chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a patient received a dose of Adacel vaccine on 07-Oct-2019 which was already expired on 05-Oct-2019/No AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case involves a patient of unknown demographics who received a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] on 07-Oct-2-019 which was already expired on 05-Oct-2019 lot number and expiry date not reported via unknown route in unknown administration site.  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 expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Information on the batch number was requested.  List of documents held by sender: none.
She relates to intermittent brief episodes of sharp "heart pains" and palpitations that last for 3 minutes at its longest duration. Usually can resolve with sitting upright, leaning forward, or standing upright/deep breathing. Denies dyspnea, n/v, diaphoresis, hx of same, fm hx of same, abd pain, fevers, chills, or recent illness. Given diagnosis of "Suspect Post Vaccinia Pericarditis" by the Working Group.
Pericarditis found on echo; vestibular labyrinthitis with severe vertigo; vestibular labyrinthitis with severe vertigo; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient (pregnant no) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 05Apr2021 11:00 (Lot Number: ER8734) at age of 55-years-old as 2nd dose, single for COVID-19 immunization.  Medical history included Hypertrophic cardiomyopathy (HCM), Semicircular canal fistula (SSCD). There was known allergies. Concomitant medications included metoprolol (12.5mg); vitamin c [ascorbic acid]; vitamin d nos.  Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6206,) on 15Mar2021 02:45 PM at age of 55-years-old in right arm for Covid-19 immunization. On 07Apr2021 11:00 AM, the patient experienced vestibular labyrinthitis with severe vertigo. It lasted for about a month. Pericarditis found on echo by cardiologist at Clinic. The events resulted in doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The patient underwent lab tests and procedures which included echocardiogram: pericarditis.  Therapeutic measures were taken as a result of the events. Pericarditis: Advil, need another echo. There was no covid prior vaccination. There was no covid tested post vaccination. The outcome of the events was recovering.
Tingling and numbness in both arms and feet started within a few days. Then only arms. And then, currently, only in the vaccinated (left) arm for the last couple weeks.  I got the J&J dose after completing two doses of the Pfizer COVID vaccine back in March/April.
Under the direction and supervision of DOCTOR, administered 0.5 mL of typhoid vaccine into patient's right deltoid, 0.5 mL of Meningococcal MenAcWy vaccine into patient's right deltoid, and 0.5 mL of Yellow Fever vaccine into patient's right arm.    Patient after administration of Yellow fever vaccination was noted to have brief moment where he loss consciousness then quickly recovered with seconds. Patient regained full consciousness. Patient shared he in past when donating blood was noted to pas out for brief moment. Patient was given water and observed for 15 minutes then left clinic ambulatory.      Call placed to patient at 1335 to follow up with patient regarding vaccinations and adverse reaction with injections. Patient shared he is doing fine and only notes a sore arm. Reviewed with patient adverse reactions to be aware of the next 30 days and if symptoms develop and worsen to be seen at local ER/UC for adverse reactions. Patient was understanding and had no further questions.
Pt began reaction on 9/10/18 in PM with body aches, chills, fever, stomach upset. This occurred for 36 hours - pt. is still having headaches to day from the vaccine.
This spontaneous report has been received from a female consumer of unknown age referring to herself. Information about concomitant medication, pertinent medical history, and drug reactions/allergies was not provided. In the morning of 04-OCT-2018 (reported as Thursday), the patient was vaccinated with one dose of PNEUMOVAX 23 for prophylaxis (strength, route of administration, batch/lot #, and expiration date were not reported). On the same day, the patient experienced redness, puffiness and fever at the injection site, and fatigue. All the symptoms were gone by 07-OCT-2018 (reported as Sunday). The causality assessment was not provided.
A report has been received from a Health Professional concerning a 24 year old, male subject, who had been receiving nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 14-Jan-2014. The reporter stated that they inadvertently administered expired FLUMIST (Preferred Term: Expired drug administered) which started on 14-Jan-2014. The outcome of the event expired FLUMIST is unknown. The report was considered to be non-serious by the reporter.
Patient states received vaccine on 4/9/2021. States she had symptoms of body aches, headache, and sore arm 4/9/2021 -4/10/2021. She noticed a full body rash without itching on 4/11/2021 and slight shortness of breath with rest and exertion on 4/12/2021 morning. Patient took benadryl after speaking to her pediatrician. HR  86, BP 118/82, RR 24 O2 sat 96%.  Labs for CBC, CMP, urine dip, and chest xray done on 4/12/2021. Patient given 4m IM decadron injection in clinic and started on zyrtec. Follow up appointment scheduled on 4/13/2021.
Overall weakness; She could barely walk to her chair; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Overall weakness) and GAIT DISTURBANCE (She could barely walk to her chair) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder and Blood pressure. Concomitant products included OLMESARTAN for Blood pressure, LEVOTHYROXINE for Thyroid disorder.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced ASTHENIA (Overall weakness) and GAIT DISTURBANCE (She could barely walk to her chair). At the time of the report, ASTHENIA (Overall weakness) and GAIT DISTURBANCE (She could barely walk to her chair) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient experienced overall weakness after taking Levothyroxine, the medication she takes for her thyroid. The day she received the vaccine, she took her blood pressure medication (Olmesartan) much later than she normally takes which she usually takes in the morning. She took one tablet of  8 hours arthritis pain relief. She stated that had been fine since that day.
Left upper extremity swelling, pain and redness that was dependent (lower) from the injection site. Treatment:  advised appling a sling to help relieve some of the pain, Zyrtec and increase fluids.
Received Varivax vaccine on 12/4/07.  Now has several chicken-pox looking bumps on leg 12/15/07.
Diarrhea, HYPERtension, Tachycardia, felt heart racing, sbp around 160-170mmhg. Admitted to ED for observation 4 hours. 1 in covid vaccine clinic Narrative:  Admitted to ED for observation 4 hours. 1 in COVID vaccine clinic. Employee states the blood pressure, and heart rate returned to normal the following date.
103 temp; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (103 temp) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced PYREXIA (103 temp). At the time of the report, PYREXIA (103 temp) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Body temperature: 103 (High) The patient had 103 temperature since the second vaccination.         No Concomitant medication information provided. No treatment medication information provided.
blood pressure rose to 200/110 with accompanying severe dizziness, difficulty walking, burning pain in arms, pt was taken to emergency department and admitted for observation.
Mother called 1 hour after patient received second influenza vaccine: Infant's abdomen covered in red rash. Called 10 minutes later, rash spreading onto shoulders. Instructed to give BENADRYL 12.5 mg/ml liquid at 4 ml Q6 hours PRN. Call or got to ER for SOB for swelling.
Severe pain immobilizing shoulder/arm 48 plus hours of mid-grade fever signs of dehydration.
A report has been received from a Health Professional concerning a 17 year old, female subject, who had been receiving FLUMIST. FLUMIST started on 05-Dec-2013. The reporter stated that the patient was inadvertently administered expired FLUMIST to four patients which started on 05-Dec-2013. The outcome of the event of inadvertently administered expired FLUMIST to four patients is unknown. The report was considered to be non-serious.
Swollen wrist, ankle, knee, and shoulder joints with intense pain at  times. Still have soreness and pain at injection site..
At exactly 12 hours after the shot at 1:30am I had uncontrollable shaking and chills. I was shaking so bad I could hardly speak. At the same time I felt nauseous but never vomited. The violent shaking lasted about 30 minutes and only after I put on a sweater, sweatpants, wool socks, two blankets and my husband provided his body heat did I finally stop having chills and shaking uncontrollably. I didn?t have any other chills after that.   Additionally I had a terrible headache the next day, felt like my head was in a fog, had full body muscle aches, and was extremely fatigued. I took an afternoon nap and felt slightly better. I also took Tylenol every 6 hours.
pt recvd vax; on 9jul95 pt exp fever of 101 & chicken pox like rash on face approx 12 lesions;
they put the shot in it and they did not squeeze or anything and it hurt going in; my arm feels weird; My hands specially feels swollen; some tightness in my hand; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (Dose 1, single (Lot Number: Not provided)), for COVID-19 immunisation. The following information was reported: INJECTION SITE PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "they put the shot in it and they did not squeeze or anything and it hurt going in"; FEELING ABNORMAL (non-serious) with onset Apr2021, outcome "unknown", described as "my arm feels weird"; PERIPHERAL SWELLING (non-serious) with onset Apr2021, outcome "unknown", described as "My hands specially feels swollen"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset Apr2021, outcome "unknown", described as "some tightness in my hand".  Additional Information: The patient received the second dose of the Pfizer vaccine about 1 hour ago (Apr2021) and was okay. The patient was not having any horrible reaction but the concern was that when the patient got the first dose, they held patient's arm and gave it a squeeze a little bit but this person made the patient's arm hang down and said to just relax the arm, hang it down, then they put the shot in it and they did not squeeze or anything and it hurt going in and told them that and then the patient's arm felt weird. The patient didn't have that the first time. It's not numb because the patient tested with a needle but the patient's hands specially felt swollen like tight inside. The patient's hand was swollen and there was some tightness in the hand and didn't know if it's because of the way the shot was administered. The patient asked if to squeeze the arm first or if it's like important. He did it in the upper arm and the patient didn't know whom to call and asked if to call primary health care doctor about it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID-19 Vaccine was given by Hospital   Frequent gout breakouts.  Approximately every couple of weeks it flairs up.  Only one server onset in February.
Injection site sore on 4/11/22 after shot (2nd booster Moderna), felt sluggish all day 4/12/22 with stomach pain starting early evening, chills, body aches and fever through out the day on 4/13/22 with continuous stomach pain.  All symptoms gone today 4/13/22 except occasional stomach pain.  My 69 year old sister had injection same day as I did.  Has had exact symptoms.   No vomiting or constipation or diarrhea., just pain in the stomach.
After vaccination was given, noticed red large rash, slightly raised to arms and upper torso. No cough or SOB or trouble breathing noted. No itching observed.
This spontaneous report as received from a licensed practical nurse (also reported as registered nurse), refers to a 21 year old patient of unknown gender. No pertinent medical history of drug reactions/allergies were provided. On 12-DEC-2013, the patient was vaccinated with M-M-R II (Lot number J003625; expiry date 22-MAR-2015; dose and route not provided. No co-suspect or concomitant therapies were reported. It was reported that the M-M-R II administered to the patient was exposed to temperatures above 8 degrees C (between 8.09 and 22.73 degrees C) during 42.78 hours, form 05-OCT-2013 until 09-OCT-2013. No adverse effect had been reported. This is one of several reports from the same reporter. Additional information has been requested.
Healthy 33-year-old female who denies any illness except for cord prolapse during her NSVD delivery.  She got her first Pfizer COVID-19 vaccine today afterwards she felt dizzy, lightheaded, and some chest tightness.  Also some air hunger.  Symptoms have improved.  She was advised to go to the nearest emergency department.   She arrived to hospital w temperature 98.6 already 146 bpm.  She received 2 L of saline 0.5 mg Ativan. Pt has never formally been diagnosed with anxiety but says she is an anxious person. She has received prior needle punctures without reaction. She is concerned about blood clots as the media has reported this with the Johnson and Johnson vaccine.  Pt was admitted for observation overnight.  Bilateral LE duplex US negative for DVT. Pt stable and discharged to home.
I had no adverse effects after receiving the first dose on Jan. 25, 2021.  The following adverse effects occurred 24 hours  after the second dose was administered on Feb. 22, 2021.  They were extreme tiredness/fatigue and cold chills.  Each lasted about 6-8 hours.
heart palpitations; jitters; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PALPITATIONS (heart palpitations), FEELING JITTERY (jitters) and HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   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, the patient experienced CHILLS (chills), PALPITATIONS (heart palpitations), FEELING JITTERY (jitters) and HEADACHE (headache). At the time of the report, CHILLS (chills), PALPITATIONS (heart palpitations), FEELING JITTERY (jitters) and HEADACHE (headache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No treatment information was provided. No relevant concomitant medications reported.
LEFT KNEE SWELLING; BRUISE ON WRIST with SKYRIZI (RISANKIZUMAB); This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (LEFT KNEE SWELLING) and CONTUSION (BRUISE ON WRIST with SKYRIZI (RISANKIZUMAB)) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 21-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced JOINT SWELLING (LEFT KNEE SWELLING) and CONTUSION (BRUISE ON WRIST with SKYRIZI (RISANKIZUMAB)). At the time of the report, JOINT SWELLING (LEFT KNEE SWELLING) and CONTUSION (BRUISE ON WRIST with SKYRIZI (RISANKIZUMAB)) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  On unknown dates, the patient experienced left knee swelling and bruise on wrist. moderna covid-19 vaccine (covid-19 vaccine mrna (mrna 1273)) was also considered suspect. The patient stated that her left knee was swelling up. It was gotten bigger since she took covid vaccine last week in sep 2021. She also had a bruise on her wrist that was new. It was unknown if patient was enrolled in a covid-19 vaccine trial. On 21-Sep-2021, patient received 1st dose covid-19 vaccine manufactured by moderna.  Causality for skyrizi (risankizumab) The reporter's causality for the event(s) of left knee swelling and bruise on wrist was not provided.  No treatment information was reported by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna
This spontaneous report received from a patient concerned a female of unspecified race and ethnicity.The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient previously received covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin, and batch number: Unknown) dose was not reported, 1 total, administered on 07-APR-2021 for prophylactic vaccination. It was unknown if the patient had any adverse events (dose number in series 1).The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number: Unknown, expiry unknown) dose was not reported, 1 total, administered on 07-JAN-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.On 07-JAN-2022, the patient experienced chills. On 08-JAN-2022, in the morning the patient experienced crawling feeling on ankles and feet (dose number in series 2). The patient had not reached out to her doctor.The action taken with covid-19 vaccine ad26.cov2.s was not applicable.The outcome of the chills and crawling feeling on ankles and feet was not reported.This report was non-serious.
First Pfizer COVID 19 given  IM 6/3/21 ,second dose 6/28/21 lot no EW0168. Patient reports that he was well until 08/01/2021. He presented to the Emergency Room on 08/03/2021 with concerns of chest pain, shortness of breath, which had been ongoing for the last 2 days. He initially started with a history of diarrhea, abdominal pain, and low-grade fever. Both he and his brother had the same symptoms at the same time  On 08/01/2021, he had gone swimming in the lake  at that time and thought it was due to exertion, but he developed chest pain and shortness of breath and his heart beating fast(palpable tachycardia).  Over the next 24 hours, his diarrhea resolved and his fever discontinued, but he continued to have chest pain intermittently throughout the day and shortness of breath.  He went to Hospital on 08/03/2021 and they transferred him, as they noted that he had an elevated troponin at 30 and EKG changes with ST-segment elevation and depression.  He was actually feeling much better. He had no headache, no history of seizures, no dizziness, no fainting, and a little lightheadedness. Occasionally his pain would extend to the jaw, but no radiation to the back. The upper abdominal pain he had was in the epigastrium. His appetite has now come back to normal. He is able to drink, able to keep fluids down, and his chest pain has almost resolved in the last 36 hours. He also has no diarrhea, and does not have any joint pains. No skin rash. Initially, he felt the heart rate going fast, but now he does not feel any tachycardia. He has had no chills. Admitted 8/3/21 -8/7/21
Per Foster mom pt's right leg red, puffy, and hard to touch. Pt does not complain of any pain.  Symptoms started on Saturday, day after vaccine given. LPN.
36 y.o. female with medical history of rheumatoid arthritis who presents the ED after allergic reaction from the Moderna COVID-19 vaccine.  Patient says she received the first dose of the vaccine approximately 90 minutes prior to arrival.  She did note that her face became hot and flushed and she developed a rash to her face and upper chest.  she noticed tingling into her lips. She was then given a IM dose of 0.3mg epinephrine and 50mg Benadryl.  She does note to having a dry throat and feels like she does not have enough secretions to swallow.  At that point she was transported to the ED for further evaluation.  She denies any known reaction to any food, medication, or additives.
Patient felt nauseous and lightheaded within 2 minutes of vaccination administration. He threw up once and felt better. VSS. Observed him for approximately 30 minutes. Patient reported he felt back to normal. Left in stable condition, without any symptoms. He did report he thinks that he had a reaction because he had not eaten all day. He is not a diabetic.
Swollen Eyelids/ Swollen Eyelids happen frequently; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING OF EYELID (Swollen Eyelids/ Swollen Eyelids happen frequently) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 016C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced SWELLING OF EYELID (Swollen Eyelids/ Swollen Eyelids happen frequently). At the time of the report, SWELLING OF EYELID (Swollen Eyelids/ Swollen Eyelids happen frequently) outcome was unknown.            No concomitant medications were provided.   Treatment information included that physician instructed patient to take OTC Antihistamines, but patient has not taken any medicine.  The swollen eyelids happen frequently.   This case was linked to MOD-2021-257961 (Patient Link).