chrisvoncsefalvay/vaers-outcomes huggingface dataset:
found out she's pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (found out she's pregnant) 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) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (found out she's pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (found out she's pregnant) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided.   Treatment products were not provided.
Started wheezing, coughing red rash and itching over body, swelling around his eyes, eventually had hives on his trunk- s/p EPIPEN Jr dosingx1 plus BENADRYL 25 mg. Vomiting 4 hours later at home, so received a second dose of EPIPEN Jr, sent to local ED for further eval.
5min p/vax pt collapsed & was unresponsive for 3 to 5 sec during which time had gen muscle contraction & reared backward;pt aroused w/1 ammonia inhalant ampule & given Celestone;transferred to ER-psychogenic syncope;pt became lighthea
A rash right below the injection site that was warm to the touch.  Did not come out until a week later.   This has happened to me some of the times I?ve gotten a flu shot in the past.
facial swelling; face rash; This is a spontaneous report from a non- contactable consumer, the patient. A 26 -year-old non pregnant female patient received BNT162B2 (PFIZER -BIONTECH COVID-19 mRNA VACCINE; Lot/Batch number: Ep-7534), via an unspecified route of administration on left arm on 15March2021 at 4.30 pm as second dose of COVID-19 immunization. The patient past drug history included BNT162B2(PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot/Batch Number: En6203) on 23Feb2021 at 4.30 pm. No concomitant medications were reported. Prior to the vaccination patient was not diagnosed with COVID-19. Since the vaccination patient was not tested for COVID-19. On 16March 2021 the patient experienced face rash and facial swelling. Therapeutic measures taken for the adverse events was unknown. Clinical outcome of the events face rash and facial swelling was recovering/resolving at the time of reporting. No follow up attempts are needed. No further information is expected.
dizziness; hot flashes; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DIZZINESS (dizziness) and HOT FLUSH (hot flashes) 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 DIZZINESS (dizziness) and HOT FLUSH (hot flashes). At the time of the report, DIZZINESS (dizziness) and HOT FLUSH (hot flashes) 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.   no treatment information was provided  no concomitant medication were reported   This case was linked to US-MODERNATX, INC.-MOD-2021-095209, US-MODERNATX, INC.-MOD-2021-095268 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: NNI; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-095209: US-MODERNATX, INC.-MOD-2021-095268:
Feeling feverish (but no fever), body aches (especially spine) and coughing within hours of getting the vaccine.  Left arm became swollen and red from the shoulder to elbow. Doctor prescribed antibiotics after 3 days and that lead to a burning sensation and spreading of rash.
Tooth decay; Sensitivity of teeth; Tooth infection; COVID-19; drug ineffective; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4282918-00.  A 49 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 28Aug2021 (Batch/Lot number: unknown) at the age of 48 years as dose 3 (booster), single, intramuscular, administration date 21Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 31Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at single (unk, single) for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 28Jan2022, outcome "recovered" (2022), described as "COVID-19"; DRUG INEFFECTIVE (medically significant) with onset 28Jan2022, outcome "unknown", described as "drug ineffective"; DENTAL CARIES (non-serious), outcome "unknown", described as "Tooth decay"; HYPERAESTHESIA TEETH (non-serious), outcome "unknown", described as "Sensitivity of teeth"; TOOTH INFECTION (non-serious), outcome "unknown", described as "Tooth infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Jan2022) positive. The action taken for adalimumab was unknown. Clinical course:On unknown dates, the patient experienced thought had an infection due to sensitive space on a decaying tooth at the gum line. On 28Jan2022, the patient experienced COVID-19. It was unknown if patient was enrolled in a covid-19 vaccine trial.   Causality for BNT162B2: The reporter considered "Sensitivity of teeth", "Tooth decay", "Tooth infection", and "COVID-19" related (reported as possible) to bnt162b2.  The reporter's causality for the event(s) of thought had an infection due to sensitive space on a decaying tooth at the gym line unknown onset and COVID-19 with Humira (Adalimumab) was no reasonable possibility.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information, a casual association between the suspect product BNT162B2 and the reported events cannot be totally excluded.
Abdominal pain; Nausea; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN (Abdominal pain) and NAUSEA (Nausea) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN (Abdominal pain) and NAUSEA (Nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) (oral) ongoing since an unknown date at a dose of 1 dosage form once a day. At the time of the report, ABDOMINAL PAIN (Abdominal pain) and NAUSEA (Nausea) outcome was 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.   No concomitant medications reported. Treatment details included, Benadryl of 25mg administered orally and the patient was monitored an additional 30 minutes by a registered nurse.    Most recent FOLLOW-UP information incorporated above includes: On 08-Mar-2021: Follow up report received on -08-MAR-2021 and included no new information
14 days after the vaccine, I developed a pruritic papular rash bilat on lower lateral flanks, with urticaria from pressure and scratching. Afebrile. (+) dermatographia. Over the last week there has been some improvement but 2 new papules developed on L inner thigh and R upper arm. No treatment. as it didn't bother me enough. Saw my dermatologist yesterday for routine f/u and he confirmed that Dermatologists are seeing an urticarial rash 1-3 weeks after the vaccine.. The question is: should I get the second shot in a week?
Information has been received from a physician concerning a 62 year old female consumer with no known allergies or pertinent medical history who on 31-MAR-2008 was vaccinated SQ with zoster vaccine live (Oka/Merck). There was no concomitant medication. Subsequently, on 02-APR-2008 the patient developed shingles. The patient had approximately ten lesions on her right forehead. The patient was seen by the the physician. There were no lab studies performed. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested. The patient's sister also had an adverse experience after vaccination with zoster vaccine live (Oka/Merck) (WAES # 0804USA05038).
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 20-APR-2016 the patient was vaccinated with an improperly stored dose of MMR II (lot#I023386, expiration date 25-JUN-2017, dose and route unknown) and an improperly stored dose of (Oka/Merck) VARIVAX (lot# reported as I04688, expiration date 23-NOV-2017, dose and route unknown). The temperature and time frame were at 14.9 Celsius degree for 280 hours. There was no out of range before. No adverse events were reported. Lot number I04688 is an invalid lot number for (Oka/Merck) VARIVAX. This is one of several reports received from the same reporter. Additional information has been requested.
My right eye became very painful, hurt and felt scratchy until 12/31/2020.  My arm still aches and it is 1/2/2021.  I also ache everywhere and still do.  I am extrememy tired all the time and at times have to lie down.  On going.
Was working in garden and began having mental status changes.  ER report states "confused but alert" and "repetition of words"
Contracted covid sometime after the vaccine. I am not blaming the vaccine for contracted it, however I did want to report that I did get it. Not entirely sure if the effectiveness of the vaccine, this is the first time I contracted it, as far as I am aware of.  I have been with covid now for about almost 2 weeks now
administered after 12hr expiration period,  vaccine was drawn up on 12/27/22 @ 2:30pm.  Pfizer stability data supports dose being valid as it was given within 24 hrs.   No need to repeat dose.  Reporting as administration error.
Uncontrollable sneezing, coughing, red blotches, periorbital swelling, nausea, hypertension, hives-taken by ambulance from school to ED. Tx with oral children's BENADRYL, discharged about noon to home on BENADRYL & Rx prednisone for prn use. 11/20 and 11/23/2009 ED and PCP records for 11/13/2009 . Dc Dx allergic reaction  Patient with c/o's sneezing and facial and eye swelling. Tx'd with benadryl and steroids.
Immediately Fast Heart Beat; Weakness; Dizziness; Throat is closing; Severe allergic reaction; Arm  is tender; A spontaneous report was received from a 43-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273, and experienced severe allergic reaction, arm is tender, immediately fast heartbeat, weakness, dizziness and throat is closing.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot number: 011-J20A) intramuscularly in the left arm for COVID-19 infection prophylaxis.  On 29 Dec 2020, The patient reported that she had a severe allergic reaction. She stated that at the time of vaccine administration, she immediately felt she had a fast heartbeat. Approximately 4 hours after vaccine administration, the patient reported that her arm was tender, that she was experiencing weakness, throat closing and dizziness. Treatment for the event included diphenhydramine and ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.  The event immediately fast heartbeat was considered resolved on 29 Dec 2020. The outcome of the events, severe allergic reaction, arm is tender, weakness, dizziness, and throat is closing, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
pt states that her left arm started swelling and developed a 4" feverish rash that is spreading down the arm.  Pt states she is going to contact her PCP for medical advise.
S: Patient experienced sudden onset severe emesis within 30 minutes of second Moderna Vaccine. B: Patient returned to the vaccine lot, driven by a family member with severe sudden onset vomiting. Upon evalautaion patient was alert but unable to speak and shaking.  Epinephrine administered via epi-pen.  Im benadryl administered.  Family declined ambulance and drove patient to ER. Report called to ER Charge.  A: Anaphylaxis post vaccination. R: Allergies updated.  Series is complete
Information has been received from a registered nurse (RN) concerning a 13 month old female with eczema who on 31-Oct-2008 was vaccinated subcutaneously in the left triceps with a 0.5ml dose of VARIVAX (Oka/Merck) (Lot#661649/1156X). Concomitant therapy included acetaminophen (Tylenol). On 10-Nov-2008 the patient developed a red nodule at injection site that was warm to touch. On 13-Nov-2008 the patient had an office visit and was examined by physician. On that day the patient had a non-tender by 1 cm erythematous patch with a 1cm induration at the injection site. The patient was treated with Hydrocortisone cream. At the time of the report, 13-Nov-2008, the patient had not recovered from the events. Follow-up information was received from the R.N. on 08-Jan-2009 concerning a 13 month old white female with eczema. On 31-Oct-2008, at 9:00 a.m. the patient was vaccinated subcutaneously in the left tricep with a first dose of VARIVAX (Oka/Merck)  (Lot#561649/1156X). On the same day, at 9:00am, the patient also received a first dose of MMR II (Lot # 662437/1251X) subcutaneously in the right tricep and a first dose of FLUZONE (lot#UT2782CA) intramuscularly in the left deltoid. There was no illness at the time of vaccination. On 10-Nov-2008, the patient developed bump at the left tricep area. On 13-Nov-2008 the patient came into the office for observation. She had a 2cm by 1cm area pink patch with induration (1cm). The area had no apparent tenderness and was not warm. It was reported that the area "was warm prior and also was more red" and the "site was improving". The patient was not afebrile. Topical hydrocortisone acetate cream was placed to the area. The patient recovered on an unspecified date. Information / Follow-up information received on 08-Jan-2009 contained the following adverse experiences: hives with eggs (November 2008). Additional information is not expected.
Itchy, red, hot to the touch, small size hive at injections site that grew to be adult palm size over the next four days.
Sudden onset of "floaters" and light flashes and clouding of right eye - nausea. Waited 2 hours after and called eye doctor - seen next day (10-20). Was told fluid begins to shed with aging. The form I was given with info at the pharmacy said to report anything at all. It is likely a coincidental effect, but thought it was best to make a report since it was close to vaccine and I never had an episode of this type.
Employee states "ever since I took my H1N1 flu vaccination on 10/29/09, I have had sinus congestion and decreased energy; I also have a cough and some nausea." Employee reported these symptoms on 2/24/10 @1430. Saw personal physician on 12/30/09, prescribed AMOXICILLIN x 10 days, with relief of sinus congestion, nausea and cough. Currently c/o continued decreased energy and persistent sinus congestion. Denies allergies. On 2/24/10 the employee was advised to F/U with her personal physician.
On 4/7/2021Patient presented without an appointment with mother to center requesting a COVID- 19 Vaccine.  Staff asked patient her age and she indicated she was born in 2001- and she was 19. Patient was given the vaccine and during  documentation/input of Vaccine staff noted her DOB as 6/2005. Conference was held with: Patient and mother , patient indicated she did tell staff she was 19 and confirmed her DOB as 6/2005. Staff explained  to patient/mother her age made her ineligible for the immunization and 2nd dose,reporting of  incident . Patient encouraged to register the vaccine with the VSAFE app and report any adverse reactions accordingly. Patient was monitored for 30 minutes after administering of vaccine.
About 10 minutes following his vaccine, patient complained his stomach was hurting. He became very pale, head began to fall back, and he vomited all over himself. Mom was able to catch his head as it went back. The RN on duty immediately checked his pulse and blood oxygen levels, proclaimed he was hypotensive and experiencing a tachycardia episode with a low systolic in the 60s.  Blood oxygen levels sustained in the high 90s consistently. While he did not fully have a syncope event, he did was very sluggish, slow to respond, but remained conscious and responsive. We transferred him to a cot, and had EMS arrive to assure safety for the young boy. They checked is vitals, spoke with patient and Mom, and believed he was okay to go home. Lt. from FD escorted Mom and patient to their car to assure his stability. This all occurred between the hours of 1720 and 1800.  Also suggested Mom make an appointment with his primary care provider.
1525 - states she is experiencing vertigo. Transported via w/c to private observation area. EMT on site in attendance. Patient able to transfer from chair to w/c without difficulty. States, "my head is swimming and I have nausea"  States she has hx of vertigo but this is different as per statement above. HR 86; BP 148/68; O2 97% on room air. States she drove self, has service dog with her. States she ate a late breakfast. States she had a COVID test this morning at for pre op biopsy to be done this Friday 1/22/2021. Denies exposure to COVID.  3:50, examined per Dr. Gave patient gatorade and granola bar. Also drank about 2 ounces of water and tolerated with n/v. Ate about 1/4 granola bar.  O2 98%; HR 88 4:02 PERRL - NO nystagmus noted. Tol. 10oz gatorade without n/v. States she has too much nausea to eat anything.  Offered ambulance transport for further evaluation. Patient unsure what to do.  4:05 - Had patient stand up next to w/c. Mobility steady. Patient looking down at her dog without any swaying noted. Patient sat back down.  4:08 Patient ambulated independently to end of hallway. Gait steady, no assistance required. Reached outside doors. No symptoms of vertigo. No n/v. States she will go home and rest. Advised to seek medical attention if vertigo returns. Declined transport to hospital. Left with her service dog to personal vehicle
Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and CHILLS (Chills) 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 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up received on 16-Jun-2021 and does not contain any new information.
she is still getting rash patches on her body intermittently; 48 hours later she developed hives on her chest, arms, and legs; This spontaneous case was reported by a nurse and describes the occurrence of RASH (she is still getting rash patches on her body intermittently) and URTICARIA (48 hours later she developed hives on her chest, arms, and legs) in a 37-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 13-May-2022,  after starting mRNA-1273 (Spikevax), the patient experienced URTICARIA (48 hours later she developed hives on her chest, arms, and legs). On an unknown date, the patient experienced RASH (she is still getting rash patches on her body intermittently). At the time of the report, RASH (she is still getting rash patches on her body intermittently) and URTICARIA (48 hours later she developed hives on her chest, arms, and legs) was resolving.        mRNA-1273 (Spikevax) (Intramuscular) dosing was delayed on an unknown date.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient did not experience similar event in the past. Patient reported that symptoms improved. Patient did not received the second dose because she developed hives (rash) after receiving first Moderna COVID-19 dose. She reported that she was at the risk of losing her job if she doesn't get the second Moderna primary series dose. No treatment details were reported.
received 2 FLUZONE HIGH DOSE QUADRIVALENT within 24 days in error with no reported adverse event; Initial information received on 24-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 71 years old male patient who received 2 INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] within 24 days in error with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Sep-2022, the patient received 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength and lot number not reported) via intramuscular route in the left deltoid for prophylactic vaccination.  On 24-Oct-2022, the patient received 0.7 mL dose of same vaccine (formulation, strength and lot number not reported) via intramuscular route in the right deltoid for prophylactic vaccination.  On 24-Oct-2022, the patient received 2 fluzone high dose quadrivalent within 24 days in error with no reported adverse event (inappropriate schedule of product administration) (latency: same day of dose 2) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported, pharmacist states that a patient received 2 FLUZONE HIGH DOSE QUADRIVALENT within 24 days in error. She states that today the patient was confused and came in to the Pharmacy requesting a FLUZONE HIGH DOSE QUADRIVALENT vaccine despite having received the vaccine 24 days prior. The Pharmacist did not catch this until after the vaccine was given and she was documenting it.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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 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.