chrisvoncsefalvay/vaers-outcomes huggingface dataset:
woke up with little aches; Dizzy; Little breathless; Heart goes pumping; Nervous; Very tired; I don't know if I'm dehydrated; Not feeling well; This is a spontaneous report from a contactable consumer (patient). A 77-year-old patient of unspecified gender received bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 14Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient  received the COVID vaccine on Thursday, 14Jan2021. The patient was doing well on the day of vaccination. The following day, 15Jan2021, the patient was very tired. At the morning of the report, 16Jan2021, the patient woke up with little aches, tired, but they don't know what it was. The night before, 15Jan2021, the patient got a little get upset from something, a door man, or some noise. But all of a sudden, they got a little breathless, and I felt little dizzy. And the patient had some orange juice, (Beverage company name withheld) and a little cereal. The patient commented, "I guess, it's the dizziness, lightheaded and you know, your heart goes pumping a little, a little dizzy and things like that. So, I just thought I'd call." The patient added, "I have Allegra here, I didn't take it though. I have a little (Beverage company name withheld). I just got a little nervous, I live alone and except the (Beverage company name withheld). I hope, I don't know if I could go or act to sleep or just a little lightheaded, you know, breathless and dizzy and I wasn't sure of that. And it's two days, Thursday afternoon and it's Friday. I don't know, this is strange, I don't know if I'm dehydrated or this reaction to the vaccine, Pfizer. I can't tell you, I am just a little scared. I am not feeling well, and I wanted to know if there is anything dangerous? Or anything I can do?" The patient's second dose was scheduled on 04Feb2021. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Patient up to date on COVID vaccinations, last dose 08/23/21, who admitted with complications of COVID.  Provider discharge note below:  " 86 year old male who presents to ED with shortness of breath in setting of home COVID test positive. States that his wife who lives in an assisted living facility tested positive for COVID last Thursday, past medical history of congestive heart failure with preserved ejection fraction, CKD stage IIIB, hypertension, diabetes mellitus Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)  treated fo Acute hypoxic respiratory insufficiency due to COVID infection No radiographic evidence of COVID pneumonia Supplemental oxygen, Decadron,  remdesivir   Chronic CHF with preserved ejection fracture No evidence of exacerbation, continue with Coreg, Lasix, Entresto   Chronic kidney disease - 3b  Stable     Diabetes mellitus type Well controlled, would monitor as patient is on Decadron, last hemoglobin A1 c from 03/22 is 6.3      Elevated troponin due to type 2 NSTEMI -with + delta. No anginal complaints. No EKG changes. Suspect this represents type 2 NSTEMI related to the covid infection. Hold off on heparin and get troponin in the AM. Did receive full dose aspirin in the ER   BPH -continue flomax   Chronic hip pain symptomatic management as needed   Hyperkalemia-mild, patient is on Entresto, low-potassium dietr COVID with hypoxia    Condition at the time of discharge-  vss   Constitutional:  Elderly, no acute distress on 2 L of nasal cannula oxygen HENT:  Normocephalic, Atraumatic, Pupils Reactive, Normal oropharynx, Nose normal.  Cardiovascular:  Normal heart rate, Normal rhythm, No murmurs, No rubs, No gallops.  Respiratory:  Normal breath sounds, No respiratory distress, No wheezing, No chest tenderness.  GI:  Bowel sounds normal, Soft, No tenderness, No masses, No pulsatile masses.  Extremities:  Intact distal pulses, No edema, No tenderness, No cyanosis, No clubbing.  Neurologic:  Alert & oriented x 3,, No focal deficits noted. Skin:  Warm and dry"
Extremely sore left arm/shoulder for about five days, unable to lift arm .  Extreme exhaustion .
vertigo; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 25Mar2021 11:45 (Batch/Lot number: unknown) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "preeclampsia while pregnant" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN B [VITAMIN B COMPLEX]; PROBIOTICS. The following information was reported: VERTIGO (non-serious) with onset 2021, outcome "unknown", described as "vertigo"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea". The events "vertigo" and "nausea" were evaluated at the physician office visit. Therapeutic measures were taken as a result of vertigo, nausea treated with allergy meds, Medrol pack, and physical therapy.  Additional Information: Vertigo and nausea lasted approx. 5 hours. The patient had Birth control medications in two weeks. No any other vaccine was received in four weeks. No Covid-19 was reported prior to the vaccination. No Covid-19 tested post vaccination. No known allergies  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Client vaccinated with Pfizer vaccine for Covid on March 17 (approx.) and April 17 (exact) 2021.  Developed Covid symptoms on 10/7/2021 - nasal congestion, cough, sore throat, mild SOB.  Tested + for Covid on 10/8 with PCR test.
COAGULOPATHY, UNSPECIFIED TYPE 12/25/2022  &  1/5/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
3rd dose given; This case was reported by a other health professional via sales rep and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st and 2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 18-OCT-2022 Reporter's comment: The patient received third dose of Shingrix vaccine. The reporter consented to follow-up. Additional Supportive Information: The patient received third dose of Shingrix vaccine, which led to extra dose administered.
No adverse event; Adult patients received pediatric doses -6 years to 11 years doses- of the Moderna COVID19 vaccine instead of bivalent booster doses; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Adult patients received pediatric doses -6 years to 11 years doses- of the Moderna COVID19 vaccine instead of bivalent booster doses) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Sep-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Adult patients received pediatric doses -6 years to 11 years doses- of the Moderna COVID19 vaccine instead of bivalent booster doses). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Adult patients received pediatric doses -6 years to 11 years doses- of the Moderna COVID19 vaccine instead of bivalent booster doses) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Adult patients received pediatric doses -6 years to 11 years doses- of the Moderna COVID19 vaccine instead of bivalent booster doses).    No concomitant medications were reported. Patient received booster dose. No treatment medications were reported. The case consisted information for the second adult patient.
Onset of large area erythema over right deltoid, extending onto upper triceps area, small area lymphadenetic change rear superior aspect of erythemous axillary lymthadenopathy. Hx previous localized reaction with induration on dose #3. Can't rule out secondary cellulitis.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 17-NOV-2015 at time- 16:31, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 4.1 and 2.9 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
At 9:45 p.m. client rpts that she became instantly "chilled" and her teeth were chattering so much that she couldn't even talk. Temp 99. Stiff neck, nausea/vomiting x 4, dizziness. Next day she had extreme myalgia as with influenza. Referred to PMD on 7/23/07.
I had a uti and was prescribed an antibiotic Nitrofurantoin on 1/23/2021 -didn't start it until the next day - finished the antibiotic - 1/28/2021.  On 2/1/2021  I started to feel sick, I had chills, temp 99.5-99.7 rash - at first just around hips, buttocks lower abdomen - areas of erythema that was raised and indurated largest area was about 8 cm diameter, very itchy, later that day  swollen hands, feel, large tender lumps that were normal skin color.   A few hours later I developed macular rash to top of my shoulders, itchy and tender - looked and left like a sunburn. ( but no sun exposure !)  My wrists , hands, elbows were sore.  As the rash on my lower torso improved I had a second outbreak abdomen ,   I took benadryl 25-50 mg every 8 hours.  I contacted my employee  occupational health - discussed with them - at the time  I was concerned about whether they wanted me to be tested for covid - I am a healthcare worker . At the time we both thought may be it was the nitrofurantoin. I also asked about whether I should hold on my 2nd vaccine- but by this time rash was much better, chills were gone, joint pain and swelling improved. Occupational health recommended I get 2nd vaccine. On 2/4/2021 I got 2nd vaccine, no new symptoms that day. Next day 102.5 fever but rash was almost completely gone and no longer itchy.  On 2/6 .2021 rash came back but much worse, same symptoms , rash more wide spread, hive like rash with white border pink in center, various sizes but including breasts , thighs, buttocks abdomen, and starting on my arms but no joint pain. I was taking benadryl 50 mg every 4  hours without much relief and pepcid 20 mg.  This morning 2/7/2021 I developed facial swelling , lip  swelling, - started on prednisone, now things improving
Case number PHEH2013US022558 is an initial spontaneous report received from a nurse on 25 OCT 2013. This report refers to a 12-year-old male child. He was vaccinated with MENVEO (batch number: X12120) intramuscularly at 0.5 ml on 17 SEP 2013. MENVEO had undergone an excursion to zero degree Celsius for 16 hours; however the vaccine was not frozen. No adverse event was reported following this administration error.
the plunger of the pre-filled syringe broke and cut the nurse's finger; the plunger of the pre-filled syringe broke and cut the nurse's finger; This spontaneous report was received from a medical assistant regarding an unidentified nurse of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 10-OCT-2019, the nurse at the pediatric center administered Hepatitis A Vaccine, Inactivated (VAQTA), lot# S021092 with expiry date of 18-MAY-2020 and the plunger of the prefilled syringe broke and cut the nurse's finger (Wound, Accidental exposure to product, Occupational exposure to product and Exposure via skin contact). It was reported that the plunger rod was pulled back fully, then the barrel broke while administering the vaccine and the defect was noted while administering the vaccine (Product quality issue). The broken Hepatitis A Vaccine, Inactivated (VAQTA) syringe could not be retrieved from the pediatric centre because it was discarded. Outcome and causality of the events were not reported.  This is a non-valid report due to lack of patient identifiers.  Follow-up information has been received from the office administrator on 21-OCT-2019. According with the reporter, the body of the syringe did not break, it was only the finger flange where the nurse placed her thumb what broke. Besides, it was stated that the patient did not miss the dose of the medication, because the nurse used a different syringe for the administration of the medication, the broken syringe was not used on the patient.  As there were no contact between the medication and the nurse the events accidental exposure to product, occupational exposure to product and exposure via skin contact were deleted.  This case was previously considered non-valid but per current process it was determined to be valid as the patient is a female
dizziness for over two days; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness for over two days) and VOMITING (vomiting) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness for over two days) and VOMITING (vomiting). At the time of the report, DIZZINESS (dizziness for over two days) had resolved and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  Patient stated that he cannot got the second dose on time due to the work. Also stated that when he received the first doce he felt dizziness for over two days and vomiting. that is other reason about he doesn't got the second dose.
STOMACH PAIN; FEVER; This spontaneous case (PVX2019-1476) was received from a caregiver on 07-Jun-2019. It describes a 15- year-old female consumer who had stomach pain and fever, after administration of Vivotif for typhoid prophylaxis.  Case report: The consumer took the first two doses of Vivotif on 04-Jun-2019 and 06-Jun-2019. She had stomach pain and fever after a few hour of the dose. The stomach pain was getting worse after taking the doses and she assumed that the fever was around 38.2 degree to 38.5 degree Celsius.  The consumer was not taking any other medication and she had no medical history.  Action taken with Vivotif was dosage maintained.  The consumer had not recovered from the events.  Company's Comment: In this case, it was reported that the consumer had stomach pain and fever after the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, stomach pain and fever are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had stomach pain and fever after the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, stomach pain and fever are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
High blood pressure, low grade fever, torturous muscle pains like bricks fell on whole body, general malaise, and a feeling as if you are about to die.
Fever and vomiting, beginning approx. 24 hours, post vax. Had 20 minutes of being hyporesponsive and pale spell. Resolved by the time of ER visit. Temperature to 101F, triggered septic workup which was negative.  Diagnosis Pyelonephritis
A nurse reported that a 33 year old male received Pnu-Imune 23 and Hep-A vaccines on 4/4/01. Later that evening, he developed an injection site reaction characterized by a 30mm area of redness and induration and inability to move his arm. He also experienced nausea and vomiting and developed a fever of 101F. The symptoms lasted about 2 days. No further information was available at the date of this report. The reporter indicated that 4 pts experienced these events following receipt of Pnu-Imune 23, lot 469401. (See HQ9560211APR2001, HQ1777407JUN2001 and HQ1777507JUN2001).
Losing my hair and its not growing back ,; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 14:00 (Lot number: ER873u) at the age of 59 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient had no known allergies. There were no concomitant medications. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient had no Covid prior vaccination and had not tested post vaccination. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6207, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 17Mar2021, when the patient was 59 years old, for Covid-19 immunization. The following information was reported: ALOPECIA (disability, medically significant) with onset 2021, outcome "not recovered", described as "Losing my hair and its not growing back ,"; ALOPECIA (disability, medically significant) with onset 2021, outcome "not recovered", described as "I'm almost bald on the top of my head and have patchy bald spots on the rest of my head". Therapeutic measures were taken as a result of alopecia, alopecia which included Lazer hair follicle treatments, Rogaine, vitamins.  It was reported that Losing hair and it's not growing back! Patient was almost bald on the top of her head and had patchy bald spots on the rest of her head. Afraid to get the booster shot now.  Follow-up attempts are completed. No further information is expected.
a couple drops of PROQUAD splashed directly into his eye; a couple drops of PROQUAD splashed directly into his eye.; a couple drops of PROQUAD splashed directly into his eye.; This spontaneous report was received from a physician referring to a male employee of unknown age. Information about medical history, concurrent conditions and concomitant therapies was not provided.  On 07-JAN-2020, when the employee was preparing measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (before reconstitution) to administer to a patient (dose, strength, route, lot# and expiration date were not provided) for prophylaxis, a couple drops of preparing measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) splashed directly into the employee's eye (occupational exposure to product, accidental exposure to product and exposure via eye contact). The eye was rinsed with water. Medical attention had been sought.
Mother noticed redness, swelling at injection site. Some pain to touch. 2 days later, site was warm to touch and area had widened. On 3rd day was brought to office and seen by Nurse Practitioner for the pain, redness, swelling, low grade fever. Given KEFLEX 500mg TID x 10 day.
it was just sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (it was just sore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced VACCINATION SITE PAIN (it was just sore). At the time of the report, VACCINATION SITE PAIN (it was just sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-352100 (Patient Link).
10/10/2001 pt presented for DTap and Varicella Vaccination. On history parents reported Toby "had a cold". Day 13 (10/23/2001) 1 maculopapular lesion on buttock, Day 16 about is maculopapular lesion. (Us cab bed (2) with fluid.
Pt received vaccine. After about 10 min. PT and Dad started to leave and pt passed out while walking - fell into display and got cut.
Intussusception  4/29/09 Received hospital medical records of 4/13-4/15/2009. FINAL DX: Intussusception, enema reduced Records reveal patient experienced bilious vomiting & bloody stools.  Admitted for observation s/p enema reduction, progressed well & d/c to home.
Numb tingly mouth, skin felt like it was burned and hurt for anything to touch it, muscle aches and spasms, headache, nausea, fever, sore arm
L sided rib pain below sternum and left in the front progressing to complete L sided pain in the rib cage progressing from front to spine including spasms progressing to gastric distress pain with food intake and chest pain heart burn after eating no previous sx or diagnosis
28 days after receiving 1st dose, had a small menstrual period (I'm 65 and have been in menopause since I was 48).  Had second smaller incident on 6/20/2021
muscle pain / muscle soreness; headache; feels sore; Feels weak; This case was reported by a consumer and described the occurrence of muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th August 2019 09:00, the patient received Shingrix. On 8th August 2019, less than a day after receiving Shingrix, the patient experienced muscle pain and headache. In August 2019, the patient experienced pain and feelings of weakness. On an unknown date, the outcome of the muscle pain, headache, pain and feelings of weakness were unknown.   It was unknown if the reporter considered the muscle pain, headache, pain and feelings of weakness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix in the right deltoid. The patient received dose of Shingrix in the pharmacy at 9 am. In the night, on the day of vaccination, the patient experienced muscle soreness and headache. The patient want to know, if he could took Advil gelcaps for muscle pain. The patient did not want to provide date of birth, address and doctor's information. No additional information was provided.