chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Maladministration of Priorix prefilled syringe (diluent only) without being mixed; Maladministration of Priorix prefilled syringe (diluent only) without being mixed; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Maladministration of Priorix prefilled syringe (diluent only) without being mixed) and inappropriate dose of vaccine administered (Verbatim: Maladministration of Priorix prefilled syringe (diluent only) without being mixed).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were 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: 6-Sept-2023 Medical information department had just received the veevaCRM.  The reporter asked that if there was any information on Priorix being reconstituted incorrectly and he was concerned that the Priorix prefilled syringe (diluent only) might be given to a patient without being mixed with the accompanying vial of vaccine.  The reporter also asked that did they have any data of the frequency of this happening. The reporter consented to follow-up. The patient received only received diluent of Priorix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
trouble breathing so went to the ER; had a flare up that has gotten worse with expansion of a rash and blisters; had a flare up that has gotten worse with expansion of a rash and blisters; had a flare up that has gotten worse with expansion of a rash and blisters; "extreme itching" over the body; They are not sure if reaction is from the vaccine, Stelera, or the combination of both; This is a spontaneous report from a contactable pharmacist. A 67-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 23Jun2021 as dose 1 single (at the age of 67-year-old) for COVID-19 immunization. Medical history was not reported. Concomitant medications included ustekinumab (STELERA) from 19Apr2021 to 19May2021, hydrocortisone (HUMERA). On 24Jun2021, patient experienced a flare up that has gotten worse with expansion of a rash and blisters with extreme itching over the body and on 29Jun2021 was having trouble breathing so went to the ER, was treated and sent home. It was reported that patient was on Humera of years but back in Apr was started on Stelara  got first dose on 19Apr2021 and a second dose on 19May2021, patient spoke with HCP and getting the Pfizer COVID-19 vaccine and HCP said it was okay to do so patient received the first dose of the Pfizer COVID-19 on23Jun2021. On an unspecified date in Jun2021, they were not sure if reaction was from the vaccine, Stelera, or the combination of both, so looking to see if we have any information on this. Adverse reactions in clinical trials, adverse reactions in post authorization experience. The outcome of the events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events dyspnoea, dermatitis, rash, blisters, pruritus, potentiating drug interaction and the suspect drug "BNT162B2" cannot be excluded. The case will be reassessed once new information is available. 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.
This spontaneous report as received from a physician, via a company representative, refers to a female patient of unknown age. Information about the patient's medical history and concurrent conditions was not provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL (Administration route, lot number and expiration date were not reported). Concomitant therapies included an unspecified Hepatitis A virus vaccine. According to the reporter, after having been vaccinated, the patient's tongue got swollen (swollen tongue), and her physician said it seemed "like an anaphylaxis reaction" (anaphylactic reaction). The outcome of swollen tongue and anaphylactic reaction was unknown at the time of this report. The reporter did not provide a causality relationship assessment between the events and therapy with GARDASIL. Additional information has been requested.
Initial report was received 03 November 2011 from a health care professional. A 55-year-old male patient with a history of COPD and allergy to Codeine had received an intramuscular left deltoid injection of FLUZONE, lot number UH486AE on 01 November 2011 and on the day of vaccination, he developed a swollen tongue, swollen lower lip, expectorating mucus and shortness of breath. The patient did not report any self treatment. The patient received FLUZONE yearly and state they felt "flu like" each time they received the vaccine. The patient had no concurrent illness, no concomitant medications and he had not received any other vaccines within four weeks of FLUZONE. Outcome was not reported. Documents held by sender: None.
4" red hot swelling at site of injection on upper arm,  pain, itchy feeling lingers  Fever x 2 days (101.4 degrees)   Nausea 1 day Headache x3 days Sniffles
A report has been received from a Health Professional concerning a, patients of unknown gender, who received Nasal FLUMIST (INTRANASAL), 0.2 Millilitres, Unknown for INFLUENZA. FLUMIST (INTRANASAL) was started on an unknown date for INFLUENZA. It was reported that FLUMIST underwent bi-directional temperature excursions. The outcome of the event of TEMPERATURE EXCURSION was unknown. The report was considered to be non-serious.
Headaches that occur on a daily basis that go away once I go to bed at night.Started a week after vaccination
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Pfizer product on 01/15/2021 and 02/05/2021. They became symptomatic for COVID-19 disease on 08/17/2021. They tested negative for COVID-19 on 08/17/2021 but then tested positive  via PCR on 08/19/2021 twice. They were seen in emergency department on 08/19/2021 and again on 08/20/2021. They were hospitalized and died on 08/30/2021.
Uveitis and retinal vasculitis symptoms that began on 05/14/2021. Currently under treatment with oral prednisone, has not resolved.
Tmax 105, vomiting, cellulitis (right upper thigh tenderness, erythema over site of vaccine injection).
Patient is a 24-year-old female with recent pregnancy and shortly after being vaccinated in August of this year.   She is currently 21 weeks pregnant and she is concerned about the possible vaccination.  She was sent home from deployment when it was discovered that she was pregnant.  She reports no problems with this pregnancy.  She is currently being followed in OB/GYN.  Dates were by her last period.  Fetal ultrasound has not be done yet but is scheduled on 9 December 2004.    5 July 2004 was first day of last menstral cycle.  Patient was likely pregnant during both of the vaccines due to her estimated date of conception was 19 July 2004.  She reports they did ask if she was pregnant but she did not think that she was pregnant.
Patient was instructed to call the clinic if he became ill after the vaccine, he stated that he started "throwing up a few times and felt nauseated" several hours after he was vaccinated. I explained that this was normal. With additional probing he explained that he felt faint and had to hold onto something to stand up. Because this was vasovagal, I am completing this form. I am on the advisory committee for the immunization coalition. I feel it is important for the safe provision of vaccines that all staff need to be aware of the reporting requirements.
Symptoms started approximately 15 hours after vaccination. Pt awoke with significant vertigo/dizziness/lightheadedness, periodic sweats/hot flashes, and extreme nausea. Vertigo/periodic dizziness continues as of 10/25/16, but improving.
Arm Pain Near Injection Site; Fatigue; Joint pain; A spontaneous report was received from a female consumer concerning a72 year old male patient, who received  Moderna covid 19 vaccine and experienced Arm Pain Near the Injection Site, Joint Pain, and Fatigue.  Patient's medical history is unknown.  On 5 Jan 2021 the patient received first dose of mRNA-1273, in the left upper arm.  On 2 Feb 2021 prior to the onset of the events, the patient received second dose of mRNA-1273(Lot #: 025L20A) injection intramuscularly in the left upper arm for prophylaxis of covid 19 infection.  On 3 Feb 2021 the patient experienced onset of symptoms. These symptoms include Arm Pain Near the Injection Site, Joint Pain, and Fatigue. the consumer is self medicating with "Tylenol", to try and help alleviate the symptoms.  The symptoms seemed to have gone away by 04 FEB 2021.
This spontaneous report as received from a pharmacist refers to five patients of unknown age. On 30-OCT-2013 the patients were vaccinated with a expired dose of ZOSTAVAX (lot # 672867/0241AE, expired on 26-APR-2013). No adverse effect reported. This is one of several reports received from same source. Additional information has been requested.
Information has been received from a registered nurse concerning a 6 year old white female with no known drug allergies, no hospitalizations or surgeries and no significant past medical history, who on 16-MAY-2001 was vaccinated with a dose of Varivax. It was unknown if there was illness at the time of vaccination. On 06-FEB-2007 the patient was noted to be itching her back and her mom saw several red very pruritic lesions with vesicles appearing in the center. When bathing the patient, her mother noted that the rash had spread across her chest and abdomen and was spreading to her extremities and face. Most of the lesions were scratched open with only a few lesions with vesicles noted. On the same day the patient presented to the emergency department. The physician noted that there were multiple scattered round red lesions on her back, chest and abdomen with the central area appearing to be vesicles or scratched open with previous vesicles present. The physician reported that the the lesions had a pox lesion appearance. It was reported that there were no lesions in the patient's ears or mouth. There was no secondary cellulitis noted. The patient was diagnosed with a pruritic viral exanthema: probable chickenpox/varicella rash. The patient was treated with a 25 mg po dose of BENADRYL and instructed to continue with BENADRYL 25 mg q6 hours for itching. The patient was also instructed to use CALAMINE LOTION and AVEENO bath for comfort. There was a reported outbreak of chickenpox at the patient's school "several weeks" prior to the patient's presentation to the ED. It was reported that the patient recovered on 06-FEB-2007. Additional information is not expected.
Patient given Booster of Pfizer approximately three months prematurely. Patient not due for Booster until 04/29/2022. Patient tolerated med pass well. No adverse reactions noted. No distress noted. Notified Parent (mother) of incident, and advised to continue to monitor patient post vaccination observation time of 15-30mins. Gave her signs and symptoms, change in behavior or level of consciousness to observe. Also advised contact Provider for further questions or concerns and ED precautions given. No further interventions needed at the time. Patient remained stable post-vaccination and through observation time of 30 min.
1/7/2021 @ 5:00 a.m. patient woke up and couldn't move her right side (neck, arm and leg).  Sister helped dress her and drove her to the hospital.  During the ride the hospital the patient had 2 seizures and a 3rd seizure in the ER at the hospital.  Patient states she has never had multiple, back to back seizures before.  States she hasn't had a seizure for 2 years. EEG was done. Was released from the hospital on 1/9/2021 and to have outpatient MRI of head, shoulder, c-spine.  Does not have full range of motion of right neck, and arm, hand and fingers and is painful. 1/14/2021 - full release back to work on 1/14/2021.
Chest pain that radiated to right side of neck and jaw, EKG done. No treatment needed.
Fever, chills, uncontrollable shaking/shivering, severe body aches, severe headache, exhaustion, insomnia, nausea, diarrhea. Started on day of injection and lasted over 7 days. The nausea and diarrhea and headache continued another 7 days (14 days total).
Dec 2 (10 days later) woke up itchy, incredibly itchy, debalitatingly itchy, on variuos parts of my body. neck, belly, back, all over my back, underarms, tops of feet are particularly bad, red swollen scratch marks, severe urticarial hives.  went to doc for Rx and got oral steriods prednisone and topical steroids triamcinolone acetonide, benadryl for night, and claritin D for day. I did begin using benadryl on Thrusday so this is now day 7 on benadryl.
Subsequently pt developed swollen lymph nodes in the groin area which lasted several weeks, she also developed an injection site reaction characterized by swelling and soreness which lasted 4 days.
Patient reports nausea, vomiting, body aches, headaches, and lethargy since receiving the vaccine on the 11th. She was most concerned about the nausea and vomiting. Patient was advised to reach out to her primary care provider if the symptoms persisted, as it was unclear if the nausea and vomiting were related to the vaccine.
Body aches; Reddish skin at Moderna vaccine injection site; Off label use in unapproved indication; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), VACCINATION SITE ERYTHEMA (Reddish skin at Moderna vaccine injection site) and OFF LABEL USE (Off label use in unapproved indication) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Osteoarthritis and Ankylosing spondylitis.    Concurrent medical conditions included Osteoarthritis and Ankylosing spondylitis.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced PAIN (Body aches), VACCINATION SITE ERYTHEMA (Reddish skin at Moderna vaccine injection site) and OFF LABEL USE (Off label use in unapproved indication). At the time of the report, PAIN (Body aches), VACCINATION SITE ERYTHEMA (Reddish skin at Moderna vaccine injection site) and OFF LABEL USE (Off label use in unapproved indication) outcome was unknown.            No concomitant medication provided. No treatment information mentioned.  Patient reported off label use of unknown indication, reddish skin at moderna vaccine injection site and body aches.  Reporters causality of event off label use with Humira was a reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
After dose 1 injection (2/4) there was normal tenderness at injection site that lasted about 24 hours then was fine. I woke up this morning ( 2/12) and arm was itching,  warm to touch, with redness and swelling that increased by the evening. This happened overnight and there is no other problem with the vaccine. Will see pharmacist on Monday and report there as well.
COVID vaccine breakthrough case. Patient was vaccinated with Pfizer EN6207 on 03/11/2021, Pfizer ER8730 on 04/01/2021. Booster information in Item 17.
swelling at the location of the shot; I had not eaten; swollen arm; hunger; Pain at injection site; headache; This spontaneous case was reported by a nurse and describes the occurrence of PERIPHERAL SWELLING (swollen arm), HUNGER (hunger), VACCINATION SITE PAIN (Pain at injection site), HEADACHE (headache) and VACCINATION SITE SWELLING (swelling at the location of the shot) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Fish allergy, Food allergy (Allergy from strawberry) and Drug allergy.    On 06-Apr-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PERIPHERAL SWELLING (swollen arm) and HUNGER (hunger). 06-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site) and HEADACHE (headache). On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling at the location of the shot) and EATING DISORDER (I had not eaten). On 10-Apr-2021, PERIPHERAL SWELLING (swollen arm) and HEADACHE (headache) had resolved. At the time of the report, HUNGER (hunger), VACCINATION SITE PAIN (Pain at injection site), VACCINATION SITE SWELLING (swelling at the location of the shot) and EATING DISORDER (I had not eaten) outcome was unknown.        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.   Concomitant product use was not provided by the reporter. Treatment information was not provided. The first vaccine caused only swelling at the location of the shot. It lasted several days. Consumer called the health line and mentioned a headache but it was because she had not eaten.   This case was linked to MOD-2021-268664 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Significant follow up appended
MYOCARDITIS; PERICARDITIS; This spontaneous report received from a consumer concerned multiple patients (123 of 3,030) of unspecified age, sex, race and ethnic origin. The height and weight of the patients 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 and expiry were not reported) 1 total, dose, 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.  Reporter states that "of the 3,030 events of myocarditis and pericarditis, 123 were attributed to Janssen COVID vaccine". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the myocarditis and pericarditis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211149169-COVID-19 VACCINE AD26.COV2.S-myocarditis, pericarditis. 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).
Starting 2 hours after vaccination: modest local reaction at injection site (red, swollen). Myalgias, arthralgias, decreased appetite, abdominal cramps.
Redness, swelling, hot injection site first noticed day after shots, 2-10. Flu-like symptoms 2-18. Fever 105.6 on 2-20. Diagnosed with flu, then pneumonia 2-23. ER visit with extreme abdominal pain 2-26. White chalky penile discharge 2-28 and 3-7-2017.
Local maculopapular rash at upper arm 48 hours after HepA injection given, pruritus.
Arrived to ED stating achy all over and has developed a cough and mild headache.  States that current episode started 12 to 24 hours ago after getting flu shot.  Diagnosis Vaccine Reaction.
crusting; hemorragic blisters; pustular rash; Varicella virus test positive; Body temperature abnormal; vesicular rash; This spontaneous report has been received from a physician, concerning a 3-years-old male patient. The patient's pertinent medical history and concurrent conditions included trichothiodystrophy, hypogammaglobulinemia, influenza A, bilateral pneumonia, tracheotomy, "AK s/p CRRT with progressive decline" (information not legible), chronic steroid exposure. His previous drug reactions, allergies included oxycodone (angioedema), and concomitant medications were not provided.  On 23-FEB-2021, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, on left arm, for prophylaxis (valid lot number T017686 [expiration date 21-MAY-2022]) (dose, dose number, vaccination scheme, route of administration, anatomical location, frequency, lot number and expiration date were not provided).   On 17-FEB-2023, a sample was obtained with vesicle lesion, the patient experienced a vesicular rash, pustular rash, crusting (scab), hemorrhagic blisters (blood blister), 710 lesions left chest an upper extremity with a temperature of 38.8 degrees Celsius (body temperature abnormal), the patient was hospitalized and as a treatment, the patient begun acyclovir. The hospital lab determined that a bronchial alveolar lavage (BAL) sample identified VZV (varicella virus test positive). The hospital would like to have strain identification performed on plasma, BAL and lesion samples. The outcome of the events was recovering (ongoing) (conflicting information, also reported as recovered).   The causality assessment between the events rash vesicular, scab, blood blister, rash pustular, varicella virus test positive and body temperature abnormal was not provided.
Pulmonary sarcoidosis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Apr2023 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "HBP" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: PULMONARY SARCOIDOSIS (medically significant) with onset 20Apr2023 at 20:00, outcome "not recovered". The event "pulmonary sarcoidosis" required physician office visit. Therapeutic measures were taken as a result of pulmonary sarcoidosis: treatment with Z-Pak Antibiotics Cough Meds Nasal Spray.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
softball size "hive", red, tender, hard, hot, itchy around injection site beginning 10 hours after 2nd injection continuing now in the 4th day.  Have used tylenol, benadryl both cream and tablet and ice.  Slowly decreasing in size.  Has decreased from softball size to golfball size but still very tender.
Delayed menstruation from February 17 2021 through May 3 2021.  May 3 began a prescription for progesterone to begin menstruating again.  Approximately March 27 2021 began to notice facial acne. Since the date previously mentioned, using multiple acne face wash and products. Previous to date listed, have not had any issues with acne.