chrisvoncsefalvay/vaers-outcomes huggingface dataset:
respiratory tract infection; cough; sneezing; ear infection; This case was reported by a consumer via call center representative and described the occurrence of respiratory tract infection in a 4-year-old female patient who received HBV (Engerix B pediatric) (batch number LP724, expiry date 18th May 2023) for prophylaxis.   On 7th September 2021, the patient received the 1st dose of Engerix B pediatric (intramuscular) .5 ml. In September 2021, between 2 and 3 weeks after receiving Engerix B pediatric, the patient experienced respiratory tract infection, cough, sneezing and ear infection. On an unknown date, the outcome of the respiratory tract infection, cough, sneezing and ear infection were recovered/resolved.   It was unknown if the reporter considered the respiratory tract infection, cough, sneezing and ear infection to be related to Engerix B pediatric.     Additional Information: GSK receipt date: 13-Apr-2022 Reporter's comment: The reporter was the father of the patient.  The reporter's daughter received what the father believed to have been her first dose of Engerix-B into her left deltoid. Two and 1/2 weeks later she developed symptoms of a respiratory tract infection including cough, sneezing, and ear infection.  The reporter reported that the patient had these symptoms on and off until January 2022 when they symptoms resolved. Did not consent to follow-up. The reporter did not gave consent to contact health care professional.
High fever  for 24 hours that couldn't be controlled with OTC meds, chills/sweats, severe headache and dizziness, shaking, muscle cramps (all lasted about 24 hours straight through. Muscle and joint pain and  weakness continued through 48 hours. Left arm, under arm and shoulder were very tender and mobility restricted through day 3.
sore lt arm hurts to lift arm-pain extending to lt ear; internal med MD referred pt to neurologist;
Pt says 2 years in a row when he has gotten flu vaccine he devolped fever, congestion, body aches within 24 hours of getting vaccine.
Patient presented for 1st dose of Pfizer vaccine. During her post-observational period, she began to feel woozy, light-headed, and like she was going to "pass out". Patient did not lose consciousness while being actively observed by staff. Patient was laid down with her feet up. Vital signs WNL (see below). Patient was able to sit up a few minutes later. Patient has a history of occurrences like this. Patient discloses a history of IBS. Patient left clinic space of own volition.
PATIENT PASSED OUT WHILE SITTING IN A CHAIR ABOUT 5-10 MINUTES AFTER VACCINE ADMINISTRATION
Had 2nd Covid booster (Pfizer) 30Sep22 and tested positive for Covid today.; Had 2nd Covid booster (Pfizer) 30Sep22 and tested positive for Covid today.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Dec2022, outcome "unknown" and all described as "Had 2nd Covid booster (Pfizer) 30Sep22 and tested positive for Covid today.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Dec2022) Positive, notes: tested positive for Covid today.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors, However on conservative basis, the possible causality cannot be excluded.
pt recv vax 15FEB99 & pt devel progressive numbness & eventually lost control of the leg & groin area;pt seen in ER & then hosp;the reporter stated that this adverse event was immed life-threatening;lymerix was discontinued
Immediately it stung. The next day, I was having a hard time moving it. I couldn't lift it on it's own. From the top of my arm to my elbow, I couldn't move, but the rest of my arm was fine. That lasted for about 2 days. On Sunday, when I was getting ready for work, I was still having a hard time brushing my hair. After being at work for a few hours, I was suddenly able to move it again. All that remained was a little soreness at the top of the joint, but the injection site was fine. It eventually went away.
No additional AE; Caller stated the vaccine was administered after a temperature excursion; This spontaneous report has been from a nurse concerning to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug or allergy history. No concomitant therapies were reported.  On 25-JAN-2022, the patient was vaccinated with varicella measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) subcutaneous injection, 0.5 milliliter, (lot #U016975 and expiration date since it makes match with the autopopulated expiration date 14-NOV-2022) (strength, route of administration, and indication were not provided), which where stored at temperature excursion. The temperature excursion was - 14 degree Celsius for a time frame of 12 minutes. There was not previous temperature excursion.  This is a one of several cases send for the same reporter.; Sender's Comments:  US-009507513-2201USA007199: US-009507513-2201USA007340:
Hives, burning arm, extreme pain when touching or moving arm, fever of 100.4, aching body, including legs and left and right arm. Nausea, dis ease, weak, uncomfortable, insomnia, I think from the pain, couldn't get comfortable in any position, everything ached.
delayed shipment vaccine of Fluzone Quadrivalent receivced by a patient/no AE; delayed shipment vaccine of Fluzone Quadrivalent receivced by a patient/no AE; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from a non-health professional.  This case is linked to cases 2019SA311015, 2019SA311021, 2019SA311022, 2019SA311023, 2019SA311024 and 2019SA311025 (same reporter)  This case involves a 48 years old female patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Prefilled Syringe Lot UT6713KA, Exp. Date: 30-Jun-2020, Box: Lot UT6713KA, Exp. Date: 30-Jun-2020) on 04-Nov-2019 after product received late due to delayed shipment.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to Incorrect product storage and Product shipment delay.  It was not confirmed whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Approximately 6 hours post vax, the pt experienced hives with itching, stomach ache, sore throat (felt funny), chills, shaking. The pt was taken to ER. Epinephrine was given and throat culture obtained. During the summer of 1998, the pt was swimming and developed the same symptoms with hives, stomach ache and throat feeling funny. Was hospitalized for several days at that time. The pt received epinephrine.
Chest pain; Rash on feet; This is a spontaneous report from a non-contactable consumer, the patient. A 21-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 06Apr2021 at 12:15 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7543) via an unspecified route of administration in the right arm on 16Mar2021 at 12:15 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021 at 02:30, the patient experienced chest pain and rash on feet. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events chest pain and rash on feet was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected
This was the patient's 2nd flu shot of the 2022 season.  The patient already received 1 flu shot on 10/17/2022.  The patient signed up for appointments for both shots.
Body aches, back ache Tired Swollen upper erm Red blotch where needle inserted Chills
Pt recvd vax & refused to drink formula also devel a fever, was fussy & t102.5; cont to scream a high pitched cry; viral meningitis; JUL93 devel ear infect; stool specimen & the spinal column fluid contained both type 1 & type 2 polio;
For the first 3 days after receiving her Covid vaccine, patient had reflux where she was spitting up small amounts of vomit.  On the 4th morning, she vomited.  She then lost her appetite for a week.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: 10-15 mins after vaccine, pt stated he was feeling dizzy. RPh went to take pt's BP, but pt fainted. called 911. pt woke up after 5 mins, no trouble breathing, but sweating. BP was 167/93 & pulse 78. First responders came and took BP and blood sugar. pt fainted again for 5-10 mins, stopped beathing few mins and decided to transport him to nearest ER. RPh called next day 6/29 & 7/1 but no response and left message.
I started off really nausea woke with severe body pains all over and threw up I stayed this way for two days
Started 6PM, feverish, shaking rigors, no vomiting; Seen 630PM t102.3 ax, p120, shaking rigors x 10min, alert, irritable, fine rash bilat legs, petechial mild cyanosis to feet; Resolved 10min; rash cleared in 48hrs; no further spread;
Within seconds of administering (GARDASIL) vaccine pt. fainted & stiffened and was laid back on table with feet elevated. He was responsive within a few seconds and able to answer questions, but appeared pale. He was given something to drink and blood pressure was taken twice (pt. was alert and oriented upon leaving office).
D69.3 - Immune thrombocytopenic purpura D69.6 - Thrombocytopenia (CMS/HCC) D69.3 - Acute ITP (CMS/HCC)
This is a literature case, initially received on 08-Apr-2019, concerning a 67-year-old, elderly male patient. The purpose of the study was to recognize that, annually, one to two cases of GBS are reported per million of patients vaccinated with influenza. The patient's historical condition included unspecified gastroesophageal reflux disease (unspecified date). The patient's current condition included hypertension, hyperlipidemia, emphysema (since an unspecified date). On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (route of administration: intramuscular, dose, anatomical location, batch number, expiry date, trade name and manufacturer: not reported) for unknown indication. On an unspecified date, after the vaccination (reported as one day prior to hospital admission), the patient experienced abdominal distention and tingling sensation of all extremities. On an unspecified date, the patient was hospitalized. The patient underwent physical examination which demonstrated diminished motor strength in all extremities and areflexia, with subsequent ataxia and generalized weakness. The patient also developed respiratory muscle weakness requiring endotracheal intubation. On an unspecified date, the patient underwent head computerised tomogram (CT) scan which was unremarkable and CSF analysis, which failed to reveal albuminocytologic dissociation or infectious process. The patient also underwent electromyography test, which was suggestive of acute demyelinating polyneuropathy. The patient was treated with intravenous immunoglobulins (IVIGs) for 5 days and there was a failure to wean from mechanical ventilation and tracheostomy was performed, along with a percutaneous endoscopic gastrostomy. Two courses of IVIGs and one course of plasmapheresis were administered which led to weaning of mechanical ventilation and improvement of motor function. On an unspecified date, the patient was discharged on physical rehabilitation. It was reported that, the only risk factor identified was the administration of influenza vaccine two weeks prior to admission. The outcome of the event was not reported. The reporter stated that, development of Guillain-Barré Syndrome (GBS) was a potential complication of the Influenza vaccine (causality: related). The reporter assessed the case as serious (hospitalization). Reporter's Comments: A 67-year-old, male patient with underlying conditions (hypertension, hyperlipidemia, emphysema) developed Guillain Barre syndrome, approximately 2 weeks after administration of INN Flu Vaccine. Considering the plausible temporal relationship between vaccination and reported event, plausible biological mechanism and lack of any underlying conditions or alternative more plausible causes, the company assessed the events as possibly related to suspect vaccine. The case meets level 4 of Brighton Collaboration criteria of diagnostic certainty. The company assessed this case as serious (medically significant).
arm soreness; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (arm soreness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Alcohol occasionally.  The patient's past medical history included Sacro-iliac pain, Osteoarthritis and Drug allergy (morphine allergy manifested by bad rash). Concurrent medical conditions included Non-smoker.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced PAIN IN EXTREMITY (arm soreness). In December 2020, PAIN IN EXTREMITY (arm soreness) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN IN EXTREMITY (arm soreness) to be probably related.    No treatment and concomitant medications information was reported.   This case was linked to MOD-2021-116240 (Patient Link).
Patient called clinic today, 8/31/18. Stated that for 2 days after receiving the SHINGRIX vaccine she was on the couch with a "terrible headache". Patient states that she took aspirin with only temporary relief for approximately one hour. Denies any shortness of breath, rash or fever. States that she is better now with only an occasional twinge of a headache. Denies any history of migraine headaches. Advised to follow up with her primary care physician if headaches continue or worsen. Patient verbalized understanding.
temperature of 102 degrees F after second dose; This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (temperature of 102 degrees F after second dose) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 23-Apr-2021, the patient experienced PYREXIA (temperature of 102 degrees F after second dose). At the time of the report, PYREXIA (temperature of 102 degrees F after second dose) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Body temperature increased: 102 High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-090662 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090662:Same reporter
The area got larger, red, swollen and sensitive to the touch. The area was at least 2" across and 4" long. Went to clinic, lasted about 6 days.
Patient experienced some dizziness and tingling of fingers and feet after receiving COVID vaccination.  It was later resolved.
Patient suffered thrombotic stroke in medulla area 4 months after vaccine was administered. Patient had no family history of stroke. Patient was in Excellent health.
3 days following vax pt exp arm discomfort lt arm from inj site to wrist, rated 4/10 (1-least- 10-most-severe) no redness, or swelling;took APAP w/o relief;discomfort cont on day 14 post vax;
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY RIGHT FACIAL MUSCLE WEAKNESS
Bleeding Gums, Rash, fatigued, shortness of breath,  random joint pain, fever, chills, brain fog, electric shock in arms, left arm weakness. 2 emergency rooms, 1 walk in medical center, 1 doctor visit,  cardiologist, rheumatologist.  Extensive blood work at both ER's and Doctors,  x-rays, EXG, cat scan.  Yesterday received cortisone shot left arm.  Presently on prednisone 2o mg 2x, hydroxyzine 25mg  2x bed, gabapentin 100 mgg 3x.
Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.No treatment medications were reported.
Headache, sore left arm, sore right hand, excessive thirst right after injection, dizziness, lack of sleep, over sleep, tiredness, nightmares.
Malaise, throat-pain swallowing, blood pressure 120/70, Temp 98.8
Information has been received from a physician concerning a 26 day old child who on 15-JAN-2008 was vaccinated with a first dose of ROTATEQ. The physician reported that the patient was not experiencing any known symptoms. There was no product quality complaint. Additional information is not expected.
Fever 102.1  Chills  Muscle aches  Cough  Headache
I developed moderate to severe pain in my deltoid (of injection) that lasted 48 hours. I would describe the pain as 8/10 and moderately affected my ability to use my right arm on 12/16/20. I reported the side effect to VSafe, who called me and asked me to submit a VAERS.
Red rash, itchy and warm to the touch. Measures approx 2 inch diameter at injection site.
On 11/30/12 went to bed and as laid down on back felt pain under left scapular area.  Took no pain meds.  In AM left arm ached and pain was no better.  Went to doctor and given Rx for Cataflam TID.  On 12/2/12 noticed redness and swelling 3 inches below injection site.
Soreness in injection site on the evening of  day 1.  Headache, dizziness,loss of appetite and fatigue, arm soreness at injection site on day 2. Headache, dizziness and diarrhea day 3. Well with no symptoms on day 4
Patient has recent diagnosis of nut allergies. She denied any adverse reaction with the first vaccination dose. After receiving the vaccine today, the patient reported feeling like her tongue was swelling. She denied any rash or itchiness. Patient was evaluated by EMT, who placed an IV and gave IV one dose (mg not documented) of epinephrine.  She was transferred to the hospital for observation.
Patient did not remember she already recieved the flu shot last week...she forgot and the pharmacist who administered the vaccine asked her and she said no.
Information has been received from a pharmacist concerning a current 56 year old female patient with asthma and no drug reactions or allergies who 3-4 years ago, in approximately 2006 was vaccinated with the first dose of PNEUMOVAX 23 and on 15-SEP-2010, was vaccinated intramuscularly into the deltoid of left arm with a 0.5 ml second dose of PNEUMOVAX 23 (Lot # 665904/0866Z, expiration date: 04-JUL-2011). The pharmacist reported that the patient experienced her injection arm being real heavy and sore for a couple of days the first dose of PNEUMOVAX 23 3-4 years ago, in approximately 2006. One month ago, on approximately 16-AUG-2010, the patient was vaccinated into the right arm with a dose of FLUVIRIN. Pharmacist also reported that on 15-SEP-2010, when the patient received the second dose of PNEUMOVAX 23, later that evening the patient experienced at the injection site swelling, redness and warmth. The next morning, on 16-SEP-2010, the injection site was fine but the swelling, redness and warmth migrated to the back of arm. At the time of the report the patient had not recovered. Patient did not seek medical attention. No lab diagnostics studies were performed. Additional information has been requested.
1. First reaction was 8 days after 1st dose.  Extreme pain in left arm, along with extreme burning and itching.  Elevated temp of 101.8 2.  Second reactions was 2 hours after 2nd dose.  Extreme pain in left arm, along with extreme burning and heat to the touch (no itching).  Fever of 104.1.  Horrible body aches, chills, and shakiness.  This lasted through the next day and night.  Woke up the next morning (2 days after 2nd dose) almost back to normal.  Arm still hurts, but now just sore, not the extreme pain I had previously had.
Immediately upon injection the patient complained of a loss of muscle control and pain and numbness in left arm. Symptoms started to improve within minutes and within 24 hours the only remaining symptom was some muscle weakness. Patient has refused medical care.
Itching at site and surrounding area.  Most prevalent during sleep hours. Continued mildly throuh the day after injection and interfered with sleep on second night after injection. Tried Calendula the first day and Hydrocortisone the second day.  No noticeable efficacy. Itching continues on third day after receiving shot.
pt c/o feeling weak, was sitting down & passed out w/quick jerky movement for less than 1min;came out fainting spell not recalling anything & felt sleepy;placed in laying position BP checked  94/58 pulse 58 (about 20min) left clinic fine