chrisvoncsefalvay/vaers-outcomes huggingface dataset:
We have some Moderna Covid-19 vaccine that was given after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that was given after the expiration date) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.   In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that was given after the expiration date). In October 2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that was given after the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   4 vials with 44 doses were initially stored in the refrigerator on 24-Sep-2021 and did not undergo any temperature excursion.  Dosing was done between 24-Oct-2021 - 27-Oct-2021.  No concomitant medication was reported by reporter. No treatment medication was reported by reporter.
Patient reported injection site pain followed by warm-hot skin. Redness at site and on arm for several days post vaccine. Arm was "heavy" unable to move it freely the night of vaccine. Back to normal 6-21-17 840AM.
DTaP reaction @ injection site left thigh 11.5 cm X 9 cm (on 09/11/02); 12.5 X 13 cm on 09/12/02
Itchiness; Acid reflux; Severe nausea; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) and NAUSEA (Severe nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced PRURITUS (Itchiness), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) and NAUSEA (Severe nausea). At the time of the report, PRURITUS (Itchiness), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) and NAUSEA (Severe nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment details included Pepto Bismol.
m Right eye and part of left eye was blinded by yellow color for about a minute.; Migraine headache; Right kneel hurting; This spontaneous case was reported by a consumer and describes the occurrence of EYE COLOUR CHANGE (m Right eye and part of left eye was blinded by yellow color for about a minute.), MIGRAINE (Migraine headache) and ARTHRALGIA (Right kneel hurting) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Gout.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced ARTHRALGIA (Right kneel hurting). On 16-Feb-2021, the patient experienced EYE COLOUR CHANGE (m Right eye and part of left eye was blinded by yellow color for about a minute.) and MIGRAINE (Migraine headache). At the time of the report, EYE COLOUR CHANGE (m Right eye and part of left eye was blinded by yellow color for about a minute.), MIGRAINE (Migraine headache) and ARTHRALGIA (Right kneel hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pt recv vax 27JUn95 & on 9JAN98 pt devel a rash;
Child developed generalized seizures on day of administration of several set of routine immunizations.  MRI scan found ul EEG 5 hours by arrhythemia.  Patient on ACTH.
Employee reports day after receiving vaccination, very cold and very achy. 3 days after receiving the vaccination her neck area was extremely itchy, no rash, also repots on 3rd and 4th day after receiving vaccination she would break out in whelps randomly all over her body.
generalized edema & urticaria onset w/in 15 mins of vax; pt was teated in the ER & observed overnoc;
4:35PM 148/90 BP 82P 97 O2 sat 12RR - 13 minutes post vaccine, pt. began feeling that hands were trembling. -0 angioedema, 0 tongue swelling. -0 rash, erythema around injection site.  -0 itching, 0 lighted-headed, 0 breathing, 0 headache 4:45 PM 126/88 P80 R12 O297%
Vaccination site pain; Tiredness; headache; Muscle pain; Chills; Joint pain; Vaccination site redness; Feeling unwell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 85 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Oct2021 (Batch/Lot number: unknown) at the age of 85 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose: 25Jan2021 , lot: EZ9261, NDC: Unknown , Expiration: Unknown , Route of administration: left arm, For US Only: Vaccination Facility Type: First and second dose: Hospital, not sure of Hospital name but the hospital is in (withheld)), administration date: 25Jan2021, when the patient was 84 years old, for Covid-19 immunization; Bnt162b2 (Second dose: 17Feb2021, lot: EZ9267, NDC: Unknown , Expiration: Unknown , Route of administration: left arm, For US Only: Vaccination Facility Type: First and second dose: Hospital, not sure of Hospital name but the hospital is in (withheld)), administration date: 17Feb2021, when the patient was 84 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 05Oct2021, outcome "recovering", described as "Vaccination site pain"; FATIGUE (non-serious) with onset Oct2021, outcome "recovering", described as "Tiredness"; HEADACHE (non-serious) with onset Oct2021, outcome "not recovered", described as "headache"; MYALGIA (non-serious) with onset Oct2021, outcome "recovering", described as "Muscle pain"; CHILLS (non-serious) with onset Oct2021, outcome "not recovered", described as "Chills"; ARTHRALGIA (non-serious) with onset Oct2021, outcome "not recovered", described as "Joint pain"; VACCINATION SITE ERYTHEMA (non-serious) with onset Oct2021, outcome "recovered", described as "Vaccination site redness"; MALAISE (non-serious) with onset Oct2021, outcome "not recovered", described as "Feeling unwell".  No follow-up attempts are possible. No further information is expected.
Accidentally administered adult dose of Pfizer instead of pediatric dose. Child denies any discomfort or side effects. Patient's parents were notified. Information given on dose error. Patient reports he feels fine. Information on possible headache or fever. RN obtained pts pediatricians information. Medical doctor was notified as well as management at site.
Patient received vaccine and was in the pharmacy waiting area for observation. Within minutes (~7min), patient came to counter to let the staff know that she wasn't feeling good. Staff told her to go sit back down and the pharmacist will be right out. She explained that she felt very nausea and wanted to vomit. She also explained that she felt lightheaded and faint. We made sure she was sitting down and protecting her in case of fainting. Other symptoms were shaking, sweating and difficulty swallowing. She was breathing fine but explained that it felt like there was something in her throat that was making it difficult to swallow. Ambulance was called (~9min) and she went to the emergency room for observation (~16m).
runny nose; cdoes not feel well after the shot; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose) and MALAISE (cdoes not feel well after the shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (runny nose) and MALAISE (cdoes not feel well after the shot). At the time of the report, RHINORRHOEA (runny nose) and MALAISE (cdoes not feel well after the shot) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication was reported. No treatment medication was reported.   Reporter did not allow further contact
Pt's grandmother reported on 7/12/01 that pt's arm was very swollen from the elbow to the shoulder and hot to the touch. She was referred to PMD. PMD reported that pt had a severe localized reaction with induration and pallor from clavicle to elbow. MD requested that pt receive no further DTAP. MD request charted and highlighted on immunization card.
11:30 am vaccinated. Symptoms started 1152am ; SHE EXPERIENCED TINGLING IN HER LIPS AS SHE WAS DRIVING OUT OF THE GARAGE AFTER HER 15 MINUTE OBSERVATION WHEN SYMPTOM AROSE. OUR ONSITE EMS TEAM WAS REQUESTED. PHYSICIAN ON SITE EVALUATED PATIENT. NO SWELLING OF LIPS OR TONGUE, NO DIZZINESS REPORTED. SYMPTOMS RESOVED. PATIENT WAS RELEASED TO HOME.
The patient started to feel anxious and lightheaded (sweaty).  We gave her some water.  We had her lay down on the floor and put her feet up, gave her some cold peas, fanned her, and gave her some candy (she had not eaten).  She started to feel better after about 5 to 10 minutes.
Fever and rash began approximately 2 days prior to dr's visit on 3/24/2004. Fever was recorded at 102. Therapies tried included Ibuprofen and Tylenol. The rash started on the abdomen and spread graduallly.
Full Body Hives, swelling, itching, ears ringing, heart beat a lot stronger, swelling inside.
Headache since 8/20; Nausea started this week; Vomiting started today; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the right arm on 19Aug2021 at 07:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine, subarachnoid hemorrhage and brain bleed in 2 places. The patient had unspecified allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had received unspecified allergy injections (MANUFACTURER UNKNOWN) from 16Aug2021 within four weeks prior to the vaccination. Concomitant medications included topiramate (TOPAMAX), omeprazole (PRILOSEC) and sitagliptin phosphate (JANUVIA), all from an unknown date for an unknown indication. On 20Aug2021, the patient experienced headache since 8/20, nausea started this week (as reported) and vomiting started today (as reported). The patient thought the headache was normal because of her history. The patient had a history of migraines and subarachnoid hemorrhage, brain bleed in 2 places. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, nausea and vomiting started today was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Following vaccination 2-3 days, child started to exhibit mini onset-seizures. Which at the time I had no idea what they were, thinking it was just his tensing of frustration and jerking. This was accompanied with varient temperature spikes.  Then towards the end of the month of Feb (22nd), my son had a full blown febrile seizure 1st time at 1:41am.  I tried to administure aid, checking for obstruction of airway, and placing him on his side.  Ambulance was called do to his lack of breathing and going limp.  By the time the responders arrived he came to.  Vitals checked, everything went back to normal, until the 2nd febrile seizure occured at 6:18am resulting in calling Ambulance again and going to emergency.
immediate metallic taste in mouth accompanied by tachycardia to 120 (usu pulse is 65)   followed by unusual  feeling in mouth, not itchy, but tingly-type sensation.       lasted about 1 1/2 hours,       same reaction happened with both first and second doses, the second time was a little more intense and longer lasting.
After the 2nd dose of Pfizer I have extreme anxiety, fatigue, weakness, body aches depression and nausea. I am not feeling myself just very worried and concerned as if I can't breath.
Information has been received from a physician concerning a 15 month old male with an HIV positive mother who on 05-MAR-2008 was vaccinated in the thigh with a first dose of VARIVAX (lot number not available). "Sometime after vaccination" the patient developed a lesion on the anterior wall of his chest 1/2 cm below his clavicle (the patient had no known exposure to anyone with chickenpox). In May 2008 the patient was diagnosed with HIV and was admitted to the hospital. The patient had the lesion prior to admission and once he was admitted the lesion was not initially addressed. While hospitalized the patient was being treated for possible pneumocystis with high dose steroids. The patient was on the steroids for three weeks prior to any change in the lesion. The lesion then looked fungal and additional lesions spread to the other side of his chest with some lesions on his face. On 30-MAY-2008 a biopsy of the lesion was performed and it grew varicella zoster virus. At the time (after the sample was obtained) the patient was put on high dose acyclovir. While hospitalized the patient was intubated for one month, he was "recently" extubated however the physician indicated that he would probably need to be reintubated. It was noted that the patient might need to have a lung biopsy performed. At the time of the report the patient remained hospitalized. It was noted that the patient's mother was initially HIV negative when screened early in her pregnancy with the patient and "must have been infected late in her pregnancy". It was not until the patient was diagnosed with HIV that she became aware that she was HIV positive, at that time she was tested and the results were positive. The patient's mother never had chickenpox and prior to her diagnosis of HIV was also vaccinated with VARIVAX. The patient's mother did not develop a rash or lesions. The patient was enrolled in the VZVIP program: the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR to identify if VZV is present and if it is present to identify if it is associated with the wild-type strain or with the OKA/Merck vaccine VZV strain. Two samples were obtained, a cell culture isolate and a swab in viral media. Additional information has been requested.
This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unspecified dates (either 17-SEP-2015 or 18-SEP-2015), the patiens were vaccinated with improperly stored PNEUMOVAX (lot # K022886, expiration date: 09-JUN-2016)(dose and route of administration were not reported). No adverse effects or product quality complaint were reported. This is one of the three cases reported by the same source. Additional information has been requested.
UTI, urinary/bowel incontinence Narrative:  first COVID19 vaccine 1.11.21, ER visit with hospitalization 1.15-1.18.21 for SIRS/Sepsis, initially thought to be urosepsis but post discharge UA and blood cultures were negative; source was not identified. Beyond symptoms listed, patient just reported he "felt terribly bad" prior to spouse calling EMS. VAERS reported by hospitalist as well from the facility where he was treated. He was discharged home with Augmentin for UTI and Physical Therapy for strengthening. Patient follows local PCP and this facility PCP. Responsible physician listed on this form is this provider's facility Medical Director.
mom reports pt had lt leg swelling from hip to knee, hot touch, crying when moved; leg red; noticed 4 1/2 hrs p/immun given; taken to ER; mom reports that MD stated it was a react to immun; DPH; t101.3 ax;
Tested positive in May and started Paxlovid.; Tested positive in May and started Paxlovid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8727) and on 15Apr2021 as dose 2, single (Lot number: Ew0169) at the age of 35 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Dec2021 as dose 3 (booster), single (Lot number: 018F21A) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE, start date: Jan2022; DOXYCYCLIN [DOXYCYCLINE MONOHYDRATE], start date: 10May2022, stop date: 20May2022; SERTRALINE HCL, start date: Feb2022; EMTRICITABIN TENOFOVIR, start date: Feb2016. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "Tested positive in May and started Paxlovid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) positive, notes: Tested positive in May and started Paxlovid; (23May2022) Negative, notes: Tested negative at the end of treatment; (14Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medication in 2weeks reported as yes. Anti-viral details reported as COVID 19 Treatment, brand name was paxlovid, treatment start date reported as 18May2022, treatment stop date was 23May2022 and indication as treatment of COVID-19. Other medication in 2weeks product was Dextroamp-amphetamin, other medication in 2weeks start date was Jan2022. Tested positive in May and started Paxlovid. Tested negative at the end of treatment. Then today (14Jun2022) tested positive again after feeling brain fog, body aches and running nose. Adverse events start date was 14Jun2022. Patient was recovering and treatment ae was reported as no.
Chronic Hives that started a little more than 3 weeks later. No doctor or emergency personnel could tell me why I got them. Been dealing with it for 2 months. No new soap, laundry detergent or new medications.
Sedation, Myalgia, Arthralgia, Fever, Diarrhea, NauseaVomiting, Chills, pain at the injection site Narrative:
Pale, very drowsy, lethargic, refusing to feed for 20 hrs p/immun; Seen by MD dx virus & ear was pink; Recovered by 22 hrs post inject;
Immediately after the shot, my arm began to get sore and hurt a lot but later that afternoon, the pain worsen and my temperature began to rise.  I was sick for 2.5 days with fever of over 103. I took advil for fever and pain and the fever would not go away.  It would go down a couple of digits and rise back up.  Not until Saturday night did the fever break. 5 days later, my arm is still very sore.
pt brought to ED with severe SOB, AMS, severe respiratory failure; O2 supplementation; admitted; found to be positive for COVID; given remdesivir, steroid, ABX; DVT LLE; given heparin; renal failure - dc'd remdesivir; developed hypotension; pt continued to be unresponsive; family made pt DNR/DNI; the following day the family decided to dc all treatment; pt passed away in the hospital
Immediate burning sensation in arm which I know is to be expected but the pain since the shot has traveled to my neck, shoulder and down my arm almost to my finger tips.  Constant nagging pain, am taking Tylenol for pain every 6 hours.
Gout left big toe; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Aug2021 at 10:45 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included unspecified birth control medication from an unknown date and unknown if ongoing. The patient previously received levofloxacin (LEVAQUIN) and prednisone (MANUFACTURER UNKNOWN) and experienced drug allergy. On 28Aug2021 at 14:00, the patient experienced gout left big toe. The event resulted in a visit to the doctors or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. It was unknown whether the patient received any treatment for the reported event. The clinical outcome of the event gout left big toe was not resolved at the time of the report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Sep2021 at 09:45 (at the age of 49-year-old) as a single dose for COVID-19 immunisation.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Patient states that the first week after injection her left arm was swollen, she had a fever and chills.  Patient states that after about a week, her temperature started to run low (97 degrees) for her.  She ask her doctor if she could get a flu shot and was told not until her temperature was back to her normal.
No additional AE details available; Caller is a HBP in charge of vaccine storage. She reports one dose of VARIVAX that had experienced multiple excursions throughout the month of January was administered to one patient. Product was administered 1/25/2023; This spontaneous report has been received from an office Manager, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 25-JAN-2023, the patient was vaccinated with an improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection as prophylaxis (lot number: U039949, which was determined to be valid, with an expiration date on 16-DEC-2023) (strength, dose, schemer, route and anatomical location of administration were not reported) (product storage error). The administered dose underwent a temperature excursion, but as they did not use a data logger, they did not have cumulative data to know at what temperature and during which period of time it was improperly storage, but after completing temperature check it was noted the temperature excursion happened multiple times throughout the month of January. The highest temperature noted was 12.9 degrees Fahrenheit (F).  It was reported that there was not any previous temperature excursion. No additional adverse event was reported.