chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a healthcare professional on 07 June 2013. A 29-year-old female patient had received an intramuscular dose 1 of ADACEL (lot number: U4612AA, exp. date: 9-10-15, anatomical site of administration was not reported) on 07 June 2013. The patient was pregnant at the time of vaccination. The last menstrual period date was 04 November 2012. The estimated date of delivery was reported as 11 August 2013. The patient's health during pregnancy, concomitant medications, medical history and risk factors were not reported. At the time of this report, the patient had not experienced any adverse event. Documents held by sender: none.
Diffuse hives with about 30-45 minutes of DTAP/HIB. Went to ER and resolved with Benadryl, a few hours later. Hives, facial and extremity swelling and angioedema of ears/lips as well as wheezing and stridor. BP stable. SC epi, IV Benadryl and IV Solu-Medrol and pt was admitted to the hospital. Impressive rash/hives/cough recurred for 1st about 12 hours. Slight rash/hives on left palm and toe. No targets.
Severe Shortness of Breath 10 days after vaccine.  Discomfort in the right lower chest that radiates to the back.
This spontaneous report as received from a male consumer of unknown age. The patient was vaccinated with ZOSTAVAX approximately on an unknown date in March 2011. No other co-suspects were reported. Concomitant medications included: gabapentin. The patient experienced pain beginning on 11-SEP-2012 that went across his chest and under his arm. The patient went to see his physician because he thought he was having a heart attack. He was also experiencing burning and itching. The patient has been treated with unspecified therapy. At the time of the report the patient was recovering from the event. Additional information has been requested.
doses administered past the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator: 14Jan2022 Dates of administration of vaccine: 14Feb2022, 15Feb2022, 16Feb2022, 18Feb2022, 21Feb2022. No concomitant and treatment medication details
23MAR91 to ER w/diffuse rash, diarrhea & temp 39R; dx viral gastroenteritis, sent home; 27MAR91 woke up w/dry diaper, mom concerned about dehydration, took pt to ER; pt had no feeling or movement of lower extremities; dec sensation t8-t10;
yesterday afternoon around 1700 she started having diarrhea, she went 21 times until 4am this morning; lightheaded; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81-year-old female patient received bnt162b2 (BNT162B2), intramuscular administered in arm left, administration date 17Mar2021 13:15 (Lot number: EN6203, Expiration Date: 30Jun2021) at the age of 81 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "chronic fibromyalgia" (unspecified if ongoing), notes: goes into flares and sometimes during flares she has diarrhea problems; "diarrhea problems" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DIARRHOEA (medically significant) with onset 18Mar2021 17:00, outcome "recovering", described as "yesterday afternoon around 1700 she started having diarrhea, she went 21 times until 4am this morning"; DIZZINESS (non-serious) with onset 18Mar2021, outcome "recovering", described as "lightheaded". Therapeutic measures were taken as a result of diarrhoea, dizziness. Additional information: The patient reported that she has a chronic fibromyalgia and goes into flares. Sometimes, during flares, the patient has diarrhea problems but nothing like what she was experiencing after the vaccine. In the afternoon of the day the patient received the vaccine, she had no problems. But on 18Mar2021, around 17:00, the patient started to have diarrhea. She went 21 times until 4:00 in the morning of 19Mar2021. The patient took antidiarrheal medication, but it kept breaking through. The patient also drank Gatorade since she got so lightheaded and figured that she needed electrolytes. The patient stated that the diarrhea calmed down finally and stated that she feels a lot better. The patient also reported that what occurred to her was shocking. The patient will get the second dose scheduled in Apr2021. The events did not require visit to emergency room and physician office. The patient has no prior vaccinations within 4 weeks, has no family medical history relevant to the adverse event, and has no relevant tests.   No follow-up attempts are possible. No further information is expected.
A few days after the vaccine I started having a rapid heart rate while doing the smallest bit of activity. Once it got over a 100 bpm I didn't feel well and would have to sit down. I saw my doctor on 10/26/2021 and he didn't think it had anything to do with the booster at that time. He told me to stop taking lisinopril and had me do an echocardiogram and a stress test that both came back normal. I also had to wear a heart monitor for 3 days which had no abnormal findings either. As time has passed it has gotten better to the point where I don't experience it anymore.
Vaccine admi at 1245, patient returned at 300 c/o flushed feeling and dizziness that started at 230. No SOB, hives, swelling noted, injection site w/o redness or swelling. Vital signs stable. BENADRYL 25mg PO given. By 325 symptoms resolved.
Patient returned to pharmacy with report of lip numbness and concerned that it may be an allergic reaction. Patient reported back approximately 45 minutes after shot administered. Patient took 2 BENADRYL in pharmacy and waited to be observed. After 20 min patient was feeling fine called a ride to take her home.
t102 p/vax;breathing rapid, lethargic;poss febrile sz
Client became diaphoretic, lightheaded and lost consciousness. Blood pressure read low after client regained consciousness, however client did lose consciousness a second time. Epinephrine was administered and EMS activated. Vitals improved over following 5 minutes at which point patient was conversational and EMS arrived for transport.
see large and or small particulate floating in the prefilled syringe; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: GT0538, Expiration Date: 31Oct2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIQUID PRODUCT PHYSICAL ISSUE (non-serious), outcome "unknown", described as "see large and or small particulate floating in the prefilled syringe". Additional information: Pharmacist was asking if it was normal to see large and or small particulate floating in the prefilled syringe (NDC 0005-2000-10, Lot #GT0538 Exp 31Oct2024). It was a little whitish or yellowish in color. They did shake the syringe 3 times and the particulate matter did not dissolve.
patient was given more than recommended dosage - she was given 0.3 of the pediatric pfizer - undiluted
I received covid 19 vaccine second dose April 1 2021 , and I have covid 19 as of 8/19/2021
Sudden sever itching, then a dime sized raised  liquid filled blister formed. after about 3 after applying green alcohol, the blister flattened to a quarter sized raised disk red in color, formed. it is hot to the touch and sore to the touch. it feels and looks like a blister that appears after a bad burn. there small indention in the center of the disk. It feels as though the body rejected the vaccine and pushed it from the muscle to sub  Q under skin.
Runny nose for 3 days; This is a spontaneous report from a contactable consumer. This 56-year-old female consumer reported that:  A 56-year-old non pregnant female patient received BNT162B2, (CONMIRATY, Solution for injection, Lot number- EM9809, Expiration date- Unknown), via an unspecified route of administration in arm left on 11Feb2021, as 2nd DOSE SINGLE for covid-19 immunization. Previously on 21Jan2021, 16:45 the patient received 1st dose of BNT162B2(, Solution for injection, Lot number- EL3247, Expiration date- Unknown), via an unspecified route of administration in arm left for covid-19 immunization. Medical history was not reported. No other medication and vaccine was reported in two and four weeks. Patient was not reported with covid prior to vaccination. Concomitant medications was not reported. On 12Feb2021, the patient experienced runny nose for 3 days. Patient was not tested for covid post vaccination.Therapeutic measures was not reported. The outcome of the event was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
This spontaneous report was received from a nurse via a company representative and refers to a currently 14 year old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated intramuscularly with unidentified Merck HPV vaccine (lot number M004116, dose was not reported). It was unspecified whether it was GARDASIL or GARDASIL 9. Lot number M004116 is an invalid lot number for GARDASIL. However, it is valid for GARDASIL 9. Concomitant therapy was not reported. On an unknown date, after being administered with this vaccine, the patient had a "syncope seizure". There were no lab diagnostics studies performed. There was no treatment given to the patient for the events. The patient was observed in doctor's office for about an hour and recovered on an unknown date. It was not known which dose of HPV vaccine it was and whether the course of vaccinations was/would be completed or not. The relatedness between the events and unidentified Merck HPV vaccine was not reported. Upon internal review the event of seizure was considered to be medically significant. Additional information has been requested.
Chills, body aches, headache, stomach pain, vomiting,  diarrhea, tiredness
This spontaneous report as received from a pharmacist refers to a female patient of unknown age with an unspecified reaction to a tuberculosis (TB) test years ago. On 23-APR-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J011337, exp. 13-DEC-2014, single dose, subcutaneous) in the left arm. Concomitant therapy was not reported. On 24-APR-2014, the patient experienced inflamed rash at the injection site. The patient called the pharmacy and was advised to take BENADRYL. Laboratory diagnostic studies were not performed. The patient's outcome was not recovered. Additional information has been requested.
Pt recvd HIB vax & 2 months following vax it was noted that pt had devel a small nodule @ inject site;
Yeast infection; This spontaneous case was reported by a patient and describes the occurrence of FUNGAL INFECTION (Yeast infection) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Yeast infection.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced FUNGAL INFECTION (Yeast infection). At the time of the report, FUNGAL INFECTION (Yeast infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications includes medication for irregular heart beat, cholesterol medication and medication for an infection  Treatment medication includes cream   Reporter did not allow further contact
Initial case was received on 08 April 2008 from a health care professional affiliated with an organization under OTIS reference number 0711271442, who received this information from the patient's parent. A newborn infant (gender not provided), had been diagnosed with multicystic renal dysplasia, ventricular septal defect, nos, atrial septal defect, nos and single umbilical artery 115 days after they had received a transplacental dose of Fluzone (lot number not reported) on 30 October 2007. The infant had also received the following medications transplacentally which consisted of prenatal vitamins q.d., Enbrel 50mg weekly injections (20 June 2007 to 30 July 2007), and one steroid, NOS injection on 30 November 2007. The infant's mother had a past medical history of rheumatoid arthritis which was diagnosed in 2006. The infant's date of conception had been 04 July 2007 and they were born at 35 weeks gestational age on 22 February 2008. While in utero, the mother of the baby had been diagnosed by ultrasound with a short umbilical cord and two vessel cord. The ultrasound also confirmed the presence of a cyst on the baby's kidney (non-functional). A glucose tolerance test was performed on 15 January 2008; results were reported as "failed one hour". A non-stress test was performed on 19 February 2008 (results not provided). An ultrasound was also performed on 19 February 2008 and revealed that the baby had not been growing so labor was induced on 22 February 2008. At the time of delivery, the infant was cyanotic and had respiratory problems. The infant was admitted to the neonatal intensive care unit (NICU) after delivery and placed on a ventilator for 24 hours after delivery. The cyanosis and respiratory problems resolved within 24-48 hours after delivery. The baby received a blood transfusion on 23 February 2008 due to complications from the short umbilical cord resulting in less blood flow during pregnancy. The infant remained in the NICU for 21 days (released on 13 March 2008). According to the reporter, the physicians felt the heart defects were related to the two vessel umbilical cord and birth defects were not related to exposures during pregnancy. No further information was provided at the time of the report.
Papular rash starting 3 days after vaccine. Fever, chills, body aches, headache and vomiting for 48 hours after vaccine.
Pt described an on and off burning sensation on one side of her back lasting around 1 month, and starting 1 week following vaccination. pt has had 2 active shingles outbreaks in her lifetime and describes this as similar, but without the itching.
SEVERE STOMACH ACHE; BODY ACHE; VOMITING; SORE THROAT; HEADACHE; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 19 year old male. The patient's height, and weight were not reported. The patient's past medical history included mycosis fungoides, and concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination.  The batch number was not reported. Per procedure no follow up will be requested for this case.  No concomitant medications were reported. On 10-APR-2021, the subject experienced severe stomach ache. On 10-APR-2021, the subject experienced body ache. On 10-APR-2021, the subject experienced vomiting. On 10-APR-2021, the subject experienced sore throat. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe stomach ache, body ache, nausea, vomiting, sore throat, headache, and fever. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Right upper arm with 1x1 patch of erythema and induration, warm and tender to palpation.
This is a spontaneous report from a contactable nurse. A 4-month-old female patient received second dose of PREVNAR 13 (lot#: S31241, expiry date: 30Jun2018), via an unspecified route of administration at left thigh on 21Aug2017 at 0.5 ml, single for routine vaccination/immunisation. The patient's medical history was none. The family history included asthma, diabetes and high blood pressure. Concomitant medication included PEDIARIX (lot#: 924Y3, expiry date: 11Aug2019, manufacture: GlaxoSmithKline), ACTHIB (lot#:UI773AA, expiry date: 29May2018, manufacture: Sanofi Pasteur), rotavirus vaccine (lot#: 9JE4H, expiry date: 22Oct2018, manufacture: GlaxoSmithKline), all at unknown dose on 21Aug2017 for immunization. The patient previously took first dose of PREVNAR 13 (lot number: R48402, expiration date: 30Apr2018) in her right vastus lateralis on 19Jun2017 at age of 2 months old for immunization and had no reaction. In the evening of 22Aug2017, the patient developed a fine pinpoint rash from head to toe, including the bottoms of her feet. The patient's parents did not indicate whether or not the rash has gotten any worse since appearing or not. The outcome of the event was unknown.
Began to get a severe ache in injection site, became worse by Friday and began limping.  Asthma breathing started on Friday and on Saturday he began to break out in a rash or hives on his forearms, then the backs of his legs, then his chest and stomach and his thighs.
RIGHT SIDED FACIAl droop couldnt move eyebrows mouth could barely close eye
Foot fracture; Pain of extremities; Limb discomfort; Muscle pain; Flu like symptoms; This is a solicited report based on the information received by Pfizer (MFR Control No. # 21K-163-3980888-00). A contactable consumer (patient) reported that a 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVCOVID-19 immunisation; and adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at citrate free for moderate to severe rheumatoid arthritis. Medical history included rheumatoid arthritis. The patient's concomitant medications were not reported. It was unknown if patient was enrolled in a covid-19 vaccine trial. The patient experienced foot fracture in Feb2021 with outcome of not recovered; pain of extremities, limb discomfort, muscle pain and flu like symptoms all on an unspecified date in 2021. It was reported that the patient had discomfort in toe, muscle pain and flu like symptoms. She experienced aches and pain in toes and hands. In feb2021, the patient experienced foot fracture. The outcome of foot fracture, pain of extremities and limb discomfort was not recovered; while Muscle pain was recovered on an unspecified date and flu like symptoms was recovered on an unspecified date in 2021. The action taken in response to the events for adalimumab was unknown. The reporter's causality for the event(s) of foot fracture and aches and pain in toes and hands was not provided. the reporter's causality for the event(s) of discomfort in toe, muscle pain and flu like symp-toms with humira (adalimumab) was no reasonable possibility.  The reporter's assessment of the causal relationship of the events foot fracture, pain of extremities, limb discomfort, muscle pain and flu like symptoms with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Fever with otc meds to reduce, chills, body aches, night sweats,nausea, headache, extremely swollen lymph node
Initial case was received from a healthcare professional on 14 MARCH 2014. A patient (whose gender and date of birth was not reported) had received an expired dose of TENIVAC, (batch number and expiry date not reported) on an unspecified date.
Pt c/o lump @ site of DT inject in rt arm, aching & itching; on exam 2cm deep nodule rt upper arm; not fluctuant or tender; imp-local allergic rxn to DT; plan-DPH 25mg;
This was the first time my daughter received the MMR and Varicella vaccine. She had severe red blotches all over her skin within minutes of the injections. They had to give her 2 tsp. of Benadryl to counter the reaction. Ever since she has received the MMR/Varicella vaccination, her moods have been horrible. She is not the same person. My husband and I noticed this within a week or two of the administration of the meds. My daughter was a very content, jubilant child; now, she is emotional, confused often times (after showing signs of extreme brightness before this); she spins in circles a lot~ something she has never done before.
Pt has received FLUZONE HIGH DOSE from Health Dept 10/21/15, 10/13/16, 10/12/17, and 9/26/18. Each year she gets a rash on her mouth, hands and feet within 1 month of receiving vaccine. This resolves on its own and has been diagnosed as hand foot and mouth disease based on clinical symptoms.
redness of the eyes; blurred vision; headache; muscle pain; body chills; blueish discoloration in hands; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration on 03Mar2021 as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Mar2021, the patient experienced redness of the eyes with blurred vision, headache, muscle pain, body chills & blueish discoloration in hands. Caller asked if she should receive the second Pfizer Covid vaccine The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
IMOVAX on day 23, developed diarrhea x 4 days the bilious emesis. RLQ abd. pain + decrease platelets. Resolved post four days (after). 8/12/03 diarrhea and vomiting began. THe hospital records received on 1/12/04 states headache and gastroenteritis.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. On 04-NOV-2013, the patient was vaccinated with an expired dose of oral ROTATEQ (lot number and expiry date were reported as H010063 and 02-NOV-2013 respectively, dose and route unspecified). The nurse did not specify which dose in the series this was for the patient. No concomitant therapy was reported. No adverse symptoms were reported. Additional information has been requested.
Redness around injection site, painful and hot. Large area as big as palm of hand. Pt said MD diagnosed her w/cellulitis.
pt recv vax 15APR98 & 16APR98 pt devel dizziness, nausea, stomach pains;