chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and following up information has been received from a physician and a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female patient with irregular periods, with a history of car accident (a few years back) and subsequently with an addiction to pain medications, who on 27-JUL-2010 was vaccinated IM with the first 0.5 ml GARDASIL (lot# 663453/0249Y). Concomitant vaccinations included DTAP-IPV (lot# C3249AA) and MENACTRA (lot# U3076AA). Concomitant therapy also included pain medications. On 27-JUL-2010, the patient was advised to see an OBGYN physician and was advised to see a Psychologist. On 27-JUL-2010, the patient had an abnormal pap smear. During the second week of August 2010, the patient called the physician's office and reported that on 30-JUL-2010 (three days after she had received the vaccinations) she had a miscarriage. The miscarriage was not confirmed by a physician. The patient stated that she had irregular periods and she was not sure that she had a miscarriage. The patient was advised to follow-up with her OBGYN physician. The M.A. did not know if the patient recovered. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
During the 15 minute wait after receiving vaccine, pt stated his lips and tongue felt tingly.  Pt was attended to by EMS. Pt stayed an additional 15 minutes for a total of 30 minutes. Pt stated he felt fine. EMS said pt could leave. pt left in stable condition.
pt recvd vax & 3 to 4 wks later pt devel transverse myelitis; It is assumed the pt was hospitalized;
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 12-FEB-2015, the patient was vaccinated with a dose of PNEUMOVAX23, which expired on 09-FEB-2015 (administration route and lot number were not provided). No concomitant medication was reported. No adverse effects were reported. Additional information has been requested.
High blood pressure: 134 Sys, 119 Dia, 86 Pulse; Tachycardia; Headache; Severe dizziness; Difficulty talking and being able to express oneself; Fever; Muscular pain; Allergy and redness to left arm and chest; Swollen glands
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Additional Details: patient reportedly presented with massively swollen arm around injection site, was concerned it might be an infection, as patient claims to have not been swabbed with alcohol at time of vaccination. reporter did not interact with patient during injection or when patient returned to different pharmacy to report
positive covid; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (positive covid) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history ).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (positive covid). At the time of the report, SARS-COV-2 TEST POSITIVE (positive covid) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Apr-2021, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
numbness from waist down/tingling weakness, tremulous - seen in ER 2-1-10 saw primary care doctor 2-5-10 who felt pat had mild case Guillain Barre.
Patient infected with SARS-CoV-2 despite receiving the Pfizer vaccination series.  Patient did not receive the booster.
Injection site is still sore, chills, severe head ache and severe body aches lasting for two full days post vaccine
My tongue was swelling; my mouth was tingly; my face was swelling; lips were swelling; my glands under my chin was swollen; I had a rash on my neck; eyes were pretty swollen; I had a spider bite; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported, Expiry date: Unknown) via an unspecified route of administration on 12Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 18Mar2021, the patient experienced my tongue was swelling, my mouth was tingly, my face was swelling, lips were swelling, my glands under my chin were swollen, patient had a rash on her neck, eyes were pretty swollen, patient thought she had a spider bite. Therapeutic measures were taken which include Benadryl for every 4 hours. The next day patient cut down Benadryl the next day, but still have to take during certain times a day. This went over the weekend. Yesterday, patient took just one dose. But patient tongue was swollen and fingers were tingly. The patient received treatment for the events. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
About 7 hours after the vaccination I began to feel cold. About 12 hours after the vaccination I began to experience body aches and pains, continued chills, headache, ear ache in right ear, and a fever of at least 101 degrees. (The fever was probably higher, but I didn't take my temperature until I began feeling better.) I continued to feel tired throughout the next day. A low grade fever of around 99 degrees continued in spite of taking Tylenol. My arm was sore for about a day after the vaccination,  and a red area about 6 square inches was apparent at the injection site for nearly three days.
Prolonged reaction to the Moderna Vaccine since April 2021. I have rashes on both arms, hands, legs, eyes and now my face and neck area. It bleeds daily and my skin is itchy and raised and discolored.
Information has been received from a certified medical assistant (also reported as a nurse) concerning her 16 year old daughter, who was vaccinated with a second dose of Gardasil. There was no concomitant medication. Subsequently the patient developed a painful, raised, brown square on her arm where the injection was given. The patient did not have any adverse experiences with the first dose. The patient did not seek medical attention. At the time of the report, the patient was recovering. No product quality complaint was involved. This is one of two reports received from the same source. Additional information has been requested.
pt recv vax 15OCT96 & devel a rash on neck, face, chest, & hands on 1NOV96; exp fatigue & muscle pain;CPK was elevated & was treated IV pred;hosp is presumed although not documented;
10/22 - experienced headache, backache, and overall fatigue. 10/23 - worsening of headache, backache, and overall fatigue during the day; in the evening, patient had chills, sweating, tremors, and fever; took 3 tablets of ibupropfen 200 mg and fever decreased from 100.8 to 99 after 4 hours; took an additional dose of ibuprofen at bedtime. 10/24 - pt now reports feeling well and no other issues.
Information has been received from a pharmacist concerning a 26 year old male patient who on 10-MAY-2010 was vaccinated with a single dose of MMR II (Lot # not reported). The pharmacist reported that the patient experienced pain at the injection site after administration of MMR II on 10-MAY-2010. On 24-MAY-2010 the patient developed redness and swelling at the injection site. He was evaluated at a local emergency room. The diagnosis was abscess and the patient was treated with an unspecified oral antibiotics. On an unspecified date, the patient recovered from the events. Additional information has been requested.
Nose bleeds, daily. 2-3 minutes, apply pressure to stop.  Pain at injection site, lasted 3 days.
The patient became diaphoretic, pale, and syncopal. initial bp 94/63, pulse 58, pulse oximetry 98% on room air, repeat 117/74, repeat 124/72. Water, juice was given and  the patient was placed in prone position. The patient improved with in 15 minutes. Denies chest pain, denied  sob,   no loss of consciousness PERL. The patient was discharged home , refuse to go the the hospital. History of Panic Attacks
shoulder pain; Inappropriate route of vaccination; This spontaneous case was reported by a physician and describes the occurrence of ARTHRALGIA (shoulder pain) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery, Aortic valve replacement (Replacement of Aortic & mitral Valve) on 23-Sep-2019 and Mitral valve replacement (Replacement of Aortic & mitral Valve) on 23-Sep-2019. Concurrent medical conditions included Dermal psoriasis since 2009, Penicillin allergy (PCN), Drug allergy (Fentanyl) and Diabetes mellitus (Diet Controlled DM) since 1990. Concomitant products included TORSEMIDE from 2010 to an unknown date for Edema, APIXABAN (ELIQUIS) from 01-Feb-2021 to an unknown date for Heart valve replacement, SECUKINUMAB (COSENTYX) from 2017 to an unknown date for Psoriasis, METOPROLOL SUCCINATE from 23-Sep-2019 to an unknown date for an unknown indication.    On 22-Jan-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 22-Jan-2021, the patient experienced ARTHRALGIA (shoulder pain). 22-Jan-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination). On 22-Jan-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) had resolved. At the time of the report, ARTHRALGIA (shoulder pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   The treatment information were unknown. Concomitant medication Potassium cler with frequency 10meq by oral route of admiration with a start date of 23-OCT-2019 was reported.   This case was linked to MOD-2021-301025 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up received and contains : Updated Reporter information, Patient demographics, Dose information, medical history, Concomitant medications and new event "Inappropriate route of vaccination"
Patient developed local skin reaction of redness, swelling, induration, and discomfort at the injection site.  Mom reports similar reaction in the past with worsening with subsequence injections.  Mom reports that reaction started by 06:00 pm on the date of immunization and continued to worsen.  Vaccination was given on 10/26/2021 and mom reports worsening until 10/28/2021.  The redness, swelling, induration, and discomfort improved somewhat on 10/29/2021, but then patient became irritable and crying for unknown reason.  Mom brought him into clinic to be assessed on 10/29/2021 due to vaccine reaction.  She showed me images of redness and swelling of patient's leg from prior days which was more red and swollen in the
pt recvd vax; pt exp'd severe muscle pains in both legs; pain kept pt awake at night; pt seen by personal MD & by neurologist; MD felt pain was a result to vax;
swollen under her left eye; tingling sensation; cold; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling sensation), NASOPHARYNGITIS (cold) and PERIORBITAL SWELLING (swollen under her left eye) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METOPROLOL SUCCINATE (TOPROL) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PARAESTHESIA (tingling sensation) and NASOPHARYNGITIS (cold). On 25-Mar-2021, the patient experienced PERIORBITAL SWELLING (swollen under her left eye). On 24-Mar-2021, PARAESTHESIA (tingling sensation) and NASOPHARYNGITIS (cold) had resolved. At the time of the report, PERIORBITAL SWELLING (swollen under her left eye) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Diagnosed him with ALS; leg muscle got worse; Muscle weakness; This spontaneous case was reported by a consumer and describes the occurrence of AMYOTROPHIC LATERAL SCLEROSIS (Diagnosed him with ALS) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Muscle weakness (Before vaccine he had some thigh muscle weakness which got worse.).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AMYOTROPHIC LATERAL SCLEROSIS (Diagnosed him with ALS) (seriousness criterion medically significant), CONDITION AGGRAVATED (leg muscle got worse) and MUSCULAR WEAKNESS (Muscle weakness). At the time of the report, AMYOTROPHIC LATERAL SCLEROSIS (Diagnosed him with ALS), CONDITION AGGRAVATED (leg muscle got worse) and MUSCULAR WEAKNESS (Muscle weakness) outcome was unknown.            No concomitant information was reported. No treatment information was reported.  Company Comment : Based on  temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding the events has been provided at this time. Further information has been request.   This case was linked to MOD-2021-240698 (Patient Link).; Sender's Comments: Based on  temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding the events has been provided at this time. Further information has been request.
A technician administered the flu and covid vaccines, then walked back to the pharmacy. About a minute later someone in the lobby reported an emergency, I (pharmacist) went to the lobby area to see the matter. Patient was on the floor and appeared to be waking up, his mother stated she thought he had convulsed then fainted. Patient stated he had difficulty breathing and was very pale, I administered 10mL of benadryl 12.5mg/5mL solution. Patient reported nausea and prepared to vomit, but he did not vomit. I stayed with patient to monitor him for changes while his mother called 911, patient stated he did not feel better or worse. EMS arrived shortly after and took over care. Patient's family refused transport to hospital via EMS but did say they would drive to the hospital afterward.  Of note, patient's mother stated he had not had a reaction to a vaccine like this in the past, including the flu vaccine.
pain in the arm; Confused; pain in the body; memory problem; fever; missed dose; Tingling; Dizzy; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling), DIZZINESS (Dizzy), PAIN IN EXTREMITY (pain in the arm), CONFUSIONAL STATE (Confused) and PAIN (pain in the body) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PARAESTHESIA (Tingling), DIZZINESS (Dizzy) and FATIGUE (Fatigue). On 18-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed dose). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in the arm), CONFUSIONAL STATE (Confused), PAIN (pain in the body), MEMORY IMPAIRMENT (memory problem) and PYREXIA (fever). At the time of the report, PARAESTHESIA (Tingling), DIZZINESS (Dizzy), PAIN IN EXTREMITY (pain in the arm), CONFUSIONAL STATE (Confused), FATIGUE (Fatigue) and PRODUCT DOSE OMISSION ISSUE (missed dose) outcome was unknown, PAIN (pain in the body) and PYREXIA (fever) had resolved and MEMORY IMPAIRMENT (memory problem) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details was not reported by the reporter. Treatment details was not reported by the reporter. Patient was afraid of getting Alzheimer from the Moderna vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 18-Feb-2021: Follow up received on 18-FEB-2021. New events was reported. On 18-Jun-2021: Follow up received on 18-JUN-2021. Reporter Email was reported. Events was added and outcome of events memory impairment, fever and body pain was updated.
24 hours after second dose. No interruption of current medications. Patient had a syncopal episode after experiencing fatigue, fevers, and chills.
Day of vaccination - 8PM felt soreness in injection site. 1 Day after vaccination - 11AM felt chills (not sure if I ran a fever); eyes hurt when I coughed -  treated with Ibuprofen. 2 Days after vaccination - 1PM felt chills again - treated with Ibuprofen.
Erythema multiforme (rash) no treatment required - just watchful waiting for now.
Information has been received from a licensed practical nurse concerning a 11 year old female patient with no drug reactions/allergies, no pertinent medical history and no concurrent conditions who on 04-JAN-2012, was vaccinated with the first dose of GARDASIL (Lot# 670048/0963AA) (dose and route not reported). There was no concomitant medication. On 04-JAN-2012, while in the doctor's office, the patient had a fainting spell and a 10-15-second seizure. The patient recovered while in the office on 04-JAN-2012, left on her own and was doing fine. There was no treatment given for the AEs. The patient was not referred to a neurologist. Upon internal review, seizures were determined to be an other important medical event. Additional information has been requested.
A couple of weeks after the 2nd Moderna vaccination I was notified by email that patient needed to talk to me RE her 2nd Moderna vaccination. I was at a training class at another facility so I forwarded the email to my supervisor, RN who called patient and talked to her. Nurse stated that patient complained of a "swollen gland under her left arm". She instructed her that she needed to see her Primary care physician and have it checked out. On May 24th I ran into patient on the parking lot and she told me "the swollen gland was about the size of an orange and soft and her doctor had her get a mammogram and a CT scan to have it checked out". She also stated that everything ok but "lump is still there but now it is hard and size of a golf ball". She also stated her doctor said "for now everything looks ok but if it is not gone in 3-4 months to come back and have another mammogram and possibly another CT scan". I encouraged her to keep me informed of what is going on and if things continue.
flu like sxms, acute exacerbation of copd/pneumonia starting 02/08/21, headache, chx pain all night starting 02/13/21.  Pt admitted to hospital 02/14/21.  Performed lab work, elevated troponin level which continued to climb.  Discovered two blockages and installed two stints to primary artery.  Pt was discharged 02/16/21
Received TDAP injection on 8/05/10 at 1400. Started having rash on neck on 8/6 and progressed to rash on legs & stomach. Rash persisted and then on 8/12 had swollen lips, swollen eyes and shortness of breath. Took 2 BENADRYL on 8/13/10. Skin itchy.
2:40pm red area visible, light red rash, P 62, O2Sat 98, BP 132/82. 2:50pm redden rash somewhat disappeared.  Ice pack given for redness.   2:55pm EMS advised Benadryl for right deltoid redness.  Stated feeling better.  Allowed to leave observation with instruction to seek medical attention if rash or reddened area increases.
Injection site swelling under arm for 2 weeks, 3 weeks after injection had an A-Fib event, now on blood thinners and heart meds, no issues BEFORE vaccination
Sudden onset, severe frontal headache lasting 16 hours, slowly dissipated over 24 hours. Continues to come back mildly up to 3 weeks later.
Severe vertigo, moderate nausea, minor soreness at injection site the next morning. By 2 pm,  down to minor vertigo and moderate headache.
Two hours post vax pt experienced general malaise, enlarged lymph nodes under his chin and difficulty swallowing. Pt was treated with Benadryl IM and taken to the ER where he was treated with an unspecified medication. the reporter states that the vaccinee denied and difficulty breathing or swallowing, his lungs were clear and no complaints of nausea or vomiting; heart rate was 80 bpm. The vaccinee stated he had a rash at the injection site. 10 minutes after the initial onset pts blood pressure was 120/80 and heart rate  60 bpm. 10 minutes later vaccinee complained of difficulty swallowing and felt like it was getting worse the pt was given Benadryl IM. the vaccinee was seen by a physician who noted that his throat had redness and swelling. He was taken to the ER where he was treated with an unspecified medication. The vaccinee was followed up with 3.5 hours later when he was reported to be back at work and feeling okay. The vaccinee stated that something like this happened last year after vax.
Vaccine was drawn up the day prior on 4/20/23 and was not wasted. By FDA guidelines, the Covid Bivalent Vaccine had expired within the 12 hours of being open on 4/20/23. The situation was discussed with patient and he elected to NOT have another Covid booster at this time.
For about 24 hours after getting shot I felt like I was having an ongoing egg allergy - even though I know there are no eggs - I would call it minor but noticeable - my neuropathy also flared up immediately so badly that my arch on my felt foot was causing so much pain I thought I must have torn something - however after about 36 hours it disappeared - my sense of taste has also suddenly changed - after about 24 hours so that when I drink something it tastes like it has turned sour or metallic
Approximately 12 hours after I received the vaccine, I got a fever, migrane headache, body aches, cramping and fatigue that lasted 24 hours.  The fever averaged 101 degrees for 24 hours.  My arm where I received the shop was very sore.  I had cramping that was a lot like menstrual  cramps and I have been in menopause for 18 years.  All I could do all day was sleep.  All symptoms lasted 24 hours and the next day, I was back to normal other than my left arm was sore where I received the shot.
Fever, redness of arm, swelling (patient applied cool compress and started taking tylenol and benadryl).
patient received Boostrix expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 26-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 4M2EZ, expiry date 03-JUN-2023) for prophylaxis.   On 05-JUN-2023, the patient received Boostrix. On 05-JUN-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: patient received Boostrix expired dose). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 12-JUN-2023 The reporter consented to follow up via email. The patient received an expired dose of Boostrix, which led to expired vaccine used.