chrisvoncsefalvay/vaers-outcomes huggingface dataset:
27 y.o. G2P0010 at 38w0d who presented to the ER this morning for persistent vomiting with coffee ground emesis, known covid infection. Patient tested positive for COVID on 12/27, with onset of symptoms on 12/25. She initially was febrile with general malaise, until 2 days ago when she began having persistent vomiting without nausea. She was seen in Urgent Care for this and given carafate and pantroprozole. Unfortunately, the pantoprozole was not covered by her insurance and alternative was sent to the pharmacy. She has only started the carafate. While in the ER, she was found to be severely dehydrated with metabolic acidosis despite IV fluid resuscitation. Given then, recommendation was made for admission. Since admission, she has slowly improved through the day. She has not vomited since this morning. She is now tolerating a regular diet. She denies fevers, chills, chest pain, shortness of breath, abdominal pain. She denies loss of fluid, vaginal bleeding or contractions. She notes positive fetal movement. No other complaints today.     Patient's last menstrual period was 04/08/2021.   1. AG metabolic acidosis due to starvation ketoacidosis related to intractable vomiting with poor po intake. Improved. Likely due to COVID-19 related gastroenteritis.Treated with IVF hydration and supportive therapy with anti-emetics. Encouraged to increase po intake. Follow up lab in 2 days and to follow OB/PCP 2. Pregnacy of 38 weeks: management as per OB. 3. Covid-19 infection. Not hypoxic. Full barrier.  4. UTI: Started on ceftriaxone and will continue the same during her hospital stay and chaged to Ceftin once able to tolerate po intake Patient was seen prior to discharge and found to be stable. Able to tolerate po intake.  OB/GYN New Consult 12/30/2021     Reason for Consult:  Pregnancy, COVID positive Impression / Plan  27 y.o. G2P0010 at 38w0d COVID+ with metabolic acidosis secondary starvation ketoacidosis related to intractable vomiting , now improving. -Primary management per hospitality service -Recommend repletion of electrolytes -Full barrier precautions for COVID, reassuring 02 saturations -Treatment of presumed UTI with Rocephin, culture pending -Zofran, pepcid ordered for severe nausea, reflux. -NST three times a day, BPP today reassuring -Monitor for signs of labor, not currently present
no adverse effects were reported; the patient was inadvertently administered one dose od expired MMR II; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 22-AUG-2019, the patient was inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) injection, 1 dose, lot # N031294 and expiration date 21-AUG-2019 (exact dose and route of administration were not reported) for prophylaxis. The dose was stored in its recommended range through the date of administration. No adverse effects were reported.
Enlarging erythematous "bump" at (R) thigh, no fever reported.
This initial non-serious spontaneous case, was received on 27-Sep-2017, from other health professional concerning a 23-year-old female adult patient. The patient's medical history and concomitant medications were not reported. On 20-Sep-2017, the patient was administered with FLUAD (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 18703 (as reported), expiry date: Apr-2018). It was reported that the patient under 65 years of age was administered with vaccine (explicitly coded as inappropriate age at vaccine administration). It was reported that, no reactions or no adverse event were observed after the administration of the vaccine. The reporter assessed the events as non-serious. Follow-up received from the reporter on 13-Oct-2017: The suspect vaccine route of administration and anatomical location were updated. Significant case correction received 27-Sep-2017: The event term from No reactions to No AE was corrected.
This spontaneous report as received from a nurse regarding multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On multiple unspecified dates the patients were vaccinated with improperly stored GARDASIL 9 (dose, frequency, route and lot number were not reported) for prophylaxis which was reconstituted with properly stored sterile diluent. No adverse effects were reported. No data logger was involved. No further information provided. This is one of the several cases from the same reporter. Additional information has been requested.
Adverse event: dizziness, sweating. Treatment: Laying down on floor, foot elevation, drinking water, consuming food, ice pack to forehead. Outcome: event resolution after 16 minutes
terrible aches/pain; staying in bed; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (terrible aches/pain), BEDRIDDEN (staying in bed) and CHILLS (chills) in a 75-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN, CICLOSPORIN (RESTASIS) and ESTRADIOL (IMVEXXY) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (terrible aches/pain), BEDRIDDEN (staying in bed) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, PAIN (terrible aches/pain), BEDRIDDEN (staying in bed) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Patient received 2 doses of the Moderna COVID19 vaccine and 1 booster dose. Patient was scheduled to receive a 2nd booster the following week.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Follow Up contains no new information
Numb feeling in hands feet and head; Blisters on her body; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient received first dose of COVID vaccine on 03Apr2021. The patient experienced numb feeling in hands feet and head she also developed blisters on her body on unspecified dates. The patient is going to urgent care. She is due to receive her second dose on the 24th. She wanted to know if she should get her second dose. Outcome of the events were unknown. The events were assessed as serious (medically significant).   Information on the lot/batch number has been requested.
Numbness and tingling (pins and needles) in left arm and pain at base of left thumb happening only after going to bed, 2-3 episodes/night, each episode lasting 10-20 minutes.
After midnight   I felt VERY cold, had to wrap myself  in blankets;  for 6 hours,  later developed cough  and sore throat and mouth,  dull headache  which continued for 5 days.   I guess I am improving now but do not want to get the second shot  in October,  do not want to get sick again.
- increased right arm pit pain and arm aching - she has increased body chills today and fatigue - " I feel like i'm walking through molasses" - using meloxicam sproadically, it helped her sleep at night - has tried heat and ice
26JUN93 Am noted soreness & itching @ inject lt arm site; welts noted on upper arm around site, inc itching also pustule noted @ inject site; very sore; uncomfortable to sleep; noted swelling of upper arm & discoloration; c/o soreness, ten;
Pt came up to me about 10 minutes after receiving vaccine stating that she had a bad tickle in her throat and needed to cough. I had her come into the immunization room where I allowed her to take off her mask and cough. She was not having any problems breathing or feeling dizzy. After about 10 minutes I administered benadryl liquid (12.5mg/5ml) 10ml (at 5:27PM), because she stated that he throat was starting to be a little itchy (more of a tickle) and she was starting to feel a little itchy under her arm (no redness or hives seen at the injection site).  I stayed with her for 15 minutes and her cough subsided. She did not have any other problems. She felt better and asked to go home. It had been almost 45 minutes since the vaccine was administered, so I felt that she was ok to go home.
Initial report was received 10 December 2008 from a health care professional. A male patient (age not reported) had received an intramuscular left deltoid injection of FLUZONE SV 2008-2009, lot number U2749AA on 08 December 2008 and the following day, he noticed a loss of sensation bilaterally in his hands and feet, a rash on the palms of his hands, blisters on two fingers of each hand, and a purple bruising on both fingers. According to the reporter, the physician had prescribed PREDNISONE that day for an unknown reason. The patient had not recovered from the event and no further information was provided at the time of the report. Documents held by sender: None.
Pt received expired dose. It was reconstituted at 11 AM and pt was given dose at 7:15PM. Pt chose not to get an addition dose at this time.
Passed out but immediately came back to. Extreme sweating no fever. Pain in chest, quickly became better after 10 minutes and given water.
Information has been received from a physician concerning a female patient with unspecified medical history, drug reactions or allergies, who on an unspecified date was vaccinated with a first dose of VARIVAX (Merck) (route and lot # unknown). Concomitant medications included "other vaccines that are usually provided at the 12 month visit". The physician reported that on an unspecified date, after receiving the first dose of VARIVAX (Merck), the patient developed varicella primarily on the upper thighs and it left some scarring and hyperpigmentation. No lab diagnostic studies performed. The patient sought unspecified medical attention. The patient recovered "about a week after developing varicella. Additional information has been requested.
pt recvd vax & 7 days p/vax exp elevated liver function tests: AST,ALT,& GGT were elevated;sx persist;
Flu-like, headache, vertigo, fever, rash, bloody diarrhea.  Patient reported this went on from 8/3/2012 until 8/27/2012. She also received other vaccines from another provider. (Tdap, ipv, Hep A & B)
Patient felt nausea and dizziness after immunization paramedics were called and cleared patient.
Small rash on left side of face about 15 not raised and about 5 on right side of face about 6. No itchiness or swelling.
Narrative:  NO NAP. WENT TO BED AT REGULAR TIME AND WAS RESOLVED THE NEXT AM Symptoms:  & FATIGUE Treatment:
Patient received scheduled Moderna vaccine and reported feeling nauseous and lighted headed within 10 minutes after administration. Patient waited in the post-administration lounge area until approximately 21:50, at which time he reported he felt well enough to catch his bus home. 2 employees escorted him to his bus stop on their way out.
sore left arm; it hurts a little bit down the injection site, like in the muscle; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm) and VACCINATION SITE PAIN (it hurts a little bit down the injection site, like in the muscle) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore left arm) and VACCINATION SITE PAIN (it hurts a little bit down the injection site, like in the muscle). The patient was treated with PARACETAMOL (TYLENOL) on 10-Feb-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore left arm) and VACCINATION SITE PAIN (it hurts a little bit down the injection site, like in the muscle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitantly, patient was taking unspecified medications for blood pressure and blood thinning.
Tested positive for Covid; Tested positive for Covid; This is a spontaneous report from a contactable consumer or other non-HCP (patient himself). A 51-year-old male patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- UNKNOWN) via an unspecified route of administration in right arm on 26Jan2021 06:45 as dose 1, single (at the age of 51-years-old) for COVID-19 immunization at Workplace clinic. Patient medical history was reported as none. The concomitant medications were not reported. 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. Patient had no allergies. Since the vaccination, the patient has not been tested for COVID-19. On 10Jul2021 at 18:00, the patient had tested positive for COVID-19. The adverse events did not result in prolongation of hospitalization. No treatment was given for the adverse event. The patient underwent lab tests and procedures which included Sars-cov-2 (nasal swab) test with result as positive on 10Jul2021. The outcome of the event COVID-19 was resolved with sequel on an unspecified date in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemic: Tinnitus-Medium, Systemic: Weakness-Medium
Woke in the middle of the night with sore arm, severe headache and severe nausea.  It lasted all the next day - very severe, with mental fogginess. 2 days of not feeling well after that, lessened symptoms.
Information has been received from a health professional concerning a 21 year old female patient who on an unspecified date was vaccinated with a 0.5 ml second dose of Gardasil (lot# not provided).  Subsequently the patient experienced mild hives. No respiratory problems. The patient did not have any AE symptoms with the first vaccination.  Unknown medical attention was sought.  At an unspecified date the patient's hives faded without further incident.  No product quality complaint was involved.  Additional information has been requested.
A large itchy lump and redness couple of inches away from injection site, not in muscle area
Patient found to have pulmonary embolism involving all of the lobar pulmonary arteries and some of the segmental branches. Patient started on Xarelto
Upper arm around injection site, 2-3 inch radius, erythema, pruritus, raised rash somewhat rough to the touch.   Benadryl at night to treat symptoms, helped with pruritus overnight.  Rash lasted about 10 days, pruritus lasted 2-3 days.
My daughter had 4-5 clinical seizures within 3hours ranging from 20 seconds to 15minutes. The seizures involved the left side of the face twitching and the left arm. Later that day after receiving anti seizure medication at the hospital, my daughter had sub clinical seizures. A MRI the following morning revealed she had had a stroke as well. We were told this would probably cause right sided weakness for life.
Started having chest pain. Went to the ER. Was parked in the ER hallway all night, around 3 or 4 am, her heart rate slowed to nothing and blood pressure dropped to zero. She was admitted to a room. Angiogram showed no blockages, doctor said it was an electrical problem from old age. Installed a pacemaker.
Case number PHEH2014US000917 is an initial spontaneous report from the pharmacist received on 08 JAN 2014 with a follow-up received on 22 JAN 2014. This report refers to a 16-year-old male patient who was accidentally vaccinated with 0.5 ml of FLUCELVAX (batch number: 010011A and expiry date: JUN 2014) intramuscularly in to the left deltoid, on 07 JAN 2014. No adverse event reported following this medication error (inappropriate age at vaccine administration).  Follow-up received from the pharmacist on 22 JAN 2014. Updated site of vaccination as left deltoid.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 22 JAN 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Swelling left thigh from hip, past knee, moderate - severe, not site erythema.
Age: 57 y.o. Birthday:  Admit Date: 7/14/2022  8:58 AM Discharge Date: 7/18/2022     Discharge Diagnosis: Principal Problem:   COVID-19 Active Problems:   Acute on chronic diastolic congestive heart failure   Hypoxia   Anasarca   HTN (hypertension)   Diabetes mellitus       HPI AND HOSPITAL COURSE   History of Present Illness:  As per admission H&P, "The patient is a 57 y.o. female, presented on 7/14/2022 with the above. . The symptoms/labs were thought to be marked in severity and unstable. Onset several days ago. Associated symptoms include shortness of breath . Alleviated by none. The has a history of chronic hypoxic respirtory failure on 4 liters oxygen at home. She states that she has had increased leg swelling and shortness of breaht over the last 3 days. She has been coughing up white phlegm. She has not had any fevers or chills. In the ER she was noted to have pulmonary edema on CXR. She was also noted to be covid 19 positive. She is on 4 liters as I am seeing her. "       Patient is a 57 y.o. female who presented with shortness of breath.  She was managed for the following:   * COVID-19 Acute on chronic hypoxic respirtory failiure- due to COVID-19 pneumonia and CHF exacerbation.  She improved with treatment of the issues below, returned to her baseline 3L NC home requirement and remained stable.     COVID 19 Pneumonia - She completed 5 day course of remdesivir.  Will complete decadron taper on discharge.  Improved to baseline O2.     Acute on chroinc diasotlic CHF-  Patient had increased BNP and pulmonary edema on CXR.  She was diuresed with IV lasix and improved.  Had increased creatinine so asked patient to hold lasix on discharge and follow-up with PCP.    Acute on chronic stage 3a CKD- creatinine peaked at 2.0, likely from IV diuresis.  Was starting to trend down but not yet to baseline.  Patient wished to go home. Advised her to have labs repeated in one week, and hold lasix and metformin in the interim, follow-up with PCP.    DM2-  HgbA1c 5.1%, to hold metformin on dc.  Elevated during admission from steroids    E.coli UTI-  Treated with rocephin, resolved   Iron deficency anemia- continue iron         Physical Exam on the Date of Discharge: Blood pressure 145/71, pulse 59, temperature 97 °F (36.1 °C), resp. rate 16, height 5' 8" (172.7 cm), weight (!) 136.7 kg (301 lb 6.4 oz), last menstrual period 07/31/2015, SpO2 100 %. General - NAD, appears stated age, obese, HEENT - EOMI, PER, MMM, oropharynx clear, nasal cannula in place Chest - lungs clear bilaterally Heart - RRR, NS1S2, Abdomen - Soft, non-tender, non-distended, +BS,  Extremities - no edema Psych - AAOx3, affect appropriate Skin -, dry   Discharge Condition: improved   Disposition: home
Constant headache; Massive fatigue; No appetite; Sluggish digestion/decreased digestion; Sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021295447.  A 68-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 09:15 (Lot number: EN6204) at the age of 68 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Lot number: EM9809, Administration time: 08:30 AM, Vaccine location: Left arm, dose 1), administration date: 10Feb2021, when the patient was 68 years old, for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 10Mar2021 18:00, outcome "recovered", described as "Constant headache"; FATIGUE (non-serious) with onset 10Mar2021 18:00, outcome "recovered", described as "Massive fatigue"; DECREASED APPETITE (non-serious) with onset 10Mar2021 18:00, outcome "recovered", described as "No appetite"; DYSPEPSIA (non-serious) with onset 10Mar2021 18:00, outcome "recovered", described as "Sluggish digestion/decreased digestion"; PAIN IN EXTREMITY (non-serious) with onset 10Mar2021 18:00, outcome "recovered", described as "Sore arm". Therapeutic measures were not taken as a result of headache, fatigue, decreased appetite, dyspepsia, pain in extremity. Additional information: Patient had no other vaccine in four weeks. Patient received any medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products.  No follow-up attempts are possible. No further information is expected.
Patient developed rash/swelling below the injection site moving down towards elbow with some swelling, we kept in contact with patient and swelling and rash has improved. Patient came in 9/30 to show improvement on symptoms. She doesnt feel appropriate to visit doctor. We advised to see dr if any worsening of symptoms on Monday.
her daughter was accidently administered an adult dose of Havrix (1ml) instead of a pediatric dose; her daughter was accidently administered an adult dose of Havrix (1ml) instead of a pediatric dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 12-month-old female patient who received HAV (Havrix 1440 adult) (batch number 3j9g4, expiry date 30-AUG-2025) for prophylaxis.   On 16-AUG-2023, the patient received Havrix 1440 adult 1 ml. On 16-AUG-2023, an unknown time after receiving Havrix 1440 adult, the patient experienced accidental overdose (Verbatim: her daughter was accidently administered an adult dose of Havrix (1ml) instead of a pediatric dose) and adult product administered to child (Verbatim: her daughter was accidently administered an adult dose of Havrix (1ml) instead of a pediatric dose).The outcome of the accidental overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-AUG-2023 The reporter who stated that the patient was accidently administered an adult dose of Havrix (1ml) instead of a pediatric dose, which led to accidental overdose and adult product administered to child. The reporter consented to follow up.
Pt reports "weakness in legs & dizziness on day 3 after ZOSTAVAX administration. No physician visit, tests, or treatment have be administered to my knowledge thus far.
Externally given vaccine 12/24/2021 - PULMONARY EMBOLISM, UNSPECIFIED -