chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with dose 1 VAQTA on 20-FEB-2009. And the patient was received the second dose and third dose of VAQTA on 31-MAR-2010 and 02-NOV-2012, respectively. No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms were reported. It was unknown if the patient sought medical attention. At the time of report, the patient's status was unknown. Additional information has been requested.
Narrative: Following second COVID-19 vaccination, patient reported chest pain and acute pericarditis. Patient reported ED diagnosed possible AMI. Patient tested negative for COVID-19 on 2/8/2021.
0.3 ml given from the pfizer vaccine vial to patient. Patient felt fine when leaving after waiting 15 mins.  After patient left, it was discovered that pfizer vial was diluted with 0.8ml of dilutant instead of 1.8ml.  When diluting the vial, I thought I had a 3 ml syringe, but instead had a 1ml syringe.  Unfortunately, we were very busy and I didn't realize this until after the injection was given.
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender.  The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date(s), the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB from lot # M047666 with expiry: 24-OCT-2019 and lot# M034187 with expiry:17-MAY-2019, for prophylaxis (dose, route and anatomical location not reported). The vaccine lots had a temperature excursion of -1.7 degree Celsius for 1 hour and 10.8 degree Celsius for 2 hours. No adverse effects were reported. The vaccines had no previous temperature excursion. The temperature excursion was identified by data logger. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001439:
No adverse effects reported; vaccinated with an improperly stored PROQUAD; This spontaneous report was received from a medical assistant, regarding an 8 year old male patient. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. Concomitant medications included hepatitis b virus vaccine (unspecified), diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and poliovirus vaccine inactivated (unspecified).     On 17-SEP-2019, the patient was vaccinated with an improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) intramuscularly (IM), (dose, dose number and location of administration were not reported) (lot # S012472, expiration date 20-OCT-2020), for prophylaxis. The patient was vaccinated at a private doctor's office hospital and the vaccine was purchased with public funds.  The vaccine was exposed to a temperature of 25.61 degree Celsius from 19-AUG-2019 to 02-OCT-2019 as recorded by a digital data logger. There were no previous temperature excursions, however on an unknown date, the vaccine was exposed to a temperature from 9 to 25 degree Celsius (25.4 degree Celsius) for a time frame of 8290 hours and 30 minutes as recorded by a digital data logger. No adverse effects were reported.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1910USA012356: US-009507513-1910USA012355: US-009507513-1910USA012352: US-009507513-1910USA012351: US-009507513-1910USA012349: US-009507513-1910USA012240: US-009507513-1910USA012357: US-009507513-1910USA007637: US-009507513-1910USA012981: US-009507513-1910USA012350: US-009507513-1910USA012353: US-009507513-1910USA012354: US-009507513-1910USA012358: US-009507513-1910USA012359:
Information has been received from a registered nurse concerning a patient who on 17-JUN-2008 was vaccinated IM instead of SC with a dose of MMR II (lot# unknown). No adverse event was reported. No product quality complaint was involved. Additional information has been requested. Follow-up information was received from the registered nurse concerning the patient with no illness at the time of vaccination who was vaccinated with a dose of MMR II previously reported on 17-JUN-2008. However, it was noted that, on 16-JUN-2008 at 2:00 PM, the patient experienced mild discomfort at the site. No vaccines were given within four weeks of vaccination and no diagnostic studies were performed. No additional information is available.
the day p/vax 17NOV92) pt noticed generalized joint & muscle pain; no fever felt fine otherwide; pain is less intense now but still having some discomfort;
I wakened this morning with massive diarrhea. I waited a couple of hours and got a banana and yogurt. The diarrhea continued and numbness in the face. Then, developed a fever (100.5). I still could not read from my left eye and have puffiness.
Developed tingling/ache in left leg, calf and knee.  Saw chiropractor twice.  Weakness is said leg for 2-3 weeks.  Has almost subsided as of today.  Saw today?s report of new adverse reaction to Jannson Vaccine and felt I needed to report it.
Marked erythema and induration to injection site in left deltoid muscle, measuring approximately 5-6 cm in size. Also warm to touch. No systemic signs or symptoms.
Information has been received from a registered nurse concerning an 9 year old male with allergies, seasonal rhinitis, and no other medical history who on 7/17/96 was vaccinated with a dose of varicella virus vaccine live (lot # 617075/1663B). Concomitant therapy included loratadine for seasonal rhinitis. The nurse reported that the patient now has breakthrough varicella. The symptoms started on 3/30/04. The patient was seen in the office on 4/1/04 with about 30 lesions generalized over the body. He was treated with diphenhydramine hydrochloride, and calamine lotion. It was noted that he was exposed to several cases of varicella at school. A product quality complaint was not involved. Additional information has been requested. The nurse also reported a 10 year old child who had a similar experience after therapy with varicella virus vaccine live (WAES0404USA01992) and five or six other children with similar experiences after therapy with varicella virus vaccine live.
45-60 seconds of staring and not moving.  Didn't respond to verbal stimuli, but after the episode, states she could hear her name being called, but couldn't respond.  This occurred 6 times over 9/23-9/24.
Received Pfizer #2 at 0845, then at 0855 pt c/o nausea and began vomiting. Vomiting continued for  10 min and did not improve. Allergist on call consulted- Epi x1 given and pt transported to ER.
This case was reported by a physician via call center representative and described the occurrence of erythema in a 55-year-old female patient who received SHINGRIX. On 22nd February 2018, the patient received the 1st dose of SHINGRIX .5 ml. In February 2018, less than a week after receiving SHINGRIX, the patient experienced erythema. On an unknown date, the patient experienced pain. The patient was treated with MOTRIN and medication unknown, Ice Pack (NOS). On an unknown date, the outcome of the erythema and pain were unknown. It was unknown if the reporter considered the erythema and pain to be related to SHINGRIX. Additional details were provided as follows: On 25th February 2018, the healthcare professional reported that the patient had a reaction to the vaccine. The reporter did not know when the reaction started. The healthcare professional told the patient to take MOTRIN and apply ice and let him know if it did not improve. This case is linked with US2018032635, as reported by same reporter.
Vaccine administered at 9:43 am on 11/27/21, the patient stated at 10:02 am that her injection site was itchy and red and was warm to the touch. There were no other symptoms noted upon questioning. a cold pack was applied to the injection site and the patient was monitored for an additional 15 minutes. At 10:20 am, the the cold pack was removed and the patient said that the injection site was still itchy but no other symptoms have developed.  A dose of 25 mg of diphenhydramine solution was administered orally. The patient left the pharmacy at approximately 10:40 am. There seemed to be less redness at the injection site than upon presentation.
I tested positive for COVID-19 on 04/29/2022. My symptoms are mild. It started with a scratchy throat, I tested myself at home and it was positive and I was cough, sore throat, running nose and some chills. I quarantine myself for about 7 days. The doctor said to stay in for about 5 days and I just wanted to make sure, so I did and extra 2 days. The doctor prescribe me Paxlovid 300-100 mg pack. I took another COVID-19 test today and it was negative.
Reported she has been having severe headaches for the past week. She complained of SOB shortly after. She was advised to seek medical attention.
The vaccination was administer and about 30 seconds after the administration, the pt began to loss consciousness. The pt began convulsing for about 1 minute. After 1 minute, the pt regained consciousness but was slightly dazed and didn't know what had happened.
Pt stated she notice some tenderness the evening of 3/14. 03/15/22 reported erythema, area larger around 5 " not as tender as what she reported in 03/14/22, She noted it was not warm to touch. Referred patient to follow up with doctor or urgent care for an evaluation
I developed a vasculitis rash mostly on my lower right leg. I had a tiny rash of he evening before the shot. That was a Thursday. The shot was Friday night.  Monday evening I had a huge rash on my lower right leg and a very tiny rash on my lower left leg.
Pain down left arm, arm eventually hard swollen at site then black n blue in color. Stood up to leave after 18 minutes.  Almost passed out.    Dizzy, light-headed,  sat down.  Legs tingled. Waited 20 more minutes.  Headache. Chills. Chills lasted 24 hours. Sore, swollen arm lasted 3-4 days paramedics at vaccine location assessed, monitored,
Fully vaccinated with booster 12/6/21.   COVID breakthrough infection with inpatient hospital stay.    Lot # of vaccine 1 and 2 are not documented.
Patient received COVID-19 vaccine on Monday - had grade 3 reactions (fevers, chills) through Wednesday, and developed redness/swelling at injection site thursday/friday. Evaluated by urgent treatment clinic, who determined to be allergy and dispensed benadryl, however per patient interview the reaction was localized and improved overnight after 1 dose of PO benadryl and a cold compress. No generalized hives, difficulty breathing, itchiness or swelling.  This provider does not think this is an allergy or contraindication to future vaccination with the mRNA vaccines.
17 year old patient received a Flublok Quadrivalent on 07Nov2019, no AE; Initial information received on 08-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2019SA327372 (same reporter).  This case involves a 17 years old female patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA1952, expiry date: 30-Jun-2020) via intramuscular route in the right deltoid on 07-Nov-2019.  The concomitant vaccine included Menactra.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate age of vaccine administration.  At the time of reporting the patient had no adverse event.  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 and Module VI of the 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.
COVID Breakthrough. Patient tested positive at an urgent care on 12/7/21. Patient presented to the hospital on 12/20/21 with ongoing/worsening symptoms.
Patient experienced malaise and shortness of breath within 2-3 hours of getting the shot. Progressed over the next 48 hours and then presented to ER where she was diagnosed with acute hypoxic respiratory failure due to a myocardial infarction. Transferred to care center on 05/15/2021.  Patient nor her family desired any heroic measures due to her age and comfort measures were instituted. She expired on 05/19/2021. Prior to the vaccination, patient had been active, going to the YMCA to exercise 4 times weekly. She had no previous history of previous cardiac or respiratory problems.
In a previous PAP test, something was detected, but it went away; numbness in the injection site area; feeling dizzy; received her first dose of GARDASIL 9 about 10 years ago and just gave herself her second dose today; This spontaneous report was received from a 33 year old female pharmacist reporting on herself. There were no concurrent conditions, medical history or concomitant therapies reported  On an unspecified date in 2010 (reported as about 10 years ago) the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscular (Lot # N035957 with expiration date on 10-OCT-2020). On 11-FEB-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(inappropriate schedule of product administration). Following administration of the second dose, she reported some numbness in the injection site area, and feeling dizzy, which resolved after 5 minutes. No treatment was received. It was also reported that in a previous PAP test from an unspecified date, something was detected (Smear cervix abnormal), but it went away.    The causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.
pain,swelling & redness at inject site. Rash on legs from groin areato calves; also on upper arms. Took benadryl, lasted 3 wks. Malaise, full body erythematous papules, itching, dry skin. Took benadryl  and tylenol.
pt inadvertently recv varicella instead of varicella zoster immune globulin;approx 8-9 wk gestation pt had a spontaneous abortion;It was also noted that pt devel a varicella-like rash on 31MAR97;MD felt that abortion was not r/t vax;
had the worse period after first shot and still spotting now; still spotting; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (had the worse period after first shot and still spotting now) and INTERMENSTRUAL BLEEDING (still spotting) in a female 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 HEAVY MENSTRUAL BLEEDING (had the worse period after first shot and still spotting now) and INTERMENSTRUAL BLEEDING (still spotting). At the time of the report, HEAVY MENSTRUAL BLEEDING (had the worse period after first shot and still spotting now) and INTERMENSTRUAL BLEEDING (still spotting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not provided.  Treatment information was not provided.
Developed aching joints, fatigue and headache within 12 hours of injection. Conditions worsened. Fever off 100.6 within 24 hours. Fever disipated to 99.6 by 9 pm, severe headache persisted. Took Tylenol. Headache disipated by 1 AM. Developed pins and needles in arms, legs, chest, neck. Symptoms of pins and needles continues but comes and goes. This is day 4 after vaccination.
UrticariaPruritis swelling, painful, red, itchy, cellulitis, dermatitis Narrative:
After my second vaccination I developed a very severe rash over my lower extremities that left scars. I spoke with my physician and he did not give me anything to treat it. I purchased store bought over the counter medications to heal. It took approximately 2 months to subside.
Patient had large reddened area on upper arm that was described as painful and hardened area. On all nurse referred pt. out to ER when red area went 1" past line of demarcation. Student on antibiotics.
I got dizzy approximately 15 minutes after receiving the vaccine.  I went home and passed out for approximately two hours and have been very tired ever since.  I had chills a few hours after receiving the vaccine.  I still feel tired despite sleeping very well and feel groggy.
A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a 29-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 06-Dec-2011, the patient inadvertently received expired FLUMIST. The product expired on 04-Dec-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
received her first dose of the Moderna Covid-19 vaccine on March 11, 2023 / now having trouble finding her second dose of the Moderna Covid-19 primary series/ More than 35 days in between her primary series Moderna Covid-19 vaccines; The patient is now having trouble finding her second dose of the Moderna Covid-19 primary series; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (received her first dose of the Moderna Covid-19 vaccine on March 11, 2023 / now having trouble finding her second dose of the Moderna Covid-19 primary series/ More than 35 days in between her primary series Moderna Covid-19 vaccines), PRODUCT AVAILABILITY ISSUE (The patient is now having trouble finding her second dose of the Moderna Covid-19 primary series) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (received her first dose of the Moderna Covid-19 vaccine on March 11, 2023 / now having trouble finding her second dose of the Moderna Covid-19 primary series/ More than 35 days in between her primary series Moderna Covid-19 vaccines), PRODUCT AVAILABILITY ISSUE (The patient is now having trouble finding her second dose of the Moderna Covid-19 primary series) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (received her first dose of the Moderna Covid-19 vaccine on March 11, 2023 / now having trouble finding her second dose of the Moderna Covid-19 primary series/ More than 35 days in between her primary series Moderna Covid-19 vaccines), PRODUCT AVAILABILITY ISSUE (The patient is now having trouble finding her second dose of the Moderna Covid-19 primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT ADMINISTRATION INTERRUPTED (received her first dose of the Moderna Covid-19 vaccine on March 11, 2023 / now having trouble finding her second dose of the Moderna Covid-19 primary series/ More than 35 days in between her primary series Moderna Covid-19 vaccines) and PRODUCT AVAILABILITY ISSUE (The patient is now having trouble finding her second dose of the Moderna Covid-19 primary series).    Concomitant medication details not reported by the reporter. Patient received her first dose of the Moderna Covid-19 vaccine on March 11, 2023 at a Pharmacy. The patient is now having trouble finding her second dose of the Moderna Covid-19 primary series. More than 35 days in between her primary series Moderna Covid-19 vaccines. The patient did not want to provide any additional information.  Treatment details was not reported by the reporter.   Reporter did not allow further contact
Progress Notes (Physician Assistant) ? ? General Surgery/Trauma Cosigned by: MD at 12/29/2020 12:36 PM Expand All Collapse All      COVID VACCINE CLINIC 12/22/2020    Date:  12/22/2020                                                                                             Subjective Patient is a 55 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination.    She denied any history of previous adverse reactions to vaccines.   She was given the Pfizer vaccination in the left deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience dizziness, anxiety.  She denied rash, hives, difficulty breathing, difficulty swallowing, throat tightness, hoarseness, itching, facial swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea and increased work of breathing, vomiting and abdominal pain.   Problem list, past medical/surgical hx, medication list reviewed and discussed with pt.  She has no hx of previous hypersensitivity reactions to immunizations.       Review of Systems Negative, except for above.    Objective    Vitals Vitals:   12/22/20 1123 12/22/20 1130 BP: 131/65 114/56 BP Location: Right arm   Pulse: 78 70 SpO2: 99% 99%       Physical Exam Constitutional:      Appearance: Normal appearance.  HENT:     Head: Normocephalic.     Nose: Nose normal.     Mouth/Throat:     Mouth: Mucous membranes are moist.     Pharynx: Oropharynx is clear.  Neck:     Musculoskeletal: Normal range of motion.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Heart sounds: Murmur present.  Pulmonary:     Effort: Pulmonary effort is normal.     Breath sounds: Normal breath sounds.  Abdominal:     Palpations: Abdomen is soft.  Skin:    General: Skin is warm and dry.     Capillary Refill: Capillary refill takes less than 2 seconds.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time.  Psychiatric:        Mood and Affect: Mood normal.         Assessment/Plan    Assessment:  Transient anxiety associated with covid vaccine administration   Plan: Treatment included observation, serial examination, monitoring of vital signs. Follow up response to treatment: no side effects. Patient discharge:  Stable to go home and follow up with PCP.   Patient was monitored for approximately 45 minutes post injection with multiple physical exams and serial vitals signs with no observance of local or systemic hypersensitivity response.  At the time of discharge she had no complaints and was able to ambulate easily without assistance.     Signs and symptoms of anaphylaxis were reviewed and discussed, and she was instructed to call 911 or report to the ED immediately if those signs/symptoms develop.  She verbalized understanding.     PA-C Electronically Signed 12/22/2020 11:53 AM