chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Teniviac expired on 08-march-2020  and was given to a 66 year old female patient with no AE; Initial information received on 09-Mar-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case is linked to case 2020SA065407 (same reporter).  This case involves a 66 year old female patient who received 0.5 ml expired dose of vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number- U5882AA, Expiration date- 08-Mar-2020) via an unknown route at an unknown administration site for prophylactic vaccination on 09-Mar-2020.  Medical history, medical treatment, concomitant therapy, vaccination and family history were not provided.  It is a case of actual medication error due to expired vaccine used.   At the time of report, 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 holders compliance with the requirements set out in Directive and Module VI of the 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.
Left arm had redness, swelling and warm to the touch. Tylenol for pain and Ice packs to site.
Pt 1 of 9 from total of 191 pts who completed series of 3 Hep B vax and failed to achieve immunity. Pt did not seroconvert.
Pt with no known PMH got the 1st dose of vaccine (9/17) and had intermittent left-sided chest pain that started ~2 hours after the vaccine. He reports some right arm pain with the vaccination which is improving however his chest pain is sharp and intermittent. He reports it is left-sided with non-radiation. Reports mild shortness breath associated with chest pain. He reports the chest pain is sometimes worse with sitting up and leaning forward and better with recumbent in supine position. Pt went to an urgent care before coming to hospital ER and was referred here because of a right bundle-branch block seen on EKG. No right bundle-branch block present upon arrival to ER today (9/20).
This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patient had received ZOSTAVAX (lot number not provided) and VARIVAX (lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. Additional information has been requested.
Received seasonal flu and H1N1 vaccine on 1-19-10. Within one hour patient began to feel funny. Throat started to swell, developed hives and had difficulty breathing. Went to ER. Treated with Benadryl and Epi.
Patient received Pfizer Covid 19 5-11 year old vaccine (Pfizer 10mcg dose) and not the Pfizer Covid 19 30mcg dose
On the night that patient received her first dose of the Pfizer Covid vaccine, she had a fever and hallucinations. When she received the second dose, she took ibuprofen preemptively and didn't have any symptoms. Over the next month, she started showing signs of prodromal psychosis and cognitive impairment, particularly with numbers. She started expressing delusional fears. In mid-June, she had a psychotic break. She was hospitalized for 16 days in June, and was released in early July. She was improving steadily and then she received the Pfizer booster on Oct. 3rd. For the next two days, she seemed dazed and out of sorts. Afterwards, she quickly slipped back into psychosis which is still ongoing. She had no prior history of mental illness or dementia, and our family has no history of dementia, living to their mid-90s and staying mentally sharp.
On May 17, 2022 I had a headache and I thought that it was allergies as it I do take Zyrtec. On May 19, 2022 I took a home COVID-19 test that came back positive and called my doctor he prescribed my Paxlovid. On May 22, 2022 I went to the pharmacy and took another test. For me it felt more like a sinus cold and I was really, really tired.
Arm soreness at injection site x4 days. Muscle contractions at site x1 week, still present. Swollen lymph nodes, tiredness x2 days.
Red swollen injection site approx 5hrs post administration. Tender L deltoid to touch & arm moment. Approx 3 days post vaccine L arm > R arm bumpy rash. Overall tired, weak feeling. Arm tenderness continues. Approx 14hrs post arm rash generalized hives over entire torso, neck, face, groom, anterior upper thighs, & L arm. Mild bumpy rash continues in R arm. Hives are prickly, itchy, burning, raised, red and warm. Hives are not responding to BENADRYL. Over all malaise continues with weakness, exhaustion. Afebrile.
Exactly a week after the shot I had an insane migraine for the whole day. After going to bed and waking up the next day, I had a swollen lymph nide under the arm that got the shot (left arm). It was very swollen the first day and gave me pain when lifting heavy things or lifting my arm over my head. Hoping it will go away I didn't do anything about it but it still remains swollen and painful the next day, although perhaps a bit less swollen than in the first day it appeared. The pain on it is always present even if I don't do much with the hand.
Mom described the rxn as 4-5hrs of unconsolable high pitched screaming; no fever; slept well p/this & was fine the next AM;
PATIENT SAID SHE FELT LIGHT HEADED THEN PASSED OUT ALMOST 2 TO 3 MINUTES AFTER RECEIVING THE VACCINE.
Patient is admitted to the hospital with chest pain and an elevated troponin concerning for myocarditis. He first presented with chest pain on 11/30. His chest pain has improved. His troponin continues to be elevated 12/1. His echocardiogram shows normal biventricular function.    COVID vaccine history 4/15/21 - Pfizer 5/8/21 - Pfizer 1st booster 12/15/21 - Pfizer 2nd booster 11/27/22 - Pfizer bivalent
Weak feeling two days following shot and lasting 5-6 days Severe esophagitis  starting 2 days after shot and not improving as of today
Initial unsolicited report received from consumer on 10-Oct-2016. This case is linked to case 2016SA027253, 2016SA027286. This case involves a 69-year-old female patient who was vaccinated with a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (FLUZONE HD) (batch number, expiry date site of administration were not reported) intramuscularly in left deltoid on 16-Oct-2015. Medical history and concomitant medications were not reported. On 17-Oct-2015, four hours following the vaccination patient experienced lethargic and could not move, could not ambulate, and weakness. Laboratory investigation was not reported. Corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
12/12/08 received TC from patient stating she is having a reaction to shots. Her lower right arm has a large bump about 4 cm. It hurts, is red, swollen and itches. Instructed to apply ice and take TYLENOL. 12/15/08 TC patient made to RN at child's school. She reports pt has no redness, swelling or probs with either arm.
got sick once; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves patient (unknown demography) who got sick once (illness), after receiving INFLUENZA VACCINE.  The patient had been getting flu shots for over 30 years.  Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient got sick once following the administration of INFLUENZA VACCINE. No laboratory data reported. It was not reported if the patient received a corrective treatment. At the time of reports, the outcome was not reported for the event illness. There will be no information on the batch number for this case.
The site of administration of the tetanus (we unsure if TD or Tdap) was on the back/bottom of the arm (normal SQ administration). Night of administration the injection site was sore, red and hard, pt also reported having fever and headaches which continue. The next morning the red area around injection site was considerably larger, warm and painful on movement. Doctor was notified and stated that the patient is probably having a reaction to the vaccine itself. Pictures of site was taken that shows the injection site on the posterior aspect of arm and length/width of redness/swelling. Friday evening the red site was larger and surpassed the markings made from the evening before. Saturday evening, redness and swelling has progressed to majority of upper arm with significant pain. He has been taking ibuprofen and Benadryl to alleviate some of the discomfort. Plan is when he returns Mon. night he will be going back to the doctor's office for intervention on Tuesday.
Developed swelling L axilla and weakness L leg per PA note/telehealth appt 11/14.  Mother advised to take pt to ED for further evaluation due to concern about Guillan Barre syndrome.  ED attending note also notes pt c/o of intermittent chest pain.  D/C'd from ED with instructions to treat with Motrin & Tylenol for c/o pain. F/U w/PCP 11/23; urine collected for UA.
upon arrival, patient had head between legs,pale,lethargic and dizziness.she was assisted to laying down on a cot,vs was hypotension,snacks and water was given,elevated legs. after 15 mins patient was stable,wheel out with assist on wheelchair.
On 04/001/2019 around 8:00 PM, he started feeling body aches and extreme fatigue. On 04/03/2019 around 9:00 AM, he started feeling dizzy when he stood up. He is still having body aches and fatigue. He is NOT having fever.
CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via Pfizer (other manufacturer) concerned a 52 year old female of unspecified race and ethnic origin. Initial information was processed along with the additional information received on 16-JUN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: unspecified drug allergy, and other pre-existing medical conditions included: patient was not pregnant at the time of vaccination and patient was not taking any other medications within 2 weeks of starting COVID-19 treatment. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: unknown) dose was not reported, 1 total administered in right arm on 10-APR-2021 13:00 for prophylactic vaccination. Age at time of vaccination was 51 years. No concomitant medications were reported. The patient additionally received non-company suspect vaccine spikevax (elasomeran) (dose number in series 2) (form of admin, route of admin were not reported, batch number: 027H21B, expiry: unknown) dose was not reported, administered in left arm on 28-NOV-2021 15:00 for prophylactic vaccination. Age at time of vaccination was 51 years. The patient took Paxlovid for treatment of Covid-19 from 12-MAY-2022 to 16-MAY-2022. The patient tested negative for Covid-19 for several days and then on 22-MAY-2022, the patient started feeling ill. On 22-MAY-2022 and 23-MAY-2022, the patient tested positive for Covid-19 (confirmed covid-19 infection) (dose number in series 2) which led to confirmed clinical vaccination failure (dose number in series 1). On 23-MAY-2022, the patient had severe nausea and vomiting and on 24-MAY-2022 was able to drink liquids. Laboratory data included: COVID-19 virus test Positive. On 23-MAY-2022, Laboratory data included: COVID-19 virus test Positive. Laboratory data (dates unspecified) included: COVID-19 virus test Negative. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000235986.; Sender's Comments: V0:20220630545 -covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
A patient had a second trimester fetal loss right after getting the Covid vaccine.; A patient had a second trimester fetal loss right after getting the Covid vaccine.; This is a spontaneous report from a contactable physician. An adult female patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at an unknown dose on an unknown date via an unknown route for Covid-19 immunization. Medical history and concomitant drug were not provided. Medical history and concomitant drug were not provided. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Patient had 32 weeks gestation period. Patient had a "second trimester" (as reported) fetal loss right after getting the Covid vaccine. The event onset date was Jun2021. Treatment received for the event. It was unknown if the patient diagnosed with COVID-19 prior to vaccination, and unknown if the patient been tested for COVID-19 since the vaccination.   The report was assessed as serious with seriousness criteria of hospitalization.   Information on lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of bnt162b2 cannot be excluded for the reported events miscarriage.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Since the vaccine  however I am experiencing arthritis type symptoms on the right side of my body which is  the side vaccine was administered. The next morning my whole side was stiff and my thumb locked. My big toe has pain my left leg at the top socket has pain  and my big toe. I cannot move my thumb in the mornings. I felt like it was maybe trigger finger but other joints unrelated like my big toe are having trouble
(R) lateral thigh with 2 injection sites with mild erythema around about 2 cm. 3 cm induration under site of erythema. No fever. (L) later thigh with injection site with erythema with induration about 2 cm.
Tachycardia; shortness of breath; dizziness experienced driving after leaving Hospital. I went to the ER. Cardiac workup negative. Symptoms resolved. Fatigue/dizziness for 3 days.
Syncopal Episode in the doctor's office, while standing, caught by nurse and myselfe(mother), accompanied by seizure activity.  We lifted her on the exam table and she "came to" after about one minute.  As a mother, I am very concerned after reading all of the internet reports of adverse effects.  I will not complete the next two treatments.
headache; neck pain; fever; This is a spontaneous report from a contactable consumer (patient herself) from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown), via an unspecified route of administration on 03Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache, neck pain and fever after the first dose on an unspecified date in Mar2021. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown), via an unspecified route of administration on 24Mar2021 as dose 2, single for COVID-19 immunization. It was reported that she got the 2 doses of the Pfizer vaccine. She noticed that the record in her vaccination card, the second dose only had the expiration date while the first dose did not have any expiration date. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Has a red circle at injection site; red circle at injection site feels like a bruise; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Has a red circle at injection site), VACCINATION SITE PAIN (red circle at injection site feels like a bruise) and RHINORRHOEA (Runny nose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and MULTI VITAMIN & MINERAL.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (red circle at injection site feels like a bruise) and RHINORRHOEA (Runny nose). On 14-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Has a red circle at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Has a red circle at injection site), VACCINATION SITE PAIN (red circle at injection site feels like a bruise) and RHINORRHOEA (Runny nose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included unknown antidepressants.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Metallic taste in mouth; Numbness below ear; Right tongue went numb; Right cheek was tingling / Tingly sensation similar to shingles; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste in mouth), HYPOAESTHESIA (Numbness below ear), HYPOAESTHESIA ORAL (Right tongue went numb) and PARAESTHESIA (Right cheek was tingling / Tingly sensation similar to shingles) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025a21a) for COVID-19 vaccination.     Previously administered products included for an unreported indication: VARICELLA ZOSTER VACCINE. Past adverse reactions to the above products included Tingling sensation with VARICELLA ZOSTER VACCINE. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced DYSGEUSIA (Metallic taste in mouth), HYPOAESTHESIA (Numbness below ear), HYPOAESTHESIA ORAL (Right tongue went numb) and PARAESTHESIA (Right cheek was tingling / Tingly sensation similar to shingles). At the time of the report, DYSGEUSIA (Metallic taste in mouth), HYPOAESTHESIA (Numbness below ear), HYPOAESTHESIA ORAL (Right tongue went numb) and PARAESTHESIA (Right cheek was tingling / Tingly sensation similar to shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Pt recv vax on 11/14/98; on 11/28/98 pt exp Guillain Barre syndrome; pt hosp
Rash on forehead, chest, back. Rash looks like acne, which I often get after exercising in the heat, sweating a lot, and not changing out of sweatly clothes quickly enough. Managing with benadryl.
administered more than 30 days after 1/11/22 are not in accordance with the EUA; 82 patients administered expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (82 patients administered expired moderna vaccine) and PRODUCT STORAGE ERROR (administered more than 30 days after 1/11/22 are not in accordance with the EUA) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A, 016B21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (82 patients administered expired moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered more than 30 days after 1/11/22 are not in accordance with the EUA). At the time of the report, EXPIRED PRODUCT ADMINISTERED (82 patients administered expired moderna vaccine) and PRODUCT STORAGE ERROR (administered more than 30 days after 1/11/22 are not in accordance with the EUA) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Date the vial was initially stored in the refrigerator on 11-Jan-2022. The vial did not undergo any temperature excursions. No patient has reported adverse reaction. No treatment medications were reported.
Information has been received from an employee in a physician's office concerning a 4 year old white male who on 07-OCT-2003 at 11:53 a.m. was vaccinated in the left arm with a first dose of Varivax (lot # 644571/1160M). On 10-AUG-2006, the patient developed chickenpox. Subsequently, the patient recovered on an unspecified date. No further information is expected.
Child developed "golf ball" size swelling on leg which received Pediarix and Hib 4 hrs after injections. Cried inconsolably X 1 1/2hrs according to mom.
Urticaria pigmentosa 7 days following injection of 1-ml IMOVAX RABIES. This was the final dose in the series. OTC H1 blockers were not effective, an injection of Kenalog was received in ECU, which did provide relief. Giant hives are resolving.
Information has been received from a health professional concerning a female employee in her 20's, with no history of shingles, who worked in a small area where close to 1000 doses of Zostavax (Oka/Merck) was administered to patients since August 2006. It was confirmed that the patient was not vaccinated with Zostavax (Oka/Merck). Subsequently the patient was diagnosed with shingles by her physician and treated. It was noted that the patient had shingles twice and suffered a miscarriage. No product quality complaint was involved. No other information was provided. Upon internal review, the patient's miscarriage was considered to be an other important medical event. This is one of several reports from the same source. Additional information has been requested.
1-2wk p/vax pt joint pain lasting 2wk (in knees & hips);numbness (desensitization) in fingertips more prominent in lt hand lasting to the present time of this report;
Achy, tired, severe chills, afebrile, headache, severe achy joints
During mass Flu Clinic for adults and children I gave "Fluarix" to a child, meant for adults 18 years and older by mistake. No known adverse events.  No adverse events occurred.