chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Insomnia; Shortness of breath\gasping; Severe edema on lower extremitis both legs and feet; High blood pressure 160/86; Could not sleep on injected side; Soreness for 2 days; Shaking; Palpitations\heart racing; Mid area in pain; Severe pounding headache; Bright red ring penny size on site injection; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Insomnia), DYSPNOEA (Shortness of breath\gasping), OEDEMA PERIPHERAL (Severe edema on lower extremitis both legs and feet), HYPERTENSION (High blood pressure 160/86) and VACCINATION SITE PAIN (Could not sleep on injected side) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced TREMOR (Shaking), PALPITATIONS (Palpitations\heart racing), CHEST PAIN (Mid area in pain), HEADACHE (Severe pounding headache) and VACCINATION SITE ERYTHEMA (Bright red ring penny size on site injection). On 20-Apr-2021, the patient experienced INSOMNIA (Insomnia), DYSPNOEA (Shortness of breath\gasping), OEDEMA PERIPHERAL (Severe edema on lower extremitis both legs and feet), HYPERTENSION (High blood pressure 160/86), VACCINATION SITE PAIN (Could not sleep on injected side) and MYALGIA (Soreness for 2 days). At the time of the report, INSOMNIA (Insomnia), DYSPNOEA (Shortness of breath\gasping), OEDEMA PERIPHERAL (Severe edema on lower extremitis both legs and feet), HYPERTENSION (High blood pressure 160/86), VACCINATION SITE PAIN (Could not sleep on injected side), MYALGIA (Soreness for 2 days), TREMOR (Shaking), PALPITATIONS (Palpitations\heart racing), CHEST PAIN (Mid area in pain), HEADACHE (Severe pounding headache) and VACCINATION SITE ERYTHEMA (Bright red ring penny size on site injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, Blood pressure measurement: 160/86 mmHg (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment medication was not provided.
Swelling and redness at injection site (right arm) pain and hot to the touch.  High fever (102.6) which lasted 24 hours.  Low grade fever for 48 hours.  Pain/stiff neck.  Complaint of headache.
This spontaneous report as received from an 84 years old female consumer refers to herself with high blood pressure, drug allergy to aspirin and sulfa. The patient's medical history included shingles two years ago, on 09-FEB-2010. The patient was vaccinated with a dose of ZOSTAVAX subcutaneous on 28-AUG-2012. No other co-suspects were reported. Concomitant medications included NEXIUM, EFFEXOR and EVISTA. On 28-AUG-2012 the patient came down with chickenpox. The patient had sought medical attention and was treated by a physician. The generic VALTREX was given for the adverse event. The outcome of chickenpox was unknown. Additional information has been requested.
Severe menstrual bleeding with clotting causing severe anemia. Hemoglobin level 9. Received first dose of Iron transfusion through IV yesterday on 4/23/2012
Dose 3; Dose 3; Herpes Simplex reactivation; This is a spontaneous report from a contactable consumer (patient) who reported for herself.  A 66-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EW0191 and expiration date was not reported), dose 3 via an unspecified route of administration, administered in left arm on 27Sep2021 14:30 (Age at vaccination was 66 years) as dose 3 (booster), single for covid-19 immunisation. The facility where the most recent COVID-19 vaccine was administered was drug store. The device date was 26Oct2021. Medical history included coeliac disease, gluten sensitivity from an unknown date and unknown if ongoing. The patient was not diagnosed with covid-19 prior to vaccination. There were no concomitant medications. The patient did not receive any other vaccines within four weeks and any other medications within two weeks prior to the COVID vaccine. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was ENV199 and expiration date were not reported), via an unspecified route of administration, administered in left arm, on 19Mar2021 at 12:30 hours as dose 2, single and dose 1 via an unspecified route of administration (lot number was EL9264 and expiration date were not reported), administered in left arm, on 23Feb2021at 15:00 hours as dose 1, single for COVID-19 immunization. Age at vaccination for both the doses was 66 years. On an unspecified date in 2021 the patient experienced Herpes Simplex reactivation within a week of first two doses and 3 weeks after booster shot. The patient was not tested for covid-19 since vaccination. The patient took Valtrex as therapeutic measure. The outcome of event Herpes Simplex reactivation was recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Started with shoulder at vaccine site being extremely sore, a few days later on January 3rd,  my lymph node under my right arm pit became sore, tender to touch and swollen. That lasted a few days. On  the 6th of January at about 330 am I started to feel ill. By 730am I had diarrhea for two days. I threw up once.  I had a horrible headache for a few days and my body was sore all over. I was very fatigued and did not have an appetite. I forced myself to drink water, tried to eat a banana so I would have something in my stomach for taking ibuprofen. I ate toast the next morning to do the same and threw that up. I also felt a  little pain in my right chest.  I had chills for two days.  I checked my pulse was a bit high and O2 level 95 on the 8th  I am feeling better on the 9th I have take 3 covid tests two negative one has not been returned yet. the two negative results wer 4 days apart. My shoulder is still sore
I gave the patient their second dose of pfizer vaccine around 945 am and received a call from the patient around 1145 am stating the patient had nasal congestion and shortness of breath.  I advised the patient to seek the nearest emergency room.
Mother made an appointment and was seen by  her pediatrician less than 24 hours after her child received his immunization due to localized redness, swelling and soreness at the injection site. Complete resolution of extensive swelling resolved by day 4, January 2. 2004.
Information has been received from a health professional concerning a 24 year old female who on 08/27/1999 was vaccinated with a dose of varicella virus vaccine live.  On 08/30/2000 the patient was vaccinated with another dose of varicella virus vaccine live.  On 01/24/2003 the patient's varicella titer was negative.  Unspecified medical attention was sought.  No product quality complaint was involved.
This spontaneous report was received from a nurse concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 25-SEP-2017, the patient was inadvertently vaccinated with an expired dose of  M-M-R II lot # L036853 and expiration date 24-SEP-2017, for prophylaxis (dose and route of administration were not reported) reconstituted with sterile diluent (MERCK STERILE DILUENT) (dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported.
When H1N1 Flu shot administered (in left shoulder), immediate pain in arm. Stinging, burning, and sharp intense pain mainly around injection site. As time elapsed, pain worsened and spread from injection site down arm to fingertips and across pec. muscle/chest. Arm felt heavy, as if dead or asleep. Tingling down length of arm, feeling of weakness (but not actually weak), and extreme sharp, throbbing pain, which radiated out from injection site. Approximately 2 hours after site was administered, pain had spread and worsened to chest/pec area, leading to intense chest pressure and pain. Slight trouble breathing, due to intensity of pain. Use of Tylenol did not relieve pain, but found that inactivity (and immobilization of shoulder) helped to ease chest pain and help with breathing. Attributed reaction to possible hitting of nerve during administration of shot (mother is a RN).    In following week, pain in shoulder (aching, burning, sharp intense pain) continued. Still have feeling of dead or heavy arm. Numbness and tingling. Pain continues to radiate from injection site out, down to fingertips, but chest pain has gone away. Additional symptoms include fatigue, runny nose, cough, body aches, chills, low grade fever, blurred vision (occurred off and on for first 3+ days), bad headache, and sore throat. Was given seasonal flu shot month prior. Have been getting seasonal flu shots for several years. Never have had an adverse reaction to the seasonal flu shot; only have had the normal side effects such as: sore arm, slight fever, and body aches, and those have only lasted a few days at most before clearing up.    No treatment has been given yet. But will be visiting doctor's office soon, should pain not subside within the next week.
shock-like response; unresponsive, tachycardia no exam in ER:
allergic reaction; hives on the arm, described as rash down the arm where she received the injection; hives on the arm, described as rash down the arm where she received the injection; This is a spontaneous report from a contactable pharmacist. A 39-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6201) on 18Mar2021 as single dose in deltoid right for covid-19 immunisation at the age of 39-year-old. The patient medical history and concomitant medications were not reported. The patient experienced hives on the arm, described as rash down the arm where she received the injection 5 days after receiving the vaccine, the pharmacist considered it as an allergic reaction. The second dose of vaccine was scheduled 28 days after the first vaccine, the patient was at risk for not getting the second dose of vaccine, due to previous reaction. The reporter considered the events were contraindicated and wanted to check with Pfizer to see if it is alright to get the second vaccine. Outcome of the events was unknown. The events were assessed as non-serious by pharmacist.   No follow-up attempts are needed. No further information is expected.
Pt recv vax on 10/9/97; on 10/10/97 pt exp malaise, myalgia, pruritus; tx=unspecified medication
The first symptoms that appeared were intense pain at the injection site, pain to the point that a simple touch or brush of the arm was significantly painful. This occurred within the first several hours of the vaccination.  On or around 12/5 (about 48 hours after vaccination) I noticed a feeling of a "racing heart" or heart palpitations.  On or around 12/7-12/8  I developed "covid arm" a large hive-like area over the vaccination site. This was approximately 3x7 inches and lasted about 36-48 hours.  Following the raised "covid arm" reaction, I developed systemic itching over the entire torso and arms. This was followed by a headache and a skin reaction of large raised pimple-like lesions that are typical when I encounter an allergen. These took about a week to clear and were concentrated on the face, arms, and torso.  As of 1/3/22, I still experience pain in the left arm both around the injection site and within the muscular structure of the shoulder and upper arm.
I began to feel flu like symptoms and then I got very dizzy and had to lay down for 24 hours.  I felt dizzy for day later and on Monday 22nd at about 9 pm into Tuesday 23rd at about 5pm I was in bed with another dizzy spell.  Then again days later I got another dizzy spell and was in bed for about 14 hours.  My equilibriumwas off for about 2 months.  Every day I felt some type of dizzy spell.
The resident has redness and warmth on her LUA from her covid vaccination. The resident states she has a headache and some wheezing. New order received for Benadryl 25 mg po now and in 6 hours then PRN q6h x 3 days.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some time to get the VARIVAX (Merck) information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse concerning a patient (age range reported as 2-5, units not reported) of unknown gender. On 03-OCT-2014, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
calling for temperature evaluation for VARIVAX and notifed it was administered to multiple patients; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 05-JUN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)(strength, dosing schedule, lot#, expiration date and route of administration were not provided) for prophylaxis. Administered dose of vaccine was exposed to the temperature from -14 Celsius degrees to -10 Celsius degrees for 4 hours 15 minutes. There was a previous temperature excursion noted: from -9 Celsius degrees to 8 Celsius degrees for 2 hours 21 minutes, as recorded by a digital data logger.  This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2007USA003458: US-009507513-2007USA004416:
Had a very sore arm starting 4 hours after the shot compared the pain to worse than childbirth it was a 10 on the pain scale for her. She started at 5am the following day with headache back pain joint pain and body aches.
No PQC or additional AE reported.; Nurse reported that they administered a booster dose of PEDVAXHIB to a patient too soon. the booster dose was administered on 7/10/2023. No PQC or additional AE reported.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 14-MAR-2023 and 06-JUN-2023, the patent was vaccinated with the first and second dose respectively of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, anatomical site of vaccination, route of administration, lot number and expiration date were not reported) as prophylaxis.  On 10-JUL-2023, the patient was vaccinated with a booster dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, anatomical site of vaccination and route of administration were not reported; lot number T042013, expiration date was reported and validated as 22-JUL-2023) as prophylaxis, too soon (inappropriate schedule of product administration). No additional adverse event reported.
The child was vaccinated with a pre-filled Novartis 0.5 mL that was sent to the schools where children were to be vaccinated. This dosage is meant to be used for patients over 4 years.
This spontaneous report as received from a medical assistant refers to a 4 months old patient of unknown gender. On 01-OCT-2015, the patient was vaccinated with improperly stored dose of oral, ROTATEQ lot # K011948 (dose, route and frequency unspecified). No adverse events were noted. This is one of several reports received from the same reporter. Additional information has been requested.
Received Pfizer covid vaccine 3/4/21 and second dose 3/25/21 Lot number EL3247 in shot in arm. Adverse effect diagnosed with narcolepsy within 8 months after symptoms began in April 2021.  Was diagnosed narcolepsy 11/16/21 Have went through meds and changes in attempt to treat, am now on sunosi 150 mg but have to continue to be monitored remainder of life due to no cure.
Sore arm at injection site 2 days Headache 2 days Aches, mild feverishness 1.5 days Fatigue 3 days
redness, swelling, warmth & itching @ inject site for 12-24 hrs p/booster dose; treated w/DPH;
No adverse effects; patient was vaccinated with improperly stored MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On 27-MAR-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # R008031 and expiration date 18-MAR-2020 for prophylaxis (dosage schedule, route, and anatomical location were not reported). Other suspect therapy was sterile diluent for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) experienced a temperature excursion above 9 degrees Celsius (8.59 C) for 15 minutes, and for sterile diluent experienced a temperature excursion above 1.18 degrees Celsius for 33 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001733:
Coming close to 6 weeks with vertigo issues , I?m off balance , unsteady, shaky movement,  I haven?t had any progress of feeling better! I have anxiety and panic attacks, I have the chills in the morning. I?ve seen my PCP who prescribed me mcylzine , and a steroid taper pack ! Didnt really see and or feel any change ! So she referred me to an ENT , and he wants me to take nortriptyline , but I?m very cautious of taking a anti depressant! These events have brought great fear to me! I was perfectly normal before the vaccine! I would run everyday , workout and enjoy life! I haven?t been able to enjoy these things! Currently taking hydroxyzine for anxiety and high vitamin to get the inflammation done!  Must be a inner ear inflammation from the spike protein we think! I cry a lot , cuz I miss my life
I24.9 ACUTE CORONARY SYNDROME, UNSPECIFIED 5/4/2021 ACUTE RESPIRATORY FAILURE I24.9 ACUTE CORONARY SYNDROME, UNSPECIFIED 5/4/2021 ATRIAL FIBRILLATION, UNSPECIFIED I24.9 ACUTE CORONARY SYNDROME, UNSPECIFIED 5/4/2021 ANEMIA I24.9 ACUTE CORONARY SYNDROME, UNSPECIFIED 5/4/2021 CARDIOMYOPATHY, UNSPECIFIED    ESRD (END STAGE RENAL DISEASE) I24.9 ACUTE CORONARY SYNDROME, UNSPECIFIED 5/4/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA
After receiving COVID booster vaccine to right deltoid on 11/03/2021. developed fever, chills, light headedness, pain at right deltoid infection site, "heat coming from injection site" 11/05/2021,.  Reports she had to leave work on 11/05/2021 due to symptoms.   Reports she has taken OTC Tylenol and Motrin.  Reports she increased sleeping due to symptoms.  Reports symptoms are somewhat better, but continues to have right arm pain and "feels heat coming from injection site."    Upon examination, tenderness over injection site to deltoid muscle.  No fluctuance or induration.  No erythema or lymphatic streaking.
Information has been received from a registered nurse, via a company representative, concerning a 26 year old female patient, who on 11-DEC-2006, was vaccinated with the first dose of Gardasil, and on 02-FEB-2007 with the second dose of Gardasil (lot # not provided). On approximately 06-MAR-2007 ("on or about 06-MAR-2007") the patient became pregnant. On approximately 26-JUN-2007 ("approximately 16 weeks later"), she had a miscarriage. At the time of this report, the outcome of "had a miscarriage" was unknown. Upon internal review, "had a miscarriage" was determined to be serious as an other important medical event. Additional information has been requested.
PATIENT RECEIVED THE VACCINE ON 9/15/2017 AT 9:00 AM AND BY 1:30 PM PATIENT WAS EXPERIENCING A FEVER OF 103 DEGREES WITH BODY ACHES AND CHILLS. BY 5:00 PM, HER HEAD AND STOMACH WERE EXTREMELY SORE AND HAD NAUSEA, ITCHING AND REDNESS OF THE INJECTED ARM AND HER HEART FELT WEIRD. HER FAMILY TOOK HER TO THE EMERGENCY ROOM AT 6:30PM AND SAID SHE WAS DELIRIOUS. THE ER GAVE HER FLUIDS AND MONITORED HER BP AND HEART, WHICH WAS EXTREMELY HIGH. THEY TOLD HER TO ICE HER ARM OVER THE WEEKEND AND TAKE TYLENOL FOR THE FEVER. TODAY SHE FEELS A LITTLE BETTER BUT HER BODY STILL FEELS WEAK AND SORE.
Vaccine given on Oct. 1st 2018. I was in immediate pain and could not raise my arm. It was inflamed and hot to the touch. I could not sleep on my right side and now 13 months later I still cannot sleep on my right side without feeling pain.  The treatment has been Physical Therapy, Ice, Heat, STIM therapy. I've received 2 Cortisone shots, both unsuccessful.
This spontaneous report was received from a female patient of unknown age consumer reporting on herself. On 03-NOV-2015 the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route of administration and indication were not reported). After receiving the injection, the patient was informed by her physician, that she already had the injection on 24-SEP-2012. No adverse effects reported. Additional information has been requested.
Vaccine was not properly diluted before giving the patient the vaccine. Patient had some arm soreness the day of the vaccine, but nothing further.
Swollen lymph nodes on left side of neck and in left armpit area.  Tender to the touch. General aches  and injection site soreness. All symptoms are on the left side, the same side of the injection site. Started around 4 pm on Friday 4/2/2021.  I took 500mg of Tylenol on Friday at 8pm,  and at 2am on Saturday 2/3/2021.
Child received DTaP mid morning on 10/7. Within a few hours, child would not eat and stopped urinating in her normal fashion (less urine output) that evening about 9 or 10, temp went up to 104. Mother gave Tylenol and Motrin but fever never came back to normal. Admitted to hosp 10/9.