chrisvoncsefalvay/vaers-outcomes huggingface dataset:
multiple lymph nodes enlarged on US neck/hypermetabolic lymph nodes on CT; dyspnoea on exertion; Enlarged liver/spleen; Enlarged liver/spleen; Chest pains; Pulmonary edema; Pneumonia; IIH; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient received BNT162b2 (BNT162B2), on 30Aug2021 as dose 2, single (Lot number: FD8448) at the age of 38 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Raynaud's", start date: 2008 (ongoing), notes: Raynaud's; "M.C.T.D", start date: 2015 (ongoing), notes: M.C.T.D, Under control/ managed since 2018; "CVA", start date: 23Jul2021 (unspecified if ongoing); "Enlarged lymph nodes", start date: Jul2021 (unspecified if ongoing), notes: Enlarged lymph nodes. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1st, Site and route of injection: Right arm, Intramuscular, Batch/Lot number: FA7485), administration date: 23Jul2021, when the patient was 38-year-old, for COVID-19 Immunization, reaction(s): "CVA".  The following information was reported: IDIOPATHIC INTRACRANIAL HYPERTENSION (disability, medically significant) with onset Aug2021, outcome "not recovered", described as "IIH"; PNEUMONIA (medically significant) with onset Sep2021, outcome "unknown"; PULMONARY OEDEMA (disability, medically significant) with onset Sep2021, outcome "recovered", described as "Pulmonary edema"; CHEST PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "Chest pains"; SPLENOMEGALY (non-serious), HEPATOMEGALY (non-serious) all with onset Jan2022, outcome "unknown" and all described as "Enlarged liver/spleen"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "multiple lymph nodes enlarged on US neck/hypermetabolic lymph nodes on CT"; DYSPNOEA EXERTIONAL (non-serious), outcome "unknown", described as "dyspnoea on exertion". The event "iih" required physician office visit. The event "pulmonary edema" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Chest X-ray: (Sep2021) Abnormal, notes: Lung opacity/edema; (Nov2021) Normal, notes: No acute disease; (Mar2022) Normal; Computerised tomogram neck: (Jan2022) Normal, notes: Multiple enlarged lymph node (word not legible) more on back; Computerised tomogram thorax: (Jan2022) Normal, notes: Multiple enlarged lymph node (word not legible); Us neck: (Jan2022) Multiple enlarged lymph nodes; Lumbar puncture: (Aug2021) Abnormal, notes: High opening neck pressure; Magnetic resonance imaging head: (Jan2022) Abnormal, notes: Venous anomaly; Oxygen saturation: (Mar2022) Dyspnea on exertion; Positron emission tomogram: (May2022) Abnormal, notes: Hypermetabolic lymph nodes with high uptake -So much more labs, test on (word not legible). Therapeutic measures were taken as a result of idiopathic intracranial hypertension, pulmonary oedema.
Expired Moderna vaccine administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered to patients) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered to patients) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.  The reporter was not sure about the date of administration of vaccine and was willing to provide more information once the reporter gets back to the office.   This case was linked to MOD-2022-577156 (Patient Link).
Label, consent form, and card have conflicting information of which product was administered for dose 1 in August. Comes in for dose 2 and staff unsure of which product to receive. The vaccine lines at the POD separate youth from adults, so it is more likely that she received Moderna and the sticker on the consent is in error.  REC: either mRNA vaccine may be given.  Prefer Moderna and wait if any new guidance occurs for additional doses in the future.
Pain in arm; Wrong injection technique; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Wrong injection technique) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3002623) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DICLOFENAC SODIUM (VALETAN [DICLOFENAC SODIUM]) for an unknown indication.    On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Wrong injection technique). At the time of the report, PAIN IN EXTREMITY (Pain in arm) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Wrong injection technique) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
pt reported pain and discomfort at injection site, since 9/15/2019. she has been feeling sick ever since, also presenting with small bump
She stated she developed a 101 fever, low appetite, her arm swelled up down to her write, had itchy rash, arm is warm and tender to touch. Reaction subsided after 4 days.
hemorrhagic bullous; she had a blister in her leg the size of 3or 4cm dose; haemorrhagic blisters in legs/ skin blisters with blood; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (she had a blister in her leg the size of 3or 4cm dose), BLOOD BLISTER (haemorrhagic blisters in legs/ skin blisters with blood) and BULLOUS HAEMORRHAGIC DERMATOSIS (hemorrhagic bullous) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Anaphylaxis (Iodine), Drug allergy (patient allergic to iodine.  DNA filaxis (contrast materisLXCT)) on 03-May-1999, Depression and Dementia. Concomitant products included DONEPEZIL HYDROCHLORIDE (ARICEPT) from 01-Oct-2015 to an unknown date and MEMANTINE HYDROCHLORIDE (NAMENDA) from 01-Oct-2015 to an unknown date for Dementia, SERTRALINE from 01-Oct-2015 to an unknown date and BUPROPION from 01-Oct-2015 to an unknown date for Depression, ASA from 01-Oct-2015 to an unknown date for an unknown indication.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced BLISTER (she had a blister in her leg the size of 3or 4cm dose) (seriousness criterion hospitalization) and BLOOD BLISTER (haemorrhagic blisters in legs/ skin blisters with blood) (seriousness criterion hospitalization). On 22-Jul-2021 at 7:00 AM, the patient experienced BULLOUS HAEMORRHAGIC DERMATOSIS (hemorrhagic bullous) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 22-Jul-2021 to 28-Jul-2021 due to BLISTER and BLOOD BLISTER, and then on 22-Jul-2021 due to BULLOUS HAEMORRHAGIC DERMATOSIS. At the time of the report, BLISTER (she had a blister in her leg the size of 3or 4cm dose) and BLOOD BLISTER (haemorrhagic blisters in legs/ skin blisters with blood) had not resolved and BULLOUS HAEMORRHAGIC DERMATOSIS (hemorrhagic bullous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received on 28-JUL-2021 contains Significant information that includes, Event update, Seriousness criteria update.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a 79 year old female patient referring to herself. Information about medical history, concurrent condition and concomitant medication was not reported. On 30-AUG-2011 the patient was vaccinated with ZOSTAVAX (once dose/once: strength, dosage and route unspecified). On 15-OCT-2015, the patient experienced a "bad case" of shingles. The shingles rash was primarily on the patient's thigh and there was a burning sensation with "nerve pain underneath". She was officially diagnosed by physician assistant. Physician assistant prescribed the patient valacyclovir as treatment. The patient also visited with her dermatologist and preferred point of contact for shingles treatment. The dermatologist prescribed gabapentin to help with the pain she was experiencing. Lab diagnostic studies were performed (exact information unspecified). The outcome of the event was reported as not recovered/not resolved. Additional information has been requested.
Approximately 5 hours after receiving injection began having moderated right arm pain which gradually worsened. By next morning was having severe arm pain (unable to raise arm without pain, couldn't touch arm or lie on it), malaise, and slight headache. Did not notice swelling or redness at injection site. Other symptoms subsided but arm pain persists. Pain now less severe but still present ; less pain with ROM; still has activity limitations with right arm due to pain.
Ears stopped up - muffled - like filled with cotton balls - no decongestant would help. Then sound started - like a shower running  or hissing in my ears - that doesn't stop. Got an ear doctor appointment and diagnosed with Tinnitus.
he was taking psychiatric medications and thought maybe this may have had a reactions with the vaccine and caused the swollen lymph nodes; developed swollen lymph nodes on his neck and his stomach; This is a spontaneous report from a contactable pharmacist (daughter). A 57-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications included psychiatric medications (unspecified). She stated that within 48 hours after having the vaccine he developed swollen lymph nodes on his neck and his stomach. There swollen lymph node are still present which was causing the caller concern. She stated that he was taking psychiatric medications and thought maybe this may have had a reactions with the vaccine and caused the swollen lymph nodes. She stated that he had called a number before reaching Agency that had give her this number to call but she was not sure who she talked to other that that it was a pharmacist. She was requesting any documentations on participants who have had swollen lymph nodes as a adverse effect be emailed to her. Spoked from attached document regarding participants in the clinical trials that experienced lymphadenopathy. Relayed to caller that I was not able to send medical information regarding each individual that experienced the swollen lymph nodes and their other medications or medical history. Stated that currently there has been no known link between psychiatric medication and swollen lymph nodes after the Pfizer COVID 19 vaccine. Referred to HCP regarding side effects for evaluation and treatment. Sharing document via email per caller request. The outcome of the events were unknown  Information on the lot/batch number has been requested
Information has been received from a registered nurse concerning a 11 year old male with no medical history, a penicillin and CECLOR allergy (causes hives) who on 07-AUG-2007 was vaccinated SC with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). On approximately 07-AUG-2007 (within 24 hours of vaccination) the patient experienced an injection site reaction. The patient had a hard raised swelling area the size of a "half dollar" following the varicella virus vaccine live (Oka/Merck) vaccination. The overall size of the swelling was about 6 to 8 inches in diameter on the arm. It was reported the patient contacted their physician. No diagnostic laboratory tests were performed. At the time of the report the patient was recovering. A product quality complaint was not involved. Follow-up information was received on 13-SEP-2007. Follow-up information has been received from a registered nurse concerning an 11-year-old white male with a penicillin and cefaclor (CECLOR) allergy who on 07-AUG-2007 was vaccinated subcutaneous in the right thigh with his second dose of varicella virus vaccine live (Oka/Merck) (Lot # 657192/0362U). Concomitant vaccines administered on 07-AUG-2007 included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (GlaxoSmithKline) (Lot # AC52B011CA), hepatitis A virus vaccine (unspecified) (GlaxoSmithKline) (Lot # AHAVB186AA) and meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (Sanofi Pasteur) (lot # U2379BA). On 07-AUG-2007 (at approximately 20:00 hour) the patient experienced "severe pain at sight", temperature of 104.4, redness and swelling at injection site, small knot at injection site about the size of one half dollar with redness surrounding the site. The patient required an emergency room visit due to extreme pain, fatigue, and fever. No diagnostic labs were performed. The patient recovered from all adverse experiences on approximately 13-AUG-2007. This is one of several reports received from the same source. Additional information is not expected.
Patient fell out of chair after receiving Moderna, never lost consciousness and ice packs were applied due to patient being clammy. Patient was coherent
Longstanding chronic ITP with platelet counts 40-50,000 since 2016.  Platelet count was found to be 11,000 on 3/9/21 when it happened to be checked 6 days after her immunization.  Previous value 39,000 12/3/20 which was her stable number.   Plts rechecked over next 3 days and stayed 11,000.   Given 2 doses of IVIG (500 mg/kg) and plts rose to 227,000 over the next week then fell to her 68,000 on 3/30/21 prior to her 2nd dose of Moderna.  Fell to 38,000 the following day then rose to 49,000 the following week.  Remained asymptomatic the entire time.
COVID Arm as identified in the literature.  1 week( 2/17/21) after shot reddened raised area about 3x5 oval shape on the R upper arm where shot was given. it is very itchy. not painful
Experienced burning sensation R arm. 5:00 AM 2/9/16 wife woke him up; Lips swollen & white; right side of neck swollen. Went to urgent care.  Dr. prescribed steroids. Night of 2/9/16 had nausea, vomiting, diarrhea.  Symptoms improved by 2/14 16. Has appointment with "specialist" on 2/22/16.
BNT162B2: Paxlovid:Treatment of COVID-19; BNT162B2: Paxlovid:Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Oct2021 at 10:00 as dose 3 (booster), single (Lot number: 30155BA), in left arm and on 27Apr2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BUPROPION; AMLODIPINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovered" (May2022) and all described as "BNT162B2: Paxlovid:Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had COVID treatment of Anti viral details (Pfizer) from 09May2022 to 10Jun2022. All COVID symptoms returned on the 5th day.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Narrative:  Pt was a 67 YO male with PMH of MDS, lung cancer, CAD, HLD, cardiomyopathy, arrhythmia, barrett's esophagus, HTN, PVD, and HLD in care of inpatient hospice who passed away from cardiopulmonary arrest due to metastatic lung cancer.
I received a Pneumovax injection Saturday afternoon 6/22/19, with no adverse effects at the time of the injection. That night my arm was so sore I could hardly lift it, which lasted about three days. About 24 hours later I started experiencing a mild dry scratchy throat. By end of day Monday I had symptoms like the onset of bronchitis. Tuesday I had a fever which went up to a peak of 100.8, then started coming down. I was also experiencing chest congestion, and a wheezing sound at times when breathing from the congestion. Wednesday my temperature dropped to 98.9, and the congestion continued. Today (Thursday), my fever is gone. Congestion continues but is improving steadily. My doctor recommended Mucinex and Flonase (via email communication), which I am taking.  This is the first time I?ve had a reaction to any type of immunization, other than a sore arm for a couple of days.
Extreme shivering, feeling cold, sick and weak; started at 6pm on 6/22/2018; went to bed early at about 7pm; covered self with several blankets. No significant fever. Kept shivering overnight until about 3pm. Sweat profusely overnight and also the following two nights. Shivering sensation for 3 days (not actually shaking). Feeling weak for 3-4 days. Left arm hurt where injection applied for 4 days.
Rash, swollen, red, itchy, extremely sore arm. Pt went to PCP for treatment (steroid, BENADRYL).
Information has been received from a registered nurse concerning an 8year old autistic male with no known allergies who on 07-MAY-1999 was vaccinated SC in the left thigh with a 0.5 ml first dose of Varivax (lot # 629254/1849H). There was no concomitant medication. On 03-FEB-2007 the patient developed chickenpox. It was reported that there were 20 to 25 lesions scattered across the body. The lesions were described as excoriated, raised, erythematous papules, the patient also had several clear vesicles on the back. The patient was seen in the office on 05-FEB-2007. There was no fever reported and unspecified symptomatic treatment was started. The patient was instructed to remain in isolation for the duration of the vesicular rash. No lab studies were performed. On an unspecified date the patient recovered. There was no product quality complaint involved. Additional information has been requested. The patient's brother (WAES # 0701USA03740) recently had the same experience after vaccination with Varivax.
This spontaneous report was received from a Medical Assistant and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On 03-FEB-2017 and on 12-FEB-2017, the patients were vaccinated with improperly stored doses of ROTATEQ orally, which had a lot # of M011832, an expiration date of 25-JAN-2018, for prophylaxis. Which were exposed to a temperature 0 to 2 C for a  time frame of 3 hours. There were no previous temperature excursion and it was call  because of a data logger. Additional information has been requested.
glands under her left arm are "quite miserable"; fever; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (glands under her left arm are "quite miserable") and PYREXIA (fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 037A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-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 LYMPHADENOPATHY (glands under her left arm are "quite miserable") and PYREXIA (fever). At the time of the report, LYMPHADENOPATHY (glands under her left arm are "quite miserable") and PYREXIA (fever) outcome was unknown.            Concomitant medication was not provided Treatment information was not provided   This case was linked to MOD-2021-081357 (Linked Report). This case was linked to MOD-2021-081344 (Patient Link).; Sender's Comments:  MOD-2021-081357:Dose-2
10 yr. old presents to TCPH for immunization.  This 10 yr old given Twinrix (Hep A & B) x2 dosage on 3/16/08 & 4/16/08.  CDC called.  Recommended to give Hep A #3 10-17-08 & Hep B #3 7-16-08.  Dr., medical director TCPH also agrees with recommendations.  Parent reports no reaction or side effects-adverse reaction from Twinrix.
Patient woke up the morning after injection with redness, swelling and pain in left arm that radiated up to neck.  Saw private MD 4 days after injection and he gave her a Rx for Keflex TID.
Headache, Myalgia, Arthralgia, NauseaVomiting, c/o body cold,injection site sore and reddness Narrative:
I didn't have any adverse effects from the shot itself. I did contract Covid at a local event on April 23. Started to feel symptoms on April 29.
Patient was exposed to Varicella 10 days ago.  Now has acute mild varicella.  Eruption on chest and proximal extremities.  Sister has same rash.
3 days of languishing in bed/it laid her out; zapped the energy she may have had; Extreme tiredness; Muscles hurt; Joints hurt; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (3 days of languishing in bed/it laid her out), ASTHENIA (zapped the energy she may have had), FATIGUE (Extreme tiredness), MYALGIA (Muscles hurt) and ARTHRALGIA (Joints hurt) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Cancer (cancer 8 years ago and was on her left side.), Blood pressure high, Pancreatic insufficiency and COPD. Concomitant products included FLUTICASONE for Abnormal breathing, AMLODIPINE for Blood pressure management, OLODATEROL HYDROCHLORIDE, TIOTROPIUM BROMIDE MONOHYDRATE (STIOLTO RESPIMAT) for COPD, DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) and EMPAGLIFLOZIN (JARDIANCE) for Diabetes, PANCREATIN (CREON) for Pancreatic disorder, GABAPENTIN, PRAVASTATIN, VENLAFAXINE, VALSARTAN and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced FEELING ABNORMAL (3 days of languishing in bed/it laid her out), ASTHENIA (zapped the energy she may have had), FATIGUE (Extreme tiredness), MYALGIA (Muscles hurt) and ARTHRALGIA (Joints hurt). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. In 2021, FEELING ABNORMAL (3 days of languishing in bed/it laid her out), ASTHENIA (zapped the energy she may have had), FATIGUE (Extreme tiredness), MYALGIA (Muscles hurt) and ARTHRALGIA (Joints hurt) had resolved.            This case was linked to MOD-2021-348554 (Patient Link).