chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 48-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included shingles (several cases of Shingles including one in December 2017 which had shingles on her face, back and in her ear). On 27th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 20th June 2018, the patient received the 2nd dose of SHINGRIX. On 27th April 2018, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced inappropriate age at vaccine administration. On 20th June 2018, the patient experienced inappropriate age at vaccine administration and drug dose administration interval too short. On 30th July 2018, 94 days after received the 1st dose of Shingrix and 40 days after received the 2nd dose of SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with Valacyclovir. On an unknown date, the outcome of the vaccination failure, shingles, inappropriate age at vaccine administration, inappropriate age at vaccine administration and drug dose administration interval too short were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: Since the patient had several cases of Shingles, she started SHINGRIX vaccination. The patient received 1st and 2nd doses of SHINGRIX at 48 years age. Thus, the patient was under the indication age for getting SHINGRIX. This led to inappropriate age at vaccination for both doses. The patient also received the 2nd dose of SHINGRIX one week shy of two months, which led to shortening of vaccination schedule. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown. The patient just finished her script of valacyclovir at the reporting time. The patient would submit a request for reimbursement. The contact detail of the physician was provided.
Hypomania; This case was reported by a consumer via call center representative and described the occurrence of hypomania in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   The patient's past medical history included chickenpox. The patient had a Family History of chickenpox (Kids (unspecified number) had chicken pox). Concurrent medical conditions included manic depression.   On 25th September 2019, the patient received the 1st dose of Shingrix (intramuscular) 50 µg and Influenza vaccine Quadrivalent 2019-2020 season. On 25th September 2019, 1 hr after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced hypomania. On 9th October 2019, the outcome of the hypomania was recovered/resolved.   It was unknown if the reporter considered the hypomania to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional information was provided as follows: This case was reported by patient herself. The patient received Shingrix vaccine in left arm. The patient reported within 1 hour she experienced a hypomania episode for approximately 1 to 2 weeks. The reporter inquired if patient should receive 2nd dose and if one dose was efficacious notably due to perceived belief of protection from a history of chicken pox and exposure again when her kids had chicken pox. The reporter consented to follow up. The consumer stated she had already contacted Food and Drug Administration (FDA). The outcome of the event was reported in source document as recovered and resolved with sequel, however it was reported as recovered and resolved in Argus. The reporter consented to follow up.
Mouth swelling; Burning mouth; Lip swelling; Burning lips; Swelling of toungue; Burning tongue; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH SWELLING (Mouth swelling), ORAL DISCOMFORT (Burning mouth), LIP SWELLING (Lip swelling), ORAL DISCOMFORT (Burning lips) and SWOLLEN TONGUE (Swelling of toungue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MOUTH SWELLING (Mouth swelling), ORAL DISCOMFORT (Burning mouth), LIP SWELLING (Lip swelling), ORAL DISCOMFORT (Burning lips), SWOLLEN TONGUE (Swelling of toungue) and TONGUE DISCOMFORT (Burning tongue). At the time of the report, MOUTH SWELLING (Mouth swelling), ORAL DISCOMFORT (Burning mouth), LIP SWELLING (Lip swelling), ORAL DISCOMFORT (Burning lips), SWOLLEN TONGUE (Swelling of toungue) and TONGUE DISCOMFORT (Burning tongue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and treatment information was reported.
PATIENT WAS ASKED HOW OLD HE WAS AND HE SAID HE WAS 18 YRS OLD SO HE WAS GIVEN FLUBLOK. UPON FURTHER CHECKING HIS BIRTHDATE, IT WAS CONFIRMED HE WAS ONLY 16 YRS OLD.
Hour and half after shot in left arm... my throat and ears nexame itchy... and right arm became itchy and a couple of hives broke out.. same are on arm where I receive weekly allergy shot.  Took 2  Benadryl.
feeling tired for about 1 day after; This is a spontaneous report from a non-contactable consumer (Patient). An adult female patient received bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced feeling tired for about 1 day after with outcome of unknown. Unsure if it was first or second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 26-MAY-2016, the patient was vaccinated with expired dose of (Oka/Merck) VARIVAX (lot # K003414 and expiry date: 06-MAR-2016). No adverse effects were reported. No product quality complaint (PQC) was reported for (Oka/Merck) VARIVAX. Additional information has been requested.
12/16/09: Office visit->presented for ataxia without other symptoms. Did have both AOM dx'd later 12/29/09. All exam findings nml except for ataxia 12/16/09.
Dr office called us to report that patient developed shingles 2-3 weeks after receiving vaccine
Stroke 11 days (2-27)  after first dose (2-16), discharged the following day (2-28). Spoke to PCP's office (nurse) who states stroke was likely due to patient's own decision to discontinue his blood pressure medications without doctor's approval. Stroke unlikely related to vaccination and determined patient should receive second dose on 3-16.
Symptoms: Starting 4 AM day after vaccine I experienced a fever rising to 100.7 on the afternoon of April 30 I had chills, headache, aches and lethargy I took Tylenol extra strength to manage the symptoms but it was ineffective The symptoms finally started to subside on May 1 and resolved entirely by the afternoon of May 2
Candidiasis; Neoplasm of uncertain behavior; Sweet taste in mouth / Savory and vegetables taste sweet / Only sweet tastes normal; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Sweet taste in mouth / Savory and vegetables taste sweet / Only sweet tastes normal), CANDIDA INFECTION (Candidiasis) and NEOPLASM (Neoplasm of uncertain behavior) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Diabetes. Concomitant products included OMEPRAZOLE, AMLODIPINE BESILATE, ATORVASTATIN CALCIUM ANHYDROUS, CARVEDILOL, LEVOTHYROXINE SODIUM (LEVOTHYROXINE NA), MONTELUKAST, LOSARTAN, COLECALCIFEROL (CHOLECALCIFEROL TEVA), METFORMIN, IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE), BUDESONIDE;FORMOTEROL, FLUTICASONE PROPIONATE, IPRATROPIUM BROMIDE (IPRATROPIUM BR) and SILDENAFIL CITRATE for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced DYSGEUSIA (Sweet taste in mouth / Savory and vegetables taste sweet / Only sweet tastes normal). On 28-May-2021, the patient experienced NEOPLASM (Neoplasm of uncertain behavior). On an unknown date, the patient experienced CANDIDA INFECTION (Candidiasis). The patient was treated with DEXAMETHASONE on 22-Apr-2021 for Candidiasis, at a dose of Elx 0.5/5ml; NYSTATIN on 22-Apr-2021 for Candidiasis, at a dose of 450; FLUCONAZOLE on 05-May-2021 for Candidiasis, at a dose of 100 mg and GUAIFENESIN on 06-Apr-2021 for Sinus disorder, at a dose of 400 mg. At the time of the report, DYSGEUSIA (Sweet taste in mouth / Savory and vegetables taste sweet / Only sweet tastes normal) had not resolved and CANDIDA INFECTION (Candidiasis) and NEOPLASM (Neoplasm of uncertain behavior) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Chest X-ray: normal (normal) Normal. On 09-Apr-2021, Computerised tomogram thorax: normal (normal) Normal. On 30-Apr-2021, Colonoscopy: normal (normal) Normal. On 09-Jul-2021, Magnetic resonance imaging head: normal (normal) Normal.         Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up received contains significant information- Demographics updated, medical history was added, relevant test results, concomitant and treatment medications were provided. Outcome was updated and additional events added.
Immediately following admin of flu vaccine pt c/o feeling strange. Face flushed with temperature. Eye began to swell shut. Adrenaline .3mg given IM in thigh muscle. Much improved within 10 min states s/s decreased. Has had flu vaccine in past. No allergy to eggs.
allergy, like red little pimples started on the throat and spread to hands and legs; temperature; really strong headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergy, like red little pimples started on the throat and spread to hands and legs), PYREXIA (temperature), HEADACHE (really strong headache) and CHILLS (chills) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 010M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PYREXIA (temperature), HEADACHE (really strong headache) and CHILLS (chills). On 25-Mar-2021, the patient experienced HYPERSENSITIVITY (allergy, like red little pimples started on the throat and spread to hands and legs). At the time of the report, HYPERSENSITIVITY (allergy, like red little pimples started on the throat and spread to hands and legs), PYREXIA (temperature), HEADACHE (really strong headache) and CHILLS (chills) outcome was unknown.            This case was linked to MOD-2021-114337 (Patient Link).
fatigue; headache; nausea; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 10Apr2021 10:30 (Lot number: EW0151) at the age of 16 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "mild exercise-induced asthma" (unspecified if ongoing); "If covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: IRON; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: FATIGUE (non-serious) with onset 11Apr2021 12:00, outcome "not recovered", described as "fatigue"; HEADACHE (non-serious) with onset 11Apr2021 12:00, outcome "not recovered", described as "headache"; NAUSEA (non-serious) with onset 11Apr2021 12:00, outcome "not recovered", described as "nausea"; PAIN IN EXTREMITY (non-serious) with onset 11Apr2021 12:00, outcome "not recovered", described as "sore arm". The events "fatigue", "headache", "nausea" and "sore arm" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of fatigue, headache, nausea, pain in extremity.  Additional Information: Facility type vaccine was Pharmacy or Drug Store. There were no other vaccine in four weeks. Patient took other medications in two weeks was Multivitamin. If covid tested post vaccination was No, there was no known allergies.  No follow-up attempts are possible. No further information is expected.
short of breath taken to ED.  At home- Had aphasia after 1st dose for about 5 minutes. PCP said to get 2nd dose
5 minutes post vaccination patient stated he was weak and dizzy. NP helped patient to lay day. BP was found to be low. NP remained with the patient and his bp returned to normal 15 minutes after injection. He was monitored for another 15 minutes after recovery.
Information has been received from a physician concerning a 17 year old female who on 24-APR-2007 was vaccinated IM with a second dose of Gardasil (lot #656051/0244U). On 26-APR-2007, the patient was seen by her physician with complaints of a sore and "tingling" tongue. The physician reported that the patient stated she "may have had the tingling " before vaccination with Gardasil, although, "she wasn't sure." Upon physical examination, the patient's tongue was noted to be reddened with some raised papules, and subsequently, the patient was diagnosed with glossitis. The patient was administered viscous lidocaine and liquid Benadryl topically to the tongue, in order to decreased the irritation, and was instructed to contact the physician if the condition did not improve. The physician did not feel that the patient's glossitis was an allergic reaction, and reported that the patient will continue with the vaccination series. At the time of this report, the patient had not contacted the physician regarding the outcome of the glossitis and tingling was unknown. No additional information is expected. This is a consolidation of two reports concerning the same patient.
Presented to ED 11/26/21 and stated he recently got the first dose of the Pfizer vaccine two weeks ago. The patient states that he has a history of blood clots and pulmonary embolisms, so he states that he discussed this with his PCP. The patient was prescribed Xarelto for his condition prior to the first dose of the vaccine. The patient states that since the vaccine, the patient has been experiencing chest tightness, and pain in both his trunk and right lateral trunk. The patient states that he becomes quickly short of breath upon physical exertion, such as ambulating.  CTA and troponins negative. Patient discharged home.
9/29/09 - Diagnosed with Intussusception. Admitted to General Pediatric Surgery at hospital and had laparotomy. 8/9/10 - Second episode of intussusception required surgery and a lead point was resected.
This is a spontaneous report from a contactable physician communicated to a Pfizer sales male patient received PREVNAR 13 intramuscular, on an unspecified date in Aug2017, at 0.5 ml single, for immunization. Medical history and concomitant medications were not reported. Since an unspecified date in Aug2017 the patient experienced lightheadedness, weakness and dizziness lasting 2 to 3 minutes after the injection. The physician resolved it by having the patient laid down and giving fluids and a glucose tablet. The patient completely recovered from the events on an unspecified date in Aug2017. Sender's Comments: Linked Report(s): US-PFIZER INC-2017380860 same reporter/product/events, different patient.
Had fever up to 100.4; chills; body aches; This is a spontaneous report from a contactable physician. A 48-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular 09Jan2021 10:00 am in left arm at single dose for covid-19 immunisation. The patient medical history was not reported. The patient had no known allergies. There were no concomitant medications. The patient previously took the first dose of BNT162B2 for COVID-19 immunization. Facility type vaccine was in hospital. Other medications in two weeks was none. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The patient had fever up to 100.4, chills, body aches on 10Jan2021 09:00 AM.  No treatment was received for the events. Outcome of events were recovering.   Information on the batch/lot number has been requested.
side effect; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a medical assistant and describes the occurrence of VACCINATION COMPLICATION (side effect) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effect). At the time of the report, VACCINATION COMPLICATION (side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Numbness on left arm and left leg particularly hands most evident while sleeping or sitting at desk office.
Initial information received on 19-Jul-2018 regarding an unsolicited pregnancy valid non-serious case received from a nurse. This case involves a 33 years old female patient who experienced swelling and redness at the injection site, while she received vaccine ADACEL. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported occurred at unknown gestation period. The date of last menstrual period was reported as 8 Dec 2017. The estimated due date is 15-Sep-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient previously received ADACEL dose in 2014. On an unknown date, the patient received a booster dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine lot number not reported via subcutaneous route instead of intramuscular route, used ¾ needle. The patient developed a non-serious swelling and redness at the injection site (vaccination site inflammation) (Unknown latency) following the administration of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine. Patient did not have any fever or shortness of breath at this time. It is an actual medication error due to inappropriate route of vaccination. Other relevant tests included No lab data. Final diagnosis was swelling and redness at the injection site. Corrective treatment included ice pack treatment. The patient outcome is reported as Unknown for swelling and redness at the injection site. Additionally, at time of reporting, the pregnancy is still ongoing. 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. List of documents held by sender: none.
Delayed menstrual cycle. Typically have a 30 day cycle (very regularly for the past 5 years), following initial vaccine had 37 day cycle (Oligomenorrhea).  Currently waiting for my next period and am now 1 day late (unsure if this will be delayed as well at this point)
considerable itching, formation of one hive (2" x 1" x 1/4 ") located 4" below injection site. Hive went away after 2 days. Itching continued for 3 days.  Injection site very hot for 3 days.  Blood glucose elevated two days.  No treatment, just observation.,  Epinephrine on hand in case of greater reaction.
VAERS reporting as required by law, death occurred on 12/11/2021. Moderna COVID 19 vaccine completed on 1/19/2021, 2/17/2021, and 10/28/2021.
Information has been received from a licensed practical nurse concerning an approximately 23 week old patient who on approximately 20-NOV-2007 was inadvertantly vaccinated PO with the first 2.0 ml dose of RotaTeq (lot# 657511/0553U) at 4 months old. Medical attention was sought at the physician's office. There was no product quality complaint. Additional information has been requested.
FEVER; CHILLS; UPSET STOMACH; This case was reported by a pharmacist via other manufacturer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced fever, chills and upset stomach. On an unknown date, the outcome of the fever, chills and upset stomach were recovered/resolved.   It was unknown if the reporter considered the fever, chills and upset stomach to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. No other information available.
In the same arm of the injection, swelling (hardness), and redness, pain in the left arm that starts two days afer the shot.
red & swollen arm;large area for >24hr;ER notified & employee started on heat packs;