chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Found unconscious in hallway. Once able to wake her, she ran to toilet and vomited profusely several times before losing consciousness again. Got her around again and she vomited more. Complained of horrible headache. Extreme fatigue. Fell into very deep sleep. Hard to wake. Temp 99 to 100. Lasted approx. 24 hours.
1. Headache 2. Swelling at redness at injection site 3. Fatigue 4, Muscle weakness and pain 5. One fainting episode
This case was reported by a nurse via sales rep and described the occurrence of anaphylactic reaction in a female patient who received FLUARIX QUADRIVALENT. In October 2016, the patient received FLUARIX QUADRIVALENT. In October 2016, 2 days after receiving FLUARIX QUADRIVALENT, the patient experienced anaphylactic reaction (serious criteria GSK medically significant) and hand swelling. In October 2016, the outcome of the anaphylactic reaction and hand swelling were recovered/resolved. The reporter considered the anaphylactic reaction and hand swelling to be probably related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not provided. The sales representative had limited details to share. The nurse stated that one of the patients received FLUARIX QUADRIVALENT on 7th October 2016 and the other patient received FLUARIX QUADRIVALENT the week before reporting date. One of the patient experienced the events two days after vaccination, but unknown which of the two patients. Also, one patient went to the emergency room, but it was unknown which of the two patients. No further information was provided. This case was linked to case US2016150175, reported by the same reporter.
An on and off headache; Had fever on and off; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: Unknown, Expiration date: Unknown), via an unspecified route on 06Apr2021 (reported as last Tuesday) (at the age of 58-year-old) as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date in Apr2021, patient experienced fever on and off, tiredness and an on and off headache. Patient wanted to know for how long this expected to last and would like to enquire if the vaccine can cause a positive test result for covid. It was unknown if the patient received any treatment for the events. The clinical outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
At 24 hours pt felt lethargic, dizzy. After dinner that night he was sweating, burping. At 48 hours pt had pain in left arm, congestion and tightness in chest. COD as per death certificate -- cardiorespiratory arrest
Punctured vial greater than 12 hours in refrigerator; punctured vial greater than 12 hours in refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (punctured vial greater than 12 hours in refrigerator) and PRODUCT STORAGE ERROR (Punctured vial greater than 12 hours in refrigerator) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (punctured vial greater than 12 hours in refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Punctured vial greater than 12 hours in refrigerator). On 24-Aug-2021, EXPIRED PRODUCT ADMINISTERED (punctured vial greater than 12 hours in refrigerator) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Punctured vial greater than 12 hours in refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter  Treatment information was not provided.  Cross-Linked with Case Numbers: MOD21-134712, MOD21-134781, MOD21-134783, MOD21-134784, MOD21-134785, MOD21-134787.
Information has been received from a physician concerning a 12 year old female who in September 1998 (reported as "9/1698"), was vaccinated with the first dose of MMR II. On 01-AUG-2001, received the second dose of MMR II. On 16-JAN-2010 the patient experienced mumps. She was afebrile, with both sides parotitis. First blood work was done on 18-JAN-2010. She was diagnosed with mumps on 18-JAN-2010. Outcome of the event was unknown. No further information is available.
This spontaneous report as received from a registered nurse refers to a 53 year old female patient with gastrooesophageal reflux disease. Her medical history included nephrolithiasis. Her concomitant therapies included FLEXERIL, PROZAC, PRILOSEC and IMITREX. On 20-OCT-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # N022703 expiry date on 27-FEB-2019, intramuscularly,  for prophylaxis and FLUZONE (dose, route, indication were not provided) at the same deltoid area of the same arm. Thereafter on 21-OCT-2017, the patient developed "cellulitis like symptoms" from the area below the injection site down to the elbow. The reporting nurse mentioned that the patient received unspecified treatment for the adverse event and no laboratory test was perform. At the time of the report, the outcome of cellulitis was unknown. The causal relationship between the above mentioned event and suspect therapies was not provided. Upon internal review, the event cellulitis was considered to be medically significant.
This spontaneous report as received from a nurse practitioner via a company representative refers to a 9 week old male patient. No medical history was provided. On 17-DEC-2013 the patient was vaccinated with the first dose of ROTATEQ (lot number, expiration date were not reported) (suspension 2 ml, orally, indication: 'routine'). Seven days later, on 24-DEC-2013 the patient was hospitalized in medical clinic. The patient was diagnosed with a bowel obstruction and congenital malrotations on an unspecified date approximately in December 2013. The patient died on an unspecified date. The outcome of bowel obstruction and congenital malrotation was not reported. No cause of death reported. The relatedness between the events of bowel obstruction and congenital malrotation and ROTATEQ was not reported. The events of bowel obstruction and congenital malrotation were considered to be life threatening and disabling. Upon internal review the event of congenital malrotation was considered to be congenital anomaly. Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single at the age of 35 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2weeks. Treatment start date was 24Nov2022 and stop date was 28Nov2022.  No follow-up attempts are possible. No further information is expected.
Inflammation sore can't puck up more then 5lbs cant raise arm up very far the Inflammation on shoulder n down side of my breast
Grandmother states child has not complained of any symptoms. Child received first dose on 11/17/21 and dose two was administered on 12/01/21, was due 12/8/21.
Felt woozy, had nausea, achy muscles, felt like I was walking through quicksand, general malaise for about 30 hours afterward.  If that is any sign of how covid feels, I am so grateful for the shot.  I did not take anything because I wanted my body to fight it off.
Large Lump at injection site. Redness, swelling, impaired movement of limb. Nauseous, diarrhea.
imz is supposed to be SQ, i administered IM, that is what i'm reporting. i tried to call pt to notify but she didn't pick up.
15-20 minutes after injection client experienced itching at injection site.  After about 2 hours had itching all over and had rash on cheeks.  Took bath in epsom salts and took benadryl at bedtime.  In a.m. - no further symptoms
got an ear infection on both ears with perforation and bleeding; got an ear infection on both ears with perforation and bleeding; may have been getting sick cause of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 15 year-old male patient received bnt162b2 (BNT162B2), administration date 04Sep2021 (Lot number: FD8448) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Autism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HAEMORRHAGE (medically significant), EAR INFECTION (non-serious), outcome "unknown" and all described as "got an ear infection on both ears with perforation and bleeding"; ILLNESS (non-serious), outcome "unknown", described as "may have been getting sick cause of the vaccine". Reporter was a mother calling on behalf of her son who received the Pfizer BioNtech covid vaccine first dose on 04Sep2021 (Lot#FD8448). Her son is a 15 year old male with Autism. Her son may have been getting sick cause of the vaccine, he got an ear infection on both ears with perforation and bleeding after the first dose on September. Reporter wants to know if these side effects are reported with people with same condition as her son, because her main concern is the seizure and if it would happen again after receiving the booster shot. (withheld) mentioned that the caller provided the Lot# and stated that her son received the pediatric dose but cannot confirm the statement as she only has the Lot#.  No follow-up attempts are possible. No further information is expected.
the next day the  site of the injection became red, swollen and hard about golf ball size as reported by patient.  It was mildly painful.  A week later on seeing her  primary physcian for a routine appointment it was only black and blue and he thought it was simplely a matter of a blood vessel being hit at the time of injection.
A booster dose from an expired vial of the Moderna Covid-19 vaccine was given to a patient today (10Nov2021); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A booster dose from an expired vial of the Moderna Covid-19 vaccine was given to a patient today (10Nov2021)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety.    On 10-Nov-2021 at 3:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A booster dose from an expired vial of the Moderna Covid-19 vaccine was given to a patient today (10Nov2021)). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (A booster dose from an expired vial of the Moderna Covid-19 vaccine was given to a patient today (10Nov2021)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Expiration date was showing 11/10/21 in Osiis & ECW so nurse administered vaccine.  Patient did not expierence any side effects, was monitored for 15 minute without signs of reaction noted.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Patient demographics, Medical history,Vaccine dose route of administration, Anatomical location, Concomitant medication added.
Fluzone High-Dose Quadrivalent the vaccine was a bright green serum that was injected, no AE; Initial information received on 23-Jul-2021 regarding an unsolicited non-valid non-serious case from a consumer via Medical Information  (Reference number- 00694840).  This case involves a 72 year old female patient who was vaccinated with the bright green serum INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included COVID (coronavirus disease)-19 VACCINE for Prophylactic vaccination.  In Sep-2020, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ4888A and expiry date: 30-Jun-2021) (Frequency: once) via an intramuscular route in the right arm (product colour issue) for prophylactic vaccination.  It was case of product colour issue.  It was reported that "when they received the Fluzone High-Dose Quadrivalent the vaccine was a bright green serum that was injected. The Pharmacist does not have any knowledge of the vaccine being green and that the vaccine would not have been administered if it were bright green".   At the time of reporting, no adverse event was reported.   Follow-up information received on 23-Jul-2021 regarding an unsolicited non-valid non-serious case from a consumer via  Medical Information (Reference number- 00694840).   Case validity was updated.  Based on information received on 23-Jul-2021, the report previously considered as non-case became valid: [reason for special event reported].
Severe abdominal pain that progressed over 2 days following vaccination. Periumbilical in location. Worse after any food or drinking. Associated with nausea but no vomiting. No fever. Fluctuating time course with pain free intervals lasting seconds to minutes with times of pain lasting seconds to minutes. Tender in umbilical region on exam without features of acute abdomen.
Red scratchy eyes, sore throat, coughing, hoarseness. 5:15 PM throat closing, stuffy nose, headache, fatigue. 5:45 PM difficulty swallowing, body aches, eyes closing, severe headache. 7:15 PM Sore eyes, fatigue, body aches, hoarseness, coughing, throat slightly opening.
mom noted fine, red, raised rash on pts arm the morning p/inject recvd; rash spread to back & chest; phoned hlth dept same day; advised to seek MD opinion; taken to MD next day;
Subsequent to receiving vax, the pt developed elevated blood pressure, 210/107 mmHg.  The pt states that her blood pressure prior to receiving vax was 150/156 mmHg. On 01/03/2001 she went to see her HCP and her blood pressure was 166/110 mmHg in HCP office. The pt was treated with Micardis mg QD. Medical history includes hypertension.
PATIENT SAYS HER ARM WAS SO SORE SHE WAS UNABLE TO MOVE IT. IT WAS SWOLLEN AND HAD A RASH FROM THE ELBOW TO THE SHOULDER.
Second day second shot, chills, headache, nausea, 4 day after second shot, bleeding gums (never had problems with my gums) nose bleed and bruising
Difficulty breathing; Swollen lips; Rash all over the body; Chills; Fever of 102/ Fever reduced to 99 in the morning; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), LIP SWELLING (Swollen lips), RASH (Rash all over the body), CHILLS (Chills) and PYREXIA (Fever of 102/ Fever reduced to 99 in the morning) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     The patient's past medical history included Seizure, Stroke in 2013, Heartbeats irregular and Sleep apnea. Concurrent medical conditions included Drug allergy (Keppra). Concomitant products included ZONISAMIDE, OXYBUTYNIN and TOPIRAMATE for an unknown indication.    On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced DYSPNOEA (Difficulty breathing), LIP SWELLING (Swollen lips), RASH (Rash all over the body), CHILLS (Chills) and PYREXIA (Fever of 102/ Fever reduced to 99 in the morning). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. On 20-Nov-2021, PYREXIA (Fever of 102/ Fever reduced to 99 in the morning) had resolved. At the time of the report, DYSPNOEA (Difficulty breathing), LIP SWELLING (Swollen lips), RASH (Rash all over the body) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Body temperature: 102 (High) High. On 20-Nov-2021, Body temperature: 99 (Low) fever was reduced to 99 in the morning.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.      The case was downgrade to non-serious because there no was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant and the patient did not seek medical attention.; Sender's Comments: The case was downgrade to non-serious because there no was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant and the patient did not seek medical attention.
Soreness in the back started on 2/5/2021 and eventually moved to the abdominal area on 2/12/2021.  Went to the doctor and got a CT scan and found an Acute right common iliac vein and infrarenal IVC thrombus.  Many blood tests were run and no common factors were located to cause the thrombus.
On rt arm pt. received GARDASIL 9 on Wed. 3-30-16. On Thurs. 3-31-16 his rt arm began to turn red and swollen at injection site. Then developed a lump. Was also itchy and painful when lifting. On Fri 4-1-16 was no longer red and swelling was decreased.
reports day p/vax w/foot pain,had vomiting & general malaise 2 day p/vax w/over all joint swelling;seen by MD;dx poss polyarthritis viral synd;
Chills, fever, severe headache, nasea. Took ibuprofen, cold compress to head, blanket for chills.  Chills and nausea lasted for 6 or 7 hours, Fever lasted for 48 hours. Headache lasted for 60 hours.  Very sore arm at injection site which lasted for about 72 hours.
shivers, body aches, headache. no treatment.  went away after 12 hours.
A report has been received from a Health Professional concerning a child, subject of unknown gender, who had been receiving FLUMIST Quadrivalent (intranasal), 0.2 Millilitres. FLUMIST quadrivalent (intranasal) started on an unknown date for INFLUENZA. The reporter stated patient administered expired dose which started on 13-Jan-2016. The outcome of the event of EXPIRED DOSE is unknown. The reporter's description of the event(s) was as follows: No pertinent medical history for any of the 3 children. The report was considered to be non-serious.
Received Zostavax shingles vax on 09/08/2008 in loose fatty tissue of RIGHT arm under tricep. Within two days onset of spasms in lower back, symmetrically in muscles adjacent to Left and Right side of spine immediately above belt line (waist) and just below rib cage. Spasms increased in pain to 8-10 level (10 pt. max.) over ensuing week. Pain spread throughout RIGHT side of back and throughout right side of abdomen, especially in (R) rear kidney area. 09/18/2008 severe pain plus nausea necessitate visit to ER. Interviews plus tests with personnel result in prescribing some muscle relaxers plus advice to take Ibuprofen. Arrange with PCP to take more lab tests in mid Oct. 2008 and visit in late Oct. 2008. Dr's examination concludes not shingles. "Try & see" for one month. Lower back spasms ebb away very slowly over period late Oct. to early Nov. 2008, but abdominal and kidney pain persist. Though kidney pain ebbs slowly away, abdominal pain persists at 3-5 level and PCP Dr. orders more lab tests and ultrasound exam in early Nov. Test results normal, but as of this report still have persistent RIGHT front abdominal pain. Conclusion: This is a VERY UNUSUAL first time experience for patient. Patient questions proximity of problems to shingles vax, "RIGHT" sidedness of everything (shot location and ensuing problems). Requests examination of still ongoing episode.
pt recvd vax & w/in 72hrs p/vax exp itching,soreness,& hard raised area @ inj site;these sx were not treated;reporter states that the itching & swelling had disappeared by day 7;pt has had no other problems;
pt claims friday he was knocked out with a fever and chills and slight cold.  then had local red reaction on arm and arm ached. called few days later and it was still red but improving,
5cm well-circumscribed induration and erythema at injection site. No other sx's, no tx.
My arm is very sore at the injection site to the point where I am having trouble lifting it or applying pressure on it. I also had a very mild headache shortly after receiving the shot. This has come and gone within the last 12-15hours (since I received the shot). I also started experiencing mild chills at about hour 15 after receiving the shot. I?m having a very difficult time sleeping due to the discomfort.
Fatigue, achy joints, extreme swelling of glands in neck,under chin, and shoulder, rash, headache, aching swollen feet, one day of difficult breathing, sore dry throat.
Low grade fever  for 12 days; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number EL9263, expiration date May2021, via an unspecified route of administration from 25Jan2021 18:00 (at the age of 43 years old) as a SINGLE DOSE in the left arm for COVID-19 immunization.  Medical history included none.  Patient had no known allergies.Concomitant medication included lamotrigine (LAMICTAL), bupropion hydrochloride (WELLBUTRIN), alprazolam (XANAX), drospirenone, ethinylestradiol betadex clathrate (YAZ). The patient experienced fever the next day around early evening, on 26Jan2021 around 06:00PM. Initially her temperature stayed between 99-100 degrees Fahrenheit, that has been where it stayed but not continuous for the first couple of days. She says she would wake up with no fever, then it would be low in the evening. Last weekend, a week after getting the vaccine, every day she had a fever and it was going above 100 degrees Fahrenheit, to like 100.5 degrees Fahrenheit. The patient experienced low grade fever for 12 days.Treatment included taking generic Ibuprofen. She says she took two tablets as needed every 6 hours, and the strength for two tablets together is 400mg, LOT: 9BE2588A, Expiration date she just realized that this expired last month, Dec 2020. She says that the medication seems to be working just fine. The patient underwent lab tests and procedures which included body temperature: stayed between 99-100 fahrenheit on  unknown date, body temperature: above 100 fahrenheit on unknown date, body temperature: above 100 fahrenheit it was going above 100 degrees Fahrenheit, to like 100.5 degrees Fahrenheit on  unknown date, flu test: negative on 04Feb2021, covid test type post vaccination- nasal swab: negative on 03Feb2021, Covid-19 virus test: negative on 04Feb2021, strep test: negative on 04Feb2021.   Outcome of the event was not recovered