chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive, notes: positive test two days after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Recurrence of Covid symptoms and positive test two days after negative test. No other medication in 2weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
c/o dizziness, heaviness in chest, cough 2 hrs p/immun slight hives started p/this; t99.2, P90, BP 150/100; on nasal 02; Seen in ER & given DPH; Referred for allergy work up by MD;
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 67-year-old female 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) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no treatment drugs and concomitant drugs are not provided.
1 day post-vax2 :8:00am-7:00pm: fatigue, muscle soreness, all over body aches, chills, slight headache (Tylenol cured headache). All resolved by 10:00 pm that day. 7 days post-vax2 : 7:00am -both hips felt like they would not hold my body up. Stretched, and seems okay 4 hrs later. 7:00am- headache, took Tylenol, mild headache remaining. 7:00am-currently 11:15am, still have the feeling of a jammed finger joint (left hand, middle finger)(no trauma to hand) Only symptoms remaining: hip pains, finger joint pain.
Intense local redness & swelling; persistent pain p/3-4 wks; On long term Coumadin therapy but does not have a hemantoma @ the site;
no adverse effects reported; inadvertent concomitant administration of PROQUAD and VARIVAX; This spontaneous report was received from a nurse and refers to a 12-month-old patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 25-OCT-2023, the patient was inadvertent vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #W039697, expiration date: 13-DEC-2024 (strength, and route of administration were not provided); concomitantly with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, lot #X013911, expiration date: 10-NOV-2024 (strength, and route of administration were not provided) both administered for prophylaxis (accidental overdose). The patient experienced no adverse effects reported.
Within 10 hours after injection, the left shoulder was extremely sore. I couldn't lift my left arm without assistance from my right hand. I described it feeling like the arm was broken.  Within a couple days, the intensity of the pain decreased, but I felt consistent pain with a limited range of motion of my left arm. (Examples: Extreme pain was felt when trying to get dressed/undressed each day. I couldn't reach the driver's side seatbelt with my left hand.) After six months, the range of motion and the pain were getting worse (I couldn't reach the dishes on the 6' shelf in our kitchen.) By that time, my husband convinced me to contact my physician. My PCP referred me to physical therapy.
Hematocrit was high; Blood pressure is higher; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 51 year-old female patient received bnt162b2 (BNT162B2), administration date 20Mar2021 (Lot number: EP7534, Expiration Date: 30Jun2021) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, single dose, Lot: EN6203), administration date: 25Feb2021, for COVID-19 Immunization. The following information was reported: HAEMATOCRIT INCREASED (non-serious), outcome "unknown", described as "Hematocrit was high"; HYPERTENSION (non-serious), outcome "unknown", described as "Blood pressure is higher". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Patient arm was sore and painful. Developed cellulitis 10-12cm on left arm around bicep. Went to urgent care and prescribed Doxycyline. Received vaccines on 10/25/19. Developed soreness and inflammation on 10/28/19 and diagnosed as cellulitis.
WITHIN 24 HOURS OF INJECTION PATIENT'S MOM CALLED IN STATING SITE WAS RED, RAISED, AND WARM TO TOUCH APPROXIMATELY THE SIZE OF A QUARTER.  MOM WAS ADVISED TO GIVE CHILD BENADRYL AND APPLY COOL COMPRESS TO AREA.  AT APPROX 36 HOURS THE SIZE OF THE REDNESS GREW TO 2 1/2" HIGH BY 2 1/6" WIDE AS MEASURED IN THE OFFICE BY DR.  MOM DID STATE THAT SHE DID NOT GIVE CHILD BENADRYL AS INSTRUCTED.  PATIENT WAS DIAGNOSED WITH CELLULITIS AND PLACED ON CLINDAMYCIN FOR 10 DAYS.  THE FOLLOWING DAY MOM DID REPORT A REDUCE IN THE SIZE OF THE REDNESS TO APPROXIMATLY THAT OF A HALF DOLLAR.  MOM ALSO STATED SHE DID NOT GIVE THE PATIENT THE ANTIBOTICS.
Client reports feeling tightness in throat.  Client denies difficulty and swelling of tongue.  Fire Rescue at scent to assess the client.  Vitals wnl.  Per fire rescue, no further examination needed.  Client released at 9:48am.  Client declined transport to ER for further assessment.
Fever; joint pain; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), ARTHRALGIA (joint pain), HEADACHE (headache) and NAUSEA (nausea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No meds no allergies.     On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Nov-2021, the patient experienced PYREXIA (Fever), ARTHRALGIA (joint pain), HEADACHE (headache) and NAUSEA (nausea). On 30-Nov-2021, PYREXIA (Fever), ARTHRALGIA (joint pain), HEADACHE (headache) and NAUSEA (nausea) had not resolved.            No concomitant medications were reported.  Treatment medications were not provided by the reporter.
He received a Covid-19 booster vaccine from pharmacy on 1/26/22 in his left arm.  A couple of weeks later he developed a protruberance from the injection site which would bleed periodically, at times profusely.  He was seen in our office on 3/2/22 because the lesion was scraped during a LaCrosse game and bled profusely. The injection site appeared to be significantly below his left deltoid muscle.  He was diagnosed with a pyogenic granuloma, silver nitrate was applied extensively and a compression bandage was applied.  On 3/7/22 he returned to our office because the granuloma had grown larger and was continuing to bleed.  He was referred to Dermatology.
This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient tested positive for Covid-19 after 2nd booster.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049L21A, 040C21A, 01M20A and 02L20A) for COVID-19 vaccination. No Medical History information was reported. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jul-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Patient tested positive for Covid-19 after 2nd booster). At the time of the report, COVID-19 (Patient tested positive for Covid-19 after 2nd booster) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jul-2022, SARS-CoV-2 test: (Positive) Positive. No concomitant medications were reported. Dose of first and second dose was reported as full. It was unknown if the AE caused patient to seek medical care. Patient had not experienced a similar event in the past. No treatment drugs were reported. Patient would like to schedule 3rd booster with Moderna. Since patient had Covid, wanted to know how long should patient wait before getting the new Moderna Covid-19 booster. Company Comment: This is an spontaneous case concerning a 76-years-old female patient with NO medical history reported who experienced the unexpected AESI of COVID-19, 40 days after the 4th. dose of mRNA-1273 vaccine. On 6-Jul-2022, SARS-CoV-2 test Positive. Also, as there were more than 35 days between first two doses, Inappropriate schedule of vaccine administration was noted in this case. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed based on medical judgement. This case was linked to MOD-2022-646999 (Patient Link). Sender's Comments: Company Comment:    This is an spontaneous case concerning a 76-years-old female patient with NO medical history reported who experienced the unexpected AESI of COVID-19, 40 days after the 4th. dose of mRNA-1273 vaccine. On 6-Jul-2022, SARS-CoV-2 test Positive. Also, as there were more than 35 days between first two doses, Inappropriate schedule of vaccine administration was noted in this case. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.
Patient received both Prevnar20 and Spikevax on the same day, each in a different arm.  He approached our pharmacy 3 days later and showed me his arms.  He had what appeared to be injection site reactions on both arms (redness approximately 3-4 inches in diameter, itching, and slightly warm over the area).   He did state that each arm looked a little less red than the previous day.  I advised patient to call his doctor's office and explain to them what was happening.  The patient did state that he would follow up with his doctor office
PAINFUL SWELLING OF THE LEFT DELTOID/ARM STARTING 3-4 DAYS AFTER SHOT: 24 MARCH 2021.   PROGRESSIVELY WORSE DESPITE MEDROL DOSEPAK TYLENOL
after shot she felt that shot is went down in her finger; tingling sensation in left hand fingers; feeling like pricking needle in her hand sometime in feet; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (after shot she felt that shot is went down in her finger), PARAESTHESIA (tingling sensation in left hand fingers) and PARAESTHESIA (feeling like pricking needle in her hand sometime in feet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE DISCOMFORT (after shot she felt that shot is went down in her finger), PARAESTHESIA (tingling sensation in left hand fingers) and PARAESTHESIA (feeling like pricking needle in her hand sometime in feet). At the time of the report, VACCINATION SITE DISCOMFORT (after shot she felt that shot is went down in her finger) and PARAESTHESIA (tingling sensation in left hand fingers) had resolved and PARAESTHESIA (feeling like pricking needle in her hand sometime in feet) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Left leg and knee swelling.  No fever.  Able to bear weight.  No LAD. Recovered by next morning 07/10/2003.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 13Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 24 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mild exercise induced asthma" (unspecified if ongoing), notes: Mild exercise induced asthma. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
injection site is itching; red, blotchy; raised spot, silver dollar size; warm to the touch; some pain on the injection site for 3 days; A spontaneous report was  received from a consumer who was 41 years old female patient   who received Moderna's COVID-19 vaccine and experienced  pain on the injection site for 3 days and then  the injection site is itching, red, blotchy, raised spot Silver dollar size , and warm to the touch.  Patient's medical history  and concomitant medication list was not available.  On 11-JAN-2021 she received   first dose of Moderna's COVID-19 vaccine in the deltoid muscle of the right arm.She had some pain on the injection site for 3 days. On 20JAN2021 she noticed that the injection site is itching, red, blotchy, raised spot Silver dollar size , and warm to the touch.  Treatment actions was unknown .  Action taken with mRNA-1273 was not reported.  The outcome of the events, pain on the injection site for 3 days was recovered/resolved and   the injection site is itching, red, blotchy, raised spot Silver dollar size , and warm to the touch was unknown.  Based comment, all events (Reported causality missing, add Not reported. Determined causality missing, add possible.
Chills; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9261, NDC number, UPC and expiry date unknown), via an unspecified route of administration on 22Jan2021 (at the age of 51-year-old) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included hyperthyroidism, thyroid disorder both from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine taken for thyroid disorder; esomeprazole magnesium (NEXIUM MUPS) taken for an unspecified indication and multivitamins taken for an unspecified indication, all start and stop date were not reported. It was reported that last night (on 04Feb2021), the patient got chills and body aches, she was just wondering if that was something that happened, after 2 weeks just wondering. Patient took some Tylenol for the events. The patient underwent unspecified lab test in Dec2020 with unknown results, but she did not have anything wrong with her. Events resolved in Feb2021. Investigation assessment was performed.  Follow-up attempts are completed. No further information is expected.
Flu shot received on 10/24/06 at 1:45PM. At approximately  6:00 PM began severe throat pain, swelling of the lips and mouth area, reddening and tearing of the eyes. Constricted breathing. Taken to emergency room and treated and released after 3 hours. Steroid treatments followed and symptoms went way after approximately 48 hours.
Lower back, painful spasm. Happened between tying left shoe and tying right shoe laces. Could not move until 1 hour after taking cyclobenzaprine 10 mg. Could not go to work all day. Still suffering spasms if cyclobenzaprine not taken.
severe hyperthyroidism; Ultrasound showed nodules in the thyroid with dysrygulated thyroid hormones, diagnosed as subacute thyroiditis; hyper inflammation; This is a spontaneous report from a contactable other health professional (patient). A 42-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 09Feb2021 16:45 at the age of 42 years old (Lot Number: EN6201) as 2nd dose, single for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 in left arm (lot number: EL9261) on 08Jan2021 08:00 at the age of 42 years old for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. The patient developed severe hyperthyroidism post 3 weeks of 2nd dose of infection. On 15Mar2021, Ultrasound showed nodules in the thyroid with dysrygulated thyroid hormones, diagnosed as subacute thyroiditis. The patient believed hyper inflammation due to vaccination damaged her thyroid resulting in excess production of thyroid hormones. He had never faced such symptoms before and neither this was in his family history. Date of start of reaction/events was 15Mar2021 20:00. The adverse events result in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included Prednisone to suppress the symptoms. The reported considered the report as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported severe hyperthyroidism post 3 weeks of 2nd dose of infection (subacute thyroiditis) and the administration of the suspect, COVID19 vaccine, BNT162B2, based on the reasonable temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
Consumer also mentioned someone who also received the vaccine who cannot lift her arm afterwards.; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Consumer also mentioned someone (patient) who also received the vaccine who cannot lift her arm afterwards on an unspecified date with outcome of unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Developed hives all over neck and arms approximately 4 hours after the shot.  Benadryl was administered and the hives subsided.  They returned the next day and were treated again with Benadryl
Patient stated about an hour after the injection she stated feeling dizzy, nauseous, headache, and fatigue for about 2 days. Also at the site of injection it swelled up to about baseball size, red and very hard. There was one blister at the injection site. Today, 5/15/17, it was about the size of a golf ball.
pt recvd vax & had fever; pt was crying, lethargy, jerking; t 104 & taken to ER;
I am a teacher and was in class teaching on September 29, when I began having numbness and tingling on the my right side of my face and my entire right arm. the numbness lasted for 4 -5 minutes. It subsided for about 8-10 minutes after which I experienced a second, stronger numbness sensation. This event lasted about 5 - 7 minutes.   Believing it might be a stroke I went to the school nurse. I was then transported to the local hospital ER for evaluation.  The symptoms indicated it might be a stroke so I was rushed in and was given a CT scan, MRI and MRA.
Patient is a 46 year old male who admitted to hospital for Facial nerve palsy. Patient felt with left sided facial droop and tingling sensation for 2 days. He reported symptoms onset at 1330 on 6/10/2021 while driving a truck. He also had left sided occipital headache and rested for 1 hour. His symptoms improved after the nap but never resolved completely. He got into a location and rested there for 1 night. In the morning after waking up he was having difficulty chewing food on his left side. He called EMS and was brought to hospital. While in the ED, he received workup including CT Head W/O, CTA Head/Neck with perfusion scan that were all negative. Other labs obtained included BMP, CBC, Troponin x1, Coag studies & CXR which were largely unremarkable. Neurology were called for stroke alert and given ASA 325mg and ordered MRI. Patient's MRI was unremarkable for stroke or masses. He was started on Prednisone 40mg once daily for Facial Nerve Palsy. He was seen by physical therapy and occupational therapy, they recommended him go home to family. His symptoms improved after therapies were initiated but are not completely resolved. Patient will continue taking his home medications per his primary care doctor. He will complete a 7 day steroid course, has 3 days remaining. He will take Acyclovir 5 times per day for 10 days. We also gave him lubricating eye drops since he continues to have difficulty closing his left eye.  He spends a lot of time outdoors and works with horses. He reports getting tick bites before in his body but never noticed a rashes. He has never received treatment for Lyme Disease. He is a long-haul truck driver and has driven all around. He reports walking in wooded areas when he stops in the rest area. We obtained Lyme Titers, which were eqivocal for IgM and negative for IgG. Western blot was ordered to rule out Lyme disease. He should followup with PCP for treatment if he is positive. We will call him with results when available.   Of note he received Pfizer 2nd COVID vaccine on 6/9/21 (LOT #EW0178). He reported fever and diarrhea that night and next morning. He then reports having presenting symptoms after 7 hours of driving. We also believe the cause of his facial nerve paralysis could have been a side effect of his vaccination.