chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This letter is written documentation of an adverse reaction to a recent vaccine my son received on Wed. April 30, 2008 1. MMR 2. varicella 3. pneumococcal 4. hepatitis A.  Friday May 2, 2008 He began running a fever and fussy.  Sat. May 3, 2008 he awoke with bright red patches over about 45-60% of his body these splotches then progressed to red spots the size of a pea with white centers  not fluid filled as in chicken pox.  His body seemed to be sore he seemed to be in pain not itchy.  fever continued he was given TYLENOL and nothing else.  The next morning he awoke with new places and now covering at least 75% of his body.  Around 2:00 p.m. he began to swell in his hands, feet, and face his hands and feet were turning a pale blue.  We checked his fever it was 101 and his o2 sats were 81 we went immediately to the ER.  He was rapidly progressing with the spots and splotches and swelling.  He had blood work done and a chest xray.  His pediatrician was not able to be reached on a Sunday May 3, 2008.  We were sent home and told to return if his breathing became difficult or blisters in the mouth or eyelids.  Monday, Tuesday old spots became dark purple and brown then progressing to pale yellow while more new spots appeared now the new spots on Monday and Tuesday were looking more like half moon shapes but still all over his body.  Wednesday still running fever and spots still present.  extreme fussiness and body aches runny nose all these continued.  5:00 p.m. May 7, 2008 the spots and redness were completely gone, leaving pale yellow spots like bruises behind.  May 9, he still has fever, low grade, and runny nose and irritability.  He had diarrhea and spitting up throughout this whole time.  I also have 2 other children that received MMR vaccines at different times they ran fever and had small spots that went away after 24 hours this is what I would call mild.  Patient's reaction I would not call mild.  He will not be receiving another MMR vaccine.  I am writing this letter May 9 2008 and I would not say that he is completely recovered from this 100% but my goal is to let it be known that these vaccines are not always helpful and that they can be more harm than good.
Pt treated with lasix for CHF and IV Remdesivirand steroids for COVID. PT discharged home with home health care.
Patient received her 12 month vaccines and within minutes developed hives on face and at site of administration of vaccines with more present left > right thigh. Afebrile; normal lung exam; given BENADRYL with improvement.
Fever 99.5 Headache Tiredness Felt normal after 24 hours
headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 20Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache". Therapeutic measures were taken as a result of headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PT claimed not feeling well right after receiving flu shot and she fainted after a few minutes. Before EMT arrived, PT regained consciousness.
Quick onset of Left sided numbness/tingling turning into facial paralysis, unable to close eye, headache, ear ringing, etc.
Nerve sensitivity; 100.7 fever; Muscle, joint pain; Muscle, joint pain; Slight headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 24Apr2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I had COVID with multifocal pneumonia" (unspecified if ongoing), notes: I had COVID with multifocal pneumonia 3 or 4 months ago.; "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: PYREXIA (non-serious) with onset 24Apr2022, outcome "unknown", described as "100.7 fever"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 24Apr2022, outcome "unknown" and all described as "muscle, joint pain"; NEUROPATHY PERIPHERAL (medically significant) with onset 24Apr2022, outcome "unknown", described as "nerve sensitivity"; HEADACHE (non-serious) with onset 24Apr2022, outcome "unknown", described as "slight headache". The patient underwent the following laboratory tests and procedures: Body temperature: (25Apr2022) 100.7.  Clinical course: The patient stated that Is it normal to have a 100.7 fever the day after first dose of your Covid vaccine. Patient had Covid with multifocal pneumonia 3 or 4 months ago. Even though patient had rheumatoid arthritis, its doctor urged to vaccinate with Pfizer. patient did so yesterday and had the fever plus muscle, joint pain, and nerve sensitivity. Also, a slight headache. Thank you in advance for your response. Patient really appreciate it.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
neuropathy; This spontaneous case was reported by a patient and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032086) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu on 16-Oct-2023. Past adverse reactions to the above products included No adverse reaction with Flu.    On 16-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 microgram. On 16-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced NEUROPATHY PERIPHERAL (neuropathy) (seriousness criterion medically significant). The patient was treated with IBUPROFEN at a dose of 400 milligram twice a day. At the time of the report, NEUROPATHY PERIPHERAL (neuropathy) was resolving.            Concomitant medication was not reported.  Patient experienced neuropathy in her left hand which was in the arm patient received the vaccination. Patient also experiencing left hand weakness at a level of 2/10. The neuropathy comes and goes and was mild but bothersome. The patient did not experience any additional symptoms/events. The patient had no medical history, concomitant disease or risk factor. There were no lab data/results available.  This is a Spontaneous case concerning a female patient of unknown age, previously vaccinated with a flu vaccine and no other medical history reported, who experienced the unexpected serious (medically significant) event of Neuropathy peripheral which began on the same day after the administration of SPIKEVAX 2023-2024 PFS vaccine. The patient experienced an intermittent neuropathy in the left hand (vaccination arm) and a left-hand weakness at a level of 2/10. Patient is being treated with ibuprofen. No further information was available in the report. The benefit-risk relationship of SPIKEVAX 2023-2024 PFS Vaccine is not affected by this report.
Patient was given a dose that was drawn up the previous day between 5:30 - 6:00PM.  Dose was administered at ~11:00AM
p/vax pt exp cutaneous lymphoid hyperplasia;pt sought unspecified medical attention;skin biopsy mult infiltrate of mononuclear cells w/both small lymphoid & large forms;dx cutaneous lymphoid hyperplasia;
The day of the vaccination the patient called and told me her arm was very sore.  I called her later in the day to see how her arm was feeling and she told me better.  She came back today (11/16/16) to let me know her arm continued to be sore and she was having difficulty moving it so she was going to physical therapy and it was improving.  She did not think it needed to be reported but I told her all adverse vaccine reactions should be reported but she wanted to let me know she had rotator cuff surgery in that arm and she thinks that might be why she had the reaction so she suggests giving the vaccine in the non operated on arm.
Got the vaccine at 11AM. around 3PM very tired, headache wok me up around 3AM next morning I was fatigued, felt hot and cold (couldn't decide if I needed a jacket or not while at work), very tired, the next day still fatigued, chills, hot and cold, went to work and decided to leave after talking to one of the doctors. I was clammy, very sluggish, had a very mild headache, did not feel well overall. That was the worst day for me (Friday). My ears felt plugged. Slept almost entire day going through cold/hot chills, even wore 4 layers of blankets. Back and forth with hot and cold chills. Next day ear pain and fatigue. Very mild hot and cold flasher.
PNEUMOVAX which caused patients arm to be "paralyzed"; not because it was infected, but because it was swollen; she lost her range of motion; she could not stand up; during sleep, her arm still aches/I still have pain and weakness in my arm; feels weak and she has pain in the muscle; feels weak and she has pain in the muscle; sometimes the injection can cause nerve injury; This spontaneous report was received from a female patient of unknown age referring to herself. The patient's medical history, concomitant therapies and concurrent condition were not provided.     On 12-FEB-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose detail, strength, route, lot# and expiration date were not provided) for prophylaxis. On 13-FEB-2020 (reported as the same night, after midnight), the patient had to go to the emergency room because her arm (unknown if left or right) was paralyzed (monoplegia). The patient was prescribed an antibiotic, not because it was infected, but because it was swollen (peripheral swelling). The skin was stretched 3 times the size of her other arm. The patient reported that she lost her range of motion (joint range of motion decreased). And the patient could not stand up (dysstasia). After a while, the swelling was improved. However, during sleep, the patient's arm was still ache and feeling weak (muscular weakness and pain in extremity). The patient had pain in the muscle (myalgia). The patient reported that she still had pain and weakness in her arm after 5 months of vaccination. She spoke with her pharmacist who stated that sometimes the injection could cause nerve injury. The patient was recommended to try gabapentin. The outcome of monoplegia, nerve injury, myalgia, dysstasia and joint range of motion decreased was unknown. The outcome of peripheral swelling was reported as recovering. The outcome of muscular weakness and pain in extremity was not recovered.   The reporter considered monoplegia, nerve injury, myalgia, muscular weakness, pain in extremity, joint range of motion decreased and peripheral swelling to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The causality between dysstasia and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.  Upon internal review, arm paralyzed was determined to be medically significant.
Dose given in error- pt received first bivalent dose 10/25/22 and patient is not above 65/not immunocompromised
approx 12 blisters (weeping) on face & under arm;varicella like blisters;
Generalized erythematous body rash and facial swelling redness. Regressed within 24 hours or so. Given Benadryl.
heart fluttering, heart palpitations,  dizziness, fatigue, lethargy.  Diagnosed with Myocarditis (enlargement of the left atrium)
hurt so bad; feeling sick like I had COVID; chills; arm was just a little bit sore; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling sick like I had COVID), PAIN (hurt so bad), VACCINATION SITE PAIN (arm was just a little bit sore) and CHILLS (chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm was just a little bit sore). On 18-Mar-2021, the patient experienced MALAISE (feeling sick like I had COVID) and CHILLS (chills). On an unknown date, the patient experienced PAIN (hurt so bad). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (feeling sick like I had COVID), PAIN (hurt so bad), VACCINATION SITE PAIN (arm was just a little bit sore) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.
No Additional AE; HCP called to report that the patient was given PROQUAD instead of MMR II. The PROQUAD also suffered from a non supported temperature excursion. TE cases 02418202, 02418066.  HCP states they do not wish to be contacted about this and declines  any fo; The PROQUAD also suffered from a non supported temperature excursion; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 28-JUN-2023, the patient was vaccinated with an improperly stored dose of with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number w029552, expiration date 14-MAR-2023, for prophylaxis instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (interchange of vaccine products and product storage error). No adverse event was reported.  The vaccines underwent a temperature excursion of 8 degrees Celsius for 2328 hours.
hive on the left arm; left arm became hot; fever; left arm became big; achy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hive on the left arm), VACCINATION SITE WARMTH (left arm became hot), PYREXIA (fever), VACCINATION SITE SWELLING (left arm became big) and MYALGIA (achy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Adhesive tape allergy (band-aid adhesives), Drug allergy (prednisone injections) and COPD.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced URTICARIA (hive on the left arm), VACCINATION SITE WARMTH (left arm became hot), PYREXIA (fever), VACCINATION SITE SWELLING (left arm became big) and MYALGIA (achy). At the time of the report, URTICARIA (hive on the left arm), VACCINATION SITE WARMTH (left arm became hot), PYREXIA (fever), VACCINATION SITE SWELLING (left arm became big) and MYALGIA (achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Patient stated that on an unknown date she had COPD Inhaler (Trelegy) and she had her flu shot on 13-Oct-2021. Patient also stated that she is on lot of medications and have been on them for many years but did not list the medication names.   This case was linked to MOD-2021-376966, MOD-2021-376967 (Patient Link).
I had swelling in my arm and the pain didn't really go away. On April 5, 2023, I had a massive headache for three weeks. I saw my doctor on April 26, 2023. I have a follow up on April 28, 2023. They thought it was Lyme's Disease, but everything came back negative. Today, I saw the Gastroenterologist to rule out other things. I am feeling a little better. The arm soreness is starting to dissipate. I can raise my arm a little higher.
pt was vaxed 21NOV95 & on 23NOV or 24NOV per dad pt broke out w/a rash all over boyd; pt did not have fever or any other sxs; pt did although take Amoxicillin from 20NOV-24NOV, rash could have been from that;Amoxicillin was prescribed URI
mom called on 22DEC93 reporting pt had sx the prev noc; pt was congested; referred to ER MD dx bronchitis;
- Vertigo/dizziness that will not get better.  - Pounding headache that will not get better.
Round rash around site of the injection in 7 th day after vaccine given. Very itchy, swollen, hard and warm to touch.  Felt a little off. Tired and achy.
positive Covid for the 2nd time; positive Covid for the 2nd time; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Lot number: EW0151), in left arm, on 25Apr2021 as dose 2, single (Lot number: ER8736), in right arm and on 26Jun2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetes" (unspecified if ongoing); "Cardiac" (unspecified if ongoing); "cholesterol" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN taken for diabetes mellitus, blood cholesterol, stop date: 10Apr2022; ENALAPRIL taken for type 1 diabetes mellitus; HUMALOG taken for type 1 diabetes mellitus; LANTUS taken for type 1 diabetes mellitus; ASPIRIN [ACETYLSALICYLIC ACID] taken for type 1 diabetes mellitus, cardiac disorder; PREVNAR 20 taken for immunisation, on 05Apr2022; FLU taken for immunisation. Vaccination history included: afluria (influenza vaccine), administration date: 26Nov2021, for immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Aug2021, outcome "unknown" and all described as "positive Covid for the 2nd time". The patient underwent the following laboratory tests and procedures: Blood glucose: (unspecified date) High; Influenza virus test: (unspecified date) Negative; SARS-CoV-2 test: (unspecified date) Negative; (13Apr2022) Positive; (26Aug2021) Positive; (unspecified date) Negative; (unspecified date) Negative. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient was having a really metallic, almost bile taste, in her saliva on 13Apr2022. Simvastatin: started 7 years ago and stopped taking it 10Apr2022 and they require her cholesterol to be below 150. Humalog: up to 5 injections a day. dose determined by meal plan and high glucose episodes. on average day does not exceed 25 units. Started taking about 20 years ago. Lantus: started 5-6 years, quarter grain aspirin: started about 10 years, it is low dose aspirin. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. Prior Vaccinations (within 4 weeks) were reported as none.  No follow-up attempts are possible. No further information is expected.
Pt recvd vax 14MAY92 & 11MAY92 recvd vax & 15MAY92 devel fine red pruritic rash on back, arms & legs but not on face; stated that felt warm, but had no fever; also had a h/a on the top & frontal area of head; No further details were provid;
PATIENT EXPERIENCED "HORRIBLE MUSCLE ACHES AND PAINS" SHE CONTACTED DR AND THEY RAN SOME BLOOD TESTS AND TOLD HER SHE HAD "THICK BLOOD" SO SHE STARTED TAKING ASPIRIN LOW DOSE DAILY AND SHE SAID THE PAIN RESOLVED BUT SHE HAD ANOTHER BLOOD TEST ON 04/15 THAT SHE DOES NOT KNOW THE RESULTS OF YET
Pharmacy technician administered vaccine in the shoulder. Possibly while standing. This caused presumed bursitis leading to pain, stiffness, decreased strength and range of motion in the affected shoulder. This has yet to resolve nearly 4 months later.
Persistent symptoms (> 7 months) of fatigue, postexertional malaise, joint pain, myalgias, lightheadedness, headaches, nausea, and decreased appetite after receiving her COVID-19 booster.  COVID-19 exposure around the same time but no documented COVID-19 infection and negative COVID-19 nucleocapsid antibodies. Patient recently had COVID-19 and has experienced worsening of symptoms.
Sudden onset of obsessive compulsive disorder, generalized anxiety disorder, and panic disorder with panic attacks immediately following an upper endoscopy on May 3rd. Have been hospitalized twice in the psychiatric wing at hospital.
pt became very nauseated-felt like fainting & then became very SOB; unable to administered Epi; BP dropped pulse inc;
Felt hot and cold on and off; 10 minutes after I felt a little lightheaded/dizzy.; entire left side from neck, down back into hip and leg in severe pain(muscles tense); entire left side from neck, down back into hip and leg in severe pain(muscles tense); felt ill; felt extreme weakness; sneezed about 20-25 times; eyes turned red; The spinning and unable to focus continued for about 6 hours; The spinning and unable to focus continued for about 6 hours; Headache was coming and going; This is a spontaneous report from a contactable other health professional (other HCP) (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EH9899) via an unspecified route of administration at left arm on 31Dec2020 at 08:30 AM at a single dose for COVID-19 immunization. Medical history included known allergies (allergies to medications, food, or other products), and no other medical history. The patient was not pregnant. Concomitant medications the patient received within 2 weeks of vaccination included vitamins/supplements. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was at facility. 10 minutes after the patient felt a little lightheaded/dizzy. At 20 minutes after her entire left side from neck, down back into hip and leg in severe pain (muscles tense), at 30 minutes she sneezed about 20-25 times, felt extreme weakness and her eyes turned red. She felt ill. The spinning and unable to focus continued for about 6 hours. Headache was coming and going. She felt hot and cold on and off. All events with start date on 31Dec2020 at 08:45 AM. The events were reported as non-serious. No treatment received for events. The outcome of events was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Initial report received from a health care professional on 07 September 2012. The 18-year-old female patient who was undergoing workup for Crohn's disease and had no reported concomitant medication received third dose of MENACTRA (batch number: U4345AA)intramuscularly in her left deltoid region and Tubersol (Batch number: C4173AA)on her left forearm (route, dose, dose number not reported) on 29 August 2012. The patient previously received two doses of MENACTRA on 19 June 2008 and 08 August 2011. It was reported that , the patient has not felt well since vaccination on 29 August 2012. On 01 September 2012 the patient was seen in URI and on 04 September 2012 she visited ER for the same. On 04 September 2012 the patient was seen for URI, sore throat, chills and temperature 99.4. The patient was treated with nebulizer and the meeting with MD was canceled. The patient's laboratory investigation for blood work was pending. The outcome of the events was reported as not recovered. Documents held by sender: none. Follow-up information was received from a healthcare professional on 10 December 2012. The responsible physicians contact details were updated. The patients laboratory work-up was unremarkable/normal.