chrisvoncsefalvay/vaers-outcomes huggingface dataset:
"Faint-like feeling after administration." "The day after redness and swelling started and it had progressed in site." Malaise-fatigue-myalgias-itching-rash. Given Loratadine 10mg PO.
Sore arm at injection site; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 57 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 10Apr2021 16:00 (Lot number: EP6955) at the age of 57 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "elevated cholesterol" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "vitamin D deficiency" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE SODIUM; ATORVASTATIN CALCIUM; LORATADINE; VITAMIN D [VITAMIN D NOS]; CALCIUM + VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]. Past drug history included: Codeine, reaction(s): "drug allergy". Vaccination history included: BNT162B2 (lot number: EP6955, administration time: 16:00, administrator route: Intramuscular, vaccine location: Left arm, dose number: 1), administration date: 20Mar2021, for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 10Apr2021 20:00, outcome "recovering", described as "Sore arm at injection site". Therapeutic measures were taken as a result of vaccination site pain.  Additional information: The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior COVID-19 vaccine. The patient received Tylenol and application of ice to the injection site as treatment for event.   No follow-up attempts are possible. No further information is expected.
Information has been received from a medical assistant, via a company representative, concerning a 15 year old female patient who had felt ill 2 weeks prior to the vaccination, who on 26-MAR-2007 was vaccinated with the first dose, 0.5ml, of Gardasil. On 30-MAR-2007 ("end of March 2007"), the patient had a low grade temperature (not specified) for one day, had body aches, throat irritation, and felt run down for a few days. The reporter confirmed that on 30-MAR-2007, the patient had recovered from all of the events.No further information is expected.
Discharge Nurse Notified PHN that Pt. was Vaccinated 8 days early 2nd dose Pfizer. PHN notified site supervisor, Snap Lead, Site Manger's. Translator used for Spanish speaking Pt. Per translator Pt. knowingly took the second dose of Pfizer early due to an emergency needing to travel to Mexico and assumed she would need to restart the series. Staff was the vaccinator said, "I assumed the reporter checked the dates on the vaccine card." PHN explained to the Pt. using the translator the side effects of the vaccine, when to seek medical attention, re-educated on the time intervals, V-safe, and the CDC guidelines of nor having to restart the series even if its pasted the 42 days.
Patient administered HIB vaccine in which the diluent had expired 4 days prior. Expiration date on diluent 11/26/20 and expiration date on the powder 5/2/21. Mom was made aware on 12/9/20 after we realized that the vaccine had expired. Mom did not mention any problems with patient at this time. Mom also made aware that this does not harm patient it just makes dose ineffective and will need to repeat the dose.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. Although the patient's gender was not provided it was reported that, the patient was not pregnant. On 01-JUL-2016, the patient was vaccinated with ZOSTAVAX (lot # L039126, expiration date: 08-JAN-2017, dose and injection site were not provided), subcutaneously. When the pharmacist was administering ZOSTAVAX most of the dose leaked out between the syringe and where the needle was attached. The pharmacist was not sure, if the patient received a full dose. No adverse effect was reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Dizziness, heart racing, nausea, severe body aches, fever, chills, difficulty breathing, extreme gas, cramps.  Was transported the Hospital and received zofran, atavan, morphine and tested negative for COVID 19 and flu and pneumonia.  released after four and a half hours but continued to experience pain in muscles and fever even today (01/14/2021).
Client recieved vaccine in L Deltoid and immediately stated that afterwards she still felt like vaccine was going into arm. L arm numb, became dizzy, Felt it traveling down her arm to her fingers, number to fingers.  She already had a fear of shots.  Bp 140/100. T 98.7 felt tired. After sitting a few minutes, she felt better and went home.
no adverse event; Patient received half of the dose; This spontaneous report was received from an administrator via company representative, concerning a 4-month-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 09-SEP-2021, the patient was vaccinated with half dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (frequency, route of administration, anatomical location, vaccination, scheme, lot number and expiration date were not reported) (incorrect dose administered). No additional adverse events were reported.
Allergic reaction / Syncope and collapse  Patient reports feeling dizzy, hot,  and that her eyes felt funny.  Patient was sweaty, heart rate within normal rhythm .  Patient lost consciousness and began seizure-like activity and was assisted to the ground.  Patient regained consciousness about 20 seconds later.  At 12:48:  BP was 91/44 upper right arm, HR 78, O2 sat 100%.  At 12:50 BP was 76/50 and patient report shortness of breath and the sensation that her throat was closing up.  She was assisted to supine position again.  at 12:54 Epinephrine 0.3ml was administered IM.  At 12:56 NS administered wide open with pressure.  Blood glucose 109.  at 12:59 BP was 133/67.  Taken to Emergency Department where she received famotidin 20mg IV, Methylprednisolone 80mg IV and KCL 20mEq po due to Potassium level of 3.4.
Shortness of breath. Deep vein thrombosis. Pulmonary Embolism. Discovered Factor V Leiden mutation
pt recvd vax & w/in 30mins p/vax pt exp hyperventilation;pt was seen in ER & all sx resolved;no further details available;
Patient felt a stream of vaccine liquid coming down his arms after the vaccine was administered. Patient claims he did not receive full dose.
Pts mother stated child experienced redness at the site of injection at 8 PM on 09/13/2021. Pts mother reported that on 09/14/2021, child experienced a knot at the site of injection, and the redness at the site had spread to the size of an orange. Pts mother reports she gave two doses of benedryl throughout the day on 09/14/2021. Pts mother reports on 09/15/2021, redness at the site of injection had increased to the size of a softball, therefore she took the child to urgent care for evalaution. Pts mother stated that urgent care called i n steriods and told her to administer as prescribed and reaction should subside in a few days.
developed a itchy bumpy rash on her torso,; developed a itchy bumpy rash on her torso,; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a non-contactable consumer or other non hcp (Patient). A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 30Dec2020 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that she took 1st dose of Covid vaccine on 30Dec and developed a itchy bumpy rash on her torso, that was lasted a month. Patient wondering what she should do now as far as getting the vaccine again and wondering if she has some level of protection after the 1st dose. She took an antibody test and it was negative. The patient underwent lab tests and procedures which included antibody test: negative. The outcome for the event was unknown.   No follow up attempts are possible. No further information is expected.
Felt a warm rush immediately following shot.  Later, as I was leaving the clinic, at about 15 minutes after the shot felt a flushing of my face.  May face became very red with a burning sensation and very warm.  Lay down after arriving home with a cold wash cloth on my face.  Ran a low grade fever. Went away after 3 to 4 hours.  (Had a similar face reaction while on antibiotics several years earlier.  Doctor switched my treatment at the time) I visited my doctor's office today to report the event and ask if there would be any problem getting a second vaccine on April 13 of this month.  They gave me this website and asked me to fill out a report stating you would let me know if a second shot is or is not advisable.
I personally experienced a sudden onset of paresthesia from my right fingertips up to my elbow on my right arm. It was associated with a severe headache and floaters in my vision. The paresthesia persisted for 15 minutes. The floaters lasted for approximately 30 minutes. And the headache lasted for three days. There were no relieving factors.
pt recv vax 27JAN96 & 12MAR96 pt exp pruritic rash (red, blotchy, itchy rash on upper part of body, under arm, neck back & chest);
The day after the shot a nickel sized lumped developed in my armpit. It took about a week for it to go away.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Aug2021 11:00 (Lot number: FC3181) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "diagnosed generalized anxiety disorder" (unspecified if ongoing). Concomitant medication(s) included: SEROQUEL. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 18Aug2021 09:00, outcome "recovered" (2021), described as "The day after the shot a nickel sized lumped developed in my armpit. It took about a week for it to go away.". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine, List of other medications the patient received within 2 weeks of vaccination are Seroquel 250mg, multivitamin, prior to and since vaccination, patient was not diagnosed with COVID-19. Device date was 09Sep2021.
Information has been received from a medical assistant, referring to an unspecified number of  patients (ages and genders not reported). The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number reported as "M0245206" with expiration date on 27-JUN-2019; lot number M046133 with expiration date on 26-SEP-2019; lot number M047666 with expiration date on 24-OCT-2019 or lot number reported as "N000237" with expiration date on 25-OCT-2019 (strength, dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported and no additional information was provided. The vaccines had a temperature excursion of 9 Celsius (C) to 25 C during 20 minutes,also was confirmed that the vaccines did not have previous temperature excursions and a digital data logger was involved. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments:  US-009507513-1706USA005670: US-009507513-1706USA005671: US-009507513-1706USA005672: US-009507513-1706USA005673:
Infected with Delta SARS-COV-2 Variant; Vaccine breakthrough cases; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (Infected with Delta SARS-COV-2 Variant) and VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough cases) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 COVID-19 (Infected with Delta SARS-COV-2 Variant) and VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough cases). At the time of the report, COVID-19 (Infected with Delta SARS-COV-2 Variant) and VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough cases) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported.  No treatment information was reported by the reporter.
Rash on forearms 1 hour following injection that disappeared within 12 hours. Vulvar irritation including lesions noticed roughly 36 hours post injection, lasting for 2 weeks. No interventions or medications used for treatment.
This patient is reported to have dizziness, headaches, joint pains, decreased eyesight. Report 2001002642-1 describes dizziness in a 54 year old male who received an injection of Lyme disease vaccine (Lymerix). This report was received from the patient's spouse and has not been confirmed by a physician or other health care professionals. Concurrent medical conditions included prostate cancer diagnosed "years ago" and allergy to Leuprolide (Lupron). The patient has no history of Lyme disease. The patient has no personal or family history of gout, Crohn's disease, psoriasis, rheumatoid arthritis, or lupus erythematosus. Concurrent medications included an unspecified hormonal injection. The reporter stated that the patient received his first injection of Lymerix approximately on year prior to 02/01/01; however, she is unsure of the date of administration, and the information supplied does not comply with the recommended dosing schedule for Lymerix. At an unspecified time following receipt of the first injection, the patient developed dizziness, headaches, and joint pains. These symptoms persisted. The patient then received his second injection of Lymerix, also "approximately one year ago" from 02/01/01. The dizziness, headaches, and joint pains continued to persist. The patient received his third injection of Lymerix in June 2000. The dizziness, headaches, and joint pains persisted. The reporter stated that all the patient's joints are affected. No joints are red or swollen. The patient has not had a physical examination within the last year. On 01/22/01, the patient experienced decreased eyesight with blurred vision. He was seen by an "eye doctor", who reportedly was "puzzled" by the "extreme" change in the patient's eyesight, which was "down by five". As of 02/01/01, the dizziness, headaches, joint pains, and decreased eyesight persisted. The adverse events of dizziness, headaches, and joint pains do not meet ICH serious criteria, but being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Resident coughing in dining room, staff suctioned, physician stated to transfer via 911 to hospital, 6:33 PM. Hospital notified Nursing Home staff resident passed away at 8:25 PM.  No adverse reaction noted to the Covid vaccine 24 hours after each dose at Nursing Home.  There was no airway obstruction, cardiorespiratory arrest, death was natural at hospital.
pt returned to clinic approx 10 minutes after vaccines administered with red, splotchy areas to head and torso...front and back. Also raised areas immersed withing splotchiness.  Increased coughing per granmother.  No audible wheeze, retractions or nasal flaring noted.  0.5 cc(25 mg)Benadryl given IM per Left arm. Sent to  waiting area for observation.  Rechecked in approx 10 minutes .  Splotchiness less red.  Advised grandmother to watch for resp distress and to obtain liquid benadryl before going home.  Also to call 911 for any reps distress or worsening of condition.
On April 15th, 2011 my son 17 year old son went to see his pediatrician. At that appointment my son was given two vaccinations: Gardasil (1st dose) and Menactra. Five days later (April 20th, 2011) my son noticed he was itchy but thought nothing of it. He went to school and noticed a rash developing all over his body. Took my son back to the pediatrician and she put him on the corticosteroid Prednisone and advised him to take Benadryl as needed. The next morning (April 21st, 2011) my son woke up with horrifying strange looking, raised welts/severe hives all over his body. My son continued with the Prednisone and Benadryl every four hours. The raised welts/severe hives raged all day and night migrating to different body parts. The would also change from welts to red, raised bumps. At the end of this night my son's lips were twice the size they usually were and he was feeling his throat getting inflammed. His hand were also swelling. Gave him another dose of Benadryl and the lip and throat swelling somewhat subsided. My son spent the whole day in severe pain. He attempted to sleep that night but his feet started to swell as well. Today is the 3rd day since these episodes have started (today is April 22nd, 2011. The welts have subsided but every few hours between Benadryl doses a red, bumpy rash starts to redevelop on his arms, back, stomach and legs. Son feels lethargic, very itchy and uncomfortable.
3rd dose of Moderna COVID vaccine 6 month-4 years administered in error to patient. No adverse reactions were noticed for patient.
12 hours after vaccines developed symptom of lip swelling and tingling and a slightly itchy, the left side swelled more than right, felt hard.
Pt received PNEUMOVAX (L) deltoid P.E. visit 4/7/14. That night area red/warm , sl. swelling. Pt used TYLENOL for mild pain. Next am 4/8/14 noticed redness moved down arm toward elbow, sl. lump under skin. No pain. Pt called doctors clinic. Spoke with triage RN brought pt in for eval. Pt seen by Dr, put on KEFLEX for precaution, ice, TYLENOL cont prn.
Patient states that after leaving the pharmacy where she received the vaccine, she ran errands and got lunch. On her drive home at 7pm the last thing she remembers is feeling nauseous and lowered her head and passed out. Car hit tree and was totalled. Spilled Windex with ammonia was in vehicle. Hospital felt that ammonia may have caused unconsciousness.
Site: Pain at Injection Site-Mild, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: low temp 92.0-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Mild
Received HAV vaccine 6/2/16 3 PM, went overnight to grandmothers home and woke up with rash "bumps" to legs and arms with c/o itching. Mom brought child to ER and doctor stated had allergic reaction. RX steroids.
Patient previously had 3 Moderna (18+) COVID vaccines. This was their first Pfizer (12+). Patient received the Pfizer Adult (Age 12+) vaccine at 3:20pm. Patient started to not feel well 10 mins after the vaccine was given. Patient stated that they felt nauseous. Patient's eyes rolled back, head was leaning back in chair, and was unresponsive for 30 seconds to 1 minute. During that time patient made noises with throat and sounded like she was gasping for air. Patient regained consciousness, laid patient down, blood pressure was 77/51 on left arm, pulse was 55 and O2 was 97%. Patient stated that they do not know what happened. Patient stated that they are feeling weak, faint, cold, shivering, and "spacey". Patient was also pale.  Patient stated that they have a history of fainting after blood draw, history of low blood pressure, history of brain lesion, and is currently pregnant. Patient stated she has never made the throat noises when she has fainted. Blood pressure at 3:35pm was 105/68, pulse 55. Nurses advised patient to call husband. Patient was advised to go to ED to get assessed. Patient was still feeling weak, cold, and shivering. Patient said they are feeling better but still feels weak. Patient blood pressure was at 110/66, pulse was 75 at 3:45pm. Patient's husband escorted patient out in wheelchair.  clinical manager informed of the situation.
20 month old female patient was given an >3 yo quadrivalent flu vaccine in error. It was a prefilled syringe with 0.5 ml of vaccine. No adverse side effects noted when error was noted. Discussed with mother immediately. Answered all questions immediately.
stomach pains, nausea, vomiting persisted for more than 24hr-accompanied by chills, fever & diarrhea-resp sx began w/sore throat, general malaise & myalgias;
Very irritable, cries in sleep; Wakened every 15 min crying sharp unusual cry. This started first night p/immun.
Fever, paleness, limpness, convuls; 1 ml APAP/3hrs;
I took a nap after around an hour of receiving my shot at around 1:40pm. Once I awoke at around 6pm, I had irritated eyes, extreme nausea, extreme dizziness, insatiably low body temperature, extreme shivers, migraine because of my head uncontrollably shaking, and dry mouth. I felt like I was in 20 degree weather and nothing I could do would heat my body up. My body grew so tired from the uncontrollable shaking that I could not get out of bed to get my phone to call 911. Every symptom I was experiencing was not mild and was to the level of extreme. This lasted until around 9am. I have been slowly recovering since then (currently almost 9pm) and feel only 70% back to normal.
This spontaneous report as received from a nurse concerning unspecified number of patients age and gender not provided. The nurse reported that since 25-SEP-2014 improperly stored oral, ROTATEQ were administered to unspecified patients. No adverse effects were noted. This is one of several reports received from the same source. Additional information has been requested.
Red and circular area began to itch incessantly on 3/11/21. Major lethargy within 12 hours.   Redness, heat and itching  area continued to grow into a circumference of 5 inches. Today is 3/22/21 and symptoms are still with me and the area where shot was administered is still hot, itchy and red.   Really bad bruising above point of administration from Fireman who administered shot. About to be a full 14 days from receiving vaccine.
I woke up and found that my left arm at injection site was red around 3 by 4 inches wide and it was swollen. I touched it and it was hard and itchy. It was painful when I pushed the swollen site. It went away after several days however it was very itchy, swollen and red.  I also have vertigo sometimes during the day
O.5 ml Influenza Quad vaccine given to a 6 month old. Discovered during chart immunization audit. No adverse effects noted.
Arm became very sore. If he move his arm up 90 degrees he gets a sharp my his biceps.
This spontaneous report as received from a pharmacist refers to a 37 year old patient. Medical history and concurrent conditions were not reported, who on 21-DEC-2013 was vaccinated with a 0.5 ml dose of GARDASIL intramuscular, lot # H015863 and expiration date:24-FEB-2015. No concomitant medication was reported. No adverse effects were noted. Additional information has been requested.
The next day patient fell asleep in the car while dad was at the grocery store. Car was running0he returned after 20 min and could not wake her up. Helped by someone to shake car, called police, ambulance came, slept though all and finally awoke-police jimmying the door.
Upper Lip Swelling without restriction of airway. Arm swelling from injection site to the elbow. No direct corrective measures were taken. Symptoms resolved spontaneously within a few days of onset.