chrisvoncsefalvay/vaers-outcomes huggingface dataset:
45 minutes after receiving the vaccine, I developed a rash on my upper chest, left side of my stomach, and my face around the cheeks. The areas was red, warm to the touch, and itchy. It was especially more itchy on my belly. I went back to the site where I got vaccinated. I was triaged by a nurse who confirmed that I was having an allergic reaction. They told me to take Benadryl and Pepcid OTC and follow up with my PCP if needed or go to the ER if symptoms got worse. I took the medication and then the reaction on my skin did not go away completely. It will come and go. I still took the medication. That same day when I got the vaccine, at night i called my doctors office. The nurse told me to follow up with my PCP and I was given an appointment. I saw the doctor on a video visit and she told me to go in person to one of the offices and to take pics of the rash so she could send them to the dermatologist. I went to do that and waited for a call from them and they did not get back to me. So I called them almost everyday. I finally got to talk to someone and they prescribed me with a cream for the rash, but no clear answer was given to me when I asked if it was safe to get the 2nd vaccine. I was told to complete the treatment with cream for 1 to 2 months before they could make a decision. I told them that I couldn't wait because at my job HR was asking for the 2nd vaccine because of them possibly letting people go if they weren't fully vaccinated or have a medical exception. I guess they are really busy so I never got an answer back that I had asked them about. I went to urgent care trying to get an answer and they told me to wait for another appointment with the dermatologist. Someone told me they would call me back from the dermatologist department. I got a message from a dermatologist from my online application from Kaiser and the provider said I needed to continue with the treatment with the cream. She said she was going to refer me to an allergy specialist. On September 20, 2021 I had the appointment with the allergy doctorand he gave me a letter saying that he does not recommended that I get the 2nd vaccine. However, he said to continue with the treatment with the cream and follow up with the dermatologist for 1 to 2 months to reassess the situation. I'm not sure if that means they will give me the okay in the future to take the 2nd dose, and I am afraid that I will get laid off if I don't get the 2nd dose. I do want to get protected but if the doctor is saying that I shouldn't because of the reaction that I had, I am not sure what to do as of now. I sent a message to my PCP yesterday trying to get all of the information all in one place because I had been getting different answers when I was trying to talk to the dermatology department. They would just tell me they don't know if the reaction was significant to the vaccine and that's why they wanted me to finish the treatment for the cream. I'm not sure if they are sure on what is going on with me. I am kind of going in circles with being told to continue to use the cream because the doctors are telling me to go to one specialists to another each time.
10 month old patient given 6-11 year dose of 0.2mL Pfizer covid vaccine .  Patient is experiencing diarrhea, malaise, productive cough and running nose
Fatigue; Arm soreness; Big tenderness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), TENDERNESS (Big tenderness) and FATIGUE (Fatigue) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and TENDERNESS (Big tenderness). On 13-Jan-2021, the patient experienced FATIGUE (Fatigue). On 14-Jan-2021, FATIGUE (Fatigue) had resolved. On 15-Jan-2021, PAIN IN EXTREMITY (Arm soreness) and TENDERNESS (Big tenderness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided
The pt experienced a fever of 102.5 with swelling and pain of the thigh after receiving pneumococcal vaccine.
withdrew the diluent portion and mixed it with the lyophilized vaccine component and it was only 0.2 ml after reconstitution, missed their second dose in the series with no reported adverse event; Initial information received on 28-Feb-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 4 months old female patient who reported withdrew the diluent portion and mixed it with the lyophilized vaccine component and it was only 0.2 ml after reconstitution, missed their second dose in the series with no reported adverse event while receiving vaccine Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination.  On 28-Feb-2023, the patient missed a dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine (Suspension for injection) (Lot UJ799AA with unknown expiry date, strength, and route) because withdrew the diluent portion and mixed it with the lyophilized vaccine component and it was only 0.2 ml after reconstitution, there was not enough diluent in the vial. Because of this the dose was not able to be used and the patient missed their second dose in the series because it was a home visit and they did not have another dose to give to the patient with no reported adverse event (product dose omission issue).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This case involves Adult and unknown gender patient who got covid about a month later and flu while receiving vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer manufacturer (dose, formulation, strength, expiry date and lot number not reported via unknown route in unknown administration site) as prophylactic vaccination.. On an unknown date the patient developed a non-serious event "got covid about a month later" (covid-19) (latency: 1 month) following the administration of INFLUENZA VACCINE. On an unknown date the patient developed a non-serious event "flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "Flu Shot Fridays last year I got a flu shot and I caught the flu not from the shot. Oh I also got covid about a month later" Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the events (got covid about a month later, Flu). At time of reporting, the outcome was Unknown for the event got covid about a month later and was Unknown for the event flu.
Patient noticed itching Sunday (5/5/13) afternoon; Monday (5/6/13) red rash the size of an egg around injection site, very itchy. Pt is using ice/BENADRYL to treat.
This case was reported by a nurse and described the occurrence of drug dose administration interval too short in a 5-month-old male patient who received PEDIARIX. On an unknown date, the patient received the 3rd dose of PEDIARIX. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administratoin interval too short was unknown. Additional information: The 3rd dose of PEDIARIX was inadvertently given early at 3 weeks and 4 days after the 2nd dose of PEDIARIX.
Patient fainted about 1 minute after vaccine was administered.  Returned to normal in about another 1 minute
Rash Narrative:  hivea at injection site five days after injection. No therapies at ED. She has had this rash before at site of bee stings
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult female patient who received SHINGRIX. On 18th April 2018, the patient received the 1st dose of SHINGRIX. On 30th April 2018, 12 days 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 information was received as follows: The age at vaccination was not reported. The reporter said that she wanted to check with the patient first to get permission to give any more information. No further information was provided.
Pfizer bivalent was given as a second dose instead of the Pfizer monovalent.
This initial spontaneous report was received on 25-SEP-2018 from a male patient who was currently in his 70's. When asked if he had any pertinent medical history or drug reactions/allergies, he replied "not that I know of." On 16-OCT-2017, the patient received PNEUMOVAX 23 at his local pharmacy for prevention of pneumonia (route and lot # not provided). He concomitantly received influenza FLUZONE. On 16-JUL-2018, the patient was driving his vehicle and he was coming to a stop in the road so he proceeded to put his foot on the break. The next thing he could recall was his body "completely shut down" and his car collided with and "T-boned" another driver on the road. He was immediately taken to the hospital the same day of the car accident (which was a Monday) and he was hospitalized in intensive care until he was released on the afternoon of 19-JUL-2018 (reported as later that week, until Thursday). He noted that just prior to the car accident ordeal, he was feeling some drowsiness related symptoms. The patient reported that he couldn't really recall anything about the accident itself after the collision occurred because he lost consciousness during the accident. While he was hospitalized, a physician who was treating the patient told him that he developed a case of pneumonia. The patient also mentioned that when he first got to the hospital, his "oxygen count was way down" and he had to be put on oxygen therapy, he was coughing up light mucous, and there were "particulates of blood and flesh" in the mucous (all considered symptoms of pneumonia). The patient also mentioned that when he was released from the hospital, his "feet looked black and blue" when he got home. The patient said he has an upcoming appointment with a cardiologist on 20-NOV-2018 to further evaluate his heart and lung health. The patient said that he received a letter from the other driver's attorney, suing him for the other driver's medical bills that incurred. The patient was requesting compensation for the remaining amount his insurance didn't cover because he felt that he got the PNEUMOVAX 23 to prevent pneumonia but he still ended up getting pneumonia anyway.  According to the patient, the pneumonia was the main factor that caused his body to abruptly shut down while driving, leading to his bad car accident. The patient said his present status was not recovered (however, loss of consciousness was considered resolved since patient reported these events). The patient did not specifically state whether he felt the events were related to PNEUMOVAX 23. Upon internal review, pneumonia and loss of consciousness were considered to be medically significant events. The patient did not provide consent for follow-up.
This is a spontaneous report from a contactable consumer (medical assistant). This report was received via a Pfizer sales representative. A male patient of an unspecified age received PREVNAR 13, (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) and right away he was light-headed and had been experiencing vertigo for the last month. He was starting to get better. The information on the batch number has been requested.
7x8cm area with 2x3cm warm, red center. Also presents with headache x 2 days. Triamcinolone 0.5 QID x 1 wk. Watch closely. BENADRYL qd x 1wk. F/U 2 days if no better.
Narrative: Headache, Myalgia, Nausea, vomiting, light headedness, chills.
Left upper leg swelling, redness, warm and tender to the touch per Mother. Redness in approx 1.5 inches across per Mother. Child was never evaluated by nurse or physician in our office. Was seen at an Urgent Care facility.
Patient began having symptoms on shortness of breath, chest pains and fatigue in the weeks following the vaccine. In June of 2022, finally went to a physician who ordered and MRI which incidentially noted 2 mass in rt Humerus bone, Ordered an ABD/PEL wow CT and found numerous lung nodules and enlarged calcified mediastinal lymph nodes. PET scan, PFT and tissue biopsy of lung nodules and mediastinal lymph nodes resulted in a diagnosis of possible pulmonary sarcoidosis. Patient is currently being treated with steriods.
Patient received her first Shingrix vaccine on 9/16/19 at about 230pm.  Immediately after administration (after ban aid application) the patient stated she felt dizzy.  She remained seated and was given water and continued to be observed by the RPH for about 10-15 minutes before the patient told the RPH she was feeling better a able to walk to the front of the pharmacy to pay and then drive home.    The next morning  (9/17/19) the patient called the pharmacy stating that about 2 hours after the vaccine, at home, she started experiencing severe pain in her left arm and shoulder.  The pain had her screaming, becoming short of breath and lead to uncontrollable shaking of her arm and head.  She was taken to the local ED where she was given 2 doses of pain medication.  She had many tests that ruled out a seizure, but she did have multiple x-rays that the MD ruled may have shown that the vaccine was administered too high in the arm.   The patient then discharged from the ED at 930pm on 9/16/19.   During her call to the pharmacy at 1030am on 9/17/19 she was still had a lot of pain in her arm and shoulder and was awaiting her spouse to return from the pharmacy with her pain meds.  She stated that the ED MD attributed her SOB and shaking all to the pain she had been feeling.  Her plan was to rest.  Her chart was documented with the reaction and it was advised that for now, she does not plan to receive the 2nd dose of the Shingirx vaccine.
pt hosp 3wks p/vax for severe laryngeal stridor & paralysis of 9th, 10th, 11th cranial nerves, felt to be form of bulbar GBS; hosp x 9 days w/spontaneous recovery;
right upper leg became swollen, red, warm to touch within 24 hrs of receiving vaccine,  no fever.  seen in clinic 2 days after receiving vaccine.  child without pain.  treatment-conservative measures as ice.
Day following 2nd Pfiezer Vaccination patient developed left arm, left chest and left leg pain. ultimately left leg pain and chest pain resolved, but with persistent left elbow pain, pain/stiffness with ROM.
Violent chills, fatigue, muscle aches, severe headache, nausea. Pain at injection site, soreness.
when she pulls it out, it made a popping sound; Gave me my vaccination two days ago; Bottle said Sep2021, that is 6 months ago; I don''t know if it was expired; Feeling funny; I can feel like a soreness in my chest; My chest, I just don''t feel right; Coughing up little bit of phlegm; Whole body feels sore; There is a lump, little lump where she gave the shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 01Feb2022 (Batch/Lot number: unknown, Expiration Date: Sep2021) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTRATION ERROR (non-serious), outcome "unknown", described as "when she pulls it out, it made a popping sound"; EXPIRED PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Gave me my vaccination two days ago; Bottle said Sep2021, that is 6 months ago; I don''t know if it was expired"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feeling funny"; CHEST PAIN (non-serious), outcome "unknown", described as "I can feel like a soreness in my chest"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "My chest, I just don''t feel right"; PRODUCTIVE COUGH (non-serious), outcome "unknown", described as "Coughing up little bit of phlegm"; PAIN (non-serious), outcome "unknown", described as "Whole body feels sore"; VACCINATION SITE MASS (non-serious), outcome "unknown", described as "There is a lump, little lump where she gave the shot".  Additional information: Consumer stated, Well I am trying to tell you an experience. I am asking you a question because when they gave me my vaccination two days ago, the Health Department people came to my house and the bottle said Sep2021, that is 6 months ago (date not clarified, hence not captured in tab). So, I do not know if it was expired or what and I am also feeling funny now. I got it two days ago, my chest, I just don't feel right. Is that supposed to happen? I can feel like a soreness in my chest which I did not have before in my chest area, I am coughing up little bit of phlegm which I did not have before. Are these things supposed to happen? My whole body feels sore and there is a lump, little lump where she gave the shot and when she pulls it out, it made a popping sound. Is that supposed to happen? Those are my questions. Product details (LOT#, expiration date, NDC#, UPC#), purchase details and other details were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 68-year-old female who in the "spring of 2007" was vaccinated with a dose of Zostavax (Oka/Merck) (lot# not available). On 11-SEP-2007 the patient was diagnosed with shingles. Unspecified medical attention was sought. The outcome is reported as not recovered. No product quality complaint was involved. The reporter considered shingles to be disabling or incapacitating. Additional information has been requested.
Imm flu vaccine 10-15-2008 2pm. Pt. states awoke 8am with stiffness. Malaise, fever, aching all over. Temp. 99 @ 2:30p today. 10-17 phone call to following- o.k. after 24 hours pt. states.
Hard golf ball size lump at injection site , itchy, red, swollen, painful, red ring
sweating profusely; This is a spontaneous report received from contactable reporter(s) (Physician and Other HCP).  A 49-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 17Dec2021 (Batch/Lot number: unknown) at the age of 49 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was none. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01, Route of administration: Intramuscular, Lot not available), administration date: 26Nov2021, when the patient was 49 years old, for COVID-19 Immunization, reaction(s): "patient reported lip swelling", "patient woke up with burning sensation of the skin". The following information was reported: HYPERHIDROSIS (non-serious) with onset 17Dec2021, outcome "recovered" (Dec2021), described as "sweating profusely". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: 12-hour post vaccine. patient reported sweating profusely but no fever. This symptom lasted 12 hours then subsided. Prior vaccinations was none.  Follow-up attempts completed. No further information is expected.
Weakness in the left leg, for example, making it difficult to go up and especially down stairs. Going down, I cannot let myself down gently. Hard to stand up from sitting position; can't squat. Intermittent numb feeling on inner aspect of right lower leg and top of foot. Symptoms developed subtly over past 6-9 months and I initially attributed the weakness to the known arthritis of the knees. Orthopedist said the weakness was not consistent with arthritis and would not improve with knee replacement.
5 minutes after receiving the vaccine while sitting I felt dizzy, started to see stars and was light headed. I also felt nauseous. The pharmacist had me place my feet up on a chair in front of me, gave me an electric fan  to point at myself and an ice pack that I applied to my head and back of neck. As the stars began to subside I felt a lump in my throat. The pharmacist then instructed me to continue to focus on breathing. Within 25-30 minutes I was clear of all adverse affects.
This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 19-MAR-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The 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.; Sender's Comments: US-009507513-1802USA001558:
Itchy rash on right side chest. Treated with over-the-counter Cortizone, no signs of rash the following morning.
ACCIDENTALLY BROUGHT AN EMPTY SYRINGE ALONG WITH TWO SYRINGES WITH THE MODERNA VACCINE FOR THE IMMUNIZATION. INITIALLY VACCINCATED THE PATIENT'S WIFE. THEN STUCK PATIENT WITH THE EMPTY SYRINGE/NEEDLE IN THE RIGHT ARM. CORRECTED SELF AND THEN ADMINISTERED THE LAST SYRINGE WITH MODERNA VACCINE IN THE PATIENT'S LEFT ARM. EXPLAINED THE SITUATION TO BOTH THE PATIENT AND THE PATIENT'S SPOUSE.
Not an adverse reaction but an administration error. A grey cap adult pfizer was prepared and administered as a pediatric pfizer. The patient received a 40% higher dose than the approved dose for children ages 5-11
Scleritis of left eye (first ever flare). Severe pain, redness, swelling.  Started 1/30/21. Began Oral Steroids from 2/6/21 until June 2021.  Saw Dr. in Eye Institute for treatment.
1. Migraine for three days; 2. Fever of 99.2 for two days; 3. Chills and body aches all over not just sore arm; 4. Diarrhea; 5. Swollen right eye lid (weird right?); 6. I was in bed for almost two days which I rarely do.
fever of 103, sleeping more per mother's report; t101.8 ax in clinic; also not taking as much formula;