chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 11/5/2019 MOC called primary care office around 2:30pm stating she had a call from daycare stating patient had fever of 102 and lump on Right thigh. Patient had received 4 yr shots on 11/4/19. Patient was able to walk normal but site of inj. was hurting. MOC was advised to draw a circle around lump, that was to see if it would spread, and call back to be seen in case it grew. At 8:11am MOC called back on 11/6/19 to report growth. Started at 4cm. At 6:00am was 7 cm. Made appointment to come to office, since it kept spreading. Appointment made at 10:30am, was seen and given a Z-pack, measured area again, now at 8 1/2cm in width, and 6cm in length (was 4 cm in length & width) at the start.
Tdap received left deltoid on 07/13/2006 that same day had redness, pain and swelling to arm.  Later developed fever 101 degrees. Redness and pain continued to increase.  On 07/18/2006 was seen by the doctor and was told she had cellulitis was given drug Septra and Lortab, saw doctor comp physician today for adverse treatment.  Symptoms improving
COVID-19 INFECTION; This spontaneous report received from a parent via a social media via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number were not reported) 1 total, dose and start therapy date were not reported for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The company is unable to perform follow up to request batch/lot number.  No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19 infection (Dose number in series 1) (reported as "had it"). The mother reported, "three in my family chose to get the J and J vax. I know you get "no love". I have been exposed multiple times. Daughter had it, hubby and I did not. We all boosted with J and J too".  The patient received booster of covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration and batch number were not reported) 1 total, dose and start therapy date were not reported for prophylactic vaccination (Dose number in series was 2). It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s. ((Dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection was not reported. This report was non-serious. This report was associated with product quality complaint number: 90000209140. This case, from the same reporter is linked to 20211261133 and 20211261154.
Pt. states that after receiving the 2nd dose of Phizer 09/22/2021, started experiencing symptoms 10/06/2021 of rash at the injection site and (10) Blemishes around the left arm. Blemishes are still currently appearing, Clinic visit 10/17/2021 with recommendations of observation. No noted Primary visit.
Information has been received from a health professional concerning a 56 yr old female pt with allergies to codeine derivatives, penicillins and tetracyclines who on 04Nov05 (also reported as 05Dec05) was vaccinated IM in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot 650541/1004P) (also reported as 650542/1005P). Concomitant therapy included influenza virus vaccine (unspecified). There was no illness at the time of vaccination. The pt had a local reaction at the injection site on 08Nov05. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information indicated that the pt called the office on 06Dec05 with pain, swelling and rash around injection site which began approx 15:00 on 05Dec05. The pt extended up toward her neck, left ribcage and left breast. On 06Dec05 she still had swelling, rash and pain around the injection site with limited mobility. On 06Dec05, the pt was advised to treat the symptoms with warm compresses and 400-600mg of ibuprofen to decrease inflammation and to help with pain. The pt was further advised to treat with diphenhydramine hydrochloride (Benadryl) (OTC), 25mg or loratadine (Claritin) 1-2 every 6-8 hrs and to call the office if symptoms persisted. At the time of this report, the pt had not called regarding above. The outcome of the events were unk. No further information is available.
This spontaneous report as received from a health professional refers to a 15 year old patient of an unknown gender. Medical history and concurrent conditions were not provided. On an unspecified date in June 2015, the patient was vaccinated with a dose of PROQUAD (Merck) (dose, route, lot number and expiration date were not reported0. No adverse effect reported. There was no a PQC involved. Additional information has been requested.
Patient fell from chair hitting head on ground after passing out. She responded to questions with appropriate answers within 45 seconds. She reported feeling dizzy and thought it was related to anxiety then woke up on the floor. Patient remained on the floor while being assessed by EMS then moved to a sitting position then to a chair when safe. Patient remained in chair for 10 minutes before leaving the vaccine site.
Pt had aches and pains that lasted for 2 days. She was in bed at this time. Took TYLENOL, was shaky and was sure she had fever. Seen today and said she was just getting over her shakiness. Wants regular flu shot next yr.
Felt cold/chilly; Swollen, stiff, red knuckles and joints; Sensitive to the temperature; Swollen, stiff, red knuckles and joints; Tired; Itchy and hot again; Rash around the injection site; Red, hot, knot at the injection site; Red, hot, knot at the injection site; Red, hot, knot at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Red, hot, knot at the injection site), VACCINATION SITE MASS (Red, hot, knot at the injection site), FEELING COLD (Felt cold/chilly), JOINT SWELLING (Swollen, stiff, red knuckles and joints) and TEMPERATURE INTOLERANCE (Sensitive to the temperature) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Red, hot, knot at the injection site), VACCINATION SITE MASS (Red, hot, knot at the injection site), VACCINATION SITE RASH (Rash around the injection site) and VACCINATION SITE ERYTHEMA (Red, hot, knot at the injection site). On 19-Jan-2021, the patient experienced PRURITUS (Itchy and hot again). On an unknown date, the patient experienced FEELING COLD (Felt cold/chilly), JOINT SWELLING (Swollen, stiff, red knuckles and joints), TEMPERATURE INTOLERANCE (Sensitive to the temperature), ERYTHEMA (Swollen, stiff, red knuckles and joints) and FATIGUE (Tired). At the time of the report, VACCINATION SITE WARMTH (Red, hot, knot at the injection site), VACCINATION SITE MASS (Red, hot, knot at the injection site), FEELING COLD (Felt cold/chilly), JOINT SWELLING (Swollen, stiff, red knuckles and joints), TEMPERATURE INTOLERANCE (Sensitive to the temperature), ERYTHEMA (Swollen, stiff, red knuckles and joints), PRURITUS (Itchy and hot again), VACCINATION SITE RASH (Rash around the injection site), VACCINATION SITE ERYTHEMA (Red, hot, knot at the injection site) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medication was not provided.   Treatment include hot compress on the site to keep the vaccine flowing and cold compress on the site for when she was itchy.    Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: Follow up received and it contain information about patient contact information updated and patient demographics updated and new events were added. On 04-Aug-2021: Non-sig follow up; patient's street address provided.
THIS FORM IS MORE DETAILED THAN I FEEL LIKE ANWERING.  I GOT COVID 3 DAY AFTER GETTING THE VACINNATE ALSO THE LINK THAT COMES FROM MOBILE APPLICATION KEEPS SAYIN OOOPS IT WON'T CONNECT. SORRY THIS IS MORE TIME CONSUMING AND STRESSFUL THAT I CAN HANDLE RIGHT NOW
I had to J/J on 04/05/2021 around the end of June beginning of July I was having heart muscle pinching. It would last for 30 seconds, and it happened off and on. After a week it resolved. Prior to 08/07/2021 I had been taking Abilify for the past 10 years. I was on Abilify, I would go without medication for 2 or 3 months. About a week before on 08/07/2021, I had stopped taking the Abilify. On 08/07/2021 I began having shortness of breath, a hard time swallowing, and could not even drink water. It happened gradually through 08/09/2021. It was not getting better. On 08/11/2021, I was hospitalized at medical center. From 08/11/2011- 08/17/2021, for 6 days. I have withdrawn from Abilify and reduced my dosage in the past, without ever having any problem with swallowing. After the Johnson and Johnson, when I withdrew from the Abilify, I started having the problem with swallowing. In the past 10 years I have withdrew from Abilify twice and I had never these adverse reactions, of swallowing. I have recovered from the AE's with the administration of Abilify. I was put back on the Medication.
experienced chills, and body aches starting at 6-7 hours post injection. He also experienced a fever. His fever spiked to 103.9 at 11:43pm, dropped to 103.7 at 1:20am and dropped further to 102.5 at 1:47am. By morning, 8:30am his temperature had returned to normal at 98.3F.took extra-strength Tylenol around 8pm and again at 4am.  I (his wife) put a fresh cold compress on his forehead every 5-15minutes from 11:40 through 1am.
Pt passed out seated in driver's seat in idle, ran into car in front of her. Pt pale, cool diaphoretic, refused transport to hospital. Pt observed until vitals within normal limits.
Has received flus hot every year with no problems. Arm sore by afternoon, couldn't lift arm for next 2 days. Vaccination area black/blue for 5 days. Still have soreness in muscle and joint, still hurts to put any pressure. Soreness gotten worse over time.
pt recvd vax & devel intermittent spasms of muscles in neck, rt shoulder & rt arm; consulted chiropractor who was unable to provide relief; pt is currently being treated w/unspecified NSAID;
Approximately 20 minutes post-vaccination patient complained of being lightheaded, EMS on-site.  Patient stated her blood pressure this morning was 72/52 prior to taking her lisinopril and furosemide medication.  Additionally she stated she started on a new medication yesterday; however, she could not recall the name of the medication. BP 112/69, 79 HR, 98% SPO2.  Patient was cleared by EMS.  Instructed patient to call the physician that provided her with the new prescription for further directions.  Additionally advised to call 911 or go to the nearest emergency room if symptoms persist or worsen.  Patient verbalized understanding.
No chills or fever. Face and arms red and itchy with pinpoint, flat, pink spots confluent over cheeks and forehead; less dense over neck and chest and a few on arms; none on back and abdomen. Mild sore throat and conjunctiva mildly injected. Mild arthralgia in knees and fingers. Rx'd Zyrtec, ibuprofen. Improved in 2 days.
This spontaneous report was received from a registered nurse and refers to a 5 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received in summer 2017. On 01-DEC-2016, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # L016124 with expiration date of 06-MAY-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 65 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA014053:
Information has been received from a medical assistant concerning an adult patient who on 16-FEB-2010 was vaccinated with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck) due to a human error.  There were no adverse effects reported.  Follow-up information has been received from the medical assistant indicated that 61 year old patient was administered with the VARIVAX (Merck) (Lot #665111/1293Y) vaccine on 16-FEB-2010.  When the physician told the medical assistant to administer the shingles vaccine she grabbed the wrong vial.  The medical assistant reported that after 28 days the patient would receive the ZOSTAVAX (Merck) dose.  Additional information is not expected.
Initial unsolicited report received from a consumer (parent) on 11-OCT-2016. This case involves an 11-year-old male patient who was vaccinated with a first dose of ADACEL batch number: C4775AA, expiration date: 16-JUL-2017 (dose, dose in series, route of administration were not reported), in left deltoid on 23-SEP-2015. Patient received previously 5 doses of DTaP without issue with the vaccination. Patient's Illness at time of vaccination was not reported and Pre-existing physician diagnosed allergies to milk, cats, dogs and crab, birth defects, medical conditions was reported as Asthma. Concomitant medications were not reported. On 23-SEP-2015, same day following the vaccination, the patient developed shortness of breath and having difficulty breathing. Lab data was reported as none and corrective treatment was reported as neb treatment. On an unspecified date, the patient recovered from the event. List of documents held by sender: none.
Pt recv vax in 11/94; 3/95 pt exp hair loss; tx=Kenalog lotion w/o imp; tx=Kenalog injections, pt imp.  Pt recv Prednisone.  Pt grows hair then falls out; dx=alopecia areata.
This spontaneous report as received from a registered pharmacist refers to a 62 year old female patient. In Fall 2013, the patient was vaccinated with ZOSTAVAX (dose, route and lot # not reported). The pharmacist reported that on an unspecified date in 2013, after receiving ZOSTAVAX, the patient experienced swelling at the injection site which had since resolved. The patient also stated that she was currently experiencing scaling and cracks kind of like eczema in between the fingers on the hand of the arm that ZOSTAVAX injection was administered (right or left arm was not specified). The outcome of scaling and cracks kind of like eczema in between the fingers on the arm that ZOSTAVAX injection was administered was unknown. Additional information has been requested.
mild bumps on the back of both hands / 4 or 5 bumps on each hand/ on the neck and arms; This case was reported by a consumer via call center representative and described the occurrence of raised rash in a 68-year-old male patient who received HAB (Twinrix adult) (batch number 3597P, expiry date 12th March 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th January 2020, the patient received the 1st dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On 17th January 2020, 4 days after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced raised rash. The patient was treated with cortisone (non-proprietary) (Cortisone Topical). On an unknown date, the outcome of the raised rash was recovered/resolved.  It was unknown if the reporter considered the raised rash to be related to Twinrix adult and Twinrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient received 1st dose of Twinrix adult and 4 days after started to notice mild bumps on the back of both hands, 4 or 5 bumps on each hand. The bumps presented on the neck and arms some time later. The patient was seen by nurse practitioner on 11th Febuary 2020 and treated with topical cortisone. For further 2nd dose of Twinrix adult, refer case ID US2020AMR253500, reporter for same reporter.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chills-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: tingling and swelling on one side of face
Employee, 1st Pfizer COVID19 vaccine today. ~6min s/p shot, he felt a little itchy just @injection site, then got anxious & felt woozy, sweaty. Wearing big mask and a face shield, seemed anxious. Walked independently to go lay down. No syncope. BP up to 140/90, HR 90, RR 20, breathing fine, no itchy throat/swelling/hives. Improved w laying down. To ER out of an abundance of caution-- vitals nL, nL exam, still itchy at shot site. Got 1L NS IV, 25mg PO Benadryl for itchiness- likely anxiety > severe allergy
At 5:30 PM she was feeling nauseous and weak.  She passed out, had a headache, chills, and intermittently experienced profuse sweating.  She had a fever at 12:30 AM that evening (next day).  She was a little nauseous and took it easy the next day and was fine after a day passed.
Post vax, the pt awoke complaining of itching and small hives all over body.
Patient received her vaccination on 2/2/11 said shortly thereafter in the car shoulder started to hurt - called me 2 days later say still sore & hard to move - documented when called again about 13 days later said she should contact Dr. again - gave cortisone inj.
Boostrix expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 224CG, expiry date 07-MAY-2023) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Boostrix expired dose). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-JUN-2023 The reporter was a medical assistant. The reporter consented to follow up. The reporter reported that a patient received an expired dose of Boostrix, which led to expired vaccine used.
Right after the vaccine, I had a very mild sore arm. I started having symptoms in March around the 20th. My symptoms became more intense. I tried to avoid going to the ER . I couldn't find anybody that could fit me in. I ended up going to the ER. It hurt to breathe on the left side of my chest. They diagnosed Pleurisy. I took 4 days of Ibuprofen and that fixed it. I really don't think this had anything to do with the vaccine because it started a couple weeks after my first vaccine. I didn't have any symptoms from the 2nd vaccine.
High fever, severe body pain, vomiting, upset stomach, sleeplessness, headache
This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (side affects after the booster shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side affects after the booster shot). At the time of the report, VACCINATION COMPLICATION (side affects after the booster shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Pain, redness and swelling at injections site, fever, body aches, headache for up to 48hrs. Muscle tremors and muscle twitches in both right and left hands have been continuous for over 13 months with no improvement.
Arm soreness at site, radiating from shoulder to elbow. Fatigue, lethargy, headache, joint pain/stiffness, body aches, fever/chills.
Pfizer-BioNTech Covid-19 Vaccine .  Ringing in Right ear and loss of hearing for approximately 5 hours, fever, headache and pain on left arm where vaccine was inserted.
Information has been received from a physician through a Merck pregnancy registry for VARIVAX (Oka/Merck) concerning a 23 year old female with no pertinent medical history or drug allergies who on 05-DEC-2007 at 23 weeks gestation was vaccinated SC with a 0.5 ml dose of VARIVAX (Oka/Merck) (lot# 659204/1470U) when already pregnant (LMP 26-JUN-2007, EDD 01-APR-2008). Suspect vaccination administered on that same day included a dose of RECOMBIVAX HB (duration and dose not reported). No other symptoms were noted. Medical attention was sought through a physician office visit. Lab diagnostic studies performed included a positive pregnancy ultrasound. There was no product quality complaint. Follow-up information from the reporting physician and obstetrician indicated that the 23 year old female (LMP 26-JUN-2007, EDD 01-APR-2008) with morbid obesity had a pregnancy history of 2 previous full-term deliveries, no pre-term births with no complications during pregnancies delivered a normal live-born female (7lbs., 6oz.) on 08-FEB-2008 at 38.5 weeks from LMP. On 05-DEC-2007 the patient experienced an upper respiratory infection (bronchitis) and was treated with clarithromycin extended release (BIAXIN XL) for a 10 day duration. Prenatal diagnostic testing included on 04-OCT-2007 included a maternal-serum-alpha-fetoprotein test (MSAFP) with a negative result, four ultrasound for growth. The last ultrasound on 18-JAN-2008 showed a normal 37 week, 4 day fetus. No amniocentesis was performed. On 08-FEB-2008 during delivery/labor, a primary cesarean section was performed for failure to progress (FTP) and non-reassuring fetal heart trace (NRFHT). No infant adverse event occurred. No maternal adverse events occurred at the time of pregnancy. Upon internal review, Caesarian-section for failure to progress and non-reassuring fetal heart pattern were determined to be other important medical events. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/16/2008. Information has been received through the Merck pregnancy registry from a 23 year old pregnant (31 weeks) female consumer with seasonal allergies and no other pertinent medical history who on 05-DEC-2007 was vaccinated with a 0.5 ml dose of VARIVAX (Oka/Merck). Concomitant therapy included antimiscrobial (unspecified). Illness at the time of vaccination included a cold. On 05-DEC-2007 the patient had a red bump on her arm at the injection site which lasted for about one week. Medical attention was not sought. There was no product quality complaint involved. No further information was provided. It has been determined that WAES 0712USA07106 is a duplicate of WAES 0801USA00953. Therefore, WAES0712USA07106 is being deleted from our files and the reports consolidated into WAES 0810USA00953 for VARIVAX (Oka/Merck). No further information is expected.
Redness, pain, itching, tenderness, warm sensation in Left arm. Prescribed Benadryl, will follow up in 3 days (2/30/15).