chrisvoncsefalvay/vaers-outcomes huggingface dataset:
That evening, I started getting achy and chills and a bad headache. I already had vertigo history on and off from the last 10 years, but I never had it this bad. My fever was 100.4. My boyfriend was worried about me. That night, chills, aches, and weird nightmares. When I got up in the morning, my body ache and I felt stiff. I was super dizzy with vertigo when I moved or stood up. My temp was 101. I treated temperature and aches, started with Aspirin, and then changed it to Ibuprofen. I slept and continued to have the bad aches and my fever went up to 102 over the next 48 hours. The horrible nightmares started to subside and the stiffness in body in about three days, but I slept for four days - off and on. The vertigo got worse though as time went on. It was really bad the first couple of weeks, and then it subsided a little bit, but it hasn't gone away. It wakes me up in the night when I turn over. My head spins and I have fallen a couple of times getting up to go to the bathroom. If I give it a minute, it will ease up, but if I get up in the night with it, I will fall. It's still happening and it's still worse than when I had it previous to the vaccine, but not as bad as it was initially.  I have an audiologist I could go to for the vertigo, to move the crystals in my inner ear,  have to sleep sitting up for 48 hours, but it doesn't ever last. I haven't done that yet, because it seems like it's getting better gradually as time goes one.   Note: I had a flu vaccine two weeks after the dose of this vaccine. I didn't have any problems after that, and I didn't notice a worsening of any of my symptoms I have noted here.
A physician reported the occurrence of polyarthritis in a 39 year old male who was vaccinated with Lyme disease vaccine recombinant OsaP (Lymerix) for prophylaxis.  The subject's medical history, concurrent conditions, and concurrent medications were not reported.  On 06/07/1999, the subject received his first injection of Lymerix (Lot # 063364621).  In July 1999, the subject developed polyarthritis.  In October 1999, the subject received his second injection of Lymerix (Lot # 10652838).  On unspecified dates, the polyarthritis worsened and was treated with "high-dose" antibiotics.  As of 02/21/03, the polyarthritis persisted, but seemed to be improving "a little".  The subject believe that Lymerix administration was "the cause" of the event.  The Lymerix immunization series was discontinued.  Comment: The reporting physician stated that the lot numbers for the Lymerix injections were 063364621 and 10652838, respectively.  However, these are not valid lot numbers.
NAUSEA; MUSCLE SORENESS  (NECK, SHOULDERS AND BACK); FEVER; HEADACHE TURNED INTO A MIGRAINE; DIZZY; SENSITIVE SKIN; FEEL TIRED/FATIGUE; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: Patient had no known drug allergies and did not had any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: 21-SEP-2021) dose was not reported, administered on 13-SEP-2021 09:30 for prophylactic vaccination. No concomitant medications were reported.  On 13-SEP-2021, the patient experienced headache turned into a migraine. On 13-SEP-2021, the patient experienced dizzy. On 13-SEP-2021, the patient experienced sensitive skin. On 13-SEP-2021, the patient experienced feel tired/fatigue. On 14-SEP-2021, the patient experienced nausea. On 14-SEP-2021, the patient experienced muscle soreness (neck, shoulders and back). On 14-SEP-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.32 F, 99.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feel tired/fatigue, dizzy, headache turned into a migraine, sensitive skin, nausea, muscle soreness (neck, shoulders and back), and fever. This report was non-serious.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027a21a) for COVID-19 vaccination.     Previously administered products included for Anaphylactic reaction: Flu vaccine. Past adverse reactions to the above products included Anaphylactic reaction with Flu vaccine.    On 10-Mar-2021, 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 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) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact
Covid positive on Monday; Covid positive on Monday; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient received BNT162b2 (BNT162B2), in Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant) all with onset Apr2022, outcome "unknown" and all described as "Covid positive on Monday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, sars-cov-2 test positive.  Clinical Course: The patient was treated with PAXLOVID for COVID-19 and started experiencing Tinnitus which led to disability/permanent damage.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, Myalgia & SkinRash Narrative:  Other Relevant History:
This spontaneous report was received from a female consumer of unknown age, referring to herself. Neither medical history nor concurrent conditions were reported. On 14-NOV-2014, the patient was vaccinated with ZOSTAVAX, subcutaneous injection (lot number and expiration date not reported) at an unspecified pharmacy. No concomitant therapies were reported. On 21-MAR-2015, 128 days after onset of therapy, the patient experienced a seizure (medically significant) and was admitted overnight at an unspecified hospital. Next day, on 22-MAR-2015, she had another seizure (medically significant) at the hospital and an electroencephalogram (EEG) was performed, which detected seizure activity. At the time of the report, the outcome of the first seizure was considered as recovered, but for the second seizure event was unknown. The reporter's causality was not provided for the reported events. No fatal consequences nor product quality complaints were reported, nonetheless, the patient declined to participate in answering questions related to the present report. Additional information has been requested.
Chills; muscle aches; Joint pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), MYALGIA (muscle aches), ARTHRALGIA (Joint pain) and HEADACHE (Headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 CHILLS (Chills), MYALGIA (muscle aches), ARTHRALGIA (Joint pain) and HEADACHE (Headache). At the time of the report, CHILLS (Chills), MYALGIA (muscle aches), ARTHRALGIA (Joint pain) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medicines was not reported by reporter   treatment information was not provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments   Reporter did not allow further contact
This is a spontaneous report from a contactable consumer based on information received by Pfizer from agency (manufacturer control number US-AMGEN-USASP2016159593), license party for etanercept (ENBREL). This non-serious spontaneous report (USASP2016159593) was reported to agency on 10Nov2016 by a consumer and involves a 85 year old female patient who experienced her arm was red at the injection site of the PREVNAR 13 injection, arm was burning at the injection site of the PREVNAR 13 injection, and itching at the injection site of the PREVNAR 13 injection while receiving etanercept (ENBREL, Lot # 1071265, exp date 30Apr2018)). No historical medical condition was reported. The patient's current medical condition included Psoriatic arthritis. No relevant concomitant medications were provided. Co-suspect medication included PREVNAR 13 for immunization. The patient began Enbrel on an unknown date. On 02Nov2016, the patient reportedly received a PREVNAR 13 vaccination single dose in her right arm. On 07Nov2016, she administered her ENBREL injection in her right thigh. The patient went to the physician for an examination. On 08Nov2016 Tuesday, the patient's arm was red, with burning and itching at the injection site of the PREVNAR 13 Pneumococcal injection. The patient placed ice on the injection site and it helped a bit. Treatment for the events injection site erythema, injection site pain, and injection site pruritus included placed ice. The outcome of the events injection site erythema, injection site pain, and injection site pruritus were reported as unknown. Action taken with ENBREL was reported as unknown. The causal relationship between the events and the product Enbrel was not provided by the consumer.
Several minutes after the shot, had a burning and shooting  pain from cervical to lumbar spine that lasted < 1 minute. Possibly unable to walk, but was standing at the time.
Severe gout like symptoms in left foot big toe joint began 4.5 days after injection.  I am currently on day 4 of pain and swelling
Headache time to time; Arm keeps hurting after the injection/ Unable to use arm daily/ Site of injection still sore/ Arm sore, can not raise or sleep on arm; Site of injection still sore/ Arm sore, can not raise or sleep on arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm keeps hurting after the injection/ Unable to use arm daily/ Site of injection still sore/ Arm sore, can not raise or sleep on arm), VACCINATION SITE PAIN (Site of injection still sore/ Arm sore, can not raise or sleep on arm) and HEADACHE (Headache time to time) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm keeps hurting after the injection/ Unable to use arm daily/ Site of injection still sore/ Arm sore, can not raise or sleep on arm) and VACCINATION SITE PAIN (Site of injection still sore/ Arm sore, can not raise or sleep on arm). On an unknown date, the patient experienced HEADACHE (Headache time to time). At the time of the report, PAIN IN EXTREMITY (Arm keeps hurting after the injection/ Unable to use arm daily/ Site of injection still sore/ Arm sore, can not raise or sleep on arm), VACCINATION SITE PAIN (Site of injection still sore/ Arm sore, can not raise or sleep on arm) and HEADACHE (Headache time to time) had not resolved.            No concomitant medications was provided. No treatment medications was provided.  The patient's ethnicity was reported as EXACT .  Patient was prescribed with steroid injection, but refused to take it. The patient was unable to use arm daily, had to sleep in certain position with arm, site at injection site was still sore and was unable to hold arm any longer.  On 29-Jun-2021, the patient visited the physician's office for arm sore, can not raise or sleep on arm.   This case was linked to MOD-2021-263574 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Race information were updated, product dose information was added, adverse events verbatim, start date and events outcome was updated; 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.
6 hours following administration of the 1st dose in the Moderna COVID-19, patient experienced tongue swelling and felt small bumps on the top of her tongue. There was no pain with the event. The patient has experienced this event 1 time prior, at the time of onset/diagnosis of Hashimoto's disease; this was diagnosed in July 2017. Her thyroid levels were last checked in December 2020, . 1 hour after she noticed her tongue swelling, patient took 50 mg  diphenhydramine PO and went to bed. When she woke up the next morning, the swelling had resolved.
We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.  On 24-Sep-2021, the vial was initially stored in the refrigerator. 4 vials (15 dose). 44 doses were used.
Pt received immunizations on 3/1/00, on 3/11/00 pt broke out in a rash on thighs, spreading to arms, by 3/12/00 they were welt like. Had rash back in 9/99 but never correlated with Hep B vaccine.
I took the shot around 11:00 am and was sleep by 8pm. I slept 17  1/2 hours straight. I was very tired. I was awake for 3 hours and then went back to sleep for  12 hours.  Sleeping this must is not normal for me. It took 3 days for me to feel normal. I has extremely tired and my head was very foggy.
The day after my son recieved the varicella vaccine in the morning he told me that he was itchy. I saw his hand where he was itching and there were 3 red dots that initally were small enough to be a flea bite. I checked my dog for fleas and cleaned his bedding and all around the house. The next day morning several red dots appreared to be on his arms and legs that again were itchy. Since then, they have not gone away and have gotten bigger in size. They are very itchy for him. I took him to his pediatrician so they can check them. AS of today they are big in size and very itchy. Everyday he has been getting more.
Awoke on 10-20-2010 at 6:00 AM and was having light headedness and dizziness.  Stated that when he would turn his head to the right or left he felt like his brain was whirling around and felt like his brain was on a merry-go-round.  Had a staggered gait.  Stated as the day when on he decided to take 2 Benadryl tablets in the late afternoon and did feel better after taking Benadryl.  On 10-21-2010 he states that he feels maybe better, has not noticed a problem with his gait, but continues to have dizziness especially lying down on his right side.  States his brain, while he lies on his right side still feels like it is whriling around.  This writer encouraged him to see his physician or be seen in an emergency room.  He stated he would be seen if he does not feel better by tomorrow, 10-22-2010.  Was instructed that if symptoms become worse, to be seen before 10-22-2010.  Understanding voiced.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions of the patient were reported. On 10-AUG-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) injection (Lot number: L006390 and expiry date: 25-AUG-2016) (dose, frequency and route not reported). No concomitant medications were reported. No adverse experiences were reported. The outcome of incorrect product storage was unknown. No product quality complaint (PQC) was filed. This is one of the several reports of the same reporter. Additional information has been requested.
Vaccine area became red and slight puffy on 01/20/2021 and of arm  01/23/2021 back near neck area on right began to itch. a cluster of bumps appeared. By end of day they had spread and become red and inflamed.  Went to urgent care and his diagnosis was  shingles. prescribed  Valacyclovir 500 mg tablets for 7 days/ 3x daily  I had taken the first covid 19 vaccine on the 20th . Dr said i should report this occurance.  my next vaccine is scheduled for 02/0
Large lump on R/arm for 2 days following injection. 2 days later large lump developed in r/arm pit, lt breast, joint pain, temp of 101-102 for 4 days. Lump in arm returned. UA showed protein, bilirubin and WBC's.
I developed and still have Sweet's Syndrome. Onset 6/1/19 to present.
While in Recovery c/o dizziness, light headed, arm tingles. Became pale. Wheeled to private recovery area. VS taken 102/72; HR 160  strong reg, resp 12 reg non labored; SPO2 99%. Gave water for hydration. Within 5 min color back to face. Pt stated feel better just arm tingled. Encouraged to wait 30 min to monitor. Provided reassurance. OK to leave with boyfriend after 30 min.
When I injected vaccine all vaccine ran down pt arm due to the needle being defective. As I  pulled the needle out of pt arm the needle seperated from the hub and the needle stayed in pt arm. I had to pull th needle out of his arm. ob
A couple hours after the vaccine I got really nauseated and felt an itching sensation on my neck and throat area, my mouth was swollen up resulting in me having trouble breathing and I just didn't feel right. I looked in the mirror and saw a horrible rash on my chest and took 2 Benadryl pills. I begin wheezing, had to use my inhaler and waited another 15 minutes but had to take another Benadryl pills and shortly after the rash faded down, the wheezing went away and the swelling went down. I used the Albuterol inhaler again and laid down. About 6-8hrs later the rash came back. I then took another 2 Benadryl pills and the rash went down again but returned again resulting in me taking another Benadryl pill again and drinking plenty of water. Then the rash went down again, but now it's like it went under the skin and is not raised anymore but look more of a heat rash now but it is getting better.
This spontaneous report as received from nurse refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA lot # N005274, expiry 03-APR-2018 (dose and route not reported) for prophylaxis. No adverse effects reported. No additional information was provided. Temperature: 32 F to 35 F. Time frame: 30 minutes. Data logger was used. Previous temperature excursion? Yes 32F to 35F (34.6F) for 5 minutes, 32F to 35F (35.1F) for 30 minutes. This case is one of the 3 reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1707USA004978: US-009507513-1707USA009024.
My adverse event  started on 03/07/2023 in the afternoon. I had a headaches which was 8/10 in a scale. I took Tylenol but it didn't go away. I had a high blood pressure which was 220/110. I called my doctor in the afternoon around 1:00pm because of the headaches since, his office was booked up I wasn't able to see him. On 03/09/2023 I went to the Urgent Care they did full Blood Work, EKG, and Urine test. EKG was normal. The doctor prescribe me Amlodipine 5 mg. I also did a follow up on 03/11/2023 my headaches were gone and blood work / urine test came out to be normal.  He told me to call my doctor and follow up with him within 1-2 weeks.
Information has been received from a medical assistant concerning a 33 year old female who on 01/08/2003 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent.  On 01/10/2003 the patient returned to the physician's office with cellulitis, body aches and chills.  It was reported that on 01/08/2003 the patient's white blood cell count was 6.1.  On 01/10/2003 the patient's white blood cell count had increased to 18.9.  On 01/13/2003 the patient contacted the office and reported that her condition had improved but she still had some itching in the area of the cellulitis.  Additional information has been requested.
swelling under his armpit; Lymphadenopathy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 42 year-old male patient received bnt162b2 (BNT162B2), administration date 07Dec2021 (Batch/Lot number: unknown) as dose 3 (booster) , single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose:1), for COVID-19 Immunization; Bnt162b2 (dose:2), for COVID-19 Immunization. The following information was reported: SWELLING (non-serious), outcome "unknown", described as "swelling under his armpit"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Lymphadenopathy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever, body aches, headache, nausea, upset stomach, overall body fatigue..  Most adverse effects lasted about 10 hours and all gradually wore off on their own within 24 hours onset.
I have a large bruise, 3" by 1.5", around the injection site and a red patch, about 2" by 1", below the site. By the 3rd day, it itched a lot and on the 4th day is more sore.  The pharmacist said he hasn't seen a reaction like that.  I'm not allergic to eggs and have never had a reaction to a flu shot.  I hope it's not a bad batch of flu shots. I decided to report this because of other instances where the medications have been tainted.
left shoulder pain; pain in left armpit; general fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 15Mar2021(at the age of 53-years) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced left shoulder pain, pain in left armpit, and general fatigue on 16Mar2021. The events were assessed as non-serious. These side effects lasted until approximately 6 pm on 16Mar2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained