chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable pharmacist. A 71-year-old female patient of an unspecified race/ethnicity received PREVNAR 13 (Lot Number S58702, Expire date Aug2019, NDC number 0005197102), intramuscular at 0.5 ml single in the left deltoid on 03Oct2017 13:17, BOOSTRIX (Lot Number 7ZZ3Z, Expire date 30Nov2019, NDC number 58160084252), intramuscular at 0.5 ml, single in the right deltoid on 03Oct2017, both for immunization. Medical history included asthma. Concomitant medication included influenza vaccine (Lot Number UI848AB, Expire date 18Apr2018) intramuscular in the right deltoid on 03Oct2017 for immunization. On 03Oct2017, the patient experienced injection site was red and painful with outcome of not recovered, pain from her neck down to the injection site with outcome of unknown. The events injection site was red and painful were assessed as serious (IME) by reporter. Sender's Comments: Based on the information currently available, a contributory role of PREVNAR 13 towards the occurrence of "injection site was red and painful" cannot be fully excluded considering the known adverse event profile of PREVNAR 13.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 02-FEB-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # N013886, expiry date: 09-DEC-2018) (route: oral). The vaccine was exposed to a temperature of 9 Cº to 25 Cº (8.3Cº) for 1 hour 17 min, on 06-JAN-2018, 9 Cº to 25 Cº (11.5Cº) for 1 hour 59 min on 11-JAN-2018, 9 Cº to 25 Cº (15.6Cº) for 1 hour 33 min on 17-JAN-2018, 9 Cº to 25 Cº (11.9Cº) for 1 hour 2 min on 23-JAN-2018 and 9 Cº to 25 Cº (12.1Cº) for 1 hour on 30-JAN-2018. There was no previous temperature excursion. The call was because of a data logger. No adverse effects reported. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA004616: US-009507513-1802USA004629: US-009507513-1802USA004629: US-009507513-1802USA004636: US-009507513-1802USA004641: US-009507513-1802USA004647: US-009507513-1802USA004652: 1802USA004654: Original Case: 1802USA002182: US-009507513-1802USA004654: US-009507513-1802USA004658: US-009507513-1802USA004663: US-009507513-1802USA002182: US-009507513-1802USA004673: US-009507513-1802USA004686: US-009507513-1802USA004692.
Patient received incorrect dose. Correct dose was 0.5 mL subcutaneous. Per documentation, patient was given 0.1 mL subcutaneous (potential documentation error regarding route).
Dry mouth going on 5 weeks, specifically top and bottom gums front teeth area as well as raised bumps, non-painful, same area and burning sensation at corners of mouth.
Raised  red area in area of vaccination approximately  2 inch by 3 inch. warm to touch. itchy.
No adverse event, but per page 6 of Moderna EUA Providers Fact Sheet there is a need to report when "vaccine administration errors whether of not associated with an adverse event". Pharmacy gave Employee Health a vial of Moderna to administer vaccines with a manufacturer's expiration date of 09.25.2021. The second covid vaccination was administered to patient in her left deltoid at 10:25am on 09.15.2021. After the vaccination was administered Pharmacy informed Employee Health that the 30 day expiration date was 09.03.2021, which Employee Health had no knowledge of prior to vaccination. No more doses were administered from this vial, it was returned to pharmacy. Writer informed patient of this information, and she had no adverse reactions.
Headache FATIGUE, CHILLS, SWEATING, LOSS OF APPETITE Narrative:
nausea; headache; physically tired; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset 10Mar2021, outcome "unknown", described as "nausea"; HEADACHE (non-serious) with onset 10Mar2021, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset 10Mar2021, outcome "unknown", described as "physically tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1/22/21 vaccinated, 2/4/21 pt woke up with rash on top of arm/shoulder
My left arm started to sting immediately after getting the shot, then the stinging subsided.  My left arm started to hurt later in the day and I had pain all the way down my left arm and left side of my chest. This pain throughout my left side was not helped by Ibuprofen and  made sleep very hard.  I had intermittent sharp pain in my neck, shoulder, and left arm for days.  The injection site turned red, hot, and a raised area the size of a silver dollar appeared  and was med-red in color for about 8 days.  The color is better/ almost normal as of today, but still a hard lump under the skin and a bit itchy.  This has caused pain throughout my back and shoulders since I got the shot....but it has not been activity limiting.  I had a slight bit of nausea for a couple of days as well.  My husband had his shot just after mine and experienced  Chills , headache, and nausea at about 9:00 P.M.  His chills subsided at about 3:00 A.M.  He continued with the headache for another day/ fatigue for 2 days/ and nausea for about 5 days.  He has also had tingling in his left arm (about 7 days)  and a funny tingling on his tongue for about a week.
Employee reporting adverse even pertaining to MMR II. Employee states that Provider reported that a woman in his practice received MMR II while pregnant or just becoming pregnant. Employee unable to provide full demographic informat; no additional adverse event; This spontaneous prospective report was received from a physician via company representative concerning a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered as prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided), while pregnant or just becoming pregnant (Maternal exposure during pregnancy). No additional adverse events reported.
Intussusception - surgery.  Child brought in with "funny breathing" & not eating. 10/9/08-records received for DOS 9/28-9/29/08-DC DX: Intussusception. Presented to PCP office on 9/26/08 C/O funny breathing, diarrhea, stools hard. Hemoccult. Vomited. Increased fussiness. Acute abdominal pain. Attempt to reduce with barium enema, partial reduction. Exploratory laparotomy and reduction of ileocolonic intussusception with severe mesentery adenitis. Pathology report mild reactive lymphadenitis.
Manufacturer: Pfizer ( drop down box wouldn't take it) Initial symptoms included extreme headache, and nose bleeds, daily. I did not realize the headaches were from high blood pressure, which was discovered when my husband put a home cuff on me and my blood pressure recorded 181/82 and continued to appear in the high range. I was unable to get a doctor's appointment until July. I have no previous high blood pressure history until about two months  after the second dose. Physician prescribed Lisinopril, 5 mg. Lisinopril in June 2021, which  was effective in lowering blood pressure but only to about 140/78.  In November the dose was increased to 10 mg and the blood pressure seems to be consisently in the 127/64 ish.
Presented to the ED with chief complain of fever, myalgia and noted low oxygen saturation. He was possibly exposed to the coronavirus at his bar during a hosted festival from 8/6-8/8 where one attendant called to inform him he tested positive to the coronavirus. His symptoms started with fever, myalgia, chills about 1-2 weeks prior to his admit on 8/24/21, In the ED, he was desaturating to the 50s and placed on a HFNC. His code status is DNR/DNI. He has received remdesivir, decadron, 2 doses of barticinib and therapeutic anticoagulation for being at high thrombotic risk from the coronavirus infection.  Patient was managed in the ICU from the time of admission. On the night of 9/5/21 patient became hypotensive and not responding adequately to IV fluids. Patient was found to have asystole at 3:06 AM on 9/6/21. Pronounced dead at 3:06 AM.
Muscle Aches Muscle Pains Shooting pains down legs Loss of sensation to finger tips Fever of 102.5 Extreme lower back pain over lumbar spine Joints are weak Heart feels like it is racing Inability to control body temperature (Extremely cold-- > extremely hot) Headache Trouble breathing Inability to sleep
STILL HAD A LOT OF ITCHY SPOTS/LITTLE IMPROVEMENT ON ELBOWS BUT NONE ON LEGS; VERY MINOR FATIGUE; ACHY ARM AFTER COVID VACCINES; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (STILL HAD A LOT OF ITCHY SPOTS/LITTLE IMPROVEMENT ON ELBOWS BUT NONE ON LEGS), FATIGUE (VERY MINOR FATIGUE) and VACCINATION SITE PAIN (ACHY ARM AFTER COVID VACCINES) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced PRURITUS (STILL HAD A LOT OF ITCHY SPOTS/LITTLE IMPROVEMENT ON ELBOWS BUT NONE ON LEGS), FATIGUE (VERY MINOR FATIGUE) and VACCINATION SITE PAIN (ACHY ARM AFTER COVID VACCINES). At the time of the report, PRURITUS (STILL HAD A LOT OF ITCHY SPOTS/LITTLE IMPROVEMENT ON ELBOWS BUT NONE ON LEGS), FATIGUE (VERY MINOR FATIGUE) and VACCINATION SITE PAIN (ACHY ARM AFTER COVID VACCINES) outcome was unknown.            Concomitant medication was not reported.  Patient might have experienced very minor fatigue, achy arm after COVID vaccines. Patient had very minimal improvement since being on Humira. Still had a lot of itchy spots. Little improvement on elbows but none on legs. Treatment details were not reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 14-JUN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml injection, lot # L044917, expiration date 05-OCT-2018 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to two temperature excursions (dates unspecified): one lasting for 72 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-0.555555556 degrees Celsius) and another lasting for 144 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Clotting disorder (the patient only had a blood clot 16 years ago after a 40hr. flight).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Achy). The patient was treated with HEPARIN for Clotting disorder, at an unspecified dose and frequency and APIXABAN (ELIQUIS) for Clotting disorder, at an unspecified dose and frequency. At the time of the report, PAIN (Achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.   This case was linked to MOD-2021-402885, MOD-2021-398618 (Patient Link).
evening fever, chills, body aches all over , dizzy,sick,tried,headaches  diarrrha and still having head ache and dizzy and diarrhea
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 infection) 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. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced COVID-19 (COVID-19 infection). At the time of the report, COVID-19 (COVID-19 infection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication reported. No treatment medication reported. Patient was not sure about when to get their booster. Company Comment: This case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the unexpected event of COVID-19. The event occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the unexpected event of COVID-19. The event occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Left arm muscle pain, Generalized pain to back, arms , and all over, dizziness, Yesterday after leaving the hospital I felt, hot (face flushed), then chills last night.
Flu like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose received: More than 3 (UNSPECIFIED MANUFACTURER and dose number)), for COVID-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 10Oct2023, outcome "recovered" (Oct2023), described as "Flu like symptoms". Therapeutic measures were not taken as a result of influenza like illness. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Headache, Diarrhea, shivering, chills,fatigue Narrative:  Pt reported severe diarrhea, shivering, chills, headache, fatigue after dose #2 of covid vaccine. Pt treated with ibuprofen.
A 55 yr old female with a medical history of rheumatoid arthritis received an injection of Fluzone SV 2005 2005 USP, lot number U1745AA, on 14Oct05. The route and site of vaccination were not reported. Within 45 minutes, she complained of tightness and a strange feeling in her throat. The pt also vomited. Per the reporter, the pt has had annual previous doses of Fluzone. There was no information regarding adverse events related to prior vaccinations. She denied illness at the time of vaccination and had no known allergies. The pt takes the medications Remicade, Fosamax, Methotrexate, Prednisone, Indocin and Folic acid. At the time of this report, the pt had not recovered. This case is linked to case number 200502114. (OMIC)
This spontaneous report as received from a consumer reporting on herself a 42 year old female patient with frequent bronchitis and environmental allergies and medical history of sinusitis and pneumonia who on 01-FEB-2013, was vaccinated with PNEUMOVAX23, (lot # not provided) 0.5 ml in the left arm for low pneumococcal levels. Concomitant therapies included LEXAPRO, NASONEX and vitamins (unspecified). The patient stated that on 01-FEB-2013 the same evening that received PNEUMOVAX23, she started to experience pain in her injection arm. She states that over the following two days, her arm began to swell and turn red. She also began to experience a fever of 101 F and 102 F; there was an area of hardness that was about 5 inches by 3 inches, extending down towards her elbow on the injection arm. She reported that she had been having difficulty lifting the effected arm. Also she state, It got so bad that she called her physician's emergency number, and he prescribed KEFLEX. She reported that her symptoms have been improving since she has started taking the KEFLEX. AT the time of the report she was not fully recovered, and she would be going to her physician for a follow-up at an unspecified date. No additional information currently available. She was agreeable to contact with her physician for follow-up information. The relatedness for events were unknown for PNEUMOVAX23. Additional information has been requested.
1/16 AM numb tingling tongue. Radiating pain jawline. 1/16 (evening after 9 PM) extreme pain right ear. Some jaw pain. 1/17 2:00 AM extreme pain in back of head right eye and forehead awakened. 7:00 AM onset paralysis.
Narrative:  Pt experienced "extreme weakness" after 3rd dose of  COVID vaccine (Moderna). Of note, no reported intolerance or ADRs  for the first 2 doses.
About 5 hours after receiving the vaccine, I started having pain in my left shoulder (I couldn't lift my arm at all) and excruciating pain in my right knee and hip.; About 5 hours after receiving the vaccine, I started having pain in my left shoulder (I couldn't lift my arm at all) and excruciating pain in my right knee and hip. It was so bad, I couldn't step on my right leg.; About 5 hours after receiving the vaccine, I started having pain in my left shoulder (I couldn't lift my arm at all) and excruciating pain in my right knee and hip. It was so bad, I couldn't step on my right leg.; About 5 hours after receiving the vaccine, I started having pain in my left shoulder (I couldn't lift my arm at all) and excruciating pain in my right knee and hip. It was so bad, I couldn't step on my right leg.; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 26Apr2021 at 08:45 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient no known allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Apr2021 at 14:00, about five hours after receiving the vaccine, the patient started having pain in her left shoulder (she couldn't lift her arm at all) and excruciating pain in her right knee and hip. It was so bad, the patient couldn't step on her right leg. The pain started decreasing after about 24 hours, went away all together after three days on 29Apr2021. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events about five hours after receiving the vaccine, the patient started having pain in her left shoulder (she couldn't lift her arm at all) and excruciating pain in her right knee and hip; it was so bad, the patient couldn't step on her right leg; the pain started decreasing after about 24 hours, went away all together was resolved after three days on 29Apr2021.   No follow-up attempts are needed. No further information is expected.
1/5/21 PT was vaccinated. 1/16/21 arm became red/itchy/swollen at vaccination site.
on 4/13/2021 patient had his 2nd dose of moderna vaccine and his symptoms included:  fatigue, myalgias, daytime somnolence, and lack of mental clarity.  he feels lots of pain, of burning in nature, to his b/l lower extremities.    the above actually happened after his allergy shots which was given after his 1st covid-19 shot, but these symptoms became more accentuated after his 2nd MODERNA vaccine
Moderna COVID-19 Vaccine EUA:  patient reports chest pain for a few days and a seizure just prior to arrival in the emergency department. Observed, NSAIDs provided, and will be managed as an outpatient.
16 year old patient rec'd Fluzone High Dose, no treatment necessary, no adverse reaction.
Injection site pain, redness, swelling, chills & low grade fever. (Covid-19 Booster received on Monday, 10/4/2021 at 0850.  At night, my right deltoid injection site started to be painful, Tylenol PM 100 mg at 2130 for pain and sleep. The following morning, 10/5/2021, more pain noted on injection site, +swelling and redness to the site, Tylenol 1000 mg taken at 0700 for pain before going to work.  In the afternoon 10/5/2021, at around 1430 chills noted. Home by 1700 checked temperature at 1730 = T38.2, Tylenol 1000 mg  taken for fever and pain).  10/6/21 morning-No more fever but will with pain, redness and swelling on the right arm/deltoid injection site.
A non-serious, spontaneous report of partial dose given was received from a nurse concerning a five year-old female subsequent to FLUMIST. On 19-Nov-2008 the patient received a full dose in one nostril and pulled away during the dose to the second nostril. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.
4-5 cm lesion with hard red center, lump under skin, itching at injection site. Received antibiotic Cephalexin