chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow-up information has been received from a physician concerning a 67 year old retired male with chronic obstructive pulmonary disease (based on long history of smoking), hypertension, coronary artery disease and hypoxia (at night with exertion), who on 01-JUN-2006 at 3:30 PM was vaccinated into the left upper deltoid with a second dose of Pneumovax 23 (lot# 651330/1048P). Concomitant therapy included atorvastatin calcium (LIPITOR), lisinopril, metoprolol succinate (TOPROL XL TABLETS), ibuprofen (MOTRIN), aspirin and tiotropium bromide (SPIRIVA). On 01-JUN-2006 (previously reported as evening of 02-JUN-2006) the patient developed pain, local swelling, induration, "doughy", warm and erythematous upper arm. He noted that the patient's lymph nodes were not swollen. The physician sent the patient to the emergency room for antibiotics. Follow-up information from the physician further indicated that the patient returned to his office on 02-JUN-2006 with left upper extremity cellulitis and swelling. He was admitted directly from the physician's office with significant swelling and some erythematous changes in the external and medial surfaces of the upper arm on the left. There was no fever, chills, rigors, nausea or vomiting. Upon examination, the physician reported that the patient was alert with breath sounds 12-14. There was some spongy feeling over the elbow, perhaps the bursal area. No adenopathy in the axilla and skin over the shoulder area, back and below the elbow appeared normal. His sensation was intact throughout and motor function was preserved. Passive flexion in the elbow and shoulder (left) movement was uncomfortable. The patient was diagnosed with a pneumococcal vaccination reaction. Arcus type. Upon admission, he was placed on vancomycin and imipenem. The physician discharged the patient home on 02-JUN-2006 with symptomatic management. The patient was considered recovered. The physician also noted that about a week after the event he met with the patient and the patient remember that he had a previous pneumococcal vaccination just 2 years prior. No further information is expected.
Information has been received from a physician concerning a 25 year old female patient with a history of vaginosis bacterial on 19-MAR-2009 who on 02-JUN-2008 was vaccinated with a first dose of GARDASIL (Lot # not reported). On 07-AUG-2008 she received second dose of GARDASIL (Lot # not reported). On 05-DEC-2008 she received third dose of GARDASIL (Lot # not reported). Recently on unspecified date she had "pap smear" that demonstrated "high risk HPV DNA detected". The physician mentioned that the patient had a "PAP smear" prior to beginning the vaccines and it was negative. As a side note the physician mentioned that the patient complained that the second injection of vaccines was more painful than the first. The patient sought medical attention office visit. Additional information has been requested.
Narrative:  COVID infection following COVID vaccine series 01/23, Pfizer, dose #1 02/12, Pfizer, dose #2 09/03 pt cc cough, rhinorrhea, dyyspnea, exposure: unknown 09/22 COVID swab, result: detected 09/22 CXR impression: Findings: Reticulonodular opacities are now noted projecting over the right midlung region new since previous examination. Negative for pneumothorax, airspace disease, atelectasis, effusions or edema. The heart size and configuration are normal. Mediastinum and pleural spaces are normal. No masses, nodules or adenopathy detected. The visualized bones are normal for the patient's age. Impression: Nonspecific reticulonodular opacities in the right midlung. Recommend CT scan to better evaluate 09/29 clinically resolved 10/07 CT Chest impression: The lungs demonstrate no consolidation, masses or effusions. There are ill-defined areas of groundglass opacification in the perihilar regions of the right upper lung, bilateral lower lungs. There is also ill-defined increased interstitial markings and groundglass in the dependent portions of the right lower lobe. The heart is mildly enlarged globally. Extensive coronary artery calcifications. There is no evidence of pericardial effusion. No significant pneumothorax. No significant mediastinal adenopathy or soft tissue mass. The visualized osseous structures show no lytic or blastic lesions. No acute osseous abnormality visualized. The visualized portions of the abdomen appear normal. Impression: 1. Patchy bilateral perihilar and lower lobe predominant groundglass opacities which are most compatible with recent viral infection (Covid 19). 2. Coronary artery disease. Cardiomegaly. 09/22 SARS-COV-2 Variant Sequencing result: pending
This spontaneous report as received from an office manager 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 histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # L018499, expiration date: 25-FEB-2017; lot # L041676, expiration date: 15-MAR-2017 and lot # L023232, expiration date: 05-FEB-2017) (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports from the same reporter. Additional information has been requested.
Severe low back pain; slight headache; The initial case was missing the following minimum criteria: No Adverse Effect. Upon receipt of follow-up information on (29Mar2021), this case now contains all required information to be considered valid.  This is spontaneous report from contactable consumer via Pfizer-sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: EN6201) via intramuscular route at left upper arm on 06Feb2021 at 13:15 as single dose for COVID-19 immunization. Patient medical history included ongoing Osteoarthritis, Ongoing Knee surgery Back, hips, and neck on Jun2020, Stroke on Jun2017. patient family history included: Stroke and COPD (mother), Lung cancer and COPD Mezolthezmalona (Father), Stroke (Grandmother). patient concomitant medication included Tylenol arthritis orally for Joint pain, Premarin 45 mg tablet orally for Hormone replacement, AREDS 2 eye vitamin orally for Eye health, Orphenadrine orally for Muscle relaxation, Women's Multivitamin orally for Health. On 06Feb2021 18:00 the patient experienced slight headache, on 08Feb2021 Severe low back pain. No treatment received. Seriousness criteria: Persistent/significant for Severe low back pain and Not serious for slight headache. The patient underwent lab tests and procedures which included Mar2020 and Dec2020 Covid-19 Result: Negative. The outcome of event was recovered on 13Feb2021.  Follow-up attempts are completed. No further information is expected.
Wicked couple of months; Diagnosed with a medical problem; Fever between 100F -102F that was fluctuating after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL BEHAVIOUR (Wicked couple of months), VACCINATION COMPLICATION (Diagnosed with a medical problem) and PYREXIA (Fever between 100F -102F that was fluctuating after 2nd dose) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 003C21A) for COVID-19 vaccination.     The patient's past medical history included Colonoscopy (A medical procedure (colonoscopy) was done for an internal infection after the first dose down the throat to diagnose for the internal infection and stated that now everything is normal regarding that infection.The patient had hiccups for 10 days before the procedure hence the colonoscopy procedure was done.). Concurrent medical conditions included Blood pressure high. Concomitant products included LISINOPRIL for Blood pressure high.   On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jul-2021, the patient experienced PYREXIA (Fever between 100F -102F that was fluctuating after 2nd dose). On an unknown date, the patient experienced ABNORMAL BEHAVIOUR (Wicked couple of months) and VACCINATION COMPLICATION (Diagnosed with a medical problem). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, ABNORMAL BEHAVIOUR (Wicked couple of months) and VACCINATION COMPLICATION (Diagnosed with a medical problem) outcome was unknown and PYREXIA (Fever between 100F -102F that was fluctuating after 2nd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jul-2021, Body temperature: high (High) High( 100-102 degree Fahrenheit).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient experienced Ran fever for 2 months (102*)  and it was treated with antibiotics.   This case was linked to MOD-2021-231193.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow-up received contains significant information. The patient initials were updated. The event was updated. On 12-Oct-2021: Follow up received  included Patient height, weight and race information, Start date of event Fever, outcome and Treatment was updated.
24 After vaccine administration patient's arm was red and swollen at site of injection 48 hours symptoms worsened without soreness. Assessment of right deltoid region on 8/31/07 shows red and swollen area approximately 3 x 5 inch, warm to touch. Patient has full ROM without c/o pain - No fever or other systemic symptoms - recommend Ibuprofen and cool compress. Call MD if symptoms increase over weekend.
Covid vaccination, Clinic: The involved Nurse was attempting to dilute vial of Pfizer vaccine with needle and syringe, some amount of saline went into vial, the rest squirted out of syringe outside of vial.
Upon leaving flu clinic had numbness and tingling in L arm and across my back. Has not fully resolved at this time. No treatment, but was evaluated by her physician.
Approximately 15 minutes after receiving vaccine, Mom saw that her left foot looked swollen and that she had small pink hives on her left lower leg. Injection site on left thigh did not have hives around it. Benadryl administered orally and hives cleared up as did swelling. No cough, oral swelling or trouble breathing.
03/11/2021 Really tired, feeling feverish, injection site was a rash and itchy, 03/12/2021, all my lymph nodes and glands were swollen and body aches for 5 days. 04/07/2021, contacted doctor was informed that these were common side effects; 06/2021, diagnosed with iritis; 09/15/2021, I started having trouble breathing, tested oxygen level and it was very low-used albuterol; 11/09/2021, prescribed Flovent to decrease inflammation in chest.
Vertigo dizziness in the head where room appeared to be tilting; Benign Paroxysmal positional vertigo (BPPV); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jun2021 18:45 (Batch/Lot number: unknown) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "eye sight issue" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VERTIGO (non-serious) with onset 13Jun2021 07:00, outcome "not recovered", described as "Vertigo dizziness in the head where room appeared to be tilting"; VERTIGO POSITIONAL (non-serious) with onset 13Jun2021 07:00, outcome "not recovered", described as "Benign Paroxysmal positional vertigo (BPPV)". Therapeutic measures were not taken as a result of vertigo, vertigo positional.  Additional information: It was reported that, after the vaccine was administered on 09Jun. Series of Vertigo episode started from 13Jun morning as soon as he woke up. Vertigo dizziness in the head where room appeared to be tilting. This continued through out the day for every hour or so. Also upon trying to lie down or walk. Upon looking up online it was referred as Benign Paroxysmal positional vertigo (BPPV). As symptoms continues even today 14Jun, he was planning a physical therapy appointment next week to treat this issue. No Covid prior vaccination. No Covid tested post vaccination  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received ZOSTAVAX vaccine on 6/10/2009. Reported shingles-like symptoms on 6/13/2009 and went to her physician. Pt received medication and is healing. (VALTREX).
sore arm; swollen; itchy; This 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 the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm, swelling and pruritus. On an unknown date, the outcome of the pain in arm, swelling and pruritus were recovered/resolved.   It was unknown if the reporter considered the pain in arm, swelling and pruritus to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 07-SEP-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient got his/her 1st vaccine and had sore arm, swollen and itchy for a couple of days but no real side effects.  The reporter did not spoke to the 2nd one yet. The patient saw a friend from work went through shingles when she was only about 23 or so.  Whatever the side effects were, had have been better than what he/she saw her endure. The follow-up could not be possible as no contact details were available.
The pharmacist did not dilute the vile so my 6 year old was given a 20 microgram dose instead of 10.
redness at injection site/ location of vaccination still a little red, slightly blotchy 12 days later; soreness at injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 18May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset May2021, outcome "not recovered", described as "redness at injection site/ location of vaccination still a little red, slightly blotchy 12 days later"; VACCINATION SITE PAIN (non-serious) with onset May2021, outcome "unknown", described as "soreness at injection site". Additional information: The patient was reported as 12 (age unit was unspecified).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Several days after vaccine was given pt developed redness to left arm. Redness on getting worse. Seen in office dx with cellulitis and tx.
Large, red, hot and tender site to upper left thigh measuring 3.8cm X 7.6cm at 24 hours. Area appeared "hivish" with irregular border, raised. Follow-up call on 6/15/01, beginning to resolve with cold compresses.
Vaccine (MMR) given 8/16/13. Patient called Occ. Health 8/28/13 to report she had developed a rash to her face which mildly spread to her extremities, a mildly sore throat, headache, and that her eyes hurt.
8 days after I received the Moderna vaccine, I got an itchy, hard red patch about the size of a quarter with a smaller patch right below about the size of a nickel at the injection site which lasted for a little over 24 hours.
pt devel hives of unk etiology following 2nd dose of Engerix-B;
A mother reports post vaccine pt developed wheezing, diarrhea, vomiting, rash and was irritable. The mother considered these events to be an allergic reaction. The patient recovered by 01/08/2001. Follow up information received from the physician on 04/22/2001 indicated the patient received Prevnar, Act-Hib, and Tripedia vaccines. The following day the patient developed nasal congestion, an "occasional" cough, runny nose, vomiting X 2 and mild diarrhea. The patient was diagnosed with a viral syndrome which resolved the following day without treatment. The patient also developed an injection site reaction characterized by redness and swelling.
Patient came back to pharmacy with big red welt at injection site. Her PCP looked at it and said it looked like the injection had been given SQ, not IM. Pharmacy RPH followed our standard protocol with injection in deltoid muscle with 1 inch needle. Patient given antibiotic by MD. Reaction not reported by patent at time of Administration.
Extreme arm pain after shot that went away within 48-72 hours (could not even lift arm over head).  Arm pain went completely away and then came back 8 days later - same pain, same location, tender to the touch but no rash.
The treatment was 200 capsules of molnupiravir.  It was cold symptoms for having tested positive for COVID-19 on October 29, 2022. I had a light fever of about 99, runny nose and occasional cough along with fatigue. The symptoms lasted for about three or four days. As of today I have no lingering symptoms.
Patient developed a 30 x 35 cm area of redness and warmth on left upper arm at site of injection.
On 03/07/2005 DTap, IVP given in LA within 2 day arm became increased swollen, red and had fever to 101. Taken to ER given 1 week of ice packs and Motrin.
Client went to Emergency Room  with right sided weakness on 5/6/2021. He was admitted for full evaluation and follow up.
cold; dizziness; extreme fatigue; muscle aches and pains; severe headaches; irritable; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABILITY (irritable), NASOPHARYNGITIS (cold), DIZZINESS (dizziness), FATIGUE (extreme fatigue) and MYALGIA (muscle aches and pains) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced IRRITABILITY (irritable), FATIGUE (extreme fatigue), MYALGIA (muscle aches and pains) and HEADACHE (severe headaches). On 01-Mar-2021, the patient experienced NASOPHARYNGITIS (cold) and DIZZINESS (dizziness). At the time of the report, IRRITABILITY (irritable), NASOPHARYNGITIS (cold), DIZZINESS (dizziness), FATIGUE (extreme fatigue), MYALGIA (muscle aches and pains) and HEADACHE (severe headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medications were reported.   This case was linked to MOD21-031737, MOD21-036106 (Patient Link).
A nurse reported that a 72 year old female received an injection of Pnu-Imune 23 on 09/17/01. That same day, the patient developed right shoulder pain. She also developed an injection site reaction characterized by swelling and redness. This is 1 of 2 patient from this facility who had an adverse experience following reipt of Pnu-imune 23 (lot 473-556) See MCN HQ6179720SEP2001
06/03/2015 4:50 PM patient came to the clinic to get Tdap. States no allergies but is scared of needles. Never had any allergic reaction to any vaccine or any medications in the past. Discussed in detail medical hx, meds and allergies. Patient sitting in the chair and vaccine consent signed. No interactions identified. Tdap administered as per clinic guidelines. 4:55PM Patient talking about school and suddenly eyes rolled back, patient became unconscious, Face flushed. Medical alert button pressed. Helped called immediately. Patient regained consciousness within less than 1 minute. Patient states what happened ? Discussed with patient that he passed out. 5:00 PM Vs taken temp 99.4 oral, pulse 92, resp 18, bp 120/60 and O2 sat 98% Pharmacy Manager and store manager in the room. Requested pharmacy manger to leave if needed will call back. Store Manager in the room. Helped patient to walk to the exam table and lie down. Patient talking and alert x oriented x 3. Called MOC; update given. Will monitor patient for next 20 minutes. Asked patient if this has happened in the past ever. Patient states one time he was watching a movie with needles and this happened and thought it was not a big deal but has never passed out with seeing a real needle. Water bottle given to patient. 5:05 PM Patient drinks half the water bottle. Skin color light pink. Vs taken again. 5:10 PM Temp 98.6, pulse 78, resp 18, bp 120/70 and O2 sat 97%. Store manager left. Discussed with manager will all if needed. Discussed with patient to call some one to drive him home. States he will call his friend. Patient drinking water and talking on the phone. 5:20 pm vs taken temp 98.5, pulse 78, resp 18, O2 sat 98%, bp 120/70. Skin color a little pale. Patient states feel a little weak but alert. 5:25PM vs taken temp 98.6, temp 74, resp 18, O2 sat 98%, blp 120/70. Skin color pink and patient feels much better. States friend has arrived and he is going to drive his car and friend will follow him. Patient stands up out of exam table without any difficulty. Standing and states feels so much better. Drinking water. 5:30 pm discharged with friend to follow him home. Patient verbalizes undersanding to keep easy tonight, drink extra fluids. Do not watch movies with needles. Patient verbalizes understanding. Will follow up. 06/04/2015 2:20 PM called patient on his cell to follow up. Patient states feeling much better today. Drink exta fluids. Will follow up with urgent care clinic or ER if any problems. Will call insurance company to find a PCP to follow up. Patient verbalizes understanding to tell in the future that he has passed out with a viewing a movie with needles and passed out after getting a Tdap shot. Patient verbalizes understanding.
Patient received Pfizer COVID vaccine on 2/1/21 and 3/1/21. On 7/12/22, patient admitted to our inpatient facility (med/surg unit) with acute respiratory failure with hypoxia due to COVID-19 and secondary bacterial pneumonia.  Patient was discharged back to nursing facility/ short term rehab on 7/21/22.
?Covid Arm? began within 24 hours, presented in red swollen, massively itchy area at injection site that grew four times its size in 48 hours. Ice and hydrocortisone cream was applied to provide slight relief. After 72 hours it Faded away to pink until 8 days after injection. Woke up with a ringworm looking  circle, bright red, started at four inches in diameter and grew to six inches within 24 hours.  Was swollen in the morning, but had subsided by that evening. Site still remains slightly pink and bruised looking.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with improperly stored doses of ROTATEQ (lot number K013408 and expiration date 20-FEB-2016, orally dose was not reported). Concomitant therapy was not reported. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.