chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client received second dose of Moderna vaccine. Client signed own consent. Client not eligible for vaccine due to under 18. Parents were notified that the first and second doses given to their child were not in accordance with the Center for Disease Control and Prevention (CDC) and manufacturer's guidelines. They were also informed that the CDC and Moderna were notified of the incident and that the CDC has allowed the second dose to be administered to children 16 years and older in similar situations.
Woke up at 6am (40.5 hours after injection) with severe vertigo, room spinning fast.  Spent first two hours sitting on bed with eyes closed avoiding any movement of any kind.  Along with dizziness I was Sweating profusely with intermittnt chills which lasted all day.  By 8:00am I was vomitting and dry heaving off & on for 8 hours straight.  Slight relief came after taking a Bonine pill for motion sickness. Multiple temperature checks ranged between 94.1 -98.5.  Headache became more prominent throughout the afternoon & evening. I ate 1 soda cracker by 6:00pm and tried to drink water throughout the day to stay hydrated but constant vomitting made it difficult. By 10:30pm I was able to keep down a 1/2 cup chicken soup.
Patient states that her legs and hips are extremely sore. She states that when standing, her legs feel like they are going to give out. Her joints in her hips hurt a lot. She states that it woke her up from a sound sleep. It hurts the most when lying down. She states that when on her feet it is a little better. It has been very bad every night, but each day it is a little better
Vesicular rash on penis and right flank which could have been shingles. Started 2 days after Shingrix vaccine. Resolved without treatment in 5 days.
On 9/17/01, the vaccinee received her 2nd injection of Engerix-B. On the day of the injection, the vaccinee experienced a change in the skin pigment at the injection site described as a ring "about the size of a quarter" that was lighter than the rest of her skin color. The vaccinee was seen by a physician. The most recent information received on 2/26/02, reported the event as unresolved.
This prospective pregnancy case was reported by a consumer and described the occurrence of sore arm in a 33-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report during pregnancy. No previous pregnancies. On 11 October 2012 the subject received unspecified dose of FLUARIX (.5 ml, intramuscular, unknown). Her last menstrual period was on 17 March 2012 and estimated date of delivery was 23 December 2012. The subject was exposed to FLUARIX during third trimester. The pregnancy was by normal conception. No evidence of defect from prenatal testing. On 11 October 2012, at the time of vaccination with FLUARIX, the subject experienced vaccine exposure during pregnancy. On 11 October 2012, within hours of vaccination with FLUARIX, the subject experienced sore right arm. At the time of reporting the sore right arm was improved. 11 February 2013 - No further information provided; patient lost to follow-up.
This spontaneous report as received from a physician refers to a patient of unknown age. On an unkonwn date in January 2014, the patient was vaccinated with GARDASIL (strength, dose, route of administration, anatomical location, indication, lot # and expiration date not reported). No concomitant medication was reported. The physician reported that the patient would receive the second dose of GARDASIL on 23-OCT-2014. No adverse effects were reported. The outcomes of the events were unknown. A product quality complaint (PQC) was no involved. No further information provided. Additional information has been requested.
hives; rash from wrist to elbow on both arms and top of arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) and RASH (rash from wrist to elbow on both arms and top of arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Hypertension.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced URTICARIA (hives) and RASH (rash from wrist to elbow on both arms and top of arm). At the time of the report, URTICARIA (hives) and RASH (rash from wrist to elbow on both arms and top of arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include diabetes and blood pressure medications.   No treatment medications were reported.
4 days after receiving the vaccine, 1/1/21, starting having itching in palms of  hands. It has progressed to rash on her arms and thighs. She also states she has soreness and redness at injection site. She has been taking OTC Benadryl caps, using Benadryl cream and Cortizone cream.
lient reported 20 mins after receiving vaccine  she experienced headache, warmth in ears, and tingling of the lip lasting 30 minutes. Per client no shortness of breath or swelling. Client stated she did not take any medication or followed up with provider
Injection site became red, swollen, sore, hot and itchy.  Welt and itchiness lasted from 2/17 to 2/22.  Only treatment was cortisone cream to ease itchiness and prevent scratching which hurt.
Rash to chest, left shoulder, left side of neck; migraine for 3 days; body & muscles aches for 3 days, tired, chills, hot flashes
Observation 6/1/22-6/2/22 cough, body aches, fatigue, weakness, lightheaded, renal insufficiency, decreased appetite, unsteady gait,
ACUTE PERICARDITIS, UNSPECIFIED 12/29/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
pt recvd vax & 6 hrs p/vax exp skin rash which lasted 18 hrs & then dissipated w/o treatment;
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 32-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 10-Aug-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 32-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Long time effects including loss of appetite after receiving the Moderna vaccine; Long time effects; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Long time effects including loss of appetite after receiving the Moderna vaccine) and VACCINATION COMPLICATION (Long time effects) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Long time effects including loss of appetite after receiving the Moderna vaccine) and VACCINATION COMPLICATION (Long time effects). At the time of the report, DECREASED APPETITE (Long time effects including loss of appetite after receiving the Moderna vaccine) and VACCINATION COMPLICATION (Long time effects) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Moderna COVID-19 Vaccine EUA - normally expected swelling and inflammation in right arm and muscle aches for approx 30 hours (3/12 - 3/13/21); lingering pain at injection site through 3/14/21; no noticeable symptoms from 3/15 - 3/17; on 3/18, approximately around 2 pm, started experiencing moderate, consistent pain in right underarm; by evening, underarm area felt swollen and tender; woke on 3/19 with slightly increased level of pain in underarm area as well as return of inflammation, pain, and swelling at the injection site; increased itchiness at injection site - concern is delayed return of symptoms
This spontaneous report was received from the registered nurse regarding male patient who on 14-JUN-2014 at 16:31 P.M was vaccinated with improperly stored first dose of RECOMBIVAX HB (Thimerosal Free) (lot # J012520, expiration date 30-JAN-2016) intramuscularly. The reporter stated that, on unspecified dates (between May 14 and July 21), vaccine storage temperature dropped to 0-1 degree in 18 different episodes, and that according to minimum and maximum, all recorded temperatures were supposed to be between 2-8. This is one of several cases received from the same reporter. Additional information is not expected because all follow up information was received.
Information has been received from a pharmacist regarding to a 83 years old female patient. Two weeks ago, approximately on 07 September 2012, the patient was vaccinated with 0.65 ml dose of ZOSTAVAX, subcutaneous in the right arm. No other co-suspects were reported. No concomitant medications were reported. In September 2012 "now" the patient had shingles at the area around the injection site. The patient was treated with ZOVIRAX and sought medical attention, called pharmacy. The patient's outcome was unknown. Additional information is not expected.
ACUTE RESPIRATORY FAILURE 2/24/2023 &  1/10/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Lethargic. Fever. Chills Swelling of lymph gland under left arm
A sore arm after the first dose; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (Lot number: ENG202) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "A sore arm after the first dose".  No follow-up attempts are possible. No further information is expected.
Patient developed paresthesias in arms, face and legs 2 days after vaccination Currently having work up for cause and will be seeing Neurology
This is a spontaneous report from a contactable nurse. A 71-year-old female patient of an unspecified ethnicity received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)) via an unspecified route of administration at single dose on 25Jan2017 for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a reaction of arm swelling at the injection site on an unspecified date in 2017 with outcome of unknown.  Patient states she was given 10 days of antibiotics.
Pt c/o dizziness, high heart rate, blurred vision, tingling to lips
After a few minutes of receiving the first dose of Moderna, this female patient sat down in the chair and went unresponsive, her head dropped down. When her husband pulled her head up, her eyes were dilated and she was not responding when we called her name and tapped her shoulder. So the rph splashed a little water on her face and tapped her some more on her cheek, and she suddenly came back to consciousness within 5 to 10 seconds. She sat up , smiled and asked if she had passed out or had a seizure. then she said she was feeling better, asked for some water. She was ready to walk out after she drank some more water. She then proceeded to wait in the waiting area for more observation for 20 more minutes, during which she seemed fine.
C/O Shortness of breath, difficulty breathing, cough, elevated temperature, runny nose and/or congestion, and malaise.
As per mother, vaccine recipient developed hives to hands, forearms, abdomen, back, and around his neck and complained of intense itching. The rash started at around 12:06 p.m. on 09/07/2010 and subsided by the early morning of 09/08/2010 after treatment with Benadryl. His treatment was prescribed for a period of three days.
Administered expired Vaccine on 03Jan2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Vaccine on 03Jan2022) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Vaccine on 03Jan2022). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Administered expired Vaccine on 03Jan2022) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE ST ELEVATION MI, INFERIOR WALL ACUTE NON ST ELEVATION MI
No additional adverse effects were reported in the patient; A patient received an expired dose of VAQTA; Information has been received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 14-JUL-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) Vial 50 (units not provided), at a dose of 1 ml for prophylaxis, (lot number S001832 with expiration date in 12-MAY-2020) (route of administration and anatomical location were not reported) (expired vaccine used).  No additional adverse effects were reported in the patient. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S001832; expirationdate: 12-MAY-2020; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
testing positive for COVID-19; testing positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "testing positive for COVID-19". It was reported that, the patient was scheduled to get a booster tomorrow. It was further stated that, however, someone advised her that she needs to wait three months to get it after testing positive for COVID-19 and she is asking for additional information if she needs to wait for 90 days. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After about 1 1/2 or 2  hours, eyes were sensitive to light and burned, watered.  Put on sun glasses for releif. Then after another hour  my throat felt tight and I would cough to clear throat.  Soon after I felt feverish and all my joints ached and my head was pounding. My body felt like it was in a vice. I had the chills also.  I took a Benadryl capsal and went to bed. Had the fever through the night and did not sleep well. The next day, my eyes were stuck closed,I was very weak, joints & muscles ached, still had a headache. No energy at all. Still had the throad tightening feeling. Cleaned my eyes open and the whites were very red. Cleared them with Visine for Allergys. Took another Benadryl. This went on all day. The next day the symptoms were very slight. By the following day, I was back to normal.
Patient reported the following symptoms: fever, chills, body pain, nausea, and diarrhea on 12/26/2020 and I recommended to take over the counter pain and fever meds, which she informed me of using already, then I recommended if symptoms persist to chick in with her primary doctor or urgent care/ER.  Patient was seen by an ER and prescribed Loperamide and Zofran for diarrhea and nausea.  I observed her arm being red about 2 inch square area on 12/27/2020 at 2:11 PM.
This case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 50-year-old female patient who received SHINGRIX for prophylaxis. On 9th February 2018, the patient received the 1st dose of SHINGRIX. In February 2018, several days after receiving SHINGRIX, the patient experienced generalized pruritus, headache, pain in arm and fatigue. In February 2018, the outcome of the generalized pruritus, headache, pain in arm and fatigue were recovered/resolved. It was unknown if the reporter considered the generalized pruritus, headache, pain in arm and fatigue to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX in unknown arm. The patient reported that she experienced itching all over her body that started several days after receiving SHINGRIX vaccine. It lasted for about two days. The 1st night itching was pretty bad, the next day it was better. The patient also experienced pain in the arm where she received SHINGRIX vaccine. It started that same night and it lasted about two days. The patient experienced fatigue and headache started on the day after receiving the SHINGRIX vaccine. The symptoms went away on the following day. The patient had denied permission to contact their physician.
24 hours after injection, fever and aches.  48 hours after redness, swelling and pain at injection site. Lasted 48 hours.
Patient did not report any signs or symptoms of adverse reaction to vaccine. Patient suffered from several comorbidities  (diabetes and renal insufficiency). Patient reported not feeling well 01/06/2021 and passed away that day.
This medically confirmed health authority (initial receipt 537914) concerns 52 year-old male patient. The patient had medical history of mild reactive airway disease (RAD), intermittent asthma (x12 years), actinic keratosis, suspected glaucoma (in 2011, the patient wads unclear with the exact nature of this ocular condition which was followed annually), herpes zoster ophthalmicus (17-OCT-2011) involving lesions on left side of his face, eyelid and left side of his scalp, chicken pox (when he was three months old), male pattern baldness (stated that his hair were thinning) and benign lipoma right shoulder (in SEP-2011). The patient's concomitant medication included salbutamol. On 24-MAY-2013, the patient received an influenza vaccination (TIV) (manufacturer or batch number not reported) as a condition of employment. On an unspecified date, about 10 days after vaccination, the patient developed fatigue which lasted for about 2 weeks. On 13-SEP-2013, the patient received intramuscular AFLURIA (batch number 08649211A) in the right arm (refer to case 2014045233). The outcome was recovered.
CHILD DEVELOPED HIGH FEVER AT 3AM. BECAME VERY IRRITABLE. WAS ADMITTED TO HOSPITAL FOR R/O SEPSIS.
EMERGENCY AUTHORIZATION FOR MODERNA COVID 19 VACCINE DOESN'T APPROVE PATIENTS UNDER THE AGE OF 18, THIS PATIENT IS 17 YRS AND 11 MO, FIRST DOSE GIVEN AT VACCINE CLINIC BY VOLUNTEER STAFF NURSE , NO KNOWN REACTION OR SIDE EFFECT
After my second shot of Moderna in April 2020, my menustration cycles have been off. After secnd shot, i did not have a period for 4 months. Then it was the hardest, haviest one I have had in my life, with lots of clottings. I received a booster in November, and have not had a period since. I am no longer wanting to have children, as I am 43, so I am not concerned about that. But do not want to have another awful cycle like I did after second booster.
Often starts with headache on top of his head.  Extreme Shaking of Body, Stuttering, Muscle Weakness.  It was an episode:  The longest one was about 2 hours.  When episode is complete all symptoms completely stop and has extreme fatigue and headache continues.
Pt adm Hep B vax (recombinant) on 7AUG90 & 7SEP90; 6DEC90 pt recvd 3rd dose of the vax which does not follow the six month protocol; No further details were provided;
After receiving both IM immunizations, patient cried for about 1 minute, his father picked him up and he calmed down immediately. Approximately 50 seconds later, he became limp, waxen and was staring. Dr was called in to examine patient. He was breathing and began to look pink and responsive.
Asthmatic reaction- breathing issues going on for upwards of 1 week. Completely out of breath and burning sensation when trying to breath. Severe sore throat Numb left had day of injection
Patient stated feeling nauseated within minutes of receiving first dose of Covid19 Pfizer-BioNTech vaccine. Patient simultaneously presented pallor and diaphoresis. Patient consumed apple juice, received ice compress, was placed in the supine position to prevent vasovagal syncope and was monitored. No dyspnea, urticaria or anaphylaxis present.  No other therapy administered.  After 20 minutes patient was able to sit and walk unassisted.
Nonstop diarrhea; Granuloma annulare generalized all over arms, hands, legs, and feet; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2022 as dose 2, single (Lot number: EW0162) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Hay fever" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:1, Manufacturer Unknown), for COVID-19 immunization. There was no vaccine in 4 weeks. The patient had no COVID-19 prior to vaccination. According to the patient, within one week on receiving vaccine the patient had two major reactions. From 12Apr2022, the patient experienced granuloma had two major reactions: Granuloma annulare generalized all over arms, hands, legs, and feet which continues to this day 02Mar2023 despite using various treatments to get rid of it and nonstop diarrhea -8 times a day- which continued until Nov2022 making the patient homebound. The events "nonstop diarrhea" and "granuloma annulare generalized all over arms, hands, legs, and feet" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Nasal swabs several times; tests for diarrhea: Unknown results. Therapeutic measures were taken as a result of diarrhoea, granuloma annulare which includes changes of diet. The outcome for Nonstop diarrhea was recovered in Nov2022; outcome for granuloma annulare generalized all over arms, hands, legs, and feet was not recovered.