back. After about 15 minutes, I started to feel some stiffness of my jaw and teeth.  About 45 minutes later, I took 25mg benadryl at home.  The tingling and stiffness lasted a total of about 2 hours.
Developed Pericarditis.  Severe chest pain, trouble breathing, shoulder and arm pain, extreme fatigue.  Went to a 24-hour medical clinic and they thought it was muscular and prescribed Prednisone.  The chest pain continued to be severe and I began to have trouble breathing.  At this point I went to the Emergency Room, where I was diagnosed with Pericarditis. **My first Covid Vaccine's LOT # was changed: someone crossed out the last number on the lot number (that was stamped on my card) and hand wrote a different number on top of it.  The original lot number was: EW0169, but when I received the card, a 2 was hand-written over the 9.  This was my first Covid vaccine, given on 04/17/2021
lost her smell; extremely tired; bad headache; congestion/ felt like a really bad sinus infection; felt like a really bad sinus infection; This is a spontaneous report from a contactable healthcare professional (HCP, patient herself). A 22-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL1283, expiration date was unknown), via an unspecified route of administration on the left arm on 21Jan2021 at 19:15 at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was reported as the hospital. The patient had no medical history; she had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. 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. Since the vaccination, the patient had not been tested for COVID-19. On Monday, 25Jan2021 at 04:00, the patient woke up with a bad headache and congestion and it worsened up until Tuesday. It felt like a really bad sinus infection. Then on Tuesday night, 26Jan2021, the patient lost her smell and she was also extremely tired. The reporter assessed the events as non-serious. The patient did not receive any treatment for the adverse events. The patient was not recovered from all the events.
acute cerebellar ataxia;awoke morning of 29SEP ataxic;also withdrawn, sl sleepy, unwilling to speak & following few commands;both truncel & appendicular ataxia;38WBC-CSF;no antecedent illnesses;other w/u negative;
4 month old patients had received a Quadracel/No adverse effects reported.; Initial information received on 30-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 4 months old female patient who received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] lot C54978A, expiry date- 17-Jul-2020 via intramuscular route in the right thigh on 29-Jan-2019.  The patient's past vaccination(s) included DAPTACEL and IPV in NOV-2018. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) for Immunisation; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation on 29-JAN-2019.  It was a case of actual medication error due to inappropriate age at vaccine administration.  No adverse effects 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.
pt recv vax & 6 days prior to vax on 9OCT95;a few days p/latter vax pt lost sense of smell;
Vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: VERTIGO (non-serious), outcome "unknown".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Child developed urticaria and peripheral angioedema approx 2-3 hours after 2-month immunizations given (DTaP, IPV, Comvax, PCV-7).  Treated with Orapred, 5-day ubrst at 2 mg/kg/day
Reporter indicated that 10 pts did not respond p/receiving 3 doses of Engerix-B; titers were checked approx 1 to 1 1/2 months p/3rd inject;
RPh gave shot, but only gave Adjuvant.  After shot given, peeling labels off vials, it was discovered that only adjuvant was given, and the vaccine was still in its vial, in powder form.  Had to use a second Adjuvant, to mix the powder, to give shot.  Pt rec'd  "2 doses" of adjuvant.    Outcome was no adverse effects.  MD was notified immediately of RPh's error.  Pt reported no ill effects and no ill effects 5months later.   Pt did report local tenderness, to both arms.  (Left arm rec'd adjuvant only) (Right arm rec'd vaccine+adjuvant).
I had knee replacement surgery on Feb. 17th and the recovery went well.  I am a healthy, athletic 63 year old male with no prior history of clots nor any known family history. On March 16th, I received the J & J vaccine at the urging of PCP and so I could visit my elderly aunt, who was on hospice care.  Toward the end of May I started to feel very fatigued and was having bilateral joint pain and achy legs which was worse at night when I layed down.  My legs had an incredible ?heaviness? to them, almost like It got so bad that in mid june I contacted my primary doctor and he referred me to the knee surgeon.  The knee surgeon said it wasn?t related to the knee surgery because it was bi-lateral and heaviness is not a common issue related to knee replacement issues.  He thought it might be vascular or nerve or spine related.  I was out of state and flew home to have blood tests done and basically they all retuned normal.  Eventually from insistence by myself, my doctor had mri?s and x-rays done which revealed my spine was not causing the issues with the legs.  During a CT scan for my kidneys, the tech found a pulmonary embolism of my right lower lobe and extending into several segmental arteries.  The doctor is calling it a ?unprovoked? pulmonary embolism. over the last few weeks, I have noticed my eye sight has had moment difficulty focusing long distance and then will clear.  I have better then 20/20 vision.   Throughout my treatment, PCP has repeatedly denied that any of my issues can be related to the JJ vaccine and my doctor said it was ?google? searches that made me think this.  While meeting with a facility Head and Throat surgeon for a parathyroid surgery consult, he urged me to notify the VAERS system because he believed it was all related to J&J vaccine as well.  I am now on blood thinners looking for answers and hoping that some answer can be given as to how this happened by a specialist.
This is spontaneous report from a Pfizer sponsored program COVAX US Support. A contactable consumer reported on behalf of a female patient (mother). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had the second dose appointment on 06Apr, however tested positive to COVID-19 Virus on an unspecified date. Caller wanted to know if her mother can take the vaccine because her quarantine would almost be over. The patient underwent lab tests and procedures which included SAR-COV-2 test which was positive on an unspecified date.  No follow-up attempts are possible. Information about lot/batch cannot be obtained.
Accidentally gave an extra hib with a pentacel. Pediarix was suppose to be the vaccine given.  No symptoms.
pt recv vax & devel an inj site rxn characterized by swelling from the deltoid to the forearm for 3 days;pt also had fever & cough for one day;pt tx w/meds;
I became very weak following my vaccine. My arm where the injection was inserted had a strange feeling. It took me about 1 hour before I felt able to drive myself home. Nurses gave me 2 bottles of water and took my blood pressure. It was 150/84 higher than normal for me.
she hurts in her body, nausea, headache. No cough, no SOB, c/o chest pain on inspiration intermittently, more a sharp pain near the center just above the breastbone, not a squeezing or a pressure substernal  Took some APAP and took alleve 20 min ago  I adv that the body aches, N, HA all may be consistent with ADR to the vaccine and generally should be limited to a few days, ok to take OTC pain relievers but not in excess to bottle recommendations. Keep hydrated. Consider a hot pack. Watch the chest pain if this persists or worsens,  consider HCF evaluation, though given the body pain throughout and location of the pain may be muscular.
INFLAMMATION OF THE OPTIC NERVE; This spontaneous report received from a consumer via social media concerned a female of unspecified age, race and ethnicity. 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, and batch number were not reported) 1 total, dose (Dose series number : 1) and start therapy date were not reported for prophylactic vaccination.  The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The reporter stated that, on an unspecified date, the "patient lost sight completely in her right eye, and 3 days later, inflammation of the optic nerve. Doctor said fault of the vaccine 100 percent." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inflammation of the optic nerve (lost sight completely in right eye) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211234734 -COVID-19 VACCINE AD26.COV2.S- inflammation of optic nerve. 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).
Woke up next day with still neck and headache.(8/2/07) Following day (8/3) still have still neck.
Expired Drug Used; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number ABXC05AA, expiry date 31-MAR-2023) for prophylaxis.   On 09-MAY-2023, the patient received Bexsero. On 09-MAY-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Drug Used). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 09-May-2023 The vaccine administration facility was the same as primary reporter. The reporter did not have patient demographics at the time of the call. The reporter consented to follow-up via postal. The patient received an expired dose of Bexsero, which led to expired vaccine used.
Patient had a scan and should stage 4 peritoneal cancer after going through esophageal cancer and being on neoadjunct chemo.  Scan in July '21 showed no evidence of mets
At injection site a welt with red line going up pt arm. Pt starting vomiting and running low grade fever.
Pt given Pneumovax 23 prior to discharge the following day developed 106 fever, flu like symptoms, and 4 x 8cm red area where received shot.
Headache, Sedation, Myalgia, Arthralgia, chills and fatigue. pain at the injection site. Narrative:
body aches; felt weird all of the next day; knot at the injection site; severe itching at the injection site; fever; chills; Redness at the injection site; This spontaneous case was reported by a dietician and describes the occurrence of PYREXIA (fever), PAIN (body aches), CHILLS (chills), FEELING ABNORMAL (felt weird all of the next day) and VACCINATION SITE INDURATION (knot at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 21-Dec-2020, Fever on 21-Dec-2020 and Headache on 21-Dec-2020. Concomitant products included LEVOTHYROXINE, ATORVASTATIN, GLUCOSAMINE, MULTIVITAMIN [VITAMINS NOS] and OSPEMIFENE (OSPHENA) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PYREXIA (fever), PAIN (body aches), CHILLS (chills), FEELING ABNORMAL (felt weird all of the next day), VACCINATION SITE INDURATION (knot at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PRURITUS (severe itching at the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. In February 2021, PYREXIA (fever), PAIN (body aches), CHILLS (chills), FEELING ABNORMAL (felt weird all of the next day) and VACCINATION SITE INDURATION (knot at the injection site) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PRURITUS (severe itching at the injection site) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Started stiff and could not move right arm for 3 days.  Then the soreness moved down arm and wake up in middle of night.  Went to orthopedic specialist and had x-ray to determine if arthritis or infection.
Initial unsolicited report received from a physician on 10 November 2016. This case involves a 55-year-old female patient who was vaccinated with a dose of Adacel (Batch number: U5502AA, expiry date: 24 November 2018, dose, dose in series and route of administration were not reported) in right deltoid on 01 November 2016. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as none. Illness at the time of vaccination was also reported as none. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were reported as unknown. On 01 November 2016 in the evening, same day following the vaccination, the patient had developed pain at injection site which was persistent and had continued for nine days. The patient was unable to abduct her right arm greater than 90 degrees. She was rating her pain a 9 out of scale of 10. There was no redness, warmth or swelling at injection site. It was reported that the patient had received prior doses of Adacel. The patient required emergency room (ER)/ doctor visit. Laboratory investigations were reported as none. Corrective treatment was not reported. The outcome of events was reported as unknown. List of documents held by sender: none.
Low grade fever (100.2) and headache; pregnant at time of vaccination, due date 3/27/2021
They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial) 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 WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial).    Concomitant medication was not reported.  Patient age was between 6 months to 5-years.  The vaccination clinic received incorrect guidance from the Department of Health in regard to the vaccination, who instructed to order and administer the vials with pink top to 6month-5year previously unvaccinated patients when the switch from monovalent to bivalent happened. This resulted in 24 patients being under vaccinated.  It was reported that 24 pediatric patients were administered underdose bivalent vaccine doses for either their first or second doses. They received 0.2 ml dose from the pink vial instead of the 0.25 ml dose from the blue cap vial. The patients were being contacted and revaccinated with the correct dose.  Treatment medication was not reported.  This case contains information for the 2nd of 24 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723339 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:master case