chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3/12/2021 - Sudden, sharp, stabbing LEFT sided CHEST PAIN lasting a few seconds with sudden, sharp, stabbing RIGHT LOWER ABDOMINAL/PELVIC. Again, had episode of same quality and location CHEST PAIN within a few hours. From 3/12 to 4/12 experienced increasing frequency of CHEST PAIN that evolved over 3 weeks. Initially as sudden, sharp, stabbing pain with heartbeat. CHEST PAIN progressed to dull squeezing pain and significant palpitations worse with laying and some SOB with laying. Including evolution of dull LEFT shoulder ache as well. Helped to push against rib cage and sit up. Phentermine was stopped on 4/5/2021, symptoms had continued beyond cessation of phentermine.  Also had  ?COVID arm? (redness, swelling, terrible itching). The itching lasted for 3 weeks, redness for a few days.  LEFT axillary lymphadenopathy x 2.5 weeks, painful to touch.  3/18 through 3/22- sore throat, headaches, congestion. Due to work protocols, had COVID PCR which was NEGATIVE 3/27/2021 ? loss of taste
Heplisav-B was administered first and pt was fine. However, after administering Menactra patient reported feeling lightheaded and about to pass out, and was visibly pale. She mentioned that she did have breakfast that morning. We got her some orange juice but it did not help her. As a result, EMS was called but patient refused to go to hospital with paramedics. Patient went home by car.
Rash/rash on his forearm that went to both forearms; elevated blood pressure/He already has high blood pressure and it was elevated after the vaccine; felt warm inside; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiry date unknown), via an unspecified route of administration in left arm, on 06Jan2021, at single dose, for COVID-19 immunization. Medical history included high blood pressure from Apr2020 and ongoing. Ongoing concomitant medication included lisinopril from Apr2020 for blood pressure/high blood pressure. The patient received the vaccine between 1:30-2:00pm yesterday afternoon (06Jan2021). He waited for 15 minutes after receiving the vaccine and he was ok. Later, on 06Jan2021, he developed a rash on his forearm that went to both forearms. He already has high blood pressure and it was elevated after the vaccine. During the night he felt like he was warm inside. He took a low dose Bayer Aspirin. The outcome of the event rash and hypertension was not recovered, and the outcome of the event feeling hot was recovered on 07Jan2021.  Information on the lot/batch number has been requested.
Myalgia  Neck pain, arm pain, and injection site discomfort Narrative:
Vertigo and significant fatigue 1.5 hour post Moderna Covid vaccine #2, with continued symptoms 8 days later. Overall, symptoms are worsening. Vertigo 6-7 times daily, unprovoked.  No intervention or meds taken for adverse side effects. Pt evaluated in clinic 12/7/21, meclizine prescribed. Pt will follow-up with PCP on 12/22/21.
Took the shot with no problems at the vaccine site, two day latter I woke up on that f Friday with ringing in my  ear right . I waited a few hours but the ringing didn't go away so I decide to go to the hospital and testing was completed, ct scan, blood work, etc, my diagnosis was tinnitus and nothing much can be done because there is no cure. I was given steroids to help with reducing the sound in my right ear. I started  doing my own research and fond out that others have been reporting the same thing, I did follow up with my ENT and I did lose some hearing and my eustachian tubes are no longer working and I have temporary tubs as for now. I been having a hard time sleeping, which nothing isn't working to help me relax. I am currently using masking sounds  but not doing much for me. I been having headaches and swelling under my right eye. I feel like am losing my mind, Pleas help me. I do have an up coming doctors appointment next week and hopefully more testing will be completed. I hope the right person gets this information and contact me or my health care provider because I would not wish this on anyone I don't even sleep and just don understand how am stilling living without proper rest.
SLEEPY MOST OF THE DAY; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 18-APR-2021, the subject experienced sleepy most of the day. On 18-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue and sleepy most of the day was not reported. This report was non-serious.
A used vial of Janssen vaccine was placed back in manufacturer box (after withdrawing 2 doses), instead of being placed in yellow vial labeled with BUD information. Next day, vial was pulled from manufacturer box and vaccine given before discovering vaccine was expired.
The patient tolerated the vaccine fine.  The concern was the patient reported she was not pregnant or planning on becoming pregnant when she got the vaccine, however about 2 weeks later she called to report she was pregnant and was concerned about if the vaccine could harm the baby.
Day 8 developed lymph node soreness & swelling in arm of injection, and swelling & redness around injection site. Still slightly swollen today. Patient did have a visit with primary care physician due to worry about  lymph node swelling
DOB used for registration of appointment by parent different than actual DOB in immunization registry. Vaccine was given to 15yo when only authorized  by FDA to 16.
Nausea, warm feeling, dizziness. Temp 97.9, pulse 75, BP 125/71, R 15
diagnosed with Polymyalgia Rheumatica (PMR); Initial information received on 28-Oct-2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional.  This case involves a 68-year-old and unknown gender patient who experienced diagnosed with polymyalgia rheumatica (PMR) after receiving INFLUENZA VACCINE.  The patient's past vaccination(s) included COVID-19 VACCINE on 03-MAR-2021, HEPATITIS A on 17-DEC-2009, FLUZONE HIGH DOSE on 02-OCT-2018, FLUZONE HIGH DOSE on 05-SEP-2019 and FLUZONE HIGH DOSE QUADARIVALENT on 01-SEP-2021.  The patient's medical history, medical treatment(s), concomitant medications and family history were not provided.  On 01-Sep-2021, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On a 28-Oct, the patient developed a serious diagnosed with polymyalgia rheumatica (PMR) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Details of laboratory data not reported.  On an unknown date, the patient received PREDNISONE as corrective treatment for the event.  Patient symptoms for PMR were intensely painful. The patient have additional anxiety over COVID now knowing Prednisone is an immunosuppressant.  At time of reporting, the outcome was unknown for the events.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns a 68-year-old patient (unknown gender) who had polymyalgia rheumatica after receiving INFLUENZA VACCINE (Unknown manufacturer). The time to onset is unknown. The patient's past vaccination(s) included COVID-19 VACCINE, HEPATITIS A, FLUZONE HIGH DOSE (first dose and second dose) and FLUZONE HIGH DOSE QUADARIVALENT. Furthermore information regarding medical history, medical treatment(s), concomitant medications, condition at the time of vaccination and laboratory data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
April 24 rush to ER because of urine retention then  april 28 he started with facial paralisis wich the doctor said it was bellpalsy but 1 week after all that he lost all the strenght on his legs he was using Foley cateter sin april 24 thrue may 21 and now he could barely move he has limited balance i have to take him out of bed hold him he could not be seat because he feel sever pain on his legs an feets and sever cramps and tingling
Fever; chills; cold sweats; extremely achy body to the point where it was difficult to lift myself out of bed; extremely achy body to the point where it was difficult to lift myself out of bed; I also had extreme fatigue; I slept for almost 20 hours straight, and slept through work without waking up to call out; This is a spontaneous report from a contactable other healthcare professional reporting for herself.  A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1238), intramuscular from 28Jan2021 15:45 (03:45 PM), (at the age of 34-years-old) at single dose on left arm for COVID-19 immunization. Patient was not pregnant at time of vaccination. Medical history included bipolar 2 disorder (reported as "ipolar 2 disorder") and attention deficit hyperactivity disorder (ADHD). Patient has no allergies to medications, food and other products. Patient was not diagnosed with COVID-19 prior vaccination. Concomitant medications (other medications the patient received within 2 weeks of vaccination) included lamotrigine (100 mg), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL; reported as "Adderall XR 15 mg") and quetiapine fumarate (50 mg).  Patient did not received any other vaccines within 4 weeks prior vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as "Other". The patient received first dose of COVID-19 vaccine on 07Jan2021 01:00 PM (lot number: EH9899), intramuscular on the left arm. On 29Jan2021 02:00 AM, the patient experienced fever, chills, cold sweats, extremely achy body to the point where it was difficult to lift herself out of bed. The patient also had extreme fatigue. Patient slept for almost 20 hours straight, and slept through work without waking up to call out. No treatment was received for the events. The events were assessed as non-serious. Outcome of the events was recovered in 2021. Body temperature on 29Jan2021 with unknown results. Since the vaccination, the patient has not been tested for COVID-19
cough; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the parent.  A 4-year-old male patient received BNT162b2 (BNT162B2), on 08Aug2022 at 16:00 as dose 1, single (Lot number: FL2757) at the age of 4 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: 27May2022 (unspecified if ongoing), notes: patient tested positive for COVID-19 on 27May2022. The patient's illness at vaccination included: "nasal congestion" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COUGH (non-serious) with onset 09Aug2022 at 07:00, outcome "recovered" (09Aug2022 at 08:00). Therapeutic measures were not taken as a result of cough. The reporter considered "cough" not related to BNT162b2. Additional information: the patient had no known allergies. Vaccine (dose 1) was received at 4 pm on 08Aug2022. On morning of 09Aug (7 am), patient awoke with an occasional cough, resolving within 1 hour. Patient had nasal congestion the day prior; reporter (patient's mother) expects the cough was unrelated to vaccine (related to congestion from daycare exposure).
TOOK TWO UNREFRIGERATED DOSES; This spontaneous case report (PVX2019-2426) received from a physician on 24-Sep-2019. It described a male consumer who "took two unrefrigerated doses" (PT: Product storage error), while being on oral Vivotif (one dose every other day) (lot number: 3003281) for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif, which was left unrefrigerated for 2 hours at 73-74-degree Fahrenheit, which was good to use. Then, he continued to take the remaining doses, which were not good to use. The doses were taken on 19-Sep-2019, 21-Sep-2019, and 23-Sep-2019.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable.
High fever, chills,, diffuse severe joint and muscle pain, headache. After 4 days all resolved except neck pain and in between shoulders pain. Resurgence of frequent headaches. Then I developed pain/numbness/ weakness in right arm and hand and I was diagnosed with thoracic outlet syndrome. I developed thyroid nodules, With PT numbness resolved, but neck and back pain and headaches persisted. Then I had positional headache with blurred vision, nausea, dizziness, numbness of nose and upper front teeth, sleep problems, severe tinnitus, pain behind my eyes. I was diagnosed with IIH. I believe something may have gone wrong with se one dose of the vaccine.
Red, swollen, warm to touch, covered full thigh from knee to hip. Around 6"-7".
groin discomfort; diarrhea; abdominal cramping; left side chest discomfort; 99.8 fever which had a high of 100.1 degrees F; body aches; This spontaneous case was reported by a nurse and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (groin discomfort), DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal cramping), CHEST DISCOMFORT (left side chest discomfort) and PYREXIA (99.8 fever which had a high of 100.1 degrees F) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Undocumented history of COVID19.).    On 12-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (groin discomfort), DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal cramping), CHEST DISCOMFORT (left side chest discomfort), PYREXIA (99.8 fever which had a high of 100.1 degrees F) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency; BISMUTH SUBSALICYLATE (PEPTO-BISMOL) at an unspecified dose and frequency and CALCIUM CARBONATE, MAGNESIUM CARBONATE (TUMS [CALCIUM CARBONATE;MAGNESIUM CARBONATE]) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL DISCOMFORT (groin discomfort), DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal cramping), CHEST DISCOMFORT (left side chest discomfort) and PYREXIA (99.8 fever which had a high of 100.1 degrees F) had resolved and MYALGIA (body aches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided by the  reporter.  Patient tested positive for antibodies in 2 antibody blood tests.
Rash appeared and skin was raise around injection site after 7 days. Mildly itchy. No pain.
I was OK for several days after the shot and then I got up 6 days later not feeling well and couldn't figure out what was going on. I am a nurse so I checked my pulse Ox and then my blood pressure and my BP was 150 over 100 which was high for me. I waited about 4 hours and still did not feel well and took it again and it was 175 over 100. I called the Doc and he told me to "watch" it and he wasn't concerned. So I sat on it until 9PM when I was really feeling bad I called the answering service and my BP was 200/110. The doc on call put me on Amlodipine and it lowered the pressure. The next day I ended up in the ER again with elevated BP and after that my cardiologist started to check things out and found that my aortic valve had gone from moderate to severe and that I needed a new valve. I cannot say if the valve issue getting worse was a factor of the vaccine but I do know that the elevated BP was....it actually saved my life because they started to dig around and found the valve was nearly closed. Had my BP not risen after the shot they may not have known the extent of the valve problem!
8-2-07 Mother phoned reporting swollen left leg and child c/o headache and vomited one time.
Lymphadenopathy in Left Axillary Region, It started as an uncomfortable feeling and turned in painful in 2 hours.; Axillary and Pectoral region is painful to touch.; Astenia and Fever accompanied; Astenia and Fever accompanied; Lymphadenopathy in Left Axillary Region, It started as an uncomfortable feeling and turned in painful in 2 hours.; Dose number= 3; This is a spontaneous report from a non-contactable reporter (consumer or other non HCP). The reporter is the patient.   A 28-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 at 17:15 (Lot number: FJ8757) at the age of 28 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EW0169, Anatomical location: Arm Left, Route of administration: Unspecified) administration date: 21Apr2021, when the patient was 27 years old and Bnt162b2 (DOSE 2, SINGLE, Lot number: EW0183, Anatomical location: Arm Left, Route of administration: Unspecified) administration date: 12May2021, when the patient was 27 years old, for COVID-19 immunisation.   The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 at 17:15, outcome "unknown", described as "Dose number: 3"; LYMPHADENOPATHY (non-serious), TENDERNESS (non-serious), ASTHENIA (non-serious), PYREXIA (non-serious), LYMPH NODE PAIN (non-serious) all with onset 03Dec2021 at 16:00, outcome "unknown" and all described as "Lymphadenopathy in Left Axillary Region, It started as an uncomfortable feeling and turned in painful in 2 hours". Therapeutic measures were not taken as a result of lymphadenopathy, tenderness, asthenia, pyrexia and lymph node pain.  Additional Information: The patient had no known allergies. The patient did not receive other vaccines within four weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
A vaccine that experienced a supported temp excursion was administered to patients; This non-serious spontaneous safety report was received with reference numbers 02202410 / 02202359 on 11-JUL-2022 and forwarded on 12-JUL-2022 from another health care professional.   The causal relationship between Vaxelis and the reported event of "Vaccine that experienced a supported temp excursion was administered to patients; Temperature 35.1F" was assessed as not applicable due to the nature of the event.  Further information is expected.
I have not had a period; Breast hurt; Injection site hurt every now and then; My sleep was disturbed and only sleep a total of about 3 hours a night; Vision in my right eye is blurry; Back and joint pain; Back and joint pain; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EP6955 and Expiration date was not reported) via an unspecified route of administration, administered in the right arm on an unspecified date in 2021 as dose 2, single (at the age of 37-year-old) for COVID-19 immunization. The patient's relevant medical history was not reported. The patient previously took Naloxone (manufacturer unknown) and experienced allergy to Naloxone on an unspecified date. Historical vaccine included patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EP7534 and Expiration date was not reported) via an unspecified route of administration, administered in the left arm on 29Mar2021 at 15:15 hours as dose 1, single (at the age of 37-year-old) for COVID-19 immunization and experienced injection site hurt every now and then. Patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included alprazolam (Xanax), buprenorphine hydrochloride (Subutex), unspecified probiotics (manufacturer unknown) and unspecified vitamins (manufacturer unknown), all from an unknown date for an unknown indication and unknown if they were ongoing. Patient was not diagnosed with COVID-19, prior to the vaccination and had not been tested for COVID-19, since the vaccination. On 25Apr2021 at 14:30 hours, patient had not had a period, breast hurt, injection site hurt every now and then, patient's sleep was disturbed and only slept a total of about 3 hours a night, vision in her right eye was blurry and back and joint pain. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The outcome of had not had a period, breast hurt, injection site hurt every now and then, patient's sleep was disturbed and only slept a total of about three hours a night, vision in her right eye is blurry, back and joint pain was not recovered.   No follow-up attempts are needed. No further information is expected.
does not feel comfortable; Initial information regarding this spontaneous and non-serious case from case was received from consumer or non-health care professional via Medical Information (MI) (Reference number: 00822738) and forwarded to the pharmacovigilance department on 21-Oct-2021.  This case involves a 7- months-old patient who experienced did not feel comfortable (discomfort) after receiving DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  On an unknown date, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [Frequency: once, lot number and expiry date not reported, Dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for tuberculin (TB) skin test 0.5 mL, Strength: standard except for Fluzone HD standard] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious did not feel comfortable (discomfort) (unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  It was reported "Practice manager reports that QUADRACEL was administered to a 7-month-old patient; asks if there are any recommendations for this situation. Practice manager states the patient did not feel comfortable completing an AE/safety report at time of call; states the patient clinical and quality service director advised the patient against completing AE/safety report at this time."  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.