chrisvoncsefalvay/vaers-outcomes huggingface dataset:
after the first shot I had some severe headache, muscle ache, fatigue, injection site pain, sleepy, and a little chills for a couple of days. But at the time of taking second shot the injection was very painful, after the second shot I had very bad headache, chills, real drowsy, muscle ache, fatigue, sleepy feeling, vomiting feeling for 3 days and also after about 20 hours of injection, on my right leg startedto have rashand itching . Itried to drink a lot of water, but evvery day it got worse and worse and after 6 days my whole right leg and part of my left leg was badly andseverwlt swelled up and my leg was filled up with my body fluid  and was veryyy blacked and violet, and was itching crazily. I was rushed to the ER and received the treatment and it was recognized as the adverse and severe reaction and allergy to the stupid PFIZER COVID-19 VACCINE.
Patient received Moderna vaccine on 3/11/21, 4/7/21, and 12/27/21. Presented to ER on 3/8/22. Found to be COVID positive. Was admitted for complicated abdominal wall/pannus cellulitis with abscess. Was asymptomatic for COVID. Discharged on 3/15/22
One week post receiving Moderna vaccine, the left  upper arm developed a large 3cm hive..itchy, warm, hard, red...about 1/2" below the injection site in that arm  Went to Clinic...recommended hydrocortisone cream and benedryl
Headache, fever 101.2, chills, body aches, left knee joint pain, right arm lymph nodes swelling and pain.
Patient became pale, clammy and light headed for 1-2 minutes while sitting being monitored.  Patient given wet cloth to forehead and water to drink. Patient's symptoms resolved in 3- 5 minutes with additional 15 minutes of monitoring after the first 15 minutes.
Patient died in his sleep overnight Oct 6-Oct 7. There have been no answers given as to how or why he died.
8cm wide x 10cm long, redness, warm to touch (L) upper arm.
bruise at the injection site; injection site was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (bruise at the injection site) and VACCINATION SITE PAIN (injection site was sore) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included Kidney transplant (2 years ago).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE BRUISING (bruise at the injection site) and VACCINATION SITE PAIN (injection site was sore). At the time of the report, VACCINATION SITE BRUISING (bruise at the injection site) had not resolved and VACCINATION SITE PAIN (injection site was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.  No treatment information was provided.
Psoriatic arthritis pain returned.  The pain was under control with Mobic and Humira injections.
inappropriate schedule of vaccine; shivering/ Chills; tired; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of product supply issue in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 21st August 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 21st August 2018, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shivering, tiredness and influenza-like symptoms. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown and the outcome of the shivering, tiredness and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the shivering, tiredness and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated he had shivering, tiredness, chills, flu like symptoms with the first dose on the evening of the event that lasted about a day or two. The patient had not been able to get the second dose due to the shortage. At this time he plans to get the second dose when it was made available.
Case number PHEH2017US008343, is an initial spontaneous report received from a consumer on 20 Mar 2017. This report refers to an 11 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: not reported) at a dose of 0.5 ml, intramuscularly on an unknown date in Oct 2016. On 18 Mar 2017, the patient got the flu, symptoms of flu and high fever. The patient had a flu test that was an A strain flu (positive test) on 18 Mar 2017. Patient received TAMIFLU. The outcome of the events was reported as complete recovery on an unknown date. The seriousness and causality of the events were not reported. The seriousness assessment of influenza, vaccination failure and pyrexia was upgraded to serious (medically significant) based on the information available in the source document.
Red rash on right upper arm to elbow. Swollen, warm to touch. Painful. Pt reported 1 day after receiving vaccine. Pt given BENADRYL, TYLENOL and ice pack.
Arm was sore; Headache; Nausea; Fever; Felt like she had been hit by truck 24 hours later.; This spontaneous case was reported by a physician and describes the occurrence of FEELING ABNORMAL (Felt like she had been hit by truck 24 hours later.), LIMB DISCOMFORT (Arm was sore), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis, ADALIMUMAB (HUMIRA) for an unknown indication.   On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced FEELING ABNORMAL (Felt like she had been hit by truck 24 hours later.). On an unknown date, the patient experienced LIMB DISCOMFORT (Arm was sore), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, FEELING ABNORMAL (Felt like she had been hit by truck 24 hours later.) outcome was unknown and LIMB DISCOMFORT (Arm was sore), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication provided.   Reporter did not allow further contact
Patient received an additional dose one month after completing vaccine series. Did not have vaccine record at time, verification completed was inaccurate
Dry eyes to the point where I have difficulty wearing contact lenses; This is a spontaneous report received from a contactable consumer, the patient. A 73-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL1283) via an unspecified route of administration in the left arm on 24Feb2021 (at the age of 73-year-old), as single dose for COVID-19 immunisation. The patients medical history was reported as none and known allergies were reported as no. The concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL1283) via an unspecified route of administration in the left arm on 01Feb2021 at 15:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Mar2021, patient experienced dry eyes to the point where he had difficulty wearing contact lenses. Treatment received for the adverse event was reported as trying different solutions and lenses. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of dry eyes was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
A report was received on 1/2/02 concerning a 75 year old male patient who experienced COPD exacerbation (OMIC) 5 days after receiving Fluvirin vaccine on 12/9/98. The event was considered serious.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 11:17 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 11:17 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 46.84.  Concomitant products were not provided.  On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The  explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   Reporter did not allow further contact
shingles after the shot / Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient's family member. The age at vaccination was not reported. The patient got the singles after the shot. The reporter stated that why don't you quit being a jerk. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required. This case has been linked with US2021AMR199003 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR199003:Same reporter
Development of 1 < 0.5 cm erythematous non pruritic papule on L cheek. no changes in VS. No respiratory distress, vomiting, swelling of lips or tongue, diarrhea, rash elsewhere
UTI; This is a spontaneous report from a contactable consumer from a Pfizer Sponsored Program. This consumer reported same event for three patients. This is the third of three reports.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation; hydrocortisone, neomycin sulfate, polymyxin b sulfate (CORTISPORIN), via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication. The patient's medical history and concomitant medications were not reported.  The patient had first covid vaccine and she ended up with UTIs within 24 hours. The reporter wanted to know if that was a side effect. The action taken in response to the event for hydrocortisone, neomycin sulfate, polymyxin b sulfate was unknown. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021391050 Same reporter/suspect product/event, different patient.;US-PFIZER INC-2021391028 Same reporter/suspect product/event, different patient.
Fever, chills and bodyaches for less than 36 hours - with spontaneous resolution. Asked to return for evaluation but cancelled appointment because she was feeling well
Patient had a first ever seizure the day after he got his influenza vaccine on 10/13/2020 Leading to ED visit 10/14/2020 (had to call 911) and requiring f/u with MD on 10/16/2020 and will need further f/u with neurology. He has  Recovered and is back to baseline at this time.
Feels like the flu; joint ache; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 72-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: ER8727), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 (at the age of 72-years-old) as a single dose for covid-19 immunization. Medical history included depression- Additional Information for Other Conditions: Diagnosed many years ago when he was young. The patient's concomitant medications were not reported. On 29Mar2021, the patient experienced joint ache, chills and headache after receiving the vaccine. Also feels like the flu on an unspecified date. The caller is wondering is it okay for him to take Ibuprofen. The caller is scheduled for 21April2021 for his second shot. Outcome of the event joint ache, chills and headache was not recovered and rest other event was unknown. No follow-up attempts are possible. No further information is expected.
Patient is fully vaccinated and boosted. 62-year-old lady with significant known history for diabetes mellitus/depression/GERD/anxiety disorder, who presented to the emergency department due to complaint of difficulty breathing; she does have known history of underlying congestive heart failure, compliant with her cardiac regimen, states has been having shortness of breath for the past couple of days with myalgia; on presentation workup including D-dimer 604 (H) and a COVID was not completed in the ER; however, she was positive for COVID approximately 8 days ago. CT: No obvious pulmonary embolism.Patchy interstitial and airspace opacities as described consistent with underlying COVID 19 pneumonitis. Anemia: Hemoglobin 9.5.  Steroids. Discharged home.
immediate gush of blood at injection site, swelled up a full inch.  Patients wife states he suffers from hematomas on occasion, has happened before.  Teated with cold pack, swelling went down  within 15 minutes.
Received a telephone call from mother stating pt's left thigh swelled up, extended down to the knee with red blotches. Took to ER 4/29/2005. The child was given Benadryl. Mom states that swelling subsides and redness went away 48 hours later. Denies any fever.
BECAME LIGHT HEAD AFTER LEAVING - 4TH FLOOR OFFICE AND GOING TO 1ST FLOOR & HEADING OUT OF BUILDING. PASSED OUT HIT THE BACK OF HEAD
No adverse reaction. The child was observed in office for 15minutes without any problems which is standard procedure in our office.  Called the clinic and was asked to report it via this form.  Mom of the patient has been notified and the child is well.
Painful gout flare. Bilateral feet.  Metatarsal phalangeal joints.
1/3 of the dose of the normal Moderna COVID-19 Vaccine; Received third dose because of low levels of B12; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (1/3 of the dose of the normal Moderna COVID-19 Vaccine) and VITAMIN B12 DEFICIENCY (Received third dose because of low levels of B12) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088O21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (1/3 of the dose of the normal Moderna COVID-19 Vaccine) and VITAMIN B12 DEFICIENCY (Received third dose because of low levels of B12). At the time of the report, ACCIDENTAL UNDERDOSE (1/3 of the dose of the normal Moderna COVID-19 Vaccine) had resolved and VITAMIN B12 DEFICIENCY (Received third dose because of low levels of B12) outcome was unknown.            Concomitant medication was not provided Treatment information was not reported   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Followup document added Lot no and event
Headache, Myalgia, Localized pain; fatigue, Narrative:  Other Relevant History:
probable vagal rxn; clammy, vascular shut down, pale lips; dec near syncope; dec HR from 100 to 60, vomitted
Patient woke up next day with left arm bicep area appearing inflamed, swollen and painful to touch.
Pt came in for 3rd dose of HPV vaccine which at the time she stated she had taken an at home test the day before and was negative, PT was given HPV vaccine . Pt scheduled an appt  a week later for an HCG test and patient was confirmed pregnant by PCP.
Ct felt dizzy, fell forward out of his chair, was unconscious for approximately 2-3 seconds, was not in respiratory distress, was able to answer questions. Ct was transfer to his back, then to sitting position, c/o nausea, paramedics arrived. B/P was 220/113, Blood sugar was 215.
got hot and was sweating; got hot and was sweating; had a headache; This is a spontaneous report from a contactable other hcp (patient). This is Report 2 of 2. This report was not related to a study or programme. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: unknown; Expiration date was not reported)DOSE 1, via an unspecified route of administration on 14Jun2021 as single dose for covid-19 immunisation. Lot number was not provided as caller unwilling to complete the report. The patient's medical history and concomitant medications were not reported. The patient got hot and was sweating, had a headache on an unspecified date. Investigation assessment was not reported. Caller stated she has not reported on this and declined to make a report as she was more worried about her son at the time of this report. No further details provided. Caller stated she can call back later if needed and report. Clinical outcome of the events was unknown.  Information on lot/batch number has been requested.
Pt rec'vd MMR #2 Rt arm with Tdap (L) arm 1/23/08. Noted some redness, soreness at both injection sites next day. Then on 1/23 she noted a lump at (L) arm injection site along with sl. itch and The Rt arm sx improved but Lump persists at (L) arm with some tenderness 20 mm palpable nodule with 25mm diam overlying erythema, no axillary nodes. Temp 99.1. To Reck in 7-10 days.
Received Pfizer lot EL1284 on 12-31-2020 in right arm.  That night she developed a fever and her armpits swelled up that she was not able to put her arm down.  It lasted several days.
Narrative:  Patient contacted telephone triage nurse today requesting advice. Patient states he and his wife had the covid vaccine on 2/23/2021 and they are both ill. States wife developed a fever, he has not, "but I have body aches, fatigue, headache, just feel sick." States he had a mild cough last evening, improved. Pt states, "Feels like I have the flu." No nausea/vomiting/diarrhea, difficulty breathing or SOB. Patient had vaccine @ "clinic", states he has been unable to contact them to make them aware of reaction or get advice. Pt was encouraged to drink fluids, rest. Go to local ER if symptoms increase, worsen or change (we are going into the weekend), verbalizes understanding. Please advise, thank you. Class Code: Other specified counseling. Patient/Caller agrees with plan. ***Patient was notified that this visit may include telephone and/or virtual video care appointment. Caller/Patient advised to call facilities Call Center or seek immediate medical attention for new or worsening symptoms. Advise caller/Patient that a note will be forwarded to the provider and/or the care manager for review, further recommendations, and/or follow-up.
Abdominal pain, abdominal discomfort and became very unbearable. Fever infection, nausea, vomiting. loss of appetite headaches. So far I've been doing okay and I will be getting the booster soon.
Fatigue & Body Aches started at the end of Day 7. Fever manifested the following morning. Fever peaked on Day 8 at 100.3 degrees and returned to normal on Day 9.
6/14/13: decreased appetite. 6/15/13:  numbness/tingling 2nd & 3rd fingers both hands & site of cat bite (L hand).  1st finger - tingling present @ this date.  Chills (6/14 only).  Body aches 6/15 - 6/18/13, severe per patient.  Almost resolved as of 6/21.  6/15 was given IV antibiotics + fluids in ER.  6/18:  saw infectious disease MD - diagnosed "serum sickness".  Given taper course of methylprednisone - 6 day course.  Began 6/18.  All symptoms not yet resolved as of 6/21.