chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "69 year old female with a history of ESRD on HD secondary to PCKD, paroxymal Afib, hypertension, hyperlipidemia, hypothyroidism, and seizure disorder who presented to facility on 1/2/23 with a two week history of nausea, vomiting, diarrhea, and fatigue. During the hospitalization she was found to be septic with fever and a leukocytosis. She was found to have COVID-19, Influenza A, and an Escherichia coli bacteremia. She was started on IV Ceftriaxone while workup began to investigate the etiology behind the the bacteremia. Patient has many sources of infection: GI translocation vs chronic cholecystitis vs infected cyst. ID was consulted - believe the source of infection is related to chronic cholecystitis. Patient was recommended in the past to have a cholecystectomy done at a tertiary care center, but patient refused. This time patient continues to resist surgery, as she does not believe the operation will prolong her overall prognosis as it relates to PCKD. She would like to forgo surgery at this time. Repeat blood cultures were drawn and were negative for 48 years - she will be discharge on (renally-dosed) Ciprofloxacin 500 mg daily with instructions to complete a 14-day course of antibiotics.  "
similar to Bells Palsy; Very dull numbness in the left side of her face; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (similar to Bells Palsy) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced FACIAL PARALYSIS (similar to Bells Palsy) (seriousness criterion medically significant), HYPOAESTHESIA (Very dull numbness in the left side of her face) and HEADACHE (slight headache). At the time of the report, FACIAL PARALYSIS (similar to Bells Palsy), HYPOAESTHESIA (Very dull numbness in the left side of her face) and HEADACHE (slight headache) had not 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
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 66-year-old male patient received BNT162b2 (BNT162B2), on 20May2022 at 15:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Contrast dye used for CT scans" (unspecified if ongoing), notes: Known allergies: Contrast dye used for CT scans; "Diabetic" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: There was no other medication in 2 weeks. Vaccine lot unknown as unable to locate or read the details.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Rash. Seen in ED and given IVP Solumedrol and ranitidine.
Info has been received from an RN concerning a 6 year old female with no known drug allergies who on 6/27/00 was vaccinated with a dose of varicella virus vaccine live. There was no illness at the time of vaccination. The RN reported that on 10/10/05, developed itchy white bumps on different areas of her body X 2-3 days. The pt was noted to be afebrile. The pt subsequently, developed 14 isolated papules on her neck, chest and right underarm. A diagnosis of mild breakthrough was made. Unspecified medical attention was sought and the pt was treated with calamine lotion. No lab/diagnostic tests were performed. In 2005, the pt's breakthrough subsequently, resolved. Additional info is not expected.
Breast cancer diagnosis a year later. No symptoms. Detected in Mamogram. No history. No genetics
Patient here for immunization visit. Received 5 vaccines total. Received three vaccines in left arm. First vaccine given in left arm was IPV, second was Hep A and last vaccine administered in left arm was HPV. Patient immediately fainted after HPV injection. Was sitting on exam table at this time, RN was able to lead patient down to exam table and patient layed down and was not injured. Syncopal episode lasted only about 5 seconds. Patient awoke and was advised to continue to lay down. Patient's head of bed elevated. Vital signs taken. All vital signs stable. Provided with cups of water and a pedialyte popsicle. Evaluated by RNP. Monitored in office for 45-60 mins after syncope. Patient stable to go home 60 mins after incident occurred.
1. Feeling itchy. 2. Nausea 3. Light-headed and feeling faint.
inconsolable crying x 2 1/2 hrs-fell asleep sleepier than usual in AM t100.6 R;
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A 14-year-old male patient received BNT162b2 (BNT162B2), on 05Aug2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer.), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever/ 102 something up, the fever"; HEADACHE (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: Reporter stated, "I have a question. My 14-year-old got his first booster ( Pfizer-BioNTech COVID-19 Vaccine) yesterday and he has a headache a 102 something up, the fever. The paperwork says that this over a 100.4. Can he take anything about fever" Reporter was informed about the Role of Pfizer Drug Safety. Reporter was informed that Pfizer Medical Information Department was closed due to weekend and was requested to contact any of the health care providers like nurse, physician or a pharmacist or visit the nearest emergency room. Reporter stated, "They did not tell me anything. But I will call my doctor. Thank you!" Product details (LOT, NDC, UPC and Expiration date) and Pharmacy details were not available over the call as the reporter hung up abruptly. Further details could not be probed as the reporter hung up the call abruptly. Hence, further probing could not be done.  Thus limited information available over the call. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever(99-101), chills, muscle soreness, nausea, headache, weakness, stuffy nose,  sore right arm and right under arm
Standard heat, redness & discomfort at injection site on first day.  Redness and discomfort started traveling down the arm the next day,.  Used marker to dot outline on second day.  Redness continued traveling outside the dots then hives showed up. on day 3.  Used Benadryl cream and took OTC Benadryl capsules.  Slowly improved but clearing of the reaction was not complete for 30 days post injection.
Approximately one month after receiving the Pfizer booster, I developed an allergic reaction to tomato-based foods and any spicy foods. My lips swelled and the corners of my mouth reddened.  The inside of my lips felt raw. This allergic reaction continues. I must now be careful of the type of food I eat. I made one visit to my doctor in January.
On 2/7/2021 at 3:00 am he started with fever of 99 then went up to 102.9.  He reports he had chills, weakness, body aches, and an elevated blood pressure.  He went to MC.  Blood was performed but results unknown.  He was diagnosed with a vaccine reaction.  He was given Tylenol while in the ER.  He was told to continue taking antipyretics.  HE was discharged from the hospital and will have to follow up with PCP concerning elevated blood pressure.
Itching, flushed, diminished lung sounds, difficulty breathing, difficuty swallowing, rash, erythema.
The first intradermal attempt at administering the vaccine the nurse was unable to obtain a bleb.  Did get a successful wheal on the second attempt.
As of April 13 I started to feel very bad I took the covid-19 test and it came out POSITIVE.
A nurse reported with in two days pt developed an injection site reaction characterized by pain and swelling. She also experienced weakness and heaviness of the arm into which the vax was injected. The pt reported that she had trouble lifting or using the arm. When she lifted the arm, she experienced shooting pains which radiated to her shoulder and the back of her neck. This is 1 of 2 pts from facility who experienced AE.
Fatigue, chills, moderate weakness, headache. Fever rising to 100.5 by 8 hours after the reaction began.
Have had two lower body heavy bleeding events, not sure if vaginally or rectal due to amount of bleeding. 1st one I believe to be vaginal as there were clots. It did stop in its own. 2nd event just happened today 9/4/21 and seems to have stopped. As you can, I am postmenopausal.
headache, muscle weakness, significant fatigue, some tingling hands and lower arms 10-25.  Shortness of breath 12/09.
Hive w/ red border, from top of deltiod to elbow. Swelling over deltiod that day into the next day that extended 2 inches below elbow. Hive went down over 2-3 days. Arm was swollen to 2"below elbow for 7days. Pain, tingling in arm and hand. I notified the clinic that day and clinic also did a follow up call to check if I was ok. Took BENADRYL, TYLENOL, and placed ice packs on area.
Left lower mil arm slight swollen, went swimming same day. Warm pack temp 97.6, Motrin 200mg 10/05/2005
This spontaneous case report was received from a registered nurse regarding unknown number of patients of unknown age and gender. No concurrent conditions  and medical histories of the patients were not reported. On an unknown date the patient was vaccinated with RECOMBIVAX HB stored outside the recommended temperature range (0.3 degree for 45 minutes) (incorrect product storage) with a lot number # of L044694 (expiry date: 04-FEB-2018), (dosing regimen, strength, route and frequency was unknown). Concomitant medications of the patients were not reported. No adverse event was reported. This is one of the several reports from the same reporter. Additional information has been requested.
STIFFNESS IN THE NECK; DIZZINESS; SHORTNESS OF BREATH; PAIN IN THE NECK; UNABLE TO ROTATE NECK TO THE RIGHT; SEVERE PAIN IN THE RIGHT SHOULDER AND SHOULDER BLADE; SEVERE HEADACHE; OVERALL WEAKNESS; This spontaneous report received from a consumer concerned a 39 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient has had no change in lifestyle to account for effects. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 16-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 17-OCT-2021, the patient experienced stiffness in the neck. On 17-OCT-2021, the patient experienced dizziness. On 17-OCT-2021, the patient experienced shortness of breath. On 17-OCT-2021, the patient experienced pain in the neck. On 17-OCT-2021, the patient experienced unable to rotate neck to the right. On 17-OCT-2021, the patient experienced severe pain in the right shoulder and shoulder blade. On 17-OCT-2021, the patient experienced severe headache. On 17-OCT-2021, the patient experienced overall weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe pain in the right shoulder and shoulder blade, stiffness in the neck, severe headache, dizziness, shortness of breath, overall weakness, pain in the neck, and unable to rotate neck to the right. This report was non-serious.
Within a few hours of receiving the vaccine my arm was in excruciating pain. Was not able to lift  more than 45 degrees. Than dizziness and vertigo started. That evening I had the chills, night sweats (possible fever). Headaches persisted for the rest of the week with dizziness. Arm pain started to subside by Monday but then came the extreme neck pain. I was not able to move my neck side to to side and  forward flexion caused pain. I sought the help of a physical therapist who was concerned about my symptoms and astonished by the pain and level of inflammation in the neck region. I received treatment the week following the vaccine and I am now on week 2 and the neck pain is still here but not as severe only pain turning to the left and the headaches are less frequent.
This spontaneous report was received from a registered nurse refers to a 1 years old patient who on 22-MAR-2012, was vaccinated with the first dose of (Merck) VARIVAX and on 14-JUN-2012, was vaccinated with the second dose (doses, routes and lot numbers not reported). No adverse events were reported. This is one of several reports from the same source. Additional information is not expected.
Patient received FLUVIRIN. Left store. Called from home stating she was itchy and took BENADRYL. Patient said she feels better after taking BENADRYL.
Left arm swelling and erythema. Tx: Omnicef 300mg 1 Bid x 4 days.
23APR acellular DTP inject given 24hr later parents called&said pt fainted,looked dusky,t100;
Mild headache; Dose number: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).  A 52-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 17Dec2021 at 14:15 (Lot number: unknown) at the age of 52 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medications included: EFFEXOR and PREMARIN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: Unknown; Administration Location: Right Arm; Route of administration: Intramuscular), administration date: 15May2021, when the patient was 52 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: Unknown; Administration Location: Right Arm; Route of administration: Intramuscular), administration date: 03Jun2021, when the patient was 52 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021 at 14:15, outcome "unknown", described as "Dose number: 3"; HEADACHE (non-serious) with onset 17Dec2021 at 16:00, outcome "recovered" (17Dec2021), described as "Mild headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   The lot number of BNT162b2 was not provided and will be requested during follow up.
During the overnight hours after recurrent my vaccine i developed fever, cold,  and headache.   All day I have had a low grade fever up to 100.9 as well as headache and weakness/ fatigue.
Extreme swelling of lymph nodes causing constant pain. Unable to put left arm down because armpit area was so swollen. Lasted 3 days and was unable to perform work.  Mild joint pain and fatigue. Torso rash (viral rash- common for me with all viral illnesses).
Information has been received from a health professional concerning a male patient who on 13 March 2000, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient experienced stomach pain, vomiting and a generalized chickenpox rash. The patient was being treated with acyclovir. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. The patient's reaction was considered to be an other important medical event by the reporter. Additional information has been requested. (OMIC)
Excessive daytime and nighttime sweating after Pfizer covid booster given on 02/22/2021 lot number EN5318.    1st dose lot number was E19265
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: patient called pharmacy few days after injection. wanted to let us know to document she had eye swelling post vaccine. self treated with benadryl. didnt improve. called md got prednisone and started to get better. per labs had luekopenia and nuetropenia. md stated to still get 2nd shot. had history of angioedema before. recieved second shot on 10.13. will monitor
nausea; swollen glands; Ear plugged; Heart beating fast; dizziness; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 16Aug2021, this case now contains all required information to be considered valid.    This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8737), intramuscular, administered in left arm, on 05Apr2021 13:05 (at the age of 52-year old), as dose 1, single for COVID-19 immunization. Medical history included hysterectomy in 2011, ovarian cyst removal of 1 ovary due to hemorrhagic cyst in 2013, gall bladder removal in 2015, allergic to corn for 7 years (2014): corn starch, corn syrup, corn mask, dextrose and black rubber mix. Family medical history also included allergy to black rubber mix, corn syrup, corn mask, dextrose, corn starch, and lactose. There were no concomitant medications and prior vaccinations. The patient guessed that her reaction was from black butyl rubber in the stopper of vaccine. On 05Apr2021, after the first dose injection, patient experienced dizziness for 5 minutes, then it was gone. On 06Apr2021 07:00, the patient experienced swollen glands, severe dizziness, nausea, ears plugged, and heart was beating fast, all for one week, then went away after 7 days. The events were reported as serious due to persistent/significant disability/incapacity. The patient underwent lab tests and procedures on 23Jun2021 which included allergy patch test to all the 3 vaccine ingredients, and patch test for PEG, eye drops and polysorbate, both with negative results. The adverse events required visit to physician office. No treatment was given for the events. The outcome of the events was recovered on 13Apr2021.   Follow-up attempts are completed. No further information was expected.
pt exp chills, sweats, & sl inj site tenderness;14AUG92 removal of a ganglion cyst from wrist;given anesthesia for post surgical pain;numbness, tingling, & swelling;examined by MD gait sl ataxic;diff maintaining balance, blurred vision;
BODY ACHES; CHEST HURT; FEVER; This spontaneous report received from a parent concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, chest hurt, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and the outcome of body aches and chest hurt was not reported. This report was non-serious.
Information has been received from a licensed practical nurse concerning a 26 year old female with no known medical history and drug allergies, who on 12-DEC-2008 was vaccinated with a first dose of GARDASIL (lot # 660620/0571X) on 12-FEB-2009.  The patient received a 0.5 mL second dose of GARDASIL (lot # 661764/0650X), intramuscularly.  There was no concomitant medication.  It was reported that the patient was pregnant.  It was noted that the patient had experienced vaginal spot bleeding that was bright red.  It was also reported that the patient miscarried.  She was in her first trimester and probably only a couple weeks pregnant.  Beta levels were negative and she will not require a dilation and curettage procedure.  The patient sought medical attention through a phone call to the practice.  Upon internal review, miscarried was determined to be an other important medical event.  Additional information has been requested.
Site: Bruising at Injection Site-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe
Pain in arm for about 48hrs/Pain was moderate; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number; Unknown) via an unspecified route of administration on the right arm on 14Mar2021 at 16:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient included GERD and asthma. The patient was allergic to Penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included Omeprazole since an unknown date for an unknown indication. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccine. The patient took penicillin on an unknown date for an unknown indication and experienced allergy. On 14Mar2021, the patient experienced pain in arm for about 48hrs.The patient also reported that the pain was moderate. No treatment received for the event. Therapeutic measure taken for the adverse event was unknown. The outcome of the event pain in arm was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained  Amendment: This follow-up report is being submitted to amend previously reported information: Patient first name added. Patient's Age/Units captured as 40 years per event's onset 14Mar2021. Vaccination Facility added. "Unknown" removed from Lot# field. For both events: "Treatment Received?" captured as "No" per source "if treatment ae: No". Final sentence "Information about lot/batch number cannot be obtained. No further information is expected." updated as "No follow-up attempts are possible; information about lot/batch number cannot be obtained." Patient's Ethnic Group captured "Unknown" removed from Lot# field "OMEPRAZOLE". Event stop date captured as 16Mar2021 per verbatim "Pain in arm for about 48hrs". Yes removed from Concomitant Therapy since already coded out.  In narrative, "This is a spontaneous report from a non-contactable consumer, the patient".  In narrative, "Therapeutic measure taken for the adverse event was unknown" should be "no" per source "if treatment ae: No". Initial information need be updated in consolidated narrative: adverse event: Pain in arm for about 48hrs. Nothing more. Pain was moderate. if treatment ae: No