chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VACCINE WAS FROZE BY ACCIDENT  PRIOR TO ADMINSTRATION; This spontaneous report received from a pharmacist concerned a 46 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: 04-JUL-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced inappropriate storage. The action taken with covid-19 vaccine  was not applicable. The outcome of inappropriate storage was not reported. This report was non-serious.
On 1/18/21 resident received first dose-Pfizer On 2/8/21 resident received second dose-Pfizer
slight headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 71-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot number not reported) via an unspecified route of administration, administered in left arm on 05Feb2021 10:30 AM (at the age of 71 years) as dose 2, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot number: EK5730) via an unspecified route of administration on 15Jan2021 10:47 (at the age of 71 years) as dose 1, single dose for covid-19 immunization and experienced pain on left side to left breast, breathing was a little compromised and oxygen saturation was down and no treatment received, and patient was fine now and also reported that pain in the left arm to leg and breast area, thinking it was pneumonia, but lungs clear. On unspecified date in Feb2021, the patient experienced slight headache. It was reported that no physician office and emergency office visit. The patient underwent lab tests and procedures which included chest x-ray results normal on 20Jan2021. Therapeutic measures were taken as a result of slight headache (headache) includes iced her arm and took Tylenol. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine was for ages 5-11. The patient was 12 at the time the vaccine was administered.
Narrative: Headache, Myalgia, Arthralgia & Fever sore throat, fever, body aches, and  headache
Pt. received 0.5 mL of FLUARIX QUADRIVALENT IM (in right deltoid) on Friday, 12/12/14. He started noticing swelling in his elbow over the weekend. On Monday the 15th, he saw his Dr, who told him he had influenza A. His arm kept swelling steadily, and on 12/25, he went to hospital. From there he was referred to another Medical Center where he was treated for gout (unsuccessfully) and later for a staph infection (successfully).
pt recv vax 17JUL95 & 24MAR97 pt exp vax failure/chickenpox dx w/varicella;
Intrauterine fetal demise at 26 weeks. 11/5/09 Multiple medical records received for dates 6/17/09 to 10/25/09. DX: Intrauterine pregnancy 27 weeks with fetal demise. Pt seen in office on 10/14/09 pt was 25 weeks prenatal visit WNL. Pt. c/o decreased fetal movement on 10/23/09.  Pt. seen in office on 10/25/09 no cardiac activity noted on US. Prenatal records indicate WNL OB visits. Pt received H1N1 vax on 10/14/09. Pt. began OB care 6/17/09.
For two days after injection, I simply had regular, dull, pain in my arm from the injection. This got better and I had no other symptoms. One week from the date of my vaccine, I woke up with a swollen and red arm below the injection site. It was itchy and painful. This has persisted for two days and I saw a physician for it. We are currently monitoring the site for possible cellulitis.
approximately one week after shot red slightly raised area mid deltoid at injection sight two days later looks larger no pain/fever
Breakthrough case admission after 4 vaccines Moderna 2/5/21 lot# 007M20A;  Moderna 3/5/21 lot# 023M20A; Moderna 12/8/21 lot# 012H21B;  Moderna 6/15/22 lot# 076C21A
p/recv vax pt exp stiff sore neck & swollen glands. further info requested
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021 at 11:56 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 11:56 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 86.29 for dose administered on 12-Feb-2021 at 11:56 AM.  No concomitant medications were reported.  Batch number 031L20A underwent temperature excursion on 12-Feb-2021 with temperature 29 degrees Fahrenheit at 09:00 AM and 35 degrees Fahrenheit at 10:00 AM to 11:00 AM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 12-Feb-2021. Vial was in cooler storage during high-pace COVID-19 vaccination clinic and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
12/08/2021 Symptom onset, which includes fever, chills, rigors, muscle aches, runny nose, sore throat, headache, cough, nausea, diarrhea and light headed.
I was congested, had a cough, achy, very tired, I took a home COVID-19 test, that came back positive. My wife and I both were positive, so we called and had a telehealth visit with our Physician Assistant to let her know about our positive test and symptoms. She prescribed Paxlovid that I was able to start that evening. In forty-eight hours, I started feeling better, it did take a couple of weeks before I was really feeling like myself.
Sweating; feeling weak; very dizzy; don't even have taste when I eat; whole body was hurting; muscles were hurting; Fever; chills; Headache; redness at my injection site; my shoulder hurts too; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), ASTHENIA (feeling weak), DIZZINESS (very dizzy), AGEUSIA (don't even have taste when I eat) and PAIN (whole body was hurting) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced HYPERHIDROSIS (Sweating), ASTHENIA (feeling weak), DIZZINESS (very dizzy), AGEUSIA (don't even have taste when I eat), PAIN (whole body was hurting), MYALGIA (muscles were hurting), PYREXIA (Fever), CHILLS (chills), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (redness at my injection site) and ARTHRALGIA (my shoulder hurts too). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweating), ASTHENIA (feeling weak), DIZZINESS (very dizzy), AGEUSIA (don't even have taste when I eat), PAIN (whole body was hurting), MYALGIA (muscles were hurting), PYREXIA (Fever), CHILLS (chills), VACCINATION SITE ERYTHEMA (redness at my injection site) and ARTHRALGIA (my shoulder hurts too) outcome was unknown and HEADACHE (Headache) had not 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 information was provided.
At site of injection I have developed a red area about 1.5 inched to 2.5 inches . I had my doctor check it in case it was infected  or a reaction  from the vaccine.  He felt it was a reaction to the vaccine.  The site doesn't hurt and it's not warm.  The site isn't changing from when I first noticed it 2 weeks ago.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 03Oct2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 Immunization.  The following information was reported: IMMUNISATION (medically significant) with onset 03Oct2021, outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021, outcome "unknown" and all described as "tested positive for COVID"; RHINORRHOEA (non-serious), NASAL CONGESTION (non-serious), outcome "unknown" and all described as "Stuffy and running nose"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "bad head cold"; HEADACHE (non-serious), outcome "unknown", described as "headache". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (26Dec2021) negative; sars-cov-2 test: (27Dec2021) positive.  Additional information: It was reported that reporter husband tested positive for COVID today. His booster was on 03Oct2021. He was 53 and felt like he had a bad head cold. Stuffy and running nose and really bad headache. He did a Rapid yesterday and was negative, but woke up today feeling bad so tested and was now positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient passed out for a couple of minutes then regained consciousness. Mom says he is still looking pale in face. He is ok now parent may take him to er if he gets worse.
Fever 102.5, terrible headache, chills, nausea, diarrhea, injection sites (especially right arm) very swollen, hot and painful.
Started feeling extreme fatigue on 2/6 at 12:33pm, soreness at injection site; on 2/7 I was more fatigued, had body aches, mild fever, headache, nausea, loose stools, weakness, generally feeling unwell, feeling a "brain fog", some dizziness, and chills. Additionally, the arm was red and swollen at injection site. On 2/8, I have continued to feel fatigued, weak, with mild body aches, no fever or chills, but still feeling weak. As of 13:05 on 2/8, I am feeling better, but still not 100%. I had previously had all these symptoms with the first shot except the swelling and redness at the injection site, that was new. With the first dose, it took approximately 3-4 days for me to return to feeling normal.
71 Year old female C/O Headache immediately after receiving the vaccine. States that "Headache is gone, I just wanted to make sure I'm Ok" Vital signs accessed. WNL.  Patient didn't want to go to the hospital or receive further treatment.
Approx 10 hours of receiving the Shingrix vaccine, I had the absolute worst headache I have ever had in my life. For the that night and the following 3 days, I suffered from fever up to 103 degrees, chills, headache, ringing in ears,  body aches. I have had the flu vaccine before without any side effects so I?m assuming these awful side effects were from Shingrix vaccine. I?m very hesitant in getting the 2nd dose in a few mos.
COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Aug2023 at 20:00 as dose 6 (booster), single (Lot number: GL2042) at the age of 72 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Feb2021 as dose 1, single (Lot number: 030L20A), on 04Mar2021 as dose 2, single (Lot number: 029A21A), on 17Nov2021 as dose 3 (booster), single (Lot number: 034F21A), on 04Apr2022 as dose 4 (booster), single (Lot number: 002M21A) and on 29Sep2022 as dose 5 (booster), single (Lot number: 027E22A) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Cypro antibiotic, reaction(s): "Known allergies: Cypro antibiotic". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Aug2023 at 20:00, outcome "unknown", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 99.0, notes: Since then highest fever is 99.0; (01Sep2023) 100.1, notes: Highest fever was 100.1 on 01Sep; SARS-CoV-2 test: (01Sep2023) positive, notes: My initial positive test was that morning; (04Sep2023) negative, notes: tested negative on 04Sep and 07Sep; (07Sep2023) negative, notes: tested negative on 04Sep and 07Sep; (10Sep2023) positive, notes: I tested positive with no initial symptoms on 10Sep. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was taken as treatment for COVID-19 from 01Sep2023 to 06Sep2023
Information has been received from a health professional concerning a 4 year old male who on 27Oct2000 was vaccinated with a dose of varicella virus vaccine live. The school the pt attends had a chickenpox breakout and on approximately 13Nov03 the pt broke out with five to seven chickenpox lesions. Unspecified medical attention was south and as of 19Nov03, the pt was recovering. There was no product quality complaint involved. The reporter indicated that the pt's brothers and two other patients had similar experiences following exposure to varicella virus vaccine live. Additional information has been requested.
The pain was immediate (no lag time) and intense enough over the following two weeks to be distracting during the day and to prevent sleep. Fever evening 11/16/2016; fever went away in about 24 hours. As of 12/13/2016 the pain continues but at a lower intensity. Still I cannot rest or sleep while laying on my right side and any sudden of my right arm is painful. The flu vaccination is clearly the source of this lingering pain. Should I be concerned about further adverse reaction?
Painful muscle spasms on and off for 48 hours, vomiting, chills, head ache, body aches
face swelling and pain where I had dermal fillers put in in August 2020.  Started with upper lip on 1/22/21 and then my eyes were swollen, bruised and painful upon waking 1/23/21 and lasted until early morning of 1/25/21.   My whole face was sore to touch during this time.   I also had fatigue and headache starting 1/21/21 which lasted a few days along with  fever, chills,  body aches and  sore left armpit which started early morning 1/22/21.  I had expected these last symptoms so was not alarmed.  I was not warned about the facial  swelling and that was a bit scary.
This case was reported by a nurse via sales rep and described the occurrence of fatigue in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fatigue and chills. On an unknown date, the outcome of the fatigue and chills were unknown. It was unknown if the reporter considered the fatigue and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported.
Headache, Myalgia, Fever, NauseaVomiting, low grade fever, headache, body aches, nausea Narrative:
Her arm was sore; This is a spontaneous report from a contactable consumer (patient) via Pfizer. This female patient of unspecified age received a dose of BNT162B2 (TRADE NAME UNSPECIFIED; lot number unknown) via an unspecified route of administration on 04Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported she received the COVID-19 vaccine yesterday (as of 05Mar2021) and four to five hours later her arm was sore, especially when lifting her arm. She reporting she had been using an ice pack. The clinical outcome of her arm was sore was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Chills, fever, headache, nausea, vomiting, redness, pain/swelling at injection site.  Taken to emergency room.  Treated with IV fluids, meds by mouth.  Found also tachycardic.  Symptoms controlled.
patient received 2nd dose at 15 days instead of 21 days from 1st dose
a patient received an expired dose of FLUBLOK QUADRIVALENT vaccine/No AE; Initial information received on 26-Mar-2021 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 33 years old female patient who received an expired 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] prefilled syringe batch number not reported and expiry date: 22-Mar-2021 via an intramuscular route in the left deltoid on 24-Mar-2021, frequency: once, strength: standard for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   It was an actual medication error due to expired vaccine used (latency: same day).  Potential Product Technique Complain: No, Description: Healthcare Professional (HCP) stated the administered FLUBLOK on Wednesday and it expired on Monday. HCP wanted to know how soon after can the patient come back in to get another shot. Or should the patient wait a certain amount of time. The nurse states that usually the Flublok vaccines expire in Jun-2021 so she was surprised to see that this one expired in on 22-Mar-2021 after the vaccine was given. There was no adverse events reported or treatment needed. The nurse plans to revaccinate the patient with the Flublok as soon as possible. Product used, First time product used: Yes, Still using product: Yes, Was Device Used: Yes.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements. 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.  There will be no information on the batch number for this case.
Individual started to feel her heart begin to race.  she said she felt a little light-headed and her vision was "off".  She had a headache coming to the clinic which she had taken excedrine for prior to arriving.  We took her blood pressure about 10 minutes after vaccination and it was 150/88 HR 130.  We moved her into a private room to monitor and attempt to relax her.  continued BP monitoring every 5-10 minutes-  148/92 147,  160/90 155.  She stated that her left lip felt tingly so at that time we decided to call 911.
stomach upset, diarrhea, chills, headache Narrative: Took Ibuprofen
I had a patient that received the Janssen vaccine this morning.  On his way to post vaccine waiting area, he became dizzy and fell to the floor.  We immediately called 911. The Paramedics came to pharmacy, where they checked his blood pressure and vitals. He went on his own power, with the paramedics, for further evaluation at emergency room
This case was reported by a healthcare professional and described the occurrence of red, swollen arm in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of KINRIX (details unknown). At an unspecified time after vaccination with KINRIX, the subject experienced red and swollen arm. The reporter refused to provide any additional information. It was unspecified whether the event was systemic or localized. At the time of reporting the outcome of the event was unspecified.
Pt presented stating she wanted her Booster dose of Pfizer vaccine on 12/10/2021. Pt informed the staff member checking her in that she forgot her immunization card, but had received her first 2 Pfizer doses at our store. Staff checked and found she had received Pfizer doses on 3/11/21 and 4/1/21 at our store. Pt presented to me for her injection, which I administered, instructing her to bring me her immunization card so I could document that day's dose. Today on 1/5/2022, she brought her card, at which time it was noted there was an additional dose of Moderna vaccine written on her card given at a different location on 8/4/2021. Pt stated that she believed by getting an additional Moderna dose, it would give her additional protection. Pt was informed there are no current guidelines for 4 doses of COVID-19 vaccines and she should have informed us of this 3rd dose that had already been given- that having more than the recommended doses could be dangerous. Pt denies any adverse symptoms at this time. Pt was advised to seek medical attention if she experiences any unusual symptoms. Pt verbalized understanding.