chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Discharge summary "Patient is a 89 YO male history of bronchiectasis, prior Pseudomonas empyema, Parkinson's disease presented with dyspnea. He was found severely hypoxic. Labs reveal COVID +.    During his stay, he received 5 days of Remdesivir and steroids for COVID treatment. He was initially placed on Rocephin and Doxycycline. His hospitalization was complicated by worsening respiratory status with concern for rapidly progressive left sided loculated effusion with concern for empyema. Pulmonary and IR were consulted and patient underwent left sided chest tube placement. ID was consulted who transitioned patient to Cefepime and Flagyl for better anaerobic coverage. He received TPA/Dornase instillation as well. His hospitalization was further complicated by worsening encephalopathy and leukocytosis despite medical management. Goals of care discussion were done with assistance from Palliative and Hospice care team. Family (son and wife) has elected to transition patient to Comfort care with plans to discharge back to prior living arrangements with Hospice team. Chest tube removed morning of day of discharge as requested by family. "
Pt was admitted on 8/21/2021 with hypoxia and sob and a cough ongoing for 7 days not responsive to out pt treatment with  antibiotics and prednisone. She tested positive for RSV and was admitted to the hospital. She was treated with steroids, nebulizers and oxygen and was discharged on 8/24/2021 home
CHILLS; VOMITING; This spontaneous case was received from a nurse on 04-Jun-2019. It describes a female consumer who experienced chills and vomiting, after the administration of Vivotif for an unknown indication.  Case report: The consumer took a dose of Vivotif at night. Then, at 2 am, she woke up with severe chills and vomited in every 30 minutes until 4:30 am. At 10:30 am, she was feeling fine.  Action taken with Vivotif was unknown.  The consumer had recovered from the events chills and vomiting.  Company's Comment: In this case, it was reported that a female consumer experienced chills and vomiting after intake of Vivotif. There seems to be a temporal association between the intake of vaccine and the events. Also, chills and vomiting are labelled as per agency. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that a female consumer experienced chills and vomiting after intake of Vivotif. There seems to be a temporal association between the intake of vaccine and the events. Also, chills and vomiting are labelled as per agency. Hence, the causality of the events with Vivotif is assessed as possible.
Pt states (R) arm at injection site was sore, red, hot & began to swell. Pt applied cool compresses to injection site. Pt stated the area continued to exhibit all of the above symptoms & continued to swell in size. Pt reports after a week the injection site began to drain green pus that had a foul odor. Pt reported a sore knot in the area under her right arm. Pt applied Neosporin & rubbing alcohol to injection site & continued with cool compresses. Pt states site drained until the week of 10/25/10 then scab formed over injection site. Pt states site is still warm to touch with no drainage, the sore knot is still present under the right arm area. Staff observed 11/5/10 a scab on the RD; site was warm to touch, no drainage present, unable to palpate any knots under pt's (R) arm.
This spontaneous report was received from a pharmacist refers to a 30 year old male patient. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with GARDASIL 9 (route, lot number and expiration date were not provided). Concomitant therapy information was not provided. On an unknown date, there was an inappropriate schedule of drug administration as GARDASIL 9 had been administered beyond the recommended age range. No adverse event was reported. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
My hypertension has been well controlled for the past 6 months.  In fact, had decreased my blood pressure medication.  Usually my blood pressure would run about the 116/68.     However , received dose # 2 of Covid vaccine on 3/29/21 at 11:40 AM .   The next morning  on 3/30, my routine B/P check prior to taking my  HCTZ 12.5 mg was unusually elevated.   At 7 AM - 135/82 and at 11 AM 148/86.  So , I took and additional dose of HCTZ 12.5 mg.   At 1:30 PM, my B/P decreased down to 140/75.   Now, at 2:30 on 3/31, my B/P is back to normal at 119/69.  I have notified my PCP.  Just wanted to notify of the increase in b/p post dose #2 of covid vaccine.  I am so grateful to have received the vaccine and have recovered from the side effect.
Pt was to receive Varicella vaccine at appt. but was given ZOSTAVAX.
1. Tinnitus 2.Bad gas (smell was very bad for about 2 months)
Fever, chills, lethargy, loss of appetite. Lasted about 24 hours
Rheumatoid arthritis flare up; This is a solicited report based on the information received by Pfizer from AbbVie Inc. (Mfr. Control No.: 21K-163-3954437-00) from a contactable consumer (patient).  Solicited report from the USA by a consumer of an adult male with an event of non-serious RHEUMATOID ARTHRITIS FLARE with HUMIRA (ADALIMUMAB). There was no reported medical history. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS FLARE. PFIZER  BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect.   A 45-year-old male patient received BNT162B2 (Lot Number unknown), intramuscular on an unknown date at single dose for covid-19 immunisation, adalimumab (HUMIRA), subcutaneous from an unspecified date at unspecified dose with unspecified frequency(Citrate free) for Moderate to severe Rheumatoid arthritis. The patient's medical history was not reported.Concomitant medication included prednisone from Jun2021. The patient experienced rheumatoid arthritis flare up on an unknown date. The action taken in response to the event for adalimumab was unknown. The outcome of the event was recovering.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event of RHEUMATOID ARTHRITIS FLARE with HUMIRA(ADALIMUMAB) was a reasonable possibility.  Causality for PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN): The reporter's causality for the event of RHEUMATOID ARTHRITIS FLARE with PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN) was probable.  No follow-up attempts are needed; information about lot/batch number cannot be obtained; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 can be excluded for the reported rheumatoid arthritis flare up. The concomitant suspect product adalimumab might provide an alternative explanation of the reported event.  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.
I experienced fever, body aches, nausea, loss of appetite, fatigue, congestion and coughing.
extreme photsensitivityand audio sens, chroni fatigue, insomnia, inability to regulate temp, migratory hot prickles and joint pain, head and neck pain, vision change, memory problems, dizziness, disorientation, loss of appetite, swollen lyph nodes and sore throat, withdrawn from school for about 4 months lack of attention - reported by mom,
Bumps on left arm and part of my back. Turned into small welts. Benadryl was used for the itching and ice. I called Teledoc and send photos. Methylprednisolone was prescribed.
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: PT received shot 9/10/21, says symptoms started on Friday 9/17/21, they are are ongoing to present day 9/21/21, pt has reddness 3-4 inches on the site of injection, along with blistering of skin, pt complains of pain/redness/ hot to touch/itchyness. This is the 3rd dose, had no issues with previous 2 doses.
MYOCARDITIS, EXERTIONAL CHEST PAIN AND DYSPNEA, TROPONIN 18.0, ADMITTED TO THE HOSPITAL
Patient was administered Hep A and Gardasil (HPV) vaccines. She immediately became light-headed, dizzy and went from sitting position to lying on exam table. The office CMA in the room described a few seconds of stiffening/posturing. She never lost consciousness but was pale and somnolent. Within 20-30 seconds she was conversant, feeling better. After 5-10 minutes she was completely back to baseline.
Severe soreness, pain at injection site started 10 hours post vaccination , dull aching, low grade fever (101), chills, exhaustion, headache started  17 hours post vaccination.  Treatment included rest, drinking fluids, Tylenol.
Itching and hives on abdomen and back. Benadryl 50mg po, Prednisone 60mg po and Zantac 150mg po were given in ED and a prescription. Still has rash and itching.
Information has been received from a pharmacist concerning a patient who about a year ago was vaccinated with a dose of ZOSTAVAX (Oka/Merck). The pharmacist reported that the patient experiencing persistent urticaria about one month after receiving the vaccine. The pharmacist did not think the urticaria was from ZOSTAVAX (Oka/Merck), he states, "this was not an adverse event from ZOSTAVAV (Oka/Merck) and he did not want to report this". The patient sought unspecific medical attention. AT the time of reporting the patient was not recovered. No further information is available.
Right side of my face went numb; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 09:00 (Lot number: EN6206) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: LORATADINE taken for seasonal allergy.  The following information was reported: HYPOAESTHESIA (non-serious) with onset 11Mar2021 09:27, outcome "recovered" (11Mar2021 18:27), described as "Right side of my face went numb". Therapeutic measures were not taken as a result of hypoaesthesia.  Additional information: Patient received BNT162B2, administered in right arm, administration date 01Apr2021 09:35 (Lot number: ER8730) as a DOSE 2, Single for Covid 19 immunization.  No follow-up attempts are possible. No further information is expected.
Patient presents  a red circle about an inch an a half on her upper left arm, one week after she was vaccinated. She also presents itching and swelling.  She also said that she feels dizzy and has diarrhea
shot at 10:45 headache at 11:30 pm fever/chills/ache at 5:30 pm
This spontaneous report was received from a registered nurse via a company representative and refers to a female patient of unknown age. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route of administration, lot # and expiry date were not reported). Subsequently, on an unknown date, the patient was diagnosed with shingles. The patient sought medical attention by contacting the reporting nurse. Product quality complaint was not involved. The outcome of the event and causality between ZOSTAVAX and the event were not reported. Additional information has been requested.
+ crying then staring, unresponsive, ?hypotonic, hyporesponsive event;
My (right) arm still aches; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: My (right) arm still aches).  The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 18-SEP-2023 This case was reported by patient via interactive digital media. The patient reported that he/she had the shingles vaccine, his/her (right) arm still aches even tho it had been over a year since.  The vaccine needs more research and work and would not recommend anyone getting the vaccine until it was made better.  Follow up was not possible, as no contact details were available.
pt recvd vax 6OCT94 & 15 mins later devel itching all over body, redness @ the inj site & SOB; pt was treated w/DPH & w/in 1 hr all sx had resolved;
Case number PHEN2011US02805, is an initial spontaneous report received from a medical assistant on 26 Aug 2011 with follow up received from a medical assistant on 12 Sep 2011: This report refers to an adult female patient. Concomitant vaccination included hepatitis A and hepatitis B vaccines. She was administered only the MenCWY liquid conjugate component of MENVEO (batch number 090601A) without being reconstituted with the MenA conjugate component, intramuscularly into left deltoid, on 23 Aug 2011. No adverse event occurred following this administration. Follow-up received on 12 Sep 2011: Patient demographics, vaccination site and concomitant medications updated.
Pt recvd DTP/OPV on 7APR92 & 8APR92 woke up w/t103.7 & vomiting; pt was seen by MD 8APR92 in PM; MD stated was a rxn to DTP; No DTP in future; 9APR92 pt feeling better;
Pain at injection site for 3 days, nausea and diarrhea for 7 days after shot?and still experiencing, itchy swollen eyes for 7 days after shot and still experiencing, fatigue for 7days still experiencing
4SEP97 pt recv vax & 5SEP97 rash this AM-seen by MD dx erythema multiforme;6SEP97 much improved smaller hives MD started Prelone;
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # reported as L030872, expiration date 11-JUN-2018; lot # L019297, expiration date 18-AUG-2017 (exact dose and route of administration were not reported). Administered doses of the vaccine experienced the temperature excursion of 0 degrees Celsius for 8 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I woke up at 1am the night of the vaccine and could not breathe. I have 2 inhalers and neither gave relief. My oximeter hovered between 87 and 89 all night. At 6:30 the next morning I used my nebulizer and it helped. The rest of the day it got progressively better.
This spontaneous report as received from a pharmacist refers to a 61 year old male patient. The patient had no relevant medical history and past drug history. On 03-AUG-2013 the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # 1716AA, expiration date 02-FEB-2013) subcutaneously in the left arm for prevention of shingles. The patient had no relevant medical history, concomitant medication, and past drug history. There was no concomitant therapy. The patient was no longer taking ZOSTAVAX and at the time of the reported, the patient was not experienced any adverse events from receiving expired ZOSTAVAX. There was no relevant laboratory data. The patient did not seek medical attention.  Additional information has been requested.
6MAY93 lt hand, forearm swollen & achy; had ringing in ears & swollen lymph glands neck;  t101 7MAY93; seen by MD 7MAY93; sx were gone by 8MAY93;
DIZZINESS; DRUNK FEELING; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, arthritis, asthma, and sulfa allergy, and other pre-existing medical conditions included patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with amlodipine besilate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, and batch number: 1802070 expiry: UNKNOWN) .5 ml, 1 total, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced dizziness. On 11-MAR-2021, the subject experienced drunk feeling. On 11-MAR-2021, the subject experienced slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from slight headache, and had not recovered from dizziness, and drunk feeling. This report was non-serious.
Left 10cm X 10cm erythematous arm, warm 20.75 ca circumference. Right arm 18.75 ca circumference PRN Tylenol, Benadryl, Atarax and Keflex.
couldn't eat any food; really bad headache; temperature of 100.8 F; arm was a little bit sore; started to feel bad; really sick; could hardly move; eyes hurt and felt really bad; hearbeat was very slow; couldn't even call 911, couldn't get up of the bed to open the door and let her dog in; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (started to feel bad), MALAISE (really sick), HYPOKINESIA (could hardly move), EYE PAIN (eyes hurt and felt really bad) and HEART RATE DECREASED (hearbeat was very slow) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003F21A, 002A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included CREST syndrome. Previously administered products included for Product used for unknown indication: Flu shot in October 2021. Past adverse reactions to the above products included No adverse event with Flu shot. Concomitant products included PANTOPRAZOLE for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced FEELING ABNORMAL (started to feel bad), MALAISE (really sick), HYPOKINESIA (could hardly move), EYE PAIN (eyes hurt and felt really bad), HEART RATE DECREASED (hearbeat was very slow), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't even call 911, couldn't get up of the bed to open the door and let her dog in), HEADACHE (really bad headache), PYREXIA (temperature of 100.8 F) and MYALGIA (arm was a little bit sore). On 23-Oct-2021, the patient experienced FEEDING DISORDER (couldn't eat any food). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (started to feel bad), MALAISE (really sick), HYPOKINESIA (could hardly move), EYE PAIN (eyes hurt and felt really bad), HEART RATE DECREASED (hearbeat was very slow), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't even call 911, couldn't get up of the bed to open the door and let her dog in), FEEDING DISORDER (couldn't eat any food), HEADACHE (really bad headache), PYREXIA (temperature of 100.8 F) and MYALGIA (arm was a little bit sore) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-363406 (Patient Link).
3 classic satellite lesions on left face; not involving eye; mild systemic symptoms. Only known treatment is observation
Pt with seizure-like activity and post-ictal somnolence.  No fevers.
Vial was initially stored in refrigerator on 04-Apr-2022, expired on 01-Apr-2022 and administered on 16-Apr-2022; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 04-Apr-2022, expired on 01-Apr-2022 and administered on 16-Apr-2022) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 04-Apr-2022, expired on 01-Apr-2022 and administered on 16-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 04-Apr-2022, expired on 01-Apr-2022 and administered on 16-Apr-2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported.  Vial did not undergo any temperature excursions.  No treatment medications were provided.
Erythema measuring approx 7.3cm by 9.5 cm and pain at injection site
Patient reporting on 1/25/22 around 5pm she noted a rash at injection site. Later that evening she noted another spot on her back and currently has 4-5 additional spots on her back and neck. She denies fever, but reports feeling off and fatigued with headache and muscle aches for a few days. Patient also reports right armpit was painful and swollen 1-2 days before the rash started. Patient reported symptoms to office and referral placed on 1/26/22 for patient to be evaluated by dermatology. Patient was seen by dermatology department  1/27/22 and diagnosed with vaccine induced varicella. Patient advised by dermatology to keep lesions covered, maintain wearing a mask and avoid contact with susceptible individuals.  Patient currently breastfeeding so topical lidocaine and  Oatmeal baths for pruritus.
Beginning at 10 AM today:  Headache, Fever up to 101, body aches
Started out as 2 pustules and then turned red; Red mark/2 inches in diameter; This spontaneous case was reported by a consumer and describes the occurrence of PUSTULE (Started out as 2 pustules and then turned red) and ERYTHEMA (Red mark/2 inches in diameter) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PUSTULE (Started out as 2 pustules and then turned red) and ERYTHEMA (Red mark/2 inches in diameter). At the time of the report, PUSTULE (Started out as 2 pustules and then turned red) and ERYTHEMA (Red mark/2 inches in diameter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.