chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection was painful; usual sore shoulder; feeling tired; groggy; Caller received the Pfizer COVID-19 vaccine; he is afraid that the ingredients in the hand sanitizer entered the muscle through the skin; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as dose 3 (booster), single for covid-19 immunization. Patient had no relevant medical history. The patient concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, on an unspecified date and received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2, on an unspecified date for covid-19 immunization. The patient states that while he was waiting for the pharmacist to assemble and prepare the vaccine, the patient saw a jar of disinfecting alcohol wipes. The patient wiped both of his shoulders with the wipes. The sanitizer dried. Then the vaccine administrator rubbed the injection site area with an alcohol swab and gave him the injection. The patient specified that she did a light rub and gave the injection. The patient was afraid that the ingredients in the hand sanitizer entered the muscle through the skin. The patient mentioned that the ingredients that were found in the sanitizer besides alcohol were: aloe Vera juice, glycerin, a food thickener (which the patient was not sure of the name) and a few other things like vitamin E, an antioxidant. The patient was worried that they could had entered the muscle along with the needle. The patient would like to know if any of these ingredients would be in risk of interacting with the vaccine and affecting the effectiveness of it. The patient also mentioned that the injection was painful. There had been no problem, except usual sore shoulder, feeling tired, groggy. The patient stated that he was doing better today. The patient wants to know when the dosage of the booster shot was injected into the muscle and how long did it take to disperse in the blood. The patient received his booster dose and while the patient was waiting to get his booster dose the patient saw that there were hand sanitizer wipes (further clarification unknown hence, captured as Unspecified Product) and so, the patient thought the patient would wipe down his shoulder before receiving the vaccine and when the patient went to get the booster he did not think that hand sanitizer was dry all the way and so, the patient was wondering if some of the chemicals in that hand sanitizer could had gotten into the injection site from getting the booster and so, the patient was just wanting to know if there would be any interaction but because of this the patient wanted him to speak with Drug and safety first in case you have additional questions for him. The outcome of the events was unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This spontaneous report was received from a pharmacist regarding a male patient of unknown age with no pertinent medical history reported and no drug reactions or allergies. Approximately in September 2011, reported as "2 years ago", the patient was vaccinated with PNEUMOVAX23 (lot number and expiration date not reported) (dose and route not reported). No other suspect therapies or concomitant medications were reported. It was reported that the patient stated that on an unspecified date the injection site became very red and swollen, the patient was admitted at an unspecified hospital and was diagnosed with upper extremity cellulitis. The patient was given unspecified intravenous (IV) antibiotics and the infection "resolved rapidly, within a day or so", date of recovery not specified by the reporter. The pharmacist did not assess the causality between upper extremity cellulitis and PNEUMOVAX23. Additional information is not expected.
One hour after shot I felt like a piece of sand was in my eye, then felt like a sore on my Adam's apple, face became flushed, eyes bloodshot, and seeing in a fog, breathing became hard.
Redness, swelling, itching and rash on area of injection from belly to knee, lasting approx. 2 weeks, beginning the day after vaccination, at (2 &) 4 mo appointments. Also, screaming and irritable during 3+ days, immediately following each set of shots. The doctor denies relationship to vaccinations, calls it a "coincidence" . Absolutely impossible as this rash and other symptoms only occurred at exactly these times.
Painful lymph node on left side of her neck; Swollen lymph node on left side of her neck; Headache; Cannot lift her arm; Almost diarrhea; Chills; Nausea; Fever; Body aches; Pain immediately spread all over her left arm to the elbow; This spontaneous case was reported by a pharmacist and describes the occurrence of LIMB DISCOMFORT (Cannot lift her arm), DIARRHOEA (Almost diarrhea), LYMPH NODE PAIN (Painful lymph node on left side of her neck), PAIN (Pain immediately spread all over her left arm to the elbow) and HEADACHE (Headache) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in July 2020.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN (Pain immediately spread all over her left arm to the elbow). On 01-Apr-2021, the patient experienced LIMB DISCOMFORT (Cannot lift her arm), DIARRHOEA (Almost diarrhea), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea), PYREXIA (Fever) and MYALGIA (Body aches). On 02-Apr-2021, the patient experienced LYMPH NODE PAIN (Painful lymph node on left side of her neck) and LYMPHADENOPATHY (Swollen lymph node on left side of her neck). At the time of the report, LIMB DISCOMFORT (Cannot lift her arm), DIARRHOEA (Almost diarrhea), LYMPH NODE PAIN (Painful lymph node on left side of her neck), PAIN (Pain immediately spread all over her left arm to the elbow), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea), PYREXIA (Fever), MYALGIA (Body aches) and LYMPHADENOPATHY (Swollen lymph node on left side of her neck) was resolving.        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.   It was reported that patient was experiencing all the symptoms, just to a lesser degree at the time of this case report.  No relevant concomitant medications were reported.  No treatment information was provided.
Seizure requiring IV insert by paramedics after 8 minutes of rhythmic shaking of bilateral upper extremities and stiffening with unresponsiveness.
fatigue; pain in her arm; short of breath; throat feels closed up, a little sore, scratchy and horse; This is a spontaneous report from a contactable consumer or other non hcp. A 55-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on 21Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient had the first dose of the Pfizer Covid 19 vaccine on Sunday.  Sunday night she began having fatigue.  Monday she had pain in her arm that has now subsided. Late Tuesday into Wednesday she felt short of breath, throat feels closed up, a little sore, scratchy and horse.  Yesterday she felt fine and was able to go running. Outcome of the events fatigue, pain in extremity was unknown, for the events oropharyngeal discomfort, dyspnoea was recovered,   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Refridgeration excursions identified; No adverse event; Patient was administered vaccine which had undergone several temperature excursions; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2022 at 11:55 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 26-Sep-2022 at 11:55 AM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified).    No concomitant medications were reported.  The patient received previous 3 doses of Moderna vaccine as intramuscular injection in deltoid. Patient received the fourth dose of vaccine in deltoid muscle.  On 07-Sep-2022, the vials were initially moved from freezer to refrigerator.  The nurse reported that, Moderna Monovalent and Bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back in Aug-2022. It was reported that, refrigeration excursions were identified, and state vaccines were housed in these units. The manufactures were notified, and the state department made aware of the situation. The storage condition of vial at the time of excursion was in refrigerator. The vials were not visually inspected.  No adverse reactions had been reported for the patient as per the reporter's knowledge.  No treatment medications were reported.
patient felt fainting after vaccine ,was placed down on the floor and was awake until paramedics arrived and checked patient and started to feel better and left the store with a family member
Ulcerativa colitis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (Ulcerativa colitis) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COLITIS ULCERATIVE (Ulcerativa colitis) (seriousness criterion medically significant). At the time of the report, COLITIS ULCERATIVE (Ulcerativa colitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. It was reported that the patient asked if they have UCI, can they get the vaccine. No treatment information provided.  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.   Reporter did not allow further contact; 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.
lymph node was sore; reddish purlpe welt; This spontaneous report was received from a pharmacist and refers to a 45-year-old female patient. The patient's concurrent conditions included allergy to penicillin, fluconazole, metronidazole benzoate (FLAGYL) and minocycline. The patient's medical history and concomitant therapies were not reported.  On 23-MAR-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly, lot # S033516, expiry date 29-JUN-2021 (exact dose was not reported), indication was reported as asthmatic.  On 24-MAR-2020, the patient experienced a reddish purple "welt" near her bicep and her lymph node was sore. No treatment was given for the events.  The outcome of the events was reported as not recovered. The causality assessment was not reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
First dose was on 9Apr2021 and the second was on 26Apr2021; First dose was on 9Apr2021 and the second was on 26Apr2021; Feeling "a little sick and stuff"; Dizziness; Nasty taste in my mouth; Weakness; This is a spontaneous report from a contactable consumer. This male consumer (patient) of an unspecified age reported for himself that he received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration on 26Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes 1st dose of BNT162B2 for COVID-19 immunization on 9Apr2021. Caller reports that he received both dose of the Pfizer covid vaccine. First dose was on 9Apr2021 and the second was on 26Apr2021. Caller reports that the night he received his second dose around 19:00 he began having symptoms. Reports feeling "a little sick and stuff" with dizziness, a "nasty taste in my mouth" and weakness. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Abdomen and arms slightly blotched in appearance, red errythemia. Given 50mg liquid BENADRYL. 745p BP 100/60, P 88. 800p BP 109/60, P 100.
Went to Emergency Room - Extremely high blood pressure and heart rate, strong headache, chest pain etc . Brought down heart rate and blood pressure with medications,  chest pain reduced, performed chest x-ray,  nuclear treadmill with imaging following morning and released. Generally unexplained reasoning for elevated heart rate and blood pressure other than coincided with two vaccines administered late afternoon before. Patient developed chronic undiagnosed muscle and joint pain subsequently - possibly from Tdap reaction.
A non-serious spontaneous report of neck pain, glandular pain, lethargic, high fever, body aches, and child has been received from a consumer, patient's father, concerning a four year old male subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient received FLUMIST on 04 Nov 2009. The patient received a total of one dose of FLUMIST before onset of the event given on 04 Nov 2009. On 06 Nov 2009, the patient experienced neck pain, glandular pain, lethargic, high fever of 100.5, body aches, and chills. The patient was feeling better. Required follow up attempts have been performed, requested information unable to be obtained.  19-Feb-2010.
Vaccine administered past published expiration date. Contacted Moderna, received this communication: The vaccine administered on November 10, 2021 and November 15, 2021 from lot number 046C21A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration, therefore there is no need for revaccination.
Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized for COPD exacerbation. Vaccination took place on 1/7/2008 and hospital admission was on 2/5/2008. According to the physician, relationship to treatment is 'None'. We would be happy to forward the Study's SAE Report Form upon request.  5/19/2008 MR received for DOS 2/5-10/2008 with D/C DX:  Non-ST segment elevation Myocardial Infarction.  Acute on chronic respiratory failure.  Acute on chronic renal failure.  Atrial Fibrillation with rapid ventricular response.  Acute Bronchitis.  COPD.  Gastrointestinal bleeding.  Anemia.  Hyperlipidemia. Pt presented to ER with 2 day hx of cough and fever with worsening shortness of breath with diaphoresis. Pt also had diarrhea 1 day prior to ER visit. On admission, troponin was (+).  PE (+) for I&E wheezing and decreased breath sounds.  Pt developed atrial fib, GI bleeding, and acute on chronic renal failure during hospitalization: multi-system organ failure. Transferred to hospice on 2/10/08 per pt request. Pt expired on 2/11/08.
Gave Varicella #1 (L) arm on 3/5. Signif swelling, itching, rash of (L) arm x 3w. Took BENADRYL and creams with some relief. Resolved now except for bruising.
Symptoms were similar to a pulled muscle on the left side of back, and lasted approximately 10 days
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 16-OCT-2014, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). The vaccine was in excursion with a sum of hours of 72 and 40. The lowest recorded temperature was 28. The highest temperature recorded was 47. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
It was reported that an adult female received Imovax ID vaccine on July 27, 1999. Reportedly sometime after the vaccination the pt experienced a local reaction which consisted of redness, itching and vesicles around the ID site. From additional information received on August 5, 1999, it was reported that on July 28, 1999, 2 x 4mm of vesicles covered the injection site on pt left arm, was red and hot. Pt saw MD on July 29th, 1999. and was told will be okay. The pt reportedly recovered from this experience.
two patients received ADACEL Adult vaccine which was stored in a fridge that had a temperature excursion that reached 34 degrees Fahrenheit (or 1.11 degrees Celsius) over the weekend/ No AE; Initial information was received on 17-Aug-2021 regarding an unsolicited valid non-serious case received from an other health care professional via consumer under Global Medical Information Inquiry Number:00727607.  This case involves two patients with an unknown age and gender who were administered with a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] that was stored in a fridge that had a temperature excursion that reached 34 degrees Fahrenheit (or 1.11 degrees Celsius) over the weekend (product storage error).  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.   On an unknown date, the patients received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number: U6964AA and expiry date not provided via unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to incorrect product storage (latency: same day).  It was reported" We currently have ADACEL TDAP (DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE) Adult vaccine stored in a fridge that had a temperature excursion. The refrigerator reached 34 degrees Fahrenheit (or 1.11 degrees Celsius) over the weekend, we do not know when the excursion began. It was noted yesterday. The refrigerator has since been reset and is at it normal temperature of 40 degrees Fahrenheit (or 4.44 degrees Celsius). The vaccine was administered to two patients. We need to know if the vaccine was safe to use."  At the time of reporting, no adverse event was reported.  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.
Immediate popping in the ears approx. 15 minutes after injection, then brain fog with fatigue. .. Then the next day fatigue was increased and had to get in bed.  Also had a fullness in the ears. Then 2 days later there was headache, neck ache, nausea and vomiting. Unable to take anything by mouth. Heightened sensitivity to light and smells. Went to hospital on the 3rd day and was admitted. Blood pressure was extremely elevated at that time.  Discharged 3 days later.  Presently has dull ache in both ears and hears an echo. Hearing is slightly decreased. Affecting balance at present.
Severe abdominal cramping, nausea, fever, malaise, body aches, fatigue