chrisvoncsefalvay/vaers-outcomes huggingface dataset:
her arm is hurting; This is a spontaneous report from a contactable consumer (patient reported herself) via Medical Information Team. A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration to her arm on 27Apr2021 2:00 PM as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, "caller was a 77-year-old female who received her first dose of the Pfizer BioNTech COVID-19 vaccine yesterday 27Apr2021 at 2:00PM and stated that her arm was hurting. She stated that she could slowly lift it up and that when she keeps lifting it, the pain subsides. She stated that the pain was "not as bad" as when she got up and could barely lift up her arm and reported that it was slowly going away. Caller would like to know if there is anything she could take for it". E-transmitting potential duplicate AE. Caller states she just spoke to someone to report her side effects, however call was not a warm transfer. Spoke from the attached document regarding CDC's guidance for taking medications such as Tylenol and NSAIDs after vaccination to treat symptoms. Referred caller to HCP for further guidance. No PQC present. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Chest Pain, Troponin Elevation, Myocarditis Also developed fever, muscle aches, joint pain, generalized fatigue Hospitalized, Treated with NSAIDS and supportive care, Telemetry, Troponin monitored q12  Echo with normal systolic function  Cardiology and ID consultation Cardiac MRI pending at time of submission (6/9/2021).   He is hospitalized at time of report, recommended complete activity restriction upon discharge, he will continue to follow with pediatric cardiology.
MUSCLE PAIN IN ARM OF INJECTION AND PECTORAL MUSCLE ON RIGHT SIDE. REDNESS AND RASH ON INJECTION ARM DOWN TO ELBOW. SORENESS, FEVER.
The patient was received their 2nd dose of the Moderna Covid -19 vaccine at 1:28pm and the patient was instructed to stay in the pharmacy waiting area for 30 minutes due to history of asthma and egg allergy. After sitting for 10 minutes, the patient approached the pharmacy saying they were dizzy and experiencing pressure on their chest. The chest pressure escalated in severity and it became painful for the patient to breathe. Paramedics were called and after evaluating the patient, they decided the patient needed to be seen for further evaluation and the patient was transported to a health facility
Information has been received from a 73 year old female consumer with a degenerative disc and allergies to LEVAQUIN, OXYCONTIN, and "Otrast" and "Otram" and a history of chicken pox who on 12-NOV-2007 who received a single dose series injection in the left arm of ZOSTAVAX (lot# "1088U".) Concomitant therapy included MOBIC, triamterene, aspirin, alendronate sodium (MSD), DYAZIDE, and Valium. On 18-NOV-2007, she developed a few red spots on the back of her neck. She reported that the day (19-NOV-2007); there were a few more spots. On 21-NOV-2007, she was seen by her physician who diagnosed her with shingles. At the time of this report, the consumer reported that she was recovering. A product quality complaint was no reported. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. Follow up information from a physician reported that six days (18-NOV-2007) post vaccination, she developed classic herpes zoster in the left C5-C6 dermatone area. He described the lesions as herpetic vesicles numbering 12-15 lesions. Current patient status was not reported. Follow up information reported that the varicella zoster vaccine identification specimens were obtained on 18-NOV-2007, and 27-NOV-2007 from a vesicle from an unspecified site. The PCR results for the specimen from the vesicle identified the presence of WT. Additional information has been requested.
fever x 3 days 101-103 degrees, decreased appetite, localized redness/papules at site of injection left thigh; scattered fine pink papules on torso; 2 Brandt ulcerations at soft palate.
Pt immediately began to cough after vaccine given and her O2 saturation dropped to 45%. Her HR dropped to 40-45 and she was given oxygen and epi-pen administered. Ambulance called during that time and she was taken to ED.
Second shot was on 8/30/2021 around 6:00 pm and on next day 8/31/2021 felt very tired and  Wednesday 9/1/2021 woke up around 1:00 am felt my face was getting swollen went back to sleep and woke up 5:00 am and noticed most of my left part of face is swollen mouth area and eye .
Dose 1 Moderna 02/05/2021 lot # 016M20A  Pt died 8/27/2021 from hemorrhagic stroke
Woke up with chills the morning after receiving the vaccine.  Piercing headaches in temples, all over body aches, mostly in the back and neck.  Body felt very fatigued.  Nausea.  Brain fog.
trouble with vision; body aches; joint pain; fever; Lingering migrane headache which she describes as full spectrum headache in the frontal lobe; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Lingering migrane headache which she describes as full spectrum headache in the frontal lobe), VISION BLURRED (trouble with vision), PYREXIA (fever), MYALGIA (body aches) and ARTHRALGIA (joint pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047821A and 008B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ZOLPIDEM TARTRATE (AMBIEN) for Sleeplessness.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced MIGRAINE (Lingering migrane headache which she describes as full spectrum headache in the frontal lobe). On 28-Apr-2021, the patient experienced PYREXIA (fever). On 29-Apr-2021, the patient experienced VISION BLURRED (trouble with vision), MYALGIA (body aches) and ARTHRALGIA (joint pain). On 29-Apr-2021, PYREXIA (fever) had resolved. At the time of the report, MIGRAINE (Lingering migrane headache which she describes as full spectrum headache in the frontal lobe), VISION BLURRED (trouble with vision), MYALGIA (body aches) and ARTHRALGIA (joint pain) outcome was unknown.            Treatment information was not provided. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-100435 (Patient Link).
Narrative:  Hospitalization: Fully vaccinated, admitted for cough and malaise and found to be COVID positive
She got her vaccine, she started getting little pimples and swelling between her fingers.  It went from her fingers to almost the palm of her hands, dots and red pimples.  She said she did not know what this way and by the time January came it was on the bakc of her hand and it was swelling and puffy and kept scratching it.  She used some over the counter stuff like Eucerin creams, etc.  Then it started traveling up her arm.  Once it got to her arm she decided to go to the doctor and once she called she could not get into February.  She went to her as she is her PCP and she gave her a salve called Triamcinolone.  Was using that in February to no avail. She went back to her in March, and she was given some more. Then in April she returned again and was told she would have to send her to a dermatologist.  It is all mover her body except on her face.  She called around for a dermatologist, and went to Dermatology.  He worke don her and said that he needed a biopsy, which he took.  He prescribed the same medication but as an ointment.  She applied it as prescribed and went back to see him 6 months later.  The biopsy showed some things.  By 2023 he said that he needed another biopsy as it was not healing.  He took another biopsy and gave her the same ointment to put on, which did not do any good.  She toldhim by the spring or summer came around she was going to another Dermatologist.  She now is under the care of Dr.  Her first apointment was 7/5/23 and put her on Otezla and told her to take it slowly and don't go over the 30 mg dosage.  Right now she is on the 10 mg of it, and then she will gradually got to the 20 mg, but only 1 pill a day.  Then after 18 days she will start on the 30 mg.  On 7/5/23 he looked at her arm and he looked at her back, and told her that she had psoriasis.  She was told that she was told she had that, as well as dermatitis and that when she was younger she had eczema every now and then as a child.  He said that she had full blown plaque psoriasis.  The first biopsy with the first dermatologist never told her that she had that.  He said that it was a possibility and that the biopsies were inconclusive and he treated her for dermatitis.  This is compromising her immune system, she has read up on it, and is under the care of Dr. and waiting to see if the medicine works and what the next steps may be.  She has return appointment on 8/9/23 to Dr.    Dr. asked her what she felt triggered it and the only thing she could think of was the new booster of Pfizer.  She itches all over, it's hard to sleep and she continues with this problem for the last 2 years.
Information has been received from a health professional concerning a patient who was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast). subsequently, 2 weeks later, the patient experienced a false positive for hepatitis b on a blood screen. Unspecified medical attention was sought. No further information was available. No product quality complaint was involved. Additional information is not expected.
lt lower thigh, mild swelling 69cm extending distal to the inj site;as opposed to surrounding shot site-warm-non tender;moderate erythema;tx cold packs no help sx worse;DPH & heat packs, observe report w/progress;
Pt. reports fever and cough started the next day after receiving the Pfizer covid vaccine 1st dose.  Pt reported to our ER for fever and cough.
Constant pain in arm. Over 10 days, pain radiated outward from injection site. Pain spanned chest, and entered chest cavity. I experienced shortness of breath for about 3 days while walking normally and going up and down stairs. Pain dissipated by the end of day 10. During these 10 days, pain radiated up my neck and at one point the right side of my cheek and upper lip went numb for about 2 minutes. Then starting on around June 6th, pain in abdomen started. Symptoms of current experience includes: nausea, diarrhea, abdominal pain in lower right, upper left, and back on left side. Pain is mild to moderate, comes and goes. Feeling of fullness and pressure in abdomen constantly, even before eating for the first time of the day. Very fatigued. Menstrual cycle is late. Pregnancy test is negative. Dr. performed a battery of tests - urinalysis, blood, and COVID-19 nasal swab. CT scan of abdomen scheduled for Monday June 14 with Oral Contrast. IV Contrast allergy.
Hypersensitivity reaction; Swelling of the arm of the injection; Itchiness of the arm of the injection; Redness of the arm of the injection; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction), VACCINATION SITE SWELLING (Swelling of the arm of the injection), VACCINATION SITE PRURITUS (Itchiness of the arm of the injection) and VACCINATION SITE ERYTHEMA (Redness of the arm of the injection) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction), VACCINATION SITE SWELLING (Swelling of the arm of the injection), VACCINATION SITE PRURITUS (Itchiness of the arm of the injection) and VACCINATION SITE ERYTHEMA (Redness of the arm of the injection). At the time of the report, HYPERSENSITIVITY (Hypersensitivity reaction), VACCINATION SITE SWELLING (Swelling of the arm of the injection), VACCINATION SITE PRURITUS (Itchiness of the arm of the injection) and VACCINATION SITE ERYTHEMA (Redness of the arm of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported Treatment information were not provided
Child received DTaP, HBV, HIB, MMR, VAR on 5/7/02. The next day-child had welts at injection sites on arms on Thursday. The child had welts all over. Mom took him to Dr's office-was told to use OTC Benadryl. Sat night child developed fever and hives con't. Taken to ER-put on oral steroids. TC 5/13- child con't with hives and under medical care.
Sudden sensorineural hearing loss (SSNHL) in left ear, beginning 8-9 days after vaccine on  March 19th Friday.   Symptoms of fullness, muffled hearing, sensitivity to sound.  This was coupled with increased/exacerbated tinnitus in both left and right ears.  Hearing test and physical exam done by ENT on March 22 Monday showed a loss of hearing in low frequencies in left ear of up to 40 DB.   Treatment with steroids was initiated (prednisone 50 mg for 7 days, 30 mg 1 day, 25 mg 1 day).   Follow-up visit to ENT on March 31 showed improvement in hearing nearly back to levels prior to the SSNHL; however tinnitus remained elevated.  Prednisone was continued at 40 mg for 1 week with taper.
Patient walked to chair to stay for observation after receiving the vaccine and patient started to stare off. And then proceeded to sit down in the chair and started having a seizure. He started sweating profusely and turned very pale. Patient vitals (blood pressure and temperature) were taken and 911 was called. Patient kept asking for water and stating that he was okay. Vitals were within normal range but patient still was sweating very badly. Then EMT and fire department showed up. They continued with care. Patient did not want to go to the hospital and called for a ride to pick him up.
Day p/receiving MMR vax, mom states pt was covered w/rash, felt hot but temp not measured; Taken to MD told was rxn to vax, no action was taken; Pt also had sore throat;
Intial reaction included rapid heart beat and dizziness. Took Benadryl. Several hours later had sever muscle pain all over body and then semi-paralysis. Was unable to stand up.
4 days after receiving 1st dose, she started with burning sensations in knees; She has been hearing some noise (cartilage moving) in left knee when she bends down; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (4 days after receiving 1st dose, she started with burning sensations in knees) and CARTILAGE INJURY (She has been hearing some noise (cartilage moving) in left knee when she bends down) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced ARTHRALGIA (4 days after receiving 1st dose, she started with burning sensations in knees) and CARTILAGE INJURY (She has been hearing some noise (cartilage moving) in left knee when she bends down). The patient was treated with GLUCOSAMINE at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (4 days after receiving 1st dose, she started with burning sensations in knees) and CARTILAGE INJURY (She has been hearing some noise (cartilage moving) in left knee when she bends down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report as received from a consumer and a nurse practitioner refers to a 53 years old female patient with diabetes, abnormal cholesterol, high blood pressure, mental illness and drug hypersensitivity to TYLENOL with codeine #3. The patient's medical history included shingles. The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) in September 2012. Other suspect therapies included a dose of Influenza Virus Vaccine (manufacturer unknown) (lot #, dose and route not reported) on the same day in September 2012. Concomitant medications included benztropine mesylate, lamotrigine, lovastatin, aspirin, lisinopril (manufacturer unknown), ziprasidone hydrochloride, metformin and venlafaxine hydrochloride. The consumer reported that five days after receiving the ZOSTAVAX shot, she broke out in a rash. She indicated she scratched so hard, sores came up. She stated she received the ZOSTAVAX and the Influenza Virus Vaccine (manufacturer unknown) shot on the same day at the pharmacy. She indicated she was treated for poison ivy and scabies. The nurse practitioner asked what could be done with the patient. The patient sought unspecified medical attention. Blood work was performed on 16-OCT-2012 and 24-OCT-2012 (results not provided). The outcome of she broke out in a rash and scratched so hard sores came out was reported as not recovered/not resolved. Additional information has been requested.
Low grade fever 99-99.5/Fever 101/Fever 102.5; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PYREXIA (Low grade fever 99-99.5/Fever 101/Fever 102.5) 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 20-Aug-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 21-Aug-2021, the patient experienced PYREXIA (Low grade fever 99-99.5/Fever 101/Fever 102.5). On 21-Aug-2021, PYREXIA (Low grade fever 99-99.5/Fever 101/Fever 102.5) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Aug-2021, Body temperature: 101 Friday and 102.5 Friday Eve. On 21-Aug-2021, Body temperature: 99-99.5 Saturday. On 22-Aug-2021, Body temperature: 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was  not reported. Relevant concomitant medications were not provided by the reporter.
I lost control of muscles in my arms, legs, bladder, and mouth. I could not sit up, stand up or even grasp a bottle of water. I had trouble speaking and lost complete control of my bladder. My husband called 911 and the end stayed with me and took vitals. I was in this state for about 7 hours. After this I continued to be very tired for about 5 days.
Recurrent Epistaxis. presented to ER 4d after Janssen Covid vaccine with epistaxis, no prior hx of this issue, no known bleeding d/o, not on antiplatelet or anticoag agent. recurrent episodes mostly R nostril since then requiring cautery x5, rhino rocket
flu-like symptoms for about 8 hours from first dose; This spontaneous case was reported by an other caregiver and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms for about 8 hours from first dose) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart valve disorders and Defibrillator/pacemaker insertion.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms for about 8 hours from first dose). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms for about 8 hours from first dose) had resolved. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-075163 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075163:dose 2
This spontaneous report was received from a registered nurse referring to an 11 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 20-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored (incorrect product storage). This is one of several reports received from the same source.; Sender's Comments: US-009507513-1709USA008666:
Patient reported mild itching about 10 minutes after flu shot administration.  There were no signs of redness or swelling for the next 30 minutes.  Pt went home with daughter, I called her later that night (~5 hours later) and she said that the itching subsided and there was no itching.  For the past week, off and on she has had redness and warmth in the flu shot injection site.  A cold compress and APAP has helped.  No signs of infection and it site is improving all week.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # M049127, expiration date: 15-DEC-2018, lot # N010107, expiration date: 28-MAR-2019) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from an other reporter concerning a 13 months old patient. On 10-OCT-2017, the patient vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # N017698, expiration date: 09-JUN-2019) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002098: US-009507513-1709USA002186.
Moderna COVID-19 Vaccine EUA  About 3-4 days after the second dose, I experienced off and on moderate chest pain for about 1.5 weeks, so far. Symptoms seem to be declining now. It was a moderate aching in the center of my chest up to my left pec and shoulder. I also experienced off and on heart pounding (not necessarily elevated heart rate, and not necessarily concurrent with the chest pain). No fainting, mild headaches.  *I also experienced  off and on heart pounding 12-72 hours after the first dose, but no chest pain.
Extreme heavy bleeding during periods. Periods also become unregular. Extreme bleeding has occurred for 3 periods since first vaccine and shows no sign of returning to normal flow as yet.