chrisvoncsefalvay/vaers-outcomes huggingface dataset:
7/30/14 temp 101.6 no other symptoms advised to give TYLENOL. 10:30 pm child was twitching eyes rolled back child was limp. Dad thought blue gave mouth rescue breaths, Seen at hospital.
ActHib was reconstituted with sterile water for injection, rather than with the included diluent of 0.4% saline and the dose was then administered with no reported adverse event; Initial information received on 09-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old male patient who had acthib was reconstituted with sterile water for injection, rather than with the included diluent of 0.4% saline and the dose was then administered with no reported adverse event after receiving vaccine hib (prp/t) vaccine [act-hib].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (dtap) for immunisation; rotavirus vaccine (rotavirus vaccine) for immunisation; and hepatitis b vaccine (hepatitis b vaccine) for Immunisation.  On 09-Jun-2023, the patient received a  dose of suspect hib (prp/t) vaccine, Powder and solvent for solution for injection lot UJ794AA, 08-Oct-2023 via intramuscular route in unknown administration site for Immunization.  On 09-Jun-2023 the patient developed a non-serious acthib was reconstituted with sterile water for injection, rather than with the included diluent of 0.4% saline and the dose was then administered with no reported adverse event (product preparation error) (latency: same day).  Lab data was not reported.  Action taken was not applicable.  Outcome: Unknown for the event acthib was reconstituted with sterile water for injection, rather than with the included diluent of 0.4% saline and the dose was then administered with no reported adverse event.  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.
Shot 1: Extreme vaginal bleeding for 6 weeks straight; Shot 2: Nausea, dizziness, vomiting, diarrhea, pounding headache and inability to raise right arm above shoulder.
site sore, feverish, chills that evening. next morning nauseated, fainted, sweating profusely, but then felt a little better later in the day, then did have temp that night of 100.1
Myalgia injected arm "felt heavy", extreme exhaustion, chills, feeling of sweats
Woke up Sunday the day after and couldn't walk. Waited to see if it would wear off the next day was admitted into emergency with a minor stroke caused by a blood clot
Information has been received from a nurse concerning two unspecified patients. No concurrent condition, medical history and concomitant therapies were reported. On 26-JAN-2016, the two unspecified patients received doses of improperly stored VAQTA (lot # L039659 with expire date 15-MAR-2017) (dosage and route not reported). The temperature/time frame was Cumulative 34.1 F for 135 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse refers to a multiple patients of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL (dose, frequency and route of administration were not provided) that was stored improperly. No adverse effects reported. Additional information has been requested.
I developed a rash at the site of injection, about 2 inches in diameter. The skin looks slightly raised, is red and warm to the touch. No itching.
The patient came in for a tetanus vaccination due to having been cut with a rusty fishing lure.  She tried to get it at her primary care physician's office but since they did not have epinephrine they recommended she come to the pharmacy. A representative from the physician's office called in advance to ask if we have the appropriate medication in the event that she has an anaphylactic reaction. After filling out the consent form, I administered the Boostrix vaccination in her left deltoid.  Within 10-20 seconds she conveyed she was feeling dizzy, after a few more seconds she said she felt like she was possibly feeling tightness in her chest and possible swelling of the throat. I then administered 0.3mg of epinephrine into her left thigh intramuscularly.  After about 30 - 45 seconds she began to feel better.  The other pharmacist called EMS and EMS arrived about 10 minutes later. They took her vitals and ran a 4-lead EKG. The patient left via EMS with her husband.
Received Phizer vaccine dose #2 Tuesday 1/26/21 at 0915.   Feverish and tired at 6pm(8hrs 45 min later)  Wed 1/27/21 5am fever, aches, chills, foggy, slight headache, exhausted.   Wed 1/27/21 7pm exhausted, foggy  Thurs 1/28/21 5am exhausted, foggy, no reserve  Fri 1/29/21 5am tired, foggy   Sat 1/30/21 Much better.
Neck glands swollen, generalized soreness & aching in hands & feet, swollen fingers;
The pt received anthrax #4 on 8/10/07 in left arm. The next day the pt had about 4cm of erythema, 1cm of induration and tenderness at the site of injection. No decrease in ROM/numbness/tingling or fever. These symptoms lasted 4-5 days and then started to resolve. About 8/17/07 the patient had left shoulder pain (2/10) no decrease ROM, no decrease in sensation/numbness/tingling. Around 8/28/07 the patient had steady 4/10 left shoulder pain. He had difficulty lifting objects. No decrease in ROM. Patient noted a "lump" on the superior aspect of his shoulder. Pt saw a PA on 9/8/07. The patient was given an ortho appt on 20 Sept 07. Dr. ordered pt to be transferred to another country for further testing (diagnosis scapular dyskenesis/ left shoulder scapular winging). Sept 24, 2007 seen in orthopedics. C-spine done. Pt transferred to home country. 28 Sept 07 seen by Dr. Consult for Neurosurgery, EMG, MRI, and NCS. Started on neurotonin. Light duty for 30 days. EMG/NCS 10/18/07. Seen in neurology 10/18/07. Seen in neurosurgery 10/19/07. (idiopathic neuritis of the spinal accessory nerve and of the long thoracic nerve). 20 Nov 07 seen in PT. The patient continues with constant 2/10 level pain in left shoulder, scapular region. Pain worsens to 4/10 intermittently about 10-20 times per day, lasting 5 minutes to 3 hours.
Extensive redness, pain and swelling at right arm (Men B) injection site without true cellulitis, fever, headache with photophobia, posterior neck pain with very mild meningismus on exam.
Patient received vaccine Mar 02, 2021, exposed around Mar 22. He reports that he developed joint pain, cough, SOB, somnolence and went to ER with subsequent hospitalization Mar 27, 2021. Currently inpatient at healthcare facility.
felt some tightness in her chest, "like a weak compression" that lasted about 20 minutes; rash around her eyes; swollen eyes all week long; the skin around her eyes is very wrinkly, like an elephant, and burgundy colored; dark circles around the whole eye; the skin around her eyes is very wrinkly, like an elephant, and burgundy colored; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route administered on 27Apr2021 (age at vaccination 53-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Apr2021 the patient experienced felt some tightness in her chest, like a weak compression that lasted about 20 minutes. The patient reported that she received her first dose of the Pfizer-Biontech Covid19 vaccine on 27Apr2021.She reported that when leaving the vaccination site, she felt some tightness in her chest, like a weak compression that lasted about 20 minutes, and was resolved within 30 minutes after vaccination. She thought about going back to the vaccination site, but was too far away, and the symptoms resolved. In 2021 the patient experienced rash around her eyes with, swollen eyes all week-long, the skin around her eyes is very wrinkly, like an elephant, and burgundy coloured and dark circles around the whole eye. She was most concerned about the rash around her eyes that has developed, this week. Her friend told her to call and let this know, Is it the symptom of the vaccine of the first shot. The patient spoke to her doctor and the doctor prescribed the Claritin, loratadine (lot and NDC were Unknown, expiration date 13May2022) 1 tablet a day. The swelling around the eyes was gone down a little bit but she was still had the effect. She was asking if the rash/eye swelling could be caused by the vaccine (Is this from the vaccine or a food allergy), and if she should get her second dose? She had spoken with her HCP prior to calling, and they think the reaction may be a food allergy. She was scheduled for her second dose of Pfizer Covid vaccine 18May2021.Therapeutic measures were taken as a result of events Skin wrinkling, swollen eyes, rash around her eyes, skin discoloration. The clinical outcome of the event tightness in her chest was recovered on 27Apr2021 and recovering for swollen eyes and unknown for other events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Child woke up from bap with low grade fever 100.6, slight swelling at injection sites. Mother gave 1 tsp of children's Tylenol. Fever came down. Today child has mottling of skin along upper arms bilaterally. No severe swelling, limb is warm to touch.
WOKE UP DUE TO ITCHING, HAD HIVES ON ARMS AND LEGS. NO TROUBLE BREATHING. DID NOT TAKE ANY MEDICATION. WENT BACK TO SLEEP AND HIVES AND ITCHING GONE WHEN AWOKE. HAD NOT TAKEN ANY NEW MEDICINES, EATEN ANY NEW FOODS AND NO NEW SOAPS OR DETERGENT.
Extensive rash on abdomen--VERY itchy and lasting for 2 weeks so far. I used a whole tube of OTC 1% hydrocortisone cream to no avail. Doctor gave me Triamcinolone cream that I am using now. I had just started Amlodopine on Sept. 21 and rash may be from that. Doctor said it could also be from poison ivy but I find that highly unlikely.
I did not know anything about the common side effects this drug had. None of the staff, at Doctor's office, told me anything about possible side effects. I started having pain in my left arm and arm would hurt reaching for something. Later, commercials for PREVNAR mentioned common side effects
11/8 entire upper arm from shoulder to elbow became red and hot, swollen. Lasted greater than 12 hrs.
Patient had some mild shakiness to both hands. Monitoring for 20 min - mom states this happened as well with HPV #1, and it lasted for about 2 hours then it went away.
10/09/2003: Nausea, dizziness, diarrhea, right arm rubbery, right leg and left foot numb, red, splotchy face, bad taste in mouth, ears felt funny. 10/08/2003: Immediately after vaccine itching, ears felt funny, PMD advised atarax. 10/14/2003: All symptoms much improved.
Myalgia and arthralgia of the forearms, stiffness of the hand and finger x5 days after vaccination
p/vax pt devel T102; vomiting x3-4; hives; 8/14 hives worsened; c/o stomach hurting; exam: 8/16;T101;not feeling well  & scratching; hives over entire body w/many lesions on face as well; tiny vesicles; Dx: urticaria & probable viremia;
Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. On an unknown date the patients administered doses of GARDASIL 9 (dose, frequency and route unknown, lot # N012093, expiration date: 13-JAN-2020) for prophylaxis following a temperature excursion of 28F for 6 hours. There was no previous temperature excursion. Data logger involved. No adverse effects were reported in any patients.
FELT AWFUL; UNSPECIFIED SYMPTOMS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 20-JUL-2021, the patient experienced unspecified symptoms. On 23-JUL-2021, the patient experienced felt awful. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt awful, and the outcome of unspecified symptoms was not reported. This report was non-serious.
pt says she developed a extremely itchy, bumpy, red rash on both forearms that moved upward towards the injection site.  Pt has is waiting on her PCP to give her a CB w/ medical advice.
child recv vax & child unvaccinated sibling exp a typical varicella illness;2wk later pt devel chickenpox w/hundreds of lesions, including several in mouth; pt recovered;
pt recvd vax 24MAR93 & 26MAR93 devel a rash on the left upper scapular region of back; It was approx 3 inches by 3 inches in size; 28MAR93 sx had completely resolved; No further details were provided;
Patient was administered vaccine that had experienced temperature excursion during shipment and should have been quarantined.  Quality report was not seen/received by provider prior to administering dose.
This initial spontaneous report was received from a medical student referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. On 25-JAN-2016, the patient was vaccinated with the third dose of GARDASIL 9 injection (lot # L014415; route, expiration date and anatomical location were not provided). The reporter stated that this dose was administered outside the dosing recommendations as the patient received the third dose shot at 12 months (it was unspecified if it was since the first or second dose). No adverse reactions were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
twitching on left cheek/Periodic facial twitching on left side of face; pain at injection site; flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed but manufacturer unknown), for COVID-19 immunization. The following information was reported: MUSCLE TWITCHING (non-serious), outcome "unknown", described as "twitching on left cheek/Periodic facial twitching on left side of face"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at injection site"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms".  Additional information: Periodic facial twitching on left side of face began a few hours after booster shot and continues into the next day. Event took place after use of product.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
14 hours after injection, developed diffuse arthralgias, severe back pain, and chills along with headache lasting 36 to 40 hours. Injections side severely bruised, painful, erythema extending almost to the elbow. I'm able to sleep on left side for more than 48 hours.
Pt was given MMR injection and developed a 1.5-2.0cm wheal at injection site within 10-15 minutes of injection.
Swelling of left leg from upper thigh to below knee-increasing knot. Inability to bear weight.
17 YEAR OLD PATIENT: AFTER RECEIVING VACCINE PATIENT SAT IN OVERVATION AREA, UPON SITTING DOWN EXPERIENCED DIZZINESS, SHORTNESS OF BREATH, FATIGUE.  PATIENT DEMONSTRTING RAPID EYE MOVEMENTS, RESPONSIVE TO DIRECET QUESTIONS AND TO PAINFUL STIMULI THOUGH UNABLE TO SPEAK IN FULL SENTENCES.  DENIED CHEST PAIN, COUGH NAUSEA, VOMITING.  MOTHER STATES SIMILIAR BEHAVIOR WHEN SHE DEVELOPED BLOOD CLOT IN THE PAST.  PATIENT THEN STATED FELT LIKE THROAT WAS SCRATCHY.
Life-threatening hypertension crisis.  Our doctor prescribed a hydrochlorothiazide 12.5 mg  and potassium tablets.   Did not seem to reduce pressure. Clonidine was administered at The Hospital. The next day our family doctor gave Metoprolol Tartrate, 25 mg which reduced the pressure.
headache; nausea; fatigue; sore arm; This is a spontaneous report from a contactable consumer reporting for herself. A 65-year-old female patient (not pregnant), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283), via an unspecified route of administration, on left arm on 16Jan2021 14:15 at single dose for COVID-19 immunization. Medical history included Diverticulosis, hypothyroid, osteoarthritis, vitiligo, psoriasis, anxiety/depression, known allergies: Iodine, sulfa, bivalve shellfish, garlic, onions. Concomitant medications included first dose of pneumococcal vaccine polysacch 23v (PNEUMOVAX) on 23Dec2020 on left arm, celecoxib (CELEBREX), sertraline, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), levothyroxine sodium (SYNTHROID), liothyronine sodium (CYTOMEL). The patient experienced fatigue, sore arm the day after vaccine was administered on 17Jan2021. Two days after administration on 18Jan2021, patient experienced fatigue, headache, nausea. No treatment received for all events. The outcome of the events were resolving.
Patient's twin brother came in to receive his Covid shot and realized that patient had already received his and realized that patient was not 18 at the time of his booster.
Shortly after the patient received the vaccine and started to walk towards the door, the patient began to experience extreme dizziness  as well as a "scratchy" feeling in her throat. The patient immediately was given a seat, drank some water, and these symptoms began to subside in the next 30 seconds to 1 minute. The patient was monitored for the next 20-30  minutes and the symptoms kept showing improvement.
Not an adverse reaction, but an administration error. Patient wanted Pfizer COVID updated bivalent booster and was given original Pfizer COVID vaccine.
I got Moderna on March 16th 2021. Last night(March 17th) I felt really horrible like PMS. then found out that I?m having my period today on March 18th. My period finished just last week. I have never had trouble with menstrual cycles. So I googled about it and found out this might be one of symptoms that some women have after the Covid vaccine.
During the 15 min. post-IMZ observation, patient complained of dizziness, light-headedness. She proceeds to rest on the floor. She was given some water and an ice-pack for the shoulder.  Her blood pressure was checked.  68bpm  <120/<80. She rested for another 5-7 minutes sitting on the chair until she was  fine again.
Clt. states flu like symptoms for 2 weeks, soreness at HPV injection site for 2 weeks, frequent twitching of right hand and the feeling that he had just had a cast removed from forearm for 3 weeks.  Symptoms resolved.
No adverse event; received Moderna original 0.5ml doses instead of the bivalent booster; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052b22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster).    No concomitant medications were reported. No treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2022: Follow up received wherein patient's DOB, initials, gender and age added.
patient stated that within 15 to 20 minutes after receiving vaccines she developed severe shaking, chills, and shortness of breath. She also noted achiness in her shoulders bilaterally. She called 911 and was placed on oxygen and transported to the hospital. She was later transferred to a hospital in another city after having a troponin level of 1.4 for a higher level of care. She was admitted to the hospital and Later determined she had a non-ST elevated myocardial infarction. She was discharged from the hospital on 10-03-2020 but was antigen positive for COVID. She has recovered and is doing fine as of 10-19-2020.
Pt vaccinated with OPV/TD/MMR/PPD approx 2 hrs after immunization broke out in welts over entire body which itched. Also rash pinkish & raised except areas of PPD where it is much darker red.
Patient experienced burning and redness, followed by nausea and dizziness, followed by swelling of the arm.
menstruation began 1 day after 2nd dose of vaccine which was only 7 days after end of last day of regular mentruation. i do not have a history of irregular menstruation or spotting in between periods
Event occurred after 2nd dose. Patient was diagnosed with COVID Remdesivir Discharged home
Hard, hot red lump at site of injection, continued to grow in size for three days. Painful and extremely itchy. Covered most of upper arm by fourth day. Upper arm swollen. Tenderness inside of breast closest to arm. Gradually subsided after fourth day.
APPROXIMATELY 7 HOURS AFTER RECEIVING ADACEL (04/11/2007) PT COMPLAINED THAT HER THROAT FELT LIKE IT WAS CLOSING AND ARM PAIN - HOWEVER, PT CALLED OUR OFFICE 04/13/2007 COMPLAINING OF SORE THROAT, COUGH, C0NGESTION AND FEVER OF 102 DEGREES.  PT INSTRUCTED TO APPLY ICE TO ARM, TAKE ADVIL AND CALL WITH AN UPDATED THE NEXT MORNING.