chrisvoncsefalvay/vaers-outcomes huggingface dataset:
reactivation of shingles; redness; itching; uncomfortable; redness; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number N99P3, expiry date 19th October 2021) for prophylaxis.   The patient's past medical history included shingles (experienced shingles on an unknown date).   On 20th November 2019, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced shingles, injection site erythema, injection site itching, injection site discomfort and vaginal erythema. On an unknown date, the outcome of the shingles, injection site erythema, injection site itching, injection site discomfort and vaginal erythema were unknown.   It was unknown if the reporter considered the shingles, injection site erythema, injection site itching, injection site discomfort and vaginal erythema to be related to Shingrix.  Additional details were received as follows: The reporter stated that the patient experienced a red ring, itching and discomfort at the injection site.  The patient also experienced a reactivation of shingles in her vaginal area with redness. The reporter did not provide any specific dates of onset or when the previous shingles case was.
Pt is describing-swelling of feet, extremities. She saw family Dr. Do not know what, if any, diagnosis were done by Dr.
patient admitted on 1/25/22 after noted in dialysis with atrial flutter, given metoprolol and blood pressure became worse.  She complains of SOB and palpitations.  Patient on 2LNC 24/7.  Patient tested positive for Covid 19 on 1/29/22.  Patient expired on 1/31/22.
This serious spontaneous case, initially received on 14-Feb-2018, from physician, concerns a 77-year-old, elderly male patient. The patient's historical condition included pancreatitis (on an unspecified date, it had occurred twice and last was 20 years ago). The patient's historical drugs included prednisone (had been off prednisone x 2 days before getting influenza vaccine) and bronchial thermoplasty (new asthma treatment) procedure performed on unspecified dates in Sep and Oct-2017. The patient underwent cardioversion for atrial flutter and right heart catheterization for ablation of abhorrent pathways. The patient's current conditions included asthma (for 40 years), normo pressure hydrocephalus (NPH) (since 6 years) and had shunt for it, diabetes and bilateral cataract induced by prednisone, supraventricular tachycardia (SVT) due to overload of beta agonist (since an unspecified dates). The patient's concomitant medications included prednisone, NOVOLOG and sliding scale, LANTUS, ADVAIR and ELIQUIS all for an unknown indications. On unspecified date in November, the insulin dose was adjusted. On 05-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number and expiry date: not reported). On the same day, within 12 hrs the patient developed painful rash on legs (entire area around ankles) which spread to chest and arms. It was difficult to walk because of the blisters on legs and ankles (look like haemorrhagic blisters). On an unspecified date, biopsy (unspecified) showed immunoglobulin A (IGA) vasculitis (Henoch-Schonlein purpura). Other lab data included elevated blood urea nitrogen (BUN) and creatinine (CR) and ion gap (results not provided). On an unknown date, the abnormal values were normalised by the time then patient visited the convenient care (CC). At the time of this report, the rash was disappeared (which took more than a month). At an undetermined time, the patient had an exercise intolerance, weakness, balance problems, strength and stamina problems. It was stated that, prior to FLUAD administration, the patient was able to walk without any problems and he did not experience any of those symptoms. At present, the symptoms were not getting better. The patient went to CC next week for examination and it was stated that, his physician did not know what to do with him. It was reported that, patient was able to walk short distances and was not able to walk long distances, he needs a wheelchair to manage. The outcome of the events (IGA vasculitis, exercise intolerance, balance disorder, strength and stamina problems) was not recovered.
COVID 19 Treatment; COVID 19 Treatment; dose 1,2 MODERNA/ dose 3 Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 55 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Lot number: FH8020) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Mar2021 as dose 1, single (Batch/Lot number: unknown), on 30Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 20May2022 as dose 4 (booster), single (Lot number: 049L21A) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Nov2021, outcome "unknown", described as "dose 1,2 MODERNA/ dose 3 Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 07Jan2023.
hives; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "hives".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101352990 same reporter, drug and event/ different patient.
Presented with SOB/weakness/coughing; pending Covid test PTA; +Covid in ED; dx Covid PNA; treated with steroids, Vit C, Vit D, Zinc, antibiotics; discharged home on O2
fatique, H/A, MUSCLE PAIN, JOINT PAIN, CHILLS, SLIGHT FEVER-99.3, PAIN/TENDERNESS AT INJECTION SLIGHT  resting at home , have not gone to a Dr.  or spoke to one yet.
24 hours after TD injection, Pt developed facial weakness left side, Severe HA, Left side neck pain, Seen Clinic ER, told Hypersensitive reaction to Tetanus, Cont to have symptoms-able to swallow difficult to chew, Pregnant EDC 12/17/2002
Patient, MA received vaccine at work by another employee MA. Vaccine was given too low.  Patient repoerted to me (RN Lead),  that it looked too low on her deltoid and that it was red and itchy. Vaccine was given Friday 9/23 and reported to me on Monday 9/26.  Site appeared red and slightly swollen.   Spoke to MA and she reported that she learned to give vaccines 4 finger lengths below acromium process. Spoke to our training clinical educators, who reported: "We do not teach to 4 finger lengths. We teach to half way between the acromion process and the axillary fold. Back in the day, it was only 2-3 finger lengths, so I?m not quite sure where she learned 4 finger lengths. Looking at this photo, it actually looks like a whole hand was used. " (unable to attach photo).  I provided training/coaching to MA and she has to be "checked off" by a preceptor with 5 different patients before giving a vaccine on her own. Clinic Incident report completed. Administration staff informed.   Clinical educators reported that revaccination was not needed: "You do not need to revaccinate. See below. I don?t want to assume, but from your account, the MA-R had the correct size needle and angle for an IM injection, so it was intended to go into the muscle. Even if some subcutaneous tissue was hit, you would not need to revaccinate.   What should we do if we give an injection by the wrong route (SC instead of IM)? There is no minimum interval between the invalid dose and the repeat dose. ACIP and/or CDC recommends that if HepA, MenACWY, IPV, PPSV23, COVID-19, and RZV vaccines are administered subcutaneously, the doses can count and do not need to be repeated.  Correct needle size was used.
Immediate onset of nausea, next day fever, diarrhea, vomiting, exhausted, rash on abdomen and itching. Patient was advised NOT to receive the 2nd dose, but she got the injection anyway - says she had a cruise booked and did not want to cancel, so since cruise line is requiring proof of vaccination, she got the 2nd dose. Says she had a much worse reaction to dose 2 with swelling of the face, difficulty breathing, rash all over the body, severe body aches and headache- lasting 2 days.
Patient is experiencing redness, soreness, pain with bruising and blistering on the arm further down from the injection site.
Vaccines given Friday at 2:00 pm, that evening feet started swelling, rash on feet and chest, hands - given Benedryl.  Seen in office Sunday, 12/2/07 - Hives, continue antihistamine.  Recheck 12/4 as fingers, toes painful, throbbing, face puffy but no shortness of breath, no fever or other illness.  Continue antihistamine.  Improved, still recovering.
Information has been received from a pharmacist concerning a 2 month old male who was vaccinated with Haemophilus B conjugate vaccine (+) Hepatitis B vaccine recombinant (yeast). Concomitant vaccination included Poliovirus vaccine (IPOL) and Diphtheria toxoid (+) Pertussis vaccine (+) Tetanus toxoid (Acel-Immune). Subsequently ten days post-immunization, the patient developed a cough, fever and irritability. The infant was seen by a physician and a Chest x-ray was performed. The x-ray showed an enlarged heart, which had been normal size at birth. A diagnosis of Cardiomyopathy was made and the infant was hospitalized at a Tertiary Care Center to under go heart transplantation. No further information is available. Other business partner's numbers included F200100095 (0) and U200100030(0).
Hands have turned black inside palms and fingers. The knuckles and base of the palm and wrist looks burnt. Have no feeling in fingers, they feel very numb, If i make a fist ,It's very tight and can feel heart beating in the palm of hands. The black burnt look has moved to both inside and outside of hands
Within less than 5 min of DTaP administration I was called back into the room by reporter and observed pt's R shoulder where she had received IM DTaP dose to be pink, swollen, and covered in hives. No swelling of the face or hives anywhere besides the affected shoulder. No wheezing or difficulty breathing. Weight-based dose of both Benadryl and ibuprofen given by mouth. No vomiting. Pt alert and appears to be upset/scared by situation and sitting on mom's lap. Confirmed with mom and in pt's chart that she has not had a reaction like this with any DTaP doses previously. Within 15-20min of Benadryl and Motrin doses hives are visibly lessening (still present but less swollen) and pt is playing and running around. Discharged in good condition. Advised mom may repeat Benadryl and Motrin dose in 6 hrs if necessary if symptoms flare back up.
The spontaneous report was received the office manager via a company representative, referring to a teenage female patient of an unknown age. The patient's concurrent conditions included a cardiac condition, the patient was healthy and involved with a lot of sports. On an unknown date in 2014 (reported as approximately two years ago), the patient was vaccinated with the second dose of GARDASIL (route, anatomical site of vaccination, lot number and expiration date were not informed). Information regarding concomitant medication was unknown for the reporter. The reporter stated that the patient waited 15 minutes after being vaccinated and when she was leaving she passed out (syncope). Apparently, her heart rate was very low and they could not get it back up. The patient was referred to see cardiologist who diagnosed that the shot aggravated the cardiac condition. Additionally, the reporter believed that the patient has aged out of the practice. At the time of reporting, the outcome of syncope, cardiac condition and heart rate was very low was unknown. The causality assessment between the events and GARDASIL was not provided. Additional information has been requested.
7/20--8/2 57-year-old male, presented from Hospital with hypotension and shortness of breath. He entered Hospital for a "liver workup" and paracentesis. When he got hypotensive, he was transferred to facility. He also had 9000 cc ascitic fluid removed initially. He is COVID positive and is partially vaccinated. He is an ex-cigarette smoker with multiple comorbidities. His hemoglobin and sodium were low as was his CO2 and magnesium. His creatinine was elevated. The patient was treated initially with his usual medications including intravenous fluids, electrolytes, and he was started on Flagyl and vancomycin as well as Levophed for an initial low blood pressure.  His low magnesium was replaced and he had  positive MRSA in his nasal swab and was started on mupirocin.  At this time, COVID isolation was removed.  On 07/23, there was evidence of acute hypoxic respiratory failure and fluid overload.  Hypotension with possible sepsis from urinary tract infection was noted.  It is obvious he had decompensated cirrhosis with ascites and later required a second paracentesis.  His hemoglobin initially dropped.  He had evidence of bilateral pulmonary edema with a rising BNP and MRSA was in the respiratory culture.  He was continued on Flagyl and Vancomycin, and electrolytes were replaced as needed.  INR was as high as 2.9 and again, magnesium was low and had to be replaced.  BNP went up to 836 and metabolic acidosis was noted as well as portal hypertension earlier, requiring Blakemore tube.  Creatinine started to rise.  Metabolic acidosis was present and he continued to deteriorate and hospice was inquired.  His mentation was very poor and there was a question of anisocoria.  A CT of the head was ordered, but he continued to deteriorate and on 08/01/2022, he was discharged to inpatient hospice. Upon hourly rounding  patient assessed and unresponsive to verbal and tactile stimuli, pulseless, respirations and heartsounds absent.  Pupils dilated, fixed, and unresponsive to light.  Date and time of death pronounced on  8/2/22 at 0545.
I tested positive for COVID-19 on 12/15/2022. I had a cough, congestion, pressure. I had severe sinus pressure in my left lob above the eyebrow from time to time and it was painful. The only relief that really works was putting my head upside. I seen my provider and I took MUCINEX and azithromycin and felt relief after the doctor prescribed it. I thought about going to urgent care but never went.
This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4471639-00. A 63-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 11628483), subcutaneous for colitis ulcerative; prednisone (PREDNISONE). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COLITIS ULCERATIVE (medically significant), outcome "recovering", described as "Colitis ulcerative aggravated"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "recovering". The action taken for adalimumab and prednisone was unknown. The reporter's assessment of the causal relationship of "colitis ulcerative aggravated" and "chronic obstructive pulmonary disease" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on available information, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events "colitis ulcerative aggravated" and "chronic obstructive pulmonary disease".
Blood taken on 6/24/2022 shows WBC and neutrophils(abolute) to be low. These nunbers eventually went so low that I couldn't fight off an infection and ended up hospitalized for something my body would have normally been able to take care of.  I have been diagnosed with neutropenia and I am taking a large dose of two antibiotics to keep the infection in check while my body attempts to heal, but they are just keeping the sore in a holding pattern. It's no better, no worse
Client called day after Hep B vaccine and complained of headache, swelling & tingling of extremities.  When asked whether patient itched or had shortness of breath she reported yes.  Was told to go to Dr. or ER.  Client reported at later date she did not but she did improve.  Client also has H/O CTOH abuse and was reportedly indulging at the time of report.
05/03/2003: Edema-redness from left shoulder to 2in above antecubital fossa.  Benadryl. 05/06/2003: Mother reports by phone that swelling/redness are gone.
Given Pneumovax injection 2/11/14. Had appt w/ Dr 2/12/14- reported that evening/night after Vaccine given rt arm became reddened, painful over rt arm injection site- felt weak. Reported had some chest pain during the night. After 2/12/14 appt- late afternoon went to ER for c/o chest pain- stated d/c same day and got home around 1830. RN called pt 2/13/14 - pt reported arm conts to be "somewhat reddened, stiff and sore". Was instructed by MD at ER may use either Ibuprofen or Tylenol po. Note:  pt had previous Pneumovax vaccine at age 60 pt reported; this vaccine given > 5 years later as vet turning at 66 this month.  Reports that after 1st Pheumo vaccine "did not feel well". Also note that pt received Flu vaccine 2/11/14 to lt deltoid; Pneumo was given in rt deltoid.
Atrial Fibrillation- Transient (lasted 1.5 hours).
Headache & Arthralgia Narrative: Morning after injection, had headache and body aches. Took Tylenol.
Severe pain in my left jaw; it (jaw) locked up/face froze; difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6202), via an unspecified route of administration in the left arm on 25Feb2021 14:00 at a single dose for COVID-19 immunisation. The patient's medical history included diagnosed with COVID-19. The patient have no known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but had other unspecified medications within 2 weeks of vaccination. On 25Feb2021 20:00, the patient experienced severe pain in her left jaw then it (jaw) locked up. Her face froze. She had difficulty swallowing. The patient had not been tested for COVID-19 since the vaccination. Therapeutic measures were taken as a result of the events and included treatment with muscle relaxer, heat and ice, and rest. Outcome of the events was not recovered.
Information has been received from a pharmacist concerning a female (age unknown), who, on an unspecified date, was vaccinated with a dose of PNEUMOVAX 23.  Subsequently, the patient developed injection site redness and swelling.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information is not expected.
Pt admitted to rehab on 10/20 post laminectomy. Pt had to be COVID negative for admission to unit. On 11/2, pt tested positive for COVID after reporting increased lethargy, confusion, and shortness of breath. Pt was transferred to the inpatient medical floor for care.
pt recv vax & became pale when pt fainted & hands & legs were jerking for about 5sec;
Symptoms included fever hives. Patient was treated with BENADRYL. Symptoms subsided after BENADRYL.
Information has been received from a physician concerning a patient who on an unspecified date was inadvertently vaccinated with a dose of VARIVAX (Merck) (lot# not reported) instead of ZOSTAVAX (Merck). No adverse effect was reported. Follow-up information has been received from a registered nurse who reported the patient's gender as male and said the event occurred on 14-NOV-2009. She explained that theirs is a small office and the person who administered the vaccine picked up wrong vial. There was no adverse event. The patient was given the ZOSTAVAX (Merck) at a later date. Additional information is not expected.
Patient was given vaccination on 6-2-06.  She returned to the clinic 6-5-06 to see Provider for her reaction.  Pt went home on 6-2-06 and said that she was feeling achy all over, she also felt warm and sweaty.  She then felt sick the next couple days.  She noticed that the site of her injection was swollen and tender to the touch.  The swelling increased in size.  Patient was treated with Keflex 500mg QID for 7 days.
1. Mild fever lasting approximately from 20 to 60 hours post-vaccination. Resolved with rest, no medication. 2. Diminished respiratory capacity, consistent with slight pulmonary edema. Detectable when standing, not detectable after lying down for extended period.  Began the day following vaccination. Resolved by post-vaccination day 6 with rest, no medication. 3. Discomfort upon urination. Began the day following vaccination. Ongoing, but possibly improving as of post-vaccination day 6. No medication.
Since vaccine, likely mild myocarditis (suspected from pcp as well).  2 cases of potential flutter, a few cases of chest pain but more tightness and feeling of inflamed heart.  Has been getting better and subsided for the most part .  I have been exercising extensively after booster so that may have aggravated that too.  Although during exercise and after, no issues.
Rash over trunk of body. Took BENADRYL and relief in 3 days. Some scarring remains on abdominal area.
Intense headache and dizziness when waking up. Muscle soreness throughout the body. Arm pain.
This case was reported by a physician via call center representative and described the occurrence of injection site indentation in a 83-year-old female patient who received SHINGRIX for prophylaxis.  On an unknown date, the patient received SHINGRIX at an unknown dose. In June 2018, less than a year after receiving SHINGRIX, the patient experienced injection site indentation, rash and pruritus. On an unknown date, the outcome of the injection site indentation, rash and pruritus were not recovered/not resolved. It was unknown if the reporter considered the injection site indentation, rash and pruritus to be related to SHINGRIX. Additional details were received as follows: The reporter was the patient's physician. Six weeks before the date of reporting, the patient experienced rash and itching and indentation at site of SHINGRIX vaccination. No vaccination date was provided. The health care professional (HCP) stated the patient inquired if she need to take 2nd dose of SHINGRIX.