chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore in arm; sore in thigh; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore in arm) and MYALGIA (sore in thigh) in a male patient of an unknown age 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 MYALGIA (sore in arm) and MYALGIA (sore in thigh). At the time of the report, MYALGIA (sore in arm) and MYALGIA (sore in thigh) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Unable to capture reporter's contact details for further followup.   Reporter did not allow further contact
VS 99/63, 82, 20, O2 stat-100% on RA, Pt c/o of "not feeling well, can't really  see (vision change), abdominal cramping (Abd BS presentx4 quadrants), pale, vomitx1.  Pt only had cookies for breakfast, gave 1 slice of orange, EMS activated and arrived within 10 minutes, reported to EMS and transferred care.  Pt's mom by side, pt transferred to hospital.
Information has been received from a registered nurse concerning a 21 month old female with no known allergies or medical history who on 29-MAR_2006 was vaccinated SC in the left thigh with a 0.5 mL first dose of Varivax (lot # 646670/0627R). Concomitant vaccination on the same day in the right thigh included a fourth dose of PREVNAR. On 22-JAN-2007, the patient presented to the office with approximately 10 lesions, small red bumps on the breast, back, buttocks, and stomach. The child also had a low grade temperature for two days. The patient was also noted to be teething. The nurse stated that no treatment was required, just TYLENOL as needed for fever. The patient was to be isolated from day care for one week. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been received from the registered nurse who reported that the patient was seen in the office on 22-JAN-2007. The mother noted a small red pimple-like bump on the center of the stomach in the AM of 21-JAN-2007. More were noted on the day of the visit. She had 10 papules with near vesicles on the trunk. She was advised of signs and symptoms and was in isolation for 7 days. She was to follow-up prn. The patient recovered on 31-JAN-2007. Additional information is not expected.
I had my first Moderna vaccine on April 2 and my arm didn't hurt, it was tender around the injection area but was only slightly painful if I accidentally poked it, I could sleep on it, etc. That got better after three days and there was nothing and on April 10,  8 days later I have significant pain and the area around the injection site is all red and swollen and the operation of my whole arm has been affected (significant pain to type on a computer) and the pain grew to include  my collarbone area as well. I took 600 mg of Ibuprofen and a sleeping aid and slept for 10 hours, it was much better the following day, although still swollen and red and still better today day 10 from the injection..
approx 8 days p/vax w/MMR pt devel persistent fever to 105 & fine red rash on arms; fever lasted approx 3 days responding to Ibuprofen & tepid baths; rash persisted for 3-4 days; recovery was complete;
ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY HYPOTENSION ACUTE HYPOXEMIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY
(L) thigh with induration & approximately 6 cm swelling & erythema at site. Resolved all erythema & swelling with BENADRYL 125 mg and TYLENOL 80 mg - Pt recovered.
Patient reported several symptoms the days and weeks following vaccination.  These included fatigue, diarrhea, headache, nausea, sweats, chills and cough.  These persisted for 3 weeks.
Information has been received from a registered nurse, via a company representative, concerning a female patient (age not reported), who on an unspecified date was vaccinated IM with a dose, 0.5 ml, of Gardasil (lot # not reported). With the vaccination, the patient experienced "severe injection site pain that seemed to radiate in the arm to the wrist." The patient sought unspecified medical attention. Additional information has been requested.
Almost 2 weeks after the shot, I have a lump under my left armpit. Shot in my left arm was 8/27 and lump appeared 4/8.
pt recv vax; warm; gave apap;MD advised to cont apap; tepid baths; devel rash & cried x 2 days;resolved x 2 days;
About two weeks after my shots, I started to develop chronic hives. I have no changes in my lifestyle or dietary habits, but will develop hives all over my body that come and go with an extreme itch. They?ll change location. Zyrtec or Claritin will take them away within 30 minutes but i really don?t want to have to take an antihistamine for the rest of my life. I found other documented cases at this site
This is a 71-year-old male with a past medical history of atrial fibrillation on Xarelto, CAD status post PCI, CHF with unknown ejection fraction, dementia, prostate cancer, hypertension, hyperlipidemia, gout, status post permanent pacemaker, DNR status, group home resident, who presented the emergency department with complaints of shortness of breath and abdominal pain over the past 3 days.   7/20/2021 tested positive 7/25/2021 discharged  This is a very pleasant 71-year-old male patient with a known medical history of atrial fibrillation on Xarelto, CAD with history of cardiac stents, congestive heart failure of unknown type, dementia, prostate cancer, hyperlipidemia, gout, hypertension who presented to the ED with worsening shortness of breath as well as abdominal pain for the last 3 days.  Patient states he lives at home alone, cares for himself independently and noticed over the last 3 days he has become short of breath even at rest.  He states that he has had associated abdominal pain without any nausea or vomiting for the last 3 days as well.  Denies any recent fevers, chills, cough, headache, nausea, vomiting, diarrhea or dysuria.  Patient states that he has not taken any antibiotics or change his medications at home.   He states he has been very compliant with his medications including his several toe.  Patient does have a cardiologist, Dr., last seen a year ago with reported echo and stress test at that time which was reportedly unremarkable.  Patient does not use home oxygen.  He had a pacemaker placed years ago.  Upon evaluation patient is hypoxic requiring supplemental O2 at 2 L nasal cannula with findings of bilateral pulmonary embolism while on Xarelto as well as bilateral pleural effusions.  Patient is on heparin drip at this time and cardiology has been consulted for evaluation as well as Hematology/Oncology.  Patient denies any chest pain, presented with a troponin of 28.  Continue to trend.  EKG showing right bundle-branch block with no prior EKG in the system.  It should be noted that patient drinks 3 beers a day, denies ever having any withdrawal symptoms. Patient will be admitted for further evaluation and stabilization.
This spontaneous report was received from a pharmacist referring to a female patient of unknown age. Concurrent conditions or pertinent medical history were not reported. On an unsepcified date in 2015 (reported as 4 or 5 days ago), the patient was vaccinated wiht a dose of ZOSTAVAX (lot #, dose, route of administration and frequency were unspecified). Concomitant medications were not reported. Approximately on Septemebr 2015, the patient received a prescription for prednisone (unspecified adverse event). The reporter stated that she did not know why the patient was prescribed the prednisone, however, she considered it was for a pre-existing condition and that the need for the medication was not related to the patient receiving ZOSTAVAX. At the time of the report, the outcome of adverse event was unknown. The relatedness between ZOSTAVAX and the unspecified adverse event was not related. Additional information has been requested.
Red, swollen, painful when movement. (NOT hot to the touch, NOT painful when touches it, only painful with movement)
pt had sz starting @ approx 1030PM on 4JUN95; mom states did not think pt had temp; became cyanotic; father gave CPR; t101;
VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced drug allergy when treated with acetylsalicylic acid, and ibuprofen.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the patient experienced vaccine exposure during pregnancy. On 19-JUL-2021, Laboratory data included: MRI (NR: not provided) baby was diagnosed with a fetal stroke, and ultrasound scan (NR: not provided) baby was diagnosed with a fetal stroke. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccine exposure during pregnancy. This report was non-serious. This parent/child case is linked to 20210922547.
Fever; Chills; Aches and pain; Nerve issues in her right leg/nerve pain similar to shingles 15 years ago; This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced 15 years ago prior to the reporting).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 5 hrs after receiving Shingrix, the patient experienced fever, chills, pain and nerve pain. On an unknown date, the outcome of the fever, chills and pain were recovered/resolved and the outcome of the nerve pain was not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, pain and nerve pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-Jun-2022 Reporter's comments: The patient received Shingrix 5 months from time of reporting, and 5 hours after her first dose, she experienced fever, chills, aches and pain which lasted for several days. The patient also reported that a few weeks after her dose, she developed nerve issues in her right leg which was still ongoing, and this nerve pain was similar to the nerve pain she had when she had shingles 15 years prior to the reporting. The reporter did not consent ed to follow-up.
Chest pain, joint pain, fatigue for more than a month now. Heart has burning sensation and feel pain neck.
Patient stopped by on 3/8 to show pharmacist the area under the site was red, circular- looked like a rash-  no pain, tingling sensation, was able to move arms without pain- the site was just red and a little itchy as per patient- ongoing after got the vaccine. Advised the patient to use hydrocortisone and if no improvement in 2 days to see the doctor to verify if a true allergic reaction.
Right after she received her dose, she just had a sore arm. 13 hours after vaccination, patient had a dry cough that woke her up from sleep. She then started to get a headache and took ibuprofen. She spike a temp of 99-102 degrees Fahrenheit. Blood pressure elevated to 165/100. One hour later it was 155/101. Normal baseline is 110-130/55. No visual changes occurred. After 8 hours, the blood pressure normalized. By 01/02/21, all symptoms had dissipated. I referred her to see her cardiologist for approval before second dose.
Reports  on 9/11/21, one day after 2nd vaccination given, has been having SOB, Dizziness, dyspnea at times, sluggish, body ache.  HBP that had been controlled with medications prior to injections.   Today: 9/23/21, continues with same adverse events  BP 180/100            HR 110       O2 @ 96% on RA.   presents with SOB, Dizziness
This spontaneous report as received from a Immunization Program refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of improperly stored PNEUMOVAX23 (lot # H010515, expiration date 13-FEB-2014) (dose and route not reported). Additional information is not expected.
Arm pain and redness, fever to 100.2, body aches, chills  for three days .   Tylenol on 2nd day. third day symptoms resolved.
Patient reports rash/redness extending from injection site to elbow along with intermittent tingling in arm
Red, swollen, warm, painful arm. Diffuse mylagias, fevers about 2 hours after receiving vaccine.
pt recvd vax & became irritable & w/ t 101-102; reported to MD ofc;
Improper administration due to expired vaccine on July 13, 2022. Patient didn't report of any side effects or other outcomes. Received notification once vaccine is received, it can be kept in the freezer for 6 months. To prevent it from happening again, will use the vaccine expiration tool to know the exact expiration date.
his wife had the Moderna vaccine and had A-Fib twice; his wife had the Moderna vaccine and had A-Fib twice; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of ATRIAL FIBRILLATION (his wife had the Moderna vaccine and had A-Fib twice) and the second episode of ATRIAL FIBRILLATION (his wife had the Moderna vaccine and had A-Fib twice) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced the first episode of ATRIAL FIBRILLATION (his wife had the Moderna vaccine and had A-Fib twice) (seriousness criterion medically significant) and the second episode of ATRIAL FIBRILLATION (his wife had the Moderna vaccine and had A-Fib twice) (seriousness criterion medically significant). At the time of the report, last episode of ATRIAL FIBRILLATION (his wife had the Moderna vaccine and had A-Fib twice) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 170 170.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The patients husband performed Carotid massage but no impact. Then patient was taken to ER and treated for A-fib. patients heart rate was 170 when arrived in hospital. Both times A- fib happened 3 weeks after the Moderna vaccine. Concomitant medications was not provided.   Company Comment: This is a spontaneous case concerning an adult female patient of unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) AESI of Atrial fibrillation which occurred twice 3 weeks after receiving a dose of mRNA-1273 Vaccine, dose number not specified. As reported, carotid massage was performed on patient, with no impact; thus, she was taken to the emergency room where heart rate was noted to be 170 beats per min. Unspecified treatment was done with unknown result. There was also no available information regarding diagnostic tests done and clinical course. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an adult female patient of unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) AESI of Atrial fibrillation which occurred twice 3 weeks after receiving a dose of mRNA-1273 Vaccine, dose number not specified. As reported, carotid massage was performed on patient, with no impact; thus, she was taken to the emergency room where heart rate was noted to be 170 beats per min. Unspecified treatment was done with unknown result. There was also no available information regarding diagnostic tests done and clinical course. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Information has been received from a physician for the pregnancy registry for GARDASIL concerning a 16 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who on 22-AUG-2008 was vaccinated with the first dose of GARDASIL. There were no concomitant medications reported. It was reported that the patient received the first dose of GARDASIL and got pregnant. On 21-OCT-2009, the patient got the second dose of GARDASIL Lot #0702) and the third dose on 01-DEC-2009 after having the baby. The patient had a "normal prenatal care". The patient sought medical attention with an office visit. All telephone attempts to obtain follow up information have  been unsuccessful. Additional information has been requested.
Allergic reaction not relieved by Benadryl for over a week. Severe itching, tingling throughout my entire body, racing heartbeat, and difficulty breathing. Give Prednisone 20mg to take twice a day for 5 days. Additionally, as a breastfeeding mother, my daughter (6 months at the time) broke out in hives from nursing and had to be taken to the ER. She was given children's Benadryl and Hydrocortisone cream to relieve the itching and hives. Furthermore, my milk supply decreased drastically and over the course of the past 7 weeks, I have worked with her pediatrician who is a lactation specialist to try and bring my milk supply back but now I am no longer producing breast milk. Her pediatrician has stated she has seen some of her other mothers have had a decrease in milk supply. I did nothing different that would warrant any of these reactions besides get the first dose of the vaccine.
had shingles shot, but ended with shingles/suspected vaccination failure; shingles; painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had shingles shot, but ended with shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and pain (Verbatim: painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 13-Mar-2023 The case was received from the patient via interactive digital media. The patient had the shingles shot but he/she had ended up with shingles and there painful. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Pt vaccinated with TD/PPD c/o pain & reddness at injection site sent to hospital for exam & treatment.
A rash that started on the shoulders and face and then spread to the trunk of my body. Eventually it covered most of my arms and legs as well.
Left humerus warm to the touch and swollen from shoulder to elbow. Improved sx next day. Reported by patient.
Axp 6 min after vaccine was given patient started to complain of tightness to abdomen below right ribs. Then some tightness in chest, nausea and tightness in throat felt like there was something stuck in throat. When assessed by this nurse noted to be slightly pale, respirations easy and even no audible wheezing or strider noted, skin warm and dry to touch. BP stable between 108/68-112/70 q 5 min x 45 min. Pulse 70-76 q 5 min x 45 min strong and steady. Lungs clear bilat. no wheezing or strider noted. Benadryl 25 mg po given at 1022am. Prior to Benadryl administration all symptoms resolved. Patient monitored for for 45 min post initial assessment. No further issues reported during observation period. Ambulated to vehicle without assist. Provider office notified of event. They will follow up with her.
flushing in her face / flushed; face is visibly red; face/ feels warm; . This case was reported by a consumer and described the occurrence of facial flushing in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th November 2020, the patient received the 2nd dose of Shingrix. On 29th November 2020, 1 days after receiving Shingrix, the patient experienced facial flushing, red face and feeling of warmth facial. On an unknown date, the outcome of the facial flushing, red face and feeling of warmth facial were not recovered/not resolved.   It was unknown if the reporter considered the facial flushing, red face and feeling of warmth facial to be related to Shingrix.  Additional details were provided as follows: Patient woke up with flushing in her face also her face was visibly red and it felt warm. Patient did not have a fever or high blood pressure Patient was not sure if that was due to Shingrix or just a coincidence. The reporter consented to follow up.
This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt lousy) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 013M20A) for COVID-19 vaccination. The patient's past medical history included Balance disorder (Balance issues). On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (Felt lousy). On 04-Mar-2021, MALAISE (Felt lousy) had resolved. No concomitant medications were provided. After the first dose the patient did not have side effects. After the 2nd primary dose, the patient felt lousy. No treatment medications were reported. This case was linked to MOD-2022-549121, MOD-2022-548661 (Patient Link).
patient began having chest pain on 6/10 that progressively worsened over the past 24 hours. He was diagnosed with pericarditis and costochondritis. We have started colchicine and ibuprofen and will monitor overnight.
pt started to feel trembly over her body. vital signs and blood sugar were checked in a subsequent manner for observation. pt was laid down to help her calm down and keep comfort.  Blood pressure was on average of 190/100 with an average heart rate in the 90s.
Vaccinated with seasonal flu shot in upper left arm at approximately 8:30am. Returned to clinic at 9:55am complaining of pain at injection site and itchiness to left arm. Raised rash to upper left and upper right arm. No hives. No difficulty breathing. Mother contacted at approx. 10:03. Father contacted and came to clinic - took son to doctor after leaving clinic at 10:34am.
Severe itching on trunk ( arms, chest, back) as well as neck and head, by 9 am the next day the hives / rash appeared as small bumps and then turned to raised spreading rash.  Called pharmacist and doctor's office I was advised to treat with Zyrtec and topical steroid. Also applied Cer?ve anti itch cream every few hours.  My husband showered and that provided temporary relief. Even the little bit of relief he gets from the Zyrtec doesn?t last more than 8 hours. Its has been  3 days and his symptoms are not resolving. I increased the  Zyrtec to 10 mg every 12-15 hours yesterday. Also stopped myrbetriq since pharmacist indicated there is possible contraindications with the antihistamine.   .