chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It looks like the vial was punctured at 10:30 and the dose was given around 4:40 maybe 10-13 minutes after the 6 hour... when it was first punctured; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (It looks like the vial was punctured at 10:30 and the dose was given around 4:40 maybe 10-13 minutes after the 6 hour... when it was first punctured) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (It looks like the vial was punctured at 10:30 and the dose was given around 4:40 maybe 10-13 minutes after the 6 hour... when it was first punctured). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (It looks like the vial was punctured at 10:30 and the dose was given around 4:40 maybe 10-13 minutes after the 6 hour.. when it was first punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: This report refers to a case of out of specification product use of mRNA-1273, lot # unknown with no associated AEs.
In retrospect, hearing about heart inflammation, twice I experienced a fluttering sensation across my upper chest area. I thought it was related to older age/post-menopause. Went away on its own. Lasted only 30-40 seconds.
PATIENR REFER BREATHING PROBLEM, TENDERNESS IN ARM, AND STOMACH UPSET INMEDIATLY AFTER THE DOSE.  BLOOD PRESSURE WAS 170/101 mmHg. PULSE 99  LIQUID DIPHENHYDRAMINE OTC WAS GIVEN TO PATIENT, 15 ML ONCE.  EMERGENCY SYSTEM WAS ACTIVATED AND ARRIVED IN 10 MINUTES. PATIENT WAS TAKEN TO THE NEAREST HOSPITAL. PATIENT WAS FULLY RECOVERED AFTER 48 HOURS OF THE ADVERSE EFFECT
Multiple ?brain zaps? of the kind associated with abrupt withdrawal from an antidepressant.  I?m not on an antidepressant nor have I been on one in  several years.  These occurred all day and  I stopped  counting after 200.  They were not painful but weird.  When I awoke the next morning, they were gone.  I called my primary care doctor and he said it was likely a vaccine side effect, and to call if they continued the next day.  They did not.
Systemic: Seizure-Mild, Additional Details: Pt experienced a short epileptic episode blacking out & unresponsive for 10-20 seconds. After episode ended pt was responsive and alert. Pt's guardians declined calling paramedics. And was transported to urgent care per guardians choice. Followed up with guardian and pt was stable.
R09.02 HYPOXIA 4/30/2023 MAJOR DEPRESSIVE DISORDER, SINGLE EPISODE, MODERATE
Redness 2.25" in diameter around injection site, warm to touch. 1" in diameter around injection site slightly swollen. Tx. apply cold compress -24-48 hours for clearing of reaction.
Vaccine 12/4. On 12/7 swelling in back at L5-S1. Cascade of events included full body skin infection, abscesses, lesions, fevers, mouth sores, decrease in blood pressure, complete muscle atrophy in right glutes, immobility. Seen at urgent care 2x, PCP 2x, rheumatology 1x, ER 2x, dermatology 2x. Required 3 months of heavy dose NSAIDs, 3 weeks antibiotics. Am now in physical therapy and awaiting MRI 8/1.   Unclear if it's related to the vaccine because I haven't had a diagnosis or received adequate health care.
12 hours after severe migraine headache lasting 13 hours.  Chills, nausea, fever of 100.3, joint/muscle soreness, fatigue
9.5. - received varicella vaccine in L arm, some redness, warmth 9.6. - site with increased redness, swelling and itching at site, took benadryl 9.7 - underside of L arm was red swollen, hot and had a lump, was seen at urgent care and given script for prednisone and told to take for several days if symptoms were no better 9.8. - symptoms were no better so starting taking prednisone, states symptoms were better that evening.
Information has been received from a health professional concerning a 16 female who was vaccinated with GARDASIL. After the first injection of GARDASIL, in January 2009, the patient developed a swollen injection site and rash, after the second injection of GARDASIL , "in January 2009" it was very painful and she could not move. On an unknown date, events diminished discontinuing of GARDASIL. No further information is available. No further information is available.
chills; moderate shoulder pain at injection site/shoulder pain; severe headache for 28 hours; axillary rash under armpit/painful armpit rash; burning on injection on left arm; This is a spontaneous report from a contactable other healthcare professional (who is also the patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9266, expiry date unknown), intramuscular on the left arm, on 12Feb2021 16:00, at single dose, for COVID-19 immunization, at the pharmacy/drug store. The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. There were no allergies to medications, food, or other products. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiry date: unknown) received at age 48 years, intramuscular on the left arm, on 22Jan2021 15:45, for COVID-19 immunization and the patient experienced moderate shoulder pain on injection arm. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 12Feb2021 at 16:00, the patient experienced burning on injection on left arm. On 12Feb2021 at 19:45, the patient experienced moderate shoulder pain at injection site for 24 hours and there was no shoulder pain 36 hours after the injection 14Feb2021 at 04:00; severe headache for 28 hours; and axillary rash under armpit/painful armpit rash which was still present 45 hours after the injection. On 13Feb2021 at 20:00 (reported as 28 hours after injection), the patient experienced chills which lasted for 2 hours. The patient was not tested for COVID-19 since the vaccination. No treatment was given for the events. The patient recovered from chills on 13Feb2021 at 22:00, severe headache on 13Feb2021 at 23:45, and moderate shoulder pain at injection site/shoulder pain on 14Feb2021 at 04:00. The outcome of burning on injection on left arm, axillary rash under armpit/painful armpit rash was not recovered.
mild pain; an erythematous area on her left deltoid, it as a welt; This is a spontaneous report from a contactable physician reported for herself. This female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is an Emergency Room physician who received the vaccine on 17Dec2020 and had mild pain only for 36 hours after the injection. She never had any redness after her injection until day 12 she noticed an erythematous area on her left deltoid, it as a welt. The physician would like to know if she should get the 2nd dose of COVID-19 considering she had a delayed reaction to the first dose. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Pt has had upper respiratory symptoms that have persisted, such as cough and congestion.  Was found to have COVID and supratherapeutic INR.
AT deltoid, red, hot to touch, hard ball 62mm x 36mm. Body aches.
I noticed my little toe hurting quite a bit and one spot under my big toe. When I looked I saw my little toe to be swollen and red. Then as I looked more I noticed red/purplish spots of color on my other toes. It looks like "covid toes." This is my left foot.
1800 hrs at work(same day as shot 1), started feeling nausea, vomited several times from 1815-1830. started with chills and sweating then and extreme fatigue. 1845 started vomiting again until about 1900 when it ended with violent vomiting and retching. Left work early, freezing the whole way home. fell asleep on the couch in clothes, sweatshirt and two blankets due to chills. Slept for 2 1/2 hours, woke up feeling much better.  next day had slight headache and slight lethargy.
Soon after 1sr injection, experienced dizziness, fatigue.  Within hours of 2nd shot, experienced loss of appetite; Fatigue; Confusion; Nausea; he fell several times; lack of grooming was noted.
Case was vaccinated for Covid in APril 2021, then hospitalized for Covid in November 2021.   Pneumonia due to COVID-19 virus Assessment & Plan With symptoms starting 11/4 with dry cough progressing to weakness, headache, myalgias, and then chills fever. Admitted on 11/3 with positive Covid test for treatment of Covid pneumonia. Started on dexamethasone, remdesivir on admission. Added baricitinib 11/6 for increasing hypoxemia then on 11/7 rapid decompensation needing 40 L high flow nasal cannula. CT pulmonary angiogram pursued on 11/6 given acute worsening but was negative for pulmonary emboli. Fluctuating oxygen requirements, still on high flow. Vaccinated. Risk for worsening Covid infection her obesity, prior tobacco use. ?Completed course of remdesivir ?baricitinib for total 14 days or until discharge, last dose on 11/20 ?Completed 10 days of dexamethasone ?Continue nighttime CPAP   Acute respiratory failure with hypoxia Assessment & Plan Noted, due to covid pna. Now back on high flow. DNR/DNI
Pfizer COVID-19 3rd dose administered to Moderna patient, The doctor intentionally gave a 3rd dose of Pfizer COVID-19 vaccine and told him that it was approved to be used; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Pfizer COVID-19 3rd dose administered to Moderna patient, The doctor intentionally gave a 3rd dose of Pfizer COVID-19 vaccine and told him that it was approved to be used) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   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 September 2021, the patient experienced OFF LABEL USE (Pfizer COVID-19 3rd dose administered to Moderna patient, The doctor intentionally gave a 3rd dose of Pfizer COVID-19 vaccine and told him that it was approved to be used). At the time of the report, OFF LABEL USE (Pfizer COVID-19 3rd dose administered to Moderna patient, The doctor intentionally gave a 3rd dose of Pfizer COVID-19 vaccine and told him that it was approved to be used) had resolved.            No relevant concomitant medications were reported.  No treatment information was provided.
Patient found deceased in his room on 5/19/21 at approximately 9:35am
Information has been received from a physician concerning a 12 month old female who on 07-NOV-2007 was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) subcutaneously in the left arm (lot #654685/0987F). The physician reported that the child moved while being vaccinated, and some of the vaccine spilled out. The physician was unsure how much volume the child received, possibly 0.4 mL. The physician reported that medical attention was sought in the office. Additional information has been requested.
After receiving the Pfizer COVID-19 first dose, patient had a rash develop around her front and back of her neck. She said she had previously used liquid Bendryl in such events and confirmed she did not have any difficulty breathing or throat closing. 20 ml of Benadryl was given and after an hour the rash seem to subside and she left the pharmacy.
pt recv vax 9DEC96 in lt leg;on 10DEC96 2AM awoke w/fever of 104.5-lt leg, red, swollen area @ site down thigh & across thigh;swelling size of egg-tender to touch until;fever 104-105;localized swelling of lt leg;
t101R,irritable 48hrs p/vax 6PM 11FEB96;DTP-became sx free;found dead at babysitters 19FEB96;
Awoke with numbness in face, tongue, gums & palate, on right side, plus tingling and numbness in fingers & toes, right side. The face & digits are now normal, but tongue, face, gums & palate remain affected.
Brief (less than 5 minutes) generalized tonic/clonic seizure. Resolved spontaneously. No treatment given.
I started bleeding 10/5/21;  I am POST menopausal. I had severe bleeding with massive clots. I went to Dr 10/19/21 to stop bleeding. Dr put me on Progestrone to stop it. It stopped for 24 hrs then back heavy again. Oct 26 was put on birth control pills to stop bleeding. Which it did. Preventative cancer screening took place. My uterus had a thickened endometrial lining (16mm) diagnosed via ultrasound. Had to have a VERY painful endometrial biopsy which was cancer negative. I lost so much blood I had blood test and it came back I'm anemic (due to blood loss). I had more labs which came back as I am absolutely diagnosed POST menopausal.
Information has been received from a registered nurse concerning a female patient with no past medical history and no known allergies who was vaccinated with a first and second dose of mumps viurus vaccine live in May 1998 and April 2001, respectively. There was no concomitant medication. Iit was reported that the patient "has not developed detectable titers. Unspecified medical attention was sought. Additional information has been requested
Approximately 10 days post vax pt experienced a dermatitis like rash consisting of red spots on the trunk and extremities.
Fever 100.5 x 16 hrs Body aches, mild x 16 hrs
Received second dose of Shingrix three years after my first dose; This non-serious case was reported by a consumer and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 years ago prior to the reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Received second dose of Shingrix three years after my first dose).  The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 25-AUG-2023 The patient reported that he or she received Second dose of Shingrix vaccine after 3 years of receiving first dose of Shingrix vaccine. The reporter wanted to know if he or she need to receive third dose. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Patient said it was her second dose of the series. Her left arm became very red and spread to the elbow. Patient went to her doctor who prescribed medication to treat reaction.
Severe headache, joint pain, fatigue,  fever with chills 101.1, not responding to Tylenol 1 gram but responding to Ibuprofen 600 mg. It has been over 24 hours now.
Sore right arm muscle tightness and numbing like my arm fell asleep from my elbow to my fingers and when I move my arm upward there is a pain shooting from the elbow to the shoulder. The numbness affect was 10 minutes after the shot it has continued for the next three weeks along with the pain when I move my arm up and down
The patient called on 8/10/19, around 2pm, told me that he wants to report serious vaccine adverse reaction. Couple hours  after the second Shingrix shot he started having severe chills, felt extremely cold and had body aches, had high fever (did not measure). The next day he was still feeling flu-like symptoms. I advised him to drink plenty of fluids, rest, tylenol for pain and headache and call doctor if he is not getting better. I explained that it may be expected, these are vaccine related reactions, may last for 24 hours.
Patient thinks she was exposed to Covid from someone she lives with; Itchiness around the injection site; Headache; Chills; Redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Patient thinks she was exposed to Covid from someone she lives with), VACCINATION SITE PRURITUS (Itchiness around the injection site), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Redness around the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010m20a) for COVID-19 vaccination.     No medical history reported.  Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), LOSARTAN and PANTOPRAZOLE for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness around the injection site), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Redness around the injection site). On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (Patient thinks she was exposed to Covid from someone she lives with). At the time of the report, EXPOSURE TO SARS-COV-2 (Patient thinks she was exposed to Covid from someone she lives with), VACCINATION SITE PRURITUS (Itchiness around the injection site), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Redness around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not receive any treatment.  The patient underwent COVID-19 virus test on an unspecified date and was waiting for the results. Patient is quarantining because of the Covid virus and he is on his 13th day.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Headache-Medium, Systemic: Weakness-Medium
This spontaneous report was received from a consumer (patient mother) refers to her son as a 15 year old male patient. No pertinent medical history was reported. On an unknown date in June 2014, the patient was vaccinated with GARDASIL 9 dose 3, 1 dose every 6 months, in the arm. No concomitant therapies were reported. After a couple of months on an unknown date approximately in 2014, the patient experienced hypersensitivity and broke out in hives. No lab diagnostics studies performed. Patient sought medical attention. No Product Quality Complaint (PQC) was involved. The outcome of events was unknown. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
nausea,  light headed, dizziness tingling in hands/fingers /numbness clam hands  / fever
The next day, after Moderna vaccine administration, around 13:00, patient experienced facial reddness and slight lip tingling. She took 25mg  of Bendadryl and reported the information to me the next business day 3/8/2021. I instructed patient to notify her PCP.
Patient complained her arm was red, then purple, swollen and painful. This took 3 weeks before it heeled. The area eventually started peeling.
After injection left arm was sore x2 days and then was fine. On 1/1/21, site felt warm to the touch, swollen and sore.
Herpes zoster (likely) - by hx and physical exam - viral cultures obtained 48 hours after beginning of treatment are negative; neg hx of varicella; had vaccine 8/2/04.
This spontaneous report as received from an unspecified reporter referring to a 38 year old female patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided. On 18-JAN-2018, the patient was vaccinated with incorrect storage M-M-R II lot # N020925, expiration date on 01-AUG-2019, for prophylaxis (strength, dose, route of administration and anatomical location were not reported). The vaccine was storaged at 34.30°F during 0.17 hours. It was reported that vaccine was good when was administered.
Localized, large Rash developed apprx 5-7 days after smallpox vaccination was administered.  Rash was around parts of chest, but mostly located in the deltoid & armpit area of the vaccinated arm on the 7th day after vax was given. Rash was generalized, not one large rash, but several small outbreaks. Rash wasn't raised.
I tested positive for COVID-19 on the 6/27/22 and went to the doctor the same day and received Paxlovid.  I felt better after 5 days of medication.  Still a little fatigued.
Patient came to Vaccination Clinic to receive first dose of Pfizer vaccine on 3/18/2021. Patient has a medical history of Ehlers-Danlos Syndrome, Mast Cell Activation Syndrome, POTS (Postural Orthostatic Tachycardic Syndrome). Patient received approval from her doctor and specialists to receive Pfizer vaccine. The patient gave verbal consent to receive the Pfizer vaccine and was vaccinated at 1431. The patient was given an observation time of 30 minutes with EMT. At 1505, the patient reported experiencing tingling in the back of her throat. The patient presented with patchy erythema on chest and neck. The patient was brought into the exam room at 1510 and proceeded to lay down on exam table. At this time, the patient's vitals were taken by RN and found to be within normal limits (BP 115/90, HR 88 BPM, RR 15/min). The patient denied difficulty breathing. She reported feeling minor dizziness and minor itching of neck and arms. The patient's vitals were reassessed as the Lead RN drew up 50 mg/1 mL of IM Benadryl. The patient's vitals at 1518 were: BP 120/85, HR 80 BPM, RR 16/min. The patient remained A&Ox4. The patient was given 50mg of IM Benadryl at 1520 in the left anterolateral region. At 1530, Patient's vitals were: BP 117/80, HR 73 BPM, RR 12/min. At this time, the patient verbalized relief of itching in neck and arms. Upon assessment, the patient's erythema on neck and chest had resolved. At 1537, the patient sat up with her feet dangling below her, her vitals were as follows: BP 132/98, HR 73 BPM, RR 13/min. The patient reported "feeling better" and requested to use the restroom. An RN followed the patient to the restroom. Patient's gait was steady and she denied any dizziness or lightheadedness. Lead nurse educated patient on side effects of Benadryl, including drowsiness. At 1544, the patient requested to drive herself home. She was escorted to her car by lead RN. Patient drove herself home AMA at 1547.
Face swelling; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04May2021, at 09:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies to latex, amalgam, shellfish and wool. 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. The patient did not receive any other medications within two weeks of vaccination. On 04May2021 at 09:00, the patient experienced face swelling and nausea. It was unknown whether the patient received any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events face swelling and nausea was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.