chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient admitted testing positive for COVID Pt is 76 yo male with PMH of RA, Hypothyroidism, COPD, HLD, BPH, depression, OSA who is presenting with fever up to 103 at home, fatigue and cough started last monday, tested negative for COVID-19 x3 times, symptoms started last week and he was seen in urgent care on 9/24/21 and was started on azithromycin and doxycyline. His symptoms continue to get worse, he was exposed to his COVID-19 positive father on 9/16/21 after he was discharged from the hospital. Father now at HCF with no active symptoms of COVID-19. He is fully vaccinated with Moderna, first dose 1/2021, second dose 2/2021.  His RA is well controlled, on 1 mg of prednisone daily and 200 mg of Hydroxychloroquine  He lives at home with his wife who is asymptomatic, he will be able to self isolate when he returns home.  He denies any recent travel history.
Shoulder pain; Severe soreness on left side of arm extending through shoulder, neck and head; Severe soreness on left side of arm extending through shoulder, neck and head; Severe soreness on left side of arm extending through shoulder, neck and head; Radiating pain; Arm was sore / Severe soreness on left side of arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th January 2020, the patient received the 2nd dose of Shingrix. On 9th January 2020, 1 days after receiving Shingrix, the patient experienced pain in arm, musculoskeletal pain, neck pain, headache and radiating pain. On an unknown date, the patient experienced shoulder pain. On an unknown date, the outcome of the pain in arm, musculoskeletal pain, neck pain, headache and radiating pain were not recovered/not resolved and the outcome of the shoulder pain was unknown.   It was unknown if the reporter considered the pain in arm, musculoskeletal pain, neck pain, headache, radiating pain and shoulder pain to be related to Shingrix.  Additional deatils were provided  as follows: The patient received dose of Shingrix in the left arm. After vaccination, the patient had arm soreness for approximately 1 week. On January 11, 2020 at night, the patient reported severe soreness on left side of arm extending through shoulder, neck and head. The patient reported that, every time moves wanted to scream. On the day of reporting, the soreness was worse. The reporter did not provide a health care professional for follow up due to changing doctors, but was not opposed to health care professional follow up.
I experienced really hard chest flutters and chest pain on 09-30-2021. On 10-01-2021 I went to the ER, they performed lab work, EKG and x-ray of the chest. On 10-01-2021 I was driving and my heart fluttered so hard to the point that my chest raised up involuntarily and so I gripped the steering wheel and parked, lasted about 5 seconds and literally took my breath away. The ER doctor recommended I be placed on a heart monitor to see if this happened again. I will see my PCP next week on 10/12/2021 for follow up and placement of heart monitor. This was unusual for me, took my breath away, never experienced this before. I thought I was having a heart attack.
Mother called office reporting taking child to ER due to "small seizure like symptoms" and child feeling light head.
expired dose administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients). On 04-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported .  No treatment information was provided by the reporter.  Date the vial was initially stored in the refrigerator 01 Dec 2021. It was reported that some patients experienced flu-like symptoms after receiving the vaccination and the details were not available at the time of this report.
mom states started vomiting 5AM has vomited x5 12noon 14OCT97;advised mom to call MD & advise him of being sick;23OCT97 had a virus;
Rapid heartbeat, increased blood pressure, both started about 10:15 and lasted for about 3 1/2 hours.
Initial unsolicited report received from a physician on 09-Jun-2017 and additional information received on 27-Jun-2017. This case involves a 25-months-old female patient, who was vaccinated with MENACTRA (batch number, expiration date, dose, route and site of administration was not reported) on an unknown date of Jun-2017 (around 07-Jun-2017) at 10 AM. Patient's medical history included infantile roseola. She received a dose of NEISVAC when she was 1 year-old, in 2016. The family moved end of February-2017. 10 days after arrival (in March-2017), the girl experienced a strong rotavirus gastroenteritis which led to hospitalization due to diarrhea, vomiting and loss of appetite. Rotavirus was identified by laboratory exam. No specific reaction after primo-vaccinations. Patient's concomitant medication was not reported. On an unknown date of Jun-2017 (around 07-Jun-2017) in the evening, few hours after the vaccination, patient developed high fever (40 degree C) that lasted 3 days, together with reactions on her legs and arms for 48 hours/rash on the body (mainly forearm, legs, bottom and slightly on the face). Rashes were made of red and round plates that appeared and disappeared; It looked like maculo-papulous rash or could make think about multiforme erythema (according to pictures received from the parents) but without clear center in the middle. Patient's other lab test was not reported. Patient received DOLIPRANE as corrective treatment. At the time of the report, the patient was recovered. Upon internal review the case was considered as serious because of important medical events' erythema multiform-like eruption, generalised rash and maculopapular rash. List of the documents held by sender none. Sender's Comments: Sanofi company comment dated 29-Jun-2017: Erythema multiforme with generalised rash and Maculopapular rash is unlisted and high fever is listed following MENACTRA vaccine. Time to onset is compatible with the vaccine. Erythema multiforme is autoimmune is self-limited disease which can be trigger by any viral, bacterial, fungal, parasitic infection, any drug reaction and neoplastic disorder. Based on available information with presence of alternative cause as concurrent viral infection, rule out role of vaccine.
I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 10/7/2021 BRAIN MASS I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 10/7/2021 PALLIATIVE CARE
dose leaked out of the syringe during administration and the full dose was not administered; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (dose leaked out of the syringe during administration and the full dose was not administered) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, the patient experienced UNDERDOSE (dose leaked out of the syringe during administration and the full dose was not administered). On 12-May-2021, UNDERDOSE (dose leaked out of the syringe during administration and the full dose was not administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided. No relevant concomitant medications were reported.
SHE HAD SORE ARM FOR SEVERAL DAYS AT THE INJECT SITE (LEFT ARM) WHICH THEN BECAME PAINFUL MIMICKING ROTATOR CUFF TEAR WITH BOUTS OF INABILITY TO USE HER ARM. SHE REGAINED HER RANGE OF MOTION AFTER 2 MONTHS AFTER ORTHOPEDIC AND PT VISITS AND AN MRI WHICH REVEALED THE INJECTION SITE WAS IN TENDON.
I noticed immediately it appeared that the shot had been adminstered very high..in the shoulder. I started having severe pain in shoulder and arm that is still continuing. I have been to 3 doctors and they cited that the shot had been administered in the wrong location. Was on oral steroids and then went back to the doctor and the referred me to an ortho doctor. Had cortisol shot in shoulder..help for 2 days. Had MRI and find reflect Severe Bursitis. They are recommending surgery. THERE WAS NOTHING WRONG WITH MY ARM/SHOULDER prior to this shot.
Narrative: COVID infection following COVID vaccine series 03/09, Pfizer, dose #1 04/01, Pfizer, dose #2 11/23, Pfizer, dose #3 08/08 COVID swab, result: NOT detected 12/27 COVID swab, result: detected 12/25 pt cc: chills, cough, fatigue, fever, headache, myalgias, nausea, rhinorrhea, dyspnea, sore throat exposure: unknown 1/1 clinically resolved
Sore at injection site; Severe nausea; vomiting; diarrhea starting 6 hours after injection; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Pfizer brand; lot number: Ek3246), via an unspecified route of administration on 13Jan2021 10:15 on left arm at a single dose for COVID-19 immunization. Medical history included psoriasis, lymphocytic colitis and allergies to pistachios (anaphylaxis). The patient's concomitant medications were not reported. The patient experienced sore at injection site, severe nausea, vomiting and diarrhea starting 6 hours after injection (pending clarification); all on 13Jan2021 14:30 (as reported). Then the same symptoms starting 22Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was at the hospital. The report was non-serious. The outcome of the events was recovered with sequelae.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 at 10:00 as dose 1, single (Lot number: EN5318), in left arm, on 25Mar2021 at 10:00 as dose 2, single (Lot number: EN6199), in left arm and on 03Dec2021 at 17:00 as dose 3 (booster), single (Lot number: FJ8757) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "depression" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "known allergies: seafood" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa; "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: FARXIGA, start date: Jan2019; IRBESARTAN HCTZ, start date: Jan2017; ROSUVASTIN, start date: Jan2014, stop date: 20Jun2022; AMLODIPINE, start date: Jan2017; DESVENLAFAXINE, start date: Jan2016; METFORMIN, start date: Jan2005; OMEPRAZOLE. Past drug history included: Tetracycline, reaction(s): "known allergies". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Jun2022 at 08:00, outcome "recovered" (13Jul2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jun2022) Positive, notes: home test. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient tested + for covid via home test 19Jun2022, took Paxlovid for 5 days, tested negative around 29Jun2022, became mildly symptomatic again 09Jul2022, tested + (very faint line), felt better 10Jul2022, tested + (very faint line) for 3 days and negative 12- 13Jul2022 and feel fine now. The patient was not sure if this was a rebound infection but wanted to report it just in case.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Vaccination failure (LOE) and COVID-19 cannot be ruled out.
blurred vision heart rate between 100-110 while laying down dizziness  all symptoms started at 9:35a on 5/1/21 and lasted for about 30 mins.  as the day progressed headache worsened along with body aches, chills and exhaustion.
Pt was given a shingrix vaccine 11/16/19- reported muscle 'cramping' in forearm of the arm injected, lower back and legs
Pt recvd 3 doses of Engerix-B 27FEB91, 27MAR91 & 20AUG91 & it was determined that pt responded w/3.7 titer result; 1 booster dose of Engerix-B was given 19NOV91 & titer result is now 6.6;
Pt given Hep B, had HBSAB blood work done, results neg for immunity.  12/21/99 pt was admitted to hospital for new onset seizure of unknown etiology.
After a few days I had pain in the left arm, I went to doctor and they stated it was a normal reaction, After a few more days I had a lump under my left arm pit. I went to the doctor and they did an ultrasound and stated nothing was found. After a month the lump went down. It has been a year and I still feel the lump. In December I had a MRI and the doctor diagnosed me with a stoke.
patient had a second cycle of her menstrual period; Very swelling lymph nodes on her armpit; Patient had her menstrual period, since she entered menopause 7 months ago; Injection site still hurts; Bleeding on the injection site; Very large bruise on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Bleeding on the injection site), VACCINATION SITE BRUISING (Very large bruise on the injection site), MENSTRUAL DISORDER (Patient had her menstrual period, since she entered menopause 7 months ago), MENSTRUAL DISORDER (patient had a second cycle of her menstrual period) and LYMPHADENOPATHY (Very swelling lymph nodes on her armpit) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F4A, 022C21A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient allergy to medications, food and other products.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Bleeding on the injection site), VACCINATION SITE BRUISING (Very large bruise on the injection site) and VACCINATION SITE PAIN (Injection site still hurts). On 12-Dec-2021, the patient experienced MENSTRUAL DISORDER (Patient had her menstrual period, since she entered menopause 7 months ago) and LYMPHADENOPATHY (Very swelling lymph nodes on her armpit). On 14-Jan-2022, the patient experienced MENSTRUAL DISORDER (patient had a second cycle of her menstrual period). On 08-Dec-2021, VACCINATION SITE HAEMORRHAGE (Bleeding on the injection site) had resolved. On 18-Dec-2021, MENSTRUAL DISORDER (Patient had her menstrual period, since she entered menopause 7 months ago) had resolved. On 22-Dec-2021, VACCINATION SITE BRUISING (Very large bruise on the injection site) had resolved. On 20-Jan-2022, MENSTRUAL DISORDER (patient had a second cycle of her menstrual period) had resolved. At the time of the report, LYMPHADENOPATHY (Very swelling lymph nodes on her armpit) outcome was unknown and VACCINATION SITE PAIN (Injection site still hurts) had not resolved.            No Concomitant No Treatment medications were reported.   This case was linked to MOD-2022-473944, MOD-2022-473947 (Patient Link).
Pt reports moderate arm pain at injection site. Said it was warm to the touch for several days after administration and that there is still a "knot" at the injection site. Pt reports her arm is still painful when she lifts it.
Almost immediately after receiving vaccine welted up and arm was swollen around injection site. Arm continued to get more red and bruised as evening continued on. Pt also had very achy joints to the point was hard to move around, developed a fever around 100 even after taking an aspirin and had body chills.
Had vaccine @ 2:30 pm (3-19-10), started fever @ 4 pm (3-19) went to Hospital ER @ 10 pm w/105 fever, seizure & listlessness. Given TYLENOL & MOTRIN. Watched till 1 am & discharged f/u with Dr. 3-24-10.
Patient died 12-15hrs after vaccination.; This is a spontaneous report from a contactable Consumer. A 40-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 25Mar2021 12:45 (Batch/Lot Number: ER8727) at the age of 40-year-old as single dose for covid-19 immunisation. Medical history reported as none. Concomitant medication included buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient patient died 12-15 hours after vaccination. The patient died on 26Mar2021. An autopsy was not performed. No treatment received for the event. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19.; Reported Cause(s) of Death: Patient died 12-15hrs after vaccination.
Patient stated that she was experiencing inflammation in shoulder.  She believes that "Flu shot administered too high"  Still having pain 3+ weeks on.
Information has been received from five authors of a published literature article concerning a patient with a history of bacteremia several years earlier who participated in a post marketing study involving pneumococcal vaccine 23 polyvalent. The 14 year old patient with hb-ss disease with crisis was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included penicillin. It was noted that the patient was not compliant with penicillin theapy and had recently discontinued penicillin prophylaxis. In 1997, the patient was infected with pneumococcal serotype (18F) and subsequently died. The cause of death was the pneumococal infection. It was also reported that two other patient's had pneumococcal infections. At this time, relationship of the patient's pneumococcal infection to pneumococcal vaccine 23 polyvalent was unknown. Patient developed pneumococcal infection that resulted in death was considered to be immediately life-threatening. Additional information has been requested.  Reported on 03/26/2003: "Follow up information received from the Primary Author revealed that the patient was almost 15 years old with a history of bacteremia at approximately 6-7 years of age.  The first pneumococcal vaccine 23 polyvalant was administered at 2 years 2 months and the 2nd dose just shy of 8 years of age.  The child was not on prophylactic penicillin therapy.  It was noted that the child had been well and out sledding all day then complained of a headache and felt a little warm.  The child was seen in the hospital, was admitted, deteriorated quickly, was sent to the ICU and in the AM died.  The child was infected with a Pneumococcal serotype (38f).  No autopsy was performed.  Additional information has been requested.  A copy of the published article is attached as further documentation of the patient's experience.
pt states that when she woke up the next day after taking the vax.  She felt very cold with body aches and pains. Her left arm was bright red and sore around the injection site.  These symptoms were getting better and then about 2 days later she developed a red rash on both arms, both legs, and chest.  She is taking Benadryl for her symptoms which help the rash fade but when it wears off it comes back.  Pt will contact her PCP if her symptoms do not subside.
Day 2 Extreme arthritic flare with painful, stiff joints.  severe muscle aches, chills Day 3 - current:  Extreme tiredness and weak muscles.  Stiff, aching joints (these symptoms are unusual as I had a Remicade infusion 1 week prior to vaccine)
Patient presented to the ED on 3/9/2021 with symptomatic anemia. The patient has a history of this. The patient received PRBC and platelets.
The day of the vaccination, I had pain and swelling in vaccine site. Nausea, headache, injection site was really hot and painful. Very fatigued. I also had cold intolerance and night sweats. Participant does not remember when she contacted a physician.
48 hrs after flu shot employee complained of fever T102 that lasted for 4 days (normal body temp 97). Relief only with Ibuprofen. Also complained of body aches and chills. Denied complaints of chest, lung or sinus congestion. Saw primary MD who did not do any testing.
This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative, with follow-up received from a contactable physician. A 24-year-old male patient of an unspecified ethnicity received the first dose of PREVNAR 13 (lot F65733, expiration date 01Aug2013), intramuscularly in the left deltoid, at 0.5 cc, once, on 07Dec2012 at 4 PM for cochlear implant. The patient had no prior medical history, no relevant drug history, no drug allergies and no family history. The patient had no adverse events following prior unspecified vaccination, had no vaccination within four weeks prior to 07Dec2012 and had no illness at the time of vaccination. Concomitant medication were not provided; the patient had no antipyretic prior to vaccination. The physician confirmed that, on 09Dec2012, the patient had experienced mild local redness (previously reported as local reaction to the shot). No treatment was required, no relevant tests, diagnostic tests or cultures were done, and the event did not result in an emergency room or doctor visit. The physician felt that the event, mild local redness, was related to PREVNAR 13. The pharmacist had reported that the patient should receive the 23-valent pneumococcal vaccine and asked if the patient could or could not have this vaccine, due to his previous local reaction. The patient recovered from the event on 12Dec2012. Follow-up (14Feb2013): New information received from a contactable Pharmacist via a sales representative includes: patient age group. Follow-up (26Mar2013): New information received from a contactable physician in response to the HCP follow-up letter includes: patient age, date of immunization, site of immunization and indication for PREVNAR 13, updated event details and clinical course, causality and outcome of event. Follow-up attempts completed. No further information expected.