chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nod at the Injection Site; This spontaneous case was reported by a health care professional and describes the occurrence of INJECTION SITE NODULE (Nod at the Injection Site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced INJECTION SITE NODULE (Nod at the Injection Site). On 10-Feb-2021, INJECTION SITE NODULE (Nod at the Injection Site) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  No Concomitant medication were reported.  No treatment medication were reported.
Breakthrough case admission after 3 vaccines Moderna 5/11/21 Lot# 023C21A;  Moderna 6/8/21 Lot# 050C21A;  Moderna 12/14/21 Lot#032H21A
red sores appearing on lower abdomen and genitals that multiplied starting 10 days after injection completion. Was diagnosed at clinic with Shingles, sent home medications and still ongoing.
Mild case of pneumonia; slight fever; Not eating well, unable to eat; nausea; Feels weak; upset stomach; vomiting; Extreme diarrhea; Initial information received on 25-Nov-2022 regarding an unsolicited valid  serious case received from a consumer/non-hcp.  This case involves a 67 years old female patient (50.8 kg) who experienced mild case of pneumonia, slight fever, not eating well, unable to eat, nausea, feels weak, upset stomach, vomiting and extreme diarrhea while receiving vaccines OFEV, TYVASO and INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Pulmonary arterial hypertension. Notes: #1 Ongoing, Current Condition, Pulmonary arterial hypertension  Concomitant medications included SILDENAFIL CITRATE (SILDENAFIL CITRATE); and MACITENTAN (OPSUMIT).  On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot Unknown at this time via unknown route in unknown administration site. On an unknown date, the patient received a  dose of suspect TYVASO not produced by Sanofi Pasteur lot 2102215 via unknown route in unknown administration site. On an unknown date, the patient received a  dose of suspect OFEV not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site.  In 2022 the patient developed a serious mild case of pneumonia (pneumonia),  slight fever (pyrexia), not eating well, unable to eat (feeding disorder),  nausea,  feels weak (asthenia)  upset stomach (abdominal discomfort), vomiting and  extreme diarrhea (diarrhoea) (unknown latency)  following the administration of INFLUENZA VACCINE, (unknown latency) following the administration of TYVASO and (unknown latency) following the administration of OFEV. This event was assessed as medically significant.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (Mild case of pneumonia, slight fever, Not eating well, unable to eat, nausea, Feels weak, upset stomach, vomiting, Extreme diarrhea).  At time of reporting, the outcome was Unknown for the event mild case of pneumonia, was Unknown for the event slight fever, was Unknown for the event not eating well, unable to eat, was Unknown for the event nausea, was Unknown for the event feels weak, was Unknown for the event upset stomach, was Unknown for the event vomiting and was Unknown for the event extreme diarrhea.; Sender's Comments: Sanofi company comment dated 30-Nov-2022: This case involves a 67 years old female patient (50.8 kg) who experienced mild case of pneumonia, slight fever, not eating well, unable to eat, nausea, feels weak, upset stomach, vomiting and extreme diarrhea while receiving vaccines OFEV, TYVASO and INFLUENZA VACCINE. Case will be re-evaluated post further update on information regarding underlying disease, risk precipitating factor, past medical history and patient lifestyle which will preclude a comprehensive assessment of this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
The incorrect Pfizer vaccine was administered; patient received Pfizer monovalent 5Y-11Y instead of Pfizer bivalent 5Y-11Y.
Information has been received regarding a case in litigation, from a lawyer, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On or about 2016, the patient was vaccinated with ZOSTAVAX, due to health care professional recommendation, for permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) (strength, anatomical location, dose, route of administration, lot # and expiration date were not provided). Later, on or about 2016, the patient was treated by her/his healthcare provider for shingles, as the patient was diagnosed with shingles or other related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient had and would continue suffer ongoing injuries, included but not limited to: mental and physical pain and suffering, extensive medical care and treatment for these injuries; significant medical an related expenses as a result of these injuries, included but not limited to medical losses and cost include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions. At the time of report, the patient was not recovered from emotional distress, injury and pain. The outcome of vaccination failure, quality of life decreased, herpes zoster and the pre-existing unspecified conditions aggravated was unknown. The reporter considered the events to be disabling, life-threatening and medically significant.
FLUZONE HD administered 10/24/16, Patient presented to pharmacy 10/30/16 with red, swollen, hot, tender deltoid. Onset claimed 10/25 or 26. Advised to seek treatment at walk-in clinic. Prescribed Clindamycin for presumed infection.
She states that no reaction with first dose but 3 hours after second dose she had a red itchy rash extend from injection site around to under arm, down her arm about 4 inches. Wider than 1 inch. Red, hot and itchy.
p/vax pt Dx 7/15 w/cellulitis at inj site; tx: Keflex
Starting on 10/14/21 following 2nd Pfizer covid-19 vaccine, pt experienced high fever, sore throat and coughing up mucous for one week following vaccine.  Also had sensation of increased heart rate, heart pounding and increased pressure in his chest.  Vomited a few times on 10/14/21.  Had a headache after vaccine also.  On 9/23/21 following his first dose of Pfizer covid-19 vaccine, pt experienced high fever, sore throat, coughing up mucous, and several episodes of vomiting.  Fever lasted 7 days.  Coughing up mucous lasted 2 weeks.  Also had sensation of increased heart rate, heart pounding and increased pressure in his chest.  Complained of headache also.
swelled up to 4 inch long and 3 inch wide; red; feels warm when touched in the middle; sore; swelling at the injection site; hurts; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (swelling at the injection site), PAIN (hurts), SWELLING (swelled up to 4 inch long and 3 inch wide), ERYTHEMA (red) and FEELING HOT (feels warm when touched in the middle) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Diabetes.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling at the injection site), PAIN (hurts), SWELLING (swelled up to 4 inch long and 3 inch wide), ERYTHEMA (red), FEELING HOT (feels warm when touched in the middle) and PAIN (sore). At the time of the report, VACCINATION SITE SWELLING (swelling at the injection site), PAIN (hurts), SWELLING (swelled up to 4 inch long and 3 inch wide), ERYTHEMA (red), FEELING HOT (feels warm when touched in the middle) and PAIN (sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information provided.
10PM on 30AUG96 very hyper then by MN screaming uncontrollable & lips very swollen;
itching on his legs, back, chest and arms.; blister scattered across both legs; Red spots on chest; red spots on both arms; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 86-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number M5325, expiry date 30th June 2020) for prophylaxis.   On 9th October 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular). In October 2019, less than a week after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced pruritus, blister, red spotty rash and erythema of extremities. On an unknown date, the outcome of the pruritus, red spotty rash and erythema of extremities were recovering/resolving and the outcome of the blister was recovered/resolved.   It was unknown if the reporter considered the pruritus, blister, red spotty rash and erythema of extremities to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: 2-3 days after receiving the Fluarix Quadrivalent vaccine the patient started to experience itching on his legs, back, chest and arms. He also had blister scattered across both legs.  The patient also reports that he has red spots on his chest and both arms which were very light in color. The red spots on his arms were bigger than the ones on his chest. The blisters on his legs have dried up. The reporter reported  that when he applies heat to his back, chest, legs or arms, it causes them to itch more. Consent to follow up was provided.
SEVERE NAUSEA FOR 48 HR, LACK OF APPETITE, LOW GRADE HEADACHE.
I went to the emergency room on 02/12/2022- pain in my right leg from the blood clot. No real treatment, they just said to use heat and try to be active. Recommended to use the suppression socks. Diagnosis was superficial blood clots. Vascular surgeon said where it was was not considered a danger to go to my lungs. I just talked to my doctor's off today about a deep vein clot that I found, these that are inflamed and hurt, I have 2 more spots that are very sore. One is in the back of my calf and the other one is in my ankle. I don't have chest pains or shortness of breath. Nobody knows why this is happening because I have been on a blood thinner for 25 years, so it should not be happening. The fact that I got 2 more after the ER is a concern. If it is not better by Monday, I will have to see my vascular doctor. I have a follow up with my doctor on Monday.
Teary eyes, throbbing pain to jaw, back of head and mouth. Symptoms started 2 days ago
Delayed reaction to vaccine on 5/29.   Woke up from a nap and lips were swelled.  Lips were hurting but no other symptoms present.   No trouble breathing or itchiness of throat or mouth present.  Advised pt possible angioedema and recommended to take benadryl 25 mg every 6 hours for 24 hours.
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored PROQUAD, lot number: M007963 expiry date: 05-AUG-2017 and L042817, expiry date: 26-APR-2017, (dose, route of administration were not reporter). Concomitant therapy was not reported. No adverse effect was reported. The vaccines went to -5.1 degree of Celsius for 2 hours. Data logger was involved. The vaccines were back in range and did not have any prior excursions. This is one of several report from the same reporter. Additional information has been requested.
I experienced COVID-19 symptoms, sore throat, cough, runny nose, headaches and had a fever for one day with some body aches. I took a course of PAXLOVID medication. I took at home COVID-19 test on 10/03/2022. I have recovered from my symptoms.
At about 5:30 pm on day of vaccine I Became extremely hot, no fever,  face became bright red and puffy ,  ears were burning down into throat. Called  primary doctor , advised to go to emergency room,   There I was Given 2. Benedryl,    About 15 minutes later I Began shaking violently and babbling uncontrollably.  I was  given a sedative ,  observed and sent home.  Redness lessened but then increased again the following evening but not as extreme.
pt recv vax & 1min post vax a raised, reddened area approx 3cm diameter noted w/o itching;no s/s resp distress &/or systemic rxn;cool compress applied to area;
PATIENT WAS SUPPOSE TO RECEIVED ONLY 2 VACCINES FOR THE SERIES.  PATIENT RECEIVED FIRST DOSE ON 6/18/19 AND SECOND DOSE ON 9/5/2019,  BUT THE PATIENT RECEIVED A 3RD DOSE BY MISTAKEON 6/5/22.  PATIENT CAME IN COMPLAINING ABOUT ARM SORE.  HIS LEFT ARM WAS SORE.
Gave extra dose of Hep B; Gave extra dose of Hep B; This case was retrieved during the Reporting System monitoring on 12-JAN-2023 with the following. The original narrative from the sender is the following:   On Oct 24th I gave pt his 6 month vaccines, Vaxelis, hep B, Rota, and PCV13. I gave pt an extra dose of Hep B 0.5 on right tigh, mom of pt was notified of incident, and I called both manufacturers, to report and ask if there was any data on giving an extra dose of Hep B. They GSK and SANOFI both stated there was no harm per their data base and the report. There was no symptoms reported by parents.  The reporter did not provide an assessment of causal relationship between Vaxelis and the event "Extra dose administered" and "Overdose".  No further information is expected.
Bruising at injection site arm and back aches for a week. Now I have yellow bruising and two lines of blood under my skin at the bruised area.
No additional adverse events were reported; The healthcare worker reported that a patient received improperly stored vaccine.  The patient received only one dose but the healthcare worker did not specify which actual lot the patient received the vaccine.; This spontaneous report was received from a health care worker regarding a 12-month-old patient of an unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 29-AUG-2022, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA), lot #W003118, expiration date: 13-JUL-2023, lot #W015191, expiration date 27-OCT-2023 (the reporter did not specify which actual lot the patient received the vaccine) (dosage regimen, strength, dose description, lot #, expiry date, anatomical location, and route of administration were not provided) as prophylaxis (Product storage error). No adverse events were reported.   The improperly stored vaccine underwent a temperature excursion of 11.3 degrees Celsius (C) for 34 minutes without previous excursions.
Slight headache began about 4:30 p.m. on the day of injection. This was one of the symptoms that was experienced when COVID 19 contracted in 2020. Elevated temperature but not a fever; aches and pains from elbow to wrist of both arms, from knees to ankles in both legs, slightly in chest and back. Also experienced feeling of those areas being on fire and headache was much more intense with aching and burning behind eyes. There was the feeling of nausea but there was no vomitting.
"By the time we got home from the health department her left leg was red and swelling.  About 5 pm, left leg began swelling and truning red about 10-15 minutes after getting shot.  It was red, swollen and hot over the weekend. Child was fussy and irritabel at night but during the day was running and walking fine."  Mother states leg is looking better today, but still going to doctor.
head itched horribly; This is a spontaneous report from a contactable consumer reported for a herself A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number "end231" via an unspecified route of administration on 13Jan2021 13:00 at SINGLE DOSE for covid-19 immunisation and minoxidil (ROGAINE). vaccine location=Right arm, dose number=1 facility type vaccine: hospital. Medical history was not provided. Concomitant medication included fluorine, xylitol (BIOTENE [FLUORINE;XYLITOL]), cyanocobalamin (B12 [CYANOCOBALAMIN]), colecalciferol (D3), omeprazole (OMEPRAZOL), rosuvastatin (ROSUVASTATIN). The patient on 13Jan2021 reporter that 2 hours after using rogaine, my head itched horribly, outcome of unknown. The patient stated that used Rogaine for over a year with no issues. The action taken was not applicable.
Patient was administered first covid pfizer vaccine approx 07:00pm and then about 7:10pm front end team member reported back to pharmacist that patient was experiencing: dizziness, dry-heaving, extreme sweating, nausea - typical vasovagal reaction. Pharmacist suggested EMT check out patient since he had to drive home. EMT arrived by 07:30 pm and monitored patient's vitals. Patient declined transport (had started to feel better by 07:30 pm).
Employee called COVID EHS on 5/18 to report she developed a rash/redness/itching on the arm she received the injection in. Vaccine received at 7:52 AM and she developed the rash/redness/itching in the LUE around 4 PM on the same day. She took Benadryl around 8 PM (same day) with marked improvement. She discussed her situation with COVID EHS NP on 5/18 and NP recommended to follow up with PCP for further direction prior to taking 2nd dose.
Information has been received from a pharmacist concerning a 70 year old female with no pertinent medical history or drug reaction/allergies, who on 17-JUL-2008 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # 659673/0557X) S.Q. into the right arm.  There was no concomitant medication.  On 24-JUL-2008, the patient developed a non-raised, red, linear rash on her right leg from her ankle to thigh after vaccination.  The pharmacist might be interested in VARICELLA ZOSTER virus analysis by PCR.  The patient sought medical attention via pharmacist.  No laboratory diagnostic studies were performed.  Subsequently, the patient recovered from the non-raised, red, linear rash.  This is in follow-up to report(s) previously submitted on 12/23/2008.  Follow up information was received from a pharmacist who reported that "after the patient received ZOSTAVAX (Merck).  The patient developed a rash down her leg" on 24-JUL-2008.  No further information was reported.
at 9:00 AM on 11/7/2021 (14.5 days after my Moderna COVID-19 booster), I noticed my neck was itching and saw a significant sized rash on the right side of my neck. I subsequently noticed hives covering my entire lower abdomen and part of my lower back. I took a Benadryl 25mg pill and the rash/hives subsided within the hour. Later that evening, the rash and hives were back on my neck, back, and stomach and had spread to my shoulders and legs. I saw my allergist (whom I see not for allergies, but for asthma) the next day and they had me start taking Zyrtec.   The hives and rashes progressively got worse throughout the week to the point that my husband had to call EMS to our home on 11/26/21 when the hives had spread to my face and I experienced tongue swelling and throat closing (anaphylactic symptoms). My allergist started me on a 5 day prednisone course the next night as well as Allegra 180mg in the morning and at night with a Zyrtec mid-day. the prednisone helped mitigate (not completely but mostly) the hives for approximately 7 days (5 days on the medication and then 48 hours afterward), but they promptly came back after completion of the steroids.  My period was also 12 days late during the onset of this issue, which is never is. It now appears to be back on track a month later.
This spontaneous report as received from a nurse refers to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unspecified dates since 01-AUG-2015, the patients were vaccinated orally with an unspecified number of improperly stored doses of oral, ROTATEQ (lot number K011952 and expiration date 17-JUN-2016, lot number reported as L010844 and expiration date 16-NOV-2016) (dose was not reported). Concomitant therapy was not reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
6 year patient was given Bexsero; as meant for a 16 year old patient in a different room because the rooms got mixed up; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB26AB, expiry date February 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd March 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 3rd March 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The Bexsero was recommended from aged 10 through 25 years. The physician stated 6 year patient was given Bexsero that was meant for a 16 year old patient in a different room because the rooms got mixed up, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up.   Follow up information received by the pharmacist on 31st March 2021: The patient's demographic details were added. The batch number and expiry details were updated. Since 2019, the patient had learning problems and was in program for several years and recently was advised to see an outside and to visit psychologist for further evaluation. The patient received 1 ml Bexsero (intramuscular).  The reporter stated that the vaccine was ordered for 16 years old patient in the office. When medical assistant called the 16 years old patient's name, the 6 year patient who was in the office for another reason waked in the room with his mother. The medical assistant did not verify the name and age of the patient and administered Bexsero to the 6 years old patient. The patient had next appointment 1 week post reporting date and the patient's mother reported that the patient was doing good and had no side effects or complaints.