chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness; Itching; Rash; Wondering if an allergic reaction; The vaccine injection site started to itch; hives all over the body; Hives appeared around the vaccine injection site; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ep7533), dose 1 via an unspecified route of administration, in right arm on 07Apr2021 12:00 (at 30-years age) as single dose for covid-19 immunisation. The patient relevant past drug history includes allergic to contrast IV Iodine and wheat. The patient's concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19. The vaccine injection site started to itch within 5 minutes after vaccination and hives all over the body on 07Apr2021 12:14. Hives appeared around the vaccine injection site within 10 minutes on 07Apr2021 12:10. Patient left the pharmacy without notification of reaction after 14 minutes. Continued to developed hives all over the body that came and went for approximately 2 weeks after receiving the vaccine. Patient was getting hives and redness around the itching rash; patient was asking if it was normal for all. Patient was wondering if it was an allergic reaction. Since the vaccination, the patient not tested for COVID-19. The outcome of the events was unknown.  Communication: Reason of delay: Daily spike of incoming calls due to COVID19 vaccine.  No follow-up attempts are needed. No further information is expected.
Fever and hives. BENADRYL given. This was patient's first dose of PENTACEL, she had received a dose of PEDIARIX prior.
Pain at injection site, elevated blood pressure 157/89, 18 hours after injection.  Took one Losartan 25 mg as usual in morning after taking BP.
Vaccine administrator gave wrong drug to a child that was meant for adults -18 year olds and older by mistake. No known adverse event.  No adverse events occured. 3-28-07.
Since shot in left shoulder have had ache or pain 24/7. Generally hurts when arm is used to do anything. Much less of an ache when arm is not in use, but still always there.
pt recvd vax; devel full blown case of chicken pox & recovered;staff in md's ofc did not observe the chicken pox;
contracted covid after receiving the 1st vaccine dose; contracted covid after receiving the 1st vaccine dose; This is a spontaneous report from contactable nurse. This Nurse reported same events for six patients. This report is for 1st of six reports.  A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 22Dec2020 at a single dose in the nursing home for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient contracted COVID after receiving the 1st vaccine dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 22Dec2020, and contracted COVID on an unspecified date.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like COVID infection date needed for a full meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021035080 same reporter/drug/event, different patient;US-PFIZER INC-2021035079 same reporter/drug/event, different patient;US-PFIZER INC-2021035081 same reporter/drug/event, different patient;US-PFIZER INC-2021035082 same reporter/drug/event, different patient;US-PFIZER INC-2021035083 same reporter/drug/event, different patient
This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On 18th October 2018, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. At the time of reporting, the patient was 54 years old. In 2018, the patient received a 1st dose of SHINGRIX about 4 months before the time of reporting. On 18th October 2018, the symptoms of shingles was started. On 20th October 2018, the patient was diagnosed with shingles.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown ages and genders. Medical assitant mentioned that in the past an unspecified number of patients had experienced nausea and dizziness after receiving GARDASIL injection (lot #, expiry date, dose, route and indication unknown). All patients recovered in less than 15 minutes while in the office. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a pharmacist refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot # J005068; expiration date: 18-JAN-2015) (dose and route were not provided). On an unknown date, the patient experienced swelling in the arm where PNEUMOVAX 23 was administered. Unspecified if the patient sought medical attention. The outcome of swelling in the arm where PNEUMOVAX 23 administered was unkonwn. This is one of several reports from the same source. Additional information has been requested.
A serious, spontaneous report of hyperthermia has been received from a physician, concerning a four-year-old female, subsequent to FLUMIST. Neither past medical history nor concomitant medications were reported for this patient. The patient received FLUMIST on 30-Sep-2010 for prevention of influenza. On 30-Sep-2010 the patient experienced hyperthermia and was hospitalized. No further details were available. The event of hyperthermia was ongoing.
I contracted COVID-19 on 07/09/2022 with symptoms scratchy throat, cough, fever of 100, sneezing, sore throat, and  body aches. I was prescribed Paxlovid on 07/11/2022. I am beginning to feel better, but my symptoms have not begun to resolve yet.
fever blisters; This case was reported by a pharmacist via call center representative and described the occurrence of fever blister in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 3L794, expiry date 21st September 2021) for prophylaxis.   Previously administered products included Valtrex (for fever blister).   On 21st June 2019, the patient received the 1st dose of Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced fever blister. On an unknown date, the outcome of the fever blister was unknown.   It was unknown if the reporter considered the fever blister to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The pharmacist reported the patient called on the day of reporting and asked if she could take Valtrex for fever blisters on her mouth.
Pt came to tx a/o x4. Pt given COVID-19 Moderna vaccine at around 1545, then RN checked on pt at 1600, and pt not verbally responsive. Pt BP in the low 100's. Pt able to open eyes, but very lethargic. Pt placed supine, given 2l 02 via, breathing unlabored, hr ok, about 600 cc ns bolus given. Pt still not responding verbally. RN noted body twitching/shaking. Paramedics called and transferred to ER at around 1615. The patient did not require the use of an Epi pen .  Patient spent the night in the hospital. It was reported that he had  elevated Ammonia levels which may have caused this issue. However as this happened so close to the vaccination we are reporting
The MMR vaccine was given in the left arm IM in the deltoid. This is charted in system and also was verified over the phone by staff that works in the pharmacy when verifying what arm each vaccine was given. Patient was given 3 vaccines but only one was charted in system. The patient states that she started having the reaction the night that the vaccine was given 02/09/2022 and it has gotten progressively worse. Her left arm is red, swollen, and hot and the redness continues onto her chest. She is going to see PCP Dr. today.
none vaccine was mixed incorrectly. mixed with sterile water instead of diluent that comes with vaccine
Severe achy overall on 11/6/2021 and 11/ 10/2021  Ears- deep pain in both ears beginning on 11/9/2021 at 8 PM.  Tylenol did not seem to help. Resorted to using a headband with handwarmers on both ears which I had to sleep with them on. That brought relief.   Never a history of ear problems whatsoever. No drainage or anything that would indicate infection. Okay the next morning.
On 9JUN92 felt hot & was given APAP; temp not taken; approx 6PM began to convulse & was found to have t105; cooling measures were used & was taken to ER; by 8PM t100 given Pediaprofen; 10JUN92 t102;
Syncope on 5/20, found to have acute myocarditis with acute systolic heart failure
This spontaneous report was received from the patient's mother concerning to her 13 year old female daughter. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 15-NOV-2017, the patient was vaccinated with the first dose of GARDASIL 9 injection, by intramuscular route (strength, dose, lot number and expiration date were not reported) to prevent HPV. The primary reporter stated that on 15-NOV-2017 to 09-DEC-2017, the patient kept having issues where she would "leak" or urinate onto her underwear. Also on 20-NOV-2017, the patient developed a high fever of 103 (units not reported). The fever decreased on 22-NOV-2017, but the reporter stated that the fever was on and off. Starting on 22-NOV-2017 to 23-NOV-2017, the patient also had headache. In approximately 2017, the patient was having issues with her bowels and could not got to the bathroom. Treatment was given for the adverse events. At the time of the report, the outcome of the events was reported as not recovered. The causality between the events and the GARDASIL 9 was not reported.
Family consented for vaccination and stated Pfizer was the first dose given.  Resident was given Pfizer as second dose. Informed had medrna as first dose not Pfizer. Patient did not have any reaction or negative side effects from the vaccination to this point.
Minor pain/soreness at IM injecti on (booster) site.; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Minor pain/soreness at IM injecti on (booster) site.) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfi zer COVID-19 vaccine (1st dose  LOT-EP7534) on 23-Mar-2021 and Pfi zer COVID-19 vaccine (2nd dose  LOT-EW0151) on 13-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfi zer COVID-19 vaccine and Pfi zer COVID-19 vaccine.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced VACCINATION SITE PAIN (Minor pain/soreness at IM injecti on (booster) site.). At the time of the report, VACCINATION SITE PAIN (Minor pain/soreness at IM injecti on (booster) site.) outcome was unknown.            No concomitant medication were reported  No treatment medication were reported  Minor pain/soreness at IM injection on (booster) site. Reported no pain from previous 2 Pfi zer doses.
9/30/2021 2:00pm received covid 19 booster vaccine                 5:30pm felt fine and did exercise workout                  9:00pm - 6:00am insomnia, did not sleep much at all 6:00 am headache and muscle soreness                 7:00am clocked in to work                 10:00am headache, muscle soreness, joint pain and fatigue                 12:00pm headache, extreme fatigue and joint and muscle pain                 3:30pm same as above with chills                  4:00pm same as above but severe chills and temp 98.8, slight chest pain                 7:30pm same as above with nausea, temp 101.0, bp 154/95, pulse 128                 10:00pm fever broke, sweating, pressure in chest, unable to sleep   6:00am most of the flu like symptoms are gone except headache and fatigue, still experiencing chest pain                                  and pressure especially in a reclined position. Subsides when I sit up or walk around.                                  This persisted throughout the day. bp and hr returned to normal. Still very fatigued and still                                  not sleeping well. 6:00am feeling better, not as fatigued. Chest pain and pressure better. Still very tired due to lack of                                  sleep. 8:00am visited RN. Performed lab tests, EKG, chest xray, all normal. Finally got some                                   much needed rest that afternoon and night.    7:00am clocked in to work, feeling better with slight fatigue and headache but much better than                                  previous days.
onset w/in 2 hours of bil arm pain, primarily in the Left arm. Sx have persisted 2 weeks
Patient had clammy and redness of skin, puffy eyes, and complained about fatigue, feeling nauseous, achy, and sore throat.  Her temperature was 98 degree F.
Pt EXPERIENCED A GREAT AMOUNT OF SWELLING, AND REDNESS IN THE LEFT ARM THAT LASTED THREE DAY. hE ONLY RECIEVED RELIEF WITH FOLLOW UP TREATMENT OF STERIODS AND MOTRIN.
Patient c/o tongue swelling approximately 10 minutes after receiving  vaccination. Noticeable tongue edema, but no other sx. SPO2-98-99%, BP: 112/80 by auscultation  right arm. Lungs clear to auscultation. Pt.?s mother administered 25 mg Diphenhydraamine po. No epinephrine administered. Pt observed until tongue edema diminished. No respiratory sx. Advised to contact pediatrician prior to second dose. Advised f/u with pediatrician if no further resolution of sx. Advised f/u in ED if sx worsen. Pt encounter lastsd approximately 1 hour and 10 minutes
No adverse event; patient received a Bivalent booster before they got their primary series today; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received a Bivalent booster before they got their primary series today) and NO ADVERSE EVENT (No adverse event) in a 35-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Nov-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patient received a Bivalent booster before they got their primary series today). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received a Bivalent booster before they got their primary series today) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient received a Bivalent booster before they got their primary series today).    No concomitant medications were reported.  Reported that a patient received a Bivalent booster before he got his primary series of vaccine on 14-Nov-2022. The dose was supposed to be his first dose however they were under the understanding the patient had received the previous vaccines and gave Bivalent booster dose to the patient.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Nov-2022: Follow-up information received includes patient demographics (initial, gender and date of birth) and suspect vaccine details (lot number and start date) were added. Reporter details and I-narrative supplement were updated.
Pt received immunizations 8/19. Later in day of 8/20 pt presented with fever (101.6) and redness, swelling and discomfort to left arm. Area approx. 3" diameter. Saw physician, took Benadryl for 3 days. Pt recovered.
Woke up sick on tuesday april 5th, found dead in his apartment on wednesday april 6th.
This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced MIGRAINE (Migraine). On 31-Mar-2021, MIGRAINE (Migraine) had resolved. Unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant details were provided. Treatment details include Ibuprofen. This case was linked to MOD-2021-109690.
Moderna COVID-19 Vaccine EUA Side effects started about 12pm on 12/23/20  Nausea, headache, body aches, cough, runny nose, congestion, very tired
Hives from head to toe, fever, chills, diarrhea, vomiting, migraine, tongue swelling, sore muscles, dizziness and very fatigued.  On Saturday signs of Pericarditis returned and therefore I began taking the prescribed medication from prior episode (colchicine).  Missed 2 days of work (Friday and Monday).  Had to utilize epi pen, and also took regular doses of Benedryl.  Could not eat or drink for three days.    A week later and the headache is still slightly there and hives are slowly diminishing.
This spontaneous report as received from a medical assistant referring to an adult patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency and route of administration were not reported) (lot # N010106, expiry date: 15-NOV-2018) for prophylaxis. The PNEUMOVAX 23 was exposed to a total time in the range at or above 0 °C to 1 °C for 8.25 hours. It was reported the exact temperature and time below 0°C was: -1.9 °C for 15 minutes, -1.2 °C for 15 minutes, -1.0 °C for 15 minutes, -0.8 °C for 15 minutes, -0.4 °C for 15 minutes and -0.2 °C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
BALANCE ISSUES; Itchy skin; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (BALANCE ISSUES), PRURITUS (Itchy skin) and HEADACHE (Headaches) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced BALANCE DISORDER (BALANCE ISSUES), PRURITUS (Itchy skin) and HEADACHE (Headaches). At the time of the report, BALANCE DISORDER (BALANCE ISSUES), PRURITUS (Itchy skin) and HEADACHE (Headaches) outcome was unknown.            No concomitant medication information was provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event(s) of balance issues, itchy skin and headaches with humira(adalimumab) was reported as not related.  No treatment medication information was provided.
Varicella from rash diffusely on trunk and face #30.  Sudden onset as seen 1 day prior and no symptoms.  Had received Varivax on 3/6/08.
a pharmacist reported that a pt received a vaccine on 6/27/2000. Two days post vaccine she developed fever and flu like symptoms, which lasted more than 36 hours. Pt also developed a 15 cm area of soreness at injection site. On 7/1/2000 pt was treated by physician.
widespread >30 papules/macules DX: Varicella TX: Symptomatic
R arm (upper) skin tender.  Mild erythema edema inferior aspect & elbow of arm.  Cool compresses.  Pt advised to take CLARITIN or BENADRYL.
At second Gardasil shot, very sick feeling, nausea, dizzy, pain, fever. More extreme than normal.
02/16/2022, coughing and I felt like I had drainage. I felt sore all over. I did have a slight temperature of 99, but it was not persistent. I took a rapid test and it came back negative. I still was cough so I decided to go to the clinic to get tested on 02/19/2022 and I tested positive for COVID-19. The PA suggested I do the monochromal infusion which I did and I started to feel a bit better that night. My coughing was not as intense. I contacted my doctor and told her I read that azithromycin would help and she prescribed it. I think it did help.
admitted with palpitation shortness of breath and cough.  She was found positive with COVID-19 infection, required Decadron and remdesivir.  She was seen in AFib with rapid ventricular response was placed on Cardizem drip. She required 3 L of oxygen during this hospitalization Chest x-ray revealing for bilateral pneumonia she received antibiotics along with COVID 19 treatment protocol.  She was discharged home on oxygen.  On the day of discharge patient was completely asymptomatic no chest pain no shortness of breaths
1st shot April 7, 2021 - sore arm upon touch at injection site 2nd shot April 28, 2021 - sore arm at injection site.  Symptoms developed next day of severe "head cold" - congestion, stuffy nose, watery eyes which resolved in a few days.  Within one month noticed  neck was sore just above collar bone on left side only.  This has not resolved and causes great discomfort.  Lymph nodes (?) do not appear enlarged. Pain is now felt along the left side of my neck as well.  Pain is always present.
Patient noticed a raised red rash on the right arm approximately 36 hours after receiving immunizations. She reported that the area was not uncomfortable nor was she having any other allergic-type reactions. She said she put a cold pack on it that night. The FLUZONE injection was given above the PNEUMOVAX injection and the raised, red area is stemming from the site of the PNEUMOVAX. It radiates down and to the inside of the arm. She felt like it was a larger area this morning compared to last night. I instructed her to continue to apply a cold pack and take some a fever reducer. I provided my name and number and instructed her to call me back if it continues to get larger or uncomfortable.
Chest pressure on 1/10/22; shortness of breath on 1/13/22; more severe shortness of breath of 1/20/22; severe shortness of breath and swollen feet, ankles, and calves on 1/22/22.  Went to the ER on 1/22 and had a number of imaging and blood tests.
Nurse administered too much vaccine.  Checked on patient today.  Sore arm, no other symptoms.  Advised to monitor for worsening symptoms.