chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle pain/local injection site pain; This case was reported by a nurse via call center representative and described the occurrence of injection site muscle pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood cholesterol increased. Concomitant products included pravastatin sodium (Pravachol).   On 9th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was recovered/resolved.   It was unknown if the reporter considered the injection site muscle pain to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient herself. The patient received a dose of Shingrix in left deltoid via intramuscular route. She stated that she had some local injection site pain along with the left deltoid muscle pain which persisted for about 10 days. The reporter consented to follow up.
Systemic: expired vaccine-Mild, Additional Details: Pfizer vaccination expiration is 9/30 and patient received dose on 10/2/2022
Shortness of breath, wheezing were the symptoms. They prescribed me prednisone and gave me a pump.  This was on February 14, 2021 around 10:00 a.m.
Approximately 6:30 AM on 2/6/06 the vaccinee developed pain in right arm and observed 6 lesions in a circular pattern at the vaccination site. Later that day, the area within the circle became red and the surrounding area became swollen. She has also had a headache that has not stopped since the day of the vaccinations. On 2/8/06 she developed fever, and pain in her back, knees and ankles. She took Aleve to relieve the pain.
Headache, wet himself at 12:30 about an hour after getting vaccine looked at by fire department at 12:45 was fine to go home by 1. Cab came at 1:15 p.
pt recv vax 11AM&5PM that evening began crying;mom unable to comfort the pt&pt cried self to sleep;awoke p/4hr&again cried to point of exhaustion again;called MD told to give APAP;pt irritable&crying for 1wk;poss colic
Her menses were normal prior to vaccines regular not heavy 28 day cycles. After second covid vaccine her cycles shortened to 21 days they were also  abnormally extremely heavy with clots.
Both feet swelled up after 1st and 2nd shot. Doctor had blood tests done, electro cardio gram, ultrasound of legs and feet. All tests ok. Swelling starting to go down each week,but very slow. Feet are painful to walk on.
This spontaneous report as received from a registered nurse refers to a 14 month old female patient. Concurrent conditions, pertinent medical history, drug reactions or allergies were not reported. On 15-APR-2015 the patient was vaccinated on unspecified dose of (Merck) PROQUAD 0.5 ml, subcutaneous, lot #K020753, expiration date 30-APR-2016, (anatomical location and dose number were unspecified). Concomitant therapies were not reported. On 29-APR-2015, patient developed pyrexia and rash, with "too many lesions to count". The patient's mother sought medical attention by calling the reporter's office. No treatment was given for the adverse events. The outcome of pyrexia and rash was reported as not recovered. The relatedness between the events and (Merck) PROQUAD was not reported. Additional information has been requested.
Redness and swelling on (L) deltoid area, some pain 8 3/4 cm x 7 1/2 cm redness...
After my vaccine I had a rapid heartbeat that lasted about 5-6 days.  The physician prescribed me betablocker and a EKG  After a few days everything stopped and went back to normal. I also had all the other normal side effects.
This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patient was vaccinated intramuscularly with a dose of GARDASIL injection (dose, lot# and expiry date were not reported). There were no concomitant therapies reported. On an unknown date, the patient developed an unspecified rash, described as hives, in an unspecified location. The outcome of the event was not reported. The relatedness between GARDASIL and the event was not provided. Additional information has been requested.
50 cent size red spot the first day then baseball size redness the next day still warm to touch
Pt had 2nd COVID-19 vaccination on Monday.  The urticaria/ hives started  Thurs, 3 days later. Possible allergic reaction to vaccine.  Pt only takes OTC Tylenol & 40mg Humira injection once a week & her  last injection was on Jan 29th, 3 days before her vaccination. Advised to hold Humira until she can  discuss this with her Rheumatologist. Also prescribed antihistamines, low dose steroid & steroid cream.
I got my vaccine twelve weeks ago and I still have problems with my left arm. I have lost a lot of the range of motion and I get shooting pains when I try to do regular activities. At first I noticed pain when I reached back. It will not work if I try to reach for something and I get a shooting pain. I have tried taking Ibuprofen and icing it and it did not help. I also tried massage which helps a little for a short period of time.
RINGING AND PRESSURE IN EARS. CURRENTLY UNDERGOING TREATMENT BY ENT. UNABLE TO WORK DUE TO TINNITUS AND VERTIGO
Local redness around injection site as large as a size of a large orange along with itchiness only around the injection site where it became red.
Patient reports right sidedness numbness starting two days after vaccination.  Next day numbness was on left side.  Numbness has resolved.
Had pain in left groin area for several days along with pain below shoulder blade on left side and pain was worst with back when I took in deep breaths.  I was concerned I might have had shignles. (I have had Shingles twice about 4 years ago and have had the vaccine Shingrix)  Went to doctors on 11/10.  Doctor felt it was colitis and ordered blood work and CATscan on lower area and put me on Amox-clav 875 Mg twice a day.  Lower pain in groin area started to subside with antibodic.  10/12 I called doctor's office on results of my test and all came back good.  But pain around shoulder blade was increasing  so I returned to doctor on 10/12.  Doctor listened to chest and all sounded good and suggest we could Xray or wait for weekend to see if it improved.  I decided to wait over the weekend.  Doctor suggested to take up to 3 ibuprofen for pain in chest.  Pain in groin was gone by this time.  Over weekend pain in chest continued.  Pain was in my old shingles area, left side, under shoulder blade, wrap around to in front in lower rib cage area. By Sunday afternoon chest pain started to subside.  No rash was ever present
Body Chills.  Off and on for 16 hours. Body Aches.  For 16 hours.
Tightness of chest, wheezing, coughing, tightness and burning in throat 4 hours after shot.  Took 1 benadryl.  Throat relaxed, chest still tight, took another benadryl 1 hour later.  Severe aches, and chills set in.  Took 2 motrin and went to bed with 3 blankets on at 10:00pm.   Woke up next morning at 9:00 AM felt better.  Just had headache, and joint and back aches.  Chest still a little wheezy.  Took 1 benadryl.  Symptoms went away by 5:00 pm.
medication error due to administering dose post temperature excursion outside acceptable guidelines for excursion stability standard, with no reported adverse event; Initial information received on 19-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 47 year old female patient who experienced medication error due to administering dose post temperature excursion outside acceptable guidelines for excursion stability standard, with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].     The patient's past medical history, medical treatment(s)  and family history were not provided.    On 23-Mar-2022, the patient received dose of 0.5 ml total 1 day of suspect diphtheria-2/tetanus/5 ac pertussis vaccine, strength: standard lot C5873AA expiry date: 30 -Jun-2023 via intramuscular route in the right deltoid for immunization.   On 23-Mar-2022 the patient developed a non-serious event of medication error due to administering dose post temperature excursion outside acceptable guidelines for excursion stability standard, with no reported adverse event (product administration error) (Latency: same day).  It was reported that low temperature was reached as negative 2.1 celsius from 07-Mar-2022 to 31-Mar-2022. Did it occur due to a human error was no. Does extended stability data cover the excursion: no and in case of negative advice: was the product used by/ administered to the patient was yes to 14 patients. Pregnancy was no. List of concomitant was no other vaccines.  Action taken was not applicable   Outcome was 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.
I have become extremely exhausted and developed a migraine headache which occurred on 07/11/21.
11 hours after administration, I experienced chills without objective fever, myalgias, localized injection site muscle soreness, headache.
AT 1:30PM ON THE DAY OF THE VACCINE MOM NOTED A FEVER TO 102, ONE EPISODE OF DIARRHEA THAT NIGHT, GASSY, TIRED/LESS ACTIVE, DECREASED APPETITE AND THE AREA WHERE THE PREVNAR VACCINE WAS GIVEN WAS RED AND WARM TO THE TOUCH. ON 7/26/17 SHE CAME TO THE OFFICE AND A 5CM ROUND AREA OF ERYTHEMA WAS NOTED WITH A CENTRAL AND SUPERIOR OF 3CM CIRCULAR INDURATION. ON 7/28/17 SHE RETURNED TO OFFICE WITH DIARRHEA AND STILL HAVING A FEVER. cbc/esr/crp/celiac panel and food allergy panel.
First noticed events approximately 1 month and 1 week after vaccination, on 12/28/22.  Symptoms were severe leg and back pain, altered mental status, inability to speak normally or think of normal thoughts/common everyday things/answer basic questions. Was unable to recall anything at all from the days 12/28/22 through 12/30/22, and for 12/31/22 through 1/1/23 was only able to recall that I was laying in bed all day due to extreme leg and back pain. Unable to recall doing anything else.
A father reported that his six month old son received his 3rd dose of Tetramune along with Engerix-B (SKB) vaccines on 10/27/97. In 10/98, at 18 months of age, the reporter alleges that the child became withdrawn, was unable to speak, was unresponsive to his environment and lost language, motor skills, and affect. The reporter described the child as being "neurologically devastated by the accumulation of Mercury" resulting in permanent neurological injuries and associated learning disabilities. The reporter alleges that these events are caused by the preservative thimersol and "do not arise from the vaccine itself". Info regarding this event has been forwarded to SKB, manufacturer of Engerix-B.
Post vax, the patinet experienced local erythema, warmth and swelling. The patient likely had cellulitis.
Client received vaccine and became pale, diaphoretic and lightheaded.  Fire Rescue at scene to evaluate client Client's vitals wnl at the time of assessment.  Client's color came back, sweating subsided and he stated he felt much better.  Per Fire Rescue no further evaluation needed.  Client released at 2:47pm.
itchy rash 2 inches below the injection site; itchiness at injection site; felt unusually tired; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (felt unusually tired), VACCINATION SITE RASH (itchy rash 2 inches below the injection site) and VACCINATION SITE PRURITUS (itchiness at injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced FATIGUE (felt unusually tired) and VACCINATION SITE PRURITUS (itchiness at injection site). On 08-Feb-2021, the patient experienced VACCINATION SITE RASH (itchy rash 2 inches below the injection site). On 08-Feb-2021, FATIGUE (felt unusually tired) had resolved. At the time of the report, VACCINATION SITE RASH (itchy rash 2 inches below the injection site) and VACCINATION SITE PRURITUS (itchiness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included acetaminophen for the unusual tiredness and Tylenol   Concomitant medications were not provided.
headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administration date 11Mar2021 13:40 (Batch/Lot number: unknown) at the age of 64 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN; ASPIRIN [ACETYLSALICYLIC ACID]. The following information was reported: HEADACHE (non-serious) with onset 11Mar2021, outcome "unknown", described as "headache". The event "headache" was evaluated at the physician office visit. Therapeutic measures were taken as a result of headache.  Additional information: Patient had someone send him a note, and it said, make sure you don't take Aspirin or Ibuprofen before you take the Covid 19 shot and he hadn't taken any that day but he had taken Ibuprofen the day before on 10Mar2021, so about 22 hours had passed. He states the (public agency name) says there is possible lack of efficacy. He had also taken aspirin prior to that. He takes that regular. He thinks aspirin stays in his body longer maybe 10 days. He didn't now if it made a difference if it was in his system. He took Aspirin last night because of a headache. Patient did not have history of any previous immunization with the Pfizer vaccine. Patient did not take any vaccination prior to covid vaccine. Patient questioned if it was ok to take melatonin and an antidepressant.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No fever but scream on and off + 12 hrs. Would not move leg 1st day, dragged leg next day, tip toe walk 3rd day.
Woke up in the middle of the night unable to breathe.  Had never happened before in her life.  Tried to calm herself from waking up in panic.  Would happen during day, or in the night more often.  Would happen like this for 2 weeks.  Would get triggered by little things like swallowing something.  Tried allergy medication.  Went to Urgent care, diagnosed as allergies.   After those 2 weeks, felt extremely fatigued for the next two months into August.  Started losing hair around August September, and then in October diagnosed with hyperthyroid.
No adverse event; 4 patients received 0.2mL doses of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (4 patients received 0.2mL doses of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation.) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. In April 2023, the patient experienced WRONG PRODUCT ADMINISTERED (4 patients received 0.2mL doses of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (4 patients received 0.2mL doses of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (4 patients received 0.2mL doses of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation.).    No concomitant medications was reported. It was reported that 4 patients received 0.2mL doses of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation. Doses were administered on 21-APR-2023 and 28-APR-2023. Each was administered as a second dose in the series. Patients ranged from 10m-5y old.  No treatment drug details was reported. This case contains information of 3rd out of 4 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723264 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723264:Patient 1
got really sick; Initial information was received on 06-Dec-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional (patient) via social media.  This case involves patient (age and gender unspecified) who got really sick (illness), while patient received INFLUENZA VACCINE.  It was reported that, at the time of event the patient has a compromised immune system and every year got Flu shot (Influenza Vaccine) and got sick (illness). Medical history, medical treatment, family history and concomitant medication/ therapy were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, the patient got really sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported for event.  There will be no information available on the batch number for this case.
rashes on face; This is a spontaneous report from a sponsored program.  A contactable consumer reported for a female (wife) patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration single dose on an unspecified date for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced rashes on face on an unspecified date, 11 hours after 1st dose, took Benadryl. The outcome was unknown.    Information on the lot/batch number has been requested
Pt developed fever of 102-103 starting about 4 hrs post vax. She was listless. This lasted 2-3 days. She then had hives for 1-2 days.
This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with the improperly stored dose of VAQTA lot #: M009377, expiration date on 17-JUN-2017 (strength, dose number, route and anatomical location were not provided). No adverse events were reported. Administered doses of vaccines experienced the temperature excursion of 31.6 degrees Fahrenheit for 2 hours 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same source. Additional information has been requested.
Information has been received from a health professional concerning a patient who was vaccinated with a 2nd dose of Hepatitis B vaccine recombinant. One week post vaccination the patient "passed out". She was brought to the health professional via EMS and was noted to have high blood  sugar level of 64, BP 80/50. Within 4-5 minutes the patient "woke up". It was noted that she had the same reaction following the 1st dose of Hepatitis B vaccine recombinant. No further info is available.
MRN:  Name: Patient Age: 48 y.o. Birthday:   Admit Date: 7/20/2022  5:34 PM Discharge Date:  7/22/2022 Unit:  Admitting Physician: Dr.  Discharge Physician: MD   Discharge Diagnosis: Principal Problem:   COVID-19 Active Problems:   Acute respiratory failure with hypoxia       HPI AND HOSPITAL COURSE   History of Present Illness:  As per admission H&P, "The patient is a 48 y.o. female who tested positive for covid on 7/17/22 presented with complaints of worsening shortness of breath, malaise, dizziness, diarrhea, abdominal pain, fever for the past few days. Not sure what makes symptoms better or worse. Denies any chest pain or any other concerning symptoms. Was found to be hypoxic in the ER. Admitted for further evaluation."   Hospital Course: The patient is a 48 y.o. female who presented with shortness of breath.  She was managed for the following:   * COVID-19 Acute Hypoxic Respiratory Failure due to COVID-19 Pneumonia -  Patient presented with shortness of breath, found to be COVID-19 positive.  Patient initially required supplemental oxygen 2L.  Pt was treated with remdesivir and decadron and improved.  Patient was weaned to room air and remained stable.  She felt improved and wished to go home. Discharged home in stable condition. Will taper steroids on discharge due to history of reported COPD.             Physical Exam on the Date of Discharge: Blood pressure (!) 132/92, pulse 61, temperature 97.6 °F (36.4 °C), temperature source Oral, resp. rate 18, height 5' 8" (172.7 cm), weight 92.5 kg (204 lb), last menstrual period 06/21/2009, SpO2 98 %. General - NAD, appears stated age  HEENT - EOMI, PER, MMM, oropharynx clear Chest - lungs clear bilaterally,  Heart - RRR,  Abdomen - Soft, non-tender,  Extremities - warm,  Psych - AAOx3, affect appropriate Skin - no rash   Discharge Condition: improved   Disposition: home
Pt. was administered MMR less than 28 days apart. The 2nd MMR was administered 16 days from the 1st.