chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Wed. 2/17/2021:  Within 30 minutes of shot, left arm burning/sore.  Within 45 minutes hip/joint pain, difficulty walking.  Within 1 -2 hours fatigue.  By evening, hip and fatigue issues gone.  Soreness in arm much worse.  Difficult to lift arm/change clothes.  Almost no sleep that night - pain in arm.  Did not take anything for it. Thu. 2/18/2021:  Muscle soreness in arm worse.  Hard to move.  Had to lift left arm with right to get to table to type in computer or eat.  Little sleep Thursday night - pain in arm.  Did not take anything for it. Fri. 2/19/2021: Muscle soreness in arm same - bad - upon awakening.  As day progressed, it got better.  By evening feeling "okay."  Able to sleep.  Sat/Sun/Mon 2/20/2021, 2/21/2021/2/22/2021 - no pain in arm Tue 2/23/2021 - noticed very slight muscle soreness in arm in evening Wed 2/24/2021 - noticed more muscle soreness in arm as day progressed; hurt to take tee shirt off in evening Thu 2/25/2021 - woke up with much more muscle soreness in arm - felt like a rerun of Friday 2/19.  Am sending this in as a result.
p/vax pt exp loss of strength in rt arm; arm feels funny & weak; feels like arm going to give out; unable to brush hair on horse;
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020). Previously administered products included SHINGRIX with an associated reaction of injection site pain (along with injection site redness after receiving 1st dose received on 1st March 2018, refer case US2018GSK102761). On 30th May 2018, the patient received the 2nd dose of SHINGRIX. In May 2018, 1 hr after receiving SHINGRIX, the patient experienced red blotches. On 30th May 2018, the patient experienced injection site pain, injection site erythema and shivering. The patient was treated with BENADRYL and MEDROL. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, injection site erythema, shivering and red blotches were unchanged. It was unknown if the reporter considered the injection site pain, injection site erythema, shivering and red blotches to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX on the left arm. One hour after receiving vaccination, the patient developed pain, redness at injection site about 4 inches in diameter along with shivering and red blotchiness above knees (in which appeared with applied pressure). The patient reported taking BENADRYL, applied CBD oil and started a MEDROL DOSE PACK for treatment of symptoms. The health care professional stated this was the first report submitted for both the initial and secondary doses received which brought about the reported adverse reactions. This case was also linked to case US2018GSK102761 and US2018GSK102762, reported by the same reporter.
Swelling in face, neck, hands, ankles and feet. Chest pain like severe gas pain on the left. Sore joints in hip, knee and back. All symptoms started within 72 hours and lasted for 72 hours, post vax.
Throat closure; loss of feeling in left hand; loss of feeling in right foot; low grade fever; inability to lift arms;  All joints were swollen and unbendable; eyes swelled up and were burning unbearably; loss of taste;
Immediate reaction to injection: dizzy, lightheaded, syncope, neck spasm lasted a few seconds. Improved quickly, appropriately. Headaches, nausea, dizziness persisted x 15 days. Pt lost 5 lbs.
Chills developed around midnight, fever at the time of chills 98.8F, later in the night 102.5. Still ongoing at 4am 04/29/21. Slight frontal headache and sore injection site.
Nurse unknowingly administered another dose of Bivalent booster today, patient's first bivalent booster was on  10/12. He was monitored for 15minutes, stable, no acute ditress noted. He was adviced to monitor for any unsual side effect, notify MD and call 911 if there  is any emergency
Information has been received from a registered nurse (R.N.) concerning an 11 year old female patient with asthma, allergic rhinitis and allergy to amoxicillin and latex who on 06-AUG-2010 was vaccinated subcutaneously with a 0.5mL dose of VARIVAX (Merck) (Lot number 666920/0547Z) (Expiration date: 08-APR-2012). Concomitant therapy included albuterol inhaler, XOPENEX and PULMICORT in nebulizer. The nurse reported that on 07-AUG-2010 the patient called to report that the injection site was reddened 3.5 inches in diameter. On 07-AUG-2010, the patient's mother called to report that patient's arm was swollen and had doubled in size. Patient was afebrile at that time. Patient was taken to the emergency room where she was examined by a physician who diagnosed the patient with cellulitis. Patient was hospitalized and put on an antibiotic and sent home. At the time of report, the patient was recovering. Follow-up information has been received from the registered nurse, concerning the 11 year old female patient who on 06-AUG-2010 was vaccinated subcutaneously with a 0.5mL dose of VARIVAX (Merck) (Lot number 666920/0547Z) (Expiration date: 08-APR-2010). Concomitant therapy also included MENACTRA (Lot # U3460BA). The nurse reported on 07-AUG-2010 that the patient's mother called to report that the patient had a 3.5 centimeter red mark on her left arm. On 08-AUG-2010 the mother called the nurse and took the patient to the emergency room. The patient was diagnosed with cellulitis. Nurse reported that the patient was not admitted to the hospital. Additional information has been requested.
Sore at site of injection, chills, aching muscles, fatigue, heaviness, lasting for 6 days. FYI, this was dose #2, administered about 3 months after the first dose. Had similar reaction after first dose but did not report through VAERS. First dose reactions eased up after 5 days. Second dose reactions are taking longer to dissipate.
About 12 lesions, trunk mostly.  One on head.  Diagnosis: Varicella  Treatment: Symptomatic
Also some spots at the back of my hand, liver sports had disappeared after the shot; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose 1, single, for Covid-19 immunization. Medical history included spots at the back of my hand. The patient's concomitant medications were not reported. The patient reported that some spots at the back of his hand, liver sports had disappeared after the shot, it cured his spots. Outcome of the event was unknown.  No follow-up attempts are needed. Information on lot/batch number could not be obtained. No further information is expected.
noticed 1 cm lump at injection site - 3 wks after shot was given- no redness-
Day after second dose, kidney pain lasting for three days.  Thereafter severe abdominal pain, swelling of feet, diarrhea, tiredness, bloodshot eyes, rash, fluid in the lungs, fluid in the abdomen, fluid around the heart.
This spontaneous report was received from a nurse via company representative and refers to a 25 year old female patient. The patient's relevant medical history, concomitant medications and concurrent conditions were unknown. On 11-DEC-2018, the patient was vaccinated with the third dose of GARDASIL 9 for prophylaxis, lot # N035957 and expiration date 10-OCT-2020 (dose, strength, frequency, and route of administration were unknown). On the same day, following the injection, the muscle at the injection site felt extremely hard in a three inch by three inch area (injection site reaction). The outcome of injection site reaction was reported as recovered after 4-6 weeks (January 2019). It was unknown if the patient sought medical attention. Causal relationship between injection site reaction and GARDASIL 9 was unknown.
Migraine visual aura 3x week x2 weeks Swollen lymph nodes in neck 6/1/21-7/22/21 Difficulty with short-term memory and cognitive processing from 6/1/21 to present
11 hours after vaccine received, low grade fever had begun. Next morning/day - severe headache, fever of 102, tired, and overall sore/fatigued. Also some mild stomach issues.  Took generic acetaminophen for fever/headache, and this eased symptoms.
This spontaneous report as received from healthcare provider refers to a patient of unknown age. On an unknown date the patient was vaccinated with an improperly stored vaccine of M-M-R II (lot # J002502, expired date 28-FEB-2015). The original reporter is unknown. Additional information has been requested.
Initial and follow up information has been received from a registered medical assistant and a 48 yr old white female homemaker with a sulfonamide allergy, allergy to sulfamethoxazole (+) trimethoprim (Septra) and had a history of breast cancer (previously reported as unspecified cancer (cancer a year ago) ). On 08Feb06 at 12:10PM (also reported as 12:00PM), the pt was vaccinated SC in the upper right arm with the first dose of pneumococcal 23v polysaccharide vaccine (lot 651320/1008P). At the same time, the pt was vaccinated IM in the opposite arm with an unspecified diphtheria toxoid (+) pertussis vaccine. Concomitant therapy included fluoxetine HC1 (Prozac) and an unspecified therapy (Temoxypin). There were no known illnesses reported at the time of vaccination. On 08Feb06 (also reported as 09Feb06), at 4:30PM, the pt developed a headache, fever, localized site with injection lump (also reported as huge knot with injection site) and body aches (previously reported to have developed chills). There were no laboratory diagnostic studies performed. The pt sought unspecified medical attention (also reported as spoke with office staff). The pt was treated with acetaminophen (Tylenol), ibuprofen and ice. On 13Feb06, 5 days later, the site was still swollen, PNFL, and a large knot was present (also reported as symptoms resolved gradually and knot was still present on 13Feb06 at last communication with pt). As of 16Feb06 the pt had recovered from the events. Additional information is not expected.
developed Guillain-Barré syndrome; This serious case was reported by a nurse via sales rep and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: developed Guillain-Barré syndrome) (serious criteria GSK medically significant).  The outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.     It was unknown if the company considered the guillain barre syndrome to be related to Shingrix.   Additional Information: GSK Receipt date: 21-AUG-2023 A nurse practitioner reported that a patient developed Guillain-Barré syndrome after receiving Shingrix.  The patient developed the syndrome after unspecified period after receiving one dose of Shingrix. This case has been linked with the case US2023114891 reported by same reporter. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023114891:2nd dose, different patient, same reporter
patient received pfizer booster on 4/7/22 after having J&J as his 1st shot at least 4 months before and stated his left armpit nodules are inflamed and enlarged after getting shot in left arm.
Pt came in on 1/4/16 to show Rph her arm where shot given. It was red, swollen and hot at injection site.
itchy over stomach; vaccination site pain; tiredness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itchy over stomach), VACCINATION SITE PAIN (vaccination site pain) and FATIGUE (tiredness) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 027L20A) for COVID-19 vaccination.     Concomitant products included TAMSULOSIN, ROSUVASTATIN CALCIUM (ROSUVASTIN), FENOFIBRATE, LOSARTAN, AMLODIPINE, FISH OIL (OMEGA 3 FISH OIL [FISH OIL]), GLUCOSAMINE, MULTIVITAMIN [VITAMINS NOS], CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 22-Apr-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain) and FATIGUE (tiredness). On 23-Apr-2021, the patient experienced PRURITUS (itchy over stomach). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at a dose of 25 milligram every four hours; TRIAMCINOLONE for Itching, at a dose of .1 % twice a day and HYDROXYZINE HCL for Itching, at a dose of 25 milligram three times a day. On 24-Apr-2021, VACCINATION SITE PAIN (vaccination site pain) and FATIGUE (tiredness) had resolved. At the time of the report, PRURITUS (itchy over stomach) was resolving.            Patient went to see doctor on 10-MAY-2021.  Patient stated that itchy reaction was getting better but still there. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments   This case was linked to US-MODERNATX, INC.-MOD-2021-098380 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Treatment information, event details were added. On 28-May-2021: Follow-up information received on 28-05-2021 contains non-significant information. On 29-Jun-2021: Follow-up information received on 29-Jun- 2021 contains non-significant information. Patient declined further follow up..; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-098380:case for first dose
Received dose in tricep; A spontaneous report received from other Health Professional concerning, unkown age and unknown gender patient who received dose of Moderna COVID-19 vaccine in tricep.   The patient's medical history was not included. Patient's concomitant was not included.    On unknown date, the patient received their unknown of two planned doses of mRNA-1273 in unknown arm (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection.   Consumer called in stated that patient received dose of the Moderna COVID-19 vaccine in their tricep.   Treatment information was not provided/ unknown.  Action taken with mRNA-1273 in response to the event was not provided/unknown.   The outcome of the event was resolved.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # unknown) with no associated AEs reported.
Vaccine administered after beyond use date (1/28/23). Staff retrained on proper storage and handling. Process reviewed to ensure safe administration. Moderna contacted regarding the administration error for stability information. Patient will be contacted and offered re-vaccination according to the CDC's recommendation.
Approximately 12 hours after receiving the 2nd Moderna COVID19 vaccine injection, I had chills, body pain and a fever of 102F. After taking Tylenol, the fever reduced to 101F and maintained for approximately 36 hours before dropping to normal range. After 48 hours, no symptoms remained.
2 YO received Kinrix; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa-IPV (Kinrix) (batch number HNNJ7, expiry date 26th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th December 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 16th December 2022, 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 Information: GSK receipt date: 21-DEC-2022 Reporter's comment: Adverse event (AE) contained all reported information per health care professional (HCP).  The HCP gave consent for safety team follow up. Additional supportive information: 2-year-old patient received Kinrix, which led to inappropriate age at vaccine administration.
Initial report received from a health care professional on 21 Dec 2009: This patient (2 year old child) was vaccinated with S-OIV FLUVIRIN (batch no. unknown) on 21 Dec 2009. No adverse event was reported.
started itching 8OCT96 & hives on 9OCT96-11OCT96;cont to have itching denies fever, edema, & SOB;
Fever, body aches, headache, fatigue the following morning after receiving 2nd dose. Symptoms subsided approximately 8 hours later.
Headache, Myalgia, Arthralgia, Fever, Diarrhea, Tachycardia, HA resolved 12/29, aches chills conts. 12/31 all symptoms resolved, Covid tested negative.
itchy rash; swelling on bottom half of  face and jawline; Bubbly rash; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727), via an unspecified route of administration in the left arm on 21Mar2021 at 11:45 (at the age of 25-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food, or other product. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included KYLEENA IUD for an unknown indication from an unknown date. On 21Mar2021 at 23:00, the patient experienced bubbly, itchy rash and swelling on bottom half of face and jawline. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if the patient received treatment for the reported events. The clinical outcome of the events bubbly, itchy rash and swelling on bottom half of face and jawline was unknown at the time of report. No follow-up attempts are needed. No further information is expected.
Patient requested Moderna and was vaccinated with Pfizer. No adverse reactions reported at this time.
Syncope immediately (within 1 minute) after administration of TDaP and HPV vaccines.  Symptoms resolved within 30 seconds and did not recur.
There were no adverse reaction.  Vaccine was given too early due to incorrect information.  Patient had her 2nd dosage in August 2021...was given in November instead of within 6 months.
fatigue (11:30 AM May 1 to 2:00 PM May 2nd) fever and chills, full body pain, dizziness (2:00 AM May 2nd to 2:00PM May 2nd)  no treatment (slept, stayed in bed until symptoms stopped)
I experienced a fluttering sensation near my heart while laying down before going to sleep. I noticed the flutter was one or two seconds in duration once I got into bed and was laying still.  It occurred a couple times for the next week at the same time of day.  I no longer notice a flutter. I figured the cause could also be my age/normal stress verses from vaccine.
lt arm got all swollen & got a hard central knot, t101 24 hrs-48 hrs devel harder lt axillary lymph node, devel nausea, myalgias weakness & fever broke w/diaphoresis; gradually improved, sx gone 5 days;
3 seizures, eyes rolled back- all 4 extremities jerked; 1st lasted 2mins; other brief;
Symptoms started one week after receiving the vaccine. Has been having weakness in legs they keep gives out, muscle ache, nausea, severe headache, dizziness, sleeping lot.
Vaccine was administered at approximately 2:30pm 4/27...later that evening at approximately 10pm when my son was resting i felt his arms and legs start spasming/twitching. Both arms, hands, legs and feet continued to do so throughout the night and are still doing so as of this moment. These twitches are noticed more while he is calm and at rest, both awake and asleep. I immediately contacted our pediatrician the morning after 4/28 and was told "it was nothing to worry about, to call back if it persists". I called back the following day for another appointment  and seen "Dr." who said my son is having a  bad/allergic reaction to the vaccine" .  Besides the spasms and twitching my sons left arm is bruising and red near the injection site. The only treatment that was suggested by the second doctor (he was taking the place of our regular pediatrician who was out of the office) was benadryl which has not changed the twitching. Blood work/labs have been drawn today 4/30 from my son but we do not yet have results.
Pt recv vax on 4/5/99; on same day pt exp fever (104) & looked sick
09/06/22 presents to ED for "L sided weakness". PMHx of "CAD (stents to LAD), CML (on hydrea), hx of ascending aortic aneurysm, CVA, HLP, HTN, previous hx of colon CA s/p partial colectomy, PAF (on eliquis)"
I became dehydrate and confused. This was noticeable in the hours leaving for the hospital at about 8:00 p.m. Once at the hospital, I was combatant and didn't recognize family. I continued in this state while the Dr's at the hospital ran tests.  Around the 16th and/or 17th, after 2-3 days of steroids, I could answer Dr's questions and recognized family.
tachycardia , breathlessness and dizziness on day 3 after vaccine.  Day 7 after vaccine right hand tremor - lasted 2 days
Pain, tenderness, hardness at injection site for 7 days. Fatigue, muscle and joint pain for 36 hours. Full recovery from all adverse events.
Very sore arm for 3 days Red rash around injection site 9 days after vaccine given; itchy and sore.
Arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Feb2021 14:00 (Batch/Lot number: unknown) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pacemaker" (unspecified if ongoing); "mild syncope episodes" (unspecified if ongoing). Concomitant medication(s) included: ALENDRONATE; CALCIUM; METOPROLOL. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "Arm soreness".  Additional information: The patient has no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medication included multivitamins (as reported). It was reported that the event was experienced for 24 hours.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
18 days after receiving MMR, Varivax and Prevnar he developed an urticarial rash. This rash then changed in appearance with the development of bruises and petechiae. The rash resolved on its own after 5-6 days.
Reporting administration error as per Agency.  We contacted Pfizer for expiration dates, pfizer vaccine specialist advised that the expiration dates are  deemed viable at the time of vaccine administration. Pfizer vaccine vials only include manufactuarer dates on the box and vials. Therefore, we contacted  pfizer to obtain expirations dates directly from them.  No adverse reaction reported from the patient at the time of vaccination No adverse reaction reported since the administration of vaccination.