chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 70 year old female who on 3/10/04 was vaccinated SC in the left arm with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647655/0869N). The RN reported that on 3/11/04, 24 hours after being vaccinated, the patient developed redness, swelling, and tenderness of the left arm. Ice was recommended as treatment. However, by the same evening, the patient developed more swelling that went around the circumference of her left arm. That same night, the patient presented to the ER and was treated with IV antibiotics. The patient was not hospitalized, but would need to continue outpatient antibiotic treatment at the hospital for seven days. At the time of this report, the patient's redness, swelling and tenderness of her left arm persisted. The RN noted the dose given was the first from the vial and he would like lot 647655/0869N checked. Upon internal review, redness, swelling and tenderness of the left arm were determined to be other important medical events (OMIC). Additional information has been requested. Follow up information was received from the RN who reported that on 3/11/04, the patient went to the ER. The patient was seen in triage at 22:10 and complained of redness and swelling. At that time, her pain was 8 out of 10. The patient was sent to an outpatient area where, at 22:35, she received 2 grams of cefazolin Na IV. The RN indicated that the patient's temperature was normal at 97.5 and her respirations were 20. A complete blood count was normal with no white count issues. There were no x-rays or electrocardiograms done. The patient was instructed to elevate the injured area and return to the ER every eight hours for 24 hours to receive 2 grams of cefazolin as an outpatient. The patient was discharged from the ER at 23:32 reporting her pain as 0 out of 10. The RN reported that the patient received a total of three doses of cefazolin and had no other problems. The RN noted that it sounded as if the patient was recovered. Follow up information was received from the RN who reported that the patient developed a small reddened area at the injection site at 12 hours. The entire upper left arm was red and swollen at 24-26 hours. The patient went to the ER with severe pain. She was started on cefazolin Na. The pain was gone after the first dose of cefazolin Na. The patinet completed the cefazolin Na therapy. Subsequently, the patient recovered. The records of testing prior to release of this lot have been checked by quality assurance and was found to be satisfactory. The lot complies with the standards and was released. No further information is available.
pt recvd vax 27JUN95 & 28JUN95 had fever of 101.2 oral, swelling of lt arm deep aching of muscle, spine & joints;dizzy;4 days for ROM to return to arm;saw MD 28JUL95
Swelling, fever 104, within 24 hrs, hospitalized 2 days given Abx.
Tiredness; sweaty; Nerve pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), HYPERHIDROSIS (sweaty) and NEURALGIA (Nerve pain) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced HYPERHIDROSIS (sweaty) and NEURALGIA (Nerve pain). On 10-May-2021, the patient experienced FATIGUE (Tiredness). On 09-May-2021, HYPERHIDROSIS (sweaty) and NEURALGIA (Nerve pain) had resolved. At the time of the report, FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient has been treating the pain with steroid dose packs given by their chiropractor. No concomitant medication details was reported.
Information has been received from a registered nurse concerning a 14 year old female who on 09-JUL-2007 was inadvertently vaccinated with a dose of Zostavax (Oka/Merck) instead of VARIVAX.  It was reported that the error was not due to product confusion.  There was no adverse experience related to this event.  There was no product quality complaint involved.  No further information was provided.  Additional information from the registered nurse indicated that there were 2 boxes in the refrigerator and she grabbed the vial out of the wrong box.  She called the patient the next day and she was fine.  Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Additional information from the physician indicated that the patient had no known allergies or pertinent medical history. There was no illness at the time of vaccination. There were no labs performed. The physician also confirmed that the patient had no adverse experience. Additional information is not expected.
This spontaneous report as received from a Nurse refers to a 29 year old patient on unknown gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 07-FEB-2018, the patient was vaccinated with M-M-R II, and on 05-MAR-2018 (also reported as "26 days later"), the patient was vaccinated with VARIVAX (dose, route, lot number and expiration date were not reported) for prophylaxis. No adverse effects reported.
Information has been received from a medical assistant concerning a female patient who was vaccinated with GARDASIL (vaccination date, dose number and lot number not reported). The patient developed pancreatitis after vaccination (date unspecified). Medical attention was sought by office visit. It was unknown if there were lab studies performed. At the time of the report, the patient not recovered. Upon internal review, pancreatitis was determined to be an other important medical event. Additional information has been requested.
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent condition, or concomitant medication. The patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 23-MAY-2012 by a physician for routine health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster (onset unknown). On an unknown date, "shortly after" receiving the ZOSTAVAX, the patient developed reduced vision eventually leading to partial blindness in one eye. Thereafter, the patient was diagnosed with retinal necrosis of his left eye. As a direct and proximate result of these malfunctions, 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. Upon internal review, reduced vision eventually leading to partial blindness in one eye/retinal necrosis of his left eye was determined to be medically significant. Additional information has been requested.
Inappropriate age./ a pediatric dose of Engerix-B was administered to an adult patient; Inappropriate age./ a pediatric dose of Engerix-B was administered to an adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 22-year-old male patient who received HBV (Engerix B pediatric) (batch number 5M93R, expiry date 05-APR-2024) for prophylaxis.   On 23-JUN-2023, the patient received the 1st dose of Engerix B pediatric. On 23-JUN-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Inappropriate age./ a pediatric dose of Engerix-B was administered to an adult patient) and adult use of a child product (Verbatim: Inappropriate age./ a pediatric dose of Engerix-B was administered to an adult patient). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 23-Jul-2023 The reporter did not consent to follow-up. Earlier on the day of reporting, a pediatric dose of Engerix-B was administered to an adult patient, which led to underdose and adult use of a child product.
Shortness of breath weeks after; gastrointestinal issues; painful menstrual cycles; This is a spontaneous report from a contactable consumer. This 29-year-old female consumer (Patient) reported. A 29-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 2 via an unspecified route of administration, administered in Arm Right on 23Aug2021 (at the age of 29-years-old) as a single dose for covid-19 immunization. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. Medical history included covid-19. The patient's concomitant medications were not reported. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was diagnosed with COVID-19. On 01Sep2021, the patient experienced shortness of breath weeks after, gastrointestinal issues, painful menstrual cycles. The patient underwent lab tests and procedures which included sars-cov-2 test: negative- Nasal Swab. Since the vaccination, the patient had been tested for COVID-19. Adverse event resulted in patient to visit doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Outcome of the event was not recovered, at the time of this report. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Mother reports that within 1 week after pt got his MMR, he stopped walking and talking and has gradually improved.  Still in speech therapy.
A report was received from a health care professional on 25 November 2003, concerning a 3 year old female vaccinee who inadvertently received Fluvirin on 12 November 2003. On 12 November 2003 the vaccinee inadvertently received 0.25 ml of Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 1, 11 March 2004: Further information received from a health care professional indicated that the vaccinee did not experience any adverse reaction at the time of the report. No follow up pending, all information received. See Ref: PJP200301183, PJP200400052, PJP200400051, PJP200400050, PJP200400049, PJP200400048, PJP200400047, PJP200400046, PJP200400045, PJP200400044, PJP200400043, PJP200400042, PJP200400041, PJP200400040, PJP200400039, PJP200400038, PJP200400037, PJP200400036.
chest pain; High blood pressure; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (chest pain) and HYPERTENSION (High blood pressure) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 020B21A) for COVID-19 vaccination.     Medical history was not provided by the reporter.  Concomitant products included LOSARTAN, BACLOFEN, SIMVASTATIN, IRON, FISH OIL and POTASSIUM for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced CHEST PAIN (chest pain) and HYPERTENSION (High blood pressure). The patient was treated with METOPROLOL TARTRATE at a dose of 25 milligram; GLYCERYL TRINITRATE (NITROGLYCERIN) at a dose of 1 UNK and ACETYLSALICYLIC ACID (BABY ASPIRIN) for Chest pain, at a dose of 81 milligram. On 26-Apr-2021, CHEST PAIN (chest pain) and HYPERTENSION (High blood pressure) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Apr-2021, Chest X-ray: inconclusive (Inconclusive) Inconclusive. On 26-Apr-2021, Computerised tomogram: inconclusive (Inconclusive) Inconclusive. On 26-Apr-2021, Electrocardiogram: inconclusive (Inconclusive) Inconclusive.         Treatment medications include Metoprolol and Nitroglycerin.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Updated stop date and outcome of the event. On 04-Jun-2021: Follow-up information included non significant information.
have been diagnosed with Dermatomyositis; had red rashing everywhere; I also had a red ring around the injection site for 4.5 months; I began to lose strength in my arms and legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FH8027) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: hypothyroidism" (unspecified if ongoing), notes: Other medical history: hypothyroidism; "Other medical history: hashimotos" (unspecified if ongoing), notes: Other medical history: hashimotos; "Other medical history: vitiligo" (unspecified if ongoing), notes: Other medical history: vitiligo; "Known allergies: pollen" (unspecified if ongoing), notes: Known allergies: pollen. Concomitant medication(s) included: PANTOPRAZOLE; LEVOTHYROXINE; ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for hypersensitivity. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EN6202, Route of Administration: Intramuscular), administration date: 08Mar2021, when the patient was 65-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247, Route of Administration: Intramuscular), administration date: 12Feb2021, when the patient was 65-year-old, for COVID-19 immunization. The following information was reported: VACCINATION SITE ERYTHEMA (disability) with onset 13Aug2021, outcome "not recovered", described as "I also had a red ring around the injection site for 4.5 months"; ASTHENIA (disability) with onset 13Aug2021, outcome "not recovered", described as "I began to lose strength in my arms and legs"; RASH ERYTHEMATOUS (disability) with onset 13Aug2021, outcome "not recovered", described as "had red rashing everywhere"; DERMATOMYOSITIS (disability, medically significant) with onset 13Aug2021, outcome "not recovered", described as "have been diagnosed with Dermatomyositis". The events "have been diagnosed with dermatomyositis", "had red rashing everywhere", "i also had a red ring around the injection site for 4.5 months" and "i began to lose strength in my arms and legs" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of dermatomyositis, rash erythematous, vaccination site erythema, asthenia included lots of medical care.  No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse concerning a female who on 02-AUG-2006 was vaccinated with the first dose of HPV rLi 3 11 16 18 VLP vaccine (yeast).  It was reported that the patient fainted "shortly after receiving the vaccination".  The nurse did not feel the experience was vaccine related and stated "the patient was very uneasy with the idea of an injection".  The patient subsequently recovered "shortly after fainting".  Unspecified medical attention was sought.  Additional information has been requested.
May 17, 2021:  sever shortness of breath, low grade temperature, muscle aches for 2 weeks. Worsening.   ER Hospital on May 30, 2021. Diagnosis:  DVT (left leg); multiple PE's bilateral lungs
A report has been received from a Medical Rep concerning 5 patients of unknown age and gender. No medical history, concurrent diseases and concomitant medications were reported. On an unknown date, the patient received FLUMIST QUADRIVALENT (intranasal). It was reported that 5 patients got FLUMIST and then came back in and tested positive for influenza A. The outcome of the event of five patients tested positive for influenza A is unknown. The report was considered to be non-serious by the reporter.
p/vax pt noted erythema @ site on lt arm;1hr ago noted pruritus & induration & pain;now w/6cm erythema & induration;sl warm to touch;non tender, no axillary adenopathy;
pt recv vax 20MAR97 & 28MAR97 pt devel a rash all over body that looks like measles;31MAR97 pt presented to MD;had t012.4;
This spontaneous report as received from a physician via field representative, refers to a female patient of unknown age. Patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (via the intramuscular or subcutaneous route). On an unknown date, the patient experienced a "reaction to PNEUMOVAX23 -she developed cold sweats, flu like symptoms, rash from elbow to shoulder on injection site arm and cellulitis. Patient sought medical attention-she visited the physician's office. Patient was treated with unspecified antibiotics. The outcome of the events was unknown. Causality assessment was not provided. Addition information has been requested.
chills; nausea; headache; dizziness; sore arm; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9267, Expiry Date: 31May2021), via an unspecified route of administration, administrated in right arm on 13Feb2021 16:40 (age at the time of vaccination 67-years-old), as a single dose for COVID-19 immunization. The patient's medical history included Asthma, and some allergies to medications. The patient's concomitant medications were not reported. On 14Feb2021, the patient experienced sore arm; on 15Feb2021 nausea, headache, dizziness, and 16Feb2021 chills. Caller would like to know how long she should expect these symptoms to continue. No further information provided. The outcome for all the events was not recovered; and dizziness was recovering.  Follow-up (17Jun2021): Follow-up attempts completed. No further information expected.
Patient felt fine directly after the shot, no discomfort or any bleeding, but 3 hours after that same night she experienced bad pain in the arm where the injection was given.  She was given ibuprofen and then a Medrol dose pack to help with the pain.  After 10 days the pain started to subside but was still noticeable.  Since then she has stated that the pain has got better each day but still not 100% away.
Headache; Diarrhea; Chills; Pressure went high; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), DIARRHOEA (Diarrhea), CHILLS (Chills) and HYPERTENSION (Pressure went high) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced HEADACHE (Headache), DIARRHOEA (Diarrhea), CHILLS (Chills) and HYPERTENSION (Pressure went high). At the time of the report, HEADACHE (Headache), DIARRHOEA (Diarrhea), CHILLS (Chills) and HYPERTENSION (Pressure went high) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information provided.
received a dose from a vial that was expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was expired) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was expired). On 22-Jun-2021, EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was expired) 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.   No concomitant medications were provided by the reporter.   Reporter stated that the patient have reported any adverse event after getting the vaccine shot. Treatment information was not provided.
Fever, body aches, red, swollen left arm, hot to touch.  Advil, Benadryl, Pepcid, Benadryl, Kenalog, Toradol, ice
-sore arm 2 hours after appt (4:30pm, 5/17) -extreme chills and shivering (2:00am, 5/18) -high fever (speculated 104-105, 2:00am, 5/18) -delirium (2:00 am, 5/18) -continued fever (101, 10:10 am 5/18)
Facial Flushing,feeling hot,dizziness,Patient became sleepy and difficult to arouse,nauseated,shallow respiration's rate of about 18. Had patient remove her mask,cool compress applied to back of neck and forehead,checked vitals and blood sugar.When patient became fully aroused gave zofran odt,Patient complained of chest pain and mild sob,Benadryl  50mg given IM. Sat with patient until EMS arrived.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On 03-JUL-2013 the patient was vaccinated with VARIVAX (Merck) (h021386, expire date 30-NOV-2014). Concomitant therapies included terazosin hydrochloride. In July 2013 (exact date of development of the chicken pox was unspecified) the patient developed chicken pox with-in 7 days of receiving the VARIVAX (Merck). The event outcome was unknown. This is one of several reports from the same reporter concerning the same adverse event. Additional information has been requested.
Given Heplisav-B Three Days Past the Expiration; Initial Report Received on 06-DEC-2022  This is a spontaneous report, received from a pharmacist in the regarding a 27-year-old male patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On 05-DEC-2022, a dose of HEPLISAV B (Lot #935848, expiration date 02-DEC-2022, NDC #43528-003-05), route and site not specified, was administered for hepatitis B immunisation.   The dose was 3 days past the expiration date. No adverse effects were experienced by the patient to the reporter's knowledge.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
6/15/09 Pt. to clinic to receive HPV #2. Pt described symptoms after receiving first GARDASIL IZ within 2 hours after injection experienced fever, gastric distress, fatigued & SOB. Went to ER had to wait 5 hours & was not seen. Symptoms resolved.
2 inch diameter painful swelling at injection site. Red and raised skin. Extreme tender/soreness
Fever, joint pain, body aches, fatigue, tingling in spine, headache, nausea, vomiting, tightening in chest when mobile, Symptoms lasted approx. 48 hours. Treatment- rest, fluids, inhaler, ibuprofen