chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site of vaccination is red and it has a rash; Site of vaccination is red and it has a rash; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246), via an unspecified route of administration on 13Jan2021 at a single dose for an COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the COVID vaccination and had several different reactions to it. The patient stated that the one thing that was bothering the most was that the site of vaccination was red and it had a rash. The patient needed to know if there is anything to put on it to keep it from itching. The outcome of the events was unknown.
This spontaneous report was received from a medical assistant regarding multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of VAQTA (dose and route were not reported, lot # K018181, expiration date 04-JUN-2017). There were no adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
severe muscle aches all over body, headaches/migraines, nausea, chills, fever
pt recv vax 24APR97 upper arm became hot, erythematous & swollen from just above elbow to shoulder;pt reported also had charley horse in fingers, wrist, forearm to elbow from 24APR97 to 27APR97;pt seen 28APR97 lt arm edema/erythema dec;
At approximately at around 11:30 pm I went to get out of bed to use restroom. Bed is 3 feet off the floor, high. My feet hit the floor, next thing I am on the floor falling into my daughter's closet. I tried to get up, but too weak. I reached up to the bed rail and was too weak to pull myself up onto the mattress. I fell back to floor and tried two more times. The next thing I awoke and tried to pull myself up again to no avail. Third time I fell to the foot of the bed to the floor unable to get up. A while later I again awoke and crawled to the other side of the bed really weak all the time the room was spinning. It was light outside from my bedroom window. I somehow pulled myself up onto the mattress, still feeling weak and dizzy. The mattress was wet with urine and my clothing was soaked. I had lost urine I guess getting out of bed. Sometime later I managed to get out of bed to use the restroom, still weak, dizzy and loss of balance, running into the walls. My daughter came into my room and I explained what happened. I lay in bed for most of the morning like in a fog. Later getting up to eat but was too nauseated which lasted three more days. The second day I was still not waling correctly. I routinely get up at night every two hours to void,I estimated I laid on the floor about 4 to 6 hours. I was too embarrassed to call for help. The next day I called the FDA 1-800 number and they gave me your web page. I have had flu vaccines since 1980s and never had any reactions. I did not call 911.
Nausea; Chills; Cramps in intestines; Vomiting; Temperature of 99.4; muscle spasms; Headache; Felt lethargic; Felt tired; Dark urine like motor oil gold; like having a bad flu.; A spontaneous report  was received from a Consumer concerning a 70-years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Muscle spasms, Abdominal pain, Vomiting, Chills, Headache, Lethargy, Fatigue, Pyrexia, Chromaturia, Influenza like illness and Nausea. Patient went to bed and his muscles involuntary contracted and curled himself in a fetal ball  The patient's medical history was not provided.  Relevant concomitant medications were not reported.   On 17-FEB-2021, approximately 2 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 024M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 18-FEB-2021, the patient experienced Muscle spasms, Abdominal pain, Vomiting, Chills, Headache, Lethargy, Fatigue, Pyrexia, Chromaturia, Influenza like illness and Nausea. Patient went to bed and his muscles involuntary contracted and curled himself in a fetal ball.  His wife took him to the ER at Hospital on the 18-FEB-2021 in the afternoon but patient decided that he would rather go home.  The patients temperature was 99.4.  Treatment information was provided as Tylenol for headache and Something for nausea and to relax muscles at the hospital.  Action taken with mRNA-1273 in response to the events was not reported.   On 18-FEB-2021, the outcome of the event's Muscle spasms, Abdominal pain, Vomiting, Chills, Headache, Lethargy, Fatigue, Pyrexia, Chromaturia, Influenza like illness and Nausea was considered as unknown.  At the time of this report, the outcome of the event's Muscle spasms, Abdominal pain, Vomiting, Chills, Headache, Lethargy, Fatigue, Pyrexia, Chromaturia, Influenza like illness and Nausea was considered as unknown.; 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.  Further information has been requested.
Awoke with fever 102.7 morning after IZ's given (6-9-15). Fever persisted through 6-10-15. Patient awoke with itchy scattered macular papular rash on bilat. ankles, spread upwards to lets, posterior thighs and few on trunk on 6-10-15.
No adverse reaction reported. In November 2022 our Immunization program did our every-other-year audits in Both our offices. It was discovered at that time, that some covid vaccines were administered outside of the 10 week expiration date (which is calculated from the date the vaccines were received from the state.)
Started with headache and  muscle aches at night. Woke up with love grade temperature, fatigue, chills, muscle aches,nausea. Temperature was normal by 9:00 AM. Other symptoms improved but still remained
Moderna vaccine to a 17 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine to a 17 year old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine to a 17 year old). On 15-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine to a 17 year old) 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.   No relevant concomitant medication was reported.  Treatment details include, none.
Patient received Jansen and Jansen at a local pharmacy in April.  Patient then received first dose of covid pfizer in the beginning of October.  Patient presented to the clinic and received the 2nd pfizer injection 3 weeks after his first injection as instructed.  Upon documenting I asked Clinic Admin what number I should list the vaccine given as in the series, and was informed that patient should not have been given the second dose of pfizer.
Information has been received from a nurse in a physician's office concerning a 5 yr old female who on 26Nov01 was vaccinated in another country with varicella virus vaccine live. Subsequently, the pt developed chickenpox. Unspecified medical attention was sought. As of 11May05, she was recovering. No product quality complaint was involved. The nurse also reported that the pt's three other siblings also developed chickenpox (WAES0505USA01835, 0505USA01836, 0505USA01837). Additional information has been requested.
Dizziness occurred within the first hour after injection and lasted about 2-3 hours. About 7 hours after injection, I developed a headache. Overnight, I had a hot flash. When I woke up the following morning, about 19 hours after injection, I had a fever. I went to work and developed chills and sweats (about 21-22 hours after injection) that lasted for at least 5 hours. I also had nausea at that time. I did take 1,000 mg of acetaminophen after checking my temperature that morning and again in the afternoon. I went home early from work, around 3 pm (about 30-31 hours after injection) and went to bed. I slept for 13 hours and when I awoke the following morning, I had a minor headache and some malaise, but it was much improved. I took 1,000 mg of Tylenol and felt better in the afternoon (about 53 hours after injection).
pt recvd vax & exp a fever of 104 & was lethargic (no other pertussis vax given to pt since that time. pt now age 5);
Dizzy; This is a spontaneous report from a contactable consumer, the patient. This 89-year-old female consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1 , single dose via unknown route of administration in the left arm on 25Jan2021 at 13:00 (at the age of 89 years-old)  for COVID-19 vaccination. Medical history included chronic obstructive pulmonary disease (COPD) diagnosed in 2016 and she never smoked in her life, it was second hand smoke, congestive heart failure diagnosed in 2015 and is hard of hearing several years back, she has had hearing aids for a long time, but they don't do any good. Concomitant medications included an unspecified flu shot. She was dizzy the night of 25Jan2021 and all day on 26Jan2021. The clinical outcome of dizzy was unknown.   Information about lot/batch number has been requested.
break out in hives especially on his lower back; his skin became red and scratchy; itchiness; itchy sensation on his genitalia and all over his body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (break out in hives especially on his lower back), ERYTHEMA (his skin became red and scratchy), PRURITUS (itchiness) and PRURITUS GENITAL (itchy sensation on his genitalia and all over his body) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030h21b, 047c21a and 014c21a) for COVID-19 vaccination.     Concomitant products included METOPROLOL for an unknown indication.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced URTICARIA (break out in hives especially on his lower back), ERYTHEMA (his skin became red and scratchy), PRURITUS (itchiness) and PRURITUS GENITAL (itchy sensation on his genitalia and all over his body). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, URTICARIA (break out in hives especially on his lower back), ERYTHEMA (his skin became red and scratchy), PRURITUS (itchiness) and PRURITUS GENITAL (itchy sensation on his genitalia and all over his body) outcome was unknown.            The patient experienced symptoms after 10-11 days following booster dose. The patient started experienced break out in hives especially on his lower back, his skin became red and scratchy, itchiness itchy sensation on his genitalia and all over his body. No medical history was provided by the reporter.   This case was linked to MOD-2022-439116 (Patient Link).
PFIZER COVID VACCINE #3 GIVEN 10/19/2021, LOT #320308D; pt to ED via EMS from SNF; pt experienced cardiac arrest at SNF; CPR started; ROSC achieved; coded again in ambulance; intubated with mechanical ventilation in ED; unresponsive; hypotensive, given levophed; found to be positive for COVID; A Fib with RVR, treated with medication; UTI; leukocytosis, lactic acidemia; ICU; family stated pt was DNR; transitioned to comfort measures and she passed away in the hospital
Swollen left arm with marked edema and requirement of opening arm surgically. 1/10/08-ER records received for DOS 11/17/07-DX: left arm cellulitis. Started with fever night before, arm at injection site painful and difficult to move. Blood culture no growth. 3/17/08-records received for DOS 11/17-11/23/07-DC DX: Cellulitis of upper arm and forearm. Upper extremity infection following vaccination as an outpatient. Onychomycosis of nail and foot. Presented to ED with swelling and pain of arm. Swelling continued to increase area dusky in color. Rash medial to injection site. Exploratory surgery of the site, incision and drainage.
17 year old female patient was inadvertently administered FLUBLOK QUADRIVALENT, no AE; Initial information received on 21-Dec-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 17 year old female patient who inadvertently vaccinated with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).   Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   Patient did not received other vaccines.  It was a case of actual medication error due to product administered to patient of inappropriate age (latency on same day).  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
Administered a Dose of Heplisav-B to 15 Year-Old; Initial Report Received on 30-Mar-2022  A registered nurse in the reported that a 15 year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 28-Mar-2022, a nurse administered to  the 15 year-old patient a dose of HEPLISAV-B (Lot # 93584, expiration date 13-Jan-2023 and NDC # not reported) in the left deltoid   At the time of the report, the nurse reported that the patient had not reported any adverse reactions.  No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
inch to an inch and a half wide red spot on the injection site. Red and hot to the touch per patient. Recommened the patient go to the doctor to check for cellulitis. The patient went in today and after seen they told her it was a normal adverse reaction from the vaccine.
Less than 24 hrs after vaccine I began to have daily headaches (I rarely if ever have headaches), sometimes 3 a day (lasting 4+ weeks) followed by intermittent headaches about every other day this past week.  Within 3 days from vaccine came dizziness, tiredness, racing heart with even slight movement (and many times when just sitting or laying down to sleep) and shortness of breath throughout the day...every day.  Primary physician felt it was a direct result of vaccine and I was sent for stat CAT scan to check for blood clot (nothing) and referred to cardiologist (never had heart problems before).  Now wearing heart monitor for a week w/scheduled ECHO this coming Monday to check for damage.  Today marks the 5th week since vaccine and symptoms seem to we lessening, tho I still have racing heart and shortness of breath w/slightest daily activity, headaches, and dizziness.
Itching in the palms of both hands and in the face.  Then redness and tightness of the face began.
Patient is a male 2 years who presents with hx rash at vaccine site. Had flu shot on Sunday 11/10. Mom noticed rash on Monday. No hx egg allergy. Not itching or bothering patient. Also had URI sxs starting Sunday into Monday. No fever. Mild cough and congestion. Sleeping and eating well. Otherwise well appearing. Scant rash on cheeks, no other rash on body. Rash is small pink bumps all over top of thigh. No redness or swelling noted. Cannot see injection site.
This case was reported by a physician via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter is the dentist, he stated that his friend's wife (the patient) experienced sore arm for several days and then she recovered. This case has been linked with case US2018163110, US2018163111 and US2018163104 reported by the same reporter.
Was given celecoxib about 2 weeks ago. Pain has not experienced more pain. Pt feels sharp pain when arm is moved. Will be taking celecoxib for about a month, then will be seen by MD.
Nausea/Vomiting. States nausea and Headache severe enough to report after vaccination. Resoled at this time.
(R) shoulder pain w/radiation to neck posteriorly and along collar bone. Pain, swelling, and erythema at injection site; pain worse with movement; injection site below deltoid muscle.
Low grade fever; Body aches; Headache; Chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 40 year-old female patient received bnt162b2 (COMIRNATY), administration date 18Dec2020 (Lot number: EJ1685, Expiration Date: Mar2021) at the age of 39 years as dose 1, single and administration date 07Jan2021 (Lot number: EL3248, Expiration Date: Apr2021) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Addison's disease" (unspecified if ongoing). Concomitant medication(s) included: HYDROCORTISONE taken for addison's disease (ongoing); FLUDROCORTISONE taken for addison's disease (ongoing). The following information was reported: PYREXIA (non-serious) with onset 19Dec2020, outcome "recovered" (09Jan2021), described as "Low grade fever"; PAIN (non-serious) with onset 19Dec2020, outcome "recovered" (09Jan2021), described as "Body aches"; HEADACHE (non-serious) with onset 19Dec2020, outcome "recovered" (09Jan2021), described as "Headache"; CHILLS (non-serious) with onset 19Dec2020, outcome "recovered" (09Jan2021), described as "Chills".  Additional information: After first dose patient experienced body aches, headache, chills and low grade fever from 19Dec2020 to 20Dec2020. After second dose patient experienced body aches, headache, chills and low grade fever from 08Jan2021 to 09Jan2021. Patient states that she is considered a healthcare professional since she is a registered dietician at a hospital, populated caller as consumer since she does not fit criteria for HCP. Patients other two vaccines she had the normal side effects like body aches, headache, chills and low grade fever. Everything went away in 24 hours, and it was no biggie. She thought that she just had a strong immune system. Her first dose was 18Dec2020 and the side effects started 19Dec2020 and ended 20Dec2020. She had her 2nd dose on 07Jan2021, and the side effects started on 08Jan2021 and then they were gone on 09Jan021. She had her first two at her work and then her third dose she got it at a local grocery store chain.  No follow-up attempts are possible. No further information is expected.
-raised red, itchy rash from neck to about hips  (whole torso)  -took benadryl 25 mg the night of reaction(2/7/21) and next morning -took claritin today (2/8/21)
Immunizations administered 06-13-08, seizure-like activity 06-16-08. 6/27/08-records received for DOS 6/16/08-Presented to ED withC/O seizure, had two episodes one week apart with tonic clonic movements of upper and lower extremities, rolling back of eyeballs, stiffening of extremities.
Intermittent episodes of widespread body aches and weakness, fatigue, and decreased mental clarity. Episodes lasting from 3-7 days with a few days to a week of improvement before experiencing symptoms again. Patient did not experience these S/S before the vaccine.
Just a sore arm in are of injection but was very mild; This is a spontaneous report received from a contactable consumer (patient). A 74-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9262, Expiration Date: unknown), via an unspecified route of administration, administered in left arm on 28Jan2021 at 13:45 pm (age at vaccination was 74 years) as a 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications the patient received within 2 weeks of vaccination included gabapentin and furosemide (LASIX). On 29Jan2021, the patient experienced just a sore arm in are of injection but was very mild. The facility where the most recent COVID-19 vaccine was administered was Doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The event was reported as non-serious. The outcome of the event was recovering.  No follow up attempts are possible. No further information is expected.
My symptoms started the day after I got the Moderna Booster shot. I woke up at 11:00 a.m. and I had been running a fever overnight so I was sweaty. But I also woke up with a bad headache and felt lightheaded and dizzy for most of the day!!!  The only thing I took for it was a couple Advil.  But it only lasted one day!!  So on Saturday I felt better!  It that was it!!
Pain with lifting and moving left arm, not alleviated with TYLENOL. Pain radiates to chest and neck. Pain is described as a burning feeling and unbearable. And skin is sensitive to touch.
Extreme stiffness in neck and jaw resulting in chronic pain of jaw and neck X 1.5 yrs. Have tried all typical treatments for TmJ with no success
Pt. rec'd 12 mo immunizations in office at 12 mo WCE 3/07/16. Woke with rash/hives to abd. AM 3/23/16. Fussy NOC at low-grade temp (99 degrees) hives spread during day seen in office in PM. Dx with rash-rxn to MMR given 16 days before no tx given.
INJECTION SITE WAS RED AND SWOLLEN, ABOUT THE SIZE OF A SOFTBALL, AND PAINFUL
Client came in and stated that he had a red blistery rash covering most of his body except his face and neck. Worst were the blisters on the bottom of his feet. He had to be on 12 days of prednisone. The rash starting disappearing quickly after he started taking prednisone. However, they returned as soon as he stopped. Last lesions were 2 spots on his left arm around Thanksgiving. Client is free from rash and only has a few fading spots. He stated they were not painful or itchy.
Headache a few hours after  injection and now it is 01/01/2021 and I still have a headache. Some nausea and overall generally feeling run-down and  unwell. Also bad pain in my arm  from site of injection.
Itchiness, redness swelling at injection site.  Dizziness and fatigue.