chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a LPN concerning a 3 year old male pt with an allergy to amoxicillin who on 05/06/2003 was vaccinated with a dose of varicella virus live vaccine live. On 06/26/2004 the pt presented to the physicians office with a severe case of chicken pox described as over 100 lesions in multiple stages over the entire body. The pt's mother reported the lesions started in the morning of 06/26/2004. Medical attention was sought. The pt recovered on an unspecified date. No product quality complaint was involved. No additional information is expected.
No pain or anything right after. They kept me an hour to observe due to past adverse event after vaccine. Body aches the next day - I took care of them with Tylenol. On Sunday, A rash started on my feet - little red dots. It didn't itch. Dr. on Tuesday. Thursday, I was super tired and the rash was continuing to get worse. My doctor called and said the labs were normal. I was getting scratchy throat, runny nose,  rash moved to stomach, my back (mainly in my shoulder blades) my upper arms; and my face was bright red -looked like it was peeling, and rash was on my scalp (in my hair). The inside of my lips were swelling and my eyelids were swelling  and I felt like I needed to cough. I called the doctor and she told me to go to ER - Thursday, the 15th. I did. They gave me: Epi shot - IV with Benadryl,  steroids, and Pepcid. I was there for about 3 hours. Everything worked with my reaction.  Epi -Pen prescription; More steroids, Benadryl and Pepcid and I have been taking this through today (today is my last day of the  steroids - I have two days of Benadryl left). My face is cleared up now, it's still super dry. I still have the rash all over my body. It looks like I rolled around in a fire ant hill.  I was told to carry the Epi-Pen with me for two weeks.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 64-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 03-JAN-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
1/26/21 @ 10:05 am:Received 1st Moderna dose Left Deltoid area. Returned to my office at HSH and at 11:55 am left arm at site of vaccine tender and I became very tired. At 1:30 pm I began to have slight chills that lasted maybe an hour. The pain in my arm progressed and by night my arm was very sore. I could not sleep on my left side. 1/27/21 at 5:00 am I woke up and was still in pain. I could not even put the slightest amount of pressure/touch at the site of injection. At 5:04 am I texted my boss that I would not be in. I felt very fatigued the entire day and my arm and left side of my body was sore. I couldn't flex my deltoid and the muscles in my upper arm hurt. My deltoid was also swollen. 1/28/21 I woke up at 4:30 am and my arm was still sore. My index finger of my left had had pain in my joints and I could not bend my finger without pain. I took Motrin 600 mg and that helped a little. Over the next couple of days then pain at site and in my arm got better but my right index finger was still sore in the joint areas. On 2/2/21 I noticed there was in induration area of approximately 1/4" at the site as well as below the site. There was also slight bruising. My arm was still a little swollen and it was warm to touch. On 2/3/21 the vaccination site became itchy.As of today 2/5/21 I no longer feel pain or itching in my arm. My index finger is still a little tender when flexing and I still have some malaise.
pt recvd vax & exp leukopenia, anemia, elevated liver function tests, fatigue, nausea, body aches (mainly joints), swelling in hands, lt flank pain, abdo tenderness, constipation, petechial rash; 1JUN94 acute hepatitis;
rash warped into a large welt, which was 4 inches long and 3 inches wide; tenderness around the injection site; itchiness below the injection site; swelling below the injection site; rash at the injection site; headaches; mild fatigue; arm redness; This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA (arm redness), URTICARIA (rash warped into a large welt, which was 4 inches long and 3 inches wide), TENDERNESS (tenderness around the injection site), VACCINATION SITE PRURITUS (itchiness below the injection site) and VACCINATION SITE SWELLING (swelling below the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced ERYTHEMA (arm redness), TENDERNESS (tenderness around the injection site), VACCINATION SITE PRURITUS (itchiness below the injection site), VACCINATION SITE SWELLING (swelling below the injection site), VACCINATION SITE RASH (rash at the injection site), HEADACHE (headaches) and FATIGUE (mild fatigue). On 19-Feb-2021, the patient experienced URTICARIA (rash warped into a large welt, which was 4 inches long and 3 inches wide). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE (topical) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (arm redness), URTICARIA (rash warped into a large welt, which was 4 inches long and 3 inches wide), TENDERNESS (tenderness around the injection site), VACCINATION SITE PRURITUS (itchiness below the injection site), VACCINATION SITE SWELLING (swelling below the injection site), VACCINATION SITE RASH (rash at the injection site), HEADACHE (headaches) and FATIGUE (mild fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Tested Positive for COVID-19; I got sick; This is a spontaneous report from a contactable consumer (patient). A 53-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 08:30 (Batch/Lot Number: ER8730) as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient stated that she got her Pfizer shot on 31Mar2021. She got sick (unknown date in 2021) after she got the shot and tested (Covid) positive on 06Apr2021. On 06Apr2021 the patient underwent lab tests and procedures which included chest x-ray: normal, covid-19: positive, sars-cov-2 test: positive. Therapeutic measures were taken as a result of tested positive for covid-19 (covid-19). No treatment received for the event sick. The outcome of events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Pt had flu vaccine on 9/29/23 at Left Deltoid. Pt developed reactions a few hours after vaccination. Initially swelling, redness, itching, and warm to touch on the left deltoid. Denies discharges. No fever. Pt still continues to experience itchiness and swelling at the injection site. Pt aware and watch for any signs of infection and worsening of symptoms. Pt is aware to follow up with her physician of choice for any worsening of symptoms.
Extreme tiredness, nausea(left work early April 2nd due to tiredness)  Leg muscles continue to be sore and stiff.  Taking Tylenol and Ibprohen.  Called my doctor and told my symptoms were normal and nothing else was offered to help with the pain.
55mm x 45mm raised erythemic localized reaction, hot to touch noted 2 days post vaccine (to left deltoid area). Adv: Advil, cool compresses, report reaction to PMD. C/o "itching but no pain at site". Gone in 5 days.
Patient had a syncopal event approximately 20 minutes following his first dose of vaccine. The patient's wife reports that the patient has similar events with previous injections. As the injection was given at a vaccination clinic, patient was evaluated by onsite healthcare professionals while EMS was called. Patient was transferred to local ED for observation and was released home late the same day with a discharge diagnosis of syncope.
Anterior cervical LA tenderness, nausea, head swimming, back and L side pain, fatigue, B sub-mandibular LA ?? palpitation. Motrin with tylenol; quarters X 48 hrs.
Pain and tingling in arms and feet, numbness, nummular lesions over entire body with scaling, itching and pain. Treated with prescription steroids and triamcinolone acetonide cream over several months.
swelling pain of both knees. 4/13/09 MR and vax info received from PCP.  In for 14 yr WCC with normal exam 11/11/08. Vax given.  Returned 12/22/08 with c/o several day hx of cough, runny nose, ear pain, chest congestion and sore throat.  PE (+) for red throat, stuffy nose, few small nodes. Assess:  Asthma.  Pharyngitis. Returned 2/12/09 with c/o sore throat and cough, H/A, presyncope.  PE (+) for T=101.5'F, nasal congestion, pharyngeal erythema, shiners.  Assess:  Sinusitis.  Fever.  Pharyngitis.  Returned 2/17/09 with same c/o as 2/12/09.  Additionally, back pain with coughing. PE (+) for red throat, few nodes and stuffy nose. Sent for CXR. Assess:  Asthma.  Returned 3/30/09 with c/o knee pain and swelling x 5 months. No injury other than foot injury prior to that. PE (+) for swollen knees with fluid in joints. Assess:  joint pain and swelling.
Broke out with a case of shingles 3 days after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Broke out with a case of shingles 3 days after vaccine) 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 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HERPES ZOSTER (Broke out with a case of shingles 3 days after vaccine) (seriousness criterion medically significant). At the time of the report, HERPES ZOSTER (Broke out with a case of shingles 3 days after vaccine) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
I developed shingles starting at the injection site and then lower on my arm as well as my wrist and shoulder. I treated it with Advil and calamine lotion. It took 2 weeks for the pain to resolve and the final marks are now fading.
1 cm erythematous and excoriated lesion involving epidermis at location of flu vaccination
A large indentation appeared at site of injection. The indentation is the size of half of an orange, dipped inward in my right buttock. Additionally had menstrual disturbances, severe depression, mood swings, memory loss, hair growth and weight loss and loss of appetite.
weakness; hurt all over; sick to her stomach; hot, feels like she is on fire; cold; nausea; drained; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), PAIN (hurt all over), ABDOMINAL DISCOMFORT (sick to her stomach), FEELING HOT (hot, feels like she is on fire) and FEELING COLD (cold) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), PAIN (hurt all over), ABDOMINAL DISCOMFORT (sick to her stomach), FEELING HOT (hot, feels like she is on fire), FEELING COLD (cold), NAUSEA (nausea) and FATIGUE (drained). At the time of the report, ASTHENIA (weakness), PAIN (hurt all over), ABDOMINAL DISCOMFORT (sick to her stomach), FEELING HOT (hot, feels like she is on fire), FEELING COLD (cold), NAUSEA (nausea) and FATIGUE (drained) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medicines was not reported by reporter   treatment information was not provided    Action taken with mRNA-1273 in response to the events was not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments
Information has been received from a nurse concerning a 4 month old patient who on an unspecified date was vaccinated with the second dose of ROTATEQ (lot number not reported). The infant vomited a few minutes after vaccination. The patient also received other routine unnamed vaccinations. Unspecified medical attention was sought. The outcome of the patient was not reported. Additional information has been requested.
Heplisav-B Administered to 5 month old; Initial Report Received on 17-May-2023  A registered pharmacist reported that a 5-month-old patient (gender, race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history, allergies, and medications at the time of vaccination were not reported.   On 17-May-2023, a 5-month-old patient received a dose of HEPLISAV-B vaccine (Lot # 939305, expiration date 29-Mar-2024, and NDC # 43528-003-05) intramuscularly in the leg (unknown if right or left) by a nurse. No adverse side effects were reported at the time of reporting.  No further information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Headache-left side above ear and near temple-throbbing pain-two acetaminophen 500 mg 3xs a day since 2/26/21 for pain.  tiredness
pt recv vax 28JAN98 & that same day pt deltoid was inflamed & warm to touch below the inj site;
Patient fainted and was dizzy within a few minutes of getting the vaccine (Janssen), patient was alert. Made the patient comfortable and helped to keep her cool, with an ice pack, as the pharmacist I spoke with her and did not see any signs of swelling.  There was no loss of conscienceness and 911 was called with the ambulance coming to escort the patient. A follow up call was made the following day and the patient was doing fine.
progressive swelling, soreness, pink over approx  40h, starting around 1pm friday?eventually covered from shoulder to elbow and approx 80% arm circumference?by early sunday am, it started to improve. early in the week (mon? tues?) noted axillary discomfort, same side as inj. also fatigue that is slowly improving.  never had fever or chills i took 2 aleve q12h sat and sunday. i used cold compresses approx q4h sunday and monday am i elevated the arm on a pillow during sleep x approx 5-6 days saw primary care provider on thurs oct 13?there was residual swelling at the elbow and inj site, also axillary lymph node swelling at that time since that appointment i started using heat periodically thru the days and trying to use the arm normally as instructed  as of today, monday oct 17, there remains residual puffiness at the medial elbow, soreness/swelling at the site and ongoing unusual tiredness but am able to do what i need to do.
The patient reported a "lupus-like" rash on her face after receiving the vaccine. She described her face as very red, swollen, puffy, and pimply but not itchy. She also stated that the rash was worse on the left side of her face than the right side. She also stated that she had a sick stomach, diarrhea, and drowsiness on the first day after the vaccine. She stated that she is feeling much better now other than the rash on her face that has not gone away. The patient stated that she had a history of anaphylaxis in the past, but the doctors were never able to determine the cause.
Limited ability to move or raise arm, severe headache, chills, body aches, swelling in arm, brain fog, fever. Symptoms slowly resolved started 3 days after vaccination.
rheumatoid arthritis flares after both covid vaccines; This is a spontaneous report received from Pfizer sponsored program. A contactable other HCP and consumer reported that a 57-year-old female patient received first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration, on an unknown date in Apr2021 as a single dose for COVID-19 immunization. Medical history included ongoing rheumatoid arthritis. The patient's concomitant medications were not reported. On an unknown date in Apr2021 patient's rheumatoid arthritis flares, after both COVID vaccines, with some improvement noted. Patient required oral steroids post first COVID vaccine and MD administered steroid injection post second COVID injection. The outcome of event was recovering.  Information on the Lot/Batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event "Rheumatoid arthritis flare up " and the suspected vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Pfizer-BioNTech COVID-19 Vaccine EUA: four months after completing immunization patient hospitalized for breakthrough COVID-19 infection and heart failure exacerbation. COVID-19 managed with dexamethasone, COVID-19 MAB, and remdesivir. Discharged to home medically stable.
Pharmacist calling requesting data on the administration of 3 doses of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Pharmacist calling requesting data on the administration of 3 doses of Shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt date: 02-NOV-2023 The pharmacist requested data on the administration of 3 doses of Shingrix.  She stated that she believed some years back a patient may had received a 3rd dose of Shingrix, but was not totally certain. The health care professional (HCP) had no additional details regarding the event. Declined follow up as she could not remember all the details of the event. The patient received 3rd dose of Shingrix, which led to extra dose administered.
PATIENT HAD THE FIRST TWO DOSE SERIES OF MODERNA VACCINE IN THE PAST. TODAY PATIENT RECIVED THE PFIZER BOOSTER DOSE.
Moderna 2/24/21, 3/25/21. Pfizer 11/19/21. Positive on 9/26/22
My vaccine was at 2pm, that night I woke up around 4am with a fever; chills; headache; sore arm; This is a spontaneous report from a contactable Other HCP.A 30-years-old female patient (non-pregnant) received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot noEL3247, Expiration date: unknown), via an unspecified route of administration in left arm on 10-FEB-2021 14:00 at single dose for COVID-19 immunization. Patient previously took first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot no. EL3247, Expiration date: unknown), via an unspecified route of administration in left arm on 22Jan2021 11:00 AM at single dose for COVID-19 immunization. Concomitant medication were not reported. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. The patient not-receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies.On 11Feb2021 at 03:00 AM patient experienced fever, chills, headache and sore arm. The outcome of the events was recovering.
After the patient received the vaccine at 8:20 PM, she felt unwell and returned to the pharmacy with shortness of breath and shakiness. 911 was called and they arrived within 10-12 minutes of the incident. The patient was found to have elevated blood pressure and the patient was taken into the ambulance to have an EKG done. The patient had a BP of 202/101 mm Hg and refused to go to the hospital. She waited on family to pick her up. This morning, I called the patient to follow up on how she was feeling and she was doing well. She stated her BP remained elevated at 170/unknown mm Hg on 11/23, however this morning (11/24) her BP was 144/70 mm Hg. She states she is feeling fine and has no other complaints with the pharmacy or myself.
Mother said large tender, warm area on right thigh 7 days after vaccine given. Mother noted area had become black but improved. Pt c/o pain. Mother stated fever. BACTRIM given in ER 10-29-13. Rash on thigh progressed to torso; pt cheeks red - seen 10-30-13 by PCP. Mom described on and off fever, of 102 degrees F at that time. BACTRIM d/c'd 10-31-13. TYLENOL and BENADRYL recommended. CBC, blood cultures and UA done. Waiting to redraw WBC.
This spontaneous report was received from a certified medical assistant regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored VAQTA lot # L032749/ expiration date- 04-NOV-2016, lot # L026600/ expiration date- 15-MAR-2017 (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. Temperature excursion and time frame was 49F for 143 hours and 34F for 24 hours. There was no previous temperature excursion and call was not because of a data logger. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Gave the shot and soon after it swelled up and became hard. The patient also noted some itching and feeling of warmth. Told her to put on some ice and see how it looks. She waited in the store for 15 to 25 minutes with no other symptoms to note. I told her if anything else happens to see PCP/urgent care or ER.