chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous case was received from other health professional on 04-Oct-2017, concerning a 60-year-old female patient. The patient's medical history and concomitant medications were not reported. On 04-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 1618621, expiry date: Apr-2017). The patient was administered with expired vaccine and no adverse effect was experienced by the patient. It was reported that, the patient had to revaccinate with current season vaccine. The reporter assessed the events as non-serious. Follow-up received on 08-Nov-2017: Added patient details (age: 60-year-old and gender: female), vaccination details (route of administration: intramuscular, anatomical location: deltoid). Narrative amended accordingly.
Information ahs been received from a registered pharmacist concerning nine patients of unknown age and gender. On unspecified dates, the patients were vaccinated subcutaneously with a 0.65 ml ZOSTAVAX (frequency was not reported) (Lot #: H011427; Expiration date: 12-SEP-2013), that had been improperly stored, exposed to 40 F for 30 days. There were no adverse effects. Follow up information has been received from pharmacist considering a 63 years old patient of unknown gender, who on 22-OCT-2012, was vaccinated with a dose of improperly stored ZOSTAVAX. Pharmacist reported that the vaccine excursion began on 26-SEP-2012, excursion was not discovered until 29-NOV-2012. This is one of several reports received from the same source (related MARRS numbers: 1212USA00449, 1212USA005678, 1212USA005677, 1212USA005680, 1212USA005681, 1212USA005682). Pharmacist reported that in the interim seven (not nine) patients were vaccinated with ZOSTAVAX that was improperly stored. Additional information has been requested.
This spontaneous report was received from a physician refers to multiple unspecified patients of an unknown age. The patients' pertinent medical history, concomitant medications and drug reactions/allergies are not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 (lot # L037554and expiry date 25-DEC-2017). Temperature excursion occurred at 46.8 F for 10 hours. No adverse events were reported This is one of the several reports received from same reporter. Additional information had been requested.
Information has been received from an RN concerning a 9 year old female with no known drug allergies, with a history of splenectomy in 1973 who in 1973 was vaccinated with pneumococcal vaccine 23 polyvalent. Subsequently, the pt experienced fever and "bad" local reaction. Unspecified medical attention was sought. Additional information has been requested.
I am type one diabetic, and I have had extremely low blood sugars during the night for the last several days. Even with eating and correcting with food my blood sugar dives back down. It has been reaching values that are so low my CGM and meter cannot read them. I monitor my diabetes with a Dexcom CGM so I get woken up to the alarms, but I fear without the alarms I could have died.
Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 15Feb2021 at 13:45 as dose 1, single (Lot number: EL9266), on 08Mar2021 at 11:00 as dose 2, single (Lot number: EN6205) and on 23Oct2021 at 16:30 as dose 3 (booster), single (Lot number: 32030BD) at the age of 38 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Gluten" (unspecified if ongoing), notes: Known allergies: Gluten; "Celiac' s disease" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (May2002) Positive; (10May2022) Negative. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical Course: Congestion and runny nose, frequent sneezing, tested positive for COVID-19 again 15 days after positive test and beginning Paxlovid regiment. Had a negative test 7 days after first positive test, which was 2 days after finishing Paxlovid regiment. Felt fine in between until about 8 days after finishing Paxlovid and have now felt sick and tested positive. Antiviral details was product COVID 19 Treatment brand Paxlovid treatment start date on 03May2022 and stop date on 08May2022.
12/1/09 vaginal birth with no reported complications. Rh factor injection received during pregnancy. 1/10 food borne illness with no treatment. 1/10 not feeling well, left sided pain, pain with tactile stimulation that progressed to left sided numbness. 2/10 routine OB appointment still feeling bad. Diagnosed with PP depression. Rx Zoloft. 2/15/10 started Zoloft still felt dizzy. Ordered to stop Zoloft. 2/22/10 full body weakness. 2/24/10 went to ED and admitted as inpatient diagnosed with ataxia due to post infectious cerebritis. Reports received testing to rule out West Nile virus and herpes inpatient for 13 days. Then to inpatient rehab on 3/9/10. Received EEG and CT of brain at this time. Then diagnosed with acute disseminated encephalomyelitis (ADEM). 3/17/10 inpatient x 7 weeks. Received plasmapheresis. Now receiving ongoing rehab, immunosuppresive therapy and steroid treatments.
needed an emergency apendectomy; missed the second dose of vaccine; This is a spontaneous report from a contactable other health care professional. A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 03Jun2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. HCP inquiring if a patient that received first dose of vaccine 03Jun20211 then the patient experienced, needed an emergency appendectomy and missed the second dose of vaccine and would like second dose 02Aug2021. Transfer to another hospital - nurse sent paperwork to facility for AE - medical treatment needed after vaccine and second dose beyond 21 days. CoVax US Support CEP 159558. The outcome of event needed an emergency appendectomy was unknown.  Follow up attempts are needed, Information on lot/batch number has been requested. ; Sender's Comments: Based on limited available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported event of "Emergency appendectomy" due to temporal relationship and current known drug safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 21-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.
WHITE BLOOD CELL COUNT INCREASE; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included stage iii myelofibrosis, and penicillin allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-APR-2021, the subject experienced white blood cell count increase. Laboratory data included: WBC (NR: not provided) 109.3. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of white blood cell count increase was not reported. This report was non-serious.
February 18,  2021, 11 a.m.: Amaurosis  Fugax, 5 minutes in duration March 22, 2021, 12:30-3 p.m., Amaurosis Fugax, 90 minutes in duration April 5, 2021, 1:00=3:30 p.m. 4:30-5:00 p.m. 7:30-9:00 p.m.,
This case was reported by a nurse via call center representative and described the occurrence of rash herpetiform in a 81-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, 7 days after receiving SHINGRIX, the patient experienced rash herpetiform. The patient was treated with acyclovir. On an unknown date, the outcome of the rash herpetiform was unknown. It was unknown if the reporter considered the rash herpetiform to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. Approximately 1 week after receiving SHINGRIX, the patient experienced a rash on her back. The rash was located right above the armpit on the left side of the patient's back and looked similar to Shingles. On 21st September 2018, the patient was seen in the office by the doctor and received acyclovir for treatment. The nurse reported that she had pictures of available of the patient's rash if needed.
Injection site itching (2 hours), redness and swelling (2 days). Chills and fatigue (2 days).
Second dose administered at 14 day interval instead of 28 day interval. No reaction noted with patient
Fever; Myalgia; This case was reported by a physician via sales rep and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and myalgia. On an unknown date, the outcome of the fever and myalgia were unknown.   It was unknown if the reporter considered the fever and myalgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient after vaccination experienced fever and myalgia. This case has been linked with case US2019AMR204582, reported by the same reporter.
Patient received vaccines on 10/28/2020. She received both meningitis vaccines in the same arm (L). Patient states arm was sore post administration, and the pain lasted throughout the day. The next day, L arm was red, swollen, hard, and hot to touch. Patient states it hurts to lift arm.
Severe headache  for 1 week. Took OTC medications and Prescription medications with no effect
Patient went to MD- he looked at the area which was red and swollen and said she had an adverse reaction . No TX was prescribed. She used warm compresses which helped.
Shaking; Weak; Cough; Shortness of breath; Itching at injection site; Fever 101.4; Pain and terrible aching; Headache; Injection site swelling; Swollen upper arm with redness for 10 days at injection site; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), ASTHENIA (Weak), COUGH (Cough), DYSPNOEA (Shortness of breath) and VACCINATION SITE PRURITUS (Itching at injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 012M26A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Influenza from 18-Jan-2021 to 25-Jan-2021. Concurrent medical conditions included Blood pressure. Concomitant products included ASA, ESTRADIOL (ESTRACE), DILTIAZEM (CARDIZEM [DILTIAZEM]), POTASSIUM CHLORATE and DIAZEPAM for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced TREMOR (Shaking), ASTHENIA (Weak), COUGH (Cough), DYSPNOEA (Shortness of breath), VACCINATION SITE PRURITUS (Itching at injection site), PYREXIA (Fever 101.4), MYALGIA (Pain and terrible aching), HEADACHE (Headache), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Swollen upper arm with redness for 10 days at injection site). On 06-Mar-2021, MYALGIA (Pain and terrible aching) had resolved. On 07-Mar-2021, TREMOR (Shaking), ASTHENIA (Weak), COUGH (Cough), DYSPNOEA (Shortness of breath), VACCINATION SITE PRURITUS (Itching at injection site), PYREXIA (Fever 101.4), HEADACHE (Headache), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Swollen upper arm with redness for 10 days at injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: 101.4 (abnormal) 101.4F.         No Treatment medications were provided   This case was linked to MOD-2021-019687 (Patient Link).
Moderna COVID-19 Vaccine EUA: 01/02/2021:Woke up with left arm feeling like it was about to go numb. Able to do normal activities throughout the day. 01/03/2021: Woke up with left arm still feeling weird and pain in the left armpit. If I put my fingertips in the middle of my armpit it hurt, sharp pain. I could not feel any lumps. I felt 2 lymph nodes swollen: above left clavicle and bottom of left neck. The lymph node above the left clavicle hurt with pressure.  Pain in both areas subsided by 01/06/2021 evening. Lymph node swelling has gone down but I can still feel them.
Information has been received from the authors of the published study literature article titled as stated below. The authors performed a transcriptome (mRNA-Seq)-profiling study after in vitro viral stimulation of PBMCs from 30 measles vaccine recipients. A total of 30 subjects were selected for an mRNA-Seq transcriptome-profiling study based on their plaque reduction micro neutralization assay (PRMN) antibody titers (15 highest and 15 lowest antibody responders) from a combined cohort of 764 randomly selected healthy schoolchildren and young adults (age 11-22 years). The informed consent was obtained from subjects' parents/guardians, as well as written assent from age-appropriate subjects at the time of enrollment. Demographic information from the subjects in the two cohorts was: Sixty per cent of the participants were male and 40% of them were females. Thus, it is important to note that gene expression in PBMCs and all immune measures (neutralizing antibody and cytokine measures after in vitro viral stimulation) were quantified in samples approximately sever years after the last/second measles (MMR) vaccine. Their median age at the time of enrollment was 15 years. On an unknown date, the subjects received two doses of (Wistar RA 27-3) MMR II that contained the Edmonston strain of measles virus (TCID50 >=1,000) (dose, route of administration, lot number and expiration date were not reported). The exact interval between the doses was unknown, but the authors reported that their median age at first immunization was 15 years and by the second immunization, the median time between the first and second immunization was 8 years and the median time since second immunization to enrollment was 7 years. Information concerning the subjects' concomitant medication was not reported. On an unknown date, the subjects' plaque reduction micro neutralization assay had a median titer of 88 mlU/mL (negative) (Measles antibody negative), which suggested lack of protection against measles (vaccination failure). At the reporting time the outcome of vaccination failure and measles antibody test negative was unknown. The investigators considered no therapeutic response to be related to (Wistar RA 27-3) M-M-R II. A copy of the published article has been attached as further documentation of the subjects' experience. Additional information has been requested.
ER 27Jan2021 Patient reports nausea and vomiting for 5 days after getting the first dose of the COVID-19 vaccine. DC home after re-hydration and antiemetics given.  CT Abd/chest  :1. Mild to moderate colonic diverticulosis without evidence for diverticulitis. No bowel obstruction. 2. Patchy basilar atelectasis with worse involvement of the right lowerlobe, superimposed infection not excluded. Additional findings as discussed. Admit to medsurg ward 28 Jan 2021
Pt developed rash on arm and fever day after receiving FLUVIRIN and PNEUMOVAX went to ER, given IV fluids, BENADRYL and antibiotics.
none.  He received what was thought to be his second dose because the actual second dose was not yet in system at the time he came to us on 1/26/22.  This patient got three doses of 0.5mL Moderna
I felt ok the afternoon of the vaccine but woke up past 4:30am with fever, chills, body aches in my hips, an arm that was not only sore but extremely tender to the touch, and pain shooting down my nerves seemingly randomly. Neither Tylenol nor aspirin helped relieve the pain. I couldn?t sleep because of the pain but I stayed in bed because standing up gave me a headache and fatigue.  This lasted about 36 hours and then subsided quickly over the next ten hours. I slept a lot when I finally felt relief. Day three I?m basically well with a slightly sore arm and slight fatigue left.
arm pain, extreme sensitivity in finger tips, poor blood flow to hands and feet, numbness in right arm
Went to be seen at clinic for pain in collar bone. Xray showed arthritis in shoulder ac joint. And a month later had pain in knee and xray showed arthritis. So thinking arthritis flared up from covid shot.
Injection site pain 3 days; Swelling 1 day; Hives 2 days; Muscle tenderness still occuring
Child was in long line in crowded gym after receiving vaccines, stated to Mom felt tingly, hot and he collapsed onto floor. Bystanders heard his head hit onto the hard floor, one person thought his body shook. 911 called, BP WNL, PERL to light, oriented to person and place.  Able to speak, remained on floor with EMS volunteer holding neck still due to possible head trauma. Color pale back to pink quickly, no respiratory distress noted. EMS did transport to ER.
Patient woke Monday morning to a very sore arm, neck and back. She stayed bedridden all day and was very lethargic. Noticed swelling in afternoon 11/08/2021. Progressively got worse until this morning 11/10/2021. Very swollen lymph nodes. Patient stated she has no collar bone and under her armpits the lymph nodes are very enlarged.
getting sick; hypochondriac; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "getting sick"; ILLNESS ANXIETY DISORDER (non-serious), outcome "unknown", described as "hypochondriac".  Additional information: Adverse event: Listening to Podcast. One of the hosts said has had a cold/ allergy for two weeks, that they were unsure which one. They did not have a sore throat or fever and sneezed at least once on the show. The other host is a hypochondriac and thought were getting sick. Likely both individuals are vaccinated. The show released 24Jun2021. Individual has gone through approximately 75 tissues in 37 mins of episode. Approximately one full 65 tissues tissue box plus around 10 more tissues. Had listened to podcast yesterday but did not hear this.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Muscle pain and rash at injection site, both lasting for 3-4 days.  Body and joint aches lasting 1 1/2 days. Feeling of being too warm, tiredness and chills lasting 1 1/2 days.  Did not seek treatment since I knew these were normal reactions that would subside.  Most of the side effects only lasted a day and a half except for the arm soreness and rash at the injection site which lasted 3-4 days.
Patient got a headache, fever and broke out in a macular rash with petechiae.  He was seen two days later at ER and given steroids for 5 days with some improvement. After a couple of days patient's rash worsened so was seen in clinic again. Diagnosis given was vasculitis with differential diagnosis of drug induced purpura vs HSP.
Patient woke up in the middle of the night after receiving the Shingrix shot feeling awful: body aches, nauseated, dizzy. Her arm hurts terribly. These symptoms continue through today which is day 4. She also developed a deep red rash at the injection site as well as excess gas and loose stools and her ears feel full. The red rash on her arm began to itch on day 4. She is not feeling better as of yet: the body aches, nausea, light headedness, arm pain, gas and loose stools, ears full...all continue. Reporting because mom asked me to. These side effects are only supposed to last 2-3 days.
Patient experienced redness, pain, and swelling on right arm in approximate area of injection site on 10/4/18. She saw her primary care physician that day and was prescribed triamcinolone 0.1% cream twice daily, azithromycin 250mg 5 day dose pak, and tramadol 50mg twice daily.
MENVEO WAS ADMINISTERED ONLY VIAL # 1. VIAL # 2 WAS NOT MIXED OR ADMINISTERED
Extreme weakness; a lot of diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Extreme weakness) and DIARRHOEA (a lot of diarrhea) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced ASTHENIA (Extreme weakness) and DIARRHOEA (a lot of diarrhea). At the time of the report, ASTHENIA (Extreme weakness) and DIARRHOEA (a lot of diarrhea) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided