chrisvoncsefalvay/vaers-outcomes huggingface dataset:
abdominal pain/abdominal cramps; diarrhea; headache; This case was reported by a consumer via call center representative and described the occurrence of abdominal pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st January 2022 11:30, the patient received the 1st dose of Shingrix. On 31st January 2022, 4 hrs after receiving Shingrix, the patient experienced abdominal pain, diarrhea and headache. On an unknown date, the outcome of the abdominal pain and headache were not recovered/not resolved and the outcome of the diarrhea was recovered/resolved.   It was unknown if the reporter considered the abdominal pain, diarrhea and headache to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. About four hours later the patient developed a headache . The patient had one episode of diarrhea and had abdominal cramps.  The patient had nothing else to report. The reporter did not have email.
Pt complained of swelling in her jaw after receiving Pfizer booster vaccine.  Experienced tingling and numbness in jaw.  Vitals were taken BP 149/87, HR 106, temp 98.3, O2 98%.  Pt was alert and oriented; Benadryl was given 50mg po 1 dose.  Vitals were rechecked at 13:40; BP 150/89, HR 101, temp 98.4, O2 98%.  Patient refused ambulance transportation to ER facility, went home with family members.
I received my first dose on 8/15/22 which was uneventful.  My 2nd dose was on 9/7/15 @1300.  That night I experienced severe joint pain and muscle spasms in my upper body.  On 9/8 by noon I was experiencing a dull headache and moderate injection site discomfort.  The headache continued to worsen until it was unbearable.  I also experienced chills, a fever of 101.2, severe hypertension, nausea and severe malaise.  I treated the symptoms with OTC medication the best I could.  Today the dull headache remains, my blood pressure and fever have returned to normal.
I contracted COVID-19 on 06/30/2022 with symptoms of runny nose, congestion, fever of 100.9, and night sweats. I was prescribed PAXLOVID on 07/03/2022. I was ill for 5 days before my symptoms began to resolve. I did have rebound symptoms with a cough and fatigue that began on 07/13/2022, and I was ill for an additional 5 to 6 days before my symptoms resolved. I am fully recovered with no lingering symptoms.
Patient had baseball size knot with redness, swelling and fever noted. Pt taking benadryl.
This 43-year old male was vaccinated with Vivotif (Batch no: unknown) on 10.Jan.2006. the same day he also received Hepatitis AB vaccine and Meningococcal Polysaccharide vaccine (Batch numbers and tradenames: unknown). On 14.Jan2006 the patient developed BACK SPASMS. These have been starting at 15:00 each night for the last several nights. They lasted for about 3-4 hours. He tried to take ibuprofen without much benefit. He denies recurrent fever. He has had more energy and was able to return to work day for 1/2 a day. Examination: Temp 37.0, pulse 80 bpm, BP 120/80, biopsies sent showed hypersensitivity reaction. X-ray from today showed some inflammation; there was evidence of granuloma from a previous lung infection. Sed rate has come back to normal. The patient is known to take Lexapro (escitalopram) for anxiety disorders, occasionally he has taken clonazepam. From the patient's history an allergy to typhoid vaccine, anxiety and previous gynecomastia is known. The patient was hospitalised for 8 days. This case was downloaded from the agency reported. The case was reported to be serious.
Approximately 1-2 minutes after receiving vax, pt fell to the floor. Eyes were rolled back in her head. Both arms were flexed and turned inward. Her head was turned to the side and her back was arched. Pt was stiff and jerking. This lasted about 45 seconds. Pt was unresponsive during this time and appeared cyanotic.  After the event pt was pale and limp, but responsive and wanting to get up. Pt was examined by physician and released.
exposed to my daughter who tested positive for Covid-19; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore) and EXPOSURE TO SARS-COV-2 (exposed to my daughter who tested positive for Covid-19) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 31-Mar-2021, the patient experienced EXPOSURE TO SARS-COV-2 (exposed to my daughter who tested positive for Covid-19). At the time of the report, PAIN IN EXTREMITY (arm was sore) and EXPOSURE TO SARS-COV-2 (exposed to my daughter who tested positive for Covid-19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not provided. The Treatment information was not provided.
Patient was very nervous about getting vaccine - she reported having rare side effects often ... she reported that about 2 minutes felt faint and dizzy and"pre-syncope ", about 10 minutes later felt legs were cold and body aches... Pt sat for 30 minutes  and called a friend . .. she felt well enough to drive home with her friend following her ... the entire time patient was alert and was able to hold conversation  Pt has an appointment with her doctor tomorrow morning already planned prior to receiving vaccine so she will follow up
Fairly high pitched, fine buzzing sound in my head when not engaged in conversation, TV, sleep or the shower.  I thought it would fade with time, but it  hasn't.  "Ringing in the ears" was listed as a possible side effect on the information sheet.  It is bothersome, but did not seem to warrent medical advise. My flu shot was administered hospital, where I work.  I am not sure of the type or manufacturer. It was 28 days prior to Shingrix
Severe redness, tenderness, swelling of left arm within 12 hours of DTaP, with fever to 103, treated with Motrin, Keflex, Benadryl
Joint pains; Muscle pains; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ARTHRALGIA (Joint pains) and MYALGIA (Muscle pains) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included SILDENAFIL CITRATE (VIAGRA CONNECT) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced ARTHRALGIA (Joint pains) and MYALGIA (Muscle pains). At the time of the report, ARTHRALGIA (Joint pains) and MYALGIA (Muscle pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
a 6 months old female patient received Quadracel instead of Pentacel/ NO AE; 6 months old female patient received Quadracel/ NO AE; Initial information received on 21-Sep-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case involves a 6-months-old female patient who received once 0.5 mL third dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (strength: standard, lot number: C5635AA, expiry date: 18-JUN-2021, via an intramuscular in the right thigh) instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (product administered to patient of inappropriate age and wrong product administered) on 10-Sep-2020 prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE, ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  It was an actual medication error case due to inappropriate age at vaccine administration and wrong vaccine administered (latency: same day).   At the time of reporting, 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.
Patient developed severe body aches, chills/rigors and fever of 101.7F, wet productive cough. Treated with ibuprofen 400mg Q4h, acetaminophen 1000mg q6h. Patient showed subjective improvement after 7.5 hours.
I developed tinnitus.  At first it was intermittent, but progressed into a very constant high pitched sound.  It occurs in both ears and sometimes feels like buzzing at the back of my skull.
12 hours after 1st dose (january 16 2021 at Haggens pharmacy, lot # EL3248, pfizer) I got a blood blister in my mouth (cheek) and saw the dr. she documented it and did a platelet blood count (normal) Then after 2nd dose of pfizer (EN6201 lot) I got very sick for 36 hours - low grade fever, chills, severe body aches, pain. not able to leave my bed for 24 hours or go to work for 48 hours.
Per Parents; Fever, pale, limp, not responding and shallow breathing.  Was instructed to call 911.  Parents did not want to wait and drove pt. to Hospital themselves while on the phone with one of our nurses.  Per ER: Uncertain to  the cause of the spell.  Would consider a seizure as a possibility or possibly a fainting type of episode.  X-ray normal.  EKG difficult to interpret due to crying and movement, but rhythm appears normal.  CBC, Urine and Chemistry panel all essentially normal.  Rash developed, red raised bumps.  Pt. also had whelps at injection sites.
Treatment of COVID-19; Treatment of COVID-19; Moderna, Dose: 1-3 / Pfizer, Dose: 4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 49 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16Mar2021 as dose 1, single (Lot number: 040A21A), in left arm, on 13Apr2021 as dose 2, single (Lot number: 016B2VA), in left arm and on 20Nov2021 as dose 3 (booster), single (Lot number: 034F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Graves' disease" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "known allergies: Kiwi" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Sep2022, outcome "unknown", described as "Moderna, Dose: 1-3 / Pfizer, Dose: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received COVID 19 Treatment from 27Jul2023 to 31Jul2023.
In September of 2020 I was diagnosed with partial central retinal vein occlusion. It had gotten better in January, but after taking the vaccine it got much worse. I went to my routine follow up and the doctors discovered that the vein is clotted and blocked. This has caused me to lose vision in my right eye. Since then I have noticed my exercise has greatly decreased. I normally run 8 minutes 30secounds per mile. Now I am struggling to get to 10 minutes a mile. I now have much more fatigue throughout the day.
Symptomatic hypertensin with a bad HA that began about 2 minutes after vaccination.  He had associated dizziness that resolved in about 20 minutes, but BP remained high. NO CP, or SOB, or any Allergic symptoms. BP initially was 190/110, but peaked at 221/152.  HR was in the 80's.   O2 sat was 96-98%.  No medications are available at this site for accelerated  HTN.  BP at transfer to LGH ED was consistently in the range of 180/140. Patient and family insisted on car transport and declined ambulance transfer.
Client noticed this afternoon when showering that his left armpit region was swollen approximately the size of a tennis ball and tender. Client declines any fever, redness, not warm to the touch either.  Client states that he thinks it feels like enlarged lymph node
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 01:00 as dose number unknown (booster), single (Lot number: OH9694), in left arm and on 25Apr2023 at 11:00 as dose number unknown (booster), single (Lot number: GJ3268) at the age of 72 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic Lymphocetic Leukemia" (ongoing), notes: dormant - no treatment at this time; "Penicillin allergy" (unspecified if ongoing); "Sulpha allergy" (unspecified if ongoing); "Immunocomprised" (unspecified if ongoing), notes: Immunocomprised - low IgG. Infusions of IV/IG taken every 5 weeks. IgG in normal range at this time.; "low IgG" (unspecified if ongoing), notes: Immunocomprised - low IgG. Infusions of IV/IG taken every 5 weeks. IgG in normal range at this time. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Blood immunoglobulin G: (unspecified date) Low, notes: low IgG. Infusions of IV/IG taken every 5 weeks. IgG in normal range at this time; (unspecified date) Normal, notes: low IgG. Infusions of IV/IG taken every 5 weeks. IgG in normal range at this time; SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (15Sep2023) Negative, notes: Tested negative on 15Sep2023; (19Sep2023) Positive, notes: Tested positive on 19Sep2023. Therapeutic measures were taken as a result of drug ineffective, covid-19.
3" x 6" swelling raised 3/4" with a red line going from injection site to armpit with a lot of pain and slight fever.
10/29/19: Severe dizziness prevented from getting out of bed at 5:30 am. Could not stand for more than one minute. After drinking some water and about 30-45 minutes rest, I was able to perform some routine activities but head was still very heavy and felt dizzy. I could not work for more than two hours. Came back home and was very tired and slept from 9am to 7pm with getting up in between for lunch and water. I have never slept so much in my life for any reason during the day. 10/30/19: Seen by PCP team member in the am and by then the symptoms were resolved without any medication. That evening, I started having pain in the right knee and right elbow as well as widespread muscle pain in the right side. The pain increased and was severe during the night and could not sleep. I could not move or turn my right knee and right elbow was hurting. Touching certain places was hurting at these sites. 10/31/19: Right knee and right elbow was visibly swollen. Seen by PCP team member around 12.30pm. Advised to take 3 X 200mg Ibuprofen in the morning and night and 1000 mg Tylenol during lunch time and asked to report in 24 hours. The pain continued and no improvement. 11/01/19 ? 11/04/19: Continued medication as advised. No improvement in the swelling. Right arm and elbow symptoms have resolved. Right knee swelling persists with pain. Have been able to bend the leg slightly but cannot apply pressure and climbing stairs is one step at a time.
Developed shingles on 9/5/20, received influenza vaccine 9/3/20
Pt presented to the clinic to receive the Pfizer vaccine, administered at approximately 11am. Pt was moved to observation area for 30 mins. Ten minutes after administration, the patient reported developing difficulty breathing, throat tightening, and wheezing in the lower left lung. One dose of Epi administered at ~11:13am and EMS called. Vitals taken at 11:17am with BP 120/72 bpm, O2 Sat 98%, & lungs clear, however, pt developed full body shaking. Pt AA0 x3. EMS arrived onsite at 11:25am and taken to ED.
Client reported  erythema at the injection site the day following the injection.  In the following days, she reported swelling, redness and tenderness.  She contacted the health department on Friday, 4-28-23, approximately  days after the injection, reporting moderate swelling and tenderness.  The client also reported inflammation reporting that the injection site was "warm to the touch".
Sick to Stomach; head feels like it weighs 50lbs"; Arm Pain; Back Pain; not feeling very well"; swelling/hardness at the Injection site; Fatigue/tiredness; swelling/hardness at the Injection site; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Sick to Stomach), TENSION HEADACHE (head feels like it weighs 50lbs"), PAIN IN EXTREMITY (Arm Pain), BACK PAIN (Back Pain) and MALAISE (not feeling very well") in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure abnormal and Cholesterol total abnormal NOS. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN), ACETYLSALICYLIC ACID (BABY ASPIRIN), HYDRALAZINE and CHORIONIC GONADOTROPHIN (PROVIGIL [CHORIONIC GONADOTROPHIN]) for an unknown indication.   On 24-Feb-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) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (Sick to Stomach), TENSION HEADACHE (head feels like it weighs 50lbs"), PAIN IN EXTREMITY (Arm Pain), BACK PAIN (Back Pain), MALAISE (not feeling very well"), VACCINATION SITE INDURATION (swelling/hardness at the Injection site), FATIGUE (Fatigue/tiredness) and VACCINATION SITE SWELLING (swelling/hardness at the Injection site). At the time of the report, ABDOMINAL DISCOMFORT (Sick to Stomach), TENSION HEADACHE (head feels like it weighs 50lbs"), PAIN IN EXTREMITY (Arm Pain), BACK PAIN (Back Pain), MALAISE (not feeling very well"), VACCINATION SITE INDURATION (swelling/hardness at the Injection site), FATIGUE (Fatigue/tiredness) and VACCINATION SITE SWELLING (swelling/hardness at the Injection site) had not resolved.            Concomitant medications were provided as Blood Pressure Meds and Cholesterol Pill.  No Treatment information provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow up contains no new information.
leg discomfort; Sore arm for 10 days after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm for 10 days after vaccine) and LIMB DISCOMFORT (leg discomfort) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm for 10 days after vaccine) and LIMB DISCOMFORT (leg discomfort). At the time of the report, PAIN IN EXTREMITY (Sore arm for 10 days after vaccine) and LIMB DISCOMFORT (leg discomfort) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       the limb discomfort was reported to be started on an unknown date in Mar2021 No concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow-up received on 07-MAY-2021 contains Significant information include, new event.
Patient experienced redness surrounding injection site. Area was warm to the touch and remained red 4 days after administration. Ice pack has been applied to the area.
Soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in the arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Had COVID-19 virus in the past.).    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the arm). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Soreness in the arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Severe diarrhea developed on day 3 after vaccination and continues through day 5.
Fevers, body aches, severe joint pain, headaches, full body burning hives.
Second vaccine was on 04/15/2021.  Lost my breath and could not breathe for a moment, I went to the ground , almost blacking out.  Paramedics came and my vitals were very high.  I don't know if it was because of the vaccine, but wanted to report it.
Immediate pain upon injection. Severe burning feeling. Left with severe pain in shoulder, back, and spine. Injection site was too high and given at the wrong angle. I was seated while pharmacist administering the injection stood above me. Still experiencing pain.