chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient is a 83 y.o. female with history of presented to Hospital with severe abdominal pain.   SBO Admit to hospitalist service Surgical consult N.p.o. Continue NGT to suction Gentle IV hydration Pain control CT showed high-grade partial distal small bowel obstruction, with suggested point of transition in the lateral right lower quadrant.   Surgery ordered SBFT and did not show obstruction 12/16, clamp trial and clears as tolerated 12/18, patient tolerates liquids. Advanced to regular diet. 12/19: tolerating regular diet On Discharge tolerating regular diet and stooling regularly on bowel regimen   Bibasilar pneumonia CT scan suggest airspace both lung bases Patient asymptomatic Cannot rule out aspiration given multiple episodes of vomiting lately Received 5 Days zosyn Blood culture with no growth to date 1 Dose po levofloxacin on day of discharge and 1 dose to complete the day after discharge for a total of 7 days antibiotics   Leucopenia Anemia combination of anemia of chronic disease secondary to rheumatoid and iron deficiency She is on iron supplementation held while n.p.o. inpatient, to be resumed in the outpatient 12/15, Hemoglobin dropped 9.7 -> 7.5. Possible effect of IVF.  Continue to monitor hemoglobin and WBC Leucopenia possible due to Zosyn.  WBC 2.71 and hemoglobin 7.5 on discharge     History of rheumatoid arthritis Methotrexate and prednisone held while inpatient Continue to hold methotrexate at discharge until 1 week after acute infection resolves Prednisone 5 mg 3 times daily resumed at discharge Patient will need to follow-up with her rheumatologist patient had no recent fill history of Lasix and it was held while inpatient, continue to hold on discharge   Chronic congestive heart failure with preserved systolic function Ejection fraction 60 to 65% with diastolic dysfunction compensated Hold home Lasix until able to maintain hydration  Covid 19 Covid-19 Virus Infection Date of onset of symptoms: 12/18/2022 (loss of smell) Symptoms present on admission: none, developed loss of smell on  Date of covid positive test: 12/18/2022 Vaccination status: vaccinated Imaging: none, no change in O2 requirements from baseline Oxygen requirements on admission: 2L, same as home Current oxygen requirements: 2L, same as home Medical therapy: not indicated Consultants following: none Anticipated special isolation end date: 12/27/2022   Chronic hypoxic respiratory failure The patient uses 2L nasal canula at home. She uses the same here.      Physical deconditioning Secondary to advanced age combined with acute illness Patient lives alone Working with PT and OT Discharged to rehab
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 10-AUG-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD for prophylaxis, lot number R007684, expiration date on 11-SEP-2019 (strength, dose number, anatomical location and route of administration were not reported). The temperature excursion was from 6 degrees Fahrenheit (°F) to 14°F for a time frame of 58 minutes without a previous temperature excursion and was called because a digital data logger. There was not adverse effect reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1809USA002855.
After going to bed I woke up around 12:30 pm with itchy sensations on my hands, underarms and torso; also my tongue became swollen.  I Felt weak and nauseous but did not vomit.  After drinking a glass of water I went back to sleep. I awoke in the morning 3/28/21  @ 8am My itchy areas were gone. I did not feel weak, just tired. The swelling of my tongue gradually reduced during the day and now  it is normal (7:30pm).   There was no treatment.
Diarrhea started 4-17-12. Green, watery stools with mucus. No fever, no vomiting. Has 4-5 stools per day. Labs neg. Referred to GI clinic for evaluation.
Sore arm; Slight headache; Chills; Low grade fever; Sweats; Still a little tender; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HYPERHIDROSIS (Sweats), TENDERNESS (Still a little tender), FATIGUE (Exhaustion) and HEADACHE (Slight headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included METOPROLOL and APIXABAN (ELIQUIS) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced HYPERHIDROSIS (Sweats), TENDERNESS (Still a little tender), FATIGUE (Exhaustion) and PYREXIA (Low grade fever). On 09-Feb-2021, the patient experienced CHILLS (Chills). On 11-Feb-2021, the patient experienced HEADACHE (Slight headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-Feb-2021, HYPERHIDROSIS (Sweats), FATIGUE (Exhaustion), CHILLS (Chills) and PYREXIA (Low grade fever) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown and TENDERNESS (Still a little tender) and HEADACHE (Slight headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-033561 (Patient Link).
Pneumonia vaccine on 2/16/06 patient had chills, fever up to 105 and redness around injection site. Seen in office on 2/17/06 temp 102 and WBC of 25.3. Patient admitted to infirmary with sepsis and renal failure. 3/13/06 Received Discharge Summary2/17/06-2/25/06 hospitalization which revealed patient experienced: acute renal failure, hematuria, acute tubular necrosis, hypotension, anemia, fever, edema & rash of his arm, myalgias & arthralgias & late anaphylaxis.  Abnormal labs included a max serum creatinine of 7.9 & nonanion gap metabolic acidosis./ss 3/30/06 Received Discharge Summary from 3/8/06-3/15/06 hospitalization which revealed patient experienced dx: probable recurrent serum sickness, improving renal function, anemia & sinusitis. He had recurrent fever, anorexia & malaise.  WBC's were elevated, sed rate was elevated & all cultures were neg. 60 day Follow-up Information 17-MAY-2006: Pt readmitted
heart palpitation; EKG abnormal; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (153987). The reporter is the patient.  A 15 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single 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: PALPITATIONS (non-serious), outcome "unknown", described as "heart palpitation"; ELECTROCARDIOGRAM ABNORMAL (non-serious), outcome "recovered", described as "EKG abnormal". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Need stat troponin levels (Image attached). The patient experienced heart palpitation after getting second dose of the Pfizer vaccine. The patient did an EKG at doctor office a few day ago and it came back abnormal and so the patient went to hospital and got checked and the EKG came back normal.  No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
09/09/22 presents to ED for "fall". PMHx of "HTN, LBBB, CHF on eliquis"
Left arm swelling and tenderness. Happened one day after Dtap vaccine, no fever. Treatment: Hydroxyzine 8mg TID PRN MOTRIN 200mg Q6 hours PRN.
Localized headache starting the afternoon after the vaccine.  Shingles outbreak near and marginal in right eye as of March 16 (4 days after vaccination.)
Pt began experiencing a short burst of nausea shortly after injection. Pt began dry heaving. Pt's skin became cool and clammy. Pt was evaluated during this time by a Physician's Assistant, as well as a Registered Nurse, and vital signs were all within normal range. Pt began feeling much better shortly after, and was able to leave the clinic after their observation period without any other medical attention.
Rash and blistering sarted 3 days after injections given. No temp. Referral to specialist to evaluate.
Pt exp a lack of response following administration of measles vax in 1976; No further details were provided;
pain and itchiness on soles of feet (12/10/21), hives on feet (12/11/21), hives on hands (12/13/21), itching on hands (12/14/21), hive on face near left eye (12/14/21). Treated at home with Benadryl and ibuprofen 12/13/21, visited GP 12/14/21: urticaria, keeping an eye on possible hand-foot-mouth symptoms. Received Rx for hydroxyzine hcl
This spontaneous report as received from a registered nurse refers to a 11 year old female patient with no pertinent medical history or drug reactions/allergies. On 08-JUL-2002 the patient was vaccinated with a dose of VARIVAX (Merck) (lot#, expiration date not reported), 0.5 ml, subcutaneously. On 08-FEB-2013, the patient got shingles. The patient had pain on the inside of the left side and then a rash broke out in a linear fashion on the left side that did not cross midline. The location of the rash and the pain was the left lower back and buttock. The patient sought medical attention via office visit on 12-FEB-2013. The patient received 10 days of acyclovir and 5 days of prednisone (manufacturer unknown), ZOVIRAX cream. No lab diagnostics studies performed. The outcome of the events was recovered on an unspecified date. Additional information has been requested.
Fever, Chills and achiness within the first 12-14 hours after the second shot; Fever, Chills and achiness within the first 12-14 hours after the second shot; It was like a horrible sunburn reaction on arm that got the vaccine it hurt, burned and itch/Fever, Chills and achiness within the first 12-14 hours after the second shot; Fatigue that was more than she usually get with rheumatoid arthritis; This is a spontaneous report from a contactable consumer based on information received by Pfizer. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), dose 2 intramuscularly on an unspecified date as single dose for COVID-19 immunisation. Medical history included ongoing rheumatoid arthritis. The patient historical vaccine included first shot of COVID-19 vaccine for COVID-19 immunisation and seven to eight days after the first shot it was like a horrible sunburn reaction on the arm that got the vaccine it hurt, burned and itch. Subsequently, the patient followed treatment with ice and Tylenol (paracetamol). It lasted for three days before it went away. The patient concomitant medication included etanercept (Enbrel, solution for injection in pre-filled syringe, lot number was 1120647 and expiration date was 31Mar2023) at 50 mg weekly for rheumatoid arthritis, start and stop date were not reported. On an unknown date, the patient had fever, chills and achiness within the first 12-14 hours after the second shot. On an unknown date, three days later, the patient had fatigue that was more than she usually gets with rheumatoid arthritis. The outcome of the events was unknown.   The reporter declined consent for follow up. No follow up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) Same patient for different vaccine dose/events
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Dec2020 as dose 1, single (Lot number: EH9899), in left arm, on 20Jan2021 as dose 2, single (Lot number: EI1283), in left arm, on 18Sep2021 as dose 3 (booster), single (Lot number: 301458A), in right arm and on 22Apr2022 as dose 4 (booster), single (Lot number: IK9894), in right arm for covid-19 immunisation; BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Morbid Obesity" (unspecified if ongoing); "Breast Cancer" (unspecified if ongoing); "Pre Diabetes" (unspecified if ongoing); "Hypercalcemia" (unspecified if ongoing); "Parathyroid Disease" (unspecified if ongoing); "Sensitive to penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" (Mar2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Mar2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient took Paxolovid from 02Mar2023 to 06Mar2023 for COVID 19 Treatment.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300108870 Same reporter/patient, different drug/event.;
FLUBLOK GIVEN- PT IS NOT OVER THE AGE OF 18, NO ADVERSE REACTIONS, MOTHER NOTIFIED
Erythematous 10x4 cm patch (L) upper arm. Warm to touch.
nausea; chills; increased urination; did not feel like eating; fast heartbeat; redness around injection site; fever; This case was reported by a consumer and described the occurrence of injection site erythema in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th October 2020 16:30, the patient received the 1st dose of Shingrix (intramuscular). On 12th October 2020, 1 days after receiving Shingrix, the patient experienced increased urinary frequency and appetite absent. In October 2020, the patient experienced injection site erythema, fever and heartbeats increased. On an unknown date, the patient experienced nausea and chills. On 12th October 2020, the outcome of the increased urinary frequency was recovered/resolved. On 13th October 2020, the outcome of the appetite absent was recovered/resolved. On 14th October 2020, the outcome of the fever and heartbeats increased were recovered/resolved. On an unknown date, the outcome of the injection site erythema was unknown and the outcome of the nausea and chills were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, fever, nausea, chills, increased urinary frequency, appetite absent and heartbeats increased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be 53 or 54 years. On 11th October 2020 around 4:30 pm, the received 1st dose of Shingrix vaccine and under 24 hours after receiving the vaccine she had a fast heartbeat in the 150s, and this lasted about an hour and then decreased and returned to normal by 14th October 2020. On the morning of 12th October 2020, less than a day after receiving Shingrix, the patient had fever and redness around the injection site that went down from the injection site and kept expanding and patient stated that the red area around the injection site looked like the state of (unspecified) and she was unsure if the redness had resolved or not and the fever lasted until 14th October 2020 and then resolved. On 12th October 2020, the patient had an increase in urination, and this lasted until that evening and then resolved and on the same day, the patient did not feel like eating and this lasted until 13th October 2020 and then resolved  The patient reported that less than 2 months after receiving Shingrix, she had chills and nausea after receiving the vaccine but was not sure how long these lasted before resolving. The reporter did not consent to follow-up with her healthcare professional.
Patient here for nurse visit for MENVEO: Apple juice given prior to injection. 5 min post injection, patient said she felt light headed. Chair reclined. BP taken 97/61. 5 min later 97/62. 10 min later 103/69. Patient monitored in office 20+ min. Left with dad.
Patient stated he has a redness around the site of injection which began Saturday morning after receiving the shot Friday. Patient stated on Sunday (today) that it has spread to a wider circle around the shot. Patient is now just waiting for redness to go away and if gets worse will head to doctor.
Father presented patient for flu vaccination without knowing the patient's mother took the patient for a flu shot the previous day. Flu vaccine administered both days.
A report was received from a health care professional on 12/19/03 concerning an 8 month old vaccinee of unknown gender who inadvertently received Fluvirin vaccine on an unspecified day in December 2003. On an unspecified day in December 2003, the vaccinee received Fluvirin. No adverse event was observed. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
pt was given the 12 and older vaccine at 0.2 and not the 11 and younger vial
I had a wierd thing happen and am reporting according to the guidance to report even if not certain it is due to Covid vaccine. About 3 weeks after my second dose of Moderna, I developed a small blood blister in my mouth while eating a cheese platter with crackers. The blood blister grew so rapidly, that I soon couldn't talk or swallow. My husband drove me to the urgent care and they called an ambulance.  The urgent care gave me a shot with an epi-pen. The ambulance took me to the hospital where an emergency surgery procedure of soft palate exam with laryngoscopy was performed.  Prior to this, I have had no allergies or reactions to food. This came out of nowhere. The ENT doctor said I may have scratched the roof of my mouth with a cracker but I don't recall doing that. I had no mouth pain prior to this blood blister. I am following up with an allergy doctor next week.
Body aches, fever (highest of 101.00), dizziness and blurred vision.
This is a spontaneous report from a contactable consumer or other non hcp (patient). A 53-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: ER8733), via an unspecified route of administration in arm left on 05Apr2021 at 09:45 (at the age of 53-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient included hypertension and asthma. The known allergies of the patient was reported as mild allergy to apples, carrots, nuts. The concomitant medications of the patient included clarithromycin (CLARITIN [CLARITHROMYCIN]), escitalopram (ESCITALOPRAM), omeprazole (PROTONIX [OMEPRAZOLE]), losartan (LOSARTAN) all taken for an unspecified indication, start and stop date were not reported. The patient previously took albuterol sulfate and experienced adverse reaction. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient had been tested negative with covid-19. On 06Apr2021 at 20:00, the patient experienced 34 hours after my shot, i felt pressure and discomfort in my chest, tingling in my left arm and blood pressure was high. The patient stated the next morning he felt fine and had resumed normal activity. His cardiologist did and exam and said it was not an arterial issue and agreed it may have been a reaction to the vaccine. His blood pressure spiked up to almost the high/9Os.  The events resulted in emergency room visit and physician office visit. The patient underwent lab tests and procedures which included Nitroglycerin brought pressure to 120/80s but it went back up to 140 afterward (blood pressure measurement): 120/80s on 06Apr2021, blood pressure measurement: 140s/90s on 06Apr2021, blood pressure measurement: spiked up to almost the high/90s on 06Apr2021, EKGs: normal on 06Apr2021, troponin tests: normal on 06Apr2021, x-ray: normal on 06Apr2021 and Nasal swab sars-cov-2 test: negative on 07Apr2021. Therapeutic measures were taken as a result of events that included patient took aprazolam, and a glass of red wine, it did not subside and nitroglycerin in hospital. The patient recovered from 34 hours after my shot, i felt pressure and discomfort in my chest, tingling in my left arm on an unspecified date in 2021 and the outcome of the event blood pressure was high 140s/90s was reported as unknown. No follow-up attempts are possible. No further information is expected.
The patient presented with acute chest pain 2 days after receiving the Moderna booster vaccine (3rd shot)and was found to have a grossly abnormal EKG and severely elevated troponin level consistent with myocarditis
Patient was alert and playing with her parents when brought into the exam room. Explained what imms she would receive. Gave 2 immuniaztions and then patient became apneic long enough for her face to become pale, her eyes rolled into the back of her head. After less than a minute she started to cry. Her mother did not want her to receive anymore immunizations. We watched her in the clinic for another 30 minutes and she appeared to be fine. Her breathing was normal, she was looking around and playing with her siblings.
Chest discomfort when breathing; Fever at 102.6; This spontaneous case was reported by a nurse and describes the occurrence of CHEST DISCOMFORT (Chest discomfort when breathing) and PYREXIA (Fever at 102.6) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced CHEST DISCOMFORT (Chest discomfort when breathing) and PYREXIA (Fever at 102.6). At the time of the report, CHEST DISCOMFORT (Chest discomfort when breathing) and PYREXIA (Fever at 102.6) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included blood pressure medications. Treatment information was not reported.
H/A - moderate to good relief with acetaminophen 750 mg , 2 doses over 24 hours;  intermittent chills, generalized achiness - some relief with acetaminophen, some fatigue
This spontaneous report was received from a pharmacist, via a company representative, referring to a 65 year old female patient. The patient's medical history and concurrent condition were not reported. On 05-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX subcutaneous in the arm (lot #, expiration date and dose was not reported). Concomitant was not reported. ON 05-OCT-2015, after being administered ZOSTAVAX "her entire arm was swollen" (peripheral swelling). The patient sought medical attention as she visited the doctor's office and was treated with BENADRYL. The outcome of peripheral swelling was reported as recovered on unspecified date. There were no lab diagnostics performed. Tke relatedness between peripheral swelling and ZOSTAVAX was unknown . Additional information has been requested.