chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US005913 is an initial spontaneous report received from a health care professional on 21 Mar 2014. This report refers to a patient of unknown age and gender. The patient inadvertently received only Men C, Y, W-135 liquid component of MENVEO (batch number: M13014) intramuscularly, without reconstitution with Men A lyophilized component on an unknown date. No adverse event reported following this administration error.
Severe headache, heart palpitations, Nausea, Vomiting, fever 104.2, joint pain, kidney issues, fatigue
Heart condition; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (Heart condition) 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 CARDIAC DISORDER (Heart condition). At the time of the report, CARDIAC DISORDER (Heart condition) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. No relevant concomitant medications were reported. No treatment information was provided.
ummunocompormised patient may receive the ZOSTAV AX vaccine; no adverse effects; This spontaneous report as received from a pharmacist referring to an over 80 years old (also reported as in 80's, roughly) female patient. The patient was immunocompromised and had none drug reactions/allergies. Information about concomitant medication was unknown by the reporter.   On an unknown date (also reported as in about 2 weeks), the patient may receive the  zoster vaccine live(ZOSTAVAX) (dose number, dose, anatomical location and route of administration, lot number and expiration date were unknown) for prophylaxis (circumstance or information capable of leading to medication error).
I was informed that I did receive the booster on May 27/2021; I was informed that I did receive the booster on May 27/2021; sick; This is a spontaneous report from a contactable Nurse (patient) reported for herself that: A 68-year-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27May2021 as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 06Aug2020 as DOSE 1 SINGLE and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27Aug2021 as DOSE 2 SINGLE for COVID-19 immunisation. The patient experienced I was informed that I did receive the booster on May 27/2021 (off label use), I was informed that I did receive the booster on May 27/2021 (immunisation) (non-serious) on 27May2021. Patient was sick in 2021. I was sick after dose 2 and the booster dose. So sick I called the hotline for clinical trials adverse events. He took the information down and called the clinical trial people and the doctor called and told me to take more Tylenol. The patient underwent lab tests and procedures which included body temperature: 102.9 on huge fever of 102.9. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
After 6 days the injection site is swollen, hard and round, as a baseball, hot, itching, painful. Surrounding area is swollen approximately 6 inches around and raised in a half inch welt.
about 1/2 hr p/receiving vax c/o dizziness, shakiness, fatigue, & diaphoresis; sx lasted almost 3 hrs;
This spontaneous report as received from a nurse practitioner refers to a male patient of unknown age (reported as child). On 11-OCT-2016, the patient was administered an expired dose of M-M-R II lot  K012473, expiration date 26-AUG-2016 (therapy type, route and site of administration were not reported). Concomitant medications were not reported. No adverse effects were reported. Additional information is not expected as no consent was given for further contact.
This spontaneous report as received from an office administrator who is also a medical assistant refers to patient of unknown age and gender. On 09-JAN-2014, the patient was vaccinated with a first dose of PROQUAD (Merck) (lot # H015641, expire date 06-JAN-2014) injection, subcutaneous for vaccination (dose and strength not reported). No adverse effects reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
This spontaneous report as received from a licensed practical nurse refers to six patients of unknown age and gender. None of their pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (which had a lot # M004116 with an expiration date of 12-OCT-2017; however, the dose, dosage number, anatomical location and route of administration were unknown). No concomitant medications were reported. The aforementioned vaccine experienced a temperature excursion of 32 F for a time frame of 30 minutes, which was called out due to a data logger. Reportedly, the vaccine had not undergone any previous temperature excursions. Additional information has been requested.
5AUG95 hive-like rash on arms & face, swollen glands below ears, sore throat, swelling of face, low grade fever by 5AUG95 rash all over body, felt terrible, little improvement by OTC DPH/seen by MD;MD told family felt rash was coincidental
4/14/21 Thirty minutes post-injection: nose, then face became numb. Rapid heart rate (90 bpm), felt lightheaded. Nurse in observation room said it was vasovagal reaction. 4/15/21 Extreme pain in left arm, extreme fatigue & body aches, abdominal pain, headache. Symptoms improved after three days. 4/18/21 Noticed that hot water did not feel as hot to left arm as it did to right. 4/28/21 All finger joints in left hand became very painful, especially in thumb. 7/8/21 Began feeling extremely fatigued and achy. Entire body was tingling and sore "like I had a sunburn on the inside". Each afternoon body temp. would elevate 1-2 degrees and face would become numb.  8/13/21 Lab tests: Lyme & tick-borne illness panel - normal, CRP - normal. 8/17/21 Began anti-inflammatory treatments - Meloxicam (15 mg) in am for 30 days, Curcumin (1 gr) 2/day, Melatonin (10 mg) before  bedtime for four months. Anti-inflammatory treatments improved symptoms somewhat, especially Meloxicam.  10/21 Began manual lymphatic drainage which improved some symptoms of body aches and fatigue.  12/21 Began experiencing stomach & intestinal irritation (gas, cramps, diarrhea), discontinued Curcumin and Melatonin.  12/21 Covid antibody test: SARS-CoV-2 Semi-Quant total >2,500 u/ml.  3/21 Began L-Glutamine (4 gr) at bedtime which helped improve GI symptoms.  5/21 Currently still experiencing fatigue, body aches, numbness in face, tendonitis in left hand, GI sensitivity, and exercise intolerance. I am functioning at about 50% of my pre-Covid vaccine ability level.
4-to-5-cm raised red lesion with "strawberry texture," warm to touch, with no surrounding erythema, which started 1 day following the vaccine, not growing in size. No fevers.  This is a known reaction to the DTaP vaccine (an immune reaction), not cellulitis, and so no treatment was given.
About 10min after injection - GARDASIL & ADACEL pt felt dizzy & lost consciousness x60-90 sec, unresponsive but breathing color sl. pale. No up rolling of eyes no incontinence but 30 sec before pt roused body stiffened hands clenched & jerked & was A+O x3 when awake. Quiet & pale on & off x5 min.
Mom contacted MD on 10/21/02. Reports fever 104 on 10/21/02 and rash on left arm (covering).
A report has been received from a health professional concerning a 1 year old male patient. The patient's medical history, concurrent diseases and concomitant medications were not reported. On 22-Jan-2014, the patient was received nasal FLUMIST QUADRIVALENT. The patient experienced inadvertently administered FLUMIST QUADRIVALENT to a 1 year old (preferred term: drug administered to patient of inappropriate age) which started on 23-Jan-2014. The outcome of the event of inadvertently administered FLUMIST QUADRIVALENT to a 1 year old is unknown. The report was considered to be non-serious by the company physician.
Covid-19 Vaccine Clinic:   @0857, after receiving Pfizer Covid-19 vaccine, patient c/o "jittering" and anxiety. Patient denies any other PMH except for preeclampsia with last pregnancy. MD aware.   Initial VS at 0857: BP 139/99 HR 86 SpO2 100% RR 20.   @0903 Patient continues to report "jitterness" and anxiety at this time.    Subsequent VS: BP 122/90 HR 84 SpO2 100% RR 18.    @0915 patients blood sugar checked. Patient did report eating breakfast this morning. BS 135   @0927 patient reports "i'm not feeling right" BP 119/82 HR 80 RR 18 SpO2 96% RA. Symptoms reported: weakness and patient states "I feel like if I get up i'm gonna fall". Denies "jitterness".    @0929 MD notified via phone regarding patients new symptoms. MD to come assess patient   @0938 MD at patients side. Pt reports feeling like "i'm gonna pass out". RN STAT called. Patient placed on bed cot initially and wheel chaired over to reclining chair.    @0954 BP 123/87 HR 78 SpO2 96% RA RR 18. Patient states "head foggy" and "I can't get up"   @1015 #20 G PIV started on right forearm. Patient reports "I don't feel right" BP 118/83 HR 66 RR 18 SpO2 99% RA.    @1045 BP 121/83 HR 57 RR 19 SpO2 96% RA. Patient still reports "I feel like passing out" MD called back for re-assessment of patient   @1105 MD at patients side for assessment. Per MD, patient is physiologically stable for mother to pick up and take her to urgent care (patient refusing to be sent to ER)(Urgent care as requested by patient as she states she is a per diem worker and does not have Kaiser insurance). BP 118/89 HR 69 RR18 SpO2 98%.   @1145 Patient picked up by mother to go to urgent care. Okay to leave PIV in place by MD d/t patient a hard stick and may require intervention at urgent care
On 2/16/00, fever of 100.7, seizure-like activity; staring and unresponsive, 2 episodes, 1 in daycare and the other in ER. Describes aching of her neck, back and increased sleepiness X 1-2 days. Faint red papular rash on legs, especially dorsal aspect and fainter yet on trunk.
Tingling/numb feeling was reported as worsened.; Tingling/numb feeling; Tingling/numb feeling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 12:00 (Lot number: ED7533) at the age of 52 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset Apr2021, outcome "not recovered" and all described as "Tingling/numb feeling"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Tingling/numb feeling was reported as worsened.".   Additional Information: No additional vaccines administered on same date of the Pfizer Suspect. No prior vaccination within 4 weeks. No AE following prior vaccination. However, she was scared to do the second dose which is scheduled for 13May2021. The report not related to a study or programme. No other products, Investigation assessment reported as no. Reporter on the line calling about the Pfizer COVD Vaccine. She thinks she was having an adverse reaction and does not know where to start. She does not know if her doctor should be contacted. She was not seen the doctor yet. However, this event has not gone away. It's still lingering and getting worse. However, she may have to so see the doctor to determine if something different needs to be done. She did not have an address to provide for the HCP. She explained she got the vaccine on 22Apr2021 in her left arm. She clarified the adverse reaction as over a week now she has been feeling a tingling feeling from above her elbow of her left arm down to her fingertips. At times it is like a numbing feeling. She struggles to hold on to stuff because it is so tingly/numb. This feeling is more noticeable now. This started either 27Apr2021 or 28Apr2021. It started during the work hours, sometime between 8am-5pm CST. Vaccination facility type was pharmacy. Vaccine administered at facility was reported as does not believe so. History of all previous immunizations with the Pfizer vaccine considered as suspect reported as none, this was the first dose. The patient did not visit emergency room and physician's office. She is unsure if we should be aware of this too. AEs following prior vaccinations reported as none. Family Medical History Relevant to AE(s) reported as none. Relevant test reported as none. Stated she will call back if she has more questions. However, she is scared to do the second dose which is scheduled for 13May2021. Informed to reach out to doctor regarding questions about getting the second dose.  No follow-up attempts are possible. No further information is expected.
20 x 40 cm. confluent erythemic rash to the left lateral thigh that is red, swollen, warm & acutely tender to palpation. No mass or abscess palpated. Fever 100 in office states 102 on 10-3-12. On antibiotics 10-5-12.
large area swollen mid thigh size of pt fist approx 1/2 of thigh area per mom; no red; no fever; advised mom to appts ice or cold to area as told; completly resolved in AM; very tender to touch;
NERVES ACTING UP; THROAT FELT SWOLLEN; CHILLS; NAUSEA; ITCHING; TINGLING; BULLS-EYE RASH AND AND RAISED BUMP AROUND THE INJECTION SITE; MUSCLE ACHES; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included migraines with nausea and blurred vision, lyme disease, pneumonia, bronchitis, anaphylactic reaction to eggs, anaphylactic reaction to red dye, penicillin allergy, alcohol user, and non smoker. The patient experienced drug allergy when treated with phenazopyridine hydrochloride, and sulfamethoxazole/trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced muscle aches. On 07-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced itching. On 09-MAR-2021, the subject experienced tingling. On 09-MAR-2021, the subject experienced bulls-eye rash and and raised bump around the injection site. On 11-MAR-2021, the subject experienced nerves acting up. On 11-MAR-2021, the subject experienced throat felt swollen. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nerves acting up on MAR-2021, chills, nausea, and headache on 11-MAR-2021, and muscle aches on 09-MAR-2021, and was recovering from bulls-eye rash and and raised bump around the injection site, itching, tingling, and throat felt swollen. This report was non-serious.
Patient was vaccinated and left with her mother to sit in her car for 30 minute monitoring period.  Patient's mother stated patient was experiencing extreme anxiety getting the vaccine and after 20 minutes was wheezing.  She brought patient inside and a Pharmacist came to check on her and her mother stated that she has had a reaction to a medication in the past and just needed Benadryl.  Benadryl was given to her and she took it orally.  Her pulse and blood oxygen were measured with a finger pulse oximeter and were both normal.  Shortly after she was panicking more and had a seizure.  Her mother reported that she has frequent seizures when she has anxiety/panic episodes.  Her seizures were persisting so 911 was called.  Paramedics arrived shortly after and took patient to the hospital.  A few hours later the patient's mother came back to us to inform us that she was released from the hospital and was feeling fine and back to normal.
severe redness in arm itching stinging welts inflamation all above symptoms traveled from injection site to wrist areas Also an outbreak of Herpes in nd outside of my mouth
pt recv vax 11FEB98 & 21FEB98 pt devel fever;21FEB98 pt devel hundreds of pox on entire body including scalp, ear & bottom of feet;the lesions were described as vesicular, pustules some scabbed & red papules;
After receiving her vaccine, client complained of itchy throat, tightness of chest and throat.  Vital signs obtained B/P 151/98, HR 80, O2 sat 100%.
Pt is 90 yo female s/p Pfizer COVID-19 vaccination: dose 1 on 1/23 and dose 2 on 2/13. PMH significant for heart failure, atrial fibrillation. Pt presented with 9/7/21 with 6 days of progressive fatigue and cough. CXR on admission with RLL infiltrate, and patient tested positive for COVID19. She was started on remdesivir, dexamethasone, and supplemental O2. Symptoms slowly improved and O2 was weaned to 1-2L prior to DC. She completed 10 day course of remdesivir/dexamethasone while inpt. She was noted to have UTI which was treated with ciprofloxacin to finish 10 day course ending 9/23/21. Given COVID19's clotting risk, patient discharged on low dose eliquis as well for 1 month.
pt recv vax & exp chills, sick stomach & insomnia;pt states that felt drained of all energy & very hot all the time;
about 4 hrs after injection I couldn't move my arm or fingers. Now 9 days later I still have limited active range of motion. Cannot lift my arm above my head, behind my back, etc. The site where the injection was given was directly below the acromion process and I think it is possible that the nurse inadvertently injected the vaccine into the bursa and missed the deltoid muscle.
patient states her left arm is very sore and she can hardly lift it up. she took a tylenol on the evening after she took the shot
This case was reported by a consumer via call center representative and described the occurrence of pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain, erythema and pruritus. On an unknown date, the outcome of the pain was not recovered/not resolved and the outcome of the erythema was recovering/resolving and the outcome of the pruritus was unknown. It was unknown if the reporter considered the pain, erythema and pruritus to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient had a large red mark that was fading slightly after seven days still was sore, also itchy sometimes and I felt should be gone.
Hospitalized (12.6.21);  COVID-19 positive (12.2.21); fully vaccinated Admission Date: 12/6/2021 Discharge Date: Dec 8, 2021 # Acute hypoxic respiratory failure from fluid overload: # Covid 19 infection: # Acute on chronic diastolic failure:         - improved after dialysis         - on room air         - dc home with instruction to continue dialysis at davita on TTS due to covid. DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: ESRD (end stage renal disease) on dialysis  Acute hypoxemic respiratory failure  COVID-19 virus infection  HOSPITAL COURSE: Pt. is a 56 year old female with insulin-dependent type 2 diabetes mellitus, chronic diastolic CHF, essential hypertension, end-stage renal disease on hemodialysis. Pt. presented to the ED with SOB. She was found to be hypoxic and admitted to the hospital. Patient reports she had been more fatigued for a little over a week and diagnosed with COVID19 on 12/2/21. She initially had no SOB, but over the last week did developed worsening SOB. Patient admits since being diagnosed with COVID she had missed last three HD sessions. Labs showed an elevated BNP, potassium 6.1. Chest x-ray showed concerns for pulmonary edema. Nephro was consulted and patient underwent HD. Her SOB quickly improved and she returned back to her baseline supplemental O2. Patient was started on decadron for which she will complete a ten day course outpatient. Nephro set the patient up with her clinic's COVID times and her daughter in law is able to take her during these times. Patient will follow up with her PCP outpatient. She is discharging in improved and stable condition.
Information has been received from a physician concerning a 41 year old male who on 15-Juo-2001 was vaccinated with a dose of measles virus vaccine live (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot number unknown). Laboratory evaluations on 21-Jan-2004 reveled that rubella IgG was negative, mumps IgG was 1.69 (positive) and rubeola IgG was 3.42 (positive). On 26-Mar-2004, the patient was vaccinated with a dose of measles virus vaccine live (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) )Lot number 642230/0181M). On 07-Arp-2004, laboratory evalutations revealed rubella IgG was negative. On 16-Apr-2004, the patient was vaccinated subcutaneously in the left arm with another dose of measles virus vaccine live (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot number 642641/0346M).  Vaccination history included hepatitis A virus vaccine on 22-Jun-1997 and 19-Oct-2001, hepatitis B virus vaccine on 07-Aug-1998, and 23-Jul-2001, typhoid USP on 03-Oct-2003, Anthrax vaccine on 01-Jan-1991, 09-Nov-2002, and 03-Oct-2003, tuberculin purified protein derivative (PPD) on 02-Oct-2003, influenza virus vaccine 02-Oct-2003, and meningococcal virus vaccine on 29-Mar-2002.   Additional information received from the physician indicated that on 12-Jul-2004, laboratory evaluations revealed rubella IgG status was immune  No additional information is expected.
Prolonged crying for 3 hours (06-14-2006) after 2 months vaccines.  Fine afterward
Case received from a healthcare professional through the MIS on 08 October 2010 under the local reference number 10-0699. A 34-year-old female patient, with no reported medical history, had received her dose of ADACEL, batch number C3517BA, on 06 October 2010. On 06 October 2010, 15 minutes post-vaccination, the patient experienced heaviness and tightness in her chest. Later that evening, she developed a red rash on her upper arm. She also presented with fever, chills and cough. The following evening, she still had fever. Twenty-four hours later, the patient's symptoms resolved and she was fine. Documents held by sender: none.