chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 28-NOV-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # M000768, expiration date 05-JAN-2018, status albumin: recombinant human albumin (rHA)). Concomitant medications were not reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. Data logger was involved. No adverse effects reported.    This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Client states injection site became red, swollen, 24 hours after injection she had hives down both arms and across her chest, she is asthmatic and was having wheezing and had to use her inhaler.
Fever, body aches, nausea, enlarged axillary lymph node on arm injection received on. All symptoms expect pain associated with enlarged axillary lymph node subsided within 36 hours.
Blurry/wavy vision Left eye-unable to read out of left eye;   visual color change Left eye- red changed to hot pink when looking at taillights when driving
Gout flare up in elbow of the arm after the second vaccination, no previous history of gout flare ups in arm; This is a spontaneous report from a contactable other healthcare professional, the patient. A 33-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an intramuscular route of administration in the left arm on 25Jan2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The medical history included gout; the patient had previous history of gout flare ups 1-2 per year. The patient had no known drug allergy (NKDA). 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. The patient did not receive any medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an intramuscular route of administration in the left arm on 04Jan2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On 26Jan2021, after the second vaccination, the patient experienced gout flare up in elbow of the arm. There was no previous history of gout flare ups in arm. The patient had 15 flare ups in the 10 months since the vaccine. Since the vaccination, the patient had been tested for COVID-19. On 17May2021, the patient underwent SARS-CoV-2 test via nasal swab and the result was found to be negative. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the reported event included treatment with additional gout medication, allopurinol (MANUFACTURER UNKNOWN). The clinical outcome of the event gout flares up in elbow of the arm was not resolved at the time of this report.
Patient shows signs of injection site reaction. States that it is warm to the touch and itchy. Patient went to her primary care was told to apply warm compress, and given prescription.
Started to get achy later that night after shot.  Achiness  got worse as all joints and bones hurt. Got up next morning with  a temp of 101* and still achy all over.  Slept most of the  day  with same symptoms. Got up next morning (Feb 17) fever was gone, aches were gone, but very very tired all day. A little unsettled stomach. Everything improved as the day went on. There is a report # 269542 from the first shot reported by telephone.
Had approx 5 brief (4min) generalized sz in the 24hr period following immun; Documented fever w/5th & last sz;
Patient developed PET echial stain lesions and edema in feet and lower extremities.  Diagnosed with HENOCH- SCHONLEIN Purpura.  Symptoms began 2 days after receiving first doses of HEP A and Hep B vaccine
Flat rash covering face, neck, and upper body. No itching.  Rash is beginning to resolve 9/14/2013.
This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives/Urticaria), RASH (Rash), PRURITUS (Itchiness), ERYTHEMA (Redness) and PERIPHERAL SWELLING (swollen arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Concurrent medical conditions included Hypertension, Cholesterol, Thyroid disorder and Contrast media allergy (Rash on arm-large and itchy). Concomitant products included METOPROLOL SUCCINATE, ROSUVASTATIN, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) and HCTZ for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced PRURITUS (Itchiness), ERYTHEMA (Redness) and PERIPHERAL SWELLING (swollen arm). On an unknown date, the patient experienced URTICARIA (Hives/Urticaria) and RASH (Rash). On 28-Feb-2021, URTICARIA (Hives/Urticaria), PRURITUS (Itchiness), ERYTHEMA (Redness) and PERIPHERAL SWELLING (swollen arm) had resolved. At the time of the report, RASH (Rash) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information were not provided. Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Additional information received and reporter information was updated On 18-Jul-2021: Patient Medical history,Concomitant medication were added.Events Hives, Rash were added.EventsItchiness,redness,Swollen arm outcome was changed from Unknown to Recovered.
Pt reports - same day "extreme headache began"- stopped up sinuses - next day lump found (same arm as rec'd vaccine) R. Deltoid.  Pt states "felt like coming down with something,  reporting feeling "tired and weak every couple of days" , "but I never got sick".
so nervous about another vaccine; rash/hives started on the right arm (Second dose), moved to right side of leg, to the hip and then around to the hip to buttock; The buttock area was more like hives; like hives but it bled and scabbed up/ Hives bled/ Hives scabbed; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (The buttock area was more like hives), SKIN HAEMORRHAGE (like hives but it bled and scabbed up/ Hives bled/ Hives scabbed), NERVOUSNESS (so nervous about another vaccine) and RASH (rash/hives started on the right arm (Second dose), moved to right side of leg, to the hip and then around to the hip to buttock) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypersensitive skin (very hypersensitive to every everything), Myalgia and Autoimmune disorder NOS (autoimmune issue). Concomitant products included PREDNISONE for Myalgia and Autoimmune disorder NOS.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced URTICARIA (The buttock area was more like hives), SKIN HAEMORRHAGE (like hives but it bled and scabbed up/ Hives bled/ Hives scabbed) and RASH (rash/hives started on the right arm (Second dose), moved to right side of leg, to the hip and then around to the hip to buttock). On an unknown date, the patient experienced NERVOUSNESS (so nervous about another vaccine). At the time of the report, URTICARIA (The buttock area was more like hives) and RASH (rash/hives started on the right arm (Second dose), moved to right side of leg, to the hip and then around to the hip to buttock) had not resolved, SKIN HAEMORRHAGE (like hives but it bled and scabbed up/ Hives bled/ Hives scabbed) had resolved and NERVOUSNESS (so nervous about another vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information included she went to the dermatologist, was prescribed cream, which did not work.   Patient stated she has Rheumatologist appointment for her Myalgia and autoimmune issue.   This case was linked to MOD-2021-309800 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Additional contact information-email ID updated, new event nervousness was added.
TM (LETM); This is a literature report.  A 69 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cervical cancer" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Restless leg syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MYELITIS TRANSVERSE (medically significant), outcome "recovering", described as "TM (LETM)". The patient underwent the following laboratory tests and procedures: antibody test: negative; autoantibody test: negative; blood glucose: normal; investigation: negative; negative; normal; negative; normal; normal; magnetic resonance imaging: extensive t2 signal abnormalities seen, notes: particularly in the anterior aspect, as well as the midcord extending from C3- 4 down to T2-3; magnetic resonance imaging head: normal; plasma cell count: normal; protein total: normal; treponema test: negative; viral test: negative. Therapeutic measures were taken as a result of myelitis transverse.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
injection site is itchy; injection site is red; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st November 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In November 2022, less than a week after receiving Shingrix, the patient experienced injection site itching and injection site erythema. On an unknown date, the outcome of the injection site itching and injection site erythema were not recovered/not resolved.   The reporter considered the injection site itching and injection site erythema to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-NOV-2022 Reporter's Comments:  This case was self reported by the patient. The patient received Shingrix in the left arm. The reporter stated that the injection site was itchy and red. The patient was currently exhibiting these symptoms. The reporter did not consent to follow up. No HCP for follow up.
PT STATED THAT HE HAD FLU LIKE SYMTOMS, AND A RASH THAT APPEARED IN DIFFERENT AREAS OF THE BODY, BUT ONLY 1 BLISTER IN EACH AREA THAT CRUSTED OVER.
Severe stiff neck, rash, tingling in neck. The event started 1-2012 - ongoing treatment calamine lotion. Doc says I have the shingles? Why!
Constant irritating nipples; stomach bloat; sharp pain in Ivorian area; other vaccine 4weeks details: Flu shot date: 13Aug2021; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FC3181), via an unspecified route of administration, administrated in Arm Left on 13Aug2021 13:15 (age at the time of vaccination 42-years-old), as a single dose for COVID-19 immunization at Pharmacy or Drug Store; and first dose of FLU VACCINE VII (INFLUENZA VACCINE), administrated in arm left on 13Aug2021 for Immunization. The patient's medical history was not reported. Patient had no known allergies. The patient concomitant medications included Latuda, and buspirone. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 13Aug2021 14:30, the patient experienced Constant irritating nipples, stomach bloat, sharp pain in Ivorian area, and other vaccine 4weeks details: Flu shot date: 13Aug2021. The patient also received second dose of BNT162b2 vaccine, (Batch/lot number: Fc3183), administrated in arm left on 03Sep2021 13:00 as a single dose for COVID-19 immunization. Patient did not received treatment for the adverse events. The outcome of the events was not recovered.  Follow-Up (06Oct2021): Follow-up attempts are completed. No further information is expected.
She felt dizziness and giddiness after the vaccine. Onsite EMS was requested.bp 104/86  99% O2 on room air.  They were able to find a specific cause and she refused additional workup
Sore arm and Covid arm - red itchy rash near injection site about 5 inches long.
Heart palpitations, sharp heart/chest pain 1 hour after vaccination and continued until the next (current) day. 6 hours after vaccination sharp bone and joint pain, especially in the right shin, continued until the next day. Mild headache and mild muscle soreness at injection sites.
Sore arm, low grade fever, exhaustion - initially -  persistent, pressure headache that has lasted two days.
pt recvd vax & 3 wks p/inject devel a rash, pain in joints & swelling; all the  pain & swelling has subsided in all joints x/the ring finger & little finger on rt hand;
I would not describe as adverse, merely a side effect, and doing due diligence to report.   I began tasting and smelling small amounts of smoke periodically.  Confirmed with my spouse that she didn't smell anything.  Started at ~18:00 and continued on until I'd gone to bed, ~23:00.  No noted lasting effects the morning after.
Approx 2 Hours after immunization, had sudden Tidal waves of fever, Weakness, Felt like he was going to pass out. Slept 2 hours and awoke with chills, shake, shiver. All lasted 3 hours.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 13-DEC-2016 the patient was vaccinated with an expired dose of RECOMBIVAX HB (dosing details were not reported) (lot # K014190, expiry date: 24-OCT-2016) for prophylaxis (expired vaccine administered). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Vaccine site: Lt arm swollen - red - hot to touch/ran fever: 100.8 3 days then came a case of shingles Lt side of back 4-25-18. Still in pain from case of shingles - starting 4-25-18 Lt. back of arm - shoulder and back. No more fever/some tenderness in vaccine site still.
RIGHT ARM NUMBNESS/LEFT ARM NUMBNESS/NUMBNESS IN LEFT TOES; SWEATS; PRESSURE IN HEAD; HEADACHE; This spontaneous report received from a patient concerned a 49 year old female. 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: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced pressure in head. On 10-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced sweats. On 14-APR-2021, the subject experienced right arm numbness/left arm numbness/numbness in left toes.  Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sweats, right arm numbness/left arm numbness/numbness in left toes, pressure in head, and headache. This report was non-serious.
Information has been received from a registered nurse concerning a 22 month old female with a history of low gestational birth weight and no allergies who on 13-MAY-2009 was vaccinated with the first dose of MMR II (lot# 663101/1728X, rHA, 0.5ml, subcutaneous injection). There was no concomitant medication and no lab diagnostics studies performed. On 26-MAY-2009 the patient was diagnosed with measles. The patient visited the office for some medication. No treatment was required and the patient was recovering at the time of reporting. This is one of several cases from the same source. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm and tiredness. On an unknown date, the outcome of the pain in arm and tiredness were unknown. It was unknown if the reporter considered the pain in arm and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient experienced very sore arms, tiredness, et cetera and the sore arms were pretty bad. The patient wanted to know that how long does this typically last. This case has been linked to the case US2019GSK039085 (husband's case), reported by the same reporter.
Have a bump in the area where she got the injected; Tingling in her nerves, like weird stimulations in her nerves/tingling from arm to the neck; numbness in arm; This is a spontaneous report from Pfizer-sponsored program via a contactable consumer (patient). A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0173, and expiry date: not reported)dose 1, via an unspecified route of administration, administered in arm on Jun2021 (at the age of 58years) as single dose for covid-19 immunisation. Medical history included arthritis, gastrooesophageal reflux disease (GERD), allergy. The patient's concomitant medications were taking medications for GERD and for allergies (she had allergies and arthritis). No investigation assessment done. The patient had received her first dose in the beginning of Jun2021 and she was experiencing side effects as like tingling in her nerves, like weird stimulations in her nerves (start date: Jun2021) and she also had like still have a bump in the area where she got the injected (start date: Jun2021) with the COVID 19 vaccine, and she told the tingling all the way from the injection site into her full arm into like a finger and then all the way back into her neck. The patient was experiencing some side effects such as tingling in the nerves, bump at injection area, numbness in arm (start date: Jun2021), and tingling from arm to the neck. Events were being still experienced and, it was actually seemed to be getting worst. It was still the same, like she said it seemed to be getting a little bit worse, the more she used her arm like it seemed to be more persistent and was not 'intermittent' anymore. No treatment was done for events. The outcome of events was not recovered.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's pertinent medical history and current condition was not reported. On 14-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K007824 and expiry date 05-NOV-2015), 0.5 ml, intramuscular. Other suspect therapies included FLUZONE (high dose). On an unknown date the patient experienced severe reaction with erythema and swelling of the upper arm after receiving PNEUMOVAX 23 and FLUZONE (high dose) in the same arm. The outcome of swelling of the upper arm after receiving PNEUMOVAX 23 and severe reaction with erythema was unknown. Causality was unspecified by the reporter. This is one of the several reports received from the same reporter (MARRS # 1410USA007922, 1410USA012696, 1410USA012695 and 1410USA008504). Additional information has been requested.
Heart feels fluttery; Extremely Weak; Sore throat; dizziness; my body turned red like I had a sun burn; rash on my body, rash under both breasts; Heart Rate increased; Chills; Red Feet; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart feels fluttery) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced CARDIAC FLUTTER (Heart feels fluttery) (seriousness criterion medically significant), ASTHENIA (Extremely Weak), RASH (rash on my body, rash under both breasts), OROPHARYNGEAL PAIN (Sore throat), DIZZINESS (dizziness), SUNBURN (my body turned red like I had a sun burn), CHILLS (Chills), HEART RATE INCREASED (Heart Rate increased) and ERYTHEMA (Red Feet). At the time of the report, CARDIAC FLUTTER (Heart feels fluttery), ASTHENIA (Extremely Weak), RASH (rash on my body, rash under both breasts), OROPHARYNGEAL PAIN (Sore throat), DIZZINESS (dizziness), SUNBURN (my body turned red like I had a sun burn), CHILLS (Chills), HEART RATE INCREASED (Heart Rate increased) and ERYTHEMA (Red Feet) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.; Sender's Comments: This case concerns a 80-year-old female with a serious unexpected event of cardiac flutter, along with nonserious unexpected heart rate increased, dizziness, asthenia, oropharyngeal pain, sunburn and expected rash, erythema, chills. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.