chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed abdominal/stomach cramping which progressed to sharp pains in the right buttock, inner thigh, and posterior thigh, swelling numbness, and pain in the right knee and lower leg . Skin warm to the touch.
Patient contacted us on Friday, November 13th stating she had received a flu shot which has affected her quality of life. She has been experiencing limited mobility for approximately 3 weeks and she also had to get a decadron shot from her doctor's office. Her doctor informed her that the shot was given too high up on her arm thus causing discomfort for this extended period of time.
After my first shot, my brain has felt fuzzy or foggy and heavy. I have also felt some depression and weird thoughts (lot #ER 2613). My ears also felt heavy. After my 2nd shot yesterday, I awoke this morning with ringing in my ears and it has not gone away and my brain fog is still there as well.
Got shingles shot on 2/24/12. The next day my arm was red and sore and the day after it spread it was red and sore almost to my elbow I slept with ice which they did not tell me to use but I talked to my Dr. & he said to use ice. It took almost a week for it to go away.
ER visit with severe abdominal pain and vomiting. Admitted to hospital due to high liver enzymes and lymph node activity. Follow up exams including extensive labs, CT, MRI and ultrasound point to autoimmune hepatitis.
12/21 had covid vaccine (dose 1). On evening of 12/29 had sudden onset of mild neck pain and significant weakness and numbness of left arm, weak hand grip, clumsiness in hand . Did not improve after trying to shake arm/move around , and took prednisone 40mg oral. Went to ER and had CT Cspine which did not show evidence of cervical pathology. Continued with corticosteroids, sought consultation with PMR and neurology specialists, and steroid dose increased to 60mg/day.   Some improvement in strength , but still have diminished sensation and strength in left hand/arm. Unable to perform full job tasks as I am left hand dominant.  Likely brachial neuritis / parsonage turner syndrome per both specialists seen. Continuing with corticosteroids at this time, pending bloodwork and OT evaluation
Nearly immediately after vax client had blotching rash on face, arm and upper trunk of body. Treatment PO Benadryl. Left arm was worse around site. 7/5/00 Client had only blotchy rash or face remaining per conversation with mother.
Kinrix was injected in a 19-month-old; This case was reported by a physician via sales rep and described the occurrence of inappropriate age at vaccine administration in a 19-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th November 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 29th November 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The 19-month-old patient received Kinrix, which led to inappropriate age at vaccine administration. The reporter stated that, dose of Kinrix was injected in a 19-month-old male, about 45 minutes ago and the representative learned of this adverse event 15 minutes ago from the date of reporting. The reporter consented to follow up.
Case number PHEH2016US005485 is an initial spontaneous report from the pharmacist received on 02 Mar 2016. This report refers to a 37 years old pregnant female patient. Patient's last menstrual date was not reported. It was reported that the patient who was expecting was vaccinated with FLUVIRIN (batch number: 15731P) on 02 Mar 2016. No adverse event was reported following vaccine exposure during pregnancy. Upon follow up reporter's new address was not found while searching on internet. Upon further follow up reporter's complete address was found while on internet search. Follow up report received on 14 Apr 2016: Added lost to follow up comment. Follow up report received on 19 Apr 2016: Updated reporters address and removed lost to follow up comment from narrative.
2 weeks 1 day post injection,red and swollen at injection site and another right above it. Places are raised from skin, red, hot to the touch and sore. Each one is about 1 1/2? in size. Just started today 4/3/21 @ 1pm
Quick background: since childhood I have tended toward having paradoxical reactions to medications. About 16 days after the first Moderna shot, I woke up feeling odd, and within an hour had the worst chillls of my entire life?from head to toe, so violent that my teeth were banging against each other. I also had nausea, the runs, and extreme weakness, especially in the thighs. It took about 4-5 hours (with Tylenol and heating pad) for chills to subside, but the other symptoms lasted all day. The following day I felt a bit better, but in the morning couldn't sit at the computer because my thighs were aching and shaking so badly. The weakness was somewhat abated, but the nausea and the runs have continued.
This case pertains to 1 of a cluster of 2 patients who experienced adverse events following administration of DAPTACEL (lot number C4310BA) and IPOL vaccine (H1354-2). Other patient is captured in case number 2013-02000 (same reporter, same events after administration of DAPTACEL (lot number C4310BA0 and IPOL vaccine (H1354-2). Initial report received from a healthcare professional on 4 February 2013. A 4-year-old patient whose gender, medical history and concomitant medications were not reported, had received a dose of DAPTACEL vaccine from Sanofi Pasteur (lot number: C4310BA, expiry date: 03-15-2015, number in series were not reported) and a dose of IPOL vaccine from Sanofi Pasteur (lot number: H1354-2, expiry date: 07/08/2014, number in series were not reported) intramuscularly in left thigh on an unspecified date. The patient had also received a dose of MMR vaccine (manufacturer: unknown, lot number, number in series and route of administration were not reported) and a dose of Varicella vaccine (manufacturer: unknown, lot number, number in series and route of administration were not reported) in right thigh on an unspecified date. On an unspecified date after vaccination, the patient experienced local site reactions of red, hot, induration at left thigh injection site which varied in size of redness and induration. Relevant laboratory data and corrective treatment details were not reported. The patient's outcome was unknown. List of documents held by sender: none.
Pt recv vax on 2/2//99; 1 hr post vax pt exp screaming x 6 days; dx=possible colic
Chicken pox on my chest; This case was reported by a consumer and described the occurrence of varicella-like rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th January 2020, the patient received the 1st dose of Shingrix. On 14th January 2020, less than a day after receiving Shingrix, the patient experienced varicella-like rash. The patient was treated with calamine. On an unknown date, the outcome of the varicella-like rash was not recovered/not resolved.   It was unknown if the reporter considered the varicella-like rash to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. Within a short period of time the patient developed what felt like a couple of chicken pox on his/her chest. The patient had them in spite of putting on calamine lotion regularly. The patient wanted to knowwould he/she experience same when receive second dose of vaccine.
I woke up the next day after the injection and my right underarm is swollen and very painful. The lymph nodes. Still swollen and sore and today is day 4.
red rash; Soreness; swelling; itching; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 77, unit unknown) received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the left arm on 23Feb2021 at 10:00 (Lot Number: EL9266) as dose 1, single for COVID-19 immunization.  Medical history included sinus infection on an unknown date. The patient was taking unspecified concomitant medications. The patient did not receive other vaccines in four weeks. The patient previously took codeine and experienced allergy. On 24Feb2021 at 08:00 the patient experienced soreness, swelling, red rash and itching. The patient did not receive treatment for the events. The outcome of the events was recovering.    No follow up attempts are possible. No further information is expected.
Swollen lymph node superior to left clavicle. Was the size of a golf ball in the am. By the afternoon it?s the size of a gobstopper.
1-25-13 Well child appt. vaccines admin. DAPTACEL, IPV, PCV 13, Rotavirus. Dad reports that the afternoon the vaccines were given, she was taken by ambulance to ED. Breathing issues. Now has nasal congestion, productive cough (1/28/13) reported.
They thought they had given MMR II and not MMR with Varicella (PROQUAD); PROQUAD and Varicella vaccine was given the same date, so the children got a double dose of Varicella; PROQUAD and Varicella vaccine was given the same date, so the children got a double dose of Varicella; This spontaneous report was received from a nurse referring to a 5-year-old female patient. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were unknown by reporter.      On 27-OCT-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) in the left arm and varicella virus vaccine live (oka/merck)(VARIVAX) in the right arm; both vaccine subcutaneous route for prophylaxis (strength, dose, lot number, and expiration date were not reported) (duplicate therapy error and inappropriate schedule of product administration). Additional it was reported that they thought that was given measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) not measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (wrong product administered).        This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA011535:
tense, walked out was fine, came back, fainted about 5min p/vax;had a vasovagal episode according to MD;
Pt starting "feeling funny." She stated her tongue was tingling and she didn't feel right. I administered 1 dose of Benadryl and monitored her for another 10 minutes. She was still not feeling good so< I called 911 and the paramedics came to look at her. They suggested another dose of benadryl and monitored her for another 15 minutes. She then began to feel better and left the store. She called me back and let me know she got home and was feeling better about an hour later.
COVID BOOSTER CAUSED PATIENT'S ARM TO BE SORE; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (COVID BOOSTER CAUSED PATIENT'S ARM TO BE SORE) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.  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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (COVID BOOSTER CAUSED PATIENT'S ARM TO BE SORE). At the time of the report, VACCINATION SITE PAIN (COVID BOOSTER CAUSED PATIENT'S ARM TO BE SORE) had not resolved.         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.  No concomitant medication information was provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was provided.
Patient reports having nuchal rigidity starting 1 week after administration of MENACTRA and BEXSERO. Currently, this stiffness is just starting to resolve. Overall he has had nuchal rigidity for 3-4 weeks now. This was also accompanied by a HA during the first 4 days when rigidity started. Called the DCD and there is no record of this ADR. Patient has had reactions in the past to receiving 2 vaccines in one day. Do not feel comfortable with pt getting 2nd series so will discontinue. Patient agrees. Will enter ADR.
Patient developed symptomatic COVID infection with symptoms starting 3/13, was admitted to the hospital for respiratory failure on 3/16 and expired on 3/18/21
Information has been received from a patient's mother concerning her 14 year old son with a drug reaction/allergy to penicillin who on 22-DEC-2011, was vaccinated with a dose of GARDASIL (Lot#, dose and route not reported). Secondary suspect therapy included unspecified flu vaccine (manufacturer unknown) administered the same night. About a week after injection, on approximately 29-DEC-2011, the patient experienced asthenia and developed red spots at the injection site. The mother stated that her son has missed a month of school because of the reaction. The patient sought unspecified medical attention. No treatment for the AEs was given. The patient had blood tests performed (results not reported). At the time of the report, the patient had not recovered. Follow up information was received from a registered nurse who stated that the male child was still having difficulties. The child was sleeping up to 20 hours a day. The nurse reported that the patient received only one dose of GARDASIL (Lot#, dose and route not reported). At the time of the report, the patient had not recovered. Asthenia, red spot at the injection site and sleeping up to 20 hours a day were considered to be disabling. Additional information has been requested.
LITTLE SICK; This spontaneous report received from a parent 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 not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On an unspecified date, the patient experienced little sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20211154706.
Persistent dizziness for 2-3 days after onset on 1/1/22. Temporary vertigo (5-10 seconds) experienced any time after laying down or changing positions while laying down. The vertigo continued from onset until Epley maneuver accomplished during ENT appointment on 1/5/22. ENT doctor described symptoms likely the result of benign paroxysmal position vertigo.
Illness duration post injection: 30 hrs.,   High fever of 101.9 began 6.5 hrs post injection,  sustained high fever for 24 hrs,  treated with Tylenol PO during this time,  fever then after 24 hrs converted to a low grade fever for an additional 6 more hours.  During this whole time, had a persistent headache, general malaise.,  5 hrs after the start of the fever, developed NUMBNESS IN FEET, ANKLES, CALVES,  which then, 1.5 hrs later evolved into  HOT & SWOLLEN & REDDENED FEET, ANKLES, CALVES, KNEES, HANDS, & FACE,  this was treated with 50 mg PO of Benadryl,  which did provide relief and was followed up with 10 mg of Zyrtec 20 hrs after the Benadryl was initially given, as a precautionary measure.
lt arm discolored 3x3cm induration, warm area;rash below lt deltoid;
This spontaneous report as received from a pharmacist refers to a 66 year old female patient. The patient had no pertinent medical history, no drug reactions and no allergies. On 12-MAR-2016, the patient was vaccinated with the dose of ZOSTAVAX injection, lot # L033311, expiration date 01-DEC-2016 (dose and route of administration were not reported). The patient had no concomitant medications. Approximately on 12-MAR-2016 (it was unspecified if the adverse events developed on 12-MAR-2016 or 13-MAR-2016), the patient developed a red, circular rash the size of a half dollar or a little bigger, below the injection site and it itched horribly. The patient sought medical attention via calling pharmacy. No treatment was given for the adverse events and no lab diagnostic studies were performed. The outcome of the adverse events and the causality between the adverse events and ZOSTAVAX were not provided. Additional information has been requested.
Face turned blood red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Face turned blood red) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hyperthyroidism (Treated in the past). Concomitant products included METOPROLOL SUCCINATE (TOPROL XL) and CICLOPIROX for an unknown indication.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced ERYTHEMA (Face turned blood red). On 04-Mar-2021, ERYTHEMA (Face turned blood red) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported Concomitant medication Ciclopirox was used under breast and toes. Batch number for suspect product was reported as 025A2(illegible 7 or 9) It was reported that after vaccination, patient was kept on observation for 15 minutes, her face turned red after she went back home which lasted for a minute tops.   This case was linked to MOD-2022-461572, MOD-2022-461618, MOD-2022-461295 (Patient Link).
This prospective pregnancy case was reported in a literature article and described the occurrence of abruptio placentae in a female subject who received Flu Seasonal QIV Dresden. On an unknown date, less than a year after receiving Flu Seasonal QIV Dresden, the subject developed abruptio placentae. Serious criteria included GSK medically significant and other: serious per reporter. Additional event(s) included vaccine exposure during pregnancy. The outcome of abruptio placentae was unknown. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy was lost to follow up. The investigator considered that there was a reasonable possibility that the abruptio placentae may have been caused by Flu Seasonal QIV Dresden. Additional information was provided. This prospective pregnancy case was reported in this literature article and described the occurrence of abruptio placentae in a female aged above 10-year who was vaccinated with unspecified seasonal inactivated influenza vaccine (manufacturer unknown) during pregnancy. The patient was part of a study that assessed the safety of seasonal inactivated influenza vaccines (IIV) and live attenuated influenza vaccines (LAIVs) in pregnant women and their infants whose reports were submitted to Vaccine Adverse Event Reporting System (VAERS) during 2010-2016. No information on patient's medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified seasonal inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). On an unspecified date between 1 July 2010 and 6 May 2016, an unknown period after vaccine exposure during pregnancy, the patient experienced abruptio placentae. This case has been considered serious as per the authors. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between abruptio placentae and unspecified seasonal inactivated influenza vaccine. However the authors stated, "VAERS also generally cannot determine whether a vaccine caused an AE." The authors concluded that "During the study period 2010-2016, the average annual number of VAERS reports following IIV in pregnancy decreased compared with the 2009-2010 pandemic period but remained higher than prior to the pandemic. Similar to the 2009-2010 period, no new or unexpected patterns in maternal or fetal outcomes were observed during 2010-2016. Maternal influenza vaccination benefits both the mother and the infant, protecting them both from influenza disease. Given that the antigenic composition of these vaccines usually changes each season, the CDC and FDA will continue to monitor the safety of influenza vaccines in pregnant women." This is 1 of the 12 valid cases reported in the same literature article.
Chills, fever, body aches, muscle/joint aches, headache, extremely elevated heart rate (~140 bpm): emergency room visit
7/23/99 immunization site, red, edematous, warm to touch w/5cm x 5cm indurated area;impression: cellulitis rt thigh DTAP site;plan: Duricef given;7/24/99 imp: resolving cellulitis;plan: finish meds f/u PRN;
Injection given in lower r arm. Site of injection throbbing hurting Radiating up arm to shoulder & neck. Seems injection given to low on arm. Injection site throbbing. 11a Injection Site elbow Throbbing at sight of injection. I have been in Physical Therapy. Seems to help some but pain returns. I cannot scratch my left shoulder without pain. Putting clothes over head there is pain. I am going to see an orthopedic physician. I want to know what this is
tongue numbness; weird taste; persistent allergies; itchy face; This is a spontaneous report from a contactable health care professional (patient).  A 39-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL8982, expiry date unknown), via an unspecified route of administration on 20Jan2021 at a single dose on the left arm for COVID-19 immunization. Medical history included pre-diabetes and allergies to penicillin both from an unknown date and unknown if ongoing. The patient concomitantly received cetirizine hydrochloride (ZYRTEC) as pre-medication and Lexi pro (as reported). The patient received the first dose of BNT162B2 (lot number: EL0142, expiry date unknown), intramuscular on 30Dec2020 at 10:30 AM on the left arm for COVID-19 immunization where the patient immediately after experienced metallic taste in mouth followed by itchy throat that felt constricted. Prior to vaccination, the patient has not had COVID-19. The patient has not been tested for COVID-19 post vaccination. The patient was premedicated with Zyrtec and 15 minutes after second dose had tongue numbness and weird tast on 20Jan2021 at 16:15 and itchy face started hours later and then continued with persistent allergies every day since the second dose until present was placed on oral steroid. The events resulted in a doctor or other healthcare professional office/clinic visit. The patient received oral steroid and Benadryl as treatment for the events. The outcome of the events was recovering.