chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via Pfizer refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was supposedly vaccinated with PREVNAR 13 from lot # J23864 (dose, route and expiry date not reported) but the patient gave consent for receiving PNEUMOVAX 23 (Wrong vaccine administered). The physician asked if lot # J23864 was valid for PREVNAR 13 or PNEUMOVAX 23. It was reported that lot # J23864 was not valid for PREVNAR 13. Lot number J23864 is an invalid lot number for PNEUMOVAX 23. Additional information is not expected as the reporter declined to provide further information.
Pruritus on arms, legs and abdomen beginning one hour after dose #1 of anthrax vaccine and dose #1 of typhoid fever vaccine.  No hives.  Treated in Allergy/Immunology clinic and has follow up with an allergist.
This spontaneous report as received from a physician via a company representative refers to a female patient in her mid-twenties. The patient's current conditions or medical history were not reported. On an unspecified date in 1994, reported as about 20 years ago, the patient was vaccinated with a dose (reported as original) of VARIVAX (Merck) subcutaneous and the booster (dose, lot numbers and expiration dates were not reported). On an unspecified date in 2014, reported as a few weeks ago, a physician, partner of the reporting physician, examined the patient who had received the VARIVAX (Merck) vaccine, original and booster, and the patient was diagnosed with herpes zoster. At the time of the report outcome of herpes zoster was unknown. The patient visited the doctor for medical attention. Additional information has been requested.
COVID + 10/21/2021. COVID-19 pneumonia.  Patient was admitted through the emergency room because the patient was getting very weak with difficulty breaithing. She was found to have hypoxia and non productive cough.    The patient was thought to have gram-positive pneumonia.  She was started on IV antibiotics and supplemental oxygen.  The patient was clinically stable to be discharged to subacute rehab for short term.
233 Patients given expired doses; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (233 Patients given expired doses) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Nov-2021 at 2:50 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Nov-2021 at 2:50 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (233 Patients given expired doses). On 26-Nov-2021 at 2:50 AM, EXPIRED PRODUCT ADMINISTERED (233 Patients given expired doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided Treatment medications were not provided Reported that 2 vials removed from -20C freezer at 12:30pm, 11/16/21, thawed for 30 min at room temp,drawn up and placed in fridge(3.8C)for duration of clinic,from 1pm-4pm on 11/26/21. Patient was not immunocompramised.
Shingles; Terrible pain on back; Terrible pain on chest; Suffering with neurology; Health problems/it has been hell; This serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 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, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles) (serious criteria hospitalization), back pain (Verbatim: Terrible pain on back) (serious criteria hospitalization), chest pain (Verbatim: Terrible pain on chest) (serious criteria hospitalization), neurological disorder nos (Verbatim: Suffering with neurology) and general physical health deterioration (Verbatim: Health problems/it has been hell). The outcome of the shingles, back pain, chest pain and general physical health deterioration were not reported and the outcome of the neurological disorder nos was not recovered/not resolved.   It was unknown if the reporter considered the shingles, back pain, chest pain, neurological disorder nos and general physical health deterioration to be related to Shingles vaccine.     It was unknown if the company considered the shingles, back pain, chest pain, neurological disorder nos and general physical health deterioration to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAR-2023 This case was reported by a patient via interactive digital media. The patient received first dose of Shingles vaccine then experienced terrible pain on his/her left side from center of his/her back to the center of his/her chest ended up in the hospital thinking that it was his/her heart but ended up with the shingles, this happened four years ago this coming August 2023. The reporter stated that these years have been beyond any thing he/she had experienced and believe him/her had gone through a lot of health problems now he/she was suffering with neurology which he/she had been told can last for years. The patient stated that to sum all this up it had been hell so please get all shots. Follow-up would not possible as no contact details were available.
feel sick; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feel sick) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, the patient experienced MALAISE (feel sick). At the time of the report, MALAISE (feel sick) outcome was unknown.            No concomitant medications or treatment details were provided by the reporter.
Slight soreness on third day. Hard swelling and itching on fourth day. Red rash about 4 inches in circumference and itching. Neck face head itchy. Constantly having to clear throat; slight burning of throat; all on starting on 25. Took Benadryl. Rash for days on arm and over 5 days. On arm at injection site and lower.
Patient lost consciousness as observed by accompanying guardian. Per guardian, patient also had a short seizure and skin color turned pale. Episode lasted less than 1 minute. Pharmacist was alerted but patient already regained consciousness and did not need epinephrine or interventions. Recommended patient lower head in seated position to increase blood flow. Patient also bit tongue during episode. Recommended patient stay for another 15 minutes for observation. Followed up with guardian on Monday 1/10/22 and no further incidents reported.
A report has been received from a physician concerning a 2 year old female patient. No concomitant drugs or relevant history was provided. The patient had been receiving nasal FLUENZ TETRA started on 30-OCT-2015. Action taken was unknown. The patient recovered from the events of general feeling unwell and tired on 31-OCT-2015. The report was considered to be non-serious by the company physician.
Patient came in today to establish care. Patient saw provider and wanted to get Hep B and covid vaccines today. Patient did not have her covid vaccine card with her. When I looked at chart, it looked like she never had covid vaccine. So I gave her Comiraty Pfizer. Patient noticed a day after that she had received a primary dose again, patient wanted to get a booster bivalent instead. Patient state she is not having any reaction. Explained to patient that no side affect to come unless she had side affects with other dose. Patient declined reactions once again. Explain to patient she will have to wait again for 60 days to receive booster.
Severe arm ache for over 24h.  Diarrhea next day.  Severe fatigue and brain 'fog'
Pain in entire arm from shoulder to wrist.  Limited motion of arm. Went to private physician on 11-08-13 and was told to take naproxen and apply heat. In January went to another doctor who told me the pain was caused by the shot and to exercise and apply cold. No improvement and would like to know prognosis.
5/19/10 at 11:38 AM employee contacted RN at Hospital regarding symptoms of fever and tonsil swelling. Also stated having sinus drainage. Concerned over reaction from vaccination received 5/18/10. Acknowledged concern. Request follow-up call 5/20/10. Unable to follow-up employee has not returned phone messages.
High blood pressure, Irregular Heartbeat, SVT (super ventricular trectarcardia), right side of my heart is enlarged
headache, upset stomach, fever, chills, (usually right after the fever broke), loss of desire to eat,  shorness of breath, started 1 hr after shot, at this time when entering this, still have fever and loss of desire to eat, and chills .  I fell like I had a mild cold with no nasal discharge.
This spontaneous report was received from a 71 year old female patient referring to herself. The patient's medical history included shingles. The patient had no concomitant medication and no drug reactions/allergies. On 16-JUL-2015 the patient was vaccinated with a dose of ZOSTAVAX single (dose, lot#, expiry date unspecified), to lessen the effects of re-occurring shingles. On 04-SEP-2015, the patient developed shingles which was just as bad as the first time she got shingles. She also reported a lack of effectiveness for the vaccine. Patient sought medical attention but not hospitalized, and was prescribed famciclovir as a treatment. No lab diagnostic studies performed. The patient was not recovered from the events at the time of this report. No product quality complaint (PQC) reported. The relatedness between the event and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Pt given Bivalent Booster 3 days post 30 day  storage date which was 10/20/22.  Moderna has been contacted. Pt was contacted and informed per Moderna Vaccine provided protection necessary against Covid. But per Provider discretion can offer another dose. Pt declined. Pt denies any s/e or symptoms currently.
Numbness/tingling in lower lip to chin, lasted around 6-7 hours Worried about allergic reaction
30-40 minutes after the vaccine administration, began to have a decreased sensation to left side of face to include jaw, lip and tongue.
patient receivced an expired Adacel, no AE; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 62 years old female patient who received a 0.5 ml dose of expired vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) (lot: C5263AA, expiry date: 12-Sep-2019), via intramuscular route in the left arm on 28-Oct-2019.  Medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the expired vaccine use.  At the time of reporting, the patient had no adverse 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 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.
looked like cellulitis; rash at 7 days at the injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE CELLULITIS (looked like cellulitis) and VACCINATION SITE RASH (rash at 7 days at the injection site) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE CELLULITIS (looked like cellulitis) and VACCINATION SITE RASH (rash at 7 days at the injection site). At the time of the report, VACCINATION SITE CELLULITIS (looked like cellulitis) and VACCINATION SITE RASH (rash at 7 days at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Treatment for the events included oral prednisone for 5 days.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Arm immediately swelled the size of baseball and bled. Applied ice and compression for 2 hours. After taking bandage off was still swollen, but not as bad. Started to bruise severely that afternoon and very painful. Pain, swelling, and bruising lasted for 18 days. Arm was also weaker than normal and still is.
Patient present with discomfort, firmness, redness, and warm to touch on her upper left arm at vaccine site.
Patient reported throat closing up, but he was able to speak. He took 25 mg of Benadryl and felt better
Fever 102.1 x24 hours, irritability, screaming, not walking.
At 9pm the day of the vaccine the patients experienced rash with bumps from injection site up through neck and back on shoulder blade.  Pt took Benadryl and saw PCP the next day who called pharmacy, nurse reported that rash was still present and pt was instructed to continue Benadryl.  They called agency who instructed the patient to not received the 2nd dose.
Vaccine given on 9/19/02 in village - was on way to Anchorage - next day arm was swollen (at deltoid area), redness, checked in with MD at clinic. pt is HIV positive.
Case number PHEH2013US015800 is an initial spontaneous report received from a pharmacist on 22 Jul 2013. This report refers to an 18-year-old male patient. He was vaccinated with an expired dose of MENVEO (batch number: A10047 and expiry date: Dec 2012) intramuscularly on 19 Jul 2013. Immediately the patient was vaccinated with the correct MENVEO (Batch number: A12009 and expiry date: Feb 2-14) on the same day. No adverse event was reported following the administration error.
itches a lot; bad rash from head to toe including her hair; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itches a lot) and RASH (bad rash from head to toe including her hair) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included Fungal foot infection.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced RASH PRURITIC (itches a lot) and RASH (bad rash from head to toe including her hair). At the time of the report, RASH PRURITIC (itches a lot) and RASH (bad rash from head to toe including her hair) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment medications were provided.  The patient had bad rash from head to toe including her hair a month after receiving her second dose of Moderna Covid-19 Vaccine and still continued to keep getting it back which she cannot handle since it itches a lot. Patient went to a allergy specialist and a skin doctor, but they cannot figure it out how to get rid of the rash. She has history of getting fungus on her toes and doctor gave her medication for it.
Sore tongue with acute  sensitivity at tip. First geographic tongue noted by dentist on 2/15/21, followed a few days later by onset of acute sensitivity at tip and right side with cuts and pustules. Now on the left side and tip.   Both physician and dentist seen since onset.  Vitamin B recommended. Now taking One A Day - Women's 50+ to no effect.
Injection given 12/10/09 in AM. H/A complaints when he came home from school. We gave him TYLENOL and he went to bed. H/A gone next AM. Full body rash started on right hand. In 4 hours he was fully covered. Described as size of pinhead and itchy. Gave BENADRYL and applied CALAMINE lotion, itching improved with medication. Hand rash is getting thicker in coverage. He has missed no school. Recommend evaluation by PMD.
Itching, onset one hour after vaccination, at site. Treated with 25 mg Diphenhydramine P.O. .
This case was reported by a pharmacist via sales rep and described the occurrence of therapy non-responder in a adult male patient who received HAVRIX (batch number 23F25, expiry date unknown). On 18th August 2016, the patient received the 1st dose of HAVRIX 1440 Adult. In November 2016, less than a year after receiving HAVRIX 1440 Adult, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to HAVRIX 1440 Adult. Additional details were provided as follows: The batch number for HAVRIX 1440 Adult was not clear on the document (either 200F25 or 23F25). The patient was vaccinated in preparation for extended overseas travel. It was not clear if the patient received anti-malarial prophylaxis or other vaccine at that time. There was an outbreak of hepatitis A in the summer of 2016. The pharmacist did not know if the store in question was otherwise having difficulty obtaining hepatitis A vaccine. In November 2016, the patient went to a medical office for the second dose of hepatitis A vaccine. For an unknown reason, the health care provider ordered a hepatitis A serology test to see if they had hepatitis A and if the second dose was necessary. The health care provider reported that the test was negative for any evidence of hepatitis A infection or hepatitis A vaccination (possible lack of immune response to HAVRIX). The patient then posted a message on the pharmacy page notifying of the serology test results and their concern that the vaccine was a dud. The patient expressed concern that other people may also have received a vaccine that did not elicit an immune response. According to the pharmacist, the notice was reviewed by several administrative layers at the pharmacy and was reported to VAERS. The pharmacist only became aware of the question in May 2017 and tried to call the patient via cell phone, but was unsuccessful. He had an email contact with the patient in which the patient asked what the center for disease control (CDC) and manufacturer was doing about the report. The pharmacist then contacted medical science liaison (MSL) to report the question directly to GlaxoSmithKline. The pharmacist said that the pharmacy was willing to accept the invoice for additional serologic testing and if necessary the second dose of vaccine. The pharmacist was reminded that HAVRIX is a two dose vaccine and recommended that the initial focus should be on medical care for the patient, especially since the patient was still traveling overseas. The patient was recommended repeat serologic testing and administration of the second doses of vaccine. Also, it was recommended to obtain details of the serologic test if possible. The sales representative would follow up with pharmacist during the week of 15th May 2017. There were no seriousness criteria (death, hospitalization, disabling, congenital anomaly, life-threatening and clinical intervention required) associated with the reported event. This case is linked with US2017GSK073867 (wife's case), reported by the same reporter.
Platelet count decreased drastically; After that he developed adverse reaction; black sores, tongue; black sores, tongue; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT DECREASED (Platelet count decreased drastically), VACCINATION COMPLICATION (After that he developed adverse reaction), TONGUE DISCOLOURATION (black sores, tongue) and GLOSSODYNIA (black sores, tongue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     Concomitant products included OLMESARTAN for Blood pressure management, SIMVASTATIN for Cholesterol, NISOLDIPINE for Heart disease, unspecified.    On 29-Jan-2019, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PLATELET COUNT DECREASED (Platelet count decreased drastically) (seriousness criterion hospitalization), VACCINATION COMPLICATION (After that he developed adverse reaction) (seriousness criterion hospitalization), TONGUE DISCOLOURATION (black sores, tongue) (seriousness criterion hospitalization) and GLOSSODYNIA (black sores, tongue) (seriousness criterion hospitalization). The patient was treated with IMMUNOGLOBULIN HUMAN NORMAL (IVIGLOB-EX) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PLATELET COUNT DECREASED (Platelet count decreased drastically), VACCINATION COMPLICATION (After that he developed adverse reaction), TONGUE DISCOLOURATION (black sores, tongue) and GLOSSODYNIA (black sores, tongue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported, after the vaccination he developed adverse reaction and his platelet count dramatically decreased. 9 days later the patient had black sores, tongue. The patient got his blood work done and the patient was hospitalized for 2 days. The patient was given IVIG and steroid after which he was discharged. His symptoms resolved after some time but both his doctor and hematologist had concern and advice him not to get the 2nd dose of Moderna COVID-19 vaccine.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt. started w/ vertigo & nausea approx. 5-10 mins after vaccine administratio. She was immediately transferred to the ER where Solumedrol 125/2mL IV, Benadryl 50mg IV & Zofran 4mg where administered. Pt. recovered w/n 5 mins.