chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right after vaccine administered, I noticed that the injection site seemed a bit high and more in my shoulder than my upper arm. Did not think  much more of it until pain started about four hours later then at 0130 in the morning awoke with much throbbing in arm such that I took 600mg ibuprofen in order to sleep.  The site remains very tender to touch not warm or red and the injection site is just under my left acromion process shoulder area.  I work in the ED and must use this arm for airway management procedures.  Fortunately I am off clinical duties until Tuesday, Jan. 19, so hopefully pain will subside by then, but I do not think I could intubate anyone in my current state.  I do not think this is a reaction to the vaccine per se but  more so a result of the site of injection in my tendon/bursa area of my shoulder. At this time, I cannot move my left shoulder without pain.  I am trying to perform ROM exercises to hopefully reduce the time of discomfort overall. I also have some vague sense of radiation down my forearm into my left pinky finger ulnar distribution.
Information has been received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history of the patients were not reported. On unknown dates from 09-FEB-2015 through 02-APR-2015, the patients were vaccinated with doses of PEDVAXHIB (lot # reported as K008873, expiry date: 06-FEB-2017), dose route unspecified, which were improperly stored on 09-FEB-2015. No adverse effects reported. No product quality complaint (PQC) involved. The relatedness between the event and therapy with PEDVAXHIB was not reported. This is one of several reports received from the same source. Additional information has been requested.
Extreme headache, treated at ER on 9/24/2017, treated at Dr. office on 9/26/2017. Pain continues even with pain and inflammation medications. It has not stopped in 4 days.
3/31/2021 2:44 PM B/P 140/88 Pulse 90 Respirations 18. Patient stated "I'm having a reaction to vaccine", evaluated in First Aid area, feeling dizzy, anxious, face and neck flushed, no uticaria, lungs clear and equal, no wheeze. 3:05 PM B/P 118/76 Pulse 78 Respirations 16 Discharged home with instructions to monitor for return of symptoms, seek further care if symptoms persisit
STOMACH FLU; VOMITED; This spontaneous case report was received from a caregiver (PVX2019-130) on 15-Jan-2019 and a follow up report was received on 17-Jan-2019. The report describes a female consumer who vomited and experienced stomach flu following the intake of Vivotif for typhoid prophylaxis   The consumer's medical history included type 1 diabetes.  The consumer's medication included Novolog (insulin) for diabetes type I. The consumer had no history of unhygienic food or water intake.  It was reported by the caregiver that her daughter was halfway through her Vivotif course and had gotten stomach flu overnight; she vomited a couple times this morning (15-Jan-2019). She was due to take her third dose of Vivotif today. She had taken the first two doses on 11-Jan-2019 and 13-Jan-2019. On 15-Jan-2019, she had only vomited during the morning and she did not vomit anymore, and she was fine. The caregiver also stated that she had type 1 diabetes, and she sometimes vomited when she had ketones, so she was not sure what the vomiting was caused by. She was constantly taking insulin due to her type 1 diabetes.   The consumer completed the entire course of Vivotif.  The consumer's laboratory test included blood sugar level which was found to be 238 (the caregiver did not know the units) and two tests for ketones, one was taken right after she threw up, which showed moderate ketones and the second test was taken later that morning, before noon, which showed trace of ketones.  The action taken with Vivotif with respect to the events vomited and stomach flu was dosage maintained.  The clinical outcome of the events vomited, and stomach flu was resolved.  Company Comment: In this case, a female consumer developed vomiting and stomach flu following the intake of Vivotif. The consumer is a known patient of diabetes type 1 and showed moderate ketones in test after the events. Also, she has had similar history of vomiting in past when ketones were present. Due to the presence of confounding factors, the causality of the event vomiting and stomach flu was assessed as not related to Vivotif.; Sender's Comments: Company Comment: In this case, a female consumer developed vomiting and stomach flu following the intake of Vivotif. The consumer is a known patient of diabetes type 1 and showed moderate ketones in test after the events. Also, she has had similar history of vomiting in past when ketones were present. Due to the presence of confounding factors, the causality of the event vomiting and stomach flu was assessed as not related to Vivotif.
admitted to hospital with sx of lethargy, SOB, fever; O2 supplementation; given Decadron, Remdesivir, Baricitinib, ABX; increase in O2 demand; small PE discovered, Heparin given; transferred to ICU; DNR; experienced drop in O2 sats (50s) and also required vasopressors; transitioned to comfort care and pt passed away in the hospital
This spontaneous report as received from a pharmacist refers to a currently 60 year old female patient. The patient's medical history or concurrent conditions were not reported. On an unspecified date in 2011, the patient was vaccinated with ZOSTAVAX (lot#/exp. date, dose and route of administration were not provided). Concomitant therapy included warfarin. On an unspecified date at some point in 2011, the patient was hospitalized related to Leukemia; however she was diagnosed on an unspecified date in 2013 with Leukemia. No treatment was given to the patient. It was reported that the patient recovered from Leukemia on an unspecified date. At the time of the report the patient was in remission from cancer. There was no significant disability or incapacity, nor the event was considered life threatening or overdose and no PQC was involved. Upon internal review the event Leukemia was considered to be Medically significant. The relatedness of the event with ZOSTAVAX was not provided. Additional information has been requested.
pt exp severe diarrhea last  year p/flu vax; pt ate eggs 24 hrs following vax; pt has no h/o allergies to eggs;
I had normal muscle soreness in my left arm (arm I received the vaccine).  When that soreness subsided, I started having pain in the inside of my elbow? at the bone/joint.  It feels like throbbing arthritis.   I have not yet sought any treatment for this, but plan to see an orthopedic
Hives - itchy skin, appeared like mosquito bites. ZYRTEC given daily. First appeared on trunk, moved to arms & legs. Fewer appeared each day.
Painful to touch, visible area of erythema, hot to touch. Treatment for cellulitis with Sulfamethaxazole 160mg tab.
every time got the flu after flushot; They are not effective, got the flu after flushot; Initial information was received on 19-Nov-2020 regarding an unsolicited valid serious social media case from a consumer via social media.  This case involves patient (unknown demography) who every time got the flu (influenza) after receiving the INFLUENZA VACCINE which was not effective (vaccination failure).  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. It was reported that the patient did not get the flu if did not get the vaccine.  This was also a case of vaccination failure (as per the reporter the vaccine was not effective).  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was unknown for the events.  There will be no information available on the batch number for this case.; Sender's Comments: This poorly documented social media case concerns a patient (unknown demography) who presented with influenza after and despite vaccination with INFLUENZA VACCINE from unknown manufacturer. The time to onset is unknown. Further information regarding medical history, medical condition during vaccination, immune status, details of vaccination schedule completion were not reported. Based upon the reported information, the role of the suspect vaccine and a case of vaccination failure cannot be assessed.
Euphoria, swelling, hallucinations, later swelling, tight chest, swollen throat and more
Acute onset of SOB presented to ED and diagnosed with a pulmonary embolism.  Tested positive for SARS-Co-V-2 on 01/25/21 using NAT.
2 DAY OLD BABY WAS GIVEN VACINE AT 2PM AND WAS SENT HOME. AT 5:30 SHE COULD NOT WAKE UP, WAS TURNING BLUE, HAD DIFFICULTLY BREATHING AND HAD HOARSE VOICE. RUSHED HER BACK TO HOSPITAL.
Diffuse macular rash on cheeks is confluent discreet, rest of body blanching.
Tingling sensation in spine; Spine and Muscle soreness around mid spine.; Spine and Muscle soreness around mid spine.; This is a spontaneous report from a contactable consumer, the patient. A patient of unknown gender and unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 19Apr2021, as a single dose for COVID-19 immunisation. Medical history included asthma and depression. The patient had known allergies to peanuts, fresh fish, some raw fruit and veggies except leafy greens and citrus. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bupropion (MANUFACTURER UNKNOWN), bupropion hydrochloride (WELLBUTRIN) and pseudoephedrine hydrochloride, cetirizine hydrochloride (ZYRTEC-D); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021, the patient experienced tingling sensation in spine followed by spine and muscle soreness around mid spine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tingling sensation in spine followed by spine and muscle soreness around mid spine was not recovered at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
This spontaneous report was received from a healthcare worker and refers to 9 unspecified patients of unknown age and gender. The patients' medical histories and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of VARIVAX (Merck) (Lot# L008271; expiration date 11-MAR-2017; dose and route of administration were not reported). No adverse effects were reported. Follow up information was received on 23-OCT-2015 from a certified medical assistant. The medical assistant noted that the number of patients who were vaccinated with improperly stored doses of VARIVAX (Merck) (Lot# L008271) was 8, not 9 as previously reported. Follow-up information has been receive don 27-OCT-2015 from the certified medical assistant. The reporter provided that the patient of unknown age and gender was vaccinated with the improperly stored dose of VARIVAX (Merck) on 17-SEP-2015. It was also reported that the vaccine was 2470 hours out of range. This is one of several reports received from the same reporter. Additional information has been requested. Patient, product and event details and analysis were updated.
Initial report was received from a health care professional on 06 February 2012. An unidentified patient had received a full series of DTAP (manufacturer, lot number, route, site and dates of administration not reported) and an unspecified amount of time later tested positive for Bordetella Pertussis. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
Tested positive for covid on 17-Jan-2022; Lack of drug effect; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Tested positive for covid on 17-Jan-2022) and DRUG INEFFECTIVE (Lack of drug effect) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 015M20A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Livalo (Livalo(pitavastatin) 4 mg tablet - Status: Inactive - Prescribed by: DOCTOR) until 12-Jun-2014. Past adverse reactions to the above products included No adverse event with Livalo. Concurrent medical conditions included Diabetes mellitus, Polyneuropathy (Polyneuropathy due to diabetes mellitus), Gastrooesophageal reflux disease (Gastrooesophageal reflux disease without esophagitis), Vitamin D deficiency, Obstructive sleep apnea syndrome, Hypothyroidism, Mixed hyperlipidaemia, Overactive bladder, Hypomagnesemia, Overweight, Drug allergy (Tramadol) and Drug therapy (Long-term drug therapy).   On 09-Mar-2021 at 4:37 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 06-Apr-2021 at 3:59 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 17-Jan-2022, the patient experienced COVID-19 (Tested positive for covid on 17-Jan-2022) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Tested positive for covid on 17-Jan-2022) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jul-2020, SARS-CoV-2 test: (Positive) Positive. On 17-Jan-2022, SARS-CoV-2 test: (Positive) Positive.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included onetouch delica lancest 33 gauge filled on 12-Aug-2019 and onetouch ultra blue test strip filled on 12-Aug-2019.  Treatment medication was not provided by the reporter.   This case was linked to MOD-2022-645838 (Patient Link).
I had extreme chest pain and felt like I couldn't breathe. This started about 2 weeks after my second dose of the Pfizer vaccine. I had to see several doctors and ended up being hospitalized for 4 days. Had to have multiple CT scans, MRIs, and various other tests done. Turns out it was myocarditis. I am a 22-year-old man who has never had a health issue in my life. Now I am sitting on a huge pile of medical bills that I can't afford to pay.
Injection given @ 4:30 pm- Pt C/0 itching @ approximately 7:00 pm. Noticed both legs and R arm had hives approximately 10:00 pm. Low grade temp 100.9 on 4/28/09. TC to Pt 4/29/09 slight sand paper rash on legs. Denies SOB. No other problems.
She only had 2 doses of GARDASIL / one dose at 0 months and the 2nd dose at 6 months; No additional AE reported; This spontaneous report was received from a Certified Pharmacy Technician (CPhT) concerning herself, a female patient of unspecified age.  The patient's concurrent conditions, medical history, drug reactions, allergies, and concomitant therapies were not reported.  In approximately 2002 (reported as "20 years ago"), the patient was vaccinated with the first and second doses (at 0 and 6 months) of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (dose, route of administration, lot #, and expiration date not provided) administered for prophylaxis. She only had two doses of the vaccine (Inappropriate schedule of product administration). No additional adverse event (AE) was reported (No adverse event). No product quality complaint (PQC) was reported. No further information was provided.
completed 2 doses of Modern vaccination (4/1 and 4/29/2021) admitted 7/28/2021 with COVID 19 disease
Reported to Rph on 10/25/11. She claimed she had redness & swelling after the injection at the site. One week later redness is gone but area still is sore. She is now experiencing sore throat & chills. Rph called PCP & they will call & discuss it with patient.
1:05PM SLIGHT SOB, FACE FLUSHED, FEELS NERVOUS.  NO DYSPNEA NO TROUBLE SWALLOWING.  1:06PM BENADRYL 50MG GIVEN P.O. HR 112, O2 SAT 98% 1:35PM SYMPTOMS IMPROVED. HUSBAND TO DRIVE PT HOME. HR 97. NO ACUTE DISTRESS NOTED. (2-10-21 9AM TC - STATES SHE FEELS 'ALOT BETTER'. DOES HAVE SOME CHILLS/ACHES./4PM TC - FELT 'FLUSHED' STATES BP124/64, HR 94 TO 101. STATES SHE CALLED HER CARDIOLOGIST AND TOOK HER METOPROLOL.)
30 Y/O male with c/o left shoulder and left arm pain commencing two days after H1N1 vaccination. Symptoms: pain.
This case was reported by a physician via sales rep and described the occurrence of syncope in a 6-month-old female patient who received BEXSERO for prophylaxis. Co-suspect products included GARDASIL 9 for prophylaxis. On 22nd July 2018, the patient received the 1st dose of BEXSERO and the 2nd dose of GARDASIL 9. On 22nd July 2018, 1 min after receiving BEXSERO, the patient experienced syncope, headache, vomiting, blood pressure decreased and heart rate decreased. On an unknown date, the outcome of the syncope, headache, vomiting, blood pressure decreased and heart rate decreased were unknown. It was unknown if the reporter considered the syncope, headache, vomiting, blood pressure decreased and heart rate decreased to be related to BEXSERO. Additional details were provided as follows: The patient was given BEXSERO along with GARDASIL 9 and the patient experienced syncope a minute later, along with headache and vomiting. The blood pressure dropped from 112/72 to 90/64 mmHg and heart rate dropped to low 50's. The patient was held at office 2 to 3 hours for observation and released from clinic's care due to improvement. It was unknown if the reporter considered the syncope, headache, vomiting, blood pressure decreased and heart rate decreased to be related to GARDASIL 9 as well.
Acute pulmonary edema and elevated lactic acid level without acidosis due to rapid atrial fibrillation is suspected although so far she has not had severe hypoxia at rest.  She also has active COVID-19 infection with radiographic findings consistent with infiltrates and pneumonia due to COVID-19 although she is not hypoxic nor is systemic inflammatory response syndrome suspected
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that the patients received (Oka/Merck) VARIVAX INJ that was improperly stored (0.5 ml once, subcutaneously; lot number not provided), between 12-AUG-2014 and 06-JAN-2015. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
slight head ache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (slight head ache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (No medical history reported.).    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (slight head ache). At the time of the report, HEADACHE (slight head ache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information were reported   This case was linked to MOD-2021-127906 (Patient Link).
This case was considered medically important. Information regarding Prevnar was received from a pediatrician regarding an 18-month-old patient who experienced empyema, drug effective. The patient received the fourth dose on an unspecified date. The patient experienced empyema, on an unknown on an unknown date in 2007. Unspecified cultures were performed, however the results were not reported. Treatments were not reported and the outcome of empyema was unknown. No further information was available at the time of the report. Culture (results: not reported) was done in Oct-2007.
Headache, NauseaVomiting, soreness at injection site Narrative:  Per supervisor report: "received Vaccine on 4/7/21 c/o headache, nausea, soreness."
really tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (really tired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced FATIGUE (really tired). On 04-Jan-2021, FATIGUE (really tired) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported that she took a high protein meal and felt better.   Concomitant medication were not reported.   This case was linked to MOD-2021-365027 (Patient Link).
Pt. developed headache, subjective fever and body aches twelve hours after vaccine, lasting until 7am on October 31st.
Breakthrough case admission after 3 vaccines  Moderna 5/3/21 Lot# 025B21A;  Moderna 6/4/21 Lot# 005C21A;  Moderna 11/3/21 Lot# no lot#  THIS INFORMATION IS NOT IN THE local state DATABASE
Information has been received from a pharmacist referring to a male patient of unknown age. No information on concurrent and historical condition was reported. On 02-MAR-2015, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, lot number: K016320, expiry date: 24-DEC-2015, subcutaneously in the left arm. On an unknown date (in March 2015, specified date unknown), the patient experienced adverse reaction. The patient had redenss, swelling, warmth at the injection site of left arm. On 04-MAR-2015 (reported as today), the patient sought medical attention by calling the pharmacy. The outcome the events reported as not recovered. The causality between events and ZOSTAVAX was not provided by the reporter. Additional information has been requested.