chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient with 3 COVID vaccines who admitted to hospital with COVID detected PCR and complications related to COVID.  Provider d/c note: "41 YO male with a history of T1DM admitted for sepsis secondary to Empyema in the setting of Covid positive infection and DKA.  . Chest CT showed R lung pneumonitis with large pleural effusion and early loculations.  Patient underwent image guided placement of large caliber pigtail catheter and antibiotic treatment with Zosyn.   Hospital Course:    Sepsis 2/2 to right Empyema in the setting of COVID-19, sepsis resolved - Exudative effusion suggested by pleural fluid studies. Continue Zosyn (9/10 - discharge).  Pleural fluid cultures no growth to date. NGTD on cultures.  - S/p chest tube with large caliber pigtail catheter (interventional radiology) on 9/12. Management per CTS. Increased chest tube output since tPA. Daily CXR.  - Scheduled Mobic for pleuritic chest pain - CT abdomen & pelvis w/ oral & IV contrast on day of discharge prior to removal of chest tube - Follow up with CTS in 2 weeks with CXR     Diabetic Ketoacidosis 2/2 infection, resolved Type II Diabetes Mellitus  - HbA1c 10.3 - Hold home oral diabetic medications - 40U nightly Lantus  - 12U prandial insulin - Aggressive Sliding Scale Insulin. - 5g Carb Control Diet - Patient now with good insurance, committed to re-establishing with endocrinology "
fever (103.4(degree)F); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Aug2021 16:00 (Lot number: FC3180) at the age of 35 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Lot/Batch number: FA7485, Route of administration : Intramuscular, Time of administration: 16:00, expiration Date: 01Oct2021), administration date: 26Jul2021, when the patient was 35 years old, for Covid-19 immunization, reaction(s): "Headache", "Nausea". The following information was reported: PYREXIA (non-serious) with onset 17Aug2021, outcome "recovered", described as "fever (103.4(degree)F)". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100958215 Same patient, same drug with different dose, similar AE
Post vax, the pt was playing badminton in high school physical education class when he collapsed. CPR started by PE teacher and school nurse until paramedics arrived. Expired at hospital. Autopsy performed. Pathology tissues of heart sent for conduction studies.
Began as lower extremity weakness and paresthesias in stocking distribution bilaterally.  Progressed to involve both upper extremities with bilateral weakness and paresthesias in glove and beyond distribution as well as changes in vision reportedly corrected while wearing glasses.  Had difficulty with tremors while trying to perform an oral biopsy on a patient.  No difficulty breathing, swallowing eating or voiding.  Paresthesias prevent sleep.  Unable to stand long time and feels too weak to drive.  Saw PCP and bloods ordered.  Neuro appt 11/12.  No treatment.  Not improving.
This spontaneous report was received from a medical assistant and unspecified reporter refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 27-JUL-2018, the patient was vaccinated with improperly stored dose of Oka-Merck PROQUAD, lot # N034561, expiration date: 03-JUN-2019, (dose and route of administration were not provided) for prophylaxis (incorrect product storage). The vaccine was reconstituted with sterile diluent which was properly stored. The vaccine underwent a temperature excursion -14 to -10 degrees Celsius for 3 hours and 30 minutes. Digital data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA006154: US-009507513-1809USA004440: US-009507513-1809USA004441: US-009507513-1809USA004442: US-009507513-1809USA004443: US-009507513-1809USA004444: US-009507513-1809USA004445: US-009507513-1809USA004446: US-009507513-1809USA004447: US-009507513-1809USA004448: US-009507513-1809USA004449.
Angioedema, HYPERtension & Tachycardia Acute mild allergic reaction //Patient placed in a cardiac monitor //Given Solu-Medrol as well as  Pepcid //No evidence of anaphylaxis, epinephrine is not indicated at this time //No worsening of sx. vs improved. //will DC home with steroids.
Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Low grade fever). At the time of the report, PYREXIA (Low grade fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant drugs and treatment medications were reported.   This case was linked to MOD-2021-074536 (Linked Report).; Sender's Comments:  MOD-2021-074536:Second Dose
Patient started feeling dizzy, then complained of Shortness of breath (on observation, shortness of breath was very severe). Patient was taken to ER department by EMT
Pfizer on 3/2 and 3/30. Positive on 11/3
First adverse event occurred on 03/17/2022: Sore throat for the first day, runny nose, slight nausea, fever (unknown temperature), headache.   Second adverse event occurred on 04/15/2022: Stuffy nose, sinus pressure, headache, slight nausea, fever (around 102 degrees Fahrenheit before taking Tylenol), watery eyes, sneezing, sore throat in the first 2 days.
Shingles on left side of chest from the front to the middle of my back.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Dec2021 09:00 (Lot number: FG3527) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Prostatomegaly" (unspecified if ongoing). Concomitant medication(s) included: FINASTERIDE; TERAZOSIN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0150, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 06Apr2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ERV620, Location of injection: Arm Left, Vaccine Administration Time: 08:30 AM), administration date: 16Mar2021, for COVID-19 immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset 27Dec2021 04:00, outcome "recovering", described as "Shingles on left side of chest from the front to the middle of my back.". The event "shingles on left side of chest from the front to the middle of my back." was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of herpes zoster.  Additional information: Facility type vaccine: Hospital. Known allergies: No. Other vaccine in four weeks: No and Other medications in two weeks reported in concomitant drugs section. Covid prior vaccination: No. Covid tested post vaccination: No. AE treatment: Valacyclovir.  No follow-up attempts are possible. No further information is expected.
Shoulder injury due to vaccine administration. Shot hit bone and resulted in rotator cuff pain and pain using left arm.  Shot given too high into bursa instead of muscle.
Body Aches, Headache, Chills, Sore throat, Cough, Dry throat   was reported as worsened. Headache; Chills, feeling chilly; Sore throat; Cough; Dry throat; Body Aches; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 25Mar2021 at the age of 51-year-old as dose 1, single for covid-19 immunisation from hospital. Medical history included seasonal allergy and patient took cetirizine for normally takes for allergy. Historical vaccine included Shingles Vaccine administered on in 2020 and patient experienced pain and feeling sick with a fever and chilly for 3 days.  There were no concomitant medications. On 29Mar2021 patient started feeling bad in her body, throat hurts, coughing, body aches, headache, feeling chilly, dry throat. Patient had an appointment but did not go because she was coughing too much. she is taking medication such as cetirizine 10mg, (expiration date in 1 year) ,delsym for cough (expiration date june2021) tylenol 500mg; (expiration date 2021), honey for cough, cepacol 15mg cough drops (expiration date Oct2021) but it is not helping. Patient states that all of her symptoms have gotten worse. When she coughs it is like something is there, but nothing is there. Patient wants to know if there is anything she can take or do about her symptoms.The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Heavy chest/tightness, wheezing, not able to walk far, exhausted from walking and wheezing. Used my inhaler every two hours and no relief. Kept getting worse. Tried Mucinex liquid Severe Chest Congestion and Sudafed.
Patient is breaking out into rash all over body, patient has history of hives but has not had a breakout in a long time, patient has not introduced anything new to her body, patient was here on Monday 5/16/11 and received both Tdap and pneumonia vaccine on that day. Both able to cause rash/hives on body, patient not having any other symptoms, patient has taken BENADRYL, and she says it looks whelped up, please advise. BENADRYL would be the treatment of choice for hives from any source. It may be impossible to tell what triggered them, if it was one of the shots, we will just need to continue the BENADRYL and wait it out as long as she is not having any shortness of breath or vomiting/severe diarrhea (if that is happening she needs to go to ER). She may be under dosing the BENADRYL, it may take 25 to 50 mg every 6 hours which she should adjust to keep herself comfortable, if not improving on the BENADRYL in 24 hours needs to be seen or ER sooner if worse as above. Patient is here today for possible reaction to pneumonia vaccine, hives started at the back of her neck yesterday and then all the way down to upper body, today patient says right arm where the pneumonia vaccine was given is really red and hot to the touch. Patient has a bad night last night and was so hot and itchy that spouse had to baby powder all over patient, no other symptoms but hives/rash and hotness on right arm. Refused weight and height.
REDNESS, SWELLING, WARM TO THE TOUCH; PATIENT USED COLD PACK AND HELPED REDUCE SWELLING.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Additional Details: pt states silver dollar sized red, swollen, hot, a little itchy spot where vaccine was given, also felt headache, aches, fever, taking advil, wants to see dr just to make sure nothing else going on, told her she needs to do what makes her most comfortable
Sore arm/arm felt sore; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: EL3247), via intramuscular route of administration, on 26Jan2021 10:15 AM (at the age of 28 years old) as a single dose in the left arm for COVID-19 immunization at work clinic. Relevant medical history were anxiety, depression. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN), aripiprazole (ABILIFY), iron, ascorbic acid (VITAMIN C). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021 at 04:00 PM, the patient experienced sore arm/arm felt sore. No treatment was received for the event arm/arm felt sore. The outcome of the event arm/arm felt sore was recovering. Since the vaccination, the patient had not been tested for COVID-19.
RECIEVED 2ND DOSE OF VACCINE AND THEN HAD A FAINTING SPELL A FEW MINUTES LATER DURING THE OBSERVATION WINDOW. NO HISTORY OF PREVIOUS REACTION, NO SOB, NO RASH/HIVES, EMS CHECKED HER OUT AND BP WAS FINE. SAID FAINTING WAS PROBABLY FROM ANXIETY AND NERVOUSNESS. NO ISSUES WITH 1ST DOSE OF COVID
The patient said that she experiences excessive shoulder pain. She has undergone nerve conduction tests and is still able to use full range of motion.
Swollen painful lymph node; Swollen painful lymph node; This is a spontaneous report from a contactable other healthcare professional, the patient. A 32-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284) via an unspecified route of administration in the left arm on 19Jan2021 at 12:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0140) via an unspecified route of administration in the left arm on 29Dec2020 at 12:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 20Jan2021, the patient experienced swollen painful lymph node. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 10Mar2021, the patient underwent nasal swab (SARS-CoV-2 test) and the result was negative. The clinical outcome of the events swollen painful lymph node was resolved on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
WAS IN GREAT SHAPE RUNNIG 3 MI PER DAY , MUSSEL AECHE SHORTNESS BREATH, HEAD ACHES, NOW DIABETIC WITH HIGH COLLISTEROL , MEMORY LOSS . ARTHREITICE  SETTING IN.
Headache, Nausea, Diarrhea, Shortness of breath. Flushed, Dizzy, Rash
A physician reported that a 36 year old female received an injection of Flu Shield '00-'01 formula in December, 2000. Approx. 8 days, post vax, the pt developed cranial nerve neuropathy. She was hospitalized. Follow-up information received from the physician on 2/20/01, indicated that this 38 year old female underwent a lumbar puncture. Results showed an increased protein level, normal glucose and 250 white blood cells. A subsequent LP showed a decrease in protein level. Unspecified testing was negative for toxoplasmosis, meningitis, tuberculosis, cytomegalovirus, Lyme disease, herpex simplex virus, Epstein-Barre virus, cryptococcosis and diabetes. A CD4/CD8 ratio was low. The physician reported that the pt is being treated for HIV. Follow-up information received on 4/23/01 via telephone message from the reporting physician, indicated that the pt is not "out of contact". Results of other tests indicate that the cause of her 3rd nerve palsy is not related to the flu vaccine.
Time course DTaP given 11/28/07 and 3/17/08.  There were no adverse reactions noted.
This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported to agent that the patient experienced pain at the injection site following a dose of SHINGRIX which resolved within 3 to 4 days. The healthcare professional did not provide the agent with any further details.
When I was outside leaving the facility, I noticed a tight knot in my chest.Less than a half an hour later,I had pulled over in the park and was trying to fix myself. Soon I realized breathing was not helping. It didn't seem to work. Exercise did not help. I started getting worse. I had difficulty getting back to my car I was fatigued my vision was getting blurry.My thinking was not sure. I couldn't figure out how to get my seat down in my car. Finally I got it down enough so I could recline. Then I decided to try to use my I watch pull up my Hart app.I measured over 155 bpm. I noticed that I was feeling better as my heart rate decreased to 141 bpm. I decided to drive home and left my car seat reclined. When I got h I stayed laying down in my bed for two hours because when I tried to get up I was way too dizzy. I've been unable to reach my primary care doctor when I got home.  I left a voice messages. I called my sisters to tell them what was wrong and while on the phone, hospital was trying to call me and then my sister said she had to hang up because hospital was trying to call her.  I got up when I heard a knock on the door. It was the police. Hospital had called the police.  My heart rate was normal before I got up Almost 3 hours after my shot.  I spent the rest of the day and the next morning trying to find out what happened to me. I have spent days trying to get warnings about what to look out for.  Finally I found this on your website as well as the handout I should've had before the vaccine because I would've known what was happening to me and what to do.
Red, tender area on left neck. Erythematous lesion on left side of neck with vertical ?ripples,? dry spot on left side of upper lip, eyes and eyebrow itching
Arm was a little sore the night after vaccine was administered. On 8/29/17 it was red from site of vaccination to elbow. Swollen in some area and a little warm to touch.
After receiving vaccines on 12/19/2007, baby developed palsy of Lt. face with drooping Lt. eyelid and drooping Lt. side of mouth.            12/22/07 trial of oral predinison and oral acyclovir given. Noted small blisters in mouth at the time of visit.
This spontaneous report was received from a pharmacist and refers to a 58 year old female patient. The patient's medical history included chronic pain. The patient's concomitant medications were reported as a bunch of medications. No information was provided regarding the patient's drug reactions/allergies. On 14-AUG-2018, the patient was vaccinated with the first dose of zoster ZOSTAVAX for shingles prevention (prophylaxis) (dose, route of administration, lot number and expiration date were not reported). The patient did not have any reactions. On 16-FEB-2019, the patient was vaccinated with the ZOSTAVAX for shingles prevention (prophylaxis) (dose, route of administration, lot number and expiration date were not reported). On 17-FEB-2019, the patient developed soreness (pain), tingling (paraesthesia), numbness (hypoaesthesia), and swelling of the forearm (peripheral swelling). The outcome of pain, peripheral swelling, hypoaesthesia and paraesthesia was reported as not recovered. The causal relationship between all the aforementioned events and therapy with ZOSTAVAX was not reported.
tiredness; This is a spontaneous report from a contactable consumer reported for herself. A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 18Apr2021 08:45 (Batch/Lot Number: EW0161) at the age of 62-years-old as single dose for covid-19 immunisation.  Medical history and concomitant medications were None.  The patient previously received first dose BNT162B2 administered in arm left on 28Mar2021 (Lot number: ER8733) for covid-19 immunisation. Prior Vaccinations within 4 weeks was None. Family medical history relevant to adverse event was None. The patient stated she took the second dose on Sunday on 18Apr2021 and did not really start to feel tiredness until last night and today from 20Apr2021. The event did not require a visit to emergency room or physician office. Therapeutic measures were taken as a result of tiredness included she took a Tylenol last night one 500mg. The outcome of the event was not resolved.  No Follow-up attempts are needed. No further information expected.
(L) back of arm - redness, warm to touch firm upon palpation. Pain.
Raised bump at the injection site. Lymp pain and swelling at the same side of the injection.
Information has been received from a nurse practitioner concerning a 4 month old female who was vaccinated PO with the first dose of Rotavirus vaccine. The NP reported that the patient subsequently vomited for a week and developed loose stools. Unspecified medical attention was sought. The patient's symptoms subsequently improved. Additional information has been requested.
Wanted a Moderna  COVID-19 vaccine Booster but was given a Pfizer COVID-19 vaccine as a booster instead.
pt recvd vax; bloating day p/ vax; still persisting; 26jan94 feels significantly better; tx w/ pepcid;
contracted (dr. diagnosed) chickenpox after receiving 2 Varicella shots mild case <50 lesions-onset 1-3-08
Pfizer 3/23/21, 4/22/21, 10/28/21. Positive on 1/30/23
Patient reported to RN on 4/10/2013 AM that right upper arm was sore with large area of hard tissue noted around injection site.  Patient reported the area of hard tissue had increased overnight.
Besides the reported side effects of fatigue, headache, muscle pain, joint pain, chills, nausea and a slight fever she also had severe lower back pain, frequent urination with larger than normal volume of urine, pain on the upper left and right arm,  the urge to have a bowel movement and she did have a bowel movement once, and difficulty keeping her eyes open.  She took Aleve for the pain.  These symptoms started hours after her second Moderna shot on March 23, 2021 at 11:20 am.   She started feeling ill at about 4 pm.  At around 10 pm she started to feel really sick and these symptoms lasted for about 36 hours but the the worst was the fist 24 hours.
Pt was given vaccines and within 10 mins. the child collapsed to the floor, was unresponsive for approximately 10-15 secs. Child transported to exam table, was easily aroused, answering questions appropriately. Was observed 15-20 mins. for further episodes. None noted.
2 days after receiving first dose of vaccine, patient describes a pulsation/spasm on her right chest, moved to right side/stomach, and now it's on the left chest/torso (belly up to breast).