chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received from the manufacturer for hepatitis A vaccine (+) hepatitis B vaccine (TWINRIX) and has been assigned a manufacturer report number. This was originally reported by a RN concerning a female with a sensitivity to yeast who was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) on an unspecified date. Concomitant therapy on the same day included a second dose of hepatitis A vaccine (+) hepatitis B vaccine (TWINRIX) into the right deltoid and a dose of tetanus toxoid. On the same date, at an unspecified time post immunization the pt developed chest tightness, aches all over her body and fatigue. Additionally, she developed a rash on the arm where the measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) was injected. It was noted that the pt had no adverse experiences following the receipt of the first injection of TWINRIX. The events resolved after seven days. Additional information has been requested.
Red face, rash on chest, shaking hands/arms, chest tightness, muscle fatigue and brain fog began about 15 minutes after injection. Lasted about 4-5 hours. Shaking hands still continues intermittently at 2.5 weeks. While at vaccine clinic, juice and water were given.
I have not gotten a menstrual period since my first COVID-19 vaccine. I have had no menopausal symptoms other than my period stopping.
Twitching of eyes, then began spreading out to other parts of body including arms, legs, abdomen, buttocks everywhere, felt "cranky" and more prominent on awaken in AM. Saw GP, eye doctor, neurologist and endocrinologist for thyroid and calcium studies. No numbness or tingling of extremities.
Cheeks swelled up, skin became splotchy red, little bumps formed on her cheeks, became extremely restless.
Patient received Pneumovax 23 and Shingrix vaccines on 2/1/18.  On 2/3 and 2/4, reported to pharmacist that patient experienced redness, swelling and severe pain in the injection area. On 2/5, patient went to Urgent Care and was given antibiotics as a precaution.
Woke up almost every hour, arm pain began around midnight. 6:45 am lower back pain, general grogginess, not able to lift arm, lump where shot was given. Began having chills and back of knee pain, around 10am, took temperature at 11 and had a low fever of 100.9.  1:30, random shooting pain from injection site to back of shoulder     Tired all day, generally sore, headache from one temple, across the eyes, and to the other temple.
no additional AE'S; improperly Stored; Administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medication were not provided.  The previous temperature excursion of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was reported as 30.28 Fahrenheit degrees (F) for 19 minutes and 34.81 F for 35 minutes. On 31-MAR-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T020616,expiration date 16-MAR-2023, dose was reported as 1 (unit unknown); strength and route were not provided) for prophylaxis (product storage error). Administered dose of vaccine was stored in the temperature of 28.34 F for 1 hour and 2 minutes. No additional adverse event was reported. Data logger was involved.  This is one of several reports received from same reporter; Sender's Comments:  US-009507513-2104USA002463:Original Case : 2104USA002463
Received expired vaccine beyond 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours post puncture) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours post puncture). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 04-Nov-2021, the vial was initially stored in the refrigerator. On 17-Nov-2021 at 10:00, the vial was first punctured. On 17-Nov-2021 at 10:53 until 18-Nov-2021 11:00, the vial was exposed to room temperature range ( 46° to 77°F).   This case was linked to MOD-2021-391046 (Patient Link).
A day after receiving the first injection, I noticed pain in my left armpit area. I thought it was a pulled muscle until someone else mentioned they had armpit pain as well. It lessened greatly after a few weeks, but was still bothering me a little when I got the second injection. After the second injection, it flared up a little bit, but did not hurt as much as after the first. But still, 6 months later, I find myself with occasional, minor pain in my left armpit/upper breast area. After 4 months I called my OBGYN to see what he thought (as I do not have a regular doctor and I understood it to possibly be lymph node related). He sent me to get an ultrasound of the area. The radiologist said she did not see anything unusual, except for maybe one odd looking lymph node. They requested I come back after two months for a second check. I have not returned yet for this second procedure.
Patient became anxious after receiving the dose. He stated he has a hx of anxiety and takes medication.   He said he had taken his medication this am but had not eaten.  He then complained of racing heart, arm tingling, heart palpitations. and became shaky.  BP 180/90 and  HR= 90.  Patient was given water and a protein bar.  He still complained of not feeling well and at that time EMS was alerted.  They arrived within 15min. and took over this patient.
Within 2hrs of administration and MENACTRA pt c/o pain at injection site which radiated to arm. This was followed by bodyache, HA, dizziness chills and nausea. S/S persistent thru the night. 4pm 12/22/09 pt noted only mild nausea and pain @ inj site.
fever (99 degrees/102.6); Heart was racing; hives on chest, throat, arms and inside area of elbows; This case was reported by a consumer via call center representative and described the occurrence of fever in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included paracetamol (Tylenol) unknown for fever.   On 22nd June 2021, the patient received the 1st dose of Shingrix (intramuscular). On 23rd June 2021 03:00, the patient started Tylenol at an unknown dose and frequency. In June 2021, 15 hrs after receiving Shingrix, the patient experienced heart racing and hives. On 22nd June 2021, the patient experienced fever. The patient was treated with benadryl (nos) (Benadryl). The action taken with Tylenol was unknown. On an unknown date, the outcome of the fever, heart racing and hives were recovered/resolved.   It was unknown if the reporter considered the fever, heart racing and hives to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The patient received the 1st dose of Shingrix and 7 hours later developed a fever (99 degree F), she took Tylenol by 3 am and 15 hours later her fever went up to 102.6 degree F, and her heart was racing.  Within 24 hours the fever was gone, but then 24 hours after vaccination, she noticed hives on her chest, throat and arms and on inside area of elbows.  Health care professional suggested Benadryl and the hives went away the next day. The patient was referred to her health care professional. It was unknown if the reporter considered the fever, heart racing and hives to be related to Tylenol. The patient did not want to disclose any more personal information. The reporter did not consent to follow-up.
Arm was sore; Rash on neck, chest, and both arms; arms were red; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), RASH (Rash on neck, chest, and both arms) and VACCINATION SITE ERYTHEMA (arms were red) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore), RASH (Rash on neck, chest, and both arms) and VACCINATION SITE ERYTHEMA (arms were red). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at a dose of 1 dosage form. On 11-Mar-2021, RASH (Rash on neck, chest, and both arms) and VACCINATION SITE ERYTHEMA (arms were red) had resolved. On 12-Mar-2021, PAIN IN EXTREMITY (Arm was sore) had resolved. Not Provided          Concomitant medication information was not reported. Treatment- Ibuprofen Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow up was attached on 05 May 2021 and contains No NewInformation. On 22-Jun-2021: Follow up received on 22-JUN-2021:contains No new information
2/25/21  Afternoon and evening of shot: felt fine 2/26/21  Next morning, pain in right upper arm, spreading throughout the day into right shoulder and down right arm into hands and fingers, and down right side into right hip, knee and foot. By evening it was difficult to use right arm/hand and leg/foot 2/27/21 Pain on movement curtailed usual activities involving movement of right arm and leg, not excruciating but painful enough to cause me to exclaim and stop movement 2/27-3/4/21 no change 3/5/21 notice pain beginning to lessen in foot, knee, hand and elbow, no change in hip, upper arm and shoulder pain 3/6/21 foot, knee, hand and elbow seemed back to normal,  still no change in hip, upper arm and shoulder pain 3/10/21 Upper arm and shoulder still very painful with or without movement. Hip is better, still hurts The worst pain is in two areas that were occasionally mildly painful before the shot: 1) right hip sciata, mild and occasional for several years and 2) right shoulder injured in fall on ice about 3 years ago. The pain in the hip seems worse than it ever was. The pain in the shoulder seems as bad or worse than it did when I fell on it
Awakened by severe cramp medial head of  left biceps femoris which lasted 90 minutes.  Since that time have experienced random cramps all over the body but more frequent in left leg.  Most now last a few seconds to a minute then spontaneously resolve.  Can be triggered by use of a muscle group.  Have been treated with Flexeril and carbamazepine without benefit.  Took a course of prednisone for an asthma flare and no cramps for 5 days.  Also frequent fasciculation of muscles, especially legs.
Swelling and redness under eyes around tear trough dermal fillers noticed about 19 hours after receiving 2nd dose of the vaccine. Taking antihistamines at home, haven?t sought treatment from a provider at this time.
This spontaneous report as received from a physician via Company Representative concerning a 14 year old male patient diabetic and bipolar. On 15-JUL-2011, the patient was vaccinated with the first dose of GARDASIL, intramuscular (dose, lot # and expiration date not reported). On 11-OCT-2011, the patient was vaccinated with the second dose of GARDASIL, intramuscular (dose, lot # and expiration date not reported). On 02-APR-2012, the patient was vaccinated with the third dose of GARDASIL, intramuscular (dose, lot # and expiration date not reported). It was reported that the patient developed increased heart rate after use with GARDASIL. Patient presented in the office on 14-NOV-2013, however, it was unknown if this was the specific start date of the symptoms. Patient's outcome was unknown. Additional information has been requested.
Pt. said approx. 2:30 P 9/25/17 he started feeling ill with dizziness, fever, 102, HA and diarrhea. Everything but diarrhea and slight weakness remained 9/26/17. Pt. said keeping hydrated with fluids but not eating anything. 9/27/17 was when he 1st called. 9/28/17 no answer when called. 9/29/17 9:50 Pt. said he's back to normal.
Information has been received from a patient's mother concerning her daughter (with a twin sister) with coeliac disease who on an unspecified date, at the age of 13 months was vaccinated with a dose of VARIVAX (Merck). Secondary suspect therapy included a dose of MMR II that was given 3 months after the VARIVAX (Merck) (when the patient was 16 months of age). It was reported that the patient was sick for a year after vaccination with "post viral syndrome", "vitaminosis" and vitamin and mineral deficiencies for a year. It was also reported that the patient had kidney and liver problems and low white blood cell counts. It was reported that the patient recovered on an unspecified date. It was reported that the patient's twin sister experienced the same adverse experiences following vaccination (0904USA03169). This is one of several cases from the same source. No further information is available.
hives; itchy blotches; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of URTICARIA (hives) and RASH MACULAR (itchy blotches) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), ASPIRIN [ACETYLSALICYLIC ACID], METOPROLOL SUCCINATE (TOPROL) and CLONAZEPAM for an unknown indication.    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 URTICARIA (hives) and RASH MACULAR (itchy blotches). At the time of the report, URTICARIA (hives) and RASH MACULAR (itchy blotches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.
There was an error placed the vaccine back into the freezer; Vaccines were administered to 60 patients after; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (There was an error placed the vaccine back into the freezer) and EXPIRED PRODUCT ADMINISTERED (Vaccines were administered to 60 patients after) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (There was an error placed the vaccine back into the freezer) and EXPIRED PRODUCT ADMINISTERED (Vaccines were administered to 60 patients after). At the time of the report, PRODUCT STORAGE ERROR (There was an error placed the vaccine back into the freezer) and EXPIRED PRODUCT ADMINISTERED (Vaccines were administered to 60 patients after) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.  Reporter stated that vials were put back in the freezer after they were already thawed and they were kept frozen between 32 and 34 degrees Fahrenheit and the Vials were taken out of the freezer on the same day doses were administered which was between 27-Sep-2021 and 01-Oct-2021.   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Product storage conditions were updated.
Pt recvd Td vax & exp prolonged mid-deltoid tenderness, which persisted to 3AUG92; dx myonecrosis due to Td inject;
Within 15-minutes of vaccination, the patient complained of nausea and lightheadedness.
On 6 November 2012 at approximately 1010 hrs, 27 year old female was vaccinated with Afluria flu vaccine to left deltoid (off site location). At 1015 patient experienced a possible anaphylactic reaction to the Afluria vaccine and needed emergency medical care.  Approximately 5 minutes after being vaccinated pt presented with lethargy, drowsiness, low voice and having difficulty keeping eyes open. Pt was ambulatory with unsteady gait and oriented. EMS contacted. Pt continued to become more lethargic and was placed in a supine position with knee bent.  At 1015 hrs EpiPen 0.3 mg was administered to left thigh. Pt began to shiver after EpiPen given and was covered.  At approximately 1032 hrs the patient became unresponsive and CPR was initiated and the patient cough, resumed breathing and regained consciousness right away and was place in recovery position. At approximately 1045 hrs the ambulance arrived, IVF started and medication administered by ambulance doctor and EMS transported the patient to the Hospital.
Dizzy after 5 min vaccine.  Eyes rolled back few sec.   Father shook him.  Took 5 sec. to respond.  Drinking water said it helps.  Didn't eat breakfast father said.  Paramedics took him to Hospital.
COVID-19; COVID-19; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Apr2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Known allergies to opioid pain medication" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (10Sep2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Sep2022) Negative. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included nirmatrelvir/ ritonavir (PAXLOVID) from 06Sep2022 to 10Sep2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Painful at injection and aching pain has continued down my whole arm since then.  Very painful and wakes me up at night.  Reduction in mobility in that arm.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EM9809), in left arm, on 27Feb2021 as dose 2, single (Lot number: EN6205), in left arm and on 28Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Penicillin, reaction(s): "known allergies", notes: known allergies: penicillin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Anti-viral Product Paxlovid from 24Dec2022 till 28Dec2022 for treatment of COVID-19.
9 days after receiving the tetanus vaccine, I woke with severe pain, intermittent numbness and tingling (L) arm shoulder to fingertips. Now less pain, but still present.
ON 8/14/21 he was seen by the RN c/o  hives and stated that his throat felt like it was closing during the night.  Pt was noted to have hives to anterior and posterior trunk, neck, and face.  No difficulty breathing noted.  Pt was treated with benadryl 50mg IM.  and scheduled for provider follow up.  On 8/16/2021 Pt was seen by NP and stated he was feeling better.  He was noted to have hives to bilateral thighs and hives with swelling to palms of both hands.  Pt was given Adrenain 1 mg IM and prednisone 10mg one tab every morning for 5 days.  On 8/18/2021  Pt seen by NP.  He reported he felt better, all hives were gone.
Patient's right arm (the one that received the FLUZONE HD) and shoulder became very sore later the day of the shot. She has continued to hurt and has had less mobility in that arm since receiving the vaccination. She has visited chiropractor for the pain.
initially extreme headache and stomach indegestion. Pain in pancrease and liver. Fast forward six moths and a cyst has been identified on my pancrease and blood clots in veins of my liver.
worse pain in the vaccination site and pain had abated; A hard itchy lump at the vaccinationsite.; A hard itchy lump at the vaccinationsite.; This is a spontaneous report from a contactable consumer (Patient). This is the first of two reports. A 41-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: en6206), dose 2 via an unspecified route of administration, administered in Arm Left on 03Apr2021 at 12:00 (age at vaccination: 41 years) as dose 2, single for covid-19 immunization. Medical history included shellfish allergy and sulfonamide allergy (reported as sulfa). Concomitant medications included AMOXICILLIN. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8733) via an unspecified route of administration in the left arm on 06Mar2021 at 11:00 (at the age of 41-years-old) as a single dose for COVID-19 immunization and experienced vaccination site pain. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient experienced worse pain in the vaccination site and pain had abated, the patient somewhat felt a hard itchy lump at the vaccination site on 03Apr2021. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The outcome of the events were not recovered.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021382052 similar report from same reporter