chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a patient who received SHINGRIX for prophylaxis. On 21st February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm, arm discomfort and mobility decreased. On 22nd February 2019, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the pain in arm, arm discomfort, mobility decreased and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the pain in arm, arm discomfort and mobility decreased to be related to SHINGRIX. Additional information was provided as follows: The age at vaccination was not reported. The patient received SHINGRIX the day before the reporting day, injected by a person in the pharmacy of an urgent care facility. The patient had constant pain as the patient felt the needle hit my bone in the upper arm, which led to vaccine administered at inappropriate site. The patient thought the injection site was high, but whateve, only to be hardly able to lift that arm halfway up. The patient wanted to know what should take for the pain, and whether he/she quit raising it to not further irritate that bone in the socket. The patient said that not all pharmacists, this one man being young, was good at giving shots the patient guess.
stomach ache; This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 05Feb2021 at 09:00 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced stomach ache in Feb2021. The clinical course as follows: Reporter was saying she doesn't want to register this on the computer. Had first vaccine last Friday at 9am had a stomach ache at 4. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
She had irregular symptoms after receiving the second GARDASIL vaccination. She had recurrent abdominal pain, nausea, dizziness, light-headedness, off and on low grade fevers, etc. I took her back to her pediatrician several times, but he didn't do anything except flu and strep cultures in December and February 1. Then she complained of joint pain as we were leaving his office on February 1. By the time we got home, she couldn't walk and had purpura all over her legs. I called the pediatrician back and he said it was an allergic reaction and to give her BENADRYL. I did but it got worse. I sent them pictures and told them it was blood under the skin, they argued with me over the phone. I hung up and took her to an urgent care. They called an ambulance because they were afraid it was meningitis. The ER diagnosed her with HSP. She had complications and we returned to the ER two days later, then more complications led to us taking her to another ER on 2/8/16. She stayed for 7 days. We are still having complications and seeing a rheumatologist and nephrologist there.
3/31/03: Conference with pt as CDNS received report this morning regarding possible cardiac symptoms. Pt related that last Monday (approx. 3/24) began noticing edema in feet. Worsened as week progressed, also fatigue and occasional SOB. Began taking a diuretic that she has as thought it was related to a pervious dx heart condition. On Thursday, 3/27, recalled again some SOB and chest pain - took a nitroglycerin tab that relieved this. She carries nitroglycerin with her for this purpose due to previous dx cardiac problem for she called her private MD and went in for lab work. All WNL except that ___ and she started on iron. Also noted on Saturday that her vaccination site seemed to swell, put antibiotic ointment on site as instructed by her private MD. Today dressing changed, site appears to be progressing as expected except where moist from ointment. Cautioned against using this. Hx - Dx with mitral valve prolapse and CHF 8 years ago, thought a complication from redux. Gets an echocardiogram yearly - but is past due for this year. 4/3/03: Conference. She had appointment with cardiologist on 4/2.  Echo showed possible increase in prolapse. Did change some of her medication. Pt feels better. Visited with Pt in afternoon - MD does not feel problems were due to smallpox. States he fussed at her for weight gain, not staying on diuretics regularly as directed, and has changed some of her meds. Told her to expect heart palpitations while adjusting to meds. Dressing changed on site - appears to be drying up.
Itchy hives/rash with whelps break out in all areas (hands, feet, legs, arms, torso, back, neck).  Treated with antihistamine, 5 days of prednisone, pepcid (and other blockers), anti itch creams/gel.  Outcome- no flares if medication stays in system.   Tried to discontinue the meds for approx 48 hours and itchy hives/rash will return
10 days after vaccines, developed hives & induration (<l cm) @  injection site for varicella & prevnar.
PATIENT WAS SEEN ON 10/14 BY OUR FNP FOR HIA ANNUAL. PATIENT SPOKE TO DR. DURING THE WEEKEND SAYING THAT HE HAD A VACCINE REACTION: FEVER OF 101, BODY ACHES, PAIN. ON 10/20/11 PT CAME IN THE OFFICE AND SPOKE WITH THE RECEPTION LETTING HER KNOW THAT HIS FEVER BROKE ON SATURDAY NIGHT AND THE FOLLOWING DAY WOKE UP WITH SWEATS AND ON SUNDAY HE WAS FINE.
Tinnitus Soon after I received my first vaccine I developed tinnitus - it sounds like a swarm of cicadas in my ear I have never had tinnitus of any other issue with my ears - I have always had very good/excellent hearing I waited about 2 weeks before going to the doctor to see if it would pass. At that time I had fluid in my ears, but no other issues. I took decongestants to dry up my ears but this did not alleviate my tinnitus I eventually went to my primary care doctor to discuss the issue My ears were clean and did not have any fluid She referred me to an ENT He saw no issues and ordered a hearing test My hearing test showed a slight reduction in my ability to hear.
Pt recv vax on 10/5/98; on 10/7/98 pt exp LA edema & erythema
PT CAME IN LOOKING FOR PRIMARY  SERIES SHOT (PFIZER COVID)  AND DUE TO  MISUNDERSTANDING AND LANGUAGE BARRIER RECEIVED BIVALENT COVID 19 BOOSTER--ON 11/26/22---PT CAME IN FOR 2ND SHOT ON 4/2/23  WHEN THIS WAS DISCOVERED---AFTER TALKING WITH  HEALTH CARE COORDINATOR PHARMACIST GAVE MONOCLONAL (PRIMARY) SHOT AS SECOND SHOT AND SUGGESTED SHE COME AND GET BOOSTED IN 2 MONTHS
Pt. received two injections MMR & VZV. Skin was pale and eyes rolled in back of head.Time 8:45am pt was out about 3 seconds. She ask if she was a sleep.
Information has been received from a medical assistant concerning an 18 year old female with no medical history, who on 08-OCT-2007 was vaccinated with Gardasil vaccine (lot #658558/1061U). Concomitant therapy included Provera, which was started the same day as the HPV vaccine. On 15-OCT-2007, the patient experienced a red itchy rash to her chest, back and arms. The patient was seen in the office but no treatment was specified. The patient's red itchy rash persisted. No further details were provided. Additional information has been requested.
Noticed itching around bra area at 6:00 PM. Then, at 4:30 AM felt itchy all over and applied medicated powder. At 5:15 AM, applied cortisone cream to areas on legs that itched the most.  When arrived at work at 5:30 AM, itching became worse and welts starting appearing.  Welts & itching continued to spread to abdominal area and nurse called Dr. and he ordered a Zyrtec and a depo-medrol shot at 6:00 AM.  In a half of hour, itching was decreasing and welts were disappearing.
Systemic: Body Aches Generalized-Severe, Systemic: Cardiac Disorder (diagnosed-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Lymph Node Swelling-Medium, Additional Details: night of 12/24/2021 patient experienced chest pain and tightness, admitted to hospital. Patient's father stated that patient has positive D-Dimer, chest pain (from base of the neck down to stomach), unable to take deep dreaths and enlarged lymph nodes (armpits). Patient currently still hospitilized as of 12/27/2021
Headache; Nausea; Running a fever / temp is 100 degrees; Severe muscle pain in whole body; Tingling in arms and legs; Neck hurts; Jaw tight; Pain behind eyes; Having trouble keeping food down; Depressed; Crying; Face pain; Shaking; Back pain; Unable to stay asleep; Throwing up; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the right arm on 28Oct2021 at 15:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included narcolepsy and depression. The patient was allergic to powder on latex gloves. Prior to the 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 cefalexin (CEPHALEXIN) and escitalopram oxalate (LEXAPRO) and experienced drug allergy. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0172) via an unspecified route of administration in the right arm on 30Apr2021 at 15:30 (at the age of 45-years-old) and also received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0162) via an unspecified route of administration in the right arm on 09Apr2021 at 16:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. On 29Oct2021 at 12:00, the patient experienced headache, nausea, running a fever, severe muscle pain in whole body, tingling in arms and legs, neck hurts, jaw tight, pain behind eyes, temperature was 100 degrees, having trouble keeping food down, depressed, crying, face pain, shaking, back pain, unable to stay asleep and throwing up. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 29Oct2021, the patient underwent body temperature test and the result was 100 degrees (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, nausea, running a fever, severe muscle pain in whole body, tingling in arms and legs, neck hurts, jaw tight, pain behind eyes, temperature was 100 degrees, having trouble keeping food down, depressed, crying, face pain, shaking, back pain, unable to stay asleep and throwing up were unknown at the time of this report.
Minor rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Minor rash) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE RASH (Minor rash). At the time of the report, VACCINATION SITE RASH (Minor rash) had resolved. Not Provided          The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-101871, US-MODERNATX, INC.-MOD-2021-101881 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101871:case for wife(dose1) US-MODERNATX, INC.-MOD-2021-101881:case for wife(dose2)
My sister and brother tested positive for COVID. On 12/25/2021 I felt very tired and I decided to do a rapid test and it came back negative. I re-tested again on 12/30/2021 and I tested positive. I did go to the ER. The ER tested me and found I was positive for COVID.
Approximately 3 days after recieving vaccine pt notes a diffuse red rash that was warm and encompassed the arm about 3-6 inches below the site of injection. Injection site not appearently involved, but no other changes present that woul warrant said reaction. Patient still had a milder version of the rash when she presented to the pharmacy on 2/20/19. Pt was reffered to MD for evaluation and to rule out other causes.
subcutaneous lymphoma; noticed a rash on the right arm where he got the second shot, near but not the same site as the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOMA (subcutaneous lymphoma) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, LATANOPROST, CICLOSPORIN (RESTASIS), MAGNESIUM, VITAMIN C [ASCORBIC ACID] and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced LYMPHOMA (subcutaneous lymphoma) (seriousness criterion medically significant) and VACCINATION SITE RASH (noticed a rash on the right arm where he got the second shot, near but not the same site as the vaccination). The patient was treated with TRIAMCINOLONE ACETONIDE (topical) for Lymphoma, at an unspecified dose and frequency. At the time of the report, LYMPHOMA (subcutaneous lymphoma) and VACCINATION SITE RASH (noticed a rash on the right arm where he got the second shot, near but not the same site as the vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: abnormal (abnormal) saw that it was a subcutaneous lymphoma of some sort.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case concerns a 62 year-old male patient with no reported medical history who experienced the unexpected serious event of lymphoma. The event occurred on an unknown date after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 62 year-old male patient with no reported medical history who experienced the unexpected serious event of lymphoma. The event occurred on an unknown date after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
expired vaccine administration; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 16-OCT-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter, lot # S003874, expiration date 15-OCT-2020, (frequency, route of administration and anatomical location were not reported) for prophylaxis. There was no temperature excursion and no product quality complaint.
following immun pt devel a large local reaction on rt thigh & very irritable & cried for several hrs;
Increased frequency and intensity of headaches starting 1 week after vaccination and continued until starting migraine prophylaxis 10/2021.  Also was having jaw pain and some dizziness with a headache about a month after the shot and was diagnosed with hypertension 5/21/22. BP was around 210/110. I was seen in the ER on 7/28/21 for a syncopal episode and my BP was high then. I'm currently taking 3 medications for hypertension and I'm still having trouble lowering my diastolic BP which I'm concerned about. The systolic has responded well to the medications. My initial Moderna shot was on 3/20/21, second shot on 4/18/21, and a booster on 11/19/21.
lump at injection site, started after vaccine and is still continuing. Patient reports it is about marble sized, does not move, not red, not painful, staying the same size. No interventions done. Just wondering if it's normal.
Large hard lump, at injection site, red, warm to the touch, approximately 2 inches by 3 onches
Patient came to lab for a COVID-19 J&J vaccination on June 30, 2021.  She was sent by employee health at to our vaccination clinic and filled out the paperwork prior to the vaccine.  She checked "NO" for the question asking if you have received any covid-19 vaccination before.  She did not ask us any questions.  The J&J vaccine was given.    The vaccines were logged in later that day (June 30 2021)  and it showed that patient had actually received the Pfizer Covid-19 vaccine on May 20 2021 and June 17 2021 at clinic.  A staff member called the patient and the patient verified that she did receive vaccines in May and June.  The patient stated she must have misunderstood about getting the covid-19 vaccine today, but did not ask any questions.    I personally called the patient on July 6th 2021 at 930am (verified name and DOB) and the patient reports no side effects that she is experiencing. No doctors visits.  No illness.  no hospitalizations.  She is a little tired (some fatigue) but no other symptoms.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot # 669692/0615AA expiration date 02-JUL-2012) that was expired on 05-JUL-2012. No adverse event reported. Whether the patient sought for medical attention was not reported. The outcome was unknown. The reported was received from the same reporter with the other 3 cases, and their MARRS# are 1207USA002230, 1207USA003759, 1207USA003760, respectively. Additional information is not expected.
12Mar2021 showing 1.06, on 19May2021 1.16 High, on 05Aug2021 1.10 High, on 16Aug2021 1.13 High, on 08Sep2021 1.29 High; This is a spontaneous report from a contactable consumer and a non-contactable consumer (patient).  A 53-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via intramuscular, administered in Arm Right on 09Apr2021 (Batch/Lot number was not reported) (at the age of 53-year-old) as single dose for covid-19 immunisation. Medical history included Hashimoto Disease. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. The patient was not had covid tested post vaccination. Known allergies was not applicable. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular, administered in Left arm on 08Mar2021 (Batch/Lot number was not reported) (at the age of 53-year-old) as single dose for covid-19 immunisation and following her 08Mar2021 dose, (name withheld) went to the doctor and bloodwork was done on 12Mar2021 showing 1.06 high creatinine levels. (name withheld) has also reported pain near kidneys. Facility type Vaccine was Health Clinic. Concomitant medications included thyroid (ARMOUR THYROID); hydroxychloroquine sulfate (PLAQUENIL), all taken for an unspecified indication, start and stop date were not reported. Creatinine levels have increased since as follows after second dose: on 28Apr2021 1.06 High, on 06May2021 1.03 High, on 19May2021 1.16 High, on 05Aug2021 1.10 High, on 16Aug2021 1.13 High, on 08Sep2021 1.29 High. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient had not received treatment. The outcome of the event was Not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Shortness of breath while at rest sitting upright, lasting a few minutes in the evening on 4/27 Petechiae on inner left leg appeared exactly 3 weeks following vaccination on 4/28
Presented to local ER with 2-3 days of Left sided chest pain that was intermittent and worse when lying on back. Diagnosed with Myopericarditis
20 MINUTES AFTER RECEIVING DOSE 2 OF COVID 19 VACCINE PT REPORTED JAW NUMBNESS, DIFFICULTY SWALLOWING AND TINGLING IN THROAT.  PARAMEDICS ON SITE ASSESSED PATIENT AND REPORT NO SOB OR DIFFICULTY BREATHING.  VITALS WNL.   EMS CALLED TO ASSESS, PT REFUSED EMS TREATMENT AND SIGNED AMA FORM.  PATIENT STATED FEELING BETTER AFTER 23 MINUTES AND WAS ABLE TO LEAVE ON HER OWN.
patient received expired vaccine (refrigerator 31 days,  expired 1 day from storage date)
Within approx. 48-hrs. of first vaccine I was overcome by flu-like symptoms that were very similar when I had COVID in May 2020.; Fever; fatigue; body-aches (especially my hands); body-aches (especially my hands); ears became very congested and are ringing; ears became very congested and are ringing; This is a spontaneous report from a contactable consumer (Patient). A 62-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: FC3183), via an unspecified route of administration on 14Sep2021 at 11:30 (at the age of 62-years-old) administered in Arm Left as a single dose for COVID-19 immunisation. Medical history included hypothyroid from an unknown date and unknown if ongoing, COVID-19 from May2020 to an unknown. Concomitant medication(s) included levothyroxine; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) (all taken for an unspecified indication, start and stop date were not reported). 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. On 17Sep2021 at 17:00 PM, approx. 48-hrs. of first vaccine the patient overcome by flu-like symptoms that were very similar when she had COVID in May 2020. Fever, fatigue, body-aches (especially her hands) lasting 2-days. The next days my ears became very congested and are ringing. She still having congestion problems with my ears and fatigue on day 9. She thought this was supposed to happen on the second vaccine. She nervous to have the second shot. The patient underwent lab tests and procedures which included sars-cov-1 test negative on 21Sep2021 Nasal Swab. No treatment was given for the events. The outcome of the events was not recovered.