chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a pharmacist on 28-Nov-2016. This case involves a 70 year old male patient who was vaccinated with a dose of Fluzone HD Batch number- UI691AA, expiry date- 30-Apr-2017, (dose, dose in series were not reported) intramuscularly in left deltoid on 18-Sep-2016. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as no known allergy. Illness at the time of vaccination was also reported as no. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 27-Nov-2016, 70 days after the vaccination, the patient was unable to raise the arm and felt sore on left arm. Laboratory investigations and corrective treatment were not reported. The outcome of event was reported as not recovered. List of documents held by sender: none.
acute myocarditis 2 days after 1st dose; This is a literature report from License Party for the following literature source(s).  A 40-year-old male patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "SARS-CoV-2 infection" (unspecified if ongoing), notes: without need for hospitalization. The patient's concomitant medications were not reported. The following information was reported: MYOCARDITIS (hospitalization, medically significant), 2 days after the suspect product(s) administration, outcome "recovered", described as "acute myocarditis 2 days after 1st dose". The patient underwent the following laboratory tests and procedures: Biopsy heart: no active myocarditis; C-reactive protein: 9.5; Ejection fraction: 47 %, notes: generalized hypokinesia; Electrocardiogram: Diffuse ST-segment elevation, notes: with depression in aVR, V1; Magnetic resonance imaging: Edema delayed enhancement, pericardial effusion; SARS-CoV-2 test: negative; Troponin: 102; 520. Therapeutic measures were taken as a result of myocarditis.  Clinical course: The patient had previously been infected by SARS-CoV-2 without need for hospitalization. The patient hospitalized with chest pain and who were diagnosed with myocarditis by laboratory and cardiac magnetic resonance imaging 2 days after 1st dose of BNT162b2. The chest pain was most commonly described as constant, nonpositional, and nonpleuritic, consistent with acute myocarditis mainly without pericardial involvement. Troponin values were elevated and appeared to peak the day after admission, whereas had no eosinophilia. The patient was tested and negative for SARS-CoV-2. Cardiac magnetic resonance imaging revealed patchy delayed gadolinium enhancement consistent with myocarditis in patient. The patient had resolution of his chest pain, was discharged from the hospital in stable condition, and were alive with preserved left ventricular ejection fraction at last contact. The patient was hemodynamically stable; endomyocardial biopsy found no active myocarditis. Therapeutic measures included prednisone and colchicine.  SUSPECT PRODUCT is under agreement with BIONTECH SE.; Sender's Comments: Based on the information provided, and a temporal association, a causal association between reported event myocarditis  and suspect BNT162B2 cannot be excluded. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Fatigue and arm pain for 6 days, red, tender area that is 13 mm x 7 mm in size
his muscles were hurting; fever was 104.5degF; This morning he woke up around 2am shaking; had severe joint pain; very hot to touch; very wet and sweaty; he felt very nauseous; trouble moving and had constricted movements; difficulty swallowing; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (his muscles were hurting), PYREXIA (fever was 104.5degF), TREMOR (This morning he woke up around 2am shaking), ARTHRALGIA (had severe joint pain) and FEELING HOT (very hot to touch) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and Lot# 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (his muscles were hurting), PYREXIA (fever was 104.5degF), TREMOR (This morning he woke up around 2am shaking), ARTHRALGIA (had severe joint pain), FEELING HOT (very hot to touch), HYPERHIDROSIS (very wet and sweaty), NAUSEA (he felt very nauseous), DYSKINESIA (trouble moving and had constricted movements) and DYSPHAGIA (difficulty swallowing). At the time of the report, MYALGIA (his muscles were hurting), PYREXIA (fever was 104.5degF), TREMOR (This morning he woke up around 2am shaking), ARTHRALGIA (had severe joint pain), FEELING HOT (very hot to touch), HYPERHIDROSIS (very wet and sweaty), NAUSEA (he felt very nauseous), DYSKINESIA (trouble moving and had constricted movements) and DYSPHAGIA (difficulty swallowing) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: abnormal (abnormal) 112/60. On an unknown date, Heart rate: abnormal (abnormal) 66. On an unknown date, Pyrexia: high degree Celsius (High) 102.8 degree fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment given included Ibuprofen pill,800mg liquid motrin, cold compress, Icy water and Cold liquids.   This case was linked to MOD-2021-083418, MOD-2021-083439 (Linked Report). This case was linked to MOD-2021-083967 (Patient Link).
Arm and hand swelling, arm pain, headache, muscular pain across back, wheezing off and on (have taken albuterol), pain in my chest and down my sides. Shortness of breath and become very winded just moving. Have taken Tylenol. Following up with physician in the morning.
Chills- HA's and feeling unwell; Chills- HA's and feeling unwell; Chills- HA's and feeling unwell; This is a spontaneous report from a contactable Other Health Professional (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EH 9899, intramuscular in the Arm Right, first dose on 16Dec2020 18:45 (or 06:45 PM) at a single dose for Covid-19 immunization. Medical history included blood pressure abnormal (reported as BP). The patient's concomitant medication included unspecified statin for BP. The patient had not received any other vaccine in four weeks. The patient experienced chills, HA (headache), was feeling unwell X four events  (pending clarification) on 16Dec2020 (onset time at 0200, pending clarification) with outcome of Recovered/Resolved with sequel. The events were reported as non-serious which requires sleep and rest. The patient was not diagnosed with COVID-19 prior to vaccination nor was she tested since the vaccination.
Extreme tiredness for two weeks after booster. Ear ringing much worse (I have tinnitus anyway). Distortion of hearing for about three days. Hearing distortions have resolved but ringing persists worse than it was before the booster.
Delayed-onset mild red rash, about two inches in diameter, occurred a week after the injection. Not itchy or painful. No treatment; went away on its own; two days later, a faint reddish ring appeared around the periphery where the rash had been; that also went away on its own after one day. No treatment needed; no pain or itching. Did not see a doctor; was not needed. Fully recovered.
Rash-like dried skin over complete body. Swelling in hands & ft. Given vaccine in PM on 10-16-12 - woke up with rash in AM on 10-18-12. Rash disappeared by AM on 10-22-12. Discontinued breast feeding infant.
developed sharp left chest pain, fever, chills.   Felt better with acetaminophen.  On 2/27/2021 left chest pain returned and was so severe caused hospital ED visit and hospital admission
Nothing till around the 20th of October, then a headache that did not go away, then on thenight of 20th vomiting, headache reached migrain status, left side of face of my face went numb all the way to the bridge of my nose and ear burning and throbbing. When that happened, went to the ER.
pt states that same evening of vax was unable to sleep, was restless, skin warm, nausea, h/a, extreme pressure front of forehead, sweating, chills & weakness;10MAY98 facial redness periods  & weakness;
Information hs been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of GARDAIL (dose, route and lot number not reported). The physician reported that she heard the patient fainted after vaccination. It was not specified if the patient sought medical attention. Attempts to verify the existence of an identifiable patient have been unsuccessful. Additional information is not expected.
After getting the vaccine, my cycle became irregular and heavy. I developed night sweats, myalgia and joint pain prior to my cycles. I have not had these symptoms prior to vaccination. Moreover, I started having unexplained dizzy spells and weakness. I am not premenopausal. My blood work does not suggest any diseases or abnormalities. I am concerned about my women's health, since I have a Family history breast cancer and since this vaccine is experimental I am not sure how it can affect my hormonal system or lead to any undesirable consequences.
An empty syringe, not filled vaccine, MAY HAVE BEEN utilized to "vaccinate" this patient.  This possible error was identified within 24-hours of the event and the parents were informed of the potential error.  The parents have decided to forego immediate re-vaccination and have spike protein antibody titers checked in 2-3 weeks to decide if they will consent to a repeat dose one or continue on to dose two.
Within 24 hours of having my second dose of the COVID-19 vaccine, I became moderately depressed. Nothing had occurred in the days prior to trigger an episode nor had I suffered from a episode for a while. I have since encountered two other people who have had the same reaction and have encouraged them to retort it as well.
Had arthritis in right knee. Friday morning began to feel like gout. Had pharmacy request Colchicine from my GP. By Monday couldn't walk very well pain in all joints on right side. Took 2 0.6 mg Colchicine followed with 0.6 an hour later for acute attack.  Tuesday night big Toe joint swelled and red. By Wednesday couldn't walk had to stay home from work. Acute dosage didn't work. By today pain subsiding except for the initial knee arthritis.  In my opinion the Bivalent booster triggered an acute gout attack.
Very swollen, hard, very warm, painful muscle. Reported to dr who ordered z-pak but I didn't take it. Cool compresses but no relief. Had same symptoms for a week.
Within 24 hours of the vaccine started experiencing colitis symptoms. Had to seek our medical advice. And they confirmed  a flare from the vaccine
No adverse event; she has a patient that received a moderna bivalent vaccinet that expired on June 9th; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (she has a patient that received a moderna bivalent vaccinet that expired on June 9th) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (she has a patient that received a moderna bivalent vaccinet that expired on June 9th). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (she has a patient that received a moderna bivalent vaccinet that expired on June 9th) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant product use was not provided by the reporter.  The patient received the vaccine this morning around 9:00 am. Expiry date of the vaccine was reported as 09-Jun-2023.  Treatment information was not provided.
I have covid arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE REACTION (I have covid 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (I have covid arm). At the time of the report, VACCINATION SITE REACTION (I have covid arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
mom called MD 2 days p/vax scrotum was very tender to touch &  sl swollen; pt ran a low grade fever & tenderness lasted for about 48 hrs;
Patient came in for 2nd hep B vaccine and received about 3/4 of the dose, which was realized after the fact that some vaccine was left in the syringe barrel.  Spoke to pt and relayed information from GSK mfr that CDC recommends re-vaccination unless testing indicates adequate immune response.
Narrative:  Patient here for shingles vaccine. He reports back in November, a few days after his first shingrix vaccine was received, he started with a slight fever, joint pain/aches and stiffness. He started with a blistery rash on bilateral feet that has slowly worked its way up his legs. He reports it is very itchy. It has now progressed to his abdomen and he has an "active area" on his left upper thigh that is especially itchy. Rash is red, raised, not blistery at visit today. He showed his left leg with has sporadic spots up and down the entire leg but he reports the right leg looks the same. He has tried triamcinolone cream on it without relief.
Feeling of pressure in chest first noticed upon awakening at 8:00. The symptom is still present. Light headed and pale, especially when bending or climbing stairs.  Chills and cold sweats on and off. Bruising at injection site.
Patient was given vaccines and had syncopal episode where she felt lightheaded, laid down and was unresponsive for about 20 seconds.
Patient started experiencing shin, back and joint pain 20 minutes after receiving the vaccination. The symptoms worsened over the next 2 days, then patient reported to ER for treatment. Pt noted to have tenderness to joints.
Pt reports severe fatigue x 1 week.  He reports " I cannot sleep enough.  I am exhausted."
TIRED; HEADACHE; This spontaneous report received from a patient concerned a 72 year old female.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 13-JUN-2021) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-MAR-2021, the patient experienced tired. On 30-MAR-2021, the patient experienced headache. Laboratory data (dates unspecified) included: SARS-CoV-2 antibody test (NR: not provided) keep going up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired, and headache on 30-MAR-2021. This report was non-serious.
Information has been received from a health professional concerning an 8 year old white female with no medical history and no allergies who on 02-May-1996 was vaccinated with on 0.5 ml dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 19-May 2003 the patient developed a breakthrough rash with 10-20 lesions on her trunk and upper extremities. Unspecified medical attention was sought and it was reported that no treatment was required. On approximately 02-Jun-2003, two weeks later, the patient recovered. No product quality complaint was involved. It was also noted that the patient's 9 year old sister was vaccinated with a dose of varicella virus vaccine live and developed a breakthrough rash with 5-10 scattered lesions on the right side of her chest (WAES #0304USA02590). No further information is expected.
Fully vaccinated with booster on 11/11/21.   Breakthrough infection, Inpatient hospital stay
Urticaria on face and lower extremities. Pruritic lesions, pharyngeal edema.  Swelling around mouth, no shortness of breath.  Given Benadryl.
Patient fully vaccinated against Covid-19 (1/22/2021, 12/31/2020). Tested positive for Covid-19 on 6/22, requiring hospital admission 6/25.
For the past week I have had much discomfort in my upper arms, back and chest. I am currently experiencing a numbing sensation and weakness in those areas, too. I cannot sleep without taking analgesics before heading to bed because of the discomfort.
About one week after receiving the vaccination, I developed a red splotchy rash at the injection site, about the size of a quarter. It remained for about 7-10 days after it began, but it would come and go throughout the day. It was most noticeable right after getting out of the shower in the mornings, and then would fade throughout the day. Sometimes it wasn't visible at all, but would come back the next morning after a shower. It was not itchy, swollen, or bumpy. I could not feel it at all, only see it.
Shivering, chills, fever, bodyache, energy less. Headache, heaviness in eyes and head. On May 8th 11:50 I got 2nd dose of Vaccination, after that normal tenderness at site, but near 8:00 pm felt uncomfortable, around 11 pm shivering, fever. 9th May stayed on bed, felt energy less, bodyache. Today feeling better, but still feel heaviness in head and eyes, not normal feeling, took day off from work.
About 1.5-2 weeks after receiving the Gardasil vaccine I had a large lymph node at the base of my neck, right behind my ear, swell up. This happened with my 1st and 2nd Gardasil vaccine. I waited past the reccommended time to get the third vaccine because I had had adverse reactions to the first two. The third time I did not have the swelling.
While having my flu vaccination at approximately 9:30 AM on Ocotber 16, 2020, I thought she seemed to be a bit high with the placement of the needle, but since I do not look, I could not see.  It felt a bit "thick" going in, but I was not sure what that meant.   Within  a few hours of having the injection, my muscle felt a bit sore - which is the usual reaction -  but by midafternoon 3:30 pm, there was this very intense pain on the front of my shoulder,  that did not feel muscular.   It intensified into the evening until I went to bed around 9 pm and took 600MG of Advil to calm the pain.  I awoke around 2:30 with such pain in front of my arm, I was awake for about an hour and then took 400 mg of Advil to return to some unrestful sleep as I could not get comfortable.  This has continued every night since - icing the front of my shoulder and taking 600 mg of Advil before sleep and then being awakened between 2-3:30 am due to the pain in my arm.    It is difficult to get comfortable even with the ice and Advil.  During the day on Saturday 10/17, Sunday 10/18 the pain was evident all day but most excruciating when I attempted to move my right arm back - to put my hand in my right pant or jacket pocket or to pull up my pants on the right side.  Additionally, I could not buckle with my right hand but had to reach over with my left.     There were times over those two days and every day since that moving my right arm just the slightest ?wrong way? causes such excruciating pain, it takes my breath away.   On Monday 10/19 I called to make a doctor?s appointment, but they could not see me for two days. I already had a previously schedule PT appointment for Wednesday 10/21, that I did not need for the previous issues but decided to keep it and have MPT examine my shoulder and arm and make a diagnosis.  She examined me and wrote her observations which can be obtained at Physical Therapy.  She recommended to ice it whenever it hurts and limit any range of motions that aggravated it but to do hanging circles to keep the shoulder moving and reduce the risk of frozen shoulder.  We made a follow-up appointment for 10/26. 10/25/20 The pain continues every day and night and has severely restricted my active lifestyle.  It has also interrupted any sense of restful sleep as I am aware of the pain every time I turn over and awakened every morning between 2-3:30AM.  This lack of restful sleep severely affects my ability to be clearheaded and productive in my job.  10/26/20 I visited Physical Therapist again today at 7:45 am.   She did some laser therapy and some message and taped it with KT tape.  She believes that either a tendon or bursae were struck with the needle and that is what is causing the pain.  She also explained that this could be a 4-6-week recovery. My shoulder felt calm when I left PT and for about 7 hours.  If is now fatigued and had some ?toothache? pain radiating out.
Rash getting bigger and bigger; Little pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Little pain in the arm) and RASH (Rash getting bigger and bigger) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE PAIN (Little pain in the arm). On 23-Jan-2021, the patient experienced RASH (Rash getting bigger and bigger). At the time of the report, VACCINATION SITE PAIN (Little pain in the arm) and RASH (Rash getting bigger and bigger) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 25-JUN-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Developed a headache that evening. Complained aboout everything hurting. Head still hurting next morning.