chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received first dose of Moderna. More than half of the first dose leaked out due to faulty syringe. Nurse called over charge nurse to verify that more than half of the dose had not been administered to the patient. Charge nurse confirmed that second dose was approved after confirming with FD. Patient consented to 2nd dose. Patient informatoin was collected by charge nurse. Shift nurse proceeded to administer 2nd dose. Left arm was used to administer. Patient was in stable condition. Nurse explained after-care. Patient began to hyperventilate and said she felt like she was going to faint. Patient asked for water. Patient said she had a history of fainting and was going to faint. (CONTINUED BELOW)-
Face swelling (cheeks,, lips, eyes); Scratchy throat; Lips and face tingling; Heavy tongue.
Bleeding from stiches; Pressure behind eyes along stiches; Soreness in arm; A spontaneous report was received from a consumer who was a 63-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced post procedural hemorrhage, vaccination site pain, and ocular discomfort.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 16-FEB-2021 or 17-FEB-2021, prior to the onset of the symptoms, the patient received the second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the arm for prophylaxis of COVID-19 infection.   The patient had eye surgery 1 week before the 2nd dose of vaccine. She experienced pressure behind where stitches were done and a little bleeding from stitches. The patient also experienced soreness in her arm. Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable.  The outcomes of the events were unknown.; Reporter'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.
Patient fainted 10 minutes after the vaccinations. Patient was okay after a minutes of waiting.
The caller's arm was tender, very tender.; Arm was sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 15:15 (Lot number: ER8732) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "she had lost weight" (unspecified if ongoing), notes: she had lost weight before Covid set in and went back to the doctor and had gained weight back, caller states this occurred prior to the Pfizer Covid Vaccinations.; "Acute respiratory Viral Infection" (unspecified if ongoing), notes: caller had Acute respiratory Viral Infection. Caller clarifies this occurred prior to the Pfizer Covid Vaccinations. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 31Mar2021, outcome "recovered" (02Apr2021), described as "Arm was sore"; TENDERNESS (non-serious), outcome "unknown", described as "The caller's arm was tender, very tender.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: First dose: Arm was sore, the first dose of Pfizer Vaccine was given on a Wednesday, by the end of the same evening caller's arm was sore. Caller's arm was also sore the next day.  Caller states this was probably gone by that Friday, 02Apr2021. Caller recovered completely. Caller thought she had Covid and was tested twice and it was negative, caller had Acute respiratory Viral Infection.  Caller clarifies this occurred prior to the Pfizer Covid Vaccinations. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history including any illness at time of vaccination was not reported.  No follow-up attempts are possible. No further information is expected.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; CHILLS; GRADUALLY INCREASING FEVER; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: seasonal allergies, high blood pressure (controlled), high cholesterol (controlled), non alcohol user, and non smoker. The patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1820095 expiry: 02-OCT-2021) dose was not reported, 1 total administered to left arm on 11-AUG-2021 09:00AM for prophylactic vaccination. No concomitant medications were reported.  On 11-AUG-2021, 12 hours after vaccination at 09:00pm, the patient experienced a gradually increasing fever and at 10:00pm it was at 102.5 degrees Fahrenheit. The patient took Tylenol which did not work till 2:00 am but after that the temperature went down. The patient also experienced chills but had no headache or aches. On 01-OCT-2021. the patient had an antibody test (serology test) through his allergist and it was a SARS-CoV2 IgG (severe acute respiratory syndrome coronavirus 2 immunoglobulin G) Nucleocap and IgM (Immunoglobulin M) Spike QL. The results were ready in 24 hours and showed antibody IgG negative and antibody IgM negative (confirmed immunological vaccine failure). The patient was concerned that he may not be protected. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and gradually increasing fever on 12-AUG-2021, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with a Product Quality Complaint.; Sender's Comments: V0: 20211018382-COVID-19 VACCINE AD26.COV2.S-Confirmed Immunological Vaccine Failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Narrative:  Per chart note on 3/15/21: "Urgent care Progress note - Allergic reaction - Itching and throat swelling times 1 month. Pt received Covid vaccine on 1/19/21, on 01/20/21 started itching, had second shot on 02/16/21 and started swelling of throat on 02/17/21." Per chart note on 3/3/21: "PATIENT CALLED WITH REPORT OF TONGUE SWELLING OVER PAST 3 DAYS. STATES "IT WAS JUST A LITTLE BIT THAT WAS BARELY NOTICEABLE, BUT THIS MORNING IT IS MUCH WORSE". PATIENT ABLE TO SWALLOW WITHOUT DROOLING AT THIS TIME BUT SPEECH CHANGE. DUE TO REPORTED SYMPTOMS, RECOMMEND URGENT CARE/EMERGENCY DEPARTMENT EVALUATION. PATIENT STATES WILL GO STRAIGHT TO URGENT CARE NEAR HOME. RECOMMEND CALLING EMS IF SWELLING BECOMES WORSE AND UNABLE TO SWALLOW. LISTED NUMBER IS GOOD CONTACT."
Mild to in very small places moderate rash covering entire body from head to mid thigh. Most severe on left arm and chest and back; not treatment or improvement
This is a spontaneous report from a contactable physician. A patient of an unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administraiton, on 19May2014 at 0.5 ml, single. The patient medical history and concomitant medications were not reported. One day after having received PREVNAR 13, in May2014, the patient developed sepsis and purpura fulminans. The outcome of the reported events was unknown at the time of this report.
developed genital herpes lesions 3-4 days after vaccination with no other prior exposure or occurence of HSV-2
Extreme body aches and chills 6 hours after and still lasting more than 24 hours later
Moderna Vaccine on is 16/ Nurse states 2 doses were given to minors; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Vaccine on is 16/ Nurse states 2 doses were given to minors) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Vaccine on is 16/ Nurse states 2 doses were given to minors). On 13-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Vaccine on is 16/ Nurse states 2 doses were given to minors) had resolved.        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.   The patient is Scheduled for 2nd dose 10Jun2021.  No concomitant medication details were provided. No treatment medication details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Significant Follow up received. Initial Source document attached
he was miserable; flu like symptoms; his legs were restless; he did not sleep well; He had achy arm, really sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (he was miserable), INFLUENZA LIKE ILLNESS (flu like symptoms), RESTLESS LEGS SYNDROME (his legs were restless), POOR QUALITY SLEEP (he did not sleep well) and VACCINATION SITE PAIN (He had achy arm, really sore arm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A. and 040A21A) for COVID-19 vaccination.     The patient's past medical history included Renal transplant (36 years ago) since an unknown date.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced FEELING ABNORMAL (he was miserable), INFLUENZA LIKE ILLNESS (flu like symptoms), RESTLESS LEGS SYNDROME (his legs were restless), POOR QUALITY SLEEP (he did not sleep well) and VACCINATION SITE PAIN (He had achy arm, really sore arm). At the time of the report, FEELING ABNORMAL (he was miserable), INFLUENZA LIKE ILLNESS (flu like symptoms), RESTLESS LEGS SYNDROME (his legs were restless), POOR QUALITY SLEEP (he did not sleep well) and VACCINATION SITE PAIN (He had achy arm, really sore arm) outcome was unknown.            No concomitant medications were provided. No treatment information was provided.
Experienced hives and rashes all over body eight hours after the shot and lasted for the whole next day.; Experienced hives and rashes all over body eight hours after the shot and lasted for the whole next day.; This is a spontaneous report from a contactable healthcare professional (patient). A 19-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on the right arm on 31Dec2020 15:30 at a single dose for COVID-19 immunization at workplace clinic. The patient had no known allergies. The patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications included influenza vaccine (FLU) on 17Dec2020 at right arm, and  prednisone received within 2 weeks of vaccination. The patient experienced hives and rashes all over body on 31Dec2020 23:45, eight hours after the shot and lasted for the whole next day. Events were reported as non-serious. The patient received diphenhydramine (BENADRYL) as treatment. The outcome of the events was recovered. Patient was not tested for COVID post vaccination.
Patient stated that on 09/05/2021 at approximately 6:00 P.M. that he fainted, he then was dizzy and got the dry heaves. Then started to profusely sweat, applied cold compresses and in 15 to 20 minutes felt better. Later got up from sitting position and fainted again, recovered and was fine. Only treatment he used was cold compresses.
This case was reported by a nurse via call center representative and described the occurrence of tiredness in a 50-year-old female patient who received SHINGRIX (batch number L7F7E ?, expiry date 22nd November 2020). Concomitant products included NUVARING. On 16th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 mg. On 17th May 2018, 1 days after receiving SHINGRIX, the patient experienced tiredness, pain, headache and shivering. On 18th May 2018, the patient experienced injection site rash. The patient was treated with prednisone and BENADRYL. On an unknown date, the outcome of the tiredness, injection site rash, pain, headache and shivering were not recovered/not resolved. It was unknown if the reporter considered the tiredness, injection site rash, pain, headache and shivering to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The nurse reported that the patient's rash started at the injection site 2 days after vaccination, went up her arm to her neck and face, and over the opposite shoulder. The nurse reported that the patient was seen at the office on 18th May 2018 and was prescribed Prednisone and BENADRYL. The nurse reported that the patient was seen at the office on 18th May 2018 and was prescribed Prednisone and BENADRYL. The reporter lot number (L7F7E) does not match any GSK lot number and was updated to L7F7E ?.
severe left chest pain, shortness of breath, severe pain on deep breathing-perfusion CT scan showed multiple blood clots in the left lung
The night of my vaccine I got sharp intense rib pain in my left rib.  The pain was made worse by deep breathing. Uncomfortable friction then developed in that same rib cage. After a few weeks of not getting better, I went to the doctor, who then also heard the pleural friction rub. The doctor ordered X-rays and I am awaiting my results.
PATIENT FEELS BUMP, REDNESS, AND WARMTH AT INJECTION SITE REACTION AFTER ONE WEEK, AND IT FEELS SENSITIVE TOO.
This started about a week or so ago, which was 2 weeks after the vaccine.  He had a band of scaly skin that itches like crazy.  When you scratch it it flakes off.  He has been putting on lotion to moisturize it and antiitch medicine hydrocortisone on it, and it stops the itching for a while but then it comes back.   Still having the same symptoms and has an appointment with his dermatologist on 2/11/21.  He said that it feels like dead skin that you can take your fingernails and just peel it off.
C/O flushing , scratchy and dry throat , anxious        elevated BP : 157/114     elevated HR : 111  improved after approx. 10 minutes,    HR: 89    BP : 148/84 DECLINED taken to ER.
Right arm became very itch for 12 hours from 7pm until 7am then lessened somewhat.  Site of injection is warm, ,hard, covering an area of 5 inches by 5 inches.  This redness and itchiness developed 2 weeks after injection.  It continues at this writing.
This spontaneous report as received from a other health professional refers to a patients of unknown age. On an unknown date, the patients was vaccinated with VARIVAX (lot # reported as N001527, N001527, N012134)  for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT). On an unknown date, the patient experienced incorrect product storage and no adverse event.; Sender's Comments: US-009507513-1707USA011188:
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Mild, Systemic: Hyperventilation-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Medium, Additional Details: Patient received 4 vaccines at 4:33pm and after 2 minutes pt had experienced hyperventilation, numbness and tingling sensation on fingers and her mouth, and laid down for 5 minutes. Paramedic came, still hyperventilated so sent her to ER
BAD SYMPTOMS AFTER MODERNA COVID VACCINE; BLEED MORE ON INJECTION; FELT NAUSEATED BUT NEVER THREW UP; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (BAD SYMPTOMS AFTER MODERNA COVID VACCINE), VACCINATION SITE HAEMORRHAGE (BLEED MORE ON INJECTION) and NAUSEA (FELT NAUSEATED BUT NEVER THREW UP) in an adult female patient who received mRNA-1273 for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (BAD SYMPTOMS AFTER MODERNA COVID VACCINE), VACCINATION SITE HAEMORRHAGE (BLEED MORE ON INJECTION) and NAUSEA (FELT NAUSEATED BUT NEVER THREW UP). At the time of the report, VACCINATION COMPLICATION (BAD SYMPTOMS AFTER MODERNA COVID VACCINE) and NAUSEA (FELT NAUSEATED BUT NEVER THREW UP) had not resolved and VACCINATION SITE HAEMORRHAGE (BLEED MORE ON INJECTION) outcome was unknown.        The action taken with mRNA-1273) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant and treatment information was provided.  The reporter's causality for the events of felt nauseated but never threw up, bleed more on injection and  bad symptoms after moderna covid vaccine was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Temp with mild shivering entire night. Swelling and pain in (R) arm she had received flu and PNEUMOVAX.
1 of 2 pts who was immunized from same DTP lot; dx poss cellulitis (no cultures taken) afebrile; pt immunized 5FEB93; devel 4mm area of redness & induration, 3cm away from site; nodule present @ site;
Hospitalization: admitted 8/19/22; discharged 8/23/22 Presentation to the ED: s/p fall on 8/15/22  w/ right hip pain.  COVID19 + date: 8/22/22 Treatment: nonsurgical treatment of T11 vertebral body fracture and L1 compression fracture. Patient was asymptomatic for COVID19. Remdesivir was not administered.  Discharge to: SNF
exposed to a coworker that was COVID positive on the 29Dec2020 for 25 minutes while she was eating lunch in the lounge; This is a spontaneous report from a contactable nurse (patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Strength 0.3 ml, lot number: EJ1685, Expiry Date: Mar2021), via intramuscular in left deltoid on 18Dec2020 at 0.3 mL, first single dose for covid-19 immunization. Medical history reported as none. There were no concomitant medications. Caller is a registered nurse that received the COVID vaccine on 18Dec2020 and her next dose is supposed to be on 08Jan2021. She was exposed to a coworker that was COVID positive on the 29Dec2020 for 25 minutes while she was eating lunch in the lounge. Her work placed her in quarantine till 12Jan2021. She was not having any symptoms. She was asking if she can get her second dose on 08Jan2021. She had a swab test that was negative for COVID on 29Dec2020. Outcome of the event was unknown.
Pt states they felt eyelids hot and felt a heachache. Pt stayed for additional monitoring.  Pt denies any other c/o. Pt  aloc x 4. Resp. unlabored and even. Pt later states her eyelids feel normal and headache went away. Pt d/c home.
Developed L to bilateral facial numbness with tingling in hands 1 months post receiving vaccine, * s/p MVA vs bike 2 week post vaccine, surgery for proximal tib/fib fx - also received TD vaccine 2 weeks after (10/10).
Awaken from sleep with onset of severe pain in anterior thighs and difficulty moving legs.  After ambulating with difficulty for approx 30 minutes pain gradually subsided.  Experienced a lot of respiratory congestion in AM (clear mucous) which lasted for 3 weeks and resulting in absence from work for 2 days 4 days later.
headache; swollen arm a little lower in her forearm/swollen large lump that was hot, itchy, and sensitive above the crook of her elbow on her forearm; It got swollen and hot and itchy and was a large bump/swollen large lump that was hot, itchy, and sensitive above the crook of her elbow on her forearm; It is like a little bump, like a little hill./swollen large lump that was hot, itchy, and sensitive above the crook of her elbow on her forearm; She looked up lymph nodes and said that the 3 areas she is dealing with (behind the knees and underneath the elbow) all look like they are lymph nodes; her daughter was really sore; had pain in the back of her knees; This is a spontaneous report from a contactable consumer or other non hcp (mother). A 16-year-old female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via intramuscular on 06Mar2021 (at the age of 16-year-old) as dose 1, single for covid-19 immunisation. Medical history included hypersensitivity from an unknown date and unknown if ongoing allergies, food allergy from an unknown date and unknown if ongoing food allergies. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced headache, swollen arm a little lower in her forearm/swollen large lump that was hot, itchy, and sensitive above the crook of her elbow on her forearm, it is like a little bump, like a little hill, she looked up lymph nodes and said that the 3 areas she is dealing with (behind the knees and underneath the elbow) all look like they are lymph nodes, her daughter was really sore, had pain in the back of her knees. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
MY DAUGHTER STARTED WITH ARM PAIN PULSING ON VACCINE SITE A FEW HRS AFTER RECEIVING THE VACCINE. SHECONTINUED LIKE THAT FOR THE REAT OF THE DAY. ON SUNDAY HER ARM WAS STILL SORE AND ARM PAIN HAD RADIATED TO LEFT UNDERARM.  PULSING WAS STIILL PRESENT, BUT NOW IT WAS RADIATING TO LOWER ARM, TO THE ELBOW.  ON MONDAY SHE WAS STILL COMPLAING OF PAIN AND SHE WAS NOW FEELING A KIND OF VIBRATION ON HER ELBOW AREA. IT WAS CONTINIOUSLY, IT WOULDN'T STOP.  TUESDAY SHE WOKE UP WITH A STRONGER VIBRATION FEELING ON HER ARM, NOT JUST THE ELBOW AREA. BY THE EVENING HER ARM WAS HAVING A TIC/ UNCONTROLABLE SHAKING.  WEDNESDAY HER ARM WAS SHAKING UNCONTROLABLY AND NOW IT WAS VERY NOTICIBLE. THAT IS WHEN I TOOK HER TO THE ER.
Cellulitis R upper arm around site of vaccination. Fever 104 with rigor, elevated white count. Onset 1 day after vaccination. 11/25/09 Hospital recs received for dates 10/28/09 to 10/29/09. DX: intravascular volume depletion, RUE cellulitis. Presenting SX: dizziness, RU arm pain, chills, rigors, sweats, fever, redness at injection site, lightheaded, urinary output decreased. Assessment: (+)erythema/tenderness of RUE/shoulder.
This spontaneous report as received from a nurse refers to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unspecified dates since 01-AUG-2015, the patients were vaccinated with an unspecified number of improperly stored doses of VAQTA (lot number K007827 and expiration date 09-DEC-2016, lot number K005323 and expiration date 10-FEB-2017, lot number L007559 and expiration date 01-JUN-2017) (dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.