chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Urticaria Dermatographia / Hives all over my body/ itchiness; This spontaneous case was reported by a consumer and describes the occurrence of MECHANICAL URTICARIA (Urticaria Dermatographia / Hives all over my body/ itchiness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.  No Medical History information was reported.   On 21-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MECHANICAL URTICARIA (Urticaria Dermatographia / Hives all over my body/ itchiness). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 10 milligram. At the time of the report, MECHANICAL URTICARIA (Urticaria Dermatographia / Hives all over my body/ itchiness) had not resolved.     It was reported that 10 days after receiving the Booster shot of Moderna vaccine, patient experienced adverse event hives all over the body and it continued . Patient had medical appointment and was prescribed with steroids for 5days . Patient took Zyrtec10mg anti-histamine that seemed to stop the itchiness but it was still there at the time of report .  No concomitant information provided by the reporter
Flu like symptoms next day. Hives beginning next day starting on injection arm, and spreading to entire body over the course of the next week. Largest is approximately 6"x3", about 1-2 dozen quarter sized on arms and legs, many more approximately dime sized or smaller covering rest of body.
A patient received Prevnar 20 in 17May and since then she developed a lump in her arm; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 17May2022 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE MASS (non-serious) with onset 17May2022, outcome "unknown", described as "A patient received Prevnar 20 in 17May and since then she developed a lump in her arm". The action taken for pneumococcal 20-val conj vac (dipht CRM197 protein) was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Soreness, pain,  itching, swelling, redness at the injection site 8 days after receiving the 1 dose of the vaccine.
bad taste like metal weeks later my mouth  still feels like it was burnt to put my toung to the top of my mouth
Blurry Vision, Gaps in Vision, Dizziness (Vision issues lasted 6 hours) Dizziness 36 hours
pt recvd  vax 1MAR94, wake up crying 3MAR93 for more than 4 hours; no fever, no react local @ inject site;
Inflammation at the injection site in the right arm; difficulty to move the right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (Inflammation at the injection site in the right arm) and HYPOKINESIA (difficulty to move the right arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 16-Apr-2021, the patient experienced VACCINATION SITE INFLAMMATION (Inflammation at the injection site in the right arm) and HYPOKINESIA (difficulty to move the right arm). At the time of the report, VACCINATION SITE INFLAMMATION (Inflammation at the injection site in the right arm) and HYPOKINESIA (difficulty to move the right arm) outcome was unknown.            No concomitant medication was reported.  Treatment information not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact
Severe headache and severe fatigue, to the point that I could not stay awake even 16 hours after the shot.  Then I was awake for a few hours then could not stay awake again about 24 hours after the shot.    I took 400 mg of ibuprofen about 14 hours after the shot, when I was first awake enough to eat some food.  I am an 110-pound female so 400 mg seemed sufficient.  At about 26 hours after the shot, I took another 400 mg of ibuprofen before sleeping for the night.  I developed a low-grade fever (100-100.5) at that point and through the night.
Enlarged heart; This spontaneous case was reported by a consumer and describes the occurrence of CARDIOMEGALY (Enlarged heart) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included Hip surgery (Had few weeks ago.).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIOMEGALY (Enlarged heart). At the time of the report, CARDIOMEGALY (Enlarged heart) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: abnormal (abnormal) ENLARGED HEART.   No concomitant medication was reported. No treatment medication was reported.  Stress test and Chest X-ray done before the hip surgery.
Cellulitis at left deltoid.  Started 1 day s/p vaccine and progressively worsened pain erythema induration warmth.
Info has been received from a person working a physician's office concerning an 8 year old male, with no medical history and no allergies, who on 11/20/97 was vaccinated with a SC, 1st dose, in the right anterior thigh of varicella virus vaccine live. Concomitant vaccine administered on the same day included a 1st, SC, dose in the left anterior thigh of MMRII. There was no illness at the time of vaccination. It was reported that on 6/1/05, the pt was seen for a rash described as greater that 25 lesions on various areas of his upper body in the form of red bumps, some with vesicles, some with scabs and some urticaria. The dx was a varicella variant. Subsequently, the pt recovered. Additional info is not expected.
4 days (4/20/2021) post vaccination pain in right calf was experienced. As the pain did not resolve over the next week and felt similar to a DVT experienced post a spinal fusion in 2018 I consulted, on 4/16/2021, with the vascular surgeon, who treated my post surgery DVT in 2018 . He performed an ultrasound and identified a clot in my right calf. On 4/21/2021 he prescribed a course of Eliquis (initial dose 20 mg per day) to resolve the clot. As of today (4/23/2021) the pain has lessened but not resolved. In addition to the DVT I experienced a significant level of fatigue for 3 days post the vaccination. While the fatigue has lessened it has not completely resolved.
The patient's mother said that patient only ran a slightly elevated temp the day after immunization but no other symptoms. No treatment required.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not provided) on 20-AUG-2012, which had expired 18-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
The patient called 1 day after receiving the PNEUMOVAX and high dose flu shot. She said that the night of the shots she had a fever of 100 and her left arm was red, swollen to the touch, and had some hives. She had been taking ibuprofen which was helping  with the fever. I recommended she apply a cold compress to the injection site and also continue to take ibuprofen for pain/fever. I also recommended she take BENADRYL to help with the injection site reaction.
Arthralgia; fever; fatigue; Severe headache; This spontaneous case was reported by a physician and describes the occurrence of ARTHRALGIA (Arthralgia), PYREXIA (fever), FATIGUE (fatigue) and MIGRAINE (Severe headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced ARTHRALGIA (Arthralgia), PYREXIA (fever), FATIGUE (fatigue) and MIGRAINE (Severe headache). The patient was treated with IBUPROFEN at a dose of 1 dosage form. On 29-Jan-2021, ARTHRALGIA (Arthralgia), PYREXIA (fever), FATIGUE (fatigue) and MIGRAINE (Severe headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: (High) over 100.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ARTHRALGIA (Arthralgia), PYREXIA (fever), FATIGUE (fatigue) and MIGRAINE (Severe headache) to be possibly related.    No concomitant medications were reported.     This case was linked to MOD-2021-028515 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up received on 07-May-2021 and added Event stop date.
T102, sore arm-red & raised, nausea, h/a-little trouble breathing when temp was elevated (arm given pneumo);
arm was hurting; couldn't straighten arm because her back was hurting; abdominal/lower menstrual cramps; pain was a 9; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was hurting), BACK PAIN (couldn't straighten arm because her back was hurting), DYSMENORRHOEA (abdominal/lower menstrual cramps) and PAIN (pain was a 9) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was hurting), BACK PAIN (couldn't straighten arm because her back was hurting), DYSMENORRHOEA (abdominal/lower menstrual cramps) and PAIN (pain was a 9). At the time of the report, PAIN IN EXTREMITY (arm was hurting), BACK PAIN (couldn't straighten arm because her back was hurting), DYSMENORRHOEA (abdominal/lower menstrual cramps) and PAIN (pain was a 9) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment for the event included paracetamol and ibuprofen.
I was scared too take the second... is it too late; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I was scared too take the second... is it too late) 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 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I was scared too take the second... is it too late). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I was scared too take the second.. is it too late) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Patient reported to have had adverse effects after first dose and was scared to have the second shot No treatment medications were provided.
No adverse reaction reported; we are reporting an administration error.  The administering pharmacist gave the patient a pediatric dose of Moderna instead of the new bivalent booster.  We have contacted Moderna, and they recommended filing this report.
The vaccinee did not have gout, psoriasis, Crohn's disease, or history of Lyme disease. There was no family history of rheumatoid arthritis or lupus. The vaccinee received an injection of Lymerix approx. 1 year ago; exact date of immunization and number of previous Lymerix injections was unknown. The reporter stated that the vaccinee began to experience joint pain "recently". IThe joint complaints were evaluated by a physician. No swollen or warm joints were noted on physical examination. Joint fluid was not obtained. The vaccinee was treated with naproxen (Naprosyn) 500 mg twice daily orally from 12/18/01 to 1/4/02 and with celecoxib (Celebrex) 200 mg twice daily orally from 1/4/02. As of 1/4/02, the outcome of the event was unknown. It was not known if he had sought medical treatment. No further information was available at the date of this report.  The adverse event "joint pain" does not meet serious criteria but is being submitted as an expedited report by special FDA request per the 6/28/00 letter.
Severe headaches originating from my right eye & thru my head. I have never experienced headaches in my life. I now have them every evening, thru the night, and into the morning. This all started on the day I received this vaccine.
Localized rxn initially and progressed to chest tightness and pain, myalgia over 2 days. Treated with prednisone burst and taper and resolved fully by 10/27/15.
Within a week I started feeling tingling in fingers and toes. This gradually increased in intensity and led to numbness and severe back pain. I thought I had a pinched nerve so went to chiropractors/physician for a few weeks (June - July 15th) . By this point I could not drive as my hands and feet were completely numb. I had to walk with assistance.  I had 3 falls, stumbled often, extreme fatigue, shaking hands. They suggested xrays and then and MRI of spine (July 14th) which showed inflammation and lesions between C4 and C7 as they suspected some other inflammation issues. She recommended seeing neurologist. Dr. reviewed MRIs and admitted to ER at General Hospital for further testing (July 16th) where Dr. did spinal tap, had MRIs of brian and spine with contrast. I was put on steroids via IV for 4 days then released to go homenwith physical therapy.
"my innards and writing are very shaky...I had a covid booster shot on Thursday and it is more noticeable since then." UNKNOWN which covid booster patient had.
About 24 hours after receiving  the vaccine, I started with a dull headache (scale of 1-5, 5 being the worst, it was a 1), and onset of chills  (scale of 1-5, 5 being the worst, it was a 3 )and flushing. The chills lasted about 4 hours. About 36 hours after receiving the vaccine, I noticed swelling of my lymph nodes under my left arm.  (scale of 1-5, 5 being the worst, it was a 4) It is about the size of tennis ball, it is causing discomfort and hard to sleep. It is painful.  The flushing, headache and chills all went away.
I took Ibuprofen and Benadryl when I got home, then went to sleep. The site are was swollen and painful. About 10 inches in diameter. Over the next couple of days, it continued to get larger. My arm was more swollen and more painful. About 19 hours after vaccine, I had a fever of 100.9. I had chills and scratchy throat. I took Tylenol. Fever didn't break until 54 hours after injection. The site reaction was less painful and less swollen at that point.  I also put some hydrocortisone cream on it as well.
I began having redness at the site of injection, or raise my arm above my elbow bend, and could not raise hand. The arm was slightly swollen. I still have the same issues with it, but can move it more. When I went to see my dr she said to keep moving it, and gave me prednisone, and that did help some.
DTP recvd 10JAN92 & morning of 14JAN92 pt c/o h/a mom took temp was 106; pt given tepid bath; no diarrhea, no nausea or vomiting only c/o h/a; Pt taken to MD who felt not related to vax; blood test done @ hosp w/no abnormal results per mom;
a patient was administered an improperly stored VARIVAX; No additional adverse events; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender.   The patient's concurrent conditions and medical history were not reported. Concomitant medications included sterile diluent.  On 05-DEC-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, frequency, route of administration and anatomical location were not reported) lot # R024265, expiration date 27-NOV-2020, for prophylaxis; which was reconstituted in a properly stored sterile diluent. The administered dose of the vaccine experienced a temperature excursion from -14 Celsius degrees (°C) to -10°C (-12°C) for 30 minutes and from -9°C to 8°C (-2°C) for 1 hour. There was no previous temperature excursion and this report was not called because of a data logger. There were no adverse events reported. No product quality complaint was involved.
Booster dose of Pfizer given on 11/29/21. Was out with a friend on 11/30/21 and developed a severe headache and loss of sight. Went to local ER and was then transferred  to the Hospital.  DX of brain bleed. Was inpatient for 2 days.  Is back at home and doing well at this time.
Got the vaccine and about an hour later started losing vision in the left eye. Everything appeared blurry and had to stop wearing contacts and switch to glasses.
Pt received vax in right deltoid and complaint of stinging at time of administration. On 5/17/2000 stated that injection site will sting periodically. Has full strength and full range of motion of right arm.
Patient did receive PEDVAXHIB series 2doses as an infant in 2003; No adverse event; This spontaneous report as received from a medical assistant refers to a 15 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2003(reported as near 2003), the patient was vaccinated with 2 doses of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) as an infant. On 17-JUN-2019, the patient was inadvertently vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # R005114, 26-NOV-2020 dose 3, intramuscular for prophylaxis as the nurse retrieved vaccine in error. No adverse effects were reported.
Information has been received on 18-JUL-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 18-FEB-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a physician's office as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 18-FEB-2014, the patient was treated by a physician's assistant at a physician's office for a blistering vesicular outbreak, which was diagnosed as shingles. The patient was prescribed VALTREX for management of his painful symptoms and chronic pain. On or about 24-JUN-2015, the patient sought subsequent treatment from a nurse practitioner for a persistent vesicular rash, which was diagnosed as post-herpetic neuralgia, a chronic condition of pain and nerve damage secondary to herpes zoster infections. The patient was prescribed hydrocodone-acetaminophen for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, 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. Additional information has been requested.
Prest swelling and erythematous rash about 8 cm in diameter with tenderness to palpation.
Patient is a 65-year-old, female. Alert, oriented X4, clear speech, able to answer to questions. History of hypertension. History of allergies of Sulfa drugs, certain fruits and red meat. Patient informed vaccinator that she had been to her PCP after receiving her first dose to report her reaction to first dose, which required treatment with IM Benadryl. Patient's PCP gave patient approval to receive second dose. Patient given 30-minute observation time with EMTs. At 9:09 am, the patient received her second dose of Pfizer (lot number EW0185, expires on 08/2021) on left deltoid. At 9:11 am, EMT noticed patient in EMT observation area in tripod positioning. EMT responded by taking patient's vitals. EMT alerted lead RN of adverse reaction. While RN drew up IM Benadryl, EMT  assessed patient and took vitals. Patient states she feels pressure starting from her lower back that radiates to the back of her neck. At 9:16 am: BP 210/148, SPO2 98%, HR 89. EMT  called 911 at 9:20 am while RN monitored patient. Patient told RN she would like to decline EMS. EMT gave phone to patient. Patient told EMS over the phone that she would like to decline EMS. EMS triaged and evaluated patient over the phone. At 9:22 am, EMS canceled services. At 9:23 am, RN gave patient 50 mg/1mL of IM Benadryl in right deltoid. Patient reports a headache, pressure in her neck. Patient experiencing generalized pruritus on arms bilaterally. At 9:28 am: BP 207/128, SPO2 97%, HR 94. Patient states she took her daily hypertension medications in morning. Patient denies SOB. At 9:33 am: BP 237/155, SPO2 96%, HR 88. Patient denies headache, SOB. Patient reporting minor neck pressure. Describes pressure as ?getting better?. At 9:38 am: BP 243/151, SPO2 98%, HR 85. Patient states she is ?feeling fine? and denies SOB and headache. Rash on patient?s arms has resolved. Patient?s husband calling PCP to report patient?s elevated BP. At 9:42 am: BP 196/118, SPO2 99%, HR 88. At 9:50 am: BP 184/112, SPO2 98%, HR 89. Patient ingested 8 oz of water, denied any discomfort. Patient provided with education on when to call 911. At 9:50 am: BP 186/112, SPO2 97%, HR 87.  At 9:55 am, patient stood up from chair, denies lightheadedness and dizziness. Patient walked to car with steady, balanced gait at 10:00 am. Patient states her husband will be taking her to healthcare facility immediately to meet with PCP concerning patient?s elevated BP.
Information has been received from a RN concerning an adult pt who on 02Nov05 was vaccinated with pneumococcal 23v polysaccharide vaccine (0.5ml) (SC) (lot 649912/0529P). On 02Nov05 the pt experienced injection site soreness, warmth, erythema, swelling and general malaise. The pt was considered to be recovering. Unspecified medical attention was sought. Attempts are being made to obtain additional information to distinguish the individual pt's mentioned in this report. Additional information will be provided if available.