chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme tiredness; Coughing; Headache; Runny nose; Stuffy nose; Short of breath; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old non-pregnant female patient received the The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on an unknown date, as a single dose for COVID-19 immunisation and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on an unknown date, as a single dose for COVID-19 immunisation. Medical history and Concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received ciprofloxacin (CIPRO) and neomycin sulfate; polymyxin b sulfate; gramicidin (NEOSPORIN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient experienced extreme tiredness, coughing, headache, runny nose, stuffy nose, short of breath and also reported that these symptoms where not present 3 days after first Dose. 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 events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events extreme tiredness, coughing, headache, runny nose, stuffy nose, short of breath was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
This case was reported by a physician via call center representative and described the occurrence of arm paralysis in a 56-year-old female patient who received SHINGRIX for prophylaxis. In December 2018, the patient received SHINGRIX (intramuscular). On an unknown date, 56 days after receiving SHINGRIX, the patient experienced arm paralysis (serious criteria GSK medically significant) and parsonage-turner syndrome. On an unknown date, the outcome of the arm paralysis and parsonage-turner syndrome were not recovered/not resolved. It was unknown if the reporter considered the arm paralysis and parsonage-turner syndrome to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 56 or 57 years old. The patient received SHINGRIX on left arm. It was reported that approximately eight weeks after receiving SHINGRIX, the patient experienced parsonage turner syndrome. The physician reported that the patient was paralyzed in her left arm. He claimed that her arm would recover but it would take approximately a year. He also claimed that her reaction was an immunologic reaction and had nothing to do with the actual needle and that the condition could happen with any of the vaccine. The reporter consented to follow up.
8-19 developed swelling of face/hands/feet. Lab work consistent with (illegible)/nephritis.  10/2/09 Hospital records, allergy/immunology and neurology consults, received DOS 8/19/09 to 9/14/09. Assessment: Nephrotic Syndrome. Child presents with increased lethargy, decreased appetite and intake, and 4 extremity swelling. Arm pain at site of vaccination. Eye swelling and eye discomfort. Abdominal distension. Decreased urinary output. Fever. Increased sleepiness. Pitting edema legs. Anasarca. Increased hunger, mood swings and hyperactive behavior attributed to prednisolone.
Breakthrough case admission after2 vaccines Pfizer 4/17/21 Lot# FA6780;  Pfizer 8/9/21 Lot# FC3180
Patient reported swelling of bottom lip about 24 hours after receiving the vaccine. Patient took a Benadryl and appeared to be fine the following day.
Immediately after receiving vaccines, pt was holding breath. Pt had a full body tonic-clonic seizure that lasted 5 seconds. Pt came out of seizure by self and was immediately alert and responsive. Dr at bedside. Observed pt for 30 min post seizure. No further seizure activity noted. Mom stated pt acting normally. Dr aware.
This spontaneous report as received from a patient's mother refers to a male young patient of an unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 29-MAR-2016, the patient was vaccinated with the first dose of M-M-R II via subcutaneous route (dose, lot# and expiration date were not reported). On 27-JUL-2016, the patient was erroneously vaccinated with the second dose of M-M-R II via subcutaneous route (dose, lot# and expiration date were not reported). On 27-JUL-2016, the patient experienced injection site swelling, red circle appeared at the injection site and area of the injection was hot to the touch. The patient's physician advised ADVIL as a treatment and icing of the affected area. It was not specified if at the time of the report the patient was already given treatment for the events. The outcome of the events was not reported. The relatedness between the events and M-M-R ii was not provided. Additional information is not expected as there was no consent for further contact.
Narrative:  Pt received Zoster Shingles vaccine on 7/15/22. On 7/15/22. On 7/17/22 around midnight pt experienced lip swelling and rash. Pt presented to ER dept early morning of 7/18/22. Pt was treated with famotidine iv, diphenhydramine iv, & methylprednisolone ivp. Pt was admitted to hospital for monitoring but discharged home with EpiPen & Oral Prednisone Rx same day. MD flagged chart with ADR.
had little appetite; arm is a bit sore; light-headedness; nauseous; This spontaneous case was reported by a physician and describes the occurrence of DECREASED APPETITE (had little appetite), DIZZINESS (light-headedness), NAUSEA (nauseous) and VACCINATION SITE PAIN (arm is a bit sore) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced NAUSEA (nauseous). On 13-Jan-2021, the patient experienced DIZZINESS (light-headedness). On an unknown date, the patient experienced DECREASED APPETITE (had little appetite) and VACCINATION SITE PAIN (arm is a bit sore). At the time of the report, DECREASED APPETITE (had little appetite), DIZZINESS (light-headedness), NAUSEA (nauseous) and VACCINATION SITE PAIN (arm is a bit sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Acid Reflux, headache, pericarditis, abdominal pain, upper and lower abdomen, fatigue, nausea
The patient came into the office today for his 19 year PE. He was given his first dose of Hep A at his last years PE. The provider wanted to complete the series and ordered the second dose today and the medical assistant administered it. The patient was given Hep A 0.5 ml not the 1.0 ml needed at age 19.
Information has been received from a 50 year old female with a history of a motor vehicle accident (07/15/03) who on 07/15/03, after the MVA, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On 07/20/03, five days later, the pt developed pneumonia that lasted 2 weeks. She was treated with 3 rounds of antibiotics as an intervention before the pneumonia resolved. Since then, she has had frequent bouts of bronchitis. Unspecified medical attention was sought. The outcome was reported as recovered. Pneumonia and bronchitis were considered to be disabling. Pneumonia and bronchitis were considered to be other important medical events (OMIC). Additional information has been requested.
had her first Pfizer Covid vaccine dose on 20Apr2021 and tested a nose swab test positive for Covid on 10May2021; first Pfizer Covid vaccine dose on 20Apr2021 and tested a nose swab test positive for Covid on 10May2021/ Patient has no symptoms; This is a spontaneous report received from contactable consumer reported for herself. This 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 20Apr2021 around 10:45 or 11 am (Batch/Lot Number: EN0169) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. No prior vaccinations within 4 weeks. The patient had her first Pfizer Covid vaccine dose on 20Apr2021 and tested a nose swab test positive for Covid on 10May2021 using a Covid self test. She took the test twice. Patient has no symptoms, does not feel tired and has no temperature. Her temperature was 97.5F, which was checked when she came into work. Patient was scheduled another Covid test on 12May2021. She wants to know if she has tested positive for Covid, can she still get the second dose of the vaccine. No emergency room or physician office visit. The event outcome was unknown.  Follow-up attempts completed. No further information is expected.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX injection, lot # M001578, expiry date 21-NOV-2018, lot # M010212, expiry date 21-JAN-2019, lot # reported as M022077, expiry date 10-MAR-2019, lot # L045117, expiry date 06-OCT-2018, lot # M001578, expiry date 21-NOV-2018 and lot # L030608, expiry date 15-APR-2017 (dose, route of administration and anatomical location were not specified). On an unknown date, the administered doses of RECOMBIVAX HB underwent temperature excursion at 1 Celsius degrees for 2 hours. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
bad hives; This is a spontaneous report received from a contactable consumer (patient) from a Pfizer sponsored program. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the Covid-19 vaccine gave me me a bad hives so, I would not be able to get the second dose. Patient was prescribed Xeljanz 5mg. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
PRESENTING PROBLEM: COVID-19 [U07.1]   HOSPITAL COURSE:    Patient is a 79 y.o. male with history of chronic atrial fib (on pradaxa), hypertension and chronic back pain who presented to Hospital on 12/27/2022 with 3 days of of fever, chills and nonproductive cough and was found to have COVID-19 with hypoxia. The patient was admitted to the hospital for further monitoring. He was treated with decadron and remdesivir, will transition to prednisone 20mg daily for an additional 3 days upon discharge as well as mucinex for supportive care. He required up to 2L NC during the stay but has been weaned to room air.    Recommend post-hospitalization follow-up with PCP in 1-week.    Other medical issues addressed this stay:    Chronic midline low back pain, unspecified whether sciatica present Has spinal stimulator in place to help with pain control  PRN pain control with tylenol    Essential hypertension Controlled, continue atenolol    Chronic atrial fibrillation  Rate controlled, continue atenolol  Continue pradaxa
late Friday had sneezing, mild coughing, scratching throat, mild body ache, headache. Still have same symptoms.
Soreness, myalgia, fatigue, headache, shivering & gastrointestinal symptoms.  Very tired ached all over.  No appetite, slept most of the 48 hour duration. Recovery was complete after 48 hours.  Had the same symptoms for the same time period from the first shot.
Patient stated that he was dizzy and experienced a high level of fatigue for a few days. Patient said that he started seeing floaters in his eyes.
Patient presented with complaints of itching, hives and swelling around areas of hives. Hives noted on arms, legs and back
pt recv 12DEC95 & sx mild low grade fever;approx 40 vesicles covering head, torso, arms & legs;no vesicle below the knees;tx symptomatic-no med prescribed;currently 4th day of outbreak-not resolved;
Acute hypoxic respiratory failure related to volume overload. Treated with dialysis. It was felt that home health follow up would be appropriate and this was ordered. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Floaters in vision; first noticed 2/2/2021 around 0900. First noticed when going outside in the snow and sun. Not any worse today (2/3/21).
Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer.  A male patient  of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in Dec2020 at single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient tested positive for COVID in Jan2021.  Details were as follows: the patient received the vaccine in Dec2020 (reported as about 14 days or 15 days ago),  and then he tested positive for COVID in Jan2021. Therapeutic measures were taken as a result of the event.  On 09Jan2021, he went and got the monoclonic infusion. The outcome of tested positive for COVID was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
pt recvd vax 3JAN96;on 4JAN96 pt c/o sore rt arm, redness from shoulder to elbow, warm to touch, c/o low grade fever;was taken by mom to clinic & was treated w/DPH only;told to have Td given next immun
Cytomegalovirus viremia; This is a literature report.  A 32-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "kidney transplant" (unspecified if ongoing), notes: since 10 months; "Cessation of prophylaxis mo/y before first CMV vaccine" (unspecified if ongoing); "IgA nephropathy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tacrolimus, notes: 250 thrice a day; Mycophenolate, notes: 250 thrice a day. Vaccination history included: Bnt162b2 (Dose 1), for covid-19 immunisation; Cmv vaccine, for cytomegalovirus.  The following information was reported: CYTOMEGALOVIRUS VIRAEMIA (hospitalization, medically significant), 44 days after the suspect product(s) administration, outcome "unknown", described as "Cytomegalovirus viremia". The patient underwent the following laboratory tests and procedures: Cytomegalovirus test: no; Lymphocyte count: 0.59, notes: admission; Polymerase chain reaction: 755, notes: highest serum; SARS-CoV-2 antibody test: negative; Transplant evaluation: 4, notes: month before first CMV vaccine; ++; Viral test (normal high range 200): 11, notes: greater than; White blood cell count: 6.3. Therapeutic measures were taken as a result of cytomegalovirus viraemia.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded. 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.,Linked Report(s) : US-PFIZER INC-PV202200004629 Same article/ drug/event and different patient_original case PV202200004629;
Information has been received from a consumer concerning her 11 year old granddaughter with no drug reactions or allergies and no pertinent medical history who was vaccinated with the first and second dose of GARDASIL (Lot# not reported) in July 2011 and in September 2011. There was no concomitant medication. On 16-NOV-2011 and on 27-NOV-2011, the patient experienced 2 seizures. The consumer stated that the patient had not had a previous history of any health issues. The consumer also stated the patient complained frequently of abdominal pain. The consumer stated the abdominal pain had gotten worse since the onset of seizures. Lab diagnostics studies performed included CT scan, bloodwork, EKG and all came back normal. The patient sought unspecified medical attention. The patient was treated with unknown seizure medication (grandmother could not remember). At the time of reporting, the patient's outcome was unknown. Upon internal review, seizures (twice) were considered to be other important medical events. Additional information has been requested.
no adverse effects reported; Patient was revaccinated with full dose of VARIVAX more than 28 days later; Patient was revaccinated with full dose of VARIVAX more than 28 days later; Syringe inadvertently slipped so dose considered only a partial dose; This spontaneous report was received from a certified medical assistant, and refers to a 12 month old patient of unknown gender. The patient's medical history, cnocurrent conditions, and concomitant therapies were not reported.   On 11-MAR-2019, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R002508, subcutaneous, for prophylaxis. However, the siringe inadvertently slipped and only partial dose was administered (underdose).  On 15-APR-2019, more than 28 days later, the patient was revaccinated with full dose of varicella virus vaccine live (oka/merck) (VARIVAX) (inappropriate schedule of product administration and extra dose administered).  No adverse effects reported.
Awakened earl y morning  12:00 am of April 9th with horrible pain in left calf of leg. Pain continued throughout the night, until I finally got up and just walked around house to try to get some relief then laid down and try elevating leg on pillows. The pain continued so got u p and walked around more and pain finally subsided enough to get some rest.  Then felt like just had a bruise in that area of the leg for a day.
PAIN HAS BEEN SO INTENSE; NOT GETTING ANY SLEEP; SHOULDERS WERE IN PAIN AGAIN; PAIN IS OCCURRING ALL THE WAY TO HER HAND/PAIN IN HAND IS NOT AS BAD AS SHOULDERS; This spontaneous report received from a patient concerned a 68 year female. The patient's height, and weight were not reported. The patient's concurrent conditions included: arthritis, breast cancer, diabetic, alcohol user, non smoker, and drug allergy to penicillin (anaphylaxis). The patient had no history drug abuse or illicit drug usage. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808980 and expiry: 20-JUN-2021) dose was not reported,1 total, administered on 07-APR-2021 on left arm for prophylactic vaccination.  On an unspecified date in APR-2021, the patient experienced pain in shoulders and worse (laid hand on top of shoulder and slide hand to deltoid area) and constant ache and soreness of muscles from both shoulders to both elbow (feels like been beat), pain in biceps (dose number in series 1). The patient was prescribed concomitant medications: diclofenac sodium arthritis pills and Advil for unknown indication. Nothing was helping the pain from massage and prescription medication. Primary care physician sent patient to see an orthopedic doctor in October. Orthopedic doctor injected both shoulders with concomitant medication prednisone for unknown indication. Within 3 days, left shoulder was better. She was pain free, until she received her next injection. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855194, and expiry: UNKNOWN) dose was not reported,1 total, administered on 22-NOV-2021 on left arm for prophylactic vaccination.  On an unspecified date in  NOV-2021, within 48 hours after vaccination, the patient shoulders were in pain again, and pain was occurring all the way to her hand, pain in hand was not as bad as shoulders. Pain had been intense. She was not getting any sleep (dose number in series 2). She reached out to doctor for another prednisone shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shoulders were in pain again, pain is occurring all the way to her hand/pain in hand is not as bad as shoulders, pain has been so intense and not getting any sleep were unknown. This report was non-serious. This case, involving the same patient is linked to 20211240436 (dose number in series 1). This case, from the same reporter is linked to 20211240355, 20211240211 and 20211241144.
This spontaneous report as received from two Medical Assistants refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-OCT-2015, the patient was vaccinated with the second dose of an expired ROTATEQ lot # J011334, expiration date 13-MAY-2015 (dose, route of administration not provided). There was no adverse effect reported. Additional information has been requested.
Pain in chest - from shortness of breath. ER: antibiotics for wk - Zpack.
Patient noted approximately 1 1/2 day after event cold, pale hands. Patient noted physician conducted testing for thoracic outlets syndrome. Patient stated she did take Naproxen after vaccine.
Information has been received from a Licensed Practical Nurse concerning a patient who on 31-JAN-2011 was vaccinated with a dose of ZOSTAVAX (dose, route and lot # unspecified). The Nurse reported that on 03-FEB-2011 the patient experienced blisters around the injection site. The Nurse reported they were not shingles like in appearance. It was also reported that "Packet offered. Nurse adamant about not receiving. Packet not faxed.". At the time of the report patient's outcome was not reported. It was not specified if patient sought medical attention. Additional information has been requested.
C/o nausea started 9/29/10 in the evening. Vomitted 4 to 5 times. Problem constipation. Denies fever aches and pain. On MIRALAX and METAMUCIL. States feeling much better today 9/30/10.
Moderna COVID-19 Vaccine EUA (first shot) Everything was fine until today. It is hot and swollen.  I can send a picture.
10 - 15 minutes following the vaccine (administration), the patient became nauseous, lightheaded, and developed mild chest tightness