chrisvoncsefalvay/vaers-outcomes huggingface dataset:
improperly stored dose of ROTATEQ  was administered to patient; no adverse effects reported; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. There was no information reported about the patient's concomitant medications, pertinent medical history and drug reactions or allergies.   On 18-OCT-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis (lot number R035369 and expiration date 10-OCT-2020 have been verified to be a valid; strength, dose, route of administration, anatomical site,). The vaccine was exposed to the lowest temperature below 36 Fahrenheit degrees (33.8 Fahrenheit degrees) during a time frame of 6 hours and 48 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects reported.
Per mom 1 day p/immun shot to rt upper arm, pt devel swelling, warm, locally tender, w/superficial blisters; Seen by MD referred to ER where given Augmentin dx cellulitis;
This spontaneous report as received from a registered nurse via company representative refers to a 2 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 09-SEP-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB, lot # L042836 (strength, dosing details, anatomical location and expiration date were unknown) for prophylaxis. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
sees circles from her left eye when she gets up; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS FLOATERS (sees circles from her left eye when she gets up) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, the patient experienced VITREOUS FLOATERS (sees circles from her left eye when she gets up). At the time of the report, VITREOUS FLOATERS (sees circles from her left eye when she gets up) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.  Patient mentioned that she is going to see an Opthalmologist on 10DEC2021. Patient mentioned that she may have a detached retinae. Patient did not mention which eye detached retina is in before she concluded the telephone call.   This case was linked to MOD-2021-407587 (Patient Link).
Tingling, lightheaded, presyncope. BP readings: 97/62 (pulse 46), 98/60 (pulse 59). Given juice and water.
A non-serious spontaneous report of shortness of breath and hives over trunk, back and arms has been received from a health professional concerning a 47-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 2009. On 01-Sep-2009, patient experienced shortness of breath within two days of receiving FLUMIST, then broke out in hives over her trunk, back and arms within a week. Patient described the hives as lesions that looked like chicken pox (raised and clear lesions which were separated). The rash lasted for six weeks. The events resolved in 2009.
leaky heart valve; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received BNT162b2 (BNT162B2), 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: HEART VALVE INCOMPETENCE (medically significant), outcome "unknown", described as "leaky heart valve". Clinical course: Agent relayed she had a patient on the line regarding Pfizer Covid 19 vaccine that she received Sep2021. Wanted to report side effects. The caller's best friend who was younger than her has side effect of leaky heart. Reported that every single person in her workplace had an adverse reaction or someone in their family had an adverse reaction. Mentioned stroke and heart attack. Mentioned trying to call VAERS and can't get to them and agent informed caller that is CDC, not Pfizer. During report caller confirmed her best friend got a leaky heart valve. Does not want follow up as she does not have her permission to share information. States she was the same age as her. Believed she had Pfizer Covid 19 vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient had 1st Pfizer vaccine on 3/13/21.  She states she went to ER on 3/19/21 and was found to have a blood clot behind her left knee (found by ultrasound).  She was put on Eliquis.  Patient had 2nd Pfizer vaccine on 4/3/21.  Patient did not mention blood clot at time of 2nd vaccine. Patient was admitted to hospital on 4/13/21 for stroke.  It was attributed to bleeding in brain and patient was taken off Eliquis and put on a new blood thinner.  She will be discharged on 4/20/21 to rehab.
2nd flu vaccine administered approx 8:20 am 1/15/15. Mom called approx 2:15 pm and reports rash to bil legs as reported by daycare. No respiratory issues. Was seen in office at 15:00 - given BENADRYL.
Information has been received from a physician concerning a 15 year old female who was vaccinated with Gardasil.  It was unknown which dose in the series she received.  Subsequently the patient experienced vaginal ulcers.  Unspecified medical attention was sought.  The outcome of the event was not reported.  Additional information has been requested.
Left arm rash on ,left arm  numbness off and on since vaccine , chest pains radiating to right arm/ chest pain off and on, sob, heavy heart. Body aches chills, headache for 3 days, swollen lymph nodes since vaccination. Hallucinating.tired /weak.
feel weak that I cannot stand up; feel weakness in both my knees, from ankles to legs feels also weak, buckling under my knees; big red welt; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (big red welt), ASTHENIA (feel weak that I cannot stand up) and MUSCULAR WEAKNESS (feel weakness in both my knees, from ankles to legs feels also weak, buckling under my knees) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included VITAMIN C [ASCORBIC ACID], CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) and POTASSIUM for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced URTICARIA (big red welt). On 22-Apr-2021, the patient experienced ASTHENIA (feel weak that I cannot stand up) and MUSCULAR WEAKNESS (feel weakness in both my knees, from ankles to legs feels also weak, buckling under my knees). At the time of the report, ASTHENIA (feel weak that I cannot stand up) and MUSCULAR WEAKNESS (feel weakness in both my knees, from ankles to legs feels also weak, buckling under my knees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2021, Bone densitometry: not reported (Inconclusive) Not reported.         Concomitant medication include blood pressure medications and thyroid medications.  No medications were taken for the symptoms.   This case was linked to MOD-2021-128578 (Patient Link).
Dizzy spells; A spontaneous report was received from a patient of unknown age and gender (Health care professional) concerning patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and dizzy spells/dizziness.  The patient's medical history was unknown. No concomitant medications was reported.    On an unknown date (Monday), the patient received their first of two planned doses of mRNA-1273 via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection.   On an unknown date, after receiving the first dose of vaccine, the patient experienced dizzy spells.  Treatment for the event was not reported.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event dizziness was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Itchy, swollen eyes with discharge still after 30 days.  The days immediately following the injection, extreme chills (wearing a winter coat with blanket in a heated home), racing heart (like I was jogging but was not) exhaustion and migraine.  Those subsided within 4 days but the eye swelling and itching has continued.
Pt developed a spontaneous superior sagittal venous thrombosis with resultant  subarachnoid hemorrhage and Frontal IPH and seizure. Pt had a sudden seizure at home and CTA/MRI showed Superior sagittal sinus thrombosis.  Pt required intubation secondary to altered mental status. Pt underwent diagnostic cerebral angiogram which confirmed cerebral sagittal sinus thrombosis. Pt tolerated extubation on 5/11.
Dizziness, Palpitations & Angina Had several days of chest tightness and dizziness.
Riding with mom, stopped talking in mid sentence. Pt turned blue-stopped breathing-heart still beating- began seizure that lasted 2-4 minutes. Mom called 911 - Emergency vehicle took pt to hospital. Responded after 20 minutes - disoriented for about 2 hrs. Given Atavan. 8/1/08-records received for DOS 6/23-6/24/08-DC DX: Seizure activity secondary to tetanus booster and Menactra. Presented to ED after seizure post vaccination. Postictal state. Prior to seizure activity C/O headache, numbness and tingling. In ED back to baseline.
This case was reported by a other health professional and described the occurrence of arm pain in a male patient who received FLUARIX QUADRIVALENT (batch number 7LE2S, expiry date 30th June 2015). On 4th September 2014, the patient received FLUARIX QUADRIVALENT. On 4th September 2014, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced arm pain (serious criteria disability), shoulder pain (serious criteria disability) and pain that radiated to his hands (serious criteria disability). On an unknown date, the outcome of the arm pain, shoulder pain and pain that radiated to his hands were not recovered/not resolved. It was not reported if the reporter considered the arm pain, shoulder pain and pain that radiated to his hands to be related to FLUARIX QUADRIVALENT. Additional information received: The caller was a nursing student. She reported that her class received flu vaccines at the local hospital. There were about 30-25 people in her class. She reported that her classmate experienced adverse events receiving the vaccine. He experienced arm pain, shoulder pain, and pain that radiated to his hand. As of right now, these events were not resolved. The caller did not know the lot number and expiration date of this patient's vaccine, but believed it was the same as the one she received. The lot number and expiration date of the vaccine she received was: 7LE2S, 30th June 2015.
Information has been received from a physician concerning an approximately 40 year old female patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot# not reported).  Subsequently the patient developed uterine cancer.  At the time of reporting, the outcome of uterine cancer was not reported.  It was unspecified if the patient sought medical attention.  Upon internal review, uterine cancer was determined to be an other important medical event.  Additional information has been requested.
p/recv vax pt c/o sore throat; woke up w/diffused red rash which was slightly itchy on body; MD dx measles from vax;
Information has been received from a Registered Nurse concerning a black 17 year old female who on 22-MAR-2007 was vaccinated, IM 0.5mL, first dose, with GARDASIL (lot# 655619/1427F). Subsequently the patient was determined to be pregnant. The patient sought unspecified medical attention. No problems were reported. Follow-up information received on 11-FEB-2008 reported that a nurse in the office stated that the patient has delivered her baby and both Mom and baby were doing fine. She also reported that the Doctor apologizes that she keeps forgetting to have the patient sign the consent forms. She will try to remember when the patient is seen again. Follow up information received on 31-MAR-2008 reported that the patient, who had a history of migraines and no previous pregnancies delivered a normal female infant on 27-SEP-2007 (40 weeks from LMP) (weight: 7 pounds 6 ounces, length 53.5 cm, Apgar score 8/9, head circumference 33). No congenital anomalies or complications were reported. At 35 weeks gestation (on approximately 24-AUG-2007), the mother developed bacterial vaginosis and was treated with FLAGYL. Additional information has been requested.
Woke up with fever, body aches, severe headache and vomiting.   These symptoms lasted all day until late evening.  I slept most of the day running a fever off and on.  Vomiting again late afternoon - could not eat anything.  Finally at around 9pm I started feeling better.  Woke up Sunday morning, headache, fever and aches were gone.  Just felt a bit tired but otherwise good.
pt recvd vax 5FEB93 & 6MAR93 devel active measles; lab eval revealed an IgM titer of 1-80; no further details were provided;
The shot was given to the patient, she sat down for observation. After about 10 minutes she came up and said she felt like her blood pressure dropped, she was shaking and had the sweats. We had her it back down and the RPh went out to check on her. The patient was super dizzy and fell into her arms. We called 911 to have her checked out and she went with the EMT's. The EMT's told us she said that she gets like that sometimes even without getting a shot.
This spontaneous report was received from a pharmacist and refers to 8 patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies was provided. On unknown dates in 2017, since July 2017, the patients were vaccinated with improperly stored doses of ZOSTAVAX injection (lot # N010494, expiration date: 16-MAR-2018; dose and route of administration were not reported). Concomitant therapy included sterile diluent (MERCK STERILE DILUENT) injection (lot # reported as N047667; expiration date: 25-JUL-2019). The reporter stated that the administered doses of ZOSTAVAX were stored at temperature of 26.4 degrees Fahrenheit (F) for 1 hour and 45 minutes. Data logger was used to detect temperature excursions. Previous temperature excursions included storage at the temperature of 23.1 degrees F for 1 hour and 45 minutes on unknown date. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Rash with raised blisters in middle and red around edges located on stomach, under breast, few on back, chest, legs had about 20 per quadrant.
Physician was paged after hours description of blotches over injection site with rash spreading down, assos with low grade ever. Rash disappeared by 03/20/2002
painfully and visibly swollen lymph nodes in left collar bone, headache, nausea, soreness, fatigue
No additional adverse events reported; Pneumovax23 was given to a 4 month old in error; Caller reports that PREVNAR 13 was intended to be given; This spontaneous report has been received from other health professional referring to a 4 month old patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.      On 03-MAR-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T032761, 0.5 milliliter for prophylaxis. pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) was intended to be given (product administered to patient of inappropriate age and wrong product administered). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T032761; expirationdate: 30-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
1. Some Swelling and redness at injection site 2. Some lymph node swelling and discomfort under right arm  Outcome not known yet, swelling and redness seem to be lessoning.
24 hours after the 2nd dose of Pfizer, while driving my heart went into Atrial Flutter and A-Fib, had to pull over on a highway to call emergency services on myself because the symptoms mirrored a stroke-no chest pain, just felt like everything was shutting down including consciousness.  Ambulance arrived, vitals were very poor and was admitted to hospital.  After treatment and heart stabilization everything returned to normal after being admitted for 24 hours.  Multiple heart tests were conducted over the following weeks and the only variable in my activity and diet during that time was the Pfizer 2nd dose.  My 6 month cardiology follow up  confirmed the same; the Pfizer was the only variable.  I am a runner, typically run about 3-5 miles a day and in strong health.
On Tuesday the 29th I noticed I had an enlarged Lymph node on my left clavicle.  I wanted my Doctor to check it out, it didn't hurt but was 2cm, I did  concern me. It is gone now.  My Doctor said it looked like was caused from the vaccine and didn't look cancerous. She ordered some  bloodwork, chest x-ray , CBC and everything came back negative. It went away in about two weeks.
headaches; Confusion; Fever; muscle aches all over; This is a spontaneous report from a contactable consumer (patient). A 19-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#: EL0140), intramuscular in upper left arm on 11Jan2021 around noon at second single dose for preventative. Medical history included ongoing attention deficit hyperactivity disorder (ADHD, diagnosed when she was 14 or 15 years old), ongoing anxiety (Diagnosed when she was 16 years old), depression. Concomitant medication included ongoing methylphenidate (has been taking for about 4 or 5 years) for ADHD, to help focus and keeps her sane, ongoing primidone (has been taking less than a year) for hand tremors, ongoing fluvoxamine maleate (taking for about 4 years) for anxiety depression. The patient previously took first dose BNT162B2 on 21Dec2020 around noon, intramuscular injection in upper left arm for preventative (Lot: EJ1685). No other prior vaccinations within 4 weeks. No AE following prior vaccinations. The patient got the second dose yesterday (reported on 12Jan2021) around noon and she was experiencing not so great side effects. The biggest thing was headaches that were pretty debilitating. She was experiencing confusion and muscle aches all over. Stated that all the side effects started around the same time around 9 pm last night. The patient reported that her fever was down a bit so she was a little bit more coherent. Fever was slightly improved at 101.5. The patient took a few medicines for ADHD or anxiety and was wondering if they could have interacted with the vaccine. The events did not require a visit to emergency room and physician office. The patient reported her headache with medication was slightly better, but consistently the same. Treatment for headache inclued Ibuprofen. Outcome of event headache and fever was recovering, of event muscle aches all over was not recovered, of event confusion was unknown.
mom noticed rash on trunk; @ visit (4hr later), rash on trunk & limbs;no other sx rash PRN head & red morbilliform rash trunk/extremities;
Severe bloating and irregular period. I missed a cycle and when period next came, it was painful. Cramps were piercing, hot, and almost burned.
Husband called indicating that patient was experiencing a rash over her arm, back and chest. Patient has not taken any new medications or food. Recommended benadryl 25 mg Q4-6H. Recommended urgent care or ER visit if difficultly breathing or rash worsens.
Information has been received from a registered nurse, for VARIVAX (Merck), a pregnancy registry product, concerning a 21 year old female patient with no drug reactions/allergies who on 30-NOV-2011 was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Merck). The patient stated that she was 18 weeks pregnant on 31-DEC-2011. The last menstruation period was approximately 17-AUG-2011, the estimated delivery date would be 23-MAY-2012. The patient was not scheduled to return to the health office and would probably not have further contact with the reporter. Lab: titer after vaccination was positive. It was unknown whether any additional tests were performed.  The patient sought unspecified medical attention. At the time of the report the patients status was unknown.  ***Follow up information has been received concerning the patient who on 30-NOV-2011 was received the first dose of 0.5 ml VARVIAX (Merck) (lot # 670802/0815AA, expired date: 02-JUN-2013) for negative varicella titer. Additional information is not expected. No further information is available.
Having back problems; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Having back problems) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (Having back problems). The patient was treated with PREDNISONE for Back discomfort, at an unspecified dose and frequency and HYDROCODONE for Back discomfort, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL DISCOMFORT (Having back problems) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Headache, Myalgia, NauseaVomiting, lightheaded; nausea; redness; swelling; pain with both Narrative:  OTC Ibuprofen as needed  Other Relevant History:
Bloody stools x24 hours. No intervention, self resolved.  No fever, vomiting or feeding difficulties.
2/8/94 date is not clear. 2/10/94 Shock (septic) threatened abortion. Immunization verified on immunization record book and lab 2/10/94. Progress notes states treatment for septic infection. Pregnant verified 6 weeks. Bleeding and blood clots. Sent to ER for hemorrhaging after Rubella immunization. Return to hospital 2/15/94 0100 Benadryl 50mg IM.
patient began to feel sick a few hours after getting the vaccine and developed a large area of swelling, warmth, tendnerness and erythema surrounding the injection site a few hours after administration.  Area grew to about 10x16 cm.
Had spontaneous bleeding 2 days after vaccine. I was 14 weeks 5 days pregnant with bleeding. Due date June 3rd