chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired dose was administered, with no AE; Initial information received on 14-Apr-2021 regarding an unsolicited valid  non-serious case from a nurse.  This case involves a 3 years old male patient who was given an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (fifth dose, frequency: once, strength: standard, lot C5611BA and expiration date: 03-Apr-2021) via intramuscular route in an unknown administration site for prophylactic vaccination on 13-Apr-2021 (expired product administered).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No concomitant medication were given.  It was a case of an actual medication error due to expired vaccine used (same day latency).  Nurse asks for follow-up information after expired product was administered and reports potential adverse event. Nurse stated she thinks this may have already been reported but no other report found.  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.
I had a severe anaphylactic reaction; This is a spontaneous report from a contactable consumer, the patient. A 43-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, administered in the left arm on 24Mar2021 at 10:30 as a single dose for COVID-19 immunisation. There was no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included ibuprofen taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 at 23:15, the patient experienced a severe anaphylactic reaction, with swallowing difficult, hives, significant swelling of the face, very puffy and watery eyes, and significant swelling in the throat and uvula that made breathing and swallowing difficult. The patient went to the emergency room (ER) and received epinephrine, prednisone, and a large dose of intravenous (IV) diphenhydramine (BENADRYL). Clinical outcome of the event severe anaphylactic reaction was recovering.  Information on about lot/batch number has been requested.
ADMINISTRATION OF VACCINE 33 MINUTES AFTER THE RECOMMENDED STORAGE TIME; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a 51 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027 expiry: 29-SEP-2021) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-SEP-2021, the patient experienced administration of vaccine 33 minutes after the recommended storage time. On 02-SEP-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine 33 minutes after the recommended storage time and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210905816 and 20210906551.
This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (injection site hurt), vaccination site pruritus (site started to itch) and vaccination site erythema (it was red (1.5")) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 025J202A) for COVID-19 immunization. No medical history reported. On Jan 10, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 10, 2021, patient experienced vaccination site pain (injection site hurt). On Jan 13, 2021, patient experienced vaccination site pruritus (site started to itch) and vaccination site erythema (it was red (1.5")). The patient treated with Advil (ibuprofen) on Jan 11, 2021 for vaccination site pain, at an unspecified dose and frequency. On Jan 11, 2021, vaccination site pain (injection site hurt) resolved. On Jan 15, 2021, vaccination site pruritus (site started to itch) and vaccination site erythema (it was red (1.5")) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant medications not provided.
pt recvd vax & when they got home pt was trembling & shaking all over-sleeping but is arousable-cries & goes back to sleep-skin cold to touch;inst mom to tak pt to ER:adm to hosp w/resp distress, fever
CONSTIPATION; STOMACH CRAMPS; ABDOMINAL PAIN; TROUBLE DEFECATING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included Hashimoto's disease. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced trouble defecating. On 28-APR-2021, the subject experienced constipation. On 28-APR-2021, the subject experienced stomach cramps. On 28-APR-2021, the subject experienced abdominal pain. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from stomach cramps, abdominal pain, and constipation, and the outcome of trouble defecating was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Extremely dizzy; A lot of body rashes; Some fever; aching/ pain all over his bod/ Severe body aches; Tired; First night didn't sleep at all; itching on both ears, itching on the back of neck, itching on left arm, itching behind both knees.; This is a spontaneous report from a contactable nurse and a consumer(patient). A 73-year-old male patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6208; Expiration Date: 08Mar2022), via an unspecified route of administration, administered in Arm Left on 18Mar2021 10:00 at the age of 73-year-old as dose 2, single for covid-19 immunisation.  Medical history included covid-19 from Oct2020 to an unknown date. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine The patient previously received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6203), via an unspecified route of administration, administered in Arm Left on 26Feb2021 at the age of 73-year-old as dose 1, single for covid-19 immunisation and had Itching on both ears, back of neck, left arm and behind both knees. Patient did not visits emergency room or physician office in response to the event. On 18Mar2021 after receiving second dose of Vaccine he experienced aching, and tired, and the first night didn't sleep at all. Patient says he didn't sleep the day after he was achy, tired, and pain all over his body. Husband says he currently has itching on both ears, itching on the back of neck, itching on left arm, itching behind both knees. Patient also experienced severe body aches, some fever, extremely dizzy, a lot of body rashes. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Received vaccine at about 3 pm, 6 hours later began having redness, swelling and pain at the site of the injection as well as episodes of urticaria (hives) that would come and go. Saw the patient in clinic 4 days later and still was having symptoms. Had induration approximately 1.5 cm at injection site and 2 rings of erythema and swelling 8 cm diameter and 12 cm diameter around injection site. No hives seen at time of the appointment, but reported there earlier that day.
on the 04/14 I started feeling pretty bad at home, I tested positive for covid because my daughter had tested positive on the 04/12. by the 04/16 I was sick short or breathe , coughing  telehealth call on 04/17 was prescribed an inhaler  by the 04/21 I was coughing uncontrollably  I felt like I had a cold called my doctor he told me to wait it out on the 04/24 I wasn't feeling better went to the er I couldn't breathe short of breathe walking short distances, I was released on the 04/27 and I was diagnosed with covid phenonium  hospital I had to go to  05/15 was re admitted to hospital for chest pain and I was having problems breathing
experiencing like its weird like a sac of fluid underneath in the arm pit / in the arm pit is where I feel like just extra fluid; I have like an extra skin; like a swollen lymph node; little sore to touch; My first dose of the COVID-19 Vaccine was Modern and then for the booster I got Pfizer; My first dose of the COVID-19 Vaccine was Modern and then for the booster I got Pfizer; booster I got Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 09:45 (Lot number: PAA173396) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Modern (First dose , Lot #:043LZ, I really don't know if it's 0, looks like 0A), for COVID-19 Immunization; Moderna (Second dose: , Lot: 004M20A), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 13Nov2021, outcome "unknown" and all described as "My first dose of the COVID-19 Vaccine was Modern and then for the booster I got Pfizer"; IMMUNISATION (non-serious) with onset 13Nov2021, outcome "unknown", described as "booster I got Pfizer"; BLISTER (non-serious) with onset 14Nov2021, outcome "not recovered", described as "experiencing like its weird like a sac of fluid underneath in the arm pit / in the arm pit is where I feel like just extra fluid"; SKIN DISORDER (non-serious) with onset 14Nov2021, outcome "not recovered", described as "I have like an extra skin"; LYMPHADENOPATHY (non-serious) with onset 14Nov2021, outcome "not recovered", described as "like a swollen lymph node"; PAIN (non-serious) with onset 14Nov2021, outcome "not recovered", described as "little sore to touch". Therapeutic measures were taken as a result of blister, skin disorder, lymphadenopathy, pain. Additional Information:- No prior vaccination (4 weeks), patient received treatment Advil. Follow-up attempts are completed. No further information is expected.
8-10 hours, post vax, child with fever and vomiting. 18-24 hours, post vax, mother reported child was listless, fever of 104F but vomiting had resolved. Child would awaken when aroused but otherwise, sleeping or lying down. Child not eating but drinking fluids.
5 cm slightly tender, slightly warm nonfluctant mass at injection site in L deltoid, unchanged in size and sxs x 6 days. 24 hour hx of erythema and increased warmth surrounding mass, suggestive of cellulitis. No axillary adenopathy, other sxs.
Initial unsolicited report received from consumer (patient's mother) via social media on 22 August 2016. This case is linked with case 2016SA157319 and 2016SA157340 (same social medica report). This case involves a 30-month-old (reported as 2 and half year old) male patient who was vaccinated with a fourth dose of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) (DPT) (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. Patient's ongoing illness, medical history and concomitant medications were not reported. On an unspecified date, within 6 hours of receiving the shot, patient went into a state of developed encephalopathy and then became unconscious. It was reported that patient was a gifted child, he was speaking full sentences, knew his alphabet and numbers. After receiving the shot he did not. On an unspecified date, patient developed multiple learning disabilities and had permanent brain damage. Laboratory investigations and corrective treatment were not reported. The outcomes of the events were not reported. Upon internal review, the company decided to consider the event serious because of important medical events encephalopathy, unconscious, multiple learning disabilities and permanent brain damage. List of documents held by sender: none. Sender's Comments: This is very poorly documented social medical case where patient had encephalopathy, unconscious, multiple learning disabilities and permanent brain damage after administration of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) (Unknown manufacturer). However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Patient fainted several minutes after receiving both vaccinations.  She turned pale and fainted for a couple minutes. She was fine after we rehydrated her with orange juice.
I believe my daughter was exposed to COVID-19 at camp where not everyone was masked. She came down with a high fever on 07/07/2022 but tested negative for COVID-19 with an at home test. That night she was coughing throughout the night so I retested her the next day and the results were positive. Her fever got up to 103. I reached out to her doctor who advised to give her cough syrup and to treat her fever with over the counter medication. Her fever went away for a few days by 07/12 but returned a few days later so I spoke with her pediatrician again who thought that she may have exposed to a secondary virus. At this point on 7/18/22 she is still running mild fevers at around 99 degrees.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided No treatment details were provided. The vial was initially stored in the refrigerator on 14Oct2021.  No adverse event was reported by the patient.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow up received on 12-NOV-2021 contains significant information and updated in the narrative.
I started getting migraines in August 2021. I was having some blood sugar problems as well and shortness of breath. I went to a doctor's appointment and they discovered some gastritis pain. They sent me for a CT scan and they discovered some tumors in my adrenal gland and 1 in my pelvic area. Then, my Dr. called me back to her office to inform me that I had cancer. I then was scheduled for a PET scan and an MRI. She told me if I had any additional pain to go to the E.R ad I did and they discovered 2 masses on my left lung. At my PET Scan and MRI, they discovered that I had 4 tumors in my brain and in my right ankle. I met with my Oncologist and she they have ruled out melanoma and they believe that it is non small cell lung cancer. I have had 5 radiation treatment on my brain at this time. I am still going through this at this time.
06/24/2021 Dizzy, light headed, muscle aches, bone aches, headaches (not migraine stage headache), loss of taste, loss of smell, concentration off bad,  felt like I was having a seizure inside,  my personality changed from being  a fun loving  happy person to just living (not having fun or making people laugh like I normally do).  06/29/2021 Went for a Covid test at Pharmacy. Work sent me do to still not filling well at all. Still had all those symptoms. Called My doctor office, Nurse told me that it was normal to feel this way after vaccine to give it a week.  Covid test was negative. 07/19/2021 Called Medical Center again because my symptoms never went away. Ordered blood work had done at Medical center. 07/22/2021 Seen for results everything looked good. She ordered more blood work and told me to start 12 day therapy step of Prednisone 10mg after bloodwork. Prednisone has helped with muscle and bone aches except for on 7/30/21 i hurt all over that day. Was a really bad day. 08/02/2021 CDC called me told me to fill out this form. 08/03/2021 as of now I still have everything going on but not aches or pains.  Last day of prednisone.  I had to leave work a couple of times to do these symptoms. Which I loss pay on.  I may be missing somethings because of my concentration being way off.  Sorry about that.
CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 39 year old of unspecified sex. The patient's weight was 68 kilograms, and height was 170 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 10-APR-2021, the subject experienced confirmed covid-19 infection. Laboratory data included: SARS-CoV-2 RT-PCR test (NR: not provided) Positive. On 12-APR-2021, Laboratory data included: COVID-19 molecular test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed covid-19 infection was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
patient did not take second dose; covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19) and PRODUCT DOSE OMISSION ISSUE (patient did not take second dose) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20a) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetes.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced COVID-19 (covid-19). On 18-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient did not take second dose). On 18-May-2021, PRODUCT DOSE OMISSION ISSUE (patient did not take second dose) had resolved. At the time of the report, COVID-19 (covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive. In 2021, SARS-CoV-2 antibody test: plenty of antibodies (Positive) her doctor tested for antibodies and she had plenty of antibodies.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reported concomitant medication included blood pressure and diabetes medication.  Treatment information included as Monoclonal Antibody infusion.  Patient reported that her doctor tested for antibodies and she had plenty of antibodies.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Added lab data and event.
Guillain-Barre syndrome; cardiac issues unspecified; This is a spontaneous report from a contactable physician via Pfizer Sales Representative.  A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on an unknown date in May2019 at single dose for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, a month later after pneumococcal 13-val conj vaccine was given, the patient had cardiac issues, unspecified. The patient had a cardiac catheterization put in. Unknown to reporter if the Cardiac Cath is the treatment for the cardiac issues (as reported). Not long after that patient developed Guillain-Barre syndrome and "the provider was pretty sure it was not the pneumococcal 13-val conj vaccine" (as reported). The outcome of the events was unknown. Information on batch number has been requested.; Sender's Comments: Based on the information currently available, both serious events cardiac issues and Guillain-Barre syndrome are unrelated to PREVNAR 13; both more likely represent intercurrent medical conditions.  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.
Pt received Gardasil vaccine 1/11/07 at 100PM - Developed c/o chest pain late evening & went to hospital ER. Pt brought this to our attention 3/12/07 when she was scheduled for her second vaccination - dose not given. No intervention other than Advil given in ER.
Patient states she started forming blisters on face and extremities and had itching 1 day after receiving vaccines. States she also did not feel well.  I instructed patient to seek medical attention to have blisters looked at.
Large red patch appeared next to (but not at) the injection. Intense itching, swollen and hot to touch for first 24 hours. Red patch continued to enlarge but tenderness and itching reduced after 24 hours. Patch disappeared gradually over five days.
Approx around 9:00pm on 3/21/19 same day I took vaccine, I started to feel tired, weak, developed a weird headache. I began to get chills, skin got itchy and began to get red bumps on upper part of my body, especially on my arms and hands. Was tired for at least 2-3 days afterwards. Approx 4th day started to feel pain usually feel when I get shingles. Went to Dr.
Pt had fever followed by generalized seizure - Requiring intubation. 3 seizures back to back.
Three weeks after second shot sudden onset of several foot pain left foot . Two weeks later severe pain right foot.  Pain now controlled by gabapentin. One week after third shot (booster) finger nails growing in with white ridges Followed by inflammation at nail beds and black areas sides of nails on both thumbs and rt.  index finger.
AFTER RECEIVING THE VACCINE SHE COMPLAINED OF BEING TIRED. ON SITE EMS RESPONDED. VITALS BELOW. SHE REFUSED FURTHER EVALUATION AND WAS RELEASED TO HOME