chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chest pain; chest tightness; This spontaneous case was reported by a health care professional and describes the occurrence of CHEST PAIN (chest pain) and CHEST DISCOMFORT (chest tightness) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced CHEST PAIN (chest pain) and CHEST DISCOMFORT (chest tightness). On 29-Mar-2021, CHEST PAIN (chest pain) and CHEST DISCOMFORT (chest tightness) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Long bruise-like and 2 inches wide; A spontaneous report  was received from a consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 5-inch long bruise-like and 2 inches wide.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On unknown date, prior to the onset of the event the patient received their dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced big-like bruise on her 8 days after having the Moderna shot. On 21 Jan 2021, in evening patient experienced 5-inch long bruise-like and 2 inches wide.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, 5-inch long bruise-like and 2 inches wide was not reported.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported event, and excluding any other etiology, a causal relationship with the event cannot be excluded.
Patient called complaining of warmth, redness, swelling occurring 1 day after vaccination. Has been swollen and red for several days seeking treatment at urgent care.
About 5 pm, went out to dinner, having chills, couldnt eat much, feeling cold, thirsty, dizziness came on @ 7pm, aching all over, temperature was 101 degrees F, hurt all night, severe headache and neck pain, then next day, radiating pain to abdomen/extremities that evening, thinks she had a seizure on Saturday, fell down and injured face, on Sunday morning, extreme pain still and fever 102, went to ER at some point in the afternoon, ran tests, stayed in hospital, fever broke on Wed morning and discharged on Wed, Oct 3rd in the evening on 7 or so different medications, MD determined it was from the SHINGRIX vaccine.
My COVID-19 infection started on 01/03/2023 in the morning as soon as I woke. I had cough, headache, body aches, chills, and difficulty breathing. I thought it was just a cold or allergy. I also had phlegm. I did COVID-19 home tests 01/09/2023 which was positive. I called my doctor right way when I tested positive. My doctor send me a prescription with PAXLOVID 5 days, WIXELA inhaler, and doxycycline.
shot was in left upper arm- swollen lymph nodes under the arm being reported, last over 4 days
RECIEVED VARIVAX VACCINE ON 8/01/2008. REPORTED TO HAVE HIVES ALL OVER ON 8/02/2008. REPORTED THAT TONGUE AND LIPS SWOLLEN ON 8/03/2008.  MOTHER GIVING BENEDRYL PO Q6HRS PRN.  NO REPORT OF RESPIRATORY DIFFICULTY
TC from mom on 13JUN; Took child to MD on 12JUN t103.4F w/APAP & swelling, redness of inject site, from hip to knee lt leg; Currently on Benalin & Advil per mom pt improving;
Upper body / chest / arm / shoulder / back pain. Diagnosis: Primary Sternal Osteomyelitis
2nd booster-Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd booster-Dose administered after 30-day Use By Date) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd booster-Dose administered after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2nd booster-Dose administered after 30-day Use By Date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The patient was administered 2nd booster dose after 30 days use by date. The manufacturer expiration date was 05-Jul-2022.  The date the vial initially stored in the refrigerator was 02-Mar-2022. It was also reported that the vial didn't undergo any temperature excursions.  No treatment information was provided.
This spontaneous report as received from a Licensed Practical Nurse. On 06-MAY-2013, multiple unspecified patients were vaccinated with VAQTA (lot # 0273AE exp. 06-DEC-2014 and lot # H012669, exp. 17-APR-2015). The nurse reported the dose of VAQTA were exposed to 30.1 degrees Fahrenheit for three hours, which was unsupported by stability data. No adverse effects reported. This is one of several cases received from same source. Additional information has been requested.
Patient called pharmacy today and reported redness that has spread to her elbow and around her arm, and that is swelling and hot. I advised her to be seen by her physician as soon as possible, not necessarily ER visit urgent but I recommended going to be seen tomorrow since the office is probably closed at this point.
Patient felt the following symptoms post vaccination: 1) sweating 2) elevated temperature 3) slight face discoloration 4) dizziness. Patient monitored closely by staff until Mother claimed he had recovered. After assessment, staff also confirmed that the patient recovered from his symptoms before he left the pharmacy.
No additional AE information; Caller is an office manager that reported a temperature excursion for VARlVAX and MMR II. / Caller stated during that time the vaccines were administered to patients.; This spontaneous report was received from an office manager, referring to a 17-year-old patient of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On an unspecified date in February 2021, the patient was vaccinate with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot number S032825, which has been verified to be valid, expiration date reported and validated as 16-OCT-2021), and (varicella virus vaccine live (oka/merck) (VARIVAX) (lot number T024286, which has been verified to be valid, expiration date reported and validated as 15-JUL-2022), both vaccines were administered at a dose of 0.5 milliliter (ml), as prophylaxis (formulations, strengths, vaccination schemes frequency, routes of administration and anatomical sites of vaccination were not reported for any of the vaccines). The vaccines administered, experienced a temperature excursion of -10 degrees Celsius (C) for a time frame of 1 hour and 15 minutes (product storage error). There was no previous temperature excursion reported and no data logger was involved. No additional adverse events were reported.
severe myalgias, lethargy, rigors, h/a, onset of sx approx 3-5hr p/inj
Pt has started with itching, urticarial rash on upper left half of her body. She is unsure if vaccine was given on right or left arm. Also has new rash on right lower ant leg that started later than the upper rash.
Diarrhea started 45mins after injection and fatigue 2 hrs later. Migraines, fever, body aches, chills started within 6hrs and lasted 48hrs.
This spontaneous report was received from a registered nurse referring to a 45 year old female patient. The patient did not have pertinent medical history, drug reactions or allergies; and she was not taking any concomitant therapies. On 02-JUL-2008, the patient received the first dose of injectable RECOMBIVAX HB for vaccination (strength, dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported). On approximately 03-JUL-2008 (reported as "the next day"), the patient developed a "stiff" neck (neck stiffness). On approximately 10-JUL-2008, the patient recovered from neck stiffness (onset date on 03-JUL-2008); no treatment was given for the event. On 12-AUG-2008, the patient received the second dose of injectable RECOMBIVAX HB for vaccination (strength, dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported). On approximately 13-AUG-2008 (reported as "the next day"), again the patient developed a "stiff" neck (neck stiffness). On approximately 13-SEP-2008 (reported as "one month"), the patient recovered from neck stiffness (onset date on 13-AUG-2008). It was reported that, on an unspecified date in 2008, a nurse recommended the patient "to put heat on it and to not receive any more doses of RECOMBIVAX HB". Additionally, it was reported that there were not diagnostic laboratories or studies performed. The relationship between the therapy with RECOMBIVAX HB and the events of neck stiffness (onset date on 03-JUL-2008) and neck stiffness (onset date on 13-AUG-2008) was not provided. Additional information has been requested.
Numb sensation in the left side of her tongue after three shots; Numb sensation in the throat after three shots; Sore arm; A litlle tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Numb sensation in the left side of her tongue after three shots), PHARYNGEAL HYPOAESTHESIA (Numb sensation in the throat after three shots), PAIN IN EXTREMITY (Sore arm) and FATIGUE (A litlle tired) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Pericarditis (myo or pericarditis when she was 2 years of age), Myocarditis (when she was 2 years of age), TIA (TIA a couple of years ago) and Numbness (TIA a couple of years ago and the left side of face and arm got numb.). Concomitant products included LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced HYPOAESTHESIA ORAL (Numb sensation in the left side of her tongue after three shots) and PHARYNGEAL HYPOAESTHESIA (Numb sensation in the throat after three shots). In January 2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (A litlle tired). On 07-Jan-2021, HYPOAESTHESIA ORAL (Numb sensation in the left side of her tongue after three shots) and PHARYNGEAL HYPOAESTHESIA (Numb sensation in the throat after three shots) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (A litlle tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment to the events not reported.  Patient got a numb sensation in the left side of the tongue and in the throat. It started about 25 minutes after the shot and lasts for about 1-2 hours.   This case was linked to MOD-2021-361902, MOD-2021-361778 (Patient Link).
Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Medium
Information has been received from a physician concerning a female who on 05-FEB-2008 was vaccinated with zoster vaccine live (Oka/Merck). "Ever since she was vaccinated", on 05-FEB-2008, the patient has experienced itchiness and a burning sensation at the injection site. It was noted that the patient's husband (WAES # 0802USA04107) was also vaccinated on 05-FEB-2008 with 0.65 ml of zoster vaccine live (Oka/Merck) and developed shingles ten days post vaccination. Additional information has been requested.
Pt admitted on 12/28/2021 and is being treated for covid, acute renal failure and DKA.   Continued to worse until because sedated and on ventilator support. Pts chest x-ray showed worsening airspace disease, congestive heart failure and bilateral pneumonias. -Pt is on IV Sublimze, Levophed, diprivan -Pt has abnormal labs - WBC 10.9, Hgb 13.4 CO2 19, BUN 81, creatinine 2.24  Pt expired 1/3/22
Within fifteen minutes of the vaccine became itchy all over and pharmacy administered Benadryl.  This morning she developed a temp of 99.4, shaking all over, chest hurts, cough and aching
Expired dose administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number unknown, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd October 2022, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 3rd October 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 03-OCT-2022 Reporter's comment: The reporter reported that expired dose of Fluarix was administered to the patient which was expired on 30th June 2022. The Fluarix dose administered was from season 2022-2023. That season was not an option available on the Adverse event (AE) form. Healthcare Professional (HCP) had no other AE information besides what was listed on the AE form. The reporter consented to follow-up. Additional Supportive Information:  The patient received a dose of Fluarix which was already expired, which led to expired vaccine used.
Superior sagittal sinus thrombosis diagnosed on 4/1/2021. Symptoms started early on April 1, 2021
Pt developed moderate to severe pain in the left shoulder joint radiating to the elbow. Pt treated with pain medication and physical therapy.
He comes in severely bradycardic with underlying atrial fib. history of COPD, HFrEF (EF 37% on last TTE 08/21/2020), AFib on Xarelto, Alzheimer's, T2DM, TIA, colon cancer, and HTN presents as a transfer from facility with bradycardia.  Patient presented to the ED on 12/07 with complaints of weakness.  In the ED he was severely bradycardic with HR 21. Per outside notes he was disheveled, dirty, and incontinent.  He admitted to not taking his medications as prescribed and not eating or drinking properly.  He reported drinking approximately 2 drinks/day of hard liquor.  He was admitted for further monitoring and treatment given his severe bradycardia.  Of note he was also hypotensive on presentation with systolic BP's i the 60s.  He was resuscitated with IV fluids.  He was admitted in facility through 12/8.
The evening following second dose of Moderna vaccine, patient began feeling chest pain resulting in evaluation in Emergency Department of local hospital.  ECG completed which showed abnormal results consisting in atrial enlargement.  Patient was discharged from ER with diagnosis of muscle skeletal pain.
patient received his first dose (28-sep) but received the second dose on (11-oct) before the 28 days with no reported adverse event; Initial information was received on 02-Nov-2023 and live follow up received on same date both were processed together regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 16 months old male patient who received his first dose (28-sep) of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] but received the second dose on (11-oct) before the 28 days with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included ELASOMERAN (MODERNA COVID-19 VACCINE) for COVID-19 immunisation.  On 28-Sep-2023 the patient received first dose 0.5 ml, total (1x) of suspect INFLUENZA QUADRIVAL A-B VACCINE, Suspension for injection (strength, lot and expiry date: unknown) via intramuscular   route in unknown administration site for prophylactic vaccination (immunization).  On 11-Oct-2023, the patient received a dose 2  dose.  On 11-OCT-2023 the patient developed a non-serious patient received his first dose (28-sep) but received the second dose on (11-oct) before the 28 days with no reported adverse event (product administered to patient of inappropriate age) (latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
02/05 night, a rash started on my left arm next to the injection site;   02/06 morning, new rash started on my  entire back, very itchy; during the day, more rashes could be seen on the back of both wrists, towards night time, I noticed rashes on thighs and ankles. Anti-itchy cream was applied in the morning and I also took allergy pills at night.    02/07 - 02/09  no more new rash. The rash on left wrist remained.
This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in an adult female patient who received Influenza vaccine Quadrivalent for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: This case was not reported previously to anyone. The age at vaccination was not reported. In 1995, 25 years or so before the reporting date, the patient received unspecified flu shot. The patient had an unspecified bad reaction after vaccination. The patient's physician told her never to get a flu shot ever again.
TD given R/deltoid, 10/28/99. Pt c/o burning, swelling x 4 days, then 11/1/99, developed urticarial rash on deltoid extending forearm. Tx'd w/Benadryl, PO. Local urticaria/allergic reaction to TD.
Following day patient reports fever, chills, achiness, redness at injection site, hardness and swelling around injection site, (swelling started and still hot).
Saturday 2/2/08 started with red bumps on belly.  Bumps are spreading.  Last Friday had fever.
It was sore with the other ones although not particularly really really sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 81-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single, (Lot # not provided)), for Covid-19 immunization, reaction(s): "It was sore with the other ones although not particularly really really sore". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "It was sore with the other ones although not particularly really really sore".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201142333 similar report from same reporter;
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 49 year old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date in 2017, the patient was prescribed and vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not provided) for long term prevention of shingles and zoster-related conditions by a healthcare provider. On an unknown date, the patient was treated by a healthcare provider from the following injuries resulting from use of with zoster vaccine live (ZOSTAVAX): shingles. The outcome of shinlges was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
This is a non-serious spontaneous case from a physician in the USA reporting a patient developed HIVES. The reporter causality between events and FluMist is not provided. This case is submitted according to the VAERS accelerated reporting agreement for FluMist. A 46 year old female developed hives under arms, abdominal pain, became restless and felt anxious after receiving FluMist. On 10DEC04, the patient received FluMist along with three allergy shots. She left the doctor's office and after five minutes became anxious and drove back to the physician's office. Her vital signs were within normal limits but she was restless with abdominal pain. She also had hives under her arms, which were not diffuse, within one hour of Flumist vaccination. There were no respiratory symptoms or swelling. The patient took benadryl before going to the ER. She as treated at the ER with solumedrol and IV fluids after which she was released. The patient has recovered from all events. The patient has a history of allergies but not to eggs and receives allergy desensitization shots in the reporting physician's office. The reporting physician feels that in the future, vaccine and allergy shots should be separated. The reporter determined the events to be unrelated to FluMist due to administation of concurrent allergy shots with the FluMist vaccination. 09Feb05 Additional information received: Pt's date of birth, confirmatin that the time of vaccine admin and onset of events were not recorded.
On 10/20/2022, the symptoms were dry cough, sore throat, nasal and ear congestion. At 5:00AM on 10/21/2022 I took the COVID-19 home test and the result was positive. I called my doctor that morning and that afternoon I had the telehealth meeting. I was given a prescription for PAXLOVID but told me to wait over the weekend and monitor with a pulse oximeter and only if the oximeter fell below 90, I should fill the prescription. My reading never fell below 90, so I never took the PAXLOVID. It took me 2 weeks to recover 100 percent. After 2 weeks I tested negative. And 3 days later I tested again, and it was negative. That is when I resumed normal activities.