chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore Arm; Tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 7-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Dec2022 at 15:15 as dose 3 (booster), single (Lot number: 6K1657) at the age of 7 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: FL8094), administration date: 08Jan2022, when the patient was 6-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: FK5618), administration date: 18Dec2021, when the patient was 6-year-old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Dec2022, outcome "recovering", described as "Sore Arm"; FATIGUE (non-serious) with onset 05Dec2022, outcome "recovering", described as "Tired". Therapeutic measures were not taken as a result of pain in extremity, fatigue. No COVID prior vaccination. No COVID tested post vaccination. No follow-up attempts are possible. No further information is expected.
Patient who does not turn 18 until December 2016 was administered FLUZONE ID. There was no adverse reaction and pt BMI is such that we are certain it was delivered ID and not SQ.
showing symptoms of COVID-19; showing symptoms of COVID-19; exposed to COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 8 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1 (tris), single 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "showing symptoms of COVID-19"; EXPOSURE TO SARS-COV-2 (non-serious), outcome "unknown", described as "exposed to COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200027212 Same drug, different patient/AE
Individual administered Moderna vaccine. Individual is 14 years of age at time of vaccination. Individual reports no adverse side effects and no adverse side effects or reactions observed. Individual and mother advised individual will not be able to receive a second dose of Moderna. Individual scheduled to receive first dose of Pfizer on October 21, 2021 to complete vaccine series. Proper authority notified.
Shingles on face; I could get acne breakout with that/it is gonna around the eyes was only the eyelid and it was on region on my eyelid; it started down my forehead and blistered.; top of my scalp near the crown there is little tenderness still. It was really tender.; She touched my hair and I didn't jump out if my skin but it hurts.; This is a spontaneous report for herself.  A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 17Mar2021 (Batch/Lot Number: Unknown) as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included pulmonary hypertension from an unknown date, arthritis from an unknown date, and rosacea from an unknown date. Concomitant medications included atenolol taken for an unspecified indication, start and stop date were not reported; enalapril maleate (LOTRIAL [ENALAPRIL MALEATE]) taken for an unspecified indication, start and stop date were not reported; guanidine taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for hypothyroidism, start and stop date were not reported, and other vitamins over the counter start and stop date were not reported.  The patient experienced shingles on face; I could get acne breakout with that/it is gonna around the eyes was only the eyelid and it was on region on my eyelid on Mar2021 with outcome of unknown, it started down her forehead and blistered on Mar2021 with outcome of unknown, top of her scalp near the crown there is little tenderness still. it was really tender on Mar2021 with outcome of unknown, and she touched her hair and she didn't jump out if her skin but it hurts on Mar2021 with outcome of unknown. As treatment, the patient received valacyclovir, that is for 7 days, 1000mg Once a day.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the available information the reported events more likely represent intercurrent medical conditions which were unlikely related to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Investigators, as appropriate.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; HEAVINESS IN UPPER CHEST AREA, FELT LIKE BRONCHITIS; ACHES AFTER BOOSTER; FEVER AFTER BOOSTER; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: bronchitis, aspirin allergy (irritates stomach), and iodine allergy (rash). The patient previously received covid-19 vaccine ad26. cov2. s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: Unknown) dose was not reported, 1 total, administered on 09-APR-2021 for prophylactic vaccination on her right arm (dose number in series 1). It was unknown if patient experienced any adverse events after primary vaccination.(dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D2 expiry: Unknown) dose was not reported, 1 in total, administered on 08-DEC-2021 for prophylactic vaccination on her right arm (dose number in series 2). No concomitant medications were reported.  On 08-DEC-2021 after vaccination with booster dose, patient experienced fever and aches for three days.  On 08-JAN-2022, the patient experienced symptoms which included sore throat, fatigue, headache, smell bothered her throat, aches, fever of 99F, patient felt very much higher and body aches (confirmed covid-19 infection). Laboratory data included: Body temperature (NR: not provided) 99 F. The patient felt heaviness in upper chest area which felt like bronchitis. On 14-JAN-2022, the patient tested Covid positive (confirmed clinical vaccination failure). Laboratory data included: COVID-19 PCR (polymerase chain reaction) test (NR: not provided) Positive (dose number in series 2). The patient reported that she had no symptoms at the time of report.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, and heaviness in upper chest area, felt like bronchitis on 21-JAN-2022, and aches after booster, and fever after booster on 11-DEC-2021, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is a duplicate of 20220156699. This report was associated with product quality complaint.  It was determined that Manufacturer Case Number (20220156699) was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number (20220156981).; Sender's Comments: V0-20220156981- covid-19 vaccine ad26.cov2.s -Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 24-AUG-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX with lot # L007720 Expiration date: 08-JUL-2016, 0.5 ml (route and anatomical location of administration were not reported). The sum of hours in excursion was 40 hours and the lowest recorded temperature reported was 33 Fahrenheit (F) (0.5555555556 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor product quality complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Bilateral swelling on upper arms, with redness and pain with touch. Resolved by 5-28-10.
pt recvd vax;1 day later,presented w/ edema, redness, warmth & pain at inj site;
Blood pressure dramatically increased to 177/115 at its highest.  Symptoms were headache?s.  No other symptoms.
normal for first 3 days except pain at injection site. Then, gradually feeling drained and numbness and tingling in thighs. Feels as if walking through water. Feeling sluggish and heavy.
Very painful stomach, persistent chills, headache, low fever. Injection was Mon morning, symptoms began very early Wed morning and continued throughout the day and Wed night. Symptoms greatly reduced by Thurs but some weakness persited until the weekend. Arm soreness has actually gotten more acute. This is the 7th day and I don't have full arm motion without muscle pain. I can usually whip off 25 pushups easily; I cannot do one.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
Information has been received from a medical assistant referring to a 2 years old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported)(Incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: pt felt nauseous and sharp pain . nauseous. kept moving arm and water and breaths. pt felt fine after sitting for 30 min.
Received Pfizer vaccine (dose 1) on 3/19/21. Patient called a PCP on 4/5/21 stating he brought a sleeping cushion upstairs from basement and began to get "little bumps that were very itchy" after sleeping on it on 3/19/21. Thought it could be bedbugs. He had not seen any bedbugs and had no prior history of them in his home. Received second doe of Pfizer vaccine 4/16/21. Per physician note on 1/6/21: severe reaction pfizer covid vaccine (severe puritis. skin got raw, lost skin palms, lips, legs now scarred. Numbness in lower lip (finally resolved); occured after first dose. Has slow healing sore since first dose. Has slow healing sore since first shot in March, left calf area.
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Severe, Systemic: Joint Pain-Mild, Additional Details: Patient reports 3 days later after having her 2nd dose of Shingrix that her arm is still swollen (size of a softball at the injection site), it is raised, red, hot to the touch.  She has taken tylenol.  I advised her to also take some benadryl in addition.
Consumer was administered with the influenza vaccine on 9/15/04. She started to feel discomfort at the time to urinate. Next Monday she was bleeding large blood clots. She went to the VA Emergency Room and doctor prescribed her with antibiotics.
Urgent Care 10/6/2021 and 10/8/2021; Ophthalmologist/specialist  10/11/2021, 10/14/2021, 10/28/2021; Family Physician 11/1/2021; Optometrist 11/15/2021. Treatments: Doxycycline Hc 1000mg, Prednisolone AC 1% Ophth Sus, Methylprednisolone 4mg dospak, Sudafed, Azelastine .1%, Advil.    ACUTE ANTERIOR UVEITIS OF BOTH EYES (diagnosed 10/8/2021).  Symptom start 10/4/2021 - blurred vision, decreased vision, severe eye pain and pressure, eye inflamation, eye redness, light sensitivity, dark spots in field of vision, floating spots, heat around both eyes. Duration - 8 weeks.  OTHER ADVERSE: BLAZING HEADACHE, HEAD PRESSURE/PAIN behind eyes and forehead,  EAR/ SINUS INFECTION, HIGH BLOOD PRESSURE, FEVER, SEVERE BODY ACHES
This case was considered medically important. Information regarding PREVNAR was received from a healthcare professional regarding a 3-year-old male patient who experienced pneumococcal bacteremia and pneumococcal bacteremia. At 13 months of age, the patient received the fourth dose on 02-Jan-2008. On 12-Nov-2009, the patient experienced pneumococcal bacteremia. The patient was treated with intramuscular ceftriaxone for 3 days. The patient recovered. No additional information was available at the time of this report.
pt recv vax; red indurated area 45x26 mm; advised cold compress x 24 hr then warm compresses; report to MD if oth sx;
Half hour after vaccination experienced visual distribution, neck discomfort, blurred vision, shortness of breath, dyspnea, clammy skin. Discharge ok. Diagnosis: Vasovagal, ER visit. Rest, hydrate. Follow up with facility.
Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 18-FEB-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Shakes, fever of 102.8, sever body aches, diarrhea, headache, dizziness Lasted 24 hours.
Acute onset of scattered bullous rash on arms, torso, back.  Started about two weeks after receiving a Moderna COVID vaccine at a local pharmacy (unsure if first or second vaccine).
No  symptoms or adverse reaction reported. Patient received adult dose of Hepatitis A vaccine instead of pediatric dose. (Packaging similar and print on box and syringe very small).
11/15/21 presents to local ED "with a fall" "back and leg pain". PMHx "Afib on Flecainide s/p pacemaker, colon cancer in remission"
vaccine dose number=2: vaccine brand other=Moderna/ Vaccine dose number=3: vaccine brand=Pfizer / BioNTech; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Oct2021 as dose 2 (booster), single (Lot number: 019F21A), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), on 02Apr2021 as dose 1, single (Lot number: 1805031), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Apr2022, outcome "unknown", described as "vaccine dose number=2: vaccine brand other=Moderna/ Vaccine dose number=3: vaccine brand=Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Immediately after receiving the shot, I felt hot and flush and a little dizzy. By 7pm, the site was swollen (baseball sized) and very painful. The skin on my arms became blotchy w/ red spots, then hives on stomach. I took 2 BENADRYL and I still have a few hives on 10/3/13 10a.m.
Redness and swelling presented on 7-26-12. 1.5in (width) 1 in (height).
Vaccine was given 10 days early from original scheduled & required date. No reaction therefore no treatment needed
ABOUT 10 MINUTES AFTER THE SHOT THE PATIENT GOT DIZZY AND REALLY HOT AND WAS SWEATING.  PT NEVER LOST CONSCIOUSNESS.
Erythema and warmth at vaccination site w/palpable lump beneath injection site; pt report low grade fever and achiness.
mom called this AM states pt was taken to MD 530PM;d/t inc fever, lt leg swelled red from knee to hip;uncontrollable screaming;Ibuprofen & APAP given;mom states pt hyperactive d/t Ibuprofen;
After vaccine administration in the right deltoid muscle, patient's arm swelled at the injection site.  Patient was given one dose of 25mg Benadryl as a precaution.
On 16JAN2023 I woke up and as I had been feeling poorly a few days earlier I took a COVID-19 test and it was positive. I called my physician and he prescribed Paxlovid due to my autoimmune conditions I had going on.   I felt better in two to three days.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "idiopathic thrombocytopenic purpura" (unspecified if ongoing); "asthma" (unspecified if ongoing). No Known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Aug2023) Positive, notes: tested positive a week after completing Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient take Paxlovid from 27Jul2023 to 01Aug2023 as Treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received Shingrix injection. Had previous shingles vaccine 10 years ago.9 days developed shingles and had to seek medical help. Presently taking Acyclovir 800 mg 4xdaily to try to prevent continued nerve problems.
This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received FLULAVAL Quadrivalent. On 9th November 2016, the patient received FLULAVAL Quadrivalent .5 ml. On 20th December 2016, 41 days after receiving FLULAVAL Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza A virus infection. On an unknown date, the outcome of the vaccination failure and influenza A  virus infection were unknown. It was unknown if the reporter considered the vaccination failure and influenza A virus infection to be related to FLULAVAL Quadrivalent. Additional details were provided as follows: The case was received on the GSK Direct Passive survey. The age at vaccination was not reported. The reporter would like to know why was  not protected from Influenza A and why should continue to purchase this vaccine. This case was considered to be suspected vaccination failure as the confirmatory laboratory result for Influenza A infection was unknown.
HEPATITIS A VACCINE GIVEN. ABOUT 90 SECONDS LATER CLIENT STATES FEELING LIGHT HEADED AND PREVIOUSLY PASSED OUT WHEN SHE HAD BLOOD DRAWN WHEN PREGNANT. APPLIED COLD CLOTH TO BACK OF NECK SUPPORTED HEAD AND OPENED AIRWAY AS CLIENT PASSED OUT AND HAD MILD SEIZURE ACTIVITY. AFTER ABOUT 2 MINUTES BEGAN TO RESPOND TO NAME AND ANSWER YES TO QUESTIONS. CONTINUED TO SUPPORT HEAD AND NECK FOR 5 MINUTES AND APPLY COLD COMPRESSES. BLOOD PRESSURE 76/40 INITIALLY AND FOLLOWUP BLOOD PRESSURE 94/60.  GIVEN GLASS OF ICE COLD WATER. CLIENT STATED SHE HAD NOT EATEN BREAKFAST THIS MORNING. RELEASED AFTER 15 MINUTES WHEN COLOR FULLY RETURNED AND STATES SHE FEELS MUCH BETTER.
Patient received first dose of vaccine 4/13/21 and was scheduled on that visit for dose 2 , 5/11/21. Patient rescheduled themselves online after the visit for 05/05/21. When the patient showed up, the vaccinator did not verify the date of dose one. Vaccine was given too early. Per the CDC revaccination is not recommended.
Intermittent rapid heart beat (resting (95 -120) for 5 days post vaccination, some dizziness