chrisvoncsefalvay/vaers-outcomes huggingface dataset:
after about 2 weeks after getting the shot, i experienced a almost a week of constant heart palpitations, irregular heat beats, easily noticeable.   I made an appointment with doctor, but it calmed down, so i did not go in.   My sister experienced the same thing.
Onset Headache, Body Aches, Chills, Fatigue 10 hours after vaccine
Systemic: Allergic: Itch Generalized-Mild, Systemic: Flushed / Sweating-Mild.
dizziness; A spontaneous report  was received from a 67 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events dizziness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot batch: Unknown) for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced dizziness. No treatment information was reported.   Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of event, dizziness, was resolving at the time of the report.; Reporter's Comments: Based on the 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.
Within 12 hours abdomen and neck rash "welt-like"; fussiness.  Office visit on 01/16/04 @ 09:00.
Information has been received form a Medical assistant (reported as M.D. in contact details) concerning a 5 year old patient with no Pertinent Medical History and Drug Reactions/Allergies who on 08-FEB-2011 was inadvertently received ZOSTAVAX (subcutaneously right thigh, lot no. 669190/1455Z, exp date 29-JAN-2012) instead of VARIVAX. Concomitant therapy included DAPTACEL and poliovirus vaccine (manufacture unknown). No adverse effects have been reported of observe. The patient sought unspecified medical attention. No treatment was given for AE. Follow up information received from the same medical assistant reported that it was not a case of product confusion. The office manger stated that the two bottles were next to each other in the freezer and that the person giving the shot did not verify the bottle clearly enough. Follow-up information was received from the office. It was reported that no adverse reactions were identified. No further information is available.
Days after receiving second dose of Moderna  COVID vaccination on 3/4/2021, patient experienced increase in her baseline auras and seizures, requiring hospitalization for video EEG monitoring and titration of her anti-seizure medications. I am reporting this due to the temporal correlation. The patient was monitored with EEG while medications were titrated and did not require ICU level care.
After I left after waiting I felt find. I went to work and about hour or two I took a tylenol 800 in case my arm got sore. But I was so sleepy my eyes felt like sand was in it. I had to call my daughter so I could stay awake. I was extremely tire. The next day I was not as sleepy but I was very tire. It just started getting better. I not as tired no more. But I didn't know how to report it until I seen on news and my sister told me how to report it.
6 months after 2nd shot, got shingles6 months after 2nd shot, got shingles/ suspected vaccination failure; Shingles on arm - 1st outbreak; Dark marks; Burning; Itching; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included No prior history of shingles..   On 24-FEB-2022, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 6 months after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: 6 months after 2nd shot, got shingles6 months after 2nd shot, got shingles/ suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster (Verbatim: Shingles on arm - 1st outbreak), skin discoloration (Verbatim: Dark marks), burning sensation (Verbatim: Burning) and pruritus (Verbatim: Itching). The outcome of the vaccination failure was unknown and the outcome of the herpes zoster, burning sensation and pruritus were resolved and the outcome of the skin discoloration was not resolved.   The reporter considered the vaccination failure, herpes zoster, skin discoloration, burning sensation and pruritus to be related to Shingrix and Shingrix.     The company considered the vaccination failure, herpes zoster, skin discoloration, burning sensation and pruritus to be related to Shingrix and Shingrix.   Linked case(s) involving the same patient:  US2023AMR047695   Additional Information: GSK receipt date: 29-MAR-2023 The reporter was the patient's husband.  She had both Shingrix shot 1 and shot 2.  The reporter did not have the exact date of Shingrix shot 1 but received toward the end of 2021. The reporter provided the pharmacy name and phone number where the shots were administered as the pharmacy would have the date of administration on file as well as the lot number, site, and route of administration.  He reported that after about 6 months (after the second shot) she got the shingles on her arm.  It sort of went away except the dark marks and all but most of the burning and itching went away.  The reporter confirmed that this was his wife's first shingles outbreak. No prior history of shingles previous to this. The wife was in the room and did not object to her husband giving her MD contact information. The reporter consented to follow up. This case was considered as suspected vaccination failure since details regarding laboratory confirmation of shingles was not reported.; Sender's Comments:  US-GSK-US2023AMR047695:same reporter
Headache, Myalgia, UrticariaPruritus, NauseaVomiting, 14 cm wheal to injection site with swelling, fatigue Narrative:
About 2 weeks post vaccine I noticed Tinnitus. I went to the doctor. They prescribed me Oral Prednisone which then made my blood sugar spike, The doctor then gave me a steroid in injection my left ear.  A1C had spiked I was 6.6 in 6/2020 and in 12/2020 my A1C 6.8 and 8.3 in 6/2021 and 12/2021 my A1C was 7.8. I'm still suffering from Tinnitus and my blood sugars are still high.
4/14/21.  Vaccine administered at 9:05am.  Around 4pm fatigue set in.  My left arm was sore.  Low appetite.  4/15/21  Still fatigued.  I had chills and a headache (no fever).  Soreness of the left arm.  Low appetite. 4/16/21 Energy has improved but still tired.  Left arm feeling better.   I did not seek medical attention.
Anaphylaxis.  Patient had immediate onset of palpitations and dizziness. 25 minutes later, developed swelling of throat, lips, tongue associated with choking on food, dyspnea, and dysarthria due to tongue swelling. Also had diffuse pruritus, erythema of face, swelling of hands and entire left arm extending downward from injection site. History is reported to me today by patient. She took Benadryl 12.5mg with which throat swelling improved. Symptoms overall persisted for a couple weeks before gradually resolving. Did not seek medical attention immediately due to distrust of emergency room care.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "cholesterol issues" (unspecified if ongoing); "chronic Prostatitis" (unspecified if ongoing); "Known allergies: certain antibiotics" (unspecified if ongoing); "Known allergies: wheat" (unspecified if ongoing); "Known allergies: various other outdoor allergies" (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 "recovered" (Sep2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Negative, notes: negative for covid two days after finishing paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 19Sep2023 till 24Sep2023.   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: Linked Report(s) : US-PFIZER INC-202300312801 same reporter/patient, different drug/event;
The patient was administered with an expired Tdap (Boostrix NDC 58160-842-43; Lot TG597; Exp 03/09/2021). Immediately the patient was informed while still present at the pharmacy.  The patient was also informed that a case would be open, and all relevant parties would be informed, and to expect future follow-up
Patient's reaction(s) noted during COVID vaccine observation period: Pain on left side of neck (same side as injection site) ) and waves of nausea.  Actions Taken: VS taken and WNL. Pt states the nausea is resolving and she feels comfortable just going home.
Pt. became light headed, pale, and diaphoretic minutes after vaccine.  Pt. reports it is not unusual for him to pass out while getting an injection. Pt back to normal in 5 to 10 minutes. Pt was observed post vaccination and released home.
Pt recvd 2 doses of Engerix-B & 8 mins following 2nd dose exp thight throat, couldn't breath, pale & wheezing inspiration, tx w/oxygen, epi & DPH, Susphrine, Solumedrol;
Case number PHEH2014US002167 is an initial spontaneous report received from a pharmacist on 28 Jan 2014. This report refers to an adult female patient of unknown age. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1309801) intramuscularly on 31 Dec 2013. On an unknown date one or two days after vaccination, she began to experience pain in left arm muscle which extended from shoulder to elbow. It was also reported that occasionally she had to pick up left arm with her right arm while sleeping. The outcome of the event was reported as condition unchanged. The causality and seriousness of the events were not reported.
Redness, heat, soreness at injection site - red area under shot location. Patient reacted to PNEUMOVAX shot in (R) deltoid.
Information regarding Flumist was received from a healthcare professional regarding a 6 year old female pt who experienced redness in the neck. The pt received a dose on 12/11/03. The patient's neck turned red immediately after receiving the Flumist on 12/11/03. The nurse stated that the tp said she felt fine. The nurse indicated that there was no sign of a rash, just redness. No additional info was available at the date of this report.
Less than 10 min following injections patient vomited x1. Patient was in facility less than 20 minutes following administration without any other symptoms.
About 4 days after I started having abdomen pain, it was like having contractions, then bleeding and spotting, and it was a different type of color instead of a period color, more burgundy. it lasted 26 days, when I'd eat it would start again, I started having headaches, and had vision problems, then SOB started and I used the inhaler to help. I also had a low grade fever of 99.8 - 100 that lasted up until about 5 days ago. I started having bruising and leg pain, the bruising would be if someone helped me get up, I have little bruising dots over my body.  I went to the ER 3/16/2021 because the stomach and headache pains, they did a MRI and Ct and said it was acute stomach pain and migraines and told me to see a OBGYN for the bleeding and gave me meds for stomach pains. Bentel for stomach and Floraset for headaches but it never worked. I had a nerve block on my head for the migraines but it didn't work.  The GYN gave me something to stop the bleeding and she's wants to do a D&C. I'm waiting to see my PCP on the 19th.  I still have the purple dots and headaches, I still get the contractions and the stomach issues have settled some.
Pt recvd DTP/OPV on 14MAY91 & pt ran a fever of 103-105; Seen by MD following day; no other signs or sx; no disease found;
Sore left injection site arm; Patient is pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Sore left injection site arm) and MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 01-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant). On an unknown date, the patient experienced INJECTION SITE PAIN (Sore left injection site arm). On 01-Sep-2021, MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant) had resolved. At the time of the report, INJECTION SITE PAIN (Sore left injection site arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Concomitant medications were reported.  The patient reported a sore left injection site arm. The due date was reported as Nov-2021.  This case concerns a 32-year-old pregnant female patient with no reported medical history, who experienced the non-serious  unexpected events Injection site pain and maternal exposure during pregnancy.  The events occurred  after the first dose  of mRNA-1273 Moderna vaccine. Last menstrual period and estimated date of delivery were not provided.  The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.   This case was linked to MOD-2021-336953 (Patient Link).; Sender's Comments: This case concerns a 32-year-old pregnant female patient with no reported medical history, who experienced the non-serious  unexpected events Injection site pain and maternal exposure during pregnancy.  The events occurred  after the first dose  of mRNA-1273 Moderna vaccine. Last menstrual period and estimated date of delivery were not provided.  The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.
pt began w/low grade fever on 8MAR94 which cont through the wk; about 1030PM 12MAR94 pt had a febrile convuls for which the paramedics were called & pt was taken to hosp for eval;
-April 2021 - bouts of extreme fatigue lasting 2-3 days, occurring once every 2 weeks.  -June 12, 2021 - Severe insomnia - 0-2 hours of sleep per night (continues for next two months) -June 12, 2021 - Extreme neurological symptoms - electric shock sensations/pains throughout entire body, adrenaline dumps, tachycardia, palpitations, brain zaps, strange pounding sensations in the back of my head, hypnic jerks -June 12, 2021 and on - Inability to go to the bathroom (#2) for days. When I did go, consistently was completely changed. Stool was small/hard/rocky. There also was no signal to go. I was going on schedule and almost forcing it out.  -June 12,2021 and on - severe weight loss, complete loss of appetite  -June 12, 2021 and on - extreme visual distortions - everything is wavy and moving in front of my eyes. I wasn't able to focus on anything. Strange sensation of being 'drunk' (was not on anything intoxicating) -June 12, 2021 and on - severe sensory loss. Retraction of emotions, feelings of hunger, feelings of 'tiredness' while doing cardio exercise, loss of the ability to sweat, loss of the ability to look into digital screens
I had my first COVID vaccine on 1/16/21. I had my second one on 2/5/21. On 2/9/21 I started experiencing a sharp pain in my left breast. On 2/10/21 I had sharp pain in between my shoulder blades. On 2/11/21 I noticed a small red rash-like spot in between my breast. I woke up on 2/12/21 in incredible pain on my back, so I lifted my shirt to look in the mirror and that is when I noticed a blister type rash from the middle of my back wrapping around the front of my body covering my left breast. I went to see the PA at my PCP's office. She diagnosed me with shingles. She placed me on an anti-viral medication for a week, and gabapentin (nerve medication) for a month. It has been 3 weeks today since I first began treatment and I have not fully recovered yet. My blisters dried up about a week ago, but ever since then I have been incredibly itchy, which has kept me up every night for over a week now. On 3/3/21 I called my PCP's office and they started me on Prednisone for 6 days. I am 2 days into treatment and I still have not had relief from the itching.
Information has been received from a registered nurse concerning a 4 year old female with no pertinent medical history who on 28-MAY-2003 was vaccinated SC with a 0.5 mL dose of Varivax. There was no concomitant medication. On 12-JAN-2007 the patient developed a varicella rash on her torso and right leg, and she had a temperature of 100.5 degrees Fahrenheit and complained of itchiness. There were about 10 lesions. The patient was instructed to use calamine lotion and take therapy with diphenhydramine hydrochloride (BENADRYL) at night. On 16-JAN-2007 the physician followed up with the patient, and the patient was recovering. She no longer had a temperature but had developed 3 additional lesions under her right eye and ear. No lab diagnostics were performed. Additional information has been requested.
infant developed chest congestion with cough 05/30/07. Taken to ER for urticaria which started 06/01/07 pm. Infant received 2 injections, on follow up 06/05/07 infant had generalized urticaria. RX oral Benadryl.
I experienced night of the vaccine at about 12:00am, fever, chills, body aches, headaches. The following day I developed swelling to my face and hands, lasting three days.  I went to see my PCP for my symptoms. After my swelling went down I had really bad diarrhea (occurred four days after my vaccine).
Dizziness, Headache, NauseaVomiting, 12/30 worst migraine 12/31 migraine, severe nausea, lightheaded, dizziness 1/4 felt like fainting and went home from work 1/6 head heavy, dizziness.  Narrative:  12/30 worst migraine took Midol and then Excedrin with no relief, 12/31 migraine, severe nausea, lightheaded, dizziness 1/4 felt like fainting and went home from work 1/6 head heavy, dizziness.
covid-19 virus; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (covid-19 virus ) 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.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced COVID-19 (covid-19 virus ). At the time of the report, COVID-19 (covid-19 virus ) 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.
Unable to extend arm after shot, currently experiencing pain and tenderness at admin. area, tingling in arms and fingers.  Feeling of pins/needle sticks in arm and fingers. Unable to sleep on side where shot was given. Treated with steroids and referred to neurologist to check nerve damage.
A week later after the vaccine on 4/3/2021, I woke up and the injection site was itchy and tender.  The area at the injection site was red, raised and warm and tender to the touch.  I contacted telehealth and spoke to a nurse practictioner.  I was instructed to use cold compresses and alternate ibuprofen and Tylenol.   I did the cold compresses and did not take any medications.  It help ease the warm and itchiness.  It took 48 hours for the symptoms to resolve. I did get the 2nd shot and experienced no adverse reactions.
administered with an expired PENTACEL and IPOL (with no reported adverse event); Initial information was received on 22-Jun-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional in the (Agency Inquiry number: 00651940).  It was reported that an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and IPV (VERO) [IPOL] was administered to a male patient (age not reported) on an unknown date for prophylactic vaccination (expired product administered).  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event 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.  There will be no information available on batch number for this case.; Sender's Comments:  00651323: 00651982:
Scarlet red rash; Itchy; Dry heaving; Diarrhea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Scarlet red rash), PRURITUS (Itchy), RETCHING (Dry heaving), DIARRHOEA (Diarrhea) and CHILLS (Chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Scarlet red rash), PRURITUS (Itchy), RETCHING (Dry heaving), DIARRHOEA (Diarrhea) and CHILLS (Chills). At the time of the report, RASH ERYTHEMATOUS (Scarlet red rash), PRURITUS (Itchy), RETCHING (Dry heaving), DIARRHOEA (Diarrhea) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information included steroids.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow up received on 2-AUG-2021 and it contain no significant follow-up.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
1st dose - Tenderness at injection site  2nd - High Fever, Sore Throat, Shaking, Headache, Muscle Ache