chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose on 08 MAR 2021, 2nd dose on 04MAY 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 08 MAR 2021, 2nd dose on 04MAY 2021) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 048A21A) for COVID-19 vaccination. The patient's past medical history included COVID-19. Concurrent medical conditions included Breast cancer since 01-Nov-2014.On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 08 MAR 2021, 2nd dose on 04MAY 2021). On 04-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 08 MAR 2021, 2nd dose on 04MAY 2021) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2021, SARS-CoV-2 test: positive (Positive) COVID-19 PCR TEST POSITIVE.No concomitant medication information was provided by the reporter. This case concerns a 65 year old female with no relevant medical history reported, who experienced Non-serious event of Inappropriate Schedule of Product  Administration after vaccination  with the 1st and 2nd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine). The interval  perioid   between the 1st and the 2nd dose was  1 month and 27 days. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine is not affected by this report. This case was linked to MOD-2021-386734 (Patient Link).; Sender's Comments: This case concerns a 65 year old female with no relevant medical history reported, who experienced Non-serious event of Inappropriate Schedule of Product  Administration after vaccination  with the 1st and 2nd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine). The interval  perioid   between the 1st and the 2nd dose was  1 month and 27 days. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine is not affected by this report.
pt recvd flu vax & w/in 10mins exp numbness of the lips & tongue; pt described rxn as similar to rxn had to inj of Lupron 1 1/2 yrs ago; sx resolved spontaneously w/in 15 to 30 mins;
Urticaria within 24 hours of administration, without other exposure. Went to ER, given hydroxyzine Rx. Took BENADRY at home. Give prednisolone by PCP on day #3.
died of pulmonary complications resulting from pneumonia; died of pulmonary complications resulting from pneumonia; Initial information was received on 18-Dec-2020 regarding an unsolicited valid serious social media case from a consumer/other non-professional (patient wife).   This case involves male patient (of an unknown age) who died due to pulmonary complications resulting from pneumonia (pneumonia) and (lung disorder), after vaccination with INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site.    On an unknown date, the patient had serious pulmonary complications resulting from pneumonia (pneumonia) and (lung disorder) (within a week) following the administration of INFLUENZA VACCINE. These events were leading to death. The event pneumonia was assessed as medically significant. It was unknown if the patient experienced any additional symptoms/events.  The reporter stated that, do not trust anything medical without knowing all ingredients and side effects.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  It was unknown if an autopsy was done. The cause of death was reported as Pneumonia and Lung disorder.  Information on the lot number was requested.; Sender's Comments: This was a poorly documented social media case involving a male patient (of an unknown age) who had pneumonia and lung disorder and died from it, after receiving INFLUENZA VACCINE from unknown maufacturer. Time to onset is unknown. Additional information regarding patient's relevant medical history, health condition at the time of vaccination, laboratory tests ruling out other alternate etiologies and autopsy results is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: died of pulmonary complications resulting from pneumonia; died of pulmonary complications resulting from pneumonia
A report has been received from a physician concerning an adult female subject, who had been receiving FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The patient experienced arm muscle pain. The outcome of the event of arm muscle pain is unknown. The report was considered to be non-serious.
Dizzyness, almost fainting, loss of appetite...headaches all day 3-5 after shot....loss off appetite, over 7 days
Arm progressively more sore throughout the day. Chills started around 9:45 pm. Body aches throughout the night, difficulty sleeping. The following day (1/28) headache and fatigue. No symptoms on 1/29
Patient presented to the ED with complaints of blurred vision. She was found to be hypernatremic which is something she has had in the past. She was discharged back to a SNF after 4 days in stable condition.
Pt received Varicella vaccine 04/20/2001, then 07/2001 had Varicella and spread to uncle.
Patient was asymptomatic for COVID-19 according to her husband and was admitted to the hospital for heart related issues
Approximately 1.0 hours after injection on Flulaval Lot#AFLLA029AA given IM patient developed diffuse erythema to back with scattered raised wheels. Scattered patches of same to both arms. NKDA. No other signs or symptoms of adverse reaction. No known exposures to new environmental elements. Symptoms responded well to Benadry by mouth.
Patient states he received the Moderna vaccination plus the booster, unable to provide dates.  Patient acquired Covid-19 during hospitalization - prolonging their overall stay.
Information has been received from a nurse concerning a 68 year old female with diabetes who on 17-MAR-2011 was vaccinated SC with the first 0.5 ml dose of MMR II (Lot number:668233/0831Z; Expiration date:24-JUN-2012). Concomitant therapy included insulin (manufacturer unknown). The nurse reported that the patient developed "mild tiny, red spots" on her abdomen and both arms on 30-MAR-2011. The patient also "felt warm". The rash was not itchy. The patient contacted the nurse by phone. The patient was not given treatment. None of lab diagnostics studies performed. Upon the time of the report, the patient's present status was not recovered. Additional information has been requested.
SICK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 18-MAR-2021, the subject experienced sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick was not reported. This report was non-serious.
NAME:  Removed Last Day Worked: 8/13/21, sick 8/16/21 Dept: RT Symptoms: cough, sneeze, stuffy nose started 8/18. S/s resolved 8/23 Covid Vaccine Series: completed 4/2021 Covid tested: 8/21/21, results: POSITIVE Medications: none S/S resolved: yes, 8/23/21 Son was cleared from quarantine and currently back in school. was tested covid pos 8/21 and done with quarantine 8/28/21. asymptomatic since 8/23/21. has not taken any fever reducing medications for over 24hrs. calling for clearance. does not have a PCP- he retired. did not call hotline to report covid pos results or symptom resolution. Advised to seek clearance at clinic.
The left cheek and eye are extremely swollen.  Have had Juvederm injections previously.
Pain in arm; This is a spontaneous report from a contactable other health care professional (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el9261 and expiration date not provided), via an unspecified route of administration (left arm) first dose on 25Jan2021 15:00 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient was not pregnant at time of vaccination. On 26Jan2021 04:00, the patient experienced pain in arm.  The patient did not received treatment for then event. The outcome of the event was recovering. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No medication was taken within 2 weeks of vaccination.
No additional AE reported; Nurse reported two temperature excursions on multiple refrigerated vaccines.  There was a prior excursion on 5/3/2022 and a recent excursion on 5/26/2022.  She said it was very likely all vaccines had been administered since the excursions occurred.; This spontaneous report has been received from a nurse, concerning a 03-months-old male patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-MAY-2022, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # U026664, and Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot# U029145 experienced a temperature excursion of 47.3 Fahrenheit degrees (F) for 5 minutes; additionally on 26-MAY-2022 experienced an additional temperature excursion of 35.2 F for 56 seconds. If a digital data logger was involved was not reported (product storage error).   Consequently, on 31-MAY-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number reported as U026664 confirmed as valid, expiration date reported and stablished as 24-FEB-2023) administered orally (formulation, strength, dose, vaccination scheme were not provided) and with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB (lot number reported as U029145 confirmed as valid, expiration date reported and stablished as 30-MAR-2024) (formulation, strength, dose, vaccination scheme, route of administration and anatomical location, lot number and expiration date were not provided), both administered as prophylaxis (product storage error). No additional adverse events (AE) reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001103:
Pt received pfizer 2nd booster dose on 5/2/22 at 620pm.. he stated that 10-15 minutes after receiving vaccine he had bad diarrhea. When he got home about 30 minutes after vaccine he experience extreme nausea and vomiting.  He states to have been vomiting every 5 minutes till about 2am or 3am.   Pt claims to have spoken to MD office around 2am on 5/3 and also to a 24 hour pharmacy.  Pt is doing better on 5/3 around 11am- still experiencing some diarrhea and appetite is not back to normal, however seems to be doing much better than the night before.   He is trying to stay hydrated by keeping up with water intake.
after that was tested and had a positive result for the disease/After the Booster dose / patient´s lab values revealed a positive HBs Ag value; booster dose of Engerix-B / tested and had a positive result for the disease/After the Booster dose / patient´s lab values revealed a positive HBs Ag value; after a primary hepatitis B vaccination series and they came back borderline low (as reported); This case was reported by a physician via call center representative and described the occurrence of hepatitis b in a female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis, HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B, the 2nd dose of Engerix B, the 3rd dose of Engerix B and Engerix B. On an unknown date, unknown after receiving Engerix B, Engerix B, Engerix B and Engerix B, the patient experienced hepatitis b (serious criteria GSK medically significant), vaccination failure (serious criteria GSK medically significant) and therapy non-responder. On an unknown date, the outcome of the hepatitis b, vaccination failure and therapy non-responder were unknown.   It was unknown if the reporter considered the hepatitis b and vaccination failure to be related to Engerix B, Engerix B, Engerix B and Engerix B.  Additional details were provided as follows: The age at vaccination was not reported. The patient had low levels of antibodies for hepatitis B virus, hence patient received booster dose of engerix B. After that the patient was tested and had a positive result for the disease. It was reported that the patient had been tested for antibodies after a primary hepatitis B vaccination series and they came back borderline low (as reported) and hence, the patient was given a booster dose of hepatitis B vaccination with Engerix B. After the Booster dose, (number of days not reported) the patient´s lab values revealed a positive HBs Ag value. The reporter consented to follow up.  This case was considered as suspected vaccination failure since the details regarding time to onset was unknown.
Went to PCP. Chronic Hives. Referred to allergy and asthma specialist. Treated with Xolair shots. Hives got . better. Also diagnosed with Dermatitis and exzema. Itchy bumps all over body. On Dupexit. Suspected over-active immune system. Symptoms continued and worsened with 2nd vaccine (IM, RA, Pfizer EW0153, 04/15/2021).
Entire body covered in hives.  Took one dose of Benadryl and the hives went away that same day.
Patient is heavy set with a large amount of fat on the arm.  The injection was given in the fat below the left deltoid.   Injection site reaction occurred the next day.
Patient was initially admitted to Medical Center on 02/04/2022for ortho surgery for ongoing issues with a left hip wound.   On 01/17/2022 she tested positive for COVID and went to Facility for treatment and was transferred to medical center for ongoing concerns of her left hip wound.  She had surgery on 2/7 for debridement of the left hip.  Postop she required vasopressor support.  She became obtunded and required intubation on 2/9/22.  On 2/11 she required a CT PE scan for concern of pulmonary embolism, the scan did not show a PE.  She also had an active GI bleed.  She was seen by ID and was started on Zosyn and Zyvox and evaluated for CKD IV.   Her renal function continued to decline and was started on CRRT.  She was weaned from sedation and continued to be very minimally responsive.  EEG showed no electrical activity indicative of global cerebral dysfunction.  On 02/17/2022 the patient was transitioned to comfort care measures, was extubated and expired on 02/17.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 07Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 03Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 20Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 12Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic urticaria" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN, start date: 01Sep2010; LORATADINE, start date: 01Dec1998; BUPROPION. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No Known allergies. The patient received Anti-Viral treatment with Paxlovid for Covid-19 started on 10Apr2023 and stopped on 14Apr2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The contributory role of the suspect product to the reported drug ineffective cannot be excluded as the efficacy of a drug varies individually and may be affected by different factors including drug potency.
I was given a flu and pneumococcal vaccine, one in each arm. I developed body aches, redness and hard swelling at pneumo injection site; worsened over 48 hours to fever, chills with intermittent shivers while I was out of state at a conference. Hard red area of injection site was so painful I could not sleep on that side for 3 nights. Left conference early to return home to recover. On Monday, 11/24, I reported this to Drs office, was given a same day appt and was advised I may have cellulitis. I was given an antibiotic which has improved swelling, redness and pain.
Information has been received from a physician concerning a 6 month old male who on approximately 05-JUN-2007 was vaccinated with third dose of Rotateq (LOT# 654248/0577F). Concomitant vaccines included DTaP (also reported as "Betap") and poliovirus vaccine. On 05-JUN-2007, the physician reported that the patient experienced "fussiness and wasn't eating". The parents took him to the emergency room (ER) and he was released with a diagnoses of "some gastrointestinal problems". The patient was also vomiting and had diarrhea and was taken to the pediactrics' office the next day and the physician checked him and sent him home. On 06-JUN-2007, the patient was still vomiting and had diarrhea and was again taken to the ER and was admitted with a diagnosis of "intussusception", he had an 'air contrast enema" done twice and "it helped him". The patient was discharged 24 hours later on 07-JUN-2007. The patient's outcome was reported as recovered. The physician considered intussusception to be an other important medical event. Additional information has been requested.
Client called with c/o neck stiffness 2 days after receiving yellow fever vaccine. She denies any other symptoms such as fever, vomiting, vision changes, parasthesias or weakness. She does report a local reaction around the injection site. She cannot attribute the neck stiffness to exercise, strenuous activity, or sleeping on it wrong.
Pt has warm, red, tender (L) arm after getting PNEUMOVAX and Tdap in (L) arm 2 days ago. It was achy, sore, and is worse today. The redness is spreading and extending down her arm.
heavy hair fall/hair falling out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "Hair loss".  The following information was reported: ALOPECIA (non-serious), outcome "not recovered", described as "heavy hair fall/hair falling out".  Additional information: The patient was a performance artist who had experienced hair loss after receiving the Pfizer COVID-19 vaccine, she had spent a lot of money trying to prevent that hair loss but had not managed to prevent it. The side effect started after receiving the first dose of the vaccine and then worsened with subsequent doses. She got her shots at and wanted to know what therapeutic alternative or what kind of help can be provided for her problems.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fever, chills, headache, neasea, fever, swelling & redness at injection site, dizzy
One day after receiving vaccine right arm was sore and had a red raised hot lump which measured 3 inches by 2 inches.  it was below the site of the injection by about 2 inches.  Today is two days after injection and it is still there.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with unspecified improperly stores doses of ROTATEQ Oral liquid, orally, which had a lot # of L010844, and an expiration date of 16-NOV-2016 (concentration, dose, and anatomical place of vaccination were not provided). Which were exposed to a temperature of 32.7 F for 31 hours. There were no previous excursion and a data logger was involved. Information regarding concomitant therapies was not reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
no appetite; cough; feels sick; exhausted; passed out; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (passed out) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced PRESYNCOPE (passed out) (seriousness criterion medically significant). On an unknown date, the patient experienced DECREASED APPETITE (no appetite), COUGH (cough), MALAISE (feels sick) and FATIGUE (exhausted). At the time of the report, PRESYNCOPE (passed out), DECREASED APPETITE (no appetite), COUGH (cough), MALAISE (feels sick) and FATIGUE (exhausted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication includes naproxen.   Patient received the first dose of the Moderna Covid 19 vaccine (Lot:045B21A, expiration:Unknown) on 26APR2021 at a pharmacy. After the administration of the vaccine, patient passed out at a pharmacy and he had to wait there for 45 minutes. Since the administration of the vaccine patient has been exhausted, has no appetite, cough, and overall, just feels sick. Patient took Aleve to help alleviate his symptoms.