chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sleepiness; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepiness) and FATIGUE (Tiredness) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced SOMNOLENCE (sleepiness) and FATIGUE (Tiredness). At the time of the report, SOMNOLENCE (sleepiness) and FATIGUE (Tiredness) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not Applicable.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Additional information received on 04-JUN-2021 was updated the Patient DOB.
Administered dose of vial that wasn't thawed as recommended; A spontaneous report was received from a consumer concerning a male patient who experienced product preparation issue (administered dose of vial that wasn't thawed as recommended).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On unknown date, approximately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   On unknown date, the patient reported that the pharmacist took the vial out and injected him immediately instead of waiting 15 minutes to administer. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event administered dose of vial that wasn't thawed as recommended was unknown.; Reporter's Comments: This report refers to a case of  product preparation issue for mRNA-1273 (lot # unknown) with no associated AEs reported.
swelling of arm that injection was given in starting within a couple hours of vaccine. Patient waited a couple days before calling family physician. Was instructed to go to urgent care. Urgent care instructed patient to apply Benadryl cream, triamcinolone cream, and ibuprofen. Also instructed to use this same treatment for second dose if she opted into getting it. (urgent care said she could get the second, family doctor advised against it.)
Some area of increased induration and redness about 3-4 cm in diameter. Large surrounding area of mild erythema without tenderness about 10-15 cm in diameter.
Information has been received from VAERS by a physician, concerning a 10-year-old female with a history of Kawaski's Disease in 1997, and a concurrent condition of asthma that does not require any chronic medications, who on 28-MAY-1997 was vaccinated in the arm with a dose of varicella virus vaccine live (Oka/Merck) (lot # 621200/0180E). There were no concomitant vaccinations on 28-MAY-1997. On 19-APR-2003, while the patient was on vacation in another country, the patient developed a red raised rash on her chest, spreading to her arms. There were over 60 lesions and lots of itching. Unspecified medical attention was sought. It is unknown if there were any diagnostic laboratory data. It is unknown if there were any other medications given. The outcome is reported as not recovered. It is unspecified if a product quality complaint was involved. No further information is available.
This spontaneous report as received from a medical assistant refers to a 4 years old patient of unknown gender. On 23-JUL-2015, the patient was vaccinated with a improperly stored dose of PROQUAD (Merck) (dose and route were not reported, lot # reported as L005296, expiration date 17-AUG-2016). There was no adverse effects reported. This is one of several reports received from the same reporter. Lot number L005296 has been verified to be a valid lot number for PROQUAD (Merck). Additional information has been requested.
The patient began experiencing  left arm numbness on 4/8/21. Five days later she noticed a red spot on top of her left eyelid and bruising in her right arm and leg and she immediately went to urgent care. She was informed her symptoms were not severe.   She has a slight headache today and thinks it is due her allergies. She rates the headache 2/10, mild, achy above the eyebrows more on the left side. She is still feeling intermittent numbness more noticeable on her fingers (pinky and ring finger) on her left hand.
eyes were swollen; rash mostly around eyes, rash on buttock area; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (eyes were swollen) and RASH (rash mostly around eyes, rash on buttock area) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-May-2021, the patient experienced RASH (rash mostly around eyes, rash on buttock area). On 18-May-2021, the patient experienced EYE SWELLING (eyes were swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, EYE SWELLING (eyes were swollen) and RASH (rash mostly around eyes, rash on buttock area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concominant medications were not reported.  On 18 May 2021, the patient went to the Emergency Room (ER) and was prescribed a steroid for the swelling. The patient believes this is an allergic reaction to the vaccine.  Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Upon comming in for 4 year old vaccines on 3/20/07, mother stated that child had hives covering entire body and facial swelling several hours after receiving vaccines. Private Physician not available, child taken to emergency room were he was treated. Mother does not remeber what medications child received.
GARDASIL given 4-23-08 - That evening developed red patch upper chest -> blistered -> 4/20 spread along T3 dermatome. By 4-27-08. Pain along rash. 4-28-28 Treated with acyclovir 800 mg 5x/day x10days.  06/23/2008 MR received from OBGYN. Pt presented to office with red, blistery rash on R side of chest in T3 dermatome and itching and burning in vaginal area. DX:  Shingles.  Yeast vaginitis. Seen again 5/5/08 with rash better. C/o difficulty sleeping and concentrating.
At site of injection, 4 inch raised, red welt. Warm to touch and itchy. Using hydrocortisone and cool compress for symptoms. Shot on 10/20/2018 with reaction occurring same day. Site 2 days later is 4 inches in diameter.
Patient was intending to receive the Shingrix vaccination and was given Janssen Covid-19 vaccination. No known ADR's followed the error. Patient had already completed his series of Covid-19 vaccinations in the previous months.
Patient reported "pins and needles" feeling in the left arm and left leg 5 minutes after the 1st dose of the Pfizer vaccine on 7/21/21, and the feeling has continued "several times every day"  since then. Patient did not report that day. He came back for his 2nd dose on 8/11/21 and discussed his reaction with the student pharmacist.  He had not tried any OTC treatments to help and nothing makes it better or worse. After discussion, patient decided to receive the 2nd dose in his left arm also. Patient was checked on after 5 minutes and he did not report any tingling. After a full 15-minute watch, patient said he didn't have any issues. Pharmacist plans to follow up on 8/12 (day after 2nd dose).
she just just found out that 7 days ago she was exposed to covid; headache; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) via an unspecified route of administration, on 18Dec202, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient is scheduled to receive the 2nd dose but she just found out that on 01Jan2021, 7 days ago, she was exposed to COVID, now she wanted to know if she could go along to get the vaccine or have her tested first.  She does not recall any symptoms aside from headache on an unspecified date. Outcome of the events was unknown.  Information about lot/batch has been requested
Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a two four-months old patient who was vaccinated with a 0.5 ml doses of PENTACEL (lot number: C5439AA; expiry date: 29-Oct-2018) each via unknown route in the thigh NOS (most likely) on 30-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used. It was unknown if any adverse event occurred following the vaccinations. 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 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. List of documents held by sender: none.
Mother states red painful area on outer left thigh yesterday after HIB (L) leg, Prevnar (L) leg.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, and due to a product confusion a patient who was supposed to be administered "Varicella" was vaccinated with M-M-R II which had a lot # of L011528, an expiration date of 03-APR-2017, for prophylaxis instead PROQUAD which contained measles, mumps, rubella  (MMR) and Varicella. The nurse also reported that the patient was not given the age recommended vaccine and she would administer the "Varicella today". Additional information has been requested.
Patient said she had a rash starting from her arm where site received flu immunization all the way on her upper back and her shoulders. It happened on 10/5/13 even though she received vaccine on 10/2/13. She also had eaten food w/ soy sauce she's not sure if it is due to that.
Severe pain in deltoid muscle where vaccine was administered.  Lasting til now, Jan 22, 2016. Pain is constant and worse at night. Treated with menthol pack, Celebrex, Ibuprofen, tramadol.
extra doses of IPOL; received a dose of Pediarix and IPOL at the same visit; Initial information received on 18-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old male patient who had extra doses of ipol (IPV (VERO)) and received a dose of pediarix and ipol at the same visit.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Immunisation.  On 24-Jun-2022, the patient received a dose of 0.5 ml of suspect IPV (VERO) lot Z1A121M via subcutaneous route in the right thigh as immunization.  On 24-JUN-2022 the patient had extra doses of ipol (extra dose administered) and received a dose of pediarix and ipol at the same visit  (vaccine coadministration) same day following the administration of IPV (VERO).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events   At time of reporting, the outcome was Unknown for all the events.   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 guidelines. 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.
Information has been received from a health professional concerning a 20 year old female with no known drug allergies and no pertinent medical history reported who on 15-NOV-2007 was vaccinated with the first dose of GARDASIL. On 25-JAN-2008, the patient was vaccinated with a second dose of GARDASIL. There was no concomitant medication. After each dose of GARDASIL, the patient developed muscle aches, stiff joints with creaking and a strange feeling. The patient did not seek medical attention. The symptoms developed within hours of vaccinations and resolved within a day or 2. Additional information has been requested.
Nausea, weakness, fever/chills, woozy .  Started at 9 AM.  Stayed in bed.  fever broke at 9 PM.  Never vomited.  Felt fine at 5 AM the next morning.  No medications taken.
I had the shot, and then got shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The reporter said shot did not help.  The patient had the shot, and then got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
A report was received from a health care professional on 11/10/03 concerning a 7 month old female vaccinee who inadvertently received Fluvirin on 10/27/03. On 10/27/03, the vaccinee received a single dose of Fluvirin 0.25ml. At the time of reporting the vaccinee did not exhibit any adverse effects. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Fever 101.0 and 100.0; Very bad headache; A spontaneous report was received from a consumer concerning who received Modern's COVID-19 vaccine (mRNA-1273) patient who developed very bad headache and fever of 101 ,100.0.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their second of two planned doses of mRNA-1273 (Batch number: 013M20A) ON 22-FEB-2021, same day prior to the onset of the events intramuscularly for prophylaxis of COVID-19 infection.  Treatment information was not provided.   Therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events were unknown.
Difficulty breathing, palpitations, chest pain, fast beating heart rate, diarrhea, vomit
This spontaneous report was received from a register nurse concerning an adult female patient (age not provided, described as being in her teens) who on her childhood, on unknown dates, completed the full vaccination series of RECOMBIVAX HB or hepatitis B vaccine (manufacturer unknown) (route and lot number was not provided). Secondary suspect or concomitant medications were not provided. The register nurse reported that the patient, had a negative or low titer test following completion of hepatitis B vaccine (manufacturer unknown) but RECOMBIVAX HB could not be ruled out at the time of the call. No other adverse events were reported. At the time of the report the patient's outcome was not provided. This is one of several reports received from the same source. Additional information is not expected.
Numbness in feet and hands beginning a week after the injection. Continued reoccurring numbness in both hands and feet then on Sunday April 16, 2017 I experienced face numbness for about an hour. During this time frame numbness would come and go periodically. On May 7th feet went numb and stayed numb until I was hospitalized on May 8th. On May 8th my hands went numb and then my face followed and stayed that way until IVIG treatments began at the hospital.
Headache, Myalgia, NauseaVomiting, Knot at injection site Narrative:
day after receiving vaccine pt has redness at injection site the size of baseball, itching, redness, pain and itching that went up shoulder. It was getting worse so patient called pharmacy
Mild aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Mild aches) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Mild aches). At the time of the report, MYALGIA (Mild aches) outcome was unknown.            Concomitant medications were not reported.  Treatment information was not provided.   This case was linked to MOD-2021-303415.
Tachycardia  Vital Signs: BP 108/78 HR 79 Resp 16 O2Sat 99 Skin Signs: Warm and dry, diaphoretic - upon arrival to triage  Circulation: Cap refill <2sec  Respiratory: Breath sound clear bilaterally  Initial Treatment: Vitals taken, expressed feeling better after laying down  10:45 AM  Vital Signs: BP 106/70 HR 62 Resp 16 O2Sat 98 Skin Signs: Warm and dry  Circulation: Cap refill <2sec  Respiratory: Breath sound clear bilaterally  Follow up Treatment: D/C with spouse, feeling 'completely normal' at 10:50 AM
Irregular menstrual bleeding (bleeding started again, last day of last period was 1.5 weeks ago). Extreme fatigue. Severe pain (6 out 10 pain scale) in right arm. Headache/migraine that has lasted 2 days. Body aches. Chills. Thirst.
Sore arm; Back pain; very sharp pain and  it felt like I cannot sit; Pain radiating up to spine; This spontaneous case was reported by a health care professional and describes the occurrence of BACK PAIN (Back pain), PAIN (very sharp pain and  it felt like I cannot sit), SPINAL PAIN (Pain radiating up to spine) and PAIN IN EXTREMITY (Sore arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced BACK PAIN (Back pain), PAIN (very sharp pain and  it felt like I cannot sit) and SPINAL PAIN (Pain radiating up to spine). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, BACK PAIN (Back pain), PAIN (very sharp pain and  it felt like I cannot sit), SPINAL PAIN (Pain radiating up to spine) and PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Red, hard lump on arm with burning and itching.  Started on day two after shot and is still very sore and very itchy on now day 4.   didn't happen with first shot.
6/5/2023 - 6/7/2023 (2 days) 006B21A 4/6/2021 031B21A 5/4/2021 041J21A 12/18/2021 azithromycin IV/ceftriaxone IV  weakness, cough
pt had high pitched scream for 3 hrs & did go limp; mom talked w/pediatrician & advised Ped DT;
This spontaneous report as received from a pharmacist via a field employee refers to a 60 year old male patient. On an unknown date the patient was vaccinated with a single 0.65 ml dose of ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient developed a rash that started at the injection and spread to the jaw. The patient sought unspecified medical attention. No treatment information was reported. At the time of the report, the outcome of the events was reported as recovering. Additional information is not expected.
Rubar, calor, dolor all present in her rash, which appeared w/ in one day of vaccine. Patient is distressed.