chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt revd vax 15JUL93 & 20JUL93 devel flu like sx of achiness & fever of 104; sx devel over a 2 wk period into abdo cramps & dyspepsia & was hospitalized; urinary tract infect beginning 25JUL93; urologic work-up revealed urethral stricture;
Third dose of Bexsero; This case was reported by a nurse via sales rep and described the occurrence of extra dose administered in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (1st dose received in 2020) and Bexsero (2nd dose received in March 2022).   On 22nd August 2022, the patient received the 3rd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 22nd August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-AUG-2022 Reporter's comment: The patient received third dose of Bexsero vaccine. The reporter consented to follow-up. Additional Supportive Information:  The patient received third dose of Bexsero vaccine, which led to Extra dose administered.
Pt noted pain in his left shoulder worsening around Saturday which has led to difficulty sleeping and limiting his range of motion.  Pt has tried using ibuprofen with limited success.  Pt notes that vaccine seemed to have been given higher in arm than usual.  He did note the typical arm soreness for the first 2 days after injection but then the left arm worsened and continues to linger today (day 6)
tiredness; Redness at the injection site; itching at the injection site; warm to touch at the site of the injection; swelling at the site of the injection; pain at the site of the injection; feel hard at the site of the injection; swollen lymph nodes right neck; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm to touch at the site of the injection), INJECTION SITE SWELLING (swelling at the site of the injection), INJECTION SITE PAIN (pain at the site of the injection), INJECTION SITE INDURATION (feel hard at the site of the injection) and LYMPHADENOPATHY (swollen lymph nodes right neck) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced INJECTION SITE WARMTH (warm to touch at the site of the injection), INJECTION SITE SWELLING (swelling at the site of the injection), INJECTION SITE PAIN (pain at the site of the injection), INJECTION SITE INDURATION (feel hard at the site of the injection), LYMPHADENOPATHY (swollen lymph nodes right neck), INJECTION SITE ERYTHEMA (Redness at the injection site) and INJECTION SITE PRURITUS (itching at the injection site). On an unknown date, the patient experienced FATIGUE (tiredness). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form and IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, INJECTION SITE WARMTH (warm to touch at the site of the injection), INJECTION SITE SWELLING (swelling at the site of the injection), INJECTION SITE PAIN (pain at the site of the injection), INJECTION SITE INDURATION (feel hard at the site of the injection), INJECTION SITE ERYTHEMA (Redness at the injection site) and INJECTION SITE PRURITUS (itching at the injection site) had not resolved, LYMPHADENOPATHY (swollen lymph nodes right neck) had resolved and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient symptoms started on 12MAR2021 & gradually worsened. She took  Advil & Tylenol along with applying some ice pack which was helpful. Symptoms  are unchanged since taking the medication.
She came into the health department because she has developed a rash after she received a TD. TD was given at 9:45am and she developed an urticaric whelps on her arms, face chest by 5:00pm
Admission COVID PCR on 2/2 was positive. Infectious Disease was consulted and recommended Remdesivir which patient received 2/2-2/6).
Pt recvd 1st & 2nd dose of Hep B vax 11SEP91 & 13OCT91; 1 1/2 hrs following vax w/2nd dose pts lt arm became swollen, red, hot, stiff, & was burning; pt applied ice packe to arm & sx subsided w/in 48 hrs; pt recovered;
syncope; Orthostatic Intolerance; autonomic dysfunction; dizziness; fatigue; headaches; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a 14-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (exact dose, lot#, expiry date, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, the patient experienced orthostatic intolerance, autonomic dysfunction, syncope, dizziness, headache, fatigue. Reported date of injury was unspecified date in 2013. The outcome of the events was not reported. The lawyer considered all events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  Upon internal review, the event of syncope was determined to be medically significant.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Approximately three weeks after shot I came down with Bell's Palsy on 12/12/2021.
Very [paonful hip and knee and joint problems. Could not walk without a walker.  Waling is ver painful and there is always an aching. Leg muscle aches. Right leg only.  Cannot move in turning motion. not circular movement.  just gives out . Shooting pains in lleg. , Some fatigue but not a problem. Cannot drive, grocerey cart cannot be use. Must use electric cart.
Initial report received from a health care professional on 27 October 2011. An 11-month old male infant received an injection (route and site not reported) of FLUZONE, lot number UT4119AA, on 18 October 2011. The patient had a history of milk allergy. The patient's concomitant medications included ZYRTEC and BENADRYL. It was not known if the patient had any illnesses at the time of vaccination. On 19 October 2011, the next morning, the patient experienced "anaphylaxis reaction" of hives, facial swelling, and difficulty breathing. The patient was being seen as a consult for "allergic reaction" after receiving the FLUZONE vaccination. The outcome was not reported. Documents held by sender: None.
Having a severe sore throat. The worst I've ever had.; Avoiding swallowing because it's so painful; I'm sneezing; my nose is running; I'm super congested.; My mouth ache.; teeth pain; Body chills; sore left arm; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 10Apr2021 at 13:30 as a single dose for COVID-19 immunisation. The patient previously took Co-Trimoxazole and experienced allergy to it. The patient did not take any concomitant medications within two weeks. The patient did not take any other vaccine in four weeks. Prior to the vaccination, the patient was not tested positive for COVID-19. On 11Apr2021, the patient experienced severe sore throat, the worst she ever had and was avoiding swallowing because it was so painful, sneezing, nose was running, super congested, mouth/teeth ache body chills and sore left arm. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The patient underwent a lab test on 12Apr2021 which included the nasal swab test (rapid antigen test) and the result was negative. The clinical outcome of the events severe sore throat, was avoiding swallowing because it was so painful, sneezing, nose was running, super congested, mouth/teeth ache, body chills and sore left arm was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Immediate: arm soreness, which worsened for the next 3 hours  Morning of 9/12:  awoke with fever, headache, myalgias, neck pain, severe fatigue, continued arm soreness
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On an unknown date "over a year ago", the patient was vaccinated with the first dose of GARDASIL (dose, route and lot number not reported). On 20-AUG-2014, the patient was in the office to receive the second dose of GARDASIL (dose, route and lot number not reported). No adverse effects were reported. Additional information has been requested.
States felt like mini COVID. Had vomiting, body aches, and headache for 3-4 days.
Patient initially only received 0.25ml dose when he was indicated to receive 0.5ml dose. After he was contacted, he returned to the pharmacy the same day to receive another 0.25ml dose to equal 0.5ml total.
Localized edema and erythema at injection site as well as itching hours post vaccination with FLUZONE vaccination and lasting for approximately 4 days. Reported to clinic 4 days post vaccination to report symptoms. Treatment: BENADRYL 50 mg PO at bedtime.
Itching as crazy; Swelling; Very hot to the touch; Sort of redness; Warm to the touch injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm to the touch injection site), PRURITUS (Itching as crazy), SWELLING (Swelling), FEELING HOT (Very hot to the touch) and ERYTHEMA (Sort of redness ) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013K21A) for COVID-19 vaccination.     The patient's past medical history included Diverticulitis (Mild). Concurrent medical conditions included Drug allergy (Amoxicillin), Diabetes and Bronchiectasis (Mild). Concomitant products included METFORMIN for Diabetes.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced INJECTION SITE WARMTH (Warm to the touch injection site) and ERYTHEMA (Sort of redness ). On 11-Mar-2021, the patient experienced PRURITUS (Itching as crazy), SWELLING (Swelling) and FEELING HOT (Very hot to the touch). At the time of the report, INJECTION SITE WARMTH (Warm to the touch injection site), PRURITUS (Itching as crazy), SWELLING (Swelling), FEELING HOT (Very hot to the touch) and ERYTHEMA (Sort of redness ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included several medications for an unknown indication. Treatment information was not provided.
They barely got anything into me. I am not sure if I am really vaccinated properly; They barely got anything into me. I am not sure if I am really vaccinated properly; This is a spontaneous report from a Non-contactable consumer (patient). A patient of unspecified age and gender received unknown dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 28Jun2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient stated "Do you know about how Pfizer Vaccine is actually administered tons of people being, you know having the thing put into your arm? Can you guys tell me something about how it supposed to be administered? I got it at hospital yesterday. From then I am watching television, they barely got anything into me. I am not sure if I am really vaccinated properly and I try get to the phone, nothing. Their phone does not work. I mean I can't find anybody to talk to about what's supposed to normal inject in the arm. Anybody who can actually tell me how it supposed to be administered, is it supposed to be a light jab or is it supposed to be little bit more into the to the underneath of your arm. I got a flu shot, it is a very light jab. I saw it on television, how people receive the first shot after flu shot, COVID-19 shot you know anything about it, no?" You have somebody there who actually is involved with proper administration of the Vaccine, who knows how to give it in people's arms? I need to talk to somebody like that. The outcome of the events were unknown.  Regulatory Authority Comment: AE Filed conservatively  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Rash over left leg and a little on right that are very uncomfortable. Rash started the day after the vaccine.The week prior, patient had a papular rash around her mouth, which mom thinks was due to eating figs, it is persisting and fading now.Rash Description : left knee and lower leg/ pretibial region with area of diffuse erythematous, raised papules. Scant papules on contralateral outer thigh. No macules. no target lesions or blisters or sloughing. nontender.  Uncertain Etiology , possible Vaccine reaction , possible other dermatitis. Zyrtec Allergy 1mg/mL oral solution - Take 2.5 mg every day by oral route for 10 days.
Scab from vx stayed in place 48 days.  Scab came off on 4/27/03.  I am a diabetic and heal slowly.  No other unusual reactions.
pt recvd vax & devel redness & swelling in arm of inject; pt tx w/ atb; pt dx w/ local erythematous rxn; pt did not have cellulitis;
Received shot 6-26-13 - 1:30 PM. Symptoms started 6 PM- on 6-26-13. Weakness and very nauseated. On 6-27-13 woke up still nauseas and weak. Could not eat, dry mouth. Forced piece of toast with swallows of water. This continued all day until 6 PM of 6-27-2013. Weight loss 3 pounds.
the patient waited 6 months to get the second dose; This spontaneous report as received from a medical assistant refers to a 16-year-old patient on unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 03-SEP-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # S005524, expiration date 29-SEP-2021 (dose and route of administration was not reported) for prophylaxis. The patient waited 6 months to get the second dose and on 09-MAR-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. 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: S005524; expirationdate: 29-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
got COVID about a month ago; got COVID about a month ago; This is a spontaneous report from a non-contactable consumer (patient's parent). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included steroids. It was reported that the patient unfortunately got COVID about a month ago on an unspecified date in 2021. The patient is being followed by Rheumatologists and is on steroids. The patient was treated with monoclonal antibodies. Outcome of events was resolved on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I was  left with a tic/ twitch in the corner of my left side of my mouth 2 days after my side effects sore off( dull headache, chills, total body ache) It comes and goes during the day. Never had this before. It is still ongoing.
Redness swelling warm to the touch on Friday afternoon. Seen at ER off base on Saturday was given antibiotics and told to f/u on base. Pt states after taking Bactrim and Cipro swelling redness went down. Pt states he feels alot better today but not 100%.
The morning after receiving a flu shot, Pt reports she awoke with no sensation from hips thru toes and elbows through finger tips. Has fatigue and episodes of loss of balance since then. Resolving, partially according to Pt.
6 hours s/p vaccine patient experienced pruritis, hives on extremities, cough & coryza, rhinorrhea, orbital swelling.  Symptoms persisted for 24 hours, gradually subsiding.
06/30/2022 My skin was very dry and I had what I thought was acne or blisters on my back. It went on all summer and continued to get worse. In September, I began getting blisters on my stomach and I could not get dressed. I went to the dermatologist; they prescribed medications and could not figure out what it was. After a few months I was diagnosed with an autoimmune disease, Pemphigus Vulgaris.
scattered rash on body , stomach that  itch and swollen eye . she was  given  steriod by her  primary care  physician
On January 6, 2021, 7 days after receiving the vaccine, I developed shortness of breath and increased heart rate that lasted briefly, followed by numbness of left arm (where I received vaccination). I was evaluated by the emergency room. Numbness to left-arm last 6 hours. During this time, I developed tingling to the tip of my tongue and tingling to lips. Later, I developed tingling to fingers and toes. The following day, the palms of my hands were tingling and turned red then a bluish discoloration. I have has extreme fatigue for 4 days starting on January 6th. Also, on the day of the vaccine December 30th, I had pain at the injection site immediately in addition to redness and swelling that lasted 3 days. On January 10, I have developed a headache. I no longer have numbness but have cold sensitivity and tingling in fingers.
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Weakness-Severe, Additional Details: Reported yesterday with the details above for a different patient, but the incident was with this patient. I went back to the drug usage report to verify and called patient this morning but call went to voicemail. The COVID vacc was appropriately recon, dosed, timed and administered by my immunization certified technician. The paperwork errror is that I put the name on the "EVENT REPORTING SYSTEM" as this patient not other patient. Please make the correction accordingly.
This case was reported by a healthcare professional and described the occurrence of arm numbness in a female subject aged between 20 and 29 years old who was vaccinated with FLULAVAL (GlaxoSmithKline). On 29 September 2010 the subject received 1st dose of FLULAVAL (.5 ml, unknown, left arm). At an unspecified time after vaccination with FLULAVAL, the subject experienced numbness down the arm from injection site. At the time of reporting the outcome of the arm numbness was unspecified. This is one of two cases reported by the nurse, see case A0884296A. Follow-up information received via the reporting nurse indicated that this patient was a temporary employee and specific medical information requested is not available. Follow-up information was received on 25 October 2010. It was reported that the subject was 22 years old at the time of events. It was indicated that the subject experienced a vaccine reaction. Arm numbness was reported. Events resolved. Numbness was present for a time period of approximately 1 to 1 and a half hours. Subject nervousness prior to the shot may have contributed to the adverse reactions.
broke out in hives on both arms and legs; red itching area at the injection site; sore arm; A spontaneous report was received from a consumer concerning a 65 year old, female patient who experienced arm sore, hives on both arms and legs, injection site redness and itching.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On 4-Feb-2021, approximately 1 day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 031L20A) via unknown route for prophylaxis of COVID-19 infection.   On 5-Feb-2021, she had a sore arm. On 11-Feb-2021, a week later she had a red itching area at the injection site and then broke out in hives on both arms and legs.   Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events was not reported.  The events, arm sore, hives, injection site redness and itching, were unknown.
Gout in 2nd toe on right foot.  Treated with methyl prednisone, tylenol, voltaren, and heating pad.  Has decreased in intensity but not fully resolved.  Also some fatigue.
Patient notified us today she was diagnosed with pneumonia 8/8/19.  Reports she was having increased respiratory difficulties requiring rescue inhaler daily beginning 8/1/19.  Sought medical help with the physician at her employee health 8/8/19.  States she was diagnosed with pneumonia based on physicians' auscultation, with a rub & wheezing audible - no CXR performed.  She was prescribed a prednisone dose pack x6 days & an antibiotic x5 days.  Reports to be much better now, but does still have a lingering non-productive cough.  She states she did not have an elevated temperature at any time.  Patient was also prescribed Typhoid oral at the time of her visit 6/29/19, which she states was taken 2 weeks later.
pt recv vax & exp breakthrough chickenpox;3 patients w/this exp reported @ this site;
Customer came for the Pfizer Bivalent Booster at a clinic at his workplace on 10/14/2022. We found out he just had his second dose on 9/19/2022 when his claim was rejected by his insurance while billing after the clinic.
Patient started to develop pain on the injection site,  flushing on face and flu like symptoms which lasted for 2 weeks so she had to go to the urgent care on the following day. Due to the symptoms, patient took prednisone and antibiotics for 10 days.