chrisvoncsefalvay/vaers-outcomes huggingface dataset:
myocarditis/ Chest Pain; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (myocarditis/ Chest Pain) in a 26-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Jun-2022, the patient experienced MYOCARDITIS (myocarditis/ Chest Pain) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (myocarditis/ Chest Pain) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported by reporter.  It was reported as patient went to the ER last night with chest pain. He was now in the hospital today and was diagnosed with Myocarditis and waiting to have a cardiac MRI.  No treatment medication was reported by reporter.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a 26-year-old male patient, with no medical history reported, who experienced the expected and serious (due to medically significant) AESI of Myocarditis, which occurred after a dose of mRNA-1273 vaccine (latency unknown). Patient went to Emergency Room due to chest pain, and myocarditis was diagnosed. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-600929 (Patient Link).; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 26-year-old male patient, with no medical history reported, who experienced the expected and serious (due to medically significant) AESI of Myocarditis, which occurred after a dose of mRNA-1273 vaccine (latency unknown). Patient went to Emergency Room due to chest pain, and myocarditis was diagnosed. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient started to feel dizzy about 5 minutes after the shot.  She laid on the ground.  She then started to have seizure and urinate.  She complained of feeling hot and clammy.  Her lips looked pale initially.  She denied of feeling shortness of breath or chest/throat tightness.  She felt very tired/sleepy.   We had her laying on her back and trying to keep her talking until paramedic team arrived.
The vaccine was administered on the following date: 1/19/21 and at approximately the following time: 10:30 AM   She works at medical and received vaccine there.    She waited the 15 mins and felt fine. Left work at 1 pm. Had blood taken at health clinic for her annual clinic, no meds or testing just a routine blood draw.    She was actually working out when the symptoms developed while she was boxing at her gym. She didn't really realize what was happening, felt a little bit confused. At 4:30 pm she developed difficulty breathing and wheezing, eye swelling (swollen shut), lips with burning and tingling and swelling, hands were swelling with shortness of breath and throat tightness. She noted a rash on the arm that was flat and red (looked like a pattern on her arms). This rash was not raised. She vomited 2 times at the gym. Her boyfriend picked her up and took her to the ED.      ED Note:  "According to the patient, she was otherwise in her normal state of health and received the moderns COVID-19 vaccine earlier this morning at approximately 1030.  Reports feeling largely well over the course the afternoon, ate a salad for lunch but nothing out of the ordinary for her.  Patient states that she was going to the gym at approximately 4 PM she began to develop diffuse itching and rash.  Over the minutes that followed she also began develop some perioral edema and swelling around her eyes.  Also states that her chest felt somewhat tight and had a dry cough.  Due to concern for allergic action, called an car service was brought immediately to the emergency department for further work-up and evaluation." Initial vitals: HR 153 BP 99/56 RR 24 SpO2 96%. Exam with diffuse erythematous rash on trunk, neck and upper extremities. Peri-occular and peri-oral edema. No tongue swelling. No wheeze.    Treated with epi, IV benadryl and oxygen. She was observed for 6 hours and all symptoms resolved, except for some eye puffiness. The eye puffiness lasted for 2 days. Discharged home. No tryptase level sent.    She had never had a severe allergic reaction in the past.
So the reason for this is that the MMR was expired on 12/3/2017 and this was given to the patient on 12/4/17, there has be nor reaction or anything and we will re vaccinate the child in the 28 days. I was told by agency that I needed to send in this form. Mother of the child is aware on this issue and has scheduled to have her daughter brought in next month for us to re due the vaccine.
terrible chills, body aches, headache, sore injection site.....lasted 4 days
acute proximal extremity muscle pain with movement. difficulty ambulating. no muscle weakness or joint pain.  diagnosed with "polymyalgia rheumatica."
injection site with redness; My arm was numb from the top of my shoulder to my elbow; This is a spontaneous report from a contactable other hcp. A 36-years-old female patient received bnt162b2 (Pfizer BioNTech, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 15Feb2021 as 2nd dose single for covid-19 immunisation (Age at vaccination was 36 years). Patient was not pregnant at time of vaccination. Past drug event was clindamycin. Historical vaccine was A 36-years-old female patient received bnt162b2 (Pfizer BioNTech, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 22Jan2021 as 1stdose single for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing, food allergy from an unknown date and unknown if ongoing.  Concomitant medication(s) included cetirizine hcl (CETIRIZINE HCL) taken for an unspecified indication, start and stop date were not reported.  The patient previously took clindamycin and experienced drug hypersensitivity, bnt162b2 for covid-19 immunisation.  The patient experienced injection site with redness, my arm was numb from the top of my shoulder to my elbow on 15Feb2021 12:45. Upon follow-up on 12MAY2021 follow-up attempts completed. No further information expected. Outcome of the events not recovered.    Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.
Generalized aching, chills, low-grade fever(99.3°F), fatigue
Information has been received from a physician concerning a 5 year old male who on 19-Jan-2008 was on 19-Jan-2008 was vaccinated with a second dose of VARIVAX (Oka/Merck) (lot# 654128/1147F) 0.5ml subcutaneously and a dose of MMRII (MSD) (lot# 654983/1168F). The patient had been diagnosed with chicken pox which developed the week of 21-Jul-2008. The patient sought medical attention: office visit. At the time of this report, the patient was recovering. There was no product quality complaint. Additional information has been requested.
Patient reported c/o rapid heart rate while under observation. Pt's stated "I feel anxious" was cold clamny, skin cool.  initial V/S : HR 145 , RR 21 BP 130/80 Sat 99  Pt's anxious, ice pack applied to head, feet elevated, water provided Lungs CTA  no SOB no dizziness  VS before D/C : BP 128/88 HR 101 RR 20 sat 99%  NP cleared patient to go home,symptoms fully resolved prior to leaving event site and encourage patient to follow up if symtoms return.
residual redness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (residual redness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040a21a and 024m20a) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ROSUVASTATIN for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ERYTHEMA (residual redness). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, ERYTHEMA (residual redness) outcome was unknown.            This case was linked to MOD-2021-073770 (Patient Link).
PT REPORTS LARGE HEMATOMA ON ARM THAT SHE RECEIVED COVID VACCINE
This spontaneous report was received from a registered nurse and refers to a 20 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-JAN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (route and site of administration, lot # and expiration date were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA002250: US-009507513-1704USA001506.
On the 11th, I started having pain in my breast, I kinda just left the pain for a week and it wasn't going away I also started spotting, I have been menopausal since mid 2018, Heavy bleeding started on May 8 to the 11th. The biggest problem is with my breast , they are swollen, under my breast are purple and red. I started to get chills, nausea, I could not wear a bra. The doctor treated it as mastitis, I was on two different antibiotics,  nothing has helped it, I'm having to see a breast surgeon. no one knows what  this is and they are not sure.
no adverse effects; Improperly stored administered doses; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 22-MAY-2019, the patient was vaccinated with improperly stored  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # R015745, expiration date 02-DEC-2019; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion from -14 to 10 degrees Celsius (C) for 15 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1906USA000180:
I think that your Covid vaccine works against herpes simplex. I usually had an outbreak every two months or so, and I have not had one since my second vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for Covid-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I think that your Covid vaccine works against herpes simplex. I usually had an outbreak every two months or so, and I have not had one since my second vaccine".  Additional information: Patient thought that Covid vaccine works against herpes simplex. Patient usually had an outbreak every two months or so, and patient have not had one since second vaccine. Perhaps Pfizer would be interested in researching the possibility that an mRNA vaccine can work against herpes.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.
I95.9 HYPOTENSION 2/4/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA I95.9 HYPOTENSION 2/4/2022 WEAKNESS I95.9 HYPOTENSION 2/4/2022 ATRIAL FIBRILLATION, PAROXYSMAL
Development of an indentation in her left buttock following varicella (shingles) vaccination. Described as lipoatrophy.
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Additional Details: patient recieved vaccine two vaccines in left arm around 11:39AM - called pharmacy at 5:30pm saying shes in excrutiation pain radaiting from neck to arm - hurts to lift arm perform normal functions
Pfizer vaccine administered when patinet has rececived Johnson & Johnson vaccine 4/12/21.
Patient felt extremely tired following the COVID-19 vaccine. Patient showed no concerning signs/symptoms until the daughter tried to bring the client out to the car, and the patient exhibited rapid-onset somnolence while walking. Patient was brought back into the vaccination clinic to be monitored further. Juice and water given to the patient, patient able to swallow. EMS called to evaluate the client. EMS determined a need for the patient to seek hospital care, but the patient's daughter refused and signed an AMA waiver. Patient and family left the facility against medical advice.
Narrative:  76yo male patient with with PMH of ESRD on HD M/W/F, MFpEF (ER 50%), COPD on 2L NC, 3vCAD s/p high risk PCI to D1 2017, RCA known CTO, stable LM disease and history of PE (Eliquis), polysubstance abuse, PVD, HTN, presented to ER on 1/21/22 after mechanical fall at home. Pt was admitted. Pt then died during this inpatient admission on 01/27/2022. Death was caused by: Cardiogenic shock secondary to acute MI. Pt had received covid vaccines on 2/5/21, 3/9/21, & 1/13/22. This death is not related to the covid vaccines. PROBLEM LIST Seen by palliative care service (SCT 441Pressure ulcer of coccygeal region (SCT 699216009) Unintentional weight loss (SCT 448765001Claudication (SCT 63491006) Breathlessness on exertion (SCT 60845006Poor sleep (SCT 301345002) H/O: pulmonary embolus (SCT 161512007) Long-term current use of anticoagulant (SCT 711150003) Dependence on wheelchair (SCT 105503008) Dependence on hemodialysis due to end stage renal disease (SCT 428982002) Hyperparathyroidism due to renal insuffiChroic kidney disease stage 4 (SCT 431857002) Coronary artery disease (SCT 53741008) Chronic obstructive lung disease (SCT 13645005) Cocaine dependence (SCT 31956009) Light cigarette smoker (SCT 160603005) Peripheral vascular disease (SCT 4000470History of male erectile disorder (SCT 429031006) Chronic kidney disease stage 3 (SCT 4331Proteinuria (SCT 29738008) Family history of kidney disease (SCT 28Multiple nodules of lung (SCT 445249002) Hypertension (SCT 38341003) DENTAL CARIES (ICD-9-CM 521.0)
Employee states left arm started hurting after injection.  C/O of numbness, pain down left arm.  Hard to lift arm up.  Tried ice.  Cannot take ibuprofen.  Referred to private physician.
On 07/18/2005 after patient had 2nd rabavert vaccine.  I had her wait 10 minutes and before she left she stated that she had a tingling feeling in her left arm and that her fingers felt cold.  Reaction started about 2 minutes after injection.  Then she stated that she had the same reaction after her 1st Rabavert injection on 07/11/2005.  States tingling feeling lasted 1 hour after 07/11/2005 injection.  States some reactions lasted less than 1 hour after 2nd injection on 07/18/2005.
Both hands (and fingers) are feeling tingling all the time since the onset.  Both legs felt some tingling/cold feelings but not as bad as in the hands.  The stronger tingling sensation in the legs only lasted for about a couple of weeks.
Soreness, swelling at injection site Developed sniffly nose ?symptoms of a cold Headache
pt recvd vax; pt devel fever w/ t 101; pt had fussiness crying;
Pt developed malaise, vomiting and fever starting on 8/9/01. Had some neck stiffness.
Over the past year, I've experienced neurological problems.  I've been diagnosed with Small Fiber Neuropathy, and a possible diagosis of Zoster Sine Herpete. I have daily burning, tingling, vibrating, buzzing sensations on back, legs, arms, feet. Skin has become so sensitive that I cannot wear 95% of clothes. Painful to sleep on cotton sheets. Treating with gabapentin, which helps but does not take away. Symptoms started right around same time as vaccines.  I was very healthy prior, active.
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. Information regarding the concurrent condition and medical history not reported. On 02-MAY-2016 the patient was vaccinated with an improperly store dose of ZOSTAVAX (lot # L044528 with expiration date of 09-FEB-2017, dose and route unknown). No adverse effect was reported. Additional information has been requested.
Information has been received from a 77 year old female with no relevant medical history or allergies who on 20-MAY-2008 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) (lot number, injection site and route not reported). Concomitant therapy included SYNTHROID, estrogens (unspecified), progesterone and alendronate sodium (manufacturer unknown). On the night of 09-JUL-2008 the patient experienced itching first on her forehead, face and back. Then through the next day and night she started to have stabbing pain/burning and itching feeling that would happen intermittently from her shoulder to her torso, she started on the forehead, back, under her breast bone etc. The consumer reported that the pain and itchiness got so bad that she started to take DYMATAP (manufacturer unspecified) during the day which help some, and took BENADRYL at night at which she could not tell if there was a problem because she thinks the BENADRYL mad her very tired. The consumer reported the pain is getting better. The consumer sought unspecified medical attention. Additional information has been requested.
Four hours after receiving second shot in left arm, arm started itching. It later moved to right arm; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Apr2021 at 14:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Mar2021 at 14:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient previously took ampicillin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 12Apr2021 at 18:30, four hours after receiving second shot in left arm, the patient arm started itching. It later moved to right arm. The patient reported that, she was still dealing with uncontrolled itching and had been to dermatologist 2 times. The patient had next appointment in one week and doctor was not sure what was going on. The patient stated, nothing had worked to cure it. Since the vaccination, the patient had not been tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported event which included treatment with hydroxyzine (MANUFACTURER UNKNOWN), cream and ointment. The clinical outcome of event arm started itching. It later moved to right arm was not resolved at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
edema over entire body started 48 hrs p/vax; denies any rash, SOB, pruritus; took DPH p/edema started; pt doesn't recall edema starting in any specific area;
Had a type of E-coli; Fever; UTI; A spontaneous report was received from a consumer who was also a 79-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who fever/ pyrexia, UTI/ urinary tract infection, and had a type of E-coli/ enterococcal infection.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 27 Feb 2021, prior to the onset of the symptoms, the patient received a dose of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On an unspecified date the patient developed a type of E-coli infection, Urinary tract infection and fever.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events was not reported.; Reporter's Comments: This case concerns a 79-year-old female who had a medically significant and serious unexpected event of Enterococcal infection along with NS events of unexpected urinary tract infection and expected pyrexia.  Event onset occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
My arm feels weak, I'm having problems holding my pencil tighter shot.  Starting feeling about 20 mins after shot.  Ice offered - student refused & wanted to return to class.  Instructed to return to nurse if needed.  Pt with equal strength bilat when squeezing this writers hand/fingers.
She noticed a few hives on her arms, then increased to few more on her chest and by 10/06/2013, she came in on 10/8/13 and during examining her, hives were all over her chest and abdomen with a few more on her arms. No signs of shortness of breathe or trouble swallowing. She stated that she didn't have hives when she had her flu vaccine last time.
arm felt tired & weak rest of day, arm became red & hot and began swelling-swelling progressed through hand by 4th day; some weeping and blistering
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Dec2022 at 01:00 as dose 5 (booster), single (Lot number: G16738) at the age of 71 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: continued symptoms and testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, patient received Paxlovid from 07Oct2023 to 11Oct2023.; Sender's Comments: Based on the known the information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely