chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHHY2017US045004, is an initial literature report received on 20 Mar 2017. The author discussed about a report of rotator cuff tear resulting from intratendinous injection during attempted deltoid intramuscular vaccination. This report refers to a 69-year-old female patient. Medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an  influenza virus vaccine (manufacturer and batch number: not reported). On an unknown date, the patient presented to the Orthopaedic clinic with left shoulder pain. The patient stated that she experienced an acute onset of sharp severe pain in her shoulder during an influenza vaccination and was unable to lift her arm overhead immediately after the injection. The patient noted that the injection was performed "unusually high" in her shoulder directly underneath the lateral aspect of the acromion and the needle was inserted as deeply as possible. She also stated that  an "unusually long needle was used during the  injection". She was initially treated conservatively by her primary care physician with a  subacromial corticosteroid injection and physical therapy for presumed rotator cuff tendinitis for 5 weeks; however, her pain and weakness persisted. She had no prior shoulder pain, injury, or surgery in either shoulder, and she was able to pinpoint the influenza vaccination as the exact time when her shoulder pain began. Magnetic resonance imaging (MRI) with intraarticular contrast was performed, which showed a high-grade,  partial articular sided tear of the supraspinatus with a delaminated component. The contrast further delineated the delaminated nature of the tear. The patient underwent arthroscopic subacromial decompression with transtendinous rotator cuff repair with a double-row, suture-bridge construct and mini-open subpectoral biceps  tendinosis.  At  the  time  of  surgery,  she  was  found  to  have  a  severely  delaminated,  nearly  complete  rotator  cuff  tear  with  significant  synovitis in the glenohumeral joint and bursitis in the subacromial space. She was immobilized in a shoulder abduction brace for 4 weeks, with physical therapy beginning the day after surgery for passive range of motion. The patient progressed well through her rehabilitation protocol, and was doing well at 1-year follow-up with nearly full strength, no pain, and full range of motion. The author concluded the article stating that this is the first report of rotator cuff tear as a complication from intended intramuscular injection. Deltoid intramuscular injection is generally safe and effective for administration of medications and vaccines; however, complications are possible. Care in the starting point, depth, and direction of needle placement into the deltoid is critical to avoid inadvertent intratendinous rotator cuff injection. The size of the injection needle should be matched to the sex and size of the patient to ensure adequate muscle penetration, and  [Due to memory limitations, the remainder of this text could not be compared.]  on, and injection should be stopped if resistance is felt to allow for redirection of the needle.
tested positive for COVID; tested positive for COVID; vomiting; headache; lower back pain; fever (101.7); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the parent.  A 7 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Nov2021 (Lot number: FK5127) at the age of 7 years as dose 2,(tris) single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot number=FK5127,, prev dose lot unknown=False,, prev dose administrator route=Intramuscular,, prev dose administration date=11Dec2021, prev dose dose number=1,, prev dose vaccine location=Left arm), administration date: 11Dec2021, when the patient was 7 years old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jan2022, outcome "recovering" and all described as "tested positive for COVID"; VOMITING (non-serious) with onset 20Jan2022, outcome "recovering", described as "vomiting"; HEADACHE (non-serious) with onset 20Jan2022, outcome "recovering", described as "headache"; BACK PAIN (non-serious) with onset 20Jan2022, outcome "recovering", described as "lower back pain"; PYREXIA (non-serious) with onset 20Jan2022, outcome "recovering", described as "fever (101.7)". The events "tested positive for covid", "tested positive for covid", "vomiting", "headache", "lower back pain" and "fever (101.7)" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) 101.7; sars-cov-2 test: (20Jan2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, vomiting, headache, back pain, pyrexia. Symptoms on 20Jan were vomiting, headache, lower back pain, and fever (101.7). At the time of submitting this report, he has improved and no longer has any of the symptoms above (only congestion). Treatment received with Tylenol. No other vaccine in four weeks and no other medications in two weeks. No covid prior to vaccination and covid tested post vaccination. No known allergies were reported.  No follow-up attempts are possible. No further information is expected.
Case number PHEH2014US001487 is an initial spontaneous report from the consumer received on 16 Jan 2014. This report refers to a 54-year-old female patient. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 14 Jan 2014. On the same date, immediately after vaccination she experienced shortness of breath, chest tightness and pain that radiated along her back. She stated that she had mild shortness of breath at the time of reporting, but the event was extremely difficult on the night, where she had to sit in a chair with a heated vibrator to get some sleep. It was reported that the patient had a concern that she would get a condition like asthma after FLUVIRIN administration. The outcome of the events was unknown.
very fast heartbeat very high blood pressure at onset low blood pressure next day and after difficulty breathing arm pain and can't raise 45 degree trouble sleeping dizzy very very weakness can't open eyes nose bleeding a lot difficulty sitting difficulty chewing food brain fog and confusion muscle joint pain yellow face and palm congestion and running sneezing nose lost smell and taste it's been more than 5 weeks still can't recover most of the symptoms seems like damaged a lot can't do as heavy physical activities and house work lot more food to keep up the energy
Received the shot around 4pm started to have extreme discomfort in my left wrist, hand area Woke up this morning unable to move the hand without extreme pain.  I have been taken 400mg of Advil  every 4 hours and the pain has lessened somewhat.
Redness/swelling of left arm at onset- then pt developed diffuse urticarial rash 04/26/14 which has continued to persist through today's date 05/13/14. Tx: Benadryl, prednisolone.
MADERNA COVID-19 Vaccine EUA ; Within 6 minutes, experienced warming feeling through chest followed by light headed and dizziness, followed by immediate sensation of nausea. Then lost awareness and surrounding noise sounded as if I were in a cave, echoes and non-discernable. Lost consciousness for several minutes.  Next recollection was regaining awareness, clothes soaked with sweat. Was lying on a bed with no recollection of being moved to the bed. Shakes and feeling of distress. Experienced shakes and a tingling sensation for approximately 15 minutes. Once that subsided I experienced chills for the better part of an hour. Would like to add, I have no phobias of injections and regularly have blood samples drawn for medical evolutions with my primary care physician.  Was counselled by administering physician to go home and skip work.
11/11/2021 Left arm  was sore. Cough, fever,  congestion and cough.  11/14/2021 cough, congestion, runny nose.  11/16/2021 I  lost my voice for two days and missed 2 to 4 days of work.  Lost voice, vertigo,  cough,  congestion and runny nose.  11/21/2021 to 11/25/2021 diarrhea,  congestion, runny nose and productive cough .  11/26/2021 I lost sense of taste and smell.  11/22/2021 I called my doctor.  He prescribed Mucinex DM and  I modicum. And to get a Covid test, which I did  11/26/2021
Patient reports numbness of all extremities continuing for more than 4 hours. Patient consulted with and treated by rheumatologist and neurologist.
Rash - raised red and itchy all over face - mostly on left side of face (same side as shot given).  On cheeks, forehead, nose, and neck
The patient had shots, ten minutes later she had "light headedness, heart beating fast, hard to breathe, feels like anxiety attack". The !st dose of epi given 0.3 cc symptoms began to subside. Symptoms still occurring after another 5 minutes. She was given 2nd dose of epinephrine sq symptoms: difficulty breathing continued, administered 3rd dose of epinephrine after another 7 minutes. Emergency staff began arriving about 5-10 minutes later. Administered oxygen and a breathing treatment, transported the patient to Independence Regional Hospital Emergency room. She was released that afternoon.
This spontaneous report as received from a consumer via Clinic refers to a currently 73 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-NOV-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 1 dose unit (lot # M036728, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1801USA000166.
Within 10min of getting the shot, pt had hives, chest pain, difficulty breathing, had called 911, pt admitted to hosp.  4/6/09 Received hospital medical records of 3/24-3/25/2009. FINAL DX: dyspnea, chest pain, likely allergic reaction to pneumovax. Records reveal patient experienced chest pain, hives, itching, throat tightness, heart racing.  Tx w/IV antihistamine, SL NTG improved.  Cardio consult done.
Given DTaP, Hep A, Flu, PCV13. That night had first ever GTC seizure, postictal afterwards. Questionable fever/OM by ER but none noted at WCE that day. Suspect DTaP.
Suspected vaccination failure; Currently with shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported for the reporter's mother. The age at vaccination was not reported. After receiving Shingles vaccine, the patient was dealing with shingles. The patient paid big bucks for the Shingles vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
REceived moderna vaccine on 2/14/21 and 3/16/21. Unknown lot number. COVID positive on 2/27/22. Presented to ER on 2/27/22. admitted on 2/27/2022 for hypertensive urgency.  Incidental finding of COVID-19 positive also noted at admission; fortunately patient was asymptomatic. Discharged on 3/1/22
Could not get out of bed; Hot and cold feeling; Sweating; Fever; Swollen Lymph nodes Armpit; Joint pain; Stomach pain; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Hot and cold feeling), HYPERHIDROSIS (Sweating), PYREXIA (Fever), LYMPHADENOPATHY (Swollen Lymph nodes Armpit) and ARTHRALGIA (Joint pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hashimoto's disease.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Hot and cold feeling), HYPERHIDROSIS (Sweating), PYREXIA (Fever), LYMPHADENOPATHY (Swollen Lymph nodes Armpit), ARTHRALGIA (Joint pain) and ABDOMINAL PAIN UPPER (Stomach pain). On 04-Feb-2021, the patient experienced ILLNESS (Could not get out of bed). On 07-Feb-2021, FEELING OF BODY TEMPERATURE CHANGE (Hot and cold feeling), HYPERHIDROSIS (Sweating), PYREXIA (Fever), LYMPHADENOPATHY (Swollen Lymph nodes Armpit), ARTHRALGIA (Joint pain), ABDOMINAL PAIN UPPER (Stomach pain) and ILLNESS (Could not get out of bed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment information was reported.
Patient received dose 2/4/2021 - called to clinic 3/2 to delay 2nd dose to 6 weeks to allow for complete healing of a cellulitis.  The cellulitis was described to me as started in the arm and traveled to face.  Currently patient still have breakout of face.  Being treated with doxycycline for cellulitis.
Developed raised, red, itchy  rash at injection site. Lasted for about 8 days.
No additional AE; VARIVAX was administered to patient with temperature excursion; This spontaneous report was received from a nurse prescriber and referred to a 12-year-old male patient. No illness at time of vaccine. No significant past medical history. The patient also received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant human albumin) (M-M-R II, lot# U039549), diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP), polio vaccine and meningococcal vaccine a/c/y/w conj (crm197) (MENVEO).  On 01-MAR-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter (lot # W008712, has been verified to be a valid lot number, expiration date reported and upon internal validation established as 14-MAR-2024), administered for prophylaxis (anatomical location, and route of administration were not reported) (Product storage error). Temperature excursion as following: 15.7 Fahrenheit (F) for 0 hours 20 minutes. No adverse events related to vaccination.   This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-2304USA001250: US-009507513-2304USA001320: US-009507513-2304USA001381: US-009507513-2304USA001557: US-009507513-2304USA002345:
arm was hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was hurting) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was hurting). On 21-Mar-2021, PAIN IN EXTREMITY (arm was hurting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment details included acetaminophen.
Pt noted by parent to have hives apprx. 2 hours after receiving Prevnar and Hep B vaccines. Brought into office 11/04/2002 due to persistence of hives and low grade fever. Exam nl except few scattered small urticaria back, chest, arms
Strong ringing in the ears within the hour. Continued for approximately 3 weeks, then subsided but continues with a constant low volume. No treatment sought by patient who is waiting to see if effects will resolve by itself.
Initial report received from literature on 28 December 2014. This case is linked to case number 2015SA000158, 2015SA000157 and 2015SA000159 (same literature report). The following is the verbatim for the article abstract: A number of medications have been associated with uveitis. This review highlights both well-established and recently reported systemic, topical, intraocular, and vaccine-associated causes of drug-induced uveitis, and assigns a quantitative score to each medication based upon criteria originally described. A 13-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of BCG VACCINE (manufacturer- unknown, batch number, route, dose number and site of administration was not reported) on an unspecified date. On an unspecified date patient had experienced chronic bilateral anterior uveitis after vaccination. It was reported that patient developed chronic bilateral anterior uveitis following BCG vaccination implicated her HLA-DR4 positivity, noting that HLA-DR4 is highly responsive to M. tuberculosis antigens. Laboratory investigation and corrective treatment was not reported. At the time of reporting, patient outcome was unknown. Upon medical review, the case was considered as serious due to important medical event: chronic bilateral anterior uveitis. List of documents held by sender: none.
HEADACHE; .This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache. This report was non-serious. This case, from the same reporter is linked to 20210740675.
Moderna COVID-19 Vaccine EUA  - First symptom was I skipped a menstrual cycle as the 2nd dose.  The had 2 cycles after that with the first being heavier than I have ever experienced.  I am now experiencing hot flashes and believe the shot has contributed to me starting menopause.  Prior to vaccine I had not signs of menopause.  -  Second symptom is I'm experiencing vertigo after the second shot.
One day post vax the pt developed a fever of 104F. Pt experienced frequent urination, coughing, head cold symptoms, pallor, muscle pains in her thighs, irritability and restlessness. Pt was treated with Ditropan.
Pt called clinic nurse line six days post administration of booster. Pt shared with RN that her arm was still sore and swollen and itchy at administration site. Pt. verbalized concern that the injection was given in the "fatty part" of her arm, not in her muscle. MA who administered injection stated that she gave it in the pt deltoid. Pt was informed that irritation at site is normal and to call clinic back if it did not improve in the next few days. This clinic writer called the CDC and was informed that giving the vaccine SQ instead of IM can be associated with more local reactions, but as long as the dose was correct no additional immunization is needed.
few hr p/vax pt devel lt wrist, elbow & shoulder aching & stiffness which lasted 3 days;
The week before 10/20/2021- I was having GI problems and diarrhea. My girlfriend did not get sick but I did. On 10/20/2021- I developed a sharp pain in my lower region went to the ER and was diagnosed with thrombosis hemorrhoid. They had to cut the hemorrhoid open and remove the blood clot inside. And I was in recovery for a few weeks unable to properly sit down. I have had hemorrhoids in the pass, but it was not that bad. I do not feel this is related to the vaccine, but I do feel it is worth reporting.
she was stressed; Scarring post outbreak; Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (2 prior episodes pre-Shingrix).   On 12th February 2020, the patient received the 1st dose of Shingrix. On 18th April 2020, 66 days after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced shingles. On an unknown date, the patient experienced stress and feeling tense. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the stress and feeling tense were unknown.   It was unknown if the reporter considered the shingles, stress and feeling tense to be related to Shingrix.  Additional details were provided as follows: After receiving 1st dose of Shingrix, the patient developed an outbreak of Shingles and received Valtrex. The outbreak was reported to be resolved at the time of reporting. The patient thought it was a bug bite at the onset of the episode, she was stressed and this outbreak scarred her more than the past episodes. The reporter was consented to follow up.
29OCT96 devel aching, fatigue, malaise & required bed rest through 31OCT;immed p/that devel severe lt hip pain;tx w/ pred temp relief;saw MD on 29JAN96 recv cortisone inj w/immed relief recurrent hip pain;sl tightness;
FLU; sick for whole week; Initial information received on 04-Dec-2020 regarding an unsolicited valid non-serious case received via social media from a consumer (patient).  This case involves patient who experienced sick for whole week (illness) with flu (influenza), after receiving vaccine INFLUENZA VACCINE.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Relevant medical history, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick for whole week (illness) with flu (influenza), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was influenza.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for both the events.  There would be no information available on batch number for this case.
Patient have Severe Covid-19. Admitted Yesterday with positive PCR Covid-19 test. On Mechanical Ventilation, in ICU with Severe Respiratory Distress, Coded 2 times yesterday.