chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccinated with a lot number that just expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated with a lot number that just expired) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated with a lot number that just expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccinated with a lot number that just expired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. The patient was vaccinated with a booster dose with a lot number that just expired 2 days ago. Number of doses or vials included 7 doses. On 09-JUL-2022 the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. No treatment medication details was reported.
extreme arm pain, very bad chills, severe body aches, head pain this occurred a couple of hours after the injection and completely resolved in 48 hours patient did not receive any treatment for these symptoms
Arm pain; Redness; Heat; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm, erythema and feeling hot. On an unknown date, the outcome of the pain in arm, erythema and feeling hot were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, erythema and feeling hot to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a dose of Shingles vaccine and asked how long did arm pain, redness and heat last. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Myocarditis Associated With COVID-19 Vaccination; This is a literature report.  A 23 year-old male patient received bnt162b2 (BNT162B2) (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, SINGLE), for COVID-19 immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "unknown", described as "Myocarditis Associated With COVID-19 Vaccination". The patient underwent the following laboratory tests and procedures: brain natriuretic peptide: 68 pg/mL, notes: initial; ejection fraction: 50 %, notes: Initial at 3 days; 60 %, notes: follow up at 177 days; electrocardiogram: st-segment elevations, notes: Initial; nonspecific  st-t abn, notes: Follow up; investigation: lge basal/mid as segments, notes: initial 3 days; resolved lge, notes: Follow up 171 days; investigation: notes: Units: ms normal; investigation: notes: Units: ms; n-terminal prohormone brain natriuretic peptide: less than 10, notes: Follow up; troponin: 7000 ng/ml, notes: initial; troponin i: 6 ng/L, notes: Follow up; volume blood: notes: Initial at 3 days units: ml/m2; notes: follow up at 177 days units: ml/m2. Clinical course: The Study investigated the Patients With Myocarditis Associated With COVID-19 Vaccination and the following conclusion was achieved: there were no instances of severe impairment of ventricular function at baseline in this series, all patients had LGE, and several had mild LV dilation. Intermediate-term (6-month) follow-up demonstrated improvement or resolution of CMR findings of myocarditis in all cases. There was no evidence of myocardial dysfunction or ongoing myocardial injury at intermediate-term follow-up and no subsequent adverse cardiac events. No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Myocarditis and the suspect drug cannot be excluded. The case will be reassessed once new information is available,Linked Report(s) : US-PFIZER INC-202200508742 Same article/Event/Drug and different patient
After 2 months my daughter started to have 2 painful menstrual periods a month, instead of one.
Following vaccine administration (pt had received 5 vaccines), patient turned pale and went unconscious, while seated in a chair. LOC 5 seconds. Patient briefly shook and then awoke. Pt was fasting. Symptoms spontaneously resolved. Patient received final vaccine and waited in office at least 30 min. following. No further symptoms. No hx of vaccine reactions. Upon d/c, mom reports that while unconscious, patient's entire body was shaking. Discussed further with RN's who witnessed event. No seizure activity reported.
Patient received 0.5mL  instead of 0.25mL for the booster.  Patient is under observation, no adverse reaction or symptom reported by patient.
Patient experienced itching throughout body, injection site redness/swelling, and scratchy throat immediately following injection.  Patient was given benadryl onsite.  Symptoms improved within 15 minutes of receiving benadryl.
Pain in arm neck back, chills fever sweating. Dizzy, nausea, fatigue, muscle weakness.
Information has been received from a licensed professional nurse (LPN) concerning a 35-month health white female with no known allergies and a history of coarctation of the aorta and heart surgery at two days old who on 11-Apr-2002 was vaccinated in the right arm with the first dose of varicella virus vaccine live (Oka/Merck) (Lot #640155/0580L). There was no illness at the time of vaccination. On 17-Apr-2002, the patient was vaccinated in the left arm with the first dose of measles virus vaccine live (Moraten)(+)mumps virus vaccine live (Jeryl Lynn) (+)rubella virus vaccine live (Wister RA 27/3)(Lot #640912/1521L). The LPN reported that on 17-Mar-2004, the patient developed a bumpy vesicular rash on her chest and back consisting of 10-12 papules with central vesicles. The patient was noted to be afebrile and in no pain. The patient was seen by her physician and a diagnosis of umcomplicated varicella was made. The patient was treated with oatmeal bathe and calamine(+)camphor(+)diphenhydramine HCl (Caldryl) and on approximately 28-Apr-2004, the patient's varicella resolved. Additional information is not expected.
eye twitching; he couldn't write normally; hand shaking; This is a spontaneous report from a contactable consumer reporting for himself.   A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the right arm on 15Mar2021 (Batch/Lot Number: ER8733) as a single dose (at the age of 68 years old) for covid-19 immunisation.  Medical history included blood pressure from an unknown date, and blood glucose increased from an unknown date. Concomitant medication included hydrochlorothiazide, telmisartan (TELMISARTAN + HCT GENOPTIM) taken for blood pressure from 2004 and ongoing at 80-25 mg once a day.  The patient experienced hand shaking on Mar2021 with outcome of recovered, eye twitching on an unspecified date with outcome of unknown, and he couldn't write normally on Mar2021 with outcome of recovered. Further details were reported as follows: he was doing some writing and filling out forms. He was done with two thirds of it and out of the blue, the right hand started shaking and he couldn't write normally.  This lasted about 15 minutes. He sat down for a break and got a little milder, then just went away. Had seen that sometimes with the first Pfizer vaccine, GBS, Gillian Barre syndrome, attacks on the nervous system, like paralysis. He is very concerned. Never had a history of muscle control or anything like this before. Treatment was not received for the events.
Joint stiffness and swelling, redness of the skin, muscle aches, cramps pains and stiffness, shivering, unusual tiredness and weakness, chills, fever 102.0
Was given booster dose 0.25 ml on 01/24/2022. Had finished her 2nd Moderna vaccine 0.5 ml on12/30/21.  Booster given too soon.
Waking up everyday with fevers and my baseline temperature has never been back to normal since the vaccine. It is always at 98 or higher. Tired all the time. Arthritis flared up and it was under control so much that I did not need mediation, until after the 2nd vaccine. I am sweaty all the time, my skin is itchy constantly, and I get these terrible headaches as well. The thing that is most concerning is my body temperature and I am always feeling hot now.
Localized rxn to varicella vaccine per mom. Patient was not brought in for evaluation. She had a nurse neighbor to look at it. She described rxn as the size of a baseball, red, whelp, now looks bruised. Indurated, hot to touch red initially. Mom did not tell of incident until she came in with the brother for a check up. She did not call. She just wanted to let us know.
Pt. returned to clinic 20 minutes after vaccine with vomiting, abdominal pain, and urticaria. Lung sounds clear. Continuing discomfort & worsening. Advised to go to Emergency Room. Tx and released same day. 8/25/09 TC with mother. Patient fully recovered after tx with "steroids" & "saline" & BENADRYL.
Patient states that his right arm has been sore and painful since getting the vaccine. At the time of discussion (3 months later), he states no swelling, no redness, no other symptoms except for the pain when he moves/flexes his arm. the pain is still ongoing and he was advise to take OTC pain medications.
11/9/2021, 2 PM: I receive the vaccine. 11/10/2021, 1 AM-8AM: I develop chills and a 100.7 F fever. 11/10/2021, 9 AM: I almost lost consciousness while brushing my teeth. I began feeling my vision closing and I had to rush back to my bed, where I stayed for the rest of the day. I was not able to work or leave the bed. The fever continued for the entire day. 11/13/2021, 9 AM: Intense headache. Throbbing pain in a band around the head, intensity 10/10. The pain diminishes after treated with Tylenol 500 mg on a daily basis until this day. The pain comes back when suspending Tylenol. The symptom remains active.
Gerd and gastritis I have been in treatment since Apr2021. I saw the D1 & D2 earlier-no improvement after the second shot Jan2022 I had another flare up of the issue I was in treatment for; It is now one year later and the caller is wondering if she can have her second shot; Gerd and gastritis I have been in treatment since Apr2021. I saw the D1 & D2 earlier-no improvement after the second shot Jan2022 I had another flare up of the issue I was in treatment for; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 17Jan2022 17:00 (Lot number: FJ1614) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid all over again /I had Covid", start date: 26Dec2020 (unspecified if ongoing); "Stomach problem" (unspecified if ongoing); "Gastritis", start date: Apr2021 (ongoing); "Gerd", start date: Apr2021 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot no: EL1283, Anatomical site of injection: arm, Route: Intramuscular), administration date: 24Jan2021, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 17Jan2022 17:00, outcome "unknown", described as "It is now one year later and the caller is wondering if she can have her second shot"; GASTRITIS (non-serious), outcome "not recovered", GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) with onset Jan2022, outcome "not recovered" and all described as "Gerd and gastritis I have been in treatment since Apr2021. I saw the D1 & D2 earlier-no improvement after the second shot Jan2022 I had another flare up of the issue I was in treatment for". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of gastritis, gastrooesophageal reflux disease.  Additional information: Patient had stomach issues and was dealing with that since a year.  No follow-up attempts are possible. No further information is expected.
3 hrs p/vax pt began running fever & became irritable; fever went up to 106 & would not come down w/APAP; pt would not eat or drink & had difficulty breathing; parents were in close contact w/MD & was adm; fontanel was bulging so spinal tap
Admitted on 1/18 for right lower leg amputation on 1/20. Found to be COVID positive. Developed some hypoxia and 1/19 requiring O2.   Decline in mental status and found to be in PEA arrest and underwent 4 rounds of ACLS before ROSC was obtained. Intubated and transferred to critical care. Unable to tolerate hemodialysis and found to have myoclonus. EEG showed evidence of severe encephalopathy. Family requested comfort care.
Rash on right side of the body; Rash in right armpit and waist area; rash in his right side of his body; Rash on stomach; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (rash in his right side of his body), RASH (Rash on stomach), RASH (Rash on right side of the body) and RASH (Rash in right armpit and waist area) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced RASH (rash in his right side of his body) and RASH (Rash on stomach). On 24-Mar-2021, the patient experienced RASH (Rash on right side of the body) and RASH (Rash in right armpit and waist area). At the time of the report, RASH (rash in his right side of his body), RASH (Rash on stomach), RASH (Rash on right side of the body) and RASH (Rash in right armpit and waist area) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-056232 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-056232:Dose 1
915AM 12SPT14 - red/hot/hard at injection site. Advised to call MD ("cold sores" corners of mouth). 12 noon 13SPT14 - saw MD. Prescribed prednisone 5PM 14SPT14 - patient reports generalized discomfort entire arm/shoulder radiating to back.
This spontaneous report was received from an unspecified person via Henry Schein Inc and refers to two patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with a dose of PNEUMOVAX 23 (lot # M038359, expiration date: 13-MAY-2018) for prophylaxis. On an unknown date, the patients experienced major swelling in their left elbow area and irritation. Both patients were given antibiotic to reduce swelling. No other medical attention was required and the patients were fine at the time of the report. The outcome of the events was not reported. The relatedness between vaccination with PNEUMOVAX 23 and the events was not reported. Additional information has been requested.
Narrative:  COVID infection following COVID vaccine series 02/26, Pfizer, dose #1 03/19, Pfizer, dose #2 10/01 pt cc: exposure: unknown 10/01 COVID swab, result: detected 10/01 CXR Impression: No acute abnormality or change since July 2021 10/01 BNP: 1145.6 10/02 FIBRINOGEN: 304 10/02 DDIMER: 1.26 10/02 LACTIC ACID: 1.35 10/02 ESR: 92 10/03 SARS-COV-2 IgG: 0.35 10/04 CXR Impression: No pneumonia. 10/04 COVID swab, result: NOT detected 10/07 clinically resolved
pt devel swelling & erythema @ the inj site along w/tenderness;also fever up to 103 orally, h/a, nausea & chest congestion;all sx devel less than 24hr p/vax & resolved about 48hr later;tx w/ice packs, APAP & advil for comfort;
Right arm anterior surface red, hot surface area 4 inches in diameter. Fever 103. Swelling of arm hard to move. Fever broke x 24 hours. No s/s since 10/22/11.
pt c/o red 2-3" spot (round on lt arm @ inj site; no fever hurts off & on; was swollen but not now 21NOV & is lighter in color now suggest;hot packs & pain if necessary;
Left axillary lymphedema started at slight discomfort on 1/8/2021 and has progressively worsened over the weekend to increased swelling and pain, no treatment, ongoing condition
Sores inside nose; This spontaneous case was reported by a consumer and describes the occurrence of NASAL DISCOMFORT (Sores inside nose) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Allergy to the flu vaccine).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced NASAL DISCOMFORT (Sores inside nose). At the time of the report, NASAL DISCOMFORT (Sores inside nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: NNI
This spontaneous report as received from a physician refers to a 11 or 12 year old female patient. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot number not reported) (dose and route not reported, in the upper deltoid exact location unspecified). Concomitant therapy included DTaP and meningitis (manufacturer unknown). On an unknown date after receiving the GARDASIL, the patient became dizzy and felt faint. The patient's outcome was reported as recovered on an unspecified date. Additional information has been requested.
This spontaneous report as received from a Registered Nurse (RN) refers to 5 patients who were vaccinated with doses of PNEUMOVAX 23 (dose, frequency and route unknown). Nurse was reporting that the patients reported to had reactions after receiving PNEUMOVAX 23. All the patients experienced fever and chills along with swelling and tenderness at the injection site. One patient experienced blisters (which was captured in this case). Three patients required antibiotic treatments. This case refers to one of the patients who on 10-SEP-2012 was vaccinated with a dos eof PNEUMOVAX 23 (lot # H009826, expired date not provided). At the time of reporting the patient had recovered from the adverse events. This is one of several reports received from the same source. Additional information has been requested.
Dose at 1:32 pm, low fever 99.5 at 8 pm high fever 102 at 9 pm. Dizziness, confusion, numbness, muscle aches, entire body skin pain, lower back pain, neck stiffness.
pemphigus; This spontaneous report from a contactable pharmacist reporting same event under the same suspect product for 6 patients. This is one of six reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pemphigus on an unspecified date with outcome of unknown. It was reported that while consulting her (reporter) dermatologist, she was informed that there are 6 patients who had pemphigus after receiving COVID vaccine.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021615653 Same reporter/drug/event, different patient
PCCV given 7/17/01 in left thigh, noted redness on7/1//01 around 2.50 cm to 5 cm medial to injection site.
Extreme joint and muscle pain, debilitating knee and toe pain. All over body pain difficulty walking because of pain. Onset next day after shot May 24th.  Pain continues, went to physician yesterday June 7th. He stated he is sure it is a reaction from the vaccine and to wait a few more weeks for blood test.
Expired Twinrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 44-year-old male patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) 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 4th March 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 4th March 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 19-OCT-2022 Reporter's Comment: The reporter called to inquire if expiration date move and wanted to know how to proceed. The reporter wanted to know if patient would need to be revaccinated. The reporter stated that, they realized their Twinrix was expired and a few patients were administered. The reporter reported that, they inadvertently administered expired Twinrix doses to three separate patients.  All administered at their facility. The reporter did not consent to follow-up. Additional Supportive Information: The reporter stated that, they realized their Twinrix was expired and a patient was administered, which led to expired vaccine used. This was 1 of 3 cases, reported by the same reporter.; Sender's Comments:  GSK-US2022150646:Same reporter GSK-US2022150647:Same reporter
Rectal temperature of 100.4°F, beginning near 7 PM, peaking to high of 101.8°F, shortly after midnight. Steady reading until 6 AM, when temp. began decline to 100.0°F; fluctuating up/down couple degrees throughout 5/23/2015. Also, moderate diarrhea, with severe gastrointestinal cramping/gas, which caused  severe painful crying/screaming until he would just pass out, too overwhelmed. Quite lethargic, to point of appearing spaced out/lost; not seeming to recognize anything, just screaming. Body aches, had to keep soft pillow between he and I, to lessen contact pressure. Stuffy nose, cough that caused choking, breathing difficulty.
Anxiety/panic attacks, tachycardia, heart palpitations, and positive D dimer
Vaccines given on 4/18/2008. Patient followed up on 4/21/2008 with complaint of redness and swelling at injection site. Treated with compresses, Benadryl, and Keflex.
Developed hiccups after vaccine and they continued for 11 days until he went to urgent care and was found to have late presentation myocardial infarct with abnormal EKG and elevated cardiac enzymes