chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via a company representative concerning an 81 year old female patient with diabetes. On 19-OCT-2012 the patient was vaccinated with ZOSTAVAX (dose and route not provided) (Lot # reported as 03638AE; expiration date: 06-MAR-2013) to prevent shingles. Concomitant therapies included gabapentin (manufacturer unknown0. The patient went to the emergency room with pain along her ribcage that extended from her front to back (onset of the event was on 21-JAN-2014). Field employee stated the patient did not develop any lesions, but the physician mentioned she believed the patient had shingles. The patient was treated with FAMVIR. On an unspecified date, a CT scan and blood work were performed, the results were not provided. The patient's outcome was unknown. Additional information has been requested.
Left armpit lymph nodes swelling; Left armpit lymph nodes itching; Whole armpit very painful; injection site was tender to the touch; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Jan-2021 and was forwarded to the company on 20-Jan-2021.    This spontaneous case was reported by a nurse and describes the occurrence of LYMPHADENOPATHY (Left armpit lymph nodes swelling), PRURITUS (Left armpit lymph nodes itching), AXILLARY PAIN (Whole armpit very painful) and INJECTION SITE PAIN (injection site was tender to the touch) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concurrent medical conditions included Latex allergy.    On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 11-Jan-2021, the patient experienced AXILLARY PAIN (Whole armpit very painful) and INJECTION SITE PAIN (injection site was tender to the touch). On 12-Jan-2021, the patient experienced LYMPHADENOPATHY (Left armpit lymph nodes swelling) and PRURITUS (Left armpit lymph nodes itching). On 13-Jan-2021, INJECTION SITE PAIN (injection site was tender to the touch) had resolved. At the time of the report, LYMPHADENOPATHY (Left armpit lymph nodes swelling), PRURITUS (Left armpit lymph nodes itching) and AXILLARY PAIN (Whole armpit very painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment include Benadryl.  Patient taking PCOS medications for latex allergy.   Reporter did not allow further contact
extreme soreness, swelling into a hard, red lump with some bruising, and extreme itchiness.  It is now 10 days later, and the bruising is faint, no soreness, but the itchiness is still there.
Noticed that eyelashes were totally gone and at eye exam February 23, 2012 asked doctor about what she thought may have caused it. Told it could be possibly allergy related or that rubbing the eyes could make them fall out.  Went to doctor in March 2012 about eyelashes and the fact that one eyebrow had started to fall out as well.  Took her for bloodwork to check for thyroid issues which was negative and we were told that if it got worse to call.  By the end of the week the eyebrow was totally gone and the other eyebrow had started to fall out.  Called Dr. back and was immediately referred to Dermatologist.  Saw dermatologist in April 2012 and he also ordered more bloodwork to screen for vitamin deficiencies or any auto-immune disorders/diseases.  Also started her on Protopic topical gel twice daily as an attempt to stimulate hair growth.  Went back to Dr. for a check up in June 2012 and both eyebrows were gone at this point.  Bloodwork was normal, only abnormality was her akaline phosphatase which the pediatrician said was from her growing and not to worry about it.  At this appointment I asked dermatologist specifically if the Gardasil vaccine could have cause this reaction.  He stated that he didn't think so, however, he also stated that he is not a "medical maintenance" physician and only practices dermatology.  In our research to see if there have been any additional cases of hair loss related to Gardasil, we have found that there are others who have had the same experience that we are having and that their children are also misdiagnosed as having alopecia areata.  This began 3-4 months after the third Gardasil vaccine which is exactly what is being reported by others and in each case all of the children were healthy and had normal bloodwork during the course of this reaction.
2 Large Areas of redness and inflammation around area of injection site. Site was warm to touch. Patient was recommended to go and see PCP after leaving pharmacy.
Fever, chills, headache, nausea, weakness in extremity that had injection, neck and arm pain. Persisting into day 7 s/p injection. Onset was 4 hours s/p injection 1 week prior to this visit.
Flu like symptoms intensified; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms intensified) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M10A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms intensified). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms intensified) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that side effects had intensified on 7-FEB-2021.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow up received on 23 April 2021 Patient Initial corrected.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
"Pfizer-BioNTech Covid-19 Vaccine EUA" Severe Soar Arm  Pain In The Injection Area Fever Of 102.3 started at around 2 A.M
IMPORTANT: This may be a waste of time, symptoms appeared 2.5 days after vaccine, perhaps shot not in system long enough to protect me.  Believe to have long Covid am sleeping longer and napping often through today and until?
Patient is experiencing redness and itching from her shoulder to elbow. It presented 2 days after the vaccine was given and started at the injection site. There was more swelling than redness for the day or two. By day 4 after administration, the swelling had decreased and redness was moving down her arm. By day 6, the swelling was all but gone, but the redness is now approaching her elbow. It has been itching all throughout the present symptoms. We advised her to start diphenhydramine 25mg every 4-6 hours as needed for itching starting on day 4. Patient reports this has helped tremendously and has maintained that therapy until day 6 (date of reporting). She will continue it until all the redness and itching stops.
Headache; This is a spontaneous report from non-contactable other healthcare professional. A 70-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the left deltoid muscle on 16Mar2021 (at the age of 70-year-old), as single dose for COVID-19 immunisation. Medical history included previous reactions of anaphylaxis to an unspecified eye gtt as a teenager. Concomitant medications were not reported. On 16May2021, the patient experienced headache during her 30-minute waiting period after the injection. Therapeutic measures were taken as a result of headache and included treatment with Tylenol, observation and snacks. The follow up response to treatment was excellent and the patient was stable to go home and follow up with PCP. The clinical outcome of headache was unknown.   No follow-up attempts are needed. No further information is expected.
Patient gradually developed a dry cough and complains of some throat tightness. States she does not feel that throat is "closing" but rather that it is related to the coughing. Patient asked to remove mask and was given warm water to drink per patient request. RN notes some mild lung congestion upon auscultation but otherwise clear lung sounds. Patient states it feels similar to asthma related symptoms and states she hasn't been taking her seasonal allergy meds regularly and also that she has had a lot of life event stress with deaths in family. Patient requests benadryl stating that whenever she has asthma symptoms her "inhaler doesn't work but Benadryl always does".  RN gives 25mg of liquid benadryl to patient. Approximately 3 minutes post-benadryl administration, patient cough decreases and continues to decrease over the next 10-15 minutes of sitting in observation area. VS WNL. Patient is able to talk without coughing. Patient, who is an RN, states that she is feeling better and she wants to go home. Patient states that she will call her family and let them know she is on the way home. Patient knows to call 911 if symptoms return/worsen. Patient states she will let her doctor know and check in about whether she needs new inhaler prescription. Family member waiting at home for patient. Patient stable and not coughing and states she feels "a lot better" as she is leaving facility.
pt arrived to receive 2nd dose. Information on IR from out of country was easy to misinterpret. Greeter/screener checked information of first dose, but misread information as 4 weeks prior. Pt had actually received 1st dose 7/1/21 (3 weeks prior to 2nd shot). Error recognized after vaccine administration. Called on-call provider to discuss, informed pt of administration error and unknown efficacy of immunity compared to receiving 2nd dose at recommended day 28. Pt verbalized understanding, stating the provider in Japan told her to receive 2nd shot 3 weeks after 1st. No adverse reaction observed during 15 minute obs period.
PATIENT RECEIVED MODERNA VACCINE ( LOT # 016C21A) ON 7 MAY 2021.  PATIENT WAS NOT SCREENED CORRECTLY AND RECEIVED PFIZER VACCINE AS 2ND DOSE.  NO ADVERSE REACTIONS NOTED.
Information has been received from a nurse practitioner concerning a 25 year old female with no medical history and no drug allergies, who on 06-JUN-2007 was vaccinated with a first dose of Gardasil (Lot# 658094/0524U). Subsequently, the patient developed local irritation. Concomitant therapy included "creatine" (CREATINE POWDER), "glutamine", "omnijust", and omeprazole (PRILOSEC). On 07-AUG-2007 the patient was vaccinated intramuscularly with a 0.5 mL second dose of Gardasil. On 07-AUG-2007 eight and a half hours after receiving the vaccination the patient developed hives and experienced difficulty breathing. The reaction occurred while she was running outdoors. The patient went to the emergency room and was released after being treated intravenously with diphenhydramine hydrochloride (BENADRYL). The patient recovered on an unspecified date. No product quality complaint was involved. The patient's difficulty breathing was considered to be life threatening. Additional information has been requested.
no additional AE; Vaqta was reported to have been administered post temperature excursion; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 13-OCT-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) at a dose of 0.5 m, lot # T013546 confirmed to be a valid lot #, expiration date 28-OCT-2021 for prophylaxis (strength, dose #, route of administration and anatomical location were not provided). The temperature excursion was as follows: 1.1 Celsius degree for 1 hour 23 minutes and 1.4 Celsius degrees for 30 minutes. There were no previous excursions reported. The digital data logger was not involved. No additional adverse events reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: T013546; expirationdate: 28-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
fainted three minutes after the first shot; Doctor got really sick after the second shot of the Moderna Vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted three minutes after the first shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 100 mcg. and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 60 mcg. On an unknown date, the patient experienced SYNCOPE (fainted three minutes after the first shot) (seriousness criterion medically significant) and ILLNESS (Doctor got really sick after the second shot of the Moderna Vaccine). At the time of the report, SYNCOPE (fainted three minutes after the first shot) and ILLNESS (Doctor got really sick after the second shot of the Moderna Vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Blood test: igg antibodies present (normal) IgG antibodies were present.         Concomitant medications were not provided.  Treatment information was not provided.  Patient stated that she never got sick as she never took second shot. She stated Moderna dose was too high and she should had to robust protection with moderna vaccine as she read it was 80% effective. Patient was asking advise.  This case concerns an adult patient of unknown age and gender with a serious unexpected event of syncope, and nonserious illness. Syncope latency 3 minutes after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow-up information received contains, New event and Co-suspect drug added. Lab details added conservatively as per the SD.; Sender's Comments: This case concerns an adult patient of unknown age and gender with a serious unexpected event of syncope, and nonserious illness. Syncope latency 3 minutes after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient passed out and fell after receiving Meningitis, GARDASIL and Hepatitis vaccines. Patient broke two teeth during her fall.
Information has been received from a medical assistant concerning several patients who have experienced rashes and local injection site reactions. Unspecified medical attention was sought. No further information is available.
Shortness of breath, pleuritic R lower chest pain since 6/15. Was seen in ED on 6/16 and diagnosed with right lower lobe pulmonary embolism. Then had OCP discontinued, and was started on Xarelto for anticoagulation treatment. Was discharged from ED 6/16. Returned to clnic on 6/17 and still having symptoms of pleuritic chest pain of right lower chest, however does not have SOB or dyspnea on exertion.
Hives & a little fever 1-2 days p/3rd dose of vax; self medicated self w/DPH; bitten on the hand by stray cat; receipt dates 2NOV92, 5NOV92 & 9NOV92;
received Pfizer's COVID vaccine on 04 Feb 2021 and tested positive with COVID on 08 Feb 2021; This is a spontaneous report from a contactable pharmacist.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown; Expiration Date: Unknown) via an unspecified route of administration on 04Feb2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received pfizer's COVID vaccine on 04Feb2021 and tested positive with COVID on 08Feb2021. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 08Feb2021. The outcome of event was unknown.  Information regarding lot/batch has been requested.
me too had guillian barre; Initial information received on 24-Dec-2022 regarding an unsolicited valid Social Media serious case received via consumer.  This case involves Adult and unknown gender patient who stated me too had guillian barre after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, batch lot number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient had an event of me too had guillian barre (guillain-barre syndrome) (unknown latency) following the administration of influenza vaccine.   Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: unknown.  Seriousness Criteria: This event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 28-Dec-2022: This case involves Adult and unknown gender patient who stated me too had guillian barre after receiving influenza vaccine. The clinical course of the event was not provided. Furthermore, information regarding latency to onset, condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Pt recvd vax & exp extremely painful react @ the inject sitte; core antibody was neg;
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for an unknown indication.     No Medical History information was reported.    On 31-Mar-2021 at 9:44 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 45.10    Concomitant products were not provided.   On 31-Mar-2021, Excursion time was 08 AM, temperature was 32, total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 15-Apr-2021. 18  vials were sent to clinic. Vaccine BUD date was 31-Marc-2021.   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Very quickly I began to feel nauseous and flush.  The nausea was strong and steady most of the night till around 9pm. My L arm kept falling asleep and my whole L side of my leg, I had to repeatedly move them around to wake them up. I had fever like sensations of hot and cold runny nose but no fever, and was tired. I slept fine but woke up to my menstral cycle starting 4 days early, significant joint pain and just sluggish. My hips were very painful most of today till around 2pm I took a nap and felt better. My joints still hurt but the pain is much more manageable now at 7:30pm.
couldn't get out of bed; felt as if somebody had beaten her bad; her joints are all activated (she has Rheumatoid arthritis) and they all hurt; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 17Jan2022 (Lot number: O33138A) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: she has Rheumatoid arthritis. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown, Dose Unknown, had never happened before with the previous vaccines.), for COVID-19 Immunization, reaction(s): "had never happened before with the previous vaccines.". The following information was reported: BEDRIDDEN (non-serious) with onset 18Jan2022, outcome "unknown", described as "couldn't get out of bed"; FEELING ABNORMAL (non-serious) with onset 18Jan2022, outcome "unknown", described as "felt as if somebody had beaten her bad"; ARTHRALGIA (non-serious) with onset 18Jan2022, outcome "unknown", described as "her joints are all activated (she has Rheumatoid arthritis) and they all hurt"; FATIGUE (non-serious) with onset 18Jan2022, outcome "unknown", described as "tired".  Additional information: The patient was enquired that if booster was exactly the same formulation as the previous vaccines.  No follow-up attempts are possible. No further information is expected.