chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered past the 30 day refrigeration time; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). On 07-Sep-2021, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The date refrigeration was reported as 20-Apr-2021 and the temperature changes (in F) was 40. Earlier this week we realized that some doses of the Moderna COVID Vaccine had been administered past the 30 day refrigeration time.  No treatment information was reported.
Client stated she felt her "heart racing".  Client continued to be coherent.   1:33 pm  B/P 144/98   pulse=103   Pulse Oximeter 98% 1:37 pm  B/P 142/78   pulse=107   Pulse Oximeter 94% 1:42 pm  B/P 110/88   pulse=087   Pulse Oximeter 94% 1:45 pm  B/P 118/94   pulse=109   Pulse Oximeter 94% 1:47 pm  B/P 120/90   pulse=107   Pulse Oximeter 94% Client stated she had a history of heart palpitations; also stated she had had a similar event after she received her flu shot. Client stated she felt fine.  Was going to return to work.  Encouraged to contact medical provider if symptoms returned.
Localized raised red area to right leg. Dime sized. Little fussy per mom.  No other s/s.
3 hours after the shot he turned a grayish color, he had a piercing headache, he had severe vomiting, fever, diarrhea, increased respirations at rest, fatigue, nausea. Nausea and vomitingwas the most serious for 35 hours but he continued to have nausea and vomiting for 4 days.
There was no adverse event. Patient received two doses of Fluzone on the same Flu season one month apart. First Fluzone given 01/11/2022. Second dose given 02/15/2022. No adverse reactions noted.  Patient doing well.
signs of "neoplasm cancer"; This spontaneous report was received from a 44-year-old female patient who was reporting on herself. She had no pertinent medical history, drug reactions or allergies and concomitant therapies. In December 2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, intramuscularly (lot # and expiration date were not reported) for prophylaxis, as recommended by her obstetrics and gynecology physician (OGBYN).  On 30-DEC-2019 , she developed "neoplasm cancer", however did not seek medical attention. On 06-FEB-2020, the patient visited her physician who performed a positron emission tomography (PET) scan which indicated signs of "neoplasm cancer". The outcome of the event was was reported as not recovered. Relatedness between the event and the suspect vaccine was not provided. Upon internal review, the event of neoplasm cancer was considered to be medically significant.
Vaccine was administered to patient beyond the 6 hour window following reconstitution.  It was administered almost exactly 7 hours after dilution. No adverse reactions have been reported at this time.
Day after vaccines, had 6 30 second episodes of shaking of extremities (not rhythmic) and head extended backward, over a 5 hr period. Alert throughout. No post/ictal period. No treatment required. EEG scheduled for 2/8/2000.
Left leg is swollen, red and warm at area vaccination site. Some moderate pain expressed. No fever or other symptoms noted.
Pt was observed after flu vaccine as she developed soreness in mouth after previous 2 flu vaccines. No swelling in tongue throat no chest tightness. She developed angioedema, difficulty breathing and swallowing. TX with Epi, Benadryl, Kenalog. Improved but catw returned tx at clinic.
Patient states she had complete loss of hearing for 2-3 hours the evening after receiving the vaccination. She states that she took a Tylenol dose, and her hearing came back to normal a few hours later.
Information has been received from a physician concerning a female patient who on 22-AUG-2007, was vaccinated IM with a dose of Gardasil.  After receiving the vaccine, the patient fainted.  It was reported that the physician had taken her blood pressure and had given her water.  At the time of this report, the patient's outcome was unknown.  Additional information is not expected.
Varicella vaccine was mistakenly given instead of zoster vaccine after contacting Merck, it was determined that there was "no specific safety concern that exists and the pt should be given zoster during same visit." No adverse event occurred.
discomfort on both breasts; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administered in arm left, administration date 10Mar2021 13:00 (Batch/Lot number: unknown) at the age of 56 years as dose 2, single for COVID-19 immunization. The patient's relevant medical history was not reported. Concomitant medications included: AMLODIPINE and simvastatin (SIMVASTAT). Vaccination history included: BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (dose 1, single; Batch/Lot number: unknown, vaccine location: left arm), administration date: 17Feb2021 at 01:00 PM, when the patient was 56 years old, for COVID-19 immunization. The following information was reported: BREAST DISCOMFORT (non-serious) with onset 17Mar2021, outcome "recovering," described as "discomfort on both breasts." The event "discomfort on both breasts" was evaluated at the physician office visit. Therapeutic measures were taken as a result of breast discomfort, which included Mortin and ice was applied.  Additional information: The vaccination facility type was the workplace clinic. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. The patient was not tested for covid post vaccination. The patient had no known allergies. Exactly one week after the patient received the second dosage, the patient started having discomfort on both breasts. The patient started feeling better on 24Mar2021, exactly two weeks after she got the second dosage.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
5/21/2022-Presents Ed via EMS, at home intially sinus brady hypotensive transcutaneously paced. Hr-40, systolic around 70 mmHg on norepinephrine mcg/min.  Intubated.  Had IO of R shoulder due to inability to place IV access. Admit hemodynamically significant bradycarida in the setting of severe mtabolic derangeent and metabolic acidosis. Potassium 7 and creatnine above 6 . CXR: bibasilar linear atelectasis.  Covid + test. Hemodialsysi catheter via IJ for emergenct dislaysis. Pancreatits based on abd CTand  lipase over 4000. Transfered to ICU.   Temporary venous pacemaker placed along with hemodialysis catheter. Vent settings Fio2 100% resp 16 ABG: 6.9/27.2 bicarb less then 6 and anion gap more then 19 Ordered IV meropenem and pressor support.  5/22/2022-Bicarb drip started , acidosis improving. Monoclonals and steroids not recommended due to amount of renal failure. Vent settings Fio2 50% resp 10 Family discussion, Patient made palliative. Terminal exubation. Time of death 1600.
Initial pain in lower abdomen followed by fever and muscle and joint pain. Fever, 101.6 F, which continued thru the next day. Worse at night. Somewhat better today. By far the worst episode of "flu like" illness I have had in the last 10 years.
Student went to emergency department with compliant of wisdom tooth pain, chills, numbness and nausea on 5/19/21, the day after his second dose of vaccine.
Transverse myelitis and temporally related to flu shot. Flu shot administered 11/30/2009. Hospitalized 12/4/2009, symptoms developing over 3 days prior.
Extreme injection site swelling for over a week, severe facial tics began within a few days of vaccine and still continue from time to time. Rapid decline in mood and personality.
Immediate trigeminal nerves  triggered, mouth tingled, slightly dizzy, blurred vision. 1/2 hr later felt like skin burning on face and arms looking like a sunburn,  small fiber neuropathy kicked up throughout body. Next morning slight headache and slight dizziness, slight sweating.  Subnormal temp all day.  Burning feeling, sunburned skin continues as it comes and occasionally lessens.
Given DTP/OPV/HIB became irritable; Temp of 103 - 104 & would not sleep; restless & was crying had inc temp; 18MAR91 awakened AM w/swollen lt leg saw MD dx cellulitis lt leg;
gotten covid a week ago; Received the first dose 5 weeks ago/supposed to get the second dose last week but they rescheduled it because he forgot.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (gotten covid a week ago) and PRODUCT DOSE OMISSION ISSUE (Received the first dose 5 weeks ago/supposed to get the second dose last week but they rescheduled it because he forgot.) in a 26-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (gotten covid a week ago) and PRODUCT DOSE OMISSION ISSUE (Received the first dose 5 weeks ago/supposed to get the second dose last week but they rescheduled it because he forgot.). At the time of the report, COVID-19 (gotten covid a week ago) was resolving and PRODUCT DOSE OMISSION ISSUE (Received the first dose 5 weeks ago/supposed to get the second dose last week but they rescheduled it because he forgot.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication was reported by patient.
somewhat more uncomfortable post-vaccine time; The initial case was missing the following minimum criteria: No adverse event. Upon receipt of follow-up information on 06Oct2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. An adult female patient received bnt162b2 (BNT162B2), on 22Feb2021 as dose 2, single (Lot number: EN6201) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "graves' disease" (unspecified if ongoing), notes: in remission; "Multiple chemical sensitivities" (unspecified if ongoing); "Over reactive immune system in general" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE), administration date: 01Feb2021, when the patient was 59-year-old, for COVID-19 immunization, reaction(s): "immune system issues", "somewhat more uncomfortable post-vaccine time". The following information was reported: DISCOMFORT (non-serious), outcome "unknown", described as "somewhat more uncomfortable post-vaccine time".  Additional Information: Regarding family medical history relevant to adverse events (AES), it was reported that "nothing other than slightly heightened (for a few days) immune system reactions-no follow-up care needed from any medical facility or physician". The patient had MCS (Multiple chemical sensitivities) and Graves' disease (in remission from graves' disease), over reactive immune system in general that probably contributed to a somewhat more uncomfortable post vaccine time. She commented that she doesn't know why the form was sent to her, she had normal post-vaccine reactions (a few days only each time) each of the 4 times she was vaccinated against COVID. She had the 2 initial vaccines for the first course, and then 2 booster, a year apart.
A non-serious spontaneous report of taste the vaccine in the back of their throat has been received from a nurse concerning ten adolescents subsequent to H1N1, Intranasal. The past medical history and concomitant medications of these patients were not reported. On 30-Oct-2009 the patients received H1N1, Intranasal. On the same day, shortly after administration of the vaccine the patients reported they could taste the vaccine in the back of their throat. The outcome of the event was not reported.
Lipoma developed in between carotid artery and jugular vein. 9.6 cm SI x3.3 cm AP x2.3 cm TV.
Severe headache 10 out of 10 started the following day with vertigo.  During this time he developed an episode of sudden onset double vision and vomiting which resolved after approximately 10 minutes.    The headache and the vertigo lasted for several days.
Vaccine was administered after being at room temperature for a total of 5 hours 15 minutes. Outside the recommended guidelines.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 01/12/2022 and 02/11/2022. They tested positive for COVID-19 on 06/05/2022. They were  admitted to hospital for this illness   on 06/04/2022. They were diagnosed with COVID-19 pneumonia and acute hypoxic respiratory failure. They were discharged 06/07/2022. However, they then presented to Emergency Department again on 06/12/2022 with a primary complaints of shortness of breath and weakness. They were admitted to hospital again. Their condition declined rapidly and they died on 03/13/2022.
This spontaneous report as received from a registered nurse refers to 2 unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of improperly stored VARIVAX (lot/batch#M034582 (invalid), expiration date 27-JUL-2018) (strength and route of administration were not reported) for prophylaxis. Sterile diluent was used. The vaccine was exposed to "6 degree Fahrenheit to 14 degree Fahrenheit" for 25 minutes.There was no previous temperature excursion. No adverse effects reported. Digital data logger was involved. There was no product quality complaint(PQC) involved.
Myalgia, Diarrhea, left arm soreness, chills, fatigue Narrative:
When I got Covid it started off as a cold. Then I couldn't eat or take my medications which put my health at risk so I went to the ER. I also had trouble breathing. The doctor said I had pneumonia. I had a fever of 101 degrees. I stayed in the hospital for 4 days. I was sent home with oxygen because of the issues with my breathing. I was also given antibiotics. I still have a little problems breathing. Sometimes I will have an episode that lasts about 20 seconds when I have to grasp for air then my breathing goes back to normal. I still need to get my blood sugar under control as well because when that event happened it caused my numbers to be high. I have to see my doctor next week for that because my blood sugar haven't came down. My numbers have been bad during and ever since that event had happened.
little tired; soreness at injection site; minor skin rash on her feet; This spontaneous case was reported by a consumer and describes the occurrence of RASH (minor skin rash on her feet), FATIGUE (little tired) and VACCINATION SITE PAIN (soreness at injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Skin allergy) and Hypersensitivity (sensitivities).    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (minor skin rash on her feet). On 08-Mar-2021, the patient experienced FATIGUE (little tired) and VACCINATION SITE PAIN (soreness at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) on 07-Mar-2021 for Skin rash, at an unspecified dose and frequency. At the time of the report, RASH (minor skin rash on her feet) was resolving and FATIGUE (little tired) and VACCINATION SITE PAIN (soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. The rash went away within 15-20 minutes after applying the cream..
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown gender and age. Information about the patients' medical history and concurrent condition was not provided. On an unknown date, the patients were vaccinated with doses od M-M-R II (lot/batch#, expiration dates, dose and dose numbers were not reported) that were improperly stored. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Patient received 1st dose of Covid Vaccine. Patient bled during the vaccination but appeared calm. Instructed the patient to stay for 10 minutes after. Patient and father left lobby. Front cashier paged pharmacist to the Front of store as patient was fainting. Pharmacist found patient sitting on floor sweating but conscious and normal breathing. 911 was called and patient was sat in a chair. Blood pressure check was 117/71 pulse 89 pharmacist stayed with patient. EMS arrived after 10 mins, EMS examined and released patient.
This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient took flu vaccine and she had same reaction. Concomitant medications were not reported. The patient's shoulder was sore at the injection site on an unspecified date and when she went to sleep the pain was still bothering her so she called  and they told her it was okay to take Advil 24 hours after the vaccine, she took 2 Advil, after a couple of days the pain disappeared. The patient was recovered from the event in 2021. Follow-up attempts are completed. No further information was expected.
sick all the day; Initial information received on 18-Feb-2021 regarding an unsolicited valid serious case received from a consumer.  This case involves male patient who developed sick all day (Illness), while she received vaccine RABIES VACCINE.  The patient's past medical history included cat scratch and bite, Past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect RABIES VACCINE produced by unknown manufacturer lot number not reported for prophylactic vaccination.  On an unknown date (latency: unknown), after taken suspect RABIES VACCINE, reported developed sick all day (Illness). It was reported having the first three shots with not getting sick and that as the 6 to 7 shot series went along getting a reaction of being sick all day long with having to lay in bed.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for this event.
On 19AUG, pt presented as a transient pt, complaining of 2 day history of bilateral ankle swelling.  Also complains of exquisite pain in bilateral malleolar region, edema in achilles region.
Patient had chest tightness, palpitations, and dyspnea on minimal exertion within days of the vaccine that lasted for 3-4 weeks.
Headache appeared at about noon on same day as vacinnation and continued until next day, evening. At the same time I felt weak in the muscles and had to push myself to continue on a regular schedule, lost my appetite, thinking very fuzzy, mood not good, On the next morning, woke up with blurry vision that subsided in a few hours and at the same time loud ringing in ears, mostly left ear that came and went until Thursday, Sight of injection upper right arm began to swell up on late Wednesday and then on Thursday a red wing about 2 inches started to appear about 2 inched down from the injection site then the itching began and if I did scratch the area then it began to burn so I stopped scratching very soon. Itching and redness continued until  Monday. The muscle weakness and lack of appetite and fuzzy thinking and mood change didn't really stop until Monday. At this point I'm not sure if I've had an allergic reaction or if all of the above is somewhat normal.
After receiving 4th injection (HPV9), child became stiff, unresponsive, eyes rolled back but child recovered immediately. Encouraged mom to FU with PMD. Spoke w/mom for FU call and mom verbalized child developed headaches, rash to left arm and fever 100.5 these symptoms developed 12 to 24 hours after injections. Returned to school 3-17-16, but still had rash to left arm.
There have been no additional adverse experiences reported; A single dose of Rotateq was inadvertently administered to a 10 year old infant; This spontaneous report was received from a physician and refers to a 10-day old patient of an unknown gender. The patient pertinent medical history, concurrent conditions and concomitant therapies were not provided.  On 21-JUN-2021, the patient was inadvertently vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1707408 and expiration date 07-JAN-2022) one single dose for prophylaxis.  No additional adverse experiences were reported as a result of the administration of the vaccine.
Pfizer vaccine was stored incorrectly. It was placed in the regular freezer instead of the sub-zero freezer. Pt's mother is notified and will converse with her husband to see if they would like to have patient be revaccinated.
Redness, no itching, no pain. Not at injection site but approximately 3 inches from bottom of deltoid. Patient doesn't know if redness is related to immunization. Unable to tell. Just wants to take proper precautions.
Patient reported to PHN during his observation time that he was feeling lightheaded and feeling like he" was going to pass out". PHN requested for assitance of lead clinic and had patient lay on the floor and put his feet up on the chair. PHN had ice placed on patients head and behind his neck. Patient appeared pale but PHN did not notice patients previous face color prior to entering observation. PHN took patents BP which was 125/90 and pulse 75. Oxygenation was 100%. Patient given water and after about 10 minutes patient felt better and returned to sitting position in chair.