chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of eye pain, headaches, body ache, muscle ache, and sinus pain has been received from a parent concerning her 14-year-old daughter, subsequent to FLUMIST. Neither past medical history nor concomitant medications were reported. The patient received FLUMIST in January 2009. Since receiving the FLUMIST in Jan-2009, the patient has had headaches, body aches, muscle aches, sever sinus pain, and eye pain. The mother of the patient stated that the patient has been miserable everyday and has had to take ibuprofen and cetirizne hydrochloride just to be able to function. The patient has seen her physician several times and was instructed to continue taking the cetirizine hydrochloride and to call if needed, however, the patient still reports no relief. The event have not resolved.
This is a spontaneous report from a contactable consumer. A 68-year-old-male patient received PREVNAR 13, via an unspecified route of administration in Jul2017 at 0.5 ml, single for immunisation. Medical history included chronic bacterial sinusitis for nearly 50 years treated with antibiotic therapy 3- 5 times every year, diabetes mellitus, nasal congestion with nasal passages almost always blocked. Concomitant medication included metformin, carvedilol, hydrochlorothiazide, valsartan (DIOVAN HCT), insulin (INSULIN) for diabetes. The patient noted an unexpected positive effect. About 4 days after vaccination, his nasal passages became completely clear, drainage and purulent discharge completely disappeared, and overall he felt much better about his sinuses.
3 hives noted on cheek, left wrist and right arm. Given Benadryl and they resolved quickly.
Approximately 45 minutes post-vaccine, I noticed my right hand was quite itchy but I didn't really think about it.  About one hour post vaccine, I began itching on my arms and a coworker noticed that I had hives on my right arm and chest.  I called my doctor and she told me to get to the pharmacy and take 50 mg of Benadryl as soon as possible.  Once I reached pharmacy, about 12 minutes away, I had hives on my face and neck, with my right eye swelling shut and swollen lips.  I took the Benadryl immediately and the hives lessened within 45 minutes.  I took 50 mg of Benadryl every 4-6 hours for the next 16 hours because the hives and swelling kept returning when the Benadryl wore off.
pt had sz on or before 23SEP97;no hx sz;no sx of CNS reported;
No adverse event has taken place with the extra influenza vaccine given. Contacted the patient today at 11:09 AM. Patient received an influenza vaccine on 12/6/2021 when seen by her provider; however, the patient came back two days later at a different clinic for she   had scheduled herself in a nurse visit to receive the COVID Moderna booster vaccine and influenza vaccine. Patient was given both vaccines that day (nurse unaware of the office visit on 12/6/2021). However, I should have reviewed the patient's immunization vaccine list before giving the  influenza injection as I had reviewed her COVID vaccine list.
1) Very sore arm the next day (10/05/2019)  2) Several days later, experienced some loss of motion due to extreme pain. Assumed pain would "go away" over time but didn't. Endured this for 2 months. 3) On 12/04/19, I saw my doctor and presented with "positional" pain in left shoulder. There was no known prior cause for this pain. I mentioned, as an aside, that I had received a flu shot in my left arm. My doctor did not react to this comment (I suspect she was not aware of SIRVA, as I was not). Doctor ordered an X-ray and physical therapy regimen which I am still doing. 4) I told pharmacy on 1/03/2020 about this issue but they were uncooperative. They said to fill out this report. The two pharmacists that I talked to were unaware of SIRVA. The pharmacy manager was not interested in seeing me to discuss this issue so I never met them.
Generalized macular papular rash - negative mildly pruritic - chest, abdomen, proximal extremities and back.  Benadryl x 2 doses by parents.
Roughly 12 days after my second Moderna dose, I developed dizziness and tinnitus. The tinnitus and dizziness worsened peaking at 4 weeks post-vaccination.  13 weeks later I still have mild tinnitus and dizziness (lightheadedness / walking on a boat sensation).  It is daily from the moment I wake up until the moment I go to sleep.   I tried a taper of Prednisone - that did nothing.   So far the only treatment has been 2mg 2x day of valium which I take on occasion.  I've been to a neurologist, my primary care doctor, and an ENT. Both the neurologist and ENT confirmed this is most likely a post-vaccination inflammatory syndrome.
Received FLUZONE High Dose flu shot on 9-09/29/2014, about 20 minutes later throat started closing up, dizzy, blurry eyes. Returned to doctors office and was sent to Emergency Room in ambulance. Was given prednisone 40 mg. and BENADRYL 25 mg. Also received 25 mg BENADRYL in ambulance.
Site: Pain at Injection Site-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Weakness-Medium, Additional Details: Patient reported numbness occuring from cheeck bone upward to the head, pain radiating from the left arm to the knee on the same side with the injection. feeling heavy on the head and fatigue overall. pt reported these symptoms have improved a bit.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with RECOMBIVAX HB dosing details unknown. On an unknown date the patient experienced ended up contracting chicken pox. The patient called to confirm a lot number. The outcome of the event is unknown. Additional information has been requested.
Right hand began to tremble; This case was reported by a consumer via other manufacturer and described the occurrence of tremor of hands in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included BIONTECH COVID-19-VACCINE with an associated reaction of pain in extremity (1st dose received on 25th February 2021, through intramuscular route on right arm with batch number EN6201), BIONTECH COVID-19-VACCINE (2nd dose received on 18th March 2021, through intramuscular route on right arm with batch number EN6208) and Shingrix with an associated reaction of pain in extremity (received 1st dose on 4th January 2021, refer case US2022AMR095656). Concurrent medical conditions included blood pressure high (since August 2019). Concomitant products included lisinopril.   On 28th June 2021, the patient received the 2nd dose of Shingrix. In June 2021, less than a week after receiving Shingrix, the patient experienced tremor of hands. The patient was treated with carbidopa + levodopa (Carbidopa-Levodopa). On an unknown date, the outcome of the tremor of hands was not recovered/not resolved.   It was unknown if the reporter considered the tremor of hands to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR095656   Additional Information: GSK receipt date: 20-June-2022 Reporter's comment: The patient had 2check up with Lisinopril for high blood pressure which was control under 3 year. The patient received 2nd dose of shingles vaccine on the left arm. The patient reported that after 1st shingles shot left arm little sore and second was without pain. By the end of June patient's hand was terrible and refer to neurologist in looking Parkinson symptoms. Blood test and urine test were done for looking kidney function,A-1C, cholesterol level, vitamin deficiency, thyroid problem. The patient reported all blood test were excellent and no abnormalities. The patient had 2 check ups and prescribed with carbidopa Levodopa since 9th March 2022, and patient had stopped taking it since 6th June 2022 to see if there was change on hand tremor.  Additional supportive information:  This case has been linked with case US2022AMR095656 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR095656:Same reporter.
Patient reports erythema and pain at injection site 2 days after immunization. Was treated with oral diphenhydramine and ice compress.
Chills; Sweaty; I was thinking it tonight thinks that it might be Covid 19(Further clarification unknown) related Covid 19 shot?; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 10May2021, as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 17May2021, Patient started getting the chills and sweaty and then got the chills and it is been going on since 17May2021 and patient was thinking it tonight thinks that it might be Covid-19 (Further clarification unknown) related Covid-19 shot. Further reported, it is the shot that patient got on 10May might be giving the chills and sweatiness. The patient was curious to know if, that is one of the side effects. The outcome of the event chills was not recovered, and the events sweaty and Suspected COVID-19 was unknown at the time of report.  Information on the lot/batch number has been requested
PT VACCINATED BETWEEN 1-4PM AND STARTED WITH ARMS HURTING AT 10PM. 230AM WOKE WITH RAPID HEART RATE, VOMITING, AND FEVER OF 102.2. 630 AM STILL HAD TEMP. TEMP LASTED ONE AND A HALF DAYS. TYLENOL WAS ADMINISTERED FOR FEVER. 8/29/08 REPORTS CHILD HAS RUNNY NOSE AND HAS GENERAL MALAISE BUT AFEBRILE.
tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Family history included COVID-19 virus test positive on 11-Apr-2021.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
I exp shingles pain it doesn't go away, thrush, horrible fatigue and a lot of sleeping. It is very painful on my skin.
Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown.            No concomitant medication was provided.  No treatment information was provided.  Patient  received second Covid vaccine last Wednesday and tested positive for COVID on Sunday.
died; found non-responsive in crib by mom; rescue squad not able to resusitate; No other info available @ this time;
Inadvertently given child Adult Hep A instead of pediatric.  Choose wrong dose from refrigerator.   No adverse reactions.  Contacted patient mother twice and other than slight site reaction, there were no other side effects.
EMS called to pt's home when she was found unresponsive; CPR started; bradycardic PEA; ROSC obtained; coded 4 more times in the ED; pt found to be positive for COVID; COVID pneumonia; intubated; admitted to hosp; found to be brain dead; pt coded again and did not survive
nausea; fever; chills; Nerve pain has come back; Nerve pain has come back; This is a spontaneous report from a contactable consumer (patient). An elderly female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: 9264)), via an unspecified route of administration, administered in the left arm on 10Feb2021 08:15 as a single dose for covid-19 immunization. The patient's medical history included trigeminal nerve damage (nerve pain) from an unknown date. The patient has no known allergies. There were no concomitant medications. On 14Feb2021, the patient's nerve pain has come back. Previous pain was dormant for almost a year. She had history with trigeminal nerve damage and the nerve pain was active again after having the vaccines. Patient also had the normal fever, chills and nausea. The patient was treated with pain medication for the events. The outcome of the events was not recovered. The patient has not had covid prior to vaccination and was not tested post vaccination.
After his vaccine, the patient was sitting in a chair, fainted and collapsed onto the floor.  Ambulance was called, which the patient refused.
Pain in right arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Pain in right arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in right arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in right arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the event was unknown.
Pronounced change in taste/smell.  These senses were not lost, but changed in pronounced ways.  Foods commonly left bad (metallic) aftertaste in mouth, and highly spiced foods sometimes caused either immediate sneezing (as in allergies) or gut discomfort.  During this period I noticed episodes of sinus and/or ear infections.    The symptoms started around the time of first injection, although I did not recognize them as a pattern for some time.   The strength of the symptoms fluctuate in time.   3.5 months after the 1st injection  it seems that taste/smell is becoming more normal, although there may be some residual, fluctuating symptoms.
Started with Running nose and sneezing approximately 2 weeks after my 2nd COVID Vaccine. LEVOCETIRIZINE, 1 per day for 35 days and then Montelukast, 1 per day for 25 days. This did not fully stop the allergy of running nose and sneezing. Visited ALLERGY Specialist, Dr. on 14 May 21 and ALLERGY test was conducted to note I was positive to tree allergy and Non-Allergic. Rhinitis. Doctor prescribed FLONASE, twice a day spray for each nostril. Got under control in 15 days. Now using Flonase once a day and feel running nose and sneezing is in control.
extreme vertigo; nausea; vomited; chills but no fever; This is a spontaneous report from a contactable nurse. A 76-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6201), intramuscular, administered in left arm on 12Feb2021 at 10:45 (at the age of 76-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The medical history included essential hypertension, irregular heartbeat, chronic superficial gastritis, GERD with esophagitis, hypercholesterolemia, subclinical hypothyroidism, moderate obstructive sleep apnea, hypopnea syndrome, eczema, osteoarthritis, nephrolithiasis, and stage 3 CKD. The patient had known allergies to amoxicillin, sulfa and fragrance. The Concomitant medication(s) included amlodipine, acetylsalicylic acid (ASPIRIN (E.C.), biotin, clobetasol (CLOBETASOL), fish oil, losartan, lovastatin, metoprolol, omeprazole, and tramadol (TRAMADOL). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982), intramuscular, administered in left arm on 24Jan2021 at 10:30 (at the age of 76-years-old) as DOSE 1, SINGLE for covid-19 immunisation. On 13Feb2021, the day after the second dose of the Pfizer vaccine, patient experienced extreme vertigo. History of same, but this was worse than her usual. It has improved over time but not resolved. Then, two-three days later on Feb2021, she experienced nausea and vomited x1. On Feb2021, She also experienced chills but no fever. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient had no Covid prior vaccination and not Covid tested post vaccination. The treatment was unknown. The outcome of vertigo was not resolved and other events outcome were unknown.   Follow-up attempts are completed. No further information is expected.
Acute cerebellar ataxia - pt noted to have falling, abnl gait 2 days after vaccinations given - lasted ~3 wks.
Arm redness/bumps "COVID arm" (duration 5 days); myalgia (duration 3 days); low fever (99.9F); tiredness; skin tenderness result of fever (duration 2 days).
redness @ inj site, pain onset day of inj & decreased p/24hr;treated w/ice, APAP & DPH;almost resolved sx p/6 days on DPH/once inc BP;
Headache, Myalgia, Arthralgia, Fever, INJECTION SITE PAIN Narrative:
Patient calls pharmacy on morning of 5/27/23 to report a reaction to Shingrix. Patient came to pharmacy on 5/25/23 for shingles vaccine. Patient reported that the next day, she felt "paralyzed" throughout her whole body. Specifically, she reports tingling and numbness in extremities, and unable to walk. She called on the second day after to report to the pharmacy, and reports it has gotten a little better since the day before. Patient also reports a tick bite 2 weeks ago and is unsure if this is related. She is going for blood work for Lyme disease in a few weeks to rule out.  Patient was instructed to contact her doctor to report the incident and to be advised whether to move forward with second dose or not. Patient also instructed to stay well hydrated, and if the symptoms get worse, to seek medical attention immediately.
After Tdap on 3/23/11, area at site had blisters/redness down arm. No systemic or respiratory symptoms. Past Hx of Td reaction age 19. Had Td in 1993, sore arm only.
Caller is a consumer who received both doses of the Pfizer Biontech COVID19 vaccine on January and got COVID19 infection this August; Caller is a consumer who received both doses of the Pfizer Biontech COVID19 vaccine on January and got COVID19 infection this August; This is a spontaneous report from a Sponsored Program. This 72-year-old male consumer reported for himself.  A 72-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date in Jan2021 (72-year-old at the time of vaccination) as dose 1, single, and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date in Jan2021 (72-year-old at the time of vaccination) as dose 2, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date in Aug2021, the patient got COVID19 infection. The patient also stated that he had received a regencov infusion which was an antibody that also boosts immunity. The patient wanted to know if he should receive the booster dose when it comes available in September or if he should wait longer than September. The patient underwent lab tests and procedures which included COVID-19: positive on unspecified date on Aug2021. The outcome of the events were unknown.   Information on the lot/batch number has been requested.
COVID 19 Treatment/Tested positive on 18May2022/Retested for Covid on 29May2022 and it was positive; COVID 19 Treatment/Tested positive on 18May2022/Retested for Covid on 29May2022 and it was positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EN6202), in right arm, on 16Mar2021 as dose 2, single (Lot number: ER2013), in right arm, on 24Sep2021 as dose 3 (booster), single (Lot number: FF2587), in right arm and on 24Feb2022 as dose 4 (booster), single (Lot number: FK9729) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Rhumatoid Arthritis", start date: 1999 (unspecified if ongoing); "Known allergies: Yes, multiple allergies" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "sleep issues" (unspecified if ongoing), notes: for 5+ years; "Diaviticulitis" (unspecified if ongoing), notes: severe Diaviticulitis resulting in surgery to remove 12" of lower large intestines 4 1/2 years ago; "seasonal allergies" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: OLUMIANT, start date: 01Mar2020, stop date: 17May2022; FEXOFENADINE, start date: 01Dec2021, stop date: 29May2022; LIVALO, start date: 01Mar2020, stop date: 29May2022; SYNTHROID, start date: 01Jan2017, stop date: 29May2022; METOPROLOL, start date: 01Jan2017, stop date: 29May2022; OMEPRAZOLE, start date: 01Jan2020, stop date: 29May2022; ATOMOXETINE, start date: 01Jan2007, stop date: 29May2022; BUPROPION, start date: 01Nov2021, stop date: 29May2022; TRAZODONE, start date: 01May2020, stop date: 17May2022; COQ10 [UBIDECARENONE], start date: 01Jan2017, stop date: 29May2022; OMEGA 3 FISH OIL [FISH OIL], start date: 01Jan1996, stop date: 29May2022; L-LYSINE [LYSINE HYDROCHLORIDE], start date: 01Jan2017, stop date: 29May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18May2022, outcome "unknown" and all described as "COVID 19 Treatment/Tested positive on 18May2022/Retested for Covid on 29May2022 and it was positive". Patient stated that she tested positive on 18May2022 and started Paxlovid that day. On 24May2022, she tested negative. On evening of 27May2022, she began with coughing and sinus drainage. On 29May2022, she was retested for Covid and it was positive. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18May2022) Positive; (24May2022) Negative; (29May2022) Positive. Therapeutic measures were taken as a result of vaccination failure covid-19.
Large hard lump about the size of a quarter developed at site the day after injection, warm to the touch and itchy.
Got the injection On Friday. Saturday around lunch I took a shower and both my upper arms and across my upper back was a bad rash that itched and burned. An hour later, the rash faded away. Saturday I woke up sick with my hear hurting a stuffy nose that has gradually increased my symptoms and here it is a month later and I'm still sick.
Patient states her chest tightened at night of vaccination and progressively got worse. She required hospitalization on Tuesday for a couple of hours due to severe asthma symptoms.