chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via call center representative and described the occurrence of alanine aminotransferase increased in a 54-year-old female patient who received TWINRIX adult. On an unknown date, the patient received the 2nd dose of TWINRIX adult. On an unknown date, an unknown time after receiving TWINRIX adult, the patient experienced alanine aminotransferase increased and aspartate aminotransferase increased. On an unknown date, the outcome of the alanine aminotransferase increased and aspartate aminotransferase increased were unknown. It was unknown if the reporter considered the alanine aminotransferase increased and aspartate aminotransferase increased to be related to TWINRIX adult. Additional details were received as follows: This case was received from other healthcare provider via click to chat. The reporter was asking, whether there were some abnormalities in liver enzymes in the clinical trials after receiving TWINRIX or acute hepatitis with the onset after vaccination. Further the reporter stated that, he had one patient who experienced an increase in alanine aminotransferase and aspartate aminotransferase after receiving the 2nd dose of TWINRIX adult. The reporter did not have batch number and expiry date of TWINRIX adult. The reporter's call was transferred to Medical Information System.
This initial spontaneous report was received on 18-SEP-2018 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 03-FEB-2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent of herpes zoster, also known as shingles, and other complications. On or about 30-NOV-2016, the patient was treated at a physician's office for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a direct and proximate result of these malfunctions, the patient 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.  The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
During 12 mon. well ck, mom states that after the last set of immunizations that child got "hives", red rash, not itchy,  all over approx. 2 hrs after shots. No other symptoms. Lasted about 24 hours
Patient fainted while waiting for 15 min required observation period, became alert a few seconds later, declined going to ER. Patient reported being  tired and dizzy a few hours after receiving 1st dose.
Case number PHEH2011US01730 is an initial spontaneous report received from a health care professional (nurse) on 15 Aug 2011. This report refers to an 11 year old female patient. She was vaccinated with MENVEO (batch number: M10058) intramuscularly on 12 Aug 2011. But, she was only vaccinated with only the Men CYW-135 liquid conjugate without reconstituting it with Men A lyophilized  powder content. No adverse event was reported following this drug administration error.
She had sudden onset of respiratory distress and chest pain/pressure.  She had been fine just right up to this point.  She had witnessed fall that resulted in laceration injury with blood loss.  It was noted by the coroner and law enforcement that her blood on the floor from the laceration had significant coagulation markedly sooner than normal from a blood loss event.  She collapsed/died.  Based on the findings of the coroner and law enforcement, it is surmised she had thromboembolic event that would have been caused by coagulopathy.  She had no history of such, nor in her family.  Such is surmised from the COVID vaccines.
Patient comes in today for neuropathic pain.  Patient is a new patient today.  He reports that on September 3rd he he received his 1st dose of the Pfizer COVID vaccination in his left deltoid.  The next day he had abnormal sensation in his right arm which developed into a flat rash from elbow to shoulder as well as a painful neuropathic type pain.  The rash quickly subsided but the pain spread into the midline of the neck.  Over the next week symptoms moved to the other arm legs and around the chest and back.  The pain is worse at night.  He presented to the ER where he was started initially on Percocet then on Lyrica for questionable herpes zoster though the rash has subsided and was never vesicular.  He discontinued the Lyrica on his own and never use the Percocet.  He continues to have symptoms though they are improving.  Upon further questioning she also reports some weakness as well as blurred vision during that time.  He never had a history of a vaccine reaction.  He has received multiple vaccine but has not received 1 since.  He does not routinely get the flu vaccine.  He has no significant neurological history in the family.
Red macular rash on upper chest, neck area (lacy looking), and left arm around vaccination site. Flushed cheek. No itchiness, or breathing difficulties. Chest clear. Throat not swollen. No swallowing difficulties. Stated she was nervous. P 148, BP 168/84/ SPaO2 98, R 16. Stated when she goes to doctor she gets high heart rate and BP and they have to wait awhile befor it returns to normal. After speaking with her it appears she had the same reaction after 1st vaccine. She did tell vaccinator but vaccine was still administered. She also stated she had a slight rash from the sun when she arrived. She complained of dry throat but on further questioning she stated she has that this time of year due to seasonal allergies. By 11:54 pulse down to 105, BP 140/82. Respirations 18. Rash still present but faded. Lungs remain clear. Discharged to home.
Numbness in mouth and throat; Numbness in mouth and throat; This is a spontaneous report from a contactable consumer (patient) reported for self. A 57-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: not available), via an unspecified route on an unspecified date in the left arm in Jul2021 at 15:00, as a single dose for covid-19 immunization. Medical history included hypothryroidism. Concomitant medications included levothyroxine sodium, clonazepam and st johns warts. No known allergies were reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On an unknown date in Jul2021 at 15:00, patient experienced numbness in mouth and throat. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. Patient did not receive any treatment for the events. The clinical outcome of the events was not recovered.  Information on the lot/ batch number has been requested.
Case number PHEH2016US032834, is an initial spontaneous report received from a pharmacist on 05 Dec 2016. This report refers to a male patient of unknown age. Medical history and concomitant medications were not reported. The patient was vaccinated with influenza vaccine INN (unknown whether seasonal or pandemic, manufacturer unknown, batch number: not reported) on an unknown date. The pharmacist stated that, the vaccine squirted on the husband of a female, sitting beside her and ran down her arm. No adverse event was reported following this administration error (inadvertent exposure to vaccine).
Fever 100.8 degree, increased to 101.2 degree; Felt exhausted; Brain fog; Bad cramps both of my legs that brought me to the floor; Face and cheeks flushed; Chill; got up mid night and was cold, I was freezing; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (got up mid night and was cold, I was freezing), PYREXIA (Fever 100.8 degree, increased to 101.2 degree), FATIGUE (Felt exhausted), FEELING ABNORMAL (Brain fog) and MUSCLE SPASMS (Bad cramps both of my legs that brought me to the floor) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma (asthma as a kid), Stroke (stroke two and half years ago), Rheumatic fever (rheumatic fever as 5 year old) and Diverticulosis. Concurrent medical conditions included Drug allergy (allergic to aspirin). Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for Anticoagulant therapy, POTASSIUM and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced NASOPHARYNGITIS (got up mid night and was cold, I was freezing) and CHILLS (Chill). On 09-Mar-2021, the patient experienced PYREXIA (Fever 100.8 degree, increased to 101.2 degree), FATIGUE (Felt exhausted), FEELING ABNORMAL (Brain fog), MUSCLE SPASMS (Bad cramps both of my legs that brought me to the floor) and FLUSHING (Face and cheeks flushed). At the time of the report, NASOPHARYNGITIS (got up mid night and was cold, I was freezing), PYREXIA (Fever 100.8 degree, increased to 101.2 degree), FATIGUE (Felt exhausted), FEELING ABNORMAL (Brain fog), MUSCLE SPASMS (Bad cramps both of my legs that brought me to the floor), FLUSHING (Face and cheeks flushed) and CHILLS (Chill) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Body temperature: 100.8 degree, increased to 101.2 degree (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication information is not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-039536 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-039536:DOSE 1
MUSCLE ACHES; EXTREME COLD FEELING; FEVER OF 100 F; CHILLS; BODY ACHES; NAUSEA; EXTREME FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's past medical history included prediabetic but become better with diet and exercise .menopause, and other pre-existing medical conditions included does the patient have any allergies? :: no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 180 8069 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced body aches. On 26-MAR-2021, the subject experienced nausea. On 26-MAR-2021, the subject experienced extreme fatigue. On 26-MAR-2021, the subject experienced headache. On 27-MAR-2021, the subject experienced chills. On 27-MAR-2021, the subject experienced fever of 100 f. Laboratory data included: Body temperature (NR: not provided) 100 F. On 27-MAR-2021 03:00, the subject experienced extreme cold feeling. On an unspecified date, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, muscle aches, and extreme fatigue on 28-MAR-2021, chills, nausea, headache, and fever of 100 f on 27-MAR-2021, and extreme cold feeling. This report was non-serious.
approx 24 hrs p/vax pt began to break out in rash on lower extremities & trunk; mom took pt to ER: MD gave hydrocortisone & steroidal medication;
Initial case received on 08 January 2010 from a healthcare professional. A 47 year old female received an injection (route and site not reported) of H1N1 (lot number UP112AA) on 08 January 2010. On the eve of the vaccination (08 January 2010), the patient experienced a sore arm all night. On 09 January 2010 the patient slept all day. She felt better on 10 January 2010. No further information was provided and no further information is expected. Documents held by sender: none.
My second Covid Vaccine was 2/4/2021 and then on 2/11/2021 I was diagnosed with Shingles. Also started with symptoms of Sciatica on 2/13/2021
Hive-like, itchy rash on back, chest, groin, and spots on leg and arm (not near injection site).  Allegra 180 mg 1/day has helped. No other treatment or symptoms.
Presented to ED w/SOB d/t unresolved COVID infection dx 1/4/2022; admitted for COVID-19 pna; tx w/abx, remdesivir, steroids, Vit-C, zinc, O2 therapy; discharged on O2 & to acute rehab d/t phsyical deconditioning
The pain in legs and muscles started in Dec2021 or Jan2022; The pain in legs and muscles started in Dec2021 or Jan2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 09Dec2021 as dose 3 (booster), single (Lot number: 33030BD) at the age of 61 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: high blood pressure diagnosed about twenty years ago; "Immunization" (unspecified if ongoing). Concomitant medication(s) included: RAMIPRIL oral taken for hypertension, taking for 20 years; METOPROLOL TARTRATE oral taken for hypertension, taking for 20 years; SHINGRIX taken for immunisation; FLU VACCINE VII. Vaccination history included: BNT162b2 (First dose Pfizer covid 19 vaccine: 17Apr2021, Lot: EW0162, Expiration: 31Jul2021, NDC: unknown), administration date: 17Apr2021, for COVID-19 immunization; BNT162b2 (Second dose Pfizer covid 19 vaccine: 22May2021, Lot: EW0177 (populated lot number), Expiration: 31Aug2021), administration date: 22May2021, for COVID-19 immunization, reaction(s): "mental brain fog"; BNT162b2 (Second dose Pfizer covid 19 vaccine: 22May2021, Lot: EW0177 (populated lot number), Expiration: 31Aug2021), administration date: 22May2022, for COVID-19 immunization, reaction(s): "having electric shock in the feet / sharp pain pain and very brief sensation", "cognitive disorder/disassociated disorder", "pain in the joints and muscles", "pain in the joints and muscles", "mental issues". The following information was reported: PAIN IN EXTREMITY (non-serious), MYALGIA (non-serious), outcome "not recovered" and all described as "The pain in legs and muscles started in Dec2021 or Jan2022". The events "the pain in legs and muscles started in dec2021 or jan2022" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, myalgia.   Additional information: The report was not related to a study or programme. The event was ongoing, he took a pain tablet a week ago and the pain tablet lasts a week, so his pain was not severe. He tried to avoid taking medication. No family medical history relevant to AE(s). He tested multiple times and haven't had covid.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200750480 similar report from same reporter
The First dose, left arm pain for 3 days.   Prior to 2nd dose, premed with tylenol and claritin.  2nd dose at 11 am.  I awaken at 5 am next day,  In my deep sleep,  I had a dream telling my self to wake up now. I was startled.   I woke up and found my left leg shivering, cold, grab blankets, and put on two layer of winter pajamas. I took a tylenol SR.   I felt zombie.  I felt scared that I may not see the morning.  The brain fog x 3 weeks, and then felt better.   April ( a month later) I started to have exacerbation of all my underlying ailments.  My carpal tunnel flare up so bad that I needed a steroid injection in wrist in May.  In Mid April, I was sitting watching TV and ACUTE ONSET of RIGHT EAR loud high pitch tinnitus and pounding tinnitus.  If I open my jaw, it made it less,.  TEN months later, I still have the tinnitus.  I stopped the  Losartan, and other Amlodipine meds.    I saw the Doctor.  hearing loss at high pitch levels.
Redness started 11-05-12 (ass ask pain) ab. 7 am (diameter ab 4 x 4 cm) (ab. 41 hrs after vacc) all symptoms resolved 11-08-12.
Immediate injection site reaction. Erythematous and swollen to 1-1.5 inches around injection site. Patient reports no other symptoms - no itching, no pain, no difficulty breathing. Patient was given 50 mg of oral diphenhydramine and an ice pack and observed for 30 minutes after vaccination.
headaches; A spontaneous report was received from a consumer, female patient who received Moderna's COVID-19 vaccine and experienced headaches.   Patient's medical history was not provided, and no concomitant medicines taken by the patient.   The patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  The patient experienced headaches and treatment include Ibuprofen.  Action taken with mRNA-1273 was not reported.  The outcome of the events, headaches is unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
I began to experience aches that evening. Fell asleep around 8:30 PM. Woke up throughout the night with aches all over my body. On the morning of 10/19/13 woke up to get ready for work but was very dizzy and hot. Fever was 101.9. Slept literally the entire day but for about 90 min total. Fever didn't break until morning of 10/20. Still very tired and headachy.
July15 2021 the patient had onset of generalized urticaria with profound pruritis which worsened over next several weeks.  No hx of prolonged or recurrent urticaria prior to this. No history of dermatitis. No fevers or chills. The urticaria had transient improvement with diphenhydramine and short course of oral steroids. He saw  two allergists over the next several months and was started on daily cetirizine with mild improvement and intermittent remission. He received his booster on January 4, 2022 and the urticaria has worsened.
Approximately 4 weeks post 2nd dose I began having severe pain to right upper arm with movement and palpation. The next day noted a large bruise and bleeding from injection site.
Moderna COVID-19 Vaccine EUA Difficulty breathing , coughing, dizziness and low grade fever 100. I have asthma, took albuterol inhaler, benedryl and tylenol.
Patient reports: Had pneumonia vaccine and flu vaccine yesterday in office; no documentation of Pneumonia vaccine given yesterday); States both were given in LD; Had a large red circle around the area of injection after she got home; Swollen like an egg, itchy; Today swollen down the elbow; Hot to touch, painful; More redness and has spread around the arm; Used ice packs on it all night; A lot of muscle aching in the arm last night, could barely sleep; Has the chills today; Very nauseated today;  Is currently on amoxicillin for sinus infection; Too nauseated to take her ABX today; Thinks she is having a reaction to the vaccines.
The Dtap was on 10/13/22. Same arm. Left delt IM. Pain originates in shoulder and goes all the way down left arm to hand. Sometimes numbness. Cannot have comfort even when non weight bearing. Wakes me up at night. Sometimes when I move it I get a huge sharp wave of pain that takes minutes to subside to bear tolerance again. I have to watch my ROM movements  Putting on clothing hurts. Day to day activities are painful.
Shoulder Pain,  Shoulder Blade Pain, Neck Pain, Trapezoid Pain ....all lefts side. .After two weeks tingling sensations in the left arm and hand, muscle spasms in left arm and left shoulder blade.  Sensations were moderately severe and lessened when raising the left arm above the head.  After x-rays, and MRI, cortisone injection to left shoulder in March 2022....symptoms subsided substantially.
Pruritus, hives within 5 minutes of vaccination. Given Benadryl 50 mg IM, Symptoms resolved within 30 minutes.
Pt recvd 3 doses of Engerix-B 1NOV90, 4DEC90 & 6MAY91 & 4SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
C/o itching immediately following vaccine admin.  Benadryl 50mg x 1 po admin per S.O.
no known adverse events. patient was given a pfizer covid vaccine after she had already completed the series for moderna
Pt recv vax on 3/12/98; on 3/24/98 pt exp abscess on vax site
Received Flu shot 10-8-12. On 10-11-12 developed fine red rash on neck & arms with pruritis. Sts had similar reaction 2 years ago & Tx with antibiotics & BENADRYL. VAERS form completed 2 yrs ago. Sts. her personal MD would not sign exemption form.
Lost feeling in my hands  huge knot on my arm at point of injection for over 2 weeks. I was dizzy lightheaded and nauseous feeling.  Chest  tightness
After administration, patient bled down her arm.  The bandage was replaced and pressure applied.  The following day the patient reported warmth, redness and bruising and went to the Emergency Department.
Noted to have difficulty swallowing approximately 1-2 minutes after injection. Palpitations noted as well as being shaky. This lasted about 1-2 hours after. Difficulty swallowing did not worsen.  Became light headed for about 1/2 hr after above symptoms subsided. Then all symptoms disappeared. Towards evening soreness in right arm started... throughout night soreness increased to the point of alternating Tylenol and naproxen. Soreness continue to increase throughout 2nd day... 3rd day soreness lessened and today(day4) almost nonexistent
17 year old received dose of vaccine; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received dose of vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received dose of vaccine). On 16-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received dose of vaccine) had 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: This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: 001B21A) with no associated AEs.
High fever, severe body aches, joint pain, chills, headache and nausea.
PATIENT STATED TO DEVELOPING EXTENSIVE RASH THROUGHOUT ENTIRE BODY WHICH STARTED SAME DAY SHE RECEIVED HER INFLUENZA VACCINE ON 10/23/2020.  SHE HAS BEEN UNABLE TO GET EVALUATED BY HER PRIMARY CARE DOCTOR, HOWEVER, SHE IS SELF-TREATING WITH OTC BENADYL AND HYDROCORTISONE.   PATIENT DENIES ANY SWELLING OF THE LIPS, TONGUE, THROAT, SHORTNESS OF BREATH, PROBLEMS BREATHING.  HER DOCTOR IS UNABLE TO SEE HER UNTIL 11/17/2020.
Vertigo began  the morning of March 12th, 2021. Increased throughout the day and subsided. Still cannot look above my head without have vertigo effects. Increased tinnitus beginning March 12th. It has increased and is now at a point where it does not subside.