chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was stored at room temperature for 25 hours post puncture; No Adverse event; Dose administered more than 12 hours post puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture), PRODUCT STORAGE ERROR (The vial was stored at room temperature for 25 hours post puncture) and NO ADVERSE EVENT (No Adverse event) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 055A22A) for COVID-19 prophylaxis.     The patient had no known allergies. The reporter believe that patient never had tested or diagnosed with COVID-19.     On 25-Aug-2022 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2022 at 9:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored at room temperature for 25 hours post puncture) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture), PRODUCT STORAGE ERROR (The vial was stored at room temperature for 25 hours post puncture) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture) and PRODUCT STORAGE ERROR (The vial was stored at room temperature for 25 hours post puncture).    It was reported that patient took several regular medications. The patient received pneumococcal vaccine on 25-Aug-2022, on the same day of COVID-19 vaccination.  The patient received booster dose.  The patient did not seek medical care for the adverse event. Total 1 dose was administered.  The vial was first punctured on 24-Aug-2022 at 8 AM. The vial was stored in room temperature post puncture. The vial was exposed to room temperature for 25 hours. The vial did not undergo any temperature excursions.  No treatment  medications were reported.
Generalized seizure. Fell after eating. Stiff, staring for 1-2 minutes.
urticaria, immed rash; pt w/hives over entire body & difficulty speaking; pt states feels restless;
STRONG IMMUNE RESPONSE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced strong immune response. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from strong immune response. This report was non-serious.
LA became red and swollen 2d post shot. Afebrile. Tender to touch. No itch or rash.
Patient received the Pfizer dose that was reconstituted with 1.8 mL Normal Saline twice (once on 10/27 and again on 10/28 am) and had a BUD of 10/27/2021 9:15pm.
1) 36 hours post vaccination rash developed below injection site approximately 1 inch in diameter, rash was red, but not itchy until 72 hours. Rash subsided in color, but was slightly itchy when arm was moved. Rash completely gone at 5-7 days post vaccination. 2) 8 days post vaccination, rash re-appeared and become red, itchy, raised  (1.5 - 2 inches diameter), same location: below injection site. Pain/tenderness in armpit of right arm, especially when pressure is applied deep into armpit. Feels bruised or soreness.
Really sick for two days.  Third day flashes of light.. and  couldn?t see well out left eye. Like a cotton ball over it.. has a thing like a curtain goin over eye? eye doctor says signs of retina detachment         I just had my annual eye exam a few months earlier and eyes were great they said?. Now I can?t work cause I?m not allowed to lift, bend, move head fast because if I do it will lead to retina detachment ..   having to go to retina specialist this week.. if this doesn?t go away I will lose my job and be unable to work? right now I?m not gettin a income for 2 weeks cause there giving me two weeks to see what  retina specialist says or to see if it gets better.  If not? then this shot that I didn?t want to begin with.  Will be the end of me workin and I have to work?.
On 03/04/2023 I started experiencing dizzy spells, nauseousness and a severe headache. I went to the ER and my blood pressure was extremely high. They gave me an injection to lower my blood pressure and that seemed to help. I was not diagnosed with anything at that time and was referred to my PCP for further analysis. They also collected Urine samples over a 24-hour period to monitor kidney function results were normal. I was prescribed atorvastatin and NORVASC for Blood Pressure. I have a follow up appointment with a Cardiologist in June.
I had the vaccine on Saturday and Monday early morning something woke me up, I was sweating and my heart was pounding like crazy. I thought it was the side effects of the vaccine. It took 3-4 hours to stop. After 2 weeks at 4AM something woke me up again and I was sweating for no reason. The same symptoms I had after getting the vaccine. On 06/18/2021 again 4AM something woke me up and I had the same sweating and I was throwing up. I thought it was the vaccine so I did not go to the hospital. I did not think this was a heart attack since I am young, healthy, non-smoker, non-drinker. Again, something woke me up. I went upstairs with my neighbor and she took me to urgent care because she thought it was COVID and I thought it was just the vaccine and they said to call ambulance immediately because I was having a heart attack. They took me to the hospital, and they started the procedure. They said it was impossible to open here. By helicopter they took me to another hospital. I was on the doctor on Friday and they told me I still have a blood clot and they try to open but they were not able to open so they left it like clotted. Now they told me they need to do the bypass surgery. No heart attack history in my family. I am not having that surgery because doctors do not care here. I am going to another country to have surgery since they do care over there and it is less expensive. They prescribed a lot of medications for my heart.
This is a prospective pregnancy case. This 31-year-old female subject was enrolled in a study during pregnancy or within 28 days preceding conception. On an unknown date, the subject received Flu QIV. The subject's estimated date of delivery was 19th January 2015. On an unknown date, an unknown time after receiving Flu QIV the subject developed exposure during pregnancy (Non-serious). The outcome of exposure during pregnancy was unknown. The pregnancy was ongoing. It was unknown if the investigator considered the exposure during pregnancy to be related to Flu QIV. Given that this was from a consumer, this report was completed only as a precaution. Additional details: A patient who was currently 6 months pregnant reported wanting to get the FLUARIX QUADRIVALENT and wondered if GSK has any information about its use during pregnancy. No administration had occurred.
Got VARIVAX inj around 3:30 2-9-11 that night started with swelling - redness - hot to touch - painful. Parents have done cold compress, BENADRYL (L) arm height=6 1/4 in width=6 inches pt notified to do CORTAID & ice.
Narrative: Patient presented to the ER due to rash after receiving the first dose of the COVID-19 vaccine. Patient tolerated second dose of the COVID-19 vaccine without any ADRs.
My arm is very sore, it is hard to move it around at all. Thought this would stop but it has continued
Localized pain within 48 hours of getting first dose. The left arm where I received the injection was broken 30 years ago and that area had immense pain for the first 48 hours. 10 days later, noticed a rash below injection site, approximately 2.5 inches in diameter. Rash is warm to the touch.
Admitted here for COVID-19 pneumonia with hypoxemia.   received 2 doses of COVID 19 vaccine and not received the booster dose yet presenting to ED. Her O2 saturation has been decreasing to 87%.  Treatment for COVID 19 PNA with Vit C and zinc and decadron.  minimal o2 requirement.
3 days post-vax pt had t103 x 2 days; extremely irritable x 2 days; mom had to hold and rock x2 days; MD stated probable reaction to pertussis;
Sore, small red spot at injection site that night. The following morning, the red area had tripled in size, red, itching, hot to touch, and very painful. This has lasted 4 days. It is slowly improving, but still has not resolved.
Patient was given a booster dose of Moderna less than 6 months from her second dose.
Right upper arm with 8 X 10 CM area of erythema, induration, warm, tender.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 11-APR-2014 the patient was vaccinated with an improperly stored dose of M-M-R II single 0.5ml dose (HSA, lot # H014989, expiration date 10-AUG-2014, dose and route unknown). This specified lot number vaccine was exposed to temperature excursion fourth times. The total cumulative excursion time of the first time was 48 hours with the lowest recorded temperature of 6 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine this time was freezer (F). The total cumulative excursion time of the second time was 312 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine this time was refrigerator (R). The total cumulative excursion time of the third time was 120 hours with the lowest recorded temperature of 8 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine this time was freezer (F). The total cumulative excursion time of the fourth time was 144 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Delayed itching and raised rash at injection site.  Hard and hot to touch.     Used OTC hyrocortizone cream on rash to stop itching.       After two days, no longer itchy but raised red area at injection site about 3-4 inches in diameter.   Today, 2/26/2021, red rash still visible.
A nurse reported the occurrence of fussiness in a 2-month-old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The pt's medical history, concurrent conditions and concurrent medications were not provided. On 04/23/2002 the pt received his first injection of Infanrix into the left leg. On that date, he also received injections of Haemophilus influenzae type b conjugate vaccine (manufacturer unknown), inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur), and 7-valent pneumococcal conjugate vaccine (Prevnar, Lederle Labs). Later that evening, the pt was fussy for over 3 hours. The fussiness resolved the next morning.
Adverse Event- Flublok vaccine administered to 15 yo female patient.  Treatment: none Outcome: No serious adverse outcome.  Guardian notified of medication error on 10/5/23 when provider notified of medication error.
This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 11-JAN-2018, the patient was vaccinated with an improperly stored dose of PROQUAD, first dose, lot# N020616, expiration date 22-JAN-2019, for prophylaxis (strength, dose, route and frequency were not reported). The temperature excursion was of -12.1 °C, during 1 hour 30 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported.
Onset yesterday (1/21/21) after stretching left shoulder.  Felt like itching and mild burning in left deltoid.  Rapidly increased to mild pain/discomfort/aching.  Went for walk.  Upon return, muscle tested and stretched arm to see if I had injured arm.  Afterwards, there was onset of pain, swelling, redness, increased itching.  Redness generalized over left deltoid with pronounced scarlet redness at site of injection, about 3mm diameter.  Today (1/22/21, Day 2 of flare-up, about 22 hours after onset of symptoms):  increased aching over entire left shoulder/trap/scapula with pronounced redness over slightly greater area on deltoid, itching at deltoid, hardness and swelling of deltoid.  Almost a burning sensation over the deltoid, but not quite.  Tissue feels irritated and hot.  Limited loss of range of motion.  Pain increases with use of left arm, pushing arm through ROM movements. Moderate headache at waking, relieved with 25mg Sumatriptan.  Still mild headache.  Mild lethargy and fatigue.
My arm is very swollen; My arm is red; My arm is itchy; Knocked out on Tuesday January 12, 2021, I slept the whole day; Not much appetite; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Knocked out on Tuesday January 12, 2021, I slept the whole day), DECREASED APPETITE (Not much appetite), PERIPHERAL SWELLING (My arm is very swollen), ERYTHEMA (My arm is red) and PRURITUS (My arm is itchy) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Heart disease, unspecified.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced DECREASED APPETITE (Not much appetite). On 12-Jan-2021, the patient experienced SOMNOLENCE (Knocked out on Tuesday January 12, 2021, I slept the whole day). On an unknown date, the patient experienced PERIPHERAL SWELLING (My arm is very swollen), ERYTHEMA (My arm is red) and PRURITUS (My arm is itchy). At the time of the report, SOMNOLENCE (Knocked out on Tuesday January 12, 2021, I slept the whole day), DECREASED APPETITE (Not much appetite), PERIPHERAL SWELLING (My arm is very swollen), ERYTHEMA (My arm is red) and PRURITUS (My arm is itchy) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the events included paracetamol.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
3MAY93 mom called saying pt started staggering p/20APR93 vaccinations & is still staggering around like a little drunk man; low grade fever but not check w/thermometer; seen by MD; muscles tight;
Pain at injection site, diarrhea,  loss of appetite,  thirst, joint pains, fatigue, chills
Nausea, dizziness, chills, fever of 102 within 2 hours of receiving flu vaccination. Was prescribed Biaifin BID on 11/14/2001. Is improving. MD felt she had lung infection. Recovery - unable to see MD only spoke by telephone.
The day after I received the second vaccine, the supraclavicular region on my right side became inflammed along with dry and itchy skin.  The swelling has not gone away and has turned into a lump.   Any time I get sick now, the skin over that area always becomes extremely dry and itchy, almost resembling/looking like elephant skin.
minor hives and itching on left side of face and neck. Wheezing (identified by physician upon examination).  I did not detect the wheezing.
Body Aches;Shortness of Breath;Chest Pain;Weight Loss; Loss of Appetite.
TSH, T4 thyroxine and T3 total all out of range, reflecting hyperthyroidism
Abnormal menstrual cycle, prolonged menstrual cycle, erratic menstrual cycle, closer together menstrual cycle
Rash on face, chest, neck, right eye swollen, painful, itchy.  Triamanalone 0.5% topically, Prednisone 40mg daily for 5 days.
I had four anaphylactic episode with SOB and rash and hives and stomach and digestive issues after my second vaccine. Three of those four events I went to the ER. I felt the vaccine pushed me over the edge. I do have auto immune issue, celiac disease. I have had extensive lab work, CT scans and all exams were normal. I have also seen a specialist who performed UA tests and bone marrow biopsy trying to figure out if I have mass cell disease.
Vaccine administration errors, not associated with an adverse event. manufacture Moderna was contacted and does not provide any specific recommendations.
Baker's cyst (popliteal cyst) behind his right knee confirmed on ultrasound. And diffuse lymphadenopathy, axillary, inguinal and submandibular. Checked blood work- no signs of inflammation, normal white blood cell count.
angioedema; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included anaphylaxis to NSIADs. The patient's concomitant medications were not reported. The patient experienced angioedema after 1st dose of vaccine and an epinephrine (EPIPEN) was administered. She subsequently was tested for a Miralax allergy which was negative. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: A causal association between administration of BNT162B2 and the onset of angioedema cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product. 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.
arm pain; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) and NAUSEA (nauseous) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain) and NAUSEA (nauseous). At the time of the report, PAIN IN EXTREMITY (arm pain) and NAUSEA (nauseous) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Concomitant drugs are not provided.
Patient had a flu shot on 10/6/20 then started weekly Kanjinti/Taxol for her HER2+ metastatic pancreatic cancer on 10/16/20. She had a slight cough after her flu shot. Following C1D1 Kanjinti/Taxol on 10/16/20, her cough, which developed in to shortness of breath, progressively worsened. Symptoms continued to worsen through the next two cycles to the point where she was barely able to walk from her bed to the bathroom. She had a chest x-ray on 10/30/20 which showed pulmonary infiltrates in a reticulonodular pattern consistent with a drug reaction or progression. She was started on 40 mg prednisone daily on 11/13/20 but symptoms did not improve significantly prompting hospitalization for supportive care on 11/20/20.
Provider ordered TD. Tdap was administered instead of TD. Ordering provider notified of vaccine immediately after wrong vaccine was administered
I took the vaccine booster vaccine on 10/12/2021 and started experiencing discomfort on 10/14/2021 by the morning of 10/17/2021 the pain was severe and unbearable. I contacted Dr. On Demand and prescribed Ibuprofen 800mg, Metoprolol 50mg, Lidocaine 3%, Diclofenac 1% for muscle and joint pain, swelling, limited movement and trouble sleeping.  I called the doctor on 10/29/2021 with same issues but the pain had moved received the same instructions. 11/26/2021 called the doctor for swelling in both hands. Was given prednisone 20mg. 11/29/2021, seen my primary doctor and was told to see an Orthopaedic doctor. I started seeing the Orthopaedic doctor and was prescribed Gabapentin 300mg and Meloxicam 15mg. Since still experience the same pain a MRI is scheduled for 2/11/2022. I was also told contact the CDC back in October but never was able to find the link. I was given the link to on 02/10/2022 to file.
High heart rate, high blood pressure starting 20 minutes after injection. Caused me to black out while driving. Almost lost consciousness, called EMT. Was observed in ambulance for almost 1 hour until symptoms calmed down.
-Severe headache, lasted all day -Body aches, lasted all day  -Fever from 100.4 to 102 , all day -fatigue , 1.5 days
Patient called this afternoon and wanted to speak to the nurse regarding questions about the Covid vaccine. Patient conveyed that he has had a headache with an onset of 1100am today and 2 episodes of nose bleeds today as well. He reported epistaxis x2 different episodes and stated "just a trickle of blood and I wiped it off and it was done." Patient reports he took some over the counter aleve a short time ago and his headache has "eased up." Denies any other s/sx. Educated patient to follow up with ER for evaluation or PCP at minimum, reviewed ASE and ITP from patient fact sheet with patient over the phone. Encouraged patient to take Janssen fact sheet to MD/ER with him as well as vaccine card. Spoke to patient second occasion about 45 minutes after 1st call and patient was on the way to be seen at his PCP. He conveyed he called them and they were going to try to work him in to see the NP at 1500. Reiterated need to follow up with urgent care or PCP if unable to be seen at PCP. -----------------------------------7/14/21 TC to patient he stated all of his symptoms have resolved, he thinks it may have been just a fluke. He has not seen his PCP at this time.
any:    Narrative:  Hospital Course: Pneumonia due to COVID-19 virus 10/ apparently sent in from the nursing home because of a positive COVID. On questioning him said he had a mild increase in cough and just felt fatigued. The results are not hear  but there could be re-evaluated. He is on 2 L which seems to be his baseline but apparently his sat did drop. The chest x-ray shows some infiltrate in the inferior region. He has had both his 1st vaccine with a booster done just recently on  September 29th. Because of the confusion that was more than likely related to hypoglycemia along with his labile cardiac status they have asked us to admit and monitor. I am not sure that he meets criteria for remdesivir and though we might use the dexamethasone will have to be concerned about its potential effect on his glycemic control 10/8 COVID pneumonia with minimal change in oxygen needs from 2-3 L. multiple issues that could make this a more unstable issue. Will continue the steroids repeat chest x-ray see if can get his O2 needs down to 2 L. get PT OT to assess and if remains stable will get out 10/9 pt stable on 2L NC and satting well. 10/10 patient stable for discharge today.