chrisvoncsefalvay/vaers-outcomes huggingface dataset:
subacromial-subdeltoid bursitis; This is a literature report for the following literature source(s).  A 38 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose), for Covid-19 immunization, reaction(s): "moderate arm pain around the injection site". The following information was reported: BURSITIS (medically significant), outcome "recovered", described as "subacromial-subdeltoid bursitis". The patient underwent the following laboratory tests and procedures: pain assessment: 10/10; ultrasound scan: left shoulder was performed in which subacromial, notes: subdeltoid bursitis was detected.  No follow-up attempts are needed. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-20220029551 Same article/drug/patient; different event.;US-PFIZER INC-202200295513 Same article/drug/event and Different patient.
Admitted to hospital after exposure to household cooking gas  (gas leak) on 9/10/21 Tested positive for COVID-19 on 9/11/21 Noted to have COPD and chronic respiratory failure which required 3 Liters of Oxygen per minute at home.  Patient expired on 9/15/21
4/21/2021   Patient was observed post Covid-19 immunization for 15 minutes .  During the observation period, she experienced an adverse reaction with the following symptoms:  swelling of face and throat.   Assessment : Time of assessment 1445. Swelling of lips and nose.   Actions taken:  Vitals sign taken  EMS called at  1520. VAERS form obtained and completed by RN. Hand off to EMS upon arrival at 1530.  VS at 1445- BP- 144/90. P- 101, O2- 99% VS taken at 1506- - BP- 165/88, P- 84, O2- 100%,        Medications administered: Diphenhydramine (Benadryl) 25 mg capsule, by mouth. Time: 1445 and 1507. Administered by RN x 2 doses.   Disposition: 911 called and patient was evaluated, she refused transport to hospital by EMS, she reports that husband will transport her. Observation time increased to 30 minutes     Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 4/21/2021  2:08 PM 0.3 mL 2/25/2020 Intramuscular   Manufacturer: Pfizer, Inc   Lot: ER8735
This spontaneous report as received from a healthcare worker via consumer (the patient's mother) refers to a 2 year old female patient with allergy to milk. No other patient's pertinent medical history was provided. On 09-JUL-2014, the patient received first dose of (Oka/Merck) VARIVAX 0.5ml, subcutaneous (lot number and expiration date were not reported). No concomitant medications were provided. In approximately July 2014 (reported as beginning over the weekend), the patient developed high fever and blister like rash. It was clarified that blistery rash was not at injection site. the events remained ongoing. The relatedness between the events and the vaccination with (Oka/Merck) VARIVAX was unknown. The patient did not seek medical attention. No treatment was given for adverse events. Additional information is not expected because we cannot contact with the physician.
Developed severe pain in the left arm, which radiated to the shoulder and neck. Ran fever intermittently for weeks. Had EKG and X-ray five days after getting injection. Diagnosed with early pneumonia - took doxycycline and went back to Dr. for a second X-ray. Weak and exhausted still!
The person giving it gave it to me in the wrong spot; Ended up with localized inflammation in the area; redness; warm to touch; pain under my arm pits and swelling; pain under my arm pits and swelling; This is a spontaneous report from a contactable other hcp. A 38-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that on an unspecified date, the patient experienced the person giving it gave it to me in the wrong spot, ended up with localized inflammation in the area, redness, warm to touch, pain under my arm pits and swelling, pain under my arm pits and swelling. it was reported that, patient received the 2nd dose of the Pfizer covid vaccine. The person giving it gave it to patient in the wrong spot. Patient was stressing what would happen. Ended up with localized inflammation in the area, redness, warm to touch, pain under patient arm pits and swelling. Yesterday went patient went to the urgent care. They gave patient antibiotics to prevent cellulitis. It was because it was administered wrong. Patient in the middle of trying to get information to write a report to the drug store. It's unfortunate there were multiple people that day that patient gave it to. What about the effectiveness of the 2nd shot since it wasn't administered into the muscle? I've never had issues with shots. The first-time patient really didn't have too much; what seemed like inflammation in patient face (left side of my face) but no drooping or anything like that. patient can almost guarantee if the vaccine was administered correctly patient would not have had a reaction to file. The outcome of event was unknown.
Received MMR 6/1/11. Developed fever, HA, myalgia, rash, post cervical cn about 6/10/11 lasted about 5 day.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tachycardia-Severe, Additional Details: pt was very complusive and her eyes rolled back. Started sweating, pulse rate going up, light headed
Information has been received from a pharmacist concerning a 52 year old female patient who on an unspecified date was vaccinated SC with single 0.65ml dose of ZOSTAVAX (Merck). Subsequently the patient had a small bump or rash at the injection site. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Rash, swelling, itching, some lethargy and slight headache, Tylenol, Rash and itching diminishing, other symptoms gone
chest pressure; I experienced dizziness, with feeling of fullness in inner ear and head; I experienced dizziness, with feeling of fullness in inner ear and head; I experienced dizziness, with feeling of fullness in inner ear and head; numbness of lip (throat ,tongue  and facial swelling) and it kept spreading to the back of my neck; numbness of lip (throat ,tongue  and facial swelling) and it kept spreading to the back of my neck; numbness of lip (throat ,tongue  and facial swelling) and it kept spreading to the back of my neck; numbness of lip (throat ,tongue  and facial swelling) and it kept spreading to the back of my neck; numbness of lip (throat ,tongue  and facial swelling) and it kept spreading to the back of my neck; This is a spontaneous report from a contactable consumer (patient, self-reported). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0186 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 06Jul2021 at 10:00 AM (age at vaccination: 56 years), as a single dose for COVID-19 immunization at doctor's office/urgent care. The patient was not pregnant at the time of vaccination. The patient's medical history included sarcoidosis with lung involvement, allergic rhinitis, asthma (environmental), sleep apnea, cardiomyopathy, and known allergies: Shellfish, Sulfa, Bee/wash venom, and penicillin. Concomitant medications included ciclesonide (ALVESCO), azelastin, fluticasone propionate (FLONASE), and paracetamol (TYLENOL). The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on 06Jul2021 at 10:00 AM, shortly after vaccine administered in left deltoid, she experienced dizziness, with feeling of fullness in inner ear and head, minutes later, numbness of lip (throat, tongue and facial swelling) and it kept spreading to the back of her neck. She also felt chest pressure. She alerted nurse immediately of symptoms and received Epi-pen, and Benadryl. Adverse events resulted in doctor or other healthcare professional office/clinic visit emergency room/department or urgent care. The patient received treatment for the events. Outcome of the events was not recovered.; Sender's Comments: Based on the information provided and considering close temporal relationship, the causal association between the reported event Chest discomfort and the suspect drug cannot be completely excluded. The case will be reassessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Day 2 woke up very  sore arm & generally felt like I had the flu.  Stayed in bed all day.  Day two very swollen eyes and one side of my mouth was very swollen.  Again felt like the flu.  Eyes hurt if I blinked hard.  Day 3 eyes still swollen but getting better.  one side of mouth very swollen.  Less achy
On 07/11/2001 the patient's right arm is swollen and red. The child is afebrile.
One week later at the site where the vaccine  was given has a quarter sized knot, it?s red hot and just slightly itchy.
she had a severe allergic reaction; Over 35 days and 2nd shot not administered; Tongue swelling; Tongue itching; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Tongue swelling), TONGUE PRURITUS (Tongue itching), HYPERSENSITIVITY (she had a severe allergic reaction) and PRODUCT DOSE OMISSION ISSUE (Over 35 days and 2nd shot not administered) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced SWOLLEN TONGUE (Tongue swelling), TONGUE PRURITUS (Tongue itching) and PRODUCT DOSE OMISSION ISSUE (Over 35 days and 2nd shot not administered). On 04-Sep-2021, the patient experienced HYPERSENSITIVITY (she had a severe allergic reaction). At the time of the report, SWOLLEN TONGUE (Tongue swelling), TONGUE PRURITUS (Tongue itching) and HYPERSENSITIVITY (she had a severe allergic reaction) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Over 35 days and 2nd shot not administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and no treatment information were provided by reporter .   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Follow-up was received on 27-SEP-2021 and contain no new information .
Pt recvd vax & devel 3 small hives & also exp itching;
Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a clinic as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated at a medical office for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
These symptoms all began approximately at 8am  (2/11) and lasted until approximately 12:30am  (2/12) Extremely lightheaded (difficulty standing for longer than 2 minutes-almost lost consciousness 4 times). Nausea Chills Body Aches  Soreness in left arm beginning approximately 3 hours after receiving the vaccine and lasted for approximately 5 days
very little ache in the arm; This is a spontaneous report from a Pfizer-sponsored program from a contactable other healthcare professional (HCP).  A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on unknown date. Medical history and concomitant medications were not reported. The patient experienced very little ache in the arm when he took the first dose. Action taken for BNT162B2 was not applicable. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Red welt and bruising appx 1.5 inch. Next day, fire red raised welt more than doubled in size, warm to touch, subdural knot appx 4 inches by 2.5 inches.
itchiness/redness on arms lungs C/E Bilat No SOB/Hives BENADRYL 12.5 mg PO 3 hours symptom free - home
This spontaneous report as received from a physician refers to a 66 year old female patient via Medical Records. The patient's concomitant medication included chronic kidney disease stage 3 with a glomerular filtration rate (GFR) mildly low, astigmatism, onychomycosis and spinal osteoarthritis. The patient's medical history included intervertebral disc space narrowing. The patient's historical drug included PREVNAR, terbinafine and celecoxib (CELEBREX). The patient did not have allergies. On 14-NOV-2017 at 17:15,  the patient was vaccinated with PNEUMOVAX 23 lot number N019348, expiration date 08-FEB-2017 (dose, route and anatomical site were not reported) for prophylaxis. Concomitant therapies included acetaminophen, diphenhydramine hydrochloride (TYLENOL PM) and acay berry extract. On 15-NOV-2017 at 02:30, the patient woke up and "could not lift the arm which was vaccinated, and whole side was throbbing". The patient also experienced "nausea, headache and chills". It was reported that she took nabumetone 500mg, but the physician did not prescribe treatment for the events. Afterwards, she recovered throughout the day. The causal relationship between the events and PNEUMOVAX 23 was not reported. All available medical records will be provided upon request.
Both Vaxelis and Pentacel was given to patient at 2 month visit; No adverse reactions were reported.; This non-serious spontaneous safety report with reference number #2022SA321965 was received by a partner on 04-AUG-2022 and forwarded on 05-AUG-2022 from a physician.  The causal relationship between Vaxelis and the reported event "Both Vaxelis and Pentacel was given to patient at 2 month visit; No adverse reactions were reported" is assessed as not applicable due to the nature of the event.  Further information is expected.
Within 15 minutes of getting the vaccine, I started having red blotchy marks all over my neck front and back, chest, and face. Constant itching. My ears were a fire red and burning feeling. The palms of my hands were red and swollen and even in between my fingers. The site of injection was a welt the size of a dime, with my arm red and swollen down to my elbow. It was difficult for me to swallow and my chest felt tight.
3/5/23 I noticed there was a red spot growing up on my right arm near my wrist that seemed to have three little peaks on it, look like a cluster and irregular edge. After a few days it looked like little blood blisters underneath one or two of the peaks. My arm felt funny and tingly around the spot. I had seen something similar to it a few months ago and it went away after a week. The blood blisters went away, but the spot is still there with a waxy look on top of it. It is not as itchy as it was. I have a doctors appointment on 3/29/23 to check this out. After this vaccination and before this red spot, I had noticed swelling and a red rash that itched on my left foot.
01/17/15 INITIAL BACK PAIN. 01/21/15 WENT TO ER FOR BACK PAIN & GOUT. 01/22/15 2ND VISIT TO ER FOR UNBEARABLE BACKPAIN, COULDN'T WALK, HIPS & THIGHS WERE TINGLING, LEGS, FEET, TOES WERE IN PAIN, SHOULDERS & TIPS OF FINGERS FEELING SORE & NUMB, OVERALL FEELING OF WEAKNESS. REFLEXES WEREN'T RESPONDING. 01/27/15 URGE TO BM, UNABLE TO TELL WHETHER NEEDED TO PASS GAS OR USE BATHROOM. 02/04/15 INCREASE WEAKNESS TO KNEES & LEGS. 02/11/15 TINGLING & NUMBNESS MOVED UP TO STOMACH, ADMITTED TO HOSPITAL FOR 6 DAYS, WHERE DIAGNOSED WITH GUILLAIN BARRE SYNDROME, & GIVEN 5 DAY TREATMENT OF IVIG PLASMA.
This spontaneous report as received from a healthcare worker refers to a 16 year old female patient. There was no concomitant medication, medical history or known drug reactions/allergies. The patient had received her the first dose of VARIVAX (Merck) on 01-FEB-2000 (lot #, en expiration date, dose, frequency, route of administration and indication were not reported). On 29-JUL-2015 the patient was vaccinated with improperly stored VARIVAX (Merck) (lot # K026384, an expiration date: 15-DEC-2015), the second 0.5 ml dose, subcutaneously. The healthcare worker reported, that the injection site became red and swollen on 30-JUL-2015, after receiving improperly stored VARIVAX (Merck). The patient was treated for the events with BENADRYL and BACTRIM. The patient sought medical attention and was seen in the office. The outcome of the events was unknown. The relatedness between the events and VARIVAX (Merck) was not reported by the reporter. This is one of the several reports received from the reporter. Additional information has been requested.
This is a spontaneous case, initially received on 05-Feb-2018 from other health professional, concerning a 54-year-old, adult male patient. It was reported that, the FLUCELVAX was exposed to temps above 8C. Later, the temperature of the refrigerator was dropped to 0.01C and was out of range for about 8.5 hours which was the second excursion (explicitly coded as incorrect product storage). On 22-Jan-2018, the patient was administered with FLUCELVAX QIV that was outside the recommended range (batch number: 195125, expiry date: 30-Apr-2018, dose, route of administration, anatomical location: not reported) (explicitly coded as drug administration error). The reporter assessed the events as non-serious.
pt screamed immediately p/shots; pt wanted to be held cried from 230PM-8PM but not continuously; cat napped but didnt sleep; cry was ear piercing @ times;
brain fog; shortness of breath; feeling weak; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (brain fog), DYSPNOEA (shortness of breath) and ASTHENIA (feeling weak) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced FEELING ABNORMAL (brain fog), DYSPNOEA (shortness of breath) and ASTHENIA (feeling weak). At the time of the report, FEELING ABNORMAL (brain fog), DYSPNOEA (shortness of breath) and ASTHENIA (feeling weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by the reporter. No treatment medication was provided by the reporter.
Child received vaccine. Mom states 30 mins after vaccine child crying, inconsolable. Legs swollen L>R warmth bilateral. Child admitted overnight for observation.
pt recv vax 19MAR96 & 23MAR96 pt devel a rash w/multiple macules on face, trunk, extremities, & erythema;no further details were provided;
patient received a re frozen dose of the vaccine; patient received a re frozen dose of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a re frozen dose of the vaccine) and PRODUCT STORAGE ERROR (patient received a re frozen dose of the vaccine) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a re frozen dose of the vaccine) and PRODUCT STORAGE ERROR (patient received a re frozen dose of the vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received a re frozen dose of the vaccine) and PRODUCT STORAGE ERROR (patient received a re frozen dose of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.    No treatment information provided.   This case was linked to MOD-2021-381132 (Patient Link).; Sender's Comments: This is a case of Expired product administered  and Product storage error for this 67-year-old patient of unknown gender with no relevant medical history, who experienced no adverse event. The medication error occurred on the day of the third dose of Moderna COVID-19 Vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Per Patient DOB 10/21/63, received her 2nd dose of Moderna vaccine Lot # 013M20A. Has a history of allergic reactions in the past but to unknown source. No history allergic reaction to first vaccine dose or to vaccine components. Has history of Melanoma of the foot in remission for  2 years. Current medications: Omeprazole for GERD. After 15 minutes developed urticarial rash on Left arm, No SOB or any other symptoms,  then redness to Right arm and Diphenhydramine 50mg  were administered orally with her consent. Vital signs stable BP 130/80 O2sat 99%  HR 100, RRR No Wheezing. She started to feel better and remained in observation and monitoring of vital signs.  Vital signs at 10:58am were: BP 125/75 HR 97 O2Sat 99%, Temperature 98.5 11:05am  130/80, 102 HR, 99% O2Sat, No SOB, AO 11:15am 140/80,  108 HR, 98% O2Sat, No SOB, AO 11:26am  Reported feeling SOB, supplemental O2 started and EMTs arrive.  No swelling of tongue. Patient Released to EMS @11:27am into their care and observation. Patient went to  the hospital.   No prior prescription for Epinephrine ever or prior need to use.
It started before the pt went to sleep and was awakened many times during the night with rigors. The shaking was so severe that when she got out of bed around 5:30 her entire body including her ribcage hurt from shaking for hours. She was totally exhausted and completely washed out. She finally got out of bed at 7:30 and had difficulty standing and walking. being concerned, she had a family member take her blood pressure because she wasn't physically able to do so due to complete exhaustion. The BP was 70/42. She sat and hydrate because she couldn't stand or move. She was very weak and felt like she was going to pass out. Subsequent BP & pulse readings were: 100/62 (10am);  96/52 (12:39 pm / P: 92); 85/61 (1:57 pm/P 85/61 (1:57 pm/P:78); 112/60 (3:21 pm / P:84); 114/58 (4:59 pm / P:91). Around 7:30am she had popcorn and a bagel for salt and to try to raise her blood pressure. She spent most of the day on the couch hydrating and chilling. it took several hours for her blood pressure to return to the normal range.