chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant drugs were not reported. On an unknown date, the patient was vaccinated with one improperly stored dose of PROQUAD subcutaneously, lot number R008203, expiration date 16-SEP-2019 (exact dose, frequency and site of administration were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The administered vaccine was stored in the range of 15 Fahrenheit degrees (F) to 46 F (14.9 F) for 1 hour and 30 minutes and in the range of 6 F to 14 F (14.4 F) for 2 hours and 30 minutes. No previous temperature excursion was provided. Digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA000909:
Product storage error; Patient received Proquad; Received Varivax and Proquad; This spontaneous report was received from a medical assistant and refers to a 72 years old male. The patient´s concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On 10-JUN-2021, 11-JUN-2021 and 14-JUN-2021, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T022314, expiration date 30-JUN-2022 and and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA) lot number T037954, expiration date 09-MAY-2022 (dose and route were not reported) for prophylaxis.  The temperature involved was 6.8 grades F for 50 minutes. A data logger was involved.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 23-FEB-2015 the patient was vaccinated with PROQUAD lot number K022445 (expiration date, dose, route, frequency and indication were not reported) that experienced a temperature excursion, which was later supported as well. There was no concomitant medication reported. At the time of the report, the patient's status was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
This report is being submitted by the guidance of the DOH. 13 patients were affected by storage and handling excursions.
Mild local rash (immediately after Tdap inoculation) at injection site left upper arm. No raised hives. TX ice pack to arm.
Generally feel not good; Tiredness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Generally feel not good), FATIGUE (Tiredness) and HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Generally feel not good), FATIGUE (Tiredness) and HEADACHE (Headache). At the time of the report, FEELING ABNORMAL (Generally feel not good), FATIGUE (Tiredness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information not provided.  Treatment information not provided.
redness of left arm, which is itchy and swollen; redness of left arm, which is itchy and swollen; redness of left arm, which is itchy and swollen; left arm sore for a day and went away; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (redness of left arm, which is itchy and swollen), ERYTHEMA (redness of left arm, which is itchy and swollen), PERIPHERAL SWELLING (redness of left arm, which is itchy and swollen) and PAIN IN EXTREMITY (left arm sore for a day and went away) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (left arm sore for a day and went away). On 31-Mar-2021, the patient experienced PRURITUS (redness of left arm, which is itchy and swollen), ERYTHEMA (redness of left arm, which is itchy and swollen) and PERIPHERAL SWELLING (redness of left arm, which is itchy and swollen). On 24-Mar-2021, PAIN IN EXTREMITY (left arm sore for a day and went away) had resolved. At the time of the report, PRURITUS (redness of left arm, which is itchy and swollen), ERYTHEMA (redness of left arm, which is itchy and swollen) and PERIPHERAL SWELLING (redness of left arm, which is itchy and swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Pfizer 3/1/21, 3/22/21. Positive on 11/28/22
happened literally 8 days after the injection. Outside running around and i started scratching my arm and later that night i took my shirt off and saw my arm was red and spread 2 inches. Lasted 6 or 7 days and gradually got better.
about 24 hours after receiving shot, fatigue but can't sleep, headache, muscle pain, chills but sweaty.
Mild rash on face and forehead which moved to trunk and upper extremities and a few on lower extremities. No itching or discomfort.
nausea; vomiting; This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number MP42R, expiry date 19th September 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 8 hrs after receiving Shingrix, the patient experienced nausea and vomiting. On an unknown date, the outcome of the nausea and vomiting were unknown.   It was unknown if the reporter considered the nausea and vomiting to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix between 5 pm and 6 pm, and approximately 8 hours later around 2 am developed nausea and vomiting.
This case was reported by a physician via a sales representative and described the occurrence of hepatitis A antibody negative in an adult male subject who was vaccinated with TWINRIX (GlaxoSmithKline). On unspecified dates in 2009, the subject received 1st and 2nd doses of TWINRIX. On 11 March 2009 the subject received the 3rd dose of TWINRIX (unknown, standard dosing). The subject received the TWINRIX on a 0, 7 and 21 day schedule. Eleven days after the 3rd dose of TWINRIX, hepatitis A and hepatitis B titers were drawn and were negative. Follow-up information was received from the reporting physician on 07 April 2009. The physician considered that the events could have been associated with lack of efficacy.
Telogen Effluvium-hair loss caused by stress or a sudden shock to the body. When I comb or wash my hair globs of it is coming out. There is no medication for this it is just supposed to clear up on its own. Hair is in a resting phase and when your hair is in this phase it is not growing!
It started out like a heavy cold. Not a lot of coughing but some coughing. Significant heavy phlegm. Over 4 days, on Friday 03/10/2023, when I called the doctor, he called a prescription for Paxlovid. I called him at about 10:00AM and his medical assistant called me around 11:30AM and we chatted. She called again around 01:00PM. I got the Paxlovid and took that that evening. I followed the course for 5 days. During that course, for 4 days I had a minor cough and heavy phlegm. No body aches or fever. About a day after I finished the Paxlovid, I had a slight increase for a few hours of the coughing and phlegm. Over a period of about 3-4 days, I still had some phlegm but it was gradually reduced, then I was pretty much asymptomatic. I did experience low energy for the next week or so after the symptoms were gone. Last November 2022, I did also have another case of COVID-19. It was a less intrusive infection than the second time around. Once again, I was feeling bad and went and saw the doctor because I thought it was a sinus infection. I was put on antibiotics for the sinus infection. I tested twice before I saw him, I was negative. Two days after seeing the doctor, I was positive. We set up a telehealth conference and we discussed things. We did talk about age and asthma and I had taken Paxlovid. I had no cough, I did have intense headaches that manifested later in the day. I also had lethargy for about two weeks during this infection. It took me about 8 days before I tested negative even with the Paxlovid. I did get a little bump in symptoms a day after I got off the Paxlovid, almost like a rebound. I did get intense headaches, but no lung involvement. No cough, no fever, a little runny nose but it felt like a light head cold.
This non-serious spontaneous case, initially received on 19-Dec-2017, by other health care professional, concerning a 26-year-old, adult female patient with weight 109 lb and height 61 inches. The patient had one previous pregnancy with no pregnancy complications (reported as no birth defect/congenital anomaly) and no concomitant diseases was reported. The patient had no history of tobacco, alcohol or illicit drug use. Concomitant medications included VITAFOL ONE for healthy pregnancy. The patient's last menstrual period was reported as on 24-Jul-2017. It was reported that there was no evidence of a defect/adverse finding from a prenatal test. On 12-Sep-2017, the patient received AFLURIA QUADRIVALENT (batch number: 00644623A, dose, route of administration, anatomical location, expiry date: not reported) at 7th week of pregnancy. It was reported that neither the patient nor the foetus experienced any adverse event. The outcome of the event was not reported. The patient's EDD (estimated date of delivery) was reported as 02-Apr-2018.
This case was reported by a consumer and described the occurrence of erythema of leg in an adult female subject who was vaccinated with influenza virus vaccine (Flu vaccine, manufacturer unspecified for prophylaxis. A physician or other health care professional has not verified this report. Concurrent medical conditions included egg allergy. On an unspecified date, 50 years ago when the subject was a child, she received an unspecified dose of Flu vaccine (unknown) At an unspecified time after vaccination with Flu vaccine, both the subject's legs became "beet red" The subject did not recall who made the Flu vaccine she received and did not recall any further information about the incident. At the time of reporting, the outcome of the event was specified.
Diffuse erythema entire left upper arm, lateral aspect, with moderate tenderness, single vesicle about 1 cm from site of injection, with tiny circular margin of raised papules surrounding injection punctum, headache in morning, and weakness of legs.
nausea; chills; achiness; headache; excruciating; sore throat; CT scan with nuclear dye as a workup for a condition she has been experiencing with her heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as 1st dose, single for covid-19 immunisation. Relevant medical history included: "migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "nausea"; CHILLS (non-serious), outcome "unknown", described as "chills"; PAIN (non-serious), outcome "unknown", described as "achiness"; HEADACHE (non-serious), outcome "unknown", described as "headache"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "excruciating"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "CT scan with nuclear dye as a workup for a condition she has been experiencing with her heart". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible. No further information is expected.
Pt reports weeping rash spread over entire body. Visited  urgent care several days later and was prescribed triamcinolone cream. Visited PCP several days later and was prescribed more triamcinolone as well as oral prednisone. Visited dermatologist today who told pt that she believes this is a reaction to vaccine and to continue triamcinolone/prednisone.
Information has been received from a consumer concerning her 73-year-old mother who has constant urinary tract infections and a history of lung cancer in 2005 (at that time she had about 16 to 18 chemo sessions) who on 21-May-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck) (lot #652966/0623F).  The daughter seems to think that the physician did not tell her mother she should not get the shot.  The patient's cancer is now in remission.  Concomitant therapy included sertraline HC1 (Zoloft).  Around late June or July the patient developed a rash that "kept growing up her arm".  She went to the dermatologist and they thought she was having a reaction to the vaccine.  They did a biopsy and found out that it was lupus.  The physician gave the patient medication that would make her get severe headaches, nausea and diarrhea (medication was not specified).  The patient has been deteriorating ever since.  The patient has been in and out of the hospital weeks at a time.  She was doing okay and feeding herself and walking and talking and now has lost a lot of weight, can not feed herself and does not talk.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  No further information is available.
Received second dose of vaccine on 4/11/2021 and felt fine after. On 4/12/2021, I had a headache and felt tired which I heard is common. What's uncommon is that on 4/14/2021, I began to get hives on my stomach and I've never had a hives break-out before receiving my second vaccine dose. On 4/15/2021, I wake up with hives all over my back, butt, stomach, shoulders and arms. My daily routine hasn't changed accept for getting my second vaccine dose. On 4/16/2021, I wake up at 1am with hives all over my body in the same places as 4/15/2021 but now my face was slightly swollen especially around my under eye area. Throughout each day, the hives would go away but they would come back at night.
Abdominal pain, headache, congestion, cough, runny nose dizziness, loss of appetite, ringing in the ears etc. Problems have continued with only two weeks relief at times.
This spontaneous report as received from a nurse practitioner refers to a 18 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 26-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. No adverse events were experienced. This is one of several reports from the same reporter. Additional information has been requested.
This case was reported by a healthcare professional (nurse) and described the occurrence of not responding to therapy in a currently 29-year-old male subject who was vaccinated with hepatitis B (unknown manufacturer). Concurrent medical conditions included Crohn's disease. Concurrent medications included PRAVACHOL, Metformin and Unknown for the treatment of Crohn's disease. On unspecified dates the subject received 1st dose, 2nd dose and 3rd dose of hepatitis B vaccine (unknown details). At an unspecified time after vaccination with hepatitis B vaccine, the subject experienced not responding to therapy. The nurse reported that a subject "with Crohn's Disease did not respond to first series of hepatitis B." The subject was treated with ENGERIX B administered on 13 June 2013. Per the nurse, this dose was the "first of 2nd series".
Information has been received from a licensed practical nurse concerning a 16 year old female who in September 2008, was vaccinated with GARDASIL. After receiving the dose of GARDASIL the patient had fainted. The patient was fine to leave the office. The patient sought unspecified medical attention. Follow up information has been received from the licensed practical nurse concerning a 19 year old female (previously reported as "16 year old") who on 27-FEB-2008 (previously reported as September 2008) was vaccinated with a first dose of GARDASIL (lot # 659657/1487U). Concomitant therapy included MENACTRA and ADACEL. The patient fainted and fell on the floor and regained consciousness. The patient recovered. The patient decided not to continue with GARDASIL. No further information was available.
I always received the flu vaccine.  The first year the H1N1 flu vaccine was included in the seasonal flu shot,  I had a horrible reaction.  I went pharmacy to get the flu vaccine and within 20 minutes of having received the vaccine, I almost fainted, had shortness of breath, dizziness, my legs were incredibly heavy like bricks and I could hardly walk and I was so beyond tired.  I had a headache too.  The following symptoms lasted about 3-4 months: extremely tired, had the horrible heavy legs (walking was hard), and a headache. I was a bit dizzy on and off to.  I went to doctors and urgent care where they checked my thyroid, blood, etc. and nothing was found.  I am too afraid to get another flu vaccine even though my parents want me to since there are young adults dying from the flu.  This is the first time reporting my reaction to the H1N1 seasonal flu vaccine.  I am not allergic to eggs.  I don't recall the specific date I received the vaccine but know it was early in the flu season in September or Oct.
Dose one, my left arm was swollen and painful for about 3 days; I was in symptoms similar to the Flu, very tired, needed to lay down for two weeks.  My system did not take to the vaccine until the end of week 3.  Second shot was no issues at all, as my system got through it.
Pt returned to clinic on 7/27/01 with red, raised whelps over face, trunk and arms with itching. No respiratory complaints. Used OTC Benadryl and told to go directly to doctor. The doctor Rx'd steroid treatment and continue on Benadryl. Took 1 shot on 6/15/01 and had a rash. Pt related it to something else and did not report it on the next visit.
I woke up on Nov 14th with extreme pain in my right arm, and I took some TYLENOL, it did not get better. But on the 17th I went to urgent care and they gave me tramadol, this is the same arm that I had a torn rotator cuff in, I took the medicine and I got worse. It was my birthday and then the November holiday and I did not want to go to the ER on those days but I went the next day and they did an x-ray and they could not find anything wrong. They gave me an injection of pain medicine and some things to take home, and sent me to an Orthopedic Dr., and he stated there was some kind of infection in my arm, some kind of blood infection or puss, and he sent me back to the ER and I was hospitalized on that day and was in the hospital for 3 days the 28-30th of November. They came back and took more tests and they could not find out what was wrong because there was no infection at all. They gave me more medicine and then discharged me from the hospital. I am still in pain, my daughter found an article that stated that the COVID-19 vaccine could cause frozen shoulder and that is what I believe that I have. This is something that effects people with Diabetes so this is what I think I have and I go back to my Orthopedic Dr. in Jan for my next cortisone shot.
Ill feeling about 2 1/2 hours, post vax. Pain was noticed to the arm around 22:00. The next AM, noticed redness at the injection site of pneumococcal vaccine. States he also had a fever (generalized). Went to health dept to see nurse but did not wait as the clinic was busy. Saw someone at a "walk-in" clinic. He had a fever of 100.7F and was started on an antibiotic 1 BID X 10 pills. Feels a little better. Temperature is now 99F. Redness at the injection site, 4 1/2" X 2 1/2", warm and slightly raised. Told to call back if any questions or problems. Given clinic number and nurses name.
Back was hurting; Back was hurting him terribly; Pain moved in from the front of his body to his neck; Back was hurting; Back was hurting him terribly; Pain moved in from the front of his body to his neck; Developed stomach virus and he started throwing up; Developed stomach virus and he started throwing up; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1ST DOSE), for COVID-19 immunization. The following information was reported: BACK PAIN (non-serious), NECK PAIN (non-serious), outcome "not recovered" and all described as "Back was hurting; Back was hurting him terribly; Pain moved in from the front of his body to his neck"; GASTROENTERITIS VIRAL (non-serious), VOMITING (non-serious), outcome "recovered" and all described as "Developed stomach virus and he started throwing up"; DIARRHOEA (non-serious), outcome "recovered", described as "Diarrhea". Therapeutic measures were taken as a result of back pain, neck pain, gastroenteritis viral, vomiting, diarrhoea.  Additional information: Three weeks ago, patient got vaccine at 9 o' clock in the morning and at 9 o' clock at night patient stood up and said his back was hurting. The next day, patient stayed mad all day long and he said that his back was hurting him terribly. Patient stayed mad and then the pain moved in from the front of his body to his neck and it lasted for about three or four days and then patient seems to be better but within another day, he developed stomach virus and he started throwing up and had diarrhea. It's had been two or three days and when that was over, the back pain was back and so patient had been taking some kind of anti-inflammatory (Unspecified Medication) and it was not really helping. It seems like patient was pretty much in and out ever since and that was his second dose. Reporter queried for Is that a side effect that anybody had reported or not. Reporter stated that trying to figure out what is wrong with him.  No follow-up attempts are possible. No further information is expected.