chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 12 hours of receiving the vaccine, I was nauseous, had a sore throat, and a headache. The nausea was like I had experienced when I had food poisoning and lasted 5 days. On day 3, a Monday, I reached out to my PCP via patient portal and he called me in a prescription for Zofran. The headache lasted approximately a month but was manageable with Excedrin. My October period came a day early but was heavier than I've ever experienced and did not taper off like a normal cycle. It lasted 3 days longer than normal. In October, I began experiencing migraines, which I've never had before in my life. I tried rotating Excedrin with ibuprofen but would eventually take pain medication left over from a surgery I'd had before the pain would subside. In November, my period was 6 days early, as heavy as the one in October, also did not taper off, and lasted longer than normal. I was experiencing cramping for the first time, starting the week before my period would start, and would not subside until I started. It would start suddenly and be debilitating until I took ibuprofen just so I could sit in an upright position. The migraines continued regularly, some lasting as long as 5 days. I reached out to my PCP again and he increased my Topamax dose and wrote me a script for Imitrex. Last month I was able to notice a direct correlation between the migraines and when my period started, the migraine started several days before my period and ended about halfway through.  January was also the first period I've had that was not extremely heavy and did not last 8 days. It did come 3 days early. I started one day early this month and woke up about 6 hours before with a migraine and had one for the first 3 days of my cycle, which has also seemed to return to normal flow. It seems my hormones are returning back to normal and the migraines are more predictable.
I have received a seasonal flu shot every year for the last 20 years with almost no symptoms ever. This is the first year I have had three days of moderate body aches. No fever after 24 hours, 99.0 Fahrenheit. Whole body felt puffy bloated. General muscular discomfort whole body. Joint pain. I went for a walk at 1 PM approximately 24 hours after the injection. During the walk I pulled a muscle in my low back whole body felt achy.  I took some ibuprofen and felt some relief. The moderate body aches, joint pain, muscle aches, weakness and tiredness continued for four days.  I finally started to feel good on Thursday the fifth day.
Pain at injection site, muscular aches, fatigue, headache, fogginess, rosacea outbreak,
Diagnosed with shingles rash 9-24-13. Treated with FAMVIR, VALTREX and prednisone.
Light headedness, difficulty focusing, headache, tired Got a cold on 2nd day - didn?t have before vaccination.
LEG PAIN; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the subject experienced leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg pain on 28-APR-2021. This report was non-serious.
Within 12 hours had slight fever on and off, about 101 degrees for 3 days. Did not give medication just used cold compresses. On 2nd day vax site had purple red mark (as big as 50 cent piece). There were 3 blisters within this area. Mom knows it was bothering patient because he tried to scratch it so had to use a cold pack. Area stayed inflamed for about 1 month. Used calamine lotion and tea tree oil. Looked like an open wound for about 1 month. Mark started to fade after 1 1/2 months. A slight bruise still is visible (size of a quarter).
Herpes zoster developed on day 8, and resolved prior to dose 2, with generic Valtrex medication.
This is a spontaneous report from a contactable consumer (patient's spouse). A 50-year-old male patient received second dose bnt162b2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 17Apr2021 12:45 (Batch/Lot Number: ER8727) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were none. No Prior Vaccinations (within 4 weeks). No AE following prior vaccinations
Patient called health clinic to report: 1hour following Pfizer vaccine full body pruritis that resolved without intervetion within 30minutes (no rash or skin irritation).  7 hours following vaccine headache (back of head) started- unrelieved with tylenol-headache lasted through night and into the next day and then slowly diminshed (history of migraines).  Next morning, 2 emesis with left low back pain developing later in day.  Pfizer vaccine administered to left deltiod- Patient reports she experienced bilateral 4th finger (pinky finger) tinging that lasted less than a couple hours.   Approximately 24hours after vaccine Patient reports  losing strength to right hand and right hand contracted (right hand dominant).  No MD visit as of last communication with Patient.
Joint aches leading to joint and muscle pain, muscle weakness. Symptoms worsened then dissipated over past 9 days.
Lrg amt. vesicles to Lt axilla & thorax - cellulitis Lt axilla-chest.  Chest pain-neg cardiac involvement after workup.  Lt arm vaccine site.
About 5 minutes after administration the patient experienced a syncope episode. I laid her on the floor, called 911. She was breathing normally and had good color with no signs of anaphylaxis. Her Dad told me waiting for the ambulance she passed out before when she gets nervous. The paramedics came and checked her out. She did not go to the hospital. She walked out of the pharmacy felling good. I called her Dad Friday evening and he said she was good. I also called Dad Sunday 9/5/2021 to check again and he said she was good
The day I received the shot, my arm got warm and sore.  The soreness traveled to my shoulder and neck.  I got headachey, alternating between hot and cold chills, a little bit of nausea and extreme tiredness.   This continued for the next 5 days which seemed like they were considered mild reactions according to the CDC website.  Most concerning though, is on day 5, (3/14/21) in the evening as I was getting into bed, I started getting a red, extremely itchy rash on both my arms, my lower back and my upper legs, to the point that I could not sleep because it was so itchy and had to take Benedryl.  I have not changed anything in my diet or in the products I use on my body, so I can only attribute this reaction to this vaccine.  I am still a little itchy on my arms today 3/15/21.   I am also still getting the hot and cold chills and still have a little bit of nausea, not bad, but enough to be "off" certain foods.
A third (booster) dose of BNT162b2 was administered; Off label use; Fever; Headache; This is a spontaneous report from a contactable consumer. A female patient of unknown age received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. On an unknown date, the patient experienced fever and headache. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events fever and headache was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
pt recv vax 13MAY97 On 14MAY97 fever gradually rose from 102 to 106;pt became more lethargic & diarrhea & later vomiting;no wet diaper for 12hr;required IV fluids in ER for dehydration;
One week to day, January 28 , 2021, woke up with itching and huge swollen area on left arm  at injection area, area red and feverish. Health dep closed that day. Called them next morning, told to me call my primary care doctor. Went to doctor that day, told allergic reaction, put on 800 mg Motrin  every 8 hours plus a Zyrtec for pain and swelling.  Knot started going down, turning to fluid filling entire arm, into left breast. And under arm   Into back area.
Immediately after vaccination started crying, sweating and not communicating well.  Complained of headaches.  Symptoms continued for 30 minutes until transported to ED.
Fluzone High Dose was accidentally administered to a patient 37 years old with no reported adverse event; Fluzone High Dose was accidentally administered to a 29 weeks pregnant with no reported adverse event; Initial information received on 20-Sep-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professionl.  This case involves a 37 years old female patient and 29 weeks pregnant who was accidentally exposed to vaccine influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] with no reported adverse event.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The reported Fluzone High Dose was accidentally administered to a patient 37 years old and was accidentally administered to a 29 weeks pregnant with no reported adverse event occurred at 29 Weeks of pregnancy  The date of last menstrual period was not reported.  The estimated due date was not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect Influenza Quadrival A-B High Dose HV Vaccine formulation, strength, expiry date, dose, lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunization) and fluzone high dose was accidentally administered to a patient 37 years old with no reported adverse event (product administered to patient of inappropriate age) and fluzone high dose was accidentally administered to a 29 weeks pregnant with no reported adverse event (exposure during pregnancy) on the same day.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the events.  Additionally, at time of reporting, the outcome of the pregnancy is unknown   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.
Yellow discoloration at area of injection; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE DISCOLOURATION (Yellow discoloration at area of injection) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 021B21A-1) for COVID-19 vaccination.     No Medical History information was reported.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jun-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Yellow discoloration at area of injection). At the time of the report, VACCINATION SITE DISCOLOURATION (Yellow discoloration at area of injection) had resolved.            No concomitant medications were reported.  The patient stated that he has not used anything to alleviate the symptom neither has he called his healthcare provider.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Patient date of birth, height, ethnic group, dose details, event onset and outcome was updated.
Patient presented with blisters on site of vaccination and rash and painful.  Treated with antibiotics today in clinic  07/22/19.
first dose in 2018, never received the 2nd.; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix in 2018 (did not have exact date)).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter would like to know if shingrix series need to be restarted. The patient had consented to follow up.
Arm soreness; Achiness; Joint pain; Muscle pain; Fever; Headache; Chills; Achiness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), the first episode of PAIN (Achiness), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain) and PYREXIA (Fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness), the first episode of PAIN (Achiness), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), PYREXIA (Fever), HEADACHE (Headache), CHILLS (Chills) and the second episode of PAIN (Achiness). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm soreness), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), PYREXIA (Fever), HEADACHE (Headache), CHILLS (Chills) and the last episode of PAIN (Achiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Dizziness.  Moved to a litter to lay down. BP 120/76, HR 68.  Drank water and felt better.  Observed for 30 minutes and released.
Fully vaccinated and tested positive for COVID; Fully vaccinated and tested positive for COVID/Congestion, headache, low grade fever for one day; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Feb2021, as single dose(Lot Number: EL3247) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Mar2021, as single dose (Lot Number: EL3247) for covid-19 immunisation. Medical history included RA(rheumatoid arthritis). Concomitant medications included abatacept (ORENCIA), methotrexate and folic acid taken for RA. The patient experienced fully vaccinated and tested positive for covid on an unspecified date in 2021. The patient had congestion, headache and low grade fever for one day. The outcome of all events was unknown.  Follow-up attempts are completed. No further information is expected.
pt recv vax 3JUN97 & that same day pt exp fever (reportedly 102-103), nausea & vomiting;
Temperature peaked to 101 about 19 hours later. By 48 hours there were no symptoms.; Headache within a hour.; Dose 3 administered; This is a spontaneous report from a contactable consumer. A male patient of age 41-year-old received third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 14Oct2021 at 08:45 (at the age of 41-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received influenza vaccine (MANUFACTURER UNKNOWN) via an unspecified route of administration on 28Sep2021 for immunization within 4 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration on 13Jan2021(at the age of 40-year-old) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration on 02Feb2021 (at the age of 41-year-old); both as a single dose for COVID-19 immunisation. On 14Oct2021 at 09:30, the patient experienced headache within an hour and temperature peaked to 101 (units unspecified) about 19 hours later. By 48 hours there were no symptoms. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of headache within an hour and temperature peaked to 101 was resolved on an unknown date in Oct2021.
herpes zoster; Information has been received from a lawyer concerning a case in litigation and refers to a patient of an unknown age and gender. No information regarding the pt's medical history, concurrent conditions and concomitant medications was reported. On or about 16-JAN-2012, the pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route, vaccination site, lot # and expiry date were not specified) for the long-term prevention of shingles and zoster-related conditions, as prescribed and/or administered by a pharmacist. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider for herpes zoster. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt has and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The causality was related.
severe chest pain and tachycardia following the shot. er visit resulted in iv fluid treatment, blood tests, chest x-ray and ct scan. hospital visit was over 6 hours and was released by the doctor stating that they have seen this recently after the second booster shot.
Information has been received from the registered nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who on 11-DEC-2012 had administered dose of GARDASIL (lot # 670048/0963AA expiration date 09-NOV-2013) that was exposed to temperature of 11 Celsius degree. No adverse effects were reported. This is one of the report from the same source. Additional information is not expected.
Previous to getting the vaccine I would only occationally have an irregular heartbeat (once or twice a month, but after 4 days of getting the vaccine I was getting the heartbeat irregularity more often (every day).
Inflammation, swelling, hardness, blistering, pain, itching. Treated with 1 tsp ZYRTEC Children's oral solution 6/30/2018. 7:00 a.m swelling and inflammation had decreased, but had multiple large blisters.
sore in the arm after the second dose; received only the adjuvant of Shingrix; received only the adjuvant of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 453S4, expiry date 19th March 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 2nd August 2019).   On 31st January 2020, the patient received the 2nd dose of Shingrix. On 31st January 2020, unknown after receiving Shingrix, the patient experienced inappropriate reconstitution technique and inappropriate dose of vaccine administered. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm, inappropriate reconstitution technique and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information received were as follows: A couple was administered with the 2nd dose of Shingrix but one of them received only the adjuvant of Shingrix, which led to inappropriate reconstitution technique and inappropriate dose of vaccine administered. The patient experienced sore in the arm after the 2nd dose of Shingrix. The reporter said that the male patient experienced more sore in the arm than the female patient. This case has been linked to US2020019077 reported by the same reporter. The reporter consented to follow up.
C/O (L) arm and shoulder extremely painful day of shot. Can't lift it straight up. Pain in joint and shoulder blade. Now whole arm hurts and (L) shoulder.