chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Three days after receiving the 2nd COVID19 vaccination, I developed chronic diarrhea, and I have lost approx. 18 lbs.  To try to figure out what was wrong, I had a colonoscopy, and was tested for Crohn's Disease, Celiac Disease, and Pancreatitis, and had many other blood tests, all of which came back with nothing wrong.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 44-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the state was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment with the State.  The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
6/1/21 (approx.. two months after second dose of Pfizer/BioNTech vaccine) first went to my primary care doctor for severe headache that had lasted 3 weeks prior. Continuous headache with severe pain levels increasing throughout the day the longer I am awake. Felt like an ice pick was being driven into the right back of my head. The longer I am in pain the headache will wrap around the side of my head and into my temple. Tried Tylenol and muscle relaxers throughout June with no effect to symptoms.  7/13/21 visited primary care doctor again due to no improvement of headache symptoms. Headaches were constant from waking to going to bed and would wake me up in the middle of the night. Started amitriptyline. 7/21/21 referred to neurologist due to such severe and debilitating headaches. Was diagnosed with new daily persistent headache and Occipital neuralgia of right side. I have never had headaches this severe or this constant ever. Would go months between any kind of headache and it would always be mild and in the front of the head.   Have since tried Topamax with no improvement to symptoms. Have had two right greater occipital nerve blocks with no improvement to symptoms. Have been going to physical therapy for two months with little improvement to symptoms. Have to take high doses of daily ibuprofen to take away pain of continuing daily headaches. Still working with neurologist to make a treatment plan for the new diagnosis.   I am submitting this report due to new medical symptoms occurring after my covid-19 shot reported on my vsafe check in. I received a call saying I needed to fill this out to report the health problems I am experiencing.
Approximately 8 hours after the vaccine, I had headache and weakness. The next morning at 8 a.m. the weakness returned that afternoon at about 1130 a.m. the weakness returned.
THE PATIENT WAS GIVEN A MONOVALENT DOSE AS A BOOSTER INSTEAD OF THE BIVALENT BOOSTER. THE PATIENT DID NOT REPORT ANY ADVERSE REACTION. WE DISCUSSED THE NEED FOR THE PATIENT TO RETURN IN 2 MONTHS TO GET THE BIVALENT BOOSTER.
Itchiness on left arm continues to this day (04Oct2021); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Jun2021 (Lot number: EW01716) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]. Vaccination history included: Bnt162b2 (Dose 1, lot number EW0176, vaccine location Left arm), administration date: 15May2021, for Covid-19 immunization.  The following information was reported: PRURITUS (non-serious) with onset 2021, outcome "not recovered", described as "Itchiness on left arm continues to this day (04Oct2021)". Therapeutic measures were not taken as a result of pruritus.  Additional information: The patient was not pregnant at the time of vaccination. Prior to vaccination, was not diagnosed with COVID-19. The patient does not have any known allergies.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received albuterol within 2 weeks of vaccination.  Since the vaccination, Patient was not tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Was given injection on 7/6/11. Developed swelling left side collar bone on 7/8/11 AM.
Initially patient stated hands and feet both felt hot and itchy, palms were red and warm to touch by HCP. Within a few minutes entire skin red & warm, bulbar conjunctiva also red. No distinguish-able hives (pt is naturaly dark skinned). Pt felt increasingly uncomfortable: itchy, restless and heachachy.  Vital signs were stable with BP 106/72. No signs of respiratory distress was noted at anytime.  Cool compressers were applied, pt. resting on pillow.  Mother noted mild edema behind child's ears.  At 5:45 Benadryl P0 60mg was given (1mg/kg dose, pt= 132lbs).  Within 20 minutes pt was much improved, redness dimished, child happy & talkative.  Advise to go to Hospital for further observation.  An additional dose of Benadryl was given/no other Tx.
Covid vaccine administered beyond expiration date. No symptoms or adverse reactions noted at the time of administration. Reported to supervisor and patient.
after 5 months of receiving the vaccine he got a real bad stiff neck and Shingles and Belles Palsy
Client immediately "felt like a ball was rolling up my neck, left side of face, throat pain, runny nose and trouble swallowing." She denies SOB or any breathing difficulties. 1/5/21 Seen in urgent care and dx with sinus infection. Given Amoxicillin for 10 day. Runny  nose continued. Seen in urgent care on 1/23/21 and started on doxycycline and prednisone. Says today is the first day she has felt better. She was due for her 2nd vaccine today but is  not going to take it.
No symptoms reported; patient received 4 doses of GARDASIL 9; This spontaneous report was received from a nurse referring to a patient of unknown age.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.  On 17-AUG-2021, the patient was vaccinated with a 4th dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, lot # T027778, expiring on 27-FEB-2023, 0.5 milliliter dose, intramuscular for prophylaxis (extra dose administered). No adverse event were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T027778; expirationdate: 27-FEB-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Moderna on 1/29 and 2/23. Positive on 8/14 admitted on 8/14-current
Breakthrough case admission after 2 Janssen Janssen 5/12/21 Lot# 206A21A;  Janssen 12/2/21 Lot# 213D21A
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Fever, arm pain and stiffness, nausea, states "I felt like I was in a fog", chills
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 21-AUG-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml as prophylaxis (lot # S036821 with expiration date 21-APR-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Pt experienced hives on arm of injection with first dose of Moderna COVID-19 vaccine and confusion and hives on lumbar area with second dose of Moderna COVID-19 vaccine. Pt reports some relief with antihistamine
Calves of both my legs cramped up really bad as if I tore my muscles or something; felt tenderness in my left hip area and on opposite arm of the shot; felt tenderness in my left hip area and on opposite arm of the shot; There was random yellow bruising on my arms but they were small; migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 (Lot number: Fh8028) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MUSCLE SPASMS (non-serious) with onset 2022, outcome "recovered with sequelae", described as "Calves of both my legs cramped up really bad as if I tore my muscles or something"; TENDERNESS (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 2022, outcome "recovered with sequelae" and all described as "felt tenderness in my left hip area and on opposite arm of the shot"; CONTUSION (non-serious) with onset 2022, outcome "recovered with sequelae", described as "There was random yellow bruising on my arms but they were small"; MIGRAINE (non-serious) with onset 2022, outcome "recovered with sequelae", described as "migraine". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of muscle spasms, tenderness, pain in extremity, contusion, migraine.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Calves of both my legs cramped up really bad as if I tore my muscles or something. Also felt tenderness in my left hip area and on opposite arm of the shot. It lasted about four days. There was random yellow bruising on my arms but they were small. Had a massive migraine as well. No Prior to vaccination, was the patient diagnosed with COVID-19. Yes Since the vaccination, has the patient been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Fever to 101.3, started 28 hours post injection, duration 6 hours.
Information has been received from a registered nurse concerning a 75 year old female who was vaccinated on 28-SEP-2006 with a dose of Pneumovax 23. On 28-SEP-2006, within 3-4 hours post-vaccination, the patient experienced severe pain in the injection arm, from the shoulder to the forearm, and chills. The nurse reported that the patient's chattering teeth caused her to bite the inside of her mouth. The patient sought unspecified medical treatment. The patient's severe arm pain lasted approximately 24 hours. Subsequently, the patient improved "on therapy," and was reported as recovering. It was also reported that in 1995 the patient was vaccinated with a dose of Pneumovax 23 "with no problem." Additional information has been requested.
Feeling weird; Head was hurting; Called out sick; This is a spontaneous report from a contactable consumer (patient's co-worker). A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced feeling weird, head was hurting and called out sick. It was reported that caller mentioned that she also had a coworker that was feeling weird and called out sick after the COVID vaccine. The patient's head was hurting, but she was fine after. The outcome of event head was hurting was recovered on an unspecified date whereas the outcome of events feeling weird and called out sick was unknown.  Information on the Lot/Batch number has been requested.
Patient states arm was sore and got red, now 6 days later is still warm to the touch and red from injection site to 2 inches above elbow.
Patient presented with redness, swelling, pain on the Left arm below the deltoid muscle where the vaccine was given. The redness is approx. 4 in x 2 in on an angle.
Redness at site of injection, patient began to itch, redness noted on side of neck and on bottom of leg that shot was administered. Pt was given 25 mg Benadryl IM. Itching stopped and redness did not worsen.
Pt presented to office today with 2 inch in diameter reddened, firm area at immunization site on (R) thigh; Received PREVNAR 11/30/15; Reddened area began 12/21/15 and low grade temp 1130/15 x 24 hours, none since.
Pt recvd a series of 3 Engerix-B vax on unspecified dates for prevention of Hep B & was tested @ one & seven wks post last dose of failed to seroconvert;
This booster had an additional side effect.  Pain in the arm pit.; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient.   A 62-year-old female patient (not pregnant) received bnt162b2 (BNT162B2, solution for injection), administration date 12Nov2021 at 16:30 (Batch/Lot number: unknown) at the age of 62 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history included Thyroid cancer (unspecified if ongoing). Concomitant medication(s) included FLU taken for immunization, administration date 15Oct2021. Vaccination history included Bnt162b2, dose 1 for COVID-19 immunization; Bnt162b2, dose 2 for COVID-19 immunization. The following information was reported IMMUNISATION (non-serious) with onset 12Nov2021 16:30, outcome unknown; AXILLARY PAIN (non-serious) with onset 13Nov2021, outcome recovering. Therapeutic measures were not taken as a result of axillary pain. The patient had adverse events normal side effects, but this booster had an additional side effect. Pain in the arm pit. Adverse event start date was on 13Nov2021. The patient has not had treatment AE. The patient has not had tested covid post vaccination. The patient had no known allergies.  Follow-up attempts completed. No further information is expected.
A few days after receiving my second dose of the covid vaccine my left shoulder and trapezius went numb and tingly. I was I between jobs and had no health insurance and had no primary care doctor. My herpes zoster flare ups became way worse but my new primary won't listen to me. Now I've been having heart palpitations, extreme digestive issues and chest pains day after day. A heart attack like event but blood tests were negative for an actual heart attack. X-rays have shown severe degeneration in my neck after I tore my trapezius because I lost all sensation. The trapezius tear came after the numb sensation after I got my second Moderna covid vaccine.
Vaccine placed right upper arm on 10/12/04, swelling, redness and pain started on 10/13/04. Pt seen on 10/14/04 with hot, tensely swollen right upper arm and edema to hand, papule at injection site. Started on Keflex, cool compresses and re-eval 10/15/04 with decreased pain, swelling and redness.
Patient received booster dose of COVID vaccine are receiving moderna as first 2 doses.; Patient received booster dose of COVID vaccine are receiving moderna as first 2 doses.; Patient received booster dose of COVID vaccine are receiving moderna as first 2 doses.; feeling of needing to run or grind her teeth; rapid heart rate; high blood pressure; feeling of needing to run or grind her teeth; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 (Patient received 1st and 2nd dose of Moderna.), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), IMMUNISATION (non-serious), outcome "unknown" and all described as "Patient received booster dose of COVID vaccine are receiving moderna as first 2 doses."; BRUXISM (non-serious), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "feeling of needing to run or grind her teeth"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "rapid heart rate"; HYPERTENSION (non-serious), outcome "unknown", described as "high blood pressure".  The lot number for bnt162b2 was not provided and will be requested during follow up.
pneumonia; whooping cough; I was sick for 6 months.; This case was reported by a consumer via interactive digital media and described the occurrence of pneumonia in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced pneumonia (serious criteria GSK medically significant), whooping cough (serious criteria GSK medically significant) and sickness. On an unknown date, the outcome of the pneumonia, whooping cough and sickness were recovered/resolved.   It was unknown if the reporter considered the pneumonia, whooping cough and sickness to be related to Flu vaccine.  Additional Information: GSK Receipt Date: 18-JUL-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient got whooping cough and pneumonia the last time when he/she got a flu shot. The patient was sick for 6 months. The reporter stated that no more flu shots for him/her. Follow-up would not possible as no contact details were available.