chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Went to ER last night because she was very pale. Mom said she felt slightly warm but she wasn't sure if she had fever. Shots were given around 3:30, this occurred around 8-8:30. After shots was eating/active but sleepier in evening she was crying but calmed down after eating and then when they arrived at the house and went to take her out of her car seat, she was pale, limp and not responding. They took baby to ER around 9 PM and mom said they took vitals and that vitals were stable and baby was more responsive and lethargic but improving. ER records show that they left before midnight and that she was not seen by a physician. Pt's mom does not speak English and perhaps thought that she was free to leave.
Initial case received on 28 October 2014 from a consumer who is the patient's wife. An 86 year old male patient with a history of two stents, "carotid surgery" and diabetes treated with oral meds was vaccinated intramuscularly into the right arm on 08 October 2014 with Influenza High Dose, batch number was not reported. The patient was not ill at the time of vaccination. On 16 October 2014, the patient was very cold, unable to get out of bed and was taken to the hospital by ambulance where he stayed for two days. His temperature on admission was 102, B/P 103/33 and blood sugar was 190. He had generalized weakness and couldn't walk. The diagnosis was reported as "dehydration?". "The infectious disease doctor at the hospital said it could be from the flu vaccine". The patient was still weak. The patient outcome was unknown. Documents held by sender: none.
Initial unsolicited report received from a pharmacist (Director of Pharmacy) on 12 October 2016. This case is linked with 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848. (Same vaccine, same reporter) This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE (batch number: UI669AA, expiration date: 30 June 2017 and site of administration was not reported) intramuscularly, 04 October 2016 (over the past month). Patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medication was not reported. On 04 October 2016 (over the past month) same day following vaccination patient experienced red and swollen. On 06 October 2016, (over the past month) two days following vaccination patient had glands on right side of neck swollen and its pushing on patients tongue (tungue) which making tongue feel weird and speech was hard to from words. Lab data and corrective treatment were not reported. Patient did not received any seek treatment. The outcome of the events was reported as unknown. List of documents held by sender: none.
Patient with history of prostate cancer. He was brought to the ED on 2/6/23 for worsening chest pain, generalized weakness, and productive cough that began a week prior. In the ED, his O2 sat was at 89% and improved to above 90% after being placed on 2-3L O2. He was admitted to the hospital on 2/6/23 - 2/9/23. A COVID PCR test done on 2/7/23 returned positive. Discharge diagnoses include acute hypoxic respiratory failure, pneumonia (possible COVID-pneumonia versus unspecified bacterial pneumonia), aortic regurgitation with dilated ascending aorta, new onset atrial fibrillation, and acute on chronic heart failure. During his hospital stay, he was treated with ceftriaxone for presumed bacterial infection and steroids for presumed COVID pneumonia. He was also started on oral dexamethasone. His hypoxia resolved during his admission.  Of note, the patient has received the primary COVID vaccine series and two booster doses. The most recent booster dose was administered 6/17/22.
pt recv vax 27SEP95 & 3JUN96 pt devel herpes zoster on chest w/a fever;pt recovered from herpes zoster;
11yr. 11 month old received vaccine for the 12 years and up, 0.3ml , parent informed. Asked to monitor vaccination site. Nurse called next day, no issues identified.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 11Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crab allergy" (unspecified if ongoing); "Lob ster allergy" (unspecified if ongoing); "Shrimp allergy" (unspecified if ongoing); "Walnut allergy" (unspecified if ongoing); "Myasthenia Gravis" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: OZEMPIC, start date: 09Dec2021, stop date: 03Apr2022. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Apr2022 at 10:00, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.Other medication in 2weeks was reported as Yes. anti viral details product=COVID 19 Treatment, Brand=Paxlovid. treatment start date=08Apr2022, treatment stop date=11Apr2022, lot number=fx8133, Indication=Treatment of COVID-19}.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Right after injection I tried to get up. My vision became blurry. They laid me down, and then I began to have tremors, and when they assessed me my heart rate was at 145. I began to feel palpitations in my chest. EMS was then called and was taken to Hospital.  Currently my cardiovascular symptoms have subsided. But now my left arm feels numb, tingly, sometimes burns. My shoulder feels stiff and I am having spasms in other parts of my body when I sleep. My leg and my hand jerks at night when resting.
Edema and erythema at injection site x 7 days  Hematoma at injection site x 10 days Swelling and knot in axillary/lymph node  area x  7 days Painful and heavy arm x 10 days Bruising x 3 days Treatment: Tylenol, Motrin, and warm compress
Information has been received from a physician concerning a 20 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who on 08-JAN-2009 was vaccinated intramuscularly with the first dose of GARDASIL (Lot # 661046/0546X).  There was no concomitant medication.  It was reported that on 08-JAN-2009 after receiving the first dose of GARDASIL, the patient experienced dizziness, nausea and pain at the injection site.  On 08-JAN-2009, the patient's vital signs after receiving GARDASIL were pulse 88, blood pressure 114/62, and neurological checks were within normal limits.  It was reported that on an unknown date, after injection was given, the patient had gone to the emergency room due to her reactions.  It was reported that she was given a lotion to apply to the injection site on her right arm.  As of 25-FEB-2009 it was unknown if the patient continued to get the GARDASIL vaccine and she has recovered from the dizziness, nausea and pain at the injection site.  Additional information has been requested.
reports stiff neck, postauricular-cerical neck  nerve like pain that comes and go, occasional muscle spasm Reports condition waxes/wanes
p/ pt recv vax approx 3yrs later pt devel numerous chickenpox-like rash on extremities, neck & face
No additional AE information provided.; HCP states that multiple patients have accidentally been given PEDVAXHIB vaccine that was diluted. HCP states that the person administering the product was diluting the PEDVAXHIB with 0.5mL of normal saline and then drawing up 0.5mL and administering; HCP states that multiple patients have accidentally been given PEDVAXHIB vaccine that was diluted. HCP states that the person administering the product was diluting the PEDVAXHIB with 0.5mL of normal saline and then drawing up 0.5mL and administering; This spontaneous report was received from a registered nurse and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-SEP-2022, the patient was going to receive the second dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot #W002453, expiration date: 24-JUN-2024, strength, dose, frequency and route were unknown) for prophylaxis. During the preparation, the vaccine was diluted with sodium chloride (NORMAL SALINE) 0.5 milliliter (ml) (strength, lot #, expiry date, route of administration, and indication were not provided) and then drawn up 0.5 ml of the mixed solution and administered it to this patient (vaccine preparation error, accidental underdose). No additional adverse events were reported.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2209USA007866: US-009507513-2209USA007891: US-009507513-2209USA007893: US-009507513-2209USA007924: US-009507513-2209USA008037: US-009507513-2209USA008058: US-009507513-2209USA008125: US-009507513-2209USA008249: US-009507513-2209USA008273: US-009507513-2209USA008275:
30 minutes after vaccination (#2) ears suddenly felt plugged. Over the next 2-3 days, plugged feeling in ears would temporarily improve then return. Never seemed to lose hearing.Mild inner ear issues with some dizziness during that first week following the vaccine. On Weds., March 24th tinnitus in left ear began and intensified throughout the day so that I was unable to sleep that night. Continued significantly into next day and night. (March 25th.) Since that time it has lessened somewhat at times, but also intensified at times to the point of being very disruptive to focus  and sometimes to sleep. Seems to be pretty much constant in the left ear at this time. Hoping it will subside over time. May not risk booster
Irregular Heart Beat (strong/fast) during irregular times or activities (such as laying down to sleep). Numerous cases of this approximately 24 hours after 3rd dosage (booster) of Moderna COVID-19 vaccine to four weeks after the 3rd dosage.  Skin rash occurred on both hands shortly after each (first, second, and third) vaccine dosage. Skin rash lasted for approximately two months after second dosage from April-June 2021. Skin rash returned within 72 hours of taking the 3rd dosage of the Moderna Vaccine on October 1, 2021 and is still noticeable on November 16, 2021. Fluocinonide (0.05%) cream prescribed by Dr. to treat skin rashes/eczema.  Dr. monitoring heart conditions.
PEDIARIX, PREVENAR and HIBERIX, ROTARIX vaccines were given within 15 hours patient developed a temp of 102F and red hard quarter size area on left leg. Patient recovered.
Dazed look with nausea and dry heaving; staff standing near her said she looked green
cried off & on p/DTP given @ 4 months; crying lasted 8 hrs; slept @ short 45mins intervals; leg very swollen; hard to console;
Headache, bodyaches, shivering, extreme exhaustion, and a sore throat appeared within the first 24 hours. Around 12 PM the day after I got the shot. Day two I felt better but felt like I had the chills and body aches of a really bad cold. Day three I have a medium range fever, body aches, and really bad nasal congestion
Moderna Vaccine was administered on 10/05/2021 vaccine expired 10/01/2021.
On 5/14/20 evening (approx 34hrs post vaccination), noted increasing fatigue and arm soreness with local reaction to injection site (redness approx 4-5cm diameter, edema, pain with arm movement). Poor sleep overnight, no night sweats. Treatment included 500mg acetaminophen. On 5/15/20 morning (approx 44hrs post vaccination) noted significant myalgia, chills, headache, fever (101.3 - 102.6F max throughout the day), right arm with expanding local reaction, up to 5-6cm patch, significantly tender to touch.  Employee Health contacted as it was a work day, suggested a COVID test due to fever (no URI symptoms). Test was negative. Treatment of 1gm acetaminophen given q6-8hr with 220mg naproxen q8-12hr. Slept well overnight. On 5/16/20 morning, awoke with only mild headache, right arm soreness/redness improving, Temp max of 100.7F. Mild myalgia returned, in afternoon/evening. Treatment requiring 1gm acetaminophen and 220mg naproxen at bedtime. 5/17/20 Complete resolution of fever, myalgia, right arm only with mild soreness/tenderness to touch, slightly fading 5cm patch of swollen skin. Afebrile.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient. A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetes". The event "diabetes" required physician office visit. Description of Event Outcome: Patient was trying to schedule her booster dose online and would like assistance in filling out information online and asking which should she select. She also mentioned that she was diagnosed with diabetes but with her recent visit with her physician she was advised that she is no longer prediabetic. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Erythema multforme minor. Started as itchy to tender small red papules on the hands, feet, nose 2 days ago. This morning I woke up and noticed classic targetoid lesions and other lesions are two-toned. Currently involves my hands, feet, nose, lips, ears.
right ear ache; overactive smell; severe rash on trunk and top of her legs and arms; This is a spontaneous report from a contactable consumer (patient) reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had severe side effects from the first dose of Pfizer's COVID vaccine with a severe rash on trunk and top of her legs and arms. She also had a right ear ache and had an overactive smell. Her rash was coming from the inside out. The patient stated that she didn't itch it and it was small and not as red as it used to be. The patient wanted to know the efficacy percentage after one dose of Pfizer's COVID vaccine and if right ear ache or overactive smell had been reported after receiving a dose of Pfizer's COVID vaccine. The patient wanted to know what would happen if there is a booster dose and she is not able to get the second shot due to her severe side effects. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Vomiting for 24 hours; Severe muscle aches; fever; no energy; sensitive skin; Tired; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 29Mar2021 at 15:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included progesterone (MANUFACTURER UNKNOWN) as contraceptive pill from an unknown date and unknown if ongoing. On 20Apr2021 at 03:00, the patient had experienced vomiting for 24 hours, severe muscle aches, fever, no energy, sensitive skin and tired. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as a result of the adverse events.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vomiting, severe muscle aches, fever, no energy, sensitive skin and tired was recovered on an unknown date in 2021.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Severe joint pain in both knees; Painful to bend and straighten legs; Soreness in vaccination location; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 12May2021 at 13:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included prediabetes, depression, graves' disease, dermatitis herpetiformis. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), sertraline (MANUFACTURER UNKNOWN), and vitamin d nos (VITAMIN D) all from an unknown date for an unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the right arm on 21Apr2021 at 13:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13May2021 at 12:00, the patient experienced severe joint pain in both knees starting the day after second shot. Same type of pain, same location. Painful to bend and straighten legs. Lasted for 3 days. Almost gone on fourth day. No other joint or muscle pain, other than soreness in injection location. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events severe joint pain in both knees, Painful to bend and straighten legs, soreness in injection location was recovering.  No follow-up attempts are needed. No further information is expected.
35 patients received a 0.25 ml dose as booster from booster dose only presentation vial; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial).    No concomitant product use was reported.   Vaccination dates reported as between 22-Jul-2022 and 28-Jul-2022.  It was unknown if patient experienced any symptoms after getting the vaccine.  Treatment information was unknown.
Admitted to Tri-Valley Medical/Stanford in Pleasanton, CA for shortness of breath and chest pain, on June 1st. Diagonosed with Pulmonary Embolism in Right Lung.  Admitted to Tri-Valley Medical/Stanford in Pleasanton, CA on June 14th for shortness of breath and chest pain, later diagnosed with a Heart Block
Two days after receiving my 2nd dose of moderna, my lip started to swell. Them that night I had hives on my eyelids. The next day I woke up with hives all over the backs of my thighs. Every day after, I would wake up with hives on my thighs and sometimes develop more patches on my forearms and neck. Sometimes they would dissipate throughout the day, others they would stay all day and through the night. After about three weeks, I went to an urgent care and received a steroid shot and was prescribed prednisone. The hives went away for the five days I was taking the medicine, but then came back with a vengeance. Every morning I would wake up with itchy red hives all over my body (including my scalp, palms of my hands, soles of my feet, lips, face and throat).  They usually would not dissipate. Over the course of the next two months I received one more steroid shot and two more rounds of prednisone, which worked as a temporary solution, but only caused the hives to come back worse immediately after I was done weening off the pills. I also took antihistamines which helped a little to calm the hives down by the end of the day. In the beginning the hives were raised but not that itchy. However after the second round of prednisone they became flat red rings that I simply couldn?t resist itching all day. And then one day, July 30th, they suddenly disappeared. However, sometimes I wake up with a few red bumps here and there.