chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist and described the occurrence of decreased therapeutic response in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B (1 ml, unknown) and experienced decreased therapeutic response. The pharmacist reported that four subjects in a row were non-reactive with a count less than 2.89. At the time of the report no additional information was provided. This is the fourth of four cases reported by the pharmacist, please see cases A0975397A, A0975398A and A0975399A. Follow-up information was received on 23 May 2012 via healthcare professional who reported who reported on 16 February 2012, 26 September 2011 and 23 August 2011 the subject received 3rd dose, 2nd dose and 1st dose of ENGERIX B (1 ml, unknown, left deltoid) respectively. On 31 March 2012, 44 days after vaccination with 3rd dose ENGERIX B, 6 months after vaccination with 2nd dose ENGERIX B, 7 months after 1st dose vaccination with ENGERIX B, the subject experienced decreased therapeutic response. On 31 March 2012 Hepatitis B titer result was less than 2.80 (9.99 or less is negative, greater than 10 positive). The subject received a booster dose of ENGERIX B on 12 April 2012. The lot number was reported as AHABVC018BA from the reporter; however, based on a safety lot number review, the lot number was updated to AHBVC018BA.
Initial and follow up information has been received from a physician, concerning a 17 year old female patient with depression and morbid obesity, and a smoker, who on 26-JAN-2007 was vaccinated with the first does, 0.5 mL, IM of Gardasil (Lot# 655619/1427F). Concomitant therapy included Zoloft and Lunesta. On 26-JAN-2007, the physician reported that the patient "became pregnant," and stated "her due date is 19-OCT-2007." An ultrasound provided "confirmation of pregnancy," and the physician reported the "prenatal labs" (unspecified) were "normal." Follow up information indicated that on 14-OCT-2007, a normal female infant, weight 9'2, "21 inches, was delivered on the mother's gestational date of 39 1/7 weeks. Complications during pregnancy and delivery included the mother's morbid obesity, and shoulder dystocia of the infant (details not provided). The infant's Apgar score was 9/9. At the time of this report, the outcome of shoulder dystocia was unknown. Additional information is not expected. Follow up information in the form of medical records from the pediatrician, indicated that on 16-OCT-2007, the infant visited the physician for a weight check. Newborn feeding problems were mentioned and a concern of weight loss, though the medical assistant indicated "normal weight for newborn." On 19-OCT-2007, the infant returned for a weight check, with "good weight gain," and was feeding better. On 19-OCT-2007, the infant parents took the infant to the emergency department with concerns related to jaundice. The infant was sent home with a bili blanket, to use for 24 hours. On 22-OCT-2007, the infant visited the physician and "jaundice on upper trunk only" was noted. The jaundice was resolving, with no dehydration and normal skin turgor noted. On 19-OCT-2007, bilirubin level was 15.9 (unit not specified), and on 20-OCT-2007, bilirubin level was 11.4. On 11-DEC-2007, the infant returned for a 2 week baby check, and the mother reported concerns of possible thrush, onset 2 days prior. The physician prescribed nystatin suspension for thrush, with "Healthy child with normal growth and development" noted. The first dose of ROTATEQ, PEDIARIX, PREVNAR, and ACTHIB were administered. The infant subsequently experienced viral enteritis, acute upper respiratory infections, and unspecified constipation while on therapy with ROTATEQ. Additional information is not expected. All medical records will be provided upon request.
The vaccine expiration date was identified to expire on June 22, 2021, but the manufacturer expiration date was February 25, 2021.  Based on the information learned, Health took the following steps: ? Contacted Moderna for guidance and based on Moderna data, the Moderna Medical Information team provided the following information:  o ?The vaccine administered on March 4, 2021 through March 10, 2021 from lot number 025J20-2A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration.?  ? Contacted a medical director and based on this information from Moderna, no re-vaccination is needed.
From initial information received on 20/May/2005 from a physician regarding an adverse event occurring in the USA, it was reported that a cluster of four patients (ages, dates of birth and genders not reported) received a fifth dose of DAPTACEL, lot number C163AA, administered on unspecified dates. The routes and sites of administration were not reported. An unspecified amount of time later all four patients developed swelling of the entire limb. It was not reported whether any of the patients recovered from the events.
Redness and swelling noted to L arm, tender area in L arm above L elbow on anterior aspect. Area not adjacent to where she had flu shot. Slightly uncomfortable. No fever or chills. Diagnosed with cellulitis. Prescribed Doxycycline.
Patient received 3 total vaccines that day including Pneumovax 23 and the seasonal flu vaccine, Fluzone HD.  Patient is unsure if her symptoms are related to the vaccines received or if she is Covid-19 positive.  Patient said she was getting tested today to rule out a Covid-19 diagnosis.  Her symptoms include fever, nausea, chilling, and headaches.  She said her arm is slightly red where she received two vaccines.
Pt recvd MMR vax & 24 hrs following vax pt devel nausea, aches, pain & flu-like sx; no further details were provided;
Symptoms of myocarditis; shortness of breath; irregular/rapid heartbeat; irregular/rapid heartbeat; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 26 year-old male patient received bnt162b2 (BNT162B2), administration date 06Jan2022 (Lot number: FJ1611) at the age of 26 years as dose 3 (booster),single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 2, Lot No: EW 0173), administration date: 11May2021, when the patient was 25 years old, for COVID-19 immunization; Covid-19 vaccine (Dose Number: 1, Lot No: EW 0153), administration date: 22Apr2021, when the patient was 25 years old, for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.  The following information was reported: MYOCARDITIS (medically significant) with onset 08Jan2022, outcome "recovering", described as "Symptoms of myocarditis"; DYSPNOEA (non-serious) with onset 08Jan2022, outcome "recovering", described as "shortness of breath"; HEART RATE IRREGULAR (non-serious), PALPITATIONS (non-serious) all with onset 08Jan2022, outcome "recovering" and all described as "irregular/rapid heartbeat". The patient underwent the following laboratory tests and procedures: heart rate: (08Jan2022) irregular/rapid; sars-cov-2 test: (08Jan2022) negative. Therapeutic measures were not taken as a result of myocarditis, dyspnoea, heart rate irregular, palpitations.  No follow-up attempts are possible. No further information is expected.
Bruising on both arms from shoulder down to top of hand.  Bruising only for first two weeks, then severe itching began on both arms and on back (which has no bruising).
Underage before the 5/12 approval for Pfizer vaccine  Suspected falsification of DOB ? guardian ?unsure? how DOB error occurred
Saw PCP for annual physical on 9/3/2021. Felt generally well at that appointment other than some mild ongoing fatigue, nothing specific. Administered first dose of Pfizer Covid-19 vaccine that day and tolerated it well. Patient reported significant increase in fatigue on 9/6/2021. Came in to be tested for Covid-19 on 9/10/2021 and tested positive. Insidious onset of respiratory symptoms which progressively got worse around this time. Came in to Emergency Department on 9/16/2021 and was found to have Covid-19 pneumonia, acute respiratory distress and pulmonary embolism but main factor for admission to hospital was the pulmonary embolism.
Approximately 10 minutes after vaccination patient complained of feeling dizzy. Brought into clinic room and laid down. Patient given juice, which she drank but then threw up about 1 minute after drinking. Patient complained of feeling dizzy, hot, and having a headache. She remained conscious but continued to stay laying down for about 20 minutes. Patient was given a cold, wet cloth for her head, which she reported helped with the heat and headache. At approximately 20 minutes she tried sitting up, but felt dizzy again about 2 minutes into sitting up. She lay down for approximately 10 more minutes, at which point she felt well enough to try sitting up again. After sitting on the floor for a few minutes she moved to a chair and still felt good. She remained seated in a chair for about 5 minutes and then stood up. She felt fine standing and was walked to her car by staff. She continued to report feeling fine, and left the clinic.
TENSION; ANXIETY; NERVOUS; LIGHT-HEADED/DIZZY; SORE ARM; FATIGUE; This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included anxiety.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced nervous. On 02-APR-2021, the subject experienced light-headed/dizzy. On 02-APR-2021, the subject experienced sore arm. On 02-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced tension. On 06-APR-2021, the subject experienced anxiety. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light-headed/dizzy on 13-APR-2021, and sore arm, and fatigue on 09-APR-2021, was recovering from nervous, and had not recovered from anxiety, and tension. This report was non-serious.
Pt had already 2 injections of the Moderna vaccine. Given a dose of Pfizer. Pt did not share that he had the Moderna series.
Improperly stored vaccine adminstration; shipment was received a day late; This spontaneous report was received from an administrator via a field representative referring to a 44 years old male patient. Information about concurrent condition, concomitant medication, medical history, drug reactions or allergies was unknown.   On 22-OCT-2020, the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) shipment was received a day late (expected arrival date was 21-OCT-2020, product shipment delay) to the reporter's practice, they were not viable for use, and someone in the office mistakenly placed them in the vaccine fridge (confliction information: the box of vaccines got placed into a refrigerator at recommended storage range once received).   On 23-OCT-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml, lot # T020638, expiration date 26-FEB-2022; route was not reported) for prophylaxis (improper storage of product in use).  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T020638; expirationdate: 26-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2011USA015360: US-009507513-2011USA015361: US-009507513-2011USA015362: US-009507513-2011USA015359: US-009507513-2011USA015363: US-009507513-2011USA015357: US-009507513-2010USA011251:
Patient developed a rash in the area of the vaccine and complained of moderately severe pain. Patient also stated he may have had a fever because he was experiencing chills.
She is scared to get her second dose tomorrow; got a few hives on my body; This is a spontaneous report from a contactable consumer. This 33-year-old female consumer (patient) reported for herself that a 33-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number were not reported), via an unspecified route of administration on 16Apr2021 at the age of 33-years-old as DOSE 1, SINGLE for covid-19 immunization. The patient medical history included asthmatic and allergies (Patient used Zyrtec) from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. On an unspecified date in Ap2021, the patient experienced got a few hives on my body, She was scared to get her second dose tomorrow. It was reported that patient had already received her first dose of the vaccine. Patient set to have her second shot tomorrow. The first shot patient broke out and got a few hives on her body. Patient was told by the doctor to take Benadryl before going. Patient read that shouldn't take any antihistamines. Patient did not know what really should. Patient asthmatic too. Patient just want to make sure it won't interact. Patient wanted to take precautions. Usually, she uses Zyrtec because she suffers from allergies but they thought she was just nervous. She thought it was weird that she broke out into certain spots. Patient stated that if she has to take something she will go purchase it. If she has to take something, then she will. Patient was worried about getting the second vaccine. Patient thought that somebody else has probably reported this same thing because she has other friends who say that they had small allergic reaction. The outcome of the events was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Numbing of jaw and arm along the vaccinated arm w/aggravated pain (joint). Elevated w/BENADRYL and ALEVE after 24 hours. Pain has decreased and almost gone; however, the arm still does not feel normal.
Took the shot on 2/18 and on 2/21 that night about 10:30 my arm started itching below where I got the shot on left arm. Wen to bed and woke up next morning it was broken out with blisters all over body, itching everywhere. I went to see my doctor and she hadn?t seen anything like this. I went to the dermatologist they took 3 biopsy?s and came back with a diagnosis of Sweets Syndrome which is an auto immune disorder, paperwork from dermatologist states that it would be favored more likely due to the vaccine. Now I have no job because I cannot work like this, it breaks out or flares up any my allergies flare up or anything that causes my white blood cells to go up.
Hives all over the body; Itches like crazy; Affecting the breathing; This spontaneous case was reported by a health care professional and describes the occurrence of URTICARIA (Hives all over the body), PRURITUS (Itches like crazy) and DYSPNOEA (Affecting the breathing) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included Diabetes (Reported diagnosed with Diabetes 2 years ago) in 2019. Concomitant products included MAGNESIUM, VITAMIN E NOS (VITAMIN E + MAGNESIUM), MULTI VIT and COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced URTICARIA (Hives all over the body), PRURITUS (Itches like crazy) and DYSPNOEA (Affecting the breathing). The patient was treated with CORTISONE for Hives, at a dose of UNK dosage form. At the time of the report, URTICARIA (Hives all over the body), PRURITUS (Itches like crazy) and DYSPNOEA (Affecting the breathing) outcome was unknown. Not Provided      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.
Information has been received from a nurse practitioner referring to 4 year old female patient with no known drug allergy. The patient had no illness at time of vaccination. The patient's birth weight was 7lb 6oz and has two siblings. Concomitant therapies included VARIVAX and KINRIX. On 28-APR-2016 at 10:19, the patient was vaccinated with M-M-R II lot # reported as L042818 dose 2, subcutaneously in the left thigh. The vaccine was properly stored at 53.2 F for 9 hours and 25 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
I stood up as normal after my vaccine, found an empty seat to sit, spoke to the gentleman next to me about how easy this process was then I'd say About 2 minutes after I got my vaccine I started feeling a warm tingly sensation in my left arm, then started getting very hot, along with dizziness. I flagged a nurse and told them I felt like I was going to pass out. I was very pale and my hands were cold. They put me on my back, with my feet up. I started to gain my color back but my blood pressure was low and my heart rate elevated. They gave me water and monitored me for about 20 minutes until my blood pressure and heart rate came back to normal. I ended up not attending work that day because when I got home I felt extremely fatigued and experienced mild vertigo. I felt like my normal self around 5-6pm that same day.
07/09/06 - Patient noticed tenderness & redness to left bicept/tricept. Took Motrin for discomfort. 07/10/06 - Patient states she woke up with her left arm in pain and with a rash. Patient arrived at clinic at 0800. Patient complains of increasing rash size, warmth, and tenderness of left arm. Rash over left tricept appears as papules in a narrow "S" pattern surrounded by a warm pink rash in an oval shape that measures five cm wide by eight cm in length. Rash over left bicept area with moderate erythema and warmth with moderate tenderness upon palpitation. Rash on left bicept is rectangular in shape and measures eight cm in length across from inner to outer aspect of bicept area by five cm from mid bicept and downward toward the elbow. Patient has full range of motion, but is slow and guarded with movement related to tenderness of left upper extremity. Capillary refill time is less than two seconds above and below rashes including left capillary nailbeds. Pulse at left brachial and radial arteries are three plus. Patient seen by Nurse Practitioner. Rocephin 250 mg IM given. Prescription given by N.P. for Keflex 500 mg QID #40, VAERS, and referral to another clinic. Diagnosis per FNP, R/O cellulitis. Plan - return to clinic for follow-up and evaluation.
Patient did not have an adverse reation to vaccine.  I gave vaccine 6 hours and 35 minutes after it was drawn up out of refrdgerater and ou policy is only to be out of refridge 6 hour.
day 2 through 3 fever, aches, chills. day 4 woke up with double vision through day 14 due to blood pressure drop. blood sugar also dropped. quit metformin to correct blood sugar.  cut losartan in half to get blood pressure corrected which was temporary. after 2 months more blood pressure drop to point quit taking losartan to correct blood pressure. after another month blood pressure spiked to point now on double losartan to get blood pressure to point of still inconsistent.
Presented with AMS; dx UTI, Covid +; treated with steroids, antibiotics, Vit D, Zinc minimal supplemental O2; returned to baseline O2
Erythema, swelling, warmth in left arm, subjective fever, chills, myalgia, arthralgia, starting 12-24 hours after Td administration in left deltoid.
Cataracts, could not read; This is a spontaneous report from a contactable other health care professional. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included rheumatoid arthritis going to the lungs from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced cataract, could not read. The reporter stated that the patient had got rheumatoid arthritis that went to his lungs, but the patient was fully vaccinated, after getting was just advised to be careful. The patient has had no problems with the vaccine. The rheumatoid arthritis going to the lungs was all prior to first and second COVID-19 doses. The reporter gave her COVID card to the patient, the patient could not read it and needed to get glasses. The reporter laughed and said they both have cataracts. The clinical outcome for the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event cataract  and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Mouth ulcers on left side; Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 9th September 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 15th October 2019, the patient experienced mouth ulcer. On 16th September 2019, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the mouth ulcer was recovering/resolving.   It was unknown if the reporter considered the injection site pain and mouth ulcer to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm and experienced pain at injection site and mouth ulcers on left side. The reporter consented to follow up.
At first, I got flu type symptoms and a couple days later, I started having muscle spasms all over my body. In my chest, my feet, my legs, my neck, everywhere. I went to doctor, they sent me to specialist. My heart was normal, they put me on Gabapentin which has helped some. I was having like 20 muscles spasms spells and now I'm 4 or 5 a day. My sugars are high now as well I use to be in 140 now my sugars are in 400s. They doubled my Metformin and added a medication Cyclobenzaprine for muscle spasms, I'm also on Atorvastatin.