chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Eye surgery after first dose; inappropriate schedule of vaccination; This spontaneous case was reported by a consumer and describes the occurrence of EYE OPERATION (Eye surgery after first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccination) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE OPERATION (Eye surgery after first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccination). At the time of the report, EYE OPERATION (Eye surgery after first dose) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided. Patient had one shot of the Moderna and was told not to get the second one the day before eye surgery.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
MD reports that pt lt arm is swollen, red, warm to touch & about twice the size of other arm;blisters around site of inj;
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-NOV-2011, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended. On or about 20-APR-2016, the patient was treated by a physician for the onset of a severe rash, which was diagnosed as herpes zoster, or shingles with complications (unspecified). As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care the treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
2nd dose given on day 42 after 1st; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving SHINGRIX, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 27-JAN-2023 Reporter's Comments: Reporter was a male patient and reports that he received his second shot of Shingrix vaccine on day 42 after his first Shingrix shot.  The patient could not remember where he got the vaccine or which location it was administered in.  He did not have any information about his HCP. The reporter did not consent to follow-up. Additional Supportive Information: the patient received 2nd dose 42 days after his first dose, earlier than recommended schedule, which led to shortening of vaccination schedule.
Per mom they noticed swelling and slight redness on the left upper arm on 05/23/23.  The following days the swelling began to worsen, pain on palpation, and the redness more defined and spreading.  Mom scheduled an appt on 05/25/23 where the patient was diagnosed with a local reaction and prescribed Triamcinolone 0.1% apply small application to area bid and Zithromax 250mg 2 tabs on day 1, and 1 tab days 2 and 3. Advised to monitor and no follow up appt necessary at this time.
Information has been received from a physician, for the Pregnancy Registry of GARDASIL, concerning a 24 year old female with anxiety and depression and no known allergies who on 15-Oct-2007 was vaccinated with the first dose of GARDASIL. On 14-Jan-2008 the patient was vaccinated intramuscularly with the second 0.5ml dose of GARDASIL (lot number 659055/1522U). Concomitant therapy included WELLBUTRIN. The patient is pregnant. Her LMP was 07-JAN-2008. Due date was 13-OCT-2008. The third dose was not administered. On 14-JAN-2008 the patient was placed on WELLBUTRIN. The patient took WELLBUTRIN for three weeks and then the patient stopped taking it since it was not working. The patient was not experiencing any problems. The patient sought unspecified medical attention via office visit. Follow-up information received from the physician reported limited pregnancy outcome information. On approximately 17-Aug-2008 the patient delivered a baby "at around 32 weeks gestation, almost two months early". The physician did not remember exactly and did not have the patient's chart at her immediate disposal. The physician also followed the baby in her practice. The physician reported " he was now around nine months old and weighed around 15 pounds. He had some failure to thrive issues and had some developmental delays". No further information was provided at this time. Additional information has been requested.
Felt dizzy and couldn't feel feet while walking (felt like walking on air). Had to go to bed.  When I woke up I was wet from sweating.  This lasted for 3 days.  Arm was swollen, itching, and painful for one week. Arm was red and warm at vaccination site. Felt tired for 8 days.
Noticeable swelling, inflamed, and tender left shoulder and lymphnodes near clavicle and neck more on the left side than the right. This happened after I took a nap on my left side on March 27th and when I woke up it was noticeably/visibly larger than the right side.   As of today, July 6th, I have 2 mildly swollen lymph nodes on my left side and am pursuing further investigation and treatment.
Have swollen and painfulhand sized axillary lymph node under L arm on same side of flu immunization none as of yet.
New onset verbal and motor tics 24 hrs after vaccine.  Query Tourettes - does meet diagnostic criteria - but had very very subtle symptoms prior to vaccine (noticble to patient but not to mother or provider). Post-vaccine with significant vocalizations, involuntary motor tics both very disruptive to daily life. Seeing specialists (neurology, psychiatry) now for treatment.
Three days after the shot, they called complained with with pain, numb and can't  move on his left arm.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 50 year old male of White race and unspecified ethnicity. The patient's weight was 340 pounds, and height was 71 inches. The patient's past medical history included: alcohol user (on weekends in his twenties), and concurrent conditions included: non alcohol user, non smoker, and allergic to penicillin causing hives. The patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 08-MAY-2021 for prophylactic vaccination. Age at the time of vaccination was 49 years. The patient had no concomitant medications. On 11-OCT-2021, the patient experienced feeling achy, congested, fever and worn down. The patient described it as "a feeling like he had after a weekend in his twenties when he drank alcohol". The patient had a COVID-19 virus rapid test in the morning (11-OCT-2021) and the result came positive (coded as suspected covid-19 infection, and suspected clinical vaccination failure). The action taken with covid-19 vaccine was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000197128.; Sender's Comments: V0 20211021482-COVID-19 VACCINE - suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. On an unknown date, the patient was vaccinated with ROTATEQ vial, lot # H17671, expiration date 25-MAR-2014 (dose and route were not reported) that was exposed to 12C for 173.5 hours, which was an excursion that was not supported by in-house stability data. No adverse effect reported. No concomitant medications were reported. This is one of several reports received from same source. Additional information has been requested.
pt recvd vax; devel warm,large, red elev 11-13cm erythematous area;
felt hot, flushed, had redness to face, developed hives to arms, stomach, back, neck, and face, itching resolved with Benadryl and Pepcid
Swollen, red, hot at vaccine site (redness continue all around the arm). Started day of vaccine worst days 2-3; continued x 6 days. Also took round the clock TYLENOL.
This spontaneous report was received from a medical assistant regarding a multiple unspecified patients of unknown ages and gender. The patients medical history, drug reactions or allergies were not provided. On an unknown date, the patients were vaccinated with a dose of VARIVAX (Merck) (dose and route of administration were not provided) (confirmed Lot number reported as L023594, expiration date 26-JUN-2017; Lot number L021215, expiration date 10-JUN-2017) that was improperly stored. Concomitant medications were not provided. No adverse effects reported. Additional information has been requested.
What are the side effects when you get the 2nd vaccine?; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (What are the side effects when you get the 2nd vaccine?) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (What are the side effects when you get the 2nd vaccine?). At the time of the report, VACCINATION COMPLICATION (What are the side effects when you get the 2nd vaccine?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitants and treatment drugs were reported.
Patient had a localized reaction that almost immediately caused his arm to swell down to his fingers.  He also had a tingling sensation in his hands and fingers.  He was given 25mg of liquid diphenhydramine orally and the swelling and redness resolved in about 10 minutes.  The tingling in his hands did remain.
rash after receiving Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash after receiving Moderna vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash after receiving Moderna vaccine). At the time of the report, RASH (rash after receiving Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment drugs were reported.
Left arm at injections site still swollen and painful six months after last injection. Sensitive to touch and fees warm to the touch.
After the vaccine I had a very rapid heart rate, hair loss, horrible anxiety. That I still suffer from now. Went to the doctor and my thyroid levels was 4 times the normal level high (25.3). I was then put on medication to control the levels. My levels were then back to normal. When I received the second dose my levels jumped back up and also after the third dose my levels increased. My eyes and GI system has been affected.
Information has been received from a nurse practitioner concerning a male patient who had received 2 doses of MMR II had negative titers for rubella. The patient received his first dose of MMR II as a child. In September 2008 his rubella titers were negative. He then received dose 2 of MMR II in January 2009. In April 2009 his rubella titers were still negative. The patient sought unspecified medical attention. Additional information has been requested.
administrated reconstituted with sterile water; administrated reconstituted with sterile water; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 5f3t5, expiry date 26th May 2023) for prophylaxis.   On 18th February 2022, the patient received Shingrix. On 18th February 2022, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient inadvertently administrated the lyophilized component of Shingrix reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No further events were reported. The reporter agreed to be contacted for follow-up The Vaccine Administration Facility was the same as Primary Reporter.
The patient fainted a minute after receiving the vaccine, woke up a minute later, and felt very nausiated 5 minutes after waking up. The patient expressed a lot of fear prior to the vaccine, due to a fear of syringes. Her guardian was around to help make sure that she did not suffer any injuries during syncope.
the patient felt yucky the next day; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (the patient felt yucky the next day) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (the patient felt yucky the next day). At the time of the report, FEELING ABNORMAL (the patient felt yucky the next day) outcome was unknown. Not provided          After the second dose, the patient felt yucky the next day and then he was up like nothing had happened to him. The caller and the patient both have high blood pressure. No Concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624885 (Patient Link).
About 8-10 hours after the vaccine started feeling very sick. Fever reached 101.8 and had joint pains in hands, feet, wrists, and ankles along with full-body aches. Felt better after about 30 hours, but on day 5 post-vaccination started having painful joints in my hands, feet and some in wrists and ankles, and also in the elbows and knees. Saw a doctor and did blood work for inflammatory markers. Some came back elevated, so followed up with additional blood week a couple of weeks later. Got a referral to a rheumatologist who said that it might be RA, but too soon to diagnose and he said I had a good chance of it resolving with time.  I never had joint pain prior to the vaccine. It has been nearly 12 weeks now and I am still suffering from intense, debilitating joint pain, mostly in the hands and feet.
As I was given the shot, I passed out. I stayed for 15 minutes and went home, Then, I threw up.
In appropriate schedule of vaccine; Pain in right kidney; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (Pain in right kidney) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (In appropriate schedule of vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 010A21A) for COVID-19 vaccination.     The patient's past medical history included Mania. Concurrent medical conditions included Bipolar disorder. Concomitant products included CLONAZEPAM (KLONOPIN), ZALEPLON (SONATA ADAMED), OXCARBAZEPINE (TRILEPTAL), ESTROGENS CONJUGATED (PREMARIN) and QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RENAL PAIN (Pain in right kidney). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (In appropriate schedule of vaccine). At the time of the report, RENAL PAIN (Pain in right kidney) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (In appropriate schedule of vaccine) had resolved. Not Provided          This case was linked to MOD21-066792 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: TCR form added and a newevent in appropriate schedule of vaccine added.; Sender's Comments:  MOD21-066792:
Vaccination received at TCPHSS, Moderna Lot 007C21A. Left side throat sore, can't swallow. Told it was probably a virus, no treatment prescribed. Because sore throat was listed as a possible side effect of the vaccine, I am reporting the symptom so your records are accurate.
12 hours after receiving my second moderna vaccination I started to get a fever of 101.  Throughout the night I fought the fever with Tylenol. The following morning I still had a fever of 100, but also great fatigue, nausea, headache, and general body ache.  From the on set of my first symptoms until they completed was 30 hours.
This spontaneous report as received from a Licensed Practical Nurse refers to a 5 year old male patient. The patient previously received one dose of M-M-R, one dose of varicella virus vaccine live (unspecified), 4 doses of diphtheria toxoid pertussis acellular vaccine (unspecified) tetanus toxoid and 3 doses of poliovirus vaccine inactivated (unspecified). On 23-JUL-2018 the patient was vaccinated with improperly stored PROQUAD lot # R002935 dose 1, subcutaneous in the left arm for prophylaxis (product storage error). Other suspect therapies included KINRIX. Concomitant therapies included sterile diluent(STERILE DILUENT).; Sender's Comments: US-009507513-1807USA007589:
Tested positive with home test  Very mild symptoms,fatigue   Dr.prescribed Paxlovid  after phone call
Woke up with searing/splitting headache, and when tried to get up almost passed out: dizziness, nausea, low fever (99.7), headache, body aches, and overall felt awful most of the day. Stayed in bed most of the day.  24 hours later, feel better but still extremely tired.
Patient received IZ's at clinic on 3-28-07. Came back to clinic 3-31-07 to have PPD read. Mom states right deltoid area started swelling and became red and warm to touch on 3-29-07.
a ball with inflammation on the right arm; redness on the right arm; itches on the right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (a ball with inflammation on the right arm), VACCINATION SITE ERYTHEMA (redness on the right arm) and VACCINATION SITE PRURITUS (itches on the right arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (a ball with inflammation on the right arm), VACCINATION SITE ERYTHEMA (redness on the right arm) and VACCINATION SITE PRURITUS (itches on the right arm). At the time of the report, VACCINATION SITE SWELLING (a ball with inflammation on the right arm), VACCINATION SITE ERYTHEMA (redness on the right arm) and VACCINATION SITE PRURITUS (itches on the right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
cried x 24 hrs p/vax; parent didn't inform MD until time of next immunizations
Swelling of injection site.  Redness, warm.  Right leg.  ER physician concerned about infection-started two antibiotics.  I discontinued after 3 days.
received 3 doses of Shingrix; first dose in Jan 2020 and the second dose in Jan 2022; This case was reported by a nurse via sales rep and described the occurrence of drug dose administration interval too long in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January 2020).   In March 2022, the patient received Shingrix. In January 2022, the patient received the 2nd dose of Shingrix. In January 2022, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In March 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the drug dose administration interval too long and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 29-MAR-2022 Reporter's Comment: The 50 years or older aged patient received 3 doses of Shingrix. The reporter shared that they were not sure if they needed to restart the series because it had been so long since the patient had received the first dose. The reporter did not consent to follow-up. Additional supportive information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. The patient recently also received another dose of Shingrix, which led to extra dose administered.
I was given a Tdap booster and the Zostavax shingles vaccine on 2/4/10. Beginning either one or two days later, I began experiencing dizziness, especially when standing form a prone position, rolling from side-to-side, or wagging my head from side-to-side or back-to-front movements. The dizziness has persisted now from over one month.