chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 days after immunization for the flu the patient developed redness and swelling of his left lower calf - he was evaluated for a DVT with US which was negative and then was placed on doxycycline for suspected cellulitis - symptoms worsened over the next 2 days and he was again checked for DVT of the left leg - the redness and swelling along with aching muscles traveled up his left leg into the thigh and over to the right thigh. His antibiotic was D/C'd and a new antibiotic cefdinir was ordered - he took this for 1 day and saw no improvement - this was day 4 - on day 6 all symptoms were getting better and meds were completely stopped and by day 8 all symptoms were resolved.
Pfizer 3/5/21, 3/26/21, 12/15/21. Positive on 5/12/22
A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7, Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353242USA. A male patient between the ages of 19-24 years who experienced Acute Pericarditis (confirmed) (Serious, since 26-Sep-2012) while enrolled in a study. Adenovirus vaccine was administered on 18-Sep-2012. The patient was seen at an outpatient visit, outcome, severity and seriousness unknown. Treatment medication included: pseudoephedrine and guaifenesin (600mg, Q12H, PO) started on 01-Oct-2012, stopped on 04-Oct-2012, unknown indication; ibuprofen (800mg, TID, PO) started on 01-Oct-2012, stopped on 05-Oct-2012, unknown indication; AUGMENTIN (500mg, BID, PO) started on 01-Oct-2012, stopped on 11-Oct-2012, unknown indication. Adverse events within 42 days of vaccination: Follow up cardio) since 27-Sep-2012, until 27-Sep-2012) treated at outpatient visit, outcome resolved, severity and seriousness unknown. At the time of the report the outcome of the AEs were: Acute Pericarditis: Unknown. The medical history of the patient was not specified. The medical history of the patient no alcohol or tobacco use within 30 days prior to Adenovirus vaccination. The patient's concomitant medication included DTP (since 18-Sep-2012); Meningococcal vaccine (since 18-Sep-2012); RECOMBIVAX-HB (unknown, since 18-Sep-2012; since 26-Oct-2012); Influenza vaccine (Nasal, since 18-Sep-2012); IPV (unknown, since 26-Oct-2012); Yellow fever vaccine (unknown, since 26-Oct-2012). The patient's past medication were unspecified. Action taken with suspect drugs: Adenovirus vaccine - Not applicable. Lab tests 20-Sep-2012, EKG: normal, 20-Sep-2012, Echocardiogram: normal. This case was considered serious based on the following criteria: (Other Serious (Important Medical Events)). This event was assessed as "unknown" in severity. The medical monitor has assessed the causal relationship of the event as possibly related to the Adenovirus Vaccine.
NOV 2021 I NOTICED A BLOTHY REDNESS ON MY RIGHT BREAST. I HAD A MAMMO AND SONO WHICH WERE NEG.FEB 2022 I NOTICED ANOTHER AREA ON THE SAME BREAST.  I SAW A GP. HAD MAMMO AND SONO.  SAW A  BRESRT SURGEON.  ALL NEG.   IN JUNE 2022 I SAW A DERMATOLOGIST WHO BIOPSIED THE SECOND SITE. PATHOLOGY WAS MORPHEA.  WHICH INDICATED AN POSSIBLE AUTO IMMUNE RESPONSE.  I SAW A BREAST SURGEON WHO  SUGGESTED IT WAS A VACCINE REACTION.  I HAVE NOW HAD ALL 4 VACCINES.  THE REDNESS REMAINS.
I was feeling sick, with mild flu like symptoms/stuffy head and ears/ within a week of the flu shot, and I had a minor nose bleed a couple times over the course of a couple weeks, with some dizziness.  I then seemed to improve and then within three weeks had some episodes of virtigo that last less than a minute.  Over the weeks following the flue shot my family members noticed that I was missing high frequency sounds and turning up tv louder to hear programming.  On Nov 30 ringing started in my ears and became progressively worse, on Sunday, it took till Fri Dec 6th to ENT, I had significant hearing  hearing loss confirmed with audio test, bilateral which the ENT says was probable viral induced. I have severe high pitch disabling tinnitus ringing in my left ear and some in right ear
- Right upper thigh over MMR-V and PREVNAR areas in right upper outer thigh Area. There was a small raised pink area 3-4mm with approximately 4cm surrounding. Blotchy erythema noted which was - non tender -& not indurated(few min later looked less intense).
could not walk - still cannot walk; a lot of pain; is in agony; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (could not walk - still cannot walk), PAIN (a lot of pain) and PAIN (is in agony) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced GAIT INABILITY (could not walk - still cannot walk), PAIN (a lot of pain) and PAIN (is in agony). At the time of the report, GAIT INABILITY (could not walk - still cannot walk), PAIN (a lot of pain) and PAIN (is in agony) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable. No concomitant medication was reported. Treatment medication included Muscle relaxer and Pain Pills.   This case was linked to US-MODERNATX, INC.-MOD-2021-079434 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079434:Sister's case
Significant pain in injection site lasting about 10 hours.  At about 10 pm on injection day, had light nausea and some joint pain in shoulders with no fever.
Grandmother reports child broke out in blotchy rash that comes and goes, started 3 days after immunization received. Seen by MD 2 times. Mom brought child by health department en route to doctor appointment. Child has reddened sported noted face, arms, legs, neck; "come and go". No drainage. Complaints of burning, raw appearance more pronounced with heat/warmth.
Pt recv vax on 3/30/99; 20 min post vax pt exp swollen rt arm & shoulder, pain/ swelling to right side face w/ itching; 3/31/99 pt exp swollen & itchy rt leg w/ rash; dx=possible poison ivy
some contractors at their site got second doses for an interval gap of 50+ days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (some contractors at their site got second doses for an interval gap of 50+ days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (some contractors at their site got second doses for an interval gap of 50+ days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (some contractors at their site got second doses for an interval gap of 50+ days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-090613 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090613:Case for patient
Diahrrea still ongoing 8-9 days post vaccine. Moderate to severe. Just wondering when to expect it to go away.  Called pharmacy they recommended Imodium. Have not tried it yet.
Patient was accidentally given vaccine while underage (17 years old) on 3/23/21 and came back to complete vaccination series on 4/20/21. Besides the administration error there were no adverse effects to report.
Within minutes post vax, the pt became faint, head down, jerky body movements of legs and torso; lasting 15-30 seconds. Awoke and said that he felt weird, color pale, decreased color to nail beds. He had nothing to eat that morning. He seemed healthy prior to IZ.
pt recvd vax; exp a 10mm area of redness & puffiness at inject site of PPD;varivax adm at a different site;f/u info indicated that pt does not have any info on charts about events on varicella vax;there were certainly no significant rxn;
severe vertigo along with lethargy and nausea. Patient rested and drank fluids.
pt recvd vax 3NOV95 & pt devel rash which started @ the inj site w/4 lesions & subsequently spread to the rest of body w/34 lesions;
Muscle Pain, Difficulty Walking, Lethargy (over 10 day period), Fever
Light headed; Woke up tired; fever of 100 Fehrenheit; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed), FATIGUE (Woke up tired) and PYREXIA (fever of 100 Fehrenheit) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced DIZZINESS (Light headed), FATIGUE (Woke up tired) and PYREXIA (fever of 100 Fehrenheit). At the time of the report, DIZZINESS (Light headed), FATIGUE (Woke up tired) and PYREXIA (fever of 100 Fehrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Body temperature: 100 fahrenheit (Borderline) fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       While waiting to be vaccinated, the patient was exposed to a person with a positive COVID-19 test. Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
NO APPETITE; NO ENERGY; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient . 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) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch numbers. No concomitant medications were reported. On 01-APR-2021, the subject experienced flu-like symptoms. On an unspecified date, the subject experienced no appetite, and no energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from no appetite, and no energy, and the outcome of flu-like symptoms was not reported. This report was non-serious.
w/in 9hr of vax started having fever (up to 102), chills, n/v, body aches, h/a, muscle spasm & dizziness;seen in hosp for nausea;
pt developed rash 8 days after reveiving vaccine. she reported the area around the injection site warm and hard for 2 days. pt will seek medical attention
Bloody stool, intussusception, requiring surgery. 02/13/07-records received and reviewed for DOS 1/11-1/14/07 DC DX:Intussusception Presented with lethargy, abdominal discomfort, paleness, and pulling up of his legs. Multiple bilious vomiting and blood in stool. Poor feeding. Palpable mass in right upper and epigastric area. Baby has currant jelly stool.
Patient was vaccinated with this vaccine after the excursion; No adverse event; Patient was vaccinated with this vaccine after the excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated with this vaccine after the excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event) in a 61-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Sep-2022 at 11:31 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 30-Sep-2022 at 11:31 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated with this vaccine after the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated with this vaccine after the excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated with this vaccine after the excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated with this vaccine after the excursion).    Concomitant medications were not reported. It was reported that Moderna bivalent vaccine was administered after a temperature excursion. Vaccine was not viable. No adverse events were reported.  Treatment information was not provided.
covid vaccine breakthrough case  Moderna dose 1 5/18/21  022B21A Moderna dose 2 6/15/21  018B2A
Information has been received from a lawyer regarding a case in litigation, which was reported in a Litigation report, concerning a 33 year old patient who in 1992 was vaccinated with two RECOMBIVAX HB.  Subsequently, the patient experienced chronic erythema nodosum, peripheral neuropathy and other symptoms.  The government agreed to $50,000 in compensation.  The outcome was unknown.  No further information is available.
suffered vision loss post vaccine/lost 50 percent of my vision; This case was reported by a consumer via interactive digital media and described the occurrence of loss of vision in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced loss of vision (serious criteria GSK medically significant). On an unknown date, the outcome of the loss of vision was unknown.   The reporter considered the loss of vision to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 02-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that the patient received Shingles vaccine and within 24 hours the patient lost 50 percent of her vision. The patient suffered vision loss post vaccine. The reporter reported that she remembered her friends had shingles, the pain and suffering they went through it was sounded unbearable the patient never wanted to experience that kind of pain, which made her want to learn more about this painful, blistering rash.  The patient educated herself about the risk for developing shingles especially for people 50 years or older, and what she could for prevention. The reporter did not consent to follow up.
(L) arm (deltoid) tennis ball size lump, warm to touch. No fever. Sx began on 8/27/08.
Patient received MMR, Varicella, and Influenza vaccines at Public Health Immunization Clinic. Patient tolerated vaccines well, returned to the waiting room to wait while sister's immunizations were drawn up, and per patient's mom and aunt, fainted.  Per patient's mother, patient was standing in front of her as she was seated in a chair, complained of a headache, and then started to fall forward. Mother caught patient before he fell and no injury sustained. Patient then had moments of lethargy, whining, and crying for three to four minutes. No difficulty breathing. Face pale according to vaccinating nurse.  Patient was laid supine on mom and aunt's laps for a couple minutes, when it was determined he had not eaten in 7 hours.  A small candy bar, a bottle of Boost drink, and a bottle of water given. No prior history of syncope. Patient's sister reacted in same manner on 9/17/19 (VAERS report also submitted) with two short seizures afterwards (this child with history of Epilepsy). Reassessment after candy and Boost started showed improvement in color, activity, and symptoms.  Patient and family remained in the waiting area for another 10 minutes without further incidence. Instructed mother and aunt that children to be vaccinated with PCP for a more controlled environment.
Minor swelling at injection site 1.5 inches. No fever. Non tender. Not hard or warm to touch.
pt recv vax 2AUG96 & on 3NOV96 pt devel a couple of lesions on trunk & groin area & fever;reporter noted pt had been exposed to children @ school w/chickenpox;
pt is a paraplegic on lt side;has a pump implanted near spine which releases med to control spasms;15 days p/MMR vax pt had severe spasms of legs & abd; & severe noc sweats x 3 nocs & on 8DEC95 devel a UTI;MD could not find cause
14 month old AA female who received varicella vaccine 40 days ago. Now presented with papular rash on both upper and lower extremities. 1 vesicle on the right hand. But no rash on the trunk. Child presented to us in the clinic after 72 hours. We recommended symptomatic treatment including tylenol for fever and benadryl as needed for itching.
Information has been received from a 65 year old female who was vaccinated with pneumococcal 23 polysaccharide vaccine (manufacturer unknown). Concomitant therapy included Effexor XR and vitamins (unspecified). The consumer reported that afterwards both of her arms were sore. Current patient status and medical attention was not reported. A product quality complaint was not reported. No further information was available. The patient experienced psoriasis of the scalp, swollen glands, and skin lesion following vaccination with zoster vaccine live (Oka/Merck) (WAES#0710USA04043). Additional information has been requested.
Tenderness, swelling and redness started on 1/14/21 and has been present since then until today 1/16/21. My arm was looking better yesterday the redness was going away but was still more swollen and tender. It is hot to the touch and today 1/16/21 the redness increased and expanded.
PATIENT RECEIVED 1ST DOSE AT APPROXIMATELY 9:35 AM.  PATIENT EXPERIENCE SYNCOPE AND VOMIT AT 9:55AM.  PATIENT WAS ABLE TO LAY DOWN UNTIL 10:20 AM AND SYNCOPE RESOLVED.  VITALS WERE TAKEN AND NOTED.
The morning after the vaccine I felt like I had the flu.  Aching muscles, headache, no fever or chills though.  Loss of appetite for a day, flu like symptoms lasted 2 days.  I had the same reaction with the second vaccination starting later the same day, but took acetaminophen which knocked down the symptoms  fairly well.
8/11/12: Red, bumpy rash to left thigh. No tenderness or itchiness noted per mom.
I had a tooth that I had a crown on- I had a root canal on it decades ago and the crown came off. The roots that were left after the root canal were there and they were now cracked. I was able to go into my dentist and they put the crown back on for the time being and sent me to a specialist to have the tooth extracted. They also took out some bone when they did the extraction. They are hopeful that the bone with regrow in that area so that I can eventually have an implant. The stiches have healed, and things are normal and closed we are just waiting to see if the bone will regrow or not. I did come across a lump on my chest and on 03/09/23 I had a biopsy. I went in on 03/06 and after they did a sonogram, they did a biopsy, and it came back benign.
Swimmy headed for 30 minutes - 1 hour, felt like eyes were puffy though they didn't look like it in the mirror, sleepy.
Jynneos vaccine was administered intradermally, past beyond use date; Jynneos vaccine was administered intradermally, past beyond use date; Case reference number US-BN-2023-000323 is a spontaneous case report initially received on 21-Feb-2023 from other health care professional via Communications (reference: USBAV23-0303) and concerns an adult male patient.  The patient's medical history and concomitant medications details were not provided.  On 16-Feb-2023, the patient was vaccinated with the first dose of Jynneos vaccine (batch number: FDP00015; expiration date: 30-Sep-2024), at a dose of 0.1 mL, at unknown site of administration, intradermally (explicitly coded as 'intradermal injection'), for smallpox/monkeypox prophylaxis, with beyond use date of 26-Jan-2023 (explicitly coded as 'expired vaccine used').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received on 22-Feb-2023 from Bavarian Nordic included local BN case ID.  This case is linked to US-BN-2023-000316, US-BN-2023-000317, US-BN-2023-000318, US-BN-2023-000319, US-BN-2023-000320, US-BN-2023-000321, US-BN-2023-000322 and US-BN-2023-000324, concerning same reporter.; Reporter's Comments: A male patient was vaccinated with the first dose of Jynneos vaccine on 16-Feb-2023, at a dose of 0.1 mL, at unknown site of administration, intradermally, which is considered as intradermal injection, for smallpox/monkeypox prophylaxis, with beyond use date of 26-Jan-2023, which is considered as expired vaccine used. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Expired product administered and intradermal injection are considered as listed per company convention. The patient's medical history and concomitant medications details were not provided. Expired product administered and intradermal injection have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient was vaccinated with the first dose of Jynneos vaccine on 16-Feb-2023, at a dose of 0.1 mL, at unknown site of administration, intradermally, which is considered as intradermal injection, for smallpox/monkeypox prophylaxis, with beyond use date of 26-Jan-2023, which is considered as expired vaccine used. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Expired product administered and intradermal injection are considered as listed per company convention. The patient's medical history and concomitant medications details were not provided. Expired product administered and intradermal injection have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
? mild sz 5min p/ vax;mom states pt whole body shook & eyes rolled back & slid down to the floor, no LOC but did not answer questions when spoken to immed & wet pants;BP initially 110/90;pt shaking, crying, sleepy;dizziness,unresponsiveness
Hives all over.  Went to doctor on 11/28/12.  Claritin & Benadryl taken.
Tested positive for Covid-19 7/26/2021.  Admitted to hospital 7/24/2021, not for Covid-19.
COVID breakthrough. I first noticed a sore throat and fatigue. Then the following day or so I was tested for travel purposes and tested positive, I just got back into the country today. I started having a really bad runny nose, coughing, fatigue, headaches, muscle aches. I had to go to the emergency room yesterday because my doctor was worried I might have a had a blood clot but I did not. I also have had shortness of breath, pain in my lungs from coughing and brain fog. My due date for delivery is July 3, 2022.