chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 33-year-old female patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 4th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 04-JAN-2023 Reporter's Comments: The reporter consented to follow up. Additional Supportive Information: An expired dose of Twinrix was administered to a patient, which led to expired vaccine used.
When the shot was administered, they sterilized that area and marked where the shot would be given on my arm. The person giving the shot didn't pull the muscle up as far as they did on the first one. The shot was extremely painful when going inside my arm. My shoulder started hurting a couple hours later. After 6 hours I couldn't lift my left arm. Within 24 hours I felt the worst at that point. I was literally bedridden for 3 days. When the fever broke, I felt better. The arm felt sore for about another week. If I overused my arm or moved it, that would cause my shoulder to ache until about 3 months ago. The pain has gotten worst. I went to the ER for the pain in September 2021 because I couldn't use my arm. They gave me muscles relaxants and an anti-inflammatory medication called Flexeril. They told me to take ibuprofen. My range of motion is down less than 30% now. When the shot was being administered, I am afraid that they had damaged something.
Symptoms: Pain and redness at injection site Fever 101?F Tiredness Muscle pain- neck, back, shoulders Headache Nausea Flatulence  Indigestion  Treatment: Rest Fluids Tylenol
Patient was given 3rd dose of Covid-19 vaccine, had said she had Pfizer with prior 2 doses. After receiving immunization, RN noted on vaccine card that patient had received Moderna vaccine for first 2 doses. RN called Pfizer to advise, was instructed no further action to be taken. Patient has been notified.
Left arm numb with tingling in the fingers, left leg numb down to the foot, but no tingling in the toes.  Knot at the injection site the size of a golf ball.  Left leg calf cramps the entire night before
VIAL WAS DILUTED WITH 0.2 ML OF NACL INSTEAD OF 1.3ML
31JUL92 pt recvd 1st dose of Engerix-B & that same day devel numbness in extremities, tingling, felt as if drunk in head, & thick tongue;
This is a spontaneous report received from a contactable consumer or other non-HCP (patient's parent). A 17-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 17, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced back pain/slight back pain and tremor (when she stands up, left leg keeps shaking), with outcome of unknown. Additional Information: The mother reported her 17-year-old daughter took the first vaccine dose at 9:30 am. Her daughter never had a flu shot or vaccine of this kind. She reported they waited the recommended 15 minutes after getting the vaccine. They went home and about 30 minutes after, her daughter started having back pain/slight back pain. When patient stood up her leg was shaking. Her left leg kept shaking alone. It came and went. The mother asked if this was normal or should she be concerned. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Information has been received from a physician concerning a 19 year old male with a history of sarcoma and treatment and who has been in remission prior to vaccination who on 14-FEB-2005 and 26-JUL-2005 was vaccinated with a dose of Varivax. He has had two episodes of rash and a culture was negative for varicella zoster virus. Another specimen had been sent to the varicella zoster identification program. The rash was not typical chickenpox but was small and pustular. The physician did not know if it was zoster, chickenpox, or a folliculitis. Information has been received which indicated that the specimen sent for varicella zoster identification was inadequate. Additional information has been requested.
slight Crackling sounf from chest  at night  started in Nov.   gradually got worse.,  doctors thought it was a broncial infectiion  and treated as such , came back in january due to symtoms continuing to get worse . cam back again in feb   brochitis treament not  working.  doctor order echocarida gram . cardiact mri diagnosed with haart failurure/ s
Patient reported getting flushed and weak 13 minutes after vaccination. She reported palpitations and feeling as though her lips and tongue were tingling.
Burning pain over whole of body, stabbing pain over all of body, left arm hurts when moved; started soon after vaccine was administered.
Pt recvd 2 doses of Engerix-B & w/in 24 hrs following the 2nd dose 23JUL92 exp itching, h/a & induration which diminished by 28JUL92;
Elevated heart rate. Normal resting heart rate is 60-80 for me. From 7:30 for the rest of the night, until the following day, my heart rate as around 110-125 resting. I wear a fitness tracker and was able to keep track of it.  Chest pains overall. Elevated heart rate went away after about a day and I did not go to the hospital. After seeing reports in the news of heart inflammation, I realized that must have been what happened to me.
Patient reported symptoms started on second day post vaccination with Tdap/Adacel. Symptoms decribed were hives, rash with blisters that itch to the arms, head, fingers, feet, and groing area. These areas are tender to touch per patient. Symptoms are intermittent lasting aproximately 2 hours at a time. Symptoms are ongoing for the past 11 days. No medications taken per patient's wishes.
Rash 8 days later on both upper thighs and on elbow only of the arm that i had the injection. The rash was dark red circles,  different than hives. Went to Dr. on 2/18/21. He said looks like reaction to the vaccine. He took pictures of my thighs and said it could take 4-6 weeks to completely dissapear. He told me to take over the counter benedryl.  On 2/22/21, rash spread to my waist, back, arms and large one on top of each foot, also very itchy.  Went to Immediate Care on 2/24/21 (Dr. doesn't work on wednesdays)  and saw the  Doctor on call. He said this is a reaction to the vaccine. He gave me a Prescription for Hydroxyzine Pam 50mg caps and Famotidine 20mg tablets to take together for itching as needed. Rash is still faintly there but still not completely gone
roundshot area. Today fever is gone but rash is visible and very redwith itch.
Pain in the arm of the injection; Mild headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in the arm of the injection) and HEADACHE (Mild headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain in the arm of the injection) and HEADACHE (Mild headache). On 11-Mar-2021, HEADACHE (Mild headache) had resolved. At the time of the report, VACCINATION SITE PAIN (Pain in the arm of the injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication including Blood pressure medication and Diabetic medication was reported. On 12-MAR-2021 patient reported little pain in the arm.
He got his vaccine and the initial reaction on the first day and the beginning of the 2nd day was soreness in the area of the vaccine.  About 9:00 AM the following morning he started feeling funny in his head.  He was going to meet one of his son's at noon and he drove to where they were going to meet, and was in the parking lot where they were meeting, and about 11:15 his condition in his head got worse, and his son called him about 10 to noon and he told him he was almost there.  He got out of his car, locked it up and leaned against the car and his head condition got worse and worse and he drove into the parking lot, but he was not aware of it, out of it, but still standing. Before his son got to him his son saw him fell over, he passed out he says.  He fell on the parking lot asphalt and hit the side of his head on the parking lot stoppers.  He struck his head and has a bump on the head on the left rear quadrant, and his fingers on his right hand are all skinned up, elbows skinned up, his knee on the left, and the palm of his hand on the right is skinned up as well.  The first thing he recalls after passing out was his son leaning over him with his cell phone in his hand calling 911, and paramedics came and got him and he went to the ER.  He went to Medical Center.  He was still messed up in the head when he arrived there, his son explained to the paramedics what happened, and he does not know what the paramedics told the hospital staff.  He was injured and bleeding.  He had x-rays, a CT scan, EKG.  He has a heart issue and has two cardiologist and an electrophysiology physician.  After the EKG they thought that he was having a heart attack or something.  They acted like it was heart related, and he told them that he had the flu vaccine, which they ignored that.    After 2 hours they cleaned up his wounds, and bandage them.  His hands had bled, and all his other areas were dressed.  They wanted to keep him at the hospital and check out his heart well, he told them that he has 2 cardiologist and they did not need to check him for that.    He had experienced the same reaction when he had the Azithromycin in June.  He thought he was dying with that and called 911 himself.  They checked his BP was 212/197 and was taken to the hospital.  He was given Carvedilol and wanted him to stay in the hospital, and was released as he refused to stay.  Discharge BP 199/119. later it was 138/82.    He went home later that afternoon, and for the next 13 days he stayed at home dressing his wounds and recovering.  He feels pretty good now, but is not completely over the consequences of the fall, and his head is still not really clear and back to normal.
Adverse effect of other vaccines and biological substances, initial encounter on 2022-03-02.
Patient developed itching at injection site almost immediately after receiving vaccination. Pt states same thing happened 5 - 7 years ago (not received at clinic). Treated with diphenhydramine 25 mg oral.
Information has been received from a licensed visiting nurse concerning a patient who on an unspecified date was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient developed a non-serious localized injection site reaction. It was unspecified if medical attention was sought. The injection site reaction resolved on an unspecified day by 06-APR-2007. No further information was provided. Additional information is not expected. This is one of several reports from the same source.
Nine days after receiving the smallpox vaccine, the patient developed generalized papular eruptions on his chest, back and neck, consistent with generalized vaccinia. This was accompanied by general malaise. He was treated with acetominophen and diphenhydramine and symptoms started improving in three days.
Progressive weakness 10 days after immunization- SOLUMEDROL IV and tapering dose of prednisone.
Headache, chills, possible fever, body aches, pain at site of injection, pain in arm and glands under arm of injection site. Chills and fever lasted ~6hours - disrupting sleep first night. Headache lasted 24+ hours. Body aches, soreness around injection site and glands under arm lasted >48 hours. Recovering - but not completely over symptoms. Advil, rest, and fluids. Like a minor flu.
Headache, Myalgia, Fever, soreness to the injection site, chills Narrative:
After vaccine was administered, within several hours, I became feverish and achy to the point I couldn't leave my home. This lasted for two days solid. I sought treatment, however, for extremely swollen glands (lymph nodes) in the neck and breast area. The nodes were swollen so large, it was somewhat visible to the eye and definitely by touch. It took another week for the nodes to go down.   I also had a second dose of Moderna on 4/23/21 and had the same reaction. It lasted for two days instead of three and the glands were swollen but not as large.
mom reports early PM of vax date, babysitter reports child was in a daze & very agitated lt arm devel penny size red area, t103; tried APAP & DPH; pt was found to have sore throat & ear infect & was started on bactrim;
Delayed left arm swelling, erythema, induration, calor, and itchiness 8 days post- vaccine. Associated neck pain (nuchal rigidity) starting 4 days post vaccine, both symptoms currently ongoing.
No adverse effects; improperly stored doses of PROQUAD and VARIVAX were administered to patient; This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.     On 19-AUG-2019, the patient was vaccinated with an improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R034398, expiration date 27-NOV-2020 and with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S003178, expiration date 30-JUL-2020 (dose, frequency, route of administration and anatomical location were not provided) for prophylaxis. The temperature excursion was between 6 to 14 degree Fahrenheit for 2 hours and 30 minutes and between 15 to  46 degree Fahrenheit (36 F) for 2 hours and 30 minutes. There was no previous temperature excursion. The digital data logger was involved. Concomitant therapies included sterile diluent which was stored properly. The patient did not experience adverse event.
The evening after receiving the vaccine, I developed  swelling at the injection site along with slight pain.  I developed  fever, headaches, body aches, chills, nausea, dizziness. fatigue about 7 hours after receiving the vaccine,  Headache, fever, nausea, fatigue lasted over 4 weeks.
pt recvd vax & devel pain @ inject site, nausea & a severe h/a; No further details were provided;
Dizzy, light headed, "hot flash", red face, facial swelling, hypotension, apnea, shaking, mouth numbness. EpiPen given and sent to the emergency department at Hospital. Currently have dyspnea, numbness in arms and legs, headache.
NO adverse event described at the time of the administration , the problem was overdose of the Pfizer vaccine.
The vial was initially stored in the refrigerator on 10-Jun-2022 at 10:38 pm and the vaccine was administered on 11-Jul-2022; patient received Moderna COVID-19 vaccine 31 days after the vaccine was placed in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-Jun-2022 at 10:38 pm and the vaccine was administered on 11-Jul-2022) and EXPIRED PRODUCT ADMINISTERED (patient received Moderna COVID-19 vaccine 31 days after the vaccine was placed in the refrigerator) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (primary series (first dose)), Pfizer (primary series (first booster dose)) and Pfizer (primary series (second dose)). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 11-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received Moderna COVID-19 vaccine 31 days after the vaccine was placed in the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-Jun-2022 at 10:38 pm and the vaccine was administered on 11-Jul-2022). At the time of the report, PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-Jun-2022 at 10:38 pm and the vaccine was administered on 11-Jul-2022) and EXPIRED PRODUCT ADMINISTERED (patient received Moderna COVID-19 vaccine 31 days after the vaccine was placed in the refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The vial did not undergo any temperature excursions.  The patient did not report any other adverse reactions or side effects.  No treatment information was provided by the reporter.
Severe local reaction, erythema. Benadryl 25mg q 4-6 hrs as needed
MUSCLE ACHES; FATIGUE; SLIGHT FEVER OF 99; HEADACHE; CHILLS; ARM PAIN; HEART RATE WENT UP TO 96-100 BPM/ELEVATED RESTING HEART RATE; BLOOD THICKER THAN NORMAL; SWOLLEN ARM; BURNING SENSATION ON LEFT SHOULDER, GOING UP INTO ARM AND UP THE NECK, AND INTO THE JAW; BURNING SENSATION TO THE SIDE OF BREAST; PAIN; This spontaneous report received from a consumer concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: heart murmur. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On OCT-2021, the patient experienced heart rate went up to 96-100 bpm/elevated resting heart rate. On OCT-2021, the patient experienced blood thicker than normal. On OCT-2021, the patient experienced swollen arm. On OCT-2021, the patient experienced burning sensation on left shoulder, going up into arm and up the neck, and into the jaw. On OCT-2021, the patient experienced burning sensation to the side of breast. On OCT-2021, the patient experienced arm pain. On OCT-2021, the patient experienced pain. Laboratory data included: Diagnostic procedure NOS (NR: not provided) Blood little thicker than normal, Electrocardiogram (NR: not provided) Blood little thicker than normal, and Heart rate (NR: not provided) 96-100 bpm. On 21-OCT-2021, the patient experienced chills. On 21-OCT-2021, the patient experienced muscle aches. On 21-OCT-2021, the patient experienced fatigue. On 21-OCT-2021, the patient experienced slight fever of 99. On 21-OCT-2021, the patient experienced headache. Laboratory data included: Body temperature (NR: not provided) Fever of 99. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain, had not recovered from heart rate went up to 96-100 bpm/elevated resting heart rate, arm pain, and swollen arm, and the outcome of slight fever of 99, chills, headache, fatigue, muscle aches, burning sensation on left shoulder, going up into arm and up the neck, and into the jaw, blood thicker than normal and burning sensation to the side of breast was not reported. This report was non-serious.
patient called on 03/11/21 and reported have symptoms after receiving vaccine on 03/09/21. symptoms include fever, body aches, injection site pain, and redness/itchiness on right arm at injection site. she stated adverse effects started on 03/10/21 and she attempted to contact her PCP. She was counseled at time of vaccine administration and on 03/11/21 to take tylenol or advil for fever/pain and benadryl for allergic reaction.
an allergic reaction.; This is a spontaneous report from a  non-contactable consumer (for her mother) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. Patient was in an ICU. Trying to figure out if it was due to the covid vaccine and an allergic reaction. Serious criteria was hospitalization. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
periodical bleeding, menstruation 10/01/2022 although in menopause since march 2019 chilblains since 15/01/2022
Generalized hives all over body except for face. Itching. had to go to emergency room and given course of prednisone, benadryl, zyrtex and pepcid.
Patient complained of red swollen arm; with nodules at the base of her left neck arm swollen from shoulder to elbow.  Band of red about 4 inches wide around arm.
Patient evaluated on 4/20/02. about 8cm warm red swollen area on left upper arm extending up shoulder. No Fluctance. Temper 98.1. Normal mobility. Treated with Keflex 500 BID x 10 days.
This is a spontaneous report received from a contactable reporter (Nurse). The reporter is the patient. A 71-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1; Lot number: en6203; Route of administration: intramuscular), administration date: 20Feb2021, for COVID-19 immunization, reactions: "a raised red and itchy rash on chest and torso lasting for 3-4 days", "fatigue for 1-2 days. Was still able to work", "a raised red on chest and torso lasting for 3-4 days/ rash on my abdomen for about 4-5 days", "a raised red on chest and torso lasting for 3-4 days"; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown"; LYMPHADENOPATHY (non-serious), outcome "recovered", described as "enlarged (minor) lymph node above left clavicle. Painless - was gone in 3 days.". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : PFIZER INC-2021438587 same reporter/patient, different dose/event;
I was really nervous about getting the vaccine.  I received the shot at 3:40pm and waited at the site for 15 minutes,  and I was feeling good, so I went home.  I had dinner around 7:00pm.  It was around 8:30pm when  I was standing at the kitchen sink  doing the dishes and I felt a wave wash over me and the rapid heart beat started.  I immediately took Metoprolol since I usually take it around 9:00pm, and my heart rate went down some what. My heart beat is usually around 72.  I didn't have my fit bit on, but I put it on after I took the medication and it was around 124, but I know it was much higher on the onset.  It only lasted about 1 or 2 minutes.  My heart beat was jumping around after that, I was scared, nervous, so I took a Xanax around 11:00pm.  I slept through the night and had a normal heart beat in the morning.
pt recv 3 doses of vax in 1995 & 9NOV98 pt tested positive for hep b;
Pt rec'd vaccination 3 days. Today the injection site is very swollen/red. She has used diphenhydramine/cortisone ointments.