chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
COVID -19; high fever (for over two weeks); pneumonia; difficulty breathing; headache/similar to sinus headache; achy; tired; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 28-Mar-2021, the patient experienced DYSPNOEA (difficulty breathing), SINUS HEADACHE (headache/similar to sinus headache), MYALGIA (achy) and FATIGUE (tired). On 12-Apr-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant). On an unknown date, the patient experienced COVID-19 (COVID -19) and PYREXIA (high fever (for over two weeks)). At the time of the report, PNEUMONIA (pneumonia), DYSPNOEA (difficulty breathing), COVID-19 (COVID -19), SINUS HEADACHE (headache/similar to sinus headache), PYREXIA (high fever (for over two weeks)), MYALGIA (achy) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Computerised tomogram: she had pneumonia. On 12-Apr-2021, Drug specific antibody: Positive.         No concomitant medications reported by investigator.  Treatment included Levofloxacin, inhaler (albuterol) and steroid dexamethasone.  Based on the information provided, a causal association between the administration of mRNA-1273 and the event of Covid-19, pneumonia is assessed as unlikely as pneumonia is of an infective etiology. Although the other events are consistent with, the known safety profile for mRNA-1273, based on onset of the events, they are more likely symptoms of pneumonia,   This case was linked to US-MODERNATX, INC.-MOD-2021-095621 (Linked Report).; Sender's Comments: Based on the information provided, a causal association between the administration of mRNA-1273 and the event of Covid-19, pneumonia is assessed as unlikely as pneumonia is of an infective etiology. Although the other events are consistent with, the known safety profile for mRNA-1273, based on onset of the events, they are more likely symptoms of pneumonia, US-MODERNATX, INC.-MOD-2021-095621:1st dose
4/20/2021 SOA, CHEST PAIN, BLE SWELLING- PRESCRIBED LASIX 40MG, INCREASED COREG TO 25MG, ORDERED STRESS TEST 9/7/2021 PT WENT TO ER WITH LEFT KNEE PAIN. -SUPERFICIAL VENOUS THROMBOSIS-PRESCRIBED ASPIRIN 325MG
Had the display of Shingles in 2 derma zones within 10 days of shot on left side of body
Rash on my chest which I still have from 1st shot. Now I have a rash on my left arm . Wrist to elbow and above my elbow. I also have a rash on my left thigh. These spots are very itchy and red. I have called my doctor to find out what I can do for this rash but haven?t heard back yet.
improperly stored vaccine; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 16-JUL-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 ml, lot # T006792, expiration date 24-AUG-2021 (route of administration was not reported) for prophylaxis. The administered vaccine experienced temperature excursion of -13.5 degrees Celsius (C), -11.4 C, -1.8 C for 24 min, 27 min and 2 h 8 min. There was previous temperature excursion reported. The digital data logger was involved.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2007USA010374: US-009507513-2007USA010434: US-009507513-2007USA010419: US-009507513-2007USA010252: US-009507513-2007USA010361: US-009507513-2007USA010001: US-009507513-2007USA010334: US-009507513-2007USA011962:
Severe headache for 28 hours, fever for 24 hours, intense muscle aches for 24 hours.  Hallucinatory type dreams or awakening.  Never had that before.
Patient presented with a red, lesion, left arm (2 1/2 x 2 1/2 inches). Patient reported this at 08:00 and came to the clinic at 09:00. Patient instructed to use warm compresses and consult her primary MD if symptoms worsen.
Heart pain, heart pounding, shortness of breath, left arm numbness, numbness in fingers and toes
fatigue, lymphedema, cough, shortness of breath, no change in symptoms as of 5/6/21
After receiving the 2nd vaccine, I have no pain in my neck and me feet. I'm not taking any new medications, and its the first time in years I'm not having any pain; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (After receiving the 2nd vaccine, I have no pain in my neck and me feet. I'm not taking any new medications, and its the first time in years I'm not having any pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Degenerative bone disease and Osteoarthritis.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (After receiving the 2nd vaccine, I have no pain in my neck and me feet. I'm not taking any new medications, and its the first time in years I'm not having any pain). On 17-Apr-2021, THERAPEUTIC RESPONSE UNEXPECTED (After receiving the 2nd vaccine, I have no pain in my neck and me feet. I'm not taking any new medications, and its the first time in years I'm not having any pain) had resolved. Not Provided          For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant product used included unspecified medications.  Treatment medication use was not provided by the reporter.
Within 2 weeks of having the 2nd dose of covid vaccine. I noticed an increase in eye shaking from the nystagmas; my vision decreased to 20/125; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06Feb2021 11:45 (Batch/Lot number: unknown) at the age of 25 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Nystagmus" (unspecified if ongoing); "LCA" (unspecified if ongoing); "Allergies:Tree nuts" (unspecified if ongoing); "Allergies:seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: NEXPLANON. Vaccination history included: Bnt162b2 (Dose Number: 1 single, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right, Vaccine Administration Time: 10:30 AM), administration date: 16Jan2021, when the patient was 25 years old, for Covid-19 immunization. The following information was reported: NYSTAGMUS (disability) with onset Feb2021, outcome "not recovered", described as "Within 2 weeks of having the 2nd dose of covid vaccine. I noticed an increase in eye shaking from the nystagmas"; VISUAL IMPAIRMENT (disability) with onset Feb2021, outcome "not recovered", described as "my vision decreased to 20/125". The events "within 2 weeks of having the 2nd dose of covid vaccine. i noticed an increase in eye shaking from the nystagmas" and "my vision decreased to 20/125" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of nystagmus, visual impairment. The patient was not pregnant during the vaccination. The patient did not receive any other vaccines within 4 weeks PRIOR to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 and Since the vaccination, not tested for COVID-19.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient experienced fainting and symptoms of seizure 7 minutes after vaccine administration while waiting in the waiting area. P t has a history of seizures.
This spontaneous report was received from a Registered nurse regarding a 17 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Vaccine on 05/06/2022. 24 hours later 05/07/2022, 05/08/2022 had a fever. 05/12/2022, I started with dizziness, a light-headed and a headache, continued until I started BP medication 05/18/2022. I knew this was not normal for me and my BP was 184/88. I have never had HBP ever. It continued to stay high, I went Urgent Care, the temp normal, BP was high, EKG was normal, Neurological exam showed no stroke otherwise normal. I was told to Monitor BP and go see my PCP. 05/16/2022 I saw my PCP BP no fever, BP was still high, I was prescribed Lisinopril 5mg, lowered BP a little bit and the headache went away. I saw my doctor on 05/19/2022 and she increased the Lisinopril 10mg still. Currently BP is a little high, but not in the danger zone. She wants me to stay on this dose for a while and I see her again in 3 months or sooner if elevated BP returns. The headache and the dizziness stopped after I started the Lisinopril 5mg.
15 sec episode of V-tach and additional PVCs (recorded by implanted pacemaker)  2 days after injection.  Experienced flu-like symptoms 2 days after injection.  All issues resolved within a few days without treatment.
Patient had received Moderna bivalent on left arm, on 10/25/22. Mistakenly administered Pfizer bivalent on right arm instead of influenza vaccine on 10/27/22. 34 year old female patient to leave out of the country on 10/30/22.  Contacted Pfizer and CDC, in which they were made fully aware of the above situation. Per CDC: 1. Although there is no data on the safety of giving Pfizer and Modern bivalent vaccines within any interval, it is clinically reasonable to assume that the type of adverse event experiences would be similar to those that would occur if the extra dose were not given.  2. In addition, local reactions are likely, however, serious reactions are unlikely. 3. Getting an extra dose of a vaccine is not likely to cause any serious problems and the patient may still receive an influenza vaccine the same day. 4. Moving forward, if CDC recommends another booster, then the patient is able to receive a vaccine at the recommended time interval.    Patient is asymptomatic as of the evening of 10/27/22. We contacted the patient's PCP and are awaiting response.
Patient tested positive for COVID on April 12th after having received both COVID-19 vaccines - pfizer.  Patient has known COVID19 exposure from her son and was COVID19 positive in April. The patient had a positive asymptomatic COVID-19 test. Patient was tested prior to planned colonoscopy. The patient completed 10 days of quarantine until April 22.  Patient presented to hospital (sister hospital) on May 2nd after 1 week of fevers and productive cough. At MSQ patient received cefepime/vancomycin/doxycycline for CAP. She initially improved, but on 5/5 she had recurrent fever with rapid decline, her respiratory status requiring 2L of NC to HFNC to NRB.  CXR with B/L opacifications.  CTA chest was negative for PE, but patient with diffuse groundglass and consolidative opacities. Also had TTE that showed LVEF 71% and grade 1 diastolic dysfunction. She was evaluated by MSQ Infectious Diseases physician and was started on bactrim for PCP prophylaxis and resumed on broad spectrum antibiotics.  She was also evaluated by rheum in sitting of her SLE and patient was started on prednisone 40 mg q8h methylprednisolone for potential SLE flare. Continued on cefepime and vancomycin. Patient was transferred to Hospital due to worsening respiratory status and tested positive for COVID-19 at MSH on 5/9. Admitted to the MICU, patient received a loading dose and one 100 mg dose of remdesivir - stopped due to elevated liver enzymes.  On 5/16 extensive new ischemic/hemorrhagic strokes throughout intracranial vascular distribution, DIC d/t COVID vs AF and intubated for mental status changes. Patient's clinical picture worsening - requiring pressors. Chest x-ray with diffuse ground glass opacities, ARDs and pulmonary edema. Patient remains in critical condition in MICU as of 5/19.
swollen lymph nodes/a big bump above his collar bone on the right side; arm was a little sore; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 10Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 on 13Mar2021 for COVID-19 immunization. Patient had BNT162B2 on his left side. He noticed last night (19Apr2021) a big bump above his collar bone on the right side. He guessed it was his lymph node that was swollen but he hads never had that before. He was looking online and saw this could occur, but it was most likely on the same side of the shot. He called his primary care doctor and this could still be a side effect. His doctor's office said that the swollen lymph node could still be a side effect of the Pfizer COVID vaccine. Patient had no physical side effects. He didn't feel sick. His arm was a little sore for a few hours after the shot (10Apr2021). Outcome of swollen lymph nodes was not resolved. Outcome of arm was a little sore was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 03-JUN-2016,  the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 08-JUN-2016, only days after being vaccinated, the patient was treated (by an unspecified healthcare professional) "the" medical center, for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, she has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Arm pain, enough to keep her from sleeping at night. Swelling, splotchy redness at injection site. Flu like symptoms (she denies fever, though did not take her temp). Achy, especially in her legs.
Migraines, I have never had a migraine before in my life. I have had headaches before but never a migraine. I had a migraine on Saturday and Sunday for a short amount of time. On Thursday, 1/14/2021, I had a bad migraine, had to go home from work. Woke up on Friday 1/15/2021 with the migraine still. They are lasting longer and getting worse.
I noticed a large bump in my left armpit, which I realized was swollen lymph nodes.  Today (6/7/2021) I noticed the swelling going down.
Patient's entire arm became red and swollen approximately 12 hours after injection. Patient went to the local ER and was diagnosed with blood poisoning and was given antibiotics and steroids.
This spontaneous reprot as received from a healthcare worker refers to a patent of unspecified age and gender. No current or historical conditions were reported. On 19-DEC-2014 the patient was vaccinated with the first dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored (incorrect product storage). There were no concomitant medications reproted. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unkown. This is one of several reports received from the same reproter. Additional information is not expected because the reporter had no further information available.
I was feeling flu like symptoms which is normal for me but the next day I was still feeling crappy so I worked from home. I was having head congestion. The 11th I was starting to have a bad sore throat that got worse over the day. It felt like I was swallowing shards of glass. I went to urgent care and they determined that I had strep throat and gave me penicillin. I ended up with a fever Thursday night and Friday I as coughing so badly and I could not stop- it sounded like the whooping cough cough. I had this gunk in my eye and was fatigued and having hot flashes and then chills. I walked to the ER since it is close and I was afraid to drive. They did a blood panel the flu, strep, and Covid tests again like at the urgent care. They diagnosed me with an acute bronchitis and pink eye. I had gone back to urgent care and they got me on new meds and steroids and an inhaler to help.
Urticarial rash starting roughly 15 hours after vaccination.  Improved with PO benadryl at home.  Parents declined clinic appointment and felt comfortable managing rash at home, as he had no other associated symptoms.
Information has been received from a medical student concerning a 60 year old female, s/p hepatic transplantation (09/01), who in "early" 08/01, was vaccinated with one dose of varicella virus vaccine live (site unknown). It was reported that she was vaccinated because her granddaughter, who had never been vaccinated or had natural chicken pox, was exposed to a child with chicken pox in school; however, the granddaughter never developed chickenpox. The pt's current medications include tacrolimus (Progaf), sirolimus (Rapamune) and prednisone At the end of 08/01, approximately 3-3 1/2 weeks post-vaccination, the pt developed a chicken pox breakthrough infection (15-20 genralized varicella lesions). It was reported that she was out-of state and underwear treatment with IV acyclovir and was discharged home. The reporter was not sure if the pt received in-patient treatment. It was reported that the initial lesions began to improve. Approximately ten days later, on 09/16/01, the pt developed a disseminated varicella (400 vesicles) and was admitted to the hospital for treatment with IV acyclovir, "to which she responded well". It was indicated that this was not a herpes zoster, but a generalized varicella. The lesions did not present in any dermatomal pattern, but rather were over the entire body. the pt has some itching and pain associated with the lesions, but no other signs or symptoms. At the time of report, the pt was improving and had been discharged home on IV acyclovir therapy. The treatment was identified to include 21 days total of IV/PO acyclovir "soon". While hospitalized, a specimen was collected from a vesicular lesion. It was reported that varicella zoster virus (VZV) was confirmed by direct flourescent antibody test and that a viral culture was also positive for VZV. The reporter stated that the health care providers were interested in typing the strain with PCR analysis. The specimen was to be sent on 10/03/01. FOLLOW-UP information received on 10/15/01, indicated that the expected specimen had not arrived at the lab. The physician stated he would "look into this". Additional information has been requested. The initial report was previously submitted on 15May02.
No additional AEs; RN calling to report that expired STERILE DILUENT was administered along with MMR II (not expired). STERILE DILUENT expired on 12/24/2022 and was administered on 12/27/2022 to 1 year old patient.; This spontaneous report has been received from a registered nurse and refers to a 1 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 27-DEC-2022, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II)(strength, lot #, expiration date, dose, route and frequency were not reported) for prophylaxis; that was diluted with an expired sterile diluent 0.5 milliliter once (strength, lot # and route were not reported) for prophylaxis; which expiration date was 24-DEC-2022. It was mentioned that the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II)was not expired. No adverse events were reported.
This spontaneous report as received from a nurse refers to a 61 year old female patient. Approximately in 1990, the patient was vaccinated with 2 doses of PNEUMOVAX23 (reported as Pneumonia vaccine). Dose and route were unspecified. No concomitant medications were reported. On an unknown date, the patient experienced severe arm swelling. It was described that the entire arm was swollen and hot to touch. The outcome of severe arm swelling was reported as recovered/resolved. Causality to the event was not provided. Additional information has been requested.
THIGH WHERE VACCINE WAS INJECTED SWOLLEN AND RED FOR 2 HOURS, INCONSOLABLE CRYING 1 HOUR. INJECTION SITE BRUISED AND SORE SEVERAL DAYS
large area ( 6in x 5 in) of swelling & erythema around inject site;
SEIZURES STARTING 5 DAYS LATER.  PT WAS TAKEN TO ER AND WAS ADMITTED FOR 17 DAYS FOR TESTING.  GRANDMOTHER WAS TOLD SEIZURE WAS POSSIBLY FROM DTAP.  WAS SENT HOME ON SEIZURE MEDS AND PLAN IS TO WEAN OFF MEDS EVENTUALLY.  PT IS NOT TO RECEIVE DTAP FOR VACCINE, WILL NEED DT INSTEAD