chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fevers developed 10 hours after injection. Fever of 102 lasted for more than 24 hours. Fevers treated with Tylenol. On day two after injection, I developed a rash and hives all over, also shortness of breath. Have taken 50 mg of Benadryl.
Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer or non healthcare professional. This case involves a 42 years old female patient who was vaccinated with 0.25 ml dose of FLUZONE QUADRIVALENT (Batch number: UP6259KA and expiry date: 30-Jun-2019) (dose in series, route and site of administration were not reported) on 02-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines were given. It was a case of actual medication error due to vaccine under dose because patient was given 0.25 mg/ml FLUZONE QUADRIVALENT Pediatric dose instead for the 0.5 mg/ml dose. No reactions were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by sender: none.
Approximately 2 hrs after received vaccine injection site left deltoid reddened with raised firm lump approximately 6 inches in diameter, itching and hot to touch. Ice applied off and on for 4 days. States area looks bruised with soreness on 6th day.
My first dose of the Phizer vaccine  was on August 25th, and on September 12,  I felt like I was going to faint while doing yard work.  My second dose was on September 15, and I experienced vertigo while walking on September 18, and was dizzy during the morning of September 19.  I didn't experience any other events until yesterday, December 20th and today, December 21.  I have been feeling a bit dizzy when sitting, and like I may fall backwards while standing, and a little unstable while walking.
8/15/2022 I had some discomfort in my buttocks. I saw a doctor and was diagnosed with hemorrhoids. I was prescribed Hydrocortisone Acetate Pramoxine HCl. I began taking the medication that day. The symptoms were intermittent, and I used the cream as needed. I have not recovered, the symptoms occur intermittently.
the inside of her nose got all sore and itchy; the inside of her nose got all sore and itchy; red skin with tiny bumps outside her nostrils and upper lip down to the corners of her mouth; red skin with tiny bumps outside her nostrils and upper lip down to the corners of her mouth; This is a spontaneous report received from a contactable other healthcare professional (herself).   A 70-years-old female patient received first dose of first bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not included) via an unspecified route of administration on 06Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in Mar2021 the patient experienced the inside of her nose got all sore and itchy and red skin with tiny bumps outside her nostrils and upper lip down to the corners of her mouth. The reporter classified the events as non-serious. The outcome of the events was unknown.  Information on LOT/BATCH number has been requested.
Case number PHEH2014US023179, is an initial spontaneous report from a health care professional received on 17 Nov 2014. This report refers to a 38-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1412401) intramuscularly in Oct 2014. On 22 Oct 2014, approximately 10 days after vaccination, the patient experienced soreness in her arms and legs. The patient consulted her doctor who found elevated liver enzymes. The patient was feeling well at the time of this report. Final outcome of the events was reported as recovered on 02 Nov 2014. Seriousness and causality of the events was not reported.
This spontaneous report was received from a health care professional refers to multiple unspecified patients of unknown demographics. Since 03-DEC-2015 unknown number of patients were vaccinated with improperly stored VARIVAX (dosing regimen and lot # unspecified). No concomitant medications reported. No adverse effects reported. There was no product quality complaint involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sore arm at first. Low grade fever and chills about 12 hours after vaccine.
After the first dose I had an excruciating headache for 2 days. On the second day, about 7 pm, every joint in my body became so painfully bad that I could hardly walk. By morning, I was back to normal. Two days after my second dose, I had an ischemic stroke.
A physician reported that an 82 year old female received an injection of Flu Shield (2001-2002 Formula) on approximately 14 Nov 2001. One week post immunization, she developed angioedema and urticaria. No further information was available as of the date of this report. Angioedema was considered medically important. FOLLOW-UP information received from the reporter on 01/15/2002 provided the Flu Shield lot number and indicated that the vaccine was administered on 10/02/2001, rather than 11/14/2001.
No adverse event; Dose administered after Manufacturer Date of ExpiryVaccine expired on 13Jun2023, 1 dose administered on 20Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of ExpiryVaccine expired on 13Jun2023, 1 dose administered on 20Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jun-2023, 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 20-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of ExpiryVaccine expired on 13Jun2023, 1 dose administered on 20Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of ExpiryVaccine expired on 13Jun2023, 1 dose administered on 20Jun2023) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of ExpiryVaccine expired on 13Jun2023, 1 dose administered on 20Jun2023).    No concomitant information was reported. Suspect product dosage text was reported as unknown. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-731903 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731903:same reporter
Patient fully vaccinated and boosted with Pfizer on 2/4/21, 2/25/21, and 10/8/21. Previously diagnosed with COVID on 12/30/21. Patient presented to  ED with a fall on 1/13/22. Previously was seen in the ED on 1/11/22 for pneumonia, however sent home on doxycycline. Patient was not eating or drinking, felt light headed, and fell. Patient admitted on 1/13/22 and discharged 1/16/22.
31AUg93 approx 1035AM pt c/o dizziness & feeling funny p/receiving vax; pt placed supine position w/feet elevated;
Dec 25 2008 hot shower, produced red itchy welts. Jan 1st 2009 to present time. Cold temp 35 degrees or below when outside for more than a few minutes. Red welts that are itchy and painfully appear. Last about 30 mins after body warms up.
Swelling aproximately 2 inches below the shot.  The swelling was in a broad band 3" x 4" across her right arm.
got / vaccination Tuesday / seems to be having a new shingles breakout; This case was reported by a consumer via media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th July 2021, the patient received Shingrix. In July 2021, less than a week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's child. The age at vaccination was not reported. The patient had got her shingles vaccination on Tuesday and developed a new shingles breakout.
I vomited for 12 hours with a low grade fever and was out of work for 3 days.
2 days after 2nd shot my lips were entirely covered with cold sores bilateral in crease of mouth. Had 102 fever. Extreme fatigue. Following Sunday had unbelievable chills. Fever was 101. Next day after showering my voice became very raspy and though it felt like part of flu symptoms had no other concurrent symptoms to label flu. Last week almost to 2 wk post vaccine thought I felt better. While urinating I had an itch over and all around left eye. Didn't touch it or anywhere else so I could look in mirror (have photos). It looked like white powder covered my left eye and surrounding areas. There was also white on right area but not as severe. Throughout from 2nd shot the fatigue has left me almost useless except for forcing myself to take care of pets. I've been sleeping some days almost 23 hours a day like yesterday, Aug 29th
Rash from both shoulders down to elbow and into underarm .  Very red, bumpy with blisters filled with fluid, itching unbearably.  Angry and hot to touch
No Additional AEs; Caller reported GARDASIL 9 was administered to a 9 month old.  No other information provided.  No Additional AEs or PQC reported.; This spontaneous report was received from a nurse and refers to a 9-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-SEP-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 0.5 ml, lot number 1780878, expiration date: 02-DEC-2023, administered intramuscularly for prophylaxis (exact dose, and strength were not provided) (product administered to patient of inappropriate age).  No additional adverse events were reported (no adverse event).
Patient fainted after injection. Mom was with her and stated she has done this in the past with vaccines or giving blood. Becomes very anxious and has needle phobia. Mom put cool pack on back of neck and wet cloth on forehead. Also gave water as she was waking up. She was fine and ready to go in about 20 minutes.
Body aches,muscle pain,hurting all over; Headache; Soreness at injection site; Stomach pain; Pressure on the chest; felt sick; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), CHEST DISCOMFORT (Pressure on the chest), MALAISE (felt sick), MYALGIA (Body aches,muscle pain,hurting all over) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stomach pain and Chest pressure.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), CHEST DISCOMFORT (Pressure on the chest), MALAISE (felt sick) and VACCINATION SITE PAIN (Soreness at injection site). On 09-Apr-2021, the patient experienced MYALGIA (Body aches,muscle pain,hurting all over) and HEADACHE (Headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ALKA SELTZER [ACETYLSALICYLIC ACID]) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain), CHEST DISCOMFORT (Pressure on the chest), MALAISE (felt sick), MYALGIA (Body aches,muscle pain,hurting all over), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication was not reported by the reporter but it is reported that patient is taking other medication, not specified. The patient did not throw up, have nausea, vomiting or fever. She never had the flu. She wanted to know should she take the second shot.
Just hype typical side effects: 1) Sore arm gradually worsening over the next five hours or so, staying sore overnight, and gradually healing over the next two days.   2) Headache/pressure in head starting Thursday evening, lasting through Friday.  3) Fever starting Thursday evening, lasting through Friday.
Upon first vaccine had mild nausea and fatigue. Upon 2nd dose within 3 days had lower back pain that progressed to extreme muscle pain under the right shoulder blade that radiated down to the elbow and wrist. This came with muscle spasms to the area that was relived with chiropractic treatment.  The pain persisted and I continued the chiropractic treatment with no further relief of the pain and missed days of work due to this. I would apply ice and heat to the area and wore a compression brace on my elbow. I went to massage therapy twice that relived the pain successfully. This complaint lasted 6 weeks from the dose of my second COVID 19 vaccination shot. My next mensural cycle was 3 weeks later than expected and lighter with continual bleeding for at least 2 weeks and still on-going at the date of this report.
Information has been received from a physician concerning a 14 year old female who was vaccinated intramuscularly on an unspecified date with her second dose of Gardasil (lot# not reported).  On 25-MAR-2008 the patient experienced dizziness, but recovered from the dizziness.  Additional information has been requested. This is in follow-up to report previously submitted on 4/14/2008. Information has been received from a physician concerning a 14 year old female with no known drug allergies, who on 24-MAR-2008 at 11:45 was vaccinated intramusculary into the left deltoid with her second dose of GARDASIL (lot#858282/1263U). On 24-MAR-2008 (previously reported as 25-MAR-2008) at 13:50, the patient experienced dizziness, but recovered from the dizziness the same day. No further information is avaliable.
This spontaneous report as received from a pharmacist refers to a 79 year old male patient without drug reactions/allergies. The patient's medical history included history of cancer, leukemia or other unspecified immunocompromising disease. On 15-MAR-2013 the patient was vaccinated with 0.65ml ZOSTAVAX (lot # J000433, expiry date 10-APR-2014) subcutaneously. Concomitant therapies included lisinopril(manufacturer unknown), TRILIPIX, omeprazole(manufacturer unknown), metoprolol ER(manufacturer unknown) and LIPITOR. On an unspecified date after administration, he developed "significant swelling that covered most of his upper arm". The "swelling went away" on an unspecified date and 'left a spot at the injection site that looked like a wart of vesicle". The patient thought it was a "scab" but he had been "picking at it and it won't come off". The patient had "no pain, but was very concerned about the spot still being present on his arm". No treatment was given for adverse event. No lab diagnostics studies were performed. The patient was recovering from the adverse event. The patient spoke to pharmacist for seeking medical attention. Additional information has been requested.
Per clients mother, on 12/2 at 7:30 am client was up and his legs were completely immobile. He could not move them, crawl, or put weight on them. Client had a fever of 100-101 degrees per mother but actual temperature was not taken. About 2 hrs later client could limp but screamed in pain until 9:00pm. On 12/3 client woke up and was sore & fussy but was back to normal by the evening.
Patient thought they had received the Moderna covid vaccine for their first dose, received Moderna covid shot for their second shot in the series. We soon found out that the patient had received the Pfizer covid vaccine for their first shot. Patient not experiencing any adverse events at this time
given FluLaval after being frozen; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 13-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2021-2022 season) (batch number AD49D, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd November 2021, the patient received FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 details were provided as follows: The nurse given FluLaval after being frozen at minus 0.45 Celsius for 15 minutes to the patient, which led to incorrect storage of drug. The reporter consented to follow up. This case was 1 of 10 linked cases, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021230186:same reporter US-GLAXOSMITHKLINE-US2021230173:same reporter US-GLAXOSMITHKLINE-US2021230181:same reporter US-GLAXOSMITHKLINE-US2021230191:same reporter US-GLAXOSMITHKLINE-US2021230195:same reporter US-GLAXOSMITHKLINE-US2021230177:same reporter US-GLAXOSMITHKLINE-US2021230188:same reporter US-GLAXOSMITHKLINE-US2021230180:same reporter US-GLAXOSMITHKLINE-US2021230192:same reporter
Symptoms:  2nd dose of COVID dose received on 4/2/21 at noon. He reports the following day early in the morning his symptoms started. They are very similar to the symptoms he had after his first vaccine. He reports body aches and upset stomach as his main symptoms. Also reports mild dizziness but that is improving. He states he at times is feeling anxious which makes his heart race and feels mildly short of breath. Denies new SOB with activity and is not feeling SOB right now. Does have medication to take for anxiety and this does help. He also states he is having bouts of confusion with what day it is, where he is, etc. RN notes pt does not sound confused on the phone and was able to verbalize name/DOB and answer questions appropriately. Advised to call 911 but patient declines. He states symptoms are worse at night and he would prefer to be seen in the office.
Woke up at 5 am to a migraine and a fever of 102.1. I was sweating. I had muscle aches. When I woke up later my fever and migraine was still there. The rest of the day I was fatigued and nauseous.
Severe bodyaches, chills, headache, fatigue, nausea For 24 hours
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 06Apr2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "total hip replacement" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (PAXLOVID Treatment). The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
w/in 1wk of vax pt reported wife exp dizziness, lightheadedness, weakness & changing refractory vision problems which persisted as of 26NOV;MRI of head & testing for hypoglycemia were neg;BP nl;pt had fallen prior to onset of sx;
I had a hard time breathing, started coughing and had rasp and scratchiness in my throat. The next day, my breathing got worse and had a hard time breathing really. I went to go to urgent care on 9/15/2021 and they said I was pretty having like asthma attacks. The gave me some prednisone 20mg but it is a week later and I am still coughing and having a hard time breathing. My chest and lungs feel heavy and they said I was at risk for pneumonia.
Patient received 12 month vaccines. Had patient wait 10-15 mins after vaccines were given. Checked patient at 10:40, and noticed patient had redness and slight swelling on right thigh where Varicella vaccine was administered. Called primary provider to get a second look and opinion on thigh. Provider prescribed Benadryl for mild reaction to Varicella  vaccine.
ADMINISTERED TO A 14 YEARS OLD; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 14 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: UNKNOWN) dose was not reported, administered on 31-JAN-2022 for prophylactic vaccination. Age at time of vaccination 14 years old. No concomitant medications were reported.  On 31-JAN-2022, the patient experienced administered to a 14 years old, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered to a 14 years old and off label use was not reported. This report was non-serious.
pretty Miserable; side effect; This case was reported by a consumer via interactive digital media and described the occurrence of feeling miserable in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced feeling miserable and adverse event. On an unknown date, the outcome of the feeling miserable and adverse event were unknown.   It was unknown if the reporter considered the feeling miserable and adverse event to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had all side effects pretty miserable. The reporter asked would experience the same effects on the booster.