chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Incredibly weak; unsteady on feet; 6cm mass on neck; rash on legs; now food all tastes metallic; This is a spontaneous report received from a contactable consumer, the patient. An 89-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown), via an unspecified route in the right arm on 11Feb2021 at 09:00 as a single dose (at the age of 89-years-old) for COVID-19 immunisation. Medical history included benign prostate hypertrophy. The patient had no known allergies. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient had been tested for COVID-19 after vaccination. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN) and prostate pill (MANUFACTURER UNKNOWN) for unknown indication and from an unknown date. On 19Feb2021 at 14:00, the patient experienced incredibly weak, was unsteady on feet, had a 6cm mass on neck, rash on legs and food tasted metallic. It was reported that the patient was perfectly healthy prior to vaccine and had a great appetite prior. The events resulted in emergency room visit twice and the patient was treated for these events. On an unknown date, the patient underwent lab tests as treatment for events which included blood work, EKG, chest X-ray, urinalysis, CT scan all with normal results. All the testing done in emergency room had been normal except for mass on neck, it was scheduled to have biopsy of neck on 23Mar2021. The doctors suggested that it was all from the vaccine. The clinical outcome of the events incredibly weak, was unsteady on feet, had a 6cm mass on neck, rash on legs and food tasted metallic was not recovered at the time of report. No follow-up attempts are needed. No further information is expected.
On April 1, 2021 developed  fleeting left shoulder pain that radiated and moved to collar bone and neck.  Moved to right side as well.  Lymph node swelling noted over collar bone.  Went to MD.
Boostrix - Not clear if this is the source - multiple vaccinations received - but having pain with swallowing, right facial swelling, within 30 minutes of vaccinations
felt crappy; This spontaneous case was reported by a physician and describes the occurrence of FEELING ABNORMAL (felt crappy) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history 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 FEELING ABNORMAL (felt crappy). At the time of the report, FEELING ABNORMAL (felt crappy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.
Abnormal period.  Heavy bleeding, late period. Severe cramping  especially on the right. Ovary
4 days after vaccination, she had heart pain, Cardiologist found hives, developed shingles, fever and in bed for 10 days. Was prescribed antiviral medication for the shingles from the ER.
This initial spontaneous case was received on 07-Nov-2017, from a consumer, concerning a 31-year-old adult, male patient. The medical history included, the administration of unspecified flu vaccine and development of similar type of rash, 2 years ago. The concomitant medication included multivitamins for an unknown indication. On 17-Nov-2017, at 11:00 hrs, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195250, expiry date: Jun-2018). After 7 to 10 days of administration of vaccine the patient developed full body rash, which has changed the daily life. The patient was treated with CLARITIN after consultation with primary physician. At the time of the report, the patient was recovering from the event. The reporter assessed the event as non-serious and the causality as related.
LIPOMAS-After the anthrax vaccine received on 3/24/03, patient noted a new onset mass on his right inner thigh. He later noted a second mass on his right flank. He then noted a mass over his mid-sternum which tripled in size over a couple of weeks. This mass was biopsied and patient recalls a large amount of drainage as the mass was removed. The final diagnosis of the biopsy was reported as a lipoma. Patient is not aware of any cultures or lab studies that were performed on the drainage from the site. Since then, the patient has noted other masses appearing on his abdomen, around his knees and along his lower ribs. The most recent mass appeared about 30 days ago and is on his left flank area (40 x 20 mm). These masses persist and fluctuate in size. They are tender to deep palpitation and the tenderness seems to decrease after the area is massaged. Patient had no history of lipomas or masses prior to March 2003. He had a biopsy of a cyst near salivary gland around his left ear which was benign prior to receipt of his anthrax vaccines. Patient reports receiving an initial series of anthrax vaccine when he was a Marine in the first Gulf War, but has no documentation of any vaccinations between 1987 and 1992. (He is not sure how many anthrax vaccines he received at that time). He was then given 4 doses of a second dose of the anthrax vaccines on 3/7/03, 3/24/2003, 4/9/2003 and 1/29/2004. Patient reports burning type pain with each anthrax vaccine injection which resolved within minutes of the injections. He experienced minimal redness and swelling at his vaccines sites. He experienced persistent subcutaneous nodules at vaccine sites with associated tenderness to palpitation. The nodules varied in size from the diameter of golf ball to the diameter of a lime. The subcutaneous nodule at the site of the anthrax vaccine received on 3/24/2003 is still present (30 x 25 mm) and tender to deep palpitation. Patient denies persistent headaches, myalgias, arthralgias, fatigue or fever or chills following receipt of any of his anthrax vaccines.
Onset severe shoulder pain. Limited movement. Resisted with worsening pain and continued very limited movement let shoulder. One week later saw primary doctor. Diagnosis adhesive capsular US. Hospitalized June with steroid injection. Severe pain severe limited movement. Saw orthopedic MD June 19. Continue with symptoms now eight weeks after Prevnar 13 with worsening of symptoms.
Headache, Body Ache, Chills and Swollen Lymph Node in my neck.  (right side)
A 5 years old patient was administered pentacel instead of Daptacel, no AE; A 5 years old patient was administered pentacel, no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (Reference number- 00313454) and transmitted to Sanofi on 13-Oct-2020  This case involves a 5 years old female patient who was administered fifth dose of 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot number not reported via unknown route in unknown administration site for prophylactic vaccination instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (product administered to patient of inappropriate age and wrong product administered)  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency same day).  A 5-year-old patient received Pentacel and not the ordered Daptacel. The reporter did not have any more information on the patient as the vaccination took place at another clinic and wanted to know information regarding dosing for correct product.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Moderna COVID-19 Vaccine EUA.  Side effect symptoms experienced  2/7/21 pm through 2/9/21: Moderate to severe muscle pain entire left arm, Moderate to severe muscle pain entire right and left legs and feet, Joint pain, low back pain, chills, fever, fatigue, headache. One instance of dizziness/pre-syncope on 2/7/21 pm.
2/22/2022 I was constantly having cramps, diarrhea, and was nauseated and was very dehydrated.   At that time, I went to Urgent care and was sent to ER. There I got a CAT scan and blood work (Normal) and was given nausea and cramps prescription. I was encouraged to get a gall bladder ultrasound, but it was too expensive and was given more pain killers, nausea, and full spec. antibiotics. Was advised if it got worse to head back to ER. Follow-up scheduled for next week.
Temperature 101 orally on 11/20/2003, after day care at 16:30.  Lethargic yesterday morning.  Complained of headache, backache "heart hurt".  Temperature 102 @ 6:00 on 11/21/2003 and given Tylenol then seems to feel better 10:00 on 11/21/2003.  Referral to provider of choice.  11/24/2003-lasted one day.
Subsequent to receiving two doses of varicella virus vaccine live the pts laboratory evaluation revealed negative antibody titers.
(R) arm and hand weakness, pain. Pain resolved in (R) arm and hand on 9/11/14 but was severe with injection. (R) leg posterior lower leg knee to foot shooting sharp pain for 4 days. No improvement.
arm swelling; aches; so tired; that evening her heart was racing for awhile and then stopped and was normal and the next day in the early morning it was racing again and then went back to normal; arm was hurting; arm felt hot and had a lump; arm felt hot and had a lump; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6206) via an unspecified route of administration in right arm on 10Mar2021 at 11:45 (at the age of 63-years-old) as single dose for COVID-19 immunization. Relevant medical history of the patient included arthritis and fibromyalgia. Concomitant medications included supplements (unspecified). Patient did not receive any prior Vaccinations (within 4 weeks). On 10Mar2021, patient experienced that in the evening her heart was racing for a while and then stopped and was normal and the next day in the early morning it was racing again and then went back to normal, arm was hurting, arm felt hot and had a lump. On 11Mar2021, patient experienced aches, was so tired, had arm swelling. Pain and aches she didn't mind those, but when her heart started racing, she did. Patient clarified that her arm was hurting within 10-15 minutes and it felt hot and had a lump within the hour, in the arm she got the vaccine in. She was out for shopping and decided to go home. Aches started the next day and she was so tired that next day in the afternoon 11Mar2021. It lasted until Saturday and she was fine on Sunday 14Mar2021, she was herself again, all the symptoms were gone. Events did not result in visit to Emergency Room or Physician office, but patient mentioned that if the heart racing continued, she would have to visit. Patient asked if it was ok for her to get the second shot. Patient got a reminder for next week for her 2nd shot and she was not sure if she should get it. Outcome of the event heart racing was resolved on 11Mar2021, arm was hurting, arm swelling, arm felt hot and had a lump, aches, so tired were resolved on 14Mar2021.  No follow up attempts are possible. No further information is expected
Running a mid to high fever and pain in the left arm and body pain as well.; Running a mid to high fever and pain in the left arm and body pain as well.; Running a mid to high fever and pain in the left arm and body pain as well.; This is a spontaneous report from a contactable consumer, the patient. A 13-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 26Jun2021 at 11:30(at the age of 13-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the right arm on 05Jun2021 at 18:00(at the age of 13-years-old) as a single dose for COVID-19 immunisation. On 17Jun2021, patient received unspecified allergy shot on both arms within four weeks prior to COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Jun2021 at 03:30, the patient experienced running a mid to high fever and pain in the left arm and body pain as well. Therapeutic measures were not taken as a result of the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events running a mid to high fever and pain in the left arm and body pain as well was not recovered, at the time of this report.
arms so sore I couldn't move them shortly after injections, by evening I had fever, chills, headache, full body aches to joints and muscles everywhere, even my skin hurt to touch it, swollen lymph nodes all over my neck, dizziness, weakness, back aches super bad that not even my norco and muscle relaxer phased it. I hurt so bad I could not sleep at all through the night.
Pt had IM shot Rt thigh at afternoon 3/10/15 - here for recheck otitis media - sibling Dx today with positive flu type B - pt fever, cough, swelling at 4:30 pm.
1/9/2021 lymph node enlargement in left axilla, started with arm pain day of injection
pt called describing she recieved pfizer bivalant dose  on 1/14/2023 and 1 day later had local itching, pain, and 'knot' on arm just at location of administration. I advised pt to ice the area to reduction pain/inflamation and adivised pt to seek medication attention if gets worse/ spreads to other areas or if remains 5-7 days after administration.
Developed multiple blood clots in the right leg around the knee and inside lower thigh area, Diagnosis was SVT
severe diarrhea; stomach cramping; vomiting; nausea; fatigue; headaches; This is a spontaneous report from a contactable consumer reporting for herself.  A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142) on 12Jan2021 at 12:00  pm at single dose via an unspecified route of administration on arm left  for COVID-19 immunization. Relevant medical history included high blood pressure and celiac disease. Concomitant medications included unspecified high blood pressure medicine. On 12Jan2021 at 20:00 patient experienced severe diarrhea, stomach cramping, nausea, vomiting, fatigue and headaches. This lasted 10 days so far (as reported). The events were reported as non serious. Treatment received includes Antacid, anti-nausea medication and immodiome. At the time of the reporting the patient had not yet recovered from the events.
5 MINUTES AFTER VACCINE GIVEN PT WENT UNCONSIOUS AND HAD WHAT APPEARED TO BE CONVULSIONS FOR ABOUT 4-5 SECONS. PT REGAINED CONSIOUSNESS. EMS WAS CALLED PT WAS STABLE. PT DECLINED EMS TRANSPORT TO ER. PT LEFT CLINIC
This is a prospective pregnancy case. This 25-year-old female subject was enrolled in an open label study. The subject received BOOSTRIX (intramuscular) on 12th May 2015. Concomitant products included Prenatal Vitamins. The subject's estimated date of delivery was 5th January 2016. The subject received BOOSTRIX at week 6 of the pregnancy and during the first trimester of pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX, the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details provided as follows: No other events reported. The nurse administering the vaccine is the reporter. Follow-up information received on 16 June 2015 from nurse: The subject's last menstrual period was on 1st April 2015. The subject's ethnic origin was provided. (Pregnancy Notes) On 20 March 2016, this case was considered lost to follow-up. Follow up information received on 5th April 2016 from nurse via call centre representative: This case was upgraded to serious due to GSK medically significant term miscarriage. The patient had a normal conception. The patient did not have any previous pregnancy. The patient was allergic to penicillin, amoxicillin and doxycycline. The patient's husband was a social drinker and was not a smoker and did not have any daily medications or allergies. In 1st week of June 2015, at 8 to 10 weeks of gestation (approximately 2 weeks after vaccination), the patient had a miscarriage. The VAERS details were updated.
Started on 24Jun2021 with left knee swelling. Progressively the swelling has become more systemic. From 25-28Jun2021, I gained 12 pounds in what seems to be 'water weight'. I have pitting edema in my lower legs and non-pitting edema in my abdomen, thighs, and upper legs. I feel 'heavy'. I've made an appointment with my primary care doctor for 01Jul2021 and will go to an urgent care-type appointment later today.
Patient experienced erythema at site of injection. Diagnosed with cellulitis by business health nurse. Pain from shoulder to wrist. At this point for 3 days pain is not getting worse but not improving significantly.
Redness and hard lump measuring 2cm x 3cm, sight also warm and tender to touch
Moderna dose 2 administered on 4/6/21. Colonoscopy was done on 4/7/21. Woke up this morning (7/8/21) with a fever of 102.1 and a rash that looks like a 'really bad sunburn' all over her face, trunk, chest, and both arms. It itches all over.  The rash was described as 'raised, but not like hives' because it doesn't look like a bee sting. She said it is typical for her to have a viral rash when she has high temps. She also woke up with diarrhea today.  She doesn't know if this is related to the colonoscopy yesterday or if it's from the vaccine.  I encouraged her to call her clinic for guidance, as the fever could be associated with infection after a colonoscopy, but it also might be a normal reaction to the vaccine.
Per 1-16/20 Pc Telephone Care Note: "Patient states that he believes he has a reaction to the pneumonia shot. He states he has had a cough since receiving the shot on 12/31. Advised patient that he may have come in contact with a virus and that may be what caused the cough. His wife is sick with a cough as well which points more likely contact with a virus. Patient would like pharmacy to be notified of his issue with the pneumonia shot." This should be considered and discussed with patient if/when another pneumonia vaccine is indicated.
p/vax pt devel local rxn;pt w/ 3-4inch long red raised area @ the inj site;area was hot to touch & arm ached;to MD put on ATB;
The pt developed a rash, rash spreading with red spots with pustules in the middle. Mother is sure they are chicken pox.
Several hours after patient received SHINGRIX he felt unwell, achy, shaky, took Tylenol, went to be, woke up around 10 pm shivering. Went back to sleep and about 8 am woke up still feeling achy and lightheaded, went to work but had to leave as he didn't feel right. He was asymptomatic by the time I spoke to him ~ 1.5 days later. He almost went to the ER given convulsing shivering. Also had swelling at site of injection.
rash behind knees, slightly raised, red, and painful.  patient also stated some rash between legs and below breast.  pain went away by 1-18-2020 when she woke up.
At 12h, LUE sore, 22h, LUE red, more pain, 48h, LUE redder, less pain, 72h, LUE larger area of redness, sore, 78h, seen by physician-NSAID, Anti-hist, cool compress
Diagnosis:  Aplastic Anemia Patient is still in treatment as of 6/26/2021
Bad rash; This case was reported by a physician via sales rep and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-FEB-2023 Reporter's Comment:The doctor mentioned that in the past that she had a patient that developed a bad rash post Shingrix immunization.  The reporter said it resolved and did not want to talk with medical about it. The reporter agreed to follow up from GlaxoSmithKline.
Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Pt experienced mild lip swelling after booster within 15min of her vaccination. She waited a total of 30min. before returning home when she took 1 tab of loratadine 10mg upon arrival. Symptoms disappeared 1 hr. afterward. Followed up with pt on 12/15 at 9:15a.m. Pt stated she was fine. Advised her to consult her MD for advice before future vaccinations. (previously rec'd Pfizer for dose 1 and 2)
patient requested the moderna vaccine.   The MA did not check DOB at the time.  Patient was 33 weeks at the time of vaccination. patient delivered with no complications.  Baby gilr weighed 6lbs 9 ounces at birth.
Severe reaction...joint aches and pains, Headache, extreme fatigue. In bed for 1 day, felt affects  for 3 more days. 2nd of 2 shots in series.  !!Had started to check blood sugar 2 weeks prior as recommended by doctor for suspected reactive hypoglycemia. Fasting blood sugar for the prior two weeks was 98 +- 2.  First day after Shingrex shot, fasting blood sugar was 85, 2nd day was 90, third day was 95, 4th day was normal at 98. This is a very surprising side affect not noted in the mfr literature so thought I would report this in your system.
The patient (DOD 02/19/2021)  Cause: Complications of osteomyelitis; OSC: COVID-19; DM2; COPD; HTN; HLD; CAD; obesity
Lower bowel symptoms (bowel regions became inflamed); Cannot have bowel movements; This is a spontaneous report from a contactable consumer (patient's neighbour). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced lower bowel symptoms (bowel regions became inflamed) and cannot have bowel movements. The consumer reported that my lower bowel regions became inflamed, and I had months of symptoms since. My neighbour just one block from here also was reporting same lower bowel symptoms. Cannot have bowel movements without laxatives and softeners, etc. The outcome of events was unknown.  Information about lot/batch number has been requested. Additional information has been requested.