chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diluted the Moderna COVID 19 vaccine that was given to a patient with 1.8 mL of normal saline; Diluted the Moderna COVID 19 vaccine that was given to a patient with 1.8 mL of normal saline. It; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Diluted the Moderna COVID 19 vaccine that was given to a patient with 1.8 mL of normal saline. It) and UNDERDOSE (Diluted the Moderna COVID 19 vaccine that was given to a patient with 1.8 mL of normal saline) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1.8 ml. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Diluted the Moderna COVID 19 vaccine that was given to a patient with 1.8 mL of normal saline. It). On an unknown date, the patient experienced UNDERDOSE (Diluted the Moderna COVID 19 vaccine that was given to a patient with 1.8 mL of normal saline). At the time of the report, PRODUCT ADMINISTRATION ERROR (Diluted the Moderna COVID 19 vaccine that was given to a patient with 1.8 mL of normal saline. It) and UNDERDOSE (Diluted the Moderna COVID 19 vaccine that was given to a patient with 1.8 mL of normal saline) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided Treatment information was not provided
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 72-years-old female patient received PREVNAR 13, via an unspecified route of administration in her right arm on 10Jun2015, single dose. On the same day, the patient concurrently received the Tdap IPV in her left arm. The patient was healthy and received PNEUMOVAX 23 in 2013. On 11Jun2015, the patient was admitted to the hospital with hypotension and fatigue, the next day, on 12Jun2015, she developed a fever of a 103 degrees, nausea, vomiting and a decreased appetite. On 13Jun2015 the patient experienced that the right arm was swollen and red, the reporter thought the patient had developed lymphadenitis, there was a 19 centimeter long rash towards the patient's lymphnodes. The reporter prescribed antibiotics, and prednisone. The patient was seen again on 19Jun2015, and everything was back to normal, except for that the injection site was still pink, but the swelling had subsided.
A few weeks after the vaccination, I was sitting in one of my college classes and out of nowhere my heart rate increased significantly and I felt extremely lightheaded/panicked. Within 5 minutes I felt normal. Throughout the next week I had several similar episodes and experienced chest pain frequently. I have never had these symptoms before.
Several days after adminstration, fever broke out 102-103 degrees followed by full blown outbreak of chickenpox.
Felt fine until 12 hours after 2nd dose - extreme nausea and vomiting, high fever, alternating chills and sweats for ~6 hours. 40 hours after dose, woke up and had several painful bumps on vulva and labia- small and white, slight redness around them. No history of STDs, more than a year since last sexual activity. Did some googling to figure out what it was and closely matched what was described/photos  in this paper .Searched "aphthous ulcers vulva" to confirm using more photos, and determine treatment/if I needed a doctor,  and came across a web site, which then led me to believe they bumps were related to the vaccine. Treated with over the counter hydrocortisone 1% every 12 hours for a total of 4 applications, and bumps are mostly painless and reduced in size.
The patient did not have an adverse reaction or any complications to vaccinations administered. However, the patient was given KINRIX at 2 mo of age and he should have been given PEDIARIX which is appropriate for his age.
Information has been received from a nurse concerning a female who was vaccinated with a first dose of HPV vaccine. It was reported that immediately upon administration of the vaccine, the patient developed excessive swelling near the injection site. Unspecified medical attention was sought. At the time of the report, the patient's outcome was unknown.  This is in follow-up to report(s) previously submitted on 12/14/2006.  Initial and follow-up information has been received from a nurse and a physician concerning a 21 year old white female student with asthma who on 24-NOV-2006, at 12:00 p.m., was vaccinated IM, into the right arm, with a first dose of GARDASIL (lot #654389/0961F) concomitantly with a sixth dose of FLUZONE (lot #U2197AA) IM, into the left arm.  On 24-NOV-2006, at 12:01 p.m., the patient developed immediate swelling at the injection site.  The patient recovered on the same day.  There were no laboratory or diagnostic tests performed.  Additional information is not expected.
Fever began before midnight and rose to over 102, child had rigors, severe irritability, severe pain at injection site, red arm, discomfort beyond the expected fatigue, inability to sleep due to rigors and fever and pain.
Sore arm, tired, chills, fever, body aches, nauseous and bad joint pain!
3 hours after vaccine, extreme fatigue and headache 12 hours after vaccine, cold chills, headache, extreme fatigue, body aches, moderate pain at injection site and surrounding muscle
about to breastfeed following vaccination; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (about to breastfeed following vaccination) in an 8-month-old infant of an unknown gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026p21a) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): The mother's past medical history included Maternal exposure during breast feeding. Concurrent medical conditions included Diabetes mellitus.    No Medical History information was reported.    On 30-Jul-2021, the mother 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 infant was diagnosed with EXPOSURE VIA BREAST MILK (about to breastfeed following vaccination). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, EXPOSURE VIA BREAST MILK (about to breastfeed following vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary) was unknown.       No concomitant and treatment information were reported by the reporter.  Upon internal review on 09-Nov-2021, Patient and parent route of administration updated to trans mammary and intramuscular respectively, causality of event exposure via breast milk updated to Not Applicable, pregnancy information and breast-feeding checkbox updated.   This case was linked to MOD-2021-271968 (Patient Link).
Pt had a large amount of redness. Swelling, and itching at site of immunization. Pt did not have any trouble with breathing. Parents gave BENADRYL and brought pt in. They were instructed to continue BENADRYL.
pt c/o achy feeling of arm, swelling of upper lt arm & shoulder, pain of lt shoulder next morning, swelling & pain gradually radiated to base of neck; c/o pain swelling & 2 swollen nodes of lt side of neck;
Information has been received from a registered nurse concerning her seven year old son, who in approximately 1997 at the age of approximately 12 months was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  Subsequently, the infant developed a rash and a high temperature.  Unspecified medical attention was sought.  Additional information has been requested.
pt recv vax 1AUG95 & pt exp titer is three p/2 doses (not immune);
Woke up the next morning feeling alittle achy, extremely tired and had a headache
C/O neck pain followed by headache , nausea, vomiting, respiratory issues, itching, benedryl 50mg im given, VS, med called, started IV, BP 189/102, HR 80 Temp 98.5, 98.1, sent to ED
Headache, Myalgia, pain in injection site; chills; lymph node swelling Narrative;
Subsequently the pt experienced a varicella like rash. The reporter noted three episodes of full blown varicella lesions. The pt sought treatment, follow up information from RN reported that on April 30, 1999 the pt's mother called the physician's office to report that the pt had developed approximately thirty generalized lesions. The patient had no other reported sx.  Approximately two weeks post vax, the pt mother again called the physician's office to report that he has another eruption of approximately thirty generalized lesions. Additionally the pt had a low grade fever. On Jun 2, 1999, the pt again experienced and eruption of thirty lesions and was seen by MD. The pt was diagnosed with Varicella.
celiac disease; currently has RSV (respiratory syncytial virus)/ now has a respiratory syncytial virus infection; asthma; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (Unknown). The reporter is the patient.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "respiratory syncytial virus" (unspecified if ongoing), notes: Clarifies have had RSV about maybe two weeks ago, not right now; "whooping cough" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization; Bnt162b2 (Dose: 2), for COVID-19 immunization; Bnt162b2 (Dose 3 (Booster), single), for COVID-19 immunization; Bnt162b2 (Dose 4 (Booster), Single), for Covid-19 immunization. The following information was reported: COELIAC DISEASE (medically significant), outcome "unknown", described as "celiac disease"; RESPIRATORY SYNCYTIAL VIRUS INFECTION (non-serious), outcome "unknown", described as "currently has RSV (respiratory syncytial virus)/ now has a respiratory syncytial virus infection"; ASTHMA (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Body height: 5'7, notes: Use to be 5'7; 5'6, notes: may be 5'6 now.  Clinical course: She is 80 years old and she has RSV, asthma, and celiac disease. She is asking if there is a test to test older people to find out if they are holding the RSV so that she can tell her doctor who works at (withheld) that she would like to be tested if she is no longer contagious. She would like to talk to us for her to be a test client and try the RSV vaccine on her. Caller states she is a social worker and worked in pediatrics for 29 years and was constantly getting RSV from the kids and hand foot and mouth disease. Once she got whooping cough along with a medical doctor and an infectious disease expert. A doctor wrote an article on how long vaccine protection lasts. She currently has RSV (respiratory syncytial virus) but is interested in being part of Pfizer's clinical trials. When I asked her if she had any other questions, she stated she got the first two Pfizer Covid vaccines, two boosters and the third booster (I asked if the third booster was the omicron and she said yes). Since she now has a respiratory syncytial virus infection, filing an AE. Caller received first two doses of primary series, two booster doses and a third booster dose for Omicron: Clarifies received first dose, second dose and three booster doses. Total of five doses received. Caller received first two doses of primary series, two booster doses and a third booster dose for Omicron: Clarifies received first dose, second dose and three booster doses. Total of five doses received.   The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
Extreme body pain, shaking, chills, fever, nausea, headache, numb legs and a feeling that something is "off"
Patient reported scratchy, irritated throat with some tightness. She was able to swallow and reported that drinking water made her throat feel better. No chest pain or shortness of breath. She reported some anxiety. VS: BP 133/81, HR 83, O2 sat 96-97% on RA Patient felt stable and went home after over 30 minutes of observation.
tested positive for COVID; tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Physician).  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "tested positive for COVID". The event "tested positive for covid" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Description of Event: Patiennt presented to the emergency department with transaminitis and tested positive for COVID and was admitted to the hospital one day after COVID 19 booster vaccine was administered. Provider is unsure if this was a Pfizer product or not. Event took place after use of product.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Appoximately 1 mo after 2nd Moderna injection, small, itchy pimples appeared on chest & arms. They grew into fluid filled lesions (not caused by scratching). The lesions spread in size (largest about 1 cm x 1.25 cm) and number, and some oozed w/ pus. Multiple lesions formed on both hands and forearms, and chest. Oddly, they formed in a  bilateral form on ea arm & hand. 1 wk ago small, itchy pimples are starting form on upper thighs (bilateral positions). 1 wk ago itchy rash formed on face, L-eyelid, R-eyelid, L-cheek, R-forehead. Extremely itchy.
Soreness at site on first day,  Soreness at site, body aches, chills, headache, nausea by 5 am next day.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding the medical history, drug reactions/allergies and concurrent conditions was not reported. On 06-JAN-2018, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneously, lot # N013277, expiration date: 28-APR-2019 (dose and site of administration were not reported) for prophylaxis. It was stored in temperature of 6 Fahrenheit degrees (F) to 14 F (7.9 F) for 19 minutes. There was no previous temperature excursion. The call was a result of a reading from a Digital Data Logger. The nurse reported that the diluent (lot number and expiration date were unknown) used to reconstitute the VARIVAX was properly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA003481: US-009507513-1805USA002990: US-009507513-1805USA003480: US-009507513-1805USA003483: US-009507513-1805USA003484.
Missed 2nd Dose; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Missed 2nd Dose) and NO ADVERSE EVENT (No adverse event) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Missed 2nd Dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Missed 2nd Dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant and Treatment Drug was Provided by reporter.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) in a 36-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hyperemesis (in 1st trimester), Induced abortion and Alcohol use (1 drink per month) in March 2020. Concurrent medical conditions included Penicillin allergy, Drug allergy, Drug allergy, Allergy to nuts and Asthma (Worsened in last 5 years) since 1992. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Allergy, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and MONTELUKAST SODIUM (SINGULAIR) for Asthma, DOCUSATE SODIUM (COLACE) for Constipation, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 06-Feb-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 08-Jun-2020 and the estimated date of delivery was 15-Mar-2021. On 18-Jun-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fourth week of the pregnancy.  On 18-Jun-2020, MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2020, Pregnancy test: positive (Positive) positive. On 07-Dec-2020, Glucose tolerance test: normal (normal) on borderline. On 17-Feb-2021, Full blood count: normal (normal) normal. On 17-Feb-2021, Treponema test: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported.
Patient received Vaccine Booster (Dose 3) which had hindsight was expired past 10 weeks in refrigerator temperatures.  (2 days past)
Patient STATES, "10 DAYS AFTER THE ADMINISTRATION OF THE VACCINES, SHE DEVELOPED TWO ERASER SIZE RED AREAS WHERE THE TDAP WAS INJECTED. THE AREA WHERE THE FLU VACCINE WAS GIVEN WAS BRUISED ONLY. THE VACCINES WERE INJECTED IN THE SAME ARM (PER REQUEST OF patient. THE TDAP SITE BEGAN TO INCREASE IN SIZE UP TO 1/2 INCH IN DIAMETER IN REDNESS. SHE STATES, "THE SITE WAS NOT RAISED."  "THE SKIN BEGAN TO DIE ON TOP." SHE THEN PEELED IT OFF AND IT BEGAN TO BLEED. SHE DENIES ANY ITCHING AND SHE DID NOT FEEL LIKE SHE DEVELOPED A FEVER. TWO WEEKS AFTER THE TDAP VACCINE WAS GIVEN, Patient STATES "THE SITE IS STILL RED AND ABOUT THE SAME SIZE BUT IT IS STILL NOT RAISED." SHE CONTINUES TO DENY ANY ITCHING OR FEVER. SHE IS APPLYING ANTIBIOTIC OINTMENT TO THE TDAP VACCINE SITE.  THE FLU SHOT SITE HAS COMPLETELY DISAPPEARED.
Evening of: Pain at injection sight (expected), pain down the left lung/torso area. Day 1 Post: Pain on left lung/torso, nausea, vomiting, fever 99.2, tiredness Day 2 Post: Pain on left lung/torso, nausea, vomiting, fever 99.6, tiredness Day 3 Post: Significant pain increase and ranging  from left collar bone down left lung/torso, nausea, increased difficulty breathing. ***Went to ER and was diagnosed with bilateral pulmonary emboli*** Day 6 Post: Coughing up blood *** returned to ER***
dizziness; Tenderness; Warm body temperature; Headache; Muscle Aches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), TENDERNESS (Tenderness), BODY TEMPERATURE INCREASED (Warm body temperature), HEADACHE (Headache) and MYALGIA (Muscle Aches) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 DIZZINESS (dizziness), TENDERNESS (Tenderness), BODY TEMPERATURE INCREASED (Warm body temperature), HEADACHE (Headache) and MYALGIA (Muscle Aches). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), TENDERNESS (Tenderness), BODY TEMPERATURE INCREASED (Warm body temperature), HEADACHE (Headache) and MYALGIA (Muscle Aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
AFTER THE FIRST DOSE, I BEGAN TO HAVE HOT FLASHES 4-5 TIMES DAILY.  JOINT PAIN, HEADACHES, FATIGUE, HOT FLASHES CONTINUE TO THE DATE OF THIS REPORT.  AFTER THE SECOND SHOT, IT TOOK NEARLY 2 WEEKS TO RECOVER TO A POINT WHERE I FELT AS THOUGH I COULD FUNCTION.  AS A RESULT OF THE ABOVE-DESCRIBED SIDE EFFECTS, I SOUGHT MEDICAL ATTENTION.  BLOOD WORK RETURNED HYPOTHYROID, AND AUTO IMMUNE DISEASE (NEITHER HAD EVER BEFORE BEEN DIAGNOSED OR SEEN IN BLOODWORK).  I AM STILL EASILY FATIGUED, EXTREMELY SENSITIVE TO HEAT, AND CONTINUE TO GET HOT FLASHES, FATIGUES, JOINT PAIN, AND SWEAT PROFUSELY.  HOT FLASHES/HEAT SENSITIVITY ARE AFFECTING DAILY LIFE AND AT POINTS I AM UNABLE TO FUNCTION AS A RESULT OF THEM.  FAMILY MEDICAL PROFESSIONAL REFERRED ME TO A RHEUMATOLOGIST TO BETTER PINPOINT THE CAUSE FOR THE POSITIVE BLOOD TESTS SHOWING AUTO IMMUNE DISEASE.
This spontaneous report was received from nurse and refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and drug reactions/allergies were not reported. On 11-JAN-2019, the patient was vaccinated with improperly stored varicella VARIVAX (dose and route of administration not reported, lot # R018931 with expiration date 02-JUL-2020) for prophylaxis. Nurse also reports the sterile diluent (unknown lot number and expiration date) used to reconstitute VARIVAX did not undergo a temperature excursion. The vaccine was stored at a temperature of 15 degrees Fahrenheit to 46 degrees Fahrenheit (15.7 degrees Fahrenheit) for 6 hours and 10 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported.
Pt recvd 3 doses of Hep B vax NOV89, DEC89, & JUN90; First 2 doses were w/Recombivax; 3rd dose was poss Engerix-B; Pharmacy did not have good records as to when Recombivax ran out & Engerix-B started;
Patient has a history of alopecia.  One week after receiving her flu shot she had a significant flare and lost about 75% of her hair
Received first dose of Shingrix in same facility.  Next day, felt extremely tired so went back to bed. Slept for about 17 hours; when woke up sporadically noticed that she was sweating profusely, every muscle in body ached, had chills, fever, but no nausea or stomach pain.   Since patient had similar problems after first dose just decided to weathered it out and did not call doctor Took Tylenol which helped with symptoms.   Patient felt better after a couple of days.