chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blood clot; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clot) in a 56-year-old female patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced THROMBOSIS (blood clot) (seriousness criteria death and medically significant). The patient died in 2021. The reported cause of death was blood clot. An autopsy was performed.            No Concomitant informations were reported.  No Treatment informations were reported.  Company comment: This case concerns a 56-year-old female patient with no medical history reported, who experienced the fatal event of thrombosis. The event occurred an unknown time after the booster dose of mRNA-1273. Autopsy report states cause of death as thrombosis. This report has been submitted by a consumer who knew the patient, though limited information regarding medical history, clinical presentation, diagnostic tests and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 56-year-old female patient with no medical history reported, who experienced the fatal event of thrombosis. The event occurred an unknown time after the booster dose of mRNA-1273. Autopsy report states cause of death as thrombosis. This report has been submitted by a consumer who knew the patient, though limited information regarding medical history, clinical presentation, diagnostic tests and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Blood clot
Pfizer vaccine was administered instead of Moderna.  Moderna was administered as first dose.  Explained the error to patient.  both patient and nurse were educated on the vaccines that were administered.  Patient was instructed to call  Health Department with any issues.
swelling-severe w/in 1 hour of immunization. Chest tightness/pain/short of breath/trouble breathing by the following day
Soreness at the injection site/pain with mobility; warmth at the injection site as well as in the opposite (right) arm; Redness at the injection site; Swelling at injection site; Pain upon movement; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in March 2022).   On 4th July 2022, the patient received the 2nd dose of Shingrix. On 5th July 2022, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site warmth, injection site erythema, injection site swelling and pain upon movement. On an unknown date, the outcome of the injection site pain, injection site warmth, injection site erythema, injection site swelling and pain upon movement were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site warmth, injection site erythema, injection site swelling and pain upon movement to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-JUL-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine into left arm and experienced soreness, pain with mobility, soreness at the injection site, redness at the injection site, and warmth at the injection site as well as in the opposite (right) arm.  The patient stated that all symptoms started on the day after dose was received. The patient reported all symptoms on the left arm had got progressively worse.  The patient reported all symptoms on the right arm had been consistent. The patient also stated that all symptoms were ongoing. The reporter consent to follow up.
Within two hours of receiving the second dose of Engerix B, the pt developed a generalized maculopapular eruption with hives. The most recent information received, reports the condition of the pt is unknown.
"Redness to chest," no itching, no SOB and no difficulty swallowing. Lungs CTA B A/W. Patient pulse ox 98.1, pulse 82, faint redness and excoriations to upper chest. Faded in 15 min.
PASSED OUT ONCE  (Passed out,  Loss of consciousness) COUGHING OUT  (Coughing,  Cough) CHILLS  (Chills,  Chills) NAUSEA  (Nausea,  Nausea)  FEVER  (Fever,  Pyrexia) HEADACHE  (Headache,  Headache)  This spontaneous report received from a patient concerned a female of unspecified age.  The patient's weight,  height,  and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s  (suspension for injection,  route of admin not reported,  batch number:  1805025,  expiry:  UNKNOWN) dose was not reported,  administered on 11-MAR-2021  14:00 for prophylactic vaccination.  No concomitant medications were reported.  On 11-MAR-2021,  after getting the vaccine,  the patient experienced achiness throughout the body,  coughing out,  chills,  fever, headache and nausea.  On 12-MAR-2021,  the patient also passed out once.  The action taken with covid-19 vaccine ad.26.cov2.s was not applicable.  The patient recovered from passed out once,  and fever on 12-MAR-2021,  and chills on MAR-2011,  had not recovered from headache,  and achiness throughout the body,  and the outcome of nausea and coughing out was not reported.  The reporter causality between covid-19 vaccine ad26.cov.2.s and passed out once,  coughing out,  achiness throughout the body,  chills,  nausea,  fever,  headache was possible.  The company causality between covid-19 vaccine ad26.cov2.s and passed out once,  coughing out,  achiness throughout the body,  chills,  nausea,  fever,  headache was possible.  This report was serious  (Other Medically Important Condition).
Pt states she had shingles "a long time ago" and was given a shot and a cream. The shingles episode resolved in several weeks and the rash was 3-4 small spots on her neck. On 5/1/13 she received ZOSTAVAX. 5/16/13 she called and stated she has 2-3 raised spots in same place as the original rash and it is "a bit itchy".
Weakness, body aches, joint pain, headaches, fatigue, overall feeling of being out of it and in a lot of pain. So far, this has lasted 12 days and is not getting any better. No treatment as of yet.
see attached slip written out by pt......injection Wed. Arm pain started Thursday am. Temp started about 10:00 am. Thursday pm, temp 103 degrees. Respiratory distress, chest pain, pulse 120. Chest x-ray clear. No wheezing. Friday temp 100-101. Saf 100-101 Shoulder red and swollen from shoulder to elbow. Sunday T 99-100 red and swollen S-E Monday T 99 red and swollen S-E
I got shingles. First shot on 4-16. I knew something was wrong by 4-21. Rash/blisters appeared on 4-24-21
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's medical history or concurrent conditions were not reported. On 22-MAR-2017, the patient was vaccinated with an improperly stored dose of VARIVAX (which had the lot # M030138, expiration date 15-JUN-2018) dosage information, route and anatomical site of vaccination were not informed, for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown). No adverse effects were reported. The vaccine experienced temperatures from 15°F to 46°F (28.4F). Time: for 75 hours. There was no previous temperature excursion. The call was not because of a "data logger". Outcome: Supported for 1 month. It was also exposed to temperatures of 6°F to 14°F for 50 hours. There was no product quality complaint involved. Additional information has been requested.
12 x 18cm area of redness, warm to touch, temp 101 noc before-8JAN98 temp 99.5;states area of redness larger 7JAN98;13JAN97 area of redness gone;knot size of walnut;
Hive like welts at injection site a week after 1st dose, and itchy. Also slight itchy ness throughout body.
Fever of 103, accelerated heart rate and breathing, was scary,  pain throughout body started that night and went into the next day. Pain was not mild.  He still occasionally complain of rapid heart rate.  Went to urgent care and didn't it was taken seriously. Even heart rate when taken at the facility was not properly done.
tongue swelling; This case was reported by a physician via call center representative and described the occurrence of swollen tongue in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2021, the patient received the 1st dose of Shingrix. In August 2021, 3 hrs after receiving Shingrix, the patient experienced swollen tongue. On an unknown date, the outcome of the swollen tongue was recovered/resolved.   It was unknown if the reporter considered the swollen tongue to be related to Shingrix.  Additional details were reported as follows: Age at vaccination was not reported. Primary care physician reported that a patient got the 1st dose of Shingrix 1 or 2 days before from the date of reporting and 3 hours after the administration developed tongue swelling.  This event resolved with Benadryl gradually.  The patient had no hives, no lip swelling, no trouble breathing. No exact date of vaccination, lot number or expiration date provided since the vaccine was administered at a pharmacy.  The reporter did not consent to follow-up.
Tingling sensation all the way from eye to hip area on the left side of body; Body hurts from all the way from head to feet on left side; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation all the way from eye to hip area on the left side of body) and MYALGIA (Body hurts from all the way from head to feet on left side) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Amoxicillin), Allergy to vaccine (Allergy to pneumonia vaccine), Autoimmune disorder NOS since 01-Jan-2000, Blood pressure and GERD. Concomitant products included DESIPRAMINE from 01-Jan-2000 to an unknown date, LEVOTHYROXINE from 01-Jan-2000 to an unknown date, LISINOPRIL from 01-Jan-2000 to an unknown date, OMEPRAZOLE from 01-Jan-2000 to an unknown date and ACETYLSALICYLIC ACID (BABY ASPIRIN) from 01-Jan-2000 to an unknown date for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PARAESTHESIA (Tingling sensation all the way from eye to hip area on the left side of body) and MYALGIA (Body hurts from all the way from head to feet on left side). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and CAMPHOR, EUCALYPTUS SPP. OIL, MENTHOL (VAPORUB) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Tingling sensation all the way from eye to hip area on the left side of body) and MYALGIA (Body hurts from all the way from head to feet on left side) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. Concomitant medication include Fibrate and Vitamin   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Updated patient demographics, updated medical history, updated second dose details and updated concomitant medications
bed ridden for a day after the 2nd dose,could not go into work; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (bed ridden for a day after the 2nd dose,could not go into work) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BEDRIDDEN (bed ridden for a day after the 2nd dose,could not go into work). At the time of the report, BEDRIDDEN (bed ridden for a day after the 2nd dose,could not go into work) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication details was reported. No treatment medication details was reported.
At about 45 min out,  I had dizziness and felt like my heart was racing. I checked it and it was 120 to 125 BPM.  Walking my heart rate went up to 154 BPM. I called my PCP and rested as prescribed. My heart rate stayed at 120 BPM. I did have the same reaction to Dose 2 which we treated the same way.
"pt felt warm hot at the right side of the neck and ear and a lot of pressure in front of the head. also, pt's throat felt tight."
2MAR93 pt had DTP inject @ arm; 3MAR93 woke up red swollen @ arm used APAP & ice packs; no fever; 5MAR93 lt arm 2" below inject site (swollen), blotchy, red-now spread to inject site; swollen lymph gland under arm;
Site: Redness at Injection Site-Medium, Additional Details: redness over whole upper arm and wrappingaround to back, warm to touch
Client was vaccinated approx 10:00am at the Health Dept. Client left after 15min without incident.  Client went to report to work and began feeling nauseated, dizzy, and feeling as if was going to faint.  Client returned to Health Department approx 12:30.  Client was diaphoretic, HR was 140bpm, and BP was 178/120.  Client was given 50mg/20mL of diphenhydramine PO and EMS was called and client taken to local ER. Client remained A+Ox3 at time of EMS transport.  Spoke with client evening of 12/28/2020.  He reports he was transferred to another facility and was told was in a-fib.  He reports that he is feeling much better but heart still fluttering. Spoke with client afternoon of 12/29/2020.  He reports that he is being discharged in a few hours and is being sent home on metoprolol and a baby ASA.  He reports they had been working on getting his BP down.  He reports that he is feeling better and is going to be scheduled for a heart cath outpatient.  He reports that he was initially in a-fib, then a-flutter, and then arrhythmia.  He reports that he has been seen by Dr. a Cardiologist, while hospitalized.
Erythema and cellulitis at site of vaccine, on KEFLEX and mupirocin. Rt deltoid.
This spontaneous report as received from a nurse refers to a 19 year old patient. On an unknown date the patient was vaccinated with VAQTA. Past medical history and concomitant medications were not reported. On an unknown date the patient was inadvertently administered a pediatric dose of VAQTA for their second shot in the series. At the time of this report, no adverse effects were reported. The outcome of inadvertently administered a pediatric dose of VAQTA for their second shot in the series is unknown. Additional information is not expected.
The vaccine I listed was my second vaccine. However I am sick and tested positive with covid-19 on 3/20/21. Symptoms begin around 3/17 with nasal congestion, sneezing, watery eyes, mild sore throat. Additionally so far headaches, myalgia, cough, chest pain, fatigue, anosmia.
Myalgia, Arthralgia, Fever, NauseaVomiting,  INJECTION SITE PAIN  Narrative:   Other Relevant History:
Not technically an adverse event. But an expired Pfizer vaccination was given to patient.  Pfizer filled syringe from the previous day was left on the countertop. That syringe was used.
Rash, pruritic, red, petechiae; began on feet and spread up legs after injection. Swelling in (R) hand. Severe pain in feet and legs and bruising.
On 9/26/18-Developed 3-quarter sized red-purplish, warm, hot to touch the area where flu vaccine was given. The patient's red area spread  6-8 inch in length and hard, warm, red to touch. Health care provider recommended Zyrtec 2 x Q daily, benadryl at HS, and cold compresses.  Physician recommended flu Mist for next seasons.
This spontaneous case was reported from a consumer, concerning a 15 years old, female patient. The patient's concurrent conditions, historical conditions and drug reactions or allergies were not provided. The patient's concomitant medication were birth control pill and ACCUTANE. On 23-AUG-2018, the patient was vaccinated with the second dose of GARDASIL 9 series for routine vaccination prophylaxis (dose, route, anatomical side of injection, lot# and date of expiration were not reported). On the same date, the patient went home and started felt dizzy and fainted. Later in that evening she felt nauseated and vomited. It was unknown if the patient received any treatment for the adverse events. The reporter specified that no laboratory diagnostic studies were performed. The outcome of dizziness, vomiting, nausea and syncope was reported as recovered/resolved. At the reporting time, the causality assessment between of GARDASIL 9 and the aforementioned adverse event was unknown.
Headache, NauseaVomiting, LIGHT HEADEDNESS Narrative:  C/O BEING VERY NAUSEOUS, w/ complaints of tension headaches. employee further endorsed she may have stressed herself out.
Our chart indicated patient was due for Tdap vaccine. There was no previous record of patient ever having this vaccine. Patient agreed to have vaccine. Patient was in the office today for a physical with NP-C.  Patients chart indicated she was due for Tdap immunization. I asked the patient if she wanted the vaccine today and she stated yes. I looked in record to see if there was any documentation showing previous vaccines for the patient, the patient had never been entered into record prior to 07/14/2016. I entered patient and logged in the Tdap vaccine that was given 07/14/2016. Patient had her visit with NP-C. I then drew her blood for blood work ordered and gave the Tdap vaccine. Patient was telling how her daughter told her she was not allowed to go to another state to see her grandchild until she got a shot. I then asked her where she got the shot, and she stated pharmacy. I called pharmacy and asked them to fax us documentation of the vaccine patient received last summer. I called patient and let her know that we gave her the same vaccine she received last summer from pharmacy. I instructed her to watch for anything out of the ordinary and call us immediately. She stated she would. I called spoke to staff and she instructed me to do a VAERS report. She asked that I fax a copy. I spoke with NP-C regarding the situation, and placed a note in the patient's chart.
her neck is swellen the side of arm took the shot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Jun-2021 and was forwarded to Moderna on 18-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (her neck is swellen the side of arm took the shot) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING (her neck is swellen the side of arm took the shot). At the time of the report, SWELLING (her neck is swellen the side of arm took the shot) outcome was unknown.            Patient experienced the event one day after receiving the vaccine.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Vaccines rec'd 5/1/2014, that evening upper (L) thigh began swelling, red and splotchy. Sat morning, screaming with no leg pain. No fever. In office, 4cm, mild, non-tender induration on 5/5/14.
I have received three doses of the vaccine. After the second dose in May I had abnormal uterine bleeding in June but it resolved on its own. In November I received the booster and in January I was COVID positive. In February I developed severe uterine bleeding that required I be hospitalized and receive a blood transfusion in March.
Fever, chills, nausea, muscle pain all over, fatigue, sinus congestion, difficulty sleeping due to chills. I received the vaccine on a Friday at about 9:00 am and the "adverse events" started that evening at about 8:30 pm, so about 11-12 hours after I received the vaccine. The next day, Saturday, I did not feel well enough to do my normal activities and just sat around all day under a blanket. I started to feel a little better Sunday afternoon when the fever stopped. Mild nausea continued until Tuesday. I would characterize these "adverse events" as surprising since I normally only get mild soreness at site of vaccines. People should probably be warned to expect to feel awful after getting the SHINGRIX vaccine so they can be prepared. Nevertheless, it was well worth it if it keeps me from getting Shingles.
Monday afternoon had a headache, but after waking up on Tuesday after the vaccine constant, Wednesday stiff neck, by Friday all same symptoms, along with not feeling well at all. Went to the local ER at  on 04/23/2021, Checked BP and it was high, they did a CT and it looked fine, the ER DR came in and said it was a migraine but I have had migraines before and this was not it.  04/27/2021 went into my primary care dr, BP was still high, and prescribed a water pill called Hydroclorophazide.
My lips started swelling and my tongue swelled and throat got all itchy. My eyes were really puffy.  I took Benadryl - I took 2. It made me sleep. I slept for about 1 hour and went back to sleep. I went back to sleep for 9 hours and the next day I I was a little tired and had some aches. Was fine after that.
Sore throat, sneezing, fever, fatigue, body aches, headache. Onset 5 days after household exposure. Positive Binex results day of first symptoms. Paxlovid prescribed.  Currently on Day 3 of treatment with symptomatic relief.
Patient reported significant left arm pain in the injection site. She has increased pain with moving her arm. Patient evaluated by, Pediatric NP on 8/27/21. Reports pain 1/2 inch below shoulder.
Day after shot (Saturday 10 April)  - nausea, headache, 101.5 fever, body aches, arm soreness, tiredness 2nd day after shot (Sunday 11 April) - slight headache, tiredness, red rash around injection site and itching.  My arm was also swollen and more sensitive to touch than movement.  The itching wasn't bad enough that I needed to take any meds.  I just wanted to report this adverse reaction to the second shot.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Additional Details: Patient reported a knot under her arm near her arm pit
This spontaneous report as received from a registered nurse refers to a 75 year old patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 06-APR-2018 the patient was vaccinated with RECOMBIVAX HB (0.5 ml/ one dose)(pediatric formulation) from lot M037248 expiration date 21-FEB-2019 by intramuscular route (drug administered to patient of inappropriate age) for prophylaxis. No adverse effects were reported. No product quality complaint was involved.
Urticarial lesions over trunk & extremities with severe itching. No respiratory issues. Vital signs were stable. Was given SOLUMEDROL 20mg IM and observed for - 30mts. Lesions began to fade; Itching resolved. Called mom about 2 hours later and all the lesions were gone.