chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H20A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14-JUL-2021contains significant information : Address and email were added, first dose start date and second dose details were added
She got tested with the COVID saliva test on 09Jan2021 and tested positive; She got tested with the COVID saliva test on 09Jan2021 and tested positive; headache; not feeling well; fell super run down; This is a spontaneous report from a contactable consumer. A 47-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EH9899) via an unspecified route of administration at single dose arm left on 06Jan2021 16:45 for covid-19 immunisation. Medical history included allergy induced asthma, neoplasm malignant since 2011 (reported as 10 years ago), ongoing white blood cell count decreased. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT) for allergy induced asthma, cetirizine hydrochloride (ZYRTEC) for allergy. No other vaccine was received in four weeks.  Patient had headache on 09Jan2021, not feeling well on 09Jan2021, fell super run down on 09Jan2021. The patient got tested with the covid saliva test on 09Jan2021 and was positive. Patient just wanted to know if she can go forward to 2nd dose. The outcome of headache was not recovered, of fell super run down was recovering, of the other events was unknown.
Initially began with tingling in hands, feet and lower legs, face.  Progressed to full body tingling with body ?buzzing? like an adrenaline rush. Increased heart rate and blood pressure. Minor tingling continues through this report. No full body experience in last 24 hours.
devel varicella 3yr p/vax;@ least 200 lesions;reported by parent-never seen by MD;
Pt has a history of CAD status post CABG.  Presents to ED with increased shortness of breath.  Admitted with COVID-19 infection with pneumonia with acute hypoxic respiratory failure.
CHILLS; FEVER; This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 03-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210437834.
Pain in left leg 12 hours after shot.  Also pain to right hip area.   feeling of weakness,.  On and off Hot and Cold with sweating.  Sunday evening developed an enlarged lymph node in my left axilla and this morning developed left neck lymph node swelling.    All the other symptoms are gone but lymph node swelling is still present
Received Herpes Zoster Vaccine 5/8/2008 got rash on L eyebrow - forehead (slight) no blisters. Oct 11, 2008 - went to eye Dr - clear. Nov 23 2008 - L eye irritated, red. Dec 4 2008 herpes zoster in L cornea still going to Ophthalmologist.
Pt was hospitalized on 10/26 with covid and sepsis. Pt died.
on 10may89, had pain & tenderness of the spine and lt jaw & paresthesia;ANA RF-neg;Dx:Fibromyalgia, anxiety, depression & TMJ pain;16may89 MRI-head and spine- nl;
Immediate shoulder pain that became gradually worse over from October 2021 to the present October 2022. I had reported the left shoulder pain to a physician and as pain became unmanageable reported again in June 2022  to another physician who was dismissive - said couldn't possibly be SIRVA. Also reported extreme numbness in both left and right arms, especially at night. After trying to manage pain on my own I finally pressed for an MRI and by  October 2022 the MRI revealed Adhesive Capsulitis in the left shoulder. Symptoms are extreme pain, inability to use left limb to lift or carry, no range of motion, sleeplessness every night from pain and constant numbness. This issue has required modification of work duties at the University where I am employed. I am currently applying for FMLA in my workplace of 21 years. I am currently getting acupuncture weekly and physical therapy, but the pain and numbness persists.
dizzy / third shot dizzy; allergy attack; second shot sick two days; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy / third shot dizzy), HYPERSENSITIVITY (allergy attack) and ILLNESS (second shot sick two days) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizzy / third shot dizzy), HYPERSENSITIVITY (allergy attack) and ILLNESS (second shot sick two days). At the time of the report, DIZZINESS (dizzy / third shot dizzy), HYPERSENSITIVITY (allergy attack) and ILLNESS (second shot sick two days) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported.
Information has been received from a RN concerning a 6 year old female with allergies to "sulfa" and PCN and with a medical condition at 34 weeks gestation (mild eczema) who on 11/07/00 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (Lot # 634843/1868J).  It was unknown if there was an illness at the time of vaccination. There was no concomitant medication. The pt developed mild varicella on approximately 01/16/04.  Follow up information received from a RN indicated that on 01/23/04 the pt developed 2 pox bumps after being vaccinated against varicella (and after being exposed to varicella). No other symptoms were noted. The duration was unknown to the reporter. No treatment was ordered. There were no relevant diagnostic tests or lab data. The outcome was reported as recovered. The reporter also indicated tat 2 of the pt's siblings developed mild varicella after vaccination with varicella virus vaccine live (WAES # 0401USA01995 & WAES # 0402USA01297).  No further information is expected.
There were two reactions. Both were the same. I didn't record the first time. They happened about 3 days apart. The second came on suddenly. Beginning at 8:24 p.m. Tachycardia 115 b.p.m. Didn't start to slow down for about 30 minutes. One and a half hours later the pulse started to slow to 84 b.p.m. Was well over 2.5 hours until down to about 70 b.p.m. During the entire time my b.p. never went above 110/71. I stayed home and didn't contact my doctor. Days followed everything was normal. Will not be receiving the second shot.
Rash which appeared consistent with Id reaction on left upper arm near site of Menactra vaccination.
Information has been received from internet concerning a 7 year old male patient who on an unspecified date was vaccinated with a booster dose of VARIVAX (Merck) (manufacturer unspecified) and a dose of VAQTA (manufacturer unspecified). Subsequently the patient experienced anaphylaxis. The patient was given skin-prick tests for components for both vaccines, including gelatin for VARIVAX (Merck) (manufacturer unspecified) and neomycin for VAQTA (manufacturer unspecified). The patient had a reaction to gelatin and a strong reaction to VARIVAX (Merck) (manufacturer unspecified). The reporter felt that anaphylaxis was related to therapy with VARIVAX (Merck). At the time of the report the patient's status was unknown. He was told to avoid dietary gelatin. Upon internal review anaphylaxis was considered to be other important medical event. This is one of several reports received from the same source. Additional information has been received from a literature article concerning 7 year old male with a history of mild intermittent asthma and no previous reactions to foods, vaccines or antibiotics, who on an unspecified date was vaccinated with a second dose of VARIVAX (Merck) (manufacturer unspecified) and a dose of VAQTA (manufacturer unspecified). The author's described a case of anaphylaxis from varicella vaccination secondary to gelatin hypersensitivity. Two minutes after received both vaccines, he developed urticaria, angioedema and dyspnea. He received prednisone and diphenhydramine before being sent to emergency department (ED). In the ED, he was tachycardic and tachyponeic, and had wheezing, urticaria and facial angioedema. His symptoms resolved after he was treated with intramuscular epinephrine. The patient was discharge that day and came to the reporting physician's clinic one week later. His initial evaluation revealed negative percutaneous testing for food allergens including yeast (VAQTA component). Further assessment included percutaneous testing for both vaccines and the associated vaccine components, including neomycin and gelatin. There were negative reactions to VAQTA and neomycin a small wheal-and-flare reaction to gelatin, and a large wheal-and-flare reaction to VARIVAX (Merck) (manufacturer unspecified). The patient developed systemic symptoms (i.e. rhinorrhoea, conjunctivitis) within seconds of testing with the varicella vaccine. The patient received EPI-PEN and was instructed to avoid dietary gelatin. No further information is available.
received their First dose of the pfizer covid vaccine on 24Mar2021; a week and half later they were tested positive for covid.; This is a spontaneous report from a Pfizer sponsored program. A contactable pharmacist reported. A 41-year-old male patient received first dose of BNT162B2 (Solution for injection, Lot number: unknown) on an unspecified route of administration on 24Mar2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medication was no reported. Question: (caller was offered to be connected with safety department but caller refused, e-transmitted the AE) (Name) transferred the call. caller stated two patients (41 years old male and 40 years old female) received their first dose of the pfizer COVID vaccine on 24Mar2021; a week and half later they were tested positive for covid. caller needed information about the second dose. The outcome of the event was unknown.; Sender's Comments: Due to implausible temporal association, the events of COVID 19 is assessed as unrelated to vaccine. The patient has taken Vaccine 12 days prior to developing COVID 19, while it is known that it takes 14 days to develop antibodies and for the vaccine to work against SARS CoV-2 virus.,Linked Report(s) : US-PFIZER INC-2021434766 Same reporter/drug/AE, different patient
rash all over their body; This case was reported by a nurse via sales rep and described the occurrence of generalized rash in a 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 generalized rash. On an unknown date, the outcome of the generalized rash was unknown.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-OCT-2022 Reporter's comment: The nurse reported that the patient received a dose of Shingrix and got a rash all over body. The reporter was unsure if either was reported so reporting since it was unknown. The reporter stated that he gave a lot of Shingrix and these were the only two times he had this reaction. The reporter did not agrees to follow up from GlaxoSmithKline. Additional Supportive Information: This case had been linked with US2022AMR159094, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR159094:Same reporter
4/13/13 following vaccination had redness and firmness of upper arm where shot given. Developed several small blisters at the injeciton site over the next 24 hours through 4/14/13. Was seen on Monday 4/15/13 and found to have reddened firm area on entire upper arm (R) with blisters at site, used cortoid cream and cool compesses overnight. On 4/16 had 3" reddened area at site and no blisters. Symptoms continued to subside over the next 2-3 days and was back to normal.
Pt received ZOSTAVAX on 3/17/08 SQ to upper left arm.  Developed 2 small red blisters (base 0.5cm) not inflamed at injection site as observed by PCP on 6/10/08.
Started with fatigue and body aches the evening after vaccination, which continued for 3 days.  Developed rash all over body 3 days post-vaccination.
Deep muscle pain in shoulder, shoulder blade, upper arm and lower arm. Could not use arm for normal activities. Very painful to move arm. Also had nausea.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Possible rhythmic jerking three days after vaccine was administered. Referral made for pediatric neurologist.
Reported Symptoms:  10013573:DIZZINESS;  10016178:FALLING DOWN;  10042772:SYNCOPE;  10047862:WEAKNESS;  10084268: COVID-19;      NARRATIVE: Patient received three doses of Pfizer COVID 19 vaccine in Jan/Oct 21. The patient presented to the ED on 31 Dec 22 with severe weakness that caused the patient to fall.   The patient was admitted for COVID-19 observation.   The patient was discharged in stable condition on 3 Jan 2023.   Reported per EUA. Other Relevant HX:   Other: COVID 19, severe weakness and fall
9 hours after vaccine sever pain entire arm and neck, fever 1005 oral, nausea, chills, body ache, insomnia, slowly recovered over 3 days, 1st time Pneumonia shot gets Flu vaccine every year.
pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 01-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). On 01-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant meds were provided. No treatment information provided.
Patient's husband called for his wife two days after having received the vaccine with c/o redness, swelling, and pain at the injection. She also had chills with no fever, and a splotchy rash on the affected arm to her elbow. It was described as being much worse than any vaccine she had recieved. Arm felt heavy and had a lot of pain when moving it. Symptoms had gotten a little better today so they opted not to have evaluation by provider. She will continue to monitor the area, apply compresses, and take oral anitinflammatory for the pain. She will present to be seen if symptoms do not improve or worsen in the next day.
pain; hot at the touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain) and VACCINATION SITE WARMTH (hot at the touch) in a 79-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pain) and VACCINATION SITE WARMTH (hot at the touch). At the time of the report, PAIN (pain) and VACCINATION SITE WARMTH (hot at the touch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-018154 (Patient Link).
5-10 minutes after administration, patient experienced the following adverse reactions to her first dose COVID Vaccine:  On-site Lead medical physician, MD, was notified and patient was moved from observation open area to sectioned area for patient care.  Nausea/vomiting, sweating, shaking, decreased blood pressure (90/40), tingling tongue.  Patient was given 25 mg Benadryl  per oral. 911 was called . Patient's blood pressure increased to 100/60 within 5 minutes.  Patient's condition improved prior to EMT transport.
Feel like a zombie: can't stay awake, after booster; Feel like a zombie: can't stay awake, after booster; Feel like a zombie: can't stay awake, after booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received third dose of bnt162b2 (BNT162B2, Batch/Lot number: unknown) as DOSE 3 (booster), SINGLE for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 Immunization; Bnt162b2 (2nd dose), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), FEELING ABNORMAL (non-serious), SOMNOLENCE (non-serious), outcome "unknown" and all described as "Feel like a zombie: can't stay awake, after booster".  Additional Information: Caller states she was calling about the PFIZER, COVID shot, all three. She explained that she was a live in caregiver, and she takes care of a patient that has a kidney transplant and a severe diabetic. Caller states she is good at being a caregiver. She stated that herself, and the man whom she caregivers with the kidney transplant and diabetes, both had the Pfizer COVID vaccines. She stated herself, and the man she caregivers, just got the booster COVID vaccine at the end of 30Oct2021. She stated since that time, both herself and the man she caregivers feel like zombies, as they cannot stay awake.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The day after patient received the vaccine he developed a red, raised swollen spot on his right thigh. Mother called and sent photos of leg to PCP. Patient was advised to be seen at an urgent care clinic. PCP then consulted with infectious disease on how to proceed. PCP was advised to have patient seen by Allergist/Immunologist to see if patient is allergic to something in the vaccines or something that is used in prep and admin of the vaccine.
Vomiting about 14 hours after vac every 15 minutes for 4 hours, fever 100.2, chills, terrible headache after 20 hours or so.
This spontaneous report as received from a pharmacist refers to a 67 year old female patient who is allergic to DEMEROL and DARVIN. Pertinent medical history was none. On 20-APR-2013 the patient was vaccinated with ZOSTAVAX (Lot number and expiry date was not reported), 0.65 milliliter (ml), subcutaneously. Concomitant medication was none. On 22-APR-2013, the patient developed 3 bumps on their forehead after receiving ZOSTAVAX. Diagnostic test performed was none. The patient sought medical attention (called the pharmacist) and no treatment was provided. The outcome of 3 bumps on their forehead was reported as not recovered/not resolved. Additional information has been requested.
05/12/2021, I got up in the morning with sore throat, congestion, aches and pains, headache, runny nose, dizziness.  I could not get out of bed.  I was like that for a couple of days.  I felt better on the 4th day.  I lost a lot of weight.  I could not eat. Teeth have severely cracked and decayed. In June, I went to the emergency room and I had an acute respiratory infection.  I also had rectal bleeding. In August, I had hives from head to feet.
Flushing; HR 88; RR 16; O2 sat 99%.  Given 16 oz water & 1 pack graham crackers. Pt stable & released from vaccination site with sister.
Patient developed nausea, vomiting and headache after vaccine. Patient was given steroids, benadry, pepcid, with improvement of symptoms
Had generalized itching on back and arm (bilateral). Given Benadryl 25 mg PO x1, ice pack applied with little relief, given another Benadryl 25 mg PO x1. Reported relief after 10 min. Stable, released from vaccination site.
Began to get red blotches that turned into hives with severe itching. Called the d/o and spoke with receptionist.  Was told to take 2 Benadryl and wait to see if the itching dissipated.  Took the Benadryl a within 2 hours symptoms gone.
Fluid in Lungs; foot Swelling; Difficulty breathing; This case was reported by a other health professional via call center representative and described the occurrence of pulmonary edema in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number AL34K, expiry date 28th February 2022) for prophylaxis.   On 23rd November 2020 10:20, the patient received the 1st dose of Shingrix (intramuscular). On 23rd November 2020, less than a day after receiving Shingrix, the patient experienced pulmonary edema (serious criteria GSK medically significant), swelling of feet and difficulty breathing. On an unknown date, the outcome of the pulmonary edema, swelling of feet and difficulty breathing were unknown.   It was unknown if the reporter considered the pulmonary edema, swelling of feet and difficulty breathing to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in right deltoid and later that day she went to the emergency room for difficulty breathing, foot swelling and fluid in lungs. The reporter consented to follow up.
On April 21, 2021 I noticed pain in my left arm(Injection site). On April 22, 2021 my left shoulder had become swollen(bigger than a baseball), red, hot, and sore.  On April 21, 2021 I also experienced uncontrollable chills/loss of movement and speech.
Temperature of 102.6 despite Motrin 800 mg X 2 (total dose 1600 mg). Complaints of extreme shivering, body aches, she states she felt like "someone was breaking her bones" all over her body.