chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; 5 patients were administered an expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 patients were administered an expired vaccine) 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)) (batch no. 041H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jun-2023, 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. On 12-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 patients were administered an expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 patients were administered an expired vaccine) 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 EXPIRED PRODUCT ADMINISTERED (5 patients were administered an expired vaccine).    No concomitant medication was reported. Dosage text for suspect product was reported as unknown. No treatment medication was reported. This case corresponds to 2nd out of 5 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-728837 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728837:Master case patient no. 01
This spontaneous report was received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients received 1 improperly stored dose of VARIVAX lot number L025207, expiration date: 07-JUL-2017 (dose and route of administration were not provided) for prophylaxis. There were no adverse effects reported. Administered doses of VARIVAX were exposed to a temperature excursion of >5°F but <14°F for 2 hours 20 minutes and >14°F but <46°F for 50 minutes. Data logger was involved.  There were previous temperature excursions of >14°F but <46°F for 6 hours 10 minutes. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA000275:
It started 2/3/2021 that afternoon and I came home and on my right leg my skin raised 3/25 wide and high. An it turn completely white inside my leg, they were black and red like polka dots. I can see it moving around in my leg. I then call my daughters. I had to hit my emergency number for her. I couldn't do anything else. All this had hours after getting the vaccine. I got paralyzed for about 10 mins and started screaming hoping that someone would hear me. I had start having cramps in my leg really bad. I started walking for abut two hours and then I passed out. I don't remember anything else. I lost control of anything.  I was very weak and then I made an appt to see a doctor. An it took me a while before I was able to be seen.
Immediately after the vaccine, I felt no symptoms, when I went to the check out desk approximately 3-4 minutes later, I felt a surge of tightness and flushing in my head, neck and arms.  I thought I had broken out in a rash on my arms, but it didn?t appear so. The feeling intensified and I felt I needed water or something for the throat constriction. After reporting to the desk clerks that something was wrong, I sat down before being escorted into a room. The constriction feeling continued along with a severe pulsating abdominal pain- feeling like deep bone pain. I couldn?t stand because of it and the weakness in my legs. I laid down. The nurse continued to monitor me and ask questions. I felt more numbness throughout my arms, hands and legs. The constriction subsided, but was followed by my upper lip feeling swollen and numb. I felt somewhat dizzy throughout.  After awhile I determined I could drive home. I did feel somewhat unsteady, but okay. The time when I left was about noon or a little after. I came home and took a benedryl and slept for a couple of hours. I still have what feels like soreness in the hip and back areas. I felt a little short of breath and had some chest discomfort off and on the remainder of the day and next. I wonder if it was an allergic reaction common to some Ehlers- Danlos patients.
Pt complains of soreness in the left arm on Friday, Saturday & Sunday. Pt's arm is red & swollen (5/7/12) in store. No itching just soreness and redness.
This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Influenza vaccine Quadrivalent. Concomitant products included THERAFLU. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent. Additional details were reported as follows: The age at vaccination was not reported. The consumer posted on the internet about 8 flu deaths of which, 7 had the flu shot and all 8 took THERAFLU. The consumer asked what's your take on who is to blame? It was unknown if an autopsy was performed or not. This case was considered as suspected vaccination failure since time to onset and the lab test confirmation for the event was unknown. This case is one of the 7 cases, reported by the same reporter for same event.
Step mom reported on 08/22/2003 that the child had "felt sick" on the evening of 08/15/2003 after vaccination. On 08/16/2003 had a "sick stomach" all day. On 08/17/2003 had episode of seizures "all day". Pt was hospitalized for 2 days. Dilantin dosage was increased to 500mg by PO. Now home and fine. Medical records state diarrhea, stuffy nose. msv
This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration in left arm on 01Apr2021 at 10:30 as 1st dose single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 18Apr2021 (3 weeks later), she experienced a large lymph node on the back of her ear. She went to the doctor and was diagnosed with an infection. But the doctor did not ask if she received the vaccine. She was put on Amoxicillin, and it went away with taking the medication. She then stated that on 22Apr2021, 3 days after being prescribed the Amoxicillin, she received her second dose (LOT ER8729, left arm injection) of the vaccine. She had no reaction until 27Apr2021, 3 days ago. She experienced a rash all over her body after second dose. The doctor told her it's a rash caused by the Amoxicillin. She said that she had never been allergic to Amoxicillin in her life, but knows that there was a possibility that you can develop a allergy. However, the patient's mother stated that it may be from the vaccine. Patient would like to verify if a rash is a side effect of the vaccine. Her mom had never seen a rash like it. Patient added hives go away with Benadryl, usually. They were weird dots on her body now and do not know if it is from the vaccine. Patient had never had hives before this. Patient asking is Pfizer vaccine a cause of this. Patient does not remember the exact date that the enlarged lymph node went away. Patient continued to take the Amoxicillin. The outcome of the event was recovered on an unspecified date in Apr2021. No follow-up attempts are needed. No further information is expected.
At about 11 hours after the shot I my arm started getting super sore.  I went to bed and started shivering uncontrollably so I took some ibuprofen and was able to sleep for a few hours.  Woke sore and with a low grade fever 99.8.  Horrible headache and muscle aches all the next day.  Finally feel better day 3 after shot although my head is still a little foggy.
1st weakness & numbness. 2nd thought had stroke went to ER ruled out. Worsening neuropathy diagnosed sent home. 3rd back to ER next night in terrible pain. 4th admitted to hospital 11/11/11 - present. Diagnosed with Guillain Barre Syndrome. Advised to never take another flu shot.
reports that she normally will premedicate with pepcid and benadryl, but didn?t know she was getting vaccine that day. She reported chest heaviness and lightheaded, itching. HTN when EMS evaluated.  transported via EMS for on site monitoring
patient was given shot and fainted and started rash at site lips turned blue also shot was given at 10:23am and at 10:26am adverse event started epipen was given at 10:26am paramedics  called and patient was taken to hospital for followup
Patient was walking to the elevators when she started to feel cold, light headed, and dizzy. Patient stated she felt as if she was going to faint. A medical emergency was called and PCP responded along with his medical assistant and other healthcare staff. Patient was placed in a wheelchair and took back to a room where she could lay down until patient felt ok to walk.
Five minutes after administration, patient reported feeling her throat swell up. She felt hot and felt like she is having an allergic reaction similar to when she eats bananas or other foods that cause her to have allergies. EMS was called and during the time we observed her, she took 1 tablet of diphenhydramine 25 mg since that is what she normally takes to relieve allergic reactions. Her blood pressure was taken 172/116 on the upper arm (cuff too small) and then 151/115 on the lower arm. EMS came, evaluated her, and she said she felt better 5-10 minutes after taking diphenhydramine. She refused to go to the hospital.
Itchy and sore patch on upper arm area where injected. Slight swelling and redness of area the size of a typical gauze pad, website gives a good description of my symptoms. Waiting to see if this subsides as it is suggested that it will.
One who went to the doctor and was now diagnosed with Parkinson's; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer (patient's friend) reported that a patient of unspecified age and gender received BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient went to the doctor and was diagnosed with Parkinson's, all of a sudden on an unspecified date. Outcome of the event was unknown.  No follow-up attempts possible; information about lot/batch number cannot be obtained. No further information is expected.
Physician Discharge Summary     Patient: MRN: Age:67 y.o. DOB: Admit Date:  7/7/2022 Discharge Date:  7/11/2022      Principal Diagnoses:  Principal Problem:   Precordial pain Active Problems:   Morbid obesity   COVID-19 virus detected     Discharge Diagnosis: Precordial chest pain   Hospital Course: Patient is a 67 y.o.  Female who is seen at local ED for concern of chest pain.  Reports that she had a CT at a hospital two days ago and was diagnosed w/ PE and was placed on Eliquis but has not take any today because she has lost it.  Reports that pain is substernal, and is worse with movement.    Precordial chest pain. Cardiology evaluated the patient. The chest pain was deemed to be secondary to pleuritic in origin. CT with no PE.  Echocardiogram with ejection fraction 50-55% with no motion abnormalities. Will continue on NSAIDS when necessary. Patient was informed that chest pain is Pleuritic and will take a few weeks before it completely resolves.   COVID 19 viral infection.  Patient tested positive on 7/7/2020. Patient had cough, fatigue, tiredness and chest pain; all resolving Patient received Remdesivir, steroids. Both discontinued due to improvement continue with Ascorbic acid and Zinc   History of paroxysmal A. fib. Continue Eliquis rate controlled.   Patient was examined in her bed today. She was calm and not in distress. She states she feels much better except for cough. She is not on supplemental oxygen and passed ambulatory saturation. She will be discharged today with cough medicine and instructions to follow up with her PCP within 3-5 days. She requested CPAP machine and was advised to discussed that with her PCP, as she will need a sleep study for qualification. She states he chest pain is improving. She is to observe COVID restrictions and use a mask after discharge.   Consults to: Cardiology      Significant Diagnostic Studies: TTE, CT Chest   Procedure(s): n/a   Disposition: Home   Discharge Condition: Stable
Arm pain got so bad, she could not move the arm; Her arm was mildly sore; This case was reported by a consumer via call center representative and described the occurrence of mobility decreased in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th April 2022, the patient received the 1st dose of Shingrix. On 10th April 2022, 3 days after receiving Shingrix, the patient experienced mobility decreased. In April 2022, the patient experienced pain in arm. On an unknown date, the outcome of the mobility decreased and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the mobility decreased and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-APR-2022 Reporter's comment:  Member of public reported that his wife (patient) received dose of Shingrix series.  Afterward less than a week after vaccination her arm was mildly sore, as to be expected after a vaccine.  However, on 10th April 2022 arm pain got so bad that by the end of the day she could not move the arm.  The pain returned to being mildly sore (as expected after vaccine) on 17th April 2022 and mobility returned as well. The vaccine administration facility was the same as primary reporter. The reporter gave permission to follow-up with the health care professional.
Extreme night sweats; Very sore and achy; Bad cough; Fatigue; Vomiting; Fever; Headache; This is a spontaneous report from a contactable consumer, the patient.   A 23-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 03May2021 at 12:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0151), via an unspecified route of administration in the left arm on 12Apr2021 at 12:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021 at 17:00, the patient experienced very sore and achy, bad cough, fatigue, vomiting, fever, headache and extreme night sweats. No therapeutic measures were taken as a result of the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events very sore and achy, bad cough, fatigue, vomiting, fever, headache and extreme night sweats were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: treatment received was ticked/selected as no and following information was added in narrative: No therapeutic measures were taken as a result of the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
BREAKTHROUGH COVID INFECTION. PATIENT FULLY VACCINATED BY FEB 12, 2021. POSITIVE COVID TEST ON SEPT 22, 2021
Pt had second Moderna vaccine around 1100.  Because he had dizziness with the last vaccine it was requested that he wait 30 minutes.  At the end of the 30 minutes the patient complained of severe dizziness.  He also had nausea but stated that this was present prior to the vaccine.  The patient was pale and sweaty.  He denied any chest pain or difficulties breathing.  Attempted to get vital signs.  O2 was 96 on room air.  HR was 52.  Unable to get a blood pressure as the patient would not keep his arm straight.  Rapid responders were called to assist and a wheelchair was brought over.  When we were going to move the patient to the wheelchair he complained of even more dizziness so we did not move him.  He declined any juice due to nausea.  He was given a few sips of water and a cold pack was placed on his neck.  Urgent triage responded and attempted to get vital signs as well.  Manual blood pressure was 80/62, HR 47, O2 97% on room air, respiratory rate 14.  Patient denied diabetes or blood sugar issues.  He had eaten breakfast and took all of his normal medications.  First responders then moved patient to the gurney to take him to ER.
One patient noted suicidal ideation after the BNT162b2 mRNA vaccine.; The initial case was missing the following minimum criteria: [unidentifiable patient]. Upon receipt of follow-up information on 07Dec2021, this case now contains all required information to be considered valid. This is a literature report.  The primary aim of this study was to assess the impact of vaccine timing, immunological status, demographics, and concomitant treatments on vaccine immunogenicity in autoimmune rheumatic disease (AIRD) patients treated with RTX (rituximab). Secondary aims were to implement an educational intervention to physicians and patients and assess its effect on timing of COVID-19 vaccination in relation to RTX infusions. Authors performed a prospective single center study to optimize SARSCoV-2 vaccination timing and to assess vaccine immunogenicity in AIRD patients who received RTX at a health care hospital. Authors first educated faculty on the rationale for timing SARS-CoV-2 vaccines 24 weeks post-RTX. Authors measured timing of vaccine administration through telephone survey of patients. Authors then analyzed vaccine immunogenicity in relation to vaccine timing and other clinical and immunologic parameters. Patients were contacted by telephone from March through August of 2021. Study participants were surveyed on recent vaccine administration, and in those who had not yet received a vaccination, whether or not they were intending to obtain a COVID-19 vaccine. Vaccine administration was not part of the study. A patient (no qualifiers provided) received bnt162b2 (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "AIRD" (ongoing). Concomitant medication included: RITUXIMAB taken for AIRD. One patient noted suicidal ideation after the BNT162b2 mRNA vaccine. The patient underwent the following laboratory tests and procedures: antineutrophil cytoplasmic antibody: unknown results; blood immunoglobulin G (normal high range 700): unknown results; serum IgM (normal high range 40): unknown results; absolute CD19: unknown results; CD20: unknown results; antinucleocapsid antibody: unknown results; serum IgG antibody levels against SARS-CoV-2: unknown results; SARS-CoV-2 PCR: unknown results. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal relationship, the association between the event suicidal ideation with BNT162b2 can not be fully excluded.  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.
Within 10-14 days of J&J vaccination patient began experiencing abdominal pain. Pain was localizing to RUQ and epigastrium with mild nausea. Unrelated to food.
COVID-19 positive day after 2nd dose vaccination. He had a fever for under 48 hours, runny nose and a bit of a cough. The symptoms were mild. Then on August 20th he started with ear infection symptoms and had a fever for about 2-3 days. Then on the on the 22nd in the evening we went to the doctor. They gave him an antibiotic.
Information has been received from a pharmacy technician referring to an 11 year old male patient. Information regarding pertinent medical history, concomitant medication and drug reactions/allergies was not reported. On 04-AUG-2016, the patient was vaccinated with his first dose of GARDASIL 9 intramuscularly for vaccination (dose, lot# and expiration date were unknown). On 27-DEC-2016, the patient was vaccinated with his second dose of GARDASIL 9 intramuscularly for vaccination (dose, lot# and expiration date were unknown). The primary reporter reported the patient experienced "sore arm at injection site". It was unknown whether soreness was after receiving the first dose, second dose or both doses of GARDASIL 9. The outcome of the event and the relationship between the event and GARDASIL 9 were not reported. Additional information has been requested.
Initial report was received from a healthcare provider on 08 November 2011. A 69-year-old female patient had received an injection of FLUZONE HIGH-DOSE (lot number, route and site of administration not reported) on 03 November 2011. On an unspecified date, the patient developed swelling, very red in upper arm from elbow to shoulder which was sore and hot to the touch. The patient received corrected treatment with BENADRYL. No further information was available at the time of the report. The patient outcome was reported as recovered/resolved on 05 November 2011. Documents held by sender: none.
There was no adverse event. I am reporting it because she was not 18 years of age to receive the Moderna vaccine.
Fatigue, headache, body aches, and low grade fever for approximately 36 hours after the vaccination. Fatigue first, then onset of additional symptoms.
2 weeks after my booster I experienced elevated heart rate which I?m still dealing with constantly, as well as heart palpitations / pounding heart constantly.   Burning sensation in chest which has gone away. Insomnia, numbness on left side of face, pressure on right side of forehead, & general malaise, all of which I?m still dealing with 7 weeks post booster. Currently waiting for a echocardiogram.  This has complete ruined my life  & I hope it gets address because I know other people are suffering as well
17 year old in clinic with limited vaccine history.  Relocated from another country.  Received Tdap in February 2019.  Given Tdap instead of TD for vaccine.  No adverse complications noted.  Pt observed 20 minutes following immunization.