chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Energy decreased/Lowenergy; Stiffness; Anemic; Stomach pain; First Dose on 21-Apr-2021 and Second Dose 05-May-2021; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Energy decreased/Lowenergy), MUSCULOSKELETAL STIFFNESS (Stiffness), ANAEMIA (Anemic), ABDOMINAL PAIN UPPER (Stomach pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose on 21-Apr-2021 and Second Dose 05-May-2021) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 05-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose on 21-Apr-2021 and Second Dose 05-May-2021). On an unknown date, the patient experienced ASTHENIA (Energy decreased/Lowenergy), MUSCULOSKELETAL STIFFNESS (Stiffness), ANAEMIA (Anemic) and ABDOMINAL PAIN UPPER (Stomach pain). The patient was treated with CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]) at an unspecified dose and frequency and IRON at an unspecified dose and frequency. At the time of the report, ASTHENIA (Energy decreased/Lowenergy), MUSCULOSKELETAL STIFFNESS (Stiffness), ANAEMIA (Anemic) and ABDOMINAL PAIN UPPER (Stomach pain) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose on 21-Apr-2021 and Second Dose 05-May-2021) outcome was unknown.            No concomitant medication was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.
had a side effect with my two doses of vaccine other than sore arm/; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (had a side effect with my two doses of vaccine other than sore arm/) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (had a side effect with my two doses of vaccine other than sore arm/). At the time of the report, PAIN IN EXTREMITY (had a side effect with my two doses of vaccine other than sore arm/) outcome was unknown.            No concomitant medication was reported. No treatment information was reported.   This case was linked to MOD-2021-290599 (Patient Link).
Feeling a little bad; Palpitations; Blood pressure elevated; Just felt weak; Flu-like symptoms; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 11Feb2021 15:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Pacemaker (She mentioned she has a pacemaker). The patient's concomitant medications were not reported. Patient received the Pfizer-BioNTech COVID-19 Vaccine first dose on 11Feb2021. She reported she did not have any problems 11Feb2021 or this morning (12Feb2021), mentioned she had a pacemaker, " She reported feeling a little bad; palpitations; blood pressure elevated; just felt weak " at around 2 o'clock today (12Feb2021 14:00). She was wondering if those events were side effects of the Pfizer COVID-19 Vaccine or just flu-like symptoms. The patient underwent lab tests and procedures which included blood pressure: elevated on 12Feb2021. The clinical outcome of the events was not recovered at the time of report.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Swelling, erythema, itch, burning sensation at site of vaccine. Elevated BP.
Right Thigh is hot and hard to touch. Thigh turned red and swollen and covered around half of the thigh. Cold Compress and Tylenol.
Fever, discomfort, restlessness.  Administered Tylenol at Dr's instruction; He collapsed and died.  He first reported nausea occurring around 4 am on 2/25/21 and was uncomfortable all day.  He felt worse that evening and was showing a fever.  He was given Tylenol around 10 pm on 2/25/21.  He fell asleep around 2:00 am on 2/26/21 and woke up around 3:00 or 3:15.  He had a drink of water then collapsed.  I performed chest compressions until the EMTs arrived but he was likely dead by the time they arrived.
When starting the day on April 10th I noticed that I was having less muscle control of my left leg from the hip down. Then at around 11 am April 12th I started to take a few steps backwards and my left leg collapsed and I fell over backwards. My left leg hyper compressed then flung up and hyper extended. I was able to get up but the left hip,knee,& ankle started swelling and became very painful. The swelling & pain increased to where I couldn't walk with that leg so started using crutches which last for over a month, and was barley able to sleep because of the severe pain and being unable to find a comfortable position. I did start taking herbs just incase of a possible blood clot and using compression for swelling.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXIA 12/15/2021,  4/12/2022,  7/29/2022,  -- RECURRENCE OF SAME SYMPTOMS
VARIVAX given 11-3-09 SC RA, pt c/o R arm pain with swelling and hives at injection site 11-4-09 at 3:30
Received phone call today from patient reporting ongoing symptoms from Johnson and Johnson COVID-19 Vaccine that she received from Pharmacy on 9/16/2021 in her right deltoid. This is the first time the patient is calling the Vaccine Support Line to report the symptoms. Patient stated she is still having pain in the right arm. Patient states she is not able to sleep on that arm at all, lifting her arm is painful, and even when pulling things it is painful. Patient stated she waited so long to call to report it because she was waiting to see if the symptom would resolve on it's own but it hasn't. Patient states that she would like to be seen by a provider for this. Advised Patient that her symptoms would be documented and a worker's comp case would be opened up for her. Once that is done an Employee Health nurse will contact her letting her know the next steps. Patient voiced understanding and had no other questions at this time.
2 hours post vax, the pt felt flushed and achy. Early the following morning, the pt felt numbness which started at the neck, moved up through entire head. Had ringing in ears was slightly confused. 911 was called and the pt was taken to the ER. Pt stated she thought she might of had a stroke.
Presents to the hospital7/25/2021 with 3 week history of increasing shortness of breath, cough with yellow sputum, n/v, subjective fever/chills.  COVID + 7/25/2021.Eventually requiring mechanical ventilation .  Developed kidney injury and septic shock.  Transitioned to CMO and expired 8/5/2021
The arm where I received the shot was very sore on the following day for 36-48 hours and had a slightly swollen, reddish area surrounding the injection site with a diameter of 3 inches. I would rate the pain when I pushed on the injection site at 6/10. It was only painful when I touched it or tried to use the muscle to lift my arm in certain ways. I also experienced some level of fatigue and slight dizziness the day after I received my shot.
sweating; loss of appetite; positive covid test; not feeling up to par; chills; fatigue; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), DECREASED APPETITE (loss of appetite), COVID-19 (positive covid test), FEELING ABNORMAL (not feeling up to par) and CHILLS (chills) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweating), DECREASED APPETITE (loss of appetite), COVID-19 (positive covid test), FEELING ABNORMAL (not feeling up to par), CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache) and PYREXIA (fever). At the time of the report, HYPERHIDROSIS (sweating), DECREASED APPETITE (loss of appetite), COVID-19 (positive covid test), FEELING ABNORMAL (not feeling up to par), CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
C/O- Feeling hot and flushed, tinkling to left hand, light headed, "I don't want to faint in my chair" Vital signs taken, Rapid Response team alerted, transported to ER via Gurney. EKG per ED MD
pt reports tingling of arm inj site & some stiffness in both shoulders;MD advised Ibuprofen up to cheek, warm compress to site;seen again 8JAN99 & 20JAN referred to neurologist or clinic 20JAN99;
Patient stated she felt lightheaded and dizzy. Had her sit down. NO problems breathing, NO swelling of tongue, No hives. A little redness around site of injection. She said she felt very tired. She was getting very anxious.
Husband had both doses of the vaccine and has immune issues; This is a spontaneous report from contactable consumer received from Pfizer sponsored program (patient's wife). A 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number, Expiry date: Unknown), via an unspecified route of administration, administered on unspecified date, dose 1 and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number, Expiry date: Unknown), via an unspecified route of administration, administered on unspecified date, dose 2, single dose for COVID-19 immunisation. The patients Medical history and Concomitant medications were not reported. On an unspecified date, reporter stated that her husband had both doses of the vaccine and had immune issues. Caller called in to know if we have a list of places that do protein antibody tests. She wanted her husband to do the test to check if the vaccine is still effective. His husband had both doses of the vaccine and has immune issues. Caller clarified that his husband is okay and was only worried because of the delta variant that is why she wanted him to do the antibody test. Escalate as NME. Referred to the health department. Created manual AE form for Precautionary as caller mentioned that her husband who got both doses of the vaccine has some immune issues and she is concerned if the vaccine works. Medical Information was not applicable, Customer's questions addressed by Program or no medical questions asked. The outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
feeling crappy / general malaise; headache; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced feeling unwell and headache. On an unknown date, the outcome of the feeling unwell and headache were recovered/resolved.   It was unknown if the reporter considered the feeling unwell and headache to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. For tolerance of 2nd dose, refer case US2020AMR040852.
Pt tested 9/2, sx onset 8/30. Pt stated that she contracted virus from later confirmed positive coworker (receptionist) through ongoing community exposure. Pt stated that due to delayed result notifications, she went to Urgent care for treatment and was tested again there, confirmed positive, DX bronchitis, rx meds. Pt stated that she was monitoring oxygen saturation levels w/ pulse ox, and levels stayed @ 94-95 until 9/6, when levels dropped below 90. Pt came to Medical Center via ambulance for SOB. Pt works at an insurance agency, last day 9/2, work notified. Pt stated that she was/is being administered Remdesivir. Pt stated that she is currently on 2 L of oxygen delivered via cannula, oxygen levels between 90-92.
Cellulitis of left thigh, redness/swelling, given Rocephin 650mg IM and Bactrim 1 1/2 teaspoon twice a day for 10 days.
she had a 2nd moderna on 7/7/2021 lot 027B21A  my note from 23 Sep 2021: She is a 70-year-old woman with progression of right upper extremity DVT to the right innominate vein from the right IJ, progressed since July 2021, who has been on Coumadin most recently at least since July 2021, (I believe she was on Coumadin remotely in the past associated with GI bleed, polyps seen on lower endoscopy, and epistaxis, in the remote past due to A. Fib I think).  With also evidence of left cephalic vein thrombosis in September 2020, and left AV fistula occlusion status post angioplasty with some cephalic vein thrombosis in April 2021, and right IJ DVT in July 2021, with progression to the right innominate vein in September 2021.  She was admitted after missing dialysis with hyperkalemia and subsequent supratherapeutic INR, s/p vit K, and hypotension, off pressors now, INR 3.0 today, with history of vaginal bleeding on Provera and negative endometrial biopsies in the past.   Atrial fibrillation: Per cardiology, potentially was going to consider watchman in the past?   History of recurrent thrombosis: Do believe she is likely a good candidate for indefinite anticoagulation, however with difficulty remaining therapeutic on INRs and with her hemodialysis would consider apixaban 2.5 mg twice daily, however would not add until INR <2.0, would check INRs daily   Vaginal bleeding: She has been on Provera, endometrial biopsies have been negative, do recommend follow-up with gynecology prn   ESRD on HD
I don't have the lot number for the second dose so i listed the lot number from my first dose. Second dose left arm Feb 4th 930am. A few days later i noticed an itchy spot left temple slightly red. Persisted and slowly spread.  Left side face, scalp neck shoulders chest, back and eventually entire body. Very itchy, red rash. Went to ER FEB 27TH.  treatment with 7 day prednisone.  Sx improved but did not resolve. Went back to ER March 13 due to increasing sx swelling and numbness in face. Back on prednisone follow ups scheduled
Nauseous; he has never been so sick before; major headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11May2021 (Batch/Lot number: unknown) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes", start date: 2020 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose), administration date: 15Apr2021, when the patient was 30 years old, for COVID-19 immunisation. The following information was reported: NAUSEA (non-serious) with onset 11May2021, outcome "unknown", described as "Nauseous"; ILLNESS (non-serious) with onset 11May2021, outcome "unknown", described as "he has never been so sick before"; HEADACHE (non-serious) with onset 11May2021, outcome "unknown", described as "major headache". Therapeutic measures were taken as a result of headache.  Additional information: The consumer was calling about the Pfizer vaccination for COVID-19. He said he was having some side effects and he has never been so sick before. The consumer said he experienced nausea. He said he got the shot yesterday 11MAY2021 and all of his symptoms started last night. consumer said he got the second dose of the vaccine yesterday, and started having side effects last night. He said he doesn't have the vaccine card with him to provide unspecified Pfizer vaccine NDC/LOT/EXP from it. He said that he thinks his first dose of this vaccine was 15Apr2021. He said that his side effect is that he has never felt so sick before. He said he feels nauseous and has a major headache. AE Treatment: consumer said he took Tylenol, the regular dose, he took one, he doesn't know how much they are. He said he thinks the EXP was 15Nov2021, but he was not looking at the Tylenol packaging currently, he doesn't have that with him. Concomitant Medications: consumer says he did not get any other vaccinations with his doses or start any new medications.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reports that 24 hours after her vaccination her arm was red and swollen. She reports it was under her arm also.  She states that the hand on the same are felt tingling in her fingers and numbness.  SHe states she also is very fatigued.  She was concerned about a blood clot.  She states she is a hypochondriac and that today, 48 hours after vaccine, she has some chest pain.  She had taken ibuprofen and acetaminophen but had not used an ice pack.  She will try this and if no improvement I instructed her to follow up with her healthcare provider.
This spontaneous report as received from a consumer refers to her 73 year old husband with complications from cancers and who was exposed to the agent Orange chemicals in a war. On an unspecified date "in late 2013", the patient was vaccinated with a dose of ZOSTAVAX (dose and lot # not reported) subcutaneously. The consumer stated that the patient was feeling quite well at the time of vaccination. The consumer reported that on an unknown date, the patient experienced lung cancer that spread quickly. The consumer stated that they could not get him enough treatment fast enough and in September 2014, the patient died, "about nine months after receiving ZOSTAVAX". The cause of death was reported as lung cancer. It was unknown if an autopsy was performed. Upon internal review lung cancer was considered to be medically significant. Additional information has been requested.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 32-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number 397B5) for prophylaxis.   On 13-FEB-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case was for one of 119 patients, reported by same reporter. The patient received unstable Tdap vaccine after a temperature excursion, which led to incorrect storage of vaccine.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
On 9/28/10 she stated "blisters" appearing on hands - then on 10-01-10 she had pain starting in ankles and knees.
In April, 1999 and May, 1999, the pt received his 1st and 2nd injections of Lymerix. Then, in July, 1999, the pt felt terrible and was treated initially for Lyme disease with antibiotics. Now he has aches and pains "arthritic-like" in his knees, hands, shoulders and sometimes elbows. The pt is now being treated with antibiotics on a daily basis. Additional information has been requested.
When I first received the shot, I experienced a feeling of being sick which consisted of fever, headache, body aches and soreness around the injection site.  After the shot, I began to experience drooping in my right eye which would eventually close completely.  I sought out a neurologist who diagnosed me with an autoimmune disease called myasthenia gravis.  I have also experienced several episodes of kidney stones and muscle/nerve pain.
Patient complained of chest pain/pressure, neck pain and dizziness 20 minutes after administration of the first dose of the Pfizer COVID vaccine. Vitals taken every 15 minutes for 1 hour. Patient used her inhaler 15 minutes after onset of symptoms. Per patient, symptoms resolved almost instantly. Patient continued to complain of neck pain and dizziness before leaving the facility but both were reported as less severe. Patient advised to go to ER per Dr., however patient declined.
Initial report received on 15 October 2009 from a health care professional. A female patient (age not provided) with no reported medical history was diagnosed with muscular degeneration after receiving FLUZONE (lot number U3207AA) on 30 September 2009 (route and site were not reported). The patient did not recover. No further information was provided. List of Documents held by Sender: none.
Patient reported to have a seizure approximately 4 hours after receiving the vaccine.  The seizure reportedly went on for several minutes with the patient denies any postictal confusion, tongue biting, or incontinence