chrisvoncsefalvay/vaers-outcomes huggingface dataset:
30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date).    This case contains information for the 20th of 30 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  There were 13, 11, and 6 different doses were given. The 30 patients received Monovalent Moderna Vaccine past the manufacturer's expiration date.   The batch lot number was reported as 022D21A which was expired on 20 April 2022. The Lot number 033F21A which was expired on 08 April 2022. The Lot number 037C21A expired on 02 January 2022.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-703461 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-703461:Master case
On 12/1, pt had temp of 101.8 & was given Tylenol; child then began staring at ceiling,stiff as a board,ticking of head.On the way to dr child turned blue & had saliva coming out of her mouth.Dr dxed as febrile seizure which lasted 20 min.
Redness and tenderness distally to elbow and proximally to shoulder. Cellulitis.
received first dose/ on 05Aug2019 / second dose/not /been administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 5th August 2019).   On an unknown date, the patient received 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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination  The pharmacist was unable to locate lot number and expiration date of first dose. No further information was reported. The pharmacist gave permission for follow up. The case had been linked with US2021151021, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021151021:same reporter
Swelling, redness, itching pain at injection site that spread to entire forearm, still present.
Mother phoned and said her daughter received DTaP around 1:30 pm on 1/10/08.  At around midnight pt had temperature of 100 degrees F and vomited.  States she felt better after vomiting and felt fine the next morning.
Patient discharged after (4) day in patient admission.  Patient is a 61 y.o. female who presents today after a fall at home last night inside her home.  Patient was walking from the bathroom to the living room, when her lower extremity weakness caused her to fall onto her left side.  Patient was able to contact her son and get herself to the chair after being on the floor for about 10 minutes.  She states that she has been having progressive weakness in her arms and legs with numbness and tingling.  She has been having workup for the past few months in regards to this.  She has had an MRI of the brain which was unremarkable.  She had a MRI cervical spine which showed C4-5 spinal count stenosis and C3-C4 and C4-C5 foraminal stenosis.  She was also scheduled to get MRI lumbar spine, however, this was unable to be performed.  She was refer to ortho spine, and PM&R.  Patient states that she was told that if she has any worsening symptoms she did come to the emergency department.  She states that in the last few weeks she has had increasing bladder and bowel incontinence.  She feels like she has more weakness and numbness in her extremities as well.  She continues to have pain in her neck as well as her lower back.   Emergency department, patient is hemodynamically stable.  Labs show hemoglobin of 9.9, though she does have a history of chronic anemia.  X-ray of her left knee as well as tib/fib did not show any acute fracture.  Patient unable to ambulate well and therefore it was felt that she should be admitted for further observation and evaluation.  PLAN B/L Upper and lower extremity weakness/numbness Bladder and rectal incontinence Multiple falls: - MRI cervical spine from 09/14 shows moderate C4-5 spinal canal stenosis with effacement of ventral and dorsal CSF and compression of the cord.  Severe right C3-4 and left C4-5 foraminal stenosis.  Bilateral C3-4 and C4-5 facet effusions with edema.   - left knee xray negative for acute fracture - left tibia/fibula xray negative for acute fracture - increasing number of falls over past few weeks - neuro checks - MRI lumbar spine - consult orthospine - consult PT/OT   Asymptomatic COVID-19: - incidental findings - patient has a sore throat but otherwise without shortness of breath or cough - onset unknown - consider reaching out to Monoclonal antibody team in AM for treatment if patient is eligible.     Chronic anemia: - occasional bleeding from hemorrhoids - check iron studies - repeat hgb in AM   Hypothyroid: - check TSH (last check in 5/2021 was WNL) - continue levothyroxine   Essential hypertension: - continue atenolol and diltiazem   GERD: - continue PPI   RLL syndrome: - continue ropinirole   DVT prophylaxis: early and progressive mobilization Code Status:  Full code, per discussion with patient
Localized cellulitis to right upper arms with significant redness, swelling, warmth, and tenderness.
56 yo female from pharmacy presented to the observation room at ~1116 after receiving COVID vaccine.  She reports feeling weakness and dizziness.  She states she fellt sensation to her neck immediately after she got the vaccine.  Pt appears very anxious.  Provided cold pack behind her neck and vital signs taken 152/90 with HR 98 O2 SAT 98%.  Pt then taken to the gurney to lay down.  Pt continued to feel weak with short of breath, tingling finger tips.  100% NR mask provided, Dr notified and arrived immediately.  vital signs taken every 5-10 min with b/p trending down within 20 minutes.  Pt states felt better around 1150.  Attempted to sit up but states felt weak again. Pt felt anxious and wanted to speak to her husband, Medic, called husband and was able to speak to him. Pt continues to feel weak. Continue to monitor and comfort provided. Discussed with medical team that patient need to be sent to the ER for further observation.  911 called at 1215 and arrived within few minutes, report given to EMS.  Patient transferred to ER at 1230 via gurney. 1117: 152/90,HR 103, O2 sat 98% 1121: 144/72, HR 89, O2 SAT 99%-applied O2 100% non rebreather mask 1126: 153/88, HR 80 1142: 160/92, HR 85, O2 SAT 100% 1147: 147/85, HR 77, O2 SAT 100% 1152: 136/85, HR 70, 02 SAT 100% 1202: 133/81, HR 68, 02 SAT 99%
Developed pain in opposite arm that then turned into muscle weakness and limited mobility. This has radiated to the other arm. Was diagnosed with Brachial Neuritis.
After getting vaccinated. Patient felt dizzy and shortness of breath, parking team sat him down in wheelchair. Medics responded, mouth feels dry. Feels a little light headed.  HR 160, BP 130/85 at 9:30am. HR 151, BP 177/94 at 9:35am.  Facial flushing. Loss of color in face.  Transport to hospital.
Swelling of tongue and lips. Benadryl administered orally. Swelling went down within 20 minutes.
I got it on Friday about 430.  Later that night my arm got sore.  Then Saturday during the day I started getting sore all over, had chills, headache, and took ibuprofen.  Saturday night I also ran a low grade temp of 100.3 and felt terrible, took Tylenol.  I started coughing during the night, which is said not to be vaccine related but I didn't have a cough or any of these symptoms prior to receiving the vaccine.  Today I still have a low grade temp, headache, fatigue, and a heavy feeling, but much better than last night.
Information has been received from a nurse practitioner concerning a 23 year old female patient with no pertinent medical history, no drug reactions/allergies who on 08-JUL-2010 received the first 0.5 ml dose of GARDASIL (lot no. 665768/1377Y) IM. Concomitant therapy included MIRCETTE, multivitamins and flax seed. On approximately 10-JUL-2010, "2-3 days after the vaccination", the patient experienced local site reaction. The injection site was red and swollen. On approximately 17-JUL-2010, the patient recovered, the reaction lasted about one week. On 07-SEP-2010 the patient received the second 0.5 ml dose of GARDASIL (lot No. 665768/1377Y) IM. On approximately 09-SEP-2010 the patient experienced local site reaction, the injection site was red and swollen. It lasted about one week and on approximately 16-SEP-2010, the patient recovered. The patient sought unspecified medical attention. Follow-up information has been received from a physician (also reported as a nurse practitioner) concerning a 23 year old female patient who at 8:12 AM on 07-SEP-2010 received the second dose of GARDASIL (lot No. 665768/1377Y) IM in the right deltoid. On 09-SEP-2010, the patient developed erythema, swelling and pruritus 2 to 3 days following injection. The patient also "felt loopy". The patient recovered at time of report. Additional information not expected.
2 weeks ago she had a mild case of Covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (2 weeks ago she had a mild case of Covid 19) in a female patient of an unknown age 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 19-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In March 2023, the patient experienced COVID-19 (2 weeks ago she had a mild case of Covid 19). At the time of the report, COVID-19 (2 weeks ago she had a mild case of Covid 19) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Patient received Moderna Covid 19 last booster and 2 weeks ago patient had a mild case of Covid 19  No treatment information was provided by the reporter.
Patient presented to the Emergency Department with Chest Pressure.  EKG presented as abnormal.  Provider states that the patient may have myocarditis as an etiology of his diffuse ST segment elevation.  Patient also has an elevated troponin.  Patient was transferred to a larger hospital with a Cardiology provider.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown demographics. On an unkonwn date the patient were vaccinated with GARDASIL that were stored improperly for an unknown indication. No adverse effect reported. Additional information has been requested.
Patient said the day after injection she was ok but the next day she had pain through her arm that she got the flu shot. Said she had to see her MD & also go to the emergency room. She still has pain to date and also claims that her range of motion was limited. Patient called 10/1/11 to notify off problem.
Mom first reported AE on 1/18/01. Evening of vax, pt developed a dozed look had been crying alot, had been limp, no longer able to sit up by herself, eyes frequently rolled back mother reports these symptoms occurred five times a day for approximately 1 min at a time for the 1st week after vax, symptoms were slowing down 1/18 on 1/19 all was normal.
numbness on left side of the face; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness on left side of the face) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced HYPOAESTHESIA (numbness on left side of the face). At the time of the report, HYPOAESTHESIA (numbness on left side of the face) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment was reported for this event.
Chills; Dizziness; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), DIZZINESS (Dizziness), HEADACHE (Headache) and NAUSEA (Nausea) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced CHILLS (Chills), DIZZINESS (Dizziness), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, CHILLS (Chills), DIZZINESS (Dizziness), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Fainting : transfer to emergency room for gash on forehead after hitting head on floor; glue suture about 1 inch Headaches, fatigue, faint: 4- 6 days following vaccine Swollen/red gums: 6 days after vaccine; treated with antibiotics Sinus Infection: 6 days after vaccine; treated with antibiotics
Flu vaccine was administered in the morning on an empty stomach and patient passed out/informed primary MD.
This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to an unspecified number of patients of unknown age and gender. Medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored of GARDASIL (lot# K010215 with expiration date 05-MAY-2017 and lot# K011562 with expiration date 08-APR-2017, dose and route of administration were not provided). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Case number PHEH2014US023710 is an initial spontaneous report received from a consumer on 24 Nov 2014. This report refers to a 53 years old female patient. She was a tobacco smoker and her current conditions included allergy to Aspirin, ibuprofen and LORTAB. Her concomitant medication included omeprazole. Her vaccination history included administration of ZOSTAVAX (other manufacturer, batch number: not reported) at a dose of 0.65 ml and PNEUMOVAX (other manufacturer, batch number: not reported) at a dose of 0.5 ml; both vaccines given on 06 Oct 2009, Tdap (other manufacturer, batch number: not reported) at a dose of 0.5 ml on 05 May 2013, FLUZONE (other manufacturer, batch number: not reported) at a dose of 0.5 ml in Jul 2014 and an unknown vaccine at a dose of 0.5 ml in the left deltoid at 4:10 pm in Jul 2014. She had no illness at time of vaccination. She was vaccinated with a dose of FLUVIRIN (batch number: 14583P) in the left deltoid on 14 Nov 2014 at 4:10 pm. Within 3 to 4 minutes after the shot, she felt ill with a head rush, dizziness, throat constriction and she was feeling hot. 20 minutes after the flu shot, at 4:30 pm, she said that she was feeling a funny metallic taste her mouth and asked for paramedics. She went to emergency room and received BENADRYL and steroid injection. She refused to leave with paramedics and stated that she would go to hospital with her husband. The event outcome was reported as complete recovery. The seriousness was not reported, but the event throat tightness was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
This spontaneous report was received from a physician refers to a 4 months old male patient who on an unknown date, was vaccinated with the second dose of ROTATEQ, oral (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that on an unknown date, the patient experienced diarrhea. The patient sought medical attention by having an office visit. No treatment was given for the experience. On an unspecified date, an ultra sound was performed and showed that the bowels were not twisted. It was stated that therapy with ROTATEQ was discontinued and not reintroduced. At the time of the report, the patient's outcome was unknown. The relatedness for patient has his second dose of ROTATEQ and experienced diarrhea was unknown for ROTATEQ, Oral. Additional information has been requested.
High fever 105.4 F; This is a spontaneous report from a contactable consumer reported for (himself). A 36-year-old male received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number & Expiry date not reported) second dose via intramuscular route of administration in left arm on 28Jan2021 12:45 (at age of 36years) as SINGLE DOSE for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient had no known allergies to medications, food, or other products. Nasal swab test was performed which was negative in 26Dec2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient previously received first dose of bnt162b2 via intramuscular route of administration in left arm on 02Jan2021 15:30 as single dose for COVID-19 immunization. On 29Jan2021 at 12:45, patient experienced high fever 105.4 F. Treatment received for event was Tylenol. Lab tests performed was: Nasal swab test which was negative on 26Dec2020. The Outcome of event was Recovering.   Follow-up (15Apr2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Severe redness, swelling and warmth at injection site that is spreading across entire back over 24 hours after injection.; Severe redness, swelling and warmth at injection site that is spreading across entire back over 24 hours after injection.; Severe redness, swelling and warmth at injection site that is spreading across entire back over 24 hours after injection.; This is a spontaneous report from a contactable Nurse reporting for herself. A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), intramuscular, administered in left arm on 03Feb2021 11:30 as UNKNOWN, SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 04Feb2021 the patient experienced severe redness, swelling and warmth at injection site that is spreading across entire back over 24 hours after injection. Therapeutic measures taken for the events included treatment with Benadryl and Prednisone. Clinical outcome of the events was recovering.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
stated patient was given TENIVAC but should have received ADACEL instead with no AE; Initial information received on 14-Dec-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 24 years old female patient who received DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Suspension for injection)(ADACEL) (wrong product administered).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  On 14-Dec-2020, patient received DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Suspension for injection)(ADACEL) (lot number: not reported, expiry date: unknown) via unknown route and site for prophylactic vaccination (wrong product administered). Nurse Practitioner wants to know how long they have to wait before administering ADACEL.  It was an actual medication error due to the Wrong vaccine administered (latency same day).  At the time of report, no adverse event was reported.  No laboratory date was reported.  The event outcome not applicable.  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.
2 Blisters developed. Contents were clear fluid only which were drained upon rupture intentionally performed by patient. Blister formed once more, drained, and did not return. Area appears to be healing post-rupture 5 days in.
This spontaneous report as received from a pharmacist via Company Representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # were unknown). On an unknown date the patient experienced shingles. The outcome of event was unknown. Additional information has been requested.