chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient inadvertently received an expired dose of VARlVAX on 9/13/2019. No adverse effects reported.; the patient inadvertently received an expired dose of VARlVAX on 9/13/2019. No adverse effects reported.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 13-SEP-2019, the patient inadvertently received an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot# N022996 with expiration date of 23-AUG-2019, for prophylaxis (route and frequency were not reported). Concomitant therapies included sterile diluent (DILUENT MRK INJ) with lot# N021894 with expiration date of 28-NOV-2019.      No adverse effects were reported. No additional information provided.
Patient reports injection site became bruised, itchy, and felt warm to touch. Patient was advised to monitor and follow up with PCP.
At 1624, RRT activated when client (22 y/o M) tensed up (as in a panic attack) immediately after getting the J&J shot. He was complaining of feeling dizzy, nauseated, and clammy. LOC intact and client was talkative all throughout the incident. Noted that he is usually anxious every time he gets a shot. Vaccinated on the R arm. Support provided, and VS taken: BP ? 130/78, RR ? 18, HR ? 74, Pain ? 0/10. Head to toe assessment completed. No PMH, not on any medication. Within 3 minutes, client felt much better and remained that way until leaving the vaccination clinic ambulatory and in stable condition at 1652 with mom and girlfriend.
Onset of elevated blood pressure...170/100. BP at most recent doctor visit was 125/70. Might have been due to aggregate sodium intake, and unrelated to vaccine booster which was three months prior.
My health has been steadily declining since I had the second vaccine. I am experiencing extreme fatigue and tiredness and am unable to do my daily work. I have been to my PCP, Oncologist, Endocrinologist and Allergist they cannot find a reason for why I am feeling this way. I am waiting to hear from my PCP for the referral for a Neurologist.
Mother called at 3:45pm on 7-22-11 and reported that child noticed at 12:00 noon an itchy whelp the size of a quarter. States there is a red "ring around the whelp making total size of a "half dollar". Heat also noted to area. Mom instructed to give BENADRYL and to see PCP if worsens or other signs of allergic reaction develop to go to ER.
9/26/2011 0900PM: Initially, inconsolable crying despite Tylenol administration two hours earlier, relieved by ibuprofen administration, followed by left arm swelling at the site of injection the following morning (8am realized by daycare staff, but parents aware in the evening) and warmth, followed by speading of warmth, swelling, red streaking (up to neck) and mottling of arm from shoulder to wrist by evening and a fever 100.0F.  Pediatrician examined at 0600PM 9/27/2011 and prescribed Keflex and Benadryl, diagnosing with "vaccine reaction and possible cellulitis". Hives developed 9/27/2011 at 0630PM on left side of face/neck - resolved with Benadryl administration.
sore arm/Pain in left upper arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 02-AUG-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 02-AUG-2023, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: sore arm/Pain in left upper arm).  The outcome of the injection site pain was not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-OCT-2023 The reporter reported that patient's upper arm was still hurting after receiving the Shingrix vaccine. The reporter consented to follow up.
T78.40XA ALLERGIC REACTION, INIT 8/8/2022 ANGIOMYOLIPOMA, RIGHT KIDNEY
I noticed achiness on right side of chest about 18 hours after vaccine. This was in addition to ache at the injection site. It progressively worsened and grew to up my side/chest to my armpit. It felt swollen and very sore and lasted about 48 hours. I googled the side effect and didn't seek medical attention.
At 2:00 am on 2/13/21 I developed fever, chills, body aches that continued till 2/14/21. Then on 2/14/21 my body broke out in an itchy rash on my neck and my wrists/lower forearm. Then on 2/15/21 my mouth formed ulcerations.
PATIENT RECEIVED PNEUMOVAX 23 IMMUNIZATION ON 11/13/20 IN HIS RIGHT ARM AND BY THAT EVENING PATIENT WAS HAVING PAIN IN SHOULDER AND TROUBLE MOVING IT. HE REPORTED TO PHARMACY ON 11/16/20 AND PATIENT SAID PAIN WAS BETTER AND HE COULD MOVE IT A EASIER. REPORTED PAIN IN SHOULDER AND TENDERNESS. COULD BEND ARM BUT PAINFUL TO LIFT AT HIS SHOULDER. THERE WAS NO EVIDENCE OF REDNESS, SWELLING, OR WARMNESS. PATIENT SAID HE NEVER HAD ANY OF THOSE SIGNS AFTER IMMUNIZATION EITHER.
sinus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cold" (unspecified if ongoing), notes: before his 1st dose. The patient's concomitant medications were not reported. The following information was reported: SINUS DISORDER (non-serious), outcome "unknown", described as "sinus".  Additional Information: It was reported that when the patient already received his 1st dose, he was asking if he can take an OTC guaifenesin (MUCINEX) for his "sinus."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Debilitating headache, nausea and malaise. Never experienced such a bad headache before. I rarely had headaches before. If there was a headache, it always got better after a nap. I've been in bed for 24 hours and this headache is still there.
Rash with white boarder next to vaccination site. Spread like a streak down to elbow. The pain was "like an electrical shock" that extended to the ring and pinky fingers of the left hand. 3 weeks later she is having numbness and tingling in the fingers "kind of like they are asleep." Pt took Tylenol the rash has disappeared but the pain and tingling remain.
Large area of redness down arm.  showed up around 2/22 or so.  she said it had been there for a few days.  vaccine was on 2/17/21
hives on neck and chest patient reports taking Benadryl and using hydrocortisone cream on the rash area with improvement denies SOB / trouble swallowing/ any other symtpoms refused appointment in office for this, she simply called in to alert us of her reaction. she told me over the phone she tested positive for allergic reaction to eggs in the past but never had a problem with the flu shot in the past.
Testing postive for COVID-19; A report was received from a consumer, a 32 year old adult female, who was participating in the mRNA-1273 Emergency Use Program and experienced the event testing positive for COVID-19.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 on 23 Dec 2020.   On 28 Dec 2020, the patient reported that they had received the vaccine on 23 Dec 2020 and now were testing positive for COVID-19. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, testing positive for COVID-19, was considered not resolved.  The reporter did not provide an assessment for the event, testing positive for COVID-19.; Reporter's Comments: This case concerns a 32 year old female with unknown medical history, who experienced a non serious unexpected event of " tested positive for COVID-19"  after receiving the first dose of mRNA-1273. Details of the event are not reported.  Based on the available information and the close temporal association with mRNA-1273 administration, a causal relationship cannot be excluded.
Heart started racing / felt and heard the pounding; Left arm tingled with pins and needles; Foggy head; Extremely tired (eyes heavy); Extremely tired (eyes heavy); Achy arm; HR ranged from 87 to 94 with more constant rate at 91-94 / Increased heart rate lasted until bed; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 14Apr2021 at 13:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC), taken for an unknown indication from an unknown date and unknown if ongoing. On 14Apr2021 at 14:15, after 30 minutes of vaccination, the patient experienced achy arm; at 14:25, after 40 minutes of vaccination, got extremely tired (eyes heavy); at 14:30, after 45 minutes of vaccination, the patient experienced foggy head for 15 minutes duration; at 14:35, after 50 minutes of vaccination, left arm tingled with pins and needles (1 to 2 minutes duration); at 14:38, after 53 minutes of vaccination, the heart started racing and the patient decided to lie down and took the afternoon off; heart rate ranged from 87 to 94 with more constant rate at 91 to 94 (per fitbit charge 3), the patient felt and heard the pounding (no pain, no shortness of breath). The patient slept for about 1 hour. On 14Apr2021, increased heart rate lasted until bed at 22:10 and the patient had GREAT sleep for 8 hours 34 minutes, woke only for toilet and water. The patient awoke fully energized, heart rate was not obvious through her chest and seemed back to normal. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events foggy head was recovered on 14Apr2021 at 14:45; left arm tingled with pins and needles was recovered on 14Apr2021 and increased heart rate was recovered on 14Apr2021 at 22:10 while the events achy arm, extremely tired (eyes heavy), heart started racing, felt and heard the pounding were recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
severe allergic reaction to the Pfizer vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (172086). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Polyethylene glycol, reaction(s): "allergic to Polyethylene glycol", notes: Consumer is allergic to Polyethylene glycol had severe allergic, reaction to the Pfizer vaccine. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "severe allergic reaction to the Pfizer vaccine".  Additional Information: Caller (name withheld) a consumer was allergic to Polyethylene glycol had severe allergic reaction to the Pfizer vaccine, she would like to know if she can ask someone from the Pfizer if the powder of the Paxlovid tablet can be manufactured near her place so that if ever they tested positive from Covid-19 they can take medication without the Polyethylene glycol in the ingredients.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Erythematous papule at site, less than 24 hours post vax, muscle aches, chills, myalgia, pain in entire arm at first then just upper arm. Pt recovering at time of report.
He got his vaccine, it was very painful and she told him to elevate his arm which he did.  It was kind of sore when he got home, and it was itching slightly.  He didn't think it for anything.  At that time the soreness was progressing, warm to touch and progressively getting warmer and sorer.  Around 8:30 PM he was sitting in his recliner, he was sitting up and wanted to get up and use the bathroom and when he tried to get up he had excruciating pain in his leg, could not bend it and had an accident.  He was on the 2nd floor about 15-20' from the bathroom, could not sit and was able to hop back to the chair.  The pain trying to sit back down took quite a while as it was so excruciating.  He had a low grade fever for 3-4 consecutive day, his arm was red with a large patch area, where the vaccine was given there was a lump, painful and itching.  He did not have much of an appetite for a few days and partially immobilized, could not get down the stairs and the pain in his right knee was worse.  His knee is still hurting, if he walks for a little while he has stiffness and pain in that knee.    He did go to his PCP, his doctor was not available and the other doctor stated that it was a very severe reaction that he had to the vaccine.  He was starting to feel better by the time he saw him.  He had some medications around him but could not get to them.  He lives alone and his family was out of town and could not get in touch with them.  The pain was a little better, was able to hop around better.  He had a broom stick and was able to go downstairs and get his crutch which was down there and was able to get around better after a few days.  It took a while before the itching went away on the right arm, the area of the vaccine started peeling after a week or so, and the lump was still there, but finally disappeared around 3 weeks later.  The itching was the last thing to go on the arm and the soreness.   He still continues to have stiffness and pain when he walks on his right knee.
pt had 3hr of crying p/vax given 30JUL97;seen in clinic 4PM;pt was nl;
No additional AEs, no PQCs; MMR II, VARIVAX, and Hep A vaccines were administered on 26FEB2021 to a patient that was 12 months old at the time, then MMR II, VARIVAX and Hep A vaccines were administered again on 03MAY2021; This spontaneous report was received from a medical assistant referring to a 15-month-old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 26-FEB-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route, lot number and expiration date were not provided),  hepatitis  A (manufacture unknown) (1 dosage form (reported as 1 time dose), strength, route, lot number and expiration date were not provided) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (1 dosage form (reported as 1 time dose), lot number reported as CE74N, conflicting information: the reporter did not know the date this LOT was administered; strength, route and expiration were not provided) as prophylaxis.      On 03-MAY-2021, the patient was vaccinated again with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T027303, expiration date was not provided, but upon internal validation established as 12-AUG-2022, 1 dosage form (1 time dose)),  hepatitis  A (manufacture unknown) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) as prophylaxis (inappropriate schedule of product administration). No additional adverse events (AEs), no product quality complaints (PQCs) (no adverse event).
Injection site itching and redness on day 11 following vaccination. Reddened area approximately 2 inches high by 1..5 inches wide. Area is slightly warm to touch.
Vaccination failure; COVID infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: EP7533), in left arm, on 23Apr2021 as dose 2, single (Lot number: EW0170), in left arm and on 25Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 48 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "depression" (unspecified if ongoing); "OCD" (unspecified if ongoing). Concomitant medication(s) included: FLUZONE QUADRIVALENT, on 03Oct2021 as dose 1, single; PRISTIQ; BUPROPION; SYNTHROID; VYVANSE. The following information was reported: COVID-19 (medically significant) with onset 16Jan2022, outcome "recovered" (2022), described as "COVID infection"; VACCINATION FAILURE (medically significant) with onset 16Jan2022, outcome "recovered" (2022). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jan2022) Positive, notes: COVID test type post vaccination nasal swab. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received Fluzone quad 2021-2022 Sanofi with 4 weeks prior to the BNT162b2 vaccine. Treatment medication included Loratadine and Symbicort.
fever 102-103 w/in 1day, went limp, eye rolling-aseptic meningitis;pt w/relentless crying;
SUPER BAD ACHES; LETHARGIC; SLEEP WHOLE DAY; HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, the subject experienced super bad aches. On 2021, the subject experienced lethargic. On 2021, the subject experienced sleep whole day. On 2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, super bad aches, lethargic and sleep whole day was not reported. This report was non-serious. This case, from the same reporter is linked to 20210427663.
Approximately 12 hrs after my 2nd dose, I started to experience chills, fatigue, aches and pains.  I was sweaty and uncomfortable.  I am not supposed to take Tylenol or ibuprofen due to gastric sleeve surgery and took 1-500 mg Tylenol to ease the discomfort around 9 pm however this did not relieve the aches, pain or chills.  I did not take my temperature at this time.  I took another Tylenol around 12 am and attempted to sleep however around 4 am I woke up sweaty and chilled and took my temperature with an infrared thermometer and it was 102.5.  I took 2 Tylenol and 1 ibuprofen at this time.  My temperature decreased to 99 by 7 am and was down to normal by 9 am.
Information has been received from a physician concerning a 16 year old female who on 25-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine (yeas). On 25-JUN-2008 the patient experienced periodic numbness in arm after vaccination. The patient experienced three episodes of numbness in the arm that received the vaccine. The patient recovered from periodic numbness in arm. The patient sought medical attention by telephone call. Additional information has been requested.
Pain in shoulder beginning shortly after administration.  Pain ongoing as of 01/16/2020/.  Treatment initiated on 01/15/2020
29MAY evening p/inject had no fever,but had one sz @ home was taken to local ER had prolonged sz there & was admitted;
The patient received an inadequate dose of the Pfizer vaccine. This error was due to a vaccinator preparing the vaccine by reconstituting with an unspecified amount (possibly 1.5ml) of diluent and drawing up 0.15ml of vaccine to be administered.  After realizing the vaccine error, a corrected repeat dose was administered per the CDC Interim Recommendations for COVID-19 Vaccine Administration Errors and Deviations.  Patient was observed for the 15-minute period without any adverse reactions.
Pt. began to cry 4 hours after vaccine adminstration. Crying loudly over 1 1/2 hours. Pt. was given Tylenol 1 hour into period. Followed up with parent who reported back to.
Information has been received from a physician who refers to himself, a male patient of unknown age and medical records. On 20-JUN-2016, about 10:00 a.m., the patient was vaccinated with PNEUMOVAX 23 lot # L033707 in the left arm. the patient stated that the injection technique seem normal; alcohol wipe, no pain on injection or immediately afterwards. At mid afternoon, on 20-JUN-2016, within a few hours of receiving PNEUMOVAX 23, the patient developed pain in bending at the elbow, swelling in his left upper arm and elbow, tenderness, redness, and soreness. There was no itching or fever. the patient reported the pain was severe enough so that he needed to take a VICODIN in the evening on 20-JUN-2016 which was very rare for him. The patient reported that he never had an immunization reaction like this. On 21-JUN-2016 at 7:21 p.m., the patient went to a Urgent Care Clinic for treatment where he was diagnosed with cellulitis and was given ROCEPHIN IM and a prescription for AUGMENTIN. the patient's current medications included AVODART, CIALIS, simvastatin, and SYNTHROID. The patient was instructed to apply ice/heat for 15 minutes each 4 times daily and monitor the redness. If the redness spread, the patient was instructed to go to the emergency room. The outcome of cellulitis is unknown. Upon internal review cellulitis was considered an important medical event. All available medical records will be provided upon request. Additional information has been requested.
Swollen glades; Vomiting; Low energy; This spontaneous case was reported by an other health care professional and describes the occurrence of LYMPHADENOPATHY (Swollen glades), VOMITING (Vomiting) and ASTHENIA (Low energy) 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 17-May-2021, the patient experienced LYMPHADENOPATHY (Swollen glades), VOMITING (Vomiting) and ASTHENIA (Low energy). At the time of the report, LYMPHADENOPATHY (Swollen glades), VOMITING (Vomiting) and ASTHENIA (Low energy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided . No treatment details were provided.
Tinnitus. Next day on off ear ringing in right ear, continued for 7 days by day 8 ringing was in both ears and constant