chrisvoncsefalvay/vaers-outcomes huggingface dataset:
15 minutes after getting the shot, both eyeballs had a feeling of electric pinpricks (like 50 in each eyeball).  This lasted 20 minutes and then repeated for the rest of the day.  One week later, I had a visual distortion where I couldn't see behind 1/3 of my visual field.  This was a moving aura across my field of vision.  This lasted for about 20 minutes.  It was an ocular migraine as was determined by the opthalmologist who examined my eyes.  The ocular migranes continue to happen randomly every couple of weeks.  The other side effect is that every night when I close my eyes, I have lights (bubble shaped yellow and blue) that move up and down in the peripheral sides of my vision.  Every day.  This continues.
Almost instantly after the shot my left side tensed up and I had pain from behind my left ear all the way to the tip on my middle finger on the left side. This caused muscle pain and began a migraine headache that lasted a month. I was drained of all energy and spent 4 days in bed, having to return to work, I would go to work and come home to go directly to bed. I did see my chiropractor and received several massages in an attempt to relax the muscles. The lethargy has still not resolved and I have still have a lingering headache although not as severe as the first month.
Swelling, redness extremely sore at inject site.  Sought medical treatment at MD.  Was diagnosed as cellulitis, resulting from Anthrax vaccine.
Swelling and edema on arm that spread down toward elbow. Sore at injections site with visible pustule present. Patient states started 2 hours post vaccination and has been present for 3 days.
Information has been received from a medical assistant(also reported as office manager) referring to a 15 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 19-APR-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis(Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program (VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.; Sender's Comments: US-009507513-1704USA014784:
I have a history of anaphylaxis, and disclosed that to the medics so they watched me more carefully, which was good, as while I did not experience anything that severe, I did immediately get itchy, turn red and feel quite nauseated. However,  after they monitored me awhile, I told them I felt okay to go home. The next day I had the expected mild flu-like symptoms, which I anticipated. However, what?s been atypical is they returned tenfold three days later. This time with a much higher fever (103), severe chills, fatigue, a seemingly never-ending headache,  muscle spasms,  chest palpitations and suddenly I am experiencing asthma (which is typically seasonal) and am coughing, too.  I?m now a week past when I was vaccinated and each day was feel worse, not better. I have had to cancel my clients and hire a sitter to care for my kids as I am too weak and ill to do it.  I looked up common reactions and nothing states chest pain and/or asthma, nor that it should last this long. That said, as I am high-risk, I work from home and homeschool both of my young kids. Thus, I have been nowhere aside from the vaccine site. Moreover, my partner, our kids and sitter get routinely tested for me,  and everyone is negative. Thus, it appears I am having prolonged, heightened side-effects much more intense than the ?mild? flu-like symptoms otherwise reported, which is concerning. I took no medication prior to receiving the vaccine, either.
This is a spontaneous report from a contactable consumer (Patient). A 42-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8736) via unknown route of administration in left arm on 21Apr2021 (at the age of 42-year-old) as single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included lisinopril. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EP7533) via unknown route of administration at left arm on 31Mar2021 (at the age of 42-year-old) as single dose for COVID-19 immunisation. On 22Apr2021, the patient experienced very high Blood Pressure/his blood pressure shot up incredibly high, almost crisis level, stated he felt off the next day and his chest did not feel right. Patient received both doses of the Pfizer Covid-19 Vaccine. Had experienced an Adverse Event after his second dose on 21Apr2021. He felt off the next day, morning on 22Apr2021, his chest did not feel right, checked his blood pressure he was evaluated for very high Blood. His blood pressure shot up incredibly high, almost crisis level. Stated he went to the doctor, and they did an EKG, they found abnormalities on the EKG so they referred him to a cardiologist where he had a stress test and an ultrasound of his heart, states those test results came back negative. He was treated with lisinopril 40 mg and within 3-4 days it returned to normal levels. Stated he was now taking 20m and it was fine. He clarified that he was on a low dose of lisinopril prior to the vaccines. He was monitoring BP heavily prior to vaccine and he was borderline low before getting the second dose. Patient was required to receive a Flu shot this year through his employer. He has never received a Flu shot. He asked if he had a reaction to the Pfizer COvid-19 Vaccine, would he react the same with a Flu shot and have there been reported of a reaction to the Flu shot after experiencing a reaction to the Pfizer COvid-19 Vaccine? Patient stated that, It is hard to believe that Pfizer hasn't tested the Covid-19 Vaccine with the Flu Vaccine. It is probably the most common vaccine that people get every year. The patient underwent lab tests and procedures which included blood pressure measurement: very high, cardiac stress test: negative, electrocardiogram: abnormal, ultrasound chest: negative. Therapeutic measures were taken as a result of events, lisinopril. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
LPN diluted Covid vial with 1.3ml of saline Chloride instated of 2.2 ml. Patient received a Higher concentrated dose of Covid vaccine. As per CDC patient doesn't need another dose. Patient received 3rd vaccine today and series is completed. Patient received a 3rd and 4th dose at once, patient is not immune compromised.
2 1/2 to 3hrs p/vax, swollen face & tongue, drooling, fussy, goose bumps; swelling lasted 10mins, other sxs 1 hr
patient came in for a Pfizer Covid Bi-Valent shot and received the Pfizer covid Mono-Valent booster. It was discovered and brought to the patient's attention. He was vey nice understood what had happened. Rph told patient he will need to come in 60 days after shot(11/11/2022) to get the Bi-Valent vaccine.
We sat for 15 minutes and everything was fine. As I was driving home, I noticed my face was itchy. By the time I got home, it had resolved and it was no longer itching. And the only reason I noticed it significantly was because when I started getting allergy shots, I was having the same reaction so I knew it was a potential reaction. This reaction also occurred after the 2nd dose as well. I talked to my allergist about it and we both agreed it was a mild reaction and that I could get the 2nd dose.
PATieNT go 1ST DOSe OF MODeRNA ON 4/18/21. He WAS ONly 17 yeARS OlD WheN he cAme FOR secoND DOSe ON 5/16/21 PHARMACIST NOTICeD He WAS ONly 17 yeARS olD. PATIeNT HAD NO SIDe eFFects WITh FIRST DOSe
sore injection site arms; felt slightly fatigued; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arms) and FATIGUE (felt slightly fatigued) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore injection site arms) and FATIGUE (felt slightly fatigued). At the time of the report, VACCINATION SITE PAIN (sore injection site arms) and FATIGUE (felt slightly fatigued) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.   It was reported that, the patient received Moderna vaccination and had no side effects to the Moderna vaccine except sore injection site arms and felt slightly fatigued. "Just like with a Flu shot". Arm was sore for a day.   No treatment details were reported.  This case contains information for the 2nd of 05 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-710705 Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710705:1 out of 5 siblings
This case was reported by a other health professional via call center representative and described the occurrence of petechia at injection site in a 29-year-old female patient who received RABAVERT. Co-suspect products included RABAVERT (batch number 643011E, expiry date 30th May 1930). Concomitant products included Tetanus. On 29th November 2017, the patient received the 1st dose of RABAVERT. On 6th December 2017, the patient received the 2nd dose of RABAVERT. In November 2017, 1 day after receiving RABAVERT and not applicable after receiving RABAVERT, the patient experienced petechia at injection site. In December 2017, the patient experienced petechia at injection site. In November 2017, the outcome of the petechia at injection site was recovered/resolved. In December 2017, the outcome of the petechia at injection site was recovered/resolved. The reporter considered the petechia at injection site to be almost certainly related to RABAVERT. The reporter considered the petechia at injection site to be almost certainly related to RABAVERT. Additional details were provided as follows: This case was reported by the physician assistant who herself was the patient. Approximately 24 hours after receiving the 2nd dose of RABAVERT, the patient noted a petechial rash over the injection site on the left deltoid and over the injection site from the first dose on the right deltoid. There was no pain or swelling associated with the rash. The rash disappeared within 24 hours of being noticed. The patient did seek medical care and reported that all laboratory values were within normal limits.
9-12 hours after injection arm became extremely sore to touch, lymph nodes under left arm swelled considerably. They stayed swollen for 24 hours after injection.
ACHY ARM AFTER COVID VACCINE; Vaccination site pain; This is a spontaneous report from a contactable consumer or other non health care professional based on information received by Pfizer from [Mfr. Control No. :21K-163-3907125-00]. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via Intramuscular on an unspecified date as dose 1, single and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via Intramuscular on an unspecified date as dose 2, single for covid-19 immunization. The patient also received adalimumab (HUMIRA, Batch/Lot number was not reported) via subcutaneous from an unspecified date and ongoing, at unspecified dose for ankylosing spondylitis. The patient medical history included ankylosing spondylitis. Concomitant medications were not reported. It was reported that on an unknown date, the patient experienced achy arm after covid vaccine, vaccination site pain. Social Media report by a consumer of a person with an event of non-serious achy arm after covid vaccine with humira (adalimumab). COVID-19 VACCINE was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. On unknown date, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer. Primary reporter contact for lot number information was not available. The reporters causality for the event of achy arm after covid vaccine was not provided. The reporters causality for the event of vaccination site pain was not reported. The action taken in response to the event for adalimumab was dose not changed. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Moderna COVID-19 Vaccine EUA Red, rectangular rash surrounding the injection site.  Rash is approximately 8 cm by 7 cm and is warm to the touch. Also a little itchy.
Local injection site reaction with swelling, redness, induration and pruritis extending from shoulder down posterior arm to left elbow; started within hours of receiving vaccine, was the worst on day #3 and was starting to improve by day #4 after vaccination. At time of evaluation by healthcare provider, induration, redness and itching were most bothersome to pt. At time of eval induration measured 7 cm l x 5 cm w, and area of erythema measured 17 cm l x 10 cm w. Patient was treated with topical steroid of medium potency (Kenalog 0.1% cream one app daily) and recommended to use cool compresses until resolution, with instruction to f/u for reevaluation if any change in or new  symptoms.
Swelling near injection.  2?x3?. Red and painful  Had first injection 2/12/21 had similar reaction
Initial information received on 19-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 24 months old male patient who received an expired fourth 0.5 ml dose of suspect DAPTACEL lot number C5065AA expiry date 08-Oct-2018 via intramuscular route in left leg muscle administration site on an unknown date. The patient's past medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications included HEPATITIS A VACCINE and INFLUENZA VACCINE. It was a case of actual medication error due to expired vaccine used. No specific adverse event information reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Pt got 2nd dose in October.  My November presented to doctor with abdominal pain and constipation and weight loss.  Diagnosed with colon cancer end of November.  Required surgery. Now diagnosed with covid on 1/26/2022
Headache, Arthralgia, Pain/Swelling/discoloration @ injection site Narrative:  Other Relevant History:
Unilateral swollen lymph nodes in the left armpit.  Left armpit visibility swollen compare to the right side.  Tender and painful to the touch.
On morning of 10/05/07, noticed large, red, raised areas on chest (described by mother as hives). By noon, hives had spread to back and starting on legs.  By the evening, both legs as well as trunk and arms were "covered" with hives. At this time, the mother called the physician, who prescribed Prednisone.  Mother reports after starting Prednisone, the hives quickly went away. The client saw the physician on 10/08/07, when the hives were almost gone.  By 10/10/07, hives are gone.
No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 5-month-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 02-DEC-2022, the patient was vaccinated with the first dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, in right thigh, lot #U031544, expiration date: 23-JUN-2024, administered intramuscularly for prophylaxis (strength was not provided). and with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), lot #W012143, expiration date: 09-NOV-2023, administered orally for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009088: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009878: US-009507513-2301USA009918: US-009507513-2301USA009933: US-009507513-2301USA009943: US-009507513-2302USA000456: US-009507513-2302USA000412: US-009507513-2302USA000403: US-009507513-2302USA000949: US-009507513-2302USA001305:
fast heartbeat; This case was reported by a consumer via call center representative and described the occurrence of heartbeats increased in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included heart attack (had heart attack at end of september).   On 25th November 2019, the patient received Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced heartbeats increased. On an unknown date, the outcome of the heartbeats increased was unknown.   It was unknown if the reporter considered the heartbeats increased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had fast heartbeat. The patient had heart attack so the reporter reported to carefull with unusual changes. The patient reported that had not checked blood pressure yet.
STARTED PERIOD A WEEK EARLY; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On OCT-2021, the patient experienced started period a week early. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of started period a week early was not reported. This report was non-serious.
Patient developed a 102 fever. It has been able to keep it to 99/100 with Tylenol.; Nickel size reddened area over injection site on the right thigh; Increased fussiness; This case was retrieved during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2418377-1. The original narrative from the sender is the following:  Mom of the client, called the clinic and shared that patient developed a 102 fever last evening, and has been able to keep it to 99/100 F with Tylenol. She also has a nickel size reddened area over injection site on the right thigh (where the DTap/IPV/Hib/HebB was given). She has increased fussiness, but has been drinking fine, and continues to have wet diapers.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Patient developed a 102 fever. It has been able to keep it to 99/100 with Tylenol", "Nickel size reddened area over injection site on the right thigh",  and "Increased fussiness".  No further information is expected.
Still have itching where I got my shot; Still have redness where I got my shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Still have itching where I got my shot) and VACCINATION SITE ERYTHEMA (Still have redness where I got my shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Still have itching where I got my shot) and VACCINATION SITE ERYTHEMA (Still have redness where I got my shot). At the time of the report, VACCINATION SITE PRURITUS (Still have itching where I got my shot) and VACCINATION SITE ERYTHEMA (Still have redness where I got my shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  Treatment medication was not provided by the reporter.
Underage before the 5/12 approval for Pfizer vaccine, Suspected falsification of DOB ? guardian ?unsure? how DOB error occurred
Hematoma secondary to flu shot on LVE.  Patient on coumarin therapy.  No obvious signs of infection.
Patient stated she developed a large rash on the vaccinated arm the day after administration.  She discussed with her doctor who thought it was a histamine reaction.
I could hardly stand; my body didn't feel right; legs were wobbly; head was achy; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (I could hardly stand), VACCINATION COMPLICATION (my body didn't feel right), MUSCULAR WEAKNESS (legs were wobbly) and HEADACHE (head was achy) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced DYSSTASIA (I could hardly stand), VACCINATION COMPLICATION (my body didn't feel right), MUSCULAR WEAKNESS (legs were wobbly) and HEADACHE (head was achy). On 28-Feb-2021, DYSSTASIA (I could hardly stand), VACCINATION COMPLICATION (my body didn't feel right), MUSCULAR WEAKNESS (legs were wobbly) and HEADACHE (head was achy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included vitamins, minerals and eye drops.  Patient reported losing her hair and eyesight. However, she said all that has been happening since before receiving the vaccine, and due to her old age.
Headache, chills, fatigue, dehydration, pain at injection site, cough beginning several hours after vaccination and worsening the next morning