chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient complained of mild "dizziness."  Had her sit down with head between knees and applied ice to neck.  No other complaints, no signs of allergic reaction.  Patient ate lunch and reported feeling better.
Patient claims to have had developed cellulitis at needle site requiring ER trip and 10 day treatment of BACTRIM DS.
Vaccine was given on 2/14/23- vaccine use by date was 2/12/23.  No harm, no reports of negative side effects.  Contacted Moderna and given the following information: "Analysis of the vials associated with your storage excursion is complete. The vaccine administered on February 14, 2023 from lot number 015B22A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration"
Nerve pain; This case was reported by a other health professional via other manufacturer and described the occurrence of nerve pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included back injury, back surgery, chronic back pain, weakness left or right side, graves' disease, hypothyroidism, achalasia (surgery) and multiple sclerosis. Concurrent medical conditions included back pain (Severe back pain) and achalasia. Concomitant products included levothyroxine sodium (Synthroid), hydromorphone hydrochloride (Dilaudid), oxycodone hydrochloride (Oxycontin) and fenofibrate.   In September 2019, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced nerve pain. On an unknown date, the outcome of the nerve pain was recovered/resolved.   It was unknown if the reporter considered the nerve pain to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. It was reported that female patient received the shingrix vaccine and then experienced nerve pain. Patient past medical history was mentioned that patient had Back injury, Back surgery, Hardware failure, Chronic back pain, MS hugging, Left sided weakness, Left leg smaller, Graves disease, Hypothyroidism, Achalasia, Achalasia surgery, Aspirated. The patient's concomitant medications included Synthroid, Dilaudid, Oxycontin, Vitamin D, Protonix, Fenofibrate The reporter did not consent to follow up.
temperature excursion; This case was reported by a pharmacist via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-Aug-2022 Reporter's comment: There was no transfer to medical information which was required. The report was not related to a study or program.  The other conditions was not provided. The investigations was not provided.  The Twinrix was not a Pfizer product.  The Twinrix manufacturer was GlaxoSmithKline. The national drug code number of Twinrix was not provided.  The reason for no lot number of Twinrix was not probed over the call. The expiry date of Twinrix was not provided.  The other products was not provided. The caller stated that he was calling from a pharmacy.  He asked if Twinrix was a Pfizer product, Twinrix was the Hepatitis A and B vaccine.  It was in regards to a temperature excursion.  The caller then stated that he just searched and that the manufacture was GlaxoSmithKline. The caller stated that he would call them.  There was no further information provided.  The call was ended. The reporter did not consent to follow-up.Additional Supportive Information: The patient received Twinrix vaccine which had a temperature excursion, which led to incorrect storage of vaccine.
localize swelling, warmth, erythema and mild tenderness approximately 10 cm x 5 cm along left arm of injection site.  Delayed hypersensitivity reaction
High fever (102), aches, chills/shivering, nausea,  extreme fatigue, rash (local)
Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (COMIRNATY), on 23Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 07May2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Dec2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), all with latency 10 days after the suspect product(s) administration, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: 4 days after testing negative; Positive, notes: Tested positive again; Positive, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Tested positive again for COVID on antigen home test 4 days after testing negative. 6 days after completing paxlovid. COVID 19 Treatment from 14Nov2022 to 18Nov2022  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Quick onset of numbness in fingers of both hands, primarily left. Thumb, forefinger and middle finger affected the worst. Numbness in arms, primarily left, ranging from shoulders to hands.  Symptoms began approximately two weeks after injection. There were no other events which may have caused these symptoms, no injury or trauma of any kind.
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were administered improperly stored GARDASIL 9 (M028323, expiration date: 26-SEP-2018; M032650, expiration date: 31-MAR-2019) (dose and route unknown) for prophylaxis. The vaccines were stored for 1 hour and 24 minutes at 35 Fahrenheit degree (F) as per datalogger information. There was no prior excursion for these vaccines. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as there is no consent for follow up.; Sender's Comments: US-009507513-1701USA003802:
The past 4 days I basically just been in bed; Haven't had the energy to get up and do anything/Real weak; I've gotten up couple of times each day to eat but not very much; Sleep for couple of hour, I wake up for an hour or hour and half and I sleep for couple more hours; Really bad gas problem; Real tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Apr2021 (Lot number: ER8735, Expiration Date: Jul2021) at the age of 59 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADVIL 12HOUR. Vaccination history included: Bnt162b2 (First dose,, Lot Number: ER8732, Anatomical location: right arm,, Vaccine Lot Expire Date: Jul2021, Time the Vaccination was Given: About 10:45 am), administration date: 03Apr2021, when the patient was 59 years old, for COVID-19 immunization; Swine flu shot, reaction(s): "diarrhea", "sick", "really bad body aches", "vomiting". The following information was reported: FATIGUE (non-serious) with onset 24Apr2021, outcome "unknown", described as "Real tired"; FLATULENCE (non-serious) with onset 28Apr2021, outcome "recovering", described as "Really bad gas problem"; BEDRIDDEN (non-serious), outcome "unknown", described as "The past 4 days I basically just been in bed"; ASTHENIA (non-serious), outcome "unknown", described as "Haven't had the energy to get up and do anything/Real weak"; DECREASED APPETITE (non-serious), outcome "unknown", described as "I've gotten up couple of times each day to eat but not very much"; SOMNOLENCE (non-serious), outcome "unknown", described as "Sleep for couple of hour, I wake up for an hour or hour and half and I sleep for couple more hours".  Additional Information:No Emergency Room and Physician Office. No Prior Vaccinations within 4 weeks  No follow-up attempts are possible. No further information is expected.
Swollen left foot, pain in ankle Pain and swollen knees ( right side) Painin left shoulder
Headache, Arthralgia, FATIGUE CHILLS, PAIN/SWELLING INJ SITE Narrative:
+ fever starting 48 hours after the shots.  + HA, + emesis and dizziness 3 hours after shots (emesis x 1).  + enlarged anterior cervical nodes.
4/9/2021 vaccination 4/10/2021 fever, malaise, body aches, chills. Lasted for 24 hours.  4/16/2021 cramping in leg, calf pain. Tried stretching, ibuprofen. Telemed. Keep eye on it, seemed muscular. Didn't get better over next few days 4/18/2021 Couldn't r/out blood clot. Noticed heart murmur. Sent me to ER to r/out blood clot. Referral to cardiologist.  4/20 observed heart murmur. blood work; normal. Echocardiogram week later 4/28 Echocardiogram results; 'Reaction to the vaccine'.  Didn't see anything alarming. To do normal check-ups with PCM.  *COVID +; 12/9/2020
This case was reported by a consumer and described the occurrence of flu like symptoms in a 32-year-old female subject who was vaccinated with ENGERIX B. A physician or other health care professional has not verified this report. The subject's medical history included gastric bypass. Previous and/or concurrent vaccination included HARVIX; unknown; unknown given on 15 February 2008. Concurrent medications included Cyanocobalamin (Vitamin b12) and Multivitamins. On 15 February 2008, the subject received 1st dose of ENGERIX B (unknown, unknown arm) and experienced wrong dose administered. The subject was given the pediatric dose of ENGERIX B. On 17 February 2008, two days after vaccination with ENGERIX B, the subject experienced flu like symptoms, vomiting, and joint pain. It was reported that the subject was given the wrong vaccine by the pharmacy. At the time of reporting, the flu like symptoms and vomiting and improved and joint pain was unresolved.
HEADACHE; FEVER; This spontaneous report received from a patient concerned a 23 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: not reported) dose was not reported, administered on 07-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on APR-2021, and had not recovered from fever. This report was non-serious.
expired dose of vaccine given to a patient with no reported adverse event; Initial information received on 20-Sep-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 3 years old male patient where expired dose of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (vero)] given to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On 20-Sep-2023, the patient received 0.5 ml TOTAL dose 1 of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine (lot UJ682AA and expiration date- 16-Sep-2023) via intramuscular route in the left thigh (strength: not provided) for Immunisation (expired product administered) (latency- same day).  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.
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 51-year-old male patient received BNT162b2 (BNT162B2), on 19Nov2021 at 16:00 as dose 3 (booster), single (Lot number: FJ1620) at the age of 50 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 included: "Psoriasis" (unspecified if ongoing); "Shell fish" (unspecified if ongoing). Concomitant medication(s) included: NEXIUM [ESOMEPRAZOLE MAGNESIUM]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" 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.  Clinical Course: Patient received other medications in 2 weeks.
None stated. Autopsy report on 05/05/04 states: SIDS.
Patient left consultation room after vaccines administered and was sitting in waiting area. After approximately 5 min or so she was noticed to be sitting stiff in her chair with head back and mouth open. Patient was red in face with whole upper body tensed up. 911 was called and pharmacist went over to assess patient. She was stiff a few moments and then slumped, waking herself up with her eyes twitching back and forth. She turned pale and sweaty, said she was nauseated and began throwing up. Paramedics responded and evaluated finding blood sugar high (188) and later evaluated pharmacy for CO due to labs coming back with carbon monoxide levels found in patients blood (still determining source).
pt given DT instead of Aplisol intradermally on forearm;arm red & indurated;
Pt c/o pain at inject site soon after vax. Next AM, R/arm from shoulder to elbow, approx 5", beet red band encircled arm. R/side of neck "was itchy". Pt called ER & was recommended Benadryl. On 12/14/99, slight discoloration but improved.
Initial report received from a health care professional in the USA on 18 April 2007. A 23 year old, male patient complained of a temperature of 100F overnight, chills, aching arm and generalized achiness, after he received Adacel (lot number not known, route and site of administration not known) and YF-Vax (lot number UE998AC, route and site administration not known) on 21 March 2007. He also received Hepatitis A vaccine and Hepatitis B vaccine (lot number (s) not known, tradename (s), route (s) and site (s) of administration not known) on the same day. He did not have ant medical history, was not on any medications and did not have any illness at the time of the vaccinations. He was not treated with medications. His symptoms resolved within 24 hours and he recovered. Follow-up information received on 14 May 2007 from a health care professional provided the following batch numbers: Adacel (C2632AA) given intramuscularly in the left deltoid, YF-Vax (UE998AC) given subcutaneously in the left arm, Hepatitis A (1278F) given intramuscularly in the right upper deltoid, and Hepatitis B (0904F) given intramuscularly in the right lower deltoid. A complete metabolic panel and complete blood count were noted to be unremarkable, and no treatment was given. No given information is expected. This case has the same reporter as case 2007-01315.
Since I was not with my husband I can only tell you what was told to me.  He walked out of the store toward our car.  Someone watched him, concerned, because he was walking very slowly (normally has a slow gait because of leg braces and toe amputations so I don't know if it was unusually slow).  The woman saw him fall and she ran to help-administered CPR immediately-and told me he died instantly. Medics tried to resuscitate and failed to bring a pulse.  (My husband left our home around 11:15 to drop a package off at store. The store is one mile from our home. At around 12:30 a deputy came to my door and when I saw him my knees buckled.  I knew something horrible happened.
Pt recved MMR vax as a child & currently exhibited a lack of response to mumps; No further details were provided;
Extreme fatigue, low energy, unable to complete physical tasks as I was able too prior to receiving the COVID19 shot.
Client's mom reported client not feeling well. Client stated she felt dizzy. Client transferred to EMS. room. Removed via wheelchair. Client had 50 ml clear emesis. Client appeared pale. Mom stated she hadn't eaten today. Client rested on cot with ice pack and was given water. Mom stated this was a common reaction to needles for the client. Client ate a few crackers and rested for 40 minutes until stated she felt better and stood without dizziness. Client walked to vehicle. Followed client with wheelchair. Client and family thanked me for my assistance.
FROM THE AFTERNOON OF THE INJECTION I NOTICED A DEFINITE INCREASE OF TINNITUS FOR 13 DAYS. 14TH DAY TO CURRENT AN EVEN MORE PRONOUNCED RINGING IN BOTH EARS ALMOST UNBEARABLE AT TIMES.
Pt said arm that she received the vax in became very painful same day and pt could barley move her arm. Went to DR and DR said it was arthritis and gave her a cortisone shot, the shot did help
Immediate numbness L-arm/shoulder blade, lungs felt "hot" on inhalation (for 5 days), progressed to mildly productive cough (5 days), nausea & GERD (6 days), headache (7 days so far), intermittent fever (7 days so far), moderate to severe muscle aches mostly upper body, increased nighttime leg cramps, exhaustion (lasted 7 days)
On 04/19/2022, I experienced extreme fatigue and vertigo. On 04/20/2022, the vertigo continued and I began experiencing extreme double vision. I was seen in the clinic and diagnosed with vertigo and prescribed Antivert which made symptoms worse. I then went to the ER. My symptoms included double vision (diplopia), progressive paresthesia (face, tongue, arm, leg, foot). The ER referred me to a neurologist and I was scheduled for an MRI. The MRI demonstrated active demyelination with lesions in the bilateral frontal and temporal subcortical white matter, pons, medulla.
On April 20th I got an extreme headache that would not go away. I went to the ER and got migraine medicines, but it still did not help. I went to my family doctor no less than 6 times over the next 2 weeks. After a couple days I started having eye disturbances. Not double vision, but halos and problems focusing. My head still hurt. On  May 3rd I went back to the ER because my left arm was numb. I thought maybe it was a heart attack. Still had the eye disturbances and headache also. They did a CT with contrast at the hospital and confirmed that I had had a stroke. On May 10th I saw a neurologist that ordered an indepth MRI and he found a brain aneurysm.
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: shortness of breath, wheezing-Mild, Additional Details: Per patient's dad, patient started to not feel well 3-4 days ago. Pt already has asthma, but his shortness of breath worsened so took him to a hospital yesterday and got discharged the same day. Patient was prescribed prednisone and albuterol inhaler
Following the first dose, I had typically side effects late that night that included night sweats, fever, chills that last just over 24 hours. I had a day of feeling good and energized then had an excruciating headache. I lost my vision in my right eye for an hour with it returning slowly. I didn?t see an eye doctor at the time since it improved and the headache was gone that Monday. I didn?t even link it to the vaccine nor had any concerns about the vaccine give I had a great day following my typically side effects. Following the second dose, typical side effects occurred and I had a great day after approximately 30 hours. On Sunday, they same as the previous shot, I started having severe dizziness and balance impairments.  The nausea started to improve after 2-3 days but the balance issues lasted for 2-3 weeks with spikes in dizziness. My blood pressure was elevated 150?s/90?s and that?s when I went to the doctor. I ended up getting an MRI, neuro consult (no availability until OCTOBER), and seeing an eye doctor.  I spoke informally to other physicians who requested that I report my symptoms to the . I don?t feel that my work up was as thorough or complete as it should have been and I haven?t met with the neurologist yet.  However, my symptoms have completely resolved. 222252
it was not available at the time; This case was reported by a consumer via interactive digital media and described the occurrence of product supply issue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 19th April 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable for this report. The patient had received initial dose of Shingrix but was not able to get the 2nd Shingrix in the 2 to 6 month period as it was not available at the time and never heard back from for the 2nd dose, which led to product supply issue. Note: VAERS reported for the 1st dose as 2nd dose was not received
Chest pain/shortness of breath/fatigue Myocharditis Ejection Fraction of left ventricle 30% Hospitalization, Nitro patch/morphine, angiogram, ultrasound, MRI, Heart Failure Clinic Still in recovery
Stroke.  Tuesday Sept 13, 2021 had bad headache, bad enougj couldn?t work. Wednesday very tired, slept all day and still had headache.  Took Covid test it was negative,  Sept 15 and 16 had ringing in ear and dizzy, took another Covid test and it was negative, Saturday dizzy and slurring. Went to hospital and found out had a stroke. Had additional stroke in the hospital. Was in the hospital 6 weeks. Couldn?t walk, could barely talk, couldn?t swallow and had a stomach tube.