chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; chest pain; rash over her left breast; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 22nd September 2019).   On 6th January 2020, the patient received the 2nd dose of Shingrix, Influenza vaccine and the 2nd dose of PNEUMONIA VACCINE (intramuscular). On 14th January 2020, 8 days after receiving Shingrix, Influenza vaccine and PNEUMONIA VACCINE, the patient experienced shingles and chest pain. In January 2020, the patient experienced rash. On an unknown date, the outcome of the shingles, chest pain and rash were unknown.   It was unknown if the reporter considered the shingles, chest pain and rash to be related to Shingrix and Influenza vaccine.  Additional details were reported as follows: The patient received 2nd dose of Shingrix vaccine and experienced chest pain and rash over her left breast. She visited her physician and was diagnosed with shingles. No other information was reported. The reporter consented to follow up.
Post vax, the pt developed temperature of 101-102, diarrhea, lethargic for the first couple of days, and red blotchy rash for one day.
Patient was administered an initial dose of the COVID-19 Pfizer vaccine. Patient's current age is 15 years, 4 months while the vaccine is authorized for patients 16 years of age and older. No adverse effects have been reported to date.
"I got real hot"; Arm pain; "I felt like I wanted to lie down, felt weak"; A spontaneous report was received from a consumer concerning a 78 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced flushing, pain in extremity and asthenia.    The patient's medical history included an open heart surgery in SEP 2019 and a procedure of cardiac stents done in NOV 2019. No relevant concomitant medications were reported.    On 19 JAN 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced events like feeling real hot, arm pain and feeling weak.  No laboratory details were provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events like flushing, pain in extremity and asthenia was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Left leg with with redness and swelling of entire thigh x 4days, mild fever 100.5 x 1 day.
Pt awoke with light headedness and fatigue. Experienced "jerking" in trunk area, had to rest on floor several time on way to kitchen. Was very weak and dropped two glasses while trying to get a drink. Had to rest on floor several times while returning to bed. Pt went back to sleep and felt better in afternoon. Felt fully recovered by following morning.
This spontaneous report was received from an office manager referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication. On 10-DEC-2018, the patient was inadvertently vaccinated with an expired dose of VARIVAX lot number M048200 and expiration date of 07-DEC-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). The lot and expiry for water sterile diluent used to reconstitute VARIVAX was unknown. No adverse effects were reported.
Patient was not at the indicated age for the moderna vaccine (18 requirement 18) at this time
This spontaneous report as received from a physician refers to a 19 year old female patient. In APRIL-1996 and MAY-1999 the patient was vaccinated with M-M-R II. On 06-DEC-2014 the patient had a panel of IgG titers drawn which were negative for M-M-R II. Please see MARRS# 1412USA007855 for event involving VARIVAX. This is one of 2 reports received from the same source. Additional information has been requested.
I developed a rash 3 weeks after my second shot on my legs arms stomach and back. Not going away does not itch red spots doctor treated with ABx didnt help gave me prednisone no help. Today noted blood when I wiped saw blood and clots in toilet my period just went off last week now I'm bleeding again this has never happened before.  I am very concerned please contact me asap
I wanted to report that 10 hours after having the shot in the right arm  I had fly like sypmtoms. Very achy and most uncomfortable in back and hips tiredness. The next morning I had a headache that last a few hours. By 4pm the next day I felt better just a little tired.
MODERATE PAIN IN LOWER EXTREMITIES (FOCUSING ON HIPS/KNEES). TO TREAT: LOCAL WARMTH, FLUIDS, IBUPROFIN.
Chronic sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Chronic sinus infection) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SINUSITIS (Chronic sinus infection). At the time of the report, SINUSITIS (Chronic sinus infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.  Patient received first dose a week or so ago and since patient had chronic sinus infection. Healthcare professional (HCP) told patient to take antibiotics. Patient wanted to know if taking these could affect vaccine's efficacy.
headache,body aches,pain in arm,pain in area. Told Patient to use tylenol or Motrin,also try ice pack & massage on the area to try & relieve symptoms.
Mild asthma triggered; Extremely itchy skin; This is a spontaneous report from a contactable consumer, the patient and contactable health care professional. A 42-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on right arm on 25Mar2021 at 04:45 (at the age of 42-year-old) as a single dose, for COVID-19 immunisation. Medical history included asthma, chronic fatigue disorder and anemia. The patient had allergy to naproxen sodium (ALEVE). Concomitant medications included lamotrigine (LAMICTAL), bupropion hydrochloride (WELLBUTRIN), cetirizine hydrochloride (ZYRTEC), Montelukast sodium (SINGULAIR) and liraglutide (SAXENDA). The patient did not receive any other vaccine in four weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not tested for COVID-19. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on left arm on 05Mar2021 at 04:45 (at the age of 41-year-old) as a single dose, for COVID-19 immunisation. On 25Mar2021 at 22:00, the patient had mild asthma triggered (just needed her inhaler) and extremely itchy skin. The patient had not received any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events mild asthma triggered and extremely itchy skin were unknown at the time of this report.  Information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a other health professional via sales rep and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. On 7th September 2018, the patient received SHINGRIX. On 8th September 2018, 1 days after receiving SHINGRIX, the patient experienced shingles and pain in arm. On an unknown date, the outcome of the shingles and pain in arm were unknown. It was unknown if the reporter considered the shingles and pain in arm to be related to SHINGRIX. Additional details were reported as follows: This case was reported by Medical Assistant. The age at vaccination was not reported. The sales representative reported the adverse events he heard, by email. The reporter had a patient who reported incidents on 9th September 2018 to the clinic. It was stated that, the day after receiving SHINGRIX, the patient experienced shingles on his shoulder. The patient also said that his arm where he received the vaccine hurt badly. This case was linked with US2018167299, reported by same reporter.
This is a spontaneous report from a contactable physician through a sales representative. This physician reported the same reaction for two patients. This is the first of two reports. A patient of unknown age, gender and ethnicity received on an unknown date a single dose of PREVNAR13 in arm. Medical history and concomitant medications were not reported. On unspecified date in 2014, within last 3-4 weeks before this report, both patients had like a reaction on their arms that their arms swelled up and they had a large reaction from the shot. After a week, the patient visited the physician and a treatment was provided. Outcome was unknown. Follow-up (05-NOV-2014): Follow-up attempts completed. No further information expected.
Itchy chicken pox rash on both arms & face for 2 days. Treatment = AVEENO bath & BENADRYL.
joint pain; skin lesions; sores; fatigue; headache; This is a spontaneous report from a contactable consumer(patient). A 41-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP7534) via an unspecified route of administration, administered in Arm Left on 29Mar2021 09:30 (Age at Vaccination 41-year-old) as single dose for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history was not reported. concomitant medications included alprazolam (XANAX). Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP6955) via an unspecified route of administration, administration in Arm Left on 08Mar2021 10:00 AM (Age at Vaccination 41-year-old), as single dose for COVID-19 immunization. The patient has no reported allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 31Mar2021 covid test post vaccination negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. patient became sick 11 hours after first does and was ill for two days took a full week for nausea and fatigue and headaches to improve. On March 19th my period was late and by the 22nd when it started I had to be hospitalized for hemorraging and a strange Blister was on my left breast over the next two weeks I broke out with multiple sores all over the left breast and still am and was diagnosed with Erythema multiforme major from a autoimmune response to the vaccine. Multiple ER and urgent care visits resulted as I was first misdiagnosed with Shingles. Then I started bleeding again only 14days after my period ended again. The pain and bleeding was intense. I have never had irregular period in my life until the vax. The patient was hospitalized for hemorraging from 22Mar2021 to an unknown date for 1 days. The patient did not receive treatment for the events. The patient second shot on March 29th and the skin lesions and sores continue to appear as well as fatigue, headache and joint pain. and never had skin issues or irregular or painful periods with this much bleeding. Patient underwent lab test which included SARS-CoV-2 test Negative on 31Mar2021.The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Information has been received from the CDC concerning a 3 year old child who on 7/17/98 was vaccinated with varicella virus vaccine live. Subsequently the patient experienced 50-250 lesions of chickenpox and a fever that lasted approximately 4 days. Unspecified medical attention was sought and it was noted that the child had four fold rise in the antibody titer. Additional patients (WAES01034332,01034334-0103435) also developed chickenpox  following exposure to varicella virus vaccine live.
Patient seen in the ED on 9/26 for fever, difficulty breathing, and suspicion of COVID. Of note, he had right eye cataract surgery on 9/26. After the surgery, the patient reported weakness in the legs, increased shortness of breath, cough, and fever of 102.7 F. He was tested for COVID in the ED which came back positive. Patient was admitted on 9/26 for acute hypoxic respiratory failure due to COVID infection. He was placed on supplemental oxygen. At time of reporting (9/30), patient was still admitted to the hospital.
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 15-MAY-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # N020016 and expiry date 17-JUL-2019) and no adverse effects were reported(product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter.
Swelling, warmth, erythema, tenderness of Left upper arm with extension to shoulder and upper scapula and down arm toward elbow.
patient happened to came back to pharmacy when his wife was getting second dose of moderna and when asked why he was not getting his second dose he said that he had developed a blood clot in his eye 10 hours after getting the vaccination and that he was not getting the second dose until he saw his eye doctor about it - not sure if it was related to vaccine or not
Tinnitus, ringing & buzzing in the ears.; This is a spontaneous report received from a non-contactable consumer (patient himself). A 67-year-old-male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6202) via an unspecified route of administration in left arm on 24Mar2021 13:00 as dose 2, single (at the age of 67-years-old) for COVID-19 immunization. Patient medical history included hypertension. Patient had no known allergies. The concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6203) via an unspecified route of administration in right arm on 01Mar2021 12:00 as dose 1, single for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Patient has not been tested for COVID-19, since the vaccination. Patient did not receive any other vaccine in four weeks. Patient did not have COVID-19 prior to vaccination. Patient was not tested for COVID-19 post vaccination. On 20May2021, the patient experienced tinnitus, ringing and buzzing in the ears. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient did not receive any treatment for the adverse events. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Adult dose vaccine was accidentally given to the pediatric patient.  Patient does not have any adverse reaction as of right now.
pt recv vax 14APR97 & 4AUG97 pt devel a scattered, papular, vesicular rash on chest, neck & ears w/approx 15 lesions;it was mildly itchy;6AUg97 pt was seen in MD office & was dx w/chickenpox & OM;
Awoke from nap Saturday 10/3 & swelling of L arm; arm warm to touch. Fever of 103 F 10/3 night. Seen by Pediatrician 10/4 and lines drawn around redness & swelling. Erythema extended past lines. Started on Keflex for cellulitis. To ER 10/5 for x-ray of extremity which was negative.
Patient presents to the emergency department after 3 episodes of bloody vomiting and diarrhea early that day. He also complains of dizziness, and abdominal pain. He required 2 units of PRBC in the ED. He was admitted for further management of GI bleed. He was discharge home 3 days later in stable condition.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant products were not provided. It was reported that the vial did not undergo temperature excursion and it was unknown when the vial was initially stored in the refrigerator. Treatment medications were not reported. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains Non-significant information.
Significant swollen of lymph nodes above left clavicle and tender. Discomfort/pressure into left side of neck
Information has been received from a Licensed Practical Nurse referring to unspecified number of patients of unknown age and gender. The patients' medical history, concomitant therapy and drug reactions were not reported. On unspecified dates, the patients were vaccinated with improperly stored VAQTA (dose and routed unspecified) (lot # L018499, expiry date 25-FEB-2017, ten doses totally, or lot# K018181, expiry date 04-JUN-2017, 3 doses totally). No adverse effects were reported. This is one of several reports received from same reporter. Additional information has been requested.
Pt developed fever 7/16/10, seen in clinic on 7/18/10, 7/19/10 and 7/20/10 for fever with rash, vomiting and diarrhea - presumed to be viral syndrome with erythema multiforme, continued to have fever, so was admitted for r/o Kawasaki on 7/22 - 7/25/10 - Pt developed fever on 7/16/10. Was seen in clinic on 7/18/10, 7/19/10 and 7/20/10 for fever with rash, vomiting, diarrhea - presumed to be viral syndrome with erythema multiforme. Continued to have fever >5 days, so was admitted from 7/22/10-7/25/10 for rule out Kawasaki disease. At that time, labs showed normal WBC, Hb and platelets; CRP > 27. Eventually, pt also developed albumin 2.8, Hb 9.3. Stool cultures positive for C. diff, so pt was discharged with 10 day course of PO FLAGYL. Continued to have low grade fevers, so was readmitted for r/o incomplete Kawasaki disease. At this admission pt with WBC 30K, ESR 95, CRP 17, Hb 9.4, Platelets> 450K, albumin 3.0, Na 133. Received IVIG and started on aspirin. Echocardiogram with + proximal coronary aneurysms.
pt admitted to hospital with AHRF secondary to COVID pneumonia; positive for COVID; severe sepsis; acute multiorgan failure; poor oral intake; generalized weakness; placed on BiPAP; acute hepatitis secondary COVID infection; acute on chronic renal failure; HTN; given IV ABX, Dexamethasone; IV fluids; pt's condition worsened; AMS, lethargy; CT showed acute CVA secondary to COVID infection; transitioned pt to DNR, comfort care; pt passed away in the hospital
Within 2 hours, felt like throat swollen, difficulty breathing.  Could not swallow, low grade fever (99.7) Body aches, hoarseness.  Felt a little like flu.  Extreme fatigue.  Was seen following day by Dr.
His wife reported shingles after receiving the second dose of the Pfizer COVID-19; gotten a rash that covered most of her body after receiving Pfizer vaccine; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included varicella and herpes zoster when she was pregnant. The patient's concomitant medications were not reported. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) on an unspecified date for COVID-19 immunization. It was reported that on an unspecified date in 2021 the caller was calling regarding his wife as his wife reported shingles after receiving the second dose of the Pfizer COVID-19 vaccine. Caller wanted to know if Pfizer can provide precaution recommendation or information for his 15-year son, so he did not get similar side effects as his mother. Caller stated he read an article in US. There were few reports of people who previously had chicken pox reporting an outbreak of shingles after receiving the vaccine. Caller also stated that his wife received the vaccine and gotten a rash that covered most of her body after receiving Pfizer vaccine and lasted for about a week. The outcome of shingles after receiving the second dose of the Pfizer COVID-19 was unknown while rash was recovered on unspecified date in 2021.  Information on the lot/batch number has been requested.
I got my first Janssen vaccine on 4/6/21 with no problems and that lot # is 041A21A.  I got the Janssen booster on 11/2/21 and I believe I started to get an itchy rash on the top of my forearms end of December or beginning of January with maybe some other allergic symptoms before...not sure.  I went to my primary and she thought it may be from the booster.  I was given steroids and topical steroids and it didnt go away.  I then went to the Dermatologist and they thought it was possibly lichen planus and they gave me topical steroids which helped that area.  I now have itchy spots all of my body and I have gone to the Dermatologist and they are going to do a biopsy to figure out whats going on.  I am not sure if its related but it is very ironic that I am having this major issue that I have never had even a tiny problem with before.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 11-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L028666, exp. date: 04-NOV-2016) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.