chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He experienced symptoms consistent with myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (He experienced symptoms consistent with myocarditis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MYOCARDITIS (He experienced symptoms consistent with myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (He experienced symptoms consistent with myocarditis) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  The reporter stated that post vaccination in Mar-2021, he experienced symptoms consistent with myocarditis. This was a self-exam; no physician was involved.   Optional information claims that while his symptoms were diminishing, they were not completely gone.  Stated that he routinely works out and the length and intensity of his workouts had not been compromised. As previously stated, the diagnosis was determined by using online sources.   He had not previously reported this issue.  Treatment information was not provided. Company Comment: This is a spontaneous case concerning a male patient of an unknown age with no reported medical history, who experienced the serious (due to medically significant) expected, AESI event of Myocarditis which occurred on an unknown date after a dose of mRNA-1273 vaccine (unknown COVID-19 vaccination schedule). It was reported that post vaccination in Mar-2021, he experienced symptoms consistent with myocarditis. This was a self-exam; no physician was involved. While his symptoms were diminishing, they were not completely gone. He stated that he routinely works out and the length and intensity of his workouts had not been compromised. The diagnosis was determined by using online sources. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
(Vac. 4-30-09) - site irritation only through Sunday 5-03-09 - Rash began Monday AM. Covering - Neck to back of thighs. Covering torso.
Persistent crying that would stop with breast feeding, temporarily and then start again from 16:00 to 08:00, post vax. Motrin was given for pain control.
Subsequent to receiving vax pt experienced a breakthrough rash with an unknown number of lesions crusted over on the trunk and face. The pt sought unspecified medical treatment. The physician noted that the lesions had scabbed on the pts trunk. Additional information has been requested.
I received the flu shot last Wednesday evening 10/11. On 10/14 Saturday afternoon I woke up with slightly red, slightly swollen eyelids. (I work night shift). On Sunday early morning before going to sleep I developed a red rash with some hives, and smaller bumps on my knees and my buttocks. That same afternoon when I woke up my eyelids were even more swollen than the day before. I haven?t been exposed to anything new other than the flu shot that I know of, haven?t changed any skin products, haven?t eaten anything different, or taken any new medications. I put hydrocortisone cream on the rash and it cleared up by afternoon, I also took Benadryl but it didn?t help the swollen eyelids. They were close to normal by Monday morning.
Nauseating feeling; Dizziness that is not severe; Injection site pain; A spontaneous report was received from a 77-year-old, male consumer who received Moderna's COVID-19 vaccine and experienced injection site pain, dizziness that is not severe and nauseated feeling.  The patient's medical history was not provided. Concomitant medications were amlodipine, losartan HCl, carvedilol, fenofibrate and thyroid medication.  On 02 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A; Exp. date: 20 June 2021)  intramuscularly in his left arm for prophylaxis of COVID-19 infection.   On 02 Jan 2021, after receiving the vaccine, the patient experienced injection site pain.  On 04 Jan 2021, the patient experienced dizziness that is not severe which is ongoing.   On 05 Jan 2021, the patient had a nauseating feeling. No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the event, injection site pain, is recovered on 04 Jan 2021.   The outcome for the events, dizziness and nausea is not recovered.; Reporter's Comments: This case concerns a 77-year-old, male patient. The patient's medical history was not provided. The patient experienced NS expected events of injection site pain and nausea and unexpected event of dizziness.  The event of injection site pain occurred the same day, dizziness occurred 3 days and nausea occurred 4 days after the first dose of mRNA-1273 (Lot number: 039K20A; Exp. date: 20 June 2021). No treatment was taken. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sore arm for less than 24 hrs.; Rash on my arms and wrists that I noticed almost 24 hrs after injections; Mildly itchy; Looked like tiny blisters; This is a spontaneous report from a contactable 41-year-old female other health care professional (reported herself). A 41 year old non pregnant Caucasian women received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; lot number: EN6207), at an unknown dosage via unknown route of administration in left arm on 12Mar2021 at 15:45 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The patient did not receive any other vaccines with 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient had no allergies to medications, food, or other products. On 13Mar2021, the patient experienced sore arm for less than 24 hrs, rash on my arms and wrists that I noticed almost 24 hrs after injections, mildly itchy. Looked like tiny blisters. Last 3-4 days. As a corrective treatment for the events the patient received benadryl and applied topical OTC (over the counter) ointment. The outcome of the events was recovered.  Additional information has been requested.
left arm edema with erythema around the deltoid  area , warm and tender with swelling extending towards elbow . No fever
This is a spontaneous report from a contactable office manager reporting on behalf of a physician. This office manager reported similar events for five patients. This is the third of five reports. This office manager reported that...Dates for Patient received vaccine after temperature excursion: (From: 22 Dec 2017 To: Unspecified). Is PREVNAR 13 a Pfizer product? Unspecified. PREVNAR 13 manufacturer: Wyeth. Dates for PREVNAR 13: (Start: 22 Dec 2017 Stop: Unspecified). NDC number of PREVNAR 13: Unknown. Expiry Date of PREVNAR 13: Dec 2019. PREVNAR 13: No change. Dates for Concomitant Products Lisinopril: (Start: Unknown Stop: Unspecified). Dates for Concomitant Products FLUARIX: (Start: Unspecified Stop: Unspecified). Additional Context: Report 3 of 5. Warm transfer from Pfizer Medical Information US18-002817 has a caller on the line who called her for PREVNAR 13 that was exposed to temperature excursion and was asking for the viability of product. Transfer agent states that agent provided caller that information, but found that there were 5 patients exposed to the PREVNAR 13 in question; Agent states she is an Office Manager. Temperature excursion went to 10.7 degrees Celsius for 50 minutes. Temperature Excursion details: Reporter clarified it was not at that temperature, 10.7 degrees Celsius for 50 minutes. That was the maximum temperature reached on the alert system they use and started coming back up as power back on. Patient 3 of 5: Information populated within this report. Other Medical Conditions: None. Denies any. Testing/Interventions/Treatment: None. VACCINE SUPPLEMENTAL FORM. Patient Age at Time of Vaccination in Years: 58 years old. Vaccine Lot Number: S74424. Vaccine Lot Expire Date: Dec 2019. Time the Vaccination was Given (24 hour clock): Unknown. Anatomical Location of Administration of Pfizer vaccine considered as suspect: Deltoid Right. Vaccination Facility Type: Other: Physician's Clinic. Vaccine Administered at Military Facility? No. Additional Vaccines Administered on Same Date of the Pfizer Suspect Vaccine Name: FLUARIX. Lot Number/Expiry Date: G29412/30Jun2018. Route: Intramuscular. Anatomical Location: Deltoid Right. Number of Previous Doses: Unknown. Adverse Event: Patient received vaccine after temperature excursion. Time of Onset (24 hour clock): Unknown. Additional Information. Did any AE(s) require a visit to: Emergency Room: No Physician Office: No. Prior Vaccinations (within 4 weeks prior to the first administration date of the suspect vaccine(s)): None. Patient's Medical History: None. Family Medical History Relevant to AE(s): None. Relevant Tests: None. Sender's Comments: Linked Report(s): US-PFIZER INC-2018017647 same reporter, different patient, same drug/event.
Patient statement " Very sore throat- felt like strep. Itchy sore eyes with matting. poor reading vision, distant vision somewhat blurred. Overall achy feeling. Rapid pulse 130+ "
He had his armpit is swollen like a ball; This is a spontaneous report from a contactable consumer (parent) or other non HCP.   A male patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Unknown, Expiration date: unknown), via an intramuscular route on 19Jun2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 1, single for covid-19 immunisation and had no reaction on previous exposure to vaccine. On 20Jun2021, the patient experienced had his armpit swollen like a ball. Reporter stated he got his 2nd COVID Vaccine and next day morning he had his armpit is swollen like a ball and really very concerned about his son's health. The outcome of the event was not recovered.  Information on lot/batch number has been requested.
Seizure activity started the day after vaccine, he was seizure free for over a yr on a low dose of Keppra 150mg/day now at 600mg twice daily with 160 seizures since vaccine administration.
4 days of axillary temp 101-104, irritability crying, dec appetite;APAP for fever;
VARIVAX underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 17-JUN-2021, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # T029533 exp date 01-SEP-2022) (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498:
Patient presented to ER on 12/14/2021. Received dialysis earlier that day, facial swelling started after dialysis. At home, patient became lethargic with altered mental status. Transported to ED, admitted to medical center with facial swelling, intermittent confusion, lethargy. On arrival, patient alert, but became obtunded. Covid-19 test in ED positive (12/14/2021). Admitted to step down unit with acute respiratory failure, type 2. Started on dexamethasone, per notes not a candidate for remdesivir, baricitinib, or Actemra. Patient remained inpatient, condition worsened, CXR showed ground glass opacities & small right PE. Required intubation on 12/24/2021 due to respiratory failure and Covid-19 per MD notes. Patient died 1/3/2022 while in hospital.
First dose within the first 6 hours hours i had muscle aches,migraine,chills and 102.0 fever. The second dose was the same symptoms which subsided after 12 hours. May 19th i went to the emergency room with a localized migraine and numbness in my head along with numbness in my left arm.I was diagnosed as having a mini stroke.
Patient reported throat feeling it was "really sore" at 4:02pm.  4:11pm swelling on tongue was noticeable, voice became hoarse when speaking EPI pen administered on left thigh at 4:11 pm in which patient reported instant relief. Paramedics picked patient up around 4:40pm where IV Benadryl was started.
Beginning 1.5 hours after the 2nd Moderna dose, my hands began shaking, and my arm was sore. These symptoms continue today and have not gotten better.  Beginning 2 days after the shot, my left foot from my toes to my ankle turned black and green.  Beginning 1 week after the shot, my toes turned purple; this has continued on and off since May 5, 2021.  Beginning 2 weeks after the shot, the lymph nodes in my neck, roof of my mouth, nose, and ears were swollen and tender. At random times, I would get hot and begin to sweat profusely 2-3 times per day, and my ears would get extremely red. At this time, my temperature would be between 100F and 101F, and my blood pressure was elevated. These symptoms lasted about 4 weeks.  Beginning 3 weeks after the shot, I developed a walnut-sized, squishy knot on the inside of the joint of my left elbow. I also began losing the hair in my armpits and have since completely lost all the hair in my armpits and on my legs.   Beginning 4 weeks after the shot, I developed a golf-ball-sized, squishy knot on the inside of my right knee, similar to the one that appeared on my elbow. I also developed a walnut-sized, squishy knot on my left knee just below the kneecap.  Beginning 5 weeks after the shot, I developed shin splints but had not completed any running or other activities that could explain the tenderness in my shins.  Beginning 6 weeks after the shot, I noticed a loss of muscle mass in my arms and legs.   Beginning 7 weeks after the shot, I have had severe chest pain three times. Each felt like I was having a heart attack; 2 times were in the middle of the night and 1 time was early in the morning.   Beginning 8 weeks after the shot, I began getting lightheaded at random which has caused me to fall multiple times. In addition, I have begun bruising very easily; the bruises take weeks to heal. My left eye is also extremely tender and waters more than normal.   Beginning 9 weeks after the shot, I notice that I have begun drooling even though I have never drooled in the past. My gums occasionally feel tender when I brush my teeth.
Narrative: Two days after receiving first dose of vaccine patient reports he started feeling symptoms, Patient stating he experienced headache, fever, body aches, cough and dizziness.
No additional AEs or PQC reported; expired dose of GARDASIL 9 administered; This spontaneous report was received from nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent condition, and concomitant therapy were not reported.   On 05-DEC-2022, the patient was administered expired dose of human papillomavirus rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) prefilled syringe injection 0.5 ml intramuscularly (IM) (valid lot# T025370 with expiry date 01-DEC-2022) for prophylaxis (Expired vaccine used). There was no further information provided. And there was no additional adverse event reported (No adverse event).
Two hours after receiving the vaccination, the client experienced dizziness and "light headed" with some nausea.  Client jogged the next day and actually experienced nausea and vomiting and was checked by emergency medical services who reported normal blood pressure and pulse.  Two days later, cleint expereincing aching and lethargy.  Clients takes no medications, but has been taking Tylenol for headaches.
This case was reported by a consumer via call center representative and described the occurrence of shivers in a 53-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). On 18th February 2019, the patient received the 2nd dose of SHINGRIX. On 19th February 2019, 1 days after receiving SHINGRIX, the patient experienced shivers and panic attack. On an unknown date, the outcome of the shivers and panic attack were unknown. It was unknown if the reporter considered the shivers and panic attack to be related to SHINGRIX. Additional details were provided as follows: The patient felt that she was about to having panic attack. The patient went to doctor without prescription, and stated that she did not see her doctor before. The reporter did give consent for follow up.
she did not receive 2nd dose / first dose was received on nov 26 2019; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 26th November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose which led to incomplete course of vaccination. The reporter consented to follow up. No further information was available.
extreme fatigue, headache, , achiness, chills, low grade fever, nausea, dizzy
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No relevant concomitant medications were reported. Vaccine was moved from freezer to refrigerator on 12/02/22. Of the ten vials in question 43 injections were given and 7 doses were wasted. No treatment medication reported.  This case contains information for the 6th of 43 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-689222 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222:master case
Gout, big toe, flare up.  worse one so far; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 08Apr2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 09Apr2021, the patient experienced gout, big toe, flare up which was worse one so far. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event gout, big toe, flare up, worse one so far was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Patient had fainted before with other shots, but had no reaction to the first shot so she wanted to get the second shot.  About 10 minutes after getting the shot she said she was feeling dizzy and called her husband in. Patient fainted while sitting in the immunization chair and shook a little bit. She woke up in about half a minute and did not know where she was initially.  Her husband came later and waited with her.  Patient started feeling nauseous and vomited a small amount of yellow/orange fluid.  Called the ambulance and they came and took her blood pressure.  Patient went to get checked out at the hospital and she said they ran tests on her and said that it was probably just a reaction to the shot.  Patient says she is doing much better now and sounded much better when I called her around 5:40 PM.
I received my first dose on 4/27.  Sometimes I recognize that my skin on left arm is very sensitive and occasionally one hive will breakout.  Fatigue for a few days.  I received my second dose on 5/27.  The next day I felt very tire.  And several days later I felt very fatique, parathesia, the bones on my fingers and feet ache, muscle pain at random spots of my body, sensitive, burning and redness of the skin especially at hand and feet.  I don't know what to do, doctor thinks there's nothing wrong with me(yet).
nausea, fatigue, pain and redness at site of vaccine.  As of today, still redness and hardness at site of injection, also for past week  skin flaking off at site of injection.