chrisvoncsefalvay/vaers-outcomes huggingface dataset:
after i received the first and second vaccine i have high blood pressure that comes and goes.; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (reported for herself). A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the reporter stated that the patient perfectly healthy, perfect blood work and after the patient received the first and second vaccine patient has high blood pressure that comes and goes. The patient needs an explanation of what is this causing from what you made that vaccine from. The reporter stated that "please do not tell me that is not the vaccine because you have the internet full of people complaining about the same thing and that is healthy individuals lime me". The patient never had covid-19 and this vaccine is going to give her a stroke. The patient underwent lab tests and procedures which included blood pressure: high on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
From 7:45pm until approximately 8:01, while sitting down watching the news,  I experienced violent head spinning, without nausea, or heart pain. Difficulty stumbling to reach my cell. 911 arrived, and the spinning was over, but my Blood pressure was extremely high ER CAT  scan, EKG and pill to lower BP. discharged before midnite.
Pt experienced immediate HA, had hot feeling, nausea and vomiting, diarrhea, pain at site of injection. Pt was observed for about 45 mins after injection, symptoms resolved after about 30 mins.
Pt recvd vax 21APR94 & edema 1/4 to 1/2" from elbow on side to shoulder blade up back;
Case number: PHEH2013US017345 is an initial spontaneous report received from a nurse on 13 AUG 2013, with a follow-up received on 27 SEP 2013. This report refers to a 13-year-old male patient. His medical history was not reported and his concomitant medication included BOOSTRIX (batch number: YJ475) received on 13 AUG 2013. He received only MenCYW-135 liquid component of MENVEO (batch number: M12092) intramuscularly at a dose of 0.5 ml on 13 AUG 2013 (at 11:15AM) without being reconstituted with Men A. No adverse event was reported following medication error (inappropriate preparation of medication).  Follow-up was received on 27 SEP 2013. Concomitant medication, vaccination dose and vaccination site were updated.
Significant muscle pain at injection site ~4hours after injection. Severe nausea early morning the day after injection, followed by severe headache the entire day.  Required alternating ibuprofen and acetaminophen every 2 hours to provide limited relief. Moderate nausea and severe headache 2nd day after injection.  Required alternating ibuprofen and acetaminophen every 2 hours to provide partial relief. Mild nausea and significant headache 3rd day after injection.  Required ibuprofen every 4 hours to provide relief. Mild nausea and moderate headache off and on daily for 2 weeks following injection.
Moderna Bivalent Booster 0.25mcg was given to patient, was to be given 0.5mcg, wrong dosage given to patient.
I felt like I was falling and I screamed; weird dizziness/light-headed; soreness in my left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in my left arm), DIZZINESS (weird dizziness/light-headed) and MYOCLONUS (I felt like I was falling and I screamed) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS and Hypertension.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in my left arm). On 08-Mar-2021, the patient experienced DIZZINESS (weird dizziness/light-headed). On an unknown date, the patient experienced MYOCLONUS (I felt like I was falling and I screamed). On 07-Mar-2021, PAIN IN EXTREMITY (soreness in my left arm) had resolved. At the time of the report, DIZZINESS (weird dizziness/light-headed) and MYOCLONUS (I felt like I was falling and I screamed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included  thyroid medicine and blood pressure medicine was reported   No treatment medication reported
This case was reported by a nurse and described the occurrence of back itch in an adult female patient who received hepatitis B vaccine recombinant Engerix B. The patients medical history includes no allergies to medication or yeast. On 01/07/2005, the patient received the first dose of Engerix B. On 2/28/2005, the patient received the second dose of Engerix B. this is longer than the recommended interval of one month between the first and second doses of Engerix B. Approximately five days following the second administration of Engerix B, on 3/5/2005, the patient experienced itching that was localized only to her back. The nurse stated that the patient reported no visible rash associated with the itching. The patient was seen by a physicians office. The outcome of the event was not reported.
Pt states injection site painful since receiving Hep B vaccine on 4/22/11. Denies fever, chills, warmth, or redness to touch but arm hurts so much at night that she cannot sleep (injection site is Left deltoid muscle).
Patient came in at 9am 5/30/2018 to report arm tenderness and swelling due to PPSV23 vaccination from yesterday. She showed me her arm, which presented a significant inflammatory reaction (redness/flushed, tenderness, swollen, painful/sensitive to touch, very warm) that involved the upper left arm, shoulder, and the top of the forearm. She stated it was so painful she couldn't sleep all night. She also stated she had a bad headache and just didn't feel good so she would go to her doctor to follow up. Considering it may have been an allergic reaction, I recommended patient take BENADRYL to reduce the inflammatory/allergy response. I also recommended for her to drink plenty of fluids, ice the area on/off for 10 minute intervals to reduce acute swelling and pain. I recommended TYLENOL for the headache. I asked if she has any GI or stomach problems and she said she just had an endoscopy and colonoscopy to diagnose some stomach pains. I recommended she talk to her doctor first before taking any anti-inflammatories (ie, ibuprofen) for that matter. The patient thanked me for taking the time and attention to address her concerns before leaving the store. I called her primary care physician's office and spoke with nurse @930am shortly after the patient left. I informed them of patient's symptoms and gave them advanced notice that patient would be coming in to be seen for treatment without an appointment scheduled. We will follow up with the patient.
Extreme arm swelling (about the size of a golf ball), redness, and pain at site of injection. Inability to lift arm for 4 days. Slowly increased movement over 2 weeks. Currently (06/09/2021) there is very noticable muscle atrophy at injection site. Feels like there is no muscle when physically touching injection site.
Urticarial type rash (erythema/blotchy and blanching rash) around areas of stick sites (legs), on arms and across chest. Mom reports, started around site of Prevnar injection.
Have not had period since shot received.  I discontinued taking birth control and my period still has not returned.  I have a scheduled appointment with my OBGYN on 8/18/21 to request tests and an evaluation.
Arm pain; fever (101-102); headache; myalgias; chills; This is a spontaneous report from a contactable physician (patient). A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FF2589), via an unspecified route of administration, administered in Arm Left on 27Sep2021 14:30 (at the age of 72-year-old) as dose number unknown, single for covid-19 immunisation. Medical history of patient was not reported. Concomitant medication(s) included omeprazole (PROTONIX) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine in four weeks. The patient experienced arm pain, fever (101-102), headache, myalgias, chills on 28Sep2021 04:00. The patient underwent lab tests and procedures which included body temperature: 101-102 on 28Sep2021. Patient did not have covid prior vaccination and covid was not tested post vaccination. The patient did not receive any treatment for the adverse events. The outcome of all events was not recovered.  Follow-up attempts are completed. No further information is expected.
Vaccination site pain left deltoid; joint pain, especially right shoulder joint where I have bursitis; joint pain, especially right shoulder joint where I have bursitis; fatigue; chills (freezing my ass off); a little headache; back pain; I also felt like I had smoked some good weed; This is a spontaneous report from a contactable Other HCP (reported for herself). A 68-year-old non-pregnant female received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EN5318 and expiry date was not provided) via an unspecified route of administration in the left arm deltoid, on 29Jan2021 at 08:45 (at the age of 68-years-old) as a single dose for covid-19 immunisation. Patient did not receive other vaccine in four weeks of vaccination. Medical history included anxiety, depression and allergies to sulfa drugs. Concomitant medications included aciclovir sodium (ACYCLOVIR), venlafaxine (VENLAFAXINE ER), bupropion and levocetirizine dihydrochloride (XYZAL). Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 29Jan2021 at 09:15, patient experienced vaccination site pain left deltoid, joint pain, especially right shoulder joint where have bursitis, fatigue, chills (freezing my ass off), a little headache, back pain and felt like had smoked some good weed. Everything was brighter and sharper especially the trees. No treatment was received. The outcome of all events was resolved.  Follow-up attempts are completed. No further information is expected.
Morning p/1st dose pt had vomiting, h/a, & SOB; adm to hosp w/resp distress & is being treated for COPD & Asthma; hospitalized 4 days as of 24FEB;
Patient experienced swelling in arm and face after 10 minutes from time of administration. Pharmacist on site administered 1 ML of diphenhydramine to patient and observed patient reaction for 45 minutes. Patient felt drowsy but symptoms of allergic reactions disappeared. Patient was instructed to continue taking diphenhydramine at home if symptoms resumed after 4 hours. Patient went home with guardian.
Patient received vaccine on 10-Nov-2021/Vaccine expired on 09-Nov-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 10-Nov-2021/Vaccine expired on 09-Nov-2021) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 10-Nov-2021/Vaccine expired on 09-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 10-Nov-2021/Vaccine expired on 09-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. Vaccine manufacture date of expiry reported was 09-Nov-2021. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains no new information.
O.45ml of Vaccine Was Administered; A spontaneous report was received from pharmacist concerning a 70-years old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273), and who experienced incomplete dose administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 on 5 Jan 2021 (Lot number 039K20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. During the administration, the pharmacist did not push the plunger correctly all the way, and the patient did not receive the full dose. After measuring what was left in the barrel of the syringe, they estimated that the patient received only 0.45 mL of the vaccine instead of 0.5 mL.  No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The event, incomplete dose administered, was considered resolved on 5 Jan 2021.; Reporter's Comments: This case concerns a 70 year old, female patient.  The patient's medical history is not provided.  The patient experienced the unexpected event of administration of incorrect dose (0.45 mL of the vaccine instead of 0.5 mL) of the first dose of the mRNA-1273 (Lot number 039K20-2A) on 5 Jan 2021.  There was no reported adverse reaction associated with this case.
Information has been received from a healthcare worker referring to multiple unknown patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # M016238, expiration date 07-DEC-2017, oral; dose was unknown) for prophylaxis. No adverse effects were reported. The excursion temperature was 52 Fahrenheit degree for 17 hours and 30 minutes. There was no previous temperature excursion. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA010696: US-009507513-1612USA001267.
He received the vaccine on Thursday.  The left nostril started running, then his eye started getting vision issues on Saturday.  He went to sleep and thought it would be better.  On Sunday morning he could not stand the sunlight at all, and pain on top of the eye.  He went to the ER and they called the eye doctor in.  He didn't know what was going on, had blood work done.  He told him to FU with his doctor.  Gave him eye drops, Ibuprofen and eye cream to go into the eye.  He is feeling better today, but when the light hits it a certain way the pain is bad, but it clears.  In the morning he has to get used to the sunlight.  His eye is red.  He is to FU with his PCP.
My arm is sore; was a bit uncomfortable; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and discomfort. On an unknown date, the outcome of the pain in arm and discomfort were unknown.   It was unknown if the reporter considered the pain in arm and discomfort to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-AUG-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient arm was sore. The patient wished to had got in other arm because this was the side he/she sleep and it was bit uncomfortable. The follow-up could not be possible as no contact details were available.
Information has been received from a physician concerning a 12 week old female who on 6/22/06 was vaccinated with a 2ml oral dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine) (lot 653754/0139F). Concomitant therapy included lansoprazole Prevacid for the treatment of reflux, which was discontinued on 6/22/06. Three weeks later, on approximately 7/13/06, the pt experienced diarrhea, with no fever. Lab tests were negative for stool culture, Giardia, and ovum and parasites. Stools for occult blood were positive three times and negative once. There was no change in formula and it was noted that it was lactose free. It was reported that the pt continued to thrive and gain weight. The pt was initially started on antibiotic but it was discontinued after the lab results were negative. It was noted that the pt was receiving lactobacillus. It was noted that no member of the pts family were ill ore experienced similar symptoms. At the time of the report the pt had not recovered. No other information was provided. Positive occult blood in the stool was considered to be an other important medical event (OMIC). Additional information has been requested.
t103.4 APAP given later temp 102 ax p/24 hrs; crying, screaming x 2 hrs, calmed down, shrieking wouldn't walk 36 hrs; parents called MD but did not go in; parents told to continue APAP; mom stated pt crying was more like a screeching;
no additional AE; When the nurse pushed down on the plunger to administer the vaccine to the patient via IM injection in the deltoid, the syringe came loose from the needle hub and the vaccine spilled out of the syringe and down the patient's arm.; Patient was informed he likely did not receive the vaccination, and declined to receive another dose.; the vaccine spilled out of the syringe and down the patient's arm; the needle hub and the vaccine spilled out of the syringe and down the patient's arm.; This spontaneous report was received from a clinic supervisor via a company representative referring to a male patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown.      On 28-JUL-2020, a nurse went to administer pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)  (0.5 milliliter, lot # S036495 with expiration date not reported, but upon internal validation established as 13-SEP-2021; frequency was not reported) intramuscularly (IM) in the deltoid for prophylaxis. The nurse expelled air from the syringe and attached the needle for administration. When the nurse pushed down on the plunger to administer the vaccine to the patient , the syringe came loose from the needle hub and the vaccine spilled out of the syringe and down the patient's arm. The patient was informed he likely did not receive the vaccination, and declined to receive another dose(syringe issue, incorrect dose administered, exposure via skin contact and accidental exposure to product). No adverse event was reported.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress: ; manufacturercity: ; manufacturerstate: ; manufacturercountry: ; devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2008USA001646:
Information has been received from a Registered Nurse concerning a 12 year old female patient without a pertinent medical history or without drug reactions or allergies who on 02-DEC-2009 was vaccinated with her 0.5 ml first dose of GARDASIL intramuscularly in the deltoid region of the left arm. Concomitant medications were not reported. The reporter mentioned that on 02-DEC-2009 the patient developed redness on, warmth and itching on the ulnar aspect of the left lower arm 45 minutes after receiving GARDASIL. No laboratory or test diagnostics were performed. It was reported that the nurse applied cold compress and BEANDRYL gel topically to the affected area and symptoms resolved within 1 hour. Follow up has been received from the registered nurse regarding the 12 year old female patient with no known drug reactions or allergies or pertinent medical history who on 02-DEC-2009 was intramuscularly vaccinated with her first 0.5 ml dose of GARDASIL (Lot#660553/0070X) in the deltoid muscle of the left arm. It was reported that approximately 30 min later, on 02-dec-2009, the patient reported to the school clinic complaining of severe itching of radial aspect of the left forearm. The patient was examined and an itching area of approximately 6 inches which was erythematous and warm, that resemble phlebitis that disappeared very quickly. It was reported that there was no mark that indicated possible injury, sting or bite in the immediate area and that there was no inflammation presented at the time or later. An ice pack was applied and within 20-30 min all symptoms and signs had disappeared. It was reported by the registered nurse that a correct injection technique was performed and that when the needle was inserted in to the muscle no blood was withdrawn. The registered nurse stated that it was difficult to determine if the event was related to the administration of GARDASIL, because there was some distance between the reaction and the injection site. Other causes such insect bite could not be ruled out. No further information is available.
pt recvd vax on 8MAR93 & by MD 10MAR93 w/ 6x9 cm papular lesion w/erythema & edema & sl induration surrounding site; mildly tender, warm;