chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My left arm was very sore , red and hurting pretty bad. I went to bed around 10:00pm thinking everything was ok and it was a normal reaction. Woke up around 1:30am arm hurting so I got up to get some more tylenol. I immediately felt sick to my stomach (both ways) and I passed out and broke my nose.  I was coherient at times and other times I could not seem to answer any questions. My husband got me to the ER and they took my blood pressure 4 or 5 times and the nurse said "I can't get a blood pressure". Another nurse came in and said we will take this one ! My blood pressure had bottomed out and caused all sorts of things going on. I left ER after 4 1/2 hrs. with a BP of 107/57 but I am not sure how low it got! At one point my husband looked at monitor and my bottom number was 39 but it is all a blur to me. As of today I still feel week (heavy arms) and I am concerned about taking my second dose!
This spontaneous report as received from a pharmacist refers to a 28 year old male patient. On an unknown date the patient was vaccinated with M-M-R II lot # L009213 for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On an unknown date the patient experienced measles antibody negative, rubella antibody negative and mumps antibody test negative. The outcome of measles antibody negative, rubella antibody negative and mumps antibody test negative was reported as not recovered/not resolved. Additional information has been requested.
T- 100.3, severe body aches, fatigue, unable to get out of bed all day.
Later in the evening, after my son received his vaccine, he just seemed not like himself. He told me he felt unwell, so I checked him, and he was warm. He had a fever that evening. I called the on-call doctor that evening who said to give him time and treat with ADVIL. With the medication, his fever went down, but would go back up as well. I would say that by late morning the next day, he was fine. Around four months after receiving the shot, more recently, in the last few months, he has been complaining of headache and belly aches. I don't know what it is from, but we have reached out to his doctor and done some blood work and will have a follow up in the next few days. They advised that we treat him with TUMS and probiotics with fiber to see if that would help his symptoms.
2nd dose pfizer vaccine was given to patient on 07/07/2021. We found out on 07/09/2021 vaccine was stored outside the recommended 31 day expiration window. We reached out to pt on 07/15/21 to get the 2nd dose again.
Eye twitching, facial muscle spasm after receiving the Flu vaccine (shot). Occurs throughout the day, multiple times. Same reaction occured last year at age 3 when he received the Flu Mist vaccination.  Reaction lasted a few weeks last year and then stopped suddenly.  Multiple tests were performed last year to rule out other illness.
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of VARIVAX, dose, route and frequency unknown. On 12-NOV-2010, the patient was vaccinated with improperly stored VARIVAX lot # 666851/0280Z, dose number 2. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Multiple falls; A spontaneous report was received from a healthcare facility staff memberconcerning a male patient of unknown age who received Moderna's COVID-19 vaccination (mRNA-1273) and experienced multiple falls.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 23 Jan 2021, approximately 18 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient was hospitalized for multiple falls.  The patient's wife stated that while in the hospital he tested positive for COVID.  Moreover, the patient's wife also tested positive for COVID-19 infection.   The patient was still in the hospital as of 17 Feb 2021.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event was unknown.; Reporter's Comments: This case concerns a male patient of unknown age, who was hospitalized for multiple falls, 18 days after the administration of first dose of mRNA-1273. The patient tested positive for COVID-19 while in the hospital. Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
falling asleep at work; swelling; hurt to blink; pain in his left arm; super tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (falling asleep at work), SWELLING (swelling), EYE PAIN (hurt to blink), VACCINATION SITE PAIN (pain in his left arm) and FATIGUE (super tired) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced SOMNOLENCE (falling asleep at work), SWELLING (swelling), EYE PAIN (hurt to blink), VACCINATION SITE PAIN (pain in his left arm) and FATIGUE (super tired). At the time of the report, SOMNOLENCE (falling asleep at work), SWELLING (swelling), EYE PAIN (hurt to blink), VACCINATION SITE PAIN (pain in his left arm) and FATIGUE (super tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. The patient used ice pack to help with the symptoms.
pt recv vax;exp abd cramping for several wk;med during pregnancy included vitamins;
Spike in blood pressure occurred 3-4 hours after injection (controlled by additional medication) and again the day after. Injection site became red and itchy within an hour of injection; redness has spread down the arm and continues to itch on day 3. This did not occur with first jab. Loss of appetite, fatigue, and brain fog,  the day of and next day.
Erythema on left thigh around injection site. No induration or tenderness. Warm to touch with itching.
Pt feeling lightheaded & sweaty 15 minutes after vaccination given.  BP 92/64 P64 Parents say she blacked out for a few seconds but did not fall.  She was transported per w/c to Observation area & laid down for 10 min.   BP 118/76 Pt discharged with parents w/o assistance.
Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event) in a 34-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown if patient had ever been diagnosed with/ tested positive for COVID-19.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023).    Concomitant medication was not reported. Vial size was reported as 10 dose vial. The vial was initially stored in the refrigerator on 14-MAR-2023. The vial did not undergo any temperature excursions. It was reported that HCP stated that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 patients on 15-MAR-2023. There was potentially a second lot number that was expired and was administered to patients on 3-MAR-2023, but HCP did not had any details on that event at the time of report.   Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
It was reported that 3- 4 days after receiving vaccine the pt's hair fell out. Pt had same experience with Hepatitis A & B vaccines, she lost 3/4 of her hair volume in 1998. Further information is requested.
52 yo   complains of continued pain  in the deltoid and shoulder at the intersection with the collar bone. Both herself and vaccinator were sitting. She does not recall atypical site placement. Pain onset  was about 6 hours later followed by dysfunction and ROM limitation due to pain. Pain has been 8/10 and currently 6/10 with motion and unable to lift things.  She self treated with heat and NSAIDs. She was seen in ER 28 OCT 20 and diagnosed myalgia and treated with Naprosyn and ice. She was refered to PT starting 21 DEC 20. She saw ortho who provided steroid injection 11 JAN 21.  Ortho referred to OT due to development of left lateral epicondylitis, and left carpal tunnel syndrome.She denies any history of injury to her affected  shoulder.  At this time she has substantial improvement in both pain and ROM, but not full resolution
My left jaw became very sore and the joint swelled to the point of being unable to chew, and my jaw was out of alignment so that my teeth couldnt meet.  I had only liquid or soft foods for the first few days.    After icing and ibuprofen for about 4 days I was able to eat solid foods again, and it gradually subsided and was resolved after about 7 days total.   I have never had TMJ before and still dont know why this happened.  The only thing different was the Shingrix vaccine I had gotten.
Vaccinated on Wednesday, 12/30/2020 about 1:30PM. The next evening, patient's arm started to swell and become hot and started to itch. She had a fever as well. She stated this continued until 1/5/2021.
Swelling, pain and red rash around injection site, about size of baseball; Swelling, pain and red rash around injection site, about size of baseball; Swelling, pain and red rash around injection site, about size of baseball; Swelling, pain and red rash around injection site, about size of baseball; dose 2 administration date=07Jan2021/ dose 1administration date=18Dec2020; This is a spontaneous report from a contactable healthcare professional (patient) reported for herself that a 30-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231) via an unspecified route of administration at right arm, on 07Jan2021 14:30 at single dose for COVID-19 immunisation. Medical history was none. Patient did not have COVID prior vaccination. Patient has no known allergies. Concomitant medications were not reported. Patient previously received first dose of BNT162B2 (Lot number: EH9899) on 18Dec2020 15:00 at left arm for COVID-19 immunisation at the age of 30 years old. The patient experienced swelling, pain and red rash around injection site, about size of baseball on 07Jan2021 16:00. No treatment received for events. Patient did not test COVID post vaccination. Patient did not receive other vaccine in four weeks. Outcome of swelling, pain and red rash around injection site, about size of baseball was recovering, outcome of other event was unknown.
Patient developed a rash on both arms, became itchy, nauseous.  Hydrocortisone cream was applied along with a dose of oral Benadryl.
Fast heartbeat (over 100 beats a minute), high blood pressure (161/81, tachycardia fluttering, and pounding heart (wife is an RN and confirmed).
Started at 3:30 pm on 2/26/21 with neck tightness and eye pressure. Approximately around 6:30 pm, experienced lip burning/numbness/swelling and facial swelling and drooping.  Went to ER  and given IV Benadryl and IV Pepcid. Discharged a few hours later.  All symptoms have since resolved.
Shot 2 PM Thurs - 24 hr later I felt very lethargic, slept 12 hrs straight - another 24 hrs and the area of shot became very warm - another 24 hrs area was very very very warm and swelled and turned bright red - took BENADRYL 1 day - all seems to slowly go away.
I am in menopause and haven't had a period in 9 months. I recieved an intense, heavy, and extremely painful period on May 16th.  I have not had such a painful period since my 20's. I needed to take pain medication and lie on an ice pack. The period lasted a week.
(R) deltoid/upper arm rash "like hives" 1/2 way down her arm, itching, warm to touch, extremely painful, bruising and hard spot down her arm, chills. TX: applied cold compress, Ibuprofen.
Headache; Chills; Body pain; Nausea; This is a spontaneous report from a non-contactable other-hcp (patient). A 25-year-old female patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL3248) in left arm intramuscularly on an unspecified date at single dose for COVID-19 immunization. Medical history included covid (if Covid prior vaccination: Yes). No known allergies. The patient's concomitant medications were not reported. The patient experienced headache, chills, body pain, nausea, all on 25Jan2021. No treatment received. Patient was not pregnant. Unknown if Covid tested post vaccination. The outcome of the events was unknown.   No follow up attempts are possible. No further information is expected.
Vaccine administered on 09/27/2004.  Pt. experienced seizures on morning of 09/29/2004.  Ambulance was called and pt. was shocked by paramedics and taken to hospital. Nurse follow up on 10/05/04 states: "cardiac arrest; encephalopathy; unresponsive; renal failure; fever." Discharge Summary received on 12/15/2004 states pt experienced coma and pnuemonia.
04/13/2022 vaccination. 06/07/2022 I had an MRI in which I had to take off my mask and swap to the hospitals. 06/10/2022 I started to experience COVID-19 like symptoms. I tested positive at 03:00AM. I felt horrible. I immediately isolated, called my doctors the next morning, and had a second test at their office. 06/11/2022 second COVID-19 positive. Had antiviral medication as I could not take the PAXLOVID. I started feeling better within 36 hours after starting medication.
muscle pain, weak, sweats, stomach pain, headache, cant stomach anything, sore stomach,  vomiting, sweats, chills
pt recvd vax; fever of 101; was crying; to er & was given apap;
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 01Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in right arm, on 22Feb2021 as dose 2, single (Lot number: en6203) at the age of 67 years and on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing); "Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (06May2022) Unknown result, notes: Covid symptoms returned after 5 days of feeling better and symptom free. Adverse event start time: 01:00 PM. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid, treatment start date: 26Apr2022, treatment stop date: 30Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
A reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (A reaction) in a female patient of an unknown age 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 ADVERSE REACTION (A reaction). At the time of the report, ADVERSE REACTION (A reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information not provided   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2021: NNI- TCR form
passes out/unconscious; dizzy; sick to her stomach; very strange taste in her mouth/ thinking her mouth is bleeding, it tasted like blood; Allergic reaction; oxygen level was low; Blood pressure low; nauseas; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passes out/unconscious) in a 120-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 39A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passes out/unconscious) (seriousness criterion medically significant), DIZZINESS (dizzy), ABDOMINAL DISCOMFORT (sick to her stomach), TASTE DISORDER (very strange taste in her mouth/ thinking her mouth is bleeding, it tasted like blood), HYPERSENSITIVITY (Allergic reaction), OXYGEN SATURATION DECREASED (oxygen level was low), HYPOTENSION (Blood pressure low) and NAUSEA (nauseas). At the time of the report, LOSS OF CONSCIOUSNESS (passes out/unconscious), DIZZINESS (dizzy), ABDOMINAL DISCOMFORT (sick to her stomach), TASTE DISORDER (very strange taste in her mouth/ thinking her mouth is bleeding, it tasted like blood), HYPERSENSITIVITY (Allergic reaction), OXYGEN SATURATION DECREASED (oxygen level was low), HYPOTENSION (Blood pressure low) and NAUSEA (nauseas) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication not provided. Treatment included Intravenous (IV) fluid; 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.
On 12/23 around 2pm exp chills, higher temp than normal. My heart rate and BP was higher than normal lasted about a hour. I had to miss a day and 1/2 of work.
Hep A rec'd/(R) arm on 5-13-2011. 6/7/11 - 16 y/o c/o aches and pain -> (L) side facial paralysis 6/7/11 adm hospital Dx "Lyme Disease" 7/11 - 7/18 adm hospital Dx Guillain Barre.
Employee states "I received flu vaccine Tues 10/3 (L) arm and I woke up this morning and my arm hurts and feels numb". Full ROM present. Radial and brachial pulse positive. No redness or swelling present.
Husband began expressing "I'm tired" which was out of the ordinary on May 1, 2021.  Again on May 2 and 3.  On May 4 he was really weak, moving much more slowly than normal, complaining of sinus headache above left eye, sleeping longer and more than normal, brain fog and confusion, not able to do normal activities.  This impairment has continued through May 11 with no improvement from one day to the next.  Visited his Dr to get checked on May 11 due to our concern over how long this was lasting.   He has had no fever but some chills here and there.  Dr checked everything she could think of and requested blood tests which we have not heard about yet.  Extreme fatigue was the major symptom.  Today, May 12, he feels better, moving around faster and doing some normal activities but still tires easily and must rest.
pt recv vax 12FEB96 & 1JUN96 pt exp a gen rash w/approx 50 lesions not itchy;No further details were provided;
First dose / Rash appeared after 2 days; This case was reported by a physician via sales rep and described the occurrence of rash in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided are as follows: The age at vaccination was not reported. The patient got her 1st dose of Shingrix from pharmacy and doctor administered it and 2 day after vaccination, the  patient experienced rash. The reporter consented to follow up.
This spontaneous report was received from a licensed practical nurse refers to a 13 month old male patient. The patient had none pertinent medical history, concomitant medication and drug reactions or allergies. On 21-AUG-2018, the patient was vaccinated with first dose of M-M-R II injection, therapy type: rHA, lot # N025894 (expiry date: 19-SEP-2019), subcutaneously for prophylaxis (dose not provided), at physician's office. Approximately on 24-AUG-2018 (reported as "3 to 4 days afterwards"), the patient experienced hives, fever and cold symptoms. The patient made an unscheduled visit to the emergency room. The patient was treated with diphenhydramine (BENADRYL) liquid, (Lot number and expiration date unspecified) at a dosage of 3/4 teaspoon every 6 to 8 hours as needed. None lab diagnostics/studies were performed. On 29-AUG2018, the patient returned to physician's office for a follow-up examination and the patient was recovering. No product quality complaint (PQC) was involved. The reporter did not provide any causality assessment.
Developed chronic uticaria with dermatographia approximately 2 weeks post-vaccine (booster shot).   Symptoms include daily outbreaks of itchy wheals and hives.  Symptoms continue now  one month later.  Taking oral Zyrtec once daily 10mg and using Benadryl cream as needed for itching.  Zyrtec does not resolve completely but does help.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included ZINC, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and ASCORBIC ACID (VITAMIN C FORMULA) for an unknown indication.    On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.