chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 89 y.o. female patient of, MD with a history of chronic respiratory failure admitted for COVID-19 infection with acute on chronic respiratory failure patient was treated with IV remdesivir and steroids patient's condition improved patient was too weak to return back to her assisted living facility hence patient was discharged to facility for physical therapy.   Discharge Diagnoses: * COVID-19 virus infection Assessment & Plan Patient has constitutional symptoms and requiring more oxygen than usual   Chest x-ray no pneumonia   Inflammatory markers improving   ID consult appreciated patient is on antiviral medication now   Acute on chronic respiratory failure with hypoxia   Assessment & Plan Due to COVID-19 infection and underlying emphysema   Elevated troponin Assessment & Plan Probably type II MI patient has no chest pain.  Delta troponin negative   Panlobular emphysema   Assessment & Plan .   Hypokalemia Assessment & Plan Potassium replacement ordered   Insomnia Assessment & Plan .   History of pulmonary embolism Assessment & Plan On long-term anticoagulation
3?x4? irregular red rash at injection site on dat 14. No treatment was necessary.
Patient did not have adverse event, but we are reporting that patient received the pediatric dose vs the adult dose.  We have communicated with the manufacturer, per their guidelines according to the CDC, we are to revaccinate with the correct dose and continue with the series where patient left off.  We were told to not count the subdosing injection as part of their series.
Information has been received from a registered nurse (RN) concerning a 16 week old patient who was vaccinated with the first dose of Rotateq (human bovine). Unspecified medical attention was sought and no symptoms were noted. Additional information has been requested.
Patient experienced syncope several minutes after immunization administration along with their twin brother. They were given water and advised to sit/lay down on floor while they were monitored. After approximately 15 minutes they felt well enough to leave and did so in the company of their guardian.
SKIN IS EXTREMELY ITCHY; SORE ARM; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 02-APR-2021 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced skin is extremely itchy. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: loratadine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from skin is extremely itchy, and the outcome of sore arm, chills and headache was not reported. This report was non-serious.
This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (shingles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) 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 relevant concomitant medications were reported. Treatment details included Not provided.
Have found like electricity in my ears; I am hearing like an electricity all the time in my ears; I am hearing like a 'zoom', like an electricity; tiredness; her muscles in all of her neck and all parts of her neck and shoulder are hurting; sound of electricity inside her ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18May2021 11:00 (Lot number: EW0176) as dose 2, single and administered in arm left, administration date 27Apr2021 (Lot number: EW0176) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ELECTRIC SHOCK SENSATION (non-serious) with onset 2021, outcome "not recovered", described as "Have found like electricity in my ears; I am hearing like an electricity all the time in my ears"; HYPERACUSIS (non-serious) with onset 2021, outcome "unknown", described as "I am hearing like a 'zoom', like an electricity"; FATIGUE (non-serious) with onset 2021, outcome "recovering", described as "tiredness"; MYALGIA (non-serious) with onset 2021, outcome "not recovered", described as "her muscles in all of her neck and all parts of her neck and shoulder are hurting"; TINNITUS (non-serious) with onset 2021, outcome "not recovered", described as "sound of electricity inside her ear".  Additional information: She says after the first vaccine she got a zoom in her ear, like the sound of electricity. She says it started two days after the vaccine but she is not sure the date or the time of onset. She says she went to the doctor because she had her shot in 3 weeks from the second shot. She said they made a sound test and told her ears are fine. She says she told them she is still hearing this; it wasn't that strong that strong like now. She says they sent her home, she was seen by a nurse practitioner because it was for an emergency. She says the doctor didn't see her. She says she decided to go get the second shot because it was about to pass.  No follow-up attempts are possible. No further information is expected.
Information has been received from a mother concerning her 20 year old daughter with a history of allergic reaction to antibiotics (unspecified) who on 30-APR-2007, at 3:00 p.m.  was vaccinated intramuscularly with Gardasil (Lot number 656051/0244U). There was no concomitant medication. On 30-APR-2007, after one half hour after receiving the vaccine, the patient experienced an unbalanced feeling "panic attack", pressure on her chest and difficulty breathing. The mother also mentioned that her 2 other daughters experienced the same reactions with two doses of the vaccine but not as severe. The physician reported that the symptoms were not reported to him until 29-MAY-2007 when he called the patient "to find out." No further details were provided. Additional information has been requested.
Complaint of pain in left arm approximately one week ago in ability to hold anything in left arm.  Seen by the doctor, states patient was immunized in the tendon causing inflammation, prescribed prednisone and Advil.
Patients parent gave the wrong date of birth to Pharmacy before the 5-11yr covid vaccine was approved, meaning, patient received a 12+ YR Covid vaccine at 11year4months. Then PT came to us to receive the "booster" where we gave her the correct dose (the 5-11yr). Mom wanted us to write her a new card with patients correct D.O.B. with the vaccine info we were giving and she would "write in the old info from Pharmacy." I informed her we couldn't do that or add onto the card she received from Pharmacy because that doesn't have the correct DOB on it.
This spontaneous report was received from a physician assistant and refers to a 47 year old patient of unknown gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 06-DEC-2017, the patient was vaccinated with PROQUAD, therapy type rHA, lot # M044575, expiration date 04-MAY-2018, for prophylaxis (dose and route of administration were not provided). Concomitant therapies included sterile diluent. The administered dose of PROQUAD was stored in the refrigerator from 18-OCT-2017, in temperature of 38 degrees Fahrenheit for 1176 hours (49 days). The call was because of digital data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1712USA009167.
This case was reported by a consumer via call center representative and described the occurrence of redness in a 64-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included Atorvastatin, Magnesium, Vitamin C, vitamin D, SYNTHROID, hydrochlorothiazide + valsartan and fish oil. On 4th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 4th June 2018, less than a day after receiving SHINGRIX, the patient experienced redness, pain, swelling, tenderness and itching. On an unknown date, the outcome of the redness, pain, swelling, tenderness and itching were not recovered/not resolved. It was unknown if the reporter considered the redness, pain, swelling, tenderness and itching to be related to SHINGRIX. Additional details were provided as follows: The patient reported that she followed up with her physician.
8 hours  after vaccination opposite arm of injection, shooting pain in elbow when I move my arm. 13 hours later still having problems.
patient states that had a pain from neck that went down her back that started a few minutes after receiving  the flu shot, stated that it was an intense tingling sensation. Patient states that this resolved within a few minutes and did not require any additional care
has a little round, pink circle roughly 3 inches in diameter; a little swollen; warm to the touch; had a little discomfort in her arm; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced limb discomfort (had a little discomfort in her arm), vaccination site erythema (a little, round, pink circle, roughly 3 inches in diameter), vaccination site swelling (a little swollen) and vaccination site warmth ( warm to the touch).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 001A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient experienced a little, round, pink circle, roughly 3 inches in diameter and that was little swollen and was warm to the touch. On 24 Feb 2021, the patient also stated experiencing a little discomfort in her arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
pt recvd vax & 12hrs p/vax exp itching & some red spots on trunk;sx lasted 24hrs & resolved;
This case was reported by a consumer via call center representative and described the occurrence of sore throat in a 55-year-old female patient who received FLULAVAL TETRA (batch number K5T45, expiry date 20th May 2018). Concomitant products included doxycycline, RESTASIS, vitamin D, ATIVAN and fish oil. On 21st September 2017, the patient received the 1st dose of FLULAVAL TETRA. On 22nd September 2017, 1 days after receiving FLULAVAL TETRA, the patient experienced sore throat. On 23rd September 2017, the patient experienced pain, runny nose, fatigue, cough and nasal congestion. The patient was treated with ALLEGRA. On an unknown date, the outcome of the sore throat, pain, fatigue, cough and nasal congestion were not recovered/not resolved and the outcome of the runny nose was unknown. The reporter considered the sore throat, pain, runny nose, fatigue, cough and nasal congestion to be possibly related to FLULAVAL TETRA. Additional details were provided as follows: The patient received FLULAVAL QUADRIVALENT on the left arm, on Thursday. On Friday, the patient began to experience events that worsened on Saturday and new events occurred on Sunday. Two days after receiving FLULAVAL QUADRIVALENT, the patient experienced aches, runny nose, fatigue, cough and nasal congestion. The patient contacted health department to inquire about relationship of events to Flu vaccine and was told not related. The patient called on reporting date seeking information about stated events and possible relationship to FLULAVAL. The patient was taking over the counter ALLEGRA for symptoms, but had not contacted her physician. The patient was encouraged to notify physician of current events. The patient noted this was a clinic being held by Health department in her town. The patient declined the healthcare professional information at this time. The patient would be seeing new healthcare professional on Wednesday. The patient was open to receive authorization form from the Safety.
Sore and painful left arm & stiffness began that AM upon awaking then pain & stiff increased to shoulder then to right arm causing difficulty straighten arms & reaching out without severe pain.
Patient presented to pharmacy and requested influenza vaccine, but was given covid-19 vaccine in error. Patient realized mistake prior to leaving pharmacy. Was not previously vaccinated with any covid-19 vaccine. Was understanding and requested pharmacy staff still administer the intended influenza vaccine.
injection site reaction Narrative:  Initially stiffness and tingling in the right arm for 24 hours, also developed redness and swelling at the stie 11 days after the injection
pt recv vax 2.5ml instead of 1ml & pt exp a sl burning localized @ the inj site, but no side effects were noted;it was also reported that pt will cont w/the hep b series;
his arm has been very sore and almost dead; throbbing and in pain; he thinks he got nerve damage; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administration date 01May2021 (Lot number: PBl211) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma; "High Blood Pressure" (unspecified if ongoing), notes: High Blood Pressure. Concomitant medication(s) included: LOSARTAN taken for hypertension; HYDROCHLOROTHIAZIDE taken for hypertension. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "his arm has been very sore and almost dead"; PAIN (non-serious), outcome "not recovered", described as "throbbing and in pain"; NERVE INJURY (non-serious), outcome "unknown", described as "he thinks he got nerve damage". Therapeutic measures were taken as a result of pain in extremity, pain, nerve injury.  Additional information: Therapeutic measures were taken. Patient had iced the arm, taken warm showers and taken Advil and Tylenol around the clock and it still hurts. He started Aleve, he thinks it was a bad shot. Patient was taking medicines for high blood pressure. He had vaccine last Saturday and his arm was still hurted. He had been taking Tylenol everything round the clock and he was in pain and his arm was almost dead. He had done laboratory tests about a month ago and that were fine.  No follow-up attempts are possible. No further information is expected.
pt recv vax & 45 mins later pt devel anaphylaxis which involved bilateral wheezing, w/rhonchi, tightness in chest, flushing dec BP, inc pulse rate, w/clammy pale skin, lips appeared blue;
Mother reports child woke up with leg red and painful, thought was normal but didn't go away so came to clinic today to get checked.  Assessment was 3x2 inch area with induration and smaller pea size (3-4) add'l indurations on lt thigh. Redness noted but not complete solid red. Not hot to touch, no blistering.  Denies itching.  Adv to use cold packs, ibuprofen, and Benadryl OTC x2 days. If no improvement or worsens to seek medical care with PCP.
nausea with vomiting 72 hours later; nausea with vomiting 72 hours later; Fever, chills for 12-24 hours.; chills for 12-24 hours; Recurring diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8734) via an unspecified route of administration in the left arm on 13Apr2021 at 13:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included prenatal vitamins (unspecified) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep7634) via an unspecified route of administration in the left arm on 23Mar2021 at 13:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. On 13Apr2021 at 23:45, the patient experienced fever, chills for 12-24 hours and recurring diarrhea. On 16Apr2021, 72 hours later the patient experienced nausea with vomiting. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever and chills was recovered on 14Apr2021, while the clinical outcome of the event recurring diarrhea, nausea with vomiting was not resolved at the time of this report.    No follow-up attempts are possible. No further information is expected.
pain right arm pain spread to arms, hand s feet later to fingers  burning on right wrist area
This case was reported by a healthcare professional and described the occurrence of arm tingling in a 48-year-old female subject who was vaccinated with TWINRIX, (GlaxoSmithKline).  On 7 November 2008, the subject received unspecified dose of TWINRIX (1 ml, unknown, left arm).  On 7 November 2008, immediately after vaccination with TWINRIX, the subject experienced arm tingling, jaw numbness, arm numbness, facial flushing and pharmaceutical product complaint.  The healthcare professional reported that a female subject received a TWINRIX vaccination on the morning of 07 November 2008 and developed immediate symptoms of tingling, numbness of her left jaw, and facial flushing.  The emergency medical service (EMS) was called and the subject was transported to the hospital.  The healthcare professional was concerned over a called and the subject was transported to the hospital.  The healthcare professional was concerned over a potential quality issue with vaccine.  At the time of reporting the outcome of the events were unspecified.  The healthcare professional considered the events were probably related to vaccination with TWINRIX.  TWINRIX lot number was reported as "AHAVB140AA".  The healthcare professional reported another subject see case A0757114A.
Severe extremity pain around rib cage received post, TYLENOL and eventually hydrocortisone and LYRICA. Also VALIUM and TYLENOL before cortisone LYRICA (not together). I paid over $400.00 for 1st and (around $200 for this second vaccine which had adverse reaction and suffered so much pain, weakness - loss of appetite therefore I believe vaccine company should reimburse me for these constant pain was suffering.
diarrhea with loose stools and abdomenal discomfort after eating beginning on the day of vaccination
injection was administered to close to a previous given vaccination and also was  given  to low from deltoid area on left arm.
Cried for a few hours.  Lethargic and would not wake up to eat throughout the night. Still somewhat lethargic on 3/12/2010
PATIENT STATES IS HAVING  DIFFICULTY SWALLOWING ON HIS OWN . PATIENT APPEARS IN  NO APPARENT DISTRESS BUT SEEMS ANXIOUS. PATIENT GIVEN WATER AND DRANK WATER WITH NO DIFFICULTY.  HEART RATE 80 AND REGULAR. PATIENT MONITORED ADDITIONAL 15 MINS AND STATES STILL HAS SYMPTOMS BUT ARE LESS INTENSE . PATIENT APPEARS TO HAVE NO APPARENT DISTRESS AND DOES NOT APPEAR AS ANXIOUS. PATIENT REFUSES ANYMORE MONITORING AND LEFT. PATIENT WAS INSTRUCTED THAT IF SYMPTOMS PERSISTED OR GOT WORSE TO FOLLOW-UP WITH EMERGENCY DEPARTMENT.
47-year-old patient (not immunocompromised) received Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 47-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 11-APR-2022  Reporter's Comments: The pharmacist reported that a 47 year old patient (not immunocompromised) received one dose of Shingrix, which led to inappropriate age at vaccine administration. The pharmacist did not want to stay to answer safety related questions but agreed to follow-up via email.
I tested positive for COVID-19 on December 25, 2022 I experienced congestion, fatigue, a cough, a sore throat.
Extreme migraine for 5 days Arm pain, tingling, spasms for 5 days Chills, sweating Flu like systems Lighting like shocks
Swelling in left arm up to 5 inches below vaccination site. Arm is very itchy and hot to touch. We will refer patient to doctor to follow up with treatment and outcome.
mild numbness and tingling in fingers of lt arm, resolved after 24 hours. Suspect
I went into work and very quickly started to not be able to breathe properly. I had shortness of breath and felt like I wasn't getting enough oxygen.  Nonproductive cough. No fever, wheezing, or fatigue. Nebulizer and oral steroids prescribed. I started to feel better after several days of the treatment and was then able to go back to work.
Vaccine that administered beyond use date after the thaw process; Third dose received 0.25 instead of 0.5; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) and UNDERDOSE (Third dose received 0.25 instead of 0.5) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown if the patient had ever been diagnosed or tested positive for COVID-19. It was reported, acute illness at the time of vaccination and up to one month before and chronic or long-standing health conditions were unknown.     On 28-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) and UNDERDOSE (Third dose received 0.25 instead of 0.5). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) and UNDERDOSE (Third dose received 0.25 instead of 0.5) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 42 year 4 months.   No concomitant medications were reported  Patient reported no adverse reactions after the administration of vaccine. Vaccine Ndc code was reported as 80777-0273-99.  No treatment medications were reported.
headache, sinus congestion, nasal congestion, post nasal drainage, starting 12/10/21