chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On day 8, I woke up with the injection site red, swollen, itchy, painful, burning, hard and hot. I am currently taking benedryl, cold compresses and over the counter pain medication for it. My pharmacist said it is Covid Arm and should go away in 3 to 5 days.
Information has been received from a doctor of pharmacy concerning a 19 month old pt who was vaccinated with haemophilus b conjugate vaccine. The pt received the vaccine at 2, 4, 6 and 18 months. Three weeks after receiving the vaccine at 2, 4, 6 and 8 months dose, the pt developed fever and lethargy. Additional information has been requested.
Inside her body is shaking; dizziness; tiredness all day; soreness in her hand; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0167), via an unspecified route of administration on 11May2021 between 03:00 to 03:30 (at the age of 45-year-old), as dose 2, single in left arm for COVID-19 immunisation at Pharmacy/drug store. The patient's medical history included ongoing hypothyroid problem. Concomitant medication included levothyroxine started taking from last 7 years for hypothyroid problem, start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FP7533), via an unspecified route of administration on 20Apr2021 between 03:00 to 03:30 (at the age of 45-year-old), as single dose in left arm for COVID-19 immunisation. The patient had no prior vaccinations within 4 weeks. On 11May2021, 1 hour after administration of second dose of vaccine, the patient experienced soreness in her hand for a duration of 1 day. On 12May2021, 1 day after the administration of second dose of vaccine, the patient experienced tiredness in the evening for all day. On 13May2021, 2 days after the administration of second dose of vaccine, morning time when she woke up inside her body was shaking and got dizziness; continued even on the 10th day. Patient did not require a visit to Emergency Room or Physician Office. Patient did not receive any treatment for the events. The clinical outcome of event soreness in her hand was resolved on 12May2021, clinical outcome of event tiredness all day was resolving; and clinical outcome of all other events was unknown.  Additional information is requested.  Follow-up attempts have been completed and no further information is expected
Swollen lymph nodes just above my collar bone on each side.; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 30Mar2021 at 10:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medication included estradiol-noreth (MANUFACTURER UNKNOWN) since an unknown date for an unknown indication. The patient had no past drug therapy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Apr2021 at 09:00, the patient experienced swollen lymph nodes just above her collar bone on each side. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event swollen lymph nodes just above her collar bone on each side was not resolved at the time of the report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: GR8737) via an unspecified route of administration in the left arm on 20Apr2021 at 11:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Vaccine site was red, hot and had abscess under the skin. Pt has received Gardasil-9 previously and never had this response. This was her 2nd Gardasil-9.
Donor stated that when she woke up the day after receiving the shot that she noticed her arm was sore and some redness. Upon evaluation: redness present at injection site and is 2 inches in dia. site is warm. Stiff and sore around 2 inch diameter barrier. Donor states her arm is sore w/certain activities. No hx of reactions for herself or any known family members.
I had the vaccine at 3:30pm, and 12 hours later at 3:30am, I woke up with muscle cramps all over my body, chills, and probably a fever. Then shortly thereafter, the vomiting and diareeha started, and then I was very dizzy with dizziness. Then at some point, I was dizzy enough that I took my blood pressure and it was very low, it was 89/62. The vomiting and diareeha lasted for 24 hours. I ate some crackers and ginger ale with lots of water though. Blood pressure stayed low for probably 5 days, it got better each day, then normalized 5-6 days after vaccine. I still get dizzy when I bend low, and it's going on 6 weeks. I only spoke with my doctor, no visits.
t105.6 R on 7AUG; seen by MD who prescribed an ATB; 8AUG temp still up mom took pt to ER dx viral infection; 10AUG broke out in blotchy rash mostly on legs;
was administered only the diluent; was administered only the diluent; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a child female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA710A, expiry date 30th April 2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 14-NOV-2022 Reporters comment: The health care professional reported that after vaccination of 5 patients they became aware one of them was administered only the diluent of menveo without the lyophilized part but did not know which patient was. The reporter consent to follow-up by email. This case was for 2 of 5 linked patients, reported by same reporter. Additional Supportive information: The patient received the menveo vaccine before reconstitution with only the diluent portion which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022168204:same reporter US-GSK-US2022168209:same reporter US-GSK-US2022168210:same reporter US-GSK-US2022168199:same reporter
This case was reported by a physician and described the occurrence of abnormal liver function tests in an infant subject of unspecified gender who was vaccinated with ENGERIX B (GlaxoSmithKline). There was no information available regarding concomitant vaccinations, medications or medical history. On an unspecified date the subject received 1st dose of ENGERIX B (details unknown) at birth. Less than one week after vaccination with ENGERIX B, the subject experienced abnormal liver function tests and fever. Blood levels were checked 6 days after vaccination with ENGERIX B and abnormal liver function tests were noted, along with fever. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. No additional information was available. Follow-up information received on 03 September 2009 indicated that the events of abnormal liver function tests were likely secondary to herpes simplex virus type II infection and not ENGERIX B. It was reported that the subject died with cause of death reported as herpes simplex virus type II. An autopsy was performed, however, results were not provided.
itching on the injection site / kind of red and it is really itchy; itching on the injection site / kind of red and it is really itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 06Mar2021 (Lot number: EN6205) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJECTION SITE PRURITUS (non-serious), INJECTION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "itching on the injection site / kind of red and it is really itchy".  Additional Information: The patient just has a question about how common itchiness is at the site of the Pfizer vaccination. I am about to get my 2nd one and I had itchiness like couple a days after at the injection site, kind of red and it is really itchy and I just wanted to know how common that was and whether I should be concerned at all that it will be worse for my second one.  No follow-up attempts are possible. No further information is expected.
No additional AE details; Improperly stored PROQUAD administered after storage outside of PI.; This spontaneous report was received from a registered nurse and refers to a patient of unknown demographics. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.  On 12-OCT-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T018275, expiration date 23-NOV-2021, albumin status rHA (exact dose, route of administration and anatomical location were not reported) for prophylaxis, outside of prescribing information (PI) storage and handling.  The vaccine underwent a temperature excursion of negative 14 degrees Celsius to negative 10 degrees Celsius for 1 hour and 11 minutes. Digital Data Logger was not involved in recording of the excursion. No previous temperature excursion was reported. No adverse effects were reported.
Blistering at the injection site; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE VESICLES (Blistering at the injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004mdoA) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced INJECTION SITE VESICLES (Blistering at the injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, INJECTION SITE VESICLES (Blistering at the injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown.            Treatment medications were not provided by the reporter. No concomitant medications were reported by reporter.
Back pain. Developed symptoms of weakness, numbness and tingling extremities, shortness of breath, activity intolerance - Guillain Barre - hospitalization 11-6 - 11-16 IGG therapy. I would like to know why these serious adverse events are not being reported. Guillain Barre is a horrible syndrome to live with. It is much more common than 2 in one million. Nurses in the hospital named over 2 to 3 people who had the syndrome. This is a rural community concerned.
This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-JUL-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N012132 with expiry date: 17-APR-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
Breakthrough case admission after 3 vaccines Moderna 2/27/21 Lot# 031L20A;  Moderna 3/27/21 Lot# 002B21A;  Moderna 11/27/21 Lot# 012H21B
Student became nauseated and feeling dizzy. Skin moist to touch, pale for 2-3 minutes. No SOB, no respiratory distress observed. Student recovered within 5 minutes - color pink feeling better. States she usually has this react to injection or blood drawn.
pt c/o lt arm pain & weakness approx 30hr p/vax;pt cont w/series #2 & #3 w/o recurrence;however, residual weakness in lt arm & lt index finger paralysis remain;
WEIGHT LOSS; This spontaneous report received from a consumer concerned multiple patients. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced weight loss. Laboratory data (dates unspecified) included: Weight loss (NR: not provided) 5-8 lbs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of weight loss was not reported. This report was non-serious. This case, from the same reporter is linked to 20210829077.
Pt had redness in the arm, a little swelling that started from the injection site to almost her elbow. It was a little warm to touch too when she was reporting it on 6/16/18. Pt said it started the night on 6/14/18 and it was progressively getting bigger. She is treating it with some TYLENOL and thinks the swelling seems to be going down. If it still persist, she will see her MD on Monday.
On 3/23, I received the vaccine. Within a few hours, my right elbow began to hurt and swell. On 3/24, I could not move my arm due to inflammation and intense pain. The skin was hot to touch. I also had a high fever and severe headache. (The fever broke within 24 hours and the headache lingered for about 48 hours.) On 3/25, the arm swelling started to decrease but was still intensely painful, red, and hot. I treated the arm with ice packs, Advil, and Bio-freeze. On 3/25, I also contacted my PCP by email with my concerns and progression photos of my arm. Another doc responded by having his nurse call me. They denied the reaction could be vaccine related. The nurse insisted on their diagnosis and that I should take antibiotics for a skin infection. I disagree because my symptoms did not match their explanation. On 3/31, I contacted my rheumatologist (due to the inflammation) and they referred me back to my PCP. I am filing this report b/c I believe this was related to the vaccine. Lesser symptoms remain.
Patient called the pharmacy 9/20/2017 to inquire on the reaction she thinks is from the flu shot she received on monday 9/18/2017. She came in so I could visually see the reaction site. There was redness and warm to the touch. With permission I was able to draw around the red reaction and measure across to be 4 inches. We gave her an ice pack and recommended topical benadry or hydrocortisone cream.
Red blotch; little itchy and pink around the injection site; little itchy and pink around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (little itchy and pink around the injection site), RASH MACULAR (Red blotch) and VACCINATION SITE ERYTHEMA (little itchy and pink around the injection site) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (little itchy and pink around the injection site). On 22-Mar-2021, the patient experienced RASH MACULAR (Red blotch) and VACCINATION SITE ERYTHEMA (little itchy and pink around the injection site). At the time of the report, VACCINATION SITE PRURITUS (little itchy and pink around the injection site), RASH MACULAR (Red blotch) and VACCINATION SITE ERYTHEMA (little itchy and pink around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information not provided
The patient said she had an allergic reaction to the Prevnar 13. Her arm was swollen and she had redness from her neck to past her elbow on the left arm. She said the rash itched. She also experienced chills, sweating and nausea. She took hydroxyzine, which was prescribed for her for allergic reactions. The arm seemed to be getting better. She said she had called her primary care physician.
dizzy; nausea; pain in stomach that lasted almost 5 days; Now I currently have a sore throat as well and coughing; I'm energy has been sparse Off and on; Now I currently have a sore throat as well and coughing; I feel hot most of the day; I felt better for 3 then became sick again with same symptoms; I get severe migraines; This is a spontaneous report from a contactable Other HCP. Patient reported that:  A 35-years-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 Vaccine, Solution for injection, Batch/Lot Number: 1474461-09258) via an unspecified route of administration, administered in Arm Right on 10Sep2021 14:30 (Age at vaccination 35-years-old) as DOSE 1, SINGLE for COVID-19 immunization. No medical history was reported. The patient had no known allergies. Concomitant medications included Gardasil the patient received second dose of Gardasil in left arm on 01Sep2021 within 4 weeks prior to the COVID vaccine and cyred for Birth Control. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19.  On Sep2021, the patient reported I get severe migraines, patient currently have a sore throat as well and coughing and patient energy has been sparse Off and on. On 10Sep2021 16:45, the patient experienced dizzy, Nausea, pain in stomach that lasted almost 5 days. It was reported that 2 hrs after injection: dizzy, nausia, and pain in stomach that lasted almost 5 days. I felt better for 3 then became sick again with same symptoms. I get severe migraines now that I have to take Advil for everyday or I can't think straight. And I'm energy has been sparse Off and on. Now I currently have a sore throat as well and coughing. I feel hot most of the day. I haven't felt like myself since. Feels like I got sick from it. I was told I would feel better by a Dr by day 4 and to keep taking Advil and drink water. Which I have done. Doctor or other healthcare professional office/clinic visit. The outcome was reported as unknown for patient energy has been sparse Off and on and not recovered for rest all of the events.    Follow-Up (23Sep2021): Follow-up attempts are completed. No further information is expected.
A report has been received from a study investigator concerning a 32 year old, female subject, height: 60.0 inches; weight: 127.0 pounds, enrolled in study. No relevant history was reported. The patient did not receive any concomitant medications. The study therapy was started on an unknown date for influenza. The date of last menstrual period was 03-Aug-2013. The patient experienced pregnancy which was started on 03-Aug-2013. The outcome of the pregnancy was reported to be a healthy baby. The number of weeks at outcome of pregnancy was 38.6. The report was considered to be non-serious. The study investigator considered that there was no causal relationship between pregnancy and study therapy.
Information has been received from a physician concerning a 15 year old patient who on 13-MAY-2008 was vaccinated with first dose of GARDASIL (Lot # not reported).  On 14-JUL-2008 patient received second dose of GARDASIL (Lot # not reported) 0.5ml.  After the second dose of vaccine patient developed allergic reaction.  Patient received third dose of GARDASIL (Lot # not reported) on 18-NOV-2008.  On approximately 18-NOV-2008.  The adverse event disappeared after got third dose of vaccine.  This is one of two reports from the same source.  Additional information has been requested.
HSV-1; Painful and feels like burning in mouth; Feels like burning in mouth; Nausea; cold sore in mouth, several in lips; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES SIMPLEX (HSV-1), ORAL HERPES (cold sore in mouth, several in lips), ORAL PAIN (Painful and feels like burning in mouth), ORAL DISCOMFORT (Feels like burning in mouth) and NAUSEA (Nausea) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ADALIMUMAB (HUMIRA), METOPROLOL, MACROGOL 3350 (MIRALAX), PREGABALIN (LYRICA), RABEPRAZOLE, LINACLOTIDE (LINZESS), ATORVASTATIN, DULOXETINE, ACETYLSALICYLIC ACID (ASPIRIN 81), BUPRENORPHINE HYDROCHLORIDE (BELBUCA), AZELASTINE HCL and LISINOPRIL for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced ORAL HERPES (cold sore in mouth, several in lips). On an unknown date, the patient experienced HERPES SIMPLEX (HSV-1), ORAL PAIN (Painful and feels like burning in mouth), ORAL DISCOMFORT (Feels like burning in mouth) and NAUSEA (Nausea). At the time of the report, HERPES SIMPLEX (HSV-1), ORAL HERPES (cold sore in mouth, several in lips), ORAL PAIN (Painful and feels like burning in mouth), ORAL DISCOMFORT (Feels like burning in mouth) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included Valacyclovir 500 mg 2 tablets everyday for 10 days
I thought my left  arm was just sore from the shot. But as days went on, my left shoulder, arm all the way down to my left hand ached constantly. It was not from the injection site but my entire left side of chest, shoulder and arm.  This lasted more or less continuously  for 4 weeks. I joked to my husband that if I died, to check for  a heart attack. As time went on, I heard reports of myocarditis and now wonder if I had that. In March 2021 I had not heard a word asbout these side effects.   I had my second Moderna shot in my right arm on March 25 at 10 am. 03A21A  Sudden severe stomach cramping and nausea 12 hours after which lasted about 1 day then I was fine. I had no arm pain the second time (right side).