chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported.; Patient received unspecified dose of ROTATEQ on 9/3/2019 after temperature excursion on 8/30/2019; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 03-SEP-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # R026541, expiration date: 11-JUL-2020 (exact dose was not provided) for prophylaxis. Administered dose experienced the temperature excursions of 34.1 degrees Fahrenheit for 20 minutes and 47.6 degrees Fahrenheit for 40 minutes on 30-AUG-2019. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No adverse effects were reported.
11/15-11/29: took 2-4 Zrytec and pepcid as needed 11/15: hives started on neck, lips, face - went to urgent care, no resolution 11/16: hives went to arm, legs, neck - went to urgent care second time, steroid shot and prednisone (1st round) 11/17-11/20: consistent rash on body, spreading to face in morning 11/21: hives got worse, went to urgent care for third time, dr said demograhia like hives/rash; no resolution; referred to dermatologist 11/22-11/23: rash continued; throat and chest tightness throughout day and night;  negative covid-19 test conducted 11/24: feet swollen with rash but no tightness in throat but sensation of residual 11/25-11/26: continued swollen feet with rash; hives worse when scratched and general swelling 11/27: severe stomach pain; resolved after using restroom and taking milk of magnesia 11/28: wheezing, bothersome throat tightness during breathing after eating 11/29: burning sensation after swelling and rashes; worsens after shower 11/30: appointment with dermatologist; prescribed prednisone (2nd round), recommended 1 allegra in morning when waking up, 2 zyrtec in the afternoon and doxepin at night before bed; also prescribed triamcinolone .1% cream as needed ;dr diagnosed possible acute urticaria or chronic urticaria;  scheduled follow-up for January 12 12/1-12/9: rash/hives continued; severity varied; continued taking prescribed medicine 12/10: primary care prescribed cetirizine 10 mg tab (however did not take due to potential side effects) 12/10-1/3: rash/hives continued; severity varied; continued taking prescribed medicine except cetirizine
pt recvd vax & w/in 24 hrs was limp & pale x 3hrs; event described as paralyzed at that time to ER; also had vomiting & diarrhea x 6 wks; stated dx was sz; tx w/meds
This case was reported by a nurse via call center representative and described the occurrence of passed out in a 18-year-old female patient who received BEXSERO (batch number 154101A, expiry date 31st May 2017). On 20th July 2016, the patient received BEXSERO .5 ml. On 20th July 2016, less than a day after receiving BEXSERO, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was recovering/resolving. It was unknown if the reporter considered the passed out to be related to BEXSERO. Additional details were received as follows: The patients received a dose of BEXSERO in their left arm. The reporter stated that, the patient passed out after the vaccination. No other information was provided. This case has been linked with case US2016GSK106551, reported by the same reporter.
This spontaneous report as received from an office manager via healthcare professional refers to an unspecified number of patients of unknown age and genders. On an unknown dated the unspecified number of patients received a dose of ZOSTAVAX, injection, (lot numbers, frequency, routes and sites of administration were not reported) that was less than the 0.65 ml. A Product Quality Complaint report has been taken because the caller stated that the diluent vials used to reconstitute the ZOSTAVAX were under filled and so the reconstituted product was less than 0.65 ml. No adverse event was reported. Additional information has been requested.
pt recvd vax; following am, pt exp h/a, lt sided weakness, lt sided facial discomfort, fatigue, numbness, speech impairment & difficulty walking; sxs resolved in approx 3 days;
developed pneumonia 3 weeks after receiving the vaccine; developed pneumonia 3 weeks after receiving the vaccine; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) 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 (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMONIA (medically significant), outcome "unknown" and all described as "developed pneumonia 3 weeks after receiving the vaccine".  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and pneumonia are related to pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20) administration cannot be excluded. The vaccine efficacy varies from one patient to another and can be affected by different factors. This case will be reassessed should additional information become available.
Also stated another neighbor had the injection previously and was "very" bruised in the injection site "looks like I was beat up"; This is a spontaneous report from a contactable Consumer. This consumer reported for a patient (neighbor). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry date were not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The re-porter stated that another neighbor had the injection previously and was "very" bruised in the injection site "looks like I was beat up" on an unspecified date. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
She got her vaccine, no adverse reaction until about 11:00 PM when she started to get stabbing pain in the scapula of that arm and neck pain.  On 7/23/22 she had flu symptoms, temp of 101, muscle aches, body aches, and then severe nausea.  That went until the next day, 7/24/22.  She slept, and felt better during the day.  She took 3 course of Tylenol 500 mg to help with the symptoms.  She is better as of yesterday.    She also had an alteration in her taste, water tasted different, and no appetite, and that has resolved as well.  The nausea has resolved as well.   She does still have arm pain, sore arm at the injection site itself.  The shoulder pain and neck pain have resolves.
Patient is a 46-year-old, female. Alert, oriented X4, clear speech, able to answer to questions. No known medical conditions. History of severe allergies to peanuts. Patient states she had no adverse reaction to first dose of Pfizer. At 10:53 am, the patient received her second dose of Pfizer (lot number EW0182, expires on 08/2021) on left deltoid. Patient walked with a steady, balanced gait to EMT observation area. At 11:20 am, patient notified EMT that she ?saw floaters? immediately after receiving her vaccine. She describes seeing black spots. Patient reports dull pain at injection site immediately following vaccination. EMT assisted patient to anti-gravity chair. Patient remained A&Ox4 and talking to EMT. Lead RN was notified of reaction. RN requested vitals Q5 minutes for 30 minutes. At 11:24 am: BP of 136/88, HR 74, SPO2 99% and respirations of 16/min. Patient's husband was notified and he sat with patient. At 11:29 am: 132/88, SPO2 96%, HR 70, RR 16. Patient no longer reporting seeing black spots. At 11:34 am: BP 132/84, SPO2 99%, HR 76, RR 16. At 11:41 am: BP 132/88, SPO2 99%, HR 74, RR 12. At 11:44 am: BP 134/86, SPO2 99%, HR 70, RR 16. Patient was A&Ox4 with no reports of dizziness and lightheadedness. Lead RN provided patient with education concerning when to call 9-1-1, including worsening of symptoms and trouble breathing. Patient was instructed to follow up with PCP. At 11:50 am, patient stood up from chair, denied lightheadedness and dizziness. Patient walked to car with steady, balanced gait. Patient's husband drove patient home.
After series shingles around eye\Suspected vaccination failure; Shingles around eye; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster. Concomitant products included valaciclovir hydrochloride (Valtrex).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingrix and Shingrix.  Additional details were provided as follows: This case was reported by patient himself. The age at vaccination was not reported. The patient reported that he had shingles around his eye. The patient was advised by his health care professional to get the Shingrix vaccine series.  The patient received the Shingrix vaccine series as per package inserts.  After getting the Shingrix vaccinations, he developed shingles again around his eye.  The patient was considering getting another Shingrix vaccine. Referred to health care professional and spoke per package inserts or content.  The patient did not pay any other additional information.  The reporter did not consent to follow-up. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
achy; Inappropriate schedule of vaccine administered (<25 days); tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered (<25 days)) and FATIGUE (tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041120A and 025L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced PAIN (achy), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered (<25 days)) and FATIGUE (tired). On 09-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered (<25 days)) had resolved. On 10-Feb-2021, PAIN (achy) and FATIGUE (tired) had resolved.            No treatment information was provided.   This case was linked to MOD-2021-333541 (Patient Link).
got sick after the first shot; This case was reported by a consumer via interactive digital media and described the occurrence of malaise in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced malaise. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had malaise.
Information has been received from a licensed practical nurse (LPN) concerning a 6-year-old male who on 13-Sep-2007 was vaccinated subcutaneously with a second dose of 0.5 milliliters of varicella virus vaccine live (Oka/Merck). The first subcutaneous dose of 0.5 milliliters of varicella virus vaccine live (Oka/Merck) was received on 31-May-2002. Subsequently, on an unspecified date after the second dose, the patient developed hives. The condition progressed to a 3x3 inch rash on the upper arm. It was raised and tender to the feel. Unspecified medical attention was sought. The outcome was reported as recovering. No product quality complaint was involved. Follow-up information has been received from the nurse who states that she was not able to identify the patient and was not able to provide any further information. No further adverse events were provided. Follow-up information has been received from the L.P.N. who indicated that no further information was available. This is one of several reports from the same source. No further information is available.
100.8° fever starting five hours after injection, lasting 48 hours. 4-inch diameter red circle at injection site, lasted 5 days. Headache started 4 hrs after injection lasting 48 hours. Extreme arm pain at injection site for 7 days. Nausea lasting 3 days. Diarrhea lasting 4 days. Reactions were strong enough to confine me to bed for nearly 3 days. Missed a day of work. Felt better by the fourth day, but arm pain lasted a full week.
For 8 days I have had a debilitating headache and chills that Motrin and aspirin get me a little relief and maybe 4 hour! I am on day 8!!!
Cough all day and night; The baby finger and the ring finger turned green; Head was spinning; Fever; Right arm was severely swollen; Asthma worsen; Lungs whistle; Phlegm on the chest; Flu like symptoms worsend; Cant bend over because everything goes outside of the nose; Itching; I'm in tears; Skin is extremely dry; Fingers hurt all the time; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHMA (Asthma worsen), WHEEZING (Lungs whistle), SKIN DISCOLOURATION (The baby finger and the ring finger turned green), VERTIGO (Head was spinning) and COUGH (Cough all day and night) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia. Concurrent medical conditions included G6PD deficiency, Drug allergy (allergic to 203 drugs) and Asthma.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced ASTHMA (Asthma worsen), WHEEZING (Lungs whistle), PRODUCTIVE COUGH (Phlegm on the chest), INFLUENZA LIKE ILLNESS (Flu like symptoms worsend), RHINORRHOEA (Cant bend over because everything goes outside of the nose), PRURITUS (Itching), LACRIMATION INCREASED (I'm in tears), DRY SKIN (Skin is extremely dry) and PAIN IN EXTREMITY (Fingers hurt all the time). On 19-Feb-2021, the patient experienced VERTIGO (Head was spinning), PYREXIA (Fever) and VACCINATION SITE SWELLING (Right arm was severely swollen). On 21-Feb-2021, the patient experienced SKIN DISCOLOURATION (The baby finger and the ring finger turned green) and COUGH (Cough all day and night). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and LIDOCAINE for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHMA (Asthma worsen), WHEEZING (Lungs whistle), SKIN DISCOLOURATION (The baby finger and the ring finger turned green), VERTIGO (Head was spinning), COUGH (Cough all day and night), PRODUCTIVE COUGH (Phlegm on the chest), INFLUENZA LIKE ILLNESS (Flu like symptoms worsend), RHINORRHOEA (Cant bend over because everything goes outside of the nose), PRURITUS (Itching), LACRIMATION INCREASED (I'm in tears), DRY SKIN (Skin is extremely dry), PAIN IN EXTREMITY (Fingers hurt all the time), PYREXIA (Fever) and VACCINATION SITE SWELLING (Right arm was severely swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment details included hydrochloride.   This case was linked to MOD-2021-049714 (Patient Link).
This was a repeat of my incident from 2/3/21 Moderna COVID 2nd vaccine, only with worse symptoms. Following the 2nd vaccine and this booster, I developed rapid heartbeat (140 bpm); during both incidents, I went to hospital ER (with the 2nd vaccine, hospitalized 1 night, heart rate converted on its own). THIS TIME, heart rate did not convert, and required cardioversion procedure to convert (hospitalized 3 nights).
Ankylosing spondylitis; Left Shoulder operation; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4418110-00 (Abbvie).  A 50-year-old female patient received BNT162b2 (BNT162B2), on 01Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 48 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at 1 in 2 wk, subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Route of administration: Intra-muscular.), administration date: 01Jan2021, for covid-19 vaccination. The following information was reported: LIMB INJURY (medically significant) with onset 2021, outcome "unknown", described as "Left Shoulder operation"; ANKYLOSING SPONDYLITIS (medically significant) with onset Aug2021, outcome "unknown". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of limb injury. Clinical course: The patient took first and second covid shot before shoulder surgery. In Aug2021, she experienced ankylosing spondylitis. It was unknown if she was enrolled in a covid-19 vaccine trial. The adverse events occurred prior to humira and did not worse on humira. Causality for Humira (Adalimumab): The reporter causality for the events of left shoulder surgery with humira (Adalimumab) was a reasonable possibility. The reporter's causality for the events of after second Pfizer shot patient was experiencing ankylosing spondylitis was not provided. Drug: Humira(adalimumab): Shoulder operation: Causality as per reporter (Drug/Vaccine): Probable, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. Ankylosing spondylitis: Causality as per reporter (Drug/Vaccine): Not reported. Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. Abbive opinion is that there was no reasonable possibility that the events of left shoulder surgery and after second pfizer shot patient was experiencing ankylosing spondylitis are related to humira (Adalimumab).  The reporter considered "left shoulder operation" and "ankylosing spondylitis" related to BNT162b2.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between the reported events: "Limb injury", "Ankylosing spondylitis" and the suspect drug BNT162B2 cannot be completely excluded.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Feels achy, tired and Oxygen fluctuating, would not stay above 90 without supplemental oxygen.   She normally wears oxygen only ad night.   She went home from work and placed herself on her oxygen on at 1 L/hour.   Increased Prednisone dosage to 20 mg daily from 10 mg daily (for at least three days) and ipatroprium nebulizer treatments three times daily.
Information has been received from a nurse practitioner concerning a 30 year old female with a history of laser removal genital wart who on 08-JAN-2010 was vaccinated with a first dose of 0.5 mL GARDASIL. There was no concomitant medication. On 08-JAN-2010 the patient experienced pain at the injection site. The patient called the office on 15-JAN-2010 and informed the reporter that her whole arm was numb, left leg was numb and bruising. At the time of the report, the patient had not recovered. Additional information has been requested.
Pfizer bio N Tech covid 19 Started with a slight cough then my throat felt like I couldn't swallow right. Then went to a persistent cough and got hard to swallow chest was tight. Went to the er and was given an epi in and 5 other meds through the iv. Also given a breathing treatment.  They diagnosed me with an allergic reaction.
This is a spontaneous report from a contactable nurse. A 18-year-old female patient of unspecified ethnicity received 2nd dose of TRUMENBA (Batch/Lot # L13515, expiration date 31Jul2016), intramuscular on an unspecified at single dose. Concomitant medications were not reported. The patient did not have drug or alcohol abuse, drug allergies, family history or relevant medical history. On 17Dec2015 the patient experienced fatigue and lethargy and on 18Dec2015 chills, fever and body aches. The patient was not admitted to hospital. No treatment required for the events. The events chills, fever and body aches recovered on an unknown date, while the outcome of fatigue and lethargy was unknown. Nurse stated that chills, fever and body aches recurred after re-administration of the vaccine, but no further details were reported. There was a reasonable possibility that the events were related to the vaccine. Comment: these side effects were seen with roughly 20-30% of the patients getting the meningococcal group b rlp2086 and nurse educated them that it can occur. Patients take Ibuprofen as needed and call if symptoms persist >24. Follow-up (18Jul2016): New information received from the same nurse includes: events details, events updated (body aches added, recurrent events reported), comment.
Pt experienced severe muscle pain and nausea following second vaccination. Also had an episode of cellulitis to hand requiring antibiotic treatment. Basic lab testing revealed new diagnosis of Lupus.
Myocarditis and associated shortness of breath. Fatigue.  Feels of pounding heart.
post covid vaccine symptoms included, fatigue, lightheadedness, cold sweats, brain fog, severe neck and back aches.
Developed fever of "104 degrees F", mild headache, chills, right flank pain, diffuse myalgias, nausea about 10-12 hours after receiving vaccines. Seen by ER MD on 4/30/03 and Rx'd with Motrin, Tylenol and Benadryl prn and discharged home. 5/1/03: states he feels much improved-denies complaints.