chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to clinic for Hepatitis B #2 as she had never received the vaccine series and her PCP recommended she start it. Vaccine was administered without incident and patient was discharged from clinic.  When documenting the vaccine the administering provider realized that patient inadvertently received a pediatric hepatitis B vaccine. She was given Engerix B 0.5 mL PFS in left deltoid rather than the adult Engerix B 1.0 mL PFS. The manufacture, GSK, was contacted for recommendation on dosing schedule for this patient. They recommended EBP supports giving adult dose at this time. Patient was contacted and informed of error, advised she get repeat adult dose in 14-28 days. Patient had no questions or concerns at this time.
Less than 24 hours later I started bleeding again and my period was done for about 2-3 days. I started to get intense cramps and I started to pass the biggest clots I have every passed in my life. It was for about 10 days, it was severe in the beginning and then started to dwindle as time passed. It stopped on May 1st, 2021. It threw my cycle out of whack. It was for about a couple months until it regulated itself.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Concurrent conditions, medical history, historical or concomitant drugs were not reported. On 26-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX Injection, lot # M035696, expiration date 07-NOV-2017, for prophylaxis (strength, route and anatomical location not reported). Later, on 18-DEC-2017, the patient received an extra dose of ZOSTAVAX Injection, lot # N025703, expiration date 16-DEC-2018 (strength, route and anatomical location not reported). Both doses were reconstituted with sterile diluent for which lot numbers and expiration dates were not reported. The registered nurse confirmed that this occurred due to a human error and was not related to product confusion. No adverse events were reported.
Patient reports: "After receiving J&J covid vaccine I developed a rash all over my back. I also became flushed. I was afebrile. I had diarrhea for 72 hours, I had enlarged lymph nodes and felt like my inner body temperature was extremely high. I was itchy for 3 weeks post shot.
Needle broke off and a portion of the vaccine dribbled down her arm; Needle broke off and a portion of the vaccine dribbled down her arm; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Needle broke off and a portion of the vaccine dribbled down her arm) and NEEDLE ISSUE (Needle broke off and a portion of the vaccine dribbled down her arm) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced UNDERDOSE (Needle broke off and a portion of the vaccine dribbled down her arm) and NEEDLE ISSUE (Needle broke off and a portion of the vaccine dribbled down her arm). On 17-Mar-2021, UNDERDOSE (Needle broke off and a portion of the vaccine dribbled down her arm) and NEEDLE ISSUE (Needle broke off and a portion of the vaccine dribbled down her arm) had resolved.        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.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
Information has been received from a physician concerning a 73 year old female who in approximately 2009 (reported as "about a year ago") was vaccinated with a 0.65ml dose of ZOSTAVAX (Merck) (Lot number not provided). It was reported that in the past couple weeks the patient developed shingles in the facial region even though she had been given ZOSTAVAX (Merck). No lab diagnostics studies were performed. The patient sought unspecified medical attention. At the time of reporting, the outcome of the patient was unknown. Additional information has been requested.
Right deltoid is sore, swollen, and red (6.5 cm by 7.5 cm) at 4 am on 10/8, vaccine given on 10/7 at 7:30 am. No treatments tried, except ice pack. Denies hives, rash, trouble breathing, lip/throat swelling, or fever.
Nursing home called and said my mother appeared to have something similar to a stroke - her right side went limp and she was non-responsive for about 10 minutes.
Bad chronic liquid diarrhea 8 to 10 times a day; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Bad chronic liquid diarrhea 8 to 10 times a day) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 024M20A and 010A21A) for COVID-19 vaccination.     Patient had no allergies to food, medications and other products. Patient did not test positive for Covid-19 diagnosis. Patient did not receive other manufacturer vaccine one month prior to receiving Moderna Covid-19 vaccine.  Concurrent medical conditions included Migraine (40 years ago, no changes observed recently). Concomitant products included SUMATRIPTAN for Migraine.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (Bad chronic liquid diarrhea 8 to 10 times a day). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at a dose of Imodium for 4 months; CHOLESTYRAMINE at a dose of UNK, qid; CIPROFLOXACIN HCL at a dose of 500 milligram; METRONIDAZOLE at a dose of 250 milligram three times a day; PROBIOTICS NOS at an unspecified dose and frequency; ATROPINE SULFATE, DIPHENOXYLATE HYDROCHLORIDE (DIPHENOXYLATE/ATROPINE) at an unspecified dose and frequency and LEVOTHYROXINE SODIUM (SYNTHROID) at a dose of Synthroid for 2 months. At the time of the report, DIARRHOEA (Bad chronic liquid diarrhea 8 to 10 times a day) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Allergy test: nothing abnormal found nothing abnormal found (food allergy panel). On an unknown date, Biopsy: nothing abnormal found nothing abnormal found. (9 biopsies performed).. On an unknown date, Blood test: nothing abnormal found nothing abnormal found. On an unknown date, Colonoscopy: nothing abnormal found nothing abnormal found. On an unknown date, Endoscopy: nothing abnormal found nothing abnormal found. On an unknown date, Endoscopy small intestine: nothing abnormal found nothing abnormal found. On an unknown date, Exocrine pancreatic function test: nothing abnormal found nothing abnormal found.         Patient reported that received 3 vaccines on deltoid muscle upper arm.  Patient received booster dose. Patient reported that episodes always appeared 20 minutes after eating anything. Patient sometimes stayed 3 days without eating to avoid having any depositions. Patient sought medical care for the adverse event. It was reported that symptoms were  worsened with all the medication doctors gave to patient except for Imodium as this medication was suspended by doctors because had opioid on his formulation. .
Headache, nausea , chills, sweating, gland?s swollen in neck and arm pits. Diarrhea on day five. I have taken ibuprofen daily and anti nausea medicine.
Patient complained of new headache . Onsite EMS was called vitals BP 103/70  98% O2 room air HR 74. Patient treated and released against medical advice.
Due to prior diffuse cutaneous eruption with last Moderna vaccine, pretreatment with double dosage of Zyrtec (20 mg) was instituted several hours beforehand.  When the Zyrtec wore off the next day (2/17) around 3:30 pm,  sensations of tingling and numbness began in the mouth and throat.  I immediately took another double dose of Zyrtec (20 mg) and the sensations subsided within an hour.  Another Zyrtec 10 mg was taken around 6 am on 2/18.  Around 5:30 pm, sensations arose again only more intense.  They progressed to numbness, tingling, and the feeling of swelling in the lips, soft palate and gums, tongue, the back of the mouth, and the throat down to the level of the sternum.  No visual evidence of swelling or auditory wheezing was noted, but the voice started sounding rasping.  I once again took a double dose of Zyrtec (20 mg) and symptoms started to improve in 1 hour.  The odd tingling of the lips, throat, and tongue persisted, and I chose to monitor them closely rather than proceed to prednisone, benadryl, or epinephrine just yet.  We will continue with strong antihistamines at this point, but further vaccines are not warranted.   A virtual tele-visit was initiated with my primary care provider, Dr.  We can update with further information, when available.
Client was given an inactivated polio vaccine dose that had been taken from an open multi-dose vial that had been subject to temperature excursion.  Vaccine had been at greater than 46 deg. F for 27 minutes earlier in the day on 4/01/2019.  vaccinating nurse was not aware of the temperature excursion at the time of administration.
Information has been received from an office manager referring to multiple unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # M023380 with expiration date 11-MAY-2018; lot # M023384 with expiration date 11-MAY-2018; dose and route were not reported). It was reported that the vaccine was improperly stored at -5.6 Celsius (C) for 1 hour and was then back in range. Prior temperature excursions included -12.4 C for 30 minutes and -12.7 C for 26 minutes. No adverse effects were reported. Data logger was involved. This is one of two reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. No concomitant medications or medical history was reported. On 15-OCT-2015 the patient was vaccinated with PROQUAD (Merck) lot # L005292 with expiry date-17-AUG-2015, which was improperly stored. No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. The events were considered to be not related to PROQUAD (Merck). Additional information is not expected, no contact details were provided.
Lots of headaches. On June 9, 2021, Vision in left eye became fragmented and jumbled and stationary objects appeared to move. Didn?t clear up for 72+ hours. Couple days later felt like I was having a heart attack, pain and tightness in chest, tightness in jaws, short of breath
soreness in arm/Arm soreness; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "soreness in arm/Arm soreness".  Additional information: The reporter reported that reporting for herself, she mentioned that she had a coworker that had it last month. She only had soreness in arm and nothing that month. She did have a few days of soreness in arm and then it was better. She did not wish to complete report for her and unable to confirm which vaccine she received. This report was to capture information for her coworker.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201377871 same reporter/product, different patient/AE;
This spontaneous report as received from a registered nurse refers to a 4 week (also reported as 2 months) old male patient. No concurrent condition or medical history reported. On 21-APR-2015 at 11:58 hours, the patient was vaccinated with one dose of RECOMBIVAX HB, (Lot# L001456) intramuscular (RVL) which was exposed to temperatures outside of the recommended range. On the same day, the refrigeration temperature was out of range for 30 minute (-1.8 degree Celsius). It was advised that the vaccine was not stable to be revaccinated. The patient was vaccinated at private doctor's office and the vaccine was purchased with public funds. Additional information has been requested.
Headache; Chills; arm soreness; The dose was given on the 34th day after the vial was thawed; This spontaneous case was reported by a health care professional and describes the occurrence of HEADACHE (Headache), CHILLS (Chills), VACCINATION SITE PAIN (arm soreness) and EXPIRED PRODUCT ADMINISTERED (The dose was given on the 34th day after the vial was thawed) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The dose was given on the 34th day after the vial was thawed). On an unknown date, the patient experienced HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE PAIN (arm soreness). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE PAIN (arm soreness) outcome was unknown and EXPIRED PRODUCT ADMINISTERED (The dose was given on the 34th day after the vial was thawed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant product were reported  On 19-JUL-2021 updated query given as event. on 19-JUL-2021 updated query has resolved   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up received on 19-JUL-2021 and does not contain any new information On 07-Aug-2021: Non-significant follow-up received on 07-AUG-2021.contact information updated ,Patient demographic was added.
Pain in the throat; Difficulty of breathing; Felt like Covid again; Body aches; Muscle pain; Headache; Fever; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (Pain in the throat), DYSPNOEA (Difficulty of breathing), MALAISE (Felt like Covid again), PAIN (Body aches) and MYALGIA (Muscle pain) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    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 OROPHARYNGEAL PAIN (Pain in the throat), DYSPNOEA (Difficulty of breathing), MALAISE (Felt like Covid again), PAIN (Body aches), MYALGIA (Muscle pain), HEADACHE (Headache), PYREXIA (Fever) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-Mar-2021, OROPHARYNGEAL PAIN (Pain in the throat), DYSPNOEA (Difficulty of breathing), MALAISE (Felt like Covid again), PAIN (Body aches), MYALGIA (Muscle pain), HEADACHE (Headache), PYREXIA (Fever) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Mom called Health Dept at 12:30 stating infant got up this morning with welps from head to toe; MD closed this afternoon; encouraged eval at ER.
Arm pain, headache, fever, severe pain in all body muscles for more than four hours, which did not decrease after two capsules of naproxen sodium 220mg and 28 oz of water.
Local erythema, indurated injection site right deltoid about 7 x 7 cm induration and erythema, warm to touch. C/O fever, fatigue.
Sore throat, cough, green, yellow phlegm from nose and chest. Low grade fever. Injection sight red and swollen. Pain in chest.
Employee states after injection he felt "burning and soreness" at injection site. Employee states the burning and soreness have continued since.
Per nursing note: The pts arm is red and swollen. Pt stated he expected to some pain or irritation but this is really bad, and he thinks he has had an allergic reaction to his pneumonia. Pt states the arm he received a pneumonia shot is swollen to his elbow and reddened. Pt states his arm hurts a lot. Also has headache since received shot.
This spontaneous report as received from healthcare worker refers to a 41 year old male patient. On 05-AUG-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (lot # J006572, exp. date 07-JUN-2015, 0.5 ml, subcutaneous in the right arm. The patient had no concomitant medication, no medical history and no drug reaction. On 16-AUG-2014, the patient developed 15-20 red, raised, itchy lesions on his scalp, torso and extremities after receiving (Oka/Merck) VARIVAX. The lesions were described as having a "head". The patient also experienced malaise, fatigue, joint pain and possibly a low grade fever. The treatment was not given for events. No lab diagnostics. The patient called office for medical attention. The outcome of events was reported as not recovered/not resolved. Action taken and causality were not reported. Additional information has been requested.
no immediate adverse effects or events.  I contracted COVID and tested positive of 12-15-2022, upon returning from a 7 day vacation.
Arm pain intensified throughout the evening elevating to total body aches (including  toes and shins) by 1:15am to the point of calling EMS to house.  She was treated with diphenhydramine 50mg.  This was able to reduce pain and allow her to sleep.  After this point, the outcome remains unknown.
patient had a reaction; This spontaneous report as received from a patient's daughter and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 26-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and influenza virus split virion 3v vaccine inactivated (FLUZONE (INFLUENZA VIRUS SPLIT VIRION 3V VACCINE INACTIVATED)) (exact dose, route of administration, lot # and expiration date were not reported) one shot in each arm for prophylaxis. On an unknown date in September 2019, the patient had a reaction. The outcome of the event was unknown. The relatedness between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and influenza virus split virion 3v vaccine inactivated (FLUZONE (INFLUENZA VIRUS SPLIT VIRION 3V VACCINE INACTIVATED) and the event was not provided.
Headache Slight fatigue, chills, injection site pain and swelling, nausea, diarrhea and fever (48 hrs. later).  Narrative:   Other Relevant History:
pt stood up immed p/last inj & stumbled around went back to chair, slid off side of chair, into floor, opt back-up, face real pale & gray, sweaty & eyes glazey, nurse laid pt on floor kept trying to get up; cant breath; tried to upchoke
On 8/10/01 at 19:00, pt vomited until 8/11/01 in the AM and then she had an onset of a headache, nausea, fever and fatigue. Symptoms continued on an intermittent basis. On 8/23/01, pt seen by PMD and put on Inderal and Vioxx for 1 month. Pt is to see PMD on 9/7/01 for evaluation. On 9/5/01, mother reports that headaches continue. Other symptoms have resolved.
Inflammation, redness and warm to touch to RD  25mg diphenhydramine given IM
Initial unsolicited report received from a consumer on 06-Jun-2017. This case involves a 35-year-female patient (also reported as 36 year) who was vaccinated with a dose of INFLUENZA VACCINE (Unknown Flu) and tested with TUBERCULIN PPD (Unknown PPD) intramuscularly (Batch number, expiration date, dose, dose in series and site of administration were not reported) on 17-Apr-2017. Patients medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was none. Illness at the time of vaccination was also reported as none. Any other vaccinations within four weeks of vaccinations were unknown. On 18-Apr-2017, one day (since the day) after following the vaccination, the patient started cough, weakness and flu like symptoms. On an unknown date, following vaccination patient developed burning in her mouth and throat had no appetite after receiving (NAPROXEN SODIUM) Aleve and corocidin (reported as Corocidin). Patient had been to the emergency room 4 times and the doctor visit was 5 times and some weeks it was 2 times in the week. They have given her medicines but, she doesn't take them they don't help. She has another appointment with her primary care physician advised her to continue his follow up recommendations. Laboratory investigations was unknown. Corrective treatment were Aleve 2 times and a weeks of corocidin (reported as Corocidin). The outcome of the events were not recovered. List of documents held by sender: none.
Patient states that her arm was swollen from shoulder to elbow and had rough raised bump at injection site. Area was hot to touch. Rough patches spread to several areas that were itchy. Urgent Care said it was allergic reaction.
This spontaneous prospective pregnancy report has been received from a female consumer (of unknown age) for GARDASIL a Pregnancy Registry product, refers to her self. In May 2012 the patient was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL, lot# not reported. Shortly after her injection she discovered that she was 2 months pregnant at the time of the injection. The patient stated that at the time of the report she was 5 months pregnant. Follow up information was received from a nurse who stated that the patient was dismissed from their clinic and possibly delivered by another physician, and the baby was fine after being delivered by cesarean section (c-section). Upon internal review, the event "Caesarean section" was considered to be medically significant. Additional information has been requested.