chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Same day post vax, the pt developed a fever. The next day the pt was pale and lethargic. On 7/26/00, the pt developed diarrhea, fever, pale, listless and rash on shoulder and right side of face. On 7/27/00, continued diarrhea times 3 today, pale, and staring off.
10/10/2010 tingling in finger tips 10/11/2010 tingling over trunk and extremities 10/13/2010 extreme low back pain and increasing numbness on soles of feet 10/20/2010 negative MRI of spine and brain 10/20/2010 mild right facial weakness 10/21/2010 CSF protein 367, cells 10/21/2010 started IVID x 5 days 10/21/2010 negative serum Lyme IgM, positive IgG.  CSF lyme pcr negative. Patient started on IV ceftriaxone for coincident chronic lyme noted on GB workup
hives w/pruritus, no fever 12 hr or next day p/vax given rashes mostly on thighs & legs;
headache; Sore arm; muscle aches; weakness; congestion; This is a spontaneous report from a contactable consumer. A 67-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 19Feb2021 at 11:45 (Batch/Lot Number: EN6200) as 2nd dose, single for covid-19 immunization. Medical history included High blood pressure, high blood cholesterol and ascending aortic aneurysm. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 27Jan2021 at 4:30 (Batch/Lot Number: EL982) as 1st dose, single for covid-19 immunization.Concomitant medications within 2 weeks included rosuvastatin calcium (CRESTOR), ezetimibe (ZETIA), omeprazole (PRILOSEC [OMEPRAZOLE]) and low dose acetylsalicylic acid (ASPIRIN ). Patient did not take other vaccines in four weeks. Patient did not had Allergies. The patient had Covid prior vaccination.The patient tested Covid post vaccination on 19May2020 which was negative. On 20Feb2021 at 09:00 the patient experienced headache, sore arm, muscle aches, weakness, congestion for about 36hours. No treatment was administered for the events. The patient was recovered from the events in 2021.  No follow up attempts are possible. No further information is expected.
pt recv vax 4MAR97 & onset of s/s evening of 4MAR97 w/pain @ site, chills, fever, h/a, fever 130PM on 5MAR97-t101.2;nauseated;sl ill appearance;BP 100/70, pulse 80, local tenderness & min redness on lt upper arm where inj given;malaise ache
Headache; OVERDOSE; This is a spontaneous report from a contactable consumer (patient's wife). A 35-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: 042B21A, Expiry date: 05Oct2021), via an unspecified route of administration on 17Apr2021 (at age of 35-years-old) as dose 2, 0.5 ml single for covid-19 immunisation. Medical history (including any illness at time of vaccination) was none. Family medical history relevant to adverse event was none. There were no concomitant medications. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: 036A21A, Expiration Date: 26Aug2021), via an unspecified route of administration on 20Mar2021 (at age of 35-years-old) as dose 1, 0.5 ml single for covid-19 immunisation. The patient had not received any other vaccine within 4 weeks.On 17Apr2021, the patient had an overdose of bnt162b2 vaccine (0.5 ml dose was administered). On 18Apr2021 after second dose, the patient experienced headache and went away, lasted a couple of days. The caller reported that her son was perfectly fine and her husband was fine but he had a headache with the second dose. Not sure if it was bnt162b2. Caller agreed to complete a report on behalf of her husband. The patient woke up with a headache on the 18Apr2021, he was going to go to work at 6 in the morning. Additional vaccines administered on same date of the bnt162b2 suspect were none. Adverse events following prior vaccinations were none. The patient was taking Tylenol. The adverse event did not required visit to emergency room or visit to physician's office. The patient underwent lab tests and procedures which included weight: 156 or 157 on an unspecified date. Relevant test was reported as none. Therapeutic measures were taken as a result of the event. The outcome of the events was recovered on 20Apr2021.
PCR test indicated positive SARS-CoV-2, the virus that causes COVID-19. Diagnosed with walking pneumonia (community pneumonia) through imaging testing. Received injection of antibiotic at the emergency room and 600 mg dose of ibuprofen and sent home with prescription of amoxicillin, 10-day supply and 25 tablets of 600 mg ibuprofen to take as needed for fever. Placed on isolation for 10 days from symptom onset (8/8/2021; sore throat), plus additional day due to symptoms of fever. Released from isolation and returned to work on August 19, 2021.
This spontaneous report was received from a certified medical assistant and refers to a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 29-SEP-2015, the patient was vaccinated with a dose of improperly stored M-M-R II (lot # L010488 with an expiration date on 26-MAR-2017; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.
Case number PHEH2014US017313 is an initial spontaneous report received from a health care professional on 22 Aug 2014. This report refers to a 12 years old female patient. Her medical history and concomitant medications were not reported. Her vaccination status was reported as up to date. She was vaccinated with initial dose of MENVEO (batch number: not reported) at a dose of 0.5 ml intramuscularly in the left deltoid on 23 Jul 2014 at 9:09. It was reported that 18 to 24 hours after vaccination, on 24 Jul 2014, she experienced red and edematous area at the area of vaccination (site). It was reported that the patient was diagnosed with a vaccine reaction. The events outcome was reported as complete recovery on 27 Jul 2014. The seriousness and causality were not reported.
Presents to the ED for management of worsening shortness of breath. admitted with Acute hypoxic respiratory failure secondary to COVID-19 pneumonia: evidence of pneumonia on chest x-ray, and hypoxia requiring low-flow oxygen,Steroids &  remdesivir.
Blurry Vision; Feeling of Room Spinning; Blood Pressure Fluctuating; administration date: 04May2021, dose number: 1/other vaccine same date vaccine date: 04May2021, other vaccine same date dose number: 2; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 45 year-old male patient received bnt162b2 (BNT162B2), administration date 04May2021 (Lot number: EW0168) as dose 2, single and intramuscular, administered in arm left, administration date 04May2021 (Lot number: er8735) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: covid prior vaccination. The patient's concomitant medications were not reported. Past drug history included: Amodiaquine?, reaction(s): "allergies". The following information was reported: OVERDOSE (non-serious) with onset 04May2021, outcome "unknown", described as "administration date: 04May2021, dose number: 1/other vaccine same date vaccine date: 04May2021, other vaccine same date dose number: 2"; VISION BLURRED (non-serious) with onset 18Jun2021, outcome "not recovered", described as "Blurry Vision"; VERTIGO (non-serious) with onset 18Jun2021, outcome "not recovered", described as "Feeling of Room Spinning"; BLOOD PRESSURE FLUCTUATION (non-serious) with onset 18Jun2021, outcome "not recovered", described as "Blood Pressure Fluctuating". It was unknown if therapeutic measures were taken as a result of vision blurred, vertigo, blood pressure fluctuation. Additional information: The vaccine facility type vaccine was other. The patient did not receive other vaccine in four weeks. The had not been covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
69 year old patient received dose of Adacel/No AE; Initial information was received on 26-Jun-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 69 years old female patient who received a DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided. On 25-Jun-2020, patient received concomitant medication included VARICELLA ZOSTER VACCINE RGE (CHO) [SHINGRIX].  On 25-Jun-2020, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot U6676AA, expiry date: 16-May-2022] via an intramuscular route in left deltoid for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration. (It was reported vaccine requirements were for 65 and younger).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
second dose was given 8 weeks after first one; changes in nerves in the skin of arms and legs; skin is more sensitive as usual; muscle aches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to Moderna on 31-Mar-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was given 8 weeks after first one), SENSORY LOSS (changes in nerves in the skin of arms and legs), SKIN SENSITISATION (skin is more sensitive as usual) and MYALGIA (muscle aches) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 24M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medication history reported).   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was given 8 weeks after first one), SENSORY LOSS (changes in nerves in the skin of arms and legs), SKIN SENSITISATION (skin is more sensitive as usual) and MYALGIA (muscle aches). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was given 8 weeks after first one), SENSORY LOSS (changes in nerves in the skin of arms and legs), SKIN SENSITISATION (skin is more sensitive as usual) and MYALGIA (muscle aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by the reporter  Treatment included Tylenol
Patient fainted in chair and regained consciousness and transferred to med bay.  Patient states vision and hearing went fuzzy, nausea, lightheadedness.  Pt given juice, decreased ____, A&Ox4.  Mild HypoTN and Brady at baseline.  BP 103/58, HR 50, RR 16 -- > 114/66,52, 16  Pt able to stand and walk. Released from vaccination site.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 24-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 23 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Peanuts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 20Sep2023 to 25Sep2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The contributory role of BNT162B2, BNT162B2 OMI BA.4-5 to the reported drug ineffective cannot be excluded since a lack of effect can generally be expected for any medicinal product as a 100% success rate cannot be reasonably assumed in every patient treated.,Linked Report(s) : US-PFIZER INC-202300314704 same patient, different drug/events;
can have a side effect of Neuralgia; pain on side of face; head aches on one side; When I say pain, I mean excruciating pain!; This case was reported by a consumer via interactive digital media and described the occurrence of neuralgia in a adult 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 neuralgia, facial pain, headache and pain. On an unknown date, the outcome of the neuralgia, facial pain, headache and pain were unknown.   It was unknown if the reporter considered the neuralgia, facial pain, headache and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had side effect of Neuralgia, pain on side of face and head aches on one side.  The patient had pain mean excruciating pain.
Face numbness on right side. I started feeling numbness in the right corner of my mouth within minutes of receiving the shot. Within a couple of hours it had spread to a larger area. From just below my eye to my chin including my lips on that side and inside my mouth and cheek. Symptoms were still there the next morning so I contacted my doctor. I was instructed to go to the emergency room. The ER doctor determined that it wasnt a stroke and said it was most likely a reaction to the covid shot. They also said it resembles a minor case of Bell Palsy but was most likely not Bell Palsy. It was probably an inflammation of the nerves in my face due to the shot. I was prescribed a steroid to use if the symptoms did not stop in a couple of days.
He received the vaccine, hours after the vaccine about 3-4 in the afternoon the point of the needle entry site started to ache, and he became tired.  He chose to take a nap, which turned into staying in bed until today.  By the next morning the back sides of his neck, rear corners have been achy.  He has been exercising them, rubbing them and trying to work them out but they still continue to ache.  It is getting less.  The arm ache has been steady as well and has been massaging it, he can list his arm but has some difficulty with it.  No previous neck problems.  Did not take anything for the achiness.
Sore arm; Tired; 16 years old and received the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old and received the vaccine), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old and received the vaccine). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old and received the vaccine), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment medication was not provided by the reporter.
Vaccine administered after use by date.  Efficacy study done by Moderna and vaccine dose deemed effective, no re-vaccination needed.
Severe allergic reaction affecting the central nervous system.  Severe muscle weakness over the course of several days.  Testing done and linked reaction to Shingrix vaccine.
SkinRash small rash at injection site that presented 2 weeks after vaccine Narrative:
Pts parent call one month post vax and complained of herpes in pts mouth that never happened prior to receiving vax. Parent was concerned if the herpes cold sores on mouth is from the vax. Pt experienced no complication and no erythema.
I received my flu shot at 0130 on Oct 21 from RN for employee health.  At 0615, I was having some muscle and joint aches. (I work the night shift)  About 1200 the pain was a 7.  I was having the chills and headache. At 1600, I had a time of 102.2 severe muscle and joint pain at pain scale of a 12 and at 2000 it has 102.8. at 1600 I took tylenol 1000 mg, and at 2000 I took tylenol 1500 mg.  On Oct 22, at 0400, I woke up was still achey but temp was 101.0 and at 0800 it was 99.1, I still felt achey and I still feel achey at 0300 on Oct 23.  I called in sick on Oct 21, I was to work 2400 to 0600.
minor pain under my arm; vaccination site was red and swollen; vaccination site was red and swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (minor pain under my arm), VACCINATION SITE SWELLING (vaccination site was red and swollen) and VACCINATION SITE ERYTHEMA (vaccination site was red and swollen) 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.    In September 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced PAIN IN EXTREMITY (minor pain under my arm), VACCINATION SITE SWELLING (vaccination site was red and swollen) and VACCINATION SITE ERYTHEMA (vaccination site was red and swollen). At the time of the report, PAIN IN EXTREMITY (minor pain under my arm), VACCINATION SITE SWELLING (vaccination site was red and swollen) and VACCINATION SITE ERYTHEMA (vaccination site was red and swollen) outcome was unknown.            No concomitant medication was mentioned. No treatment medication was mentioned.  Patient just received the booster shot on Monday at noon.
MMR was the last vaccine given out of the 4.  The patient had a syncopal episode.  He passed out and lost consciousness for a few seconds before becoming alert again.  The medic in the room caught the patient on the way down and prevented him from hitting any part of his body on any surfaces.
Healthy male presented to ED on 5/25/21 per PCP recommendation for PLT transfusion given PLT count of <3K. Interval history significant for receiving 2nd dose of COVID-19 Vaccine (Moderna) on 05/12/21. Patient also noted to have a pruritic rash on bilateral arms and legs for the past 3 days. CBC upon ED presentation revealed WBC 10.3, ANC 6720, Hgb 13.8 g/dL, PLT <1K. CMP, PT/INR, and PTT unremarkable. Patient transfused 1 unit of PLTS in ED and was administered 125 mg Solumedrol and IVIG at 0.5 g/kg daily dose. He endorses ongoing asthenia and fatigue following his 2nd dose of COVID-19 vaccine (Moderna) on 05/12/21.  First dose was administered on 04/15/21 without adverse effects. He also reports a non-pruritic rash on his right forearm that was first noticed on 05/15/21 along with blood-filled blisters in his mouth. The rash has since evolved and now involves bilateral upper and lower extremities. Upon evaluation in the ED, patient denies chest pain, SOB, DOE, calf pain, lower extremity edema, fever, chills, headaches, lightheadedness, dizziness, decreased appetite, epistaxis, hemoptysis, gross hematuria, BRBPR, or melena. Denies prior history of thrombocytopenia. Patient was discharged on 5/27 and readmitted from 6/2 to 6/5 and again from 6/9 to 6/12, and 6/22 to 6/24 for recurrent thrombocytopenia. He received IVIG, platelet transfusions, and prednisone (6/3), methylprednisolone (6/9) and Promecta (after latest admission) for these recurrent hospital admissions per oncologist/hematologist.
Patient experienced flu symptoms;  nausea, headache, body aches, fever and chills
Swollen left arm. Prednisone 20 mg tab 2 tablets QD X 3 days. Continue MOTRIN PRN & ice.
pt recvd vax & c/o heat sensation; weakness; soreness back of neck & arm; c/o tingling; shakiness & inc heart rate; burning sensation back & neck; fatigue; joint aches;
Within few minutes of getting flu shot developed itching all over body/including lips with slight chest tightness-cough. Resolved after approximately 3 hrs.
Patient received 0.3ml of pediatric vaccine instead of 0.3ml of adult vaccine.
The patient said she had muscle pain at the injection site and had a mild rash on her right arm that was itchy. Her left arm looked unaffected and she did not mention any soreness in that arm. The patient also said she also had some "chills" the night before but that side effect had resolved. I counseled the patient on over the counter items like tylenol and ibuprofen to help with the pain and mentioned she could try benadryl to help with the itching and redness. I told the patient to monitor the rash and if it worsened to contact her doctor.
a day after receiving the vaccine, she felt some soreness to injection site and arm, unable to raise arm up; felt achy, fatigued then at the end of the day, noticed fever, temperature going up from 97 to 99 to100, then as high as 101 F over a 4 hour time frame; she took ibuprofen 400mg that night then awoke this morning feeling better; she has not taken any more fever reducing medications and has no fever today even though her arm is still sore, she can move it more now and just sore to touch
"August period was 10th-13th.  8-15-21 received vaccine 3 hours after injection lower abdominal pain started.  8-16-21 lower abdominal contracting pain affected lower abdominal and lower back.  Sept 16 spotting of blood started after going to bathroom  lasted 2 days.  Sept 20 period started extremely heavy went through 3 pads major cramping.  Sept 21 woke up in night to extreme bleeding went through 1 pad.  2-3 pads a day lasted until Sept 24 ended. Stopped 2 days began Sept 27 heavy bleeding lasted 2 days ended Sept 27-28 ended." Per patient's recollection
ACUTE STROKE DUE TO OCCLUSION OF LEFT MIDDLE CEREBRAL ARTERY 5/18/2021 ACUTE STROKE DUE TO OCCLUSION OF LEFT MIDDLE CEREBRAL ARTERY
Nose itching, development of herpes-like breakout under nose.  Breakout is still visible as of 8/2/2013.
covid vaccine breakthrough  dose 1 1/23/21 EL3249 dose 2 2/13/21 EL9267