chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Confirmed a blood clot in the left leg; Like a "Charlie Horse"; left leg started to feel pain; Left leg swelled; Left leg got hot; Soreness on the left calf muscle/like a sore muscle; This spontaneous case was reported by a nurse and describes the occurrence of THROMBOSIS (Confirmed a blood clot in the left leg) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced MUSCLE SPASMS (Like a "Charlie Horse"), PAIN IN EXTREMITY (left leg started to feel pain), PERIPHERAL SWELLING (Left leg swelled), FEELING HOT (Left leg got hot) and MYALGIA (Soreness on the left calf muscle/like a sore muscle). On 28-Aug-2021, the patient experienced THROMBOSIS (Confirmed a blood clot in the left leg) (seriousness criterion medically significant). The patient was treated with RIVAROXABAN (XARELTO) for Clot blood, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (Confirmed a blood clot in the left leg), MUSCLE SPASMS (Like a "Charlie Horse"), PAIN IN EXTREMITY (left leg started to feel pain), PERIPHERAL SWELLING (Left leg swelled), FEELING HOT (Left leg got hot) and MYALGIA (Soreness on the left calf muscle/like a sore muscle) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Aug-2021, Ultrasound Doppler: abnormal (abnormal) Confirmed a blood clot in the left leg.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant medication was reported as birth control pills. She went to see her physician on 28-Aug-2021, and her doctor performed a Doppler test and test confirmed a blood clot in the left leg. She was prescribed Xarelto and will need to take the medication for three months. Company comment: 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. However, 7 months since the second dose and birth control pills as concomitant medication could be confounders for the events. Further information has been requested.   This case was linked to MOD-2021-003812 (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. However, 7 months since the second dose and birth control pills as concomitant medication could be confounders for the events. Further information has been requested.
Hallucinations, unbalanced walking, loss of appetite for 3 days, joint pain, with all 3 injections  UNABLE to complete page #2 for unknown reason! Please contact for list of medications and allergies
Informations has been received from a registered nurse referring to unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On unspecified dates in September 2015 the unspecified patients were vaccinated with 4 doses of improperly stored PROQUAD (Merck) (lot # L026728, expiration date 15-JAN-2017) (dosage, strength and route were not reported). There was no concomitant medication reported. No adverse symptoms was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a licensed practical nurse concerning a 26 month old female with allergic rhinitis who on 29-JUL-2008 was vaccinated with a dose of VARIVAX (Merck), lot number 659603/1903U, 0.5 ml, subcutaneously (site not reported). Concomitant therapy included ZYRTEC. It was reported that on 26-JUL-2009 the patient developed chickenpox. The patient presented with rash, no fever and a runny nose. The patient was advised to use oatmeal bath, CALAMINE LOTION and BENADRYL along with no day care. On an unspecified date, the patient completely recovered. Follow up information has been received concerning a 26 month old (also reported as 2 year old) female patient with allergy to ZYRTEC who on 29-JUL-2008 was vaccinated with a first dose of VARIVAX (Merck), subcutaneous - right thigh route, (lot # 659603/1903U); with the third dose of COMVAX (OMPC) (MSD), intramuscular- left thigh route, (lot # 655549/1415F); with the third dose of RECOMBIVAX HB (MSD), intramuscular- left thigh route, (lot # 148F) and with the first dose of MMR II (MSD) subcutaneous - left thigh route, (lot # 658165/0040X). Concomitant therapy included ZYRTEC. On 29-JUL-2009 the patient presented to the clinic and reported rash and red bumps for 3 days (26-JUL-2009). At the time of this report the patient had recovered on an unspecified date. No signed informed consent form reported. This is one of several reports from the same source. No further information is available.
Initial report received from a Health care professional on 26 April 2012. A 32 year old pregnant patient, whose medical history and concomitant medications were unknown, had received intramuscular dose of ADACEL vaccine (batch number-C3927AA and site of administration- not reported) on 16 April 2012. The patient prior pregnancy details were not reported. The LMP date was reported as unknown. The patient did not have any adverse event during pregnancy. The outcome of events was unknown. Follow-up information was received from a health care professional on 14 June 2012. Based upon the new information this case has been upgraded to serious. The patient had a spontaneous abortion of one fetus in the beginning of May 2012 (also reported as around the 1st of May) around seven weeks gestation. Last menstrual period (LMP) and estimated date of confinement (EDC) were unknown since the patient's menses were irregular and she did not know she was pregnant at the time of vaccination on 16 April 2012. The patient had no illness at the time of vaccination. The father of the fetus was 39-years-old with no health problems. There was no family history of congenital abnormalities. The patient had two previous pregnancies. One resulted in a live birth with no congenital abnormalities, who is now a healthy eight-year-old child. The patient lost a baby in 2007 that was a breech birth with the cord around the baby's neck. The patient had a history of irregular periods, was healthy with no tobacco or alcohol use. Concomitant medications included vitamins. The patient's outcome was unknown. Document held by sender: None.
Chills throughout night and awful headache following day. Took Tylenol but minimal improvement. After 24 hours subsided.
No additional AE reported.; An adult dose of VAQTA was administered to a 1-year old patient on 30-SEP-2022.; An adult dose of VAQTA was administered to a 1-year old patient on 30-SEP-2022.; This spontaneous report was received from a pharmacist and refers to an 1-year-old patient.  The patient's medical history, concomitant therapies and previous drugs reactions or allergies were not reported.  On 30-SEP-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) at a dose of 1 milliliter (Inappropriate dose of vaccine administered), lot #U036184, expiration date: 02-MAR-2023, administered for prophylaxis (strength, and route of administration were not provided) (Drug use in unapproved age group). No additional adverse event was reported.
7/19/21 Patient began having sinus symptoms. 7/23/21 patient was tested and tested positive. 7/23/21-tested positive for DELTA.
Developed itchy red rash shortly after receiving vaccine.  Stated skin feels "on fire."  Treated in ED with Benadryl, Pepcid and Solu-Medrol.  No epinephrine required. Symptoms resolved and patient discharged to home.
Diarrhea; A spontaneous report was received from a consumer concerning a 74-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event diarrhea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   24 hours after the vaccination patient developed diarrhea.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, diarrhea was unknown.
Shortness of breath, chest heaviness onset 1 week. 1st vaccine injection 2/17/21, 2nd vaccine 3/17/21
Two days prior to ED presentation, the patient felt chest pain while working in his garden. He also felt lightheaded and dizzy. Patient was seen at urgent care and told he was in A-fib and tested positive for COVID-19. Today, patient presented to ED in A-fib with RVR with heart rate in the 150s. Patient will be admitted for management of A-fib with enoxaparin and diltiazem.
pt recvd vax & exp a fever (99-103); pt was seen by MD-sx has not resolved;
This spontaneous report as received from a pharmacy technician refers to a 39 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 30-JAN-2018, the patient was vaccinated with improperly stored dose of Oka/Merck VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The Oka/Merck VARIVAX) temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558:
He and his wife received the third dose of the Covid-19vaccine; He and his wife received the third dose of the Covid-19vaccine; They have also received the Influenza Flu vaccine on the same day; His wife can barely walk; Weak; Headache; This is a spontaneous report from a non-contactable physician reported from a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 22Sep2021 as dose 3 (booster), single for COVID-19 immunisation; influenza vaccine (INFLUENZA) via an unspecified route of administration on 22Sep2021 (Batch/Lot number was not reported) as single for immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) dose 1 via an unspecified route of administration on an unspecified date as single, and dose 2 via an unspecified route of administration on an unspecified date as single, both for COVID-19 immunisation. The patient experienced as, he and his wife received the third dose of the covid-19vaccine, they have also received the influenza flu vaccine on the same day on 22Sep2021, his wife can barely walk, weak, headache on Sep2021. Reported as, reporter and his wife (patient) received the third dose of the Covid- 19 vaccine yesterday. They have also received the Influenza Flu vaccine on the same day. Reporter told that his wife (patient) can barely walk, was weak and has a headache. Outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Got flu shot 11/12/2003 and by 11/14/2003 broke out in hives, went to dermatologist and prescribed Zertec but still get hives every night even to this day 11/21/03.
purplish hue; slightly itchy; red mark appeared below inject site; "red mark appeared below inject site and it hot to touch"; Red bump at injection site; muscle soreness-arm, neck and leg on right side; tiredness; 1.5 below inject site hurt to touch/ red mark increased in size, still hotter than other skin temperature, and hurts to touch; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 08Apr2021 at 14:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and mild strawberry allergy. Concomitant medications included metformin (MANUFACTURER UNKNOWN) and vitamin d nos (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 18Mar2021 at 14:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 09Apr2021, day after shot, the patient experienced red bump at injection site, muscle soreness - arm, neck and leg on right side, tiredness, and 1.5" below inject site hurt to touch. On 10Apr2021, day two, the patient experienced same as above but red mark appeared below inject site and it hot to touch. Day three, the patient experienced muscle soreness and tiredness ebbs, red mark increased in size, still hotter than other skin temperature, and hurt to touch. On 12Apr2021, day four, the patient experienced same but the mark had a purplish hue and slightly itchy. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event red bump at injection site, muscle soreness-arm, neck and leg on right side, tiredness, 1.5 below inject site hurt to touch, "red mark appeared below inject site and hot to touch"/ red mark increased in size, still hotter than other skin temperature, and hurts to touch, purplish hue and slightly itchy was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Area is itching; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Area is itching) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Area is itching). At the time of the report, VACCINATION SITE PRURITUS (Area is itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.     Reporter did not allow further contact
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient had unknown vaccination history and it could not be established if the patient was ever vaccinated with VARIVAX in the past. The patient's medical history included chickenpox. On an unknown date, titer was performed which showed the patient was not immune to varicella. On 25-FEB-2019, the patient was vaccinated with improperly stored dose of VARIVAX (exact dose and route of administration were not provided; lot # R023501, expiration date: 16-AUG-2020) reconstituted with properly stored diluent. The dose of the vaccine experienced temperature of -10.6 degrees Celsius for 1 hour and 44 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse events were reported.
Flushing - entire body; like when you receive an injection of contrast for a CT Scan Burning - Eyes, face, abdomen  Nauseous  Pressure in head/face/ears Throat discomfort  Headache  Overall sick feeling   Over the next couple days, my lips have broken out. I have some small mouth/tongue sores. Feeling of a cold coming on. Sinus pressure. Throat discomfort, congestion. Sneezing.  Eyes burning. Face burning. Itchy patches on scalp. Face breaking out.
Hospitalization for Covid-19 on 8/15/21.  Mild hypoxia, n/v at presentation- day 4 of symptoms
cobblestones blisters on left back side and shingles terrific pain not getting better
vomiting, diarrhea, shaking, paroxysmal supraventricular tachycardia (240 bpm).
Patient reported that at approximately 6:00 pm. on 1/8/2021 that she began experiencing "soreness" at the injection site.  While patient was preparing to go to bed she noticed that the injection site was red, warm to touch, swollen and sore when touched.  Currently, patient reports that her arm remains sore, red, warm to touch and swollen.  She denied any other symptoms (no fever, no rash, no difficulty breathing, no tongue swelling, etc).  Patient reported she is not working today.  Instructed patient to place warm compress over site throughout the day and if new symptoms develop or current symptoms worsen to call her primary care physician or go to Urgent Care  or Emergency Department.  Patient verbalized understanding and agreement and reported she will notify this RN if her condition worsens.  Follow-Up: Spoke to patient, 1/11/2021 at 4:50 p.m.  Per patient, her arm is better except a little residual soreness.  She stated the redness, warmth and swelling has subsided.  Patient also reported she did not seek any medical care for this problem.
The vaccine was injected at 800am and around 9PM my lower back was extremelly painful, around 12 midnight I run a fever or 101 and slept w/ mild fan all night. Woke up multiple times during the night, but in the morning around 645AM, my urine was dark like Lipton tea persian style very dark. My normal color is light yellowish like lemon peel. I was very alarmed of the color because it was too brown, and the second time in the morning was still dark color, but I started to drink water. I drank 7-8 huge glasses of water & in the afternoon the color was light, but very smelly. The lower back pain still present, but I don't have fever right now. In Jan 17, 2021 I was very sick with Covid19 with fever of 102-3, extreme body pain, lost of taste & smell, bitter mouth, diarrhia the first day,  all painful feeling lasted for 60 days. This vaccine gave the same type of sick feeling around 9PM plus the lower back pain, and terrible headace in the back of my head.
expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received Men B NVS (Bexsero) (batch number ABXB06AA, expiry date 31st March 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th April 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 25th April 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-APR-2022 Reporter's Comments: It was reported that the patient  received expired dose of Bexsero was administered by error to a patient. The reporter consented to follow up by email. Additional Supportive Information: The patient received vaccine which was already expired which led to expired vaccine used.
This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored ROTATEQ, lot number was either M014753 with expiration date of 11-OCT-2017 or M004542 with expiration date 18-OCT-2017, orally (strength and dose were not reported). There were no concomitant therapies nor adverse effect reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
first vaccine given was flu, then menactra in right arm, then HPV in left arm, approximately 3 seconds after last vaccine given  patient said she felt "something" and lost consciousness for 3-10 seconds. Patient was put in supine position on her right side on exam table. revived with calling her name and ammonia salts. patient was pale, no clamminess or other complaints. After event client reported to her mother that she passed out or nearly passed out after a blood draw in the past.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 31-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot#, and expiration date were not reported). At the time of vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through the patient's healthcare provider that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated. Alternatively, on or about 31-OCT-2013, the patient's healthcare providers included but not limited to a healthcare provider, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis that it did not carry any significant risks of adverse effects. On an unknown date, reported as subsequent to the vaccination, the patient was treated for herpes zoster. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffered ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of herpes zoster was not recovered. The reporter considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
pt recv vax 21OCT96 10AM & 12hr later devel redness, swelling & itchy area around inj site;saw MD & was placed on Augmentin;