chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalized (9.23.21);  COVID-19 positive (9.25.21);  Fully vaccinated  Discharge Provider: MD Primary Care Provider: MD Admission Date: 9/23/2021 Discharge Date: Sep 26, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute cholecystitis [K81.0] Fever and chills [R50.9] Nausea and vomiting, intractability of vomiting not specified, unspecified vomiting type [R11.2] Left lower quadrant abdominal pain [R10.32] COVID-19 virus infection [U07.1]   HOSPITAL COURSE: Patient is a  65 yo female with a PMH of HTN admitted for abdominal pain secondary to acute cholecystitis and COVID pneumonia.  She presented with a 2 day history of acute abdominal pain radiating to her back associated with food intake.  In the emergency department, a right upper quadrant ultrasound was obtained and concerning for cholelithiasis/CBD dilation/acute cholecystitis.  General surgery was consulted and HIDA scan was obtained which confirmed acute cholecystitis.  Patient was also noted to be febrile on admission for which she was started on Zosyn.  She also tested positive for COVID, and other than fevers, she had no other COVID symptoms.  Due to her COVID positive status, general surgery recommended IR consult for cholecystostomy tube placement with plans for cholecystectomy in 6 weeks.  Cholecystostomy tube was placed successfully on 09/25.  Patient was started on a diet and able to tolerate oral intake with no problems.  She was discharged home stable condition on Augmentin to complete a 5 day course of antibiotics.  She will follow-up with Interventional Radiology for drain management as well as General surgery for cholecystectomy.  Of note, patient also was noted to have hypokalemia during admission, and was discharged on 5 days of supplementation with instructions to follow-up with PCP for repeat check. Discharge Disposition:  home or self care  Active Issues Requiring Follow-up:  1. Acute cholecystitis: Follow up with IR and General surgery to discuss plans for cholecystostomy tube removal and cholecystectomy plans 2. Hypokalemia:  Follow-up with PCP for repeat potassium check
Grand mal tonic-clonic seizure,  pt put in bed on 2 l oxygen  , postictial sleep x 2 days
Strong initial reaction, which was not unexpected. Fever, chills, extreme sweating, painful arm/injection site lasting 4 days.  Subsequent feeling ill, loss of smell, lower back pain, hip joint pain, leg pain.
Swollen arm lymph nodes and pain in same arm as shot was given. Rash lasting two days, in underarm area and inside upper arm. Treatment with Tylenol and over the counter cortisone cream.  Pain persisting in underarm area.  No noticeable swelling after 3 days.
tingling in both hands ( left more than right),; she feels tired; Feels with  no energy; headache that has not resolved; pain at both injection sites in hands(left and right arms); She "didn't sleep well last night; now left hand "feels funny; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   The patient's past medical history included shingles.   On 11th October 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and Flu vaccine (intramuscular). On 11th October 2022, less than a day after receiving Shingrix and Flu vaccine, the patient experienced injection site pain, insomnia and headache. On 12th October 2022, the patient experienced tingling, tiredness and loss of energy. In October 2022, the patient experienced abnormal sensation of limbs and diarrhea. On an unknown date, the outcome of the injection site pain, abnormal sensation of limbs, headache, tiredness and loss of energy were not recovered/not resolved and the outcome of the insomnia, tingling and diarrhea were recovered/resolved.   It was unknown if the reporter considered the injection site pain, insomnia, tingling, abnormal sensation of limbs, headache, diarrhea, tiredness and loss of energy to be related to Shingrix and Flu vaccine.   Additional Information: GSK receipt date: 12-OCT-2022 Reporters comment:  The patient received the first dose of shingrix and flu vaccine and experienced insomnia,pain at both injection sites,tingling in both hands left more than right, left hand feels funny. The patient stated that headache that was not resolved, and diarrhea. She states she called in from work today(day of reporting)because she feels tired and with no energy. The reporter did not consent to follow-up. Additional Supportive information: As per source document the flu shot was administered, since this case was about Shingrix, but in narrative was not mentioned the Flu shot so as conservative approach Flu vaccine coded because this flu shot was administered and narrative describes both injection sites.
general malaise; general weakness; fever; chills; body ache; This is a spontaneous report from a contactable consumer. A 50-year-old male patient received his second dose of BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported), unspecified route of administration on 01May2021 as 2nd dose, single dose (at the age of 50 years old) for COVID-19 immunization. The patient's medical history includes hypertension but it is under control with medication (not mentioned). Concomitant medications included unspecified hypertension medication. Historical vaccine includes first dose of Pfizer COVID vaccine on 08Apr2021 (at the age of 50 years old), for COVID-19 immunization and no reported issues. On an unspecified date, while the reporter was playing cricket with his teammates against another team, he overheard the patient talking about general malaise and weakness. The patient also mentioned how he feels exactly how he felt after the 2nd shot of vaccine, which was the Pfizer COVID vaccine. The patient had body ache that night (01May2021) but took paracetamol (TYLENOL) and even played cricket the next day. On 03May2021, the patient had chills and fever, took paracetamol again and then no issues afterwards. On 12May2021, the patient had chills and general weakness but no fever and continued until 14May2021. On 15May2021, the patient was starting to feel better, no fever or chills but slight weakness. On an unspecified date, the patient experienced malaise. The reporter was not sure if the most recent malaise was vaccine related, but he figured he should err on the side of too much information. The outcome for general weakness was recovering; outcome for body ache, fever and chills was recovered on an unspecified date; outcome for malaise was unknown.   No follow-up attempts are needed. Information about lot/batch number can not be obtained.
Patient immediately felt light headed and notified immunizer.  He then quickly fainted.  Pharmacist and technician carefully lowered him from the chair to the floor and laid him on his back.  Pharmacist quickly checked for a pulse and removed his mask.  Patient came to within 10 seconds and pharmacist then elevated his legs using a chair.  Patient remained laying on the floor for 10 minutes and then felt ready to sit up.  After sitting up, patient was given a cold water to drink and a snack, and remained under pharmacist's supervision for 30 minutes. Patient then felt back to his normal self and felt confident he could safely leave the pharmacy.
Varivax given and redness and swelling @ site since vaccine. 2 to 3cm warm to touch. Shortness of breath 11/13/2007. Posite for wheezing. 11/14/07 given albuterol, benadryl and predisone.
Beginning eight hours after injection,  severe flu-like symptoms - high fever, headache, chills, shakes, nausea and vomitting.  Confined to bed for 24 hours. Fever broke  the next evening,  One additional day required to return to normal activity.  Also, several hours following administering of vaccine, upper left arm was in extreme pain extending to the elbo.  Continued to be very sore for 36 hours, and slightly bothersome for 72 hours.
Patient reported severe pain and swelling of the injected arm (left), also a severe headache.
I am submitting this form per a phone call I received today. I have lost my voice and currently not able to call her back to discuss. As I indicated on my weekly COVID report yesterday, the instance of "feeling bad" this week is not directly related to the COVID injection. I am feeling bad due to sinus issues brought on by a cold I contracted from my grandsons.
Patient had side effect after receiving every single dose of the Moderna vaccine; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Patient had side effect after receiving every single dose of the Moderna vaccine) in a 79-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Patient had no allergies to medications, food and other products. Patient had no history of acute and chronic illness at the time of vaccination.  The patient's past medical history included COVID-19 (Night before patient passed out and called the ambulance. Hospitalization 30 days, treatment received for Covid19:oxygen, some pill ,insulin shot for glucose.) in November 2019.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Patient had side effect after receiving every single dose of the Moderna vaccine). At the time of the report, IMMUNISATION REACTION (Patient had side effect after receiving every single dose of the Moderna vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2019, SARS-CoV-2 test: (Positive) Positive.         It was reported that patient was taking other medication. Treatment medications were not reported.   This case was linked to MOD-2022-658658, MOD-2022-658660 (Patient Link).
back pain; abdominal pain; abnormal feces; excessive flatulence; This is a spontaneous report from a contactable consumer. A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number was not reported) via an unspecified route of administration on 26Mar2021 as dose 2, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, as single dose for COVID-19 immunization. It was reported after receiving the second dose of vaccine, on an unspecified date the patient experienced back pain after vaccine, abdominal pain, abnormal faeces and excessive flatulence. He further reported that he used cold and hot patches, massages and has been taking Coca Cola to treat gases but none of these have worked. He had not made the consult with his physician for management treatment. Reporter called for requesting information about the adverse effects of vaccine. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 18 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 (Lot number: EW0168) at the age of 18 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TRI LINYAH taken for contraception. Vaccination history included: Bnt162b2 (Product: COVID 19 Dose 1, Pfizer,Lot number: EW0162, left arm.), for COVID-19 Immunization, reaction(s): "Dizziness"; Bnt162b2 (Dose 1 COVID 19 Pfizer,Lot number: EW0162,left arm.), for COVID-19 Immunization, reaction(s): "Abdomen pain in the upper right quadrant"; Bnt162b2 (Dose 1 COVID 19 Pfizer, Lot number: EW0162, left arm), for COVID-19 Immunization, reaction(s): "Nausea". The following information was reported: DIZZINESS (non-serious) with onset 19Apr2021, outcome "not recovered", described as "Dizziness". The event "dizziness" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of dizziness.  Additional information: 3 days after the second dose, the dizziness started again. As of now (10May) it has gone on for two days (since 09May). The dizziness occurs on and off, and the patient frequently feel like she was going to fall over in the chair sitting in. The patient did not  received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not  diagnosed with COVID-19. Since the vaccination,  the patient did not  tested for COVID-19. No known allergies.   No follow-up attempts are possible. No further information is expected.
24hrs p/shot fever 102;48hrs p/ t101;sl inflammation, swelling, minimal back pain;taken to MD-findings: hurt on lt neck when turn head
1420: sitting in chair in general observation area. C/O left arm tingling. Encouraged to move arm and flex hand.  1424: states that the tingling is moving up her neck and it is throbbing now. Moved to private observation area. States her left arm is sore, throbbing with tingling down arm into hands. C/O soreness up neck and that chest feels heavy. Hx of asthma requiring new monoclonial antibodies started two months ago. BP 138/88; HR 98; O2 sat 97% on r/a. Color pink. States that her BP usually runs under 120 systolic and under 80 diastolic. States her pulse is usually in the 60-70s. No SOB noted. Lungs clear bilaterally, diminished in left lower lobe. Does not have inhalers with her. Denies throat swelling or itching. Gave water and denies difficulty swallowing.  1434: - HR 89; O2 95% on r/a. she drank a fruit smoothie she had in her purse.  1437: - EMT on site arrived for further evaluation. States that her pain in chest is 4/10 and now describes "feels like pressure" and states the pain is radiating up the neck and outward from left chest area.  1440: BP 146/90; HR 90: )2 97% on room air. Speaking without SOB noted.  States that pain is now radiating into her left side of back.  1442: EMS 911 activated, clinic manager notified 1446: O2 97% on r/a; HR 87. States pain less throbbing, but still radiating. 1450: Stall have decreased sensation and tingling in left arm.  1455: States pain is now 2/10. State left arm tingling improved. Color remains pink, no SOB noted, No resp. distress noted.  1500: EMS ambulance crew arrived. Patient states pain now 1/10 1504: HR 86, BP 111/73; O2 97%  1508: 12 lead EKG run per EMS. Advised transport to hospital. Patient agreed.  1510: Patient began stating that she did not want to go to hospital. Clinic manager had contacted MD on call and explained to her that he is approving transport due to her symptoms. Patient started talking about being worried about getting back to her car. EMS and clinic manager spoke to her about the dangers of driving self with her symptoms. Reassured that several hospitals can provide taxi or bus vouchers back to her car once evaluated and released. She then began talking about her dog being alone in a crate at home. States she just moved here several months ago and doesn't know any of her neighbors. States her only child lives in a different County and that he currently has COVID.  1515: Refusing transport via EMS 1519: Stood with lightheadedness, no SOB, States she feels fine now. Signed AMA refusal for transport to  hospital.  1520: Ambulated down hall with difficulty. EMS left. Walked back to restroom - voided.  1523: Ambulated per self to personal vehicle. Gait steady. No lightheadedness. States chest pain resolved.
Shortness of breath; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pulmonary arterial hypertension. The patient received covid-19 vaccine (suspension for injection, route of admin) and dose were not reported, administered on 2021 as prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included macitentan for pulmonary arterial hypertension. On APR-2021, the subject experienced shortness of breath. The action taken with covid-19 vaccine was not applicable. The outcome of shortness of breath was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
about 12 hours later I developed a swollen and burning tongue, sore throat, low grade fever of 99, and pain at injection site
The usual side effects but yesterday my lips started feeling sore and I also developed fever type blisters on the left side of my lower lip. I have never had fever blisters or herpes type sores. But I have had chicken pox. My mother suffers from the lip sores and she had ZOVIRAX on hand and I started them today without consulting my provider. It's the weekend and I wanted to start asap. I work in the health care field. The sores were blossoming and I didnt want to wait when my mom had a supply of ZOVIRAX. I will contact my provider Monday.
Painful for a couple of days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Painful for a couple of days). The outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she got his/her first dose of Shingles vaccine and experienced pain for a couple of days. The follow-up could not be possible as no contact details were available.
Patient felt dizzy and anxious after Pfzier dose. Patient was anxious. Had her lay flat with her legs elevated. BP was 116/70. Pt left home with mother OK.
21months female patient received Kinrix; Kinrix dose by error as a 4th Datp dose; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 21-month-old female patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th April 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 4th April 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered 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: 28-Apr-2022 Reporter's Comments: The reporter wanted to know if Kinrix could be consider a 4th Dtap dose because a 21 months female patient received on April 4th 2022 a Kinrix dose by error as a 4th Datp dose. The reporter did not consent to follow-up. Additional Supportive Information: The 21 months patient received Kinrix dose by error as a 4th Datp dose, which led to inappropriate age at vaccine administration, Inappropriate schedule of vaccine administered. This case has been linked to US2022071360 and US2022071352, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022071360:Same reporter US-GLAXOSMITHKLINE-US2022071352:Same reporter
Pt. given 2nd flu vaccine today was at office seeking VARIVAX. Miscommunication of scheduling and nurse/parent. 1st FLUZONE 11-2-2017.
The day after the vaccine 6/9, right thigh became very hard, swollen and deep red about 3 inches.  This continued to spread the next day, until it covered her thigh from her knee to an inch below her groin.  It also spread toward the back of her thigh.  It did not seem to be painful, though a little itchy.  We gave her benedryl several times.  The morning of 6/11 it seemed to stabilize and very slowly receded over the next few weeks.  It is now 6/28 and she still has just a 3 inch discoloration of her skin (mottled and darker than surrounding skin and a little rough).
Patient has throat discomfort on 6/23, and then reported to the hospital 6/24 with throat and lip swelling.
ocular swelling; allergic reaction; This is a spontaneous report from a non-contactable pharmacist. A 16-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 16 years old on 26May2021 on left arm at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced ocular swelling and allergic reaction in May2021. The events were resulted in Emergency room/department or urgent care. Treatment was received for the events. Since the vaccination, the had patient been tested for COVID-19 with unknown results in 2021. The outcome of the events were not resolved.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided, the events are considered related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).
clinic is not sure how much got into the patient arm; the needle was not aligned properly on the syringe; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (clinic is not sure how much got into the patient arm) and DEVICE CONNECTION ISSUE (the needle was not aligned properly on the syringe) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (clinic is not sure how much got into the patient arm) and DEVICE CONNECTION ISSUE (the needle was not aligned properly on the syringe). At the time of the report, UNDERDOSE (clinic is not sure how much got into the patient arm) and DEVICE CONNECTION ISSUE (the needle was not aligned properly on the syringe) had resolved.        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.   No concomitant medications were reported. Treatment information was unknown.
Thick Black Mucus in the back of left nostril. Sinuses were not fully clogged but I had to blow my nose around 3 times a day.  Lasted for 2 days and went away.