chrisvoncsefalvay/vaers-outcomes huggingface dataset:
NOT FEELING WELL; VACCINE CAUSED SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (NOT FEELING WELL) and VACCINATION SITE PAIN (VACCINE CAUSED SORE ARM) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received 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 MALAISE (NOT FEELING WELL) and VACCINATION SITE PAIN (VACCINE CAUSED SORE ARM). At the time of the report, MALAISE (NOT FEELING WELL) had not resolved and VACCINATION SITE PAIN (VACCINE CAUSED SORE ARM) had resolved. Not Provided          No concomitant medications was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of NOT FEELING WELL and VACCINE CAUSED SORE ARM with HUMIRA was not provided for Humira.  No treatment drug details was reported.
Burning pain up to neck and back of shoulder blade itching. Swelling and increase warmth at site. Hard to touch 80 x 110 mm size.
Approximately one week after receiving the second dose of the vaccine my wife felt a pain in her left leg. The pain did not feel like a muscle pain and continued for a few days. She went to an urgent care and an MRI of her leg was conducted. She was diagnosed with a blood clot and has begun treatment. My wife is healthy, young and has no family history of blood clots prior to this incident.
After about 5 minutes after getting her Pfizer dose, she was pale. She vomited and was not able to see. EMS called and when they came they checked her blood pressure which was 74/49. EMS stayed with patient for another 20 minutes until the patient became better and was okay to return home with her mom.
patient said she developed redness, swelling and fever in the area where to vaccine was administered. she presented to the pharmacy 5 days since receiving the immunization and said it has been much worse, but still red, swollen, hot to the touch. she has been treating with tylenol.
I have arthritis in my hips and arthritis symptoms in my shoulders. I have neuropathia in my feet and tingling pains running down my legs. I need a right hip replacement which I am going in for very soon. I also have neurological symptoms with my memory.  03/02/2007 MR received from PCP spanning 02/1999-11/2004, including an orthopedic consult regarding the reported symptoms of arthritis and arthritis pain on 7/13/2004.  Lymerix given 3/23/1999, 4/22/1999 and 2/17/2000. Multiple OVs for Diabetes and HTN F/U, as well as for several injuries, rectal bleeding and UTI. OV of 8/26/2002 for c/o 1-2 month hx. of right shoulder pain.  Impression:  Frozen shoulder tx'd with Celebrex. OV 3/13/2003 with c/o elbow pain. Seen by orthopedic surgeon 6/29/2004 following a fall in January for which he is still complaining of pain.  Impression:  Synovitis of the hip 2' to mild degenerative arthritis.
Supraclavicular lymph node swelling in arm of injection (right); This is a spontaneous report from a contactable consumer, the patient. A 27-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the right arm on 18Mar2021 at 14:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included Ehlers Dalnos Syndrome type 3, postural orthostatic tachycardia syndrome, mast cell activation syndrome, hashimotos hypothyroidism, epilepsy, autoimmune chronic urticaria and angioedema on an unspecified date. The patient was on concomitant medications, names unspecified. The patient had known allergies to penicillin, cefazolin (MANAFACTURER UNKNOWN), hydrocodone; acitomenophen (VICODIN), and topiramate (MANAFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced supraclavicular lymph nodes enlarged on 24Mar2021. (Supraclavicular lymph node swelling in arm of injection (right) 6 days after vaccine). Treatment was not received for the events. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.   Clinical outcome of supraclavicular lymph nodes enlarged was not recovered.   No follow up attempts are needed. No further information is expected.
Chills, headache,  general ache for 1 day. Lymphadenopathy for 3 days.
Patient brother came in on 10/17/18 and stated that patient had a bad reaction to flu shot and patient went to ER for swollen left arm that has spread to her left side. Patient brother stated that MD stated that area is clogged and infected, and if it burst to bring patient back to ER. Patient brother stated that it is affecting her breathing, and MD wrote an Rx for doxycycline, MEDROL DOSE PACK, and albuterol HFA inhaler.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 17Nov2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Patient previously received a COVID-19 Vaccine. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course included no seriousness criteria reported. Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. It was reported that patient tested positive 4 days after negative test. But symptoms are mild.     The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Bloody nose, headache (same as first vaccine). My menstrual cycle started a week early (I?ve been obsessively charting for fertility reasons? I am like clockwork) and was full of large blood clots and painful.
This spontaneous report as received from a pharmacist refers to an 19 year old patient on an unknown gender. On an unspecified date in September 2002, the patient was vaccinated with the first dose of M-M-R II (lot # L040961, expiration date 19-OCT-2017) (dose and route not reported). The second dose of M-M-R II was administered on 20-MAY-2016 (lot # L040961 exp. 19-OCT-2017) and a third dose was administered on 14-JUN-2016 (L040961, exp. 19-OCT-2017). No adverse effects reported. Additional information has been requested.
At 7 days, a slight rash at the injection spot.  Spot hard and itchy.  Applied Cortisone (OTC) cream.
No additional information; patient received their first GARDASIL 9 vaccination at age 22, their second vaccine at age 24 and the patient is now 25 wanting to complete series; This spontaneous report was received from a pharmacist and refers to a 24 year-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On an unspecified date in 2018, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis.  On an unknown date in 2020, the patient was vaccinated (Inappropriate schedule of product administration) with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis.  At the time of reporting (reported as "now is 25"), the patient wanted to complete the series of vaccinations. No additional information was provided (No adverse event).
My son received his first Covid vaccination on  1/7/22. On 1/16/22 he was noted to have bright red, painful rashes behind both knees. On 1/28/22 he received his second Covid vaccination. He now is dealing with swollen, red and painful rashes behind both knees and now both hands and all fingers.
(1) 1-1-11 -  injection site grew to half-dollar size, was red, hard, raised, warm to touch & itching. (2) 1-3-11 had seizure & stopped breathing approx 6:45 AM - temp was only 102 degrees.
Rec'd Engerix-B inject 21FEB90, 21MAR90 & 20SEP90. On 22OCT90, Hepatitis B S Antibody was negative.
Haven't had a normal period since getting vaccine. First period was 15 days late, and every period since then has been every two weeks.
Within 2-3 minutes of receiving vaccines, the right thigh had a single indurated lesion at the injection site of 1x2cm with a large, blotchy erythematous flat lesion surrounding it. Varicella injection site. All 3 sites had erythema approx. 3-4 cm.
tested positive in at home test, went to Emergency out clinic; tested positive in at home test, went to Emergency out clinic; tired; sore throat; headache; runny nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Dec2020 as dose 1, single (Lot number: EL3246), in right arm, on 21Jan2021 as dose 2, single (Lot number: EL9261), on 17Aug2021 as dose 3 (booster), single (Lot number: EW0171), in right arm and on 10May2022 at 13:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Patient had no Known allergies. Patient had not received other medication in 2 weeks. The following information was reported: HEADACHE (non-serious) with onset 23May2022, outcome "not recovered"; RHINORRHOEA (non-serious) with onset 23May2022, outcome "not recovered", described as "runny nose"; OROPHARYNGEAL PAIN (non-serious) with onset 23May2022, outcome "not recovered", de-scribed as "sore throat"; VACCINATION FAILURE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant), outcome "not recovered" and all described as "tested positive in at home test, went to Emergency out clinic"; FATIGUE (non-serious), outcome "unknown", described as "tired". The events "tested positive in at home test, went to emergency out clinic", "sore throat", "headache" and "runny nose" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (23May2022) positive; (25May2022) positive; (04Jun2022) positive; (05Jun2022) positive; (06Jun2022) positive; (07Jun2022) positive. Therapeutic measures were taken as a result of vaccination failure, sars-cov-2 test positive, oropharyngeal pain, headache, rhinorrhoea, fatigue. On 23May started with sore throat, headache, runny nose, tested positive in at home test, went to Emergency out clinic on 25May and tested positive there. Pre-scribed Paxlovid for 5 days. Felt great after 2 days, continued taking all med, tested negative for 4 days, then tested positive again on Jun 4,5,6,7. I feel fine except very tired. Patient had not received treatment for ae.
I have had mild tinnitus (ear buzz) in my left ear from 2014. The onset of that had coincided with a flu shot I had taken then on the left arm. Since then the tinnitus had subsided to a tolerable level. I took the Pfizer Covid 1st shot on the right arm on 04/07/2021 9am. Other then mild fatigue, I was fine through the day. But that night at 3am, I woke up with significant tinnitus in my right ear. Over the next day it went away from the right ear but the tinnitus still lingered overall and was a little aggravated. Since then, it has now settled back in the left year but still at the aggravated levels it was back in 2014. Also, the left ear feels stuffed up as do my sinuses.
Pt had PNEUMOVAX at workplace (school) by pharmacy on 10/16/17. Came to clinic on 10/17/17 and was diagnosed with allergic reaction--right upper arm swollen, warm with red raised rash down into axilla.
extremely dizzy, especially in the morning and mid-afternoon/ past week her dizziness has gotten worse; erratic blood pressure that's high and low.; "as if her mind is all over the place."; nausea; headache; chills; was in bed for the first 24 hours.; extremely dizzy, especially in the morning and mid-afternoon/ past week her dizziness has gotten worse; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (extremely dizzy, especially in the morning and mid-afternoon/ past week her dizziness has gotten worse), HEADACHE (headache), CHILLS (chills), BEDRIDDEN (was in bed for the first 24 hours.) and CONDITION AGGRAVATED (extremely dizzy, especially in the morning and mid-afternoon/ past week her dizziness has gotten worse) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced DIZZINESS (extremely dizzy, especially in the morning and mid-afternoon/ past week her dizziness has gotten worse). On 04-Mar-2021, the patient experienced HEADACHE (headache), CHILLS (chills), BEDRIDDEN (was in bed for the first 24 hours.) and NAUSEA (nausea). On 11-Mar-2021, the patient experienced CONDITION AGGRAVATED (extremely dizzy, especially in the morning and mid-afternoon/ past week her dizziness has gotten worse), BLOOD PRESSURE FLUCTUATION (erratic blood pressure that's high and low.) and THINKING ABNORMAL ("as if her mind is all over the place."). On 04-Feb-2021, DIZZINESS (extremely dizzy, especially in the morning and mid-afternoon/ past week her dizziness has gotten worse) had resolved. On 04-Mar-2021, HEADACHE (headache) and BEDRIDDEN (was in bed for the first 24 hours.) had resolved. At the time of the report, CONDITION AGGRAVATED (extremely dizzy, especially in the morning and mid-afternoon/ past week her dizziness has gotten worse), BLOOD PRESSURE FLUCTUATION (erratic blood pressure that's high and low.) and THINKING ABNORMAL ("as if her mind is all over the place.") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information were not provided by the reporter. Treatment information were not provided by the reporter.   This case was linked to MOD-2021-209818 (Patient Link).
Diagnosed with COVID again; Diagnosed with COVID again; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4501159-00.  A 59-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Diagnosed with COVID again". The action taken for adalimumab was unknown.  The reporter considered "diagnosed with covid again" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and possible temporal association the causal relationship between the  reported events and  suspect drug  cannot be excluded. The case will be reviewed further with FU information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Throat closed, but not completely; injection site ached, joints started aching, difficult to think. By 3 p.m. cancelled the rest of my students for the day; cheeks swollen, eyes bloodshot. By 5 p.m. neck started to stiffen, took 1000mg Tylenol. At 5:30 called the Advice Nurse. At 6 Advice nurse calls back, back of throat is read and uvula is a little swollen. Nurse advises take a 25 mg of Benadryl and get to the ER. 6:55 arrived at ER; Benadryl already seemed to be helping. Face very hot, body very cold. 9 p.m. seen by a PA, chest sounds good, heart sounds good, decides I can go home. Difficult night sleeping; upper sinuses very swollen. 8 a.m. 10/17 throat is open, voice husky, upper sinuses still swollen, eyes swollen.
Fever 101.3 lasting around 36 hours; no treatment, resolved Redness/swelling/warmth on right anterior thigh around injection site; approximately the size of a half dollar, has gotten slightly bigger after 48 hours.
Patient received the Flu Quadrivalent vaccine; probably the egg-free version.  At 04:20pm, itching and swelling on left eyeeye swelled shut. Patient did not have other symptoms.  At 4:30pm, patient given Benadryl and it did not help. Took patient to urgent care, given a steroid injection IM around 5: 45pm and it did help. Patient given prescription for oral steroids (Prednisolone) for 3 days and antibiotic eye drops (Polymyxin b sulfate) to use of necessary.  Swelling began to decrease as night went on and today it is almost gone.  Patient went to see pediatrician and specified that it was an allergic reaction  A little bit of symptoms remain.   Pediatrician gave prescription to extend steroids for 2 more days if needed.
Within 2 hrs after the shot, it was sore and  the next day, my arm was very sore and no other symptoms. 2.30PM I went very tired and took 3 hr nap. Achy and tired and brain fog until 9.30PM. Then slept the whole night. 21Oct I was back to normal except for the arm soreness. The arm soreness after a week it was still sore and tender. Currently when I lay on my arm, it's still tender or sore. During the injection, she took it very slowly and injected it into my arm very slowly. Went to doctor for, I fell and hurt my wrist and hand on the right arm.
Felt sleepy. Patient usually wakes up at 6AM. Slept until 9AM the next day.; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Felt sleepy. Patient usually wakes up at 6AM. Slept until 9AM the next day.) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M02A and 032L20A) for COVID-19 vaccination.     Concomitant products included INFLUENZA VACCINE (FLU) for an unknown indication.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SOMNOLENCE (Felt sleepy. Patient usually wakes up at 6AM. Slept until 9AM the next day.). At the time of the report, SOMNOLENCE (Felt sleepy. Patient usually wakes up at 6AM. Slept until 9AM the next day.) outcome was unknown.            No medical history information was provided.   The patient received his booster dose of Moderna Covid-19 vaccine on 29-Nov-2022 (lot number : 939909)The patient received his booster dose in his left arm. Patient did not report any side effects or adverse reactions to his first dose or booster dose.  No treatment medication was provided.
Information has been received from a consumer concerning her daughter (age not reported) who on 14-MAY-2008 was vaccinated with a first dose of GARDASIL. On 17-MAY-2008, three days later the patient felt weak, was shaky, loss of consciousness and fainted. Medical attention was not sought. At the time of reporting it was unknown if the patient had recovered. Additional information has been requested.  07/04/2008 Reviewed PCP medical records of 5/14/08.  Vax record included but no Lot Numbers available.  Records reveal patient experienced major depression & insomnia for approx 6 mos on day of vaccination.  Started on psych meds & referred for counseling.  Had dropped out of school, stating financial concerns as part of depression. This is in follow-up information has been received from a consumer concerning her 20 year old daughter who on 14-MAY-2008 was vaccinated with a first dose of GARDASIL (lot number 600387/1967U) IM the left arm at 3:30PM. On 15-MAY-2008, the patient felt weak, was shaky, loss of concentration and fainted. Medical attention was not sought. On an unspecified date the patient had recovered. Additional information is not expected.
Received Moderna Vaccine #1 - 01/09/202-1 L arm.         Immediately tingling face, chest and arms, rush of nausea or warmth and face bright red. Also had sense of impending doom. Then by afternoon - nausea, diarrhea, chills, headache and fatigue. Injection site reaction        01/10/2021 - some improvement with return of lips tingling briefly        01/11/2021 - continue to improve        01/12/2021 woke vomiting, diarrhea, abdominal cramping, cold/chills, fatigue. Whole body aching. Heaviness in chest. Has not taken her temp but feels she may have a fever. No specific shortness of breath, cough. Injection site improving.        01/13/2021 - chest improved, min n/v/d, + fatigue and headache        01/14/2020 - fatigue and headache        01/15/2021 - headache        01/16/2021 - nasal congestion only
This case was reported by a physician via sales rep and described the occurrence of anaphylactic reaction in a 13-year-old female patient who received BEXSERO. Previously administered products included HPV vaccine (1st dose). Concurrent medical conditions included multiple allergies. Concomitant products included HPV vaccine. On an unknown date, the patient received BEXSERO. On an unknown date, 10 min after receiving BEXSERO, the patient experienced anaphylactic reaction (serious criteria GSK medically significant) and difficulty breathing. The patient was treated with EPIPEN. On an unknown date, the outcome of the anaphylactic reaction and difficulty breathing were recovered/resolved. The reporter considered the anaphylactic reaction and difficulty breathing to be probably related to BEXSERO. Additional details were received as follows: The reported concomitant dose of HPV vaccine was a subsequent dose of HPV vaccine. The patient did not experience an anaphylactic reaction with first dose of HPV vaccine. The patient was monitored for one hour at vaccination center and then sent home.