chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Allergic reaction; swelling in his trunk; web-like rash; This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number B4527, expiry date 2nd May 2022) for prophylaxis.   On 2nd September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced allergic reaction, swelling and rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the allergic reaction was unknown and the outcome of the swelling and rash were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix. The reporter considered the swelling and rash to be related to Shingrix.  Additional details were provided as follows: The patient had 1st dose of Shingrix 0.5 ml (intramuscular) in unknown deltoid. After receiving 1st dose of Shingrix, the patient experienced web-like rash and swelling on his trunk. The reporter was a pharmacist at a pharmacy. The reporter said the patient was advised to take oral Benadryl. On 12th October 2020, patient woke up and still has the same problem and he dose not want to keep taking Benadryl. He states he was calling to report an allergic reaction. The patient indicated that he was going to see his doctor and that he was not going to receive the 2nd dose of the series. The patient indicated that if he had known this was going to happen he would not have gotten the first dose and that he wants compensation because this has been going on now for more than one month. The reporter said he did not ask the pharmacist for the patient's MD contact information. The reporter consent to follow up.
On 5/18/15, 72 yo F was seen in clinic for follow-up visit. During this visit, pt was ordered to receive TDaP vaccine. At 1120, pt was administered 0.5 mL in right deltoid. After injection, pt developed abnormal swelling at the injection site. Nurse manager and MD were notified and ice was applied to the affected area. Pt was evaluated and reported itching and slight tongue swelling. Pt was ordered and administered diphenhydramine 50 mg IV. Pt was monitored with noted improvement in symptoms. Pt was then discharged in stable condition.
From charting for point of care services before EMS transport:    Chief Complaint: Immunization Visit: Client received Pfizer Vaccine at 11:30am. At 11:32 am client reports "throat feels a little funny" and Chest tightness.  No difficulty breathing reported. Lung sounds clear bilaterally per RN at 11:38am. Pt reports that her throat still feels funny after administration of benadryl by RN. Epi was administered at 11:40am by RN. EMS arrived at 11:42am. Client has is now complaining of jaw pain. Reports shoulder pain ( residual from recent accident). Vital signs obtained by RN Her husband was present when EMS arrived and will follow client to the hospital.
This case was reported by a physician via sales rep and described the occurrence of Bell's palsy in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced Bell's palsy (serious criteria GSK medically significant), fever and rash. On an unknown date, the outcome of the Bell's palsy was unknown and the outcome of the fever and rash were recovering/resolving. It was unknown if the reporter considered the Bell's palsy, fever and rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. After vaccination with SHINGRIX, the patient spiked with a high fever and presented Bell's Palsy on injection side of the body. The patient also had a small rash on head. The patient was tested for Zoster and test was showed to be negative. The patient was treated with antibiotics. Lab Comments: The patient did laboratory test on an unknown date.
The next day after my second vaccine I developed a red rash under my injection site. It is where my first vaccine was administered. Throughout the day it grew in size and became itchy.
Within five minutes of vaccines being given client fainted.  She had some twitching and very shallow breathing- after a minute or two she was wide awake.
Patient stood up and walked around corner and started complaining about trouble breathing, had patient sit down and continued to complain of trouble breathing, face started getting red.  Called 911 gave patient epipen and started feeling better. EMS came and took patient to hospital.
I had a headache that started the next day. It didn't go away for a month. Three to 4 weeks after the vaccine, I started developing muscle pain and stiffness and that did not go away. I felt like I had tender lymph nodes and fatigue. In May, I went back to my doctor. He wanted to test me for polymyalgia rheumatica. He started me on prednisone and had complete resolution of my symptoms within 48 hours. I tapered off prednisone gradually and discontinued it in September of 2021. My symptoms reoccurred. I restarted prednisone on 02/22/2022 and I'm currently symptom free on prednisone.
The patient complained that he had a headache, dizziness, and he felt agitated. The patient was better when seen at around 8 PM on the same day.
This spontaneous report as received from a registered nurse refers to a 44 year old female patient. The patient was vaccinated with 0.5 ml VARIVAX (merck) (route of administration and lot number unknown) in October 2012. No other co-suspects were reported. No concomitant medications were taken. The patient has no pertinent medical history and no drug reactions/allergies. In October 2012 the patient developed a rash consisting of 13 lesions on her thigh and hips subsequent to the vaccination. The patient sought unspecified medical attention. No treatment was given for the event. No lab/diagnostic studies were performed. The outcome of rash consisting of 13 lesions on the thigh and hips was reported as recovering. The relatedness for rash consisting of 13 lesions on the thigh and hips is unknown for VARIVAX (Merck).
Pt experienced significant erythema, induration after TD vaccine, 2 1/4 x 3" area. Treated with ice, Benadryl.
couldn't get her 2nd booster, because she had shingles; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HERPES ZOSTER (couldn't get her 2nd booster, because she had shingles) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (couldn't get her 2nd booster, because she had shingles). At the time of the report, HERPES ZOSTER (couldn't get her 2nd booster, because she had shingles) had resolved.            No concomitant medications were reported.  Patient received the first and second dose of Moderna vaccine on an unknown date.  Patient daughter reported that the patient couldn't get her 2nd booster, because she had shingles. They wouldn't give it to her, because of that.  No treatment details were reported.
chills; achiness; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 25Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 Immunisation. The following information was reported: CHILLS (non-serious) with onset 26Mar2021, outcome "unknown", described as "chills"; PAIN (non-serious) with onset 26Mar2021, outcome "unknown", described as "achiness". Additional information: Patient denies having any symptoms except some chills and achiness the day after receiving the second dose. Patient asks if having been exposed to covid will change how the vaccine works or if the patient needs to repeat the dose. Patient has not tested positive for covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Developed Tinnitus and the ringing making me crawl out of my skin, Its full time. Went to an ENT and he said there is nothing that can be done. I never had Tinnitus until the day after I got the Vaccine
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old male patient received BNT162b2 (BNT162B2), on 15Nov2021 as dose 3 (booster), single (Lot number: 330308D) at the age of 26 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. No known allergies were reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient did not receive other vaccine in 2 weeks. Patient had no known allergies. COVID 19 Treatment with Paxlovid was started from 24May2022 to 29May2022.
Pt is diabetic - blood sugar dropped very low for 3-4 days. Mom state gets worse with every dose of this vaccine.
received a dose reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA721A, expiry date 30th September 2023) for prophylaxis.   On 23rd August 2022, the patient received Menveo. On 23rd August 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 24-AUG-2022 Reporter's Comments: The medical assistant reported that the patient received a dose of Menveo incorrectly reconstituted with sterile water. No symptoms were reported. The patient were twins. The reporter consented to follow up by email. Additional supportive information: The patient received a dose of Menveo incorrectly reconstituted with sterile water, which led to wrong solution used in drug reconstitution. This case was linked with case US2022123184 reported by same reporter.; Sender's Comments:  US-GSK-US2022123186:Same reporter
Area where the vaccine was administered is sore; Big red circle that is the size of a baseball; Area where the vaccine was administered is itchy; Arm was little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Area where the vaccine was administered is sore), VACCINATION SITE ERYTHEMA (Big red circle that is the size of a baseball), VACCINATION SITE PRURITUS (Area where the vaccine was administered is itchy) and PAIN IN EXTREMITY (Arm was little sore) 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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (Arm was little sore). On 24-Jan-2021, the patient experienced VACCINATION SITE PAIN (Area where the vaccine was administered is sore), VACCINATION SITE ERYTHEMA (Big red circle that is the size of a baseball) and VACCINATION SITE PRURITUS (Area where the vaccine was administered is itchy). At the time of the report, VACCINATION SITE PAIN (Area where the vaccine was administered is sore), VACCINATION SITE ERYTHEMA (Big red circle that is the size of a baseball), VACCINATION SITE PRURITUS (Area where the vaccine was administered is itchy) and PAIN IN EXTREMITY (Arm was little sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and Treatment medications were not provided by reporter.   Reporter did not allow further contact
9/5/21: had profuse vomit , headache , backaches  9/18/21: profuse diarrhea and severe headache for 24 hrs  10/15/21: Started to bleed profusely , vaginally, with severe cramping that went on for 3 days. OBGYN did ultrasound and found 3cm ovarian cyst. I?ve never had complications with profuse bleeding or cysts and this was 2 weeks after 2nd vaccine dose
Immediate itching and hives. Progressed quickly into anaphylaxis - stridor, difficulty breathing. Taken immedietly to ER, O2 sats observed of 84%. Given IM Epi in ER triage area.  Brought back to room, racemic epi started and given additional IM dose. Please refer to ED for further treatment.
After taking the vaccine, I didn't have any symptoms. The next day, my arm got a little sore later on in the day. That day at night, I started to feel a little headache. The next day after that, I started to get a little fever and a little headache. After that, everyday I was getting a headache and a fever for over a week. I went to the hospital and they said I had covid.
See ER notes attached.  11/27/07 Reviewed autopsy report which states COD as encephalomyelitis due to enterovirus (EV 71) & manner of death as natural. States history as: found supine in crib, unresponsive; no recent illness; no previous medical history;brain swelling; SDH, minimal; SAH, bilateral; microglial clusters, neuronal loss, neuronophagia & mild perivascular lymphocytic infiltrate w/gliosis in keeping with a viral poliomyelitis.
This spontaneous report received from a pharmacist refers to a patient of unknown age and gender. On 19-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # H009826, expiration date: 11-FEB-2014), 0.5 ml. There was no concomitant medication reported. The patient received an expired dose of PNEUMOVAX 23. No symptoms were reported. No product quality complaint (PQC) was reported. Additional information has been requested.
gout flared up, both knees; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (gout flared up, both knees) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 088D21A) for COVID-19 vaccination.     The patient had no known allergies.  Concurrent medical conditions included Borderline diabetes.   On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GOUT (gout flared up, both knees). The patient was treated with INDOMETHACIN [INDOMETACIN] for Gout flare, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Gout flare, at an unspecified dose and frequency. At the time of the report, GOUT (gout flared up, both knees) outcome was unknown.            Concomitant medication of the patient was not reported.   This case was linked to MOD-2021-323228 (Patient Link).
rash on forearm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on forearm) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided.).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rash on forearm). At the time of the report, RASH (rash on forearm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-034842 (Patient Link).
Immediately: Fever, extreme fatigue, joint pain Continued: Extreme fatigue, joint pain, chest pain
PFIZER-BIONTECH COVID-19 VACCINE EUA.  Administration error:  Patient presented for Pfizer vaccine with consent form stating no previous doses of vaccine.  Patient received what was believed to be 1st and 2nd doses on 3/31/21 and 4/21/21 respectively. It was just discovered that patient received a 1st dose of the same brand at a pharmacy on 1/25/21. No adverse events reported to date.
Left lower extremity sciatica came on gradually beginning Dec 31, 2020.  Symptoms worsened requiring hospitalization on January 11, 2021.  MR Lumbar spine demonstrated a stable mild disc bulge left paracentral at L5S1 unchanged from 2013.
Very rapid heart beat, trouble catching my breath, high fever 102.0 headache and body aches. I took Aleve and Mucinex and a left over anti biotic. I finally felt better and could move around approximately 4 days later.
Tiredness; Diarrhea; Not feeling well; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the right arm on 06Jul2021 at 09:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included type II diabetes and cardio vascular disease. The patient had unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 08Jul2021, the patient experienced tiredness, diarrhea and did not feel well. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events tiredness, diarrhea and not feeling well was not resolved at the time of this report.
No adverse side effects at this time. Client is 11 years old. Pfizer is approved for 12 years and older. Vaccine administered in error.
mild ache at the needle site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "mild ache at the needle site".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
COVID breakthrough. Routine testing upon presenting for childbirth. COVID+ 4/4/22 asymptomatic.
Got shingles with first vacine.; Bad; Nerve damage; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles, feeling bad and nerve damage. On an unknown date, the outcome of the shingles, feeling bad and nerve damage were unknown.   It was unknown if the reporter considered the shingles, feeling bad and nerve damage to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient experienced shingles, nerve damage and felt bad after first dose of Shingles vaccine. The patient went back and got updated second shot. The follow-up would not possible, as no contact details were available.
Information has been received from a registered nurse concerning a 33 year old female who on 24 JUL 2001 was vaccinated with Hepatitis B vaccine recombinant (yeast) 1 ml intramuscularly. On 25 JUL 2001 the patient developed soreness at the injection site. The patient stated that she cannot lift the affected arm all the way up and the arm feels heavy. Unspecified medical attention was sought. Additional information has been requested.
Pt started with pain in arm early AM day prior to shot. Small area (about pencil eraser size) at site of injection. Pain increased throughout day & was unable to touch/move arm. Area at site increased in size to thumbnail by 600 pm. By 730 was upper arm & welting & tracking down & around arm given Prednisone 60 mg & Lortab ER.
Dizziness and balance issues.  Numbness in my feet. I have not taken my BP in two days as I thought that it may caused my dizziness.
My left arm where the shot was given has swelled up.  I looked it up and apparently it?s called ?Covid arm? an allergic reaction. I?m no expert though. That?s just what I found.
Rashes and hives with the booster dose; Rashes and hives with the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes and hives with the booster dose) and URTICARIA (Rashes and hives with the booster dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis.    No Medical History information was reported.   On 05-Jan-2022, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rashes and hives with the booster dose) and URTICARIA (Rashes and hives with the booster dose). At the time of the report, RASH (Rashes and hives with the booster dose) and URTICARIA (Rashes and hives with the booster dose) outcome was unknown.            Concomitant medication was not provided.  It was stated that one twin was fine and other twin had rashes two days after the vaccine. Stated that on 07 Jan or 08 Jan 2022 that he had rashes on his body and tummy. Stated that he got itchy legs and had rashes in middle of night and applied coconut oil. Stated that he was itchy because of the weather. Stated that he was in the cold and snow and two the three hours later his son showed him some rashes and he thought maybe the temperature could be causing the itchiness. Stated that later in the night that his hands and legs were itchy and it went away. Stated that there were patches which were itchy also. Stated that the rash on his body subsided in 8-10 hours. Stated that the rash on his legs subsided in a couple of hours. Stated that the rash on his tummy and back started first and subsided the same day. Stated that he had Covid testing before the vaccine on 29-Dec-2021 or 30-Dec-2021. Later clarified that it was Pfizer Pediatric Covid vaccine received by one of the twin.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in