chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given an adult dose of Pfizer that was diluted using 1.3mL of sodium chloride and drawn up to administer a 0.2mL dose. Patient was observed for 15 minutes with no signs of allergic reactions. Patient's parents were contacted by Doctor and they report no side effects or symptoms.
Bell's Palsy - Onset 06/05/2005.  Saw physician 06/06/2005.
vaccine administered after 11 days from first puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered after 11 days from first puncture) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered after 11 days from first puncture). On 10-Aug-2021, EXPIRED PRODUCT ADMINISTERED (vaccine administered after 11 days from first puncture) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Given the vaccination at a conroe location yesterday morning and i it started to build in size on my arm last night today it feels; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Given the vaccination at a conroe location yesterday morning and i it started to build in size on my arm last night today it feels) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Given the vaccination at a conroe location yesterday morning and i it started to build in size on my arm last night today it feels). At the time of the report, VACCINATION SITE SWELLING (Given the vaccination at a conroe location yesterday morning and i it started to build in size on my arm last night today it feels) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.  No treatment medications were reported
A report has been received from a Health Professional concerning a 7 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on 16-Jan-2014. The patient was inadvertently given expired FLUMIST QUADRIVALENT. The patient experienced gave expired FLUMIST QUADRIVALENT which started on 16-Jan-2014. The outcome of the event of gave expired FLUMIST QUADRIVALENT is unknown. The report was considered  toe non-serious by the reporter. Corrected report 05-feb-2014: Case medically confirmed box ticked.
Pain and swelling at injection site and from shoulder to elbow.  Injection site hot to touch.  Red streaks from injection site to interior of elbow appeared on the morning of 02/05/10.  Resolved 5 days post vaccination.
Day1: flu-like symptoms.   day2:  that night, intense rigors and chills accompanied by shortness of breath lasting probably twu hours.   Followed by vomiting 4 or 5 times until about 6 am.    then headache lasting into 10/24.
Mother reports started  itching over weekend.  Started getting welts on Tuesday.  Noting on arms and legs.  Under arms and outer thighs are worst.
This spontaneous report as received from a physician via company representative refers to a 18 year old female patient. The patient's medical history, current conditions and concomitant medications were not reported. On 05-JAN-2017, the patient was inadvertently vaccinated with ZOSTAVAX (dose, route and lot number were not reported) for prophylaxis instead of receiving VARIVAX. On the same day, she also received her last dose of GARDASIL 9 (dose, route and lot number were not reported) for prophylaxis. On 05-JAN-2017, after receiving the vaccines, the patient developed soreness at the injection site (injection site pain) which lasted for an unspecified duration of time. The outcome of injection site pain was unknown. The causality between the suspect drugs and injection site pain was not reported. Additional information has been requested.
Pt. received first dose of the vaccine at 11:05.  Pt. was instructed to sit for 30 minutes due to a nut allergy, after five minutes of sitting Pt. stated that he was started to get nauseous.  Pt. was moved into the back room where he walked himself without difficulty.  Initial set of vitals was obtained at 11:15, and pt. had stable vitals of 132/98, HR of 91, RR 16 and SpO2 of 98.  Pt. was given a rubbing alcohol pad at 11:12, and after smelling it nausea was depleted.  Pt. had stable vitals with a blood pressure of 132/98 at 11;15.  Pt. had a second set of vitals after no complaints of nausea with stats of 113/76 PR of 88, RR of 16 and SpO2 of 98.  Pt. had a patent self-maintained airway, and was speaking in full clear sentences without difficulty.  Pt. had clear and equal lung sounds and was speaking in full clear sentences with no obvious difficulties.  Patient had a regular and strong pulse with no signs of major bleeding.  Pt. sat for five minutes after his original time and after Pt. walked out stated that he had no other signs or symptoms.  Pt. was informed that after he left if he experienced any other difficulties or reactions to call.  Pt. stated that he was feeling fine, and walked out of the clinic without difficulty.
had an unconstituted dose be given to a pt; had an unconstituted dose be given to a pt; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 19-JUL-2022 Reporter's comment: The reporter stated that the office used the Shingrix elastitags because they had an unconstituted dose be given to a patient so the elastitags ensured the dose was reconstituted. The reporter consented to follow-up. Additional Supportive Information: The patient received an unconstituted dose of Shingrix, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered.
Patient complained of heave feeling in her legs and had no strength to stand up. Patient 's brother said she gets severe anxiety and will have this happen when she is severely anxious. She was very sleepy and was responsive but would have to shake her a bit to get her to wake up. She did tell me that she used Valium before but she said she had not taken any prior or after the shot. but she was very sleepy . As she sat in the motorized scooter in front of the pharmacy she was shaking almost looked like having seizures. 911 was called and she was taken to local hospital
Having an allergy issue; I felt kind of low energy; face its warm; Benadryl because it raise my heart rate; pain in the arm; Had pain in arm where I got the shot; shoulder joint hurting; Itching under under the arms, legs, in my pant, my back, in my bra, my face and my head; My feet close to ankle had some red small spots look like size of a pin head on my both lower legs; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old female patient received first dose of bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Formulation: Solution for injection, lot number: EW0175 and expiration date: unknown), via an unspecified route of administration in left arm on 19May2021 as a single dose for COVID-19 immunisation, diphenhydramine hydrochloride (BENADRYL), via an unspecified route of administration from an unspecified date for an unspecified indication. Medical history included seasonal allergy and concomitant medications were not reported. It was mentioned no other products were taken by the patient. On an unspecified date the patient experienced side effects when she took the first dose vaccine. The patient did not realize, perhaps that it could be she thought that she was just having an allergy issue. The patient had the first dose of vaccine on 19May2021 and the early in the week she kept itching under the arms, the legs and especially in face it is warm (not clarified), where in her pant, her back and in her bra and even on her face and her head on an unknown date in May2021. At first she thought maybe got bitten up by some mosquito and just itching. Last night when she was taking shower and applying some lotion on leg because she didn't get bitten up by mosquito but her feet close to my ankle when she looked down at her ankle had some red spots look like size of a pin head on both lower legs on an unspecified date. It wasn't raised up like anything. It was just red small spot all on both lower legs, so she did not know the only thing different she did was take that vaccine because she was using the same soap and using the same detergent. She didn't eat anything different, so she was itching and could not take Benadryl because it raised her heart rate, so she had been taking Allegra (treatment for event), so it's not taken away the itching but it still happens as not as much as if she didn't take it. Consumer further stated at first she had pain in the arm, shoulder, she noticed by the next day that shoulder joint was hurting and she didn't do anything like lift anything heavy, she felt kind of like low energy that she noticed. When probed for event start date, consumer stated, it was after (first dose) vaccine, the next morning my arm was paining on my shoulder joint that arm where I got the shot. I noticed by next morning (20May2021). The action taken in response to the events for for diphenhydramine hydrochloride was unknown. Therapeutic measures were taken as a result of having an allergy issue, itching, my feet had some red small spots. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
inconsolable crying for more than 3hr duration w/in several hrs of vax;resolved & back to nl the next day;
Cellulitis began day after shot, progressed over the course of a few days. Afebrile.
patient only had the flu a few years back; Initial information received on 21-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer/ non-health care professional via social media.  This case involved a patient of unknown age who got the flu (influenza), while patient received vaccines INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (few years back), patient got the flu (influenza), (latency: unknown) following the administration of suspect vaccine.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Outcome of the events were unknown.  There will be no information available regarding batch number in this case.
Redness, swelling, pruritis, pain at site of vaccination, started 9 days after the vaccine. No systemic symptoms. Started 1 day ago, worse today.
I started with a mild sore throat progressed to a week of nasal congestion and an extremely runny nose. I went through about a case of Kleenex. I had at the beginning for two or three days, mild exhaustion.
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12Feb2022 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions.  No treatment medication was provided.  This case contains information for the 9th of 43 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-689222 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222:Master case
Itching, raised red warm area the size of baseball for one injection and golf ball size for the other on her left arm. She received the Shingrix and the PPSV23 in left arm on 11-22-19
I have diverticulitis, partial bowel blockage, my liver enzymes came back really really off. They think that I have liver disease. A colonoscopy back in November was normal .
Approximately 5 hours after the shot, was very fatigued, had a headache, chills/shivering, body aches and a fever of 101.4.  Took Aleve. Symptoms lasted about 24 hours.
I had the onset of 99.8-degree fever, headache, myalgias, malaise, cloudy urine, and suprapubic tenderness. Those symptoms lasted about three days. I took levofloxacin 250mg twice a day for one week. Symptoms improved the next day but worsened again the following day before gradually clearing. I contacted medical advice two days after onset of symptoms. They recommended going to the emergency room, but I declined. Two weeks later, I had a post void residual measured which was normal. On October 11, 2022, I had a prostate procedure for B Benign Prostatic Hyperplasia, so I do not think this was vaccine related.
damaged dose, tip where needle is put on was broken off from vial and was inside of the manufacturer packaging; no patients involved; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 23Dec2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose 1, single (Lot number: GH4081, Expiration Date: Jun2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "damaged dose, tip where needle is put on was broken off from vial and was inside of the manufacturer packaging; no patients involved". Additional information: The reporter provided information on a damaged dose that practice received and was wanting to request a credit for the dose that was damaged if that was possible. The reporter clarified that they were reporting in regards to Prevnar 20 which was damaged upon receiving shipment, the tip where the needle was put on was broken off from the vial and was inside of the package, confirmed inside of the manufacturer packaging. No longer has the damaged product because the reporter was worried about someone getting cut, so the damaged product was put in a sharps container. It was pretty sharp, and nipple was broken off where needle attached to. The reporter confirmed there were no patients involved. The packaging was sealed and intact; confirmed manufacturer packaging was unopened.  No follow-up attempts are needed. No further information is expected.
Within 4 hours of injection: fatigue, muscle aches, chills, numbness of arm and fingers on side of injection, dizziness  Within 12 hours of injection: chest pain, severe chills, severe muscle aches, nausea, headache, numbness of arms/fingers on side of injection, bilateral wrist pain, overall joint pain
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received SHINGRIX. The patient's past medical history included neurological disorder NOS. On 29th May 2018, the patient received SHINGRIX (intramuscular). On 29th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 30th May 2018, the patient experienced headache, nerve pain, insomnia, hypotonia and eye pain. On an unknown date, the outcome of the injection site pain, headache, nerve pain, insomnia, hypotonia and eye pain were not recovered/resolved. It was unknown if the reporter considered the injection site pain, headache, nerve pain, insomnia, hypotonia and eye pain to be related to SHINGRIX. Additional details were provided as follows: The patient reported this case for herself. The patient reported that she was on many other medications, but did not have her list available at time of report. It was reported that, the patient she received her SHINGRIX injection at around 3 PM. Less than a day after receiving SHINGRIX, the patient experienced pain at the injection site, but had no redness or marks. At 1 AM, the patient was still wide awake and could not sleep. The patient was experiencing nerve pain, which began on her hands and arms and spread to her entire body. The patient could not specify further. The patient also reported that she had difficulty gripping her walker. The patient has denied permission to contact their physician.
After patient received 1st covid dose we realized the vaccination had expired the day before. The frozen expiration date was 10/2021 but the vaccination had been placed in the fridge on 06/25/2021 which with the 30 days it expired 07/25/2021.Called Moderna and they stated vaccine should be ok and the patient doesn't have to get another dose and to report to VAERS according to their guidelines. Called and notified patient, patient states she didn't have any reaction but fatigue to report.
No report of negative event after 15 min wait past receipt of vaccine.   Notified by Coronor, on 3/11/2021 that this patient expired on 3/11/2021 at home.   Not sent to hospital.   Pronounced at home.  Sent to Funeral Home
Narrative: COVID infection following COVID vaccine series 01/09, Pfizer, dose# 1 01/30, Pfizer, dose #2 08/20 pt cc: cough, chills, fever exposure: unknown 8/19 COVID swab, result; detected 08/30 COVID swab, result: detected
Swelling, redness, heat in injection site.  Has had same reaction before, worse this time.
Heart pain dull constant pain, Sharp chest pain for a second random times of day, Tiredness, Lack of appetite, Difficulty Breathing, and Out of breathe while Sitting, Standing, Walking,
Seen 10/17/07 for pneumovax injection. Given vaccine left deltoid IM. On 10/18/07 was seen at office with left upper arm swelling and redness. Red area approximately 3x5 inches and warm to touch. Denied fever. Told to take benadryl 25 mg q 6 prn and apply ice to area. Pt left office. Around 3 pm 10/18/07 received call from CVS pharmacy that patient nearly fainted. Pt was sent to Hospital.
Patient came in for his first dose of covid vaccine. After administration, I asked patient to wait 15 minutes. A few minutes after this, he walked up to door and knocked, stating that he did not feel well and that usually after vaccinations  he gets dizzy and light headed. At this time, I went out to sit with him and ask more questions. I also had my intern call 911. He mentioned that he usually gets dizzy after shots and I asked if he usually either takes anything for that or if the facilities that administer his routine shots do anything different. He mentioned no and that is when he blacked out. This lasted a few seconds as I tapped him a few times. He came back and he looked pale. He was also sweating profusely and during this time, the local police came in.  His wife and brother were also called into the store. They gave him oxygen and EMT followed suit. They checked for his vitals and everything was normal. He was asked if he wanted to go to the hospital but he opted out. He was assisted to the car by the EMT. Later on during the day, I called to see how he was doing and his wife mentioned that other than feeling tired, the patient was okay
A report has been received from a Physician concerning a 10 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 01-Nov-2012. The patient experienced tested positive for influenza and had a runny nose which started on 02-Nov-2012. The outcome of the event of tested positive for influenza and had a runny nose is unknown. The report was considered to be non-serious.
Chest tightness, after taste in mouth, palpitations, temp 98.4 degrees, BP - 122/82, Pulse - 80 (patient states vitals elevated from normal); shaking, dizzy, nausea
HEART WENT OUT OF RYTHMN AND A CARDIOVERSION WAS NEEDED TO CORRECT
c/o reaction to pneumonia shot @ clinic: h/a, redness from shot area down to elbow; tx @ ER Kefzol, Lortab, Duricef, Darvocet; apply heat or cold;
mild soreness in arm; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm on an unspecified date at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced mild soreness in arm on an unspecified date. The patient outcome of the event was unknown.  The information on the batch number has been requested.