chrisvoncsefalvay/vaers-outcomes huggingface dataset:
underage girl got the first Moderna dose/17 year old getting the vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Sep-2021 and was forwarded to Moderna on 16-Sep-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (underage girl got the first Moderna dose/17 year old getting the vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (underage girl got the first Moderna dose/17 year old getting the vaccine). On 16-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (underage girl got the first Moderna dose/17 year old getting the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were provided. No Treatment information was provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Non Significant Follow Up received on 16-SEP- 2021 contains no new information.
Facial/bridge of nose/eye swelling  Notified drs office.  Called again when child came home from school as it has worsened. Have not received any medical advise or return call as of yet. Still waiting.
Patient received a Zostavax vaccine from me on 4/7/15 under the immunization protocol for physician.  She called the pharmacy on 4/9/15 at approximately 2:00-2:15pm complaining of a site reaction and an acute illness that began this morning.  She informed me that she had on the back side of her left arm at the injection site a silver-dollar sized, red, firm and irregularly shaped area that was painful which she had noticed this morning.  She also said that she had felt fine until this morning when she began to have vertigo, stiffness at the back of her neck, stomach upset and vomited all brown liquid one time.  She said her stomach was still a little upset and that she had 4 large, loose bowel movements already today. She said that she was still feeling light-headed and had taken her temperature today and that it was 98.1F. She said she had taken some of her usual medications this morning including her allergy medication.  She had already called her primary care doctor and informed them of her symptoms. She wanted to know if this was related to the vaccine she had received and I told her that it was possible but that I would like to call her back after I spoke with the protocol physician regarding the situation. I informed her that I was going to call the protocol physician immediately.  She said that was okay and gave me a phone number to call her back.  I called the protocol physician's office at approximately 2:30pm to let them know that a potential adverse reaction may have occurred and the receptionist informed me that unless she was actually a patient of doctor, there was nothing they would be able to do.  I then called the patient's primary care physician, and spoke with someone at approximately 2:35pm.  I informed her that I was aware of what the patient had called them regarding and that she had called me as well.  She said she would give the information to doctor and took the number of the pharmacy for him to call.  I called the patient back at approximately 3:00pm on 4/9/15 and she informed me that she was feeling better but her stomach still felt a little upset and she was still light headed.  She also noted that the site reaction seemed to be improving and was not as red, raised and painful as it had been earlier. She described it as being more like a bruise now but still being a little tender.  I advised her to apply ice to the site reaction to help with pain, redness and swelling.  I also advised her to make sure she was drinking plenty of fluids due to the bowel movements and the vomiting.  I informed her that the symptoms she was experiencing could have been due to the vaccine (headache, diarrhea, nausea, flu-like symptoms, injection site reaction).  My source for confirming this information was Facts and Comparisons.  I also informed the patient that should her symptoms worsen or persist beyond 1-2 days she should again call doctor's office.  As of 8:15pm on 4/9/15 I have not received any reply from doctor's office.  Both pharmacy supervisor and immunization coordinator had also been notified by 3:15pm on 4/9/15.
chills; fever; couldn't even walk; whole body muscles; This is a spontaneous report received from a contactable consumer. A 58-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown), via an unspecified route of administration in Mar2021 as single dose for COVID-immunization. The patient previously received the first dose of bnt162b2 two weeks ago for COVID-immunization. Concomitant medications were not reported. On an unspecified date, the patient experienced chills, fever and whole body muscles. The patient couldn't even walk. The patient was taking vitamins for immune system. The reporter asked what adverse events to anticipate with the second dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Received 0.5 mL instead of 0.25 mL for booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Received 0.5 mL instead of 0.25 mL for booster dose) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Received 0.5 mL instead of 0.25 mL for booster dose). On 22-Oct-2021, ACCIDENTAL OVERDOSE (Received 0.5 mL instead of 0.25 mL for booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received single dose of Johnson and Johnson vaccine.  No relevant concomitant medications were reported.  No treatment information was provided.
Client went to bed Tuesday evening feeling more tired and temperature of 99.4.  Woke up Wednesday feeling worse with body aches, shaking, fever of 100.2 and headache.  Took Tylenol throughout the day and had a loss of appetite but woke up Thursday morning feeling better.
I developed Shingles.  What started as a tiny itchy rash above my navel, rapidly formed a band of blisters that wrapped around the side of my body to my spine. The headaches pounded, the nausea was abundant and every nerve ending inside and outside my body felt like electric live wires.  I was extremely sensitive to light and my eyes hurt.  I had the chills, I had the sweats. Walking was difficult, lying down was difficult, and sometimes the pain was so bad, breathing was difficult.   After 5 days, the blisters and most of the symptoms were gone, and I was even able to work.  The burning pain lasted until week 5.  I still get fatigued really quickly, but the rash is better.  I've lost some feeling and my skin is still sensitive.   I caught it just in time to be given a 10 day course of the Antiviral Valacyclovir.  I took Tylenol and Advil for the pain, used ice packs and calamine lotion.  Took Lysine to help kill the virus.  I had Chickenpox as a child.
Pt reports she received the Moderna vaccine booster, #3 on 2/24/22 at the  Pharmacy. Pt initially experienced a fever of about  99.4 F . The fever resolved within 48 hours. Pt also experienced localized pain, erythema measures 7x6" and swelling 3x2.5" noted 4 days after vaccination during clinic visit. The examination showed a swollen tender lymph node under the patient's L arm. The erythematous area was warm to touch. The patient has been treating with Benadryl which she states helps her sleep at night.
22 patients received expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (22 patients received expired Moderna Covid-19 vaccine) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (22 patients received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (22 patients received expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter stated that she had 22 forms (from the CDC) about patients that were administered expired vaccines, she was asking if they should revaccinate those patients.  The date of vial initially stored in the refrigerator was unknown.  The patient received her Second booster in her right arm.  The vial did not undergo any temperature excursions.  No treatment information was reported.   This case was linked to MOD-2022-553503 (Patient Link).
Information has been received from Merck Pregnancy Registry for VARIVAX (Merck) from a nurse practitioner concerning a 29 year old nursing mother with pertinent medical history reported as none and drug reactions or allergies reported as none who on 08-SEP-2008 was vaccinated with a first dose of VARIVAX (Merck) (lot # not reported) 0.5ml, subcutaneously.  On 18-AUG-2009 she received second dose of VARIVAX (Merck) (lot # not reported) 0.5ml, subcutaneously.  There was no concomitant medication.  On 31-MAY-2009 the patient had a healthy infant.  The patient was examined in the office on 20-AUG-2009 and was found to have a small Hematoma at the injection site of the left upper arm.  There were no laboratories diagnostics studies performed.  Additional information has been requested.
A lot of Clotting  during my cycle they are just dropping out and it still happening and it?s July 2023 my mental cycle are heavier and dark red  bleeding and I?m bleeding every 2 week or every 18/20 days
extreme pain left arm, nausea/vomiting with movement, full muscle aches, headache lightheaded.
Enlarged painful lymph nodes on right side neck and body under arm. Hot arm,  diarrhea, extreme fatigue, headache. My neck and underarm are still achy and enlarged.  My body is still sore and I have not been able to continue with my daily activities. I have not felt like this since I had mono as a 19 year old. I have 5 children and have gone through natural childbirth 3 times. I?ve received all my vaccinations faithfully and have never in my life reacted this way.  I am not getting the second dose until I have blood work done to see how my high my antibody levels are.  I respect and am grateful for your work However I need to see data on my body?s reaction to even consider getting another dose.
Patient stated to vaccinator that she sometimes feels faint with vaccines. Vaccinator held her in her seat for about 2 minutes and then she insisted she felt fine and started towards observation area. She got close to the observation area and she started feeling faint and flagged over a National Guardsman who came over and caught losing her balance and slowly lowered her to the ground. She waited in the observation area for 15 minutes and then left on her own.
Sustained HR 130's for 20 minutes, no chest pain, no SOB, taken to ED for evaluation.
Arm pain, headache, body aches, light headed, racing heart, chest discomfort, shakiness
Patient stated that she felt itchy at 9:41am. Patient was given diphenhydramine 25 mg PO at 9:42am. Patient felt better at 9:52am. Patient was monitored for 30 minutes. Patient had no issues breathing or talking. Patient reported that itchyness stopped.
65yr female presents for reported poor reaction to pneumococcal vaccination (PSV 13) on 23Jan2017.  She notes pain, erythema, swelling, itching, subjective fevers, headache, nausea and diarrhea after getting the immunization.
PATIENT WAS DID NOT FIT THE CRITERIA TO RECEIVE A SECOND BOOSTER SHOT (AGE AND NOT IMMUNOCOMPROMISED). PATIENT HAD ZERO ADVERSE EFFECTS SO FAR. SHE IS DISABLED, LIVES IN A GROUP HOME, AND HAS CEREBRAL PALSY. SHE THOUGHT SHE WAS ELIGIBLE SINCE SHE WAS IN THE PRIMARY ORIGINAL GROUP PRIORITIZED TO RECEIVE THE VACCINE WHEN IT BECAME AVAILABLE.
presented to ED with nausea, vomiting, epigastric abdominal pain, fatigue, fever.  Symptoms for the past few days, Some shortness of breath on exertion
VACCINE PRODUCTION FACILITY FILTHY AND DIRTY; FEEL AWFUL; HEADACHE; FEELING SICK; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) .5 ml, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced feeling sick. On an unspecified date, the subject experienced vaccine production facility filthy and dirty, feel awful, and headache. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from headache, and feel awful, and the outcome of feeling sick and vaccine production facility filthy and dirty was not reported. This report was non-serious. This case, from the same reporter is linked to 20210526416 and 20210525676.
Urticaria rash  on 1/24/22 in armpit region 10 days after vaccination.  11-12 days after vaccination urticaria spread to waist. Patient began Benadryl twice daily. 13 days after vaccination urticaria became severe with enlarged bumpy welts on waist and covering all of groin area, arms, upper thighs, and right palm. Patient went to PCP who prescribed Zyrtec (x1 daily), Pepcid (x2 daily), and Pregnisone course (patient declined). Patient began prescription course of prescribed antihistamines and was advised to continue Benadryl as needed. 14 days after vaccination the anti-histamines provided minor relief from symptoms. Urticaria spread to forehead, eyelids (puffy), and neck. 15 days after vaccination patient experienced tightness in throat and neck. Patient continues to experience flare ups all over randomly which subside quickly. As of today 2/8, the urticaria  continues. Patient is only taking zyrtec x1 daily.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 07-JUL-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
No adverse affects reported; a improperly stored dose of MMRII was administered; This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 23-AUG-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S006647,  expiration date on 05-MAR-2021, for prophylaxis  (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 50 degrees Fahrenheit for 49 minutes. Data logger was involved. There were no previous excursions reported.
Right after injection the area around site turned red and splotchy (looked like hives). After a few minutes the redness calmed down. Patient was informed to take benadryl when she got home to help with reactions.
Information has been received from a physician concerning a patient who was vaccinated with a 0.5 ml dose of PNEUMOVAX 23. Subsequently the patient developed rash from elbow to shoulder on the arm that received the injection. No lot number was provided. The patient had sought unknown medical attention. At the time of report the patient's status was unknown. This is one of several reports from the same source. On 15-SEP-2009 all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Severe swelling of left upper arm, left anterior chest wall; Severe swelling of left upper arm, left anterior chest wall; Underarm and neck with pain; Underarm and neck with pain; Heat; Redness; This is a spontaneous report from a contactable healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1686; Expiration date was not reported) on 08Jan2021 (15:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. The patient had no relevant medical history. The patient's concomitant medications were not reported. On 10Jan2021 (15:00), the patient had severe swelling on the left upper arm and left anterior chest wall; underarm and neck were with pain; was in heat; and had redness. The adverse events resulted in the patient having a visit on the doctor or other healthcare professional office/clinic. The patient had received treatment for the reported adverse events. The outcome of the events, 'severe swelling on the left upper arm and left anterior chest wall', 'underarm and neck were with pain', 'heat' and 'redness', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination.
MOTHER NOTED RASH FOR 1 DAY ON THE RIGHT THIGH. THEN SOME PAPULES NOTED TO LEFT THIGH AND BOTH UPPER EXTREMITIES. PER MD 3MM ERYTHEMATOUS PAPULE ON RIGHT ANTERIOR THIGH. 10-12 1/2MM PAPULES LIGHT COLORED ON LEFT THIGH. 6 PAPULES ON UPPER EXTREMITIES.
Extremely exhausted, fever, chills, nausea, headaches, leg numbness and arm pain.
She reports on 5/6/2021 evening she started with a headache. She said as the evening went on she had nausea and a burning sensation in her stomach. She said around 11 pm she started to have chest pains and did not sleep at all last night. She said now today 5/7/2021 she is having 5-10 second contractions in her rib cage area. She reports being worried. Was advised to see physician.
Father noticed patient arm was red, swollen and itchy. He had not looked at his arm until 2/12/10. Benadryl was rdm on 2/12 as well as Abx. txt.
On April 12 right after my vaccine I got dizzy, very dizzy and I felt the need to hold on to things. I felt ringing on my left ear I went to the doctor my PCP and they did lab work and they didn't know what it was and I was referred to and ENT PA that specialize in vertigo. She did an MRI of the head and VN testing MRI was normal and for the VN testing it was abnormal.
Information has been received from a registered nurse concerning a 16 year old Caucasian male with seasonal allergies only who on 3/24/03 in the PM was vaccinated with a first dose of varicella virus vaccine live (lot # 644089/1064M), SC in the right arm. There was no concomitant medication or illness at the time of vaccination. The patient's younger brother had developed chicken pox after the patient had been vaccinated. Subsequently, the patient developed a very mild case of chicken pox. The patient recovered. Additional information is not expected.
Patient came in for the new Pfizer Bivalent vaccine and received the Pfizer monovalent vaccine instead.  Nurse checked with me when she got a lot number that did not match the computers' record and I went back to the vaccine room to doublecheck.  I then found that the bivalent vaccine had the matching lot number and brought  it back to the clinic, but the nurse had already vaccinated the patient.
1st dose - Sore Arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 48-year-old female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 16:30 (Lot number: ER8727) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hashimoto" (unspecified if ongoing), notes: Hashimoto; "depression" (unspecified if ongoing), notes: depression; "anxiety" (unspecified if ongoing), notes: anxiety; "Known allergy: Penicillin" (unspecified if ongoing), notes: Known allergy: Penicillin. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "1st dose - Sore Arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Patient was not pregnant at the time of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID since the vaccination.  No follow-up attempts are possible. No further information is expected.
June1,2023 -72days i the hospitals more than one hospital. Diagnosed Guilloin Barre Syndrome. Lost all lost all feeling and functioning of body from neck down. Lost bladder and bowl , knees, feet and hands no control. They done cat scan of stomach, MRI of back, MRI of brain,blood test,cat scan of back ,ultra mist treatment for sever beds our ,occupational and physical therapy. Plasma  For 4 days
Feel very sick like the kidneys are ripping apart, and vomiting since 10 o'clock last night. Starting on Wednesday after the shot have a headache, right hand side of the head had shooting pain and flu-like symptoms. Left arm hurts. Had flu like symptoms from the 1st Hep B shot per patient.
Sore arm, headache, feeling drowsy, achy and dehydrated. Lasted 2 days. 4th day felt back to normal.
High fever (104F), extreme body aches, headache, raw mouth, dizziness, bedridden.
Had immunization 6-14-2011 about 6:30 pm, on 6-15-11 in the AM noted redness and swelling in Rt. arm at site. Became warm & spread to 5"x6" redness & induration on 6-16-11. On 6-17-11 came to our office & redness, warmth & swelling is now 12"x10". Started on KEFLEX.
significant tinnitus; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of TINNITUS (significant tinnitus) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Tinnitus.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced TINNITUS (significant tinnitus).        For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.   Reporter did not allow further contact
This spontaneous report was received from a registered nurse concerning to an unspecified number of patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions or concomitant therapy was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (strength, dose, interval and route of administration were not reported) lot # K007828 with expiration date of 08-APR-2017 and lot number K007828 with expiration date of 02-MAR-2017. No adverse events or product quality complaints (PQC) were reported. This is one of several reports from the same reporter. Additional information has been requested.