chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Almost immediately after giving the injection  for the janssen covid vaccine, the patient felt light headed and dizzy.  After asking if it was ok,  I rolled up her jacket and put it on the floor and assisted her in laying down with her feet up on a chair.  After less than 5 minutes the patient felt better, got up, and sat in one of our designated post-vaccine chairs to finish out the 15 minutes. When asked, she stated that she had a similar reaction to another injectable at the dr office and she wasn't too concerned.  Before leaving, her husband had come to meet her (he was already in the store) and she said she was feeling fine.
On 10/7/21 about noon started with pain in the L armpit that continued to worsen and move into the L breast. Got home from work around 7 pm and took a shower and noticed my armpit was swollen and tender to touch. Continued with pain and swelling to the area which was the size of a baseball. Woke up around 0300 10/8/21 with what felt like my chest pounding. It didn?t hurt just felt like my heart was beating abnormally. Check my watch and it showed frequent pvc?s. This continued to worsen and nausea started. Pvc?s are still continuing and are more frequent. Nausea has persisted still at date of writing this. Swelling and pain in armpit has gone down.  Had ekg done at work which showed frequent pvc?s also on 10/11/21.
Within 2 hrs after administration, pt had fever, chills, nausea, vomiting, itching at injections site, slightly itchy all over, overall redness, muscle weakness.
pt stated that right after he got the vaccine, "within a few minutes", started to have chest tightness.  they didn't tell him that it was a concern.  Pt states that the chest tightness has gotten worse as the day went on , and had to come outside to get some air and it hasn't helped.
w/in 1hr of vax above eyes & around eyebrows became red & started swelling;had given APAP;saw family MD in early afternoon;recommended cold compress for eye & DPH;breathing OK;t99.4 ear;pt hyper for 2-3hr;
RECEIVED PFIZER COVID VACCINE 02/19/21 REPORTED TO ER ON 02/20/21 WITH LOWER ABDMONIAL PAIN.  DIAGNOSED WITH DIVERTICULITIS AND LOWER ABDOMINAL PAIN AND THEN DISCHARGED FROM THE ER.
Information has been received from a RN who is the grandmother of a pt who about 2 years ago, in  approximately 2002 was vaccinated with a SC 0.5ml dose of varicella virus vaccine, live. Subsequently, the pt was getting over a "breakthrough case of varicella" No TX  was required. Unspecified medical attention was sought. There was no product quality complaint involved. At the time of the report the child was 5 years of age. The reported also mentioned another grandchild was vaccinated with a dose of varicella virus vaccine, live and experienced a simialr reaction. WAES 0405USA01744.  Additional information has been requested.
Developed chronic Tonsillitis (Strep A), unable to treat successfully with antibiotics, resistant to multiple/various antibiotics, constant inflamed sore throat after vaccine. Never experienced this before like this. Will need to have surgery as no treatment has worked.
given the Moderna vaccine to a 14 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (given the Moderna vaccine to a 14 year old) in a 14-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (given the Moderna vaccine to a 14 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (given the Moderna vaccine to a 14 year old) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reporter was not sure if it was the patient's first or second dose. Everything was okay.  No treatment medication was reported.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 27-SEP-2016, the patient was vaccinated with an expired dose of ZOSTAVAX injection (lot# L011534, expiry date 03-JUL-2016; dose and route of administration were not reported). There were no concomitant therapies reported. The patient did not report any adverse experience to the pharmacist. There was no product quality complaint involved. Additional information is not expected as the reporter refused consent for follow-up.
On April 26, 2007 patient became jaundiced, felt feverish (she did not measure her temp), had some itching, diarrhea, and orange-colored urine.  Other than feeling tired, she did not feel "sick".  She saw her PCP on 4/30.  He obtained urine and blood and referred her to her oncologist.  Patient saw her oncologsit on 5/1. Serum obtained for liver function tests and a liver ultrasound scheduled for 5/2/07.  Oncologist also referred her to Health Department, where vaccine was administered.  Patient's condition is improving at this time, but she has not fully recovered.
Pain and throb on left upper arm. Taking ADVIL for a regular basis. Constant discomfort.
Bilateral pulmonary emboli; A Spontaneous report was received from a consumer concerning a 90-Years-old male patient who received both doses of Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bilateral pulmonary emboli.   The patient's medical history was not provided. NO Concomitant medication was reported  On  15 Jan 2021, the patient received their first planned doses of mRNA-12 (lot no: 012L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 12 Feb 2021 prior to the onset of the events, the patient received their second planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 16 Feb 2021, the patient was hospitalized due to Bilateral pulmonary emboli.  Treatment for the event included apixaban for blood thinning and Atorvastatin which was stopped a month before was restarted.  The action taken with the drug in response to the event is unknown.  At the time of this report, the outcome of the event Bilateral pulmonary emboli was considered resolved.; Reporter's Comments: This case concerns a 90-Years-old, male patient who experienced serious event of Bilateral pulmonary emboli. Treatment for the event included apixaban and Atorvastatin (which was stopped a month before) was restarted. Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
headache; Felt really tired; Rash on arms neck and torso; This case was reported by a consumer via call center representative and described the occurrence of headache in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th May 2019, the patient received the 1st dose of Shingrix. On 15th May 2019, less than a day after receiving Shingrix, the patient experienced headache and tiredness. On 16th May 2019, the patient experienced widespread rash. On an unknown date, the outcome of the headache, tiredness and widespread rash were recovered/resolved.   It was unknown if the reporter considered the headache, tiredness and widespread rash to be related to Shingrix.  Additional case details were reported as follows: On 15th May 2019, evening the patient started getting a headache and felt really tired.  The next day she developed a rash on her arms neck and torso. The rash resolved after about 3 days.  The patient saw her healthcare professional for the rash and was referred to an allergist.  The allergist thought that the rash was probably due to an immune response, but the rash had already resolved by the time she saw him. The reporter consented to follow up.
39-year-old male who was admitted with a 1 day history of chest pain on 5/15/21.  Initial labs showed elevated troponin with diffuse ST changes consistent for myopericarditis.  Patient had his second dose of the Pfizer Covid vaccination on May 12.  Patient was initiated on colchicine with improvement in his symptoms.  Echocardiogram performed showing normal LV function with no significant valvular abnormalities.  Patient was seen by cardiology, plan for 3-month treatment with colchicine and high-dose ibuprofen for at least 2 weeks until CRP has normalized.  Patient will be on PPI while continuing his medications.  Outpatient cardiac MRI will be completed.  Patient discharged home in stable condition.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a five-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. FLUMIST was given intra-nasally for flu prevention. The product expired on 04-Mar-2012. On 09-Mar-2012, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was obtained on 17-Apr-2012: Suspect drug information and the reporter stated that the patient did not experience any late occurring adverse events.
myocardial infarction w/in 24hr of both pneumovax & flu inj;
Client's mother called and states client woke up this morning and found that she had a welt the size of a silver dollar on the side of her Right arm, it itches/burns so much "she wants to rip her skin out," it hurts to move the arm so much that she did not go to school 11/4, felt normal other than arm hurting.  Mother gave client Benadryl and Ibuprofen. F/u tc 11/5 mother stated clients welt was larger, the size of a manderine orange, temp 99.6 11/5. Recommended mother call cl's Dr. both 11/4 and 11/5, which mother states she did.  TC f/u with mother some weeks later (date not recorded), mother states cl recovered w/o problems.
Headache, neck pain, stiffness, fatigue and incredibly sore arm lasting days.
Pt had a flu shot and 20 minutes later got "sudden hot flash" and "felt heart racing."  Instructed him to follow up with his physician.
1st dose on 23FEB2022, 2nd dose on 12AUG2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 71-year-old male patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 23rd February 2022).   On 12th August 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 12th August 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 08-Sept-2022 Reporter's comment: The pharmacist reported that the patient received 2nd dose delay due to unknown reason. Nothing else was reported. The reporter consented to follow-up. Additional supportive information: The patient received 2nd dose of Twinrix later than the recommended interval, which led to lengthening of vaccine schedule.
MISSED TO TAKE THIRD AND FOURTH DOSE ON SCHEDULE; A spontaneous case report was received from a nurse on 19-Jun-2019 for two consumers.  Based on the information obtained from the nurse, two individual case safety reports PVX201906-000516 (PVX2019-1598; husband) and PVX201906-000517 (PVX2019-1599, wife) were created and cross-linked in the database.  This case describes a 63-year-old adult male consumer who "missed to take third and fourth dose on schedule", while being on oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took the first two dose of Vivotif on 03-Jun-2019 and 05-Jun-2019. Then, he went to a non-endemic zone trip from 07-Jun-2019 to 17-Jun-2019. Hence, missed to take the remaining two doses.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed to take third and fourth dose on schedule" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed to take third and fourth dose on schedule" was considered as not applicable. US-PaxVax Berna GmbH-PVX201906-000517:
13th, I noticed some redness on the site; it started to spread quickly - it was probably 6 inches by 3 inches of a warm spot. And tender and swollen. I did a telehealth appointment with a physician  through a service at work (physician's through Hospital - the doctor was ) and they said since it was warm to the touch and swollen they wanted to give me a prescription of Keflex for 10 days in case it was cellulitis. Next day (after I got on the Keflex) it was so swollen it was like the size of golf ball and I had a low grade fever of 99.5 and my arm hurt really bad. I took Tylenol and did cold compresses and it was still very painful. I went to my Dr in person on January 14 and he just said to continue on the antibiotics and if it didn't get better in a couple of days he would prescribe steroids but he didn't have to. It started to gradually go down.
Pain, stiff arm, cannot move left arm, fever of 102, tenderness at injection site, chills.  Gave Childrens Motrin
Information has been received from a medical assistant referring to an adolescent patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On 03-DEC-2015, the patient was vaccinated with second dose of improperly stored VAQTA, lot # L028666; expiry date 04-NOV-2016, (dose, route and frequency unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
I got sick; Flu-like symptoms; Headache; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness, influenza-like symptoms and headache. On an unknown date, the outcome of the sickness, influenza-like symptoms and headache were unknown.   The reporter considered the sickness to be related to Shingles vaccine. It was unknown if the reporter considered the influenza-like symptoms and headache to be related to Shingles vaccine.  Additional details were provided as follows:  The reporter was the patient.  The age at vaccination was not reported.  The patient got sick from the vaccine, but he/she stated that it was far better than having shingles.  The patient had flu-like symptoms and a headache. The follow-up would not possible as no contact details were available. For tolerance of the 2nd dose, refer US2021AMR205341 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205341:Same reporter,same patient, same suspect, different dose
This case was reported by a consumer via call center representative and described the occurrence of burning sensation skin in a 61-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose was received on 4th May 2018). Concomitant products included Calcium, Vitamin D3, Escitalopram, WELLBUTRIN, Vitamin B6)and magnesium. In August 2018, the patient received the 2nd dose of SHINGRIX. In September 2018, less than a year after receiving SHINGRIX, the patient experienced burning sensation skin, pruritus and fatigue. In November 2018, the patient experienced white blood cell count decreased and red blood cell count decreased. On an unknown date, the outcome of the burning sensation skin, pruritus, white blood cell count decreased and red blood cell count decreased were unknown and the outcome of the fatigue was recovering/resolving. It was unknown if the reporter considered the burning sensation skin, pruritus, fatigue, white blood cell count decreased and red blood cell count decreased to be related to SHINGRIX. Additional details were provided as follows: In September, the patient started to experience a burning skin sensation on her arms bilaterally. It was itching on her left lower forearm and she was fatigued. The pharmacist stated it could be lingering nerve sensation from the injection. In October, the fatigue worsened. In November, the patient's family doctor ran a complete blood count (CBC), metabolic panel, checked for iron deficiency, autoimmune conditions, hepatitis, etc. Her white and red blood cells were low. The hematologist repeated tests in December. White cells were still low. He would see patient again in March 2019.  The patient went home early from work twice in December due to fatigue and she lost pay. The fatigue was somewhat better now but was still there. Although her doctors did not think it was related to SHINGRIX, the patient thinks it was and wanted to call and report this event.
Heart palpitations; rapid resting heart beat, general feeling of unwell, random vomiting, surgery for appendicitis
Within 6 hours began to experience heart palpitations. When attempting to excercise later that night, severe dyspnea and palpitations occurred with light movement. Palpitations continued into the night with new onset spastic muscle twitching and headache.   Palpitations: frequency decreased through days 2-3. They do continue to occur between two and three times daily Spastic Movement: still continues to awaken at night and occurs a minimum of 2 times daily Dyspnea: appears to have subsided after the third day
FAINTING. PATIENT HADN'T EATEN ALL DAY AND WAS VERY ANXIOUS. SAT IN CHAIR, HAD A PROTEIN BAR AND WATER AND ISSUES RESOLVED.
Contact dermatitis manifested in identical area as contact dermatitis, which was a reaction to the back brace post-surgically following lumbar fusion. At about the same time, I developed acute itchiness primarily on neck. I continued to have severe itching. Per dermatologist, in her clinical experience, skin rashes are more common than reported from COVID-19 vaccines.  My rash resolved by the time of my appointment with her.
Patient claimed to not feel well (hot) shortly after receiving the vaccine. Pharmacist observed patient to look slightly pale, and out of precaution called the EMS.
Room spinning, vertigo,  on rising most mornings, now close to 1 month post vaccine, worst episode last Thursday.  Hoping it will get better soon.
2 days after vaccination, site is now red, warm to touch and swollen. Patient Tx with antibiotics (CLEOTIN) with next day follow-up. 4/2/10 -after 3 doses of CLEOCIN all much improved.
This spontaneous report was received from a licensed practical nurse and refers to multiple unspecified patients of unknown age and gender. Patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with improperly stored VAQTA (lot number L043209 and expiration date17-SEP-2017, dose and route of administration were not reported). Concomitant therapy was not reported. The vaccine was exposed to a temperature of 0.6 Celsius degrees for 12 hours and 28 minutes total cumulative time. There was no previous temperature excursion. It was stated that it was a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
I started becoming congested and I was coughing. Because I have COPD, I don't like to let anything get ahead of me. The next day, I went to the doctor. I was tested and I tested positive. I never felt too bad. I had mild headaches off and on. The congestion and coughing was the primary symptoms I dealt with. I was quarantined for 10 days. When I went to the doctor, they prescribed Paxlovid and Dexamethasone 6mg.
anaphylactic shock; Headache; Pain behind the right eye; Swollen joints; Weakness; Body rash; This case was reported by a pharmacist via call center representative and described the occurrence of anaphylactic shock in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number K735H, expiry date 20th September 2022) for prophylaxis.   On 13th July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced anaphylactic shock (serious criteria GSK medically significant and life threatening), headache (serious criteria life threatening), pain behind eyes (serious criteria life threatening), swollen joints (serious criteria life threatening), weakness (serious criteria life threatening) and generalized rash (serious criteria life threatening). The patient was treated with corticosteroid nos (Corticoids). On an unknown date, the outcome of the anaphylactic shock was unknown and the outcome of the headache, pain behind eyes, swollen joints, weakness and generalized rash were not recovered/not resolved.   It was unknown if the reporter considered the anaphylactic shock, headache, pain behind eyes, swollen joints, weakness and generalized rash to be related to Shingrix.  Additional information was provided as follows: The patient suffered and adverse reaction (Headache, Pain behind the right eye, Swollen joints, Weakness, Body rash) after fist dose of Shingrix administration. The patient was still under medical treatment with corticoids after the adverse reaction. Patient's doctor informed that the reaction was  consequence of an anaphylactic shock after receiving Shingrix. The reporter consented to follow up.
parent reported fever of 102-104 when using rectal thermometer @ 12:30AM on 4JUN97 & again 930AM;parent administered APAP every 3hr, cool liquids & tepid baths;
Information has been received from a physician concerning a healthy 8 week old female with no known drug allergies and no past medical history who on 5/2/01 was vaccinated with the first dose of pneumococcal vaccine 23 polyvalent (lot 637263/1448K), IM in the right thigh, instead of Streptococcus pneumoniae vaccine (Prevnar). There were no concomitant medications. It was reported that there was a small area of erythema at the injection site. The pt sought unspecified medical attention. The mother of the pt reported the day after the injection that her child was "fine." Follow-up info reported that the physician stated that the error occurred as a result of "human error" on the part of the nurse. No further info is expected.