chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Symptoms: Left arm erythema, urticarial, hives, no SOB, no CP, no N/V, no dizziness, VSS Pt kept in treatment area for 30 minutes and was dc home. Treatment:  Received 1 dose Benadryl 25mg PO per order.  MD ordered for pt to take a total of 3 doses of Benadryl 25mg PO every 6 hours (including the first dose) Per pt, symptoms improving but redness, hives remained present.  Instructed pt to call 911 or go to ER if symptoms or addtl symptoms (CP, SOB) start or worsen.
This spontaneous report as received from a pharmacist refers to a 67 years old male patient with prostate cancer and not receiving any immunosuppressive treatment. The patient was vaccinated subcutaneously in the ventral aspect of his right forearm with 0.65 ml ZOSTAVAX (Lot number H012523, expiration date 09-OCT-2013) on 19-OCT-2012. No other co-suspects were reported. Concomitant medications included FLOMAX and CLARAVIS. On 19-OCT-2012 the patient experienced injection site pain at the moment of receipt of the dose of ZOSTAVAX. And the following day on 20-OCT-2012, the patient developed redness and swelling at the injection site. His injection site reaction progressed to developing a rash in the area of the redness and swelling. The patient had consulted physician for medical attention. BENADRYL was given for treatment. At the time of this report, his pain, redness, swelling and rash was reported as recovering/resolving. Additional information has been requested.
Patient Non-Reactive; Initial Report Received on 09-Oct-2019  A nurse reported that a patient (unknown age, gender, and race) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and was non-reactive.   Relevant medical history and concomitant medications were not provided.   On 07-Jul-2019, the patient received the first dose of Heplisav-B (lot #, expiration date, and NDC # unknown).   On 19-Aug-2019, the patient received the second dose of Heplisav-B (lot #, expiration date, and NDC # not reported). The nurse did not provide the lot number, but stated it was a prefilled syringe.   On 19-Sep-2019, approximately 1 month after having received the second dose, the nurse reported that the patient's titer was checked, and showed that the patient was non-reactive.   At the time of the report, the outcome of the event was not reported.  The caller did not want to provide additional information.    The reported did not provide a serious assessment for the event.   Company comment: The company assessed the event of therapy non-responder as non-serious. The event is listed per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of therapy non-responder  as non-serious. The event is listed per HEPLISAV-B USPI and IB.
This case was reported by a nurse via sales rep and described the occurrence of face edema in a 11-year-old male patient who received FLULAVAL QUADRIVALENT 2018-2019 season for prophylaxis. On an unknown date, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. On an unknown date, less than a day after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced face edema, cough, rash and dizziness. The patient was treated with BENADRYL. On an unknown date, the outcome of the face edema, cough, rash and dizziness were recovered/resolved. The reporter considered the face edema, cough, rash and dizziness to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The patient received FLULAVAL QUADRIVALENT in left arm on 8th time. The patient experienced coughing, rash on face, mild edema on cheeks, dizzy, lasted after 8 min. The patient given BENADRYL, same day he was fine within hour. The reporter thinks reaction was related to product. The reporter was agree to follow up from GlaxoSmithKline.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown) at the age of 51 years, in left arm, on 24Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 03Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fish allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) Positive; (24May2022) Negative; (31May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
17 hours post injection I had terrible back pain!!!  Preceded by headache, chills and fever.  The pain was excruciating for six hours, finally relenting slowly.  After six more hours, all effects but the brain-fog disappeared.  Brain-fog lasted three days.
Within three hours of receiving the vaccine, the patient developed a fever of 103F and hives head-to-toe. The patient was treated with Ibuprofen.
This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 48-year-old female patient who received SHINGRIX. Concomitant products included PRISTIQ. On 26th December 2017, the patient received the 1st dose of SHINGRIX (subcutaneous). On 26th December 2017, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site itching, injection site induration, injection sire discoloration, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site itching, injection site induration, injection site erythema and injection site pain were recovered/resolved and the outcome of the injection site discoloration was not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the injection site itching, injection site induration, injection site discoloration, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provide as follows: The patient received the vaccine subcutaneously instead of intramuscularly, which led to inappropriate route of vaccine administration. Almost immediately, the site of injection turned red and the redness was spreading around bigger and bigger. The reporter said that the site of injection itched, hurt and was hard. She said that it even hurt if something touched it. The redness and other symptoms went away after one week and a half. After the redness went away, the patient started having discoloration or brownness at the injection site. The patient said that she had an x-ray that same day before having the injection, and she hoped that would not be a problem.
Patient just got the covid vaccine and after he sat down for observation.  He turned to the nurse and said "I am dizzy."   Per LVN, patient slid down his chair, collapse for about 2-3 minutes, witnessed the patient had stiffening of the body, pale, sweating and was unresponsive for 2-3 minutes.  911 called and STAT RN called for assistance.  All four LVNs including RN assisted patient to the floor and secured his head.  He didn't hit any body part.  No nausea and vomiting.  Once he was on the floor, he woke up crying and nervous.   911 called.   orthostatic BP done.  BP standing dropped.
The patient caught COVID-19 seventeen days later; The patient caught COVID-19 seventeen days later; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000003148 (Novavax).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "The patient caught COVID-19 seventeen days later".  Clinical Course: On 25Aug2022, it was reported that a patient started treatment on unspecified date with Pfizer-BioNTech COVID-19 Vaccine dose 3 for an unknown indication. It was reported the patient caught COVID-19 seventeen days later. No further follow-up is anticipated.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The first 24 hrs following injection had exhaustion and cold symptoms.  Then fine until 3/2 when had sudden onset diarrhea and nausea in afternoon which lasted 24 hrs.  Then experienced extreme fatigue, headache, cold symptoms with stuffiness, sore throat.  No fever.  General malaise.  This lasted for 3 last till 3/4.  On 3/5 these symptoms disappeared and then noticed redness, swelling, itching at injection sire.
left side gluteal muscle pain; back pain like epidural pain; terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL PAIN (left side gluteal muscle pain), BACK PAIN (back pain like epidural pain) and HEADACHE (terrible headache) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced MUSCULOSKELETAL PAIN (left side gluteal muscle pain), BACK PAIN (back pain like epidural pain) and HEADACHE (terrible headache). At the time of the report, MUSCULOSKELETAL PAIN (left side gluteal muscle pain), BACK PAIN (back pain like epidural pain) and HEADACHE (terrible headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Nausea, loss of speech, diplopia, upper body weakness, dysphagia.
Developed local erythema at vaccine site approximately 7 x 4 cm. Advised ice/TYLENOL.
PATIENT WAS GIVEN A DOSE WHICH WAS OVER-DILUTED WITH SODIUM CHLORIDE. NO ADVERSE REACTION WAS EXPERIENCED. PATIENT WAS CONTACTED AND WILL RETURN FOR ADMINISTRATION OF ANOTHER FIRST DOSE
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced breakthrough varicella zoster with less that 50 spots and no systemic symptoms or complications.
The caller states the rash is persisting, nothing beats the first time the caller witnessed the rash. The rash was swollen like a new tattoo; The caller states the rash is persisting, nothing beats the first time the caller witnessed the rash. The rash was swollen like a new tattoo; Skin reaction was hives; The caller basically has been itching all over since Saturday evening; This is a spontaneous report from a contactable consumer (Patient). A 26-years-old male patient received bnt162b2 (Pfizer Covid-19 vaccine, Solution for injection, Batch/Lot Number: ER8736), dose 2 via an unspecified route of administration, administered in Arm Left on 20May2021 on Thursday of last week as DOSE 2, SINGLE for covid-19 immunisation (at the age of 26 Years). Medical history and concomitant medications were not reported. The patient previously took bnt162b2 (Pfizer Covid-19 vaccine, Solution for injection, Batch/Lot Number: ER8736), dose 1 via an unspecified route of administration, administered in Arm Left on 29Apr2021 as DOSE 1, SINGLE for covid-19 immunisation at the age 26 years. No investigation assessment. The patient experienced on 22May2021 the reaction started happening about two days after the caller received the second dose Pfizer Covid 19 Vaccine. The caller reports the skin reaction was hives. The caller basically has been itching all over since Saturday evening, 22May2021. The caller stated on an unspecified date the hives are ongoing and persisting to keep it short. The caller stated the rash is persisting, nothing beats the first time the caller witnessed the rash. The rash was swollen like a new tattoo. The caller stated he had no reactions after receiving the first dose Pfizer Covid 19 Vaccine. Skin reaction was hives with outcome of not recovered, the caller basically has been itching all over since Saturday evening and the caller states the rash is persisting, nothing beats the first time the caller witnessed the rash. the rash was swollen like a new tattoo with outcome of unknown.   Follow-up (29Jun2021): Follow-up attempts completed. No further information expected.
Received second SHINGRIX 50mcg inoculation in upper left (non-dominant arm) on 29 June 2018 from pharmacist at local pharmacy. Within six hours a red splotch began developing below (not at) the injection site. The splotch spread until it covered the entire upper arm bicep area including site, (which is large due to gym workouts) and was extremely sore to touch and squishy. It was bright red, like the very first hours of a very serious sun burn and remained that way for a week. At same time went to bed for two days with fever, chills, headaches, general malaise, and aching all over the body. After two days returned to more normal function but soreness and significant heat remained in red upper arm. After about two weeks red spot gradually diminished in color but not size, its outline and slighter tenderness and slight discoloration over entire area of red upper arm remain after two weeks. Tissue under continued discolored area remains squishy with slight soreness unlike right arm. Additional info: received a second pneumonia shot in upper right arm at same time with no noticeable reaction. I am a 69 year old male in extremely good health.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient passed out a few minutes after receiving the 2nd dose of Pfizer vaccine. She came back from fainting about a minute or two. We called 911 and the paramedic came over to access her. Patient's mother was with her whole time and patient had no problem and left the store without going to the hospital.
Noted hives on hands. The next day hives on legs. 8/16 hives on wrists and hands. Injection site, no hives, small bruise noted.
Sudden drop in blood pressure (systolic dropped to 80s, unsure of exact number), vertigo and lightheaded-ness, increased heart rate, fading vision and changes to hearing, tingling in extremities. Nurses started checking bp, apple juice to increase blood sugar, symptoms started to abate after 5-10 minutes. Free to go 30 minutes after vaccination.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 23-APR-2015, the patient was vaccinated with a 0.5 ml improperly stored dose of PROQUAD (Merck) (lot # reported as L002213 exp date 21-JUL-2016) subcutaneously. No adverse events were reported. Additional information has been requested.
The patient presented with confusion and generalized pain after her 3rd COVID vaccine dose. EKG showed low voltage QRSST elevations in leads II, III, aVF, V5 and V6 along with initial troponin of 6,015. She underwent coronary catheterization, negative for stenosis or occlusion. Echocardiogram showed reduced LV systolic function ( EF 30%) with mid to distal anterior, apical and inferoseptal, hypokinesis and mid to distal inferolateral hypokinesis as well .  LV apical mural thrombus seen. NT-proBNP also very elevated >30000, CK 40680. This presentation and timeline was consistent with vaccination-induced myocarditis. Apparently the patient had adverse reaction requiring hospitalization (confusion, pain, leg weakness) with all COVID shots. Treated with heparin gtt for the thrombus and IVIG (2g/kg over 2 days).  She was also treated with iv Solumedrol 125 then tapered down to 80mg. On 12/12 she went into SVT concerning for A. fib with RVR and became unstable requiring cardioversion, She did not respond to electrical cardioversion but she converted after amiodarone drip. Repeat TTE showed EF 35% and worsening pulmonary hypertension.
This spontaneous report as received from a licensed practical nurse referring to an unspecified number of patients. The patient's medical histories and concurrent conditions were not provided. On an unknown date in JANUARY 2016, the unspecified number of patients were vaccinated with LIQUID PEDVAXHIB (lot # L030870, expiration date 18-JUN-2018)(route, dose number, frequency and concentration were not reported). It was reported that the vaccines administered were improperly stored at 47.1 F for a time frame of 5 minutes and 45 seconds. No product quality complaint (PQC) was reported. This is one of two reports from the same source. Additional information has been requested.
Within 24 hours of receiving my booster, I had a sudden onset of heart palpitations and a racing heart. My pulse was around 100 BPM and would not go down. I could tell I was experiencing arrhythmia. It was diagnosed yesterday from the Hospital to be Sinus Arrhythmia. I had an EKG, complete blood comprehensive panel and checked my blood enzymes. The enzymes were excellent. There was no indication of myocarditis or pericarditis. Based on my blood work, my white blood cell count was normal.
had shingles despite having the vaccine/suspected vaccination failure; shingles; still shooting pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. The patient was treated with gabapentin and vicks vaporub nos (Vicks Vaporub). On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 08-JUN-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had shingles despite having the shingles vaccine.  The patient was on Gabapentin for a year but after that the doctor took him/her off despite still shooting pain.  The patient tried Vicks VapoRub and it had allowed him/her to sleep at night.  The patient did not know why he/she had shingles, despite having the vaccine.  It was been 2 years and still get shooting pain but he/she tried putting Vicks VapoRub on the area and it had really helped. The patient was not sure why, but after the doctor took him/her off Gabapentin and he/she had to try something so he/she could sleep through the night. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Initial report was received 19 June 2008 from a consumer, who is also the patient.  A 42-year-old female patient with a history of diabetes, had received an injection of ADACEL (lot number, route/site not reported) on 30 May 2008 and on "approximately" 06 June 2008, she complained of muscle weakness, sore bones, sore joints, and tiredness.  She was seen by her physician on 12 June 2008 at which time laboratory tests for iron and B12 were performed (results pending).  The patient had no concurrent illness at the time of vaccination and had received ADACEL because she sustained a cut while at work.  At the time of vaccination, the patient had been taking concomitant medications which included ZYRTEC, metformin, PROTONIX and YASMIN.  No other vaccinations had been received during the four weeks prior to ADACEL.  At the time of the report, the patient had not recovered from the event.  Follow-up information was received 12 August 2008 from a health care professional.  The reporter verified that the patient had received a first booster dose of ADACEL in June 2007 with no adverse events experienced.  The dose of ADACEL administered on 30 May 2008 had been a second dose (lot number, route and site of administration not reported).  Per the reporter, the results from the B12 and Iron laboratory tests would be forwarded.  No further information was provided.  Follow-up information was received 18 August 2008 from a health care professional.  The reporter stated that "the patient had an overload of pertussis so the doctor put her on antibiotics because she was symptomatic without a cough.  The patient is better now".  Laboratory results included Vitamin B12 (406) and Ferritin (12.8).  Additional information was provided for both ADACEL doses received by the patient.  The patient had received a second dose right deltoid intramuscular injection of ADACEL, lot number C2888AA on 30 May 2008 at 13:05.  The reporter also confirmed the patient had received a first dose right deltoid intramuscular injection of ADACEL, lot number C2688AA on 29 June 2007 approximately one year prior.  The patient recovered from the event (date not reported) and no further information was provided.  Follow-up information was received 26 September 2008 and 30 September 2008 from a health care professional.  On 26 September 2008, the reporter stated that "the patient was treated for pertussis because she had the symptoms of pertussis without the cough".  The reporter indicated that additional follow-up information would be forwarded.  From information received on 30 September 2008, the reporter confirmed the lot number for dose two of ADACEL administered on 30 May 2008 had been C2888AA.  The date for dose one of ADACEL was confirmed to have been 29 June 2007 with no adverse events experienced.  Based upon this new information received, this case has been upgraded to serious.
Vaccine that administered beyond use date after the thaw process; 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) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 prophylaxis.     It was unknown if patient had chronic or long lasting health conditions.     On 11-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 11-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported  It was unknown if patient had acute illness at the time of vaccination and up to one month before. It was unknown if patient had been diagnosed with or tested positive for COVID-19.  Patient reported no adverse reactions after the administration of vaccine. Vaccine number 1 NDC code was reported as 80777-0273-99
She had rashes, worsening concentration and "brain fog" after the vaccine. On 4/14/21, she went to the ED for heart palpitations, shortness of breath, and fatigue for 3 weeks. At that time, she was found to be hyperthyroid.
For about one week, Bug bite like itchy swollen spot, decreased upon taking daily allergy medication. Turned into a large patchy slightly raised mildly itchy rash at injection site