chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles outbreak at right back spreading to front chest under the breast.  Bad case.  Started acyclovir night of 5/19 for 10 days.  The weekend of the 16th I woke up feeling a deep dull ache at my lat and shoulder blade on the right side at 2am.  Thought it was muscular and used a ball to massage the area which felt better, but I could not fall back asleep.  Got better during the day and some thing happened on the 17th.  I put a heating pad on the area and fell asleep.  Woke up with a rash, but thought it was a heating pad burn and this is what it felt like.  Blisters were starting to form on the 18th and I had the chills all day.  I thought this was because it was a 2nd degree burn so made an appointment to see the doctor on the 19th at 4pm.  At the doctor, they diagnosed this as shingles and said I was not the only person who had come in 2-3 weeks post Pfizer shot with Shingles.   2 weeks post shingles- The rash is fading.  Still experiencing rib pain, and dull aching pains in my back where it originally started- at the Lat/shoulder blade.  I wake up every night in pain at 2 or 3am and sleep on/off for maybe 1 hour at a time the rest of the night.
This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. On 16-APR-2007 and on 30-MAY-2007, the patient was vaccinated with doses of VARIVAX (Merck) (dose, lot #, route of administration were not reported). On an unknown date, the patient was found to have negative varicella titers. Product quality complaint (PQC) was not involved. The outcome of the event and the relatedness between the event and VARIVAX (Merck) were not reported. Additional information has been requested.
had both vaccination shots and was hospitalized for six days due to a breakthrough case of covid-19; had both vaccination shots and was hospitalized for six days due to a breakthrough case of covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non healthcare professional).  A 76 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as DOSE 2, SINGLE and (Batch/Lot number: unknown) as DOSE 1, SINGLE for covid-19 immunisation. Relevant medical history included: "AFib" (ongoing). Concomitant medication(s) included: ELIQUIS 5 milligram twice a day, orally. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 20Jul2021, outcome "unknown" and all described as "had both vaccination shots and was hospitalized for six days due to a breakthrough case of covid-19". The patient was hospitalized for drug ineffective, covid-19 (hospitalization duration: 6 day(s)).  The lot number for bnt162b2 was not provided and will be requested during follow up.
PATIENT RECEIVED FIRST DOSE AS MODERNA ON 5/10/21 AND SECOND DOSE AS PFIZER ON 6/7/21. PATIENT SHOULD HAVE RECEIVED SECOND DOSE OF MODERNA ON  6/7/21. PATIENT IS AWARE AND HAS HAD NO ISSUES.
Severe (migrane type) headache = lasted for over 12 hours - had Tramadol HCL 50mg on hand for back problem, so I took 1 pill in the AM and a second in the PM. Headache gone on the morning of April 4th.  No further reaction since then.
Presented to Hospital for dyspnea. Diagnosed with large right sided pulmonary embolism; platelet count 138 T/UL at time of ER visit.  Transfer to larger facility for higher level of care on 4/19/21.
Narrative: Patient reported dizziness, hot flashes, and lethargy following administration of Moderna covid vaccine. No interventions were provided to the patient and patient was able to be released.
Tired; Headache; Body ache; Sensitive skin; This is a spontaneous report from a contactable consumer, pfizer colleague. A 44-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 29Aug2021 at 14:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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. The concomitant medications were not reported. On 30Aug2021, the patient experienced tired, headache, body ache and sensitive skin. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tired, headache, body ache and sensitive skin were resolving 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.
Symptoms: Chest tightness, pale face, nausea, stomach did not feel good, dizzy, light-headed, felt like blood sugar was dropping, "saw stars" Treatment: ate a quest bar, drank gatorade, took blood pressure (128/80), 911 was dailed when pt said he wanted to see a doctor, Outcome: paramedics declared pt can no longer get IMZ from a pharmacy. pt has to go to doctor's office. pt waited well over 30 mins to make sure he can leave
Expired fluzone given to pt in clinic. Expired 6/30/22. No adverse reactions displayed. Spoke with pt's mom will repeat fluzone dose at follow up appt in 2 weeks.
Patient developed Rash on the left arm and having some pain.  The symptoms began few days after the immunization was administered.   Patient had notified their Doctor's office and have suggested the patient to follow up with the doctor if the symptoms continues to persist.
This spontaneous report as received from an office administrator refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 28-NOV-2016, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23, injection (lot# M042599, expiration date: 17-JUN-2016; dose and route of administration were not provided). The vaccine was exposed to temperature: 99 degrees Fahrenheit for 9 hours. The temperature information was not logged with a digital data logger and there were no previous excursions. No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
Purple dots and pain developed on hands.  Recurrance of a resolved problem.  Pt may now need more finger amputations.  Ulcerations on hands.  Worse on right hand the side of the vaccine.
L arm pain and swelling at injection site. Upper body aches unable to sleep. Lasted about 12-15 hours was gone about 27 hours after injection. Fatigue and feeling flush then chilled very mild. No fever
This spontaneous prospective pregnancy report as received from a health professional refers to a female patient of unknown age. On an unknown date the patient was exposed to VARIVAX lot # M046924. The patient was pregnant. The LMP and EDD is not known. The pregnancy outcome was outcome pending. On an unknown date the patient experienced accidental exposure to product, no adverse event and exposure during pregnancy. The outcome of accidental exposure to product, no adverse event and exposure during pregnancy is unknown. The reporter considered accidental exposure to product, no adverse event and exposure during pregnancy to be not related to VARIVAX.
24-May-2022/Result: Positive; 24-May-2022/Result: Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Lot number: ER2613), on 28Apr2021 as dose 2, single (Lot number: EW016) and on 16Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 22 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Patient did not receive any other vaccine in four weeks. Patient did not had covid prio vaccination nor tested post vaccination. Patient had no known allergies.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24May2022, outcome "recovered" and all described as "24-May-2022/Result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jul2021) Positive, notes: Covid test type post vaccination=Nasal swab; (24May2022) Positive, notes: Covid test type post vaccination=Nasal swab. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
severe chills started 15 hours after injection and lasted 6 hours.  I felt quite sick and took until next day to get some strength back.
Gradual development of a motorneuropathy, possible Guillane -Barre like syndrome, resulting in lower extremity dysfunction.
Client experienced syncopal episode before receiving ID jynneos vaccine. Client was provided care and symptoms resolved.  Client did NOT receive the vaccine
partial dose of vaccine received; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INCORRECT DOSE ADMINISTERED BY PRODUCT (partial dose of vaccine received) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and #010A21A / 017A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (Patient is medication for high blood pressure) and Asthma (Patient is under medication). Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for Asthma.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced INCORRECT DOSE ADMINISTERED BY PRODUCT (partial dose of vaccine received). On 09-Feb-2021, INCORRECT DOSE ADMINISTERED BY PRODUCT (partial dose of vaccine received) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications and treatment information were reported.
Sore Right arm and fever for 2,3days which went away. Mild headache everyday on temporal ( switch R to L ) it is still happening after 7 weeks. Sensations like took a benadryl or some kind of meds, it happens everyday but it only last hour or two. I am waiting for this events to wear off or go away but it hasn't.
Welts to left leg, since vaccine.  3x3 cm red, warm, induration L ant thigh.  2x2 cm red, warm, induration L lat thigh.
It was reported that a two month old male pt received ActHIB, IPOL, and Tripedia on 4/22/03. The pt had also received hep B vaccine. On 4/24/03, the pt developed a rash on face and both legs. It was reported that the pt recovered from this event.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with the local Dept. of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Local Healthcare is working on a compliance improvement plan and has been reinstated vaccination privileges.
Pt complained of arm pain, some reddened at injection site. pt was treated with naproxen, she was monitored after 2 days, improvement noted.
one day after flu like symptoms that lasted 2 day-on the 3rd day severe diarrehea for 2 days-then the next day body rash-mostley upper torso
patient is pregnant and received vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (patient is pregnant and received vaccine) in a 28-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 15-Oct-2020 and the estimated date of delivery was 22-Jul-2021. On 27-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (patient is pregnant and received vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifteenth week of the pregnancy.  On 27-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (patient is pregnant and received vaccine) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Blood test: normal (normal) normal. On an unknown date, Ultrasound scan: normal (normal) normal.     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.   Concomitant information was not provided. No treatment information was not provided.
Arm had a knot the size of a baseball; Really hard; Painful; Could not lay on side of body; Felt like her body was rejecting vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (Arm had a knot the size of a baseball), INDURATION (Really hard), PAIN (Painful), DISCOMFORT (Could not lay on side of body) and FEELING ABNORMAL (Felt like her body was rejecting vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE NODULE (Arm had a knot the size of a baseball), INDURATION (Really hard), PAIN (Painful), DISCOMFORT (Could not lay on side of body) and FEELING ABNORMAL (Felt like her body was rejecting vaccine). At the time of the report, VACCINATION SITE NODULE (Arm had a knot the size of a baseball), INDURATION (Really hard), PAIN (Painful), DISCOMFORT (Could not lay on side of body) and FEELING ABNORMAL (Felt like her body was rejecting vaccine) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-080253 (Patient Link).
Information has been received from a medical assistant concerning a 47 year old female with rheumatoid arthritis and sulfa allergy who on 11-OCT-2010 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (lot#665924/0930Z). Concomitant therapy included nifedipine, HUMIRA and TOPAMAX. On 12-OCT-2010 the patient developed redness and swelling at injection site and had myalgia from her neck to right wrist. Unspecified medical attention was sought via office visit. There were no laboratory diagnostics studies performed. At the time of this report, the patient had recovered from redness at injection site, swelling at injection site and myalgia from her neck to her wrist. The medical assistant requested a lot check. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow-up information has been received from a medical assistant and medical records concerning the 47 year old female patient who on 11-OCT-2010 at 13:30 was vaccinated IM with the first dose of PNEUMOVAX 23 into her right deltoid and a dose of influenza (manufacture unknown) (lot # 111816P1). The patient previously was vaccinated with a dose of influenza (manufacture unknown) (lot # U32098AA) on 23-SEP-2009. On 13-OCT-2010 (previously reported as 12-OCT-2010), the patient experienced redness and swelling 6 cm diameter around injection site with myalgia. On an unspecified date, the patient recovered. This is one of several reports from the same source. Additional information has been requested.
Body ache, headache, pain at the joint, fever, Body temp 104. Severe shivering. pain all over body. Tiredness, vomiting. Swollen at the shoulder about 6".
Treatment of COVID-19; 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 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: 6H9693) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative. Therapeutic measures included Paxlovid from 01Aug2023 to 06Aug2023 were taken as a result of drug ineffective, covid-19.
Cellulitis L arm around vaccine site - onset 8/19 tx with PO AUGMENTIN.
Her blood pressure was 200/over something; A rapid heartbeat; She was having a bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Her blood pressure was 200/over something), EXTRASYSTOLES (A rapid heartbeat) and HEADACHE (She was having a bad headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 028L201A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, AMLODIPINE, MELOXICAM, SIMVASTATIN, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]) and ELDERBERRY [SAMBUCUS NIGRA] for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced HYPERTENSION (Her blood pressure was 200/over something), EXTRASYSTOLES (A rapid heartbeat) and HEADACHE (She was having a bad headache). At the time of the report, HYPERTENSION (Her blood pressure was 200/over something), EXTRASYSTOLES (A rapid heartbeat) and HEADACHE (She was having a bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2021, Blood pressure measurement: high (High) blood pressure was 200/over.         Treatment information was not provided.
Felt shooting pain down left arm at moment of injection, but no redness or swelling at site initially.  Swelling at site began about 2-3 hours later, with no redness or pain, and resolved by the next morning.  No systemic Sx's.  Began to notice swelling and tenderness in her left axillary region by the evening following the injection, but no fever or erythema.  The swelling increased by the next day, and was seen in the clinic later that day (about 48 hours post injection).   Exam reveals mild diffuse swelling just anterior to left pectoral muscle in the left axilla, with no discernible node or mass.  Has been advised to apply icepack for 10-15 minutes every several hours, and take Aleve every 4-6 hours, and follow up early next week to report on response. Day 2:
Mother reported that child has a fine red raised rash on legs, arms, and trunk and rash got worse after child had a bath today.  Child has had a fever off and on since 06/26/2007. Child has diarhhea and has been fussy and will not sleep at night.  And immunization sites are tender to touch. Mother told to call emergency room to see if she needed to bring child in.
Patient received first Pfizer COVID shot on 9/17/21. Second dose given on 10/1/21. Patient was not due til 10/8/21.
pain at injection site & referred pain down arm & into hand - onset <1 hr - treatment none nausea & lightheadedness - onset ~3 hrs - treatment none headache & neck pain, severe - onset ~12 hrs - treatment 400mg ibuprofen, 50mg tramadol, 500mg methocarbamol fatigue, slept 14.5 out of 16 hrs beginning 2pm 10/6 - onset~24 hrs fever 101.5 - onset ~34 hrs - treatment none throat constriction - onset ~34 hrs - treatment none
Per Client received vaccine on 1/19/2021 at 12:30 pm in left deltoid. Per Client four hours after vaccine, around 4:30 pm started to have itchiness and skin turned "beet red" on scalp, torso:chest, back, bilateral sides, bilateral arm pits and bilateral arms. Per Client also noticed red "welps" that appeared on areas already listed. Per Client started taking Bendryl 50 mg by mouth every six to eight hours and red welps would dissipate, beet red skin would resolve and itchiness would subside for several hours. Per Client is still taking the Bendryl 50 mg by mouth every six to eight hours for symptoms that are continuing to come and go. Per Client will be following up with his PCP if by this weekend r/t symptoms.
Patient reports muscle spasms and soreness following vaccination. She states that the spasms are within her pectoral muscle. She presented to her physician who diagnosed her with upper body systemic inflammatory response and recommended she go on a supplement to help with inflammation. She has a follow up scheduled with her provider on 04/22/2021.
The pt experienced 12 lesions, was feeling nauseous and tired. No further information is available.
Localized swelling at injection site, tenderness, redness, warm to touch, fever.
Pain at site of inj for >3 wks. Pt got both vaccines in same arm (> 1 inch apart).
Pt originally came 12/28 to get moderna booster after getting Sinopharm somewhere else.  Came back today 2/4/22 for another booster based off recommendations from their md's. Today they said they only got first dose of Sinopharm and did not complete series.  Per official recommendations, If pt has incomplete Sinopharm, it is recommended to receive 1 full dose of moderna or pfizer.  If full dose is not given it is recommended that it be repeated and completed, That is what was done today
Received Pnuemovax Vaccine in her right arm at approx 11 am on Jan 12,2005. At approx. 3PM had swelling  and pain around vaccine site with erythema encompassing entire upper arm. Site was hot and endurated. Applied cold packs to site. Did not seek medical attention. Reported reaction on 1/20/05. Still has some redness around site, complains of itching around site and upper arm. Advised pt. to contact her primary physician for follow up.
That night after the immunizations were given, the pt began to cry uncontrollably for approx. 2 hours or so. The next day, he began the same crying and we took him to the doctor.
24 hours after receiving vaccine, patient started to develop body rash on torso which spread. Rash is red and itchy.
fever, sweating, nausea, muscle aches, lethargic, dizziness, lightheadedness, running nose