chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chest pain that radiated to my back (between by shoulder blades); chest pain that radiated to my back (between by shoulder blades); difficulty breathing; Disease recurrence; Pericarditis; This is a spontaneous report from a contactable consumer (patient).  A 49-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Arm Right as single doses for covid-19 immunisation on 24Mar2021 at 08:00 (first dose at 49 years; Lot Number EP6955) and  on 14Apr2021 at 08:00 (second dose at 49 years; Lot Number ER8731) . Medical history was none. Prior to vaccination, the patient was not diagnosed with COVID-19.Concomitant medications included vitamin b complex (B COMPLEX) and minerals nos, vitamins nos both taken for an unspecified indication, start and stop date were not reported.On 06Apr2021 at 06:00 AM, patient began having chest pain that radiated to her back (between by shoulder blades) and was having difficulty breathing.  After two days, she got better (recovered in Apr2021).  On 28Apr2021, she had another episode similar to the one noted above.  That episode lasted 3 days. On 21May2021, she had a third episode which lasted 3 days (recovered in May2021). She saw a cardiologist on 11Jun2021 who stated that she likely had Pericarditis (onset on an unspecified date in 2021, unknown outcome). She has had a number of episodes since.  On 03Aug2021, the chest pain was so bad, she had to go to the Emergency Room.  The chest pain has gotten progressively worse even with treatment (anti-inflammatory). Nasal Swab on 03Aug2021 was negative. On 23Aug2021 the patient been tested for COVID-19, no result provided. Events required Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care; Sender's Comments: ~~~
24 hours after vaccination, I experienced migraine headache, chills and vomiting. These events lasted for approximately 16 hours. Within 72 after vaccination, I had an unexpected menstrual cycle.  This cycle was abnormal in its timing and length. I have continued to experience menstrual-related symptoms since his cycle - breast tenderness, cramping, headache.
Back of left arm where VARICELLA given became hot & hard at injection site (about 2 1/2 X 3 1/2) with redness spreading toward under arm.  Site is tender.  No fever.  No body aches.  (5/5/10).  A little less red 5/6/10 but cont's hot & hard.  No fever.  5/11/10 phone call to mother.  Reaction got worse before getting better.  Site became very swollen & itchy.  Given BENADRYL 5/6/10 & 5/7/10 with good results.  5/10/10 began coughing & sore throat but no fever and went to school.
This elderly woman was admitted with covid.  She was treated with remdesivir and steroids.  She has improved and is on room air.   Her course was complicated by the development of severe leukocytosis and c diff colitis.  She is now on treatment for c diff and today says her belly is better.  She wants to go home.  Family came and talked with her today and she will go home with hospice care.  She will complete 2 weeks of treatment for c diff.
She got her vaccine, the first thing she noticed is a headache like she never had before, her face felt hot from the inside, but not read when she looked in the mirror.  Then she noticed weakness and pain in her lower back and legs.  The arm hurting probably started around the weakness.  Then this overwhelming need to just lie down and take a nap.  When she did that she started coughing, which she states it is insane.  She also has a weird sensation in her chest, like she has on a bra that it way too tight and is putting pressure on her chest.  She has had a heart attack prior and has reflux and it does not feel anything like that, just a tightness.  The cough is deep, dry hacking cough, but sometimes rattly like.  She ended up taking some OTC Ibuprofen last night for the back and leg pain as she could not rest.  She did not take anything for the cough, but it persists.  Her leg and back pain is about the same.  The arm is actually worse than yesterday as she could move it yesterday without a problem, today as she put on her sweatshirt it felt like somebody hit her in the arm with a hammer.
Resident was noted to have increase weakness on 1/15/2021.  Resident was warm to touch with low grade fever of 99.3 F.  Resident was up propelling self in w/c on 1/16/2021 he was pleasant, accepted medications and ate lunch.  He was found slumped over in his w/c not responding and vital signs absent.
pt recvd vax; 1/3 tongue (front) began to tingle; dec taste; very small blister like lesion; tingling &  dec of taste remains;saw MD on 25oct; MD said rxn from flu shot;
Employee received 2009 seasonal flu vaccine on 9/9/09 (CSL 07749111A exp 6/30/2010).  Pt reported rash on arms after approximately 1 week.  Pt stated rash continue to get worse after she received H1N1 2009 vaccine on 10/30/09 (Sanofi Pasteur Lot # UP018AA exp 04/1/11).  Pt reported rash to both arms, back and face.  Rash was also on the back of her legs.  Employee did not report to the employee health physician as she opted to go to her private rheumatologist as she was "recently diagnosed with Lupus and Fibromylagia about 6 months ago".  Pt was initiated on Medrol dose pack by her rheumatologist on 11/13/09.  Of note patient tolerated 2007 and 2008 seasonal Flu vaccine without problems.
On April 15 2022, , I was sent to have an ultra sound on my lower left leg as it was getting worse in the swelling, coloration and pain level. When it was completed and read by the dr I was told I had a blood clot and would need to go to the ER for evaluation. After a stay in the ER with blood work having been completed, I was started on Eliquis.
This spontaneous report as received from an approximately 29 year old female physician regarding herself. The patients medical history included gastroesophageal reflux disease. On an unknown date in September 2013, the patient was vaccinated with GARDASIL dose 1, 0.5 ml, (lot number and expiry date unknown) (dosing regimen and frequency unknown) intramuscularly. Concomitant therapies included ZOLOFT. On 12-DEC-2013 the patient developed a rash on her arms, legs, hands and torso after receiving her second dose of GARDASIL on 11-DEC-2013. It was reported that the patient had sought medical attention however no intervention to prevent serious criteria was done. The patient did not experience any significant disability or incapacity and was not hospitalized. The patient was evaluated and treated with Intra Venous SOLUMEDROL and an epinephrine injection on an unknown date in December 2013 in the Emergency room and was discharged to home from the emergency room. The physician reported that prior to going to the emergency room, she tried using BENADRYL, ALLEGRA, prednisone and ZYRTEC with no relief of the rash. The outcome rash on her arms, legs, hands and torso was reported as recovering. The relatedness of the events to the therapy with GARDASIL was unknown. No product quality issue was reported. Upon internal review the event rash on her arms, legs, hands and torso was considered as medically significant. Additional information has been requested.
I had an outbreak of shingles one day after  receiving the bivalent Covid booster + influenza vaccine.
Had an ongoing migraine with nausea; Had an ongoing migraine with nausea; Stiff neck pain; Stiff neck pain; Overall body fatigue; Cough; Fever; Right arm where injection site is feels like someone punch the crap out of, cannot lay on the right side when sleeping; This is a spontaneous report from a contactable healthcare professional, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the right arm on 31Aug2021 at 09:45 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication was not reported. The patient had no known drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Aug2021 at 11:00, since the patient got the first dose and had an ongoing migraine with nausea, stiff neck pain, overall body fatigue, cough, and fever. Her right arm where injection site was felt like someone punched the crap out of her, the patient could not lay on the right side when sleeping. Since the vaccination, the patient had not been tested for COVID-19. The therapeutic measures were not taken as a result of the events. The clinical outcome of the events had an ongoing migraine with nausea, stiff neck pain, overall body fatigue, cough, and fever; her right arm where injection site was felt like someone punched the crap out of her, the patient could not lay on the right side when sleeping was not resolved at the time of this report.
Patient has a low fever and pain in the area of vaccine administration, such as the first time he was vaccinated. The vaccine was administered 0.2ML which had not been diluted. Pfizer was called and they gave the reference number. The recommendation is that the dose not be repeated again. The patients mother was informed of what happened and the steps to take to avoid subsequent events. She reports that her son does not report any abnormal effects and that he has not had to visit the Doctor or give him any medication for his symptoms since they are mild or what considers normal since they gave him the first dose on 11-16-2021 and the second dose was on 12-06-2021. This dose is due to arise events of recommended Booster for the population of that age. We called the CDC and reported the event.
Patient went to bed totally fine and woke up saying he could not see in one eye. I rushed him to the emergency hospital they ran cat scans, MRI, heart tests etc. He stayed overnight while they checked. The next day we went to eye doctor who told him he had a eye stroke. He would regain some of his site not all of it. Something to do with blood clot or loss of blood to the eye. I was not satisfied with that so made another drs appointment for the next day with a different eye doctor. The first eye doctor gave us some blood test to do so we did it then. Later that evening we got an emergency call form the first eye doctor to get back to the hospital right away he could lose sight in the other eye.. They found some high c-reactive protein. Normal is 8 his was over 40. They put him on heavy steroids and did biopsy on both temples of his eyes. This started last Wednesday morning. He was released from the hospital Monday Morning to see his regular doctor that afternoon. Test results for the eye would be Tuesday and all other vital tests came back fine thank goodness. On Tuesday the biopsy tests also came back negative so they are stopping steroids. I think they were looking for auto immune issues. Today we are going to Rheumatologist
slight dull headache part of the time; Arm was sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EL9264) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "cardiac ablation", start date: Jan2020 (unspecified if ongoing), notes: she had cardiac ablation. She was on 4-5 different heart meds since the ablation; "leukemia" (unspecified if ongoing), notes: she had leukemia while she was in the hospital for Afib; "She is high risk" (unspecified if ongoing); "Afib" (unspecified if ongoing), notes: she was in the hospital for Afib. There were no concomitant medications. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "slight dull headache part of the time"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm was sore".  Additional information: The reporter was a radiologic technologist but she was retired not. They did pretty good with side effects for the 1st injection, their arms were sore and she had kind of a slight dull headache part of the time but it was okay when you consider not taking the vaccine what could happen that was okay. But their arms were much more sore this time. Product details: First dose on her vaccine card says 92 or LL, someone should have written a little neater. 92 or an LL9264. She clarified when looking at her husbands vaccine card that her first dose lot number looks the same as his, EL9264. The patient later received second dose of BNT162B2 (lot number: EN6205) on an unspecified date (on Monday) and on Tuesday evening her arms were a lot more sore this time and she got blisters right there at the injection and the blisters may have pulled the serum out of her body.  No follow-up attempts are possible. No further information is expected.
Mother reported child ha significant nose bed within 24 hrs. after in H1N1 vaccine on 2 separate occasions. She did not report first incident. H1N1 mist in on 11/09/09 and 1/4/10. Require tx. Resolved itself.
A patient who received a FLUZONE HIGH-DOSE QUADRIVALENT vaccine had already received a flu vaccine this season no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via consumer/non-health care professional via Regulatory Authority (Reference number- 00809130) and transmitted to Sanofi on 12-Oct-2021.  This case involves an 86-year-old female patient who received a INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] had already received a flu vaccine this season [extra dose administered].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included coronavirus disease-2019 (COVID-19) VACCINE MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE) for prophylactic vaccination.  On 11-Oct-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ747AC, expiry: 30-Jun-2022) via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to extra dose administered (latency same day).  It was reported "Pharmacist states that a patient who received a FLUZONE HIGH-DOSE QUADRIVALENT vaccination in her pharmacy may have already received a flu vaccine this season, according to the patient's daughter. Pharmacist asked if there was any information available on how to proceed if the patient did receive a second flu vaccine in 2021. Pharmacist states that her pharmacy only has records of the FLUZONE HIGH-DOSE QUADRIVALENT that was given to the patient on 11Oct2021, and that the patient may have received the other flu vaccine at a different location."  No other adverse event was reported.  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.
I95.9 HYPOTENSION 12/10/2021 HX OF ACUTE KIDNEY INJURY I95.9 HYPOTENSION 12/10/2021 ASTHMA, UNSPECIFIED
At approx. 0855, pt reported feeling "lightheaded, nervousness, and I feel hot internally"; RN observed pt's bilat hand/legs shaking, pt eating/drinking water and pt appears pale; pt denies dyspnea, difficulty swallowing; pt alert and oriented x 4. Vitals taken and pt remained in observation with RN.  At approx. 0905 RN obtained 2nd vitals; vitals WNL.  RN observed pt to no longer have hand/leg shaking and skin color is back to pt's normal.  Pt denies all other symptoms.  At approx. 0915, pt states "I feel fine to go now."  Pt then stays in observation and takes a phone call and continues to eat/drink.  At approx. 0923 Pt reports to RN "My chest feels tight, like a stabbing pain." Pt denies dyspnea, anxiety, difficultly swallowing. ER team was paged to assist.  RN obtained 3rd set of vitals.  At approx. 0933 Pt reports worsening symptoms: stabbing in chest but non-radiating, lightheaded, memory fog, severe headache, hands/legs shaking uncontrollably; Pt is alert and oriented x 3 and is again, pale.  At approx. 0936 ER team arrived and spoke with pt; ER did not assess/treat pt but did speak with pt.  Pt denied further assessment, refused to be evaluated in ED and declined to allow this RN to contact her emergency contacts at approx. 0940.  ER Team left scene at approx. 0943 and at that time pt reports she will drive herself home.  At approx. 0947, pt left CENTER
Now it is the next evening and I feel somewhat better but have developed a little cough; By evening I was not feeling well at all; This spontaneous case was reported by an other health care professional and describes the occurrence of COUGH (Now it is the next evening and I feel somewhat better but have developed a little cough) and MALAISE (By evening I was not feeling well at all) 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 12-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2022, the patient experienced MALAISE (By evening I was not feeling well at all). On 13-Jan-2022, the patient experienced COUGH (Now it is the next evening and I feel somewhat better but have developed a little cough). At the time of the report, COUGH (Now it is the next evening and I feel somewhat better but have developed a little cough) outcome was unknown and MALAISE (By evening I was not feeling well at all) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 3/7/2022 HX OF ACUTE KIDNEY INJURY ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 3/7/2022 NONTRAUMATIC ACUTE KIDNEY INJURY
After 2nd shot, I developed a fever (102.4), bad headache, nausea, body aches, chills.  These symptoms lasted approx 60 hours.  On May 29th, I developed diarrhea.  On May 30th, I developed a fever (101.8), body aches, chills and a bad headache. I rarely, if ever, get sick.  This was the first I had to call off from work in over 5 years.
(red, swollen, warm, painful;  he had fever last night)  Cellulitis L lateral leg that developed 8 days after receiving immunizations;  it is immediately over vaccine site.
Myocarditis. I had to go to the ER on last Monday after having chest pains. After doing EKG, chest x ray, and other tests, they determined it was myocarditis due to an infection. Pain level was an 8/10
Per Patient: Severe headache with aches and pains all over my body! Uncontrollable violent shaking , freezing, arms and hands going to sleep , vomiting , feeling like I was going to pass out and extreme swollen lip when I woke up yesterday morning! This went on for 11 hours!
Mother called pharmacy on 5/21/21 and said she just took her daughter to the doctor and was informed that she should not have received the Moderna vaccine as a 16 year old.  Patient's mother reports patient had a sore arm, headache, some hot flashes after receiving the vaccine. Only lasted a few days after vaccination. Today she reports feeling fine.
Migraine headache and body aches started overnight after receiving my second dose.  I have been taking Tylenol every 4-6 hours as needed to keep the aches to a minimum.  The body aches  disappeared about 36 hours after the shot, my headache is greatly reduced from what it was but still persists 48 hours post shot.
Deep, and at times sharp, muscle pain started at left shoulder blade and has migrated across upper back to right shoulder blade. This started in the second day after vaccination and has now lasted for two and a half days.  The pain feels deeper than at first. I am treating it with Naproxen Sodium and a heating pad.
feels a little weak; fever of 102.5 and went up 102.9, then 104.2; achiness; fever; uncontrollable shivering; chills; joint pain; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feels a little weak), PAIN (achiness), PYREXIA (fever), CHILLS (uncontrollable shivering) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Transfusion since an unknown date. Concomitant products included LETROZOL, ACYCLOVIR [ACICLOVIR], ALPRAZOLAM (XANAX) and TEMAZEPAM for an unknown indication.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 28-Jan-2021, the patient experienced PAIN (achiness), PYREXIA (fever), CHILLS (uncontrollable shivering), CHILLS (chills), ARTHRALGIA (joint pain) and MYALGIA (muscle pain). On 29-Jan-2021, the patient experienced PYREXIA (fever of 102.5 and went up 102.9, then 104.2). On an unknown date, the patient experienced ASTHENIA (feels a little weak). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 31-Jan-2021, PAIN (achiness), PYREXIA (fever), CHILLS (uncontrollable shivering), CHILLS (chills), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and PYREXIA (fever of 102.5 and went up 102.9, then 104.2) had resolved. At the time of the report, ASTHENIA (feels a little weak) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Body temperature: 102.5 degree Celsius High, 102.9 degree Celsius High and 104.2 degree Celsius High.         Treatment included ice pack.   This case was linked to MOD-2021-016748 (Patient Link).
I have received several the several vaccinations, all with Moderna: 2/7/21, 3/2/21, 10/3/21, 4/23/22 (and just recently 10/22/22). In July 2022 I began having visual disturbance in my left eye which has turned out to be macular degeneration. I never had eye problems before. I want to report this in case there might be some relationship to the vaccinations I received.
Patient reported on 7/29/2020 that she had an adverse reaction to a Shingles vaccine (dead virus) given on 7/13/2020.  By day 3 she had chills and headaches. By day 8 she had bumps on her forehead.  By 14 days she had it all over her face/eyes.  Patient believes she has shingles and got it from the vaccination.