chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported that the Physician Assistant she saw today stated she developed Cellulitis from the flu vaccine that she was given on 10/24/19. She said she had to be given an antibiotic to treat the cellulitis.
patient inadvertently received a dose of Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old female patient who received DTPa-IPV (Kinrix) (batch number 25ZH4, expiry date 27-OCT-2024) for prophylaxis.   On 07-AUG-2023, the patient received Kinrix. On 07-AUG-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: patient inadvertently received a dose of Kinrix). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-Aug-2023 The reporter consented to follow-up. The patient received a dose of Kinrix inadvertently at an inappropriate age, which led to inappropriate age at vaccine administration.
Experienced tachycardia evening of vaccination ( 4/12/22); resting heart rate approximate 105 bpm, episodes tapering over time.
FATIGUE, MALAISE, INJECTION SITE PAIN, VERTIGO, HYPOTENSION
My period came 7 days earlier than normal. I started cramping and bleeding the day after dose 2, which was 7 days earlier than normal. My cycle is usually exactly 28 days.
After I administered ACTHIB I realized I had just given the diluent. I did not mix. I gave a second injection of the ACTHIB & diluent mix. I called & spoke with immunization rep who suggested I fill out VAERS form.
no additional AE's were reported; The caller states that a patient received an expired dose of GARDASIL 9.; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.  On 29-NOV-2022, the patient was vaccinated with expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml, lot #1687290 with expiration date 06-SEP-2022, administered intramuscularly for prophylaxis (anatomical location was not provided). No additional adverse events (AEs) were provided.
No adverse event. The vaccine administered on 3/30/22 expired on 3/17/22. Moderna tested the stability of the same lot number and determined that the dose given was still protective against the Covid-19 virus.
after 2 to 3  minutes of giving vaccine patient went unconscious  for 30 seconds, i was holding him, got conscious and sat on chair spoke for  few seconds saying  he is ok, then went unconscious again for 15 to 20 second this time it looked like mild  seizures but got awake very quickly and he looked ok within 3 to 5 minutes first responders came with ambulance , they were with him for about 30 minutes and looks like they offered to drop him or take hospital patient wanted to home , will follow op tommorow
After taking the vaccine Janssen 24 hours, injection area appeared a dime size red rash, and it turned into 2 x 3.5 in. Swelling.  In the 48 hr,  it expanded to downwards towards elbow, around 1/2 upper arm, the 72hrs, it expanded to 2/3 of the upper arm. Feeling sore, swelling, itchy. Took the Advil, Vick?s cold medicine, and benadry, did not relieve the symptoms much.
Left arm swelling with redness & tenderness. He was evaluated in the office on 6/7/12. Rx - BENADRYL syrup was given. Course - improved with Rx.
Lethargic; Chills; Hot & Fever; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), CHILLS (Chills) and PYREXIA (Hot & Fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced LETHARGY (Lethargic), CHILLS (Chills) and PYREXIA (Hot & Fever). At the time of the report, LETHARGY (Lethargic), CHILLS (Chills) and PYREXIA (Hot & Fever) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
Patient started to have itching  immediatley at the injection site (arm) which we applied an icepack to area. Then after about 5 minutes patient said she felt itchy head to toe. We gave patient 25mg of Diphenhydramine and her itching subsided
Headache, fatigue, muscle aches/increased sensory sensations on skin (clothing brushing on skin was uncomfortable). Water, rest, ibuprofen and Benadryl.  1 day moderate-had to call off of work and slept most of the day; day 2 mild to resolved by the afternoon with no medicine past 8:00am.
Patient developed 101.3 fever, chills, body aches, and swelling/redness of the limb within 12-18 hours of vaccination. Patient took advil which helped alleviate fever and pain. Encouraged mother and patient to continue to alternate ibuprofen and acetaminophen every 4-6 hours as needed and to seek further care if sx worsen or do not resolve within a few days or if temperature does not decrease with otc meds.
This is a non serious spontaneous case reported by a nurse in the USA of a 43 year old female who developed hives after receiving FluMist. The reported did not provide casual relationship to FluMist vaccine. A 43 year old female developed hives on both legs within 24 hours of receiving FluMist on Apr 12 2005. the patient had planned for a trip and decided to get the FluMist from a travel health office. Per the reporter, the patient proceeded with her travel plans even when the hives began to appear, However, she reported the event to the travel health office only upon coming back where she was advised to consult with her family physician. the patient is not allergic to eggs but claimed to be prone to skin sensitivity and getting sick easily. The patient did not report any doctor visits or hospitalizations related to this while she was abroad. She has not recovered from this event. The hives are resolving, but the sites were described as still tender and somewhat black and blue in color, Reporter causality was not provided.
Patient stated he felt light-headed about 5 min after the vaccine. He sat down and leaned forward with his head in his hand. Witness states he then appeared to tense up and fall forward. He regained consciousness quickly and was able to talk and understand. EMS arrived. He got back into the chair and a few moments later he had another episode. Parents agreed to let EMS transport to the nearest ER as a precaution. Duration from onset of symptoms until transportation by EMS was about 20minutes.
10mins p/vax pt c/o itching @ inj site;had 6cm redness, 2cm induration;reported itching getting increasingly worse;DPH given;10mins p/DPH itching & induration resolved, redness fading;10 mins later pt ambulated from office w/rxn resolved;
Patient was accompanied by her mother to come receive Pfizer booster #1. After immunization, patient and mom were sitting in observation when mom asked for the bathroom because the patient was feeling nauseous and might throw up. As mom walked the patient toward the bathroom away from pharmacy department, the patient started to slouch, and I ran over to help because she looked like she was about the pass out. Mom and I lowered her to the floor next to meat department. Mom had a sports drink ready for her to sip as she quickly regained consciousness. The patient then vomited onto the floor. We provided paper towels, cleaning wipes and trash to help with clean up. Mom informed me the patient has history of syncope/NV with shots and blood draw. Mom was very calm and prepared for the incident. I let her know they both handled the situation well but, in the future, please feel free to request to stay inside our vaccine room for private observation as the patient was clearly embarrassed and was teary. Later that day Mom posted on the social media page that she felt the store associates handled the patient's incident with support and kindness.
2:28 Post vaccination reports "swollen lip", denies any additional symptoms / complaints, none noted at this time; medical monitoring w/vitals assessed: BP 101/85 /  P99 /  RR 14 /  O2 sat 99%RA; NAD, no respiratory symptoms reported/ noted. Reports "same reaction for 1st dose".  2:40 No change in symptoms/ status. Reports "feeling fine";  BP 111/86 P93 RR 14; released from facility w/ self.
Information has been received from a 78 year old female consumer with penicillin allergy who in 2007 "3 years ago, one time in 2007", was vaccinated with one dose of ZOSTAVAX (Merck) (Lot# not reported), concomitant medication included acyclovir and TYLENOL and just recently on 01-SEP-2010, was diagnosed with shingles. The consumer was currently prescribed with acyclovir and TYLENOL (unspecified manufacturer, dose and frequency for both medications). The consumer was quite upset due to the fact that she was led to believe she would never get shingles by her getting the vaccination. At the time of the report, the patient had not recovered. The patient sought medical attention. Additional information has been requested. Follow up information was received from the consumer who reported that two years ago (previously reported as 3 years) she was vaccinated with a dose of ZOSTAVAX (Merck). The consumer mentioned that for the past 7 weeks she had been suffering from shingles. The patient had paid for 3 doctor visits and numerous medications to treat this. The patient was still battling the pain and agony. No further information is available.
First arm pain at site, then the next early AM fever and as the day progressed, headache, neck ache, lethargy, fever 100-101.
Pentacel was not reconstituted. No adverse reaction just did not receive complete dose. Will repeat vaccination for full protection.
PATIENT WAS SITTING IN ONE OF OUR WAITING CHAIRS WHILE HIS MOTHER PAID FOR OTHER MEDICATIONS. HE THEN TOLD HIS MOTHER HE WASN'T FEELING WELL. HIS HEAD WENT BACK AND IT LOOKED LIKE HE PASSED OUT. HIS MOTHER WENT OVER AND TRIED TO WAKE HIM UP. PATIENT THEN STARTED RESPONDING TO HER. WE GAVE HIM SOME WATER AND IMMEDIATELY LOOKED AND STARTED FEELING BETTER. HE COMPLAINED OF NAUSEA, DIZZINESS, BLURRED VISION. THE MOTHER STATED HE HAD BEED SWIMMING BEFORE THE VACCINATION AND HAD NOT EATEN SINCE BREAKFAST. I CALLED HIS MOTHER ABOUT AN HOUR LATER AND SHE SAID HE WAS DOING FINE. I BELIEVE HE FAINTED IN THE CHAIR.
Right arm redness 7.5cm x 3.5cm, tender and itchy for 2 days. Rx'd  Benadryl.
Vaccine 2 days ago on Monday. Approximately 4 x 4 cm area with hardening, warmth, erythematous at Lt thigh.
Cough; chills; joint pain; Tested positive for Covid-19; This spontaneous case was reported by a nurse and describes the occurrence of   in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DEXAMETHASONE for an unknown indication.    The patient's past medical history included No adverse event.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started DEXAMETHASONE (unknown route) 1 dosage form. The patient was treated with AZITHROMYCIN (ZITHROMAX) at a dose of 1 dosage form; PREDNISONE at a dose of 1 dosage form; DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Polymerase chain reaction: positive Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
High fever began about 8 hours after injection. Delirious weak headache muscle & joint aches. Slept for 24 hours. Fatigue continues but getting better. Headache still be getting better. Arm got very red hot & itchy on day 3.
Note: This was Pfizer booster shot, administered 7 months after second round of Moderna vaccine.   10 hours - Escalating pain and stiffness at sure of shot and shoulder. Lower back pain and stiffness.  11 hours - Took Excedrin 14 hours - Moderate escalating chills. Fever. Moderate escalating body aches. Joint pain.  16 hours - Took ibuprofen 17 hours - Fever broke. Sweating. Aching present but minor.
Pfizer vaccine for kids was administered and not diluted. The child received 0.2ml of the vaccine undiluted
Body aches; Low grade fever 99; chills; headache; fatigue; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 23Mar2021 at 13:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199), via an unspecified route of administration in the left arm on 06Mar2021 at 13:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. On 23Mar2021 at 13:00, the patient had inappropriate schedule of vaccine administration. On 24Mar2021 at 03:30, approximately 12 hours later after second injection, the patient experienced low grade fever 99, chills, body aches, headache and fatigue. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events low grade fever 99, chills, body aches, headache and fatigue. The clinical outcomes of the events low grade fever 99, chills, body aches, headache and fatigue were recovering at the time of the report while that of inappropriate schedule of vaccine administered was unknown.   No follow-up attempts are needed. No further information is expected.
Ache joints,  no energy,  sharp shocking pains intermittent in different areas, knees feel like kneeling on nails...general feeling ill
patient received an empty syringe in error.  We called them when we discovered & they came back in for the vaccine within a few hours.
Deterioration of speech and development noted on 8-8-12 exam. was normal on 5-30-12 exam, received MMR, VARIVAX and PENTACEL on 5-30-12. Developed fever and rash on 6-14-12.
Breakthrough COVID-19 case with symptom onset 8/3/2021: Nausea/Vomiting, Cough
having blisters and they were dark in the center; broke me up in pox after 7 to 10  days after vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of blister in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In FEB-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced blister (Verbatim: having blisters and they were dark in the center) and chickenpox (Verbatim: broke me up in pox after 7 to 10 days after vaccine). The outcome of the blister and chickenpox were resolved.   It was unknown if the reporter considered the blister and chickenpox to be related to Shingrix.  It was unknown if the company considered the blister and chickenpox to be related to Shingrix.   Linked case(s) involving the same patient:US2023AMR107200   Additional Information: GSK Receipt Date: 07-AUG-2023 The patient reported for both doses of Shingrix vaccine and received both doses at a local pharmacy The reporter reported that it broke him/her up in pox after 7 to 10 days after vaccine. The reporter reported that having blisters and they were dark in the center. The reporter had to disconnect from the call and not all information was collected.  Not all information was available.  The reporter did not provide injection site or lot numbers or expiration dates for neither one of the doses. The patient provided consent to follow up with healthcare professional. For tolerance of 2nd dose of Shingrix, refer case US2023AMR107200.; Sender's Comments:  US-GSK-US2023AMR107200:
Patient has Covid-19 currently although patient had 3 doses of Covid-19 vaccine; Patient has Covid-19 currently although patient had 3 doses of Covid-19 vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 61 years as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Patient has Covid-19 currently although patient had 3 doses of Covid-19 vaccine". The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based pm the limited available information, the events vaccination failure and COVID-19 are considered possibly related to BNT162B2.
This spontaneous report as received from a registered nurse refers to 10 unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On 24-SEP-2015 and on 25-SEP-2015, the patients were each inadvertently administered a dose of PNEUMOVAX 23 (dose and route of administration were not reported) instead of an intended dose of FLUVIRIN. An unspecified number of these doses were administered on 24-SEP-2015 and an unspecified number of these doses were administered on 25-SEP-2015. Each of these 10 doses of PNEUMOVAX 23 were from 1 of 3 different lot numbers (lot number K021030 and expiration date 22-JUN-2016; lot number L010598 and expiration date 06-AUG-2016; lot number L003227 and expiration date 13-OCT-2016). It was unspecified how many or which of the 10 unspecified patients were administered doses from each of the 3 lot numbers. All 10 unspecified patients had each received either one or two doses of PNEUMOVAX 23 previously (dose, route of administration, lot number, expiration date and dates of administration were not reported). It was stated that these 10 unintended doses of PNEUMOVAX 23 were administered by a different nurse who, due to her inexperience, confused PNEUMOVAX 23 for FLUVIRIN since both vaccines and the same labeled dosage of 0.5 ml and had been stored in the same location. No adverse effect was reported for any of the 10 unspecified patients. Additional information is not expected as the reporter did not wish further contact.
Maderna COVID-19 Vaccine EUA Red rash on face, neck, and chest
Status epilepticus approx 60 min. Intubated.  Intensive care unit.
Extreme headaches (progressive from 1st dose) Dizzy/haze/foggy feeling Loss of Memory/difficult focus & remembering simple things that I did before
Case previously recorded as MA2009-4031. Initial case report received from a physician via MedCom on 05 NOV 2009. A 30-year-old female patient was vaccinated during pregnancy with 0.5 mL of S-OIV FLUVIRIN (batch no. 100738) i.m on 03 NOV 2009. No adverse events were reported. MedCom reference no.: NA09-007596.
Patient reported  feeling dizzy after few minutes of receiving the vaccine. No air way compromised, vital BP: 164/84, HR: 103, SpO2: 100.83. TAKEN TO THE HOSPITAL BECAUSE HISTORY OF ADVERSE REACTION TO PENICILLINE AND LEPTOSPIROSIS VACCINE.
woke up with a headache that hasn't subsided with taking Aleve and stuffy sinuses (these are listed as side effects). Around 9 pm started developing hives along my entire abdomen and around to my back, on both sides of my neck and upper chest to my shoulders, and at the hairline around my neck. They aren't raised, but they are warm and very itchy.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. The patient, who completed 3-dose of GARDASIL, inadvertently received another dose of GARDASIL 9 (Lot# L016429, expiry: 09-AUG-2017) on 02-MAY-2016 (dose, route and site of administration not reported). Concomitant medications were not mentioned by the reported. Patient received first dose of GARDASIL on 20-AUG-2008, second dose of 09-DEC-2008 (inappropriate schedule of drug administration) and third dose on 18-NOV-2010 (inappropriate schedule of drug administration) (route, site of administration and lot# not reported). No adverse effects reported. No additional information provided. Product quality complaint was not filed. Additional information has been requested.
Her arm around where they gave her the shot, its like reddish and purple and there is a lump on it. Its also itching a lot; Her arm around where they gave her the shot, its like reddish and purple and there is a lump on it. Its also itching a lot; Her arm around where they gave her the shot, its like reddish and purple and there is a lump on it. Its also itching a lot; This is a spontaneous report from a contactable consumer (patient son). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation:Solution for injection; Batch/Lot number, Expiry date, NDC number was not reported), via an unspecified route, administered in Arm on an unspecified date as Dose 1,Single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Reporter calling about his mom, he was just calling for her because she doesn't speak very good English, so he was interpreting. She got the vaccine and had few questions. She got her first dose at the hospital. They gave her this paper to call if she had questions. The patient arm around where they gave her the shot, its like reddish and purple and there is a lump on it. Its also itching a lot on an unspecified date, she has been putting cold towels on it and putting no pressure on it. She wants to know what she can do further, Is the red, purple, and itching normal. She wants to know if she can put a band aid or cream like Neosporin on it. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.