chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles on her left back; This case was reported by a physician via call center representative and described the occurrence of shingles in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th October 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 31st October 2022, 3 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-NOV-2022 Reporter's comment: The physician reported that the patient received first dose of Shingrix into left deltoid and the patient broke out in shingles on left back.  The reporter consented to follow up.
redness/irritation; redness/irritation; This is a spontaneous report from a contactable nurse  A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) , via an unspecified route of administration on an unspecified date at 0.5 mL, single dose for immunisation .  The patient medical history and concomitant medications were not reported.  The patient experienced redness and irritation  on an unspecified date with outcome of unknown. The reported events were considered non serious.  No follow-up attempts are possible, information about batch number cannot be obtained
tooth issue; This spontaneous case was reported by a consumer and describes the occurrence of DENTAL DISCOMFORT (tooth issue) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DENTAL DISCOMFORT (tooth issue). At the time of the report, DENTAL DISCOMFORT (tooth issue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information were not provided. Treatment information were not provided.
Information has been received from the pharmacist referring to a 70 year old female patient. On an unknown date (reported as "over the past couple of days") the patient was vaccinated with ZOSTAVAX (dose, strength and route were unknown, lot # L029482, expiration date: 06-NOV-2016). On an unknown date the patient experienced a swollen, red, itchy area at the injection site that had pus coming out. This could be considered a rash. The patient had to see a physician on an unspecified date and got a prescription for an unspecified antibiotic. The outcome of the event was unknown. Causality was not provided. This case is one of several cases received from the same source. Additional information has been requested.
Arm is swollen such that the nurses I work with are drawing circle to watch.  Its hot, itchy.  I understand from the people I work with "Nurses) that the individual went to low with the injection which could have cause the swelling, heat and itch? I have sent pictures to my primary care M.D. as we want to watch for possible cellulitis.  (I'm told)
Patient reports on 04/07/2021 at 12:30 pm  The injection site became very hard and red and hot inflamed with lassted 1 week. she also reports Nausea headaches and dizziness and then on 04/17/2021 she started having abdominal pain bloating and abdominal swelling which lasted one week.  Also on 04/17/2021 she started having very heavy menstrual bleeding and back pain and cramping which is un normal for her since she is on Depo Provera .
Information has been received from a published literature article. The article discusses infections of the adrenal glands remain an important cause of insufficiency, especially in the developing world. Indeed, when person first described the condition that now bears his name over 150 years ago, the vast majority of cases were attributable to tuberculosis. Here we describe a classic, but relatively uncommon, presentation of adrenal insufficiency followed by a review of the current literature pertaining to adrenal infections. This literature marketed report as received from a other health professional refers to a 46 year old male patient. Patient had a 3 month history of generalized weakness and 15-pound unintentional weight loss. He also reported mild dyspnea on exertion and decreased appetite. His past medical history was significant for hypertriglyceridemia, primary hypothyroidism, and vitamin D deficiency. Patient denied sick contacts, specifically exposure to tuberculosis, smoking, alcohol consumption, or the use of illicit substances. On an unknown date the patient started therapy with BCG vaccine. On an unknown date in 2007 tuberculin skin test performed, resulted in induration (diameter unknown) and it was attributed to prior BCG vaccine. There was no evidence of pulmonary tuberculosis on a chest radiograph. On an unknown date physical examination revealed abdominal distension and free fluid but was otherwise unremarkable. A diagnostic paracentesis revealed an exudative effusion with a positive Ziehl Neelsen stain for acid fast bacilli (vaccination failure and tuberculosis). On an unknown date patient started treatment with (Isoniazid, rifampicin, pyrazinamide, and ethambutol) for presumed extrapulmonary tuberculosis which was later confirmed by culture. One month after starting antitubercular therapy patient was presented to the hospital with worsening fatigue, salt craving, vomiting, loss of libido, and erectile dysfunction. On examination, he had low blood pressure and appeared cachectic. The patient had bitemporal muscle wasting and hyperpigmentation of skin, oral mucosa, and nails. Laboratory evaluation was significant for hyponatremia, hyperkalemia, and mild hypercalcemia. A random cortisol was 2.5 mcg/dL with an ACTH of 531.2 pcg/mL. The basal and cosyntropin stimulated serum cortisol were, respectively 1.8 mcg/dL and 2.0 mcg/dL, which was consistent with the diagnosis of primary adrenal insufficiency most likely due to tuberculosis. A computed tomography scan of the abdomen with intravenous contrast revealed bilaterally enlarged adrenal glands (4 cm x 3.3 cm on the right, 2.3 cm x 2.1 cm on the left). Patient's prior CT scan of the abdomen revealed the patient had bilaterally enlarged adrenal glands at the time of his initial presentation as well. A study that looked at tuberculosis patients with bilaterally enlarged adrenal glands found that treatment with antituberculosis drugs does not improve or help recover adrenal functionality. The outcome of vaccination failure was unknown. The reporter considered vaccination failure and tuberculosis to be related to BCG vaccine. Additional information has been requested.
No adverse effects; received 1st dose ofGARDASIL 9 "about 1 and a 1/2 years before 10/1/2019; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported. Approximately on an unknown date in April 2018 (also reported as about one and half years before the second dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)), the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route of administration, anatomical location, lot # and expiration date were unknown) for prophylaxis. On 01-OCT-2019 (about one and half years after the first dose), the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route of administration, anatomical location, lot # and expiration date were unknown) for prophylaxis (inappropriate schedule of product administration). No additional adverse effects reported. There was no product quality complaint associated with the case.
Large bumps on site/area of shot (thigh) inner elbows w/bumps too (smaller) itchy.
Case number PHEH2013US021859 is an initial spontaneous report received from a nurse on 16 Oct 2013. This report refers to an 11-year-old female patient. Her medical history included seasonal allergies and allergy to amoxicillin. Her concomitant medications were not reported. She was vaccinated with an initial dose of MENVEO (batch number: A11082) at a dose of 0.5 ml intramuscularly in the left deltoid on 31 May 2013. It was reported that the vaccine adminsitered was compromised due to refrigeration error. No adverse event was reported following the medication error. The patient was re-vaccinated on 30 Aug 2013. No further information was provided.
Expired vaccine given, no adverse reactions reported. Stability from manufacturer supports use of product through 10/19/2022 and we gave dose on 10/01/2022 but original manufacturer expiration date was 9/30/2022.
One week post vax, the pt developed a red, itchy rash on her lower body.
My Blood pressure which had been stabile at !10/70 for 20 years became out of control. My cardiologist tried some new BP drugs, but they didn't work. My heart was racing at times. These symptoms lasted for about 3 weeks and then vanished.
2 days of soreness/redness on L arm at site of injection, not worsening, no fever. 6-8 cm erythema without induration or tenderness. Reassured mild reaction, RXed steroid treatment. RTC in 2 days if worsening or not resolved.
She developed shortness of breath 3 days after the 2nd dose of Pfizer in March 2021. She went to the ED and they ruled-out any acute issues, but she progressively developed generalized weakness in the weeks following which we found out a few months later it was amyotrophic lateral sclerosis ALS symptoms. She was diagnosed with ALS 11/2021 and deceased 12/12/21.
7X5 ERYTHEMATOUS RAISED PATCH ON LEFT UPPER THIGH FOR 2 DAYS AS OF TODAY 06/19/2020 PT COMPLAINS OF LEFT LEG PAIN.
Moderate pain at injection site beginning +6 hours from vaccine. Moderate swelling at injection site for 48 hours from vaccine. Fatigue beginning at +6 hours from vaccine requiring additional sleep and continuing for at least 72 hours. Fatigue results in some periods of moderate weakness and general malaise requiring lying down.  Stomach cramps and discomfort.
I was flushed, my arm hurt, palpitations, dizziness, foggy brain, fast heart rate, fever, vomitting, nausea, headache, stuffiness, congestion, swelling on the arm at the injection site, pain and rash around the injection site.
Spinning, dizziness, blurred vision, with tingling sensation L side of face 24 hours post injections. T elevation that evening 103.5 along with chills/aches. Erythema around Td site approx. 7" yellow fever site erythema 50 cent size.
starting 2 days after the vaccine pt reported severe anxiety, panic attack, and heart racing, checked blood pressure, with a reading of 200/100, unable to work because of increased anxiety and panic attacks, on 8/23/21 was the first visit to the clinic to report symptoms. On 8/27/21 pt reported to the clinic for the same reason, panic attacks are not improving and wants a referral and more time off, states he is not going to be able to work due to his panic and anxiety. Pt reports feeling good and never having panic attacks until the vaccine.
A 19 year old male was seen on 07/31/03. Clinical info: Rule out Smallpox Inoculation Transmission. Date of Onset: 07/26/2003. Symptoms: 6mm x 6mm annular erythematic area with a 4 x 4mm papular vesicular type lesion noted inside the 6 x 6mm erythematic area. These symptoms are localized on the distal potion of the right arm and hand. Labs: Culture and touch prep pending.
2/12/2023 I had coughing and low-grade fever for 4 days 02/14/2023 prescribed a 5-day course of Paxlovid. I tested negative on 02/24/2023.
Pt called on 10/20/21 and stated the she has developed a red, itchy rash, on her arm, approximately the size of her hand 5 days after receiving 2nd dose of immunization. Advised this is a probable case of "covid arm" and she could do symptomatic treatment with benadryl, cortisone cream, tylenol, and cold compresses. Advised to monitor rash and to follow up with physician if it becomes noticeably worse or if she develops breathing difficulties.
On 01Apr2021 patient experinced Headache, noise running, Fever, sore throat, difficulty breathing and took a test covid19 and came positive; On 01Apr2021 patient experinced Headache, noise running, Fever, sore throat, difficulty breathing and took a test covid19 and came positive; This is a spontaneous case from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number unknown), via an unknown route on 25Jan2021 and second dose on 19Feb2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 01Apr2021, the patient had symptoms like headache, noise running, fever, sore throat, difficulty breathing. On 03Apr2021 the patient was tested positive for covid19. Outcome of the events On 01Apr2021 patient experienced Headache, noise running, Fever, sore throat, difficulty breathing and took a test covid19 and came positive was unknown.  Information related to lot/batch number has been requested.
101.3 deg F temperature; too week to get out of bed; This is a spontaneous report from a contactable consumer. An 87-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in left arm on 05Mar2021 at 11:30 at single dose for covid-19 immunisation. Medical history included covid-19 from 22Nov2020 to 03Dec2020 with hospital stay required, but patient was not on ventilator. The concomitant medications were not reported. On 05Mar2021, the patient received the first dose of vaccine. After this first dose on 06Mar2021 at 05:00PM, paramedics called because patient was too week to get out of bed. Paramedics helped patient come to a sitting position and measured a 101.3 deg F temperature. Patient transferred to hospital for observation. Blood & urine samples taken. Administered nasal oxygen and paracetamol (TYLENOL). Patient released approximately on 07Mar2021 at 2 AM. The outcome of the events was recovered in Mar2021.  Information on the lot/batch number has been requested.
10/5 got shingles vaccine # 2 woke next AM with RLE feeling heavy dragging  R leg to walk, pain in left calf, feels weak from waist down today daughter notes more confused. he fell 2 times yesterday  Has lost 10 pounds since last ov  Has felt feverish .  Has had some diarrhea .
Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Weakness-Medium, Additional Details: pain in right leg shooting down entire leg and numbness in right foot
PATIENT RECEIVED VACCINATION ON 07/12/18 AND BEGAN SHOWING SYMPTOMS HOURS AFTERWARD. PATIENT WAS ADMITTED TO OUR FACILITIES ON 07/14/2018 WITH COMPAINTS OF GENERAL WEAKNESS AND DIZZINESS. PATIENT SPECIFICALLY COMPLAINS OF: COLD SWEATS, SORE THROAT, LUMP IN THROAT, HEADACHE, FEVER, COUGH, STIFF NECK, DIARRHEA, GENERAL WEAKNESS, PHOTOPHOBIA, NAUSEA, VOMITING, AND PAIN AND ERYTHMIA AT INJECTION SITE.
anaphylaxis; treated with epinephrine, benadryl, steroids.  Prior anaphylaxis to foods previously  not reacted to after first series of COVID vaccine as well as subsequent appendicitis noted
Information has been received from a 60 year old female consumer with a history of cold sores who in early April (on approximately 01-APR-2010) was vaccinated with a dose of ZOSTAVAX (Merck) (lot number not provided). The consumer reported that ever since she was a child, cold sores appeared on her mouth 3-6 times a year. The consumer reported that since she had ZOSTAVAX (Merck) she had not had any sores appear. Sometimes there was a tingling as though one wanted to appear but none had erupted since April. The consumer reported that she was very happy with this outcome as the sores had progressively gotten worse over the years, sometimes erupting down her chin. At the time for the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
3 days after the vaccine, the patient woke up at 530 in the morning with sharp chest pain that lasted about 1 hour. He was also short of breath and the pain was worse when lying down. The day after the vaccine, he had fever and emesis, but that resolved within 24 hours. He was taken to  hospital where he was noted to have a troponin of 6.611, and CRP of 1.8. He was transferred to another Hospital for further care. He was treated with IV Toradol. He was seen by cardiology and infectious disease. He showed improvement with nothing more than NSAIDs, and since his MRI was normal, he was not given IVIG.
Slight swelling and soreness at place of shot...next day...swelling of lymph nodes under left arm down to elbow...last over a week.
Runny nose, fever, ear infection, irritabilty, hoarse cough. Diagnosed with pneumonia 12/24/2011.
This spontaneous report as received from a physician refers to a female patient of unknown age. On 03-MAR-2014 the patient was vaccinated with VAQTA (lot # J005081, 0.5 ml, intramuscular). On 03-MAR-2014 the patient received VAQTA instead of an unspecified Hepatitis B vaccine. No adverse event was reported. Additional information has been requested.
1 day after providng immunization the patient returned with a large red welt at the site of injection.
Around 10 minutes after the dose, I started feeling my throat close up, I could not concentrate and felt very dizzy. 20 minutes later I felt a sharp stabbing pain in right side of my throat and my chest/lung area. I started feeling itchy in that area as well. I started getting bumps all over. I took 2 puffs of my Symbicort, Benadryl, and Loratadine. I continued taking the Symbicort and Benadryl. I fell asleep siting up. By 12/24 I could not swallow and it would hurt my chest to breath so I decided to go to the ER.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The nurse stated that on an unknown date, RECOMBIVAX HB was improperly stored outside of temperature range that was in prescribing information and that dose of RECOMBIVAX HB was administered (dose, route of administration, lot#, expiry date not provided) to a patient on an unspecified date. No adverse effects were reported. No further information was provided. This is one of several reports from the same source. Additional information has been requested.
Developed a whole body rash 6 days after my first Pfizer vaccine. The rash was very large and covered about 80% of my body. The rash consisted of redness, small bruise spots and extreme itching. I self treated myself by taking several cool showers and took acetaminophen two times two capsules. On the second day, blotches are subsiding but I have fatigue and weariness in limbs. Skin is less red but has a sallow color and blotchy which is unusual.
LOSS OF SMELL; LOSS OF TASTE; PINKY AND RING FINGER WENT NUMB; NOT ABLE TO LIFT ARM; NOT ABLE TO SLEEP DUE TO ARM PAIN; ARM HURTING; CHILLS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On APR-2021, the subject experienced not able to lift arm. On APR-2021, the subject experienced not able to sleep due to arm pain. On APR-2021, the subject experienced arm hurting. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced pinky and ring finger went numb. On 23-APR-2021, the subject experienced loss of smell. On 23-APR-2021, the subject experienced loss of taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on APR-2021, was recovering from pinky and ring finger went numb, and the outcome of arm hurting, not able to lift arm, not able to sleep due to arm pain, loss of smell and loss of taste was not reported. This report was non-serious.
Local edema, hematoma and reactive axillary adenopthy in 4 palpable pea size nodes. Slight tender, possible allergic reaction may need antibiotics (Duricif) if increase in tenderness or swelling.
pt mom phoned 3:00 approx;it was shaking,temp up to 103.8,vomiting&very fussy;came to office to see MD;info giving to mom containing rxn to inform;
This spontaneous report was received from a 58 year old female licensed practical nurse, reporting on herself, with asthma, congestive obstructive pulmonary disease (COPD), cramping, diarrhea and flushing all over the body to penicillin, hypothyroidism and drug reaction/allergy to sulfur. In October 2005, patient was vaccinated with the first dose of PNEUMOVAX 23 (dose, dose number, lot number, expiration date and route were not reported). Concomitant therapies includes Basic Water Pill, thyroid, asthma and COPD unspecified therapies. Licensed practical nurse reported she was admitted to the Hospital on 05-NOV-2014 for asthma exacerbation. Nurse reported she was discharged from the hospital on 08-NOV-2014. At the time of the report the outcome was reported as not recovered. Patient did not performed lab diagnostics studies. Patient sought medical attention. The licensed practical nurse considered the event as serious due the hospitalization. This is one (1) of two (2) reports from the same source. Additional information has been requested.
Patient was given 0.25mcg of Moderna Bivalent Booster, patient was to be given 0.5mcg. Wrong dose was given to patient.
Patient given DTaP/Hib vaccine and DTaP/IPV/HepB vaccine on the same day.  Spoke with mom on 9/26/08 130PM - patient has no fever or swelling.  Called mom on 10-1-08 and she states patient was a little "fussy", but no fever or swelling.
10/09/2022 I started with a sore throat.  On 10/10/2022 I had sore throat, fatigue, and tiredness. On 10/11/2022 I had fatigue, fever, and tiredness. On 10/12/2022 I only had cough, and fatigue.  On 10/11/2022 I tested positive for COVID-19. I called the nurse at the healthcare facility. She advised me to take Tylenol and Ibuprofen as needed. As of today 11/02/2022 I have lingering cough but all the other symptoms are gone.
Weakness, nausea, vomiting and retching. Oct. 19, 2012 started 2pm - 8 pm. COMPAZINE one dose.
10/19 Raled left lung; temp 97.4. 10/20 Mild congestive heart failure seen on x-ray, noisy breathing; started antibiotics. 10/21 Temp 99.5. 10/24 Temp 98.8. 10/25 Pale, rochi/crackles, decreased appetite, decreased voiding, slept all day. 10/26 Refused food, dehydration, water given, shallow breathing, O2 saturation 79%. Care refused by prior request. Medical Record received on 11/23/2004 states pt experienced rales and cough. Follow up 01/19/05, Recovery status unknown, patient expired in October.
sick for a week; flu like symptoms for a week; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for a week) and INFLUENZA LIKE ILLNESS (flu like symptoms for a week) in a male patient of an unknown age 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 ILLNESS (sick for a week) and INFLUENZA LIKE ILLNESS (flu like symptoms for a week). At the time of the report, ILLNESS (sick for a week) and INFLUENZA LIKE ILLNESS (flu like symptoms for a week) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       no concomitant medications are provided, treatment to the events given as laid in bad.   This case was linked to MOD-2021-358900 (Patient Link).