chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The very next I started having tingling in my left leg and then it gave me the feeling like I slept on it. These feeling continued and then in March I started having issues feeling like my heart was tender. The feeling in my left leg continued along with the tender feeling in my heart and then I started having discomfort and tingling in my arm.  The next day I went to the doctor, and I was told I should've gone to the ER until I saw a doctor because it could've been a stroke. He did an EKG and it was fine and then he did bloodwork. The doctor said he found high cholesterol and high triglycerides range was off. The doctor told me I was too young for medication, so he gave me a nutrition's to try and fix the issue naturally. I changed my diet over 5 months and exercise on paper it looked like it fixed everything but tested me again the numbers were even high 150 and now its 173. The doctor suggested 6 more months of a strict diet and more exercise   to see if it would improve. I am set to go back to the doctor next week so I will call back to give an update.
59 year old female patient received dose of FLUZONE HD QIV vaccine with  no AE; 59 year old female patient received dose of FLUZONE HD QIV vaccine with  no AE; 59 year old immunocompromised female patient received dose of FLUZONE HD QIV vaccine with  no AE; Initial information received on 29-Sep-2021 regarding an unsolicited valid non-serious case from a Pharmacist via Medical Information (Reference number- 00791205).  This case involves a 59 year old immunocompromised female patient who was vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age, overdose and contraindication to vaccination).  The patient's past medical history included Organ transplant with immunocompromised.  The patient's past medical treatment, vaccination, concomitant medication and family history were not provided.  On 20-Nov-2020, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ482AA and expiry date: 30-Jun-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration and Overdose (latency on same day).  It was also case of contraindication to vaccination (latency on same day).  It was reported "Consumer is 59 Pharmacist states the consumer received the Fluzone High Dose last year on 20Nov2020 and is asking to receive it again this year since she is a transplant patient but she hasn't given it yet. Pharmacist is very busy and limited information provided also consumer received it at a different location last year".  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 the 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.
Pfizer-BioNTech Covid-19 Vaccine EUA Headache all night, achy, chills, fatigue, injection site pain,  Feeling a little better by 8am next morning. Taking Tylenol and it helps
Very mild abdominal tightness within the first 15 min, no big deal and I did not report. About 4 hours later notice marked abdominal/gut tightness and bloating. Very fatigued. Swelling in extremities and moderate joint pain. Increased thirst. Next morning had sharp pleuritic type of chest pain increased with inspiration lasting about 20 min. Moderate/severe fatigue. Abd tightness, bloating, and fatigue continued for the next 48 hours and persisted but is milder today on 3/9. Continued fatigue. And the expected headache.
Localized allergic reaction 6-7 cm diameter of erythema and heat at injection site right deltoid. Treatment: ice, hold physical therapy, Medrol dose pack.
PT DEVELOPED PAIN, REDNESS, TENDERNESS, SWELLING AND BRUISING.
(symptoms, signs, time course, etc.) Multi-system Inflammatory Syndrome in Children (MIS-C)
full body rash that was terribly itchy.  had to take 2 Benadryl to help
Narrative: There was enough overfill remaining in the vial to withdraw a 6th dose. The nurse withdrew the overfill from the vial and administered it to the patient. The patient did not have a negative reaction to the vaccine.
72 year old male received influenza vaccine and 23-valent pneumococcal vaccine in the left arm on 10/10/17. Of note, pt has previously received both the influenza vaccine and 23-valent pneumococcal vaccine with no previous documented reaction. Pt called later that evening c/o redness, heat, and (3 inches across) swelling of injection site as well as minimal itching. Pt was instructed to apply cold compresses and take NSAIDs and hydroxyzine. On 10/12/17, pt reported he still felt weak and dizzy, swelling had improved but still warm. Pt presented to ER 10/12/17 c/o fever, chills, and body aches with temperature 102.1 and physical exam noted diffuse tenderness and erythema of left deltoid/proximal arm. Pt was diagnosed with fever and left arm cellulitis s/p vaccinations and discharged home on cotrimoxazole. Fever and Pruritus; Erythema; Cellulitis. Acetaminophen 1000 mg PRN, Sulfamethoxazole/trimethoprim 800/160 mg BID, hydroxyzine 50 mg PRN.
23JUN94 pt recvd vax & had elevated temp that noc w/chills; pt was brought to ER & mom was informed that pt had a react to shots; pt given APAP & Ibuprofen;
had tested positive for Covid-19; He was due to receive his 2nd Pfizer vaccine on 4/27/21 and he had to cancel due to "He had Covid-19 at the time."; This is a spontaneous report from a non-contactable consumer or other non Healthcare Professional. A 62-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Expiration date: Not reported), via an unspecified route of administration on 08Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had tested positive for covid-19 on an unspecified date in Apr2021 following his 1st Pfizer vaccine dose and he was due to receive his 2nd pfizer vaccine on 27Apr2021 and he had to cancel due to he had covid-19 at the time on an unspecified date in 2021. Patient was due to receive his 2nd Pfizer vaccine on 27Apr2021 and he had to cancel because He had Covid-19 at the time. On 14May2021 patient had a negative Covid-19 test and went to get a 2nd Pfizer vaccine dose, but he did not receive a vaccination card. When he received his 1st Pfizer vaccine. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on Apr2021 (He had tested positive for Covid-19 following his 1st Pfizer vaccine dose), sars-cov-2 antibody test: negative on 14May2021 (He had a negative Covid-19 test). The outcome for the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Started a few hours after injection.  Next day jitters and arm pain were worse.  In the evening the next day after the injection he had a severe seizure and could not stand as his legs would not hold him.  He  did have a slight temperature (98.9).  I got help to get him into bed.  By Monday Morning (today) jitters were gone, however,  he still had pain in his arm.
Nausea beginning approximately 4 hours after injection. Vomiting beginning about 8.5 hours after injection and lasting for approximately 8 hours intermittently without being able to keep water down. Headache, body aches and in particular joint aches. Chills, cold sweats, and slight fever. Side effects lasted for approximately 36 hours.
Inconsolable crying, w/o fever, shortly p/DTP for @ least 4 hrs; Subsequent 3 days of fussiness & dec appetite;
Small red bumps; skin rash; itchy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Feb2022 18:30 (Lot number: 33036BD) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN; SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8729, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 22Apr2021, when the patient was 38 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8733, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 01Apr2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported: RASH PAPULAR (non-serious) with onset 05Feb2022 10:00, outcome "not recovered", described as "Small red bumps"; RASH (non-serious) with onset 05Feb2022 10:00, outcome "not recovered", described as "skin rash"; PRURITUS (non-serious) with onset 05Feb2022 10:00, outcome "not recovered", described as "itchy". Therapeutic measures were not taken as a result of rash papular, rash, pruritus.  Additional information: It was reported that no other vaccine in fourweeks. No treatment for the events. No covid prior vaccination. Patient was not tested covid post vaccination. Patient had No Known allergies.  Follow-up attempts are completed. No further information is expected.
Numbness and tingling and weakness  in both arms and hands and pain and pressure in armpit area for 3 months.
Sore arm; Head ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HEADACHE (Head ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (Head ache). At the time of the report, PAIN IN EXTREMITY (Sore arm) and HEADACHE (Head ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-026644 (E2B Linked Report).; Sender's Comments:  MOD-2021-026644:Crosslinked to MOD21-038768, Same reporter
4/15/21 woke up with severe pain in left upper thigh. Fatigue and headache began a few hours later. Needed to leave work. Early evening a rash developed in the left thigh and left foot swollen size of balloon and bright red. Went to the ER 10:30PM, admitted from ER on 4/16/21 for possible deep vein thrombosis and cellulitis of left leg. Shortly after admission, unable to obtain venous  access, central line inserted for IV fluids and IV vancomycin and Zosyn. Foot swelling increased up to below knee with bright red skin color. No open wound noted on extremity. Ultrasound did not find a thrombosis but enlarged lymph nodes. 6 days later leg still swollen and red, repeat doppler ultrasound negative, but report stated could not compress to complete test due to severe swelling.  He was also tachycardic and hypertensive during admission. Infectious disease doctor consulted and confirmed severe cellulitis but it was written in discharge summary the covid vaccine can not be ruled out as a cause of the infection and admission. Lasix was initiated to decrease swelling in lower extremity. He was on SQ heparin 3 times a day during the admission. He was discharged on Doxycycline and Augmentin.  After discharge saw primary care physician who palpated large lymph nodes in neck. Mild headache persists. Ultrasound of neck to be completed on 4/27/21. Started on Tizanidine for pain.
mom states this AM pt noticed a rounded mark @ the site of the rt arm where an immun was given;the mark is about the size of a fifty cent piece & is tender;pt has 2 small red marks on the lt arm where 2 other immun given;
Had 2 doses of Energix and then 1 dose of Heplisav-B; Initial Report Received on 28-Jun-2023   A nurse reported that a 79-year-old male (race and ethnicity not provided) received two doses of Engerix-B and then one dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.    No medical history or concomitant medications at the time of vaccination were reported. The patient had no known drug allergies.   On unknown dates, the patient received two doses of Engerix-B (no details provided).     On an unknown date, after having been vaccinated with two doses of Engerix-B, the patient received one dose of HEPLISAV-B (Lot #, expiration date,  route, and injection site not reported, NDC # 43528-002-01).     No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
i got sick; headache; no appetite; joint pain; temperature of 102.8 F; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (i got sick), HEADACHE (headache), DECREASED APPETITE (no appetite), ARTHRALGIA (joint pain) and BODY TEMPERATURE INCREASED (temperature of 102.8 F) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 016M20A) for COVID-19 vaccination.     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) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced MALAISE (i got sick), HEADACHE (headache), DECREASED APPETITE (no appetite), ARTHRALGIA (joint pain) and BODY TEMPERATURE INCREASED (temperature of 102.8 F). At the time of the report, MALAISE (i got sick), HEADACHE (headache), DECREASED APPETITE (no appetite), ARTHRALGIA (joint pain) and BODY TEMPERATURE INCREASED (temperature of 102.8 F) outcome was unknown. Not Provided          No concomitant medication was provided.  Treatment details included acetaminophen.
Systemic: Fainting / Unresponsive-Severe, Additional Details: patient fell as he passed out called 911 paramedics checked out  patient
Muscle and joint stiffness. Very fatigued.   Started after the injection of the Janssen vaccination.  Never let up
On 04/03, pt developed swollen and red down arm. and on 04/09 she developed horrible shooting pain in arm and neck.
I had a large red spot around the area of the vaccine. About a week after the vaccine it became painful  and hot and about 3 or 4 inches in diameter which got worse and expanded. The doctor marked the area at the Urgent care marked the area. About two weeks after vaccination it was worse and I visited my doctor and got diagnosed with Cellulitis and was prescribed with Antibiotics. It started to disappear about 48 hours after starting antibiotics. I had no reaction with the second vaccine.
a friend did experience that, from his back down he could not move his legs; This is spontaneous report received from contactable consumer, reporting for friend (patient).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on an unknown date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  When getting the second, the patient did experience that, from his back down he could not move his legs and had to go to the hospital, in 4 or 5 days he left. The outcome of the event was not reported.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Patient reported feeling numbness and tingling in her arm about 1 hour after receiving vaccine. She noticed it on her drive home and it had not subsided yet during our phone call conversation when she was reporting effects to me. The numbness/tingling starts at injection site at left deltoid and radiates down to her fingertips.
Report 20010058291 described a 30 year old female who received hep B vaccine recombinant (Engerix-B) for prophylaxis of hep B. Allergies, medical history, and concomitant medications were not specified. On 02/05/2001, the vaccinee received her first intramuscular dose of Engerix-B. At the time of injection, the vaccinee complained of severe pain and "burning." No treatment was given. As of 02/28/2001, the outcome of the event is unresolved.
my daughter developed hsp vasculitis 21 days after injection.she know has a chronic form of hsp and is on methotrexate.severe purple lesions on legs,buttocks,and elbows.she also has abdominl pain.  11/24/08 PCP records received beginning 11/1/2006 with WCC with normal exam. Gardasil #1 given. Pt returned 12/14/06 with c/o rash on legs x 7 days. Assessment: Vasculitis.  HSP.  Referred to Rheum.  Rheum consult 1/8/07 with DX: HSP. PE (+) for purpuric lesions, some ulcerated. Few recent nosebleeds reported. Tx with prednisone. F/u 2/27/07 with c/o abdominal pain. F/u 2/13/08 with c/o ankle problems/swelling. 15 yr WCC on 9/9/08 with c/o knee and abd pain and stiffness.PE (+) for pink papulopustular rash. Assessment; h/o vasculitis-no signs of active disease. Rash. Knee pain. 11/26/08 ER rec of 8/23/06 with DX: wrist sprain. Pt developed wrist pain after doing a handstand. No fx.
He got his vaccine, got it in the ball of his shoulder, it immediately started hurting and went down his entire left arm, all the way down to his wrist which hurt real bad.  He first called this in when it happened and reported it and has lived with it.  His arm slowly stopped hurting and moved back into his shoulder, ball of his arm, and has kept getting worse.  He takes Oxycodone for a broken back and the pain comes through despite taking that.  He has tried to use arm weights to try and work the pain out, and has never went away and it getting worse.  He now has a black and blue mark on the inside of his arm about 1" in diameter.   It is about 4" down top of his arm, inside about the breast area and is growing.  Seems to be growing from the inside out.   He recently noticed this about a week ago.  He is also having headaches for months that will not go away.  He has not hurt himself or injured the area in any way.  He has marked the area and says that it is growing.    He had a PCP, who poked at it and said that it would go away and it has not.  Did not seem concerned.    Had the flu vaccine about 2 weeks prior to the vaccine, believes he got it in his butt.  Dr. also gave it to him.    The headaches are in the back of his head and deep.  He did not have headaches prior to the vaccine itself.    He has not had other COVID vaccines, and states that he will not get another one.
10 days after her second vaccine, patient had bloodwork done for a previous vision problem (Visual Snow) and her TSH came back very low: 0.10. She repeated the bloodwork 11 days later, resulting in an even lower TSH level: 0.02.  Her FT4 is 1.62, and her Free T3 is 5.8.
Vaccine kept in refrigerator on 10/31/2021, expiration date is 10/13/2021, administered on 11/5/2021; Expired Vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) and PRODUCT STORAGE ERROR (Vaccine kept in refrigerator on 10/31/2021, expiration date is 10/13/2021, administered on 11/5/2021) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine kept in refrigerator on 10/31/2021, expiration date is 10/13/2021, administered on 11/5/2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) and PRODUCT STORAGE ERROR (Vaccine kept in refrigerator on 10/31/2021, expiration date is 10/13/2021, administered on 11/5/2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.  No treatment medication were provided.  On 31-Oct-2021, the vaccine placed in refrigerator. There were no temperature excursion and did not experience any adverse event.
Raised red circle around injection site. Swollen, itchy, warm to touch. Started the size of a half dollar expanded to the size of an orange by day 3, subsiding in size  on day 4.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: WEIGHT DECREASED (medically significant), outcome "unknown", described as "lost 20 lbs."; NEURALGIA (non-serious), outcome "unknown", described as "nerve pain"; ILLNESS (non-serious), outcome "unknown", described as "extremely sick"; PAIN (non-serious), outcome "unknown", described as "body aches"; CHILLS (non-serious), outcome "unknown", described as "chill"; HEADACHE (non-serious), outcome "unknown", described as "severe headache". After the booster shot of Covid-19 vaccine have been extremely sick from it (body aches, chill, lost 20 lbs., severe headache, nerve pain). The patient wanted to know if someone can contact the patient. The patient underwent the following laboratory tests and procedures: Weight: lost 20 lbs. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.