chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received 2nd Moderna dose 5/10/2021 at noon. Symptoms started 5/10/2021 around 10pm. Symptoms: chills, bodyaches, fatigue, nausea, vomiting, diarrhea, abdominal pain, decreased appetite, ear pain. Symptoms still present 5/11/2021 during clinic visit. During visit, patient appeared ill, had fever 100.8 deg F, tenderness to RUQ and LUQ of abdomen, and had bilateral acute suppurative otitis media. Treatment: amoxicillin 875mg PO BID x10days for otitis media; ondansetron 8mg PO BID PRN nausea for up to 4 doses; tylenol and ibuprofen standard adult dosing per pkg directions for vaccine reaction, fever, chills, pain. Advised to follow up with PCP in 1-2 days or to report to ER for severe symptoms.
Extreme shoulder joint and muscle pain unable after 12hrs of receiving shot to raise arm waist high continued severe pain and immobility for next 12 hrs after continued use of salonspas getting minor relief.
Patient became ill the evening after getting the vaccine. She started feeling like a flu was coming on. The next day, 08/03, she had chills, fever, and began shaking. On 8/4/21, she began feeling better, but had canker sores throughout her mouth and a swollen lip. On 8/5/21, she noticed blood in her stool and went to the hospital. They performed blood tests (nothing abnornal) and released her. She had blood in her stool on 8/6/21 consisting of hard clumps of blood. The hospital told her her blood pressure was reading high and told her to see an endocrinologist.
Four days after receiving my second dose of the COVID-19 vaccination I got red dots all over the bottom half of my body followed with headaches bodyaches and a general feeling of unwellness. The rash burned itched and hurt
Nauseated; Threw up once, maybe twice; Soreness in right arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 80 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Apr2021 14:15 (Lot number: EW0158, Expiration Date: 31Jul2021) at the age of 80 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing), notes: Verbatim: Arthritis in hands; "Diabetes" (unspecified if ongoing), notes: Verbatim: Diabetes. The patient took concomitant medications. Vaccination history included: Bnt162b2 (First dose:, NDC: Unknown, Lot: EN620X, Exp: 30Jun2021, Received in left arm), for COVID-19 Immunization, reaction(s): "I wasn't feeling so great so I did get sick", "Get sick to my stomach", "threw up one time two hours after the first shot". The following information was reported: NAUSEA (non-serious) with onset 28Apr2021, outcome "recovering", described as "Nauseated"; PAIN IN EXTREMITY (non-serious) with onset 27Apr2021, outcome "recovering", described as "Soreness in right arm"; VOMITING (non-serious) with onset 28Apr2021, outcome "unknown", described as "Threw up once, maybe twice". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She had the first shot on 01Apr2021. She got sick to her stomach and threw up one time two hours after the first shot. She got her second shot yesterday, 27Apr2021 at 14:15. She did not get sick yesterday, just had a sore arm. Ten minutes before 08:00 she had to thrown up one time. It wasn't a lot, but it happened just a short time ago. At 07:50 this morning she had not had any breakfast yet. Was getting ready to put breakfast together when she felt this feeling come over her. She dashed to the bathroom and threw up once, maybe twice, it wasn't much. She didn't have any food in her. She had taken a couple of pills earlier and doesn't know if those pills came up or not. The throwing up stopped and she thought that was probably it since she only threw up once after the first shot. Caller did not provide product names of pills she took earlier this morning.  No follow-up attempts are possible. No further information is expected.
This is a spontaneous case received from a medical assistant reporting on a 50-year-old female who received a dose of ZOSTAVAX on 05-Apr-2017 (lot # M041669, exp. 09-Jan-2018). The primary reporter reported that the physician 'confirmed shingles' after the ZOSTAVAX was administered. Onset of confirmed shingles was 10-APR-2017. Unspecified treatment was given to the patient on an unspecified date. There were no labs or diagnostics performed. At the time of the report the patient was not recovered. Additional information has been requested.
Significant adverse reaction to the second round of Moderna? COVID-19 vaccination. Fever, aching, sweats, headache for several days. Injection site extremely sore.  The most significant outcome was the onset of profound Tinnitus, which occurred at the peak of the extreme reaction period following the second injection and has lasted ever since. It is manifested by very loud ringing in both ears which overpowers all other normal sounds. Occasionally there is an intermittent buzzing noise in addition to the constant ringing noise.
5 doses were given from a vial exposed to several temperature excursions; 5 doses were given from a vial exposed to several temperature excursions; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses were given from a vial exposed to several temperature excursions) and PRODUCT STORAGE ERROR (5 doses were given from a vial exposed to several temperature excursions) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses were given from a vial exposed to several temperature excursions). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (5 doses were given from a vial exposed to several temperature excursions). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 doses were given from a vial exposed to several temperature excursions) and PRODUCT STORAGE ERROR (5 doses were given from a vial exposed to several temperature excursions) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB, lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9, lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a timeframe of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 13-year-old patient of unknown gender. On 21-JUN-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot number N023828 (expiration date 25-JUN-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
This child had a 2" reddened, warm area on the left upper arm, with slight swelling on the left lower arm. Advised Benadryl and cool compresses.
Patient c/o slight numbenss at the injection site and to the back side of the arm along with feelings of queasiness. Ears were flush, no redness noted at the injection site or arm after fifteen minutes. Pt was able to lift her arm and hold it without any difficulty. Pt reported not eating anything this morning before recieving the vaccine. Pt allowed to lie down and monitored for 15 more minutes. Pt verbalized that she felt better after the additional 15 minutes, ears were with in normal color.
2 hours after shot general giant hives. Pulse 02 100, looks happy.  Earlier hoarse voice none on exam.  Has twin-same shots no reaction.
The influenza vaccine administered to the patient had been removed from the refrigerator on 10.23.23 at approximately 9 am and had remained at room temp (68-70 F) until the morning of 10.24.23 at approximately 7 am when the dose was administered to the patient. in her right deltoid. Patient had no other adverse events reported. GSK was contacted on 10.24.23 at approximately 10 am to check for any extended stability of Flulaval Quadrivalent vaccine. GSK reported that they have extended stability data for Flulaval of 72 hour at 77 F. We are reporting this event because the vaccine was administered prior to checkin with the manufacturer for extended stability data.
Patient has generalized anxiety disorder .Onsite EMS was called they woke the up vitals BP 180/80    100% O2 room air HR 80. Patient Refused Evaluation/Care, Left aginst medical advice.
No effect on the day of injection, but the following morning I experienced dizziness that prevented me from leaving the house.  I did not contact the primary care doctor since August and hoped the dizziness would ease as I was preparing for morning chores.  I spent the entire morning seated.  After lunch the  dizziness had gone.
Pt experienced a delayed serum sickness, hypersensitivity reaction, rash, fluctuating urticarial rash and erythema macular rash. Pt also experienced large joint swelling. No treatment given. Symptoms cleared in 48-72 hours after onset.
Received the vaccine at 12, about 15 minutes after the injection began to have itching eyes, face hot, bil ear pain and throat and chest tightness
One day after receiving the first shot of Moderna Vaccine (on January 15, 2021), I became EXTREMELY dizzy; this slowly lessened and went away within 3 to 5 days.  I received the 2nd shot of Moderna vaccine on February 9th, 2021.   ON FEBRUARY 28th I AWAKENED AT 7AM AND IMMEDIATELY BEGAN TO EXPERIENCE A SUDDEN HEARING LOSS IN BOTH EARS.  I tried to make an appointment with my then ENT but was unable to get in until April 14th, 2021.  The "sudden hearing loss" lasted only one day, but left me with an increased ringing/tinnitus in my left ear which has lasted until now, and has not improved or gone away.  I have also begun to develop tinnitus in my left ear as well which was not preexisting.  The tinnitus in my right ear was preexisting, but barely noticeable until February 28th, when it increased substantially and has since become much, much worse.  It keeps me awake at night the ringing is so LOUD.  It was never that bad before!
35mm X 60mm red area at left arm, warm to touch, complained of itching.
Itching in various body areas within a few hrs. after receiving the immunization - hands, feet, back, chest, and scalp.  No local reaction in the left arm deltoid injection site.
Teammate was given a 4th dose of the Monovalent vaccine as her booster does when the Bivalent Booster should have been administered.
3 days after the vaccine patient presented with headache, body ache and chest pain. Found to have elevated troponin, and abnormal EKG
Myalgia numbness in right bicep. numbness and tingling in ring finer and pinky Narrative: patient was kept in the clinic an additional 15 minutes to monitor for additional signs and symptoms. patient is also being monitored to make sure her symptoms do not get worse.
Left deltoid with 6cm x 7cm red and warm area which developed 48 hours post vaccination.
stomach is upset but nothing major with diarrhea; cramping in my stomach; severe diarrhea; slightly sore where vaccine was injected; couldn't move upper arm it was very painful; It was progressing toward shoulder and neck; normal soreness in arm; tired; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (cramping in my stomach), ABDOMINAL DISCOMFORT (stomach is upset but nothing major with diarrhea), PAIN (couldn't move upper arm it was very painful), DIARRHOEA (severe diarrhea) and NECK PAIN (It was progressing toward shoulder and neck) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history was provided by reporter.  Concomitant products included ESCITALOPRAM and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN (couldn't move upper arm it was very painful), NECK PAIN (It was progressing toward shoulder and neck), PAIN IN EXTREMITY (normal soreness in arm) and FATIGUE (tired). On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (slightly sore where vaccine was injected). On 31-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (cramping in my stomach) and DIARRHOEA (severe diarrhea). On 01-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach is upset but nothing major with diarrhea). The patient was treated with IBUPROFEN at a dose of UNK dosage form. At the time of the report, ABDOMINAL PAIN UPPER (cramping in my stomach), ABDOMINAL DISCOMFORT (stomach is upset but nothing major with diarrhea), PAIN (couldn't move upper arm it was very painful), DIARRHOEA (severe diarrhea), NECK PAIN (It was progressing toward shoulder and neck), PAIN IN EXTREMITY (normal soreness in arm), FATIGUE (tired) and VACCINATION SITE PAIN (slightly sore where vaccine was injected) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-103307 (Patient Link).
It began slowly, after the second dose, once the flu symptom went away, I noticed shortness of breath and my blood pressure issues. I had intense sweating and being fatigue. I was retaining fluid in my ankles, they had me set up for a heart doppler ultrasound. They prescribed me to another blood prescribed Amlodipine Besylate tab once a day, in addition to my other medication. I see my doctor again next week on Wednesday.
seizures because of a shot that had eggs in it; Initial information was received on 08-Oct-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional.  This case involves patient who had seizures because of a shot that had eggs in it (seizure) when received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious seizures because of a shot that had eggs in it (seizure) (unknown latency) following the administration of INFLUENZA VACCINE.   This event was assessed as medically significant.  No laboratory data was provided   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  Information on lot number was requested.; Sender's Comments: This case concerns a patient of unknown demographics who had seizures after vaccination with INFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
I got sick Tuesday during the day. I felt drainage and thought it was allergies. By that afternoon I was really tired. I woke with something that felt like a sinus infection. I called my doctor Wednesday morning after I completed a COVID-19 home test and it was positive. I was placed on antivirals and have since completely recovered. I was symptomatic for about 3 to 4 days and then I was no longer symptomatic until 4 days later when I started running a higher fever and vomiting. This lasted for about 24 hours and then all symptoms resolved.
Per patient's significant other's report: Chest pain, hypothermia, incoherence of speech, and ataxia occurred 30-45 minutes after the injection. Patient was taken to a neighboring hospital where CT scan, blood draws, and physical examination took place. Patient states that the diagnosis was an anxiety attack, but the patient and the significant other disagree with this assessment. At the time of this report, the patient reports movement return, but still slowness of speech and thought. Patient is being followed by a primary care physician now.
Patient developed sinus congestion, headache, nausea, and vomting.  Symptoms worsened through the month and is now being admitted to the hospital with numbness and tingling of her leg.  11/09/2007 Reviewed hospital medical records which reveal patient experienced URI symptoms & fatigue soon after initial HPV vaccine. Then received 2nd dose HPV & symptoms worsened.  Began to have sudden tingling & numbness of right foot & leg on 10/17 along w/nausea & extreme fatigue.  Admitted 10/18-10/20/2007.  Neurology consult done. FINAL DX: UTI; paresthesias of unclear etiology; possible conversion disorder; gallstones; probable GERD. Follow-up Information 20-DEC-2007: After receiving the 2nd dose of HPV Vaccination, 24 hours later I was light-headed, dizzy, nauseous, vomiting, severe headaches, sinusitis and had a bright red face. On October 18th I was hospitalized after 3 trips to the emergency room and numerous visits to my physician with severe nausea, and vomiting and inability to eat anything. I was treated unsuccessfully with Bactrim, Protonix, and Reglan. I received a CT Scan, MRI, Ultrasound, all that revelated nothing that could explain my symptoms other than what the vaccine has done to me, which seems to be unknown and not yet found. On November 15th I required a laparascopic cholecystectomy secondary to cholecystitis with cholelithiasis, my symptoms were the same as previous severe headaches, nausea, vomiting and inability to eat. The only thing that changed in my life was receiving the second dose of this vaccine on September 19th, 2007 and i have not been the same person since, I have been unable to work, eat regular meals or live the regualr life of a 25 year old.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On 29-DEC-2014 the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K006682 with expiration date of 17-DEC-2015; dosage and route unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Tingling in lips and mouth and  a very odd and comfortable feeling in chest and abdomen after about 15 mins of receiving injection. Symptoms waxed and waned throughout day. Took Benadryl  after getting home  and again at bedtime. 4/22 /21: woke up feeling better initially but symptoms returned at 0800 and waxed and waned throughout day though  less intense than on 4/21..... Benadryl has been helpful. Headache has been intermittent.
Hives/rash (looks similar to shingles) on right arm, and right torso (back and chest); Body was itching for a week.; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male 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 12Mar2021 at 11:30 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient did not take any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received morphine (MANUFACTURER UNKNOWN) on unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On unspecified date in Mar2021, the patient's body was itching for a week after the vaccine and a week later on 19Mar2021, broke out into hives/rash (looked similar to shingles) on right arm, and right torso (back and chest). The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the events. The clinical outcome of the events hives and itching was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
kept on falling; couldn't get up; she started feeling dizzy; This spontaneous case was reported by a consumer and describes the occurrence of FALL (kept on falling), DYSSTASIA (couldn't get up) and DIZZINESS (she started feeling dizzy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Kidney stones, Fibromyalgia and Acid reflux (oesophageal). Concurrent medical conditions included Blood pressure high, High cholesterol, Parkinson's disease, Breast cancer, Arthritis, Osteoarthritis, Neuropathy, Diabetes and Hepatic disease. Concomitant products included GABAPENTIN, INSULIN GLARGINE (BASAGLAR), LISINOPRIL, CARBIDOPA, LEVODOPA, FISH OIL (FISH OIL OMEGA 3), TRAMADOL, EZETIMIBE, SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]), CARBIDOPA, LEVODOPA (CARBIDOPA + L-DOPA) and ALUMINIUM HYDROXIDE, DICYCLOVERINE HYDROCHLORIDE, MAGNESIUM OXIDUM LEVE (DICYCLOMINE CO) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced DIZZINESS (she started feeling dizzy). On 18-Mar-2021, the patient experienced FALL (kept on falling) and DYSSTASIA (couldn't get up). On 20-Mar-2021, FALL (kept on falling), DYSSTASIA (couldn't get up) and DIZZINESS (she started feeling dizzy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was reported as doctor increased her Parkinson's disease medication.   This case was linked to US-MODERNATX, INC.-MOD-2021-068365 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068365: