chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3/3/2021 - Left Upper Arm Swollen Hard Muscle, no Pain, 3/8/2021  - Periodic Tingling up and down beneath skin of Left Arm,in addition to Swollen Muscle Applied Cold Compresses and Tylenol Caplets with relief of tingling sensations 3/16/2021 - Covid Pfizer Vaccine #2 (Right Arm) - only temporary small bruise spot at injection site 3/25/2021 - Urgent Care for Swollen Upper Left Arm and unchanged Tingling discomfort (Advised to continue Cold Compresses and follow up with Primary Care Provider) 3/29/2021 - Left Arm increasing pain up to Shoulder and Neck - weakened arm strength, use challenge, and sleep discomfort 4/12/2021 Earliest Upcoming Appointment with my Primary Care Provider
H1N1 vaccine given IM in the late afternoon. Pt experienced hives and pain legs, arms and neck.
Narrative:  62 yo male with PMH of COPD, not on home oxygen, HFpEF, chronic IDA, HTN, hep C, hx of prostate CA s/p radical prostatectomy, was found dead in his home on 04/23/2021. Prior to his death, patient left AMA on 4/19/2021. Pt was admitted on 4/18/2021 for shortness of breath/acute on chronic hypoxic respiratory failure. Per discharge summary on 4/19/21, patient had increasing SOB for past 2 weeks, unable to walk 10 feet without become SOB. He was found to have orthopnea, PND, and bilateral pedal edema. Records also showed that patinet left AMA on 3/30/21 at the ED. It was recommended that he went to ED due to low hemoglobin of 7.2 (trending downward).
Started with a headache, dizziness, feeling flushed nausea and vomiting. Vomited approx 2 cups of stomach contents. No problem with previous shot. Felt okay today. Took Motrin for headache. ? empty stomach last meal was 7 am.
This spontaneous report as received from a other health professional refers to a patient of unknown age. No current condition was reported. No historical medication was reported. Approximately in 2014 the patient was vaccinated with M-M-R II lot # J010208, expiration date- 23-FEB-2015 (dose strength and route was unknown). No concomitant medication was reported. Nurse stated that an unspecified number of patients received (unspecified doses in series) M-M-R II that was stored at 47F for 120 hours. Nurse also reported that temperature issue occurred on 29-JUN-2014 through 03-JUL-2014 so doses administered somewhere after 04-JUL-2014 and 23-SEP-2014. The outcome of M-M-R II stored at 47F for 120 hours was unknown. This is one of the several reports. Additional information has been requested.
pt came into office w/dx chickenpox 30 scattered vesicles over body p/seen by MD;
This spontaneous report was received from a pharmacist and refers to a 71 year old female patient. The patient did not have any known medical history, allergies or reactions. On 01-MAR-2017, the patient was vaccinated with ZOSTAVAX 19400 PFU intramuscular route for prophylaxis (dose, lot number and expiration date were not reported), the vaccine was reconstituted with the sterile diluent(DILUENT MRK) intramuscular route for vaccination (strength, lot number and expiration date were not reported). Concomitant medications were not provided. On approximately 04-MAR-2017 (reported as "3 days later"), the patient developed an unspecified rash. An unspecified treatment was given for the adverse event but no laboratory tests were performed. The patient sought medical attention by visiting the pharmacist. The outcome of rash was reported as not recovered. The relatedness between the event and the suspect therapies was not provided by the reporter. Additional information has been requested.
Started within minutes of injection. Numbness of upper lip, edema between eyes and around mouth, sharp pain in both ear canals, tingling of right leg. Edema inside both nostrils and a headache 6/10. Within a hour- I was unable to sit due to severe pain 9/10 as well as severe cramping of the stomach which was eight out of 10. Over 24 hours had rose colored urine. Also had chills. Last menses July 2021 so it was not related to a menstrual cycle plus I have not had cramps since I was 11-12 years old, never as a teen or adult.  My face, both my fingers and toes are very swollen-painful. Taking a PRN diuretic does not help at all.
Pain, redness, itching and swelling an injection site 12 hrs post vaccination.    Fevers >102 on Day 1 with nausea, fatigue, headaches, chills, diaphoresis, right arm pain radiating under arms down left side.    Fever symptoms improved on Day 2 but nausea, fatigue, diaphoresis, arm pain persistent.  Redness and swelling at injection site increased in size.  Day 3 symptoms improved with persistent mild nausea, chills, diaphoresis and site and underarm pain.  Site remains red, tender, and swelling.  Employee health called, incident report completed.
Father said pt developed swelling & redness around the injection site, which progressed and turned black/blue. He was treated at ER for Cellulitis. Now has a rash and blisters, according to father.
Patient received Janssen vaccine was told to sit for 15 minutes post observation. He came up shortly after (less than 5 mins post imz) saying he didn't feel well, like he was going to pass out. I immediately came from the pharmacy, my tech sat a chair behind him. I called for optical to call a code white. The patient requested to sit on the ground. At this point, his wife was present. He was sweating. I gave him an ice pack, a water after it was determined he was breathing okay. He was pale, extremely lethargic and sweating. After sitting him on floor I told my tech to call 911. I took his blood pressure, it was 99/73, pulse 75. Very low for him. Hes on blood pressure medicine but been having issues controlling it. He later tells me hes terrified of needles. He also tells his wife he hadn't eaten all day. I stayed with the patient until ems left with him because when standing his heart rate dropped 20 points, after they stuck him again to check his blood sugar. They determined then he should be checked out at the hospital and they took him.
Fever 101-102 degrees. fussy. vomiting x 2 07/09/2002-07/10/2002
received vaccine on 29-Oct-2021 with an expiration date of 11-Oct-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received vaccine on 29-Oct-2021 with an expiration date of 11-Oct-2021) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine on 29-Oct-2021 with an expiration date of 11-Oct-2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received vaccine on 29-Oct-2021 with an expiration date of 11-Oct-2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported.   This case was linked to MOD-2021-370033 (Patient Link).
Right arm slight swelling; pain in the arm; neck and shoulder pain; neck and shoulder pain; This is a spontaneous report from a contactable female consumer (patient). A 75-year-old female patient received second dose of bnt162b2 (Pfizer COVID 19 vaccine, solution for injection, Lot number: EN6024), via an unspecified route in the right arm on 21Mar2021 at 09:15 (age at vaccination: 75-year-old), as a single dose for covid-19 immunization. Medical history included Graves disease and allergies to Penicillian. The patient concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer COVID 19 vaccine, solution for injection, Lot number: EL3302), via an unspecified route in the right arm on 28Feb2021 at 16:30 (age at vaccination: 75-year-old), as a single dose for covid-19 immunization and experienced left side neck and shoulder pain, back and inner left arm muscle pain after the first dose. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On an unknown date, patient experienced right arm slight swelling and pain in the arm, neck and shoulder pain returning. Patient did not receive any treatment for the events. The clinical outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
I received the second shot of the Pfizer vaccine on may 13th. Since the day following the second dose, I developed a fever and that fever has continued for the past 15 days in a row now. I have also had gastrointestinal distress including diarrhea and vomiting on a few of those day. I also have had body aches, fatigue, and a headache. My doctor ran blood tests and my liver was showing elevated enzymes that were not elevated before taking the vaccine.
This spontaneous report was received from an office manager and refers to an unspecified number of patients or unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. The office manager reported that the patients received unspecified doses of VARIVAX (lot # M010480 with expiration date: 01-MAR-2018, lot# M020899 with expiration date: 27-APR-2018 and lot# M009765 with expiration date: 23-FEB-2018) that were improperly stored (freezer: temperature of 31F for 5 hours; refrigerator: temperature of 54F for 7 hours; there was a data logger in combination with manual monitoring system). Vaccinations occurred between 15-SEP-2016 and 16-SEP-2016. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. In October 2012 (2-3 weeks ago), the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot not provided). There was no concomitant medication. The pharmacist stated that in October 2012 4 days after vaccination had an approximately 1/2 dollar size raised red area at the injection site that was more rashy looking. The pharmacist did not have any further details on this patient. At the time of the report the patient's outcome was unknown. The relatedness for the events was unknown for ZOSTAVAX. This is one of several reports, received from the same source. Additional information is not expected.
adverse event; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of ADVERSE EVENT (adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (adverse event). At the time of the report, ADVERSE EVENT (adverse event) 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 drug information was provided. No treatment information was reported.   Reporter did not allow further contact
After receiving the first dose, I experienced a numbing of the tongue and metallic taste approximately 30 minutes after receiving the shot. These subsided after about 8 hours. Spoke with my physician and they advised that I can proceed with my 2nd vaccine. Approximately 2 hours after administration, I began having similar symptoms. For the past 2 weeks, I have had intermittent but regular occurrences of the same. Sometimes it is really strong and others not as much.
Blood in stool; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on 15Apr2021 at 12:00 AM (at the age of 36-years) as single dose for COVID-19 immunisation. The patient received vaccine at a pharmacy or drug store. The patient has no medical history and no concomitant medications. The patient has no known allergies. The patient has no other vaccine in four weeks. The patient has no covid prior vaccination. Covid was not tested post vaccination. The patient experienced blood in stool on 15Apr2021 at 01:00 PM with outcome of recovering. The patient did not receive treatment for the adverse event.  Information on the lot/batch number has been requested.
I still feel some dizzy today; Dizziness, wasn´t able to stand on my feets/Lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness, wasn´t able to stand on my feets/Lightheaded) and DIZZINESS (I still feel some dizzy today) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 17-Mar-2021, the patient experienced DIZZINESS (Dizziness, wasn´t able to stand on my feets/Lightheaded). On 22-Mar-2021, the patient experienced DIZZINESS (I still feel some dizzy today). At the time of the report, DIZZINESS (Dizziness, wasn´t able to stand on my feets/Lightheaded) and DIZZINESS (I still feel some dizzy today) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant and treatment information were not provided.
expired dose of ADACEL was administered with no reported adverse event; Initial information was received on 18-Apr-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a expired dose of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was administered to the 22 years old female patient with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.   On 15-Apr-2023, the patient received dose of 0.5 ml once suspect of diphtheria-2/tetanus/5 AC pertussis vaccine (strength: standard) (lot number: C5854AA, expiration date: 14-Apr-2023) via intramuscular route in the right deltoid for Immunization (immunization) with no reported adverse event (expired product administered) (latency: same day).  No lab data reported.  Action taken: not applicable.  Outcome: Unknown for the event expired dose of adacel was administered with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt color turned pallor; pt became non-verbal; began to slide from her chair; Information has been received from a health authority regarding a 15-years-old female patient. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were reported as none known.  On 09-SEP-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly in the left arm, as prophylaxis (lot number 1621934 with expiration date not reported but upon internal validation established as ) (dose and strength were not reported).  On the same date, after receiving the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, the patient color turned pallor, and she became non-verbal and started to slide from her chair. The patient's mother cuddled her and she did not slide from the chair. Within 30 seconds, the patient was alert, oriented and verbal again. The patient never lost consciousness. The patient was allowed to lie down in the clinic room where she was observed. On the same date, the patient recovered from the events.  The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the aforementioned adverse events was not provided.  Per information received on 23-OCT-2020, all telephone attempts to obtain follow-up information have been unsuccessful.  This is a downgrade case.  System mistakenly auto-checked serious criteria medically significant for the adverse event became non-verbal (Unresponsive to stimuli ) but the reporting health authority considered the events non-serious. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: 1621934; expirationdate: 29-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
The pain awakened me approx 2 am (Tues) and sleep was very restless. Any mvt from my rt arm was very painful. Took an ASA. Didnt feel real well off/on throughout the day but didnt think it warrented me from not going to work that night. I work 12 hr shift at the Sleep Diagnostic Cntr this week Tues, Wed and Thrs. By 6:30 (I was at work) I was nauseous, Headache and then started running a fever (eyes started burning, chills and body aches). Fever broke approx 830pm and then sweat profusely. My fever came back approx 1am, chills, body aches, arm was/is feverish, headache) I had this the rest of the night. Left work at 7am, went straight to bed and slept 8.5 hrs that day (Wed) (I never sleep this long during the day). When i awakened, I felt better, arm felt a little better.
Had chills and shaking a couple days after the vaccine. The following week he started having a dry cough. He also developed pleurisy. Went to the doctor on Aug 31st. He continued coughing.  When taking long walks or walking up any steps he becomes winded. On Oct 12th he went back to the dr and that's when they discovered a large avocado size Empyema in  his chest. He had major surgery on Oct 19th to remove the Empyema. He was started on antibiotics and they put in a pick line in his left arm and he had to get antibiotics in it every 6wks. 2wks after he had to take oral antibotics.
pt recvd vax & started high pitched cry fr 6:30pm to 11pm; left leg was red, edematous & sore to the touch;
While administering the vaccine the syringe/needle leaked from the joint of the needle/syringe.  The amount of vaccine the patient actually received couldn't be determined.
Nine days after the shot. I felt itchy where my shot was given. When I looked at it there was a rash. It was not very itchy. The rash was a circle around the shot and there were a few splotches for an inch or two around it. It was firm, swollen and hot just like after I got the shot but it had gone away and returned. It lasted four days after it reappeared and gradually went back down. I had the second shot in the other arm and it was irritated and swollen after two days. It was not as itchy as the previous time and only lasted 24 hours.
At time of shot got a slight medical type taste in mouth - about 9 hours later my face (around mouth area and then expanding out) started going tingly and numb. After a little while (about 30 mins) that sensation spread into my tongue. I started to get quite worried at that time and took 2 benedryl. The benedryl did seem to kick in and work. Arm also started to get sore around that time in the evening and was very sore the next day and then less sore, but still sore for a few days.
Peri-oral rash and slight numbness, no swelling of lips or tongues.
Initial information received on 26-Mar-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 65 years old female patient who received vaccine IMOVAX RABIES. The patients past medical history and family history were not provided. The patient did not receive any concomitant medication. On 26-Mar-2019, the patient received post-exposure prophylaxis of 1 ml, of suspect Rabies (HDC) Vaccine lot number not reported, expiry date 18-Mar-2019 via unknown route in unknown administration site. (It was day 7 dose in series). The patient was first seen in the emergency room (ER) to begin post-exposure prophylaxis on 19 Mar 2019. It was an actual medication error due to expired vaccine used. It was reported that expired dose (expiry date 18-Mar-2019) of IMOVAX Rabies was given to a patient on 26-Mar-2019. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Aches, feer, chills. Midchest chest pain. Onset interval 12 days. ST elevation. Echo normal.
I woke up feeling sick and coughing. I experienced a runny nose, slight cough, scratchy throat and slight headache. My symptoms lasted for about 2 weeks. I took a home test and it showed a slightly positive. Things were not clear. Instructions said that may be positive. So, I scheduled an appointment to get tested and that test was also positive. I had a telemedicine visit on June 1st he prescribed me Paxlovid, which I took for 5 days.
Patient had No Adverse Reaction. In November 2022 our State Immunization VFC program did our every-other-year audits in both our offices. It was discovered at that time, that some Covid vaccines were administered outside of the 10 week expiration date (which is calculated from the date the vaccines were received from the State).