chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Crohn's disease; Hashimotos disease; This spontaneous case was reported by a pharmacist and describes the occurrence of AUTOIMMUNE THYROIDITIS (Hashimotos disease) and CROHN'S DISEASE (Crohn's disease) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced AUTOIMMUNE THYROIDITIS (Hashimotos disease) (seriousness criterion medically significant). On an unknown date, the patient experienced CROHN'S DISEASE (Crohn's disease) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE THYROIDITIS (Hashimotos disease) and CROHN'S DISEASE (Crohn's disease) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. The patient received the 1st booster shot and on 08Nov2021 the patient was diagnosed with immunocompromised conditions: Hashimotos disease and Crohn's disease after November 8th, 2021. The Pharmacist stated that the patient has received 3 doses so far, primary series (2 doses) and 1st booster dose. No treatment medications were reported.  Company comment-This spontaneous case concerns a 31-year-old female patient, with no medical history reported, who experienced the serious (medically significant) unexpected events of Autoimmune thyroiditis (AESI) and Crohn's disease unspecified days after first booster dose of mRNA-1273 vaccine. No further details on primary vaccination schedule, clinical course, lab test results and treatment received were reported. Outcome of the events was unknown at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 31-year-old female patient, with no medical history reported, who experienced the serious (medically significant) unexpected events of Autoimmune thyroiditis (AESI) and Crohn's disease unspecified days after first booster dose of mRNA-1273 vaccine. No further details on primary vaccination schedule, clinical course, lab test results and treatment received were reported. Outcome of the events was unknown at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
A mother who is also a nurse, reported that her 7 month old daughter received her 1st dose of Prevnar, as well as, her 3rd dose of DTAP and Recombivax vaccines on 12/13/00 and the next day, developed induration on both sides of her right leg below the level of the Prevnar injection site. The mother stated that she feels "that the nurses technique was faulty" and the route of administration was either subcutaneous or intradermal.
Information has been received from a physician concerning an approximately 4 year old male patient who on 09-AUG-2007 was vaccinated with the first dose of MMR II (Lot number 656033/0280U, Exp. Date: 02-FEB-2009) and on 05-MAY-2010 received the second dose of MMR II (Lot number 664655/0640Y, Exp. Date: May-2011). The physician reported that "few months" after the second dose was given (approximately August 2010), the patient was diagnosed with insulin dependent diabetes. The patient was hospitalized at the time of the diagnosis. Insulin was given as a treatment for the experience. At the time of the report, the patient was still insulin dependant diabetic. This is one of several reports from the same source. Additional information has been requested.
9:30 P.M.08/04/2006 ELEV. TEMP 102.1 TOTAL BODY ACHES ( SEVERE )FEVER LASTING FOUR DAYS. HEADACHE LASTING FIVE DAYS. SUNDAY 08/06/2006 NOTICED REDNESS, SWELLING AND THE INJECTION SITE FEELING HOT , REDNESS PERSISTED FOR SEVEN DAYS.
2nd day after shot - low grade fever, fatigue, muscle aches, brief nausea and hot flashes for about 24 hours. 8th day after shot - small quarter sized rash on right arm about  3-4 inches below injection site. Does not itch. Slightly warm to the touch.
This is a spontaneous report from a contactable pharmacist. A 69-year-old white female patient received PREVNAR 13 (lot M79320, NDC number 00005197102, Expiry Date Aug2017) at 0.5ml single dose via intramuscular route for prevention of pneumonia on 05Oct2016. Medical history was unknown. The patient received unknown concomitant medications. On 08Oct2016 the patient experienced a Rash like a band across the arm, 3 inch wide at the injection site more to the size of the Band Aid. The patient described the rash as pink in color and a little itchy but not painful. The outcome was not recovered. The nurse did not think the rash was related to the vaccine. Sender's Comments: The reported event might be compatible with the known adverse event profile of PREVNAR 13; a causal relationship therefore cannot be excluded.
Patient came in with his family right at closing time on Friday.  Normally we stop giving shots at 5pm in order to have the paperwork, waiting time, etc done before closing, but we had some doses that we didn't want to waste so we agreed to administer the shots.  The checklist was reviewed for contraindications and the vaccine was administered without incident.  We waited after hours for the 15 minute observation time to pass, which was also without incident.  It wasn't until reviewing the paperwork the next day that we realized that this individual was only 15 years old.
Flu Like Symptoms; GI Symptoms; Body Ache; Joint pain; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu Like Symptoms), GASTROINTESTINAL DISORDER (GI Symptoms), MYALGIA (Body Ache) and ARTHRALGIA (Joint pain) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No medical history was reported.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu Like Symptoms), GASTROINTESTINAL DISORDER (GI Symptoms), MYALGIA (Body Ache) and ARTHRALGIA (Joint pain). On 16-Feb-2021, INFLUENZA LIKE ILLNESS (Flu Like Symptoms), GASTROINTESTINAL DISORDER (GI Symptoms), MYALGIA (Body Ache) and ARTHRALGIA (Joint pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication and treatment information were not reported.  Route of administration was reported as Deltoid Muscle (Unknown Arm).  Action taken with mRNA-1273 in response to the event was Not Applicable
Bruising at injection site / site of the injection turned black and blue then purplish; redness at injection site / large area turned red, then purplish; injection site swelling; injection site warmth / felt hot to the touch; This case was reported by a consumer via call center representative and described the occurrence of injection site bruising in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax.   On 14th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 16th March 2019, 2 days after receiving Shingrix, the patient experienced injection site bruising, injection site erythema, injection site swelling and injection site warmth. The patient was treated with antibiotics nos (Antibiotic (Drug Name Unknown)). On 21st March 2019, the outcome of the injection site bruising, injection site erythema, injection site swelling and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site bruising, injection site erythema, injection site swelling and injection site warmth to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine on left deltoid. Two days after first dose of Shingrix, the patient noticed the site of the injection turned black and blue and below the site, a large area turned red, then purplish. It was swollen and felt hot to the touch. After five days, patient went to her doctor who said it was not a systemic reaction but a topical one. The patient received an antibiotic and four to five days later, it resolved. The reporter consented to follow up.
Within 10 minutes of injection face and neck felt hot and became very flushed. Hands white and cold. Within minute or two after that face, lips, tongue, and hands became numb and tingling. Felt weak all over basically. Lasted approximately  10-15 minutes.
Rash/ multiple vesicular/ papular erythematous rash some crusting (vascular rash)
lt arm swelling, tenderness over the lt upper arm radiating up into the neck, afeb, breathing w/o diff, erythema & induration extending from the inj site up lateral arm to deltoid w/some irritation @ the bra line-erythema 14x10cm
I had more difficulty sleeping. The next morning I felt little energy. On normal days I can walk a loop trail around a lake in the mountains. However, I sat down three or four times and did not make it to the other parking lot, about 1 mile. I sat down a few times while returning to the trailhead. That afternoon, I fell asleep while sitting in my car at a parking lot for the adult center. I think I recovered as of this evening. I'm speculating whether the 2nd booster shot sapped my energy.
C/o nausea & vertigo - relieved with head down and feet up. Sips of H2O given. BP 122/84 P 64 child checked by Dr prior to leaving clinic.
Information has been received from a pharmacy student concerning a child who was vaccinated with the first dose of hepatitis B virus vaccine rHBsAG (yeast) series and "has had a cough for the past month", since approximately February 2004.  No lot number was available.  Unspecified medical attention was sought.  No product quality complaint was involved.  No other information was available.  Additional information has been requested.
HCP reporting a temperature excursion states that doses have been administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.      On 23-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), lot # T030479, expiration date 07-MAR-2022, 0.5 milliliter for prophylaxis (anatomical location and route of administration were not reported).  Digital Data logger was involved. The vaccine was stored at the temperature that was reported as -7.2 degrees of Celsius for 2 hours 21 minutes. There was a previous temperature excursion reported (-5.9 degrees of C for 2 hours 31 minutes).
Pericarditis 7/11/21 - Pericarditis: Was seen in the emergency room and then transferred to Hospital and underwent a cardiac cath which was normal.  Was treated with colchicine and discharged home on July 12.  Was seen by cardiologist as an outpatient over the next couple months  10/19/21: Had worsening shortness of breath.  Was found to have large circumferential pericardial effusion.  He had a pericardiocentesis and drain placement remove the next day.  Cultures were negative.  He was resumed on colchicine and ibuprofen  He continues to follow cardiology as an outpatient
This spontaneous report as received from a pharmacist via company representative refers to a 57 years old male patient. On 08-FEB-2014 the patient was vaccinated with one single injection ZOSTAVAX (strength, dose number, dose unit, lot # and expiry date, route unknown) for prevention of shingles. On an unknown date of February 2014, patient developed a purple bruise at the injection site after receiving the ZOSTAVAX vaccine. Patient did not sought medical attention and no lab Diagnostics Studies were Performed. The outcome of developed a purple bruise at the injection site after receiving the ZOSTAVAX was unknown. No further AE information was provided. Additional information has been requested.
This spontaneous report as received from a healthcare worker and a certified medical assistant refers to a patient of unknown age and gender. On 26-AUG-2014, the patient was vaccinated with a dose of (Merck) VARIVAX (dose, units, route of administration, anatomical location were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. No product quality complaint (PQC) involved. This is one of several reports from the same source. Additional information has been requested.
From correspondence received at manufacturer on 15 MAY 2002 it was reported that a 24 year old female patient received a Menomune A/C/Y/W-135 vaccination on 19 NOV 1995. Reportedly, the patient complained of a headache for approximately 2 days prior to 1 MAR 2000. The patient presented to the hospital complaining of headache, initially sent home. The patient went back to the hospital later that evening. Patient was diagnosed with bleeding brain stem, suffered right side paralysis, was unable to speak or swallow. The patient recovered spending approximately 2 months in rehab center. The follow up received on 5/30/02 states call to RN to verify hospitalization. Pt was in ICU on a ventilator for over a week. AFter hospitalization was transferred to a rehabilitation center. Pt stated she had regained most of her strength back. She had called to ask if there were any other cases similar to hers. She inquired about what preservative is used in this vaccine, and if thimerosal was used. Was planning to discuss this with her neurosurgeon. From additional information, it was reported that the patient's current medical condition is unknown.  From additional information received on 05May2004 from a health care professional, it was reported that there has been no contact with the pt since the event of hemorrhage occurred. No further information is anticipated, this case is considered closed.
On 5/18 I started having difficulty breathing. Had no fever, but chills and a cough developed and I started wheezing. This persisted off and on for about 6 weeks. I was prescribed a Z-pack Antibiotic and my breathing treatments were increased, but the Z-pack didn't work so I was then placed on another antibiotic which did help. In early June my SOB increased so I went to the hospital and was administered a nebulizer treatment and IV prednisone meds. As a result my PCP prescribed a titrating prednisone to help open up my bronchioles and Brio and Spiriva Respimat, albuterol and Aprivent Med nebulizer all to help with my breathing and wheezing also and to date I am currently still taking all meds.
Pt received MMR on 6/5/01 and developed acute measles on 6/11/01.
Pt fainted about 1-2 minutes after receiving the vaccine, after patient was on the ground patient began having a seizure that last roughly 45 seconds to 1 minute. Pt came to and was evaluated by MD.  vitals taken and were WNL, there was some bruising and scratches to R elbow as well as a lump to r back of head. Pt was re evaluated by physician before being medically cleared to go home.
pt admitted to hospital 3/6/22 for evaluation and treatment  of PVD with subsequent left TMA a nd right hallux amputation; given ABX; decline in renal function - started on HD; positive for COVID; DNR; pt's condition continued to decline; admitted to hospice.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 01Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Known allergies: Lactose intolerance" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; DEPLIN [CALCIUM LEVOMEFOLATE]; LOSARTAN HYDROCHLOROTHIAZIDE; METHYLPHENIDATE. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Antiviral treatment of Paxlovid for COVID 19 were started from 09May2022 to 14May2022. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.
1st 12 hours- When I got the shot, I felt that it got me a little high. Woke up with achy muscles, fever up 4 degrees, bad headache.  Weak and couldn't get up. Took Tylenol and did nothing about 12 hours in. 20 hours- Finally took aspirin and headache and fever and aches went away. 36 hours- had some pretty bad diarrhea. Low energy. 48 hours to present- Low energy
Intussusception - acute onset stiffness and crying after feeding days after vaccination with Ultrasound confirmation
Her family got Pfizer Covid vaccine primary series and boosters and all four of them still got Covid; Her family got Pfizer Covid vaccine primary series and boosters and all four of them still got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Her family got Pfizer Covid vaccine primary series and boosters and all four of them still got Covid". The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Extreme fatigue, body aches and pain, swelling in left arm where vaccines were given, itching of face and neck, patient states that swelling and itching are still occurring today 4/20/2016. Patient visited doctor and was prescribed prendnisone and Benadryl.
Per patient: she stated that she had experienced mumps and into swelling of the tonsils per MRI/CT scans
Initial and follow-up information has been received from a physician concerning a 73 year old male who on 26-SEP-2008 was vaccinated with PNEUMOVAX vaccine (Lot # 658074/0961U) (Lot # originally reported by physician as 660685/0619X) IM in his right arm (dose not reported), the patient had COPD exacerbation at time of vaccination. Concomitant therapy included amyl nitrite, GLUCOPHAGE, paroxetine and lisinopril. On 26-SEP-2008 (also reported as 29-SEP-2008) the patient developed cellulitis in the arm, arm red, swollen, painful and warm. WBC 21800. The patient was treated with KEFLEX 500mg, three times a day for 10 days. At the time of the report the patient recovered from cellulitis in the arm. The patient sought medical attention at the office. This is one of several reports received from the same source. No further information is available.
a dose of MMRII which was not supported due to a temperature excursion, was inadvertently administered to the patient; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not reported.  On 09-NOV-2020, the patient was inadvertently administered with a dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  (dose, strength, vaccination scheme, route of administration and anatomical site of vaccination were unknown, lot # S037499 has been verified as valid, expiration date 20-NOV-2021) for prophylaxis (incorrect product storage), no adverse events were reported.  The stored temperature excursion was above 8 degree Celsius (13.5 degree Celsius), time frame: 8 hour and 45 minutes, no previous temperature excursion. The temperature excursion was detected by a data logger.
Developed rash on 4/27 - progressed, Fever on 4/29. Seen at medical associates on 4/29 - Dx with serum sickness. Seen at ED on 4/29 - dx with serum sickness - given Rx for oral steroids. Seen at medical associates on  4/30 - improved, on oral steroids
Information has been received from a registered nurse concerning unspecified patients (identifier unknown). The patients were inadvertently administered doses of improperly stored GARDASIL (dose, strength and route were not reported, lot#: K005881, expiration date: 14-JAN-2017). No adverse effects were reported. Additional information has been requested.
About 2 weeks later started noticing different things in her body. Eventually started having heart palpitations, started gaining weight, thyroid issues began to worsen and she was lethargic.
Breakthrough case of COVID-19; It started on Monday June 27th with feeling hard to swallow, my throat but it was getting hard to swallow, by that evening I felt like I had full blown flu symptoms, I had chills, and aches and pains, and headache, and skin sensitivity to the touch. But no fever that I could tell of. I was on vacation so I could not take my temp. Those symptoms lasted through the night and until the next day until I went to the urgent care and got a positive COVID 19 test. My husband had been coughing two days prior and he also tested positive as well which is why I went to. I received PAXLOVID, and I started that Tuesday the 28th and the next 4 days after that. I felt after two days I felt much better. As of last Monday July 11 I was still testing positive for COVID-19.
Patient began seizure activity 3 days after receiving Flu Vaccine. Patient transported 9-1-1 to the local hospital. Patient not admitted.
Diffuse macular rash began on 13th day following immunizations. Rash has persisted to present. Some extremity / now appear like cold petechiae - clinically well otherwise.
Within 30 seconds of receiving ENGERIX B 20mcg/mL patient passed out for about 5-10 seconds. He regained consciousness, VSS. 911 called. Pt observed. Pt has h/o needle phobia.
erythema, edema, itching, warmth to the injection site lasting 6 days