chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 13 month old 21 lb. 14 oz. male who on 02-OCT-2007, received his first dose subcutaneous in his right arm of MMR II (lot # 655383/1410). Concomitant vaccines included his first subcutaneous dose of Varivax (MSD) (lot#  658017/1071U) and a first intramuscular dose of (HAVRIX) (lot# AHAV3172BA). There was no reported illness at the time of the vaccinations." One week after the immunization" on 09-OCT-2007 he developed Kawasaki disease and was seen in the physician's office. Treatment and the current status of the patient was not reported. Follow up information from a physician concerning this 13 month old male reported that on 04-OCT-2007, he developed a high fever and red eyes that progressed to rash vomiting and diarrhea. On 08-OCT-2007 he was seen, diagnosed with Kawasaki syndrome, hospitalized for 2 days and treated with intravenous immunoglobulin (IVIG). It was reported that as of 11-OCT-2007 he had recovered. Additional information is not expected.
05/28/2018 Client developed red, itchy, rash bilateral upper and lower extremities/feet/buttocks/ trunk with blood filled blisters that became painful. She has been evaluated and treated locally and at clinic who have done several biopsies of the purpura and dx client with IGA Vasculitis. Client has been on tapering prednisone doses, steroid creams. Dr started her on gabapentin for nerve pain in these areas.
erythematous papules in a cluster on left thigh with underlying erythema atopic base. Tender, hot to touch x 24 hours
patient was given PNEUMOVAX23 that was recalled; Vaccine was  incorrectly stored/Incorrect Product Storage; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 08-OCT-2020, the patient was vaccinated with incorrectly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S036495, expiration date 13-SEP-2021, 0.5 milliliter; route was not reported) that was recalled for prophylaxis (recalled product administered and product storage error). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Received shot 12-5-08.  Patient reports she noticed pain on eve of 12-05-08.  She called nurse line 12-6-08- applied cold with relief.  Called nurse line 12-7-08 - applied heat with relief.  Called doctors office 12-10-08 and we made appt to see her same day.  Site 12-10-08 @ 17:30 is warm, sis cm X 4 cm induration, erythemia central puncture lesion scabbed over.  Temp = 36.8 degrees C.  Tx= cold compress tib + prn for comfort.  Call for increased swelling & pain.
Presented with SOB; CXR with Covid PNA; admitted for Covid-19 pneumonia and acute hypoxemic respiratory failure. He was treated with dexamethasone, oxygen support, and supportive care (Vit C, Vit D3, Lovenox, Zinc). He improved clinically with treatment and was discharged home on day 5 in stable condition without oxygen supplement.
sore, heavy arm for about 2 days.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore, heavy arm for about 2 days.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore, heavy arm for about 2 days.). At the time of the report, PAIN IN EXTREMITY (sore, heavy arm for about 2 days.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-080444 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080444:dose 2
I received my first vaccine shot March 26. Got sic two weeks later after first dose; Sinus infection; I have now waited too long . What do I do now? Start over with Vaccine 1 or go ahead a; Missed 2nd dose/More than 35 days since first dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I received my first vaccine shot March 26. Got sic two weeks later after first dose), SINUSITIS (Sinus infection), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have now waited too long . What do I do now? Start over with Vaccine 1 or go ahead a) and PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose/More than 35 days since first dose) 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 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I received my first vaccine shot March 26. Got sic two weeks later after first dose), SINUSITIS (Sinus infection), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have now waited too long . What do I do now? Start over with Vaccine 1 or go ahead a) and PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose/More than 35 days since first dose). At the time of the report, ILLNESS (I received my first vaccine shot March 26. Got sic two weeks later after first dose) and SINUSITIS (Sinus infection) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have now waited too long . What do I do now? Start over with Vaccine 1 or go ahead a) and PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose/More than 35 days since first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The Patient treatment medication was included with steroids to treat sinus infection. No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up received and reporter details updated. patient demographics updated. added new events events outcome updated.
This spontaneous report was received from a pharmacist refers to a female patient of unknown age. No medical history was reported. On 03-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry, dose, route not reported). No concomitant medications were reported. On an unknown date June 2013, the patient experienced a red, raised and itchy rash about the size of a quarter around the injection site where the ZOSTAVAX was administered. Patient sought medical attention-contacted pharmacist. Varicella Zoster Virus Identification Program (VZVIP) packet faxed. The outcome of red, raised and itchy rash about the size of a quarter around the injection site was reported as not recovered. Additional information is not expected.
4 days after injection of vaccine felt awful nausea, dizzy , headache, body aches and relentless fatigue. The other stuff got better but the fatigue and dizzy/ headaches are still happening. I work out hard every day and can't even go for a walk without having crazy fatigue wash over me. I cannot work out with weights or high intensity AT ALL.. exhausted by evening and then dizziness and headache get worse in evening. Today ill be 19 days of this happening. VERY scary. I am a very active person and I can't be active I have no energy.
Pain, redness at sight. Now worsening pain, swelling, and warm on leg. Trouble walking.
Admitted to the hospital 8/28/2021 with Covid pneumonitis - cough, SOB, hypoxia. Treated with Dexamethasone (plan 6 mg qD for 5-10D), and Remdisivir.  Submitter does not have access to any further follow up information on this case. If further information is needed, please contact:  HOSPITAL -
Received injection on Monday and on Wednesday woke up with sore joints, 2nd knuckle on all fingers, both hands, sore joints at shoulders, knees and hips. Also had nausea, lightheadedness, hot and cold sweats. Symptoms lasted X 24-36 hours. Head congestion also developed.
Tingling/ burning sensation first started in toes on bilateral feet. On day 17, severe tingling/burning started on left hand.
Copper taste in mouth; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration on an unknown date in 2021 as dose 2, single for COVID-19 immunisation. Medical history included postpartum within 2 months and known allergy to penicillin (Pcn) and NSAIDs (non-steroidal anti-inflammatory drugs). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included venlafaxine hydrochloride (EFFEXOR) and unspecified multivitamins; both for an unknown indication from an unknown date and an unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient also received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG199) via an unspecified route of administration in the left arm on 09Mar2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. On an unknown date in 2021, the patient experienced copper taste in mouth within 5 minutes of vaccination, lasting up to 2 hours post vaccination. The event did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event copper taste in mouth was resolved on an unknown date of 2021.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Amendment Of vaccination information and narrative.
pt recvd vax; T 102 R by 7pm;on way to hosp,mom rpts pt was sleepy & was jerking & shaking,again later lasted 2 short time;
Above individual rec'd flu shot in (L) arm 11/1/11 at clinic and states arm became itchy the next day and a 1/4-1/2" boil developed. "Where the needle went in there's (on boil) a red circle and pus in the boil and underneath that area are a few little boils." Felt tired 2 days after flu shot; arm felt "heavy". Took a nap on Thursday 11/3/11. Felt run down. Pt. did not want to seek medical attn.
Red rash on both cheeks and lightly on arms - no complaint of itchiness or irritation. Mild fever (no higher than 99.1). Slightly swollen right cheek. No treatment given - temperature and skin tone were monitored. As of the submission of this report, it has been  4 days since noticing the rash. We plan on a doctor's visit in the next day or so.
Extreme bout of Raynaud's (primary) in right hand; This is a spontaneous report from a non-contactable consumer (patient). A 61-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in Arm Left on 04May2021 08:30 (Batch/Lot Number: EW0150) as unknown, single for covid-19 immunisation. Medical history included very occasional Raynaud's (primary) usually in chilly conditions. The patient concomitant medication was not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 04May2021 09:30, the patient experienced extreme bout of Raynaud's (primary) in right hand. The patient reported it was probably triggered by very brief visit to frozen section of grocery store. The patient reported that her fingers numb and turned dark blue (rather than the usual white) and base of thumb also turned dark blue and feeling numb. The patient drive home and applied warm water, which relieved attack. The patient stated that it was first time in 40 years she had a Raynaud's attack that has been swift and severe. The outcome of the event was recovered on unspecified date in May2021.  Information on Lot/Batch number was available. Additional information has been requested.
Immediately after injection site red & itchy increased warmth today to Lt deltoid. reddened 5"x7" area of redness Lt deltoid muscle pain with movement of arm.
Felt lightheaded, dizzy, throat slightly "closing" (2 on a scale of 1-10 of "throat closing") and dry/scratchy.  1430 VS 144/92, 99% RA, P90, RR22 Gave Benadryl 25mg at 2:40pm.  1441 VS 146/88, 97% RA, P88, RR22  PT states felt site originally felt "inflammation" on L side of throat and has now felt it on R side of throat, no longer feels on L 1450 PT reports throat feeling "going away" 1 out of 10. sitting up. feeling lightheaded but getting better 1455 VS 138/82, RR 20, 97% RA, P78 1504 VS 138/82, RR20, 98% RA, P 74 0 out of 10 sensation in throat, sat up, longer lightheaded, feeling better 1511 Went home w/ daughter, advised daughter to drive. Rest at home, seek medical attention if necessary.
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Left arm tingling 10 min post immunization. Patient recovered\r\n
Pt received FLUZONE 0.5ml IM to LA on 11/2/11. Mom called to report pt. has red, swollen, sore area at injection site. Mom instructed to give ibuprofen, BENADRYL and use cool compresses to site.
Arm is very sore, I cannot lift it; Nausea; Headache; Have feel the pain with first one, but with this one they put in the injection and I can feel the pain right away; This is a spontaneous report from a contactable consumer (patient). A 60-year-old patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date 2021, the patient felt like arm was very sore, nausea and headache for a duration of 2 days. Patient had felt pain for the first shot like that, but this one was when they put in the injection and the patient felt the pain right away. The clinical outcome of all the events was unknown.  Information on lot/batch number has been requested.  No follow-up attempts are possible. No further information is expected. The information about lot number and expiration date cannot be obtained. The case was closed for follow-up activities.
Vaccine administered 10/25/17-Pt woke w/bright red rash around injection site on 10/30/17. Applied hydrocortisone and BENADRYL to site. Rash is resolving but still present on 11/3/17. Pt reported all of this to Rph 11/3/17.
Shingles; Rash onleft, lower arm and "other parts of his body"; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number Z4359, expiry date unknown) for prophylaxis.   On 2nd August 2019, the patient received the 2nd dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced shingles and generalized rash. On an unknown date, the outcome of the shingles and generalized rash were unknown.   It was unknown if the reporter considered the shingles and generalized rash to be related to Shingrix.  Additional details were provided as follows: The patient experienced a rash on his left lower arm and other parts of his body. The reporter could not confirm if it was only a rash or if it was shingles. The reporter also could not confirm when the rash started after receiving the vaccine. The reporter consented to follow up.
administration of a booster dose or a complete dosing schedule of the Engerix-B vaccine if a patient tested negative for HepB antibodies; This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a child patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The patient received engerix B vaccine nad tested negative for Hepatitis B anibody which led to therapy non-responder.  The reporter called to request information about the administration of a booster dose or a complete dosing schedule of the Engerix-B vaccine if a patient tested negative for Hepatitis B antibodies but was vaccinated during childhood. The reporter did not consent to follow-up.
No desire to eat or drink/ No hunger/no hunger growls of stomach; No thirst; Slept most of day of vaccination and most of sat; Severe armpit pain; Running fever; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Apr2021 at 09:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included severe bilateral leg lymphedema and morbid obesity. The patient had known allergies (unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included medroxyprogesterone acetate (PROVERA); for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 at 11:00, the patient had no desire to eat or drink since shot, no hunger/no hunger growls of stomach and no thirst. On 23Apr2021, the patient slept most of day of vaccination and most of 24Apr2021. On 23Apr2021 late night, the patient got severe armpit pain and started running fever. On 25Apr2021 morning, the patient realized she had not eaten nor drank anything since 23Apr2021, was not too concerned about not eating but very concerned about not feeling thirst. The patient started making it a point to eat and drank at least minimal amounts. At the time of this report, the patient's armpit pain was a lot better so was energy. On 25Apr2021 late night, the fever broke. But the patient still had absolutely no feelings of hunger or thirst. If was not mindfully making herself consume food/h20 she would not be taking in either. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever resolved on 25Apr2021, while that severe armpit pain was resolving. The clinical outcome of event of no desire to eat or drink, no hunger/no hunger growls of stomach, no thirst and slept most of day of vaccination were not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Ball on arm, inflammation under arm like a big baseball ball,very red,hot,on same arm that he got vaccine, ball is under arm next to breast, confirmed it was armpit,ball on arm that is very inflamed; Ball on arm, inflammation under arm like a big baseball ball,very red,hot,on same arm that he got vaccine, ball is under arm next to breast, confirmed it was armpit,ball on arm that is very inflamed; Ball on arm, inflammation under arm like a big baseball ball,very red,hot,on same arm that he got vaccine, ball is under arm next to breast, confirmed it was armpit,ball on arm that is very inflamed; fever; pain; Feels so bad; This is a spontaneous report received from a contactable consumer. A male (Age: 62, unit: Unknown) patient (reporter's husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in arm on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, after first dose of vaccine he had a reaction. He has a ball on his arm, inflammation under the arm like a big baseball ball, it is very red and hot. It was on the same arm that he got the vaccine. It was also reported that he feels so bad but this was the worst symptom. She stated the ball is under the arm next to the breast and confirmed it was the armpit. She said he has fever and pain and everything but she was worried about the ball on his arm that is very inflamed and asked if it was normal. Outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
numbness & tingling of 4th & 5th digit along ulnar nerve distribution;onset uncertain, but is becoming progressively noticeable;MRI & nerve studies negative;
arm is stiff, when she moves it; arm is slightly tender; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (arm is stiff, when she moves it) and TENDERNESS (arm is slightly tender) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     Concomitant products included CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]) from 27-Apr-2021 to an unknown date, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), LEVOTHYROXINE, PRAVASTATIN and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (arm is stiff, when she moves it) and TENDERNESS (arm is slightly tender). At the time of the report, MUSCULOSKELETAL STIFFNESS (arm is stiff, when she moves it) and TENDERNESS (arm is slightly tender) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment information provided
hives all over body; This is a spontaneous report from a contactable Other Health Professional. A 4-decade old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient complained of hives all over body after 3 days later on an unspecified date. Rash disappeared a few days later. The clinical outcome of the event was recovered on an unknown date.  Information about Lot/Batch number has been requested.
Fever or Chills  Muscle or body aches  Headache  New loss of taste or smell  Congestion or running nose