chrisvoncsefalvay/vaers-outcomes huggingface dataset:
anaphylaxis; This is a literature report for the following literature source(s).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis". In another study, anaphylaxis was confirmed after the first dose in 7 patients who received BNT-162b2 vaccine and 9 patients who received mRNA-1273 vaccine. The CDC had reported a rate of 2.5 cases per million doses.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between reported event and the suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202200681973 Same article/ drug/event and different patient:;US-PFIZER INC-202200681973 Same article/ drug/event and different patient:
I63.9 REVERSIBLE ISCHEMIC NEUROLOGIC DEFICIT SYNDROME 4/22/2023 ANEMIA DUE TO CKD I63.9 REVERSIBLE ISCHEMIC NEUROLOGIC DEFICIT SYNDROME 4/22/2023 METABOLIC ENCEPHALOPATHY
patient was given undiluted vaccine and upon questioning on 7/26/22 the caregiver reported only a sore shoulder
Guillain Barré - Fisher Miller variant; tingling, paralyzation, speech, muscle movement, coordination, respiratory failure: nerve damage/myelin damage peripheral nervous system; IVIG - intraveinous immunoglobulin.
This case was retrieved via a search of scientific literature on 11 November 2011. The reporter for this case is the same as in case numbers: 2011-11264, 2011-11265, 2011-11267, 2011-11271, and 2011-11272. "Background: TDAP vaccine was not licensed for use in adults aged greater than or equal to 65 years due to lack of sufficient efficacy and safety data. To characterize reports to the Vaccine Adverse Event Reporting System (VAERS) among adults aged greater than equal to 65 years who received TDAP vaccine 'off label' to assess for potential vaccine safety concerns. We searched VAERS for reports of adverse events (AEs) in subjects aged greater than or equal to 65 years who received TDAP vaccine from 9/1/2005 to 9/08/2010. Medical records were requested for all reports cases as serious (death, hospitalization, prolonged hospitalization, permanent disability, life-threatening illness). Proportional reporting ratio (PRR) was used to assess for higher proportionate reporting for AEs after TDAP compared with Td reports in subjects aged greater than or equal to 65 years. VAERS received 243 reports following TDAP administered to persons aged greater than or equal to 65 years. Eleven (4.5%) reports were serious, including two deaths. Most common AEs were local reactions in 100 (41.2%) reports. Seventy-eight (32.1%) reports contained coding terms that denoted inappropriate administration of vaccine. 'Cough' was the only term associated with disproportionately higher reporting after TDAP compared with Td. Six of seven Tdap reports containing the term 'cough' were non-serious. Clinical review of serious reports identified no unusual patterns of AEs. Our VAERS review of the 'off label' use of TDAP vaccine in adults greater than or equal to 65 years did not find any safety concerns that warrant further study. These date will provide useful baseline information to assist CDC and FDA with monitoring efforts as permissive recommendations for TDAP in older persons are adopted." A 77-year-old female patient had received DTAP (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later was diagnosed with generalized weakness and cough. The patient was not hospitalized but according to the report she had not recovered and the event was considered to be life threatening resulting in permanent disability. Documents held by sender: none.
allergic reaction; my throat closes up; I have to take a puff to be able to breathe; I have secretions coming out my nose and eyes; I have secretions coming out my nose and eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; ibuprofen (IBUPROFEN); acetylsalicylic acid (ASPIRIN (E.C.)), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer covid vaccine (Dose 1), for Covid-19 immunization. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "recovered", described as "allergic reaction"; THROAT TIGHTNESS (non-serious), outcome "recovered", described as "my throat closes up"; DYSPNOEA (non-serious), outcome "recovered", described as "I have to take a puff to be able to breathe"; EYE DISCHARGE (non-serious), RHINORRHOEA (non-serious), outcome "recovered" and all described as "I have secretions coming out my nose and eyes". The action taken for ibuprofen and acetylsalicylic acid was unknown. Therapeutic measures were taken as a result of hypersensitivity, throat tightness, dyspnoea, eye discharge, rhinorrhoea. Additional information: Patient got the 4th dose of the Pfizer covid vaccine (2 doses and 2 boosters) that last one in Apr2021. The query is because after the second application when patient took ibuprofen or aspirin, patient get an allergic reaction. It never happened to the patient before but now patient's throat closes up, had to take a puff to be able to breathe and had to take an antihistamine or corticoid because patient had secretions coming out of the nose and eyes. The effect only lasts for a few hours and then its gone. No follow-up attempts are needed. No further information is expected.
The pt was given a 12 and up dose of pfizer covid-19 vaccine and she is under age 12, she is nine.
A few days after receiving the first dose I started experiencing body aches, headache and minor back pain.  The body aches only continued to get worse over time as  well as the back pain. I did not have back problems or pain until the vaccine. I contacted my primary physician and explained that I received the vaccine and told her about my symptoms. She asked me to get a Covid-19 test. I did and the results was negative. At his point, May  6, 2021, the symptoms have only become worse. My back pain is so severe I can barely stand it. I have tried ice packs, a heating pad, over the counter pain medication and nothing has made it better. My physician does not know what to do. Another side effect is it has made my fibromyalgia pain much worse. I have had fibromyalgia for about fifteen years and my pain is tolerable but the past few weeks have been unbearable. I may have a weakened immune system due to the fibromyalgia so maybe  that could be a explanation for my symptoms. I wanted to know if other people have experienced severe side effects. The only treatment is over the counter pain medication and ice packs and a heating pad.  As of today, May 6, the back pain and body aches are still present and I would say severe. The headache is tolerable but still lingers and does not go away. The body aches, headache and back pain is twenty four hours a day and never get better.
Really sick; Shaking really bad; Big knot on right upper deltoid and has a little bump on itit; Felt really tired; Achy, body ache; Fever at 102.8 degrees Fahrenheit; Severe headache; Really worst reaction after the booster shot; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Really worst reaction after the booster shot), MALAISE (Really sick), TREMOR (Shaking really bad), SKIN MASS (Big knot on right upper deltoid and has a little bump on itit) and FATIGUE (Felt really tired) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 013M20A and 011620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported .  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (Really worst reaction after the booster shot). On 21-Aug-2021, the patient experienced MALAISE (Really sick), SKIN MASS (Big knot on right upper deltoid and has a little bump on itit), FATIGUE (Felt really tired), PAIN (Achy, body ache), PYREXIA (Fever at 102.8 degrees Fahrenheit) and HEADACHE (Severe headache). 21-Aug-2021, the patient experienced TREMOR (Shaking really bad). The patient was treated with IBUPROFEN on 21-Aug-2021 for Adverse event, at an unspecified dose and frequency. On 22-Aug-2021, VACCINATION COMPLICATION (Really worst reaction after the booster shot), MALAISE (Really sick), TREMOR (Shaking really bad), PYREXIA (Fever at 102.8 degrees Fahrenheit) and HEADACHE (Severe headache) had resolved. At the time of the report, SKIN MASS (Big knot on right upper deltoid and has a little bump on itit) outcome was unknown and FATIGUE (Felt really tired) and PAIN (Achy, body ache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Body temperature: 102.8 (High) The patient's body temperature was 102.8 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was unable to recall the injection site and other reactions after first both doses.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No concurrent conditions and medical history were provided. The reporter stated that on 03-APR-2015, 17-APR-2015, 11-MAY-2015, 27-MAY-2015, 01-JUN-2015 and 02-JUN-2015 an unspecified number of patients were vaccinated with an improperly stored GARDASIL (dose, route of administration, lot number and expiration date were not reported). No concomitant medication therapy was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Parent brought the patient into the clinic the day after vaccination 8/4/2017 noting that the patient had a 5" x 7" area of redness, swelling and warmth. Patient was seen by Dr. and recommendation was to use Tylenol and ibuprofen for pain or discomfort, Benadryl for swelling and ice to area if needed. Antibiotic was prescribed because they were going out of town and concerned that the reaction could get worse. I spoke with the patients mom 8/10/2017 and antibiotic did not need to be used.
After receiving dose 2 of Pfizer COVID vaccine, approximately 12 hours after administration developed left eye swelling.  Rested with head elevated on face, and felt right eye swelling 30 minutes later.  Went to sleep and woke up 1/5/2022 with bilateral eyes still swelling, but with some improvement.  Denies taking medication for symptoms.  Denies swelling of lips, tongue, throat, denies difficulty breathing, shortness of breath, or coughing.
The patient received Prevnar 13 and the recommended vaccine was the newer PCV20.  The pharmacy had not received that vaccine and was not available yet in the store.  The patient was contacted but did not answer the phone.  They are due for PCV 23 in 1 year
Swelling and pain in upper left arm.  Redness and tenderness of muscle.  Started 11-3-2020.  Pt is elevating arm and icing and taking Tylenol.
At 11:25 am client states she's having shortness of breath and has heart racing.  Vital signs obtained by EMS:  BP 150/78, Pulse 75, O2 sat 99%.  At 11:30 am client states she feels better.  EMS discharge client home.
This spontaneous report as received from a patient's wife refers to a 75 year old male patient with a history/a prior case of shingles (approximately in November 2011, exact dates not reported) accompanied with severe pain on his head and nerve pain and drug reaction/allergies to sulfa. Then in May 2012 (reported as: 6 months later) the patient was vaccinated with ZOSTAVAX (1 shot, in the arm route of administration, lot#, expiration date not reported) to prevent another episode/recurrence of shingles. Concomitant medications were not reported. It was reported that nerve pain and head pain originally associated with the shingles still occurred even after the patient received the ZOSTAVAX, and now 2 years after receiving the ZOSTAVAX the patient was reporting a slight worsening of the head pain and nerve pain (onset date of symptoms worsening reported as: 05-MAY-2012). There was treatment given with lidocaine 5%, hydrocodone and LYRICA for the reported events. The outcome of the events was reported as not recovered. The patient sought medical attention (not specified). The relatedness between the therapy with ZOSTAVAX and the reported events was not reported. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the pain in arm and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the pain in arm and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine in an unknown arm. The healthcare professional (HCP) reported that the patient received the a dose of SHINGRIX 2 months before the time of reporting and stated that he was unable to lift his arm since getting the vaccine. The HCP was unable to provide any further specifics of the event.
headache; fatigue; This is a spontaneous report from a contactable consumer (patient) reported in response to Non-HCP follow-up letter sent in cross reference case. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EK7176) second dose via an intramuscular, administered in right arm on 08Jan2021 at 15:50 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 18Dec2020 at 15:50 (Batch/Lot no: EH9899) as single dose for COVID-19 immunization and experienced headache and fatigue. On 09Jan2021 at 08:00, the patient experienced headache and fatigue. The patient reported that the events recur on re-administration of product and provided the time lag from stop date as 12 hours post 2nd injection. The reporter considered a reasonable possibility that the event is related to suspect product. The outcome of the events was recovered.
Arm was sore & heavy shortly after the shot, but chills & severe body shakes started at 8:30 PM & continued until 12:30 AM, accompanied by a fever. The shakes stopped, then I started to sweat, aching joints & body aches, severe headache, nausea, whole body malaise. Still sick, feeling weak, out of sorts.
Patient reported severe back pain after approximately 10-15 minutes after receiving the vaccination. Pharmacist examined patient for any rash, hives, anaphylaxis. Patient stated is was only her back that hurt and arm was okay. Pharmacist gave patient an ice pack to help with back pain and monitored patient further. Pharmacist gave patient water and offered Tylenol, Ibuprofen, and Benadryl, pt declined. After approximately 15 minutes patient wanted to go home to lied down. We advised patient if pain persisted or worsened or new adverse events developed to call 9-1-1 or seek emergent care.
She had a rash in three days from her arm to left shoulder.  Three days later she had stroke symptoms, numbness.  Five days later she had a bigger stroke symptom, and she still has numbness on the left side from face all the way down to the end of her fingers.  She had it in her leg all the way to the end of her feet, but her feet and legs are a little better.  Face down to her fingers are still numb.
Fever, severe shivering, aching, headache, lethargy, nausea
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Pt stated her tongue felt funny a little tingly-Mild, Additional Details: Pt refused 911. stated her tongue felt a little numb and "funny." but not swollen just different feeling
Hard lump; Pain; Swelling; This spontaneous case was reported by a patient and describes the occurrence of MASS (Hard lump), PAIN (Pain) and SWELLING (Swelling) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced MASS (Hard lump), PAIN (Pain) and SWELLING (Swelling). At the time of the report, MASS (Hard lump), PAIN (Pain) and SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information were not provided.
Soreness & severe limited mobility of arm for approximately a week; it is now over a month & still have pain/discomfort in the arm; difficult to sleep at night & still pain when moving arm.
pt recv vax & exp dizziness, diff swallowing & uncoordination was reported that pt did not recv 2nd dose of vax;@ the time of report pt exp had persisted;
lost my hearing first in my right ear then in my left hear, my hearing constantly cuts off then slowly returns with a following persistent loud ringing in my ears.
Sore arm; Aching; Extreme high blood pressure 200/100; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PAIN (Aching) and HYPERTENSION (Extreme high blood pressure 200/100) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Diabetic (Patient  had  been diabetic for 20 years.). Concomitant products included ENALAPRIL MALEATE for Blood pressure high, METFORMIN, METOPROLOL and SITAGLIPTIN PHOSPHATE (JANUVIA) for an unknown indication.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PAIN (Aching) and HYPERTENSION (Extreme high blood pressure 200/100). The patient was treated with AMLODIPINE BESYLATE for Blood pressure high, at a dose of 5 milligram and ENALAPRIL MALEATE for Blood pressure high, at a dose of 20 milligram. At the time of the report, PAIN IN EXTREMITY (Sore arm) and PAIN (Aching) outcome was unknown and HYPERTENSION (Extreme high blood pressure 200/100) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Blood pressure measurement: 195/76 (abnormal) 195/76. In February 2021, Blood pressure measurement: 200/100 (High) 200/100. On 20-Feb-2021, Blood pressure measurement: 150/63 (abnormal) 150/63. On 22-Feb-2021, Blood pressure measurement: 171/74 (abnormal) 171/74.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient went to the pharmacy the next day and her blood pressure was still high. She later contacted her doctor who increased one of her blood pressure medication Enalapril Maleate from 10 mg to 20mg.   This case was linked to MOD-2021-435439 (Patient Link).
F/U report for this member - unknown VARES#:flu like symptoms, fatigue, myalgia, arthralgia, abdominal pain, short term memory loss, and dizziness following receipt of his Anthrax series January-February 2001. This 30 year old service member reported exacerbation of pre-existing symptoms of abdominal pain and swelling, left shoulder and back pain, and fatigue following receipt of three AVA vaccinations Jan-Feb 2001. His symptoms initially included flu-like signs with fatigue. He attributed these symptoms to jet lag from a recent deployment  (1/11/01-2/25/01).  He reported these symptoms continued following his second and third anthrax vaccinations (1/27/01, 2/15/01). Following his third AVA vaccination he complained of chronic fatigue.  He described this fatigue as a tiredness/exhaustion similar to feelings of "jet lag" felt while deployed for "two months to 49 states and 7 countries".  Upon his return from deployment in February 2001, he transferred jobs and moved 20 Oct 2001.  He later stated he was experiencing problems with chronic joint pain, abdominal pain and swelling that persist as of 2005. Each body system complaint will be reviewed separately.
Received IZ 10/22/08; 1st sign itching immediately after on both deltoids.  Noticed redness and swelling today.  Right shoulder has silver dollar sized erythema with slight swelling and slight pain about 1 inch below the shot.  Left shoulder shows 2 dime size and 2 nickel size reddened area, underneath shot as well.  Local reaction.
Admitted to hospital on 5/21/06. States received "Pneumonia Shot" on 5/19/06. Right upper arm swollen and reddened, entire upper on upon admission. Diagnosis, cellulitis. Treated pt with Levaquin. Called Pharmacy for vaccine used there.  5/30/06 Received medical records from 1st hospital which reveal patient was admitted 5/16 w/chest pain & diagnosed w/MI.  Received vax prior to d/c.  7/3/06 Received medical records from 2nd hospital which reveal patient experienced cellulitis at injection site within 2 days after receipt.  Also had symptoms of URI.  Final dx was bilateral bronchial pneumonia & right upper arm cellulits & s/p MI.  Improved immediately w/IV antibiotics.  Initial labs: WBC 30.9 & blood c/s + for staph hominis subsp/ss Discharge summary states fever, tachycardia. msv
MILD SNIFFLE; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had never contracted covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included influenza vaccine for prophylactic vaccination. On an unspecified date, the patient experienced mild sniffle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild sniffle was not reported. This report was non-serious. This case, involving the same patient is linked to 20220336317. This case, from the same reporter is linked to 20220336438.