chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Burning pain/Stabbing pain; Tenderness; Tingling; redness under my left breast and left side; skin is so sensitive to touch; Stress; Anxiety; Burning even in my mouth, lips, and tongue; she felt like her body was raw; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain burning in a 60-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced pain burning (Verbatim: Burning pain/Stabbing pain), tenderness (Verbatim: Tenderness), tingling (Verbatim: Tingling), redness in breast (Verbatim: redness under my left breast and left side), touch sensitivity increased (Verbatim: skin is so sensitive to touch), stress (Verbatim: Stress), anxiety (Verbatim: Anxiety), burning mouth (Verbatim: Burning even in my mouth, lips, and tongue) and feeling abnormal (Verbatim: she felt like her body was raw ). The patient was treated with diclofenac (Voltaren) and steroids nos (Steroid (Not Specified)). The outcome of the pain burning, tenderness, tingling, redness in breast, touch sensitivity increased, stress, anxiety, burning mouth and feeling abnormal were not resolved.   It was unknown if the reporter considered the pain burning, tenderness, tingling, redness in breast, touch sensitivity increased, stress, anxiety, burning mouth and feeling abnormal to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the pain burning, tenderness, tingling, redness in breast, touch sensitivity increased, stress, anxiety, burning mouth and feeling abnormal to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt date: 11-JUL-2023 This case was reported by patient via interactive digital media. The patient reported that she had both shots at age 60 and had burning pain, stabbing pain, tenderness, tingling, and redness under her left breast and left side. The skin was so sensitive to touch, wearing a bra was difficult, she thinks it all started with severe stress, anxiety, and getting into a chlorinated pool. This was going on six weeks of misery. The patient states that she had been on a steroid pack, volterian gel, and meds for pain and she felt like her body was raw and burning even in her mouth, lips, and tongue. Follow up was not possible, as no contact details were available.
This spontaneous case reported by a consumer, describes the occurrence of COVID-19 (designated positive for COVID-19), inappropriate schedule of product administration (scheduling the second dose of the vaccine more than 36 days after the first dose) and infusion (received the antibody infusion) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jan 7, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 11, 2021, patient experienced COVID-19 (designated positive for COVID-19). On an unknown date, patient experienced  inappropriate schedule of product administration (scheduling the second dose of the vaccine more than 36 days after the first dose) and infusion (received the antibody infusion). At the time of the report, COVID-19 (designated positive for COVID-19) and infusion (received the antibody infusion) outcome: unknown and  inappropriate schedule of product administration (scheduling the second dose of the vaccine more than 36 days after the first dose) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication, treatment information or causality assessments reported.
Pt received her 2nd dose of Shingrix on Monday, 6/29/20. On Wednesday, 7/1/20 in the AM, pt stopped in to report she was having an adverse reaction. Her arm was red across a large area, probably at least 6 inches long and 3 inches wide. She said it was warm, tender, and was throbbing and very uncomfortable. She was due to see her provider on Thursday so she was going to address it with them. Called on 7/8/20 to f/u with patient. She said it had just resolved, but it had taken a full week. Her provider had not prescribed anything for her. It resolved on its own over the 7 day time frame.
Initial and follow up information has been received from a respiratory therapist and a physician concerning a 54 year old white male utility compliance supervisor, non-smoker with unspecified allergies, snoring, and a history of appendicitis, tonsillectomy, recurrent bronchitis symptoms, haemolytic anemia, kidney stones (required hospitalization), gallbladder resection, status post splenectomy (1996), asbestos (1990-1992), hiatal hernia, hiatal hernia repair x2 and hand surgery. Illness at the time of vaccination included staphylococcal pneumonia. Family history included colon and bone cancer. On 06-JUN-2006 at 15:00, the patient was vaccinated IM into the right deltoid with a first 0.5 ml dose of Pneumovax 23 (lot # 649697/1038P). Concomitant therapy included meprednisone, fluticasone propionate (+) salmeterol xinafoate (ADVAIR), "gamifloxacin", montelukast sodium (MSD), acetaminophen (TYLENOL), amoxicillin (+) clavulanate potassium (AUGMENTIN), trazodone Hcl, guaifenesin (MUCINEX) and hydrocodone polistirex (+) phenyltoloxamine polistirex (TUSSIONEX). On 07-JUN-2006, the patient developed cellulitis of the right deltoid. The patient's right upper arm was hot to the touch, with a hard area 25 centimeters in diameter. On 07-JUN-2006, a chest CT scan revealed lungs within normal limits and a small hiatal hernia and some calcifications were seen involving the tail of the pancreas. On 08-JUN-2006 the patient was seen by his physician for a follow up visit. His arm was described as a large 8.5 cm indurated, hot, and tender with a painful shoulder that showed streaks which had become progressively worse. The patient was treated with ciprofloxacin hydrochloride (CIPRO), amoxicillin (+) clavulanate potassium (AUGMENTIN), sulfamethoxazole (+) trimethoprim (BACTRIM), methylprednisolone (MEDROL), rifampin and clarithromycin (BIAXIN). On 10-JUN-2006, the physician noted that the patient was symptom free and his events resolved (patient stated symptoms resolved after 2 days). No product quality complaint was involved. Cellulitis was considered to be an other important medical event. Additional information is not expected.
MEDICATION CAUSED FEELING OF SEVERELY DRUNK; TEMPORAL ARTERITIS; WEAK VOMITTING; This spontaneous report received from a patient via a company representative concerned a 50 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced temporal arteritis. On 07-APR-2021, the subject experienced weak vomiting. On MAY-2021, Laboratory data included: CT scan (NR: not provided) temporal arteritis, and Ultrasound scan (NR: not provided) temporal arteritis. On 28-MAY-2021, Laboratory data included: Biopsy artery (NR: not provided) Negative to giant cell. On an unspecified date, the subject experienced medication caused feeling of severely drunk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weak vomiting on 10-APR-2021, was recovering from temporal arteritis, and had not recovered from medication caused feeling of severely drunk. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Initial misuse report received from a healthcare professional on 08 July 2013. It was reported that during administration of MENACTRA vaccine the patient pulled away and had received only half dose. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
BREAKTHROUGH COVID INFECTION. PATIENT TESTED POSITIVE ON 10/21/2021. PATIENT FULLY VACCINATED ON 03/19/2021.
A non-serious spontaneous report of not being able to sleep, fever, gagging and cough has been received from a consumer concerning a three-year-old female, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's pos-marketing commitment on accelerated reporting for the newly indicated population of 2years to 59 months of age for FLUMIST. The only medical history reported identifies the child as being "pre-asthmatic". The patient received FLUMIST on 08 Sep 2009. The day after receiving FLUMIST the child experienced not being able to sleep, fever, gagging and cough. The primary care physician recommended she continue breathing treatment at home. After three days the symptoms have not resolved. All follow up attempts have been made per company SOPs.  No further information is available. 08 Mar 2010.
expired vial was initially stored in the refrigerator on 20-Sep-2022; No adverse event; Patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine), PRODUCT STORAGE ERROR (expired vial was initially stored in the refrigerator on 20-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M21A) for COVID-19 prophylaxis.     It was unknown if patient had allergies to medication, foods and other products.   It was unknow if patient had ever been diagnosed with and or tested positive with COVID-19.  Acute illness at the time of vaccination and up to one month before was unknown.     On 20-Sep-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired vial was initially stored in the refrigerator on 20-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine), PRODUCT STORAGE ERROR (expired vial was initially stored in the refrigerator on 20-Sep-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and PRODUCT STORAGE ERROR (expired vial was initially stored in the refrigerator on 20-Sep-2022).    No concomitant medications were reported.  Patient received 0.5 dose of vaccine at PM time.  Expired Moderna vaccine had been given to 21 patients. The reporter explained that the vial was taken out of the freezer recently. The vial size was 5.5 ml. The vial was initially stored in the refrigerator on 20-Sep-2022.  The vial did not undergo any temperature excursion.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Live follow up received with updated reporter's address.
12/14/22 - five days after vaccine got extreme headache and chills. Lasted through the night even with medication. 12/26/22 - 17 days after vaccine got severe case of shingles. Still have severe nerve pain today, 1/13/23, from shingles outbreak.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Pertinent medical history and concomitant medications were not reported. On 30-JUN-2015, the patient was vaccinated with improperly stored VAQTA (lot # K010579 with expiration date 12-FEB-2017, dose and route not reported). No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Shortness of breath, dyspnea, chest tightness, coughing, high blood pressure, dizziness.  Admit to Emergency Room 12/30/2020 @ 12:13, diphenhydramine IV 25mg given.  Symptoms seem to have resolved.  Discharge planned 14:22.  To follow-up with PCP.
Information has been received from a nurse concerning a female who was vaccinated on an unspecified date with a dose of GARDASIL (lot# not reported) and fainted. Subsequently, the patient recovered from fainting. The nurse was told about this AE from another nurse. Additional information has been requested. 07/08/08 This is in follow-up to report(s) previously submitted on 5/14/2008. No additional information is expected.
6 month old female - got ROTATEQ on 12/3/10. On 12/8/10 evening started vomiting - admitted to hosp. Dx UTI - started on Cephalexin - home 12/9/10 in AM - Pt had a current jelly bloody stool in mid day - seen in our office 12/9/10 with in the after noon. Stable - in view of vomiting current jelly bloody stool. Dx of intussusception with spontaneous resolution.
Post kidney transplant 11/2017, presented w/ SOB, fatigue, myalgia, chills, sore throat, HA, cough, hematuria and decreased appetite. Covid pneumonia, tx for acute resp. failure w/ hypoxia. O2, IV steroids, abx, IV Remdesivir. D/C home w/ HH on O2.
18 hours after vaccine experienced chills, joint pain,  fatigue followed by sweats and low grade fever . Flu like symptoms subsided 36 hours later. Next about 3 days later FLASHING LIGHTS IN LEFT EYE WHICH SUBSIDED AFTER THREE OR 4 DAYS AND ,PERSISTENT DAILY CHRONIC HEADACHE AND INTRACRANIALPRESSURE  WHICH HAS NOT SUBSIDED AT TIME OF THIS REPORT 26 DAYS IN DURATION AND STILL PRESENT.NO PREVIOUS HX OF HEADACHES.
WITHIN 5 DAYS OF VACCINE PT STARTED HAVING LOW BACK PAIN AND NUMBNESS TO EXTREMITIES,  CAUSING WEAKNESS,  BY DAY 7,  SEVERE PAIN COULD NOT WALK,  WAS BROUGHT IN VIA WHEELCHAIR FOR FIRST VISIT.    SUSPECTED TRANVERSE MYELITIS GIVEN THE ABRUPT SYMPTOMS
Patient complains of swelling and pain in arm. She saw her physician and he said it would take time to get better-maybe up to 12 weeks. This is now 14 weeks and she still has pain and injection site soreness. She says she is slowly getting better but very slowly.
This case was reported by a other health professional via call center representative and described the occurrence of dizziness in a 18-year-old female patient who received BEXSERO (batch number 16B501, expiry date 28th February 2019). Previously administered products included BEXSERO (1st dose received on 20th July 2017, batch number 158501C, expiry date 31st March 2018) and BEXSERO (2nd dose received on 22nd August 2017, batch number 16B701, expiry date 27 February 2019). On 24th May 2018, the patient received the 3rd dose of BEXSERO. On 24th May 2018, unknown after receiving BEXSERO, the patient experienced extra dose administered. On 25th May 2018, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was not recovered/not resolved and the outcome of the extra dose administered was unknown. It was unknown if the reporter considered the dizziness to be related to BEXSERO. Additional details were provided as follows: At the time of reporting the patient was 19 years old. The patient was inadvertently vaccinated with a third dose of BEXSERO, which led to extra dose administered. One day after vaccination, the patient began to experience dizziness. No emergency room (ER), doctor visit, hospitalization or intervention was required. The dizziness was not considered life threatening or disabling. The healthcare provider was unsure if lot was 15B501C or 158501C, however as per sale data review corrected to 158501C.
Approximately one hour after vaccination, the patient reported ringing of ears. Shortly after, she experienced dizziness, vomiting, sweating, and a headache. No treatment was needed.
1. Swelling warmth, redness injection site 2. Left axilla pain -> tender enlarged isolated 2.5 cm lymph node 3. Non-tender, sl. irritated rash - both axillas L>R 4. Fatigue, achiness, back pain 2-3 days later.
On 5/25/21 patient noted arm pit swelling and pain in the arm she received the injection (right). Patient took motrin and applied ice. Symptoms went away for a couple of hours and returned again
My upper left arm where I got the injection became sore, red, hot and itchy in the evening  on 12/20/2021.  I dismissed it as something expected from a vaccine injection.  Tuesday, the 21st, my arm became swollen, redder, hotter and more itchy. I was sick on Tues with a temperature and severe chills.  Wednesday morning I felt better but my upper left arm was seriously worse. The swelling was from my upper arm to my elbow all around. My arm was twice the size of my right arm and bright red and very  hot.  I went to my primary care  doctor.  He diagnosed that I actually had cellulitis and needed medical attention which included 5 days of an antibiotic every 6hrs around the clock. He said this was not a reaction to the vaccine, but a bacterial infection at the injection site. I initially went to the Health Department to get my booster shot.  I had gotten the two previous doses of Moderna( May/June) at the Health Dept.  I was  informed at the Health Department they were no longer giving the Moderna vaccine  so I would have to go to a local pharmacy.
Received the shot around 12:15 PM 11/24/21.  A headache began about 4:00 PM.  Joint and muscle pain started close to 5:00 PM.  By 7:00 PM I was curled in fetal position experiencing all-over body tremors/shakes that were so bad my muscles started cramping.  A low-grade fever (100.6) began about the same time.  Chills were intermittent. This went on until 1-2 AM.   This morning, my head is pounding and I have really bad joint and muscle pain.  The injection site is extremely sore as well, easily the worst of any shot I've been given before.
This spontaneous report was received from nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about patient's pertinent medical history reported and concurrent conditions. The patient's concomitant therapies included sterile diluent. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX, lot number M047661 with expiration date 02-DEC-2018; lot number M045204 with expiration date 11-NOV-2018; lot number M036272 with expiration date 07-AUG-2018; and lot number reported as N002203 with expiration date 19-JAN-2019 (dose, route and anatomical location were not reported) for prophylaxis. The vaccines were exposed to temperature of -14 Celsius (C) during 9 days, there was no previous temperature excursion and digital data logger was filed. This is one of two reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA004367:
Patient described driving to meet a friend after leaving pharmacy. She felt strange and closing of throat. She was close to hospital. Went to ER. They administered IV steroid and antihistamines.
IT STARTED AS SORETHROAT ON 02/20/2010 THEN PROGRESSED TO PRODUCTIVE COUGH ON 02/22/2010, WITH ASSOCIATED TIREDNESS, MUSCLE ACHES AND HEADACHE UNTIL TODAY 02/24/2010.
Swollen sore tongue and mouth mucus membranes and throat  Has been slowly resolving
Veteran received covid-19 (moderna) vaccine #1 on 3/17, developed SOB 3/22 requiring EMS transport to ER for evaluation, which was unremarkable, attributed to vaccine reaction. Mild leukocytosis also noted (WBC 12.8). Of note, Afib listed per ER notes, resolved, but mave have additionally contribute to SOB.
No Additional AE; Two month old recieved the MMR II vaccine; This spontaneous report was received from a pharmacist via regulatory authority referring to a 2-month-old infant patient of unknown gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.    On 22-DEC-2021, the 2-month-old patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rha (recombinant human albumin) M-M-R II) (dose, frequency, route of administration lot#, expiration date were not provided) vaccine for prophylaxis. The Pharmacist did not have any additional information but provided permission to reach out the physician. No additional Adverse event nor PQC.
I experienced swelling in my face (i.e. both eyes, cheeks, lips and chin).; I experienced swelling in my face (i.e. both eyes, cheeks, lips and chin).; I experienced swelling in my face (i.e. both eyes, cheeks, lips and chin).; This is a spontaneous report from a contactable other healthcare professional (hcp) (patient). A 30-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: EW0153), dose 1 via an unspecified route of administration, administered in Arm Right on 25Apr2021 14:00 (at the age of 30-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The vaccine was administered in a Health Clinic/facility. The patient did not receive any other vaccines in four weeks prior to receiving bnt162b2. Medical history was none. No known allergies. The patient was not pregnant during vaccination and adverse events. The patient had no history of COVID prior to vaccination and was not tested for COVID post vaccination. Concomitant medications were none. On 27Apr2021 04:00, the patient experienced swelling in her face (i.e. both eyes, cheeks, lips and chin). As the patient stated, "I experienced swelling in my face (i.e. both eyes, cheeks, lips and chin)." Therapeutic measures were taken as result of the adverse events which included an IV with Antihistamine, Steroid, and Benadryl. Outcome of the events was recovering. The adverse events resulted in Emergency room/department or urgent care.; Sender's Comments: There is a reasonable possibility that the events "swelling in her face (both eyes, cheeks, lips and chin)" were related to BNT162b2 based on known drug safety profile.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.