chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BACK ACHE; BAD HEADACHE; FEELING QUEASY; WANTED TO LIE DOWN; CHILLS; STOMACH UPSET; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: 6 stents in heart, non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known drug allergies and had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the patient experienced stomach upset. On 12-MAR-2021, the patient experienced wanted to lie down. On 12-MAR-2021, the patient experienced chills. Laboratory data included: Body temperature (NR: not provided) NO FEVER. On 13-MAR-2021, the patient experienced back ache. On 13-MAR-2021, the patient experienced bad headache. On 13-MAR-2021, the patient experienced feeling queasy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach upset, back ache, wanted to lie down, bad headache, and feeling queasy on 13-MAR-2021, and chills on 12-MAR-2021. This report was non-serious.
Low grade fever, reached 102.5 on this day. Spiked to 104 following evening (7/16) and a measles-like rash started to appear.
Flu like symptoms (felt being in bed for several days); Diarrhea; High fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms (felt being in bed for several days)), DIARRHOEA (Diarrhea) and PYREXIA (High fever) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms (felt being in bed for several days)), DIARRHOEA (Diarrhea) and PYREXIA (High fever). On 06-Feb-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms (felt being in bed for several days)), DIARRHOEA (Diarrhea) and PYREXIA (High fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   This case was linked to MOD-2021-226415 (Patient Link).
felt like was going to pass out; very cold; This is a spontaneous report from a contactable consumer. This consumer reported different events under the same suspect product for four patients. This is the fourth of the four reports. A female patient of an unspecified age (reported as 20 something) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first vaccine that day at a mass vaccination event. The reporter learned this one from a friend who was at the same event. The patient became very cold and felt like she was going to pass out. She had to lay down after 10 minutes and EMT's were called, not sure of the end result or any other information except she didn't eat that day. The outcome of the events was unknown.   Information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021433228 Same reporter/drug; different patients/events
Extreme bloating/stomach distended (i look 6 month pregnant) and bad cramping in my uterine region and my upper abdomen
PAIN AND SWELLING - AT SHOT SITE, REDNESS, FATIGUE, MILD FEVER.TREATMENT: ANTIHISTAMINES, ICE AND BACTROBAN CREAM    PATIENT' PARENTS SOUGHT TREATMENT ON 12/6/02.
A report has been received from a Medical Rep concerning a 6 year old, female subject who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 22-SEP-2014. The patient experienced tested positive for Flu A. The outcome of the event of tested positive for Flu A is unknown. The report was considered to be non-serious.
drug eruption of central chest pruritic rash that spread to upper and lower extremities not responsive to hydrocortisone cream, zyrtec and keeping area dry
Localized rxn-redness, swelling, pain shooting down arm; p/reaching home temp 103&104, light sensitivity, intracranial pressure, nausea; Following day "upper respiratory infection", "in my chest".
SUSPECTED COVID-19 INFECTION (TESTED POSITIVE FOR CORONA VIRUS BY USING COVID-19 TESTING KIT AT HOME); This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On JUN-2021, the subject experienced suspected covid-19 infection (tested positive for corona virus by using covid-19 testing kit at home). Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection (tested positive for corona virus by using covid-19 testing kit at home) was not reported. This report was non-serious. This case, from the same reporter is linked to 20210666578.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Symptoms started 14 hours after 2nd shot. Cold chills, low grade fever, cold chills, severe head ache, body aches, restlessness, tiredness. That lasted for 7 hours. All symptoms subsided 7 hours later except body aches and severe head ache which lasted another 8 hours. All symptoms subsided after 24 hours.
This spontaneous report as received from a registered pharmacist refers to an unspecified number of patients of unknown ages. The patients were vaccinated with improperly stored doses (exposed to 31.1 F for 8 hours 10 minutes) of GARDASIL (Lot # not reported) on an unspecified date. No known adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Site: Redness at Injection Site-Mild, Additional Details: 911 took her to hospital. No evidence of allergy reaction, and most likely anxiety issue. She did indicate that she has anxiety in general.
Experienced 2 days of worsening fever, chills, myalgias, mild chest pain, fatigue and malaise. Went to the ER after having a low grade fever, chills, shortness of breath, mild chest pain, and an elevated resting heart rate. Was diagnosed with SIRS as a response to the covid vaccine and hospitalized for observation. Was discharged the next day.  Diagnosed with SIRS, possibly due to the COVID vaccine with a secondary diagnosis of asthma.
developed cellulitis after receiving the shot of Prevnar 20; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: GN1898), in right deltoid for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CELLULITIS (medically significant), outcome "unknown", described as "developed cellulitis after receiving the shot of Prevnar 20".  Clinical course: Caller mentioned that they have two patients who developed cellulitis after receiving the shot of Prevnar 20 and they believe that there is something wrong with the batch; Sender's Comments: Based on the available information in the case, an association between the reported events CELLULITIS and The suspected drug cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 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 included: "PH necrotizing pneumonia" (unspecified if ongoing); "Known allergies: Pcn" (unspecified if ongoing), notes: Known allergies: Pcn. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive test. Therapeutic measures were taken as a result of covid-19, drug ineffective (PAXLOVID).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported Drug ineffective and COVID-19 cannot be ruled out.
Patient reported feeling lightheaded then became pallor, slumped over in chair, and lost consciousness for approx. 30 sec. Given known peanut allergy, administered 0.3mg epi immediately and placed in supine position with legs on chair. Upon regaining consciousness was alert and oriented, BP 101/59, HR 62, T 36.2, SPO2 99%.  Reports no difficulty breathing or respiratory compromise. Called 911 and remained with patient until EMS arrive. Patient felt well and at baseline and did not want to pursue going to hospital. Friend will drive her home today. Agreed to see PCP prior to next dose of vaccine.
11/17/21  patients mother called stating that patient tested positive for Covid yesterday and would like to know if he qualifies for the regineron infusion     Advised:  Called pt. Wife has covid. Pt had test yest - pos. Reports asymptomatic at this time. Is high risk. D/w pt re regenron tx - pt would like, will order
Swelling, redness/purple, itching, spreading in upper right arm. Was diagnosed with cellulitis at  urgent care on 1/17/21. Started taking doxycycline. On 1/21/21 went to physical appt  and was sent by APRN  who saw improvement in my arm and thinks this was an adverse reaction to the covid 19 vaccine and said You can now stop taking the antibiotic. She stated she doesn't believe this is cellulitis.  She said a few other patients came into the office with the similar issue, a kind of delayed reaction to the shot. Please call her and she will tell you her thoughts.
patient reported to pharmacy she experienced severe swelling beneath the right eye beginning 2 days post vaccination. The area beneath the eye was reported to be swollen, red, and sensitive to the touch.
At 3:15 patient received Moderna Vaccine. Approximately five minutes after receiving Vaccine patient began to feel chills throughout his body and began to feel very dizzy. Staff & Observer walks over to the patient and notices patient's face is completely pale and lips have no color. Staff notifies the clinical group supervisor and she takes patient's vitals. Patient can barely keep his head up, and is weak. Patients vitals at 15:29 44 67/42 96. We lay him on the floor with his feet on a chair. Staff calls paramedics at 3:29. At 15:37 48 78/42 97. At 15:40 55 98/64 96. At 15:46 54 98/64 96. Paramedics arrived at 15:51 and his vitals are 57 82/62 97. Patient is stable. Paramedics clear him.
Left side chest pain and pressure started Monday October 11, 2021 around 3 am. Tingling down left arm into hand and fingers started October 13th in the evening. I was also having dizzy spells which started on October 11, 2021.  I went to the emergency department. I was examined and given blood tests and received an EKG. I was given sodium chloride and ketorolac. I was given a prescription for ibuprofen for the chest pain.  I was also given a prescription for amoxicillin for a sinus infection that is unrelated.
Woke up with swollen eyelids, like hives.  Also, hive on forehead and wrist.  Otherwise, feels okay.  Spoke to doctor on call (not our usual doctor) and administered liquid Benadryl.  Waiting to see what ensues.
I received the vaccine at 1050hrs on 12/16/20.  At around 0900hrs on 12/18/20, I began to experience severe fatigue.  At ~1330 on the same day, I had a mildly elevated temperature - normal baseline for me is 97.6, with that reading at 99.4.  Due to the fatigue, I slept from 1400 hrs until 0500 on the following day, 12/19/20.  No other symptoms to report besides a tender injection site for the first 48 hours.
fatigue, body aches, headache for 24 hours after vaccine, 36 hours post vaccine patient broke out in large hives from face (eyelid) through trunk, pelvis, genitals, and legs, Patient advised to take OTC pain reliever, anti-histamines including Zyrtec and Zantac. Patient took benadryl and zyrtec and alleve. Hives continued for 4 days even under maximum doses of anti-histamines.
@ 3 hrs post injection sore arm @ 8 hrs post injection chills and fever 100+ degrees which lasted for 24 hours myalgia, arthralgia and severe headache. @ 36 hours post injection still headache and body aches but no fever or chills
awoke w/ 4 reddened spot on face; By 1PM pt had numerous large raised blotches over entire body; pt had been placed on Ceclor by MD; seen by MD -acute allergic reaction to Ceclor dx;
I was diagnosed with shingles on June 8.  They first appeared on my forehead on May 31, 2021.  This was approximately 6 weeks after my last shot.  I never had Covid before the shots.  I am 46 years old and have not had my shingles vaccine yet.  This was my first experience with shingles and am not sure if it is related to the shot or not.  But thought I should report.  I am on anti-virals and symptoms are healing/improving.
Felt dizzy following immunization.  Needed support to walk (vaccine administered in arm, not leg).  Fever of 102 later in evening around 6:30pm.  Complained of headache.
pt w/on going diarrhea recv vax & pt cont to have diarrhea & was seen by MD;testing of stool for rotavirus antigens was negative;
DID NOT COMPLETE HER IMMUNIZATION ONE WEEK PRIOR TO TRAVEL; A spontaneous case report was received from a consumer on 02-Jun-2019 for two consumers.  Based on the information obtained from the consumer, 2 individual case safety reports PVX201907-000560 (PVX2019-1729; female consumer) and PVX201907-000561 (PVX2019-1729) were created and cross-linked in the database.  This case describes a female consumer who "did not complete her immunization one week prior to travel". She was receiving Vivotif for foreign travel.   Case report: The consumer started taking Vivotif on 26-Jun-2019 and took her last dose on 02-Jul-2019. Meanwhile, on 29-Jun-2019 she travelled.   Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "did not complete her immunization one week prior to travel" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not complete her immunization one week prior to travel" was considered as not applicable. US-PaxVax Berna GmbH-PVX201907-000561:
11/23/21 presents to ED for "coronavirus concern, tested positive today at nursing facility" "some congestion and muscle aches, especially in his shoulders". PMHx of "aortic stenosis, CKD, Diabetes mellitus, type II, DVT"
Patient received the pediatric dose of the vaccine at a pediatric 5-11 clinic but patient is 12 years old
Received vaccine.  Five minutes later he stated he had a severe headache and was dizzy.  He sat down and an ambulance was called. He was transported.  Spoke with mother.  Hospital advised her that he had more of a reaction from the act of receiving the vaccine then to the vaccine itself.
p/vax s/s runny nose/congestion 1:30PM;nauset @ 3:00;fatigue 7 weakness 5:00;body aches 6:45;diarrhea, fever overall;ill feeling all noc next day;
Over 102 fever, severe body, muscle, joint pain. Severe headache. Stomach pain. Dry mouth. Severe fatigue and brain fog. Barely was able to move.
Information has been received from a registered nurse concerning a 9 year old female with no pertinent medical history and no drug reactions/allergies who on 05-AUG-2002 was vaccinated with the first dose of VARIVAX (Merck), and on 03-AUG-2010 was vaccinated subcutaneously with the second 0.5 mL dose of VARIVAX (Merck) (LOT# 666490/1659Y). There was no concomitant medication. On 05-AUG-2010 the patient returned to the office with itchy, hive-like, raised bump centered on the injection site on her (unspecified left or right) arm that was surrounded by a larger area of localized inflammation. Nurse reported that patient was treated with an unspecified dose of BENADRYL, and was asked to return to the practice, if the injection site symptoms did not resolve in the next few days. There was no lab diagnostics studies performed. As of the time of the telephone called on 09-AUG-2010, the patient had not returned to the practice; therefore the practice could not provide any definitive information on the patient's recovery. No further information is available at this time of reporting. Follow-up information has been received from a physician who reported that the 9 year old female student with no illness at time of vaccination who on 03-AUG-2010 at 14:00 was vaccinated subcutaneously at left arm with the second dose of VARIVAX (Merck) (LOT# 666490/1659Y) and at the same time was vaccinated intramuscularly at left arm with the first dose of HAVRIX (LOT# AHAYB362BA). On 04-AUG-2010 the patient experienced exuberant local reactions: warm, slightly tender, with minimal indurations upper posterior 1/2 of upper arm with pruritic urticarial center. The patient required doctor visit. The physician didn't report the patient's outcome at this time. Follow-up information has been received from a physician who reported that the 9 year old patient on 03-AUG-2010 at approximately 14:15 (previously reported as 14:00) was vaccinated subcutaneously at left arm with the second dose of VARIVAX (Merck) (LOT# 666490/1659Y). On 04-AUG-2010 experienced large exuberant local reaction, red, warm, slightly tender with indurations and itching in center at the injection site. No fever or systemic symptoms. Duration was around 3 days. On 10-AUG-2010, the patient recovered. No further information is available.
The Hep A was not due until 6/9/20. The TDaP-IPV was the incorrect dose for a 15 month old.
Vertigo  started during the night following the vaccination. It felt like the room was spinning, while I was lying in bed and on getting up. It is mild, and I can still go about my regular activities.
Initial misuse report received from a pharmacist on 01 October 2013. The patient had received FLUZONE HD. Nurse gave a dose from last year which was expired. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
18NOV96 3 days hx of tender enlarged occipital & posterior cervical lymph nodes;rash on both arms;
No additional AE reported. No PQC.; the 50 year old male received a pediatric dose instead of an adult dose; This spontaneous report has been received from a nurse, referring to a 50-year-old male patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 27-AUG-2021, the patient was vaccinated with a pediatric dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) 0.5 ml (incorrect dose administered) (route of administration, vaccine scheme, anatomical site of vaccination, lot number and expiration date were not reported) as prophylaxis.  No additional adverse event (AE) reported.
24 hours late has raised itchy bumps all over body and fever 101.8. Rash improved.
Injection site redness/swelling & warm to the touch, itching.  Pt given ibuprofen & Benadryl w/ relief.  Advised to continue ibuprofen & Benadryl along w/ ice compression as needed.
Felt faint after receiving vaccine.  Did not faint.  Ear ringing and headache lasting several hours.  One episode of vomiting about 2 hours later after vaccine.  No appetite for rest of day.  Mother reported he didn't feel well for the rest of the day.
Patient reports that following the injection his whole left arm was swollen and painful.  Per pt report the diameter of the arm increased by ~1".  Patient reports that the swelling is going down 2 days following administration.  Denies redness, or discharge from arm
Patient had two flu shots and got deathly sick from each of them; Initial information was received on 14-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involved an unknown age patient who had two flu shots and got deathly sick from each of them (Illness), while being received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, INFLUENZA VACCINE produced by unknown manufacturer lot number and expiration date not reported via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency) after the administration of INFLUENZA VACCINE, it was reported that patient had two flu shots and got deathly sick from each of them (Illness).  No relevant laboratory test was reported.  It was not reported if the patient received a corrective treatment.  The outcome was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Fever started at 9 pm the evening of the vaccine, with chills, headache and all over body ache. Fever/chills lasted 2 days.  Some symptoms persisted such as headache, extreme fatigue and body aches/all over weakness.  Pre-existing hip and back pain worsened significantly. After 2 weeks I went to Dr, who ran blood work.  Rheumatoid factor was elevated, and test for lyme  disease was positive for a recent infection.  I have no knowledge of being bit by a tick and had no rash.  I am just finishing treatment of doxycycline and have an appointment with a rheumatologist next week. ***I do not know if any of these adverse events were a result of the vaccine, or sheer coincidence.  But I thought it was worth reporting, since the timing coincides with the vaccine.
Tingling and numbness  and cold sensation and warm to touch in legs/  pt started taking 2 tabs of Aspirin81 mg from yesterday/ still have the same symptoms
Possible sepsis and necrotizing enterocolitis, apnea. Information from Discharge summary states vomiting, abdoninal pain.
Information has been received from a consumer concerning her child who on an unspecified date was vaccinated with a dose of MMR II. It was reported that the child "had a reaction" and had a fever following vaccination with MMR II. This is one of several cases from the same source. No further information is available.