chrisvoncsefalvay/vaers-outcomes huggingface dataset:
exactly one day later I felt was feeling severe fatigue, nausea, headache at the base of my head and diarrhea for 1.5 days; exactly one day later I felt was feeling severe fatigue, nausea, headache at the base of my head and diarrhea for 1.5 days; exactly one day later I felt was feeling severe fatigue, nausea, headache at the base of my head and diarrhea for 1.5 days; exactly one day later I felt was feeling severe fatigue, nausea, headache at the base of my head and diarrhea for 1.5 days; This is a spontaneous report from a contactable health care professional nurse, the patient. A 37-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE),  intramuscular in the left arm  on 30Dec2020 13:00 as a single dose for COVID-19 vaccination. The patient had no known medical history or allergies. Concomitant medication included sertraline hcl (ZOLOFT). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested .  Facility where the most recent COVID-19 vaccine was administered was at a Hospital. On 31Dec2020 13:00, the patient experienced exactly one day later I felt feeling severe fatigue, nausea, headache at the base of my head and diarrhea for 1.5 days. No treatment was given for the events. The clinical outcome of feeling severe fatigue, nausea, headache at the base of my head and diarrhea was recovered.  Information regarding lot number has been requested.
Pregnant; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (Patient was using 1 glass per month.) in June 2020. Concurrent medical conditions included Mitral valve prolapse since 2010 and Social anxiety disorder (Social Anxiety). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMIN [MINERALS NOS;VITAMINS NOS]) from June 2020 to an unknown date for Pregnancy, FLUOXETINE HYDROCHLORIDE (PROZAC) from June 2017 to an unknown date and PROPRANOLOL HYDROCHLORIDE (PROPRANOL) from June 2020 to an unknown date for Social anxiety disorder.    On 30-Dec-2020 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 18-May-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was pregnant on 12-Aug-2020 and at the time of vaccine administration patient was 20 weeks pregnant.  Treatment information was not provided.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 36-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
brief & limited tonic-clonic convuls w/LOC 10 mins p/IM inject;
8 days post vaccination, injection site is suddenly red, swollen, hard and warm to touch.
I got the shot and went to work for four days straight and had no problems, then that weekend I had a fever, chills, and felt kind of week, and dizziness, and severe fatigue. It has been two weeks since then, and I'm still feeling fatigue, and I have not had a proper bowel movement in two weeks. Diminished appetite.
Patient reports wheezing, dry mouth, coughing 2 hours post injection. Beginning approximately 5 hours post injection, began having worsening headache, fever, sore throat and body aches. All symptoms resolved 48 hours later.  No medical treatment received.  Patient treated symptoms with Tylenol.
Tested positive for Covid-19 on 09/20/2021; mild respiratory symptoms, fatigue, loss of appetite
Acute headache developed approximately 8:30a.m. the following morning. Extreme nausea onset approximately 11:30a.m. Arm extremely sore, began approx. 8 pm the night of injection.
Dose administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered past the published expiry date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Oct-2021, the patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered past the published expiry date). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. No treatment medication was reported by reporter.  Vial was removed from refrigerator on 15-Oct-2021, 08:00.
Fatigue; General pain at site of injection; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FATIGUE (Fatigue) and VACCINATION SITE PAIN (General pain at site of injection) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue) and VACCINATION SITE PAIN (General pain at site of injection). At the time of the report, FATIGUE (Fatigue) and VACCINATION SITE PAIN (General pain at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication were provided.
Please see accompanied occurrence report form. Pt spouse phoned in this am to state that pt had an adverse reaction to the imm. received on 11/26/08. She stated that she was concerned as he had received  FLUZONE and PNEUMOVAX in the same arm (L). Upon review of pt. record these two imm. were given in separate arms. She states that pt. had swelling and redness from the elbow to the shoulder and that the area was hot to touch. She states that she gave him Benadryl and that she was concerned as the patient had lost mobility to the affected arm for 3 days. The patient did not seek medical attention. When I offered an appt. for eval. of the arm she refused stating that the patient was better. She stated that she was concerned because the FLUZONE and PNEUMOVAX shots were given in the same arm and shouldn't have. I encouraged her that I appreciated her concern and that I planned to speak with the nurse, the physician involved as well as Administration to let them know of the incident. I also encouraged her that we would discuss this issue at our next nurse meeting and that maybe a better thing to do in the future is to request for the pt. to come back in a week for the 3rd imm. injection (Patient had BOOSTRIX , PNEUMOVAX AND FLUZONE shot ordered on 11/26/08). She thanked me for my time and I also told her that I would additionally contact VAERS to see if anything additionally needed to be done 12/5 Adverse reaction state # contacted. 12/9/08 VAERS form completed and mailed.
Small raised bump with left arm area reddish in color as if a light rash. Raised area itchy.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 73-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included herpes zoster (multiple zoster virus outbreaks). On 29th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. On 12th April 2018, 14 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX in the left deltoid. Two weeks after receiving SHINGRIX, the patient experienced shingles. The patient took Valtrex for treatment. The administering pharmacist instructed her to keep moving her arm after the vaccine was administered and she did not experience any injection site reactions. The patient missed to receive 2nd dose of SHINGRIX, which led to incomplete course of vaccination.
Developed bilateral PE. Then died; Developed bilateral PE. Then died; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 Immunization. The following information was reported: DEATH (death), outcome "fatal", PLEURAL EFFUSION (medically significant), outcome "unknown" and all described as "Developed bilateral PE. Then died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received. Sender's Comments: The event indicating an unknown cause of death is assessed as related by the company until sufficient information is available to confirm an unrelated cause of death   The impact of this report on the benefit/risk profile of the Pfizer drug 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.; Reported Cause(s) of Death: Died.
Information has been received from a physician, concerning a patient whom a colleague indicated had been vaccinated with a dose of Gardasil (date, route, lot # not reported), and "in the past year" developed "medium vesicle vasculitis." No further details were reported. The outcome of the event was not specified. This is one of several reports received from the same source. This is a hearsay report in the absence of an identifiable patient. Attempts are being made to verify the existence of a patient.
Woke up feeling extremely exhausted with body aches and fatigue. Spent a majority of the day sleeping with fatigue.
vaccination site pain; lump arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain), MASS (lump arm) and FATIGUE (Fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A. and 002A21A) for COVID-19 vaccination.     The patient's past medical history included Kidney transplant and Urinary tract infection from 20-May-2021 to 21-May-2021. Concomitant products included RABEPRAZOLE for Acid reflux (oesophageal), CEVIMELINE for Dry mouth, VITAMIN B3, CRANBERRY [VACCINIUM MACROCARPON], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), TACROLIMUS, MYCOPHENOLIC ACID, PREDNISONE, PRIMIDONE, ROSUVASTATIN CALCIUM, FLUOXETINE HYDROCHLORIDE (PROZAC), LORAZEPAM (ATIVAN), HYDROCODONE, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]) for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain), MASS (lump arm) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; FLUCONAZOLE (DIFLUCAN) at an unspecified dose and frequency; ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency; PROMETHAZINE (PHENERGAN [PROMETHAZINE]) at an unspecified dose and frequency; PHOSPHORUS at an unspecified dose and frequency and DOXYCYCLINE at an unspecified dose and frequency. On 16-Feb-2021, VACCINATION SITE PAIN (vaccination site pain) and MASS (lump arm) had resolved. At the time of the report, FATIGUE (Fatigue) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Endoscopy: candida candida in her throat. On an unknown date, Renal function test: normal normal (normal) normal. On an unknown date, Sigmoidoscopy: normal normal (normal) normal.         Treatment information also included fluids.   This case was linked to MOD-2021-169159 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: follow up received on 25-may-2021 contains Non significant follow up
Initial unsolicited report received from other non-health care professional on 10-Oct-2017. This case involves a 66-year-old male patient who was vaccinated with 0.5 ml second dose of FLUZONE HIGH-DOSE (frequency once, batch number: UI824AA, expiration date and site of administration was not reported) via intramuscular route on 10 Oct 2017 in morning. The patient's medical history and concomitant medications were not reported. It was reported that, the patient was not allergic to eggs or other ingredients known to be in vaccine. On an unspecified date (also reported as this afternoon), following the vaccination, the patient experienced difficulty breathing and he could not take a deep breath. Lab data was not reported. The patient received corrective treatment with 2ml of DEXAMETHASONE (Decadron) and 0.5ml EPINEPHRINE (epinephrine) and had him sit in a treatment room for 30 minutes until they were sure his symptoms resolved. On an unspecified date, the patient recovered from events. Upon internal review, the company decided to consider the event serious because of important medical event difficulty breathing. List of documents held by sender: none.; Sender's Comments: Difficulty breathing was reported following FLUZONE HIGH-DOSE. Time to onset is compatible with the role of vaccine. Patient treated with 2ml of Decadron and 5ml epinephrine. More information regarding patient's medical history, previous history of similar episode, confirmation regarding diagnosis and investigation reports is needed for complete assessment. Based on the available information role of vaccine cannot be excluded.
Soreness at injection site, fever, extreme fatigue, dizziness, fast heart rate. 24 hour duration
Patient reported side effects of whole body aches within 24 hours of second dose and it lasted about 24 hours.
EMPLOYEE HAD RECEIVED FIRST DOSE OF PFIZER VACCINE ON 12/9/2020. PRESENTED TO CLINIC AND WAS VACCINATED WITH MODERNA FIRST DOSE ON 1/8/2021. EMPLOYEE ADMITTED SHE CIRCUMVENTED THE REGISTRATION PROCESS BECAUSE SHE DID NOT WANT TO DRIVE TO THE ORIGINAL LOCATION NOT REALIZING THIS WAS A DIFFERENT VACCINE. MONITORED FOR A 30 MINUTE PERIOD AND WAS RELEASED.
Patient unintentionally received a third COVID-19 vaccine that has not yet been approved in children her age.
pt recv vax in the AM;1 to 1.5hr later pt devel redness & swelling @ the inj site, chills, & became flushed;this is 1 of 12 pt from this site to have an adverse rxn;
Day 1-5: Fever onset, became "spacy" - would not respond to interaction as previous, diaper rash formed (had never had this before).  Day 6: Fever still at 102, Infant Tylenol administered. Day 6 night: Restlessness - not sleeping through the night any longer. Day 7: Woke up at 4am. Would only nap for about 1/2 hr at a time. VERY fussy. Would scream for 45 minutes. Began to not eat. Day 8: Went to Dr. and explained what happened. Dr. made excuses and tried to talk me out of it. Day 9-10: Double ear infection, Sore throat. Diarrhea. Diaper rash.  Day 11- 18: Not eating well, loss of appetite. Losing weight. Diarrhea and diaper rash continued.  Lot # FF723
Itchy; Chills; sore eyes; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female (non pregnant) patient received first dose of Pfizer BNT162B2 (BNT162B2, Solution for injection, Lot number; EN6203 and expiry date was not provided) via an unspecified route of administration,  administered in left arm region on 25Feb2021 16:15 (at the age of 54-year-old) as single dose for COVID-19 immunisation.  Patient was not pregnant at the time of vaccination. Patients medical history includes known allergies to Penicillin. The concomitant medications were not provided. The patient was not diagnosed with COVID prior to vaccination. And  patient had not tested for COVID post vaccination. On 26FEB2021 12:00 AM, the patient experienced itchy, chills and sore eyes. No treatment was taken for the events. The outcome of the events was reported as not recovered.  No follow up attempts are possible. No further information is expected
I did not have an reaction to the vaccine. On 08/13/2022 I started feeling systems like scratchy throat, congestion, fever, achiness and tired. I tested positive for COVID-19 on 08/13/2022 which was negative put tested positive for COVID-19 at health clinic on 8/14/2022. I was prescribed PAXLOVID and felt much better within a day. As of today, I'm feeling better.
Breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced EXPOSURE VIA BREAST MILK (Breastfeeding). At the time of the report, EXPOSURE VIA BREAST MILK (Breastfeeding) had resolved. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable.  no concomitant drugs included no treatment drugs included; Reporter's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.
Information has been received from a retired Registered Nurse concerning a few patients who were vaccinated with pneumococcal 23v polysaccharide vaccine. Subsequently, the patients experienced a sore arm after receiving the vaccination. No further information is available.
Tired after vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was unknown.   It was unknown if the reporter considered the tiredness to be related to Shingles vaccine.     Additional Information: Reporter's comment: This case was reported by a patient via interactive digital media. The patient was tired after taking vaccine.  Additional Supportive Information: Follow-up would not possible as no contact details were available.
Tongue itching (given 25 mg benadryl) in 1 hr 45 min progressed to throat swelling (patient self admin epi pen  while in car) drove to ER and given IV steroids. At time of report still mild tongue itching + headaches        Some dizziness, MD followup 2-12-21.
swollen hand; itching in her hand; big red spot; hot; burning; getting bigger and more red; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen hand), PRURITUS (itching in her hand), RASH MACULAR (big red spot), FEELING HOT (hot) and BURNING SENSATION (burning) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history provided.  Concomitant products included ZINC for Supplementation therapy, ASCORBIC ACID, BIOFLAVONOIDS NOS, HESPERIDIN, MALPIGHIA GLABRA, ROSA CANINA, RUTOSIDE (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS;HESPERIDIN;MALPIGHIA GLABRA;ROSA CANINA;RUTOSIDE]) for Vitamin supplementation.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen hand), PRURITUS (itching in her hand), RASH MACULAR (big red spot), FEELING HOT (hot), BURNING SENSATION (burning) and ERYTHEMA (getting bigger and more red). At the time of the report, PERIPHERAL SWELLING (swollen hand), PRURITUS (itching in her hand), RASH MACULAR (big red spot), FEELING HOT (hot), BURNING SENSATION (burning) and ERYTHEMA (getting bigger and more red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient states that she read on CDC website, where 14 people were reported with same reactions   Received vaccine at her home.  No treatment information provided.
Swelling & tenderness on left collarbone (same side as vaccine).  Symptoms of tenderness subsided after several days.  Swelling was diminishing each day.  Slight swelling in collarbone still remains approximately 3 weeks later.
PALPITATIONS; HEADACHE; FEVER 102 F; This spontaneous report received from a patient concerned a 26 year old male. 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: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced palpitations. On 14-MAY-2021, the subject experienced headache. On 14-MAY-2021, the subject experienced fever 102 f. Laboratory data included: Body temperature (NR: not provided) 102 F. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, fever 102 f, and palpitations. This report was non-serious.