chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown dates, the patients were vaccinated with improperly doses of GARDASIL 9 (lot # L043214, expiration date 30-AUG-2017, exact doses and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for two patients. This is the second of two reports. A 65-year-old female patient of an unspecified race and ethnicity received PREVNAR 13 at single dose via an unspecified route of administration on an unspecified date for immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced rash on an unspecified date after the vaccination. Outcome was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017063162 Same reporter/suspect product/event, different patient.
Rash on back/chest/belly/face/hairline and diaper area. Loss of appetite. Fatigue /unable to sleep. Throat is red. Tested for strep-negative.
Received shot at about 9.30 am. Within a half hour experienced a more than moderate pain on inside of arm from elbow to wrist. Happened 3 times for a duration of about 10 seconds. I have never had that pain before and it happened only those three times. By 5pm tired, some muscle pain and injection site quite sore. The next day was the worst, with muscle aches, headache, moving the arm was somewhat painful, swelling and redness of injection site and body was cold...not shivering but close to it. Extremely tired.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Anaphylaxis (hives, oropharyngeal swelling, cough, shortness of breath) 20 mins following vaccine administration. Patient given epinephrine at vaccine site 20min after symptom onset with significant improvement in symptoms including improved pharyngeal swelling and resolution of hives.  Patient presented to the emergency department 1.5 hours following onset  of anaphylaxis with mild cough and mild pharyngeal swelling for observation.
Popping sensation and immediate pain and decreased range of motion in right arm following administration of vaccine on 9/21. Flu shot was placed very high on arm and into shoulder joint. Patient self-treated with rest and MOTRIN at home; pain worsened over the following week. Severe pain with numbness and tingling in right palm was noted, which is what caused patient to seek medical treatment. Patient seen by corporate care on 10/2 and was evaluated and an ultrasound was performed. At follow up visit on 10/3, patient was diagnosed with SIRVA and given a prescription for prednisone oral. At follow-up appointment on 10/6, pain was still present but range of motion was improved. Patient was instructed to finish oral steroids and to ice area and take ALEVE as needed.
sore muscles in left arm where injected; This is a spontaneous report from a contactable consumer. A 40-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247 and expiration date: unknown), via an unspecified route of administration on the left arm, on 26Jan2021 at 13:30 at a single dose for COVID-19 immunization. Medical history included polycystic ovarian syndrome. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metformin (METFORMIN), spironolactone (SPIRONOLACTONE), ethinylestradiol, norethisterone acetate (JUNEL), and escitalopram (ESCITALOPRAM). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore muscles in left arm where injected on 26Jan2021 at 19:00. Since the vaccination, the patient has not been tested for COVID-19. No treatment was administered for the event. The event resolved on an unknown date in Jan2021.
This study case was received from the investigator in a trial on 06 November 2013. A 19-year-old male subject, with no reported past medical history, received the following vaccination: an injection of ACAM2000 (lot number not reported) on 17 July 2013 and anthrax (manufacturer and lot number not reported) on 28 June 2013. On 05 August 2013, the subject was diagnosed with encephalitis following immunization procedures. On 30 July 2013, the subject had an abnormal Troponin I of 00.11, a normal echocardiogram and a normal lumbar puncture (spinal tap). The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Developed fatigue, low grade fever and body aches approximately 10-12 hours following vaccine. Symptoms persisted for 12-14 hours and subsided following dose of ibuprofen 800mg.
pt had temp off & on for approx 2 wks;suspected that pt had ear infect;MD said that there were no ear infect;in addition mucus was running from nose;cried majority of next 4 days;dx /w 2 ear infect & a sinus infect;
Pt woke up  in morning (7:30am) 2 days after 2nd dose of pfizer covid-19 vaccine unable to stand or walk.  Pt reported to pharmacy and 4:00pm and could then stand, but still unable to walk due to weakness in legs.
Information has been received from a 57 year old female consumer with no known allergies and high cholesterol who on 27-MAR-2008 was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, on 28-MAR-2008 the patient experienced flu like symptoms including rhinitis, body aches, fever and pruritus. Medical attention was sought, the patient spoke to the physician. There were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information is available.
Patient filled out name only on form, was assumed to be >18 years old because I did not see a parent/guardian. I asked if he knew what vaccine he was to get today & he shrugged. He was given Moderna vaccine. After patient waited 15 minutes it was noticed in the computer system that the patient was under 18 years old & should have received pfizer.
my face became numb from the nose down; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received first single dose of BNT162B2 (Solution for injection, lot number: EL3246, exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 11Jan2021 12:30 for COVID-19 immunization. Facility type vaccine: Hospital. The patient had allergies: any sulfa medication. The patient was not pregnant. The patient did not have covid prior vaccination. There were no other vaccine/s in four weeks. Other medications in two weeks include: ethinylestradiol, ferrous fumarate, norethisterone acetate (Blisovi 24 FE), citalopram and lamotrigine. On 11Jan2021 12:45, also reported as 'after 20 minutes of receiving the vaccine,' the patient's face became numb from the nose down. Within three hours, the right side of her face had feeling again. Then, another three hours later she began to have feeling in her nose. She went to bed, and the next morning she had complete feeling in the face. No treatment was received for the event. On 01Jun2020, nasal swab: negative. The patient recovered from the event on 12Jan2021.
Started having a sore throat and fever, and tested positive for COVID-19.  Was prescribed Paxlovid and seemed to be getting better. Then 10 days later, I became extremely lethargic and could barely get out of bed. Went to the Emergency room and was given an EKG and a blood test and Chest X-ray, nothing was found. Was given another COVID-19 test and was positive. Was prescribed Propranolol and Naltrexone. Was really sick for 2 months and could barely get out of bed. Gradually a couple months after, I was able to get out of bed and move around a little, but had shortness of breath, brain fog with Orthostatic, Hypertension  and extremely tired. Since then I'm still tired all the time and haven't been able to work yet, I'm on Sick Leave and receiving Disability. Believe I have Long-Covid.
Localized redness and swelling just days after vaccine in left deltoid. Since Monday, pain is gone and rash almost gone.
Hands swelled,  face was numb and lips tingled and became swollen. Took Benadryl 50 mg po and a half an hour later I had difficulty swallowing. I took another dose of Benadryl and made myself stay awake for most of the night until the symptoms subsided.
I had a sore throat, low-grade fever, congestion, I tested with a home COVID-19 test it came back positive.  I called made an appointment with my doctor, he also tested me with a PCR Rapid COVID-19 test. I was prescribed Paxlovid. I started taking it that evening. I did get a little tired that lasted a few weeks.
Fever chills and bodyaches initially. days later having chest pain with activity has happened multiple times while exercising since vaccine booster
had palpitations lightheaded about 1:00 on 10/28/98 MD called;MD upset w/BP reading ordered pt to ER;
This case was reported by a consumer via call center representative and described the occurrence of erythema in a adult male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after received SHINGRIX, the patient experienced erythema, arm discomfort, inflammation localized, skin warm, pain in arm and wrong injection technique. The patient was treated with clindamycin. On an unknown date, the outcome of the erythema, arm discomfort, inflammation localized, skin warm, pain in arm and wrong injection technique were unknown. It was unknown if the reporter considered the erythema, arm discomfort, inflammation localized, skin warm and pain in arm to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient received SHINGRIX through a bandaid, which led to wrong injection technique. The injection didn't hurt but the delivery was hugely uncomfortable. Soon afterwards patient's arm got very pink, hot and uncomfortable. It was not at the injection site but about an itch away. The inflammation spread to a large area over patient's upper arm and was very warm to the touch. It didn't itch, nor did the patient get sick, but the nurse practitioner had her take clindamycin for 7 days. The patient's arm was still tender but most of the inflammation was gone. The patient was assuming a fiber or particle of that shielded through which the nurse injected was injection into patent's arm. The patient's issue was with the pharmacy not. The patient could not get the pharmacy to stop this corporate decision to putting the Band-Aid on after the injection rather than going through it. Inject through a shield and wanted to let GlaxoSmithKline know how their product was being misused to the disadvantage of the customer or patient. The reporter was asking GlaxoSmithKline might want or need to have a chat with corporate of the pharmacy where the patient received the vaccine. The reporter stated that they would go to the same pharmacy for her husband's injection since she had checked and they did not inject through something that can be delivered in to his arm.
the results came back on 07/17/2020 which showed that she did not have immunity to MMR or Varicella; she did not have immunity to MMR or Varicella; she did not have immunity to MMR or Varicella; she did not have immunity to MMR or Varicella; 20-year-old patient was administered a dose of PROQUAD; the patient was administered a dose of PROQUAD instead of being administered a dose of MMR and Varicella vaccines seperately; This spontaneous report as received from a nurse refers to a 20-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 16-JUL-2020, the patient had titers drawn and the results came back on 17-JUL-2020, which showed that she did not have immunity to Measles, Mumps, Rubella or Varicella. On 17-JUL-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, subcutaneously, lot # S022104, expiration date: 12-JAN-2021, albumin status has been verified as recombinant human albumin (rHA), subcutaneously for titers (strength, exact dose, frequency were not reported), which was reconstituted with sterile diluent injection, lot #T000494, expiration date: 06-JUL-2022 (strength, dose, frequency, route of administration, indication  were not reported) as a treatment, instead of being administered any Measles, Mumps, Rubella or Varicella containing vaccines in the past. The patient had unspecified blood work done, but result were not reported.  Outcome of the events was reported as not recovered. The relatedness between the events and suspected therapies was not provided.
I21.4 ACUTE NON ST ELEVATION MI 12/3/2021 ESRD (END STAGE RENAL DISEASE) I24.8 DEMAND ISCHEMIA 11/19/2021 ESRD (END STAGE RENAL DISEASE) I95.9 HYPOTENSION 11/25/2021 ESRD (END STAGE RENAL DISEASE) J96.00 ACUTE RESPIRATORY FAILURE 11/25/2021 ESRD (END STAGE RENAL DISEASE) R09.02 HYPOXIA 11/25/2021 ESRD (END STAGE RENAL DISEASE) R57.0 CARDIOGENIC SHOCK 11/25/2021 ESRD (END STAGE RENAL DISEASE) I21.4 ACUTE NON ST ELEVATION MI 12/3/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA I24.8 DEMAND ISCHEMIA 11/19/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA I95.9 HYPOTENSION 11/25/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA J96.00 ACUTE RESPIRATORY FAILURE 11/25/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA R09.02 HYPOXIA 11/25/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA R57.0 CARDIOGENIC SHOCK 11/25/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA I21.4 ACUTE NON ST ELEVATION MI 12/3/2021 DM 2 I24.8 DEMAND ISCHEMIA 11/19/2021 DM 2 I95.9 HYPOTENSION 11/25/2021 DM 2 J96.00 ACUTE RESPIRATORY FAILURE 11/25/2021 DM 2 R09.02 HYPOXIA 11/25/2021 DM 2 R57.0 CARDIOGENIC SHOCK 11/25/2021 DM 2
Feeling unwell/was sick and in bed for 3 days.; This case was reported by a consumer via other manufacturer and described the occurrence of mobility decreased in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced mobility decreased. On an unknown date, the outcome of the mobility decreased was recovered/resolved.   It was unknown if the reporter considered the mobility decreased to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient was in bed for 3 days after receiving shingrix vaccine and then she was fine. The reporter consented to follow up. For tolerances for 2nd dose, refer case US2021AMR043127.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR043127:same reporter
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 06/26/2021. PATIENT FULLY VACCINATED ON 02/18/2021.
My wife was sick and she was just diagnosed with Covid. She got tested 3 times and they were all positive. On 09/17/2021 I started getting some chest congestion and nasal drainage. I thought I had bronchitis because of my asthma. I called on Monday to see the doctor but according to CDC guidelines I should get tested for Covid first. I got tested and it came back positive on 09/20/2021. By the next day my doctor scheduled monoclonal antibody infusion. My doctor prescribed some antibiotics and steroids. I was told not to take the steroids until I was sure the antibiotics were not going to work. I still have some chest congestion.
Five weeks of violent coughing of phlegm from the lungs, followed by two weeks of light-to-moderate coughing of sinus mucus.  Five days of antibiotics (seemed to mitigate), daily nebulizing with saline and hydrogen peroxide solution, plus flushing sinuses with saline solution via neti pot.
Patient reported the feeling of needles in ankle and thigh. She has had shingles in the past and the sensation was similar. She also reports feeling very sleepless, only sleeping for about ~6 hours a night. Symptoms resolved after two days.
About 5:00pm, she became agitated.  She was screaming and saying she wanted to run away.  We kept her home.  Per doctor, administered additional doses  of peptide bpc-157, thc free cbd oil, took  an epsom salt bath, evening medications.  Felt better but had a hard time falling asleep.   Next day, seemed to be ok.  Administered morning medications and sent her off to school.  Arrived off bus a little down and not feeling well.  Over the course of the next few hours, she became agitated, raged, hit staff, screamed and yelled, tried to exit classroom.   She attends a therapeutic school with special education teachers.  They tried everything to get her to calm down, including restraint when she was hitting or trying to exit the building.  This went on for an hour and after 6 holds, the school called me.  Administrator informed me of situation and when i tried to talk to her on the phone, she screamed into it.  That was when everyone knew something was seriously wrong and they call 911.  She went to emergency room.  After a few hours she completely calmed down but due to the severity of the episode, the doctors wanted to keep her.  She was evaluated by a psychiatrist and was sent to inpatient hospital the next day due to bed unavailability.  She is now at streamwood behavioralhealth, arriving tuesday, 12/14/2021.  No medications were changed.  She attends therapy and they are watching her.  She is doing well and will be discharged monday, 12/20/2021.  Doctors and i agree that this seems to be a one time reaction.  However after inpatient, she will attend intensive outpatient therapy and i will work on securing the rest of her outpatient assistance.
IMMEDIATELY AFTER GIVING THE VACCINE, PATIENT SAID HE IS NOT FEELING WELL, TURNED PALE AND PASSED OUT, HIS ARMS LOCKED, HE START SHAKING AND HIS HEAD TUNRED ON THE SIDE. HE LOST CONSCIOUSNESS.  AFTER FEW SECONDS HE RECOVERED, BUT WAS VERY PALE AND  HE WAS SWEATING. 911 WAS CALLED AND PARAMEDICS CAME.
Chest pain; difficulty in breathing; Dizzy weak; Tired; short pain on head; Blur vision; Extreme pain on arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blur vision), PAIN IN EXTREMITY (Extreme pain on arm), CHEST PAIN (Chest pain), DYSPNOEA (difficulty in breathing) and DIZZINESS (Dizzy weak) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history Provided.). Concurrent medical conditions included Drug allergy (Sulfur Allergy.).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced VISION BLURRED (Blur vision), PAIN IN EXTREMITY (Extreme pain on arm) and HEADACHE (Headache). On 11-Feb-2021, the patient experienced CHEST PAIN (Chest pain), DYSPNOEA (difficulty in breathing), DIZZINESS (Dizzy weak), FATIGUE (Tired) and HEADACHE (short pain on head). At the time of the report, VISION BLURRED (Blur vision), PAIN IN EXTREMITY (Extreme pain on arm), CHEST PAIN (Chest pain), DYSPNOEA (difficulty in breathing), DIZZINESS (Dizzy weak), FATIGUE (Tired), HEADACHE (Headache) and HEADACHE (short pain on head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant included Blood pressure medicine and Diabetes Medicine Treatment information not provided
Swollen at vaccine site, (left arm) not itchy, warm to touch 4 inches across (redness). 9/4: pt saw other RPh, who said see MD cellulitis diagnosis started ampicillin/AUGMENTIN 9/4/13.
Fever of 102 degrees. Delusions. Headache. Nausea. No vomiting. Photophobia. (L) shoulder pain - all started about 5 hours after ADACEL. Went to ER for 1 liter NS bolus, COMPAZINE, BENADRYL PO.
Initial report received from another manufacturer, report number WAES0511USA00146, on 09-NOV-2005. A nine-month-old female patient received in the left thigh an injection of FLUZONE, lot number 01754AA, on 11-OCT-2005. The patient has a history of facial rash and eye discharge, and her mother was vaccinated with varicella virus vaccine while pregnant. The patient also has a history of febrile seizure and urinary tract infection on 28-SEP-2005. On the day of vaccination the patient had been constipated for one day, was afebrile and had completed cephalexin that was being taken for a urinary tract infection. Eighteen days post-vaccination, on 29-OCT-2005, the patient complained of constipation and fever for four days. The patient's vaccination history includes, on 29-OCT-2004, a first dose of IPOL, lot number X1006, given in the right thigh; a first dose of DAPTACEL, lot number C1996AA, given in the left thigh; a first dose of PREVNAR, lot number 495-721, given in the left thigh, and a first dose of COMVAX, given in the right thigh; a second dose of ACTHIB (dose one was a different product), lot number UE335AC, given in the left thigh; and a second dose of PREVNAR, lot number A7400E, given in the right thigh. Vaccinations received on 28-JAN-2005 include a third dose of DAPTACEL, lot number C2131AA, in the left thigh; a second dose of IPOL, lot number X1189, given in the left thigh; a second dose of COMVAX, lot number 6481423/0128P, given in the right thigh; and a third dose of PREVNAR, lot number A57562B, given in the right thigh. Vaccinations received on 29-MAR-2005 include a third dose of Hepatitis B virus vaccine (doses one and two were COMVAX, lot number 647593/0465P, given in the left thigh; and a first dose of FLUZONE, lot number U1381AA, given in the right thigh. Vaccinations received on 29-APR-2005 include a second dose of FLUZONE, lot number U1381AA, administered in the left thigh. The patient has a history of a previous adverse event recorded in case 2005-02398. At the time of this report, the patient's recovery status was unknown.
Fridge temp went out of range by 4 degrees overnight sunday due to storm, RIDOH closed on 1/17. Vaccines were administered to patients in the morning
(Lot # may be 939903). Severe wheels and urticaria diffusely.
8x7cm redness, tenderness in the area of lt upper lateral thigh;c/o cellulitis;tx med;
Developed mild sensory issues (fear of loud noises) and some mild anxiety within 10 days of vaccine. Report to doctor in April 2016. Referred to O.T.
This patient received Td vaccine in her right deltoid. Two days later she notes a small hematoma; she applied ice at that time at 2:30 PM. The site was red, swollen warm, and raised.