chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakthrough COVID-19 case with unknown symptom status. Hospitalized unknown date and duration. Death 8/31/2021. From Vital Records COD = COVID 19 PNEUMONITIS, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, DILATED CARDIOMYOPATHY. Per vital records, COD ICD Codes include: Not yet coded ; Other Significant Conditions include: None listed. place of death: HOSPITAL-INPATIENT, HOSPITAL; certified, PRONOUNCING AND CERTIFYING PHYSICIAN; occ/ind: CASHIER, CIVIL SERVICE
rash on middle section of her body like hives; This spontaneous case was reported by a pharmacist and describes the occurrence of URTICARIA (rash on middle section of her body like hives) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (rash on middle section of her body like hives). At the time of the report, URTICARIA (rash on middle section of her body like hives) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Vaccine Given: 6/21/2018 1st symptoms (R)ight knee jt. very stiff on 7/3/2018. 2nd symptom (L)eft knee jt. also stiff on 7/4/18. 3rd symptom red rash, not itchy, both arms 7/4 and 5/2018.
Received vaccine on 10/21/2016 approximately 6:30pm. Instantly felt pain at injection site which radiated to (L) shoulder and upper back. Experienced HA for first week and could not lift arm. Treated by physician w/cortisone shot, NSAID TX.
Redness, swelling and itchiness at injection site with no defined boundary. Warm to touch.
Shingles; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 14Feb2021 at 12:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included atorvastatin calcium (LIPITOR) from unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL5248) via an unspecified route of administration in the left arm on 24Jan2021 at 12:00 (age at vaccination unknown) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Mar2021 at 00:00, the patient experienced shingles. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of shingles and included treatment with Acyclovir. The clinical outcome of the event shingles was resolved on an unknown date in 2021.
Arm stated to itch, became red and hot. BENADRYL taken P.O.
Initial case received from a executive director via agency on 19 NOV 2009. A elderly patient was vaccinated i.m. with Influenza virus vaccine (batch no. unspecified) on an unknown date. They experienced aspiration pneumonia and hypoglycaemia. The patient's outcome was unknown. Company assessment: On a case level, the case was considered unexpected. Seriousness criterion: Hospitalised Causality: Possible (Temporal relationship plausible or reasonable) Expectedness assessment according to the agency: Aspiration pneumonia and hypoglycaemia are unexpected after vaccination with influenza virus vaccine. No change in benefit-risk ratio: No measures required. Agency reference no: NA09-008595
Hives on trunk, face & extremities on 9/12/11. PRELONE & ZYRTEC given for treatment.
Initial report was received on 23 June 2014 from a consumer, who is also the patient. A 74 year-old male patient with no reported past medical history had received on 11 January 2013 an intramuscular injection of ADACEL (lot number and site of administration not reported) and later the same day, experience an increased heart rate. The patient stated he was previously on a diet program when he was taking a diet pill and during the checkup they found the heart rate increased. The reporter stated, the heart rate was as high as 181. The patient was seen by a physician and diagnosed with atrial fibrillation. Outcome was not recovered. Documents held by sender: none.
07/19/2003: Pale, gray complexion, current-Staring and shakes, loss of appetite, mild rash, pale complexion 07/26/2003: Fever of 101F, vomiting, loss of appetite, still pale; 07/26/2003: Current-poor appetite;  07/28/2003: Current rash 08/01/2003: Vomiting, fever 103F; 08/01-08/03/2003: Fever 103F, no appetitie;
worsened asthma; extreme tiredness; Pain in arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Mar2021 (Lot number: EN6208) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing), notes: She has asthma. It was ok before she got the vaccine but has worsened.; "Blood pressure" (ongoing); "Reflux" (ongoing); "Lactose intolerant" (unspecified if ongoing). Concomitant medication(s) included: FLOVENT taken for asthma (ongoing); HCTZ taken for blood pressure measurement (ongoing); OMEPRAZOLE taken for gastrooesophageal reflux disease (ongoing). Past drug history included: Nsaids, reaction(s): "Swelling", notes: She is concerned about the ingredients because she has swelling with NSAIDS and the fillers that are in Tramadol.; Tramadol, reaction(s): "Swelling", notes: She is concerned about the ingredients because she has swelling with NSAIDS and the fillers that are in Tramadol. The following information was reported: FATIGUE (non-serious) with onset 27Mar2021, outcome "recovered with sequelae" (28Mar2021), described as "extreme tiredness"; PAIN IN EXTREMITY (non-serious) with onset 27Mar2021, outcome "recovered" (28Mar2021), described as "Pain in arm"; CONDITION AGGRAVATED (non-serious) with onset 30Mar2021, outcome "recovering", described as "worsened asthma".  Additional information: The patient did not have any family history. There was no history of any previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines were administered on same date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had been taking Flovent for years, HCTZ for about 40 years and Omeprazole for at least 10 years. The patient received the first dose of the COVID-19 vaccine and was due the second dose on Saturday. She has had extreme tiredness and pain in her arm. She was concerned about the ingredients because she had swelling with NSAIDS and the fillers that were in Tramadol. She was also lactose intolerant. She had noticed anhydrous lactose was in a drug that she took and it caused her to swell. She wanted to know the ingredients that are in the vaccine such as polyethylene glycol. The patient had asthma. It was ok before she got the vaccine but had worsened. She was unsure if it was because of the weather or the vaccine. She saw her allergist. She wasn't sure if it was that or the inhaler that she uses or something else. She was told to not take the Moderna vaccine because of Solumedrol. People have had a lot of allergies to those. She did not have any patient details to provide. She was previously taking Tramadol but she quit taking it because of complications with the doctor and surgery. The adverse events did not require a visit to Emergency Room or Physician Office. No relevant tests were done.  No follow-up attempts are possible. No further information is expected.
The patient was 17 years old when she received the vaccine and we didn't understand that the Janssen vaccine was only labeled for 18 and over until after the vaccine was administered. The patient had no significant adverse reaction to this vaccine.
Over 24 hour period experienced moderate body aches, low grade fever (99.4 - 100.6), fatigue, and mild nausea.  Self-treated with alternating doses of Motrin and Tylenol. Symptoms resolved by morning of 7/14.   Site of injection was mildly sore as well.   I had also experienced similar body aches, low grade fever and fatigue with the first injection in January 2020 but did not complete a VAER report.
This case was reported by a healthcare professional and described the occurrence of arm knots in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of FLULAVAL (unknown). After an unspecified time after receiving FLULAVAL, the subject experienced arm knots, arm pain and fever. The healthcare professional first reported on a 30-year-old male subject who experienced arm pain, 2-3 knots formed on the arm next to injection site, and a fever of 104 degrees Fahrenheit on the night of the day he received FLULAVAL and pneumonia vaccine (see case id  A0887470A for more details on this subject). At that time, the reporter also stated she is aware of another patient who had similar adverse event after getting the FLULAVAL. For this reason, this case (A0887476A) was created for the other subject. At the time of reporting the outcome of the events was unspecified.
received the J&J covid vaccine in mid Oct2021. On about 29Dec2021, he received a Pfizer covid vaccine dose as a booster dose; booster dose; had bad nightmares the first night; subsequently felt tired; had body aches for the two days after; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 50 year-old male patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: J&J covid vaccine (Dose: 1), administration date: Oct2021, for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 29Dec2021, outcome "unknown", described as "received the J&J covid vaccine in mid Oct2021. On about 29Dec2021, he received a Pfizer covid vaccine dose as a booster dose"; IMMUNISATION (non-serious) with onset 29Dec2021, outcome "unknown", described as "booster dose"; FATIGUE (non-serious) with onset Dec2021, outcome "recovered", described as "subsequently felt tired"; PAIN (non-serious) with onset Dec2021, outcome "recovered", described as "had body aches for the two days after"; NIGHTMARE (non-serious) with onset 29Dec2021, outcome "unknown", described as "had bad nightmares the first night".  Additional information: It was reported that, patient was 50yo male who received the J&J covid vaccine in mid Oct2021. On about 29Dec2021, he received a Pfizer covid vaccine dose as a booster dose and subsequently felt tired and had body aches for the two days after and had bad nightmares the first night.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information was received from a health professional concerning a 16 year old male employee with attention deficit/hyperactivity disorder and no allergies who on 25 JAN 2005 was vaccinated with a SC 0.5ml dose of Varicella vaccines live.  Concomitant therapy included dextromethorphan polistirex (delsym) and methyphenidate HCl (Concerta).  "Within a week" on approximately 28 JAN 2005 the patient experienced a rash with 20 spots.  No treatment was required and no labs were needed.  It was reported that the patient received a TB test.  It was also noted that topical, lidocaine/prilocaine (EMLA) was used prior to vaccination and TB test.  Unspecified medical attention was sought. No product quality complaint was involved.  Follow-up information from a health professional indicated the patient was diagnosed as having hives.  Follow-up information from a health professional indicated that according to the mother of the patient he was diagnosed with hives related to nerves not a reaction to the injection of Varicella vaccine.  Additional information is not expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL (lot, dose and route not reported). Concomitant medication was not reported. The temperature excursion for the GARDASIL was supported with in-house stability data. No adverse symptoms reported. At the time of the report, action taken regarding therapy with GARDASIL was not reported. Additional information has been requested.
After vaccination, patient noted a "lump" in injection which persisted a long time.  She returned to clinic today because about 1-2 weeks ago she developed redness, scaling and slightly raised border over injection site.  No other signs or symptoms.
Patient received first Moderna Vaccine on 02/26/2021 and second Moderna Vaccine on 03/26/2021. Health Department was notified of patients death on 03/27/2021, today 04/22/2021.  Any further information is unknown  by the health department for patients cause of death that occurred on 03/27/2021.
Tinnitus; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included shingles on an unknown date in 2013, hay fever, and acid reflux. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ethinylestradiol/ferrous fumarate/norethisterone acetate (JUNEL FE), fluticasone propionate (FLONASE), and famotidine (PEPCID); all taken for an unknown indication from an unknown date and unknown if ongoing. On 09Apr2021 at 18:00, the patient experienced tinnitus. The patient's ears were ringing every few hours ever since, the first dose of the vaccine, more so the left ear than the right. It had been 2 weeks and had not stopped. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event tinnitus was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pain R shoulder and arm; weakness R arm - found to have brachial plexus inflammation.
Rash to R Lower extremity. Pap ulnar, no scabbing. Still present 1 month later. No response to steroid or antibiotic or anti fungal creams.
Pain in the arm; Headache; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm right, administration date 25Mar2021 09:15 (Batch/Lot number: unknown) at the age of 60 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 25Mar2021 16:00, outcome "recovered" (Mar2021), described as "Pain in the arm"; HEADACHE (non-serious) with onset 25Mar2021 16:00, outcome "recovered" (Mar2021), described as "Headache"; FATIGUE (non-serious) with onset 25Mar2021 16:00, outcome "recovered" (Mar2021), described as "Tiredness". Therapeutic measures were not taken as a result of pain in extremity, headache, fatigue. Additional information: Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination.  No follow-up attempts are possible, information on the batch/lot number could not be obtained. No further information is expected.
Information has been received from a health professional concerning a class of 44 pre-school age children, 33 of whom were vaccinated with varicella virus vaccine live. The immunization project coordinator reported after a compliance visit to the preschool that 15 children had developed chicken pox after an 'outbreak'. It was unknown if any of the patients sought medical attention. Additional information has been requested.
developed a localized itchy erythematic maculopapular rash to injection site 8 days after vaccine administration. Now rash is spreading outward.  About 10cm across. no other symptoms
Temp 102,  large swelling at injection site and axilla of same side,  swollen lymph nodes, HA,  SEVERE WIDESPREAD BODY PAIN
Patient was moving their leg around and the vaccine was not fully given to patient.  Most of the vaccine spirted outside of the site because of the patient moving their leg so much.  Parent didn't have a good grip on the patient. Vaccine was not given fully.
single binax at home positive; single binax at home positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EL9266), in left deltoid, on 15Mar2021 as dose 2, single (Lot number: EN6204), in left deltoid and on 23Aug2021 as dose 3 (booster), single (Lot number: FA7485) at the age of 52 years, in left deltoid, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing); "Allergy Environmental" (unspecified if ongoing), notes: Allergy Environmental; "Late term food allergies", start date: 2012 (unspecified if ongoing), notes: Late term food allergies , onset date: 2012, 2013, 2015, increase in prednisone for food reactions(avoid); "Environmental allergies" (unspecified if ongoing), notes: Environmental allergies; "Elhers danlos syndrome" (ongoing), notes: Ehlers-Danlos syndrome. Concomitant medication(s) included: SHINGRIX, on 21Jan2021 as unk, single; AIMOVIG intramuscular taken for migraine, start date: Oct2017 (ongoing); ALLEGRA oral taken for hypersensitivity, start date: 2008 (ongoing). Vaccination history included: shingrex (Shingrex, dose1), administration date: 23Nov2020; prevnar 13, administration date: 12Dec2019.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "single binax at home positive". The patient underwent the following laboratory tests and procedures: Neurological examination: 70-140; SARS-CoV-2 test: Positive.  Clinical Course: Food allergies med allergen are avoided. Use of medications that suppress immune system: for allergies to food not taken. Food allergies med allergen are avoided. Cary epi-pen. Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus. All negative except single binax at home positive 01Jan2022. Negative which tested by school.
tight throat; bump close to the clavicle; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (tight throat) and SWELLING (bump close to the clavicle) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, 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 experienced THROAT TIGHTNESS (tight throat) and SWELLING (bump close to the clavicle). At the time of the report, THROAT TIGHTNESS (tight throat) and SWELLING (bump close to the clavicle) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medication provided by reporter. No treatment medication received by reporter.    Reporter did not allow further contact
Mom reports pt developed a fever-102 deg F that evening and throughout the night.  Vomited formula bottle on 2/17/07 at 6:00 am. Continued with fever throughout the day. Tolerated smaller amounts of fluid that day. Fever ended at 6:00 pm 2/17/07.
01/04/22 presented to EC ED "by EMS" "found to be collapsed and unresponsive". PMHx of "DM II and HTN"
no additional AE's were reported.; The patient was administered and expired dose of MMR-II.; This spontaneous report was received from a Licensed practical nurse regarding a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 30-MAR-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) 0.5 milliliter, lot #U009511, expiration date: 25-MAR-2023, administered subcutaneously as prophylaxis (strength was not provided) (Expired product administered). No adverse events were reported.
Patient received vaccine approximately 5:15pm. Patient was sitting in waiting room and at approximately 5:25pm patient reached for something on the ground and fainted onto the ground.  911 was called. Police and EMT arrived at the scene. Patient refused to go to the hospital. He called his family to come pick him up. Patient left with out notifying anyone.