chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not reported.  On unspecified dates between 24-SEP-2016 and 13-OCT-2016, the patients were inadvertently vaccinated with improperly stored doses of GARDASIL 9 injection (lot # reported as M021407, expiration date: 30-APR-2018; doses and route of administration were not provided). The administered doses of vaccine were exposed to a temperature excursion of 35 degrees Fahrenheit (F) for a time frame of 40 minutes. No previous temperature excursions were reported. Data logger was not used to track the temperature. No adverse effect was reported. No product quality complaint (PQC) was involved. Lot number M021407 is an invalid lot number for GARDASIL 9. However, lot# M021407 is valid for GARDASIL. This is one of several reports received from the same reporter. Follow up information has been received from the medical assistant on 20-DEC-2016. The medical assistant stated that she would go through her system and fax the patient identifiers and dates of vaccination. Additional information has been requested. Narrative has been updated. Sender's Comments: US-009507513-1610USA012377: MERCK 1610USA005999: Mfr number.
Dizziness, headache beginning approximately 4 hours following injection,  progressing in severity throughout the day.  Same evening, nausea, GI upset, chills, body aches throughout the night.  Continued with aches, headache, fatigue, nausea on day 2.Headache,  severe fatigue through day 3-4, along with left arm pain, swelling. Day 5, headache, fatigue, left arm swelling, redness, pain, warm to touch, extending down upper arm.
1-2 days after vaccine, child became very fussy. Subjective intermittent fevers. Then on the 28th July, mother noticed an erythematous rash on left thigh, that quickly progressed to vesicular. THe patch of vesicles was about 5cm in diameter. Over the next couple of days she developed vesicular rash on both knees and right arm. She still has the rash. My concern is wth the pregnant mother. I understand vaccinal type is attenuated, but does mother need Varicella immunoglobuly post exposure? Thank you.
Pt recv vax on 3/30/98; 6 hrs later pt was fussy and very irritable.  Pt seen by Dr and given Tylenol.
Pt reports swelling due to tetanus toxoid. Vaccine was not administered at this facility, so very little information can be reported. Patient just reports a historical allergy.
Vaccine Administration Error ONLY  - 5-11yr Bivalent booster administered without diluent in vial - NO adverse effects observed or reported
I contracted COVID-19 on 06/19/2022 with symptoms of dizziness, congestion, cough, and losing all of my strength. I was prescribed PAXLOVID on 06/20/2022. I was ill for 3 days before my began symptoms began to resolve. I am still experiencing lingering cough, and congestion.
Patient received a Pfizer Monovalent booster instead of a bivalent booster. Patient has been informed of the vaccine adminstration error. Reports no adverse reaction to the vaccine.
expired pentacel vaccine being administered with no reported adverse event; Initial information received on 09-Dec-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old female patient who experienced expired pentacel vaccine being administered with no reported adverse event after receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination; and HEPATITIS A VACCINE (HEPATITIS A) for Prophylactic vaccination.  On 08-Dec-2022, the patient received 2 dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE at a dose of 0.5 ml (lot UJ320AAA)(unknown strength and expiry date) via intramuscular route at Vastus Lateralis for prophylactic immunisation(immunisation).  On 08-Dec-2022 the patient had a non-serious event of expired pentacel vaccine being administered with no reported adverse event (expired product administered) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired pentacel vaccine being administered with no reported 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 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.
Post vax, that evening, the pt developed a small red and hard area. On 8/26/01, redness was approx. 2" X 3", warm and tender. Parent treated with ice and Motrin. On 8/27/01, reports that redness is gone and only the hard knot remains. No fever and no fussiness.
Pt. came in and said that his arm hurt more than usual and thought that the shot was given higher than it should have been. I didnt notice any swelling around the injection site however there was some redness closer to the elbow. He said he already used ice, took ibuprofen and the discomfort had significantly reduced since the first day. After 4 days on a follow up call he said his arm felt much better. Pt was advised to see his PCP but he decided not to.
Jaw pain; Lightheadedness; Itching/pins and needles sensation throughout right arm; Itching/pins and needles sensation throughout right arm; Soreness at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the right arm on an unknown date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date, in 2021 the patient experienced light headedness for about 1 hour after vaccination, itching/pins and needles sensation throughout right arm for about 2 hours after vaccination, moderate jaw pain for 48 hours after vaccination and intense soreness at vaccination site starting 12 hours after vaccination which lasted for 48 hours after vaccination.  Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events light headedness was resolved on an unknown date, in 2021 (after duration of 1 hour), itching/pins and needles sensation throughout right arm was resolved on an unknown date, in 2021 (after duration of 2 hours), soreness at injection site was resolved on an unknown date, in 2021 (after duration of 36 hours) and jaw pain was resolved on an unknown date, in 2021 (after duration of 48 hours).  No follow-up attempts are possible. No further information is expected.
red marks in the corner of her mouth that started yesterday and is worse today/but this morning it seemed to have spread more; red marks in the corner of her mouth/The side of her mouth, in the corners, are red; This is a spontaneous report from a contactable consumer via medical information team . A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9263)) via an unspecified route of administration in arm Left on 21Jan2021 as single dose for covid-19 immunisation.The patient medical history and concomitant medications as not reported. She got the Pfizer shot and stated that on 10Feb2021 she has red marks in the corner of her mouth (the side of her mouth, in the corners, are red) that started yesterday and is worse today (11Feb2021). She clarified that the redness in the corners of her mouth actually started yesterday, but this morning it seemed to have spread more (11Feb2021).The events were considered as non serious.It was reported that patient used vaseline on it. She also looked online and it said to put honey on it. The outcome of the event Red marks in the corner of her mouth/The side of her mouth, in the corners, are red was not recovered and outcome of the event red marks in the corner of her mouth that started yesterday and is worse today/but this morning it seemed to have spread more was unknown.
An expired dose of PENTACEL was administered with no reported adverse event; Initial information received  on 02-Feb-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 6-month-old female patient and it was reported that an expired dose of Diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] was administered 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 Rotavirus vaccine live reassort oral 5V (ROTATEQ) for immunisation; and pneumococcal vaccine CONJ 13V (CRM197) (PREVNAR 13) for immunisation.  On 01-Feb-2023, the patient received 0.5 ml (millilitre) (dose 3) (once) (strength: standard) of suspect Diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection (lot UJ640AAA, expiry date: 28-Feb-2023) via intramuscular route in the right thigh for immunization.  On 01-Feb-2023 the reporter reported that an expired dose of pentacel was administered with no reported adverse event (expired product administered) (latency: same day).  No lab data were reported.  Action taken: not applicable.  At time of reporting, the outcome was Not Recovered / Not Resolved 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.
pt noted profuse perspiration, clamminess, vertigo, pale color, sensation of slowed heart rate;pt went to ER; BP was 204/90;pt was given procardia sublingual & 02; BP readings 192/94 10mins, 207/80, 159/82;135PM was 132/68 pt observed
Symptoms: Severe chest tightness and shortness of breath, intermittent chest pain, uncomfortable pain and chill sensation down the spine from the neck area radiating down the left shoulder and arm, down the spinal cord area, or up the left side of the brain / head area. Severe feeling of malaise similar to having a severe flu (feeling "like garbage" or "like getting hit by a train").  Treatment: None Time Course: Better in the mornings, almost unbearable at night.
3 days after the vaccination I started my menstrual cycle even though I had already had one 10 days before. My menstrual cycles are very regular and this was not normal to start it so soon after the previous one. The cycle that started 3 days after my vaccination was lighter than my normal cycles and only lasted 5 days (as opposed to 7-8).  6 days later, I started spotting again. It only lasted 2 days that time and was very light spotting.
Consumer never her 2nd dose of the vaccine.; allergic reaction to the vaccine; Shortness of breath / minor breathing issue; 6 hours later I got hives; she had some lethargic issues after the vaccine/felt crummy for couple of days; Feeling unwell/felt crummy for couple of days; level of intense itching 15 to 20 minutes after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (allergic reaction to the vaccine), DYSPNOEA (Shortness of breath / minor breathing issue), URTICARIA (6 hours later I got hives), LETHARGY (she had some lethargic issues after the vaccine/felt crummy for couple of days) and MALAISE (Feeling unwell/felt crummy for couple of days) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: DOXYCYCLINE HYDROCHLORIDE (doxycycline almost killed her before). Concurrent medical conditions included Allergy (allergies to multiple products).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced ALLERGY TO VACCINE (allergic reaction to the vaccine), DYSPNOEA (Shortness of breath / minor breathing issue), URTICARIA (6 hours later I got hives), LETHARGY (she had some lethargic issues after the vaccine/felt crummy for couple of days), MALAISE (Feeling unwell/felt crummy for couple of days) and VACCINATION SITE PRURITUS (level of intense itching 15 to 20 minutes after vaccination). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Consumer never her 2nd dose of the vaccine.). The patient was treated with ACRIVASTINE (BENADRYL [ACRIVASTINE]) for Adverse event, at an unspecified dose and frequency. On 26-Jan-2021, URTICARIA (6 hours later I got hives) had resolved. At the time of the report, ALLERGY TO VACCINE (allergic reaction to the vaccine), DYSPNOEA (Shortness of breath / minor breathing issue), LETHARGY (she had some lethargic issues after the vaccine/felt crummy for couple of days), MALAISE (Feeling unwell/felt crummy for couple of days) and VACCINATION SITE PRURITUS (level of intense itching 15 to 20 minutes after vaccination) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Consumer never her 2nd dose of the vaccine.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative.     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 concomitant products reported. Consumer states that she had level of intense itching 15 to 20 minutes after vaccination. Consumer states 4 hours later she had minor breathing issue and shortness of breath. Consumer states 6 hours late she got hives.
Consultation requested on a 36 y/o WM for Smallpox vaccine induced skin rash and pre syncope. The patient presented to the ED on this morning and was subsequently admitted to the medical ward. The patient is currently housed in the ICU step down unit. Symptoms: Rash, pruritic, Flu-like symptoms< 95 hours, Dyspnea (shortness of breath), Fever. 10/16/2009 records from ED visit 9/25/2009. patient 10 days post vaccine presented with sx of rash, itching, SOB upon exertion, fever, syncopal episodes. PE noted large area of erythema  lt deltoid. Patient was admitted to ICU and  placed on respiratory and contact isolation. Dermatology and Cardiology consults, Telemetry, Antihistamine tx. Dx: acute myocarditis, dermatitis.
Initial misuse report received from a healthcare professional on 31 May 2013. A patient was administered 0.5 ml MENACTRA vaccine intradermally instead of PPD and then received 0.1 ml IPOL intradermally in the arm. No information was provided regarding the patients. No adverse event was reported. Documents held by sender: None.
Patient received vaccine and1 minute after patient had a warm flushing sensation that she described as being similar to getting contrast. She stated that the back of her throat was warm and the tip of her tongue as well, she was remvoed from the cell and brought to the observation area, her blood pressure was 173/87, heart rate 109, pulse ox 98 in the L arm. She was observed and follow up at 0906 was 174/96, pulse 99 and pulse ox 100. She was observed for another minutes and at 0920 in the R arm her blood pressure was 152/ 85 and heart rate 101. She stated that the warm feeling was resolving and that her tongue still felt a little warm. She did have reddened arms as well in her bilateral arms, no other skin changes noted.
Patient had large local eyrethatous patch at injection site that was raised. Patient later presented with wheezes to the ER.
My entire back is covered in a rash of red, raised, itchy, burning bumps.
My son developed symptoms just like the first time. He started to feel hot and nausea and then convulsions started and lasted for 3 minutes long. From 7:45 PM to 7:48 PM is when the convulsions started and stopped. The outcome to both seizures is now he has temporal lobe eplilepsy. A healthy 17-year child never had one thing wrong until after the vaccinations. Now his whole life has been uprooted.
C/O pain in throat and difficulty swallowing and speaking.  Also hives on wrists.  Sx started a few hours after immunization and stay the same 48 hrs later.  No fever, no dyspnea, no cold sx's.
This spontaneous report as received from a 65 year old diabetic female consumer with high blood pressure, irritable bowel syndrome, drug reaction/allergy to morphine and DARVOCET-N refers to herself. On 10-NOV-2013 the patient received unspecified flu vaccine (manufacturer unknown) (lot #, dose and route unknown) and pneumococcal vaccine(manufacturer unknown) (lot #, dose and route unknown). On 17-NOV-2013, reported as the following Sunday, she experienced a severe cough with respiratory distress which caused her difficulty breathing and eventually she was hospitalized (hospital unspecified) over Christmas time (unspecified date) for 3 days. Consumer stated that she used a nebulizer with an unspecified medication to help treat her condition while in the hospital. Consumer stated that after she was discharged from the hospital, she was seen by another physician at the same facility. Consumer noted that the physician stated that her lungs indicated that she had a severe asthma attack. Outcome of adverse event was not reported. The relatedness between adverse event and pneumococcal vaccine (manufacturer unknown) and unspecified flu vaccine (manufacturer unknown) was unknown. Additional information has been requested. This report is linked to same patient report MARRS 1401USA013330.
Pt reported  pruritic hives 9 days after vaccine.  A few days after receiving she got swelling, redness and heat at site. Also got hives at site and on cheek. Sx lasted a week or two after  No additional info available
2 days status post anthrax immunization and Typhoid immunization the patient states that he incurred a rash on the flexor aspects of both elbows with itching.
Immediately following left arm felt hot burning sensation, followed by chills, heart rate spike and fever. Symptoms continued into lesions (similar to chicken pox)  on left arm with hives and spreading toward back/shoulder, causing lack of sleep and irritation by the itching/burning that it is causing. It has been several weeks and the symptoms are continuing and worsening. (Staff and school advised that even though she had her 2 shots, one was given a few days before her 1st birthday "therefore doesn't count", she would need another or couldn't return. She always gets extreme reactions to vaccines and allergy medications have not reduced these symptoms.
Vesicle on upper right arm with small vesicles on face with some red papules. Some crusted papules on shoulders and face.
48 hours post administration patient experienced a shingles rash on read end. (Pt. said he had hx of chicken pox as child). Currently taking acyclovir expected to recover.
She felt temperature; Felt throwing up; Sick to stomach; Feeling dizzy/light headed; Pulse started to raise; Blood pressure was 150/90/felt pressure/blood pressure was going up/Blood pressure went 210/100; Feeling terrible/felt like having stroke; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling dizzy/light headed), HEART RATE INCREASED (Pulse started to raise), BLOOD PRESSURE INCREASED (Blood pressure was 150/90/felt pressure/blood pressure was going up/Blood pressure went 210/100), VACCINATION COMPLICATION (Feeling terrible/felt like having stroke), FEELING OF BODY TEMPERATURE CHANGE (She felt temperature), ABDOMINAL DISCOMFORT (Sick to stomach) and VOMITING (Felt throwing up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-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 an unknown date, the patient experienced DIZZINESS (Feeling dizzy/light headed) (seriousness criterion hospitalization), HEART RATE INCREASED (Pulse started to raise) (seriousness criterion hospitalization), BLOOD PRESSURE INCREASED (Blood pressure was 150/90/felt pressure/blood pressure was going up/Blood pressure went 210/100) (seriousness criterion hospitalization), VACCINATION COMPLICATION (Feeling terrible/felt like having stroke) (seriousness criterion hospitalization), FEELING OF BODY TEMPERATURE CHANGE (She felt temperature) (seriousness criterion hospitalization), ABDOMINAL DISCOMFORT (Sick to stomach) (seriousness criterion hospitalization) and VOMITING (Felt throwing up) (seriousness criterion hospitalization). The patient was treated with EPINEPHRINE (EPIPEN) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Feeling dizzy/light headed), HEART RATE INCREASED (Pulse started to raise), BLOOD PRESSURE INCREASED (Blood pressure was 150/90/felt pressure/blood pressure was going up/Blood pressure went 210/100), VACCINATION COMPLICATION (Feeling terrible/felt like having stroke), FEELING OF BODY TEMPERATURE CHANGE (She felt temperature), ABDOMINAL DISCOMFORT (Sick to stomach) and VOMITING (Felt throwing up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 150/90 (High) 150/90 and 210/100 (High) 210/100. On an unknown date, Heart rate: 65/72 (normal) 65/72.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-024420 (Patient Link).; Sender'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.
Few welts starting 7/26/03. 7/29/03 onset of neck and check swelling with itching. On 7/29/03 Epinephrine 0.3 mg given SQ. Solumedrol 250 mg IV. Benadryl 50 mg IV. Prednisone 60 mg PO.