chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had severe and very painful swelling starting around the area where the shot was administered. Then the sweeling and pain traveled to my left underarm, elbow and forearm. The shot was administered on 9/9/2008 and within 24 hours it left me unable to bend my left arm completely. The IV  in my left arm was also affected and had to be moved a day later.A week later I still have pain and some swelling,especially around the area where the IV was. I was on antibiotics for a different problem the whole time this reaction took place.
Mother described client experiencing high pitched crying episode approximately 1.5 days after receiving immunizations on 8/9/05. Crying reported to last approximately 1 hour - very shrill cry. Client experience episode of vomiting and questionable difficulty breathing. Transported by EMS to hospital.
pinprick blood rash all over/ diagnosed as immune thrombocytopenia; rash on chest and neck; fever; chills; headache; body ache; joint pain; fatigue; nausea; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female (not pregnant) received the first dose (dose number 1) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6202) via an unspecified route of administration in the left arm on 15Mar2021 08:15 AM at a single dose or COVID-19 immunization.  Medical history included Hashimoto's disease, pulmonary hypertension, obstructive sleep apnea, dermatomyositis. Concomitant medication(s) included escitalopram; tramadol; levothyroxine; all from Mar2021 (received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had allergy to morphine. The patient was seen in the Emergency Room at a hospital on 20Mar2021 for pinprick blood rash all over the body on 16Mar2021; a doctor diagnosed it as immune thrombocytopenia from the Covid vaccine received 5 days earlier. On 16Mar2021, she had also been experiencing rash on chest and neck, fever, chills, headache, body ache, joint pain, fatigue, nausea for the past 5 days. The adverse event(s) result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the events included prednisone. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.
facial swelling; fever; body aches; chills; Rash on the neck spreading to head/rash on ears; This is a spontaneous report from a contactable other HCP (Patient). A 42-years-old non-pregnant female patient received second dose BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Lot Number: EL3302) via an unspecified route of administration, administered in Arm Left on 03Feb2021 as SINGLE DOSE for covid-19 immunisation. Historical vaccination first dose of BNT162B2 (Lot number: EL3302) via an unspecified route of administration in Arm Left on 13Jan2021 10:00 for covid-19 immunisation. Patient medical history reported none. Known allergies: IV ANCEF [cefazolin sodium]. The patient concomitant medications included multivitamins. On 13Feb2021 19:00 (after 10 days following 2nd dose) the patient experienced rash on the neck spreading to head and facial swelling, fever, body aches and chills and rash on ears. Patient received treatment as Prednisone, H2 Blockers and Antihistamine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No covid tested post vaccination. The outcome of the event was not recovered.
This spontaneous prospective pregnancy report was received from a consumer (patient's husband) refers to his 29 year old wife. On 27-JUN-2014, the patient was vaccinated with VARIVAX, (1 injection, subcutaneous). On the same day, the patient was vaccinated with three other vaccines, one of which was flu vaccine (name unspecified). On 22-JUL-2014, the patient went to her physician who performed blood work and found out that she was pregnant. Patient's husband estimated that his wife was approximately four months pregnant, but he did not know if the estimate was exact. Her husband also stated that it was not explained to husband and wife that they should not conceive until after three months of receiving the vaccines. It was reported that the patient sought medical attention. Action taken, outcome and causality were not reported. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 at 11:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 31Mar2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 21Apr2021 at 10:30 as dose 2, single (Batch/Lot number: unknown), in right arm and on 04Dec2021 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient was on Paxlovid treatment from 18Sep2023 to 23Sep2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300314720 same patient, different drug/event (Paxlovid Case);
prolonged high pitched cry of about 6 hrs duration immed p/DTP vax @ 4 mos of age also had lcoal redness, swelling & tenderness @ site of inject; sx resolved w/in 12 hrs;
Patient received ZOSTAVAX at pharmacy on 10/14/12. She came to PCP on 10/15/12 her (L) arm, site of injection was swollen, painful & hot to the touch.
area right outer and anterior upper arm which has confluent erythema, induration, and tenderness over 12x6cm extending down to lower portion of bicep which is mostly subcutaneous.
Headache, Myalgia, Fever, chills, rhinorrhea, sore throat, chills, fatigue Narrative:
p/receiving vax pt c/o heavy pressure feeling fr lt shoulder up to the throat; stated stomach hurt & felt like was going to faint; c/o diff breathing;
Patient came back to the pharmacy for her second shot, she said that she had a rash all over (chest area) and itching after getting the first shot of Moderna
Rash at injection(3/02) site 2days after lasted about 3 days  cleared up & reappeared on 3/12 twice as bad & larger.  Very warm to touch. Began using Benadryl ointment on 3/13 which helped somewhat.  Inner areas of redness have turned kind of brown but outer edge is still red & spreading further down my arm. Feels burning/itchy
Swollen/painful lymph nodes in left armpit and along left collarbone; Swollen/painful lymph nodes in left armpit and along left collarbone; Fever; 3rd Booster dose; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301358A) via an unspecified route of administration in the left arm on 29Sep2021 at 16:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications included unspecified vitamins and levothyroxine (MANUFACTURER UNKNOWN); both for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 24Feb2021 (at the age of 31-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 18Mar2021 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 01Oct2021, the patient experienced swollen/painful lymph nodes in left armpit and along left collarbone and also had a fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not 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 swollen/painful lymph nodes in left armpit and along left collarbone and also had a fever was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Per vaccinator, after inserting needle into patient's arm, he went to push the dose and the needle separated from the syringe and the vaccine sprayed out. Since more than half the vaccination dose was not administered, a replacement vaccine dose was given. Needle and syringe were separate components and the threads and lip seemed to have malfunctioned causing them to come loose.
This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS INADEQUATE CONTROL (blood sugar is skyscraping since the shot) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for an unknown indication. On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, the patient experienced DIABETES MELLITUS INADEQUATE CONTROL (blood sugar is skyscraping since the shot) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Arms is a little sore). At the time of the report, DIABETES MELLITUS INADEQUATE CONTROL (blood sugar is skyscraping since the shot) and PAIN IN EXTREMITY (Arms is a little sore) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Treatment information was reported. It was reported that patient is with insulin pump but is not helping. This case concerns a 59-year-old male with a serious unexpected event of diabetes mellitus inadequate control, and non-serious pain in extremity. Event latency 1 day after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 59-year-old male with a serious unexpected event of diabetes mellitus inadequate control, and non-serious pain in extremity. Event latency 1 day after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Described started "itching 30 minutes after shot administered. That night she noticed a "rash all over her body, no problems breathing". The next day she experienced "swollen lips and tingling and itching from head to toe". She reports she is taking Pepcid and Benadryl. She also reports " no problems with breathing".
Fevers 102, chest x-ray, blood, urine, ceftriaxone.
fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included PREDNISONE for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.
Information has been received from a pharmacist referring to 4 newborns (numbered, 78, 79, 80 and 81). Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 07-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Patient experienced Temperature increase to 99.3 oral; increased blood pressure 136/94 with dizziness about 30 minutes after injection.  Blood pressure remained elevated for about 2 hours; normal blood pressure 112/64 for this young man. Vitals were taken every 30 minutes. BP and temp 134/84, 99.5  140/92, 99.1 128/92, 99.1 112/76, 97.8 vitals prior to patient leaving. Dizziness improved and patient taken home by friend.   Dizziness continued. Patient taken home and told to report to ER if symptoms return
Patient received pneumococcal vaccine in the R deltoid at 20:59 on 9/25/18. At 0300, patient woke up with "immense pain" radiating from shoulder down into the shoulder blade and within the deltoid on the R side. Patient describes an increase of intense pain with movement of arm, but  neither positioning or lack of movement relieves pain. Patient is tensing back and neck muscles on the R side. Cannot fall back to sleep. Medications given (650mg TYLENOL at 0329; 50mg Tramadol at 0300), gentle massage, heat and ice tried to relieve pain - patient states none of it helped.
itchiness on site of injection; soreness on site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness on site of injection) and VACCINATION SITE PAIN (soreness on site of injection) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness on site of injection) and VACCINATION SITE PAIN (soreness on site of injection). On 06-Feb-2021, VACCINATION SITE PRURITUS (itchiness on site of injection) and VACCINATION SITE PAIN (soreness on site of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Describes cramping of arms and legs. Told to call occupational medicine for follow up. Cramping occurred 3 days after vaccination.
Breakthrough case admission after 2 vaccines Moderna 4/4/2 Lot# 046L21A;  Moderna 9/12/22 Lot# AS7145B
fever 104 R x 48 hrs; slow to respond to APAP; mom called MD;
right upper wisdom tooth abscess, pericoronitis one week following COVID vaccine. tired, joint pain.
Information has been received regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2011, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), administered at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 27-JUN-2016, the patient was treated by a physician at an urgent care center for a blistering vesicular outbreak that was diagnosed as severe shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, and as a result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Arthralgia, NauseaVomiting, numbness, tingling Narrative: Nausea, joint pain; numbers & tingling of arms & legs on third day. Resolved in 72 hours.
Moderna COVID-19 Vaccine EUA Fever, chills, aches, cough and nausea
Dizziness. A worsening of my usual problem. Comes in waves and lasts all day/night. Difficulty walking. Intensified spacy, disequilibrium feeling.
HPI: Chief Complaint: L sided weakness  HPI: 75M with HTN, mild cognitive impairment who presented with L sided weakness and neglect. I spoke with wife who stated she was with the patient today, he worked outside shoveling and snow blowing with the winter storm. She saw him minutes before 4pm (she estimated 3:58p) and he was his normal self, then she walked to another room, called out to him, he didn't respond, so she ran back to where he was and saw him slumped over and weak on the L, she immediately called 911. She has record on her phone of calling a family member (daughter?) about this at 4:01, right after she had called 911, so LKN consider just before 4pm.  Patient states he takes only medications for hypertension at home. Denies being on any blood thinners and no record of blood thinners in his chart. Denies recent surgeries, denies history of ICH, denies bleeding issues in the past, denies ever having had a prior stroke.  BG 122 on arrival. BP initially 121/84 then increased requiring some labetalol.
Patient has continued to have pain radiating down his left shoulder and arm, subjective and objective weakness.  MRI study of shoulder suggestive of brachial neuritis.
Intense pain  in lower back and right leg from hip to just above knee. Fatigue. Increased Advil to 12 a day with no effect. Also hot and cold compress. (I forgot to list Advil on previous page. Usually take  6 a day.) Appointment with doctor on February 12, 2019. Doctor said he thought pain may be related to vaccine but he doubted it. He thought a had pulled a muscle and prescribed a muscle relaxer and heat compress in am and cold compress 2 times a day. I do not think I pulled a muscle. Took 1/2 tab three times a day and compresses. Pain alleviated. Ceased taking muscle relaxer after one week. Pain has not returned.
Started having pain hours after shot. The next day I started having trouble moving my arm without pain. Over the next few weeks it got worse, and by June I was unable to lift my left arm up high enough to do things like trim my hedges. By fall, I had very limited movement in my left arm. I went to the doctor on December 2, 2021, and she said it was likely adhesive encapsulitis, and she sent me to have physical therapy. I've been doing PT since Dec 29 (the first appointment available) at the clinic she suggested. The pain has decreased somewhat and I have regained some forward movement; however, I still have limited outward and particularly backward movement.
Unable to read, confused, unable to process information, recognized items but slow to process actions (ie toothbrush- brush teeth) Lasted for 2 days, continue to have some processing delay.
itching on her hands; redness; swollen; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th May 2019, the patient received the 1st dose of Shingrix .5 ml. On 15th May 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the patient experienced itching both hands. The patient was treated with benadryl (nos) (Benadryl), ibuprofen, prednisone and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the injection site erythema and itching both hands were unknown and the outcome of the injection site swelling was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling and itching both hands to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and returned to the pharmacy with redness and swelling at the injection site.  She was advised to ice it and take benadryl and ibuprofen. She came back with a prescription from the urgent care for predisone for itching on her hands.  The reporter consented to follow up. There is a discrepancy between the outcome reported in the structured field (not recovered/not resolved) for swelling and the outcome reported in the source document (recovering/resolving). Kept as per fields.
Started with chills and very sleepy, headache and brain fog about 10 a.m. the morning after the injection.  Worked but just felt VERY fluish and went home after work, which probably should not of drove myself home because I felt so bad.  Got right on the couch and slept from like 5 p.m. to 10 p.m. and very chilled and feverish feeling but felt so bad but did not take temperature.  Got up at 10 p.m. and went to bed and slept all night long.   The next day felt much better but still had a little brain fog and headache.
A wrong vaccine was given to a 6-month-old baby. Patient should have received Pentacel (recommend for 2 months to 6 years old children) The patient received Kinrix (recommend for 4- to 6-year-old children)
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Mild, Additional Details: Roughly 3 minutes after vaccination the patient became lethargic, pale and unresponsive. This has happened previously after vaccination and the patient fainted in her chair. She was in and out of conciousness 5 times within a span of 3 minutes. Pulses always intact. RPh did not lie her down as mother and patient were not comfortable. Patient waited 30 minutes and walked out of pharmacy.
Severe arm pain at area of injection about 9 hours after shot (bedtime). Next morning very severe total arm, head and joint pains, total fatigue, mild fever, no appetite. Unable to get out of bed except once to urinate which was a painful struggle. Next morning most symptoms subsided greatly. Only a mild headache and moderate arm pain remained. As of this writing headache is gone but moderate arm pain at injection site continues.
Client c/o tingling in throat 15 minutes after vaccination. Observed and symptoms resolved. VS stable. Discharged home at 12:28p.m.