chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu like symptoms; Fever; Started feeling sick from the next day; no appetite; hypersomnia sleepy at work; blurred vision; inability to go exercise therapy because his muscles are too weak; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Started feeling sick from the next day), INFLUENZA LIKE ILLNESS (Flu like symptoms), DECREASED APPETITE (no appetite), HYPERSOMNIA (hypersomnia sleepy at work) and VISION BLURRED (blurred vision) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included TEMAZEPAM (RESTORIL [TEMAZEPAM]) and CLONAZEPAM for Sleep disorder, OMEPRAZOLE for Stomach discomfort, DEXTROAMPHETAMINE [DEXAMFETAMINE] for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021 at 4:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced ILLNESS (Started feeling sick from the next day), DECREASED APPETITE (no appetite), HYPERSOMNIA (hypersomnia sleepy at work), VISION BLURRED (blurred vision) and MUSCULAR WEAKNESS (inability to go exercise therapy because his muscles are too weak). On 06-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever). The patient was treated with ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. On 01-Apr-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever) had resolved. At the time of the report, ILLNESS (Started feeling sick from the next day) had not resolved and DECREASED APPETITE (no appetite), HYPERSOMNIA (hypersomnia sleepy at work), VISION BLURRED (blurred vision) and MUSCULAR WEAKNESS (inability to go exercise therapy because his muscles are too weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and 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.   The patient had been sick, no appetite, hypersomnia sleepy at work, blurred vision, inability to go exercise therapy because his muscles was too weak.   This case was linked to MOD-2021-218567 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up received: New events (blurred vision and muscular weakness) were added.
Achy joints; tiredness; Sore arm where injection site; This is a spontaneous report from a non-contactable consumer (patient). A 65-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: En6204, expiration date: not reported), dose 2 via an unspecified route of administration, administered in arm left on 04Mar2021 08:15 (at the age of 65-years-old) as DOSE 2, SINGLE for covid-19 immunisation at Hospital. The patient medical history was not reported. Concomitant medication included other mediation in two weeks (unspecified). Historical vaccine included that the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Em9810, expiration date: not reported) dose 1 via an unspecified route of administration, administered in arm left on 04Feb2021 08:15 (at the age of 65-years-old) as DOSE 1, SINGLE for covid-19 immunisation at Hospital. No other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination. On 05Mar2021 08:15, the patient experienced achy joints and tiredness, had sore arm where injection site. No treatment received for all the events. The outcome for all the events was recovering.  No follow-up attempts are possible. No further information is expected.
UPPER GASTROINTESTINAL ISSUES; SORE ARM AFTER COVID VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL DISORDER (UPPER GASTROINTESTINAL ISSUES) and VACCINATION SITE PAIN (SORE ARM AFTER COVID VACCINE) 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 Ulcerative colitis.    Concurrent medical conditions included Visual impairment and Ulcerative colitis.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jul-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose once a week. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced GASTROINTESTINAL DISORDER (UPPER GASTROINTESTINAL ISSUES) and VACCINATION SITE PAIN (SORE ARM AFTER COVID VACCINE). At the time of the report, GASTROINTESTINAL DISORDER (UPPER GASTROINTESTINAL ISSUES) and VACCINATION SITE PAIN (SORE ARM AFTER COVID VACCINE) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: Result elevated.         No relevant concomitant medications were reported.   The reporter's causality for the events of upper gastrointestinal issues, sore arm after covid vaccine with humira was not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was provided.  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.
slight headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (slight headache) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (slight headache). At the time of the report, HEADACHE (slight headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.   This case was linked to MOD-2021-301429 (Patient Link).
4 days after injection,  severe headache,  unresponsive to otc medicine,  stiff neck for more than 24 hours
two large lumps in his right breast; This spontaneous case was reported by a consumer and describes the occurrence of BREAST MASS (two large lumps in his right breast) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 013A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced BREAST MASS (two large lumps in his right breast) (seriousness criterion medically significant). At the time of the report, BREAST MASS (two large lumps in his right breast) outcome was unknown.            he noticed "two large lumps in his right breast" and he is "getting surgically removed" No concomitant medications were provided. Treatment medications was not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient reports: "I received my covid 19 vaccine on Friday April 9th (J&J) and need to report my reactions afterward. Had the usual immediate arm pain after injection along with nausea. Took a Benadryl and napped when got home and woke up 6 hours after injection with a tingling and swollen lower lip and constricted breathing. Took 3 Benadryl in fear of going to hospital and waited it out. Once lip went back to normal as well as breathing went to bed since it was late and slept all day Saturday. Woke up Sunday in agony from lower back pain and tailbone. Now, thurs 4/15 still in extreme pain in my tailbone. Went twice to chiropractor to help and nothing is alleviating the pain and have been practically bed ridden since Sunday. Can?t work, can?t sit, can?t walk can?t stand can?t anything without extreme pain. Been taking ibuprofen everyday and not helping."   She had a visit with us on 4/15/2021: "Patient here for extreme pain on her tailbone. She had the Johnson and Johnson vaccine about 6 days ago and about 6 hours later she woke up with a tingling and swollen lip, constricted breathing, and dizziness. She wanted to avoid the hospital, so she took benadryl 75 mg and it slowly resolved her symptoms. These symptoms have not returned since. She was finally able to fall asleep that night and then slept all day the next day. The following day she woke up and experienced extreme pain in her lower back and tailbone. She saw her chiropractor twice this past week, which helped to resolve her low back pain. Per patient her chiropractor noted that her back seemed very inflamed. However, she is still having extreme pain with her tailbone and is unable to sit, stand, bend or work for more than 20 minutes without extreme pain. The only thing that seems to improve her pain is laying on her back with several pillows tucked behind and all around her. However, she is only able to stay in this position for a period of time before her body becomes stiff from immobility. She has been taking ibuprofen 600 mg TID, flexeril PRN, icing and applying moist heat to her back, but none of these measures seem to improve her pain. Lastly she has noticed that when she sits/stands for too long, her buttocks start to spasm. Denies fever, chills, n/v, numbness, tingling, incontinence or loss of bowel/bladder function."
No hoarseness but did have body aches night of; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Feb2021 (Batch/Lot number: unknown) at the age of 41 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose, Batch/Lot no: Eh9899, Route: intramuscular, Time: 10 AM, Anatomical Location: Right Arm), administration date: 12Jan2021, when the patient was 41 years old, for Covid-19 immunization, reaction(s): "Body aches night of vaccine", "had lost voice (very hoarse) for a week after". The following information was reported: PAIN (non-serious), outcome "recovered", described as "No hoarseness but did have body aches night of". Therapeutic measures were taken as a result of pain. Additional information: It was reported that the patient took Advil 800mg 16 hours after vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 27SEP95 & 6JUL96 pt devel chicken pox w/110 lesions, fever of 101 to 102 & appeared ill;18JUL96 pt exp itching;no fever noted;
Patient states had reaction directly after receiving vaccine with primary symptoms of headache and nausea, which was followed by major fatigue. The major fatigue, headache, and major nausea have continued from the date of receipt to today's date of 3/31/21 (13 days). The primary complaint is edema (swelling) which has made it so her shoes do not fit at this time and has been very discouraging to the patient. She has had similar responses to a Shingrix and Hepatitis A per the patient's statement as received from another pharmacy, but had recently recovered after months of diuretic (water-pill) therapy and appropriate electrolytes such as potassium.
Metallic taste in Mouth; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 03Sep2021 at 18:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to melons. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Jul2021 at 17:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 03Sep2021 at 20:00, the patient experienced metallic taste in her mouth. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event metallic taste in mouth was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a Licensed Practical Nurse and a Registered Nurse referring to multiple unspecified patients of unknown age and gender. Concurrent conditions and medical history of the patients were not reported. On unknown dates the patients vaccinated with improperly stored doses of oral, ROTATEQ (lot # K010325, expiry date 10-MAY-2016)(dose unspecified). Other suspect and concomitant therapies were not reported. No adverse effects were reported. This is one of several reports received from same source. Additional information has been requested.
Redness and tenderness of injection site same night; next afternoon about 3pm low-grade fever, listlessness. Occasional chills. After about 24 hours injection site felt slightly itchy on contact with clothing. 3 days after injection, the site of injection is still red and hot to the touch, but fever and chills are gone.
My friend got the shot in April,/ In November she got the Shingles really bad/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, between 6 and 8 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The patient got the shot in April and in November she got the Shingles really bad for about four months. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available. The case had been linked with US2021AMR187284 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR187284:same reporter
Noted immediately with vaccine there was pain that shot up through shoulder and to neck. Also had pain in shoulder area radiating down same arm which began same day. Neck, shoulder, and arm pain continues daily, area of vaccine still burns and stings even today. Arm is also easily fatigued and pain/discomfort is worse at night. She experienced numbness down left leg for 2 nights after vaccine but this has since gone away. Patient went to orthopedic doctor who did xrays with no significant findings. No treatment was ordered.  Patient follows up with him Oct 28, 2022.
lesions at the back of her throat; she is not feeling well; This is a spontaneous report from a contactable consumer (patient). A 33-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, mRNA, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 14Sep2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Sep2021, the patient experienced lesions at the back of her throat, she is not feeling well. Caller wanted to know if what she is experiencing is a reported side effect with the Pfizer COVID-19 vaccine. Caller also asked if it was okay for her not to see her doctor now because she called her doctor, and the doctor can't see her now. The outcomes of events were unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Over time I experienced increased Shortness of breath with activity, it became difficult to walk and stay active. I also experience chest pain and dizziness.
patient's husband called and said patient was experiencing swollen ankles and wrists and hives across body except for face. no local injection site reaction reported. advised patient to go to the doctor, and husband said he would take patient to urgent care. i will call patient tomorrow to follow up.
Bells palsy; fever blisters; got rash and pruritus all over the trunk; rash and itching all over the trunk; This spontaneous case was reported by a physician and describes the occurrence of BELL'S PALSY (Bells palsy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL, LISINOPRIL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), OMEPRAZOLE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), DULOXETINE, FOLIC ACID, VITAMIN A NOS, BALOFLOXACIN, VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]) and AMLODIPINE for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PRURITUS (rash and itching all over the trunk) and RASH (got rash and pruritus all over the trunk). On 28-Feb-2021, the patient experienced BELL'S PALSY (Bells palsy) (seriousness criterion medically significant) and ORAL HERPES (fever blisters). The patient was treated with PREDNISONE for Adverse event, at a dose of 15 milligram and VALACYCLOVIR [VALACICLOVIR] for Adverse event, at a dose of 1 gram. On 27-Feb-2021, PRURITUS (rash and itching all over the trunk) and RASH (got rash and pruritus all over the trunk) had resolved. At the time of the report, BELL'S PALSY (Bells palsy) and ORAL HERPES (fever blisters) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company comment : This case concerns a  77 year-old female subject, who experienced the unexpected event  of  BELL´S PALSY The event occurred three days after the first dose of mRNA-1273. The event was considered related to the product per the reporter's physician. The benefit-risk relationship of drug Spikevax mRNA-1273 is not affected by this report   Most recent FOLLOW-UP information incorporated above includes: On 02-Mar-2021: Upon internal review on 17-Sep-2021, case was unlocked to get company comment from MSAand removed event of facial paralysis , added new event rash; Sender's Comments: This case concerns a  77 year-old female subject, who experienced the unexpected event  of  BELL´S PALSY The event occurred three days after the first dose of mRNA-1273. The event was considered related to the product per the reporter's physician. The benefit-risk relationship of drug Spikevax mRNA-1273 is not affected by this report
Patient had adverse event/reaction to 2nd dose of COVID-19 (Pfizer) vaccine on Sat. 6/5/21 at about 245PM. Immediately after receiving dose, patient began to tremor eyes rolled back in head, stiffened body, slid down chair into indian style sitting. Nauseous. Called EMS.
Fatigue; Body aches; Headache; Weakness; This is a spontaneous report from a contactable Nurse (patient). This 28-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: Ek4176) intramuscular on 12Jan2021 11:15 at single dose on Left arm for covid-19 immunisation.  The patient was not Pregnant at the time of vaccination. The patient medical history and the concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number=Ej1685) intramuscular on 22Dec2020 at single dose on Left arm for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient experienced Fatigue, Body aches, Headache, Weakness on 13Jan2021 12:00 AM. The outcome was Recovering. No treatment received for the adverse event. All the events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.
Patient presented with isolated left facial nerve palsy  (Bell's Palsy) 24 days after receiving Pfizer/BioNTech Covid-19 vaccine. No other trigger identified. Unclear whether related. Started on prednisone taper.
I got Shingles a week after the vaccine. It lasted 4-5 months afterwards.
Cellulitis at Injection site.    Have had similar reactions to insect bites.   Hot to touch,  swollen.  radiated about 3 inches from center around.   I ended up drawing a circle around area on Saturday (1/11);  on Sunday I started the Moist Heat routine.   This is what I have had to do done in the past for my adverse reactions to spider bites.    Appears to be working...redness has faded,  only now it looks like a ringed target--similar to what the pictures are for tick bites.    Still warm to touch,  but appears to be improving.
This spontaneous report as received from a pharmacist refers to a 59 year old female patient with none of pertinent medical history and none of drug reactions/allergies. On 01-NOV-2013 the patient was intradermally vaccinated with a dose of 0.65 ml ZOSTAVAX (lot # J004270, exp. 12-JUL-2014). None of concomitant medication was reported. The patient felt it was given intradermally because it was given under the arm and because of "the sensation". The area was swollen, hot to the touch and there is tingling down an unspecified pinky finger which was transient and not there now. The swelling went down. The patient called pharmacist for seek medical attention. No treatment was given for AE. None lab diagnostics studies performed. Additional information has been requested.
EAR ACHES, TINNITUS, SORE THROAT (TINNITUS BEGAN AFTER SECOND SHOT); EAR ACHE BEGAN 20 DAYS AFTER SECOND SHOT; FATIGUE (NEED NAP IN AFTERNOON UNLIKE PRE-VACCINE);;BEGAN AFTER FIRST SHOT AND CONTINUES 20 DAYS POST SECOND SHOT