chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Janssen COVID-19 Vaccine EUA - Persistent cold sores with swollen neck glands, treated with Docosanol 10% cream with limited effect. Condition is on-going.
patient (staff member) received their vaccine at approximately 0817, they returned to the clinic at 1000 stating they were starting to feel tingling in their fingertips, metallic taste in the mouth, and trouble breathing. Vitals were taken and found to be within normal limits as described by patient. At 1002, 50mg PO Diphenhydramine  was given orange juice. Patient asked if they could lay down to see if that would help her to catch her breath. She went to the bed and practiced her breathing exercises while waiting for the ambulance to come and take her to the emergency room. Ambulance arrived and care was transferred.
This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. A 10-year-old female patient received on 07Oct2015 TRUMENBA at single dose. Concomitant medications and medical history were not reported. On an unspecified date, in Oct2015, the patient experienced pain at the injection site. Clinical outcome was unknown at time of this report.
got the flu every time after shots; Initial information received on 12-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves patient (unknown demographics) got the flu every time when received vaccine INFLUENZA VACCINE.  The patient's past vaccination included Influenza vaccine with reaction of influenza.  The patient's medical history, past medical treatment, concomitant medication 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 not reported) via an unknown route at an unknown administration site prophylactic vaccination.  On an unknown date, the patient got the flu every time (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for influenza.  There will be no information available on the batch number for this case.
Pt. admitted on 11/29 with generalized weakness. 11/27 Pt. noted to not be able to bear weight on R. leg. Then pt. unable to sit or stand unassisted. He didn't want to talk and voice soft when he did. 11/28 Appetite diminished, would choke on couple of sips. Did not want to raise arms above his head.
Palpitations Narrative:  Began to experience tachycardia on 1/17/21. Seen in urgent care 1/22, transpo by ambulance to MC admin 1 dose adenosine for SVT, went back to sinus rhythm. Also takes wellbutrin, otc allergy med both none to be associated to svt. No known h/o svt
Information has been received from a Registered Nurse (R.N.) concerning an "approximately 20 year old" female patient who was vaccinated with a dose of Gardasil. The patient fainted after receiving the Gardasil. The patient recovered. The nurse reported that two other patient experienced fainting after receiving the dose of Gardasil. Additional information has been requested.
7 Days after the shot I woke up with a quarter size red bump at the injection site it was very itchy but not warm to touch. Treated topically with Benadryl spray for hours later extremely itchy treated topically with Cortizone cream red and area has increased in size to about 6? x 4?
Drug ineffective; We both came down with Covid; 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 78-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 15May2023, outcome "unknown", described as "Drug ineffective "; SUSPECTED COVID-19 (medically significant) with onset 15May2023, outcome "unknown", described as "We both came down with Covid". Clinical course: Patient's husband and patient have had all our vaccines and boosters except the last one out now. They both came down with Covid, 15May2023. It was mild-4 days and no worse the a cold or bad allergies. Patient asked when should they take this last booster available now.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300220253 same patient/product, different dose/event;
Inadvertently the dose was give with no dilution of the product.  The only adverse event thus far known is a sore arm.
Severe swelling of right deltoid with heat and redness. Mild to moderate discomfort. BENADRYL, TYLENOL and cool packs advised.
Ischemic Stroke occurred  on December 8, 2021 at 8:25am and was transferred to local hospital where he received emergency surgery for carotid angioplasty. Patient is still in the hospital receiving treatment and has not yet been released.
When 2nd dose was injected, felt slight pain, unlike first dose which was totally painless. 2nd dose was injected much lower than first dose, mid arm and  missed Deltoid muscle.  Day after 2nd dose, site of vaccination was reddish, swollen. Measured area to be approximately 3" up and down, 3" side to side. 5 days now after 2nd dose and still slightly red, measures 3" up and down and between 4-5" side to side. Also notice below skin within reddish area there is a hardness..not entire area, but partial. No pain, and so far, has not effected mobility. Definitely feel pharmacist injected vaccine improperly causing this sympton and worried about future problems and also that vaccine will not be as effective
tested positive for COVID; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (tested positive for COVID) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for COVID). At the time of the report, COVID-19 (tested positive for COVID) outcome was unknown. Not applicable    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive Positive.     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 concomitant and treatment information were reported by the reporter
Case number PHEH2013US009035 is an initial spontaneous report received from a consumer on 14 Feb 2013: This case refers to a 66-year-old male patient. His concurrent conditions included of hemorrhoids, high blood pressure, high cholesterol, and colonoscopy every three years. He was vaccinated with influenza vaccine (manufacturer and batch number: not reported, hence conservatively taken as pandemic or seasonal INN) on an unspecified date and experienced an allergic reaction. The seriousness, outcome and causality were not reported. No other information was available.
HEARING LOSS IN LEFT EAR; PAIN IN LEFT EAR; PRESSURE IN LEFT EAR; WETNESS IN THE LEFT EAR; DISRUPTING SLEEP; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included: anaphylaxis, and concurrent conditions included: allergies undefined, non smoker, and non alcoholic. The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A expiry: UNKNOWN) dose was not reported, 1 total, administered at left arm on 09-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-NOV-2021 within 15 minutes of vaccination, the patient experienced pressure in her left ear like it needed to pop as if she was in an elevator and had pressure which got worse with time. On 09-NOV-2021 (last night), the patient went to the emergency room, they examined and told there was wetness in her left ear and recommended to make an appointment with an eye, ear, throat specialist. The patient reported ringing in her ear along with a muffling sound where the patient cannot hear clearly. She reported sound was muffled and ringing was disrupting her sleep.     The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hearing loss in left ear, pain in left ear, pressure in left ear, and the outcome of wetness in the left ear and disrupting sleep was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211125661-COVID-19 VACCINE AD26.COV2.S-hearing loss in left ear. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
arm soreness; Second dose 2 weeks after the first one; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 2 weeks after the first one) and PAIN IN EXTREMITY (arm soreness) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 2 weeks after the first one). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness). On 23-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 2 weeks after the first one) had resolved. At the time of the report, PAIN IN EXTREMITY (arm soreness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Follow-up information received captured patient demographics, suspect drug information and event. On 15-Apr-2021: Follow-up information received captured no new information.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot # 013M20A for second dose) with no associated AEs reported.
Dose given was not diluted.  Was given 20 mcg instead of 10 mcg
Information has been received from a woman in a doctor's office concerning a 66 year old female with no known allergies who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot # 636846/0801L). The patient developed swelling in her hand. The area was described as red and has a burning sensation. The swelling lasted for about 48 hours. After the swelling subsided the patient stated area is itchy/tingly with red dots. There were no other details available. The patient sought unspecified medical attention. Additional information has been requested.
Tinnitus, beginning March 16 2021 Constant ringing in my ears--still continuing high pitched--never ceases, wakes me up sometimes
Patient experienced an itching sensation approximately 10 minutes after vaccine administration. Was treated with 25 mg of PO diphenhydramine and itching subsided.
Reports a bump the size of marble between eyebrows with pain to touch that appeared the next day after receiving the vaccine.  Patient had fever and tiredness the following day.  On 08/19/2021 patient reports body aches.
pt recvd vax & following 2nd inject pt had allergic react to alcohol & p/ingesting alcohol developed hives that lasted 3 days; pt was seen by MD;
Subsequent to receiving one dose of rubella virus vaccine live (second generation), the pt sought medical attention and was found to have an undetectable antibody level. Additional information has been requested.
Throbbing, tender, sharp pain persisted after initial 2 days she expected; aggravated by up and across chest, felt in shoulder joint. Throbs lying on Rt side as can't lie on left. No redness, swelling, numbness, tingling.
Patient experienced throat swelling, shortness of breath, and a rash on his throat. The PA administered epinephrine. The patient went to the Emergency room. The Emergency Room administered diphenhydramine, SOLUMEDROL, ranitidine, and albuterol. The patient's breathing improved and the rash disappeared. The patient was discharged home.
Diagnosis of peripheral neuropathy  Being treated with Gabapentin since February 2022 Condition improving
A week or 2 after the 2nd shot  experienced sporadic heart palpitations.; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 08Apr2021 at 16:00(at the age of 63-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Apr2021, a week or two after the second shot the patient experienced sporadic heart palpitations. They have since diminished. The  primary care doctor ran tests on the patient. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. The clinical outcome of the even sporadic heart palpitations was recovering.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Flu like symptoms; Pain in injection site; This is a spontaneous report from a contactable 50-year-old male consumer (Patient). A 50 year old female patient had received bnt162b2 (PFIZER COVID-19 VACCINE, Batch/lot number:En6203, Solution for injection) via an unspecified route of administration on 10Mar2021; 01:15 AM in left arm as DOSE 2, SINGLE for covid-19 immunization(age at the time of vaccination 50 year) at Pfizer. The patient medical history had included High Blood Pressure and Cancer. The patient's concomitant medications included Methotrexate sodium within 2 weeks of vaccination. The patient previously took BNT162B2 (PFIZER COVID-19 VACCINE, Batch/lot number:EL3247, Solution for injection) into left arm at 01:00 AM,as Dose1, Single for covid-19 immunization. It was reported that patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. It was also reported that since the vaccination the patient had not been tested for COVID-19. On 11Mar2021 at 08:15 AM the patient had experienced Flu like symptoms, pain in injection site without fever. The patient had not received any treatment. The clinical outcome of the events were not recovered.  No follow-up attempts are needed. No further information is expected.
Approx 1 1/2 - 2 m after vaccine - pt became shaky and sweaty, dizzy. Pt vs checked and placed in supine position. These symptoms began to worsen and Dr to assess pt. 911 called. Pt blood glucose 93. Pt then c/o difficulty breathing. HOB up and 10L 02 mask placed on pt and then EMS arrived - IV and BENADRYL given by EMS and transported to hospital.
I have completed at 10 k and marathon races for many years and always monitor my BP and pulse at least 2 times a week. My normal pulse rate at rest for 15 minutes around 6pm was 58 to 62.  Now my lowest pulse rate measured a week or so after the 2nd shot is 88 to 92. 36 hours after the 1st shot my heart had severe pain especially on deep breaths. After 7 days the pain subsided. Now even with lite training  jogs of up too 7k I am tired and really Now it is walk jog.  Not so before the 2 shots  I received the shots in a specific country where I am retired
Loose stools started 24 hrs after vaccines. Vomited for 1 day - started 24 hrs. No fever.
Fever (102.5) chills, joint pain.  Treatable with acetaminophen
A serious spontaneous report of erythema multiforme has been received from a physician concerning a 42-month-old male, subsequent to FLUMIST. The patient had no medical history and was not taking any concomitant medications. He has not received any vaccinations since his 18 month visit and has not experienced any reactions after other previous vaccinations. The patient received his first dose of FLUMIST on 22-Oct-2009. On 25-Oct-2009, the patient experienced a fever of 101.3 degrees Fahrenheit and erythema multiforme which covered his entire body. He was treated with cetirizine. During a follow-up visit on 30-Oct-2009, his throat was noted to be "a little red but not sore." The patient did not experience any other symptoms. On 30-Oct-2009, the events were considered resolved. The reporter was not sure if the event was caused by FLUMIST or coincidental and caused by another virus. The sponsor considered the event medically important and conservatively assessed it as related to FLUMIST.
Two days after the vaccine I was very sick with similar symptoms as Covid - muscle aches, etc., for 3 weeks.  After that I was fatigued and brain fog with anxiety, headache, trouble sleeping, weakness in my legs, dry eyes, cannot tolerate heat anymore, possible hair loss.  I was presumed to have Covid (false negative) in January 2022.  I still have the original symptoms.  But now I also have joint pain.  My brain fog is horrible.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a patient (pt) of unknown age and gender. The pt's medical history, concurrent conditions and concomitant medication were not provided. On or about 22-DEC-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX), (lot#, dose and route unknown), as prescribed and/or administered by a pharmacist at a Pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a health care provider for shingles. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX), the pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was unknown. Causality was assessed as related.
pt first reported swelling, tenderness & erythema of rt deltoid on 24JUL98 in afternoon;T99.2;advised to use cold or warm packs PRN to arm;may use APAP or advil as instructed;
I was diagnosed with A-Fib in 2011 following a stroke. I had been in a normal sinus rhythm until 3 days after receiving my second shot. The shot is the only thing different that occurred heath wise during this period. It is believed that the shot is the contributing factor.
Seizure lasting ~ 2minutes, patient incontinent of urine. Patient transported to ER via ambulance for treatment and observation. Patient post-ictal for several hours prior to discharge.
due to COVID they had delayed patient's 2nd doses of Shingrix; This case was reported by a pharmacist and described the occurrence of social problem in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2nd dose of Shingrix due to covid-19 The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021007458:SAME REPORTER
-Swelling of LA, tender, hot, itchy - 2nd patient with same reaction to same Immunization
Noticed continual palpitations (pvc,pac) the night of the second dose.  Woke up with palpitations and mild fever (100.4) at 4am. Took 2 Tylenol went back to sleep. Palpitations and fever resolved within 36 hrs after vaccine.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (subcutaneous) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site pain and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. The age at vaccination was not reported. The healthcare professional was a retail pharmacist. The healthcare professional suspected that the patient received a dose of SHINGRIX subcutaneously instead of the indicated intramuscular route, which led to possible inappropriate route of vaccination. He thought the patient received a dose of SHINGRIX subcutaneously instead of intramuscular because the patient complained of site pain and described a subcutaneous route of administration. The vaccine was not administered at the notifying healthcare professional's site. The patient was not a customer, and no vaccine or patient information was available.
Severe chills, 101.8 fever, bodyaches lasted 24-30 hrs. Took Acetaminophen
First dose on 12/15/2020 / wondered if they can get the second dose today; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 15th December 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The case was reported by the patient for herself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient wondered if she could get the 2nd dose on the day of reporting as she was at the pharmacy. The patient inquired if she can get the 2nd dose or she needed to start over. The reporter did not consent to follow-up.