chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cold chills for 6 hours, fever for 24, headache for 24 hours, body aches for 24 hours, trouble deep breathing next day for 12 hours
A medical assistant reported VARIVAX was improperly stored and administered; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 04-JAN-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen was not reported), lot# T021824 and expiration date 25-JAN-2022 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 16.1 degree fahrenheit (°F) for 1 hour and 45 minutes on an unknown date; no previous temperature excursion were reported.  The call was made due to a digital data logger.  This is one of two cases received from the same reporter.; Sender's Comments:  US-009507513-2101USA000916:
Pt is a physician. Received PNEUMOVAX around 2002 with no problem. Within a couple of days developed full blown symptoms of pneumonia. Symptoms included chills, fever, muscle pain, muscle aches, productive cough, loss of appetite, weight loss and fatigue. No chest x-ray done, no doctor visit but spoke to nurse who told him to give it a couple of days. Doctor prescribed no medication but took over the count cough syrup, Guaifenesin. Checked in with his physician friends and concluded that it was a severe immunological reaction to the vaccine. 6 weeks after just beginning to feel normal again.
We had been giving Pfizer vaccine for months, Moderna had just come in. I had not familiarized myself with it.  Busy day. Guardian had requested Pfizer but the child insisted she wanted the Moderna. I was busy familiarizing myself with the preparation and dosage to give and although I noticed on her form she was 13 it did not register to me that this vaccine was not indicated for her age.  Spoke with patient next day, she had no adverse effects. I Informed her that when it was time for second dose we would be giving her the Pfizer.
08/24/2016 The patient is a 21 year old male presenting to the clinic today with a CC of rash. States he received a Meningitis vaccination (TRUMENBA) in the left deltoid region last week on 8/18 at home at his PCP's office. Directly after the injection he noted swelling and soreness in the left deltoid region and felt slightly achy. He reports a rash started on Sunday 8/21. He reports it is red and bumpy in appearance. States the area is achy and somewhat itchy. He reports his discomfort as a 3/10. He has been applying OTC hydrocortisone 3 times over the past day and 1/2 which doesn't really help (slightly reduces the itch). He did not contact his PCP's office. Denies any fevers, difficulty swallowing or breathing. Never had a rash like this before. Aware that he is to have 2 more vaccinations to complete the series. Use LIDEX cream 0.05% to AA's twice daily for no > 2 weeks. Discontinue Kw/ resolution. Discussed side effects. Recommended use of OTC antihistamines to aide Kw/ itch and reaction. Recommended CLARITIN 10 mg during the day and BENADRYL 25 - 50 mg in addition every 6 hours PRN. Discussed future immunizations of TRUMENBA. Recommend he continues to receive the vaccination series, but suggested pre-medication Kw/ CLARITIN. May use LIDEX as currently prescribed if rash were to occur again.
Fever 101, body aches, swollen arm, red circle around injection site, stamach pain, nausea and vomiting mucus, tirdness, sore skin, nose bleeding when I blow it, severe lower back pain.
Patient admitted to Hospital on 3/24/2022 with left sided weakness, left facial droop and slurred speech.
A few hours following vaccination, psoriatic arthritis ?flare? began. 24 hours of feeling feverish. 48 hours of severe fatigue with severe joint pain. Symptoms slowly resolved over the next 48 hours and returned to normal. Psoriatic Arthritis is well managed at this time.
This spontaneous report was received from a medical assistant concerning a 23-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 11-MAY-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot number: L026602, expiration date: 19-OCT-2017, dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There were no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as al the data was already obtained.
4/30/21 patient tested positive for COVID-19 after a high-risk close contact exposure. Meets criteria for vaccine breakthrough case.
I developed Covid after my J&J vaccine. I experienced cough all night, felt cold, runny nose and stuffy nose, congestion, felt low energy, and felt very tired. Then after two days later after my cold,  I lost my sense of taste and smell.  My symptoms lasted four-six days. I went to the doctor I got tested for Covid and was positive and within a week my symptoms started to go away.    I have no symptoms today.
Patient came to popup clinic requesting a second dose of Pfizer COVID-19 vaccine 7/12/21.  He had a record of  Sinopharm vaccine doses administered 12/9/20 and1/9/21 and a first dose of Pfizer COVID-19 vaccine 6/2/21, patient states he was advised abroad that he should get Pfizer vaccines after having received the Sinopharm vaccines due to efficacy.  Informed vaccinator and patient that this RN was researching recommendations, and in the meantime vaccinator  administered the second dose of Pfizer COVID-19 vaccine to the patient.  Advised patient and CDC guidelines did not recommend a fu series, they both acknowledge understanding.   Incidentally, The patient offers that he is glad to be vaccinated with a Pfizer series as some locations don't recognize the Sinopharm vaccine and he was required to quarantine for one week because he did not have an FDA approved vaccine  though he had had the Sinopharm vaccine.
4-5 days after administred client reported sharp stabbing pain above left ear about 10mins about or closer. Pain also radiated to front of head and Into left eye. Left eye was red and tender to touch. No fever no rash.
Round red rash on the same arm as injection, but not at injection site. So far the rash is not itchy or it doesn't hurt. I just noticed it today.
About 12-14 hours after my 4th dose I started having nausea, chills, body aches,  fatigue, and fever 102 for 2 days. My arm also swelled and stayed that was for about 2 weeks.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Inject site area is swollen-Medium, Additional Details: Patient says her arm is swollen and hot to the touch at injection site.  The swelling is as big as a fist.
This case was reported by a nurse via call center representative and described the occurrence of upper respiratory tract infection in a 72-year-old male patient who received SHINGRIX for prophylaxis. On 14th June 2018, the patient received the 1st dose of SHINGRIX. On 15th July 2018, 31 days after receiving SHINGRIX, the patient experienced generalized aching. On 4th September 2018, the patient experienced upper respiratory tract infection. On an unknown date, the patient experienced appetite lost, chills, night sweat, fatigue, fever, sore throat, neck pain, lethargy and myalgia. The patient was treated with amoxicillin trihydrate (Amoxicillin), ceftriaxone sodium (Rocephin), amoxicillin sodium, potassium clavulanate (Augmentin), levofloxacin (Levaquin), prednisone, magic mouthwash (nos) (Magic Mouthwash) and medication unknown (Over Counter Medicines). On an unknown date, the outcome of the upper respiratory tract infection, generalized aching, chills, fatigue, sore throat, neck pain and lethargy were unknown and the outcome of the appetite lost, night sweat, fever and myalgia were not recovered/not resolved. It was unknown if the reporter considered the upper respiratory tract infection, generalized aching, appetite lost, chills, night sweat, fatigue, fever, sore throat, neck pain, lethargy and myalgia to be related to SHINGRIX. Additional details were reported as follows: The healthcare professional was also the patient's wife. The healthcare professional reported that 1 month post the dose of SHINGRIX, the patient began to exhibit a constellation of symptoms including generalized aches for which the patient self-medicated with over-the-counter products. On 4th September 2018 the patient was seen in an urgent care facility where 82 days after vaccination, an upper respiratory infection was suspected. The patient was treated with Amoxicillin, Prednisone and Magic Mouthwash for a sore throat. He had pain on the back of his neck. Two weeks later he returned to urgent care, still complaining of lethargy and a sore throat. He was found to have an elevated WBC.   He received 1 gram of Rocephin and was prescribed Augmentin. Two days later the patient visited his LMD where the Augmentin was discontinued in favor of Levaquin. The laboratory tests for mononucleosis, Streptococcus test, west nile and lyme disease were negative. The course of Levaquin has been completed and the patient was still experiencing myalgia, fever occasionally spiking to 101 degrees F, night sweats and loss of appetite. The helath care professional did not have access to the lot number or expiration date of the SHINGRIX.
Severe rash and itching over entire body except face.  Took 2 Benadryl tablets; started to subside within an hour; took 2 more Benadryl 4 hours later; completely cleared up overnight.
Cerebrovascular accident -MRI showed multifocal areas of infarct involving the left cerebral hemisphere. Suggesting an embolic phenomenon, will need 30 days holter monitor on  discharge. Other hospital problems treated and discharges to home. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Information has been received from a nurse practitioner concerning a 10 year old female with environmental allergy and penicillin allergy who in June 2008, was vaccinated with the first dose of GARDASIL 0.5 ml IM. ON approximately 29-JUL-2008, about 2 weeks ago, the patient was vaccinated with the second dose of GARDASIL 0.5 ml IM. Concomitant therapy included ZYRTEC as needed. The patient experienced dermatitis on her extremities after each of the 2 doses. The patient was treated with oral steroids. The patient has some scarring on her wrists from the dermatitis. the patient sought medical attention in an office visit. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a 20 year old female patient. Patients pertinent medical history, drug reactions and allergies were reported as none. On 16-APR-2014, the patient accidentally received PNEUMOVAX 23 injection, (lot number J009827 expiry date 10-AUG-2014), 0.5 ml, subdermal instead of Purified Protein Derivative (PPD) test. Concomitant therapy was reported as none. The healthcare worker states that the patient was seen in the office on 18-APR-2014 to have her PPD read and it was realized then that PNEUMOVAX 23 was accidentally administered on 16-APR-2014 instead. On 18-APR-2014, swelling was noted at the injection site. The patient reported that the physician prescribed the patient ZYRTEC on 18-APR-2014. No lab diagnostics studies were performed. No product quality complaint was involved. The outcome of event swelling was noted at the injection site was reported as recovering. The outcome of a patient accidentally received PNEUMOVAX 23 instead of a PPD test and PNEUMOVAX 23 administered subdermally was unknown. The reporters causality assessment for the event swelling was noted at the injection site with the therapy of PNEUMOVAX 23 was not reported. Additional information has been requested.
Fever; Chills; Muscle aches; Headache; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle aches), HEADACHE (Headache) and NAUSEA (Nausea) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. frstct/ft) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since 01-May-1999 and Postmenopause since 04-Jan-2018. Concomitant products included ESTRADIOL (ESTROGEN) from 25-Nov-2020 to an unknown date and PROGESTERONE from 25-Nov-2020 to an unknown date for Menopause, LEVOTHYROXINE SODIUM (SYNTHROID) from 15-Jan-1999 to an unknown date for Thyroiditis NOS, ACETYLSALICYLIC ACID (BABY ASPIRIN) from 01-Feb-2021 to an unknown date for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle aches), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle aches), HEADACHE (Headache) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-007722 (Patient Link).
no PQC or additional Adverse Events Reported; Caller reported vaccine administered after temperature excursion.; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender.  No information regarding concurrent conditions, medical history or concomitant medications was provided.  On 29-MAR-2021, the patient was administered 2 ml orally of improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot 1691300 and expiration date 24-NOV-2021 for prophylaxis (dose number and vaccination schemes frequency were not reported). The involved vaccine underwent a temperature excursion of 11.7 degrees Celsius for 75 minutes. A data logger was used.  At the time of the report no adverse event was reported.
Information has been received from a physician concerning a female pt who in September 1996 was vaccinated with varicella virus vaccine live. On 03/12/04 the pt's mother called the MD's office and reported that her daughter had gotten a few spots of chickenpox. The pt sought unspecified medical attention. There was no product quality complaint involved.  It was also reported that four other pt's developed chickenpox after being vaccinated with varicella virus vaccine (WAES # 0403USA01611, 0403USA01645, 0403USA01646 & 0403USA01647).  Additional information has been requested.
After 2nd shot in 3-shot series, she developed an ovarian cyst larger than an orange. Ovarian cyst with torsion.  It twisted and she had to have emergency surgery.
pt recvd vax & exp t101, fell to sleep @ approx 1030PM; 12AM pt cries p/picked up noticed pale & began convuls; pt breathing shallowly; pt fussy;
Expired dose administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Infanrix) for prophylaxis.   On 11-OCT-2023, the patient received Infanrix. On 11-OCT-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Expired dose administration).  The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date 11 Oct 2023: Nurse reported a patient inadvertently received an expired dose of Infanrix, which led to expired vaccine used. Nurse did not report any patient demographics. The reporter consented to follow up.
The day after he got his vaccination a maculopapular rash across his chest and under both armpits associated with fatigue subsequently followed the next day with sores on his mouth and after day 3 a complete resolution of symptoms except for the onset at day 2 of bilateral tinnitus which has yet to resolve.  With that he is had no vertigo and no hearing loss.  He wanted to touch base and decide what else might he try at this point.  On that day on October 7 he received 3 vaccinations Shingrix vaccine, quadrivalent standard dose influenza vaccine and a Tdap vaccine. All symptoms resolved except bilateral tinnitus as of 10/30/2020.
The date and times listed above are estimates. I lost fifty (50) pounds by December 2013 but I started gaining some back in February 2014. Right arm sore at times also some stomach pain and legs pain at times. Memory Loss.
after a below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a female patient who received Men B NVS (Bexsero) (batch number abxb35aa, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th July 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The Physician reported that the patient was administrated with Bexsero after a below freezing temperature Excursion,which led to incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case was 1 of 29 linked cases,reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164798:Same reporter. US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164797:Same reporter. US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164799:Same reporter. US-GLAXOSMITHKLINE-US2021164795:Same reporter. US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter
2 days after 1st shot I felt extreme fatigue and shortness of breath for several days. Got tested for COVID with negative results. Went to hospital on 16th of February and was admitted due to heart condition and recent heart attack. I told them my next vaccine was due on the 18th and they gave it to me while I was admitted.  Within 24 hours I had another heart attack. I was sent to another hospital for an Angiogram where they expected to find blockage and prepared to install a stint. They found no blockage. There is no medical explination.
Malaise; Achy; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Malaise) and MYALGIA (Achy) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included CLONAZEPAM for Anxiety, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced MALAISE (Malaise) and MYALGIA (Achy). On 09-Apr-2021, MALAISE (Malaise) outcome was unknown. At the time of the report, MYALGIA (Achy) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications included birth control pills.  Patient was treated with anti-nausea medication, IV fluids, IV potassium  Patient took second dose of on 05-MAY-2021.   This case was linked to MOD-2021-213293 (Patient Link).
Approximately 7 mins after administration of vaccine, patient reported to RN complaints of elevated heart rate, trouble breathing, and that her throat felt tight.  VITALS: HR 80, BP 122/82, O2 92% Lungs CTAB Patient had no dermatological presentation, and was closely monitored for 30 mins without progression of symptoms. Patient was offered water and snack and tolerated.
5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date). On 21-Jan-2022, EXPIRED PRODUCT ADMINISTERED (5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   5 doses were given past beyond use of 15-Jan-2022 to 5 patients from 3 vials. On 16-Dec-2021 the vial was initially stored in the refrigerator. The vial does not undergo to any temperature excursions.  Concomitant medications was not provided by the reporter. Treatment information was not provided.
pt received her shot and was told to sit and wait for 15 minutes- pt instead walked around the store and then felt lightheaded and fainted.  pt was conscious and claimed to feel nauseous as well.  we gave her water and some crackers and pt felt better and like she did not need any further medical attention.  called pt this morning to check on her and pt father reported that she is fine and doing well.
Pt given first Pfizer Covid Vaccine dose and within five minutes c/o pain ,burning and itching at left arm site.  Given Benadryl 50mg IM for sx reddness and raised rash at site, and chest. Pt felt immediate relief after Benadryl injection. vss 144/76,hr 80, o2 Sat 100%
COVID-19 vaccine given after BUD date of 4/29/22.  Expiration date:  5/31/22.  Letter being sent to parents to re-vaccinate.
Patient complaint of severe, prolonged pain in arm following vaccination. Feels the vaccine may not have been given in appropriate location on arm.