chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizzy; labored breathing; headache; body aches; soreness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 65-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6955) via an unspecified route of administration in the left arm on 26Mar2021 at 17:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not have any allergies to medications, food, or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 05Mar2021 at 17:45 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 17:00, the patient experienced dizzy, labored breathing, headache, body aches, and soreness at injection site. and it was felt like he had hit by a truck within seconds and most symptoms had passed in intensity during 15 minutes waiting period. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcomes of the events dizzy, labored breathing, headache, body aches and vaccination site pain were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Pt subsequently developed and injection site reaction. MD described the reaction as a "5 inch ring of cellulitis".
This spontaneous report was received from a nurse who was the female patient of unknown age, reporting on herself. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided. On an unknown date in 2011, reported as 8 years ago, the patient was vaccinated with the first dose of GARDASIL 9 or with GARDASIL (route, anatomical location, lot # and expiration date were not provided) for prophylaxis. In approximately 2011, 4 days after vaccination, the patient developed weakness in the legs, "just not clear headed", and eventually she experienced a tic. The patient reported, these adverse events lasted about 8 months. Additionally, the patient reported, she never got the second dose of the vaccine. The outcome of muscular weakness and tic was resolved. The causality between the events and therapy with GARDASIL or GARDASIL 9 was unknown. It was not verify if the suspect therapy was GARDASIL or GARDASIL 9.
This was after booster #1. Injection was too high on the arm. Has caused ongoing tendonitis, swelling that persists even now. My physician has ordered physical therapy.
The day after the patient received SHINGRIX dose 2 she complained of weakness in arm where vaccination occurred. This weakness spread up and down the arm and continued to bother patient even 1 week after injection.
Nausea, heavy fatigue, dizziness, fainting - 2 times. Fainted twice within 5 minutes. milder symptoms lasted about 1/2 hour. Very mild similar symptoms continuing.
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M007762 with expiration date 07-DEC-2018; lot # L051124 with expiration date 14-OCT-2018; dose and route were not reported). The vaccine was improperly stored at 32 Fahrenheit for 41 minutes. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
broke out at the site of injection after the 1st dose; Rash at injection site; missed the 2nd dose appointment; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (broke out at the site of injection after the 1st dose), VACCINATION SITE RASH (Rash at injection site) and PRODUCT DOSE OMISSION ISSUE (missed the 2nd dose appointment) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed the 2nd dose appointment). On an unknown date, the patient experienced VACCINATION SITE REACTION (broke out at the site of injection after the 1st dose) and VACCINATION SITE RASH (Rash at injection site). On 31-Aug-2021, PRODUCT DOSE OMISSION ISSUE (missed the 2nd dose appointment) had resolved. At the time of the report, VACCINATION SITE REACTION (broke out at the site of injection after the 1st dose) and VACCINATION SITE RASH (Rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No Treatment medication was reported.  On 01-Sep-2021, when the patient went to the vaccination center, the patient was told to reschedule the appointment.
Chills, aches. Ocular pressure x 1 week.  Approximately 4 months after vaccination, patient had consecutive retinal tears within 10 days of each other.
Patient called 9-21-15 and said received shot FLUZONE HD 9-20-15 woke up feeling achy and weak all over, flu-like symptoms. Felt like going to faint in shower. She said she did not feel well the night of 9-20-15 either and woke up worse.
This patient had a slightly raised red macular lesion on the left upper arm approximately 6-8 cm above left elbow. The lesion was warm and tender to touch,approximately 5 cm in diameter.
About 30 hours after our daughter recieved the Rota Teq oral vaccine, she got diarrhea accompanied by a bright red rash around her anus. The rash is extremely painful when touched or when she has a bowel movement, which leads to her screaming and crying for about 30 min each time. There was previously absolutely no rash in the affected area. There were no other changes in diet or routine except Rota Teq oral vaccine.
This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown age and gender. No medical history, concurrent conditions and drug reactions/allergies were reported for the patients. On unknown dates beginning since 11-JAN-2016, the unspecified patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # L005300 with expiration date 17-FEB-2017, (dose, frequency, route and anatomical site of administration were not reported), which were previously exposed to temperatures outside of the recommended range. No concomitant medications were reported. No adverse experiences had been reported. No product quality complaint was involved. This is one of two reports received from the same source (MARRS # 1602USA005288). Additional information has been requested.
FIRST: An ache at the injection site progressing to a  throbbing aching. The peak-pain lasted 18 hours. Icing the area did nothing to reduce the throbbing.  SECOND: Progressive Myasthenia Gravis weakening began about 20 hours after the injection. It was escalating toward being a full-blown crisis. I have an emergency stash of Prednisone, and I alerted my Neurologist that I began taking it. Prednisone effect saved me from a full-blown bulbar deficit, which would have required hospitalization. For MG, I've long only needed to take CellCept to be symptom-free. The Pfizer shot IS to blame for the MG exacerbation
This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at the injection site, of about an inch and a half diameter) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On 15-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 13-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection site, of about an inch and a half diameter). At the time of the report, VACCINATION SITE ERYTHEMA (redness at the injection site, of about an inch and a half diameter) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Concomitant medications included vitamins. No treatment medications were reported. This case was linked to MOD-2022-452074, MOD-2022-452101 (Patient Link).
I spoke to employee  Cma , she was already outside of work but I asked my manager if we should called and ask her about what happen  or wait until the next day when CMA was back in the office . As per my manager she told me to reach to her. when I called CMA and spoke to her and asked her if she remember diluting the Covid pfizer 5-11 vaccine before administering the first dose. She stated that she was sure but then she said so much is going that she was doubting herself. I told her that when I went to draw out the fourth dose of the vaccine for my patient, I noticed that there was not enough for the rest of the vaccines. I contacted my colleague which is also a lead supervisor about it. I immediately put the vial and the vaccine, I inspected the vial and the liquid was cloudy and there was not even enough for a fifth dose. Second vial had to be open to be able to administer my vaccine to my patient. On 10/13/22 my colleague and myself grabbed a whole new vial of Pfizer vaccine; without diluting it and drew it out into 4 vials and it came the same as the day before. Meaning vial and color was the same amount and cloudiness.
8 days after receiving vaccines, pt. had a seizure that lasted a little under 2 minutes. We were seen in the ED and sent home a couple hours later. Pt. seems to be back to herself since.
General feeling of illness beginning at 10 pm. Violent shaking chills lasting for 3 hours, nausea and upset stomach beginning 2 hours after injection and lasting through next day
Throbbing headache followed by nausea and vomiting, started approximately 24 hours administration, symptoms experienced following day 2 of administration, headaches continue on day 3 thus far
AT 2130 ON 1/20/21 DEVELOPED SHAKES, THAT PROGRESSED TO 'CONVULSING. DEVELOPED FEVER OF 104.3. SEVERE ARM, NECK, AND CHEST PAIN. SHORTNESS OF BREATH THAT IMPROVED OVER TIME. ON 1/23/21 COMPLAINED OF SEVERE ITCHING OVER ENTIRE BODY
24-year-old white male visited the vaccine clinic this morning. At 09:36 Am patient received the first dose 0.3ml of Pfizer vaccine lot #ER8734 to his left Deltoid . At 09:46 AM While patient in the observation area, he complained of feeling light headed and not feeling to well. While assessing the patient, he had a syncopial episode with eyes fixed, jerking body movement for 5-10 seconds. Patient immediately assisted the floor , all safety measure provided. Oxygen applied. VS: BP 100/60, o2 sat 98% . Pulse 78, resp 18. Patient denies any medical condition. However, he sated" I usually pass out when I take shots" . 10:00 Am sitting Blood pressure 110/72. Patient condition improved, and assisted back to chair. At 10:05AM still complaining of light headedness and requested to lay back to floor. Blood Pressure supinely 100/80. Patient stated " i feel much better when I am laying down. Water provided as requested. Pos t po fluid patient voiced feel much better. Sitting blood pressure rechecked at 10:14 am BP 110/80. Patient assisted back to chair. Closed observation maintained. 10:29 am Patient stated " I am feeling 100% of myself now, standing blood pressure 130/80. Patient denies any further light headed. Patient instructed to follow with his Primary Physician also his was referred for his second dose of vaccine . Patient left clinic in stable condition.
5 mins p/vax pt had been crying but cry became agitated-gargling rales bilaterally lower & upper lobes; EPI given;
redness, warmth, and pain, throbbing, swelling left shoulder to forearm. Headache.
1/8/21 reported general soreness for 2 days post vaccination.  1/3/21 noted redness rectangle below injection site. 1-6 to 1-7 noted lymphedema R axillary node Taking Motrin and monitoring
Circular skin rash on arm that vaccine was administered in. Was itchy, now just warm to the touch and red.
Demarcated red area/itchy rash, approximately 4 inches in diameter. Has been applying hydrocortisone cream 1%.
Patient presented to the ED and was subsequently hospitalized for Subarachnoid hemorrhage due to cerebral aneurysm within 6 weeks of receiving covid vaccination.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 13Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FO9943), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Known- allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Sep2022) positive, notes: Re-bound infection, tested positive 8Sep2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Covid-19 treatment with Paxlovid from 29Aug2022 to 03Sep2022.
FEELING TIRED; MEMORY LAPSES; REAL BAD BODY ACHES; MUSCLE TIGHTNING AS SHE WALKS; SEVERE POST PARTUM SHINGLES PAIN  ACTIVATED; This spontaneous pregnancy report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included drug allergy. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced severe post partum shingles pain activated. On 26-APR-2021, the subject experienced muscle tightning as she walks. On 28-APR-2021, the subject experienced memory lapses. On 28-APR-2021, the subject experienced real bad body aches. On an unspecified date, the subject experienced feeling tired. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from real bad body aches, had not recovered from muscle tightning as she walks, severe post partum shingles pain activated, and memory lapses, and the outcome of feeling tired was not reported. This report was non-serious.
Started with a lump on 2/24 then itching on 2/25 to waking up to a large itchy heated lump on the left arm on and around the injection site.  Also experienced some crusting of the eyes that morning and some  odd feelings in the lips also  not sure if they are related or just symptoms of other issues or nervousness.
J96.00 ACUTE RESPIRATORY FAILURE 7/6/2022 FEMALE BREAST CANCER, UNSPECIFIED SITE OF LEFT BREAST J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/26/2022 FEMALE BREAST CANCER, UNSPECIFIED SITE OF LEFT BREAST J96.02 ACUTE HYPERCAPNIC RESPIRATORY FAILURE 7/6/2022 FEMALE BREAST CANCER, UNSPECIFIED SITE OF LEFT BREAST R09.02 HYPOXIA 5/26/2022 FEMALE BREAST CANCER, UNSPECIFIED SITE OF LEFT BREAST J96.00 ACUTE RESPIRATORY FAILURE 7/6/2022 NONTRAUMATIC ACUTE KIDNEY INJURY J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/26/2022 NONTRAUMATIC ACUTE KIDNEY INJURY J96.02 ACUTE HYPERCAPNIC RESPIRATORY FAILURE 7/6/2022 NONTRAUMATIC ACUTE KIDNEY INJURY R09.02 HYPOXIA 5/26/2022 NONTRAUMATIC ACUTE KIDNEY INJURY J96.00 ACUTE RESPIRATORY FAILURE 7/6/2022 HX OF LEFT BREAST CANCER J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/26/2022 HX OF LEFT BREAST CANCER J96.02 ACUTE HYPERCAPNIC RESPIRATORY FAILURE 7/6/2022 HX OF LEFT BREAST CANCER R09.02 HYPOXIA 5/26/2022 HX OF LEFT BREAST CANCER
Red rash, hives, itching all over entire body. Going to take benedryl liquid and use benedryl creme. We are given the Flu shot free for state workers.
Vacc injection given 9/30/11. Reported to ER 10/3/11 for (L) arm cellulitis with fever & increased WBC. Clindamy Rx Tx - Sx resolved & discharged 10/7/11.
ON 11.5.19, PT'S HUSBAND CALLED THE PHARMACY AND STATED THE PT HAS A "LOSS OF HEARING".  SINCE 10.21.19 INJECTION DAY.  HE SAID SHE HAS TAKEN BENADRYL AND IT HAS NOT HELPED.  HER PROVIDER'S OFFICE, WAS CALLED ON THAT DAY.  RPh, THE INJECTING PHARMACIST, CALLED AND SPOKE WITH STAFF.  SHE WAS CHECKING TO SEE IF THEY HAVE COMPLTEED A VAERS REPORT.  NO RETURN CALL HAD BEEN MADE, SO I (RPh, PIC) COMPLETED THIS REPORT.  PT WAS CALLED BY RPh ON 11.6.19 TO DETERMINE HER CONDITION BUT LEFT A MESSAGE.  PT HAS NOT CALLED BACK.
Anaphylactic reaction/Shortness of breath/ Trouble swallowing; Weakness; Sore throat; Night sweats; Elevated blood pressure; Heart rate in 120s; feel lethargic; A spontaneous report was received from a consumer concerning for a 73 years old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events anaphylactic reaction, shortness of breath/ dyspnoea, trouble swallowing/ dysphagia, feel lethargic/lethargy, weakness/asthenia, night sweats and sore throat/ oropharyngeal pain, elevated blood pressure and heart rate in 120s.  The patient's medical history was not provided. The concomitant medications on use were also not provided.  On 11 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA (lot number: 024M20A) through intramuscular route of administration for prophylaxis of COVID-19 infection. On 12 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA (lot number: 032M20A) through intramuscular route of administration for prophylaxis of COVID-19 infection.  On 12 Mar 2021, within 10 minutes of second dose, patient experienced anaphylactic reaction. She experienced flushing and shortness of breath and was given oxygen, benadryl 50 mg and depomedrol intramuscularly by an EMT on site. Patient was taken to the ER for evaluation and discharged on medrol dose pak, tagamet BID and benadryl. As of today 12 days later, patient still has  he following side effects: flushing beet red, trouble swallowing feels like throat is closing in, night sweats, feels lethargic, weakness, elevated blood pressure and heart rate in 120s and a sore throat. She has consulted with three HCPs since discharge and all have said to continue on her medications.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The events anaphylactic reaction, shortness of breath, trouble swallowing, feel lethargic, weakness, night sweats and sore throat blood pressure and heart rate in 120s were not recovered at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
1. Fever - took MOTRIN. 2. Injection site - swelling and a 3"x 3" circular mass, warm to touch, dime size redness on the injection site. Treated with cold compress.
Slight swelling  of upper lip; was given Benadryl 50 mg.  Waiting 45 minutes; went home; arm swelled at injection site and hand. Took two more Benadryl. Swelling went down.0
After the dose is given patient started dizziness, and complained about her ears being filled, and then started to loose consciousness and started shaking the hands and legs. I helped her lay on the floor. I gave the patient a dose of  epipen and she regained her senses immediately. EMS came and checked on her , she had her blood pressure and heart rate checked and was slightly elevated and they stayed with the patient for 15 to 20 minutes and left as the patent denied further treatment. Patient stayed at the pharmacy until her family member picked her up to take home. I called at 5.30 pm to check on her and she said she is doing fine and was back to normal.
Puffy lips the night of injection went away after taking benadryl Sore throat which began a few hours after injection--still present Headache which began a few hours after injection--not sure if this is a migraine or side effect Soreness at injection site--stopped today (1/4/21)
The reaction I'm reporting may have been from the pain ease that was administered at the injection site with the flu vaccine.  That  product is by Gebauer's Pain ease and is a topical anesthetic spray. My arm had a big black spot that turned into a sore and begin to peel.
Hard at injection site; Really Really Itchy; It came back Swollen; It was itchy; It hurt for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (It was itchy), VACCINATION SITE PAIN (It hurt for a couple of days), VACCINATION SITE SWELLING (It came back Swollen), VACCINATION SITE INDURATION (Hard at injection site) and VACCINATION SITE PRURITUS (Really Really Itchy) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event found.).    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (It was itchy) and VACCINATION SITE PAIN (It hurt for a couple of days). On 16-Jan-2021, the patient experienced VACCINATION SITE SWELLING (It came back Swollen) and VACCINATION SITE PRURITUS (Really Really Itchy). On an unknown date, the patient experienced VACCINATION SITE INDURATION (Hard at injection site). At the time of the report, VACCINATION SITE PRURITUS (It was itchy) and VACCINATION SITE PAIN (It hurt for a couple of days) had resolved, VACCINATION SITE SWELLING (It came back Swollen) and VACCINATION SITE INDURATION (Hard at injection site) outcome was unknown and VACCINATION SITE PRURITUS (Really Really Itchy) had not resolved. Not Provided      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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.