chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Awoke 4 am next morning w/migraine- worst migraine I have ever had and it lasted 36 hours;; vomited once;; lethargic; weak in limbs;/Still have some weakness in limbs; lost five pounds; could not eat for 3-1/2 days.; This is a spontaneous report from a contactable consumer. This 60-year-old non-pregnant female consumer (Patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0153) via an unspecified route of administration on 02Jun2021 at 10:45 AM in right arm (at 60-year-old), as dose 2, single for COVID-19 immunization. Medical history of the patient included seasonal allergies, Known allergies: Seaweed (start date and ongoing status unknown), Malignant tumor removed in 2015 (mucoepidermoid carcinoma), mucoepidermoid carcinoma (2015). The patient did not have covid prior vaccination and was not tested for covid post vaccination. Concomitant medications included pravastatin, irbesartan, vitamin D3, biotin, niacin (taken for an unspecified indication, start and stop date were not reported). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0179) via an unspecified route of administration on 05May2021 at 04:45 PM in right arm (at 60-year-old), as dose 1, single for COVID-19 immunization. On 03Jun2021 at 04:00AM, the next morning the patient was awoke at 4 am w/migraineworst migraine she have ever had and it lasted 36 hours, she vomited once, was lethargic, was weak in limbs, lost five pounds-could not eat for 3-1/2 days. On her fourth day out of work no pay. She still have some weakness in limbs. No treatment was received for events. The patient was recovering.  Follow-Up (04Aug2021): Follow-up attempts were completed. No further information was expected.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 01-DEC-2017, the patient was administered an improperly stored dose of ROTATEQ, lot # N015129 with expiration date on 11-DEC-2018 (dose was not reported). The administered dose of vaccine underwent a temperature excursion of 47.6 degrees Fahrenheit, which lasted for an unspecified time. There was no previous temperature excursion. A digital data logger was not involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1712USA002258: US-009507513-1712USA008157: US-009507513-1712USA008158: US-009507513-1712USA008159: US-009507513-1712USA008161: US-009507513-1712USA008162.
OFF LABEL USE; VACCINE ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a health care professional concerned a 17 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 20-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-SEP-2021, the patient experienced off label use. On 20-SEP-2021, the patient experienced vaccine administered to patient of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine administered to patient of inappropriate age was not reported. This report was non-serious. This case, from the same reporter is linked to 20211217956, 20211218297, 20211218548 and 20211218731.
12/16/03 noted localized pain at 0500. At 1200 developed redness, tightness in the skin developed around around 1700 and swelling of the arms and itching. There has been progression of the swelling and erythema to below the elbow since 12/17/03. 12/18/03 has erythema measuring 25cm.
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 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: en6208), in right arm, on 13Oct2021 as dose 2, single (Lot number: FH8020), in left arm and on 20Feb2022 as dose 3 (booster), single (Lot number: EN5318), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 25May2022 as dose 4 (booster), single (Lot number: cvs3951), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa and Cephalosporins; "Known allergies: Cephalosporins" (unspecified if ongoing), notes: Known allergies: Sulfa and Cephalosporins. Concomitant medication(s) included: SYNTHROID, start date: Jan2015. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.
Eyes, nose, and throat itching. Numbness and tingling to extremities. Hyperventilation.
Vaccination site warmth; Vaccination site pruritus; Vaccination site swelling; headache; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PRURITUS (Vaccination site pruritus), HEADACHE (headache), MYALGIA (Myalgia) and VACCINATION SITE SWELLING (Vaccination site swelling) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Erythromycin.).    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced HEADACHE (headache) and MYALGIA (Myalgia). On 04-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE SWELLING (Vaccination site swelling). At the time of the report, VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PRURITUS (Vaccination site pruritus), HEADACHE (headache), MYALGIA (Myalgia) and VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Additional information included patient Contact details were  added.
Fever 105 less than 5 hr. after vaccine administration in context of afebrile OM. Flu and RSV neg. WBC 19.5 with left shift, CRP less than 0.3, UA RBC 10 and WBC 5/HPF, CMP normal. Normal PE at time of fever and normal PE at follow up 2 wk. later.
After receiving vaccine stated she felt a pain shoot across her chest and down her right arm.  States after about 15 minutes began to having itching on entire right arm and red splotchy area down right arm to wrist.  Returned to hospital after 50 minutes to report symptoms.  Red irregular shaped areas noted going down right arm from shoulder to wrist.  Complained of itching.  Band-aid on right arm removed and area cleaned to remove any residue from band aid since she stated tape would break her out.  Benadryl 25mg PO given and Hydrocortisone cream applied to right arm at 1625.  Recheck at 1700 with stating she felt better.  States no itching and redness was fading.  Rechecked again at 1800 with still no difficulty breathing or swallowing.  Denied wheezing.
Excruciating pain approximately 2 1/2 hours after inoculation in my non-dominant shoulder.  Unable to move my arm without help of dominant hand.  Area vaccinated, warm to the touch.  Took 2 Tylenol 8-hour and kept ice on shoulder all night.  Slept for about 4 1/2 hours; awakened by pain.  Continue to ice upper arm.  Called primary care physician and spoke to a covid doctor who said this is common, monitor for 48 hours and continue doing what I've been doing.  If continues, can see my doctor or specialist.
incredible allergic reaction causing plum sized lump in lymph glands in the armpit; Initial information received on 29-Dec-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves patient who experienced incredible allergic reaction causing plum sized lump in lymph glands in the armpit (axillary mass), after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE 2020-2021 (lot UT7108KA and expiration date not reported)  via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious incredible allergic reaction causing plum sized lump in lymph glands in the armpit (axillary mass) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the reports, the outcome was not reported for the event axillary mass.
At end of observation period (15 minutes) patient came to counter with  symptoms of hives and complained of itching and began coughing.  She stated the cough was normal.  Gave patient 25mg  diphenhydramine which she was able to swallow. Itching got worse and patient contacted her husband, we contacted EMS who arrived and took over patient care.  Cough was getting more frequent and worse as was itching and redness of patients skin, arms, legs, face and head. Patient left pharmacy area with EMS.
Information has been received from a registered nurse concerning a 10 year old patient who was vaccinated SC with 0.5 ml dose of Zostavax (Lot # 657675/0618U) instead of Varivax. It was reported that the office was expecting an order of Varivax and an order of Zostavax and the Zostavax vaccine arrived first. According to the nurse, vaccine boxes looked similar and thus the Zostavax box was put into children's freezer instead of adult freezer. The nurse also reported that the names of both vaccines sound similar. The patient did not experience any known symptoms. Unspecified medical attention was sought. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
10 days  late on period (regular entire life). Persistent cough, fatigued, muscle aches, immune system seems off
Arm pain, fever and red marks, the next morning the red marks are extending to pt's elbow, no fever, arm pain still persistent. Pt's mom brought her to ER.
2 days after my shot I developed a sore throat. Then on Nov 1st I noticed when I woke up that my throat is hoarse now.
Information has been received from a lawyer 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. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 17-AUG-2013, the patient was administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided) at a pharmacy. On or about 23-JUL-2016, the patient was treated by a healthcare provider at a healthcare clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
15AUG late PM lethargic hard to wake, would not feed; 16AUG S&S cont 16AUG t101;
Hair loss, painful blisters on scalp, can not lift up right arm, teeth are falling out.
NOSEBLEED; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced nosebleed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of nosebleed was not reported. This report was non-serious.; Sender's Comments: :V0 Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Patient presented the next day (Wed 09/28/11) with 102 Temp and nausea. Thursday patient woke up with nosebleeding. Nose bleeding continued sporadically until Monday 10/03/11 when she was seen by us. Patient c/o non productive cough, chest pain, head ache, vomiting, malaise, decreased appetite. Pt denied sore throat, SOB. Patient's parents gave children's Tylenol 2 tsp q6hr for symptomatic relief. Lungs were CTAP, nares were red and inflammed. No fever, all other vitals within normal limits. A/P possible ADR to Flumist with mild flulike symptoms and persistant nose bleeds. Tx: Flonase 50MCG/ACT nasal spray, BID
This case was reported by a nurse and described a 41 year old female patient who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series.  On an unspecified date in 2002 or 2003, the patient received the third dose of Engerix-B.  Approximately 6 to 12 weeks later, a hepatitis B surface antibody titer was negative.  The nurse stated that, "All injections were given intramuscularly in the deltoid muscle with a 1 inch needle.  All vaccine is refrigerated and the temperature is monitored daily.  The nurse considered the event to be probably related to vaccination with Engerix-B.
Violent shaking for 30-45 seconds at a time followed by a period of a few minutes of clam, then repeat.  Did this for 3-4 hours.  Fever over 101 degrees, chills, sweats.
Erythema of upper right arm, fever, chills, lymphadenopathy.  Treated with Bactrim DS 1 tablet 2 times a day for 10 days. Follow up with Dr. on 10-9-09.
By receiving such vaccines; MMR's (viral) after my Stem Cell transplant (Auto log.) (Multiple Myeloma) in November 2006, my remission was no more! These vaccines caused me to relapse at this time.
Rash and redness around neck, front and back. Felt very warm but wasn't running a temperature. Felt soreness in area of left arm where both shots were given -- which were spaced at least one inch apart. Also had redness and rash in shot area. Lasted about a week. My head also felt itchy but not the entire time. Mouth felt funny but just kept drinking fluids.
Information has been received regarding a case in litigation concerning a 52 year old male who in approximately 1950-1960 was vaccinated with a dose of poliovirus vaccine (manufacturer unknown) believed to contain the SV-40 virus. In approximately October 2001, the patient was diagnosed with mesothelioma, a condition related to exposure to asbestos and asbestos-containing products and the SV-40 virus. It was reported that the patient's exposure to asbestos, asbestos-containing products and the SV-40 virus caused severe and permanent injury, including, but not limited to breathing difficulties, asbestosis, lung cancer, other cancers and lung damage. The patient had to stop working in November 2001 due to the mesothelioma. The patient's conditions were considered to be other important medical events (OMIC). No further information is available.
Rash on inside of left elbow.; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm at the age of 51 years old on 02Feb2021 12:00 (Batch/Lot Number: EN5318) as dose 1, single for covid-19 immunisation. Medical history included allergy to penicillin. Concomitant medications were not reported. On an unspecified date, the patient experienced rash on inside of left elbow. No treatment was received. The outcome of the event was recovered.   No follow-up attempts are possible. No further information is expected.
Patient inadvertently received vaccine after published expiration date. Moderna Company analyzed lot 007B21A and advised vaccine maintained  activity needed to protect against covid 19 at time vaccine was administered. Patient did not call in to complain of any adverse events. This is administrative error without adverse event.
Development of local reaction and cellulitis sxs developed 1-2 days after injection KEFLEX 500mg T.I.D x 10 days.
Right upper arm hard, red, swollen, hot and painful.  Local treatment advised unless pt develops signs of infection.
Patient received Fluzone HD on 10/21/19. Had typical pain at injection site the next day. Pain persisted and spread to entire arm. Pt state there is no redness or swelling of arm just the pain. pain is mainly between shoulder and elbow, hurts to push on arm or try to lift arm. Patient stated she called MD and he ran a course of steroids and pain went away. after completing steroids the pain came back. Patient is awaiting follow up with MD at this point.
had redness and swelling in both right and left arm, was more pronounced in the left arm which received two vaccine, she also had intense itching at the site of administration and significant erythema, was told to take benadryl for itching and allergic reaction and to seek medical care if she has facial swelling or trouble breathing or any worsening symptoms
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 77-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2022 at 12:30 as dose 4 (booster), single (Lot number: FJ9943) at the age of 76 years, in right 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), all with latency 10 days 18 hrs. after the suspect product(s) administration, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected Covid-19. Clinical course: Vaccine received and no other medications with in 2 weeks. Adverse event: Symptoms were completely gone on 13May, but came back worse than they originally were on 15May. No known allergies. No follow-up attempts are possible. No further information is expected.
I got 2 Moderna vaccines and then my booster and in October I developed laryngitis, and then brochities. I was put on a steroid because I was wheezing. I had a cough as well. Everything was much better and then I started coughing again. Throughout the entire time I never felt ill, I just had a terrible cough. At that point, my Dr. decided that I go to the pulmonologist and everything was fine. Then I went to see an ENT and the scoped me and the only thing he could see was a lot of mucus. I went back to the pulmonologist and got a CT scan and it was fine. Then, I had an endoscopy and it was fine. I visited another ENT and had a CT scan sinuses and it was fine. Next week I will have a swallow test to make sure everything is working properly.
Patient was administered vaccine that was improperly stored (in freezer for too long and considered expired by manufacturer at date of administration due to lack of study data). Patient acknowledged recommendation and was revaccinated 6/6/22 at our pharmacy.
PART OF THE DOSE MAY HAVE BEEN  ADMINISTERED SUBCUTANEOUSLY; PART OF THE DOSE MAY HAVE BEEN  ADMINISTERED; HARDNESS AT INJECTION AREA; This spontaneous report received from a pharmacist concerned a 45 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 in left deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced hardness at injection area. On an unspecified date, the subject experienced part of the dose may have been administered subcutaneously, and part of the dose may have been administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hardness at injection area, part of the dose may have been administered subcutaneously and part of the dose may have been administered was not reported. This report was non-serious.
MODERNA COVID-19 VACINE  Day 1 received vaccine at 0800 no pain, felt dizzy and slight dull headache, tongue felt a little thick at first but subsided in 5 min. Dizziness and headache continued through day but was able to work my whole shift. 9pm right side of my face felt itchy and had some blotchiness, went to bed by 10pm. Day2 Woke up and felt fine all day, worked my entire shift without problems, right arm slightly sore, went to bed at 10pm and started to have shortness of breath, mild wheezing and tachycardia but fell asleep. Day 3 woke up at 10 am,  still tachycardic, heart rate in the high 90's and shortness of breath. Around 1130 am I had severe chills, dizziness and couldn't get warm, temp 98,  I took a hot shower and fell asleep till 3pm. I woke up and felt fine, heart rate back to normal and just some mild congestion in my right ear. went to bed at 10pm Day 4 Woke up at 1030 am felt fine no problems, around 5 pm I noticed a bruise on my right hand near my thumb, didn't bang it or injure it that I remembered, around 6 pm their was another bruise in the middle of my hand, then shortly after that I had one near the pinky of my right hand, before I went to bed I had one on the top of my wrist and my hand felt like it went to sleep. Today day 5 I feel fine so far, no more bruising.
COVID-19 Vaccine EUA Day 1;  pain at injection site, chills, and fatigue; Day 2;  pain at injection site,  joint pain(arthralgia), muscle & body aches(myalgia), fatigue; Day 3;  pain at injection site,  joint pain, body aches, chills, low fever (97.1)