chrisvoncsefalvay/vaers-outcomes huggingface dataset:
- fever and chills during overnight hours the past 2 nights after shot, unable to sleep for more than an hour at a time. - headache most of the day on Sunday, headache area more so on top of head and some tingling in head at times. - worse chills overnight the 2nd night, had to change pajamas due to chills and sweating 2nd night. - 2nd shot given in left arm, 2 mornings later (Monday), excessive swelling in left armpit and pec muscle, swelling almost size of baseball and protruding, no bruising or pain, just very tender and uncomfortable, feels tight and can certainly feel skin stretched due to swelling.
One week after injection, periphery neuropathy. Significant burning sensation in both ankles, top of feet, and lower calves. The following day, today, doing much better. It may have built up in the preceding days, but by day 7 it was overwhelming. It is not day 8, symptoms are mild to non existent.
patient had an extreme headache almost immediately after first dose pfizer immunization. when her 15 minutes were almost up, she started to say "she felt like someone was choking her". She could barely talk but was responsive but wouldn't keep her eyes open for us. Just kept complaining of a headache. I ha gotten her an ice pack for her head and massaged her head to help relax her headache. she said it was helping. Husband was very calm. said she had covid back in August and she acted the same way. Husband kept asking her if we should call the ems but after several attempts of not answering, we called ems
No additional adverse event reported; Administration of improperly stored ROTATEQ; This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On 22-DEC-2021, the patient was vaccinated with improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally (Lot# 1741817 and expiration date 30-JUL-2022) (exact dose and frequency were not reported) as prophylaxis. (product storage error). The vaccine underwent a temperature excursion of 50.5 Fahrenheit for a period of 57 minutes. There was no previous temperature excursion. No additional adverse event reported.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-DEC-2017, the patient was vaccinated with an expiry dose of PNEUMOVAX 23 expiration date 12-NOV-2017 (strength, dose, route and lot number were not reported) for prophylaxis. No adverse effects reported.
Chills, Night Sweats, Fever of 101 degrees, Hallucinations ( hearing noises that weren't happening).  Lethargic, lack of energy.
No additional adverse event; Expired Merck Sterile Diluent used to reconstitute vaccine that was administered; Expired Merck Sterile Diluent used to reconstitute vaccine that was administered; This spontaneous information was received from a nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 18-NOV-2021 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) lot # T025927 with expiration date on 30-JUL-2022, for prophylaxis that was reconstitute with an expired sterile diluent (STERILE DILUENT) lot number S002625 with expiration date on 09-NOV-2021, for prophylaxis (strength, dose, frequency, route of administration and anatomical location were not provided) (expired product administered/ product preparation issue).  No additional adverse event reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2112USA004666:
Initial information received on 11-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves patient (age and gender unknown) who experienced hives, while received vaccine ADACEL. The patients past medical history, medical treatment, concomitant medication and family history were not provided. On an unknown date in the year 2012, the patient received injection of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number, expiry date and dose not reported via unknown route in unknown administration site. Patient had all CDC recommended vaccines in 2012 during the same timeframe. On an unknown date, the patient developed a non-serious hives (urticaria) with unknown latency following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Lab data was not provided. Final diagnosis was hives. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for hives. List of documents held by sender- none.
local reaction of redness extending 10 cm x 10 cm and local achiness; lasted 2.5 days; no trouble breathing; otherwise felt fine
first and second dose of  FLUZONE HIGH-DOSE QUADRIVALENT vaccines was received in in same month with no reported adverse event; Initial information received on 05-Nov-2021 regarding an unsolicited valid  non-serious case from a other health professional.  This case involves a 76 years old male patient who received first and second dose INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] within same month (inappropriate schedule of product administration).  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for prophylactic vaccination.  On 14-Oct-2021, the patient received a 0.7 mL first dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE and on 28-Oct-2021 he also received a 0.7 mL second dose of the same vaccine (strength: high-dose, lot UJ747AA, expiry date: 30-Jun-2022) via an intramuscular route in the left deltoid for prophylactic vaccination (at a different facility).  It was an actual medication error case drug dose administration interval too short (latency: same day).   At the time of reporting, 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.
Patient developed fever of 104 in the evening on 8/26/09. Was seen in office on 8/27/09 for fever. Admitted to hospital on 8/28/09 for paleness and unresponsive.  10/15/09 Received Medical Records and Discharge Summary for Dates of Service 8/28/09-8/30/09.  Discharge Dx: Unresponsiveness, fever.    ICD 9 Codes:  7825, 5990, 07999, E9478 Assessment:  Cyanosis,  Urinary Tract Infection, Unspecified viral infection in conditions classified elsewhere and of unspecified site, Other and unspecified complication of medical care, Drug/medical substances causing adverse effects in therapeutic use. Presenting sx:Pt. presented to PCP office cyanotic, pale and unresponsive a couple of days after her two month vaccinations.  She developed a fever to 104 degrees, and had an elevated WBC count.  She was catherized and found to have a UTI, started on Rocephin and discharged to home.  PO intake was decreased.  She subsequently had another event of cyanosis and unresponsiveness and was admitted to  the hospital for a rule out sepsis evaluation and monitoring.  On examination she was lethargic and limp, but did respond to painful stimuli.  Started on IV Ampicillin and ceftriaxone.  The mother stated that the child had a "spell" when she went limp, an electroencephalogram was preformed and was normal.  After 48 hours all cultures were negative.  Discharged to home alert and smiling.
Low grade temperature, "aching all over" HA, stomach pain, up all night Monday went to immediate care Monday night physician prescribed pain med - Hydrocodone; He stated probably symptoms from vaccine
APATIENT STATES STARTING FROM SITE OF INJECTION DOWN TO THE TIPS OF HER FINGERS SHE WAS STARTING TO FEEL TINGLY AND NUMBNESS INTO BOTH ARMS. SHE THEN STARTED TO FEEL DIZZY AS MINUTES WENT BY.THEN WITH MOVEMENT OF HER ARMS AND FINGERS PATIENT STATES SIDE AFFECTS WERE STARTING TO DECREASE WITH A PERIOD OF TIME.PATIENT WAS AFRAID TO GET MORE DIZZY,CHOSE TO GO HOME AND REFUSED TO STAY.
Menorrhagia; This is a spontaneous report from a contactable nurse (patient). A 38 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Dec2020 at 07:15, (lot number EH9899), as the first single dose, in left arm, for COVID-19 immunisation. Medical history included migraines and cephalosporins allergy. No other vaccine was administered in 4 weeks. No other medications were administered in 2 weeks. Concomitant medications were none. The patient experienced menorrhagia on an unspecified date after first dose with noticeably heavier flow that eventually stopped on its own. The event resolved on an unknown date. Then the patient received the second dose on 11Jan2021 at 07:15 (lot number EK9231) in left arm. The patient experienced menorrhagia following both doses. Flow following second dose lasted longer than 10 days and eventually required hospitalization for hemoglobin of 5.7. She received 2 blood transfusions, IV venofer infusions, oral TXA, and had to be started on birth control for the first time in her life in order to control the bleeding. She was still having abnormal bleeding to the day of report.; Sender's Comments: Linked Report(s) : PFIZER INC-202101491147 same reporter/pt/drug, different dose/event
pt took 1st dose of vax 25APR&evening of 26APR pt felt poorly;awoke w/splitting h/a 27APR,had sweats&chills,subjectively high fevers 27-28APR,severe myalgias;still achy 29APR but much better;
on day 8, redness and warmth near injection site, approx. 1.5 x 2 cm in size.  No pain, minimal itch
My arm is very warm and the injection site is very red but below the injection site is bumpy and red. from above the injection site down to the bumpy area is very red and blotchy. My back is hurting on my left side. Nausea, achy, headache.
MMR vaccination 2 weeks prior to gradual onset of diffuse muscle and joint aches unexplained by lifestyle changes or illness as well as development of diffuse enlargement of posterior cervical lymph nodes without significant tenderness to palpation.
pt recvd vax; exp local rxn consisting of redness, induration/swelling & diff breathing; epi given;tx included dph,pred,cold compresses;
Very Severe muscle aches , swollen lymph nodes under arm , painful neck and shoulders and very severe bleeding during  monthly periods since I told the vaccine . Also had a large lump in my right breast after taking the vaccine . The radiologist couldn?t decide  it?s nature and said he has never seen such a thing before .
Swelling, induration, redness from shoulder to elbow on vaccinated arm. Improved after  3 days.
had vaccine January and February, tested positive for covid; Diagnosed positive covid-19 yesterday; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed positive covid-19 yesterday) and DRUG INEFFECTIVE (had vaccine January and February, tested positive for covid) 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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced COVID-19 (Diagnosed positive covid-19 yesterday). On an unknown date, the patient experienced DRUG INEFFECTIVE (had vaccine January and February, tested positive for covid). At the time of the report, COVID-19 (Diagnosed positive covid-19 yesterday) outcome was unknown and DRUG INEFFECTIVE (had vaccine January and February, tested positive for covid) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medication was not provided.  Treatment information was not provided.   Reporter did not allow further contact
Pt described development of stiff neck and increased stiffness and soreness of joints (specialized/occurring on 3/25/2005). She developed an ascending rash which started from legs and noted swelling of lower extremities. Evaluated in ER on 3/26 and admitted. Addendum: Above named pt was admitted to hospital on 3/26/2005 for what she described as a reaction to MMR given 2/26/2005. She reports she was informed of this by the attending physicians; however, I am enclosing the final discharge diagnosis that indicates exanthem. At this time she is on steroid therapy for this condition and is pending follow up testing if symptoms reoccur. Per follow up report received on 06/14/2005:  Patient's recovery status is still unknown.
Periods of fluttering; rapid heart beat; This is a spontaneous report from a non-contactable consumer (patient).   A 35-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Left arm on 26Aug2021 09:00, at the age of 35-years-old, (Lot Number: FD8448) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included none. The patient's concomitant medications were not reported.  On 29Aug2021, the patient experienced periods of fluttering and rapid heart beat. The event involved physician office visit. The outcome of the event was unknown. It was unknown if treatment was received for the events.  No follow-up attempts are possible. No further information is expected.
Varying symptoms for one week, up to and including today - weakness, chills, headache, body aches, cough.
Patient was given 0.3 mL of undiluted Pfizer pediatric vaccine in error. Patient approximately received 42.85 mcg instead of 30 mcg. Patient reports fever (102 F) and diarrhea. Pharmacist counseled to take Tylenol for fever and hydrate with Gatorade or Pedialyte. Patient did report she tended to be sensitive to vaccines
Injection site reaction. Swelling, redness and warm to the touch.  About 2? circumference , 13 days after injection.
received her first dose of the Moderna Covid -19 and did not return for the second dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Apr-2021 and was forwarded to Moderna on 11-Jun-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received her first dose of the Moderna Covid -19 and did not return for the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intra-articular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (received her first dose of the Moderna Covid -19 and did not return for the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received her first dose of the Moderna Covid -19 and did not return for the second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intra-articular) was unknown.       Reporter did not allow further contact
24Mar2021 Went to see Neurologist now have optical neuritis and balance issue.; 24Mar2021 Went to see Neurologist now have optical neuritis and balance issue.; 19Mar2021 headache and shakiness; 19Mar2021 headache and shakiness; This is a spontaneous report from a contactable consumer (patient herself). A 57-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Lot Number: Er2613), via an unspecified route of administration in the left arm on 18Mar2021 at 10:00 as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis (with no symptoms) and known allergies to Flagel, aspirin, dairy, oats, tomatoes, and garlic. The patient did not have COVID prior to the vaccination. The patient had no other vaccine in four weeks but had other medications in two weeks (unspecified). On 19Mar2021 at 07:00 AM, the patient experienced headache and shakiness. On 24Mar2021, she went to see a Neurologist and now had optical neuritis and balance issue. She was the scheduled an MRI. The patient wanted to know if she should get her second dose. The patient was not COVID tested post-vaccination. The patient received no treatment for the events. Outcome of the events was not recovered.
First/Second dose: Second dose No reaction to first dose. Constitutional: Fever, Chills, Fatigue The fever is: 39.0-40.0 C or 102.1-104.0 F The chills: Prevents daily activity and requires medical intervention Cutaneous: Axillary swelling/tenderness ipsilateral to the side of injection Neurologic: Headache, Weakness, Lightheadedness Respiratory: Shortness of Breath
Pollen allergy; Eye lens get foggy towards the evening; Felt slightly sick; This spontaneous case was reported by a consumer and describes the occurrence of SEASONAL ALLERGY (Pollen allergy), VISION BLURRED (Eye lens get foggy towards the evening) and MALAISE (Felt slightly sick) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       The patient's past medical history included Bullous pemphigoid. Concomitant products included LEVOTHYROXINE for an unknown indication.  On 27-Sep-2018, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SEASONAL ALLERGY (Pollen allergy), VISION BLURRED (Eye lens get foggy towards the evening) and MALAISE (Felt slightly sick). At the time of the report, SEASONAL ALLERGY (Pollen allergy) outcome was unknown, VISION BLURRED (Eye lens get foggy towards the evening) had not resolved and MALAISE (Felt slightly sick) had resolved.     No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a child. Neither the patient's medical history nor the concomitant medications were reported. The product expired on 25-Dec-2011. On 12-Jan-2012, the patient received expired product. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age.
FUSSY, CLINGING, AGITATED AND WARM TO TOUCH, DECREASED EATING AND FEEDINGS.
Shivering fever, joint pain, headache, medicated with TYLENOL and Ibuprofen.
red circle under injection site; itchy bites all over body, possible hives; itchy bites all over body, possible hives; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red circle under injection site), PRURITUS (itchy bites all over body, possible hives) and URTICARIA (itchy bites all over body, possible hives) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (red circle under injection site), PRURITUS (itchy bites all over body, possible hives) and URTICARIA (itchy bites all over body, possible hives). On 24-Mar-2021, VACCINATION SITE ERYTHEMA (red circle under injection site) had resolved. At the time of the report, PRURITUS (itchy bites all over body, possible hives) and URTICARIA (itchy bites all over body, possible hives) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided. List of concomitant medication were not given.
Mom presents w/child to clinic ER. Rash on chest and back several hours after immunization. No fever or other Sx. BENADRYL dispensed.
Site becomes warm, very red/purple, itchy, blisters. On 10/29/17 noticed around noon, the site was 5"x4". By 6pm had increased another inch. By 8am on 10/30/17 the site was 8"x? and still growing. Received Prednisolone from Doctor. The same thing happened last year.
Severe arm pain starting within hours of vaccine; unable to move arm without significant pain for three days; took pain meds the night after injection and ibuprofen 800mg TID for around two weeks following (until it started bothering stomach. Have used topical NSAIDS and lidocaine patches. Ache down arm continuing four weeks after vaccine as well as pain with movement of shoulder/ flexion/ internal and external rotation. Painful to brush hair, lift covers at night; pain on ADL. Typing is causing ache down arm. Apt with orthopaedics tomorrow for further evaluation.
By evening of vaccination on Feb 12 2021, I could barely lift arm without pain, I needed to use other hand to assist lifting arm from lap to armrest of chair.  Pain was down length of arm. Different than 1st covid vaccine in Left arm, when only injection site and surrounding area was sore as common with vaccines.  Pain continued and increased throughout next days.  Other vaccine effects were as expected (slight chills, nausea, general aches and fatigue..........all resolved by 3rd day)  Arm pain has continued to hurt with pain and weakness similar to rotator cuff injury with pain reaching behind neck, only able to do full range of motion with pain and assist of other arm. This impacted simple self care tasks, grocery shopping, home management tasks. Luckily I am currently not working at usual job of  Occupational Therapist where I would have needed to lift patients, train in exercise and locomotion, maneuver wheelchairs etc. Symptoms are resolving slowly, but as an example it is still painful to lift a gallon of milk from the refrigerator.   I start each day with active assist range of motion though uncomfortable in order to avoid a frozen shoulder, and have used heat pad. My health practitioner today suggested I start using NSAID cream as well.
Got J&J vaccine Sunday and have experienced every side effect listed. Had 103 degree fever, took tylenol, drank water. Fever broke @ 4am, still have excruciating headache, eyes hurt from the light, body aches, can't move right arm more than 90 degrees .  Fever is now at 2pm 3/8 inching up, is 99.5.