chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 10:12 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 10:06 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   administered on 27-Feb-2021 and 54.52 for dose administered on 27-Mar-2021. No concomitant medication was reported. Batch number 014M20A underwent temperature excursion on 27-Feb-2021 with temperature 35 degrees Fahrenheit from 01:00 PM to 02:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Batch number 019B21A underwent temperature excursion on 27-Mar-2021 with temperature 35 degrees Fahrenheit at 9:00 to10:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021. 15 vials were sent to clinic. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a  traceable temperature monitor at every hour. No treatment medication was reported.
Tested positive with coronavirus despite for completing 2 doses of Moderna Vaccine; Lack of efficacy; experienced a little sore on arm; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (experienced a little sore on arm), FATIGUE (felt tired), CORONAVIRUS TEST POSITIVE (Tested positive with coronavirus despite for completing 2 doses of Moderna Vaccine) and DRUG INEFFECTIVE (Lack of efficacy) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 040B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (experienced a little sore on arm) and FATIGUE (felt tired). On 27-Jul-2021, the patient experienced CORONAVIRUS TEST POSITIVE (Tested positive with coronavirus despite for completing 2 doses of Moderna Vaccine) and DRUG INEFFECTIVE (Lack of efficacy). At the time of the report, PAIN IN EXTREMITY (experienced a little sore on arm), FATIGUE (felt tired), CORONAVIRUS TEST POSITIVE (Tested positive with coronavirus despite for completing 2 doses of Moderna Vaccine) and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jul-2021, SARS-CoV-2 test: positive (Positive) Tested positive with Corona Virus despite for completing 2 doses of Moderna Vaccine.         No relevant concomitant medications provided.  No relevant treatment medication information provided.   This case was linked to MOD-2021-294138 (Patient Link).   Reporter did not allow further contact; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of Coronavirus test positive and mRNA-1273 is assessed as not applicable. For the events fatigue and pain in extremity, 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.
AT VACCINE SITE R ARM - REDNESS, SLIGHTLY SWOLLEN, TENDER. ALSO C/O H/A SINCE 1500 1/26/21. NOTED CHILLS 1/26/21 PM ALSO
at about 5pm pt started experiencing flu like symptoms and then at 04/14 broke out in a total body rash excluding the head and itching.
10/1/21 at 01:15 am left arm swollen and sore. 05:00 am headache, body aches, warm. 07:00 am cold and nauseated. by 08:00 am I was so cold my teeth were chattering. 11:00 am temperature 100.2. Started alternating between Tylenol and Ibuprofen. 09:00 pm fever was 100.5. Between the hours of 10:30 - 11:00 pm fever broke. Slept overnight. Woke up at 04:30 am body aches were going away. They were slight. Headache was light. Maybe due to not eating. 10/2/21 was slightly fatigued. All flu like symptoms gone except the arm injection site pain. Arm stayed swollen until 10/4/21. 10/5/21 arm still slightly sore. No swelling.
Patient felt sick in evening. Chills possible fever, vomiting, diarrhea. Next day ok but "felt weak as a kitten".
COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: 18-SEP-2021) dose was not reported (dose number in series 1), 01 in total, administered on 21-MAY-2021 at left arm for prophylactic vaccination. No adverse events were reported following administration of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1045021A expiry: unknown) dose was not reported (dose number in series 2), 01 in total, administered on 09-DEC-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient tested positive for Covid-19 (captured as COVID-19) at home (dose number in series 2). Laboratory data (dates unspecified) included: COVID-19 virus test was positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 test positive was not reported (dose number in series 2). This report was non-serious.
Catch the virus and have a mild case; This spontaneous case was reported by a consumer and describes the occurrence of VIRAL INFECTION (Catch the virus and have a mild case) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VIRAL INFECTION (Catch the virus and have a mild case). At the time of the report, VIRAL INFECTION (Catch the virus and have a mild case) outcome was unknown.            No concomitant medication reported.  No treatment medication reported.
Frontal headache, nausea, abdominal cramps, diarrhea.
After administration of TDAP pt experienced immediate strong headache followed by stress and impellent need to defects. No hypotension, no other associated symptoms, no incontinency, recovered with no meds in about 10 min.
Patient is a 71 y.o. male patient of MD with history of inclusion body myositis, CAD s/p PCI x 3, pacer in place, renal carcinoma s/p L nephrectomy, CKD, HTN, HLD,  presented to Hospital with weakness, nasal congestion.   Acute hypoxic respiratory failure-resolved Covid 19 Infection with URI Generalized weakness Date of onset of symptoms: 11/05 Symptoms present on admission: sore throat, nasal drip, weakness Date of covid positive test: 11/6 home, 11/7 MGH Vaccination status: vaccinated CXR no acute finding on admission new chest x-ray today indicates new airspace disease in left lower lung field without obscuration left costophrenic angle pleural effusion versus infection Medical therapy: Started Decadron and routine inhalers Anticipated special isolation end date:11/16 PT recommended 5 to 7 days per week of intense skilled therapy  Currently on room air, spo2>93%   Elevated troponin, likely from renal  HTN/ HLD Pacer in place  CAD s/p Lcx and LAD PCI, RCA CTO Denies any chest pain or SOB EKG paced, no ST changes Trop 150- 149 Cont ASA, statin, plavix, hydralazine, Imdur, coreg, amlodipine Low concern for ACS, possible chronic elevation of troponin due to CKD   AKI on CKD stage 3 S/p L nephrectomy for renal carcinoma Hyperkalemia: Cr 1.44, baseline variable 1.2 Creatine trending up, start with gently hydration and hold home PRN lasix Likely pre-renal in the setting of Covid  Avoid nephrotoxic agents, renally adjust meds as indicated  Strict I&Os, daily weights    Monitor renal function and electrolytes.  Creatine levels fluctuating, back to baseline 1.47 (11/14)  Encourage oral intake    DM controlled Hyperglycemia, likely from steroids SSI Last A1c 6.1 Monitor BG and ISS Added small dose of Lantus Inclusion body myositis Wheelchair bound Worsen weakness but able to move bed level PT/OT SW to assist on discharge needs    Chronic normocytic anemia Hb 10, baseline ~9 Monitor. Pt on iron and recent blood stool positive, but denies melena Possible anemia of CKD EGD from 04/26/2019, showed 1 nonbleeding crater duodenal ulcer with no stigmata of bleeding in the 1st portion of the duodenum measuring around 8 mm. There were some changes of chronic gastritis seen as well.  Colonoscopy 4/2019 showed many small and large amounts of diverticula in the sigmoid colon. Otherwise, the colon was normal, and no specimen was collected.  Stable hemoglobin 9.3 (11/14) No overt bleeding noted
Pt vaccinated with FLU experienced vomiting (forceful); Diarrhea.
Pt had 2 syncopal episodes at work early on morning of 1/26 (works overnight shift). He became weak, dizzy, flushed, a friend helped him to the ground and he said he was passed out nearly 20 minutes.  He was aware of surroundings but felt weak and couldn't respond.  Had second similar episode around 7 am after reaching home.   Came to clinic 10:30 am and was flushed and complaining of difficulty getting his breath and blurry vision.  had normal vitals and oxygen and no swelling of lips/tongue. He had some facial flushing.  He was alert and awake but weak and needed assistance walking.   It is not clear if this was related to vaccination of one or both of vaccines but patient had no prior history of syncope and no apparent other changes in routine or illnesses.
Pt was inadvertently administered third dose of Pfizer covid 19 vaccine earlier than 5 months after second dose. No side effects reported.
Patient received pneumococcal & influenza vaccine in left arm. Following evening injection site began to swell, redden & become warm. Progressed to become more widespread & painful over next 2 days.
This spontaneous report as received from a pharmacist refers to a patient of unknown gender between 60 and 65 years of age. It was reported that pharmacist got this information about 2 years ago. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose and Lot# not reported). On an unknown date, the patient experienced patient developed a rash on the patient's lower back. The outcome of a rash on the patient's lower back was unknown. The pharmacist declined VZVIP (Varicella Zoster Identification Program) packet sent for this patient. Causality assessment was not provided. This is one of several report from the same source. Additional information has been requested.
Day 1 after injection redness of arm and sore, with headache Day 4 after injection swelling of both tops of feet up to ankle, with dark red/purple coloration under skin (like bruising).  Not on toes, only top of feet and around ankle.  Felt hot like sunburn.  Some itching.  Subsided after 2 days. (by Day 7).   Day 5 after injection, very restless sleeping, tossing and turning.
Extensive cellulitis with erythema, induration from site of injection, upper arm to below elbow. Treated with Keflex.
Fatigue and slight arm pain started about 3hrs after the shot, which was at 6pm. Around 3:30am, I woke up with a strong headache, arm pain, and some body aches. I had a mild fever of 100. Over the course of the morning (until 8:45am), fever became higher (until over 101), body aches increased, pain at injection site remained, and nausea appeared. Headache was receding somewhat. I took a 200mg Advil at 8:45am.
Arm got red & hot, swelling occurred around whole arm. Firmness felt around whole upper arm. 9/18/11 swelling has subsided somewhat but arm still warm. Taking BENADRYL will contact MD.
GI reaction with spasms; GI reaction with spasms; bloating and uncomfortable like you over eat and have tight pants in; bloating and uncomfortable like you over eat and have tight pants in; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021 at 04:30PM in left arm at single dose for COVID-19 immunisation at the age of 57-year-old. Lot number was 59267-1000-01. Medical history included no gall bladder, ongoing bloating and uncomfortable like you over eat and have tight pants in on 11Jan2021 at 02:00PM. Patient was not pregnant. Past drug history included allergy to codeine. Concomitant medications included venlafaxine, verapamil, tocopherol (VITAMIN E), ascorbic acid, biotin, folic acid, iodine, pantothenic acid, pyridoxine hydrochloride, retinol, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc (CENTRUM), atenolol (ALTENOL), zopidem tartrate (ZOLPIDEM). On 11Jan2021 at 02:00PM (also reported: wishing 2 minutes, as reported), inside stomachs and gut, the patient felt it spread over that area (not warm, not painful, weird) and afterwards that night bloating and uncomfortable like you over eat and have tight pants in, then the next day (on 12Jan2021, also reported on 11Jan2021 at 02:00PM, as reported) she had a gastro-intestinal (GI) reaction with spasms that were very painful (something that happens very seldom and the patient was sitting at her desk working so no irritable factors) so she had to take strong meds because this GI spasm was very painful and hurt when you breath, so she took strong medication (hyosymin and mepitab). The patient recovered with lasting effects from abdominal distension, the patient recovered from other events.
rash started 19JUL93 low temp 19JUL93 PM on 20JUL93 @ 2AM pt awakened crying w/high temp (not checked) then started convuls (lips turned blue, eyes rolled back, mild jerking or arms lasted approx 3 mins followed by lethargy; taken to ER;
This spontaneous case was initially received on 19-Oct-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. The patient received AFLURIA on 16-Oct-2015, Batch no: U55106, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 16-Oct-2015, after starting treatment with AFLURIA the patient experienced Fever/Temperature of 101.8 degree F, and chills. Event treatment: Over the counter paracetamol. Reporter's assessment: The reporter considers events related to AFLURIA.
Swollen Left Axillary Lymph Nodes Left elbow pain Left arm weakness Severe headache  Cellulitis of injection site
Pt reported fever, chills, muscle and bone aches, an incredibly sore arm to the point she could not lift it, nausea and headache for about 24 hours. As of this morning, she is starting to feel better. She took ibuprofen with some relief.
This case was considered medically important for the event of encephalitis. Information regarding PREVNAR was received from a literature source. Regarding a participant in a study who experienced encephalitis that developed 41 days post-revaccination with PREVNAR, presumably due to herpes simplex virus. The participant received a dose on an unspecified date. On an unspecified date, the patient experienced encephalitis that developed 41 days post-revaccination with PREVNAR, presumably due herpes simplex virus. The author noted the patient was treated with acyclovir and the event of encephalitis improved. The assessments of the investigator(s) and medical monitor(s) for herpes simplex were unknown. The investigator(s) considered encephalitis possibly related to the study product. The medical monitor(s) assessment for encephalitis was unknown. No additional information was available at the time of this report.
This spontaneous case reported by a healthcare professional, describes the occurrence of administered expired product (expired doses administered to patients) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 041C21A) for COVID-19 immunization. No medical history reported. On Nov 5, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On Nov 5, 2021, patient administered expired product (expired doses administered to patients). On Nov 5, 2021, administered expired product (expired doses administered to patients) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Fullness under my armpit which is on the same side as the vaccine, which looks like swollen lymph nodes under my armpit/kind of benign; Generalized malaise low grade; Headache; Both eyes are very swollen; inflammatory prosthesis in my eye; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3247) via an unspecified route of administration at arm on 15Jan2021 11:00 at single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. Nurse stated that she just wanted to report what she thinks is adverse reaction to the Covid-19 vaccine from Pfizer not sure what to do about it at this point. She was vaccinated Friday 11 o'clock in the afternoon. Both days felt really fine. Last night (16Jan2021) got some fullness under her armpit which was on the same side as the vaccine, which looked like swollen lymph nodes under her armpit which you can see was kind of benign. But in addition to that some generalized malaise lowgrade and headache (Jan2021). Seems totally fine but her both eyes are very swollen (Jan2021). Nurse took some ibuprofen (ADVIL)-600 mg, she was taking Prednisone for inflammatory prosthesis in her eye as treatment (Jan2021). Outcome of the events was unknown.   The nurse considered the occurrence of the events are because of COVID-19 Vaccine.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Swollen eyes and Eye inflammation cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
pt recvd vax; exp significant local rxn w/in 24 hrs p/ vax;sxs included entire arm, redness & swelling, dec in range of motion w/ pain,fever,site hot to touch; tx w/ advil, ice & arm elevated;
Information regarding Flumist nasal solution was received from a healthcare professional regarding a 12 year old female patient who experienced high fever. At 12 years of age, the patient received vaccine. Relevant medical history was not provided. Indication for Flumist was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. The patient developed high fever within 24 hours of immunization. No additional information was available at the time of this report.
pt recvd vax @ 1130 am heart palpitations started @ 1145 am BP 100/70, P64, R20; hx of palpitations from 15 mins to 1 hr;
Pt reported being "Anxious about Janssen". Water provided , pt felt better and reported she wanted to go home.
Headache all day 24 hrs after receiving 2nd covid vaccine.  Lasted all day until bedtime.  Drank fluids and took tylenol to supress.
Tested positive for coronavirus and strep pneumonia. Turned into Bacterial Meningitis which led to multiple organ failure and spontaneous bacterial paratonalious. (Other complications unknown at this time due to still being in a medical coma.)
Redness, swelling, pain and tactile warmth at left arm injection site. Mother did not report until it had resolved, no Tx attempted.
intense dull, throbbing pain behind eyes; Light sensitivity; Loss of sleep; Headache; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (intense dull, throbbing pain behind eyes), PHOTOPHOBIA (Light sensitivity), INSOMNIA (Loss of sleep) and HEADACHE (Headache) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced EYE PAIN (intense dull, throbbing pain behind eyes), PHOTOPHOBIA (Light sensitivity), INSOMNIA (Loss of sleep) and HEADACHE (Headache). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, EYE PAIN (intense dull, throbbing pain behind eyes), PHOTOPHOBIA (Light sensitivity), INSOMNIA (Loss of sleep) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.